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Benoxaprofen Irony Is Inescapable That While Manuscripts BRITISH MEDICAL JOURNAL VOLUME 285 18 SEPTEMBER 1982 809 Br Med J (Clin Res Ed): first published as 10.1136/bmj.285.6344.809-a on 18 September 1982. Downloaded from favourable groups of alcoholics (such as single, trials and post-marketing surveillance pro- the carefully controlled and monitored clinical divorced, or widowed men and women) is as grammes, often undergo extensive revision trial. Unless there is prompt reporting of the yet unknown but may appear doubtful to the before acceptance for publication, paid results of such trials by the sponsoring drug practising clinician.3 The statement that, advertisements extolling only the virtues of company to all governmental agencies in "Treatment may actually make some alco- various products generally are accepted countries marketing or planning to market a holics worse" by protecting them from the without modification. particular drug, the Committee on Safety of consequences of their drinking or by fostering In the face of the need to maintain fiscal Medicines, the Food and Drug Administration, inactivity surely applies only to utterly inade- viability while upholding the highest editorial and similar agencies in other countries will quate "treatment." The risks arising from the standards, what is a medical journal to do in not be acting on the best available information. behaviour of well-meaning "enablers" who regard to advertising? The issue needs to be shelter the alcoholic from experiencing the explored by both editors and medical associa- SIDNEY M WOLFE painful effects of his drinking on himself (and tions at their meetings. One proposal has been EVE BARGMANN others) and the importance of fostering the raised' and seconded2 for a "physician Health Research Group, patient's responsibility for his recovery, his boycott" of drugs that are unethically pro- Washington DC 20036 own initiative, and active participation in the moted. Alternatively, I would propose that July 2, 1982. Submission by Lilly to the Food and therapeutic programme are surely nowadays medical journals reject advertising for pre- Drug Administration. well known to every experienced therapist. The scription products that are also promoted and finding of some community-based studies that advertised in the lay press. In addition, as a sociopathy did not predict outcome is sur- way of discouraging the rush to prescribe new Prescription-event monitoring prising; it contrasts with most clinicians' drugs, I would propose that journals either observations'-3 and also with the statement in wait for a period of time after the introduction ***The following is a draft of a letter to be your leading article that "the best predictor is of a drug before accepting an advertisement sent to all GPs in England.-ED, BM7. stability in one's own job and marriage." for it, or confine the content of the advertise- Social stability (with its link with "good ments to prescribing information. SIR,-In my letter of 26 February this year I outcome") is hardly a characteristic feature of In my opinion, the benoxaprofen affair described the preliminary results of our pilot sociopathy. points out the need for more careful "peer study of prescription-event monitoring. Your M M GLATT review" by medical editors and other doctors response was excellent and I felt that the rapid University College Hospital of -pharmaceutical advertisements submitted feedback, less than one month after the Alcoholism Teaching Centre, for publication. St Pancras Hospital, "green forms" had been distributed, would be London NW1 ALAN BLUM appreciated. Although this was only a small- Editor scale study designed to test the system, some Glatt MM. Br y Addict 1955;52:55-92. Medical Journal of Australia, interesting and fairly reassuring data on the 2 Glatt MM. Lancet 1959;ii:397-8. Glebe, 3 Glatt MM. Alcoholism. London: Teach Yourself two drugs-fenbufen (Lederfen) and benoxa- Books, 1982. New South Wales, 'Orford J, Edwards G. Alcoholism. London: Oxford .Australia 2037 profen (Opren)-were also obtained. University Press, 1977. 'Solomon SD, Grimmett BL, Maurer KH, Levin NW. Among approximately 6000 green forms re- N Engl J Med 1979;300:203. turned for benoxaprofen, there were eight in 2Mallace AH. N Engl3' Med 1979;300:734. which jaundice had been reported as an "event." copyright. Benoxaprofen Further inquiries eliminated some patients with ***The BMJ has a code which it applies to all alternative causes and others who were not taking SIR,-In analysing the suspension of the advertisements; the prime requirement is that: the drug, and there remained only three cases in product licence of a drug linked to at least "Statements of fact should be supported by which benoxaprofen was a possible cause. 61 deaths and 3500 adverse reactions in the trustworthy evidence." We do reject advertise- Prescription-event monitoring had thus signalled the author of your leading a potential risk, but I considered that these few past two years, ments or ask the advertiser to modify the reports did not justify raising an alarm, at least article (14 August, p 459) has raised serious wording or presentation on grounds of until the hypothesis had been tested in a larger but necessary questions about the roles of the accuracy or taste. For us to object to an series. manufacturer, pharmaceutical companies in advertisement on the grounds of frequency Four months later, a small cluster of reports of general, the Committee on Safety ofMedicines, would, however, be unduly quixotic.-ED, benoxaprofen-associated jaundice appeared in the the lay press, practising doctors, and even BM7. journals. They tended to strengthen our earlier the public at large. No mention was made, signal, and defined the problem as one which however, of the role of editors and advertising mainly affected elderly patients. The manu- http://www.bmj.com/ managers of medical journals, under whose facturers circulated a warning to prescribers on SIR,-While we generally agree with the 21 June recommending that elderly patients aegis Opren (benoxaprofen) was provided should take no more than 300 mg daily. On with a credible context from the outset. thoughtful leading article on benoxaprofen 3 August, it was announced that the licence for The influence of pharmaceutical advertising (14 August, p 459), there is one correction benoxaprofen had been temporarily suspended by directed at prescribing doctors-and the which is germane to your query as to whether the Department of Health and Social Security. responsibility of those persons at medical the Committee on Safety of Medicines acted The following preliminary statistics from the journals who approve an advertisement for too slowly in banning the drug. pilot study may be of interest: also be considered. In this In a letter to the BMJ (29 May, p 1630) (1) Ninety-five per cent of benoxaprofen and publication-must 96% of fenbufen patients had been prescribed Lilly vice-president Ian Shedden stated that on 27 September 2021 by guest. Protected instance, two-page and three-page advertise- daily doses of 600 mg or more. ments for benoxaprofen appeared prominently "no jaundice" had been seen "in approxi- (2) Fifty-six per cent of both groups had been in no fewer than 20 issues of the BMJ alone mately 2200 carefully followed patients who treated for osteoarthritis. Twenty per cent of the in the two years since the introduction of the participated in clinical trials in the USA." benoxaprofen and 11 % of the fenbufen group drug. One such advertisement favourably This statement is repeated in the leading had been treated for rheumatoid arthritis. compared the five-letter brand-name product article. In fact five cases of reversible jaundice, (3) Thirty-six per cent of the benoxaprofen with the more unwieldy generic name-counter- including four cases with concomitant (also group were under 60 years of age, 29% were aged parts: diclofenac, flurbiprofen, indomethacin, reversible) renal disease, occurred in patients 60-69, and 35% were over 70. Corresponding in US clinical trials prior to the US marketing figures for fenbufen were 33%, 25%, and 42% and piroxicam. As in many pharmaceutical respectively. advertisements, the prescribing information of benoxaprofen in May 1982.1 The first case (4) About 40% of patients on benoxaprofen was obscurely placed, and included -vague occurred in 1978. and 43% of those on fenbufen continued their sentences such as "Peptic ulceration has Although the US cases occurred in younger treatment beyond the 12 months of the study. Of occured (sic) only rarely." patients, they bear a striking similarity to the remainder, the mean duration of treatment was Practising doctors and medical editors alike many of the fatal cases reported in the UK. approximately 18 weeks for benoxaprofen and may resent the implication that frequency and Until we know whether Lilly informed the 15 weeks for fenbufen. prominence of advertisements for a drug Committee on Safety of Medicines promptly (5) In both groups the overall mortality during about these cases, we cannot determine the 12 months of the study was 3%. increase the number of prescriptions. I believe Excepting that relatively fewer patients with most doctors would say they pay little attention whether the Committee on Safety of Medicines rheumatoid arthritis were treated with fenbufen, to the advertisements, much less prescribe a acted too slowly in banning benoxaprofen. the two groups were very similar in other respects. drug on the basis of one. None the less, the The best mechanism for early warning of Although the questionnaires were not designed to irony is inescapable that while manuscripts, side effects, especially those occurring more test efficacy, a number of doctors volunteered the including those dealing with clinical drug frequently than once in a thousand patients, is information that patients taking benoxaprofen.
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