At least 1% -- and possibly as many as 5% -- of drug trials
are compromised by fraudulent data, a British pharmaceutical fraud investigator
said on January 15.
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 3,000 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," he added.
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 included a surgeon who claimed
to have assessed a patient 6 months after he 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.
Wells told the meeting on fraud and misconduct in
biomedical research that in Britain, doctors face 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, he added. In the United States, the maximum penalty under Food
and Drug Administration (FDA) rules is being barred from using federal
funds for research for 3 years.
In France, silence is generally the golden rule on
fraud, though it is hoped action will eventually be taken at EU level.
In Germany, rules about misconduct in science were
only introduced a couple of years ago, while in Italy and Spain there
are no anti-fraud measures worth reporting, Wells said.
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
involved protocol violations and 24% 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, Wells noted.
He urged disciplinary standards to ensure employees
know that fraud will be treated seriously.
Reuters London, January
15, 2001
