Nexus - 0214 - New Times Magazine-pages

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Goddard's immediate successor at the FDA, Dr Ley, spoke before the US Senate hearings of a spot check that showed up the case of an assistant professor of medicine who had reputedly tested 24 drugs for 9 different companies. "Patients who died while on clini- cal trials were not reported to the sponsor," an audit revealed. “Dead people were listed as subjects of testing. People reported as subjects of testing were not in the hospital at the time of tests. Patient consent forms bore dates indicating they were signed by the subjects after the subjects died." Another audit looked at a commercial drug-testing firm that had apparently worked on 82 drugs and 28 sponsors: desired results that would assist the intended application of the drug.” The incentive for clinical investigators to fabricate data is enormous. As much as $1,000 per subject is paid by American companies, which enables some doctors to earn up to $1 million a year from drug research," and investigating clinicians know all too well that if they don't produce the desired data, the loss of fumure work is inevitable. Patient consent forms bore dates indicating they were signed by the University Scientists—The More Than Willing Pawns subjects after the subjects died."* Bestiteralie cies en PRS eneee: . a : . . y of safety testing violations that Another audit looked at a commercial drug-testing firm that had pave shown that university laboratories had the worst record for vio- apparently worked on 82 drugs and 28 sponsors: latin than all other lsberatorice in the sur- vey.” Braithwaite writes: Patients who died, left the hospital or wis aim emente betas A study conducted by the estaba tas et Forty-one patients reported as partici- FDA has revealed that1 in tate ol fie Rospital during the studies... 5 doctors investigated, who {ound to have a worse record of GLP Siservation of paents'n general were carry out field research of than sponsor labs. The word record o rnin Rew ciruips, Riad invented tres One. be exremely cautous Between 1977 and 1980 the FDA have — the data they sent to the five university laboratories in the study. discovered 62 doctors who had submitted 5 a nit . Nevertheless, it must undermine any auto- manipulated or downright falsified clinical drug companies, and matic assumption that university data.’ A study conducted by the FDA has keted the fe researchers, with their supposed detach- revealed that one in five doctors investi- poc ete e S. ment from the profit motive, are unlikely gated, who carry out field research of new to cut corners on research standards.” drugs, had invented the data they sent to the drug companies, and pocketed the Inappropriate Clinical Trials fees.” a. Even if data obtained from clinical trials is not falsified, it is of Citing case examples, Dr Braithwaite states: little worth, because they are not performed appropriately. Trials involve relatively small numbers st le; so many h; ‘ul effects y peop The problem is that most fraud in clinical trials is unlikely to of a new drug appear only when it has been marketed and widely even be detected. Most cases which do come to public atten- used. tion only do so because of extraordinary carelessness by the Furthermore, the subjects taking part in the trial usually do not criminal physician...* represent those who will use the drug after its approval. Very young ri \ - or elderly people, women of child-bearing age and people with liver According to Dr Judith Jones, Director of the Division of Drug or kidney disease are usually not included in clinical mals, although Experience at the FDA, if the data obtained by a clinician proves —_such people may be given the drug after it is marketed. Also, opti- unsatisfactory towards the drug being investigated, it is quite in mal dosages for el © are calculated on the basis of what is most order for the company to continue trials elsewhere until satisfactory —_ effective for an average-size adult. Many adults differ from this results and testimonials are achieved. Unfavourable results are very average, and about 45 per cent of ordinary adults are probably going pte published and clinicians are pressured into keeping quiet to respond atypically to some classes of drugs. about such data. Patients who died, left the hospital or dropped out of the study were replaced by other patients in the tests without notification in the records. Forty-one patients reported as partici- pating in studies were dead or not in the hospital during the studies... Record-keeping, supervision and observation of patients in general were grossly inadequate.‘ As one would predict from the foregoing discussion of how contract labs can be used by sponsors to abrogate responsibili- ty for quality research, contract labs were found to have a worse record of GLP [Good Laboratory Practices] violations than sponsor labs. The worst record of alt, however, was with university labora- tories. One must be extremely cautious about this finding since there were only five university laboratories in the study. Nevertheless, it must undermine any auto- matic assumption that university researchers, with their supposed detach- ment from the profit motive, are unlikely to cut corners on research standards.” The problem is that most fraud in clinical trials is unlikely to even be detected. Most cases which do come to public atten- tion only do so because of extraordinary carelessness by the criminal physician...* According to Dr Judith Jones, Director of the Division of Drug Experience at the FDA, if the data obtained by a clinician proves unsatisfactory towards the drug being investigated, it is quite in order for the company to continue trials elsewhere until satisfactory results and testimonials are achieved. Unfavourable results are very rarely published and clinicians are pressured into keeping quiet about such data.’ It is ng) easy for the drug company to arrange appropriate clini- cal trials by approaching a sympathetic clinician to produce the It is very easy for the drug company to arrange appropriate clini- | Drug Companies Concealing and Misrepresenting Dangerous cal cists Uy approaching a sympathetic clinician to produce the Drug Effects Dr Braithwaite cited a number of cases where drug companies concealed and misrepresented dangerous effects of drugs noted by their own investigators. Braithwaite writes: In 1959 Wallace and Tiernan put a new tranquilliser, Dornwal, on the market despite the strenuous objections of its own medical director. Other company experts warned that Dornwal could cause serious and possibly fatal blood damage. They were right. Wallace and Tiernan failed to send to the FDA reports of side-effects which induced nine cases of bone mar- row disease and three deaths from using the drug (Johnson, 1976)... One could list a number of similar types of cases. Johnson and Johnson's subsidiary, McNeil Laboratories, was denounced by the FDA for concealing information on side-effects of Flexin which according to Johnson (1976) included the drug being associated with 15 deaths from liver damage. Such more bla- tant cases are merely the tip of an iceberg of selective misin- formation. The most dramatic recent case has been the disclosures in the British Parliament and US Congress that Eli Lilly and Co. knew of the dangers of Opren, an anti-arthritic drug associated with 74 deaths in Britain alone, 15 months before the drug was with- drawn (Sunday Times, 27 February 1983)... The problem is not restricted to Anglo-Saxon countries. In November 1982, a Japanese company, Nippon Chemiphar, admitted to pon nang data to the Japanese Government with its application to market a pain-killer and anti-inflamma- JUNE - JULY 1993 22¢NEXUS