Exposure of fraud in GP drug tests 'on the increase' (CORRECTED)

CORRECTION (PUBLISHED 25 JANUARY 1993) APPENDED TO THIS ARTICLE

(First Edition)

FRAUD and misconduct by doctors in general practice using patients in clinical trials for drugs companies are increasingly being exposed, according to a book published yesterday.

Fraud and Misconduct in Medical Research, published by the British Medical Journal, is likely to outrage many GPs. It suggests that fraud by doctors who recruit patients to take part in clinical trials of new drugs is as much, if not more, of a problem than fraudulent research by the drugs companies.

And it claims that while academic researchers are motivated by 'peer pressure' and the unreasonable demands and expectations of drugs companies, GPs are driven by greed.

The book reports that since 1990 there has been increasing concern about fraud in the pharmaceutical industry-sponsored research carried out by academic researchers. But this has been matched, if not overshadowed, by fraud in clinical trials involving GPs, according to several of the contributors. The book claims: 'There is another focus for fraud; in general practice, where family doctors have invented data for multicentre clinical trials.'

In a resume of recent events the book lists five cases since 1990 of British family doctors who were struck off the medical register by the General Medical Council for faking data in drugs trials which involved their patients.

But these represent just the tip of the iceberg, according to several contributors to the book, edited by Stephen Lock, editor of the BMJ, and Frank Wells, medical director of the British Pharmaceutical Industry. 'The frequency of the detection of fraud at the moment is probably at its highest. It is a sad fact that a (physician who is a) 'fast recruiter' (of volunteers for clinical trials) is now one of the people in whom fraud is most often discovered.'

In a chapter on the pharmaceutical industry and contract research organisations which conduct clinical trials for drugs companies, the authors say the drugs industry has stepped up its fight against fraudulent data. 'This would not have been the case in the 1970s. It was always felt that doctors were professional, above reproach; that doctors had signed the Hippocratic oath, that they cared for life, and were sensitive, ethical individuals who had no interest in, or reason for, fabricating data. This belief is unlikely to have been true . . . When suspected fraud was stumbled on usually nothing was done about it.'

The book highlights some recent examples, discovered by accident. These include a doctor who sent in identical electrocardiograms for each of six patients, and another who sent in data on 18 patients in each of whom the level of potassium in the blood was always, at each visit, between exactly the same narrow limits.

In another case a doctor sent in to the drug company 10 case report forms completed with data on 10 patients. The clinical researcher had been on holiday and, not realising the forms had been sent in, asked the doctor to return them. The GP promptly sent in 10 new case report forms with the same patient numbers but completely different data.

CORRECTION

THE British Medical Journal has asked us to point out that the editor of the publication is Dr Richard Smith and not Stephen Lock, as was stated in the Independent last Saturday, in a story concerning fraud in general practitioners' tests on drugs. Mr Lock is a former editor of the publication.