indian Journal of Medical Ethics

Indian Journal of Medical Ethics Vol VII No 1 January - March 2010

Contents

Indian Journal of Medical Ethics Vol VII No 1, January-March 2010 (incorporating Issues in Medical Ethics, cumulative Vol XVIII No 1)

EDITORIALS Effective public-private partnership in healthcare: Apollo as a cautionary tale..................................................................................... 2 George Thomas, Suneeta Krishnan World trade, the poor and swine flu............................................................................................................................................................ 4 Bebe Loff COMMENTS Should the Bt Brinjal controversy concern healthcare professionals and bioethicists? ........................................................................ 9 Sridevi Seetharam Was the Gadchiroli trial ethical? Response from the principal investigator.......................................................................................... 12 Abhay Bang Impact of bioethics on patentability of inventions.................................................................................................................................. 14 Vishwas H Devaiah White coated corruption............................................................................................................................................................................ 18 Vijay Mahajan A farce called the National Board of Examinations.................................................................................................................................. 20 Suptendra Nath Sarbadhikari Diplomate of the National Board: inefficient parallel education............................................................................................................ 22 Murali Poduval Medicine, merit, money and caste: the complexity of medical education in India................................................................................ 25 Abhijit M Bal Financial incentives and the prescription of newer vaccines by doctors in India . ............................................................................... 28 Rakesh Lodha, Anurag Bhargava Vaccines: for whose benefit?...................................................................................................................................................................... 30 Yash Paul DEBATES Disability and the Medical Termination of Pregnancy Act, 1972............................................................................................................ 32 Divya Bhagianadh A legal precedent: reproductive rights of mentally retarded persons in India . ................................................................................... 34 Renu Addlakha Right to human dignity.............................................................................................................................................................................. 36 Ujjwala Mhatre Concerns around the human papilloma virus (HPV) vaccine.................................................................................................................. 38 Memorandum Cervical cancer screening and vaccination in India................................................................................................................................. 41 Surendra S Shastri The HPV vaccine demonstration projects: we should wait, watch and learn......................................................................................... 43 Mala Ramanathan, Joe Varghese Ethics in Ethics Committees Assessing the social value of research involving “minimal risks”: who is accountable?....................................................................... 46 Sunita Bandewar Process, pitfalls and probity: sharing experiences on setting up and running ethics committees in India........................................ 48 Anant Bhan, Prabha Desikan, S Swarnalakshmi, SP Kalantri Use of blanket consent for retrospective research in academic institutions: need for scrutiny and integrating safeguards......................................................................................................................................................... 51 Anant Bhan SELECTED SUMMARY HPV vaccines: separating real hope from drug company hype.............................................................................................................. 56 Gagandeep Kang REVIEWS Book review : An industry without borders.When experiments travel: clinical trials and the global search for human subjects, by Adriana Petryna ................................................................................................................................................... 58 Divya Pamnani Book review : How to catch a thief. Fraud and misconduct in biomedical research, edited by Frank Wells and Michael Farthing............................................................................................................................................. 59 Sanjay A Pai Film review : Medical emancipation. My sister’s keeper, directed by Nick Cassavetes........................................................................... 60 Mridu Markan FROM THE PRESS............................................................................................................................................................................................................................................6 Meeting Report.........................................................................................................................................................................................................................................54 FROM OTHER JOURNALS...........................................................................................................................................................................................................................61 LETTERS.......................................................................................................................................................................................................................................................... 64 FINANCIAL REPORT 2008-09....................................................................................................................................................................................................................65 ANNOUNCEMENT: NBC 3...........................................................................................................................................................................................................Back page Photograph courtesy: Parth Sanyal/Reuters/Scanpix

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Editorials

Effective public-private partnership in healthcare: Apollo as a cautionary tale George Thomas1, Suneeta Krishnan2 St Isabel’s Hospital,Oliver Road, Chennai 600 004 INDIA email: [email protected] 2Women’s Global Health Imperative, RTI International, San Francisco; University of California, Berkeley; 114 Sansome Street, Suite 500, San Francisco, CA 94104 USA email: [email protected]

1

Very few in the medical fraternity, if any, would have been surprised by the Delhi High Court panel finding that Apollo Indraprastha Hospital, New Delhi was not honouring its mandate to provide 33% of its beds free of charge to the poor and indigent. In 1986, the Delhi Administration invited proposals to establish a multidisciplinary, super speciality hospital on “a no profit no loss” basis. Two years later, the government leased prime property to the Apollo Hospital Group (AHG) on a token payment of one rupee a year, to set up the Indraprastha Hospital. The hospital is a joint venture with the Delhi government. By the terms of this agreement, the government provided 15 acres of land and Rs 16 crore. In return, the AHG agreed to provide free services to patients occupying at least one third of its 600 beds and to 40 per cent of those seeking outpatient care (1). A landmark public-private partnership (PPP) was thus embarked upon. A review of the terms of agreement clearly indicates that the expectation and agreement were not for the AHG to render “charity” or even to engage in corporate social responsibility. Rather, the Delhi Administration had established a legal obligation for the AHG to provide certain clearly specified services for its citizens in return for a substantial financial subsidy to the company. In practice, the AHG failed to provide any such service. The media image of Dr Prathap C Reddy, the founder of the AHG, which has been in large part carefully crafted by the Group itself, credits him with having brought modern multidisciplinary super specialty care (henceforth called high tech care) to India for the benefit of patients. Much media coverage has been focussed on the AHG as the pioneer and leader in high tech care in India. More worrying is the fact that policy makers hail the Apollo model as something to be emulated. For example, speaking at the launch of Apollo Reach, the venture by the AHG into small towns and rural areas, the prime minister, Dr Manmohan Singh, said: “Dr Prathap Reddy is a role model for many in the medical fraternity who aspire to emulate his example.” (2) Coming from a person who is not only the prime minister, but a noted economist, it may be read as a sign of government intentions for the medical care sector. In this article we argue that commercial, for-profit entities such as the AHG are primarily for the benefit of shareholders and cannot be effective partners in a public-private linkage to provide accessible, equitable care.

Evolution of public-private partnership in India In the 1980s, with an economic crisis facing India, there was a substantial increase in the utilisation of medical services in the private sector, with explicitly governmental support (3). The 1983 National Health Policy for the first time proposed to expand healthcare provision through the private sector. The Sixth Plan (1980-85) also suggested utilisation of the private sector. In 1986, the hospital sector was recognised as an industry, which meant that financing was available from public financial institutions. Customs duties on high technology medical equipment were reduced (3). What ensued was a rapid, unregulated, expansion of commercial medical services not only at the primary but also at the secondary and tertiary levels. Until this time the private sector was largely characterised by individual doctors or small groups of providers practising in nursing homes. These providers could not afford the capital cost for cutting edge technologies, which were found in government-run tertiary care centres (mostly medical college hospitals) or in the better endowed charitable trust hospitals. Under this scenario, at least in theory, specialised medical care was made available to all regardless of their socioeconomic position. Privatisation coincided with huge developments in medical technology. At the same time, governmental outlays for health were stagnant and even declined. Over the years, the government had reduced its expenditure on health and it had fallen from 3.30% in the mid-1950s to 1.80% by the beginning of 1980 (3). Public sector hospitals had insufficient funds to keep pace with technological advances. Private hospital enterprises like the AHG (followed by others like Max, Fortis and Wockhardt), entered the space. All have employed the strategy of lobbying the government for concessions, promising free or subsidised treatment for a percentage of patients - a promise unkept. For example, the twelfth report of the Public Accounts Committee 2004-2005 (Fourteenth Lok Sabha) which deals with allotment of land in Delhi at concessional rates to hospitals, observes, “Ultimately, what was started with a grand idea of benefiting the poor turned out to be a hunting ground for the rich in the garb of public charitable institutions.” (4) Simultaneously, government hospitals have seen an obvious decline in infrastructure, qualified personnel, and patronage of most sections of society - except perhaps the poorest. According to the National Sample Survey 60th round, more than 70% of expenditure on healthcare in India is met out of pocket.

Problems of privatisation The increasing concentration of high tech care in the private sector has also been accompanied by ethically questionable practices such as kickbacks to doctors referring patients for expensive investigations like computerised tomography (CT) scans. []


Although government medical colleges have ceased to be the last word in difficult medical problems and are limping on with rudimentary infrastructures, the quality of care provided by private hospitals such as Apollo remains unstudied. The AHG and others of its ilk ushered in an era dominated by the corporate hospital model, that is, a company whose business is medical care, whose stockholders profit from people’s illness. Given the motivations underlying for-profit provision of medical care, we do not believe that it was reasonable for the government to have expected the AHG to meet its obligations (5). Moreover, evidence has been accumulating on the adverse health impacts of medical care privatisation. By the 1990s, it was evident that health disparities were on the rise. The Working Group on Health Care Financing (6) states that paying for medical care is a cause of indebtedness in 3.3% of the population. By the time the National Health Policy of 2002 was drafted, it was apparent that 13 of the 17 goals articulated in the 1983 policy were unmet (7). Yet, remedial action on the part of the government was not forthcoming until very recently. The Qureshi Committee which insisted that the government enforce agreements with private sector providers was formed only in 2006 followed by the current judgment levying a fine on the AHG.

Healthcare delivery in India: the way forward There is no doubt that the public sector model of medical care as practised in India has not met the expectations of patients. The major reasons for this failure are cogently summarised in the National Health Mission document that provides a framework for implementation (8). They are: poor infrastructure, poor human resource planning, poor financial planning and excessive bureaucratisation. It is notable that both The National Rural Health Mission (8) and the draft National Health Bill 2009 (9) emphasise PPP for delivery of tertiary medical care. It is clear that utilising non-State abilities in delivery of healthcare can be a powerful tool. The question is how to properly use this tool. The Working Group on Health Financing lauds the success of PPP with SEWA in Gujarat, which has been developed and controlled by the people themselves (6). Other observers have also come to the conclusion that direct participation by the users themselves is a good way to ensure success in a public-private partnership (10). We argue that the AHG’s failure to meet its obligations to offer free and subsidised care is inevitable in a society where regulatory frameworks are poorly implemented, and a for-profit entity will do all it can to maximise profit. Regarding medical care, India is a country of tremendous disparities, where the wealthy have access to the most sophisticated treatment options, the poor die for want of basic ones. On the one hand, treatments that entail a recurring expenditure of over Rs 1 lakh a month are now easily available in all the metropolises. On the other hand, pregnant women still die for lack of access to basic surgical facilities. For the political class, these treatments are often provided free in return for favours granted or to be granted at the cost of the public exchequer, this is an important cause of the impunity with which the AHG has ignored its obligations. This kind of politician-industry nexus is unlikely to change in the near future, which is another argument against PPP of the Apollo kind.

Conclusion Considerable public action - from government as well as from civil society - is needed to make equitable provision of high tech care a reality in India. First is the need to regulate the expansion of the private sector. The role and nature of subsidies and PPP needs careful scrutiny. As noted by Muraleedharan and Nandaraj, “very clear incentives for businesses to make contributions” are needed in the context of PPP; that said, carefully designed and implemented PPP have - successfully improved access to care, reduced costs, and enhanced effectiveness of service provision (11). Second, substantial improvements in the enforcement of laws and regulations pertaining to the registration, licensing and accreditation of medical care practitioners and various types of medical care institutions are urgently needed. Rational expansion and establishment of medical care facilities is critical - ample data demonstrate the abundance of care providers in urban compared to rural areas. Third, there needs to be far greater attention to the quality of care provision. The drafting of the Indian Public Health Standards, the National Health Bill, the National Rural and Urban Health Missions are steps in the right direction. A concerted effort is needed to ensure that the challenge of equitable and fair access to medical care is addressed in India (12). The present system of providing the most rudimentary services in the government sector and leaving hightech care largely in the private sector is completely unjust, especially when public funds are used to subsidise private providers, as was done in the case of the AHG. Public-private partnerships can be an effective means of providing rational, affordable and comprehensive care to the entire population, provided that the private partners are chosen with care. Current evidence suggests that the best private partners are the not-for-profit entities like self-help groups. Instead of a misplaced enthusiasm for corporate bodies, the government would do well to heed the advice of its own creation, the National Rural Health Mission, and depend on them to take its stated agenda forward. Or else we will see the same drama played out, only too common in India - public subsidy, private profit. Acknowledgment: The authors are grateful to Amar Jesani for comments. References 1. Staff reporter. Court directs Apollo to provide free medicines to poor and needy patients. The Hindu [Internet]. 2009 Sep 23 [cited 2009 Dec 28]; New Delhi: [about 2p.]. Available from: http://www.thehindu.com/2009/09/23/stories/2009092354760400.htm 2. Prime Minister’s Office- speeches [Internet]. New Delhi: National Informatics Centre, Government of India. PM launches Apollo Reach Hospitals; 2008 Sep 5 [cited 2009 Dec 28]; [about 2 screens]. Available from: http://pmindia.nic.in/speech/content.asp?id=710 []


3. Lefebvre B. Bringing world class care to India: the rise of corporate hospitals. In: Vaguet A, editor. Indian Health Landscapes under Globalisation. New Delhi: Manohar and Centre de Sciences Humaines; 2009. 4. Public accounts committee, Ministry of urban development. Twelfth Report (2004-2005) Allotment of land to private hospitals and dispensaries by Delhi Development Authority. New Delhi [Internet]: Lok Sabha Secreteriat, Government of India; 2005 Apr[cited 2009 Dec 28]. 77p. Available from: http://164.100.24.208/ls/committeeR/PAC/12threp.pdf 5. Bhat R. Issues in Health. Public-private partnership. Econ Pol Wkly. 2000 Dec 30; 35 (52): 4706-16. 6. Ministry of health and family welfare. Report of the working group on health care financing including health insurance for the 11th five year plan [Internet]: Government of India; 2006 Oct [cited 2009 Dec 28]. Available from: http://planningcommission.nic.in/aboutus/committee/wrkgrp11/wg11_ rphfw3.pdf 7. Ministry of health and family welfare. Health Activities- National Health Policy 2002[Internet]: Government of India;[cited 2009 Dec 28]; 36p. Available from: http://mohfw.nic.in/np2002.htm 8. Ministry of health and family welfare. National Rural Health Mission- meeting people’s health needs in rural areas, frame work for implementation- 20052012 [Internet]. Government of India; [cited 2009 Dec 28]; 168p. Available from: http://www.mohfw.nic.in/NRHM/Documents/NRHM%20-%20Framewo rk%20for%20Implementation.pdf 9. National Rural Health Mission, Ministry of health and family welfare. The National Health Bill, 2009: working draft for feedback from public (proposed by Ministry of health and family welfare, Government of India) [Internet].Government of India.[cited 2009]. Available from: http://mohfw.nic.in/nrhm/ Draft_Health_Bill/General/Draft_National_Bill.pdf 10. Kumar G. Promoting public- private partnerships in health care. Econ Pol Wkly. 2003 Jul 19; 38 (29):3041-4. 11. Muraleedharan VR, Nandraj S. Private health care sector in India - policy challenges and options for partnership. In: Yazbeck AS, Peters DH, editors. Health policy research in South Asia: building capacity for reform. Washington D.C:The International Bank for Reconstruction and Development and The World Bank;2003. 12. Joe W, Mishra U S, Navaneetham K. Health inequality in India: evidence from NFHS 3. Econ Pol Wkly. 2008 Aug 2;43 (31): 41m-7

World trade, the poor and swine flu Bebe Loff Department of Human Rights and Bioethics, School of Public Health and Preventive Medicine, Monash University, Alfred Hospital Campus, Melbourne, Victoria 3004 AUSTRALIA email: [email protected]

In the last edition of this Journal Anant Phadke provided readers with the dreadful story of the death of Rida Sheikh from the H1N1 flu virus (1). Moving from this local and most concerning incident to the international arena reveals further matters worthy of consideration in the context of pandemic influenza. In 2005 the World Health Assembly adopted revised International Health Regulations. The purpose of these Regulations is to prevent the international spread of disease while avoiding unnecessary interference with international traffic and trade (2). According to the Regulations countries are obliged to develop certain minimum public health capacities for the detection, assessment and reporting of infectious disease outbreaks. Member States are urged to support developing countries in this regard. While it is unlikely that Member States will privilege the interests of developing countries, the question of what constitutes “unnecessary interference” with international traffic and trade and how this issue ought to be considered in the context of a threat to “global” public health seems not to have been the subject of conspicuous debate. Similar issues were of concern to the rulers of the European populus during the13th and 14th centuries. Their regulatory systems were directed towards limiting the impact of the plague on trade and controlling the rampaging poor once the rich had fled the confines of their cities. Armed militia were employed to put down rebellions of the poor and to stop them from pillaging the property left behind by the rich. Quarantine including house arrest was ordered. Plague victims and their carers could be sent to pest houses, hospitals such as there were, and monasteries. Schools were closed and religious assemblies banned. Goods thought to be contaminated were confiscated and destroyed. Travellers were banned. Cordons sanitaire were established and specified travel routes mandated. Information was exchanged between health authorities. In early 2009 the H1N1 flu virus was described as the heir to the so-called Spanish Flu that had led to the death of millions at the end of the First World War. That flu virus spread quickly and had been capable of causing death within 24 hours of otherwise healthy young men and women. Governments expressed concern over how this new flu pandemic was to be managed. On April 29, 2009, the New York Times reported Dr Michael T Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, as saying that closing borders is dangerous because many goods needed in a pandemic are made abroad. After making reference to masks, gowns and gloves, and the raw materials to make drugs, he continued, “Our global just-in-time economy means we are dependent on others.” Much of our food is from overseas. “A Kellogg’s Nutri-Grain bar has ingredients from nine countries in it.” On April 30, 2009 the Kellogg company and its subsidiaries reported a solid first quarter operating profit $529 million(3). While most of us could do without Nutri-Grain bars if the choice is between the bar and contracting the H1N1 flu, legitimate questions may be raised about the privileging of the current international trade regime and the extent to which developing states should be supported so that they might have available what is needed during periods of national emergency (and otherwise). In this context it seems industrialised countries would like to have their cake and eat it too, having constructed world trade law so that their domestic producers and manufacturers have unfettered access to international markets but evincing limited []


concern when the threat to health is faced by others and is accompanied by risks to export income. For example, World Trade Organisation members cannot agree to an amendment to the Agreement on Trade Related Intellectual Property Rights proposed in 2005 intended to improve global access to patented drugs. This amendment enables countries with the ability to manufacture patented drugs to export these products under a compulsory licence in order to protect public health in another country in the “event of national emergency or other circumstances of extreme urgency”. A number of stringent conditions must be met before such a licence can be relied upon. This being so there has been only one instance of reliance on this mechanism in the form of two shipments of drugs from Canada to Rwanda. The deadline for this amendment to be agreed by Member countries has now been extended by two years to 2011. Furthermore over the last couple of years generic drugs made in India intended for use in developing countries have been repeatedly seized in European ports. Customs officers have relied upon a European Commission regulation directed towards goods suspected of infringing intellectual property rights to support the seizures. India has argued that this regulation is inconsistent with the Agreement on Trade Related Intellectual Property Rights, yet it is unlikely to be repealed by the EC. India has asserted that the seizures have an adverse systemic impact on: (i) the principle of universal access to medicines, (ii) national public health budgets, (iii) legitimate trade of generic medicines, (iv) South-South commerce, (v) use of TRIPS flexibilities, and also (vi) seriously impair the efforts of civil society organisations engaged in providing medicines and improving public health in the least developed parts of the world (4). The failure to reach agreement on the international regulation of agricultural trade during the Doha Round because current rules gravely disadvantage developing countries further reinforces the notion that the protection of trade, as currently constructed, should be accorded less weight in the health/trade balance. An editorial in the Lancet quoted an estimate predicting that 96% of the deaths in the next global influenza pandemic would occur in low and middle income settings with displaced populations at particular risk (5).Sangeeta Shashikant of the Third World Network, which campaigns for better drug access for the poor, announced in a media release that “advance purchase agreements” for flu vaccines and other deals that secure medicines for wealthy governments could bleed the global supply chain of effective medicines. During an earlier outbreak of avian influenza, Indonesia sensibly stated that it would not provide its virus samples without an assurance that States unable to afford the vaccines developed in consequence of Indonesia’s assistance would be provided with them (6). Indonesia was subjected to international criticism for insisting upon this as a condition of its cooperation. The WHO Director-General has called for international solidarity to provide fair and equitable access to flu vaccines. WHO states that it has helped secure donations of about 200 million doses for 95 low and middle income countries and aims to provide these countries with enough vaccine to immunise at least 10% of their populations (7). However there is no doubt that geopolitical issues will figure in decisions regarding which countries are provided with assistance and by whom. There is also no doubt that the countries with most to fear are the countries who are least likely to receive the assistance they need, countries already dealing with AIDS, tuberculosis, pneumonia, malaria, diarrhoea and other diseases, the names of which those of us living in economically wealthier countries would not recognise. The distribution of disposable masks, a popular measure in some countries, is an unthinkable in countries where uniform access to clean water and soap is a distant dream. How is the most fundamental preventive measure of hand washing to be recommended in these circumstances? So while developed countries attempt to protect their export earnings and selectively decide which countries other than themselves might benefit from drug stockpiles and future vaccine development, little is done to strengthen the capacity of developing countries to detect, manage and treat outbreaks of infectious disease. This remains so even though it is very well known that diseases like influenza do not respect borders, especially in an age where international travel occurs with a frequency never imagined possible. While our pharmaceutical remedies may have improved, not much else has altered in the way that we deal with infectious plagues like pandemic influenza. The rich protect their interests while the poor are controlled. References 1. Phadke A. Response to an epidemic of novel H1N1 flu in Pune: need for introspection. Indian J Med Ethics [Internet]. 2009 Oct-Dec [cited 2009 Nov 24];6(4). 176-8. Available from: http://www.ijme.in/174ed176.html 2. World Health Organisation. International Health Regulations [Internet]. Geneva: WHO;2005[cited 2009 Nov 24]. 82p. Available from: http://whqlibdoc. who.int/publications/2008/9789241580410_eng.pdf 3. McNeil DG Jr. Containing flu is not feasible, specialists say. The New York Times [Internet]. 2009 Apr 29[cited 2009 Nov 25]: Sect. A: 1. Available from: http:// www.nytimes.com/2009/04/30/health/30contain.html 4. Third World Network. TRIPS council takes up public health, TRIPS/CBD, drug seizure issues. TWN Info Service on WTO and Trade Issues[Internet].2009 Nov 4[cited 2009 Nov 25]; about 4 screens. Available from: http://www.twnside.org.sg/title2/wto.info/2009/twninfo20091104.htm 5. Swine influenza: how much of a global threat? Lancet. 2009 May 2;373(9674):1495. 6. Reuters. Developing nations could face flu drug shortages. TWN Info Service on Intellectual Property Issues [Internet]. 2009 Apr 30 [cited 2009 Nov 25]; about 2 screens. Available from: http://www.twnside.org.sg/title2/intellectual_property/info.service/2009/twn.ipr.info.090403.htm 7. World Health Organisation [Internet]. Geneva: WHO; c2009. Global alert and response- Production and availability of pandemic (H1N1) 2009 vaccines; 2009 Oct 30 [cited 2009 Nov 25]; 2p. Available from: http://www.who.int/csr/disease/swineflu/frequently_asked_questions/vaccine_preparedness/ production_availability/en/index.html []


from the press

Delhi hospitals to be made user friendly

health institutions is deplorable. There is an urgent need to address the issue of rehabilitation of people who have been in such homes for a very long time.”

Existing advisory committees in Delhi hospitals may soon be replaced by more user-friendly Rogi Kalyan Samitis run by the government. All hospitals, including maternity homes, will have a Rogi Kalyan Samiti. These Samitis will ensure community participation in healthcare and monitor the utilisation of funds allotted to these healthcare institutions. This system put in place by the Delhi government, as part of its moves to improve healthcare institutions and make them accessible to the poor, will also check if public health standards are met.

There is also a need to move beyond custodial confinement of mentally ill people to care and treatment that allows them to become a part of society. The NHRC has also voiced the need for providing mental health care to villages. It has been organising meetings on mental health, involving nongovernmental organisations and mental hospital authorities. National Human Rights Commission, Delhi. Human Rights Newsletter, Vol 16, No. 9, September 2009. http://nhrc.nic. in/Documents/NewsLetter/SEPTEMBER2009_ISSUE.pdf Indo-Asian News Service, MBBS students should have separate paper on mental health: NHRC. Hindustan Times, October 19, 2009

A state-level Rogi Kalyan Samiti cell will coordinate and monitor the administrative functions of all the Samitis. Every Samiti will have a maximum of 11 members, with a member of the legislative assembly as chair, a senior government officer as vice-chair, and the hospital medical superintendent as secretary.

WMA meeting, 2009

Special correspondent. Rogi Kalyan Samitis for better health care in Delhi. The Hindu, October 5, 2009.

The World Medical Association (WMA) meeting, held in New Delhi in October, expressed concern about the medical profession’s involuntary involvement in torture. It noted, for example, that in Iran, doctors have been forced to support inaccurate clinical documentation. Those who have examined bodies bearing evidence of physical torture and sexual abuse have had to remain silent.

Confidential medical records leaked A television documentary exposing the sale of private medical records has caused a furore in the UK. A journalist posed as a marketing executive seeking patient information for promotional purposes. He bought 116 files containing detailed medical records from two people who claimed to work at a medical transcription centre in India where medical records were outsourced from the UK to be digitised.

Dr Otmar Kloiber, secretary general of the WMA, said, “We are very concerned about the rights of patients and physicians in Iran and wanted to send out a strong signal with this motion.” The WMA comprises national medical associations of 95 countries. Iran is not among the 95 member countries.

Data leaks, however, are not new to the UK. Neither do they occur only during outsourcing. The National Health Service itself has lost thousands of medical records. Passwords of confidential health data have been carelessly left on the same storage device. Hard disks have been discarded without erasing the stored data. According to the assistant information commissioner, “Medical history is very sensitive personal data, which is likely to cause harm or distress. The law dictates they must keep this information confidential, but the NHS is by far the biggest offender within the public sector.”

The 183rd /184th Annual General Assembly of the WMA also commented on the practice of pharmaceutical companies giving doctors gifts. When these companies fund medical conferences and research, they are likely to set the agenda in these areas. The meeting called for increased transparency on this subject. If gifts could not be stopped, they could at least be made public. The WMA can only draw up guidelines but cannot enforce them. However, such guidelines encourage medical associations to promote behaviour in keeping with the recommendations of WMA.

Anonymous. Thousands of NHS medical records lost. The Telegraph, May 25, 2009. Jo Macfarlane. Private medical records for sale: Harley Street clinic patients’ files outsourced for computer input - and end up on black market. The Daily Mail, October 18, 2009.

Jacqui Wise. World Medical Association calls on Iran to respect medical ethics code. BMJ, October 20, 2009. Times News Network. Docs told to avoid gifts from drug firms. The Times of India, November 2, 2009.

Need for mental health care training: NHRC The National Human Rights Commission has voiced the need for a compulsory paper on mental health, at the MBBS level. There is a severe shortage of mental healthcare professionals, and of research and institutions in mental health. P C Sharma of the NHRC noted: “The condition in most state-run mental

No palliative care for the dying in India The terminally ill in India are let down by the healthcare system in more ways than one. A Human Rights Watch report reveals []


how terminally ill people whose main need of the hour is palliative care do not receive any. India is the world’s largest producer of opium, which is used to manufacture morphine. Yet many people in India suffer as most of this opium is exported.

commemorating a private hospital’s services and has raised questions given that Apollo has made it to the news or other reasons as well. Not too long ago, Apollo − along with other private hospitals like the Rajiv Gandhi Cancer Institute and VIMHANS − was pulled up by the Delhi government for violating its agreement with the government. Under this agreement, private hospitals are given land at concessional rates in exchange for providing free services to poor and needy patients. However, this clause is more often flouted than respected. When Yogi Mehrotra of Delhi’s Apollo Indraprastha was asked why the agreement was violated, he said, “We signed the agreement with the government but realised the difficulties only later.”

The Human Rights Watch report states that the problem of palliative care has more to do with state policy than drug availability. The government has allotted funds for cancer control but not for palliative care. “This is despite the fact that more than 70 percent of (cancer) patients are incurable and likely to require pain treatment and palliative care,” noted the lead researcher, Diederik Lohman. The situation is further worsened by narcotics regulation, which makes it difficult for pharmacies to acquire morphine.

Apollo hospitals had earlier come under the scanner in 2003.

Even the largest of cancer hospitals does not have trained health workers who can administer palliative care. There is a need to focus on training doctors to administer palliative care as well as allocating adequate funds for it. Given that 70% of the patients seen at cancer hospitals are beyond cure, and the only option that remains is providing them with palliative care, a failure to meet this need of theirs can cause them endless suffering.

The deputy chief minister of Tamil Nadu, M K Stalin, who was present at the function applauded the involvement of Apollo Hospitals with Tamil Nadu state development programmes. The stamp, he said, was a token of appreciation. He added, “Tamil Nadu is proud of its Apollo Hospitals. There was a time when the country’s most talented moved abroad and Apollo Hospitals was one of the biggest reasons for the situation to change because of its superior healthcare services.”

Peter Moszynski. Lack of palliative care causes unnecessary suffering for India’s terminally ill people. BMJ, October 31, 2009.

Special correspondent. Special stamp on Apollo Hospitals released. The Hindu, November 3, 2009. Soumya Viswanathan, Sapna Dogra. Free treatment clause is ambiguous, say hospitals. Express Health Care Management, August 15-31, 2003.

Sex determination out in a Mumbai nursing home Two doctors from Mumbai have been sentenced to three years’ imprisonment for violation of the Pre-Conception & Pre-Natal Diagnostic Techniques (prohibition of sex selection) Act of 2003. Dr Shubhangi Adkar and Dr Chaaya Tated of Shree Maternity Nursing Home, Dadar, were found guilty of conducting sex determination tests. The judge ruled against adopting a lenient stand towards these doctors and each has been fined Rs 10,000 per violation proved. This, along with the three year sentence, is the strictest possible punishment for violating the PNDT Act, 2003. The doctors violated the norms regarding advertising ultrasound equipment, especially with regard to sex determination during pregnancy.

Obama lifts entry ban on HIV positive travellers In the US, President Barack Obama announced that the long-standing ban on the entry of HIV positive travellers will be lifted effective early 2010. He made the announcement when signing a bill to extend the Ryan White HIV/AIDS programme, a government-funded treatment service for people with HIV/AIDS. The ban, which was put in place in 1990, not only had no grounding in public health, but also was a violation of basic human rights.

An inquiry into an advertisement in a magazine promising the couple a baby boy led to a case being filed by a BMC officer against the nursing home in November 2004. The doctors have been made to pay a fine of Rs 30,000 each and have been on bail since the case began five years ago and continue to be on bail even after their conviction.

The Associated Press. Obama to lift U.S. entry ban for those with HIV. MSNBC, October 30, 2009.

Tracing abandoned babies An application under the Right to Information Act brought to light the lack of documentation of details regarding abandoned infants. The application, filed by Rajmangal Prasad, a social worker, sought details about abandoned infants at Babasaheb Ambedkar where they were sent and how many of them were handed over to the Delhi Council for Child Welfare.

Swati Deshpande. Two docs in city get 3-yr jail for pre-natal sex tests. The Times of India, November 2, 2009.

Apollo Hospital commemorated by a postal stamp Apollo Hospital has been commemorated by a Rs 5 postal stamp. The stamp was presented to Prathap C Reddy, founder and executive chairman of the Apollo Hospitals Group, by A Raja, union minister for communications and information technology, in Chennai on November 2. It is the first stamp

While taking action on the application, the Information commissioner, Shailesh Gandhi, found that the hospital did not have documentation that would help trace the infants. This lapse, if not remedied, can lead to trafficking in infants. Though []


some of the infants about whom the appellant had enquired could be traced, there was no system of documentation. The RTI application has led to efforts being made to put such a system in place.

travel or money, either in their own name or in the name of their family members. Research grants from the industry will be allowed provided that the source of funding and any conditions for this funding are declared. The modified code also mentions a number of requirements such as obtaining ethics committee clearances. Doctors and their associations are not permitted to endorse drugs or any other healthcare product.

Press Trust of India. Serious lapse at Delhi hospital in handling abandoned babies. Hindustan Times, October 2, 2009.

Aruna’s story and the right to live with dignity The much publicised story of Aruna Shanbaug, a nurse at the KEM hospital in Mumbai, who was raped and strangulated by a ward boy in November 1973, is in the news again. The Supreme Court has received a request for permission to allow Ms Shanbaug to die by stopping nutritional support. The plea has been made by a journalist, Ms Pinki Virani, who has moved the court on Aruna’s behalf.

Deccan Herald News Service. MCI sharpens ethics code for doctors. Deccan Herald, January 1, 2010.

3.5 year long course for rural doctors The health ministry along with the Medical Council of India (MCI) is planning a 3.5 year long course of Bachelor of Rural Medicine and Surgery (BRMS). While this is done with the express purpose of remedying the shortage of doctors in rural areas, as doctors from other (largely urban) areas are not willing to practise in villages, it will also provide students from rural areas an opportunity to study medicine.

Since she was assaulted, Ms Shanbaug has been lying in a vegetative state in the KEM hospital where she is cared for by the hospital’s nurses. Her doctors have declared that there is no scope for improvement in her condition. A Supreme Court bench comprising K G Balakrishnan, A K Ganguly and B S Chauhan has asked if Ms Virani’s request is any different from a request for euthanasia.

According to the scheme, “(s)election of students would be based on merit in the 10+2 examination with physics, chemistry and biology as subjects. A student who has had his entire schooling in a rural area with a population not more than 10,000 would be eligible for selection.” (The MCI will also ensure that these BRMS students are registered with the MCI, thereby including them in the mainstream.) Dr Ketan Desai, director of the MCI, has stated that the scheme will be finalised by March 2010.

The hospital’s dean, Sanjay Oak, has stated “(w)e have no moral right to terminate her life. I am hopeful that the Supreme Court will also pass a judgment against euthanasia.” Dr Oak has added that Ms Shanbaug is well taken care of at the hospital where she shares a special bond with the nurses who take care of her. Shekhar Naphade, Ms Shanbaug’s counsel, has asked: “Is not keeping the woman in this persistent vegetative state by force feeding violative of her right to live with dignity as guaranteed by Article 21 (right to life) of the Constitution?”

The new scheme follows a public interest litigation filed by Dr Meenakshi Gautam in the High Court that sought to get the MCI to decriminalise the practice of medicine by nonMBBS holders. This was seen as necessary if rural health Dhananjay Mahapatra. SC admits woman’s plea to end life. Paralysed after sexual assault in 1973, nurse says stop workers and middle level healthcare providers were to be force-feeding. Times of India, December 17, 2009. Jinal able to prescribe scheduled drugs, which at present can be Shah. Against mercy death, KEM remembers Aruna as she done only by MBBS doctors. The current situation deprives was. Indian Express, December 18, 2009 the majority of the poor from access to healthcare by accredited providers.

MCI ethics code to be more stringent

Dhananjay Mahapatra . Medical degree in 3.5-years for rural docs. Times of India, December 30, 2009.

The Medical Council of India has modified the Indian Medical Council Regulations, 2002, its voluntary code of ethics concerning issues of professional conduct, etiquette and ethics. The modified code, published on January 8, 2010, forbids doctors from accepting gifts in any kind, whether hospitality,

Compiled by Supriya Bandekar email : [email protected]

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COMMENTs

Should the Bt Brinjal controversy concern healthcare professionals and bioethicists? Sridevi Seetharam Swami Vivekananda Youth Movement, Saragur, H D Kote Taluk, Mysore District 571 121 INDIA email: [email protected]

Abstract

well as the interpretation of biosafety tests. The GEAC’s decision needs to be ratified by the minister of state for environment and forests, Jairam Ramesh, before it becomes policy. Mr Ramesh announced that a series of consultations with scientists, agricultural experts, farmers’ organisations, consumer groups and non-governmental organisations would be held in January and February 2010 before a final decision is taken in March 2010 (4). It is unclear whether healthcare professionals will also have a voice in these consultations.

The Genetic Engineering Approval Committee’s approval of Bt brinjal, the first genetically modified crop for human consumption in India, has sparked off protests across the country. This article questions the so-called benefits of GM crops and highlights some major concerns. These include: inadequately addressed health and environmental risks, inadequate safety guidelines, a lack of transparency in sharing test data, the implications to seed sovereignty of farmers and the lack of informed choice for consumers. Some concerns about field testing by Mahyco, the developer of Bt-brinjal, and the process of evaluation by GEAC remain unresolved. With inadequate information about the crop’s long-term safety, a precautionary approach is advocated before national policy allows commercial release of the seeds. A fair process is also needed in the public consultations being proposed by the minister of state for environment and forests. In addition to issues of procedural justice, a basic ethical question remains: do humans have a right to dominate the land and make expendable those creatures that they deem “undesirable”?

The ethics of gene manipulations in the animal and human reproductive sciences, their clinical applications, and the impact on people’s aspirations and life choices have been debated extensively by the healthcare professions. Genetic interventions in the food that we eat also affect our health, aspirations and life choices. As a healthcare professional concerned with bioethics, I decided to explore this controversy. Numerous and diverse issues emerged as I explored.

Why GM foods? GM foods have been projected as a solution to world hunger, crop failures and farmer suicides. GM foods are promoted with the claim that they increase yields and reduce pesticide use, which benefits farmers, consumers and the environment (5).

On October 15, 2009, the Genetic Engineering Approval Committee (GEAC) of the ministry of environment, the regulatory body for approving genetically modified crops (GM crops) in India, approved Bt brinjal, the first GM crop for human consumption in India, for commercial use (1,2). The approval came following the review of reports submitted by the Maharashstra Hybrid Seeds Company Limited (Mahyco), the Indian subsidiary of the US-based company Monsanto, that uses biotechnology to produce high yielding, pest resistant crops. The Tamil Nadu Agriculture University and the University of Agricultural Sciences, Dharwad, were partners of Mahyco in the development of Bt brinjal.

Indeed, many studies demonstrate that GM crops like Bt maize and Bt cotton produce higher yields (6,7). However, it has been argued that such claims are blown out of proportion as the Bt toxin is basically an insecticide, and insecticides cannot increase yields, only reduce losses. It has also been argued that farmers have shown equal or greater yields with high-yielding native (non-GM) seeds and a careful planning of the season and location for planting (8). GM crops cannot even claim to address world hunger, which is due not to a lack of food, but to the fact that the poor do not have buying power. Finally, US studies indicate that pesticide consumption is low only in the first three years, after which its use has actually increased by about 4.1% in farms with GE varieties (9,10).

Bt Brinjal is a genetically modified plant in which a gene from the soil bacterium bacillus thuringensis is inserted into the genome of the brinjal, which can then produce a protein, Cry1Ac. This protein behaves as a toxin against the shoot and fruit borer (SFB), a pest that commonly affects brinjal. The gene modification also includes the addition of two antibiotic resistance marker genes.

What are the concerns about GM food? A number of concerns regarding GM foods have been inadequately addressed: the risk that they pose to people’s health and the environment, the inadequate guidelines for assessing safety, the lack of transparency in sharing data related to safety testing, the implications for farmers’ seed sovereignty, and the lack of informed choice for consumers.

Some media reports have been upbeat about the GEAC’s approval (3), but the decision also sparked off protests. Environmental and health concerns were cited that extend to other GM crops in the pipeline like GM tomatoes, GM potatoes, GM cabbage, etc. Doubts have been raised about the science used in the technology as []


Any gene manipulation involving the insertion of foreign DNA sequences into a plant genome can cause disruption, silencing or modification of the expression of existing genes. Some effects may be anticipated. Others may come as a complete surprise (11). It is worrisome that Mahyco has overlooked public communication about the potential risks in this technology.

The safety assessments done so far cannot exclude the possibility that humans may develop resistance to antibiotics, allergies or biochemical abnormalities due to the toxin. A number of reputed scientists have expressed concerns about GM foods (22). Jeffrey M Smith’s Genetic Roulette (23) has a long, fully referenced list of the health risks of genetically engineered foods.

Risks to health and the environment Mahyco plans to extend Bt brinjal to nearly 50% of the acreage under brinjal cultivation in India (5). Environmental activists and farmers are concerned that gene migration can result in contamination of other crops; resistance can develop to the Bt toxin, which would result in an increased use of pesticides; soil may get contaminated with this increased pesticide use, and weeds resistant to the Bt toxin may emerge (12). Since 2002, three public interest litigations have been filed seeking a moratorium on GM crops (13). Mahyco’s strategies for resistance management, submitted to the GEAC, are vague and not reassuring (14). The gene transfer in Bt brinjal involves two antibiotic resistance marker genes for resistance to Kanamycin and Streptomycin. These are important drugs among the very few that we have in our armamentarium against tuberculosis. Mahyco states that these genes need a bacterial promoter for their expression, which would not be present in Bt brinjal (13). However there is a possibility that these genes can spread to other pathogenic bacteria by horizontal gene transfer and become active (15,16). Some media reports record allergic symptoms and toxic reactions in both humans and animals after exposure to Bt cotton (17,18). Laboratory studies also show that the Bt protein has immunogenic and adjuvant capacities (19). The testing requirements for GM crops are more lax than those for drugs. Drug trials are conducted in five stages, with the first stage, known as pre-clinical studies, involving only animals. Safety and efficacy issues in humans are addressed in the remaining phases (20). Government guidelines (21) for research in transgenic seeds or plants only require toxicity (with testing periods of 14 to 90 days) and allergenicity tests (with testing periods of 14-37 days). It is surprising that regulations for a product meant predominantly for human consumption do not insist on human trials. Though the guidelines state that information related to toxicity and allergenicity to both humans and animals must be generated by the developer (18), Mahyco’s toxicology studies have been performed only on animals and are therefore equivalent only to the pre-clinical studies that are prescribed for drug trials. Save a test that demonstrates that the toxin is undetectable within one minute of cooking, there are no other tests that demonstrate the safety of Bt brinjal for human consumption. It must be noted that Bt tomatoes and Bt cabbage (currently under development) would often be eaten raw. It is estimated that a kilogramme of Bt brinjal would contain 5-47 mg of the toxin, 100 times the minimum inhibitory concentration (MIC95) for the pest larvae (13).

Was there research misconduct? Some science organisations have alleged that appraisals of the Mahyco-Mosanto safety dossiers by independent scientists indicate that there has been incomplete disclosure regarding the bio-safety test results (24, 25). A French scientist, GillesEric Seralini of the Committee for Independent Research and Information on Genetic Engineering, reviewed the safety dossiers. He discovered that safety tests found significant differences between GM and non-GM brinjal. But these differences were deemed biologically irrelevant and not investigated further. Seralini has also stated that some of the testing protocols are inadequate or invalid (22).

Was there conflict of interest? Several NGOs had opposed the GEAC decision, in 2006, to appoint Deepak Pental, vice-chancellor of Delhi University, as chairperson of the 13-member expert committee on Bt brinjal (26). He was a known promoter of GM crops, he was working on GM mustard and his university was undertaking the same system of biosafety testing followed for Bt brinjal; the committee’s recommendations would have a bearing on his own project. Also, at least three other members of the committee were actively involved in testing and developing other GM crops or were associated with biotech companies (27, 28). These commercial interests may have compromised the approval process. A second expert committee (EC II) was constituted by the GEAC in January 2009 and submitted its report to GEAC on October 8, 2009 (29). The GEAC’s approval took only six days and was not unanimous. Three members are reported to have expressed concerns and did not want the approval to be passed (1). Pushpa Bhargava, the only independent expert on the GEAC, a special invitee due to a Supreme Court ruling, is reported to have said that the safety assessment was not complete and noted that the regulators had not asked for an independent validation of any of the test reports submitted by Mahyco. However, his views were not supported by the GEAC.

Implications for farmers’ seed sovereignty Bt brinjal was developed by transforming the brinjal proprietary line of Mahyco, which will therefore own all Bt brinjal seeds. The company is awaiting a patent for its technology (5). Seeds for GM crops have to be bought from Mahyco and their franchisees, at the price set by them, which is a threat to the seed sovereignty of Indian farmers. The high seed cost will surely outweigh any advantage of reduced pesticide use. Farmers in Andhra Pradesh have already protested against

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the exorbitantly high price levied for Bt cotton seeds (30) -- Rs 1,800-2,000 for 450 gm of Bt seeds, compared to Rs 450 for non Bt hybrid seeds. This amount includes Rs 1,200 as royalty to Monsanto. This is a major concern, given the credit constraints of Indian farmers.

commenting and holding hearings in an empowering spirit. Civil society organisations too have an important responsibility to participate actively in the consultations and ensure that India’s policy on Bt brinjal encompasses economic concerns, environmental health, people’s health and choices.

Bt cotton hybrids require more water than the traditional varieties (31). In a predominantly rain-fed agrarian economy, high water requirements may destroy many GM crops as well as deplete already scarce ground water sources.

References

Implications for people’s informed choices Currently, there are no procedures to ensure that GM foods are labeled as such. When these foods are put on the market, people who would like to avoid GM food cannot exercise their informed choice.

Is there a need for precaution? Genetic technology in the food industry has uncovered many exciting possibilities, but we must ensure that they are indeed safe and will not spring any surprises in future. We must pay heed to past lessons. DDT pesticide, promising in its early days, is now viewed as a major environmental pollutant and the UN is now considering banning it (32). The much hailed Green Revolution has caused irreparable damage in some regions (12). Since GM seeds will be released widely for agriculture, it is important to consider their effects on the integrity of complicated ecosystems and delicate biospheres. It may actually be impossible to reverse the changes that will occur in the environment. India is a party to the Convention of Biological diversity (33) and the Cartagena Protocol on Biosafety (34). The Protocol is based on the Precautionary Principle which states that “When an activity raises threats of harm to human health or environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.” The Protocol also states: “Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk;”. The brinjal is an indigenous Indian crop with maximum genetic diversity. The Cartagena Protocol calls for extreme caution in introducing GM crops to countries which are the centres of origin for the non-GM varieties of those crops. In view of the seemingly irreconcilable concerns about the biosafety of Bt brinjal, would there not be justification to plead for a more precautionary approach? In addition to concerns about safety, there is a basic ethical issue here. Do humans have a right to dominate the land and make creatures that they deem “undesirable” expendable? Is an industrial, commercial and profit-driven civilisation our goal? The Bt brinjal controversy has elicited a very polarised and emotional debate between those for and those against the technology. Jairam Ramesh has an important responsibility to ensure a fair process in the consultations, including issuing advertisements, making documents available to the public for

1. Conservation and survey division, genetic engineering approval committee. Decision taken in the 97th meeting of the GEAC held on 14th October, 2009 [Internet]. Ministry of Environments and Forests. 2009 Oct 14 [cited 2009 Nov 27]. Available from: http://www.envfor.nic. in/divisions/csurv/geac/information.html 2. Menon S. Experts’ panel approves Bt brinjal, final okay now with Jairam. Business Standard [Internet]. 2009 Oct 15 [cited 2009 Nov 27]. Available from: http://www.business-standard.com/india/news/experts/-panelapproves-bt-brinjal-final-okay-nowjairam/373318/ 3. The Financial Express. FE Editorial: generally marvelous. The Financial Express [Internet].2009 Oct 16 [cited 2009 Nov 28].[about 3 screens]. Available from: http://www.financialexpress.com/news/fe-editorialgenerally-marvellous/529526/ 4. Domain-b.com. Decision on Bt-brinjal after due consultations: Jairam Ramesh [Internet]. India: The Information Company Private Limited; 2009 Oct 15 [cited 2009 Dec 8]. Available from: http://www.domainb.com/industry/biotechnology/20091915_government_oneview.html 5. The Hindu, Business Line. Machyco to give Bt brinjal tech to other seed cos. The Hindu[Internet]. 2009 Apr 14 [cited 2009 Nov 28]. Available from: http://www.thehindubusinessline.com/2009/04/15/ stories/2009041550121000.htm 6. Qaim M, Zilberman D. Yield effects of genetically modified crops in developing countries. Science. 2003 Feb 7[cited 2009 Nov 28]; 299(5608):900-2. 7. Brookes G. The existing and potential impact of using GM insect resistant [GMIR] maize in the European Union. PG Economics. 2009 [cited 2009 Nov 28]; 29p. Available from: http://www.pgeconomics.co.uk/pdf/ btmaizeeuropejune2009.pdf 8. Sharma Devinder. A scientific fairytale: providing a cover-up to the Bt cotton fiasco in India. Norflok Genetic Information Network [Internet]. 2003 Feb 14 [cited 2009 Nov 28]. Available from: http://ngin.tripod.com/ 140203a.htm 9. Premnath V. Genetically modified (GM) crops increase pesticide use and fail to alleviate poverty, reveals new report. CCSR, Centre for Contemporary Studies and Research [Internet]. 2009 Apr 3 [cited 2009 Nov 27]. Available from: http://ccsrindia.blogspot.com/2009/04/ genetically-modified-gm-crops-increase.html 10. Benbrook CM. Genetically engineered crops and pesticide use in the United States: the first nine years. BioTech InfoNet. Technical paper: 7. 2004. Available at www.biotech-info.net/Full_version_first_nine.pdf 11. Sahai S, Rahman S. Performance of Bt Cotton, data from first commercial crop. Gene campaign [Internet]. 2003 Aug [cited 2009 Nov 28]. 5p. Availablefrom:http://www.chiemgau-inn-salzach.de/upload/pdf/ projekte/gentechnikfrei/infos/Indien_Erfahrungen_mit-Bt-Baumwolle. pdf 12. Shiva V. Trouble on the plate. Financial Express [Internet]. 2009 Oct 25 [cited 2009 Nov 27]. Available from: http://www.financialexpress.com/ printer/news/532814/ 13. EPA.EPA’s regulation of Bacillus Thuringiensis (Bt) crops.US Environmental Protection Agency [Internet].2002 May[cited 2009 Dec 1] Available from: www.epa.gov/oppbppd1/biopesticides/pips/regofbtcrops.htm 14. Genetic Engineering Approval Committee. Biosafety data on Bt- brinjal [Internet]. New Delhi: Conservation and survey division, Ministry of environment and forests, Government of India; [cited 2009 Dec 8]. Available from: http://www.envfor.nic.in/divisions/csurv/geac/ information_brinjal.htm 15. de Vries J, Herzfeld T,Wackernagel W.Transfer of plastid DNA from tobacco to the soil bacterium Acinetobacter sp. by natural transformation. Molecular Microbiology. 2004;53:323-34. 16. Nielsen K, van Elsas JD, Smalla K. Transformation of Acinetobacter sp. strain with transgenic plant DNA in soil microcosms and effects of kanamycin on selection of transformants. Appl Environ Microbiol. 2000;66:1237-42. 17. Ho Mae-Wan, Cummins J. GM Egg Plant contains Bt toxin linked to

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hundreds of allergy cases and thousands of sheep deaths. Institute of science in society [Internet]. 2006 Jul 13 [cited 2009 Dec 1]. [about 5 screens]. Available from: http://www.i-sis-org.uk/GMeggplant.php 18. Bidwai P. Opening the door to Bt brinjal: a step towards disaster. Rediff Business [Internet]. 2009 Oct 26 [cited 2009 Dec 1]. [about 6 screens]. Available from: http://business.rediff.com/column/2009/oct/26/btbrinjal-a-step-towards-disaster.htm 19. Vazquez RI, Moreno-Fierros L, Neri-Bazán L, De La Riva GA, López-Revilla R. Bacillus thuringiensis Cry1Ac protoxin is a potent systemic and mucosal adjuvant. Scand J Immunol. 1999 Jun;49 (6): 578-84. Cited in PubMed: PMID 10354369 20. Wikipedia, the free encyclopedia. Clinical trial. Wikipedia [Internet]. [last modified 2009 Nov 27, cited 2009 Dec 1]. Available from: http:// en.wikipedia.org/wiki/Clinical_trial 21. Genetic Engineering Approval Committee, Department of Biotechnology. Revised guidelines for research in transgenic plants & guidelines for toxicity and allergenicity, evaluation of transgenic seeds, plants and plant parts. Ministry of Science and Technology, Government of India [Internet]. 1998 Aug[cited 2009 Dec 1]. 109p. Available from: http://www.envfor.nic.in/divisions/csurv/geac/biosafety.html 22. Serallini Gilles-Eric. Effects on health and environment of transgenic (or GM) Bt brinjal. Biosafety Information Centre[Internet]. 2009 Jan 22 [cited 2009 Dec 1]. [about 3 screens]. Available from: http://www.biosafetyinfo.net/article.php?aid=556 23. Smith JM. Genetic roulette: the documented health risks of genetically engineered foods. 2007 May. Vermont (USA). Chelsea Green Publishing. 312pp. 24. GMWatch. Doctors call for a moratorium on GM crops. GMWatch [Internet]. 2009 Jan 15 [cited 2009 Dec 1].[about 5 screens]. Available from:http://www.gmwatch.eu/archives/50-Doc tors-call-formoratarium-on-crops.html 25. Rodrigues A. Bt brinjal: Poison on your plate. The Sunday Indian [Internet]. [cited 2009 Dec 1]. [about 3 screens]. Available from: http://www. thesundayindian.com/01112009/storyd.asp?sid=7979&pageno=1 26. The Hindu, Business Line. Move to appoint Pental as Bt-brinjal panel chief opposed. Business Line [Internet]. 2009 Sep 14 [cited 2009 Dec1]. [about 2 screens]. Available from: http://www.thehindubusinessline.

com/2006/09/15/stories/2006091503910800.htm 27. Dutta A. Something is fishy about Bt brinjal. Financionomics [Internet]. 2009 Oct 15 [cited 2009 Dec 1]. [about 4 screens]. Available from: http:// financionomics.blogspot.com/2009/10/something-is-fishy-about-btbrinjal.html 28. Jishnu L. Gaping holes in regulation of GM crops. Business Standard [Internet]. 2008 Jul 5 [cited 2009 Dec 1]. Available from: hhttp://www. business-standard.com/india/storypage.php?autono=327852 29. Maharashtra Hybrid Seeds Company Ltd, University of agricultural sciences, Tamilnadu Agricultural University. Report of the expert committee (EC-II) on Bt brinjal event EE-1. Ministry of Environment and Forests, Govt. of India [Internet]. 2009 Oct 8 [cited 2009 Dec1]. 105p. Available from: http://moef.nic.in/downloads/public-information/Repo rt%20on%20Bt%20brinjal.pdf 30. Pragoti, progress and struggle. All India Kisan Sabha Statement on Bt brinjal. Pragoti [Internet]. 2009 Oct 19 [cited 2009 Dec 1]. [about 2 screens]. Available from: http://www.pragoti.org/node/3655 31. GMWatch. Thirsty Bt cotton devastated by water shortage, mealy bugs. GMWatch [Internet]. 2009 Jul 24 [cited 2009 Dec1]. [about 5 screens]. Available from: http://www.gmwatch.org/index.php?option=com_co ntent&view=article&id=11320:thirsty-bt-cotton-devastated-by-watershortage-mealy-bugs 32. Pethokoukis J. UN seeks to ban DDT pesticide and still fight malaria. Reuters [Internet]. 2009 May 6[cited 2009 Dec 1]. [about 3 screens]. Available from: http://www.reuters.com/article/environmentNews/ idUSTRE54542W20090506 33. The convention on biological diversity. Text of the Convention on Biological Diversity. Convention on biological diversity [Internet]. 2009 Aug 11[cited 2009 Dec 1]. Available from: http://www.cbd.int/ convention/convention.shtml 34. Ministry of Environments and Forests, Government. of India. Ratification of Cartagena Protocol on Biosafety by India. Ministry of environments and forests [Internet]. 2002 Sep 5[2009 Dec 1]. Available from: www. envfor.nic.in/news/janmar03/cartagena.doc

Was the Gadchiroli trial ethical? Response from the principal investigator Abhay Bang Society for Education, Action and Research in Community Health (SEARCH ), Shodhgram P O Dist Gadchiroli, Maharashtra INDIA email: [email protected]

In 2007, Oxford University Press published a book titled Ethical issues in international biomedical research: a casebook edited by James Lavery and others (1). One of the case studies presented by the editors and discussed by two discussants, Zulfiqar Bhutta and Marcia Angell, is titled ‘Evaluating home-based treatment strategies for neonatal sepsis in India’. This case study is about the field trial of home-based neonatal care (HBNC) conducted in Gadchiroli, India by us (2). Earlier, Prof Anthony Costello from the Institute of Child Health, London (3) and now Sadath Sayeed from Boston (4) have put forward some facts and arguments about the ethics of the Gadchiroli trial. As the principal investigator of that field trial, I wish to add a few things. 1. In 1993, when we started this trial of HBNC, newborn mortality in developing countries was perceived by global policymakers and international organisations as a hopeless case for which not much could be done. For ethical consolation, most standard guidelines on the care of neonates in the community added the sentence: “If a neonate is sick,

immediately hospitalise.” Usually nothing more was offered to sick neonates. Because hospitals were neither accessible nor affordable, this advice practically meant: “Let them die.” Four million neonates thus died every year, mostly in developing countries, the majority of them without receiving any medical care. When we realised this cruel reality we were baffled but also compelled to do something for these millions of unreached, uncared for vulnerable neonates. There was little precedent to guide us. The challenge was daunting because standard medical advice was a joke in this situation but anything different would require taking an unchartered, risky path. The choice before us was either let four million neonates continue to die silently, every year, or take a risky path. 2. In 1993, our organisation SEARCH in Gadchiroli district had an ongoing child health programme area and also a nonprogramme area where only demographic surveillance was

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done. The non-programme area represented the situation in rural Maharashtra and was served by the government healthcare services. For the HBNC trial these areas of SEARCH were selected as “intervention” and “control” areas respectively. They were not selected anew for the sake of an experiment. However, the baseline parity of two areas was established by a two-year period of baseline measurement. This has been described clearly in our articles on the HBNC trial (5). 3. The study design thus included an intervention area of 39 villages where a new experimental intervention package, HBNC, was introduced from 1995 onwards in a stepwise manner. It also included a comparison area which we called the “control area” served by the government health system and where the child mortality rates were recorded by our demographic surveillance system. Marcia Angell has criticised this strategy. According to her, we should have introduced state-of-the-art (i.e. the US standard) neonatal care in the control area and compared the efficacy of HBNC against it. What she fails to realise is that health service research is different from a laboratory experiment or a hospital-based clinical trial where the researcher might be able to control most variables in an artificially created experimental situation. Health service research has to be conducted in a reallife situation, and a researcher does not own or control all the health services in the area. Further, what makes her think that it would have been possible to create an island of state-of-the-art medical care in the control area in remote Gadchiroli, 1,000 km from Mumbai, where no doctor wants to go and live? What then is one expected to do? Should one wait until the best standards, and the resources needed for using them in the control area, are made available, and allow children to die until such time? In a world that hardly cares for the disadvantaged and vulnerable, what would be the ethical obligations of a physician-researcher?

The Helsinki Declaration (6) guides us:

17. Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to benefit from the results of the research.

Moreover if we had introduced the state-of-the-art newborn care service in the control villages, could we ethically withdraw it after the trial was over? Hence, we limited the HBNC only to the intervention villages. Ethics cannot be made a matter of armchair discourse. It must respond to the situation at the ground. 4. A major question raised by the editors is: “Was it ethically permissible for the investigators not to treat those neonates in the control villages identified with sepsis during the study with effective treatment?” This criticism is based on incorrect information. We observed neonates only in the 39 intervention villages, and provided them treatment when sepsis was suspected. We did not observe neonates in the control villages for morbidities. This area was a demographic surveillance area wherein we

enumerated the population and recorded births and child deaths usually a few weeks to a few months after the event had occurred. Hence no ante-mortem diagnosis of neonatal illnesses was made in the control area. When a child death was reported, the cause of death was assigned by verbal autopsy i.e. retrospective verbal inquiry. This fact has been repeatedly stated very clearly in various articles on the Gadchiroli field trial published in the supplement of the Journal of Perinatology (5), including in the diagrams on the study design wherein the observational study was limited only to intervention villages. Thus the criticism is without basis. 5. An important question is: what did we do after the HBNC trial was over? What about post-trial access? Our approach has been different for the intervention villages, where we directly introduced HBNC, and for the “control” villages where we intervened politically. As an ethical responsibility, we have continued care in these 39 intervention villages until today, 11 years after the original trial was over in 1998. We considered that the situation in the “control” villages represented the situation in the rural areas of Maharashtra state and in India as a whole and it was our responsibility to change it once the HBNC trial had shown that the approach was effective. Hence, for the last 11 years, we have strived to influence policy at the state and national levels to incorporate home-based newborn care in rural areas. These efforts included, apart from scientific publication and dissemination, an extensive use of action-research, the media, judicial activism and political lobbying. For years we have managed to ensure that child mortality is seen as a major social issue that needs attention in Maharashtra. We conducted a 13site study to record the level of child mortality in Maharashtra using the same method that we used in our “control” villages. These data provided powerful evidence (7, 8). Debates on the subject were held three times in the state legislature. An official evaluation committee was appointed by the state government, of which I was the chairman, whose reports were submitted to the government and discussed in the legislature. The Mumbai High Court initiated public interest litigation citing our 13-site study report on child mortality in Maharashtra. In this case we presented the evidence on child mortality as well as the possible solution of HBNC as implemented in the Gadchiroli trial. I am glad to write that, partly due to these efforts, the HC ordered the government to introduce the Gadchiroli model of newborn and child care in five districts including all of Gadchiroli (including the “control area” of SEARCH) and the government of Maharashtra made a political commitment in the legislature to introduce community-based newborn and child care in rural and tribal areas of the state. To monitor the progress, we have continued to record births and deaths in the “control area” in Gadchiroli, and we now find that the infant mortality rate has started falling, from the baseline 76/1,000 to 47/1,000 in the last four years. And finally, the 11th Five Year Plan has recommended the introduction of HBNC in nearly 250 districts in India (9). Our interest and efforts did not cease once the trial was over, nor have we disappeared from the area. We continue to live and strive in Gadchiroli. 6. Another of Angell’s criticisms concerns the standard of care.

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According to her, anything less than (or different from) the internationally accepted standard medical care is unethical. All human beings have a right to receive that standard of care. Now this “standard care” usually means what is accepted in the US or western Europe. Is that necessarily the most desirable medical care? The desirability of a particular medical care is not based only on medical or technological reasons. Other issues, such as its appropriateness, acceptability, feasibility and affordability to people will influence the decision. Obviously in different socioeconomic situations and cultures, different models will be more appropriate. These cannot be called sub-standard or “unethical”. That position is absurd because it dictates to developing countries that even if they can’t eat bread, they must eat cake and only cake. Oral rehydration therapy or community health workers may not be used in developed countries, but they are life-saving solutions for many developing countries. 7. The last question I wish to pose is: Is it ethical to evaluate and pass judgement against any study without completely and carefully studying the available information? The Gadchiroli trial had been extensively reported in 12 research articles published in 2005 in the supplement to the Journal of Perinatology, and these have been available on the Internet (10). These articles are not included in the references in the case study in this book published by the editors in 2007. If they had read these, their misconception - that we observed neonates with sepsis in the control area but did not treat them - would have been corrected. Shouldn’t they at least verify the facts with the concerned person or organisation (as Zulfiqar Bhutta did by approaching us for certain clarifications) before passing an adverse judgement which reverberates internationally? This is an elementary part of journalistic ethics. Shouldn’t the editors of a book on ethics accept this as the minimum standard of ethics?

References 1. Lavery J, Grady C, Wahl E, Emanuel E, ed. Ethical issues in international biomedical research : a casebook. New York: Oxford University Press; 2007. 400p. 2. Bang AT, Bang RA, Baitule SB, Reddy MH, Deshmukh MD. Effect of homebased neonatal care and management of sepsis on neonatal mortality: field trial in rural India. Lancet [Internet]. 1999 Dec 4[cited 2009 Dec 4]; 354: 1955-61. Available from: http://www.searchgadchiroli.org/ Research%20Paper/lancet%20field%20trial.pdf 3. Costello A. Debating how to do ethical research in developing countries. Lancet. 2007 Sep 22; 370(9592): 1025-6. 4. Sayeed SA. Reflections on Gadchiroli. Indian J Med Ethics [Internet]. 2009 Oct- Dec[cited 2009 Dec 4]; 6(4):202-5. Available from: http://www. issuesinmedicalethics.org/174co202.html 5. Journal of Perinatology. Neonates in Gadchiroli : Field trial of home based neonatal care in rural India (1993-2003). Supplement to Journal of Perinatology [Internet]. 2005 Mar [cited 2009 Dec 4] ; 25(Suppl 1): S1S122. Available from: http://www.nature.com/jp/journal/v25/n1s/index. html 6. World Medical Association. World Medical Association Declaration Of Helsinki - Ethical Principles for Medical Research Involving Human Subjects [Internet]. France: WMA; 2008 Oct 22 [cited 2009 Dec 7]. Available from: http://www.wma.net/en/30publications/10policies/b3/ index.html 7. Child Death Study Action Group, Maharashtra. Kowli Pangal. Gadchiroli: SEARCH; 2001. 8. Bang AT, Reddy MH, Deshmukh M. Hidden child mortality in Maharashtra. New Delhi: The National Commission on Population, Ministry of Health and Family Welfare, Govt of India; 2006 9. The Planning Commission, Government of India. 11th Five Year Plan 2007-2012 [Internet]. New Delhi: Government of India; 2008 [cited 2009 Dec 7]. Chapter 3- Health and family welfare and AYUSH; p 89-91. Available from: http://planningcommission.gov.in/plans/planrel/fiveyr/ 11th/11_v2/11th_vol2.pdf 10. Bang AT, Bang RA, Baitule SB, Reddy MH, Deshmukh MD. Management of birth asphyxia in home deliveries in rural Gadchiroli: the effect of two types of birth attendants and of resuscitating with mouth-to-mouth, tube-mask or bag-mask. Journal of Perinatology [Internet]. 2005 [cited 2009 Dec 7] ; 25:S82-S91. Available from: http://www.nature.com/jp/ journal/v25/n1s/full/7211275a.html

Impact of bioethics on patentability of inventions Vishwas H Devaiah Doctoral candidate, Liverpool Law School, University of Liverpool, Liverpool, UK L69 7ZS e-mail: [email protected]

Abstract

Introduction

This paper examines the impact of bioethics on patent claims. The increase in research activities involving human biological materials, and the rush to commercialise inventions derived from such biological materials, can at times result in unethical conduct of research. Questions arise as to whether patent law should concern itself with tainted research that has resulted in an invention or whether it should grant patent rights solely on the basis of the technical improvements resulting from such research. This paper highlights the significance of ethical practice in biomedical research, an issue that may influence the decision to grant patents on inventions. It explores the relation between morality, bioethics and patents from the perspective of the objectives of the patent system and current developments in the law on patents. The inclusion of the morality provision in patent law introduces a mechanism through which inventions derived from tainted research can be filtered at an early stage.

The race for patents over inventions derived from human biological materials has given rise to concerns about the private control of human genetic resources. But a far more serious issue has surfaced in the wake of the South Korean stem cell fraud. South Korean scientist Hwang Woo-Suk is said to have coerced his junior colleagues to provide their gametes for stem cell research (1). Hwang fraudulently claimed success in creating human embryonic stem cells through somatic cell nuclear transfer but had inadvertently succeeded in deriving embryonic stem cells from parthenogenesis (1). While the scientist and his group of researchers have had to abandon further research, they have sought patents in various jurisdictions. The grant of a patent to Hwang and his group for this research would enable them to seek royalties and profit from immoral conduct.

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The above account raises questions as to whether inventors should be rewarded with patents for inventions that are tainted by unethical behaviour. While patents are usually granted on meeting the technical criteria of novelty, non-obviousness and utility, there are provisions within the patent laws of various countries to deny patents on the grounds of “morality” (3). The United States, the European Union, Australia, New Zealand and India have provisions within their patent laws to deny patents to those inventions that are against public morality. The Andean community, consisting of Bolivia, Colombia, Ecuador, Peru and Venezuela, developed regional rules that require the inventor to show that s/he has obtained the voluntary consent of the people from whom the biological material is sourced (4). In doing so, the Andean community has moved in the direction of using patent law as a tool to filter unethical or immoral inventions. Further, the Italian patent law, through Article 5, requires the patent applicant to file a declaration that the person from whom the biological material is derived has expressed his prior informed consent for such use (5). The Italian Patent Office may refuse the patent application if this requirement is not met. This paper looks at the patent system and how it has incorporated provisions to filter and prevent the grant of patents to inventions that are tainted by immorality. It explores the relation between morality, bioethics and patent laws. It attempts to illustrate the importance of ethical research, a value that could play a significant role in securing patent protection for new technology. While links between bioethics and patents are not so obvious, the exclusion clause based on morality may require patent offices across the world to seek information regarding the ethical sourcing of human biological materials when patents are claimed for inventions derived from them.

The patent system and morality The patent system has often been portrayed as neutral and devoid of any moral or ethical values (6). Historically, the patent system originated in mainland Europe and was later on adopted by England in the form of “letters patent”. The idea behind introducing monopoly rights through the patent system was to encourage the inventor to disclose his inventions to the public without fear of being copied by competitors (7). Monopoly rights protected the inventor’s interests while at the same time the public disclosure mandated by the patent system enabled the public to learn about the invention and improve upon it in the future (7). If not for a patent system, inventors and businesses would maintain secrecy about their inventions and new technologies (8). The lack of disclosure about the working of a technology or invention would affect the progress of science and technology related to the field (8) and the technological progress of a society. The patent system, by making it mandatory on the part of the inventor to publicly disclose the working of the invention, ensures that inventors provide public access to the working and development of their inventions, resulting in openness in the development of science and technology(8).

Although downstream development of technologies in current times has been hampered by patent pools, non-commercial development of downstream technologies continues to be unhindered by the grant of patents. The patent system was devised not merely to provide incentives to inventors so that the working of the invention is publicly disclosed, but also to benefit society (8). The question arises as to how the patent system confers benefit to society. The disclosure of a new technology is ultimately meant to benefit society as the invention falls into the public domain after the expiry of the monopoly period (20 years) which will allow anyone to commercially replicate the invention (9). Besides, this patent system also enables the government to use the invention during the monopoly period if it deems fit to do so. While monopoly over an invention does create a market imbalance, as is witnessed in developing countries, the provisions of compulsory licensing (i.e, the government may issue - without the voluntary consent of the patent holder a commercial license to any enterprise to market the patented product for certain social benefit) serve to redress market imbalances (10). The idea behind having such safeguards in patent laws is primarily to ensure that the public benefits from such a system rather than be inconvenienced by it (11). Given that the patent system was developed to incentivise the public disclosure of inventions, it would not seem to be at odds also if it came with a rider that it would grant a monopoly to fitting inventions that conformed with the current morals of society (2). After all, the monopoly granted to the invention is a mere privilege recognised by the governmental authority and it is only befitting that a privilege is granted to those inventions that lead to scientific progress without harming public morality. Granting monopolies to inventions that encourage offensive, immoral or anti-social behaviour would be against the larger interests of society and would therefore be against public policy (8). Issues of morality do not fall directly within in the patentability criteria of novelty, non-obviousness and utility. But it can be argued that it cannot be the objective of any state to encourage the diffusion of technologies that promote immorality within a society (8, 12). As a result the patent system has incorporated provisions that would prevent the introduction of a technology that is “frivolous or injurious to the well-being, good policy, or sound morals of the society”. (13) The issue of patents and morality arose in Darcy v Allen, an English case in which the courts determined that it cannot be the purpose of the patent law to encourage inventions that are contrary to law or morality. If indeed a person intends to seek patent monopoly, then the inventor has an obligation to comply with conditions imposed by society on him in exchange for the grant of the monopoly (14). This obligation on inventors arises from the understanding that the public does not endorse or promote actions of individuals that may cause harm to society or promote wrongful actions (5). Thus, patents were not granted to inventions that were tainted by immorality. It would be impossible to brush off claims that the patent system is linked to moral standards as it operates within a culture that subscribes to certain community values and shared economic and social interests (2).

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Patent jurisprudence in the European Union has evolved to permit the challenge of patents that are against morality. Patents may be rejected on the basis of immorality if the invention is publicly unacceptable or abhorrent to the current morals of society (9). The recent decision of the Enlarged Board of European Patent Office (EBEPO) to deny patents to human embryonic stem cell compositions on the grounds of morality serves as a reminder that the patent office is required to find a balance between public policy and technological development (15).

TRIPS Agreement and the semantics of “morality” In recent years, the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), through Article 27.2, allows member countries to exclude from patentability those inventions, the commercial exploitation of which is necessary to protect public order or morality, protect human, animal or plant life or health or avoid serious prejudice to the environment. As per the agreement, member states have the right to refuse patents to those inventions that are against the public interest or against the prevailing morals of the member state. This provision is specifically included in the TRIPS Agreement so that the member states have the right to protect their public interests. The provision retains the tradition followed in the European countries which gave primacy to the prevailing morals in their countries rather inventions that could potentially harm the public interest (2). The TRIPS provision specifically addresses the concerns of member countries as regards their right to exclude or deny patents to those inventions that threaten or damage the moral fabric or structure of society. The inclusion of morality as grounds for denying a patent was done with the objective of ensuring that an invention conformed to the prevailing moral principles or values in the country in which it is being patented (2). Thus, ethical or moral values within a member country hold the key if a patent is to be granted. Where an invention is derived from a tainted source which has the effect of breaching the moral or ethical values of a country, it could be excluded from being granted a patent.

“Morality” provision and biotechnology Rapid innovations in the field of biotechnology have meant that inventors and companies invested in biotech research place emphasis on protecting their inventions through patents. While the patentability criteria set for biotech inventions remain controversial, it is all the more important to ensure that patents are excluded for inventions that are regarded as repugnant to the values within a country. Whole organs and tissues have been excluded from being patented on the grounds of morality and the failure to meet the criteria for patentability (16-19). But biotech patents granted to human biological materials such as isolated and purified or synthetic genes and DNA have already resulted in arguments that granting private monopoly over the common heritage of humankind could be detrimental to the future of humankind as it puts control of key components of human life

in the hands of a few private companies (16, 17). While these concerns remain, the move by the EBEPO in November 2008 to deny patents to human embryonic stem cells derived from the destruction of an embryo has raised concerns regarding the need to exercise caution in seeking patents from inventions that may be regarded as immoral within a society (15). Concerns also arise when patents are sought for biotech inventions that are sourced unethically. Unethical sourcing of biological materials used in an invention could raise issues of morality. It raises concerns about respecting the autonomy of the tissue provider. Respecting the autonomy of the tissue provider includes a moral obligation not to interfere with the body of a person (20). Interfering with the body or mind of the person amounts to treating humans as objects and impinges on people’s freedom to decide for themselves (21). Doing something without individuals’ consent would amount to forceful overriding of their autonomy. The right to self-determination relies on the notion that freedom must be the overriding value in our body politic and respect for human dignity must be the ultimate concern of every society (21, 22). The human dignity of each individual is respected by allowing autonomous individuals to determine what they shall do, and allow or permit others to do, with their bodies or minds (22). Thus, people should have ample freedom to decide whether they must agree, withhold, or deny access to their biological materials (23). If human dignity is to be fully respected, then individuals should also have the freedom to decide whether the biological materials extracted or derived from their bodies can be used for specific purposes (23). This could be vital given that certain communities and religious groups may not agree on the use of biological materials for research that may advance better techniques for, say, abortion, or xenotransplantation or for fusing human and animal genetic material (24). The value of a life depends wholly on the value that individuals give to their lives through their choices. Therefore, individuals from whom human biological materials are sourced must be allowed to determine their choices without coercion or undue influence from researchers or medical practitioners who are involved in sourcing and inventing a biotech product. Compromising the autonomy of a person strikes at the very root of the existence of a liberal society and results in harming society if human beings are treated as mere means to an end (17). When patents are claimed for inventions that are derived from a tainted source, as in the case of Hwang and his colleagues, the patent office may have to take into cognisance the unethical sourcing of the human biological materials from which the invention is derived. In the case of Hwang, coercing junior colleagues to provide tissues for research would amount to lack of respect for the autonomy of his junior colleagues. This in itself can be regarded as immoral and abhorrent to the ethical values or moral principles prevailing in a society. Thus the patent offices in various countries could refuse to grant patents to tainted inventions on the ground of immorality. In India, the Patent Act of 1970 provides for moral and ethical considerations in granting patents to the inventor, thus

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establishing a link between invention and morality. Section 3(b) of the Patent Act 1970 states that “an invention, the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human life, or plant life or health or to the human environment are not inventions within the meaning of the Act”. Section 3(b) is listed under chapter II of the Patent Act and relates to exclusion of inventions that may have otherwise qualify as patents (25). Thus, in India the Patent Act provides room for excluding inventions that may be contrary to public order or morality. Under current practice, it is not an explicit requirement for the inventor to disclose to the Patent Office that he has respected the autonomy of the tissue provider at the time of sourcing the biological materials. But, it is implicit within the language of the Act that patents may be refused if the inventor approaches the Patent Office with unclean hands. The Patent Office could deny the inventor to benefit from his tainted act. The lack of well developed jurisprudence in the Indian case will leave inventors uncertain as to the exact meaning of the provision. But the Patent Office could be guided by the interpretations of the European Patent Office which has in the recent past dealt with issues of patents and morality.

Conclusion While the patent system is devised mainly to examine the patentability of an invention it has, over the years, evolved to look at issues of morality. Issues of morality of an invention have become more relevant in the era of biotechnology where patents are being sought for inventions that have been derived from tainted sources. Requiring patent applicants to furnish information about the ethical sourcing of the human biological material does not necessarily digress from the primary objective of the patent law. The morality provision in the patent law acts a filter to discourage patents for inventions that are derived from tainted sources. (26). References 1. Cyranoski D. Hwang work granted patent: Australia criticized for issuing a patent for a method the Korean lied about using. Nature.2008 Oct 2; 455(7213): 571. 2. UNCTAD,ICTSD. Resource Book on TRIPS and Development [Internet]. Cambridge: Cambridge University Press; 2005 Jun 1 [cited 2009 Nov 25]. 811p. Available from: http://www.iprsonline.org/unctadictsd/ ResourceBookIndex.htm 3. Carvalho N P. Requiring disclosure of the origin of genetic resources and prior informed consent in patent applications without infringing the TRIPS agreement: the problem and the solution. Washington University Journal of Law and Policy [Internet]. 2000 [cited 2009 Nov 25]; 2: 371-402. Available from: http://law.wustl.edu/journal/2/p371carvalho.pdf 4. Casciano L & Fiusello F. Italy’s take on biotech issues. Managing Intellectual Property.2006; 224-36.

5. Coulter M. Property in Ideas: the patent question in mid-Victorian Britain. Missouri: Thomas Jefferson University Press; 1991. 6. Grubb PW. Patents for Chemicals, Pharmaceuticals and Biotechnology: Fundamentals of Global Law, Practice and Strategy. Oxford: Oxford University Press; 2004. 7. Kuflik A. Moral Foundations of Intellectual Property Rights. In: Weil V, Snapper J, editors. Owning Scientific and Technical Information. New Brunswick (USA): Rutgers University Press; 1989. 309p. 8. Goldman A. Ethical Issues in Proprietary Restrictions on Research Results. In: Weil V, Snapper J, editors. Owning Scientific and Technical Information. New Brunswick (USA): Rutgers University Press; 1989. 309p. 9. Jones AW. Patenting rDNA: human and animal biotechnology in the United Kingdom and Europe. Witney, Oxon (England): Lawtext Pub; 2001. 10. Devaiah VH. TRIPS flexibilities. In: Ashiya M, editor. TRIPS and global pharmaceutical industry: perspectives and implications. Hyderabad (India): ICFAI University Press; 2007. 11. Drahos P. A Philosophy of intellectual property. Aldershot (UK): Dartmouth Publishing Company Ltd; 1996. 12. Jones AW. Vital parameters for patent morality- a question of form. Jnl of Intellectual Property Law & Pract. 2007; 2(12):832-46. 13. Verkey E. Law of Patents. Lucknow (India): Eastern Book Company; 2005. 14. Thambisetty S. Understanding morality as a ground for exclusion from patentability under European law. Eubios J Asian Int Bioeth [Internet]. 2002 Mar [cited 2009 Nov 25]; 12(2): 48-53. Available from: http://www. eubios.info/EJ122/ej122b.htm 15. Managing intellectual property. EPO rejects WARF stem cell patent. MIP[Internet]. 2008 Nov 28 [cited 2009 Nov 25]. Available from: http:// www.managingip.com/Article.aspx?ArticleID=2059365 16. Resnik DB. Owning the Genome: A moral analysis of DNA patenting. New York: State University of New York Press; 2004. 17. Heyd D. Genethics: Moral Issues in the Creation of People [Internet]. Berkeley: University of California Press; c1992-1992 [cited 2009 Nov 25]. Available from: http://www.escholarship.org/editions/view?docId=ft30 9nb1nd&brand=ucpress 18. Oman R. Biotech Patenting issues raise ethical concerns. The National Law Journal. 1995; 17 (36): C42. 19. Looney B. Should genes be patented? Law and Policy in International Business. 1994; 26 (1): 231-72. 20. Freedman B. A moral theory of informed consent. Hastings Cent Rep. 1975 Aug;5(4):32-9.Cited in PubMed: PMID 1158676. 21. Goldstein J. For Harold Laswell: some reflections on human dignity, entrapment, informed consent and the plea bargain. Yale Law J. 1975; 84(4):683-703. 22. Hansson HG. Respect for the individual as a person with moral and political authority - integrity from a philosophical perspective. Philosophical Studies in Contemporary Culture.2007; 15:71-89. 23. Perley NS. From control over one’s body to control over one’s body parts: extending the doctrine of informed consent. N Y Univ Law Rev. 1992 May; 67(2):335-65. Cited in PubMed: PMID 11659626. 24. Ghosh S. Patents and the regulatory state: rethinking the patent bargain metaphor after Eldred. Berkeley Technol Law J.2005;19(4):1315-88. 25. Intellectual property India, patents/designs/trademarks/ geographical indications. Manual of patent practice and procedure(draft) [Internet]. Patent Office, India; 2005[cited 2009 Nov 25].163p. Available from: http://www.patentoffice.nic.in/ipr/patent/manual-2052005.pdf 26. Gold ER, Caulfield TA. The moral tollbooth: a method that makes use of the patent system to address ethical concerns in biotechnology. Lancet.2002 Jun 29;359(9325):2268-70.

Indian Journal of Medical Ethics is indexed on Pubmed. Articles from the journal’s previous titles, Medical Ethics (1993-1995) and Issues in Medical Ethics (1996 to 2003), are also indexed.

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White coated corruption Vijay Mahajan Department of Evening Studies, Panjab University, Chandigarh 160 014 INDIA email:[email protected]

Abstract This essay documents the state of the medical profession which was once a respected line of work but today is corrupted at every level, from medical education to medical practice, and in both the private and government sectors. It calls for doctors, the government and the public to act against dishonest doctors, restore the dignity of the profession and work for the benefit of society. India is said to have one of the most corrupt medical systems in the world (1).The situation has become so bad that patients today approach the doctor with mixed feelings - of faith and fear, of hope and hostility. This leads to a distorted doctorpatient relationship, with high chances of exploitation both ways - doctors may fleece patients and, if some lacunae are exposed in treatment, patients or their relatives may blackmail doctors (2). Such unethical practices may no longer be cause for comment. But there are many reports of doctors actually committing crimes - distorting medical reports in medico-legal cases, providing false certificates to protect criminals, sexually assaulting their patients, and even trading in human organs (3). It goes without saying that such criminal doctors are in a minority. Unfortunately their number seems to be increasing.

Inhuman doctors One can quote innumerable reports pointing to the inhumanity of persons in white coats. Pregnant women have been refused care because they are HIV positive. Hospital authorities have refused to release the bodies of patients who died in their care because the relatives could not afford to pay the medical bills (4). There are reports of doctors amputating the limbs of poor people at the bidding of the begging mafia. Poor people who resisted the extraction of their kidneys have reportedly been operated upon at gunpoint. The list of such practices is endless. It starts in medical college as MBBS seats are sold for lakhs of rupees. This is merely the tip of the iceberg (5). Rampant corruption exists at every level, from medical college admissions, getting a degree, to registration with the medical council. Question papers have been leaked and “jockeys” have written medical examinations on behalf of students (6). Medical college managements are known to charge unofficial “donations” in addition to official fees. Students have been reported to bribe faculty to get good reports, and doctors have been reported to pay bribes to get registered with the state medical council (7). New graduates quickly learn the rules of the game in government service. Within medical administrations, lucrative

posts are sold to the highest bidder. Government vehicles and machinery are misused. Pharmacists perform the duties of doctors in government dispensaries. Medical supplies get diverted from the intended users. Health officers serve VIPs in order to benefit from their proximity to the powerful. Government doctors pay more attention to their private practice despite receiving non-practising allowances. They do not attend rural postings despite drawing wages from the government. Patients are forced to bribe everyone in the hospital hierarchy to get the medical treatment that is their right. Private medical services are no better. Though medical professionals are expected to work in the interests of the public in general and of the poor in particular, all of us know that this does not always happen in practice. There are some doctors for whom making money is the only goal. So, spurious and adulterated drugs proliferate, and licensing, accreditation and regulatory systems are subverted. Pharmacists sell their licenses to unqualified persons to run chemist shops. Even in the big cities, quacks practice without registration (8). Sex determination tests are performed though they are illegal. Doctors are known to prescribe unnecessary diagnostic tests, hazardous drugs and inappropriate surgical procedures, all for the kickbacks they receive from the healthcare industry (9). The avenues for corruption are endless. Medical establishments work closely with drug manufacturers whose main objective is to maximise profits. Large quantities of drugs must be sold, and for this, anything goes. Doctors are the principal salespeople of drug companies and they are rewarded with research grants, gifts, lavish perquisites and foreign tours. The principal buyers are the public, who must be thoroughly medicated and vaccinated at any cost.

The government is also responsible Though India is a welfare state, the role of the government at the centre and in the states in providing healthcare facilities is deplorable. Against the recommendations of the WHO that the total health expenditure should be 6.5% of the gross national product (GDP), India spends only 4.8% of GDP on health. Further, public health expenditure is just 1.2% of GDP, or barely 25% of the total health expenditure; the rest of the money is paid by patients directly to private doctors and hospitals (10) for whom profits may take precedence over their patients’ interests. Even in government hospitals, medical facilities favour the wellto-do and are often beyond the reach of the poor who need them the most. The allocation of funds is often determined by the influence and manipulations of hospital authorities, and

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the maintenance of government hospitals is poor (11). Public funding for research and development is inadequate and whatever meagre resources are available may actually be used by people at the top to serve their own interests.

The connivance of regulators The dubious functioning of regulatory bodies of the medical profession, namely the Medical Council of India (MCI) and the Indian Medical Association (IMA), has helped spread corruption in the profession. What can we expect if the president of the MCI, who also happens to be head of the IMA, must be removed from his post after being found guilty of dishonest practices and misuse of power (12)? Large amounts of money can be involved in getting the MCI’s approval for setting up a private medical college. Even government medical colleges and hospitals go on reckless spending sprees before an MCI inspection. As medical and nursing colleges are income generating ventures, their owners readily offer huge bribes to the officials who matter in the establishment of such institutions. Unfortunately, we cannot rely on justice from the legal system. When prosecutions do occur, only a small fraction of these cases reach the courts. In some cases of medical negligence, the punishment has been notional. Many cases of medical negligence are pending in various courts in the country; in the Supreme Court of India alone, there are some 3,000 cases of medical negligence (13).

The organ trade has been fuelled by poverty; poverty drives people to fall into the trap set by unscrupulous elements who lure them with offers of money and jobs in exchange for a kidney. At the same time, voluntary donation of human organs is not properly promoted or utilised because of poor hospital infrastructures, inefficient transportation systems for the timely revival of organs, and a shortage of cadaveric transplant surgeons. Because of the shortage of cadaver donors, doctors, donors and patients waiting for transplants collude in illegal practices. Social compulsions accelerate the process of medical corruption. A medical professional finds it very difficult to refuse a VIP’s request; it could mean isolation or posting to a remote area. When honest doctors cannot afford to even buy their own houses, but see that their dishonest colleagues enjoy a luxurious life, they may wonder if they are right to stick to their principles.

The task ahead It is not too late to restrain the medical profession. This calls for a well-coordinated campaign involving doctors, the government and the public. A beginning has to be made by health professionals launching a zero tolerance assault on medical corruption. The MCI code has to be practised in letter and spirit. The list of things that doctors must do is long. A few of them are given below.

By the 1990s, India had achieved the distinction of being the biggest bazaar for the sale of human organs and the sale of kidneys was described as a cottage industry in India (14). Such scandals prompted the government of India to enact the Transplantation of Human Organs Act, 1994 but the nexus of doctors and brokers involved in the sale of human organs has never been afraid of the law (15), which has been violated with impunity. For example, the Gurgaon kidney scamsters, who had been arrested for conducting illegal kidney transplants in the 1990s, evaded punishment (16) and managed to run their trade in kidneys for years, obviously with the connivance of law enforcement authorities (17). It is known that the main accused evaded arrest by bribing Delhi police officials (18).

l

Refuse to take bribes.

l

Collectively publicly oppose outside interference - political, bureaucratic or otherwise.

l

Make a commitment to rational drug use, referral and evidence-based interventions.

l

Shun erring colleagues.

l

Refuse to accept any favours from pharmaceutical companies.

l

Follow medical ethics and treat poor patients the same as rich ones.

Poverty and public ignorance

l

Evolve a transparent system for the allocation of funds, for deciding the location of medical facilities and for the posting of medical personnel; this system must be insulated from political and other interference.

l

Have people of integrity conduct prompt enquiries into reports of medical corruption, and take prompt action on the basis of these reports.

l

Let doctors know that transgressions will be met with punishment. Medical corruption is not a crime committed in the heat of the moment. It is calculated and based on greed, and the punishment must be severe and deterrent.

l

Plug the loopholes in the law on human organ transplants that enable transplant tourism and marriages for the

The nexus between corrupt medical professionals and politicians, bureaucrats and the police is one of the major factors multiplying medical corruption. The common man is afraid of exposing wrongdoings - the authorities may hush up the matter and target the whistleblower instead. Public apathy and fear are also partly responsible for breeding medical corruption. Even if people come to know about unethical and illegal activities in the profession, they turn a blind eye, either because it does not concern them, or because they are afraid of the doctors. For example, many people were aware of the kidney racket but did not report the matter to law enforcing agencies fearing the consequences to themselves (19).

The government must support and protect the interests of upright doctors. For this, it must take the following steps:

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purposes of kidney “donation”. A campaign must be started to dispel myths on cadaveric donations. The transplant programme must include a computerised national database, efficient transportation and a network of state-of-the-art transplantation centres with expert surgeons. Reward upright doctors to encourage role models for new entrants in the profession. l Tackle the problem of doctors shunning government service. l Support and protect whistleblowers who report medical corruption. l Form a task force to defend high ethical standards in the medical profession and to fight corruption in public healthcare. Medical corruption contributes to poverty and misery in a developing country like India. The public must contribute to efforts made by medical professionals and the government to clean up the medical system. It can do this by: l

acting as a watchdog reporting corruption or wrong doing; checking unscrupulous elements who blackmail doctors in cases of inadvertent lapses in medical treatment; l being more responsive to the stress that doctors have to deal with, and l running awareness groups to educate people on the necessity of organ donation and to encourage the framing of laws that would empower medical authorities to extract organs of unidentified and unclaimed dead bodies within the stipulated time for organ revival. Corruption is spreading its tentacles far and wide in the medical system. To restore its noble and distinct status, all sections of society must work together to stamp out the biggest killer in the medical system - corruption. l l

Acknowledgement: The author thanks Dr Keerti Vardhan, Dept of Evening Studies Panjab University, Chandigarh, for assistance. References 1. Potter C. Corruption mars India’s healthcare system. Express Health care Management [Internet]. 2003 Jan 1-15[cited 2009 Aug 27]; [about 5p.]. Available from: http://www.expresshealthcaremgmt.com/20030115/ comment1.shtml 2. India kidney trade. TED Case Studies; Case number 240[Internet].[cited

2009 May 21]. Available from: http://www1.american.edu/TED/KIDNEY. HTM 3. GMCH employee in CBI net. The Tribune Chandigarh [Internet].2009 Feb 3[cited 2009 May 21].Page 2 (col. 3). Available from: http://www. tribuneindia.com/2009/20090203/cth2.htm 4. Bhalla S. Child dead, broke father struggle to clear dues. The Hindustan Times(Chandigarh Ed.).2009 Jan 1:3 (Col.6). 5. Dey A. Education and corruption. Asian Correspondent [Internet]. 2009 Jun 5[cited 2009 Dec 10]. Available from: http://us.asiancorrespondent. com/atanu-dey-blog/2009/06/05/education-and-corruption 6. Two arrested for impersonation in PMT of Baba Farid University of Medical Sciences, Faridkot. Times of India (Chandigarh Ed.). 2009 Jan15:1. 7. Mittal R. Corruption roko. In: Corruption Report On Karmayog Online [Internet] Lucknow, India: Karmayog; 2008 Apr 21[cited 2009 Aug 31]. [about 2 screens]. Available from: http://www.karmayog.org/roko/roko_ 14866.htm 8. Tiwari A. Farzi Doctor Ne Lee Maasoom Ki Jaan. Chandigarh Bhaskar (Chandigarh Ed.). 2009 Mar 16:3(col.1). 9. Tribune News Service. Dr Dhaliwal gets five-year RI. The Tribune [Internet]. 2009 Mar 4 [cited 2009 Aug 31]; [about 1 screen]. Available from: http:// www.tribuneindia.com/2009/20090304/cth1.htm 10. Tandon A. The eport of NSSO. The Tribune (Chandigarh Ed.). 2009 Feb 2:2 (col.7). 11. Singh V. Five newborns were burnt alive. The Sunday Tribune. 2009 Feb1:1(col. 2). 12. Sharma R. Head of Medical Council of India removed for corruption. Student BMJ [Internet]. 2001 Dec 15 [cited 2009 May 21]; 323(7326):1385 Available from: http://www.bmj.com/cgi/content/ extract/323/7326/1385 13. Tandon A. 11 years after, Ohio doc’s fight for justice still on. The Tribune[Internet]. 2009 Jan 31 [cited 2009 Aug 31]; [about 1 screen.]. Available from: http://www.tribuneindia.com/2009/20090131/nation. htm#6 14. Jyothi PT. Where kidney donation is a cottage industry. The Indian Express(Mumbai Ed.). 1995 Jan 25: 1(col.1). 15. Kidney donor alleges fraud by doctors. Bio-Medicine[Internet]. Available from: http://www.bio-medicine.org/medicine-news/Kidney-DonorAlleges-Fraud-by-Doctors-22445-1/ 16. Machiah M G. Senior politicians, cops collude to bury kidney scam. The Indian Express (Mumbai Ed.).1995 Feb 4: 9(col.13). 17. Not first time for Dr Amit. Hindustan Times[Internet]. 2008 Jul 7[cited Aug 31]. Available from: http://www.hindustantimes.com/FullCoverage/ FullCoverage.aspx?Special=TheKidneyScam 18. Fatah S. Indian officers charged in kidney scandal February. The Star.com [Internet]. 2008 Feb 16[cited 2009 Aug 31]; [about 4 screens.]. Available from: www.thestar.com/News/World/article/304157 19. Makkar S. Gurgaon kidney scam or Nithari murders, apathy was same. Boloji.com[Internet]. 2008 Feb 1[cited 2009 Aug 31]; [about 3 screens]. Available from: http://news.boloji.com/2008/02/17157.htm

A farce called the National Board of Examinations Suptendra Nath Sarbadhikari Department of Biomedical Informatics, PSG Institute of Medical Sciences and Research, Peelamedu, Coimbatore 641 004 INDIA email: [email protected]

Abstract The National Board of Examinations is a body formed to enhance the standards of post graduate examinations in modern medicine in India. Unfortunately, the outdated mode of examinations and the arbitrarily set high cut-off marks for passing the examinations defeat the very purpose of its formation and functioning.

The National Board of Examinations (NBE) was established in 1975 with the prime objective of improving the quality of medical education by elevating the level and establishing standards of postgraduate examinations in modern medicine on an all-India basis (1). However, as has been the case with the Medical Council of India (MCI) (2), the NBE has not been able to

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carry forward its mission in a transparent and scientific manner.

Accepted methods of postgraduate medical assessment The Postgraduate Medical Education and Training Board of the United Kingdom (3) has developed specific guidelines for assessment. I quote relevant portions from these guidelines below: The overall purpose of the assessment system must be documented and in the public domain. l The purposes of each and all components of the assessment system must be specified and available to the trainees, educators, employers, professional bodies including the regulatory bodies, and the public. l The sequence of assessments must match the progression through the career pathway. l Individual assessments within the system should add unique information and build on previous assessments. l Assessments will together systematically sample the entire content, appropriate to the stage of training, with reference to the common and important clinical problems that the trainee will encounter in the workplace and the wider base of knowledge, skills and attitudes that doctors require. l Methods will be chosen on the basis of validity, reliability, feasibility, cost effectiveness, opportunities for feedback, and impact on learning. l The rationale for the choice of each assessment method will be documented and evidence-based. l The methods used to set standards for classification of trainee’s performance / competence must be transparent and in the public domain. l Assessments must provide relevant feedback. Further, the World Federation of Medical Education states that, as a basic standard for assessment methods (4):

multiple choice questions (MCQs), assessments by supervising clinicians including direct observations and video recordings of actual procedures done by the students, clinical simulations involving objective, structured clinical examinations, multisource or 360( assessments and portfolios. This sort of linking of teaching, learning and assessment methods to each learning objective is now globally used to achieve excellence in postgraduate medical education.

l

Postgraduate medical training must include a process of assessment, and the competent authorities must define and state the methods used for assessment of trainees, including the criteria for passing examinations or other types of assessment. Assessment must emphasise formative in-training methods and constructive feedback.

I am leaving out the quality development portion since that can be addressed only after the basic standard is met. The Accreditation Council for Graduate Medical Education has also published guidelines for evaluating the postgraduate programmes of various disciplines like psychiatry (5) where formative (during the course) assessment is given more weightage than the summative (at the end) assessment. In another specialty, anaesthesiology, Kimatian (6) has commented that an ideal system for assessment would provide a continuum of performance data, combining a mechanism for practice surveillance and outcomes assessment with a means for formative and summative feedback. Epstein (7) discusses the various modern methods of assessing medical students. He talks of written examinations including

The outcomes of the DNB examinations For the DNB examinations (8) we find that there are four theory papers, each of which consists of 10 short notes of 10 marks each, to be completed in three hours. If the examinees pass this, they will be allowed three attempts to clear the practical examinations. Now if we compare the methodology of the NBE with that of those enumerated in the previous section, the irrationality and outdatedness of the method becomes evident. Unless a student passes in these 40 essay-type questions, that cannot measure performance or competence in any way, there is no question of the practical examinations or logbook or dissertation being of any value. The essay type questions (and MCQs) can only judge the cognitive aspects of knowledge (“knows”) and competence (“knows how”) of [C1]the student. For the assessment of higher aspects, the [C2]competence (“shows how” ) and (performance (“does”), these essay type questions are simply inadequate. The knowledge pyramid shows the transition of data to information (organised data with content and perspective), from there to knowledge (useful information that can be used as a guideline), and finally to wisdom (understanding and making the knowledge useful or applicable). Bloom’s taxonomy (9) has conceptualised the cognitive domain through the successive steps of knowledge, comprehension, application, analysis, synthesis and finally evaluation. It was later modified (10) through the sequential steps of remembering, understanding, applying, analyzing, evaluating, and ultimately creating. In the affective domain, Bloom’s taxonomy has been represented through receiving, responding, valuing, organising and conceptualizing, and eventually characterising by value or value concept. In the psychomotor domain, Bloom’s taxonomy evolves through the order of imitation, manipulation, precision, articulation and naturalisation. The DNB examinations do not take care of these which should have been accorded due weightage to further the founding vision of the organisation. Further, the pass rates through this obsolete method of theoretical knowledge testing are hardly 15-25%, and often as low as 4-6% in disciplines like orthopaedics and anesthesiology (11). And the handful of those who pass are not recognised by the MCI unless they possess an MD (Doctor of Medicine ) or MS (Master of Surgery) that are the MCI-recognized post graduate degrees, defeating the very purpose of DNB. Many of those who clear DNB do already possess MD , but the possession of degree or its lack should not interfere with the results/certification of

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DNB being accepted by the MCI. Of course, anyone who has cleared DNB exams, especially in the last couple of years, is no less than a genius. But does it mean that the vast majority, especially those who have been fortunate enough to have completed their rigorous training in highly reputed hospitals, are good for nothing? The National Board approves certain hospitals for imparting training and allows them to collect fees up to Rs 50,000 per annum. However, since the pass rates of the trainees from most such hospitals are dismal, the examinations formally declare that the centres approved by the Board are not fit to train the trainees sufficiently to pass the examinations even with repeated attempts. So, what is the value of the approval and the thorough and painstaking training that many such hospitals offer? Are the pass rates of DNB examinations reflective of quality or farce? During the DNB practical exams the examiners do not even bother to look at the logbook or dissertation.What are these for, then? Not even looking at the logbook means that the meticulous training at the approved centers count for/amount to nothing. In many other countries like the UK (12), Hong Kong (13) and Oman (14), the logbook is given due importance. To make effective use of technology, the UK and Ireland have already operationalised the Pan-Surgical Electronic Logbook (15). To make matters worse, the NBE does not formally publish the pass rates or even the rating criteria. At present it does not even send candidates their marksheets. However, a recent notification announces that starting in December 2009, marks will be provided, but only to unsuccessful candidates (16). In other words, those who pass are not entitled to know how they have fared in the examinations. The time may have come to rename it the National Board of Eliminations. References 1. National Board of Examinations. About Us [Internet]. New Delhi: National board of examinations;2006 [Cited 2009 Nov 20]. Available from: http:// natboard.edu.in/aboutus.php 2. Pandya SK. Medical Council of India: the rot within. Indian J Med Ethics [Internet]. 2009 Jul-Sep [cited 2009 Nov 20];6(3): 125 -31. Available from: http://www.ijme.in/cgi-bin/getpdf.cgi 3. Southgate L,Grant J.Principles for an assessment system for postgraduate medical training [Internet]. London: Postgraduate medical education

and training board; 2004 Sep 14[cited 2009 Nov 20]. Available from: http://www.pmetb.org.uk/fileadmin/user/QA/Assessment/Principles_ for_an_assessment_system_v3.pdf 4. World Federation of Medical Education. Postgraduate medical education: WFME global standards for quality improvement [Internet]. Denmark: WFME office, University of Copenhagen;2003 [cited 2009 Nov 20]. Available from: http://www2.sund.ku.dk/wfme/activities/ wfme%20standard%20documents%20and%20translations/ wfme%20postgraduate.pdf 5. ACGME:Accreditation council for graduate medical education [Internet]. Chicago: ACGME; c 2000-2009. ACGME program requirements for graduate medical education in psychiatry; 2007 Jul 1[cited 2009 Nov 20]; p.29-30 .Available from: http://www.acgme.org/acWebsite/downloads/ RRC_progReq/400pr07012007.pdf 6. Kimatian S J. Postgraduate medical education: how do we know it’s working? Anesth Analg [Internet]. 2006; 102:209-12. Available from: http://www.anesthesia-analgesia.org/cgi/content/full/102/1/209 7. Epstein RM. Assessment in medical education. N Engl J Med [Internet]. 2007 Jan 25 [cited 2009 Nov 24]; 356 (4): 387-96. Available from: http:// content.nejm.org/cgi/content/short/356/4/387 8. National Board of Examinations . Information Bulletin for December 2009 examinations [Internet]. New Delhi: Ministry of health and family welfare; 2009 Jul [cited 2009 Nov 24].p.22. Available from: http:// natboard.edu.in/dnbfinal/bulletin/NBE-Book%20page%2052%20Dece mber%20Final%202009_Broad%20Specialties.pdf 9. Bloom BS. Taxonomy of educational objectives, the classification of educational goals-Handbook I: cognitive domain. New York: McKay;1956. 10. Anderson LW, Krathwohl DR. A taxonomy for learning, teaching, and assessing: a revision of Bloom’s taxonomy of educational objectives. New York: Longman; 2001. 11. DNB PG doctors of the national board of examinations. DNB PG doctors petition [Internet]. [place unknown]: DNB pg. com; 2008 Jun 17 [cited 2009 Nov 20]. Available from: http://petition.dnbpg.com/ 12. University of Ulster. Postgraduate certificate/ postgraduate diploma/ masters forensic and legal medicine [Internet]. UK: University of Ulster; [updated 2006 Sep; cited 2009 Nov 24]. Available from: http://www. science.ulster.ac.uk/courses/biomed/pgd_msc_forensic_medicine_ and_legal.pdf 13. Hong Kong College of Physicians. Structured postgraduate medical training in internal medicine [Internet]. Hong Kong: Hong Kong college of physicians; [Updated 2005 Nov 29; cited 2009 Nov 24]. Available from: http://www.hkcp.org/ 14. Oman Medical Specialty Board. Postgraduate training programme for family and community medicine [Internet] [Cited 2009 Nov 24]. 21p. Available from: http://www.squ.edu.om/LinkClick.aspx?fileticket=UEH QFAStnmE%3D&tabid=4930&language=en-US 15. Elogbook. Pan-surgical electronic logbook for the United Kingdom & Ireland - A log book for life [Internet].[ Cited 2009 Sep7]. Available from: http://www.elogbook.org/ 16. National Board of Examinations. Notice regarding statement of marks[Internet]. New Delhi: Ministry of health and family welfare; 2009 Jul 10 [Cited 2009 Nov 24]. Available from: http://natboard.edu.in/ matter.php?notice_id=415

Diplomate of the National Board: inefficient parallel education Murali Poduval Department of Orthopaedics, Pondicherry Institute of Medical Sciences, Kalapet, Pondicherry INDIA 605 014 email: [email protected]

Abstract The National Board of Examinations conducts the Diplomate of the National Board in broad specialities as well as in core super specialities. The programme was meant to provide a common standard and a mechanism of evaluation the These programmes, as

per the prospectus of the DNB course are meant to provide the basic level of competence required for the postgraduate qualification in that subject. However, it has failed to meet these objectives. It is imperative to re-examine and revamp the system to improve its credibility and acceptability at both the national and international levels.

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The National Board of Examinations conducts the Diplomate of the National Board (DNB) in broad specialities as well as in core super specialities. Established in 1975, the programme was meant to provide a common standard for postgraduate education and a commonly accepted evaluation mechanism for national and international comparison. It has attained the status of a parallel system of postgraduate education in India over the years. In his critique of this system, Sarbhadikari describes the DNB examination as a farce (1). He has attempted a study of the evaluation and examination system in light of recommended standards for postgraduate medical education and found it wanting on several counts.

The national board of examinations The National Board, in its prospectus, states: The setting up of a National Body to conduct postgraduate medical examination was intended to provide a common standard and mechanism of evaluation of minimum level of attainment of the objective for which postgraduate courses were started in medical institutions. Moreover, intra country and international comparison is facilitated with the availability of commonly accepted evaluation mechanism like DNB.(2) However, the DNB has been relegated to the sidelines. What should have been a prestigious asset to the field of medical education is now a tool utilised by institutions to obtain a cheap workforce and by candidates who do not make it to the regular mainstream MD and MS courses to pursue a degree in a postgraduate discipline of their choice. It is now known that postgraduate seats in government-sponsored institutions are extremely hard to come by. With the advent of postgraduate entrance examinations and reservations in all levels of recruitment into the postgraduate courses, an average student would find two ways out: buy a seat or opt for a similar or smaller course. The DNB is a good alternative for these students. At the same time the country is seeing a great increase in institutions and hospitals in the private sector. Starting a DNB course is an easy way to label the institute as a postgraduate institution. The students who join the course would continue to work as regular residents throughout the period of study and would regularly be replaced by a new set. Stipends paid have been a bone of contention as noted by many students in an online petition. The downside remains the raw deal for students. The institution gets a renewable workforce, and a title of a teaching postgraduate institution; the students get a seat, but hardly any teaching and practically no hands-on experience, as all the patients are private patients of the concerned consultant in charge of the hospital. In addition to the primary examinations in broad specialities and super specialities, the board provides a platform for students who have procured a postgraduate diploma to undertake further studies by obtaining a degree equivalent of the MD/MS (Doctor of Medicine, and Master of Surgery). The national board has also introduced direct five-year courses in the super specialities of neurosurgery and plastic surgery. It also provides opportunities to super specialise in sub specialities such as arthroplasty and spine surgery.

In its scope, the DNB is impressive. But in implementation it has probably been a failure. It is still premature to write it off as a “has been”. But it may be necessary to take corrective steps in order to produce a qualified and useful workforce.

Selection criteria and examination routines The process of selection for the DNB primaries is fairly well spelled out and all the prerequisites need to be fulfilled. Candidates who already have their MS/MD just need to ensure that their degrees are recognised (3). The theory and practical exams are standardised and the candidates are allowed a choice of centre to take their exams. There are four theory papers (there are no objective papers), each consisting of 10 essays. Though these are fairly comprehensive and cover the subject well, they can hardly be considered a measure of the student’s abilities. They can, at the most, be used as a primary screening before candidates appear for their practical examinations. It may not be practical to do away with these sessions but an addition of multiple choice and analytical tests that simulate a clinical situation and also test decision making ability may help improve assessment in theory papers. Once the theory examinations have been cleared, the candidate is given three attempts at the practicals. In the practical examinations, the DNB follows the same pattern as that of the MD/MS exams. The theory papers are just a matter of learning by rote, it’s the practical examinations which challenge the student and test his training and ability, and unless the student undergoes a well defined system of appraisal and training, s/he is unlikely to be fit to give the examination, leave alone pass the examination. It is easy to hold the national board responsible for these problems, but the examination system alone cannot be blamed for the maladies afflicting the board.

Results of the examinations The DNB examination is noted for its poor pass percentages. Sarbhadikari notes, correctly, that a number of the students who do pass the DNB at the first attempt are those who already have their MD and their MS degrees. It is difficult to understand what use the DNB is to them besides the addition of an equivalent qualification on their visiting cards. However, few of those who give the DNB as their primary postgraduate exam manage to clear it in the first attempt. Is the DNB going largely to candidates who have no use for it, or who are anyway not likely to benefit from it? The DNB students in their online petition state:

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DNB final exams rarely depicts [sic] the published board syllabus and the exam pattern is largely descriptive, outdated and scientifically invalid. The dates of the theory and practical parts of the exam are not published in due time for the candidates to prepare effectively for the exams. This along with the long waiting period between the theory exam and the publishing of the results makes the candidates anxious and reduces the performance during the practical exam which follows very shortly after the


publishing of the theory results. The practical exams are conducted erratically with no fixed dates and venues. There are numerous instances, where practical exam venues were cancelled and few [sic] unfortunate instances, where practical exam results were cancelled after the conducting of exams forcing the candidates to reappear for the exam. This is adding up to the misery of the already stressed exam going candidates leading to a suboptimal performance by the candidates.(4) Now, many universities have prevented government institutions from running both MS/MD and DNB courses within the same institution. The DNB candidate is therefore at the mercy of private players who institute the course to acquire the status of a postgraduate institute, and at the same time, acquire staff at a low price. The DNB may be less lucrative than an MS / MD seat, but it is also cheaper for the candidate. Many institutions offering DNB courses have adequate qualifications and are reputed enough to sustain a teaching programme. Many others are not so well equipped and do not have a good patient load, and consequently the candidate is likely to suffer for want of adequate clinical material. This evil does not afflict DNB institutions alone; many institutions offering MD and MS courses suffer from a similar malady, especially outside the government sector.

The internal appraisal system of the national board The board has set up an appraisal system both for candidates and for centres, to be conducted at six monthly intervals. These appraisals are mandatory for the centre to continue its training programme and for the student to be able to continue the course (5). It would be interesting to learn how honest these appraisals are, but such an analysis has yet to be carried out or published. These appraisals are meant to be carried out at the local level and should include a short theory paper, feedback on the theory paper, thesis and log book review, practical examination, hospital infrastructure appraisal, a report and suggestions on the DNB training and appraisal process (5). In practice, one finds just two essential steps in the appraisal process − a reproduction of the exam and feedback based on it, and an analysis of thesis progress and log book records. The review of progress of skills here is entirely subjective, and there is no objective analysis of the method and progress of the training programme. The appraisal should ideally be bilateral and independent of the institution. Both the candidate’s self assessment and the assessment of the appointed assessor should be read by a third, uninvolved party. This may help identify defects in the training programme. The stress on theory examinations could explain why it is easier to pass the theory examinations than it is to pass the practical examinations. Theory examinations hardly measure the ability and sound clinical judgement of the candidate or the progress in his/her training. They can at best be a measure of the ability to reproduce what has been read. Practical examinations depend on the acquisition of basic clinical skills and the ability to give the rationale for a plan of

clinical management. This is possible if the training includes these basic skills. Davidoff lists a number of educational initiatives designed to develop competence in individual patient care which include problem-based learning, evidence based medicine and training in the use of clinical guidelines. Problem-based learning, described as “quasi-experiential”, is a model that uses a written case rather than a living patient as a trigger to evolve a definition of the student’s learning goals as well as independent self-directed learning which can be reinforced under faculty supervision in group discussions(6). Any form of assessment must include protocol-based enquiries based on treatment plans and current concepts. A simple reproduction of exam patterns in the assessment protocols will not suffice. A detailed assessment of patient loads and teaching protocols in the institution must also be mandatory. This would ensure that the candidate gets adequate handson experience. Such requirements gain more significance in light of the fact that under current rules DNB candidates have equal rights to be selected for teaching posts provided they have completed an additional year of training following their qualification (7). Further, many grievances have been expressed by DNB candidates, regarding their passing percentages and their stipend payments (3). These too need to be addressed. Dr Sarbhadhikari, has correctly noted that transparency and accessibility of all results and assessments in the public domain are a must. Above all these, the DNB appraisal should also include a periodic appraisal of its faculty and there should be prerequisites for qualification, teaching experience, ongoing research and conference involvements and publications, in parallel with the Medical Council of India’s rules on faculty promotions. This would ensure quality amongst all faculty which would reflect on the quality of teaching and training. The DNB’s fellowship programmes and super-speciality teaching programmes are both welcome steps, as certificate programmes of this type do not exist in the standard postgraduate teaching schedules of the universities in India. They therefore provide an opportunity for the student to acquire further qualifications without leaving the country. These programmes are relatively new and the National Board must bring in a quality control system to monitor the viability, reliability and acceptability of these qualifications, if necessary in collaboration with universities in India and abroad.

Conclusions The National Board is a necessary institution in a country that is short of medical professionals. But it has failed to meet its objectives. The dismal pass percentage of the DNB course is not a comment on the difficulty or comprehensive nature of the course; instead it reflects on the poor training imparted to its students that prevents a good pass percentage despite the three attempts permitted for the practical exams. Urgent steps need to be taken to revamp the training, assessment

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and creditworthiness of the DNB courses to bring them on par with world standards and to achieve the goals set out in the constitution of the National Board. The National Board of Examinations needs to upgrade itself urgently to avoid the tag of “National Board of Eliminations”. The author declares no conflicts of interest in relation to the contents published in this commentary. References 1. Sarbhadikari S. A farce called the National Board of Examinations. Indian J Med Ethics. 2010 Jan; 7 (1); 20-2. 2. National board of examinations. Information bulletin & application form for diplomate National Board final exam (broad specialties) [Internet]. New Delhi: Ministry of health and family welfare; [cited 2009 Nov 20]. Available from: http://www.natboard.edu.in/dnbfinal.php 3. National board of examinations. Guidelines for admission to DNB

programme [Internet]. New Delhi: Ministry of health and family welfare; 2007 [cited 2009 Nov 20]. Available from: http://www.natboard.edu.in/ notice_for_dnb_candidates/Guidelines.pdf 4. DNB PG doctors of the national board of examinations. DNB PG doctors petition [Internet]. [place unknown]: DNB pg. com; 2008 Jun 17 [cited 2009 Nov 20]. Available from: http://petition.dnbpg.com/ 5. National board of examinations. Periodical appraisal for DNB ; new guidelines for July 2008 local appraisals [Internet]. New Delhi: Ministry of health and family welfare; 2008 Jun 6 [cited 2009 Nov 20]. Available from: http://www.natboard.edu.in/Periodical_Appraisal_for_DNB/final %20revised%20soodAppraisal%20formJuly20085.6.2008.pdf 6. Davidoff F. Focus on performance- the 21st century revolution in medical education. Mens Sana Monograph [Internet]. 2008 Jan- Dec [cited 2009 Nov 20]; 6(1): 29-40. Available from: http://www.msmonographs.org/ temp/MensSanaMonogr6129-1486009_040740.pdf 7. National board of examinations. DNB equivalence important notifications. [Internet]. New Delhi: Ministry of health and family welfare; [cited 2009 Nov 20]. Available from: http://www.natboard.edu.in/dnb_ equivalence_imp_notifications.php

Medicine, merit, money and caste: the complexity of medical education in India Abhijit M Bal Department of Medical Microbiology, Crosshouse Hospital, Kilmarnock KA2 0BE Scotland, UK email: [email protected]

Abstract Private medical colleges in India are under the scanner. There is a longstanding debate about the selection methodology that should be followed for admissions in medical colleges. A significant proportion of aspirants are able to afford medical education in private colleges despite not clearing entrance examinations. Others gain entry purely on the basis of caste. Medicine deals with human life and, consequently, there is a widespread feeling that admission criteria in medical schools should be based only on merit as assessed in entrance examinations. This article examines some of these contentious issues. “She is quite a serious thinker, even though her grades are very good.” School teacher in Shanti Niketan, West Bengal, quoted by Amartya Sen (1) Medical education is a hotly debated subject in India these days. Government colleges have not increased in number while new private medical colleges are established each year, many of them with dubious infrastructures and questionable motives. The fact that private colleges make obscene amounts of money and allow rich people who can afford the exorbitant fees to bypass entrance examinations is anathema to many ordinary Indians. Similarly, the concept of caste-based reservation generates passionate arguments and the side one takes is generally, and indeed ironically, dictated by one’s own caste. Many have castigated the entire admission process as based on money and caste. As merit is apparently the loser, some have

called for a single annual selection process for placements to all medical colleges with an end to caste-based reservations as well as paid placements. Others support privatisation of medical education for they see it as a necessary consequence of caste-based reservations in government institutes. The purist would simply want all private medical colleges shut without any debate on the subject. None of these views is without foundation. In the following paragraphs, I attempt to examine these issues in detail. It is hard to argue against the use of entrance examinations for medical college placements in a country with relatively limited opportunities. Candidates selected through this formal assessment process, generally based on a multiple-choice format, answer more questions correctly than those who miss out on placements, with the cut-off grade based on the number of available placements. Entrance examinations for MBBS seats usually assess the applicant’s knowledge in fundamental sciences; some universities give higher weightage to biology. A few universities have additional criteria. A passing grade in Gandhian thought is a prerequisite for entry into Mahatma Gandhi Institute of Medical Sciences, Sevagram, while 50 out of 60 seats in Christian Medical College (CMC), Vellore in the year 2009 were under the sponsored category. Candidates applying under this category are sponsored by Chrisitian organizations which are members of the CMC Vellore Association or Council (2). The process is extremely rigorous and there are few survivors.

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But does performance in entrance examinations define merit and measure brilliance? The examinations relate only to academic merit which is not what a doctor is all about. Moreover, true merit is the ability to convert competence into performance. However, when people put a case for meritbased entry, all they are saying is that when choosing students for a fixed number of placements, those candidates who score higher in a certain test format should be preferred over those who do not score as well. This does not imply that those who fail to gain entry have no merit; if that were the argument, the presence or absence of merit would be dictated solely by the number of available seats. Private medical college is an option for those students who don’t perform very well in entrance examinations conducted by government institutions − provided these students can afford to pay the fees. In turn, private colleges in many states subsidise the fees for a certain number of “government quota” students. This arrangement offers an opportunity to students who narrowly miss out in entrance examinations for government medical colleges. Students who fill the government quota in private colleges pay lower fees than others in these medical colleges. The challenge therefore is to see that both these groups achieve the same level of competence as their counterparts in prestigious government colleges. The task is not easy because while over the years reputed institutes have created an environment which has led to sustained academic excellence, the new players lack in motivation and, often, in infrastructure. Moreover, the turnover of teachers in private colleges is high, as private jobs lack long-term security and adequate pension schemes. On the other hand, government colleges are more successful in retaining teachers who then develop a sense of belonging to the institute. However, the situation is fast changing. Few talented medical professionals are willing to teach at medical universities − private or government − because private practice offers better remuneration. And in any case most doctors from high quality institutions leave India (3). As a result, academic teaching has taken a turn for the worse in most institutes, government and private. Attractive pay packages in government and private colleges are essential to retain teachers. It is a popular notion that only the most brilliant can become good doctors. But popular views are not necessarily right. Excellence in mathematics is popularly thought to relate to the ability to compute numbers speedily and chess is perceived to be a game where the player who calculates all possible moves wins. Anyone who has played chess at a higher level would be quick to see the fallacy of this line of thinking. Great chess players simply know the best move without the need to calculate. What they figure out is how best to place the pieces, although some of it may be a result

of deep-seated mental calculation; we do not know. But, certainly, calculations in chess are not made in the manner that people commonly perceive. Micheal Bezold, a German grandmaster, sums this up when speaking of the world chess champion Bobby Fisher: “He just felt that a certain move was the right move without calculation. And after analysing, we saw it was the right one.” (4) Similarly, a skilled mathematician relies on abstract ideas, not on quick multiplication of digits. In much the same way, medicine is not about knowing, say, Harrison’s textbook of internal medicine, for that is a relatively simple task and, in any case, not a measure of brilliance. It is the training component of medicine that makes a good doctor. This training gives an insight into the myriad conditions that affect humankind while imparting an ability to make sound judgements in relation to various illnesses by putting disease symptoms into a specific pattern. All of this is accomplished by well-directed effort and is the culmination of rigorous training. It requires years of experience. Anyone with reasonable ability can become a good doctor by fulfilling these conditions. Over the years, stiff competition in India ensured that only the high-end performers at entrance examinations could get placements in medical schools, given that medicine was a highly sought-after profession. Thus, although medicine does not need brilliance, only hard-working, diligent, and possibly brilliant people could hope to become doctors. Moreover, the growth of private medical schools in the 1980s and 1990s coincided with changing social values in India. Money was no longer seen as evil. For the average person, therefore, the private medical college graduate was out there to get returns on his or her investment. If brilliance is not a prerequisite, how do we address the issues surrounding placements in medical colleges? One option is to use interviews as an addition to other evaluations. However, although interviews should be an important part of the selection process, they are unlikely to gain acceptance in India because we lack a transparent system. Public confidence in an interview-based selection process is bound to be low. Few institutes in India have remained free of accusations of malpractice and sooner or later, an interview-based selection process would be tainted with allegations of corruption. Hsuan Tsang, a Chinese traveller in 7th century India, said of Indians: “They do not practice deceit, and they keep their sworn obligations...They will not take anything wrongfully, and they yield more than fairness requires.” (5) Much has changed in India since then. It is likely that government funding in medical education will be further curtailed in the future. Private colleges should therefore be allowed to flourish in order to meet the demands of healthcare and medical education. However, it is equally important to ensure that private institutes invest the money

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back into education while keeping a reasonable profit for themselves. If assessment standards are clearly defined and if examinations are conducted by external boards comprising members who are above suspicion, private colleges will be forced to invest in their infrastructure, or else a string of poor pass percentages will dissuade people from taking admissions in these colleges. Even if regional authorities are unbiased in overseeing the process, external committees for final year assessments will help generate confidence in the system. Also, once these assessments are conducted in a fair and transparent manner, the original method of entry at the MBBS level will become less relevant. On the other hand, it is reasonable to have a two- or even a three-tier fee structure so that students who get selected through an examination process pay lower fees while ensuring that everyone gets the same level of training without any discrimination. The same arguments apply to caste-based reservations. Reservations based on economic criteria find many sympathisers. Indeed, individuals who despise the concept of caste-based reservations often agree to some kind of reservation for the poorer sections of society. Further, their argument that caste-based reservations compromise merit still finds a place in forums and debates. Surely, there is a contradiction. Merit is compromised no matter what the basis of reservation is. Why do we think that while the poor would catch up at a later stage of their careers, those from backward castes will struggle and end up as incompetent doctors? This reflects a deep-seated bias in the minds of the majority of Indians. It is only fair that social settings are taken into consideration when providing opportunities for higher education. And once again, fair exit assessments would nullify the merit argument. CMC has consistently been voted amongst India’s best medical schools despite religious sponsorships accounting for a fair proportion of places. It has even been awarded a five star rating by the National Assessment and Accreditation Council (6). This further underlines the fact that academic merit is not the sole indicator of performance. A great deal of competence can be acquired with rigorous training in professional life irrespective of one’s performance in graduate level entrance examinations. The need to regulate doctors’ performances throughout their professional careers cannot be over-emphasised. We must understand that the selection process is only needbased. The education component and, in this context, medical training, has little to do with the attributes judged in the selection process. Moreover, we need to define the objective of medical education. If the sole objective of the graduate level MBBS education is to produce doctors who will be expected to acquire the ability to pass postgraduate entrance examinations, and if the objective of the postgraduate course

is to produce specialists who will do well at super-specialist entrance examinations, then of course we need a merit-based graduate entry process that selects candidates with a flair for the particular format of assessment. But if the objective of medical education is to produce good doctors who can provide healthcare, then these attributes are meaningless and the sole reason to continue with the rigorous selection process is lack of opportunities in a country with so many young people. The need for a selection process − whether based on merit or any other measure − is therefore understandable but the principle is not all that sacred. It is a boon that we have different kinds of medical establishments. Some have religious affiliations while others have unique selection criteria as mentioned earlier. There are government-funded colleges with a selection process based on entrance examinations. There are private colleges with selection based on central university-conducted examinations as well as self-funded placements to those who fulfill basic criteria for undergraduate medical education. In fact, there is enough room for international colleges now so as to attract non-Indian foreign nationals and not just non-resident Indians or people of Indian origin. We need to invest in this diversity rather than create a rigid, monotonous, structure with the dull uniformity that is the hallmark of decadence. India has tremendous potential to prosper as a knowledge economy if we manage to address some of our basic problems. Finally, we must revisit our teaching format. India traditionally worships knowledge. The hymn from the Brihadaranyak upanishad is recited in many Indian homes at prayer times:

“Lead us from falsehood to truth, from darkness to light and from death to immortality.”

Accessible to only a select few for thousands of years, knowledge became a highly precious commodity. It is therefore not entirely surprising that our education system is based on information gathering that is considered an end rather than a means, and the one who has most information usually ends up getting the highest grade. The subsequent self-fulfilling idea equating examinations with knowledge and wisdom soon finds its feet. But too much emphasis on acquiring information can kill raw curiosity without which scientific ideas cannot advance. And this is what has generally happened with our university education. As a result, we acquire degrees without a proportionate level of skill, and learning is deprived of curiosity. The effect that traditions and culture can have on education is an interesting subject in itself. For example, it has been suggested that countries with Buddhist traditions have done well with regards to literacy because of the Buddhist emphasis on enlightenment (7). We do not have to look outside for bringing about a change. Asks a vedic sage (8):

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Why does the wind not cease? Why does the mind not rest? Why do the waters, seeking truth, Never ever cease? The freshness need not be borrowed from elsewhere. Competing interests: The author graduated from private medical college and paid full fees. He has been unsuccessful at all entrance examinations. References 1. Les Prix Nobel. The Nobel Prizes 1998, Editor Tore Frängsmyr, [Nobel Foundation], [Internet]. Stockholm, 1999 [cited 2009 Aug 17]. Available from: http://nobelprize.org/nobel_prizes/economics/laureates/1998/ sen-autobio.html

2. Admission page [Internet]. Vellore(India): Christian Medical College; [cited 2009 Aug 17]. Available from: http://home.cmcvellore.ac.in/ admissions/degweb/ugbulletin%202009.pdf 3. Kaushik M, Jaiswal A, Shah N, Mahal A. High-end physician migration from India. Bull World Health Organ 2008; 86(1): 40-5. 4. Edmonds D, Eidinow J. Living Chess. In: Bobby Fischer Goes to War. [place unknown]:Faber and Faber; 2004.p.62-71. 5. Eraly A. Death of the future. In: The Mughal Throne: The Saga of India’s Great Emperors. London: Phoenix; 2004.p.517-21. 6. Assessment and accreditation [Internet]. Bangalore(India): National assessment and accreditation council; [cited 2009 Aug 18]. Available from: http://naacindia.org/Colleges.asp?state=22 7. Sen A. Identity and violence: the illusion of destiny. [place unknown]: Penguin books; 2006. Chapter 6, Culture and captivity; p.103-19. 8. Griffith RT. The hymns of the Atharvaveda [Internet]. 1st ed. [place unknown]: Evinity Publishing Inc; 2009 Apr 16. Hymn 7: 37, Skambha, the pillar or fulcrum of all existence; [cited 2009 Aug 18]; [about 5 screens]. Available from: http://www.sacred-texts.com/hin/av/av10007.htm

Financial incentives and the prescription of newer vaccines by doctors in India Rakesh Lodha1, Anurag Bhargava2 1 Department of Paediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110 029 India email: [email protected] 2Jan Swasthya Sahyog, I-4, Parijat Colony, Nehru Nagar, Bilaspur, Chhattisgarh 495 001 India email: [email protected]

The pharmaceutical industry spends a significant amount of resources on marketing its products. According to one estimate, the top 50 companies in India alone spent Rs 5,340 crore in 2004 on drug promotion, spending 290% to 1,025% more on marketing than on research and development (1). The interactions between the pharmaceutical industry and the medical profession related to promotion of medicines have been described as an entanglement; 16 forms of this entanglement have been described (2), and they range from acceptance of gifts and sponsorship of lavishly organised continuing medical education events featuring industrysponsored speakers, to industry-sponsored research (2). While physicians claim that they are not influenced by the promotional practices of the industry, there is compelling evidence that aggressive promotional efforts lead to irrational and incautious use of more expensive, newer medicines, and escalation of healthcare costs (3,4). The primary responsibility of physicians is to promote their patients’ best interests, while the primary concern of the industry is to promote profitability (4). In the past few years, there has been increasing concern over the influence of the pharmaceutical industry over the practice of medicine, medical education and research (5), and guidelines of professional bodies strongly discourage physicians from accepting costly gifts, hospitality, trips and subsidies of any type from the industry (6). The WHO’s criteria for ethical medicinal promotion clearly prohibit industry from offering financial inducement and incentives (7). In India, where unethical drug promotion is a significant problem (8), the Medical Council of India’s code of conduct (9) still does not address what constitutes appropriate, ethical and legal conduct

in the interactions between professionals and their associations with the pharmaceutical industry. We report, here, a new and disturbing form of entanglement being employed as a marketing strategy by vaccine manufacturers in India, and discuss briefly its ethical, scientific and public policy implications. This strategy involves the promotion and sale to doctors of newer vaccines - including polyvalent vaccines which are not part of the Expanded Programme of Immunisation (EPI) − at a highly discounted price in relation to the maximum retail price (MRP). The prices of vaccines quoted in a communication sent to doctors are given in Table 1. As highlighted in the table, the percentage margin between the price to doctors and the MRP ranges from 30% to 69%, while in rupee terms, the discount over the MRP per vaccine dose ranges from Rs 85 to Rs 620. Many vaccines require the administration of three or even more doses, wherein the margins of profit for each vaccine could even be Rs 1,800 per child vaccinated. In addition to the private communications to physicians, companies have now started advertising the price of their vaccines to doctors in medical journals. Another company (Chiron Panacea) has placed advertisements in paediatrics journals quoting the price of the pentavalent vaccine ‘Easyfive’ as Rs 275 to the doctor while the MRP of the vaccines is Rs 585. While physicians will incur some costs for the storage of vaccines, the margin of profit is still huge, and could be termed as profiteering. Such high margins are difficult to find in other professions or industries or in the case of other goods. Unlike other goods, in the case of medicines, patients are unable to make an informed choice about the need and choice of medicine, and rely on the

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Table 1 Difference in a vaccine’s MRP and the price at which it is offered to physicians Vaccine

Constituent vaccines

MRP, in rupees, Price offered to Discount in Percentage Margin of profit 2008 (A) physicians, in rupees (B) rupees (A-B) for the physician (A-B)*100/ B

Pentaxim

Diphtheria, Tetanus, acellular pertusis, inactivated poliomyelitis vaccine, Haemophilus influenzae b conjugate vaccine

2066

1446

620

42.9%

Imovax Polio

Inactivated Poliomelitis vaccine

365

280

85

30.4%

Tripacel

Component pertusis, Diphtheria and tetanus toxoids

1211

762

449

58.9%

Okavax

Varicella vaccine

1468

986

482

48.9%

Avaxim 80

Hepatitis A Vaccine

952

665

287

43.2%

TetractHib

Diphtheria, Tetanus, pertusis, Haemophilus influenzae b conjugate vaccine

504

305

199

65.2%

ActHib

Haemophilus influenzae b conjugate vaccine

426

251

175

69.7%

Source: Letter from the manufacturing company to pediatricians

judgement of the practitioner to make a reasoned choice on their behalf. Whereas other medicines are administered in illness and have limited indications, vaccines are administered to prevent disease, and every healthy child can be considered eligible in a sense. In the case of many new and expensive vaccines, as well as the combination vaccines that are being promoted in these communications, the indications for use in the Indian context are not well established, in terms of the epidemiologic rationale or cost-benefit analysis (10). In fact the price of combined vaccines for some diseases is more than the cost of the separate vaccines. The immunisation subcommittee of the Indian Academy of Pediatrics has issued guidelines for the use of some of the vaccines that are being promoted (11). These have been placed in the category of “vaccines to be administered after one-to-one discussion with the parents”, as there are insufficient epidemiologic grounds for their routine administration. The guidelines of the IAP are vague and open to interpretation and, given the significant financial inducement to prescribe, they will facilitate over-prescription of some of these vaccines (12). The communications to doctors highlight the prices without providing drug information related to the vaccines. This violates the basic tenets of ethical drug promotion, which should involve provision of prescribing information rather than inducements to prescribe. One of the handouts to doctors even mentions the price of a vaccine for yellow fever (which does not exist in India), without making any reference to the fact that it is required only for those travelling to an area endemic for yellow fever. The significant financial incentive being offered to doctors on dispensing newer and combination vaccines alters the nature of the relationship between the doctor and the patient and opens a wide area of conflict of interest: the doctor benefits significantly by prescribing a particular vaccine whereas the benefit to the recipient may be marginal. “What would my patient think of this arrangement?” (6) is a question that can test the ethical appropriateness of our interaction with the pharmaceutical industry. In the above case, patients’ knowledge of these marketing practices, and the acquiescence

by doctors, will serious undermine patients’ and the public’s reliance on the trustworthiness and professional judgement of Indian doctors. This promotional campaign raises numerous issues for public health and policy in India. First, the aggressive marketing of vaccines of questionable public health significance in the private sector is occurring in the backdrop of shortages of essential vaccines required for the EPI (10). This is consequent to the closure of the three public sector units which were manufacturing these vaccines, on grounds which are highly questionable and have been widely criticised (13). Private sector manufacturers have been reluctant to provide low-cost essential vaccines to the government even though they are marketing the same vaccines in combination with other vaccines. A large number of children in India are at risk of suffering and dying from vaccine-preventable diseases, because of vaccine shortages. We agree with the demand that vaccine manufacturers should be made to provide vaccines for the EPI before they are allowed to promote expensive vaccines for their profits (10). Second, the huge margins on offer clearly indicate that the retail prices being paid by parents and patients are highly inflated. The companies could have afforded to sell their vaccines for far lower prices without a loss in profitability. This indicates that there is scope for a substantial reduction in vaccine prices. These practices can be curbed only by placing all vaccines back under price control. Vaccines were under price control till 1995 when the criteria for inclusion in the list of price controlled drugs were changed. Thought vaccines and antisera are essential medicines, the new criteria implemented used market-based criteria without any regard to the importance of the drug. Third, the manner in which these vaccines are being promoted represents the nadir of drug promotional ethics. We are in need of institutional and legal mechanisms to curb aggressive, misleading and unethical promotion of medicines.

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The United States Food and Drug Administration, for example, closely monitors promotional material and makes manufacturers accountable for this material by issuing letters of warning (14). References 1. Soneji H, Banerjee A. Indian pharma majors prefer brand promotion over R&D. Economic Times. 2004 Dec 15. Available at: http://economictimes. indiatimes.com/articleshowarchive.cms?msid=959093 2. Moynihan R. Who pays for the pizza? Redefining the relationships between doctors and drug companies. 1: Entanglement.BMJ. 2003;326:1189-92. 3. Liu YM, Yang YH, Hsieh CR. Financial incentives and physicians’ prescription decisions on the choice between brand-name and generic drugs: evidence from Taiwan. J Health Econ. 2009; 28: 341-9. 4. Wazana A. Physicians and the pharmaceutical industry. Is a gift ever just a gift? JAMA. 2000;283:373-80. 5. Relman AS, Engell M. How the drug industry distorts medicine and politics. America’s other drug problem. The New Republic. 2002 Dec. 16:27-41. 6. Coyle SL, for the Ethics and Human Rights Committee, American College

of Physicians-American Society of Internal Medicine. Physician- Industry relations. Part 1: individual physicians. Ann Intern Med. 2002; 136: 396402. 7. WHO Ethical criteria for medicinal promotion. WHO, Geneva 1988. 8. Gulhati CM. Marketing of medicines in India, BMJ. 2004 2004;328:778779 (Apr 3 ), doi:10.1136/bmj.328.7443.778 9. Medical Council of India. Code of Ethics Regulation. 2002. Available at: http://mciindia.org/know/rules/ethics.htm 10. Puliyel JM, Madhavi Y. Vaccines: Policy for public good or private profit. Indian J Med Res. 2008; 127: 1-3. 11. Indian Academy of Pediatrics Committee on Immunization (IAP COI). Consensus recommendations on immunization, 2008. Indian Pediatr. 2008; 45: 635-48. 12. Lodha R, Kabra SK. One to one immunization guidelines. Indian Pediatr. 2009; 46: 1021-2. 13. Vishwanathan S. Painful Shot. Frontline. 2008;Volume 25: Issue 7. Available at; http://www.flonnet.com/fl2507/stories/20080411250702200.htm 14. US FDA. Warning letters 2009. Available at: http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Enforcement Activities by FDA / Warning Letters and Notice of Violation Letters to Pharmaceutical Companies/ucm055773.htm

Vaccines: for whose benefit? Yash Paul Consultant paediatrician, A-D-7 Devi Marg, Bani Park, Jaipur 302 016 INDIA email : [email protected]

Development of vaccines is a priceless gift from humans to humankind because vaccines prevent diseases while drugs treat or control diseases. Without any research grant or government funding, in 1796 Edward Jenner developed an inoculum. It is said that when the British government asked him to license his inoculum technology for a small royalty on each dose, Dr Jenner refused, electing instead, to give all rights to his preparation technology and preparations to the public free of any royalty. Unfortunately, today’s bottom-line-driven vaccine manufacturers are more interested in developing vaccines that maximise their profits. A doctor must care for individuals. Advice regarding immunisation, like other aspects of medical care, should be given after full consideration of the financial status and circumstances of the family but in the best interest of the individual concerned. The list of essential vaccines should be decided by experts and not by the pharmaceutical industry; the industry should cater to our needs. But at present newer vaccines are being dumped in our country and experts or experts’ group(s) are coerced to create a need for these vaccines. The government should give some sort of incentives for immunisation as vaccines prevent diseases, reducing the burden of expenditure on treatment of diseases and also reducing absenteeism from work and education. The government should consider exempting vaccines from sales taxes and charges in order to reduce the price of vaccines. Similarly, there should be some mechanism to regulate the difference between the maximum retail price (MRP) and

the price to doctors or chemists. At present there is a huge difference in these rates for some of the expensive vaccines. I would like to cite the example of one such vaccine. Currently the varicella vaccine is available in India from three manufacturers. Their price structure is given in Table 1. Even if all the three vaccines happen to be of similar efficacy, one may be tempted to recommend vaccine C because of the huge profit margin to the doctor. If the difference between the MRP and cost to the doctors is equal or nominal, doctors may consider the comparative merits of the vaccines instead. TABLE 1 Price structure of three varicella vaccines Vaccine MRP Cost to doctors Difference A. Earlier 1430 1120 310 1599 1102 497 Now B. 1468 1005 463 C. 1690 1050 640

Market forces play a role in the reduction or increase in a product’s price. Strangely, the increase in MRP of brand A vaccine is not related to an increase in the cost of production. On the contrary, the table shows that the price for doctors was actually reduced, though marginally. The difference between the MRP and the price for doctors or chemists is very small for those vaccines which are part of the National Immunisation Programme. The difference between the MRP and the price for doctors is Rs 500-600 for some newer vaccines. The MRP of DPT is Rs 15.50 and the cost to doctors is about Rs 12.50 whereas the MRP of DaPT is Rs 699 and the cost

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for doctors is Rs 595. Doctors would prefer to administer the DaPT vaccine. These days some of the new vaccines are advertised in the electronic media on the pretext of creating public awareness. Consumer products are advertised, but no new medicine is advertised in a similar manner. Some of these vaccines are not recommended for universal immunisation but are recommended for specific conditions, but this is not mentioned in the advertisement. So when parents ask their doctors about such vaccines, doctors finds themselves in a piquant situation. For example the influenza vaccine is recommended when a vaccinee is suffering from chronic pulmonary and cardiac disease, immunodeficiency, HIV infection, etc. On the other hand the absence of such indications is no contraindication for this vaccine, and no harm is expected to occur. The doctor may choose to explain the true situation and spend a lot of time to convince the parents that the vaccine is not required for that child. Two questions may be asked. First, will any harm occur to the child if this vaccine is administered? The answer is “No”. Second, is there any possibility, although it is not likely, that this child could suffer from a severe form of

influenza in the future? The answer of course is “Yes” as this possibility is always there. Thus, through advertisements, a sort of fear is created to increase sales of this vaccine. Under these circumstances doctors cannot be blamed for administering such a vaccine. Such advertisements should not be permitted. For some time the medical profession has been in the news, but for all the wrong reasons. Earlier it was the “kidney racket”, then abortions of female foetuses, and now, in August 2009, a “blood scandal” has been reported from Lucknow and Kanpur. If information regarding the huge difference between the MRP and the cost to the doctors - in other words the profit to doctors - becomes public, the reputation of the medical profession will take a further nose dive. Vaccines are to provide benefit to people, with a nominal financial benefit and not for huge financial gain, which may act as enticement for the doctors. Perhaps it is high time that some introspection is done and remedial steps taken to win respect and trust of people. Some of these issues were raised by the author during the consultative meet on a sustainable national vaccine policy held in New Delhi on June 4-5, 2009.

ETHICS IN SOCIAL SCIENCE RESEARCH Ethics in health research: a social science perspective Editors: Amar Jesani, Tejal Barai-Jaitly. Published by: Centre for Studies in Ethics and Rights (CSER), Mumbai. November 2005. 272 pages. Rs 150. This volume brings together papers by social scientists and researchers dealing with the relation between social sciences and bioethics. It contains a review of ethics in epidemiological, biomedical and social science research and essays covering issues such as ethics in research using anthropological and qualitative research; mental health and sexuality research; research with women; ethical responsibilities in social science publishing; and ethics review and institutionalisation of ethics in social science research in health. To order copies, please send a demand draft or cheque in favour of “Forum for Medical Ethics Society” to Forum for Medical Ethics Society, c/o Centre for Enquiry into Health and Allied Themes, Sai Ashray, Survey No 2804-2805, Aaram Society Road, Vakola, Santacruz (E), Mumbai 400 055 INDIA Email: [email protected] Please add Rs 30 for outstation cheques.

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DEBATE

Disability and the Medical Termination of Pregnancy Act, 1972 Divya Bhagianadh Centre for Studies in Ethics and Rights, 501,’B’ Wing, Dalkhania House, Near SBI, Vakola Pipeline, Nehru Road, Santacruz (East), Mumbai 400 055 INDIA email: [email protected]

On July 21, 2009, the Supreme Court (SC) of India stayed the order of a division bench of the High Court (HC) of Punjab and Haryana in a civil writ petition filed by the Chandigarh administration. The Chandigarh administration had asked for orders in the case of a mentally challenged, 19-year-old woman who had become pregnant after she was sexually assaulted in a government institution. In its judgment the HC ordered that the woman should undergo a medical termination of pregnancy (MTP) and stated that this was in the best interests of the woman in question (1-3). The SC stated that in this particular case it refused to dilute the provisions of the Medical Termination of Pregnancy Act. It stated that, as per subsection 4a of section 3 of the MTP Act, “No pregnancy of a woman who has not attained the age of eighteen years, or, who, having attained the age of eighteen years, is a mentally ill person, shall be terminated except with the consent in writing of her guardian” .(4) The court interpreted that the victim being a mentally retarded woman (and not mentally ill) above the age of 18 years, she alone is competent to accord consent for the termination of her pregnancy. The woman had been raped at Nari Niketan, a welfare institution at Chandigarh, where she had been institutionalised. She was later shifted to another institution, Ashreya, where her pregnancy was detected on May 18, 2009. Both the institutions were government-run, the former under the administration of the director, social welfare, and the latter under the directorprincipal, Government Medical College, Chandigarh. The pregnancy was then confirmed by a medical board comprising two gynaecologists and a radiologist. The woman’s mental condition was evaluated by a three-member medical board headed by the chairperson of the department of psychiatry of Chandigarh Medical College who opined that she fell in the category of “mild mental retardation”. An ossification test was also conducted which set her bone age as between 19 and 20 years. Following this, a four-member multidisciplinary medical board was constituted and asked to submit its considered opinion on the consequences of continuation of pregnancy and the capability of the woman to cope with it. The board recommended that the woman undergo an MTP after considering her physical, mental and social well being. The Chandigarh administration approached the HC seeking permission to have an MTP conducted as, according to the senior standing counsel for the petitioner, the administration

was unwilling to become a “judge on its own cause”. Considering the sensitive nature of the case, including the rights of mentally retarded women and issues related to the interpretation of the statutes relevant to the case, the HC requested the assistance of the advocates general for the State of Punjab and Haryana and also appointed two senior advocates as amicus-curiae to assist the court in making a decision. The hearing in the HC saw discussions on the interpretation of the MTP Act as well as medicolegal literature concerning mental retardation and MTP. The counsel for the Chandigarh administration argued that while interpreting the MTP Act, a mentally retarded person, like a mentally ill person, should be considered incapable of making an independent decision regarding her pregnancy. He supported the argument by citing the appointment of a guardian under section 14 of the 1999 (National Trust for Welfare of Persons with Autism, Cerebral Palsy, Mental Retardation and Multiple Disabilities) Act which includes both mentally retarded and mentally ill patients in the wider category of disabled persons and treats them at par. He doubted the mental capacity of the woman to give consent for the retention of her pregnancy. He referred to the medical records of the girl and made the plea that the woman, with a mental age of a nine-year-old and who is incapable of looking after herself, should be freed from the burden of pregnancy caused by a rape. The views and arguments were supported by the advocate general, Punjab. Opposing the arguments of the Chandigarh administration, the amicus-curiae argued that while amending the Act in 2002, the legislation was fully conscious and informed of the consequences of excluding mentally retarded women from the category of mentally ill persons. He drew attention to medical literature suggesting that in ordinary situations, most people with mental retardation can lead an independent life with some assistance in matters concerning family, housing and employment or when they are under unusual stress. He referred to the Declaration on the Rights of the Mentally Retarded Persons by the United Nations General Assembly Resolution of 1971 which entitled a mentally retarded person to the same rights as any other human being to the extent possible. The petitioner (the Chandigarh administration) drew severe criticism from the amicus-curiae for treating the woman as a subject, and for seeking MTP “for the sake of convenience and not for the reason of necessity”. The amicus-curiae countered the argument that the woman lacked the mental capacity to

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give consent for retaining her pregnancy by stating that the MTP Act provided autonomy to mentally retarded women in matters concerning their pregnancy. The amicus-curiae held the view that since the woman had clearly expressed her wish to retain the child, the court did not have much option but to allow the retention of pregnancy. The amicus-curiae asserted the right of self determination for persons with intellectual disabilities. The advocate general of Haryana shared a similar stand and opposed the petitioner’s plea for MTP. The HC also considered the opinion of the medical board which had recommended that an MTP be carried out. The court refused to accept that the particular case could be decided based solely on the interpretation of legal provisions and cited the 1995 Persons with Disabilities Act which, while distinguishing between mentally ill and mentally retarded persons, clubbed them together with reference to education, employment, affirmative action and non-discrimination. The HC decided to exercise its parens-patriae jurisdiction (applied in situations where the State must make decisions to protect the interests of people who are unable to take care of themselves) considering the fact that the woman was in the custody of the petitioner State who had to take a decision on the MTP as well. The court held the view that a literal interpretation of section 3(4) of the MTP Act cannot impinge on the constitutional powers of the court, especially its parens-patriae jurisdiction. The court decided to get a second medical opinion from an independent expert body at the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. A senior lady judicial officer was appointed as member-cum-coordinator to the expert body, to attach judicial sanctity behind the verdict of the expert body. The division bench ordered that if the opinion of the expert body was in favour of MTP, the administration should proceed with it without any delay. The HC further clarified that if the woman, after acknowledging fully the consequences of the pregnancy, wished to retain the pregnancy, her views along with the report of the expert body should be placed before the HC for further deliberations. The Chandigarh administration was criticised by the HC for its “casual approach and negligence” towards the woman. “We are at pains to observe that (because of ) the mechanical approach and callousness with which the welfare institutions are being apparently run, the victim has been deprived of an environment which could have been conducive to her mental growth, social behaviour and an overall personality development.” The court in its order also gave directions for improving the conditions of government-run welfare institutions. The second phase of the hearing was held on July 17, 2009. The expert medical board expressed hesitation in deciding whether the MTP should be conducted. In addition, the expert body’s coordinator, the senior judicial officer, expressed her opinion against conducting an MTP. The medical board in its report expressed satisfaction with the woman’s physical condition and ability to bear a child. The board suggested that a neural tube defect in the mother was not an indication for termination of pregnancy and refused to comment on the inheritance of spinal cord tumours without knowing the exact

nature of the tumour. They also suggested that the health of the foetus could be monitored for any major congenital defects. On assessing the mental capacity of the woman, the experts’ opinion was that there was a “high tendency of suggestibility, poor understanding of life phase demands, significant emotional immaturity and limited understanding of the sexual act and the social stigma associated with a child born out of rape”. The experts also suggested that although she was keen on bearing the child and rearing it, she was highly suggestible and her opinion could change in the future. The medical report highlighted the limited mental capacity of the woman and also expressed the medical board’s concern regarding social support and care for the mother and child. The report concluded by saying that “ any decision that is taken keeping her best interests in mind as well as those of her unborn child ... has to be based on the holistic assessment of physical, psychological and social parameters.” The division bench in its judgment observed that there were no government-run institutions in the area that could provide emotional and social security to the woman and her child in the future. The court concluded that, apart from her physical ability, the woman lacked the intellectual, social, personal, financial requirements and family support to bear and raise a child. The court observed that “if born, the child would not only be deprived of the care and protection of a father, but, on account of the mental handicap of the victim, the mother also.” The court held the view that continuation of pregnancy would constitute a grave injury to the woman’s mental health and directed the Chandigarh administration to act promptly and arrange for the woman to undergo an MTP. On July 20, the appellants in the case, Suchita Srivastava and Another, approached the Supreme Court against the High Court ruling and requested an immediate hearing as the woman’s pregnancy was fast approaching 20 weeks, the statutory limit for permitting a medical termination of pregnancy. On July 21, the Supreme Court heard the rationales and deliberations of both sides and decided to grant a stay on the HC order, thereby ruling against conducting an MTP. The SC noticed that the HC’s decision to terminate the pregnancy without the woman’s consent was in violation of the MTP Act. The SC also questioned the HC’s decision to exercise its parenspatriae jurisdiction and order an MTP when the pregnancy was already 19 weeks old and there is a medical consensus that a late-term abortion is not advised and can endanger the physical health of the woman. The SC pointed out that even though the woman needed care and assistance in the future, this could not be used as an excuse for denying her the exercise of her reproductive rights. The SC in its ruling observed that a woman’s reproductive choice itself is a dimension of the personal liberty promised by the Indian Constitution. “The crucial consideration is that a woman’s right to privacy, dignity and bodily integrity should be respected.” Further, this gives the woman the right to carry the pregnancy to its full term, give birth and subsequently raise the child. The SC made it clear that none of the conditions

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for proceeding with an MTP as stated in the MTP Act were applicable in this particular case. The SC referred to the United Nations Declaration on the Rights of Mentally Retarded Persons, 1971, which clearly protects the personal autonomy and rights of the mentally retarded, and observed that the MTP Act protected that very autonomy and right by demanding her consent when it came to the termination of her pregnancy. The Court urged the authorities to look beyond social prejudices and to accept the fact that even people with borderline, mild or moderate mental retardation are capable of being good parents. In view of the medical board’s opinion that there was no physical threat to the continuation of pregnancy and no indication that the child would be born with congenital disabilities, and in view of the desire expressed by the woman to have the child, the SC stayed the decision of the HC ordering that an MTP be conducted. The SC ordered that the best medical facilities should be made available to the woman during her pregnancy as well as during the postnatal period. The SC also cautioned against the possible exploitation, with far reaching repercussions, of the dilution of the provisions of the MTP Act in a society still struggling with the social evil of sex selective abortions.

The National Trust for Welfare of Persons with Autism, Cerebral palsy, Mental Retardation and Multiple Disabilities filed an affidavit taking responsibility for protecting the best interests of the woman, including assistance with child care. It was decided that the trust would ensure proper care for and supervision of the woman and her child by coordinating with the Chandigarh administration and experts from PGIMER. The SC also ruled that any one with future grievances regarding the same subject matter should seek directions from the HC of Punjab and Haryana. References 1. Punjab and Haryana High Court at Chandigarh. C.W.P. No.8760 of 2009, Judgement information system [Internet]. 2009 Jun9 [cited 2009 Nov 20]. Available from: http://lobis.nic.in/phhc/showfile.php?sn=22 2. Punjab and Haryana High Court at Chandigarh. C.W.P. No.8760 of 2009, Judgement information system [Internet]. 2009 Jul 17 [cited 2009 Nov 20]. Available from: http://lobis.nic.in/phhc/showfile.php?sn=8 3. Supreme Court of India. Judgments, the judgment information system of India. Civil appeal no.5845 of 2009.Supreme Court of India [Internet]. 2009 Aug 28 [cited 2009 Nov 20]. Available from: http://judis.nic.in/ supremecourt/imgs.aspx 4. Government of India.The Medical Termination of Pregnancy Amendment Act, 2002 (No.64 of 2002)- an act to amend the Medical Termination of Pregnancy Act, 1971. Ministry of Health and Family Welfare [Internet]. 2002 Dec 18[cited 2009 Nov 27]. Available from: http://www.mohfw.nic. in/MTP%20Act%20(Amendment)%202002.htm

A legal precedent: reproductive rights of mentally retarded persons in India Renu Addlakha Centre for Women’s Development Studies, 25 Bhai Vir Singh Marg (Gole Market), New Delhi 110 001 INDIA email: [email protected]

The reader is familiar with details of this landmark case: in the first instance, the Chandigarh Administration petitioned the Punjab and Haryana High Court (HC) to terminate the pregnancy of a 19-or 20-year-old, unmarried, mildly/moderately mentally retarded, orphaned, pregnant woman residing in a state-run institution for the mentally challenged in Chandigarh. The HC in its orders dated June 9 and July 17, 2009, permitted termination. Subsequently, the young woman petitioned the Supreme Court (SC) through her advocate, to be allowed to continue with her pregnancy against the order of the HC. Due to the urgency of the situation requiring a decision before the statutory 20-week limit of legal abortion, the SC passed an order immediately. The order was in favour of the petitioner to continue with the pregnancy (1-3). The case has opened up an unprecedented discussion on the reproductive rights of persons with disabilities. Existing disability legislation, such as the Persons with Disabilities (Equal Opportunities, Full Participation and Protection of Rights) Act, 1995, addresses issues of prevention of disabilities, medical rehabilitation, education and employment. The National Trust for Welfare of Persons with Autism, Cerebral Palsy, Mental Retardation and Multiple Disabilities Act, 1999 focuses on guardianship issues. During the past few years a handful of researchers and activists in the disability rights movement have initiated discussions on this issue (4-12). The Convention on

the Rights of Persons with Disabilities (CRPD) and its Optional Protocol, which India signed and ratified in 2007, have created the legal space for engagement with the whole range of issues around disability, including sexuality and reproductive health that were hitherto invisible in public discourse. Furthermore, it is now binding on India to make existing legislation compliant with the CRPD. It is against this backdrop that the present commentary should be read. Underlying the legal proceedings is a strong ideology of genetic determinism, moral conservatism and normalisation in the articulation of notions of motherhood, family and childhood. The petitioner was considered incapable of producing a normal healthy baby because of her anatomical and mental deviations. As the report of the First Medical Board constituted by the Punjab and Haryana HC, which the court endorsed, stated: 4. Continuation of the pregnancy in this case can be associated with certain complications considering her age, mental status and previous surgery. There are increased chances of abortions, anaemia, hypertension, prematurity, low birth weight babies, foetal distress and more chances of operative delivery. Even if the baby was without disease and disability, her capability to parent was summarily dismissed because, as the same medical report stated:

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5. Being mildly mentally retarded, she is unable to look after herself and cannot fend for herself if left to her own devices. She was aware that there is a child inside her, although she had absolutely no idea how it came to be there. She cannot mother a child. Motherhood is not only holding the child but it is a complex relationship which is beyond her capability and comprehension. Furthermore, if allowed to proceed with the pregnancy, the petitioner would carry the identity of an unwed mother and the child would be a bastard who, in addition to having a mentally retarded mother, would end up growing up in a dilapidated environment with other mentally retarded inmates in a staterun home. To make matters worse, the young woman was herself an orphan with no social or financial support. Phrases like “Pregnancy of an unwed mentally retarded girl” and “... this Court should avert the tragedy of a ‘child’ bearing another child...” underscore the underlying prejudices. All these factors “logically” militate against having the child. And yet missing from this equation is the fact that the medical boards and high courts, which claim the power of decisionmaking, are themselves the organs of an inert state: a state that vociferously claims to uphold the human rights of its citizens but shows no willingness to protect the most vulnerable. The CRPD clearly affirms the right of persons with disabilities to a family and parenthood for which state parties are duty bound to provide the necessary assistance and resources. In the face of such apathy and indifference, one wonders what course the SC would have taken in the absence of a more or less literal reading of the amended Medical Termination of Pregnancy (MTP) Act, 1971 * wherein the consent of a mentally retarded adult woman is essential for termination of her pregnancy before 20 weeks.* In the exercise of its parens patrie jurisdiction, the HC argued that an orphaned mentally retarded woman cannot be equated to one with legal guardians, parents and kin, and hence the issue of giving consent takes on a different hue. Consequently, the June 9 and July 17 orders rejected a literal reading of section 3(4) of the MTP Act requiring the consent of a mentally retarded adult woman in the best interest of the guardee. One can ask why the state could not in its parens patrie function challenge prevailing norms of marriage and the heteronormative family and put forward alternative ideas of care. While biomedical knowledge is cloaked in a garb of scientificity, variability in biomedical practice is taken for granted, which is why the opposing decisions of the two medical boards constituted by the Punjab and Haryana HC did not come up for interrogation. While the first board recommended termination on grounds of substantial risk to the physical and mental health of the woman and the strong possibility of serious physical or mental abnormalities as to result in serious handicap in the child, the second board gave a more nuanced verdict. While it noted several health problems including her positivity for the hepatitis B surface antigen (HBsAg), it did not rule in favour of termination of the pregnancy. It opined:

Her physical status poses no major physical contraindications to continue the pregnancy. The health

of the foetus can be monitored for any major congenital defects. Her mental state indicates limited mental capacity (intellectual, social, adaptive and emotional capacity) to bear and raise the child. Social support and care for both the mother and child is another crucial component. Therefore, any decision that is taken keeping her best interests as well as her unborn child has to be based on the holistic assessment of physical, psychological and social parameters. In its order of July 17, 2009, the HC directed termination of the pregnancy in the best interest of the petitioner in spite of the Medical Board’s findings that the petitioner had expressed her willingness to bear a child and was physically fit to do so. Working from another set of premises, the SC stayed the order of HC primarily because termination of the pregnancy at this late stage (19 weeks) was not in the best interest of the petitioner. If she were a minor, then the welfare institution would be her guardian; and it could legally sanction abortion in her best interest, but since she is a major her consent is vital. Taking cognizance of reproductive rights, it ruled that a woman’s right to reproductive decision-making is a dimension of the fundamental right to liberty under article 21 of the Constitution .The SC ruling is path-breaking as it unequivocally endorses respecting the autonomy of mentally retarded persons in the area of reproductive choice. There are those who would argue that since the petitioner was not provided with the necessary supportive assistance to arrive at giving an informed consent, it was unethical to force her to continue with the pregnancy considering she did not have a clear understanding of its consequences. But is it not also true that if this case had occurred in a family context, abortion would have been the automatic choice of the kin? This is not say that allowing the petitioner to continue with the pregnancy should be a test case to push for recognition of reproductive rights of mentally challenged persons, but the reality is that precedents arise out of unique situations: and when codified, they can have beneficial consequences in future judicial interpretations. In that sense, this case is a watershed development in disability jurisprudence in the country, which is still in its infancy (13). It is hoped that the Court will monitor the National Trust, which came forward to take responsibility for the welfare of the petitioner and her child during her lifetime. That will be the ultimate test of the Indian state’s commitment to the overall wellbeing of its citizens with disabilities. References 1. Punjab and Haryana High Court at Chandigarh. C.W.P. No.8760 of 2009, Judgement information system [Internet]. 2009 Jun 9 [cited 2009 Nov 20]. Available from: http://lobis.nic.in/phhc/showfile.php?sn=22 2. Punjab and Haryana High Court at Chandigarh. C.W.P. No.8760 of 2009, Judgement information system [Internet]. 2009 Jul 17 [cited 2009 Nov 20]. Available from: http://lobis.nic.in/phhc/showfile.php?sn=8 3. Supreme Court of India. Judgments, the judgment information system of India. Civil appeal no.5845 of 2009.Supreme Court of India [Internet]. 2009 Aug 28 [cited 2009 Nov 20]. Available from: http://judis.nic.in/ supremecourt/imgs.aspx 4. Addlakha, R. Disability and sexual issues. Parenting. 2004 Nov; 12: 88-90.

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5. Addlakha R. Disability, sexuality and reproductive health in India: a training manual for professionals working with adolescents and young people with physical disabilities. New Delhi: MacArthur Foundation in India; 2005. 70 pp 6. Addlakha R. Adolescents, youth with disabilities unable to access programmes targeting sexuality [Interview]. DNIS, Disability News and Information Service [Internet]. 2005 Sep 15 [cited 2009 Nov 24];3(18): about 3 screens. Available from: http://www.dnis.org/interview. php?issue_id=18&volume_id=3&interview_id=70#maincontent Interview by Bhambhani M, Singh P. 7. Addlakha R. Gender, subjectivity and sexual identity: how young people with disabilities conceptualise the body, sex and marriage in urban India. New Delhi: Centre for Women’s Development Studies. Occasional Paper Series.2007;46.31 p. 8. Addlakha R. How young people with disabilities conceptualise the body, sex and marriage in urban India: four case studies. Sexuality and disability. 2007 Sep;25(3):111-23. 9. Addlakha R. Healthy sex life for visually challenged women. In: A K Mittal ed. Handbook for women with visual impairment. New Delhi: All India Confederation of the Blind (Sponsored by Dr H E Schulze and Marga

Schulze Foundation, Germany);2008. p. 60-7. 10. Addlakha R, Mandal S. Disability law in India: paradigm shift or evolving discourse? Econ Pol Wkly. 2009 Oct 10;44(41 and 42):62-8. 11. Das K. Desexualising her. Combat Law, the human rights magazine [Internet]. 2008 Jan- Feb [cited 2009 Nov 24]; 7(1). Available from: http:// www.combatlaw.org/v7i1.php 12. Ghai A. Disembodied form: issues of disabled women. Delhi: Haranand Publications; 2003. 13. Sengupta S.. No rights for the mentally disabled. Infochange news and features [Internet]. 2008 Apr [cited 2009 Nov 24].[about 3 screens]. Available from: //infochangeindia.org/200804117032/Disabilities/ Analysis/No-rights-for-the-mentally-disabled.html

* Amendment introduced vide Act No 64 of 2002 that though mental retardation may be incurable, the person has a fundamental right to be a part of the social mainstream. A mentally retarded woman above 18 years of age has the right to self-determination with regard to the continuation or otherwise of her pregnancy.

Right to human dignity Ujjwala Mhatre Centre for Enquiry into Health and Allied Themes, Survey No 2804 &2805, Aaram Society Road, Vakola, Santacruz East, Mumbai 400 055 INDIA email: [email protected]

The Supreme Court (SC) judgment on the right of a mentally retarded woman to continue with her pregnancy (1) was the outcome of a petition filed in the apex court. This petition appealed against the order of the Punjab and Haryana HC to terminate the pregnancy of a woman who had been raped by staff at the government shelter, Nari Niketan, in Sector 26, Chandigarh where she was an inmate. The High Court had based its reasoning on the fact that the woman was an orphan suffering from mental retardation and would therefore, be unable to look after the child once it was born. One of the arguments that the SC accepted, while reversing the HC judgement, was that the Medical Termination of Pregnancy Act did not permit a medical termination of pregnancy (MTP) to be performed on a mentally retarded (not mentally ill) woman who had attained the age of majority, without her consent. It also accepted the arguments of the advocate appearing in the SC that the woman wanted the child, was physically fit to bear the child and would be capable of looking after it with supervision. The Bench consisting of Chief Justice K G Balakrishnan and Justice P Sathasivam was confronted with this human rights issue in a special leave petition against an interim order of the Punjab and Haryana HC for immediate termination of the pregnancy. The Bench issued a notice to the Chandigarh administration, on whose petition the July 17, 2009, order was passed. It was argued that doctors did not form the opinion that termination of pregnancy was in the best interests of the girl, and that the medical report suggested that she required support and supervision to help her raise the child. The girl had expressed

an unambiguous and unequivocal desire to keep the child. The petitioner argued that termination of pregnancy against the mother’s wish was against the provisions of the MTP Act, 1971, and the Rights of the Disabled. It is granted that a girl, even if mentally retarded, should not be deprived of the right to motherhood provided she is given proper support in fulfilling the tasks entailed. However, the condition in which the woman has been living, and will continue to live even after the birth of her child, does not suggest that she will have any such support system. Besides, this woman was a victim of sexual abuse by the institution’s staff − the very people appointed for the inmates’ welfare and security. What guarantee is there that this situation will change and that she as well as her child will not be targeted in a similar fashion in the future? In fact the central issue in this case concerns the treatment of a destitute and vulnerable, mentally handicapped woman in a government-run institution. Medical experts have certified the woman’s mental age to be just nine years. This makes the crime even more complicated and heinous. And what do we make of the fact that her pregnancy was not detected for more than two months even though an attendant is apparently assigned the duty of recording the menstrual cycles of all the inmates? This reflects gross negligence on the part of the staff assigned to look after the inmates. One has to visit any of the shelter homes for women and children, institutions that are supposed to provide protection, care and training in skills that would enable them to earn their

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living if the need arose, to believe the dire state of affairs that prevails there. These may be homes for juvenile delinquents or destitute women, reform homes for women convicts or homes for the mentally retarded. The lack of serious attention given to this issue by the media, in this particular case, suggests that we have started taking such incidents for granted. It is good that in this case, the lower court called for an inquiry into the conditions of such shelter homes, leading to an FIR being filed and interrogation of security guards from the institution. However, we have little reason to believe that things are going to change for the better and ample reason feel sorry for the inmates of these homes. To give just one illustration, a report of the Delhi Commission for Protection of Child Rights states that inmates in government juvenile homes are living a life “worse than that of animals”. Conditions of extraordinary filth, inadequate, ill-qualified staff, gross overcrowding - these are the normal situation in these institutions, as described in the commission’s report following its inspection. The people housed in these buildings were unwashed and unclothed, sleeping on the floor, and eating inedible food. They suffered from numerous illnesses caused by overcrowding and unhygienic conditions. They were beaten often, they were kept locked up at night, the list goes on (2). There has been much debate in the media about the right of a mentally retarded woman to motherhood. However, there has been a complete silence on what should be the central issues for all concerned - the safety and security of inmates in shelter homes, the guarantee of their human dignity, and compassion for these vulnerable and often neglected people. It is not the first time that the inhabitants of such homes have been exposed to such indignities. All the more reason therefore that there should have been a hue and cry about this serious lapse on the part of the authorities in providing protection to this most vulnerable section of society, whose guardianship is their responsibility. Yet, this is the state of affairs in most homes for the destitute, the disabled and delinquents. To make things worse, sectional legal battles tend to limit our vision regarding the fact that comprehensive justice -ensuring the mental, physical, social and economic well-being of every individual and which is the right of every human being - is being denied to a vast section of the population in this, the world’s largest democracy. The second question is whether the woman under consideration was capable of giving her informed consent - for or against medical termination of pregnancy. Can her refusal

to undergo an abortion, and her insistence on continuing the pregnancy to term, be considered valid given her mental age, her understanding of sexual relationships and the consequences for a child born as a result of sexual abuse, that too in a shelter home? The woman apparently described the child she was carrying as a toy she would like to play with. Medical opinions with respect to this case suggest that a mentally disabled woman can successfully mother a child though she will need supervision to rear it and tend to its needs. The expert body appointed in this case had also opined that “She knows that she is bearing a child and is keen to have one.” The same body also points out, however, that the woman is “unable to appreciate and understand the consequences of her own future and that of the child she is bearing”. Will such a woman be able to contribute to the mental, emotional needs of the child as it grows up? For that matter, will she even be able to anticipate its physical needs? Finally, is this really about the right to motherhood? This “right” is, more often than not, thrust upon women who, in a country like ours, have no control over their own sexuality and cannot decide whether or not to resort to contraception, whether or not to get pregnant, whether or not to have a baby, when to have children and how many to have. Even the decision to seek abortion is never that of women alone. The rights of disabled women and girls cannot be seen in isolation from this context. The judgment sets a precedent while at the same time trying to change the stereotypes that society has constructed. However, many a good judgment fails to translate into a better quality of life for the person in whose favour it is passed. Similarly, unless the treatment meted out to mentally retarded persons by society undergoes a radical change, and social institutions meant for the welfare and security of destitute and disabled persons stop abusing their vulnerable inmates and adopt a sensitive attitude towards them, the fate of these people is not going to change. References 1. Supreme Court of India. Judgments, the judgment information system of India. Civil appeal no.5845 of 2009.Supreme Court of India [Internet]. 2009 Aug 28 [cited 2009 Nov 20]. Available from: http://judis.nic.in/ supremecourt/imgs.aspx 2. Srinivasan S. Life interrupted - at Delhi’s inhuman juvenile homes. IndoAsian News Service[Internet]. Bangkok (Thailand): Thaindian News; 2009 Jun 25 [cited 2010 Jan 14]. Available from: http://www.thaindian. com/newsportal/health/life-interrupted-at-delhis-inhuman-juvenilehomes-feature_100209302.html

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debate

Concerns around the human papilloma virus (HPV) vaccine To Shri Ghulam Nabi Azad Union Minister for Health and Family Welfare Ministry of Health and Family Welfare Nirman Bhavan, Maulana Azad Road, New Delhi 110 011 October 1, 2009 Subject: Concerns around the Human Papilloma Virus (HPV) vaccine.

But there are over 100 HPV subtypes and one of the main concerns is that if the vaccine was to work and indeed “block” subtypes 16 and 18 then the other carcinogenic subtypes may become dominant. l

There is lack of conclusive data regarding the length of immunologic protection that the vaccine confers against HPV subtypes 16 and 18 (4). Studies so far have followed up with the vaccinated “subjects” for five years and have shown that it offers protection only for five years. Thus it is not clear whether protection lasts longer than this time period. Since the long-term efficacy of and protection by the vaccine is unknown we cannot claim that even 60-70% protection will be achieved. Moreover, since the highest incidence of cancer of the cervix in India is in women above 35 years of age, it is not clear whether a three-dose schedule will provide long lasting immunity or if boosters will be required.

l

If booster doses are needed, and it is not known how frequently, what will be the impact of the booster doses on the safety of the vaccine? Moreover, booster doses would certainly increase the cost of vaccination per woman as many times as the booster would be given.

l

HPV vaccination is not a substitute for cervical cancer screening. All women, including those who are vaccinated, should continue to have regular Pap test screening and also HPV test as the preventive effect of the vaccine on cervical cancer has not yet been demonstrated.

l

HPV infection rarely leads to progression to cancer. Only a minority of infections persist for several years, and only about 10 per cent of low-grade lesions progress to a higher grade. About five per cent of high-grade lesions progress to invasive cancer (5).

Sir, We, the undersigned, public health organisations, health networks, medical professionals and women’s groups, write to express our concern with regard to the introduction of the human papilloma virus (HPV) vaccine, Gardasil, to young girls in the country. On July 9, 2009 under the demonstration project being implemented by the union ministry of health and family welfare in association with the Indian Council of Medical Research (ICMR), PATH International and the state government, the Andhra Pradesh minister for health and family welfare launched a pilot programme for vaccination against cervical cancer. The three doses of the HPV vaccine are to be administered to 16,000 girls between 10 and 14 years in the mandals of Bhadrachalam, Kothagudem and Thirumalayapalem in Khammam district in Andhra Pradesh (1). The vaccine will be administered in three doses at the interval of 0, 2 and 6 months. Similarly, on August 13, 2009, the Gujarat government launched a two-year ‘Demonstration Project for Cancer of the Cervix Vaccine’ in three blocks of Vadodara District − Dabhoi, Kawant and Shinor − to immunise 16,000 girls between 10 and 14 years with three doses of Gardasil. The Gujarat state minister for health and family welfare claimed that this demonstration project would help the Centre to examine the possibility of introducing the vaccination project across the country (2). We are alarmed by this decision by state and union governments and we oppose the introduction of the vaccine on the following grounds:

Efficacy of the vaccine l

Information about the efficacy of Gardasil remains uncertain. The current HPV vaccine prevents infections, resulting from just two of the HPV subtypes (16 and 18) that may cause cervical cancer, and also HPV subtypes 6 and 11 that can lead to genital warts. The subtypes 16 and 18 account for 70% of the cases of invasive cervical cancer globally (3).

Side-effects 1. The Federal Vaccine Adverse Event Reporting System (VAERS) in the United States has logged a total of 12,424 adverse events following HPV vaccination, according to the US Centers for Disease Control and Prevention. Between June 2006 through December 2008, more than 23 million doses were administered in the US alone. Of these, 772 were reports of serious events (6.2% of the reports) including 32 deaths and the remaining 11652 (93.2% were classified as non-serious. The most common events reported were, syncope, local reactions at the site of immunisation (pain and redness), dizziness, nausea and headache(6). Venous thromboembolic events, autoimmune disorders, Guillian Barre Syndrome, motor neuron disease, anaphylaxis, transverse myelitis, pancreatitis and death were amongst the serious adverse events reported. Amongst reports of

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autoimmune disorders to the VAERS system, 88% were associated with the HPV vaccine alone (7).

each healthy year of life saved, instead of the USD 43,600 estimated for a vaccine providing life-long protection. Most researchers believe that even in the US, interventions costing more than USD 50,000 per quality-adjusted year of life (QALY) saved, are not cost-effective, while others use a higher ceiling of USD 100,000 (12).

2. In Australia, the rate of anaphylaxis shock after Gardasil injection has been reported as 2.6 per 100,000 doses (8). 3. The official Gardasil website itself clearly mentions, “GARDASIL may not fully protect everyone, and does not prevent all types of cervical cancer, so it’s important to continue routine cervical cancer screenings. GARDASIL does not treat cervical cancer or genital warts.” The side effects listed include, pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Sometimes fainting is accompanied by falling with injury, as well as shaking or stiffening and other seizure-like activity (9). 4. The Indian Academy of Pediatrics Committee on Immunization (IAPCOI) in its recommendations mentions that the vaccine is contraindicated in those with a history of previous hypersensitivity to any vaccine and should be avoided during pregnancy (10). Moreover, there have been no adequate and well-controlled studies in pregnant women, and animal reproduction studies are not always predictive of human response (7).

l

Looking at our public health system, no government in India can afford this expense. The average per capita annual income in India in 2009 is Rs 38,000, while the current per capita annual public health expenditure in India is about USD 10.

l

Given this totally unfavorable cost-efficacy in the Indian context, we see no chance that this vaccine can be included in the Indian national immunization programme. Hence conducting such a demonstration project in India would mean using Indian people as mere guinea pigs.

Aggressive marketing l

Merck Sharp & Dohme (MSD) India Pharmaceuticals Private Limited, which is the Indian subsidiary of Merck & Co. Inc., the manufacturers of Gardasil, has also recently started a cervical cancer prevention programme that informs Indian women to help protect them against cervical cancer and related HPV infections. The programme’s tagline, “What will I do to save my daughter from cervical cancer? - Everything that I can!” (13), is uncannily similar to Gardasil’s tag line “We chose to help protect ourselves against cervical cancer and other HPV infections: Now the choice is yours.”(9) Similarly, PATH, that supported the formative research for the HPV vaccine Gardasil in India, highlights the demand for the vaccine through quotes like “Our granddaughters’ generation should be a generation without cancer.”(14) In this way a false signal is sent out that claims that the vaccine can prevent cancer although Gardasil prevents cancer of cervix associated with just two types of HPV.

l

These advertisements induce fear with regard to HPV and cervical cancer and thus create an inaccurate impression of a “public health emergency”.

l

A 15-second commercial on Indian television urges parents to get their young girls inoculated with the vaccine Gardasil to protect against cervical cancer, Advertising prescription drugs on television is unethical enough, but using fear and inaccurate claims to sell them is worse (15).

Moreover, while this data is mostly sourced from US-based research and trials conducted in other countries, the adverse reactions in the Indian context are unknown. Thus, the approval of a vaccine that claims to prevent a sexually acquired infection that sometimes causes cancer of cervix, and that too only if vaccination is completed before exposure, is highly questionable.

Cost effectiveness l

l

l

The current cost of the vaccine is Rs 3,000 per dose (approximately USD 60). So for every 10-year-old girl, three shots initially, and eight shots (assuming the need for a booster shot every five years) over the next 40 years (until she becomes 50). This would amount to Rs 33,000 by present estimates. Can the ministry afford an injection that costs Rs 9,000 for every woman in a country where we cannot give DPT (costing Rs 3) to 50 % of children of the country? In a recent study from India, published in the New England Journal of Medicine (NEJM), 31,488 women (30 to 59 years old), were followed up over eight years with no intervention (in the control group). 64 died of cervical cancer. The absolute risk of cervical cancer was 2.5/10,000/year. If we optimistically assume that every case of cervical cancer will be prevented by the vaccine, the absolute risk reduction is 0.00025 and the number of women needed to be vaccinated to prevent one death is 4,000. So the cost per life saved is Rs 75 million (11). A cost effectiveness study published in the NEJM in 2008 concluded that if the vaccine provided protection against HPV for only 10 years, then vaccinating preadolescent girls would only provide a “2% marginal improvement in the reduction in the risk of cervical cancer as compared with screening alone.” Moreover, it would cost USD 144,100 for

We urge that 1. The Government should review the decision to conduct a demonstration project of the HPV vaccine in the mass immunisation programmes in the absence of sufficient longterm evidence of its effectiveness and complete and unbiased information, and without any prior public debate. The huge cost incurred in this mass immunisation even if the current price of the vaccine is reduced substantially should be seriously considered. 2. The state initiates comprehensive access to reproductive and sexual health programmes / services for adolescents,

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women and men. l

justified.

The focus should be on increasing access to preventive healthcare services such as Pap screenings, visual screening of the cervix with acetic acid (VIA) and Visual Inspection of cervix with Lugol’s Iodine (VILI).

2. To place before the public: l

All the documents pertaining to the agreement with vaccine manufacturers and all other bodies regarding the government’s plan to introduce the HPV vaccine. The list of all trials planned, proposed, approved and completed, the agencies involved, the donors involved and the proposed locations and all the results of the pilot phase trials as well as clinical trials.

l

Screening programmes should be augmented with newer technologies such as the use of liquid-based Pap testing in women, who have abnormal Pap test results.

l

Provide population-based outreach Pap screening services for cancer of cervix, particularly for women from the tribal and rural areas.

l

Undertake special measures towards promoting awareness among women and communities so that they come forward without any inhibitions to undergo such screening tests.

The status of approval accorded to the vaccine and the data which has been submitted by the company (vaccine manufacturer) for the purpose.

l

The estimated total cost, as per the government’s assessment, of purchase of the vaccine and its administration.

l

l

l

Instead of an expensive vaccination strategy, monitoring measures should be made available to detect cervical cancer at a very early stage. Treatment of all women with the diagnosis of cervical cancer in situ is likely to cost the public healthcare system much less than buying the vaccine. Public health services be made available to all, with special emphasis on women’s health, by filling in the vacancies of gynaeocologists and para-medical workers and by providing basic screening facilities.

3. As mentioned earlier the current vaccines target only two oncogenic types: HPV-16 and HPV-18. Secondly, the relationship between infection at a young age and the development of cancer 20-40 years later is not known. So how should a parent, physician, politician, or anyone else decide whether it is a good thing to give young girls the vaccine that partly prevents infection caused by a sexually transmitted disease that in a few cases will cause cancer 2040 years from now? (16) 4. It is learnt that the union health ministry has signed a memorandum of understanding (MoU) with the US company Merck, covering the entire gamut of the trial and the launch in the country. As per the MoU, the preintroductory trial will be carried out at several centres in the country, including the Institute of Cytology and Preventive Oncology (ICPO) (www.icpo.org.in) for a duration of six months. What is the status of these trials and if they have been completed, what are the results / findings? 5. Financial support from industry or from an international organisation should not be the criterion to introduce any vaccine in a pilot phase or in a universal immunisation programme. 6. The role of PATH is not very clear. It appears that PATH is trying to find ways of influencing policy makers through its formative research.

Our demands 1. All trials and studies to be immediately brought to a halt till, in an open forum, questions relating to the safety, efficacy and cost effectiveness of the planned intervention can be

3. A vaccine policy to be formulated based on public health needs. 4. Open up the issue for public debate with the opinion of health groups, women’s groups and other civil society members to be actively sought. We urge you to consider these demands very seriously and act upon this matter in the larger interest of the health and wellbeing of women and adolescent girls of this country. We ask you to provide the information and documents that we have requested within a month of the receipt of this letter. Yours sincerely, Dr Gopal Dabade, All India Drug Action Network (AIDAN); Medico Friend Circle (MFC); Jan Swasthya Abhiyan (JSA); All India People Science Network (AIPSN); Centre of Social Medicine and Community Health, Jawaharlal Nehru University (JNU), Delhi; Sama Resource Group for Women and Health, Delhi; Dr Y Madhavi, National Institue of Science Technology and Development Studies (NISTADS), Delhi; Jagori, Delhi; Dr Imrana Qadeer, Delhi; Dr N Raghuram, Guru Gobind Indraprastha University, Delhi; All India Democratic Women’s Association(AIDWA), Delhi; Action India, Delhi; Human Rights Law Network (HRLN), Delhi; Delhi Forum, Delhi; Centre for Women’s Development Studies (CWDS), Delhi; The Other Media, Delhi; TARSHI, Delhi; Partners in Law and Development (PLD), Delhi; MATRIKA, Delhi; Indira Chakravarthy, Public Health Researcher, Delhi; Ranjan De, film maker, Delhi; KRITI, Delhi; Dr Veena Shatrugna, Hyderabad, Andhra Pradesh; Dr Sagari Ramdas, ANTHRA, Andhra Pradesh; Andhra Pradesh Adivasi Aikya Vedika, Andhra Pradesh;Dr Rukmini Rao, President, Gramya Resource Centre for Women, Hyderabad, Andhra Pradesh; Yakshi, Hyderabad, Andhra Pradesh; Locost, Vadodara, Gujarat; SAHAJ, Vadodara, Gujarat; Utthan, Ahmedabad, Gujarat; Sahiyar, Baroda, Gujarat; Dr Hanif Lakdawala, Ahmedabad, Gujarat; Dr Hemant Shah, Deputy Director, Bhansali Trust, Radhanpur, Gujarat; Mahila Sarvangeen Utkarsha Mandal (MASUM) Pune, Maharashtra; Dr Anant Phadke, Sathi-Cehat, AIDAN, Pune, Maharashtra; SATHI-CEHAT, Pune, Maharashtra; CEHAT, Mumbai, Maharashtra; LABIA, Mumbai, Maharashtra; Forum Against Oppression of Women, Mumbai, Maharashtra;

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Ravi Duggal, Mumbai, Maharashtra; Dr Amar Jesani, Independent Consultant on Bioethics and Public Health, Mumbai, Maharashtra; Dr Lakshmi Lingam, Professor, Women’s Studies, Mumbai, Maharashtra; Dr Dhruv Mankad, Hon. Director, Vachan, Nasik, Maharashtra; Amitava Guha, FMRAI, Kolkata, West Bengal; Dr Narendra Gupta, Chittorgarh, Rajasthan; Drug Action Forum, Karnataka; Community Health Cell (CHC), Bangalore, Karnataka; Dr Daisy Dharmaraj, TEST Foundation, Chennai, Tamilnadu; Dr Subhashri, Chennai, Tamilnadu; North East Network, Assam; Dr Ajay Khare, Madhya Pradesh Vigyan Sabha, Bhopal, Madhya Pradesh; Jagannath Chatterjee, Bhubaneswar, Orissa. This memorandum was compiled by Anjali and Sarojini, Sama, with inputs from various individuals and organisations. It was submitted to the Union Minister for Health and Family Welfare, Government of India in October 2009. It is also available on the website www.holyhormones.com C/o Sama, B-45, 2nd Floor, Shivalik Main, Malviya Nagar, New Delhi 110 017 INDIA email [email protected]

R, Miller N, Braun MM, Markowitz LE, Iskander J. Post licensure surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009 Aug 19;302(7): 750-7. Cited in PubMed: PMID 19690307 8. Brotherton JM, Gold MS, Kemp AS, McIntyre PB, Burgess MA, CampbellLloyd S; New South Wales Health HPV Adverse Events Panel. Anaphylaxis following quadrivalent human papillomavirus vaccination. CMAJ. 2008 Sep 9;179(6):525-33.Cited in PubMed: PMID 18762618. 9. Merck & Co. Gardasil, human papillomavirus quadrivalent (Types 6,11,16 and 18) vaccine, recombinant [Internet]. USA: Merc & Co, Inc; c 1995-2009 [cited 2009 Nov 25]. Available from: http://www.gardasil.com/ 10. Indian Academy of Pediatrics Committee on Immunization(IAPCOI). Consensus recommendations on immunization. Indian Pediatrics [Internet]. 2008 Aug 17[cited 2009 Nov 26];45:635-48. Available from: http://medind.nic.in/ibv/t08/i8/ibvt08i8p635.pdf 11. Aneja H, Puliyel J. Selling vaccines: deciding on who can afford HPV. Indian Pediatrics [Internet]. 2009 Jul 17 [cited 2009 Nov 26];46: 647. Available from: http://indianpediatrics.net/july2009/647.pdf 12. Kim JJ, Goldie SJ. Health and economic implications of HPV vaccination

References

in United States. N Engl J Med [Internet]. 2008 Aug 21 [cited 2009

1. The Hindu. Pilot programme for vaccination against cervical cancer launched. The Hindu (Hyderabad ed). 2009 Jul 10 [cited 2009 Nov 25]. [about 3 screens]. Available from: http://www.thehindu. com/2009/07/10/stories/2009071059770500.htm 2. Press Trust of India. Gujarat Launches Cervical Cancer Vaccine. 2009 Aug 13. 3. Schiffman M, Castle PE, Jeronimo J, Rodriguez AC, Wacholder S. Human papillomavirus and cervical cancer. Lancet. 2007 Sep 8; 370(9590): 890907. 4. Lippman A, Melnychuk R, Shimmin C, Boscoe M. Human papillomavirus, vaccines and women’s health: questions and cautions. CMAJ [Internet]. 2007 Aug 28[cited 2009 Nov 26];177(5):484-7. Available from: http:// www.cmaj.ca/cgi/reprint/177/5/484 5. Prescrire International. Human papillomavirus: often harmless but in some cases carcinogenic. Prescrire International. 2007 Jun 1; 16(89): 115-9. 6. CDC: your online source for credible health information [Internet]. Atlanta: Centre for Disease Control and Prevention. Summary of HPV adverse events reports published by JAMA; 2009 Oct 9 [cited 2009 Nov 26]; [about 2 screens]. Available from: http://www.cdc.gov/vaccinesafety/ Vaccines/HPV/jama.html 7. Slade BA, Leidel L Vellozzi C, Woo EJ, Hua W, Sutherland A, Izurieta HS, Ball

Nov 26];359:821-32. Available from: http://content.nejm.org/cgi/ reprint/359/8/821.pdf 13. Maggon K, Djelouat S, Bhagia M. Gardasil (Merck) for cervical cancer and genital warts:Gardasil a quadrivalent HPV vaccine [Internet]. [cited 2009 Nov 26]. Available from: http://knol.google.com/k/krishan-maggon/ gardasil-merck-for-cervical-cancer-and/3fy5eowy8suq3/89. 14. PATH, a catalyst for global health. Shaping a strategy to introduce HPV vaccines in India [Internet]. USA: PATH; 2009 [cited 2009 Nov 26]. 32p. Available from: http://www.rho.org/files/PATH_FRTS_India.pdf 15. IANS. Cancer vaccine kicks up controversy in India. Thaiindian news [Internet]. 2008 Dec 30 [cited 2009 Nov 26]. Available from: http://www. thaindian.com/newsportal/world-news/cancer-vaccine-kicks-upcontroversy-in-india_100136358.html 16. Haug C. The risks and benefits of HPV vaccination. JAMA [Internet]. 2009 Aug 19 [cited 2009 Nov 26]; 302(7):795-6. Available from: http://jama. ama-assn.org/cgi/content/full/302/7/795

Cervical cancer screening and vaccination in India Surendra S Shastri Department of Preventive Oncology; Head, WHO Collaborating Centre for Cancer Prevention Screening and Early Detection, Tata Memorial Hospital, Parel, Mumbai 400 012 INDIA email: [email protected]

Cervical cancer is the most common cancer among women in the less developed countries which account for 80% of the global burden of the disease and over 80% of the global mortality due to cervical cancer. Latin America and the AsiaPacific region account for about 60% of cervical cancer cases worldwide. An estimated 2,05,496 new cases and 1,19,097 deaths due to cervical cancer will occur in India by 2020, contributing to 29% and 30% respectively of the global burden of cervical cancer cases and mortality (1). The human papilloma virus (HPV) as a causative agent for

cervical cancer was first proposed in the 1970s and was soon shown to be the primary etiology of the disease (2-4). Several studies later established that all cervical cancers were the outcome of a process that was initiated by infections due to a specific group of high-risk human papilloma viruses (5-10). Randomised controlled studies suggest that VIA (Visual Inspection with Acetic Acid) is an attractive alternative to Pap smear screening (11-13). A recently published report from India indicates that screening women once in their lifetime at the age of 35 with HPV DNA testing reduced the lifetime risk

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of cervical cancer by up to 36%, at a cost of less than $500 per life saved (14). Low cost HPV tests that would provide quality results within one working day and would allow for screenand-treat protocols have been recently tried in China (15). When available, these tests would help reduce the costs of the cervical screening programmes significantly worldwide, making them sustainable even in the less developed countries. HPV vaccines are certainly a major breakthrough in the primary prevention strategies for cervical cancer and vaccine trials till date have shown very good immunogenicity in HPVnaive girls and have been reported to be generally safe. The currently licensed HPV vaccines − quadrivalent HPV 16, 18, 6, 11(Gardasil(r), Merck & Co., Inc., Whitehouse Station, NJ USA) and bivalent HPV 16, 18 (Cervarix(tm), GlaxoSmithKline Biologicals, Rixensart, Belgium) − contain virus-like particles and are expected to prevent an estimated 70% of cervical cancers. Immunisation of young women with virus-like particles of oncogenic HPV types 16 and 18 has been shown to confer almost 100% protection against infection and disease related to these virus types (16-23). Vaccine pricing, cost of vaccine delivery to the eligible population, eligible population coverage, long term sustainability and cultural acceptability should be the driving variables in the adoption of any population-based vaccination programme. The HPV vaccines currently available have not been proven to be therapeutic, necessitating the identification of very young pre-pubertal girls who are likely to be HPV naive for vaccination. This is likely to raise cultural and ethical issues. Besides the final proof of vaccine efficacy − reduction in cervical cancer mortality − is yet to be proven and might take another 10-15 years to be conclusively demonstrated. Reviewing countrywide HPV vaccination strategies in the above context, I would advise a limited number of pilot programmes that study, in depth, vaccine efficacy, safety, acceptability and sustainability in girls of different age groups in a variety of population groups across the country. Such data and the evidence therein, when available in the next four to five years, should form the basis of future national policies on the subject. References 1. Ferlay J, Bray F, Pisani P, Parkin D M. GLOBOCAN 2002 Cancer Incidence, Mortality and prevalence worldwide, IARC CancerBase No. 5, version 2.0, IARCPress, Lyon, 2004. 2. zur Hausen H. Papillomaviruses in anogenital cancer as a model to understand the role of viruses in human cancers. Cancer Res. 1989 Sep 1; 49(17): 4677-81. 3. zur Hausen H, Meinhof W, Scheiber W, Bornkamm GW. Attempts to detect virus-secific DNA in human tumors. I. Nucleic acid hybridizations with complementary RNA of human wart virus. Int J Cancer. 1974 May 15;13(5):650-6. Cited in PubMed: PMID 4367340. 4. Orth G, Jablonska S, Jarzabek-Chorzelska M, Obalek S, Rzesa G, Favre M. Characteristics of the lesions and risk of malignant conversion associated with the type of human papillomavirus involved in epidermodysplasia verruciformis. Cancer Res. 1979 Mar 1;39(3): 1074-82. 5. Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Munoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999 Sep;189(1):12-9. Cited in PubMed: PMID 10451482. 6. Durst M, Gissmann L, Ikenberg H, zur Hausen H. A papillomavirus DNA from a cervical carcinoma and its prevalence in cancer biopsy samples

from different geographic regions. Proc Natl Acad Sci USA. 1983;80(12): 3812-15. 7. Gissmann L, Boshart M, Durst M, Ikenberg H, Wagner D, zur Hausen H. Presence of human papillomavirus in genital tumors. J Invest Dermatol. 1984 Jul;83(1 Suppl):26s-28s. Cited in PubMed: PMID 6330218 8. de Villiers EM, Wagner D, Schneider A, Wesch H, Miklaw H, Wahrendorf J, Papendick U, zur Hausen H. Human papillomavirus infections in women with and without abnormal cervical cytology. Lancet. 1987 Sep 26;2(8561):703-6. Cited in PubMed: PMID 2888940 9. Bosch FX, Manos MM, Munoz N, Sherman M, Jansen AM, Peto J, Schiffman MH, Moreno V, Kurman R, Shah KV. Prevalence of human papillomavirus in cervical cancer: a worldwide perspective. International biological study on cervical cancer (IBSCC) Study Group. J Natl Cancer Inst. 1995 Jun 7;87(11):796-802. Cited in PubMed: PMID 7791229 10. Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, Shah KV, Snijders PJF, Meijer CJLM. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med [Internet]. 2003 Feb 6 [cited 2009 Dec 4];348(6):518-27. Available from: http://content.nejm.org/cgi/content/full/348/6/518 11. Gaffikin L, Blumenthal PD, Emerson M, Limpaphayom K; Royal Thai College of Obstetricians and Gynaecologists (RTCOG)/JHPIEGO Corporation Cervical Cancer Prevention Group [corrected]. Safety, acceptability, and feasibility of a single-visit approach to cervical-cancer prevention in rural Thailand: a demonstration project. Lancet. 2003 Mar 8;361(9360):814-20. Erratum in: Lancet. 2003 Jun 7;361(9373):1994. Cited in PubMed: PMID 12642047 12. Blumenthal PD, Lauterbach M, Sellors JW, Sankaranarayanan R. Training for cervical cancer prevention programs in low-resource settings: focus on visual inspection with acetic acid and cryotherapy. Int J Gynaecol Obstet [Internet]. 2005 May[cited 2009 Dec 4];89: S30-7. Available from: http://www.rho.org/files/IJGO_89_S2_2005_05.pdf 13. Sankaranarayanan R, Esmy PO, Rajkumar R, Muwonge R, Swaminathan R, Shanthakumari S, Fayette JM, Cherian J. Effect of visual screening on cervical cancer incidence and mortality in Tamil Nadu, India: a clusterrandomised trial. Lancet. 2007 Aug 4;370(9585):398-406. Cited in PubMed: PMID 17679017 14. Sankaranarayanan R, Nene BM, Shastri SS, Jayant K, Muwonge R, Budukh AM,Hingmire S, Malvi SG, Thorat R, Kothari A, Chinoy R, Kelkar R, Kane S, Desai S,Keskar VR, Rajeshwarkar R, Panse N, Dinshaw KA. HPV screening for cervical cancer in rural India. N Engl J Med [Internet]. 2009 Apr 2[cited 2009 Dec 4];360(14):1385-94. Available from: http://content.nejm.org/ cgi/reprint/360/14/1385.pdf 15. Qiao YL, Sellors JW, Eder PS, Bao YP, Lim JM, Zhao FH, Weigl B, Zhang WH, Peck RB, Li L, Chen F, Pan QJ, Lorincz AT. A new HPV-DNA test for cervical-cancer screening in developing regions: a cross-sectional study of clinical accuracy in rural China. Lancet Oncol. 2008 Oct;9(10):929-36. Epub 2008 Sep 19. Cited in PubMed: PMID 18805733 16. Harper DM, Franco EL, Wheeler C, Ferris DG, Jenkins D, Schuind A, Zahaf T, Innis B, Naud P, De Carvalho NS, Roteli-Martins CM, Teixeira J, Blatter MM, Korn AP, Quint W, Dubin G; GlaxoSmithKline HPV Vaccine Study Group. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet. 2004 Nov 13-19;364(9447):175765. Cited in PubMed: PMID 15541448 17. Harper DM, Franco EL, Wheeler CM, Moscicki AB, Romanowski B, RoteliMartins CM, Jenkins D, Schuind A, Costa Clemens SA, Dubin G; HPV Vaccine Study group.. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet. 2006 Apr 15;367(9518):1247-55. Cited in PubMed: PMID 16631880 18. Paavonen J, Jenkins D, Bosch FX, Naud P, Salmerón J, Wheeler CM, Chow SN, Apter DL, Kitchener HC, Castellsague X, de Carvalho NS, Skinner SR, Harper DM, Hedrick JA, Jaisamrarn U, Limson GA, Dionne M, Quint W, Spiessens B, Peeters P, Struyf F, Wieting SL, Lehtinen MO, Dubin G; HPV PATRICIA study group. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet [Internet]. 2007 Jun 30[cited 2009 Dec 4];369(9580):2161-70. Available from: http://www. cnz.uzh.ch/PaavonenLancet09.pdf 19. J. Paavonen. Human papillomavirus infection and the development

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of cervical cancer and related genital neoplasias. Int J Infect Dis. 2007 Nov;11 Suppl 2:S3-9. Cited in PubMed: PMID 18162244 20. Villa LL, Costa RL, Petta CA, Andrade RP, Paavonen J, Iversen OE, etal. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of followup. Br J Cancer [Internet]. 2006 December 4[cited 2009 Dec 4]; 95(11): 1459-66. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC2360730/ 21. Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med [Internet]. 2007 May 10[cited

2009 Dec 4]; 356(19):1928-43. Available from: http://content.nejm.org/ cgi/reprint/356/19/1928.pdf 22. The Future II study group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection. J Infect Dis. 2007 Nov 15;196(10):1438-46. Epub 2007 Oct 31. Cited in PubMed: PMID 18008221 23. The FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med [Internet]. 2007 May 10[cited 2009 Dec 4]; 356(19):1915-27. Available from: http://content.nejm.org/cgi/reprint/356/19/1915.pdf

The HPV vaccine demonstration projects: we should wait, watch and learn Mala Ramanathan, Joe Varghese Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala 695 011 INDIA email: [email protected], [email protected]

The introduction of newer vaccines into the immunisation programmes in India has been the subject of heated debates in recent years. While a number of concerns have been identified, the often obvious commercial interest of the vaccine manufacturing lobby has been the major point of objection based on which civil society groups have taken their position. Recently there have been many concerns raised about the demonstration projects on HPV vaccines in India (1), ranging from those regarding the vulnerability of researched populations to the cost-effectiveness of the vaccines used in national programmes. While acknowledging the threat of potential commercial interests in shaping vaccine policy decisions, we call for a balanced approach to various research projects on this subject. We shall look at the various concerns raised by others and give our point of view. A genuine debate is about our health priorities; India has several other health priorities; inclusion of the HPV vaccine in the government programme may not be among the top in the list. Similarly, considering the present low health expenditure by the government of India, some have raised doubts as to how it proposes to meet the cost of this vaccine, even at the negotiated prices, unless this is done by putting other programmes in jeopardy. We do agree that, given the present health expenditure by central and state governments in India, the cost of introducing the vaccine may not be justified. But we cannot anticipate what will happen a few years down the road when and if the contour of government expenditure expands. One should consider that the present level of health spending by the government of India is abysmally low and this needs urgent correction. More than 25% of the total number of women dying globally due to cervical cancer are from India. This fact should not be far from our minds (2,3). No doubt the cost effectiveness and opportunity costs need to be considered while deciding a health intervention. But we call for much wider considerations while prioritising. In India, marriage

and associated initiation into sexual activity are universal. HPV infection occurs in the early phases of initiation of sexual activity but can remain dormant for decades. From the rights perspective on health, as HPV threatens every young girl in the phase of her initial exposure to sexual activity, we need to take this into the calculus of our decisions; we need to find ways of offering universal protection to all young women in the country. India as a country has regions in different stages of health transition. Even if we consider states to be co-terminous with different stages, each state may want to prioritise differently. Legislatively, health choices for a state are within the purview of the state under the Indian Constitution. We therefore cannot speak for the country as a whole when we talk of prioritisation. Another debate is about vaccine effectiveness; is it enough to show that the prevention of precancerous lesions by the vaccine is going to prevent cervical cancer? According to the WHO position paper on HPV vaccines, persistent HPV infection may lead to the development of precancerous lesions or severe adenocarcinoma in situ which have a high chance of progressing to squamous cell cancer or adenocarcinoma respectively within an average of about 20 years (4). The interventions based on screening and testing for early identification of precancerous lesions and its treatment have already proved their efficacy for prevention of cervical cancer. Ambiguity also arises as there is no evidence on how many shots of vaccine are required for lifetime protection. Most studies, including those which have estimated cost effectiveness, having assumed three doses of the vaccine along with screening as sufficient to prevent lifetime occurrence of cancer of the cervix, showed an effective reduction of 63% of the lifetime risk (2). The quadrivalent vaccine was found to offer significant protection against HPV-16 or HPV-18 after follow-up for three years following the initial dose (5). There is definitely a need for long-term follow-up in order to determine the duration of actual protection, if possible.

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It may not be wrong to argue that any new vaccine introduced without creating a demand among the population may have poor coverage. This is true of the other vaccine that target women, that is tetanus toxide given to women in the antenatal period which has a coverage of about 75%(6). Thus poor coverage with the HPV vaccine may defeat its purpose which is protection of a significant number of needy women. This is also a strong possibility. We do hope that vaccine preparedness studies and many other studies examining the logistics of service delivery and the health system’s requirements are undertaken in addition to the clinical trials to test efficacy and safety of the vaccines before we even consider the option of making the HPV vaccine available through the immunisation programme in the country. Another major area of contention concerns the present research on Indian (less educated rural) populations which is projected as unethical. It is true that populations in India in general and women in particular are vulnerable to unethical research. But this is also the population that is most vulnerable to HPV and cervical cancers. As has already been mentioned, more than 25% of all women dying globally due to cervical cancer are from India (3). The most dominant types of HPV − namely HPV 16 and 18 - are responsible for 70% of the cervical cancers found globally (5). Within Asia, HPV types 16 and 18 account for about 67% of all HPV infections (7). This seems sufficient reason to initiate studies in India. The results of such studies should be used to benefit these populations and others like them. As civil society players, should not researchers and activists within this country work with research groups to ensure that the trial is not unethical and does not exploit vulnerable women? Experts have pointed to the difficulty in creating acceptability for the vaccine as it is going to generate several debates situated in moral and cultural contexts. This is very true given the manner in which many health debates tend to get politicised and polarise populations (8) It has also been found that compulsory vaccination recommendations for prophylactic vaccines tend to be opposed for a range of reasons based on philosophical, political, scientific and ideological grounds (9). Therefore, undertaking well crafted and scientific studies on the way to deliver such vaccines and the implications for the health system that gears to deliver it is extremely important. This, according to PATH’s summary sheet on the cervical cancer vaccine project, is the objective of the demonstration project being undertaken in India and three other countries, Peru, Uganda and Vietnam (10) Should we not then wait for the results of these studies and evaluation of the demonstration projects both within India and elsewhere in order to strengthen the debate? Finally, we need to address the issue of the vaccine option itself, when screening alone may, in theory, reduce incidence significantly (11). Many screening programmes have failed to deliver significant reductions in cervical cancer incidence or associated mortality. It is now acknowledged that the best prevention strategy includes both vaccination of adolescents

before initiation of sexual activity and screening for surrogate markers of cervical cancer − such as precancerous lesions − and treating them. The WHO position paper states:“WHO recognizes the importance of cervical cancer and other HPV-related diseases as global public health problems and recommends that routine HPV vaccination should be included in national immunization programmes, provided that: prevention of cervical cancer or other HPV-related diseases, or both, constitutes a public health priority; vaccine introduction is programmatically feasible; sustainable financing can be secured; and the cost effectiveness of vaccination strategies in the country or region is considered.” (4) The first of the recommendations is open to debate. Should a condition that disables 5,00,000 and kills 260,000 women globally every year (4) not be prevented by all means possible? But in order to decide on the second and third criteria recommended by the WHO, we need sound scientific studies that examine the required health system preparedness and costs involved in delivering the vaccine and the screening programmes to women in poor rural settings. If this has to happen we need to de-link our concerns emerging out of potential commercial exploitation of vaccine lobbies with that of our analysis of potential benefit of health interventions. After all, in India we do have options such as compulsory licensing to be used in the face of a public health emergency, (12), and indeed countries such as Thailand, Indonesia, Malaysia, Mozambique, Zambia and Brazil have should the various options available to enhance access(13). References 1. Memorandum submitted to Govt. of India, 2009. Concerns around Human Papilloma Virus(HPV) Vaccine. Memorandum addressed to Shri Gulam Nabi Azad, Union Minister for Health and Family Welfare, Govt of India, New Delhi. 2. Diaz M, Kim JJ, Albero G, de Sanjose S, Clifford G, Bosch FX, Goldie SJ. Health and economic impact of HPV 16 and 18 vaccination and cervical cancer Screening in India. Br J Cancer. 2008 Jul 22;99(2):230-8. Epub 2008 Jul 8..Cited in PubMed ; PMID 18612311. 3. Ferlay J, Bray F, Pisani P, Parkin DM. GLOBOCAN 2002: Cancer incidence, mortality and prevalence worldwide, IARC CancerBase No. 5 version 2.0, IARC Press, Lyon, 2004. 4. WHO. Human Papillomavirus Vaccines WHO position paper. Weekly Epidemiological Record [Internet]. 2009 Apr 10 [cited 2009 Nov 20]; 15: 118-32.Available from: http://www.who.int/wer/2009/wer8415.pdf 5. The FUTURE II Study Group. Quadrivalent vaccine against Human Papillomavirus to prevent high-grade cervical lesions. N Engl J Med [Internet]. 2007 May 10 [cited 2009 Nov 20]; 356 (19):1915-27. Available from: http://content.nejm.org/cgi/content/full/356/19/1915 6. IIPS and Macro International. Table 8.6. Components of Antenatal Care in Chapter 8. Maternal Health, National Family Health Survey (NFHS-3), 2005-06, Volume 1, 2007, IIPS, Mumbai, pp.198. 7. Agosti JM, Goldie SJ. Introducing HPV vaccine in developing countries - key challenges and issues. N Engl J Med [Internet]. 2007 May 10 [cited 2009 Nov 20];356 (19):1908-10. Available from: http://content.nejm.org/ cgi/content/full/356/19/1908 8. Charo RA. Politics, parents and prophylaxis- Mandating HPV vaccination in the United States. N Engl J Med [Internet]. 2007 May 10 [cited 2009 Nov 20]; 356(19):1905-08. Available from: http://content.nejm.org/cgi/ reprint/356/19/1905.pdf 9. Colgrove J. The ethics and politics of compulsory HPV vaccination. N Engl J Med [Internet]. 2006 Dec 7 [cited 2009 Nov 20]; 355:2389-91. Available from: http://content.nejm.org/cgi/reprint/355/23/2389.pdf 10. PATH.Cervical cancer vaccine project [Internet]. WA (USA): PATH, a

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catalyst for global health; 2006 Oct [cited 2009 Nov 20]. Available from: http://www.path.org/files/RH_cc_vacc_proj_fs_update.pdf 11. Sankaranarayanan R, Nene BM, Shastri SS, Jayant K, Muwonge R, Budukh AM, Hingmire S, Malvi SG, Thorat R, Kothari A, Chinoy R, Kelkar R, Kane S, Desai S, Keskar VR, Rajeshwarkar R, Panse N, Dinshaw KA. HPV screening for cervical cancer in rural India. N Engl J Med [Internet]. 2009 Apr 2 [cited 2009 Nov 20]; 360 (14):1385-94. Available from: http://content.nejm.org/ cgi/reprint/360/14/1385.pdf

12. Mueller, JN. Taking TRIPS to India-Novartis, patent law, and access to medicines, N Engl J Med , 2007, Feb 8; 356(6):541-543. 13. Steinbrook, R. Thailand and compulsory licensing of Efavirenz. N Engl J Med. 2007, Feb 8; 356(6):544-546.

Acknowledgements: This commentary has been revised with inputs from Dr.V Ramankutty, AMCHSS, SCTIMST. Errors, if any, are entirely our own.

Indian Journal of Medical Ethics The Indian Journal of Medical Ethics (earlier Issues in Medical Ethics) carries original articles, reports, comments, case studies and other material on a range of issues related to healthcare ethics in developing countries, with special reference to India. Some of these: Corruption among medical professionals • Ethics education during medical college • Issues in high-technology medicine • Problems of research among poor populations • Contraceptive research and population policies. In order to engage people in debates on health and medical practice, IJME encourages comments from all points of view. Some debates in recent issues: Is it right to perform pre-implantational genetic diagnosis for sex selection? • Is ECT without anaesthesia unethical? • May doctors refuse to treat people with HIV? • Should doctors advertise? IJME is owned and published by the Forum for Medical Ethics Society, a not-for-profit, voluntary organisation in Mumbai, India. The FMES was born out of an effort by a group of concerned doctors to focus attention on the need for ethical norms and practices in healthcare. Subscribe to IJME and participate in the debate. If you’re already a subscriber, why don’t you gift a subscription to a friend? I would like to subscribe to the Indian Journal of Medical Ethics Enclosed is my cheque/ demand draft for Rs /US$ ---. Name: Postal address: Email address: I would like to gift a subscription of IJME to a friend. Please send this subscription as a gift from me to: Name of person to whom the subscription is gifted: Postal address: Email address: Please refer to the subscription information at the end of this page. Subscribers from other SAARC countries (Bangladesh, Bhutan, Maldives, Nepal, Pakistan and Sri Lanka) please pay the Indian rates adding Rs 100 per year extra for postage. Special one-year subscriptions for Rs 150 are available to students in India. Demand drafts /cheques should be in the name of ‘Indian Journal of Medical Ethics’. Please add Rs 30 for out-station cheques (US$2 for international subscriptions). Please send your subscriptions to: Indian Journal of Medical Ethics, c/o Centre for Enquiry into Health and Allied Themes, Sai Ashray, Survey No 2804,2805, Aaram Society Road, Vakola, Santacruz (E) Mumbai 400 055 INDIA e-mail: [email protected] SUBSCRIPTION RATES Indian

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ETHICS IN ETHICS COMMITTEES

Assessing the social value of research involving “minimal risks”: who is accountable? Sunita Bandewar University of Toronto, Toronto, Canada email: [email protected]

Over time the debate has matured regarding the governance of research ethics boards (REBs), their roles and their mandates, and how their services can be audited for quality control. With the fast changing character of research in every field involving human research participants, today’s REBs can be expected to encounter newer challenges. The last decade of health research has witnessed unprecedentedly large budget initiatives with a global sweep. It is also marked by its growing transdisciplinary nature. Accordingly, the terrain of research ethics is also changing, and posing new problems. For example, in the absence of a harmonised global research ethics framework and regulatory arrangements, how will the various stakeholders in a research enterprise respond to issues of data sharing, biobanking, benefit sharing with study communities and research participants and credit sharing in the ever-increasing quantum of international collaborative research in the life sciences that leads to healthcare innovations? Indeed, there is enough to challenge our brains to address these issues in coming times. Can we assume, then, that the very “primordial” research ethics issues have been addressed fully so that we may move on to look at newer challenges in the field? It seems not. While the old challenges may be less visible and viewed almost as “trivial”, they have not necessarily been resolved. This essay refers to discussions among a group of friends and colleagues called A7, currently located in Toronto, Canada. We belong to different nationalities and come from diverse sociocultural contexts. We come from different disciplines and professional backgrounds although all of us are connected to the health field in one way or the other. In hindsight, the unstructured, informal and, above all, non-judgmental ambience of this forum allows us to talk about several issues fearlessly and without much awkwardness. In a recent discussion, one of the group members talked about the issues she confronted during her work in the late 1990s. The concerns expressed regarding REBs’ role in determining the “social value” of research, and the serious implications it could have, continue to be very relevant today.

The “social value” of research It is still fresh in my mind how passionately I had argued during my bioethics programme that the principle of “social value” should take precedence over that of “scientific validity” alone. To date, I continue to hold this stand. It has been further

strengthened based on the opportunities that I have had to witness the research enterprise in an ever growing globalised context. The “social value” of any proposed research continues to be one of the core principles of research ethics (1). Although it is most basic, it appears that it is the least attended to, particularly in empirical social science research including empirical bioethics. REBs are no exception to the disregard of this principle. Such disregard may be due to pragmatic constraints, the unhealthy academic culture of “publish or perish”, or the ever increasing pressure to be innovative, novel and unique. Let me share the story that my friend discussed with us. In the late 1990s, Rosanna was associated with a mega project that appeared to be unique and perhaps exemplary in several ways: its global scope, its multidisciplinary nature, its being in the limelight and its being almost a flagship project for the funder. It played a key and strategic role in a large global health initiative conceptualised and sponsored by the funding agency and consisting of about 25 projects meant to address international health issues and located all around the world. Rosanna’s team’s mandate was to offer solutions to ethical concerns encountered by the scientists working on these 25 projects during their scientific endeavours. Her own project, therefore, was evolutionary in nature. It played the role of advisor and support of all these projects on ethical, social, cultural and regulatory challenges as and when these project teams confronted them. Rosanna’s team, therefore, was an assured resource made available by the Sponsor agency to ensure the quality of this global health initiative including its ethical content, socio-cultural sensitivity and regulatory soundness. Indeed, it appeared to be a pathbreaking model bringing bioethics, social sciences and life sciences together from the outset of this large global health initiative. The initiative seemed to be crafted with ingenuity, creativity and a sense of commitment to the developing world’s health concerns. Overall, it was a collective commitment − of scientists from around the world, sponsors, and Rosanna’s Team members − to people’s health and well-being. Rosanna was also involved in a sub-project concerning empirical bioethics. Its mandate was to conduct primary research to better understand how research ethics norms and principles get translated in real-life situations. It did this while interacting with research participants, their families and people in their neighbourhoods. It also looked at how these

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principles played out in different socio-cultural settings and in different health research contexts including biomedical research and public health interventions. Again, this looked like an interesting, relevant topic of enquiry. However, as we discussed what Rosanna narrated to us, one of us asked if the topic warranted such a large investment at that point. However, others felt differently. Clearly, a thorough review of the contemporary literature on the theme was necessary to ensure that it warranted systematic empirical research in international settings. Interestingly enough, the relevance of the topic seemed obvious to several other sectors outside health. To us, this implied that it would be a very demanding task to review the literature on the topic across several sectors to state confidently whether or not it needed further exploration. Rosanna traced the genesis of the sub-project to the needs articulated by some projects in the initiative. Their expectations were in line with the strategic position that the project held in this initiative. One could imagine how the “pressure to respond” might be exerted on the team just by virtue of its being a “problem solving” team in this global health initiative. The “pressure to respond” seemed due to the fact that Rosanna’s project was handsomely funded to address other teams’ concerns and challenges in meeting goals of the respective projects without compromising on their quality as described earlier. The creation of such resource in the form a Rosanna’s project was also a thoughtful strategy of sponsors to optimise on the huge research resources in the initiative to ensure either tangible gains or the creation of knowledge to form foundation for further enquiry into the respective research areas Against this backdrop, Rosanna said that her team took the position that the topic was “insufficiently explored” and therefore needed further enquiry based on its informed guesses. Consequently, it occupied a prime spot in the project and claimed substantial allocation of project funds. To her, it was less justified at least at that point in time. We all stopped to ponder over the question: In a multi-million dollar international health project, what weight should the question of its social value have? And who should be responsible to ensure this social value? Could research ethics boards be safety nets to prevent redundant research?

seminal aspect of the research. However, to her surprise other than asking for some minor clarifications, the REB approved it at one sitting. So her expectation that REB could work as safety net did not materialise in reality. On further discussion, one of the group members asked whether the REB was appropriately chosen to review this research proposal. In the larger academic setting with numerous disciplines and numerous REBs, each REB is assigned to conduct ethics review for particular departments. This seemed to be a pretty robust system within a huge, centralised bureaucracy in an academic setting. However, it turned out that her institute was categorised under a life sciences stream. It was therefore assigned to an REB that is primarily equipped to look into hardcore biomedical research protocols, especially clinical trials, with a minimum of the focus and orientation that social science research demands. Rosanna also noted that the REB checklist, for researchers to respond to as part of the REB submission, was not geared to capture the nuances of empirical bioethics and social science health research. This is because such research is usually put the category of “minimal harm”. Once researchers classify their protocols as doing “minimal harm”, REB scrutiny is nominal. Our sustained discussion within A7 about Rosanna’s project left us with the following questions that we thought could be educative for the peer community of researchers, REB members and bioethicists alike:l

What if the team did not take up the literature search and did not produce quality work of relevance to international health research?

l

How important would it be to have an REB equipped to review research that involved only “minimal risks” to study communities and/or participants?

l

In large academic settings where REB functioning and operations are systematised, super-standardised, and are constituents of the academic administrative system, who should take responsibility to point out mismatches between designated REBs and the departments assigned to these REBs?

l

What other fool-proof mechanisms could be set up at the REB level to help discourage “me too” research, especially on projects which are uniquely situated, such as the one described above?

l

The specific context and nature of the project that Rosanna discussed with us seemed to be a situation with potential conflicts of interest. Should there be better mechanisms for REBs to capture such potential threats?

l

Should REBs have additional, special mandates to scrutinise big projects involving large research funds for their social value? What could those mechanisms be?

l

Would tighter and closer scrutiny only confirm the skepticism and criticism of those who believe REBs are policing structures that obstruct research more than they facilitate better research ethics compliance?

Can Research Ethics Boards be safety nets? In any case, Rosanna said, her sub-project proposal was developed and submitted to the designated REB at the academic institution where her project was located in North America. REBs in this part of the world are quite sophisticated when it comes to infrastructure, human resources allocation and overall resource allocation at an institutional level to run them. Nonetheless, there is no reason to believe that they are without constraints. Rosanna’s frustration at this stage was at two levels. First, the research protocol that the team had prepared was not to her satisfaction for a number of reasons, the most important being that the team did not adequately develop the justification for focusing attention on an indepth, multi-centric, international research study. Second, she therefore anticipated that the REB would raise questions on this

Some of us in the group came from low-resource settings

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where we strived to obtain scarce research dollars to pursue research of relevance. Often, the topics of our enquiry stemmed from our work on the ground. Also, research findings got fed back to advocacy campaigns and policy and legal reforms. They had on occasion helped shape healthcare and related services at the grassroots level. Rosanna herself came from a country in Latin America where she was involved in health activism and trained in the critical theory tradition. As a consequence she found it challenging to be in an academic setting which appeared to be so far removed from the ground realities that people are confronted with. It was heart wrenching to learn that research supported with millions of dollars was not necessarily socially relevant, nor did it generate much new knowledge. The debate around the social value of research is not new (2) and it is not easy to resolve. It is harder to lay down general guiding principles to arrive at fair decisions on the social value of a particular research project. This leaves all stakeholders in

the research enterprise with much more accountability for the quality of their own research and the use of scarce research funds. Postscript: Rosanna told us that eventually the team undertook a systematic, structured review of literature, spanning several sectors beyond health. Some of us in the group are acquainted with the products of her project. Indeed, these are outstanding and made original contributions to the field in the early 2000s. On the other count, efforts to explore other appropriate REBs from within the academic setting were not encouraged at her institute. To her, this was because REB approval came by quickly through the current arrangement with the current, designated REB. References 1. Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. The Journal of Infectious Diseases. 2004 Mar; 189: 930-7. 2. Freedman, B. Scientific value and validity as ethical requirements for research: a proposed explication. IRB: A Journal of Human Subjects Research. 1987 Nov/Dec: 7-9.

Process, pitfalls and probity: sharing experiences on setting up and running ethics committees in India Anant Bhan1, Prabha Desikan 2, S Swarnalakshmi 3, SP Kalantri 4 Independent Researcher, Bioethics and Public Health, Flat 405, Building A-11, Planet Millennium, Aundh Camp, Pune 411 027 INDIA email: [email protected] Department of Microbiology, Bhopal Memorial Hospital and Research Centre, Raisen Bypass Road, Karond, Bhopal 462 038 INDIA email: [email protected] IRB manager, Y R Gaitonde Center for AIDS Research and Education, Voluntary Health Services, Rajiv Gandhi Salai, Taramani Chennai 600 113 INDIA email: [email protected] 4 Department of Medicine, Mahatma Gandhi Institute of Medical Sciences, Sevagram 442 102 INDIA email: [email protected]

1 2 3

Jesani recently (1) pointed out in his editorial that even after 30 years of having ethics committees (ECs), we still do not have empirical and factual knowledge about how ethics committees function in the country. He rues that information on how “ECs function, the problems and dilemmas faced and experiential sharing is not available in the public domain.” Brahme and Mehendale (2) provide one of the few accounts in the literature of characteristics of ECs, focusing on institutions in Pune. In this article, we describe the framework of a workshop that we organised at the Second National Bioethics Conference in Bangalore in December 2008; we also highlight the challenges in establishing and administering ECs in India identified during the discussion among workshop participants. We believe that our experience will help researchers and institutions better understand how to start and sustain an EC, efficiently and effectively.

Concept and structure of the workshop The workshop was organised with three objectives: to learn about the requirements for setting up an EC; to identify the potential obstacles to setting up an EC, and to find ways to conduct the day-to-day activities of an EC effectively

The workshop was also conceived as a venue for participants to discuss the problems, pitfalls and processes involved in setting up an EC. This was done through a structured discussion which was initiated during the second half of the workshop. The 35 participants and five facilitators had varying levels of experience in the field of EC functioning. The workshop began with an introduction to the rationale of the workshop, followed by a presentation on the guidelines for setting up an EC and the challenges in building it from scratch. A discussion with the participants was then started with a focus on the challenges faced in setting up and running ECs, and the responses to these challenges. These were finally distilled and presented as a summary at the end of the workshop.

Highlighting regulatory guidance on ECs and practical tips in running an EC Following the introduction, one of the facilitators (S Swarnalakshmi) presented guidelines for setting up of an EC. Universally, ECs resemble each other in concept as their focus remains the safety and dignity of human participants in research studies. However, they may be differentiated by regional variations and cultural nuances.

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Worldwide, a number of laws, regulations, and guidelines govern biomedical and social science research in health. Researchers from institutions in developing countries such as India often collaborate with researchers from developed countries. In such collaborative research projects, we need to understand the guidelines of both the host and the sponsor countries. In this context, the relevant sections of international guidelines focusing on ECs/Institutional Review Boards (IRBs) − ICH-GCP, 45 CFR 46, 21 CFR Part 56, E6 (R1) (1996), Section 3 (1996), World Medical Association Declaration of Helsinki (2004) - Section B.13, CIOMS International Ethical Guidelines for Biomedical Research involving Human Subjects (2002) Guidelines 2 and 3, Article 19 of the Universal Declaration on Bioethics and Human Rights of UNESCO − were explained. The relevant website links and sources from which these international guidelines could be accessed were provided. The different situations under which particular international guidelines that govern human subject research in many countries are used were described. The importance of the EC as per the Indian Council for Medical Research (ICMR) Ethical Guidelines for Biomedical Research on Human Subjects (4) was highlighted. This was followed by a detailed description of Chapter II of the ICMR guidelines, on ethics review procedures. This covered the basic responsibilities of an EC; the composition of the EC including the quorum required for drug trials; type of training required for EC members. Details of the format of the EC application for protocol submissions were also explained. The review procedures to be followed by an EC were elaborated including procedures to be followed for deciding if a proposal is exempt from review, procedures for expedited review and those for research requiring full review. Approaches to monitoring following EC approval and record keeping were described. The administration and management of an EC was outlined. The need for special consideration for research involving vulnerable populations was also briefly explained. The strengths (clear and comprehensive guidelines appropriate for the Indian scenario) and limitations (no mention of funding of ECs, such as for example in terms of percentage of the total project grant; minimum qualification of EC members are not prescribed, and lack of legalisation of the guidelines which limits enforceability) of the ICMR guidelines were discussed. This was followed by a case study of best practices followed in the EC (the institution uses the term institutional review board or IRB for its EC) of a Chennai-based Indian non-governmental organisation, YRG CARE (http://www.yrgcare.org/). YRG CARE provides a comprehensive range of services in HIV/AIDS, functions in a hospital setting and conducts socio-behavioural research studies and clinical trials on HIV/AIDS. An in-house committee reviews the science of the research proposals and a trained bioethicist (the IRB coordinator) examines the proposal for ethical issues before the proposals are submitted to the IRB. A key practice in the IRB was the face-to-face interaction between investigators and IRB members during the IRB meeting. This practice reduces delays spent on correspondence

and provides a great learning opportunity for IRB members as well as investigators (who better understand IRB concerns). All research projects, including short term studentships, are reviewed thoroughly. The IRB members are kept informed about research outcomes including publications and conference presentations by YRG CARE researchers. The English versions of the informed consent forms are translated in local languages, and the translated documents are “back-translated” to ensure reliability and validity of translated documents. YRG CARE has also instituted a community advisory board (CAB) to provide community inputs for its research, and the IRB and CAB meet on an annual basis to exchange views. IRB members are independent of the institution and this helps reduce possibilities of conflict of interest. There are clear documentation procedures instituted in the IRB. Access to files is limited only to the IRB desk, and records are kept under lock and key. There is a duly indexed archiving of completed project files in a record maintenance unit. The IRB desk has established good contacts with both the national apex biomedical research body (ICMR) and international/ foreign collaborators, including the National Institutes of Health (NIH) from where clarification is obtained on IRB procedures when needed. A test of understanding is prepared for some trials when there is a possibility that the participants may not understand the complicated procedures involved in the study. Sections dealing with specimen banking forms have been introduced in informed consent forms where relevant. The presentation concluded with a discussion on how the success of an IRB depends on well-trained and committed EC members, clear and transparent procedures, rigorous documentation, and support from the institute in terms of financial resources, degree of autonomy and investigator adherence to norms. The participants found the practical experiences in running an IRB successfully very useful.

Key questions used to initiate discussions After the presentation, a facilitator (Mala Ramanathan, Sree Chitra Tirunal Institute of Medical Sciences and Research, Thiruvananthapuram) led a structured discussion among the participants to identify challenges faced by ECs in the country, and also innovative practices at local EC level. The key questions used to initiate the discussion were: A. Questions related to membership requirements in an EC. What are the skills required for a person to be considered for membership of an EC, given that proposals need to be evaluated from both technical and ethical perspectives? Since the skills required may not always be available within the same institution, where else could we look for these skills? Should it be mandatory for members to have an orientation course, as it were, to understand the existing requirements that need to be fulfilled before initiating, and during the process of

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conducting, any kind of biomedical research?

bioethics to join and thus reduce the burden on the EC; internships with ethics committees could be developed, paying due attention to confidentiality concerns through prior signed agreements.

B. Questions related to finances for setting up an EC We need resources to set up and run an EC. When resources for research are scarce, how can we generate resources for the ethical review? Is it possible to: l

Charge all researchers a stipulated EC fee? If yes, what happens to research that is not funded?

l

Seek government or other funding for this activity? If yes, will the review really be unbiased and independent?

l

Should it be possible to pay for the skills required for EC membership? Would paying for the review create conflicts of interest in reviewing proposals?

C. Questions related to logistics and administrative support EC meetings need to be convened, conducted and documented. That requires resources, staffing and autonomy. Therefore, l l l

What kind of administrative and infrastructural support would be needed for ECs to function? What kind of staffing would be required? From where can we draw properly qualified staff?

Themes identified in the discussion in the workshop The following key themes emerged during the discussion and provide important insights into ECs in India. Membership issues: Several participants felt that because EC members often lack training and skills to understand ethical issues and therefore, they need to be formally trained and certified in ethics. The process of training (who, where, how and when) and curriculum was discussed; it was suggested trainings should be periodic like Continuing Medical Education seminars. Online certification of EC members (a mandatory requirement for NIH-sponsored researchers) was also identified as a quick and efficient step. Participants also mentioned that for a EC to succeed, EC members should be well trained with minimum qualifications, they should have enough time and interest to attend the meetings, and ECs should also actively involve community members and leaders, especially when dealing with community-based research protocols. Logistics and administration: The EC should: a. Announce well in advance the date and times for EC meetings and introduce strict deadlines for protocol submissions to provide enough time for members to go through the proposals. b. Demand and get enough staff, space and infrastructure to run the EC secretariat. It should hire at least one full-time employee for the secretariat. c. Ensure that the EC secretary gets dedicated time for conducting the EC activities. The post could be rotated among EC members. d. Actively encourage young researchers interested in

e. Should monitor research proposals and, if need be, visit the sites. They should not rely solely on paper-based progress reports. f. Develop Standard Operating Procedures (SOPs) to serve as a template for EC operations, and to ensure that meetings are conducted according to quorum requirements and proceedings are documented properly. Financing mechanisms for running ECs: Running ECs consumes time and costs money. While most ECs run as not-for-profit entities in their institutions, there are direct and indirect costs associated with the day-to-day functioning of ECs. Some institutions charge a fixed application fee from research proposals sponsored by funding agencies or pharmaceutical companies. A system of proportionate allocation of funds to ECs from project budgets could thus be put in place. However, it may not be desirable to ask for fees from non-funded or student-initiated research proposals. ECs should ensure that all fees are deposited with their parent institution in a separate designated account. One of the facilitators brought up the issue of indemnity of ethics committees and pointed out that some ECs were beginning to get insurance for committees in case of any legal claims about decisions being instituted. Engendering respect for ethics committees on the same level as academic committees among institutional leadership would help in addressing some of these needs. Accreditation and registration of ECs: A system of keeping tabs on ECs through periodic audits and instituting quality control measures is required. This is only possible if ECs are registered and accredited by a central body. This has been discussed as being a responsibility which the Forum for Ethics Review Committees in India (FERCI) could undertake in collaboration with the Indian Council for Medical Research. Other issues: A participant felt that we need to introduce bioethics in medical curricula and thus sensitise students of health sciences to ethical challenges in research. Similarly, ECs could also take the responsibility of conducting investigatortargeted courses on bioethics in their institution. Participants raised concerns regarding dilemmas faced by ethics committees when issues like specimen/tissue banking and long term storage of samples for use in research (and taking consent while collecting samples for unspecified future uses) came up in research protocols. It was stated that word “banking” itself was perhaps inappropriate and the connotations could be misused for exploiting communities and individuals. It was also suggested that we need research to find out how

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much it costs an institution to run an effective and streamlined EC. This information would also be useful for institutions planning to set up ECs.

Limitations It was challenging to use the limited time we had for conducting this workshop, given the incessant enthusiasm of the participants. We acknowledge that the themes identified and discussion might have been constrained due to paucity of time.

Conclusion Effectively functioning ECs are crucial for ethical research. This article provides a synthesis of discussions from a workshop at the Second National Bioethics Conference and provides insights about ethics committees in India. We hope that the discussion in the workshop will encourage researchers, heads of institutions and policy makers to identify strategies to further improve the functioning of ECs.

Acknowledgements: We would like to acknowledge the contributions and involvement of Mala Ramanathan, our cofacilitator for the workshop and Ashish Goel’s inputs in planning the workshop. We would also thank all participants for their active participation and inputs. Conflict of interest: none References 1. Jesani A. Ethics in ethics committees: time to share experiences, discuss challenges and do a better job. Indian J Med Ethics[Internet]. 2009 AprJun; 6(2):62-3. Available from: http://www.issuesinmedicalethics.org/ 172ed62.html . 2. Brahme R, Mehendale S. Profile and role of the members of ethics committees in hospitals and research organisations in Pune, India. Indian J Med Ethics [Internet]. 2009 Apr-Jun; 6(2): 78-84. Available from: http://www.issuesinmedicalethics.org/172ar78.html 3. Indian Council of Medical Research. Ethical Guidelines for Biomedical Research on human participants [Internet]. New Delhi: Indian Council of Medical Research; 2006 Oct [cited 2009 Nov 24]. 120p. Available from: http://www.icmr.nic.in/ethical_guidelines.pdf

Use of blanket consent for retrospective research in academic institutions: need for scrutiny and integrating safeguards Anant Bhan Independent Researcher, Bioethics and Public Health, Flat 405, Building A-11, Planet Millennium, Aundh Camp, Pune 411 027 INDIA email: [email protected]

The quantum of research is increasing in most Indian institutions. Linked with academic activities such as postgraduate thesis studies, or with externally and internally funded research projects, this research is often useful in devising better treatment modalities as well as in making policy suggestions. As knowledge about ethical requirements in research becomes commonplace, the need for informed consent (IC) from patients and/or research participants has become the norm. Some institutions have started encouraging researchers to take consent from patients for the use of their samples or case reports for unspecified future research purposes; such consent is often referred to as “blanket consent”. Ethicists and researchers in a previous issue have debated whether the use of blanket consent can be justified (1-3). This commentary looks at the concept of blanket consent in the context of research in India. It highlights issues from the perspectives of the researcher and the patient and provides examples of ways to address these concerns.

Informed consent in our context Obtaining IC is a key component of ethical research and requires that the patient or research participant be adequately informed about the research so that s/he can make a decision about whether or not to participate in the research. This is not just a one-time requirement but a process which is reinforced at the time of subsequent research visits (if these are required

by the research protocol). Conventionally, IC requires that all relevant information be understood by the participant, and that the decision to participate be made voluntarily. However there are challenges in obtaining effective consent in our settings due to factors such as low literacy levels and high levels of trust in healthcare providers (4). The quality of IC thus remains an ongoing concern in Indian institutions, whether in the public or the private sector.

Why blanket consent Often researchers and clinicians do not know in advance what they might want to study in the future, or what might be clinically relevant research in their disciplines. They might be treating a patient or a series of patients with an interesting clinical condition but without the technical knowledge to be able to conduct research on patient samples at that point in time. They may therefore want to preserve tissue samples for possible use in future research. Allowing researchers to store interesting samples will enable them to conduct research and come up with relevant findings once they have new tools or novel research methodologies to apply to the samples. This research could help in the enhancement of knowledge as well as in the discovery of new treatments or research information which might be relevant in treating patients with that clinical condition (including, possibly, the patients to whom the samples belong).

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However, researchers will be unable to use the samples at a later time unless the patients to whom the samples belong have permitted to their use in future research. Since consent is usually taken at the time the sample is collected, when the patient reports to hospital, consent for future use of patient samples for unspecified research purposes would have to be “blanket consent” for future use. Blanket consent means that no restrictions are put regarding the purpose of future research. American regulations “allow for existing biological materials to be used for research without consent if they are de-identified”. (5)

Why is blanket consent problematic? Consent is usually specific to a particular clinical procedure or set of procedures or research project; the basic premise of consent in research is based on the participant knowing what kind of research is to be carried out with the samples. Can you give valid consent if you do not know what you are consenting to: the purpose of the research that uses your specimens and samples? This argument is usually countered by researchers who say that there is no problem with taking blanket consent as long as it is made clear to participants that their samples might be used for research purposes in the future. Usually this assurance is supplemented with an assurance that the samples will be anonymised, thus maintaining the patient’s confidentiality. This method might work when conducting research with large data sets. However, it will not work if the research concerns just one very interesting patient with unique clinical characteristics who remained a diagnostic quagmire, and hence will be easily identifiable even in the future to the hospital’s staff members. Such a patient could face stigmatisation or loss of confidentiality. The other problem with blanket consent arises when there is a possibility of future commercial use of research derivatives from tissue samples. This may not at present be a concern in public hospitals, but could become one as the government is encouraging the commercialisation of research through agencies like the Department of Biotechnology (http:// dbtindia.nic.in). An example would be stem cell lines developed from the tissues of patients with specific clinical conditions which could have commercial applications. This then raises the question: who owns the tissue? Is it the patient, the hospital or the researcher, or a mix of all of these stakeholders? This would be linked with the question of whether the patient should receive a part of the profits or royalty fee if commercialised products are derived from the stored tissue products. Conceptually it would also operate beyond the tissue samples of individual patients to the larger question of tissue ownership. This had happened some years ago, when the Indonesian government refused to share tissue samples from patients with avian (H5N1) influenza with the WHO without an advance commitment that developing countries would get any products, especially vaccines developed from these samples at an affordable price (6). The third problem concerns the quality of IC. As discussed

earlier, when the quality of IC in most institutions (both public and private) is itself doubtful, what difference does the detail (for example, the mention of blanket consent) of the form make? Only when IC is given the importance that it deserves as part of research and clinical activities in public and private institutions, will we be able to also ask whether consent for blanket use was indeed truly informed (otherwise it will just be another clause in the IC form to which no one really pays any attention while administering consent, though it would be used by researchers to be able to justify future research). It has also been pointed out that patients might not approve of “downstream research uses” of their tissue sample because of personal beliefs or disagreements with the subject of research, such as, for example, stem cell research (5). In this case, general blanket consent would be troubling.

How to approach the issue of blanket consent The use of blanket consent clauses will probably become common in IC forms. The usual way to build in protection mechanisms in such cases is to ask for anonymisation of samples to respect the confidentiality of the patients to whom the samples belong. In addition, ethics committee should evaluate all future research proposals which aim to use stored tissue samples. Ethics committees in institutions should get involved in developing clear institutional policies on the issue of blanket consent, and ensure that they remain committed to their key duty of protecting patient interests. Training of researchers is an important part of this approach. Ethics committee members and/or ethics experts can work with the researchers in developing consent forms with clauses which give the participant the right to provide or refuse blanket consent, after giving information about the implications of a particular choice. In a research project that I have been involved with, the laboratory scientists and clinicians were trained on ethics/ regulatory issues; ethics and science policy experts worked with researchers in devising the consent form (so that they would see the importance of the wording and the various clauses through this process and feel ownership of the consent form and consent process). The Regulatory and Ethics Board also deliberated to arrive at a consensus about the permissible content of a blanket consent clause in the IC form. There was a section in the consent form with three choices: a) The patient does not want to be contacted in the future, and allows for any sort of future use of his/her samples. b) The patient wishes to be contacted for “re-consent” in the future if the research purposes are different from those of the current research project. c) The patient does not want to be contacted in the future, and also does not consent to the use of his/her samples for any future research project. This serves as an example of giving the patient the right to decide on whether or not to go in for blanket consent, and also

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what approach to take to anonymisation. Of course this also requires a good, secure system of linking samples with patient information/identifiers to enable the patient choices to be implemented.

Conclusion Taking blanket consent from patients in institutions for use of their samples for research purposes in the future raises questions about whether this approach is ethical as the patient might not be truly informed about research objectives. Respecting patients’ rights and yet accommodating possible future research would require devising consent forms which provide flexibility to obtain blanket consent while respecting the key elements of IC to a large extent. The axis of control of decisions about consent, blanket or not, should remain with the patient. It is for researchers, ethics committees, institutional leadership, and regulatory and policy makers to ensure that this happens.

References 1. Jesani A. About student research and blanket consent from patients. Indian J Med Ethics. 2009 Oct-Dec;6(4):216-8. 2. Pandya S. Blanket consent for retrospective studies: patients’ obligation. Indian J Med Ethics 2009 Oct-Dec;6(4):218. 3. Desikan P. Blanket informed consent for retrospective studies is justified. Indian J Med Ethics. 2009 Oct-Dec;6(4):219. 4. Bhan A, Majd M, Adejumo A. Informed consent in international research: perspectives from India, Iran and Nigeria. McMaster University Medical Journal. 2006 March. 3(1): 36-41. 5. Aalto-Setälä K, Conklin BR, Lo B. Obtaining consent for future research with induced pluripotent cells: opportunities and challenges. PLoS Biol. 2009 Feb 24;7(2):e42. 6. Rambhia K. No agreement reached between WHO and Indonesia on sharing H5N1 samples [Internet]. Pittsburgh (USA): University of Pittsburgh, Biosecurity Briefing;2007 Nov 30 [cited Nov 19]. Available from:http://www.upmc-biosecurity.org/website/biosecurity_ briefing/archive/avian_pandemic_flu/content/2007/2007-11-30noagreewhoindonesiashareh5n1samples.html

Books on ethics in health Technology in health care: current controversies Editors: Sandhya Srinivasan, George Thomas Published by: Forum for Medical Ethics Society and Centre for Studies in Ethics and Rights, Mumbai. December 2007. 288 pages. Rs 200 This collection of essays covers important discussions related to medical technology that have been carried in the Indian Journal of Medical Ethics. Each of the nine sections is preceded by a commentary by an expert in the field. The nine chapters cover placebo controls in research; intellectual property rights; family planning and population control; the HIV/AIDS programme and research; electro convulsive therapy without anaesthesia, liver transplant technologies, end-of-life care, medical professionals and law enforcement, and technology in public health programmes. Selected readings 1993-2003 Editors: Neha Madhiwalla, Bashir Mamdani, Meenal Mamdani, Sanjay A Pai, Nobhojit Roy, Sandhya Srinivasan Published by: Forum for Medical Ethics Society and the Centre for Studies in Ethics and Rights, Mumbai. November 2005. 248 pages. Rs 150. This selection of essays previously published in the Indian Journal of Medical Ethics serves as a short education on health care ethics in the Indian context. The articles are divided into five sections: personal integrity, communication, technology and social justice, research ethics, and law, policy and public health. The preface gives an overview on the emergence of medical ethics as a topic of interest to each section and article give the reader a background to the discussions and current relevance. To order copies, please send a demand draft or cheque in favour of “Forum for Medical Ethics Society” to Forum for Medical Ethics Society, c/o Centre for Enquiry into Health and Allied Themes, Sai Ashray, Survey No 2804-2805, Aaram Society Road, Vakola, Santacruz (E), Mumbai 400 055 INDIA Email: [email protected] Please add Rs 30 for outstation cheques.

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meeting REPORT

This is no low risk game: social science researchers reflect on their work Divya Bhagianadh, Supriya Bandekar, Deapica Ravindran, Sachin Nikarge Centre for Studies in Ethics and Rights, 501-B, Dalkhania House, Vakola, Santacruz (E), Mumbai 400 055 INDIA emails: [email protected] , [email protected] [email protected] , [email protected]

The ethics of conducting social science research is a largely unexplored field in India even years after the development of guidelines on this activity. It is often believed such enquiry does not pose any risk to participants; no experimental drugs are administered, no blood samples are taken, and no invasive tests are conducted, so the ethical dilemmas that biomedical researchers commonly face do not exist in this type of research. Some ethics committee members seem to view social science research as “just a bunch of questions”, approving these proposals without proper review. However, people can and do face harm as a result of their participation in such research. And researchers often face difficult decisions related to the ethics of their work. In November 2009, the Centre for Studies in Ethics and Rights in Mumbai conducted a two-day consultation at which investigators in large community-based projects presented case studies on the ethical challenges that they faced in the course of their work. The observations below give a flavour of the discussions that followed

Do we really need research? The first question concerned the ethics of doing research itself. Why do we need research to tell us what we already know? How do we justify the resources that are spent on such research? One of the researchers at the meeting mentioned that she spent two years doing a community survey when the same information could have been collected from available secondary data. The discussions highlighted the importance of properly done research. For example, evidence gathered in behavioural research can help us to design interventions to positively alter a particular behaviour or habit. Research can also gather evidence to convince decision makers regarding important policy matters. Many times the numbers or figures in a well documented report will convince authorities to act when they have failed to see what is right there in front of their eyes. Decisions based on systematic research will have greater impact than decisions made without complete information, or without taking into consideration the peculiarities of the region. Ethics committees who review research proposals, and research organisations that carry out the studies, should keep this in mind. Further, sometimes there is a need for an independent

study even if secondary data are available. This will give the researcher a better perspective about the situation which might be different from what is depicted by official figures or secondary data. Researchers also obtain a lot of qualitative information while in the field, regardless of whether they are doing a quantitative or qualitative study. Such insights provide faces to the numbers and figures that appear on official reports and documents. One also needs to think about translating research into action. Research ethics does not end with data collection, analysis and finalisation of a report. It is the ethical responsibility of the researcher or research organisation to share the findings with all stakeholders and make efforts to ensure that results are used in a fruitful way. This addresses the ethical dilemma that the researcher faces about the utility of doing a particular study.

On ethics and methodology If the first step in research is to answer the question: “Is this research really necessary?”, the next is to recognise that the social scientist’s actions have an impact on the community that is being studied. However, little attention is paid to the agency of the researcher. This “invisiblisation” of the researcher seems to be an inheritance from the biomedical approach to research ethics. As social science researchers we should place participants and ourselves in a matrix of social relations to understand what exactly is meant by harm, and informed consent, and what the implications are of accepting one’s own agency. Many participants during the ethics consultation articulated the need to do “research on research”. Writing a project report is not the end of the enquiry; it is the beginning. It enables researchers to distance themselves from their own work and view some of their choices in a different light. One of the studies documented health indicators across gender, caste, class and location in Maharashtra in order to identify problems that limit vulnerable groups’ access to healthcare. One problem that researchers faced was how to treat the consent of the woman who participated because of familial pressure. Should they treat it as true consent? And what about the woman who was pressurised by her family into refusing consent? Did her exclusion from a state-wide survey affect the generalisability of the findings?

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Another participant noted that researchers, who are usually outsiders to the village, go door to door asking people very personal questions. Why would women reveal their gynaecological details to an outsider? Would researchers answer questions about their own bodily functions and sexuality? On the other hand, such research could be conducted through unstructured interviews allowing the women to share experiences, rather than a survey that seems to embody a top-down approach. It might reveal a lot more on the gendered nature of social realities. Wouldn’t sharing experiences women feel freer to talk? Of course, this process would bring its own ethical dilemmas. It was pointed out that in order to be able to give “concrete” findings and conclusive data, we give up a more engaging process of ethnography and choose surveys that allow us as researchers to remain outsiders and often the more powerful of the two. We all operate in a matrix of power and cannot ignore the fact that this matrix shapes social relations and, by extension, social research.

The ethics of the researcher-respondent relationship The ethical implications of the researcher-respondent relationship were discussed extensively in the presentations. Social science researchers do not want to restrict their work to identifying specific problems and producing data on these problems. In a study on living conditions of women prisoners in Maharashtra, researchers found that many of the women they interviewed complained of sexual harassment. As researchers they could only ask the women to complain to the authorities but the women did not view this as an option. In the discussion that followed, a number of participants reported facing a similar dilemma. For example, research participants may expect some help from the researchers who interview them. The researchers, on the other hand, can only give them information. They may advise them to complain to the authorities, or they may refer them to the nearest health service. But they are aware that these agencies have failed to fulfil their duties, and asking the people to go back to these agencies is certainly not a solution. Researchers were acutely aware of the ethical dilemma in mutely collecting data, while knowing they could do nothing about the problems of the people whom they interviewed. Researchers also described the problem of the gatekeeper’s interference in the research environment. In the research conducted in prisons, they had to get prior permission from the prison authorities to schedule their visit. The prison authorities deliberately make the situations look better on the day of the researchers’ visit. This meant researchers had to report on what they saw though they knew the reality was otherwise. Another issue that provoked discussion concerned “off the record” comments from respondents. Respondents have sometimes given valuable information which is directly

relevant to the research, but then asked that it be kept “off the record”. Since the respondent has not consented on the use of that piece of information, researchers are not able to report it. Several dimensions of this issue were discussed. This was seen by some as reflecting the personal relationship between the respondent and researcher. The respondent may have given that information in the hope that the researcher would do something about it in the future. It might also be a means to vent one’s feelings. In any case, researchers felt frustrated because they had useful information that they could not use for the research.

The need for ethics review Social science researchers have always felt that social research is far too complex to be subjected to the framework of the biomedical research model set up on the four pillars of beneficence, malfeasance, justice, and autonomy. A strong, equity-driven human rights vision was all that social scientists thought to be important in order to undertake good research. It was felt that procedural issues like ethics reviews, consent, and norms to be followed by researchers - largely imported from the biomedical ethics model - would automatically fall in place if the fundamentals were sound. However, the research case studies presented at the consultation were distinct for their reflection and selfcriticism. For example, the research study to improve reproductive health in 600 villages across Jharkhand dwelt at length on sample selection and study design. Jharkhand is a region ravaged by intermittent conflicts, lacking even basic reproductive health services, with a largely dysfunctional government infrastructure and with no large nongovernmental organisations. After considering how to select the control area in the study, the researchers decided to do away with the control arm for fear of withholding an intervention to a group that was deprived of even minimum access to basic reproductive health services. This decision led to concerns about the scientific strength of the study design. Indeed, modifying the study design in this case called for striking a balance between ensuring scientific validity and retaining minimum access to basic health services. A number of case studies presented subsequently recorded the trade-offs between sound scientific design and ethical issues. Several ethical issues emanated from the very situations and contexts in which the projects remained embedded. Indeed, it takes courage on the part of researchers to present and simultaneously provide a critical review of their own case studies. In the animated discussions that took place after each presentation, both logistical as well as methodological issues that lead to ethical problems came to light. Only ongoing ethical oversight would help identify the different types of issues and help develop solutions to ethical, logistical, and methodological problems.

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SELECTED SUMMARY

HPV vaccines: separating real hope from drug company hype Gagandeep Kang Department of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu 632 004 INDIA email: [email protected]

Rothman SM, Rothman DJ. Marketing HPV vaccine. Implications for adolescent health and medical professionalism. JAMA. 2009 Aug 19;302 (7):781-6. In 2008, Harald Zur Hausen received the Nobel Prize in physiology and medicine for showing that two human papilloma viruses, HPV16 and HPV18, were associated with the bulk of cervical cancers, and that some of the genes contained within the viruses were incorporated into the infected host tissue, resulting in carcinogenesis. These carcinogenic strains of HPV cause 70% of cervical cancer and kill an estimated 175,000 women annually. In 2006, the first HPV vaccine, Gardasil(r), made by Merck, was launched on the US market, as the “first anti-cancer” vaccine. Subsequently, a second HPV vaccine, Cervarix(r), has been released by GlaxoSmithKline. As with other pharmaceutical company products, both vaccines have been widely marketed and promoted by the companies. However, the marketing of these vaccines and the nature of the information and advocacy provided have led to concerns regarding the role of pharmaceutical companies in the dissemination of information relevant to consumer and public health decision making. In an article published in the JAMA, Rothman and Rothman have considered the marketing strategy for Gardasil(r) and its implications for medical professionals (1). In order to understand the ethical issues surrounding the marketing of this vaccine, it is important to understand key facts about HPV infection and disease and the role of these vaccines in prevention of cervical cancer. Essentially, HPV infections occur in sexually active individuals and the risk of infection increases with increasing partners. Infection can result in no symptoms or a range of symptoms, from warts to cervical cancer depending on the virus type. The risk of cervical cancer is associated not only with HPV infection, but also with socio-economic status, smoking and other risk factors. The vaccine contains four common virus types, and, if given before sexual activity, prevents infection. Once infection has occurred, the vaccine is ineffective. In vaccine trials, because cervical cancer occurs several years after infection, it was not possible to demonstrate an actual decline in cervical cancer incidence, but based on the pathogenesis and natural history of disease it is likely that cervical cancer due to HPV 16 and 18 will be prevented. Again, because of the length of the follow-up required, the studies have not been conducted to show long protection due to the vaccine will last.

With these facts, Rothman and Rothman point out that the drug companies have adopted a multi-pronged strategy to promote the vaccines. Professional medical associations are offered educational and training grants that come with strings attached, where it is clear that the message to be delivered at all costs is to have the vaccine used as much as possible. This is, at least, in part to the prior experience where hepatitis B vaccine had little uptake for the period when it was viewed as vaccine for particular risk groups (2). While the lay media is known to fasten on to new products and present them as the panacea to end the disease of the moment, it is a matter of concern that medical scientists are being asked and encouraged to deliver a message that may present an unbalanced view, and where the emphasis on promoting the vaccine discounts key facts or hides information. In so doing, clarity in communication is lostand the public receives an incomplete message that presents a one-sided view of the disease and prevention of cervical cancer. There are four important ethical issues that need to be considered in using HPV vaccines. The first is that public knowledge needs to be sufficiently detailed to enable informed choices. The vaccine is currently being presented as an alternative which will remove the need for Pap smears. However, both vaccines contain only two types, HPV16 and HPV18 which cause 70% of cervical cancers and offer no protection against types not in the vaccine. Additionally, with no data on the duration of persistence of antibody response, it cannot be stated with certainty whether the proven protection from persistent infection and cervical intraepithelial neoplasia will result in a life-long protection from cervical cancer (3). The vaccines are not therapeutic, which means that women already infected will continue to need monitoring for early detection. These are important issues, but in the hype surrounding the vaccine, promoted by the “educational material” or Speaker Lecture Kit provided by companies, the authors report that trainers are asked to focus instead on the possibility that a woman infected with one type may yet benefit from protection against the other types (4). The second important ethical question is regarding access to medical intervention, including preventive interventions such as vaccines. In most countries where the vaccine is available outside a trial setting, the mortality rates due to cervical cancer are low, because most women have access to and participate in screening which allows earlier detection and effective

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management of the lesions. In the settings where cervical cancer rates and mortality are high, women have limited access to screening programmes (5), and most likely will not receive the vaccine in the near future, given the pricing models adopted by the companies, where cost recovery and profit must come before altruism. However, if low or tiered pricing were to be made available, a vaccination programme may, in time, be a more effective means of reducing the burden of disease in countries where the considerable resources needed in terms of trained personnel, laboratories and functional referral systems, for running screening programmes are unavailable or inadequate. In the marketing of these vaccines, the target audiences are largely in developed countries, and even within them, issues of healthcare disparities across ethnicity, socioeconomic status and education are not a priority.

In all of these issues and their careful consideration, professional medical associations have critical roles to play in educating their members, disseminating appropriate, balanced information to the public and helping to develop policy. As the authors highlight, in allowing themselves to latch on to the hype surrounding a new product without presenting a complete picture, the associations do themselves a profound disservice and diminish their role as leaders and policy makers for the populations they serve. To enable public trust in fair and well-founded research and resulting products, healthcare professionals and academic bodies need to act without fear or favour enabling appropriate decisions about the role of vaccines and secondary preventions programmes, particularly for those populations most in need of these interventions.

The third question is the role of women and the development of inappropriate gender stereotypes. At present the vaccine is to be given to female adolescents, and the implication is that women are responsible for issues related to reproductive health. This is inaccurate as both men and women are infected and spread the disease, although the bulk of the disease burden is on women.

1. Rothman SM, Rothman DJ. Marketing HPV vaccine. Implications for adolescent health and medical professionalism. JAMA. 2009 Aug 19;302 (7):781-6. 2. Centers for Disease Control. Recommendation of the Immunization Practices Advisory Committee (ACIP) inactivated hepatitis B virus vaccine. Morb Mortal Wkly Rep.1982 Jun 25;31(24):317-22,327-8. 3. Haug CJ. Human papillomavirus vaccination- reasons for caution. N Engl J Med [Internet]. 2008 Aug 21[cited 2009 Nov 25];359(8):861-2. Available from: http://content.nejm.org/cgi/reprint/359/8/861.pdf 4. Institute on Medicine as a Profession. IMAP HPV vaccine sources [Internet]. New York: IMAP; 2009 Jul 28[cited 2009 Nov 25]. Available from: http://www.imapny.org/about_imap/news__announcements/ hpv_vaccine_sources 5. Freeman HP, Wingrove BK. Excess Cervical Cancer Mortality: A Marker for Low Access to Health Care in Poor Communities [Internet]. Rockville, MD: National Cancer Institute, Center to Reduce Cancer Health Disparities; 2005 May [cited 2009 Nov 25].96p. Available from: http://crchd.cancer. gov/attachments/excess-cervcanmort.pdf 6. American College Health Association. Who we are? ACHA brochure [Internet]. Maryland: ACHA; 2009[cited 2009 Nov 25]. Available from: http://www.acha.org/about_acha/mission.cfm

Finally, the vaccines are to be given at adolescence. Children at this age should be asked for assent, and the purpose of the vaccine and its risks and benefits explained. This could lead to difficult situations, with parents being uncomfortable with having the vaccine discussed or worried about the vaccine potentially promoting unsafe sexual behaviour. However, in the marketing campaigns, no reference is made to the fact that this “anti-cancer” vaccine does not prevent sexually transmitted disease and no advice is offered on practising safer sex (6).

References

Thank you, reviewers All submissions to the journal are reviewed by at least one member of the editorial board or editorial advisory board. Some submissions are also sent out for external peer review. We would like to thank all our editorial board reviewers and the following external experts who have reviewed articles for the journal during 2008: Gracy Andrew, Anant Bhan, Padma Deosthali, Roop Gursahani, Koffi Isidore, S P Kalantri, Kalpana Kannabiran, Gagandeep Kang, Arvind Kasargod, Sanjay Mehendale, Samiran Nundy, Imrana Qadeer, Soumitra Pathare, Anant Phadke, Jagadeesh Narayan Reddy, Peush Sahni, S Sridhar and S Srinivasan.

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Reviews

An industry without borders Divya Pamnani University of Michigan School of Public Health, Ann Arbor Michigan 48109 USA email: [email protected]

Adriana Petryna. When experiments travel: clinical trials and the global search for human subjects. Princeton, NJ: Princeton University Press; 2009. 258 pp The words “randomised controlled trials” have taken on new meaning for me. In When experiments travel, Adriana Petryna reveals the experimental machinery manipulated by the globalising clinical trial industry in the quest for blockbuster drugs. She chronicles interviews of people who are not so much heroes or villains but ordinary actors engaged in a partly dirty business across national boundaries. In this anthropological account, Petryna explores how the research industry has mastered the science of “evidence making”, which includes configuring to which countries to offshore clinical trials, teasing out the loopholes of existing regulatory frameworks and seeking out “foolproof, treatmentnaïve, steroid-naïve, statin-naïve” clinical trial populations in the most ailing healthcare systems. Through her interviews of clinical trial industry players in Eastern Europe and Latin America, the author weaves an intricate web of issues involved in the politics of pharmaceutical globalisation. She reveals a paucity of accountability, oversight and transparency. She expresses concern over “commodified patients” and exploitation of the vulnerable, raising questions about the scientific integrity of research, wondering whether ethics is simply “workable documents on paper”. The author describes how the epidemic of cardiovascular diseases in Poland in the 1980s and 1990s was the pull factor leading to a “gold rush” of drug and surgery trials in cardiac care in that country. According to the director of a global contract research organisation (CRO), Poland among other Eastern European countries was used as a “rescue country” where failed projects of me-too drugs were often dumped. Salvage research and floating “garbage trial” protocols to low-income countries began to be seen as a profitable form of rescue for pharmaceutical companies. The author flags concerns about the aftermath of these trials which leads to the worsening of health inequities, complicated by the lack of post trial access to treatment. While in Brazil, healthcare is the duty of the state. Pharmaceutical access is a cornerstone of healthcare coverage providing for all kinds of medicines - whether they are on the country’s essential drug list, part of specialised programmes or even in experimental stages not yet approved for marketing.

This “pharmaceuticalisation” - a term coined by medical anthropologist Joao Beihl - paved the way for a strained health system offering too much. The irony is obvious; “you might be out of work and hungry but you could still claim your free antianxiety pill” at the local health post, writes Petryna. In Brazil’s context of poverty, people die mostly of infectious diseases while the consumption of drugs for lifestyle diseases soars. The apparent disconnect between clinical experimentation and local health needs is starkly evident. “We have no idea what their value is for our patients. All we know is that many of the new drugs can’t kill, but we don’t know if they can save” explains Dr Andry Costa, a cardiologist and researcher. She goes on to explain the exploitation of Brazilian real-life patients who are much sicker than the ideal patients in clinical trials and in these scenarios biased data is an inherent flaw. They use human subjects not only to generate drug value through R&D, but they also turn them into vociferous consumers of treatment via the state, creating a dangerous “public health trial”. A running theme through the book is that of cold blooded research at the hands of CROs, the data generating enterprises working on behalf of sponsor companies. They care most about getting the data, ensuring their “integrity,”“engineering out” the possibility of adverse events by including a “randomised” (read “highly edited” and cautiously selected) patient population and making data from international sites portable and usable within the US drug approval process. In the unsettling words of a CRO professional, “I don’t see patients, I see data.” The benefit of this lop-sided approach, he claims, is that while data are transferred out of the country, a lot of clinical investment comes back in. Providing context, Petryna highlights a notable event for the clinical trials research industry: the International Conference of Harmonization’s Good Clinical Practice (ICH-GCP) guidelines. Their main aim was to make clinical data from international sites transferable and acceptable to regulatory authorities in the US, Western Europe and Japan. They also served to undercut the regulatory significance of the 2000 revision of Helsinki Declaration regarding placebo-controlled trials. The Helsinki Declaration requires a new drug to be tested against the best or standard treatment for a particular indication. ICH-GCP on the other hand allows placebo-controlled trials. The experimental drug can be tested against “equivalent medication”, not necessarily standard or best treatment, but whatever was locally available and accepted by local review boards - which could be no treatment, or a placebo. This ethical

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variability allowed pharmaceutical companies to bypass ethics in the developing world. Placebos also happen to reduce trial costs and provide better evidence. Though India’s clinical trial scenario receives nothing more than a few passing references, one can’t help but draw parallels and wonder about the fate of pharmaceutical research in this

country. How is India going to respond in the wake of being dubiously hailed as the “global clinical trials hub”? With the inflow of clinical trials investments, will the Drugs Controller General of India beef up regulatory mechanisms? Or will clinical trials become a part of healthcare delivery for disadvantaged groups? At present, one can only guess.

How to catch a thief Sanjay A Pai Department of Pathology and Laboratory Medicine, Columbia Asia Referral Hospital, Malleswaram, Bangalore 560 055 INDIA email : [email protected]

Frank Wells and Michael Farthing, (eds). Fraud and misconduct in biomedical research. London: The Royal Society of Medicine Press; 2008, pp 300 (paperback) Paperback ISBN 978-1-85315-786-8 45 £ UK Fraud and misconduct have probably always existed in biomedical research and, as is evidenced by recent events, they are here to stay. Witness, for example, two recent cases, one in basic science from 2006, that of the Korean stem cell researcher Hwang Woo-Suk, and the other from clinical medicine in 2009 (after the book under review was published), that of Scott Reuben, the anaesthesia and pain researcher. Both of them published papers in leading journals in their field which changed the way we think about and practise science and medicine - until their fraud was detected. Thus, the authors begin the book with these appropriate words in the preface: “It is with some regret that a fourth edition of this book still has relevance today.” Fraud and misconduct in biomedical research, in its earlier avatar (with the redoubtable Stephen Lock as one of the editors) has been acclaimed as a masterpiece and this edition, which is largely rewritten, is meant to be a textbook for dealing with fraud. In this, the editors of the book have succeeded. The six sections of the book deal with the basics of fraud (value systems, issues in publishing and a definition of misconduct), a review of the history of fraud in North America and Europe, the prevention of fraud, how to detect fraud, how to investigate it and, finally, the way ahead. The book reiterates that fabrication, falsification, plagiarism and theft are the four cardinal examples of fraud. Much of this is to achieve fame, financial gain, promotions and at times, to use Stephen Lock’s term, because of a “Messiah complex”. However, our changing values and a changing society have dictated that many things which would once have been considered entirely acceptable are now looked upon entirely differently. Richard Smith, ex-editor of the BMJ, discusses some of these ethical issues that arise in publication. These include, among other things, failure to obtain informed consent for research, failure to publish (!) or publishing too much. Informed consent is perhaps the best known aspect of research ethics and needs

no elaboration. But failure to publish, particularly if the results are negative, also constitutes misconduct. This is because, it is argued, it is the researchers’ duty to publish, and because negative results rarely get published, this can result in a bias in favour of a treatment - which would be unscientific. Journals nowadays insist on patient consent even for the publication of case reports. I must confess that I had never understood the logic of this, but Smith explains why the BMJ started asking for this - and I now see the logic of it. Yet, Smith himself admits that they sometimes felt they were going too far in this and thus, there are still many unanswered questions about the appropriateness of consent in all cases. About one third of the book deals with the methods of detection of research misconduct - appropriate indeed for a textbook. The means of doing this are varied and at many levels - right from using the electronic media to identify fraud to the use of audits to the use of appropriate statistical analysis to unearth fraud. There are explanatory examples but the authors do not divulge all details. Of course, it makes sound sense not to reveal your hidden strengths to the enemy. It is interesting to learn that most cases of misconduct are brought to light because of whistleblowers. Yet most of these whistleblowers - as seen in numerous anecdotes in the book - suffer financially, professionally and mentally after blowing the whistle. Other thought-provoking bits of information in the book were these: research fraud is not considered by many, it appears, as heinous as financial fraud; none of the 26 cases of fraud in the UK (p 73) are by women; and as recently as 2007, 41% of over 200 leading biomedical journals gave no instructions about authorship criteria. Can this book be improved further, in the next edition, perhaps? My only wish, or perhaps grouse, is that the book is largely West-centric. It is, of course, entirely up to the editors to decide who they wish their target audience to be (European and American), but given that they intend this to be a text, I believe they should address a larger, global audience. Indeed, while the preface states that the contributors are “from all corners of the world”, I could only see contributors from Europe and the USA. Even the excellent histories of fraud are largely about cases from North America and Europe. Surely South America, Africa,

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Asia and Australia have also had their share of problems with fraud - and certainly, all of us could learn valuable lessons from these. Russia and India are now centres of clinical trials and ethical issues (and thereby issues dealing with misconduct) have arisen in a considerable number of trials. It is of course well known that India, like many other developing nations, lacks a proper mechanism to check fraud. This has

been discussed in some detail elsewhere (1). If the good guys are to stay ahead of the bad guys, they would do well to read this book and put the methods in it to good use. Reference 1. Padma TV. Medical journals struggling to unearth research fraud [Internet]. UK: Science and development network; 2005 Aug 5 [cited 2009 Nov 19]. Available from: http://www.scidev.net/en/health/news/ medical-journals-struggling-to-unearth-research-fr.html

Medical emancipation Mridu Markan School of Social Work , Tata Institute of Social Sciences, P O Box 8313, Deonar, Mumbai 400 088 INDIA email : [email protected]

My sister’s keeper (Curmudgeon Films 2009) Director: Nick Cassavetes, 109 minutes.

her own medical treatment. She asks the court to take this authority away from her parents.

“I was born for a very specific purpose. I wasn’t the result of a cheap bottle of wine or a full moon or the heat of the moment. I was born because a scientist managed to hook up my mother’s eggs and my father’s sperm and come up with a specific combination of precious genetic material.”

This evokes sundry reactions. Anna’s father understands her need to be heard, but her mother - a lawyer turned homemaker is determined to lengthen Kate’s life and moves to fight the battle in the court. As the legal case proceeds, a speech in the courtroom twists the reality of the case, bringing to light the most decisive part of the movie.

This comment by a teenaged Anna Fitzgerald sums up the fundamental nature of this frighteningly thought-provoking piece of art. My sister’s keeper peeks into family dynamics, marvelously capturing the parent-child bond. Based on Jodi Picoult’s novel by the same name, it traces the life of Anna Fitzgerald (Abigail Breslin) who lives in California with her parents, Sara (Cameron Diaz) and Brian Fitzgerald (Jason Patric), brother Jesse ( Evan Ellingson), and her sister Kate( Sofia Vassilieva). When Kate is diagnosed with promyelocytic leukemia at the age of two, the peaceful and joyful life of this family takes an ugly turn. Following the unofficial advice of the doctor, the parents decide to conceive another child exclusively with the intention of saving Kate’s life. Anna, an allogenic donor, is genetically engineered to be a perfect match for her elder sister. She undergoes innumerable surgeries and donates genetic material, including blood and bone marrow, to keep her sister alive. Because of her sister’s dependence on her, Anna is unable to live the life she wants. The parents make Kate the epicentre of their lives, and struggle each day to keep her alive, often overlooking the other two children in the house. Kate suffers from relapses despite infusions of stem cells from her sister’s umbilical cord, as well as platelets and bone marrow. When she goes into renal failure, the parents want Anna to donate a kidney to Kate. Having spent her life in the shadow of her elder sister’s illness, the time comes when Anna starts questioning her own existence and the purpose of her life. Tired of being a living donor for her sister, she does the most improbable - she hires a “91% successful lawyer”, Campbell Alexander (Alec Baldwin), to get her rights to her own body. She confidently files a lawsuit against her own parents demanding “medical emancipation” - the right of a minor to decide on

Underlining the physical and psychological ordeal faced by a family to keep a sick child alive, My sister’s keeper brings to the forefront several ethical and moral dilemmas. Is it morally correct to do whatever it takes to keep one’s child from dying? In this quest, how ethical is it to infringe the rights of the other child? Is it ethical to focus on one child at the cost of neglecting the other children? Is it ethical to bring a life into the world with a vested stake? Under what conditions, should medical emancipation be granted? Should it be granted at all? Is there an appropriate age to seek rights on one’s own body? Ethical issues regarding genetic engineering of humans and distributive justice also emerge. (Treatment in medical establishments undertaking work of this nature is costly and not accessible to the majority of people.) The film underlines the pivotal issue of medical emancipation of minors. Obstacles faced in organ transplantation are also succinctly mirrored when the family pressurises Anna to donate her kidney to her elder sister. This movie is a string of scenes brilliantly shot and woven together by admirable acting: when love sprouts in Kate’s life even as she is undergoing treatment, Kate walking down the stairs of her house to go for a party, Kate’s visit to the beach, the proceedings of the case in the courtroom... such scenes will stay long in my memory. Nick Cassavetes has successfully dealt with a complicated subject, reflecting the different points of views thoughtfully. Powerful dialogues add magic to the tale. “There is no shame in dying,” says the judge in a conversation. Good editing, the topicality of the subject, a harmonious soundtrack and a distinguished cast with well-defined characters all make this a moving film.

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from other journals

Publication ethics Everyone agrees that it is unacceptable to copy another person’s ideas and words. Plagiarism is downright intellectual theft. The concept of self-plagiarism is a little more ambiguous. What’s wrong with copying from yourself? After all, you are only reprinting your own ideas. The driving force behind self-plagiarism is the intense pressure on academics to: “publish or perish”. The greater the number of publications one has under one’s belt, the better one’s career chances, whether for promotion or to obtain grant money. It is also true that researchers and clinicians have limited time to devote to writing for publication This can tempt authors to cut corners. It has been argued that one cannot steal one’s own words. The reply to this has been that there are a limited number of ways to say the same thing, and the same thing needs to be said in different forums. It has also been pointed out that there is a distinction between self-plagiarism of original research and of review material. Another form of editorial misconduct related to self-plagiarism is submitting large parts of the same original research paper to different publications. This is called “duplicate publication” or “redundant publication”. Publishing separate parts of the same study with approximately identical introduction and methods sections in different journals is described as “salami publication”. The problem with these practices is that they distort the research record. Some writers hold that self-plagiarism in review or opinion papers is, arguably, less unethical, with no real harm done. Editors, however, hold that this too is an attempt to deceive editors and readers. At best, it constitutes intellectual laziness. Deception, say editors, is the key issue in all forms of selfplagiarism, including in reviews. Few editors would like to republish a paper that contains large parts of previously published material. Readers, too, do not wish to read the same material in different journals. An attempt to deceive amounts to fraud and editors feel that it should not be tolerated by the academic community. Lancet editors. Self-plagiarism: unintentional, harmless, or fraud? Lancet. 2009; 374: 664

Equity and climate change Rich countries are consuming enormous amounts of energy. If they are responsible for global warming, why should the poor be asked to reduce their already low consumption? This is the crux of the climate change controversy as it is played out today. Shouldn’t the rich be doing all the cutting back?

In this editorial published in advance of the UN conference in Copenhagen on climate change, the writers argue that the climate change is global, the response should be global too. Further, saving energy always helps household budgets, just as drought-resistant crops help poor farmers. And everyone benefits from environment-friendly actions and technologies.. In fact, poor countries are more vulnerable to the impact of climate change in the form of drought and the impact on natural resources. Social conflict can be a consequence of such shortages. The authors suggest that all societies should view this as a challenge. It is not possible to address climate change without tackling inequalities between rich and poor. Health has socioeconomic context and it is not possible to improve people’s health without changing the iniquitous conditions in which they live and the forces that create these inequalities. The authors make a plea for constructive discussion at the UN climate change conference in Copenhagen. Such a discussion is necessary if we are to ward off disaster The rich must acknowledge their obligationsm, and the poor must realize that both rich and poor will have to act to reduce the impact of climate change. Jay M, Marmot MG. Health and climate change. BMJ. 2009;339:b3669

The problem of ragging It is called ragging or hazing in English, “bapteme” in French, “doop” in Dutch, and “mopokaste” in Finnish. Every language has its own word for the harassment that new students are submitted to as part of an initiation ritual. This harassment can be physical as well as psychological and it has a severe impact on the victims. In addition to bearing the scars of corporal punishment, the victims may be left emotional damaged and also at greater risk of suicide. This article reviews the history and context of ragging and proposes measures to check it. The author proposes various practical steps that authorities in educational institutions can take to control ragging. These include a ban on alcohol within the campus, surprise raids in hostels at night, postings of wardens in hostels, separate hostels for juniors, the establishment of college “disciplinary committees” and “cultural committees,” strict punishments for those involved in ragging, action by Medical Council of India and the University Grants Commission against erring colleges and universities, and the formulation of anti-ragging laws. The author concludes that ragging should be declared a public health problem. Garg R. 2009. Ragging: a public health problem in India. Indian J Med Sci. 2009; 63; 6: 263-71

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Poor access to drugs

Reporting conflict of interest

Substandard drugs constitute a serious problem in developing countries. This is the justification for international collaboration to regulate drug quality and use appropriate procurement policies and practices to supply countries with the best quality drugs. The absence of such policies has often led to flourishing informal drugs market. Retailers sell tablet, creams and injections in appalling conditions. And public health authorities turn a blind eye. Fake drugs and those that have deteriorated are often the only option for many people who cannot afford good healthcare. Pharmacists selling branded medicines are restricted to urban areas.

Financial conflict of interest in biomedical research has been associated with a number of unethical practices, such as reporting of pro-industry conclusions, exclusing negative results, and using biased study designs. Historically, physicians have been left to disclose conflicts of interest in their work and these declarations have not been verified independently.

Many countries permit these informal drug markets instead of enforcing international regulations for drug production and marketing. Drugs should be made affordable to local populations, and stored and transported properly so that they remain effective. Such action requires support from international health agencies. Basile Keugoung. The availability of drugs for rich and poor people in the developing countries. Lancet. 2009; 9; 586-7

Anticipatory science and bioethics The four principles of bioethics seem to articulate the problems faced in the doctor-patient interactions. But this framework may be more difficult to apply in other situations. The author examines this subject using the example of the artificial heart, which involves experts from outside the field of clinical medicine. Bioengineers are more likely to be experts in aeronautics, fluid dynamics, or materials science, disciplines that are considered essential for the design of artificial hearts. Their focus is on manipulating devices and calibrating them in order to ensure that they work well and dependably. This preoccupation can overshadow clinical issues, which they consider the business of medical experts. In the case of a mechanical heart, the partnership between bioengineers and surgeons can focus on technical discussions regarding the device. Patients already face anxieties over feeling a “less human”, mechanical dependency or failure, and their new status as research subjects or “implantees”. They are often left out of the discussion. The attitude of professionals - in both engineering and medicine - can be that these patients are lucky to be alive. But saving lives is not enough. It’s not equal to alleviating suffering. The author of this essay argues that in such experimental realms, one has to be prepared to be imaginative about the emerging moral questions. While the themes of nonmalfeasance, beneficence, autonomy, and justice do have application here, they may be insufficient to capture the openended, moral complexities of such “anticipatory science”. Sharp L. The art of biomedicine: Bioengineered bodies and the moral imagination. Lancet. 2009; 374: 970-1

This study compared physicians’ disclosures in academic fora to their disclosures when they were required to make them for regulatory reasons. Five US companies controlling 95% of the markets for total hip and knee prostheses were compelled to make financial disclosures, as part of a settlement with the U S Department of Justice. Researchers compared these disclosures to declarations made by the same physicians when they published or made academic presentations. They found that 71.2% of the payments were disclosed. 79.3% of payments directly related to the topic of the presentation were disclosed; 50% of payments indirectly related were disclosed; and 49.2% of payments unrelated were disclosed. Payments were also more likely to have been disclosed if they exceeded $10,000, were directed toward an individual physician rather than a company or organisation, or included an “in-kind” component. The justification for not disclosing was often that the payment was unrelated to the topic of presentation or that the physician had misunderstood the disclosure requirements Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandari M. Accuracy of conflict-of-interest disclosures reported by physicians. NEJM. 2009; 361:1466-74

Ethical principles and the practice of urology Urologists are often confronted with situations with major ethical implications. The author of this essay examines the following situations: seeking informed consent from patients for interventions, selecting patients for educational workshops, recruiting patients for clinical trials, and employing technology in treatment. The author emphasises that in all these situations, proper communication of the benefits and risks should become an integral part of the ethical physician-patient relationship Three essential elements of effective communication are mentioned: communication of the certainty of risk (evidence base), the level of risk, and the effect of such risks. Mohan A. Ethics and contemporary urology practice: Setting out principles Indian J Urol. 2009; 25: 340-2

Pros and cons of human microdosing Human microdosing is a technique to study the behaviour of drugs in humans through the administration of very low doses. These doses are just high enough to elicit a cellular response but low enough to avoid the production of whole-body effects. This new experimental technique - also described as a “phase 0 study - is viewed as an efficient approach to identify promising molecules in the early phase of development. The authors suggest that drug researchers have underutilised this methodology due to lack of understanding of its benefits and

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limitations. In fact, human microdosing can help shorten the time to phase-I studies, lead to early selection of promising compounds, avoid exposing participants to new drugs unnecessarily, and, because of the low doses, are less risky to humans.

percent reported that they kept the subject in the trial anyway.

The authors also list a number of disadvantages. Participation in such trials may reduce the pool of subjects for traditional phase-1 trials that may have some therapeutic intent. Microdosing also requires ultra sensitive equipment which is not easily available and it may be difficult to predict different levels of absorption for certain drugs.

Lidz CW, Appelbaum PS, Joffe S, Albert K, Rosenbaum J, Simon L. Competing Commitments in Clinical Trials. IRB: Ethics & Human Research. 2009;31, 5:1-6

Despite these obstacles, the authors conclude that human microdosing is a promising strategy that needs scientific validation in the field of drug development. Seth SD, Kumar NK, Dua P. Human microdosing, a boon or a bane? Indian J Med Res. 2009; 130; 202-4

Balancing clinical and research commitments in clinical trials The authors look at the conflict of interest between research and clinical practice in clinical trials. They conducted an online survey of 744 clinicians, including physicians, research nurses and other clinical staff, and asked questions regarding recruitment of patients, clinical management within a trial, and the decision to withdraw a patient from a trial. Their findings suggest a significant bias towards clinical interests. Approximately 64 percent of respondents thought that researchers should deviate from the protocol to improve subjects’ care. 52 percent of respondents worked on a trial that prohibited using a medication that they believed to be in a subject’s best medical interest; over 28 percent of these reported giving the medication at least once, despite this restriction. Of the 69 percent who reported having had a patient ineligible to participate in a trial, but for whom they believed the trial would be beneficial, 22 percent recruited the patient anyway. [ss1]Of the 36 percent who reported having patients who met criteria for termination from the trial, irrespective of any medical benefit that it might have, nine

The authors conclude that the scientific validity of clinical trials may be compromised by researchers’ desire to act in best medical interests of their patients/ trial participants.

Factors affecting organ donation in Pakistan Pakistan (along with India) is a centre of organ transplantation in Asia. This has raised many ethical questions given the existence of an organ trade despite a law against it. The authors sought to study bioethical issues surrounding organ transplantation in Pakistan. They conducted face to face interviews with a convenience sample of 408 people in Karachi, Pakistan and looked for independent predictors of knowledge of and motivation for organ donation. They found awareness of organ donation to be correlated with education and socioeconomic status. The motivation to donate was in turn associated with the awareness of organ donation. Religious beliefs play a major role in deterring many people from donating. This is despite the fact that a number of Islamic organisations around the world have issued opinions and edicts in favour of organ donation, describing it as “an act of merit.” The authors express the need to educate people with relevant information, including the benefits of organ donation and the possible risks as well, so that people can make informed choices on the matter. Taimur S, Ishaque S, Habib N, Hussain S, Jawed A, Khan A et al. Knowledge, attitudes and practices survey on organ donation among a selected adult population of Pakistan. 2009; BMC Medical Ethics. 10:5

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Compiled by Sachin Nikarge email:[email protected]


letters Need reforms in medical education The recent controversy on the efforts made by the Medical Council of India and the government of India to bring transparency in medical education highlights the urgent need for reforms in this area.

assessed. Other medical universities should consider amending their rules for conducting medical examinations. They should provide students opportunities for reexamination if they can demonstrate that their examinations had been unfairly assessed.

The present system of medical education does not assure the option to re-total marks or call for re-examination when doubts are raised about the quality of assessment.

N Manjunatha, Department of psychiatry, National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore 560 029 INDIA

Further, students who report unfair practices in assessment during a university examination for a medical degree have no avenues of redress, which compounds their agony as their future is harmed. A newspaper recently reported on a reexamination at the Rajiv Gandhi University of Health Sciences (RGUHS) in Karnataka for a single student. This was a practical examination in oral medicine and radiology for the final year in the Bachelor in Dental Surgery programme. The Chancellor of RGUHS made a landmark decision in the history of medical education by conducting the re-examination after consulting experts who judged that the examination was improperly

References

email: [email protected]

1. Pandya SK. Medical Council of India: the rot within. Indian J Med Ethics [Internet].2009 Jul-Sep [cited 2009 Nov 25];6(3): 125-31. 2. Hira RS, Gupta AK, Salvi VS, Ross MW. Medical education in Maharashtra: the student perspective. J Postgrad Med [Internet] 2009;55(2):127-30. Available from: http://www.jpgmonline.com/article.asp?issn=0022-38 59;year=2009;volume=55;issue=2;spage=127;epage=130;aulast=Hira# cited 3. Times News Network. Re-exam held for single student! Sunday Times of India [Internet]. (Bangalore Ed.). 2009 Sep 6 [cited 2009 Nov 25]; Times city: 4(col.2). Available from: http://epaper.timesofindia.com/Archive/ skins/pastissues2/navigator.asp?AW=1259137243703

Opportunities for internships in ethics Centre for Studies in Ethics and Rights (CSER) was set up in January 2005 by the Anusandhan Trust (AT) to undertake research in ethics and human rights. CSER is engaged in research and training in ethics, rights and capacity building of voluntary organisations/NGOs. It organises training programmes in various fields, including bioethics, ethics in clinical trials and programme management. Our priority areas include professional ethics, research bioethics, public heath ethics, development ethics, law, human rights and ethics, comparative ethics, and exploring linkages between the discourses in ethics and rights in the Indian context. CSER faculty members include social scientists, medical professionals, bioethicists and public health practitioners. These include Dr Amar Jesani, Dr Nobhojit Roy, Dr Padma Prakash, Ms Padma Deosthali, Ms Sandhya Srinivasan, Ms Pranoti Chirmuley and Ms Neha Madhiwalla. CSER offers internships to graduate, postgraduate and doctoral students from the fields of medicine, law, social work, social sciences and others who are interested in these areas of study. Faculty at CSER offers mentorship through out the internship period and resources like; libraries and documentations centres of CSER and CEHAT in Mumbai can be accessed by the intern. Interns will be expected to do a time-bound project or assignment to the satisfaction of CSER faculty. Certificates of experience will be provided to the students. The internships are for a minimum of six weeks and can extend to six months. An intern from Mumbai and outstation who has an accommodation facility in Mumbai will get Rs. 8000/- as stipend. Any Intern from outstation who does not have any accommodation in Mumbai will get Rs.12, 000/- as stipend. CSER will offer partial support. CSER will cover the costs of any local travel and related expenses incurred by the intern while doing project-related work. Interested applicants can email Mr Shinde [[email protected] or (call +91-22-2668 1568)], with updated resumes, areas of interest and contact details. A faculty member will follow up with the applicant. Interns will be selected based on their interests, skills, experience and requirement of the centre.

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FINANCIAL REPORT 2008-2009

The income in the year 2008-09 was from the following sources: Subscriptions: Rs 66, 553, sale of publications: Rs 980, membership fees: Rs 600, bank interest (including fixed deposit interest): Rs 191,344.15, and donations: Rs 35,000. In the year 2008-09 we incurred expenses for services of regular staff, payment of honoraria and printing of journal. The Forum for Medical Ethics Society spent Rs 1,97,207 on printing and posting the journal and Rs 167,462 on honoraria. Approximately Rs 45,000 went into establishment and other expenses including website expenses. Rs 305,462 was spent on the Third K R Memorial Seminar on Clinical Trials and Healthcare Regulation in India. The seminar was co-organised by the Centre for Studies in Ethics and Rights and the Indian Journal of Medical Ethics. There are 790 current subscribers. This includes 219 medical colleges receiving gift subscriptions and 155 life subscribers. Donations to the Forum for Medical Ethics Society are eligible for 50 per cent tax exemption under sections 80G of the Income Tax Act. BALANCE SHEET Properties and assets Fixed assets

Income during the year Sr No. (a)

Particulars

Rs

Bank interest

1

On fixed deposit

2

On saving bank account

132,056.15 59,288.00 191,344.15

(b)

Income from other sources

1

Membership fees

600.00

2

Sale of publication

980.00

3

Subscription

66,553.00 68,133.00

(c)

Donation

35,000.00

Expenses incurred on objects of the trust (educational) Sr. No. (a)

Particulars

Rs

Journal expenses

1

Printing and posting journal

197,207.00

2

Third KR Memorial Seminar

305,462.00

3

Honorarium

167,432.00 670,131.00

Rs

(b)

1,703.00

Establishment expenses

596,855.69

1

Miscellaneous expenses

2,251,175.00

2

Computer expenses

1,500.00

Accrued interest

18,786.91

3

Conveyance expenses

3,096.00

Advance tax deducted at source

58,717.00

4

Staff welfare

420.00

2,927,237.60

5

Photocopying charges

916.90

6

Website expenses

7

Telephone charges

8

Repairs and maintenance

(c)

Other

In saving bank account Fixed deposit

Fund and liabilities Trust funds or corpus Contingencies reserve fund Life subscription fees (refundable)

Rs 11,157.00

275.00

34,499.00 65.00 3,652.00 44,423.90

45,000.00 430,570.00

Balance as per last balance sheet

2,864,346.35

1

Depreciation

Excess of expenditure over income

(-) 423,835.75

2

Audit fees

2,927,237.60

387.00 3,371.00 3,758.00

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Indian Journal of Medical Ethics NATIONAL BIOETHICS CONFERENCE - 3

Theme : Governance of healthcare − ethics, equity and justice Dates: November 18, 19 and 20, 2010 Venue: All India Institute of Medical Sciences, New Delhi

For the last 17 years, Indian Journal of Medical Ethics (IJME) has been involved in promoting ethics in healthcare: in clinical practice, public health and research; in institutional functioning and health policy. In this process it has also helped in the development of bioethics in India, as a discipline as well as a movement for healthcare reforms. IJME provides a platform for the publication of peer-reviewed, evidence- and experienced-based bioethics literature. In addition, since 2005, the IJME National Bioethics Conference (NBC) has provided an opportunity for collaboration among organisations and institutions from biomedicine, public health, social sciences, law and the non-governmental sector. This collaboration brings together practitioners and scholars for reflection and debate on the ethical issues that confront our healthcare system. The first NBC was organised in Mumbai in November 2005, by 20 collaborating organisations. The second NBC was organised in Bangalore in December 2007, by 38 collaborating organisations. Participation in the NBCs has been highly encouraging - the first attracted over 300 and the second over 600 participants. For the organisation of the NBC, while IJME provides a platform, sets the theme and assists in running the secretariat and in logistics, the conference programme is drawn up and the conference is conducted through the democratic participation of representatives of the collaborating organisations who constitute the National Organising Committee (NOC). The NBC is also partly financed through a collective process. Each collaborating organisation bears the cost of sending one representative to the NOC and sponsors the registration, travel, accommodation, and other expenses of six participants of its choice. Other participants are required to register and bear the cost of participation. IJME and the Centre for Studies in Ethics and Rights mobilise funds for the main event, the expenses of plenary speakers and fellowships for some of the paper writers and participants. The scientific committee of the NOC reviews and selects papers for presentation in scientific sessions and proposals for the organisation of workshops and other events. Please contact the national secretariat of the third NBC for more information and to join as a collaborating organisation.

National Secretariat, NBC-3 Indian Journal of Medical Ethics National Bioethics Conference Centre for Studies in Ethics and Rights 501, Dalkhania House, B Wing, Behind State Bank of India, Nehru Road, Vakola Pipe Line, Santacruz (East), Mumbai 400 055 INDIA email: [email protected]/[email protected] Please visit www.ijme.in for reports on the previous bioethics conferences.

INDIAN JOURNAL OF MEDICAL ETHICS VOL VII NO 1 JANUARY-MARCH 2010

(incorporating Issues in Medical Ethics, cumulative Vol XVIII No 1)

Editor Emeritus Sunil K Pandya Editor George Thomas Executive Editor Sandhya Srinivasan Editorial Board Prabha S Chandra, Bangalore Amar Jesani, Mumbai Neha Madhiwalla, Mumbai Sanjay A Pai, Bangalore Nobhojit Roy, Mumbai Editorial Advisory Board Anurag Bhargava, Bilaspur Chhanda Chakraborti, Kharagpur Vinay Chandran, Bangalore Sujith Chandy, Vellore Suneeta Krishnan, Bangalore Parthasarathi Mondal, Mumbai Vasantha Muthuswamy, Chennai Sanjay Nagral, Mumbai Vikram Patel, Goa Mala Ramanathan, Thiruvananthapuram G D Ravindran, Bangalore Sridevi Seetharam, Mysore Amit Sengupta, Delhi International Advisory Board Aasim Ahmad, Pakistan Solomon Benatar, South Africa Richard Cash, USA Fatima Castillo, Phillipines Angus Dawson, Canada Aamir Jafarey, Pakistan Bebe Loff, Australia Ruth Macklin, USA Bashir Mamdani, USA Meenal Mamdani, USA Fiona Miller, Canada Aliya Naheed, Bangladesh Julian Sheather, UK Helen Sheehan, USA Sisira Siribaddana, Sri Lanka Antony Zwi, Australia Production Team Supriya Bandekar Divya Bhagianadh Chitra Borkar (Webmaster) Sachin Nikarge Vijaya Saraogi Santosh Tirlotkar (Administration and Accounts) Period One year Two years Five years Life

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Subscription Rates Subscribers from other SAARC countries (Bangladesh, Bhutan, Maldives, Nepal, Pakistan and Sri Lanka) may please pay the Indian rates adding Rs 100 per year extra for postage. Special one-year subscriptions for Rs 150 are available to students in India. Demand drafts /cheques should be in the name of ‘Indian Journal of Medical Ethics’. Please add Rs 30 for out-station cheques (US$2 for international subscriptions). Please send your subscriptions and subscription queries to: Indian Journal of Medical Ethics, c/o Centre for Enquiry into Health and Allied Themes, Sai Ashray, Survey No 2804,2805, Aaram Society Road, Vakola, Santacruz (E) Mumbai 400 055 INDIA e-mail: [email protected] Editorial Correspondence: [email protected]

Debates The recent ruling by the Delhi High Court that Apollo Indraprastha Hospital had not honoured its obligation to provide free treatment to the poor is the subject of an editorial in this issue. The writers call for regulation of the private sector and a scrutiny of the role and nature of the public-private partnership in healthcare. The Genetic Engineering Approval Committee’s approval of Bt brinjal, the first genetically modified crop for human consumption in India, has sparked off protests across the country. A comment discusses some major concerns regarding this decision and calls for experts and the public to engage in the public consultations currently underway. In June 2009, the Supreme Court ruled that a pregnant, mentally retarded woman could not be forced to undergo a medical termination of pregnancy against her will. We carry two comments on this issue. One argues that the judgement represents a watershed development in disability jurisprudence in India. Another suggests that the focus should be on the living conditions in institutions for the disabled and destitute. Following the launch of “pilot programmes” for vaccination against cervical cancer in Andhra Pradesh and Gujarat, health organisations, medical professionals and women’s groups have joined in a campaign against the introduction of the human papilloma virus vaccine in India. We carry the campaign memorandum as well as comments expressing a range of views on this subject. In our column on the ethics of ethics committees, we carry a reflection on the need for review boards to assess the social value of research; a report on experiences in setting up and running ethics committees in India, and another comment on the use of blanket consent for retrospective research.

The Indian Journal of Medical Ethics (formerly Issues in Medical Ethics) is a platform for discussion on healthcare ethics, with special reference to the problems of developing countries such as India. It hopes to involve all cadres of, and beneficiaries from, this system, and strengthen the hands of those with ethical values and concern for the underprivileged. The Journal is owned and published by the Forum for Medical Ethics Society, a not-for-profit, voluntary organisation. The FMES was born out of an effort by a group of concerned doctors to focus attention on the need for ethical norms and practices in health care. Contributions to the journal, in the form of original papers, research findings, experiences in the field, case studies, debates, news and views on medical ethics, are welcome. All submissions must be in English and are subject to editorial review. Contributors are requested to refer to the detailed guidelines for submission available on the journal website, www.ijme.in Printed and published by Sanjay Nagral on behalf of the Forum for Medical Ethics Society Printed at Vibha Offset, Royal Industrial Estate, Wadala, Mumbai 400 031 Published at FMES, 0-18, ‘Bhavna’, Veer Savarkar Marg Prabhadevi, Mumbai 400 025 Editor: George Thomas