Fraud in drug research

477

Monze district, is AIDS. Since 1987 there have been about 3600 cases in a population of 160 000, and by 1997 it is likely that about one-third of households will have experienced at least one death from AIDS. With AIDS comes a major reallocation of labour towards the care of the sick individual. On the death of the breadwinner the household is likely to split up. The tradition is that the dead man’s relatives can claim all the household’s possessions, right down to the cooking pot, and the widow may be left without the means to support the family, forcing her to return with the children to her own relatives. Despite legislation designed to prevent this the problem remains serious in Monze district, as elsewhere in Zambia. Maize planting and weeding are viewed primarily as women’s jobs, while land preparation is the man’s domain. The yield is very dependent on female labour input but the burden of caring for AIDS patients is also falling primarily on women. Unless men agree to look after the sick or to take on agricultural "women’s work" farm families with one or more sick members may soon face a labour shortage for the production of maize. In Monze, facing the triple catastrophes of drought, corridor disease, and AIDS, much effort has been devoted by district authorities to identifying the households at most risk, and the food aid now entering Zambia should reach vulnerable families in time to prevent starvation. Families weakened by AIDS or soon to be affected by the disease will have more than usual difficulty in recovering from the drought, and interventions targeted at these households could help them to avoid economic ruin and break-up of the family. Right now stocks of mealie meal are needed to see families through to the next harvest; in October they will need seed for planting-not to mention the most essential

production, and indeed to the economy of

in the recycling of plastics waste and has been licensed since 1988 for surface storage of plastics awaiting treatment. Instead, it is alleged, hospital waste was simply dumped, despite persistent complaints from residents in the area about the health risks of landfill operations close to a lake. Between August 7 and 14 a total of ten trucks were intercepted. Two truck drivers recrossed the frontier after being escorted back to Germany and were caught attempting to fly-tip their loads at Neuilly-sur-Suize in Haute Mame. Initially, M. Michel Picard, owner of Sodex, maintained that the waste contained only a small number of syringes, which might have been discarded by individuals, but customs officers said thay had found "hundreds" of syringes per cubic metre of waste. Picard was then ordered to exhume the equivalent of three weeks tipping. Pending agreement on European Community rules on waste self-sufficiency, transfrontier transport of nonhazardous waste is still possible within the EC, particularly when it is destined for recycling. But the French authorities have been growing restive about the volume of imports, notably those from Germany. The environment minister Mme Segolene Royal is due to meet her German counterpart in Strasbourg on August 31 to discuss the possibility of new control measures. Meanwhile, stung by fierce criticisms from her predecessor, M Brice Lalonde, Mme Royal has published (August 19) legislative proposals for a total ban on allimported waste--domestic, commercial, and industrial. It remains to be seen how these proposals are greeted by France’s partners in the European

specialises

Community. Arthur

Rogers

thing, rain. Susan Foster

London

Medicine and the Law France:

Illegal disposal of hospital

waste

A scandal involving thousands of tonnes of hospital waste fraudulently imported from Germany has led to legal proceedings and the introduction of systematic customs checks on waste consignments entering the country. Evidence from police and customs interceptions suggested that hospital waste had been imported from east Berlin and Leipzig hospitals, and other health centres in the former German Democratic Republic, where on-site hospital incineration facilities have yet to be brought up to standards required in the west. On August 16, three men appeared before an examining magistrate in Chaumont to face charges that include allegations that import documents had been falsified to suggest that the imported waste was intended for recycling. The defendants, who face up to two years’ imprisonment, are the head of an import company, the proprietor of a recycling firm (Sodex), and a member of the family that leased a disused quarry to Sodex. Reports claimed that the Sodex operation alone could have been on the scale of ten truckloads of German waste per day over the past two years. The authorities in Berlin admitted that there

had been unspecified errors of administration. The first interceptions were made on August 7. The trucks were ordered to return to German territory after it was found that the loads included syringes, dressings, and blood. The lorries had been en route to the Sodex plant near Chalons-sur-Mame in Champagne. Officially, Sodex

Fraud in

drug research

The danger that drug research may occasionally fall victim to misdemeanour by clinicians is well recognised in the USA, where the Food and Drug Administration has a system for policing research work done for drug registration purposes. The pharmaceutical sponsors of a clinical study, faced with data of which they are suspicious, may be reluctant to expose such incidents for fear of incurring the displeasure of the profession at large. At last, however, the UK medical profession and pharmaceutical industry are acknowledging that a small but significant amount of research misconduct does occur and that action must be taken to prevent abuses and to punish fraudulent doctors. In May, 1992, the Association of the British Pharmaceutical Industry (ABPI) published its recommendations in a report entitled Fraud and Malpractice in the Context of Clinical Research. In response to a Royal College of Physicians’ working party reporting in 1991 the ABPI had set up a group of its own. All ABPI member companies are reminded of their obligations under the principles of good clinical research practice and are invited to state their commitment to reporting all cases of fraud and taking action. Companies are urged to introduce standard procedures both in the monitoring of trials, to facilitate the uncovering of misconduct and its investigation, prosecution, and prevention.

478

In a radical move indicating that it means business the ABPI has provided a "hotline" to its director of medical affairs, Dr Frank Wells, to enable him to compile an informal list of doctors against whom he is satisfied there are reasonable grounds for suspicion and concern. Dr Wells tells’me that a complainant can telephone or write to him in confidence explaining his or her concerns and the grounds for suspicion and any data on which these are based. If Wells is satisfied that there is a cause for concern and that the complaints are made in good faith, he will note the name of the doctor and the complainant and his company. If contacted by a second complainant in respect of the same doctor Wells will follow the same procedure and the two complainants will be put in touch with one another to pool their data. The list will not be held on computer, to avoid the possibility of enforced disclosure under the Data Protection Act: All other background information will be held in Wells’ head. Where there are several complaints in respect of the same doctor, a rountl-table discussion may be convened at the ABPI and, if appropriate, a case for referral to the General Medical Council may be drawn up. Does this black-list procedure breach natural justicenamely, the right of an accused person to answer critics and be confronted with complaints and allegations of misconductor dishonesty and given an opportunity to answer them before an unbiased tribunal? Wells feels that the procedure is fair. He was satisfied that in each case the doctor whose actions gave rise to suspicion would have been asked to verify his results-and it was only when verification was not forthcoming that the hotline would be used. This liotline depends for its credibility to a large extent on the’ trust placed in Dr Wells=who is as popular as he is respected in pharmaceutical medicine-and on the integrity of complainants. Wells hopes thatcin time confidence in the system would grow so that the list might be circulated and brought out into the open as in the’ USA where the FDA disclosed its black list under the Freedom of Information Act. But what about libel laws in UK, which are far stricter than those in the USA? The ABPI system has been running since the beginning of the year (some months before publication of the report) and so far Wells has put complainants in touch with each other on three occasions, in respect of different doctors. In the past four years, with the mediation of the ABPI, 26 instances of research fraud involving eight doctors have been proved to the satisfaction of the GMC. But what if a name should get on the black list from a single complainant without justification? The doctor may be aware of a subtle change in attitude towards him but not able to tackle or pinpoint the cause or challenge the. suspicion. From the USA over the past decade or so have come spectacular examples of biomedical research misconduct. However, much of the fraud uncovered by the ABPI’s initiative is likely to be on a more modest scale. A few weeks ago the GMC struck off a general practitioner for fabricating data in a study for a pharmaceutical company. He claimed to have recruited five patients and was found to have improperly completed data on four of them. All eight cases to have come before the Professional Conduct Committee of the GMC in the past four years have ended in a verdict of serious professional misconduct, and a further 18 cases are being investigated. Some frauds are blatant and would become obvious on careful audit--eg, the doctor who dated the assessment of patients before the date when the drugs ’

.

were

supplied. Diana Brahams

Noticeboard Prospects for cystic fibrosis carrier screening Testing for cystic fibrosis (CF) carrier status is likely to become routine in North America within the decade, says the congressional Office of Technology Assessment (OTA).1 The OTA estimates that in the past year the number of such tests done in the USA increased nearly sevenfold, despite calls by professional societies and government agencies for caution in the introduction of the new test, especially for individuals without a family history of CF. The conclusion that the trend toward widespread testing is irreversible may lead doctors to conclude that failure to offer CF testing will soon be a mark of substandard practice, even though the personnel, technical, and public education advances needed are still lacking. Critics of the acceleration in CF testing point out that the existing test has a sensitivity of only 85-95%. Another argument is that the country is unprepared for clinical applications of molecular genetics research. There have been almost no federally funded public education programmes targeted to genetic diseases for a decade, and one estimate is that CF testing for all couples conceiving in one year could require each trained counsellor in the USA to spend 25% of his time on this task alone. The OTA noted that all but one of the steps involved in genetic diagnosis are automated or involve instrumentation under development, and efforts are being made to develop tests that identify several disorders simultaneously. Prepackaged test kits are expected in the next year or two, though there may be a delay before they are approved for marketing. But even if tests are offered to patients, the OTA found that few will accept them without reimbursement by health insurers. A CF carrier test ranges from$55 to$270 (mean$170). An OTA survey of health insurers indicated little likelihood of reimbursement for individuals without family history of the disease. The OTA also found that although few insurers expect to require genetic tests in the next 5 or 10 years, most think that it is fair for insurers to use these tests to identify individuals with increased risk of genetic disease and to use the information to determine risks. Most health insurers who responded to OTA’s survey would accept a CF carrier at standard rates, but a few would exclude benefits related to CF, impose a waiting period, or decline coverage--even though a CF carrier will never have the disease and would be expected to have CF-related costs only if his or her partner was also a carrier and they had children with CF. The results of the calculations of cost-effectiveness of CF carrier screening were impressive and will be further evaluated. Since pre-symptom treatment for CF still shows no substantial benefit, the key variable is whether testing leads to avoidance of the birth of a CF-affected child. 1 Office of Technology Assessment. carrier

Cystic Fibrosis and DNA Tests. implications of screening. Washington: Government Printing Office. 1992. Pp 301. $16

GPO stock 052-003-01291-0

US

growth

The

petition

hormone trials to be reviewed to

halt the US National Institutes of Health

(NIH)-sponsored testing of human growth hormone (hGH) on children, filed by the Foundation on Economic Trends (FOET) and the Physicians Committee for Responsible Medicine (Lancet, July 11, p 110), seems to have met with some success. In her July 24 reply to Jeremy Rifkin, president of FOET, NIH director Bernadine Healy said that "NIH has made the determination to review the hGH research through a newly constituted and independent data safety and monitoring body, which will report to within three months. We have considered the rate of patient accruel in the hGH studies, and are assured that the review will be completed before any further patients are enrolled". But the petitioners are not satisfied, since their aim is that the two hGH trials-one in non-growth-hormone-deficient children with short stature and the other in children with Turner’s syndromeshould cease. Andrew Kimbrell and Katharine Matthews of FOET me