More MS news articles for Jan 2002

Up to 5% of clinical trials may be fraudulent

Jan 15, 2002
By Richard Woodman
LONDON (Reuters Health) 

At least 1%, and possibly as many as 5%, of drug trials are compromised by fraudulent data, a British pharmaceutical fraud investigator said on Tuesday.

Dr. Frank Wells, director of Medico Legal Investigations Ltd, urged countries to set up new disciplinary bodies to ensure doctors found guilty of research fraud are struck off the medical register.

"The incidence of clinical research fraud is difficult to assess but my own estimate is that it is at least 1% and possibly much higher," he told the Society of Biomedical Research in London.

"If we estimate that there are about 3000 sponsored clinical research projects taking place within the UK at any one time, this means that at least 30 will include investigators who are generating false data."

Dr. Wells, who has investigated cases of suspected fraud for the past 10 years, said some doctors become clinical investigators out of greed, vanity, arrogance, boredom and the pressure to publish scientific papers.

Examples of fraud include a surgeon who claimed to have assessed a patient 6 months after the patient had died and a doctor who claimed to be assessing blood flow in the leg of a patient that had been amputated. Another doctor had forged 191 patient signatures and other data in 21 studies.

Dr. Wells told the meeting on fraud and misconduct in biomedical research that in Britain doctors faced the deterrent of being reported to the General Medical Council's disciplinary body which can strike doctors off the medical register for serious professional misconduct.

But similar sanctions do not yet exist in many other countries. In the United States, the maximum penalty under Food and Drug Administration rules is to be barred from using federal research funds for 3 years.

In France, silence is generally the golden rule on fraud though it is hoped that action would eventually be taken at the EU level, he continued.

In Germany, rules about misconduct in science were only introduced a couple of years ago. In Italy and Spain, there are no antifraud measures worth reporting, Dr. Wells claimed.

American pharmaceutical consultant Arthur Horowitz said complaints filed with the FDA against investigators had increased from 11 in 1992 to 118 in 2000. Thirty-five percent of complaints involve protocol violations and 24% involve falsification of data.

Another area of concern is the huge expansion of clinical trials in eastern Europe, Africa and South America where ethical review boards are often inexperienced.

Copyright © 2002 Reuters Limited