cectomy in the middle of the night in children? BMJ. 1993;306:1168. (1 May.) Authors' reply ... wound sepsis presented seven to 14 days after ... 2 Marks R. Dermatology and extension of limited list of drug tariff. ..... remembered episodes.
The problem with a policy of postponing operation for appendicitis is that the operation may have to be postponed for longer than the 6-18 hours reported by Rajendra Surana and colleagues. The authors make the point that it is the policy in their hospital to operate on postponed cases the following morning. This is simply not possible in many hospitals. Available operating theatres are used for scheduled operating sessions. If a theatre is not being used during the day, nursing staff will usually not be on duty. If both theatre and nursing staff are available, then surgical staff are often in outpatient clinics or engaged in other duties. It is sometimes possible to fit in a case at lunch time by missing a meal or a lunch time meeting. In my experience, most cases that could be postponed would not be operated on until the end of scheduled operating sessions for the day after admission. Until fully staffed emergency theatres are available during daytime working hours, junior doctors have no choice but to operate at all hours of the night. In the present financial climate it seems unlikely that it will be possible to provide the necessary facilities. Junior medical staff will continue to suffer from sleep deprivation, since it is cheaper to keep a doctor awake than to provide daytime facilities that may not be used cost effectively because they would not be used continuously. M CADE
Seedfield, Bury, Lancashire BL9 5DG 1 Surana R, Quinn F, Puri P. Is it necessary to perform appendicectomy in the middle of the night in children? BMJ
1993;306:1168. (1 May.)
Authors' reply EDITOR,-We are delighted that our paper has stirred up controversy among the medical profession. At our hospital theatre time and nursing, surgical, and anaesthetic staff are available 24 hours a day. The decision to postpone appendicectomy overnight is based on the experience of paediatric surgeons and is not made because of administrative constraints as some of the letters indicate. We would like to point out to R J Morgan that, with the cooperation of the anaesthetic and nursing staff, all the patients who are diagnosed as having appendicitis and cannot be operated on before midnight are dealt with before the routine lists are started or at a suitable time in between the lists in the morning. To answer Nigel Kellow, we clearly stated in our paper that this was not a prospective randomised trial. We agree that the best way to address this issue is to carry out a prospective controlled study. Kellow asks whether any appendicectomies were done after midnight. During the study 12 patients were operated on after midnight, of whom two had perforation, five had a normal appendix, and five had acute appendicitis; these patients were operated on by new registrars who were not aware of the policy for the study, and they were therefore excluded from the study. We do not believe that these patients warranted surgery during the night. N Williams mentions patients being observed overnight before appendicitis is formally diagnosed. Our study included only patients in whom appendicitis had been diagnosed and surgery was postponed until morning. We included macroscopic and microscopic perforations as perforated
appendicitis. We included all the patients who developed wound sepsis. Indeed, 10 of the 11 patients with wound sepsis presented seven to 14 days after discharge from the hospital. Restraints on space did not permit us to publish a graph showing the duration of hospital stay. The mean duration of stay was 3-5 (SD 19) days in those who were operated on within six hours and 4-1 (3 0) days in the other patients. The two groups were comparable with regard to age, sex, duration of
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symptoms before admission, operative techniques, and prophylaxis with antibiotics. Although early appendicectomy remains the preferred treatment, the operation can be safely postponed overnight without increasing morbidity and mortality. R SURANA F QUINN P PURI
Children's Research Centre, Our Lady's Hospital for Sick Children, Crumlin, Dublin 12, Republic of Ireland
Limiting the drugs list Wrn halt therapeutic progress EDITOR,-"The Selected List" editorial' fails to inform readers of the "grim future ahead for patients" so vividly described by Ronald Marks.2 It also fails to represent the opinions of general practitioners, 70% of whom want to see the proposals withdrawn.' Targeted categories like gynaecology, dermatology, rheumatology, allergy, and otology are marginal therapeutic belittled as "in the main areas," while the 1993 measures are further trivialised by being bracketed with the 1984 blacklisting of "tonics and bitters." We are informed "the cost of drugs has risen well ahead of inflation ... around 12% a year," but we are denied the explanation that drug prices have risen by only 1 7% in circumstances of greatly increased usagefrom preventive healthcare screening, major demographic shifts, and cost effective substitution of medication for hospitalisation. The editorial makes light of industry's warnings about therapeutic progress grinding to a halt. It dismisses as "unconvincing" the evidence of stagnation in the seven categories already blacklisted; it regards the prospect that "research will be cut and investment reduced" as merely "worrying." As an independent, British company with all its products in categories targeted by Mrs Bottomley's bombshell announcement last November, we have had to freeze all further investment and commitments to new product development. We are one of many similar firms threatened by the iniquitous discrimination of these lists. The notion that "true innovation should be rewarded" is laudable, but naive. For the most part, improvements to drug therapy are modest; small steps rather than giant leaps. "Me too"s can be dismissed too easily. In 1989 a US Senate Committee concluded that "the bulk of R & D . . produces insignificant new compounds that add little or nothing to drug therapies already marketed."4 This indictment was subsequently firmly rebutted: "The majority of [these] drugs are now considered to have clinically significant advantages. ... It is crucial to take into account the entire period of drug development and experience in assessing the value of a drug."' Peremptory judgments by an advisory committee are no substitute for the combined clinical experience of thousands of doctors over many years. MICHAEL YARROW
Dermal Laboratories Limited, Hitchin, Hertfordshire SG4 7QR 1 Bateman DN. The selected list. BMJ 1993;306:1141-2. (1 May.) 2 Marks R. Dermatology and extension of limited list of drug tariff.
BMJ1993;306:1198. (1 May.) 3 Other groups oppose the survey. ABPI Whitehall News 1993; No 47:4-5. 4 Prescription drug prices: are we getting our money's worth? United States Senate Special Committee on Aging, 1989. (Briefing;
July 18.) 5 Yasuda SU, Woosley RL. The clinical value of FDA class C drugs approved from 1981 to 1988. Clin Pharmacol Ther 1992;52: 577-82.
The trouble with genetic prescribing EDITOR,-D N Bateman suggests that increased generic prescribing would not be detrimental to patients or prescribers,' but I do not agree that this is necessarily the case for drugs applied topically. The Food and Drug Administration requires bioequivalence of any generic substitute, but this term is so defined that simple studies of drug release suffice and no studies of clinical efficacy or safety are required.2 Thus generic topical steroids are widely available in the United States. Comparative studies have shown large and significant differences between the biological activity of some generic formulations and their branded counterparts commonly prescribed in the United States." In general, branded topical steroids have a greater biological activity than their generic "equivalents," but the degree of difference between them is not constant or predictable.' All generic substitutes are chemically equivalent, but the vehicle in which the active component(s) are formulated may differ between "comparable" topical preparations. A change of vehicle can profoundly affect the stability of the steroid moiety or its penetration, as can the addition of certain compounds such as urea, propylene glycol, salicylic acid, or tar. Thus chemical equivalence does not necessarily equate with biological or therapeutic equivalence for topical corticosteroids. Generic prescribing of topical drugs may in addition cause problems for people sensitive to one or more ingredients found in topically applied products. Though the exact formulation of a branded product can easily be determined from a well known manufacturer, this is not the case for generic preparations. Patients using potent treatments such as topical corticosteroids should know exactly how to apply them. In recent years pharmaceutical companies producing branded topical products have developed a range of patient information leaflets to aid compliance and encourage correct use of their products, but manufacturers of generic products have shown little commitment to developing such leaflets. If generic prescribing of topical preparations becomes more widespread there should be a minimum standard that all topical generic substitutes are shown to be chemically, biologically, and clinically equivalent to their branded counterparts before release on to the market. Safeguards should also be brought in to ensure that patients sensitive to one or more components of a topical product are not unnecessarily exposed to that ingredient. Full labelling of ingredients or a system whereby prescribers can indicate when a person should receive only a particular stated brand of product would help overcome this problem. SUSAN E ELLMERS
National Eczema Society, London WC I H 9RA I Bateman DN. The selected list. BMJ 1993;306:1 141-2. (1 May.) 2 Stoughton RB. Are generic topical glucocorticosteroids equivalent to the brand name?J7Am Acad Dermatol 1988;18: 138-9. 3 Jackson DB, Thompson C, McCormack JR, Guin JD. Bioequivalence (bioavailability) of generic topical corticosteroids. _Am Acad Der,natol 1989;20:791-6. 4 Stoughton RB. Are generic formulations equivalent to trade name topical glucocorticosteroids? Arch Dermatol 1987;123: 1312-4. 5 Olsen EA. A double blind controlled comparison of generic and trade name topical steroids using the vasoconstriction assay. Arch Dermatol 1991;127:497-500.
Behavioural treatment not drugs for chronic pain EDITOR,-The recent discussions regarding reducing the NHS drug bill beg the question whether it would not be more logical and appropriate to reduce drug consumption, especially among long term users, than to change the paymaster.'
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We have examined the drug consumption of a random sample of 20 patients suffering from chronic pain of diverse causes who were admitted to a pain management programme this year. The mean age of the patients was 47 1 years, and they had had pain for a mean of 9-6 years. The average cost per person of prescription drugs related to their pain (including analgesics, psychotropic drugs, antidepressants, and muscle relaxants) on entry to the programme was £5.32 a week. After four weeks' cognitive behavioural treatment, during which the patients were encouraged to reduce and stop all classes of drugs, 11 of the patients had stopped all their drugs and the average cost per person among the remainder was £1.57 a week. This represents a mean saving across the group of £4.61 per person per week, or £240 a year. This is concomitant with considerable improvements in functional, psychological, and quality of life measures. Our long term follow up data on a much larger group of patients suggest that on discharge 58% have been able to come off all drugs and that this has increased to 65% at one month of follow up.2 By six months the figure has fallen to 50%. This suggests that patients do not return to using drugs in the longer term. Given that it has been estimated that 1 1% of the population suffer from chronic pain and that 70% of these take painkilling drugs,' the savings across Britain could be substantial. Patients with chronic pain represent a substantial proportion of most general practitioners' workload. Medicines are often prescribed for want of more effective treatment, but these are continued long term, often with the dose being increased and side effects developing. We suggest that long term use of all classes of drugs in chronic benign pain should be questioned by frequent analysis of the benefit to individual patients. Behavioural approaches show that worthwhile functional improvement can be achieved without the use of drugs. CHARLES E PITHER JUDITH RALPHS
St Thomas's Hospital, London SEl 7EH 1 Bateman DN. The selected list. BMJ 1993;306:1 141-2. (1 May.) 2 Williams ACdeC, Nicholas MK, Richardson PH, Pither CE, Justins DJ, Chamberlain JH, et al. A cognitive behavioural programme for the rehabilitation of the chronic pain patient: results of the first 200 cases. BrJ7 Gen Pract (in press). 3 Rigge M. Pain. Which? way to health 1 990;April:66-8. 4 Flor H, Fydrich T, Turk D. Efficacy of multidisciplinary pain treatment centres: a meta-analytic review. Pain 1992;49: 221-30.
The gall stone debate Develop the surgery ... EDITOR,-Never has such interest been created as
by the advent of laparoscopic cholecystectomy, and the achievement of teaching surgeons an entirely new technique-such that 60% of cholecystectomies were done by the new method in 1992, only three years after publication of the technique-is scorned. "Lack of proper data," cries Professor Johnson' when such data have been gathered through the Royal College of Surgeons by an NHS consultant showing that English surgeons do the operation with commendable safety. "Danger," mumbles an academic surgeon in a national Sunday newspaper, when the number of reported bile duct injuries rises, yet sound information gathered through audit confirms that the incidence is low. The cholecystectomy rate in the United Kingdom is low at 70/100000 in Ashford, Kent, and 60/100 000 in the Lothian audit (S J Nixon, personal communication, 1993) compared to 240/100000 in Windsor, Ontario, Canada, and 238/100 000 in New England, United States.2 Perhaps the rate in Britain is too low, and many patients are disadvantaged by waiting too long
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when symptoms develop. The point of J0rgensen's study is that the symptomatic patients were treated, so it is hardly surprising that in this well studied selected population there was no difference between pain location in those with a normal gall bladder and those with gall stones.3 Cross sectional studies all suffer from this drawback, which "limits conclusions which can be drawn as regards associations between abdominal pain and gall stones."' Recent reviews and editorials have emphasised the need to preserve the gall bladder when stones do not cause symptoms. There is one rule for assessment by surgeons and another for the Health Services Research Unit. The study by Scott and Black5 was a retrospective casenote review by non-gastroenterologists'; the data were presented at a symposium to a mixed group of surgeons who were asked to comment. Such methodology is hardly likely to produce quality data on which the criteria for the indications for cholecystectomy are founded. Prospective studies with preoperative and postoperative questionnaires by non-academic surgeons have done better. This article for debate underlines the confusion within the surgical fraternity between science and technology. It is doubtful if a surgeon can still be a true scientist, but in this era of technological advance the need for technologists with the ability to assess advances and develop new technologies has never been greater. The new breed of surgeon needs nurturing, monitoring, and developing to keep abreast of changes in health care technology which will provide a large number of people with a gain in overall health benefit. R C G RUSSELL
after cholecystectomy have shown persistent pain in 20-30%.5 Johnson is right that we have focused too much on how to remove gall stones and too little on who should have their stones removed. With present knowledge we cannot tell exactly who should be treated, and we have to wait for further studies on the indications for treatment. We need follow up studies in unselected populations unaware of their gall bladder condition to assess development of pain; studies of the development of pain in patients who have had only their gall stones removed; and studies of pain in relation to the motility of the gastrointestinal tract and gall bladder in unselected populations. Meanwhile, we should restrict treatment to those patients with severe attacks of pain in the upper right quadrant of hours' duration in well remembered episodes. By constant monitoring of the indications in a department the number of cholecystectomies should be kept constant. T JORGENSEN
Department of Surgery K, Bispebjerg Hospital, DK-23400 Copenhagen NV, Denmark 1 Johnson AG. Gall stones: the real issues. BM7 1993;306:1114-5. (24 April.) 2 Diehl AK. Epidemiology and natural history of gallstone disease.
Gastroenterol Clitt North A?n 1991;20:1-19. 3 Jorgensen T. Abdominal symptoms and gallstone disease: an
epidemiological investigation. Hepatolog 1989;9:856-60. 4 Heaton KW, Braddon FEM, Mountford RA, Hughes AO, Emmett PM. Symptomatic and silent gall stones in the community. Gut 1991;32:316-20. 5 Jorgensen T, Teglbjerg JS, Wille-Jorgensen P, Bille T, Thorvaldsen P. Persisting pain after cholecystectomy. A prospective investigation. Scandj7 Gastroenterol 1991;26:124-8.
Middlesex Hospital, London WIN 8AA 1 Johnson AG. Gallstones: the real issues. BMJ 1993;306:1114-5. (24 Apnrl.) 2 McPherson K, Wennberg JE, Hovind OB, Clifford P. Small-area variations in the use of common surgical procedures: an intemational comparison of New England, England, and Norway. NEniglJ Med 1982;21:1310-14. 3 Jorgensen T. Abdominal symptoms and gallstone disease: an epidemiological investigation. Hepatology 1989;9:856-60. 4 Walsh TN, Russell RCG. Cholecystectomy and gallbladder conservation. Br_J Surg 1992;79:4-5. 5 Scott EA, Black N. Appropriateness of cholecystectomy: the public and private sectors compared. Atm R Coll Suirg Etngl 1992;74(suppl):97-1 0 1.
... or investigate the epidemiology? EDITOR,-Alan G Johnson emphasises two important aspects of gall stone disease-namely, can we prevent gall stones and who should be treated for their stones?' Although several epidemiological studies have identified some risk factors for gall stone disease,2 no interventional studies have so far been published. The two main risk factors are pregnancy and fatness, but women will hardly find it relevant to weight their wish of having another child against the risk of a gall stone developing, and weight reduction may have the opposite effect from that intended as excess formation of gall stones seems to occur during weight reduction. We need further investigations to identify those people who are vulnerable to different lifestyle factors. Who should be treated? Those who develop complications of their stones need treatment. But what about those without complications? If we interpret the vast literature several facts indicate that we treat too many people. Epidemiological studies of random populations' 4 and clinical studies of patients referred to x ray departments have found it difficult to identify symptoms specific to stones in the gall bladder. Rates of cholecystectomy vary greatly. Screening studies of random populations have shown a variation in the rate among countries from 5% in Norway to 60% among Cuban-American women.4 Furthermore, studies have shown great regional variation within countries. Prospective series following up patients
General Medical Council Students keen to contribute EDITOR,-I wish to comment on the recent editorial concerning the reconstitution of the GMC and the possibility of medical student involvement.' I currently represent both the National Association of Medical Students and the BMA Medical Students Group Committee on the GMC's working party on basic medical education. Our input has, so far, been most welcome and has shown the valuable contribution that medical students can make to the whole debate on undergraduate medical education-if only they are consulted. This arrangement has existed for a few years now but is a non-statutory one and due to last only as long as the working party exists. At present the GMC is keen to have medical students involved in the future concerning these matters. I believe that there should be statutory medical student representation on the GMC education committee. It would be preferable to have two medical students present, both for mutual support and because there are currently two national medical student organisations interested in undergraduate medical education. However, I also feel it is essential for junior doctors to be similarly represented at both premembership and postmembership stages. This would provide valuable feedback on aspects of postgraduate medical education that concern the GMC and, in particular, preregistration house officer training, which requires much attention at present. MARK S BAILEY
Liverpool University Medical School, PO Box 147, Liverpool L69 3BX 1 Smith R. The GMC: size and public accountability. BMJ 1993;306:1356-7. (22 May.)
Editorial attack misguided EDITOR,-The editor's enthusiasm for writing about the General Medical Council seems to be
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