CORRESPONDENCE
Finally, Wilcken and Stockler make reference to the absence of overall survival data in the three publications referenced. At the time these papers were submitted for publication, survival data from the two trials were immature and therefore not available for inclusion. These data are now available and will be in the public domain by the end of 2003. The authors are advisory board members and members of speaker’s bureaux for AstraZeneca.
*Anthony Howell, C Kent Osborne, Louis Mauriac *CRC Department of Medical Oncology, Christie CRC Research Centre, Christie Hospital NHS Trust, Manchester M20 4BX, UK (AH); University of Texas Health Science Center, San Antonia, TX, USA (CKO); Institut Bergonie 18, Bordeaux, France (LM) (e-mail:
[email protected]) 1
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Wilcken NRC, Stockler MR. Fulvestrant: spreading the word, but not too thinly. Lancet 2003; 362: 1254. Howell A, Robertson JFR, Albano JQ, et al. Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol 2002; 20: 3396–03. Osbourne CK, Pippen J, Jones SE, et al. Double-blind, randomised trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. J Clin Oncol 2002; 20: 3386–95. Mauriac L, Pippen JE, Quaresma Albano J, Gertler SZ, Osborne CK. Fulvestrant (Faslodex) versus anastrozole for the second-line treatment of advanced breast cancer in subgroups of postmenopausal women with visceral and non-visceral metastases: combined results from two multicentre trials. Eur J Cancer 2003; 39: 1228–33.
Practical strategies to combat biopiracy Sir—In her Oct 14 lecture hosted by The Lancet and the University College London International Health and Medical Education Centre, Vandana Shiva summarised the antipathies and imbalances of the global trade debate; richer countries dominating poorer, national governments ignoring local communities, and big business quashing small-scale enterprise. Intellectual property rights were presented as both the facilitating driver of this imbalance and a necessary protector of scientific endeavour. Shiva identified as the driver of imbalance clear examples of biopiracy validated by the TRIPS (trade-related aspects of intellectual property rights) agreement. She made the call for “structures and processes” to counteract the negative
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effect of patenting life forms. However, Shiva did not address the form these structures and processes should take. Whereas developed countries receive extensive support on intellectual property decisions, low-income countries are unaware of what to patent and how. The Food and Agriculture Organization’s International Treaty on Plant Genetic Resources for Food and Agriculture1 “has the ability to protect traditional knowledge of plants and the right to equitable participation of sharing the benefits of plant genetics”. Unfortunately, few highincome countries have ratified the treaty thus far. At the Framework Convention for Tobacco Control negotiations in May, 2003, wide disparities in the size and composition of national delegations provided a major challenge to effective participation. The prior coordination of agreed regional positions among southern states, particularly by member states from WHO’s southeast Asia and Africa regions, strengthened their capacity to play a leading part in the negotiations.2 This process was further assisted by the gradual expansion of participation from other ministries to enhance the skills of health officials.3 Indeed, despite the gulf in resources at their disposal, the final text in many respects more clearly represented the stronger positions adopted by the WHO Regional Offices of southeast Asia and Africa than the minimalist stance adopted by an alliance of the USA, Germany, and Japan.4 Poorer countries need to send the right people to the negotiating table, faster and better equipped to navigate the legal minefield. In preparation for the trade talks in Cancun, Mexico, in September, 2003, negotiators from poorer countries were trained in the art of negotiation. It has been suggested that this preparedness, rather than the walk out, was the bigger surprise at that round of talks. If communities are empowered to negotiate within the national framework, their needs are more likely to feature in the national agenda. If nations are empowered to negotiate within the international framework, their needs are more likely to feature in the global agenda. The current global framework is entrenched, and it might be more effective to make the system work for the disadvantaged while civil society takes on the larger task of reforming the system altogether. Designing appropriate “structures and processes” is the next challenge in the world’s move towards fairer global trade. Broadly speaking, we know what
is wrong with the current dispensation and few can sum up this argument as well as Shiva. From the passion of activism we need to evolve the dispassionate discourse of solution and simple empowerment around the negotiating table might be an effective place to start. Sue Lawrence, *Jolene Skordis Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK (e-mail:
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Commission on Genetic Resources for Food and Agriculture. International Treaty on Plant Genetic Resources for Food and Agriculture. http://www.fao.org/ag/cgrfa/ itpgr.htm#text (accessed Dec 1, 2003). Bates C. Developing countries take the lead on WHO convention. Tob Control 2001; 10: 204f. World Health Organization. Intergovernmental Negotiating Body on the WHO Framework Convention on Tobacco Control, List of Participants: Representatives of Member States, 18 March 2002 and 26 February 2003. http://www.who.int/ gb/fctc/E/E_inb5.htm (accessed Dec 2, 2003). Hammond R, Assunta M. The Framework Convention on Tobacco Control: promising start, uncertain future. Tobacco Control 2003; 12: 241–42.
Neutralising antibodies against interferon beta in multiple sclerosis Sir—Per Soelberg Sorensen and colleagues’ study (Oct 11, p 1184)1 of the effects of neutralising antibodies against interferon beta on the clinical efficacy of interferon beta in patients with multiple sclerosis is flawed by a methodological tautology. Sorensen and colleagues use the effect of neutralising antibodies on relapse rate to define a clinically relevant titre, and then use the same cohort of patients to claim that neutralising antibodies affect the clinical efficacy of interferon beta. It would have been appropriate to use one cohort of patients to define a relevant titre and a second independent cohort to confirm the results. Sorensen and colleagues also use a non-standard assay, making comparison of these results with those of other studies difficult. It would be very helpful, in view of the potential impact of their findings, if their results could be standardised according to the WHO guidelines.2 The fact that patients received different interferon products has not been accounted for. The efficacy or lack of efficacy of interferon does not solely depend on the presence or absence of neutralising antibodies, but also on the dose, potency, frequency,
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