http://www.reutershealth.com/archive/2002/01/15/eline/links/20020115elin024.html
Jan 15, 2002
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
By Richard Woodman
LONDON (Reuters Health)