DRUG CO. GIFTS UNDERMINE CONFIDENCE
IN FDA & MEDICAL JOURNALS
Richard Smith, professor of medical journalism at Nottingham University, UK, has announced that he will resign that position in response to a poll he conducted on the university's acceptance of $5.4 million from British American Tobacco.
The gift is to be used to finance a center for studying business ethics, a rather curious sponsorship coming from the tobacco industry, which knowingly used animal experiments to demonstrate the harmlessness of tobacco smoking for humans with the result that people continued to smoke long after the companies were aware that smoking tobacco caused lung cancer and heart disease in humans. Smith also happens to be the editor of the prestigious British Medical Journal in which the poll was conducted.
Out of over 1,000 responses 84% thought the university should return the gift and 55% indicated Smith should resign from the university if the gift was not returned. He has announced his intention of doing so.
In another case, Richard Horton of The Lancet, another of the world's most respected medical journals, has accused the Food and Drug Administration, the world's most powerful drug control agency, of favoring the interests of GlaxoSmithKlein Plc in approving its dubious bowel drug, Lotronex, which the company subsequently withdrew voluntarily nine months later after it had killed five people. The drug was designed to treat irritable bowel syndrome but turned out to cause severe constipation, diarrhea, ischemic colitis, pain and bloating. These effects probably did not surface in mice who typically eliminate drugs from their bodies in a mere three hours compared to three days for humans.
"It is an impossible safety conflict for safety issues to be overseen by a centre that receives funding from industry to review and approve new drugs," Horton commented.
He accused FDA of (1) ignoring serious side effects during the approval process; (2) dismissing an independent review that questioned the research protocol of FDA-sponsored studies on bowel disease; and (3) excluding employees who raised concerns from any further evaluation of the drug.
A survey by the New England Journal of Medicine in 1998 determined that authors who supported the use of a
drug for treating heart problems were much likelier to have financial ties to the manufacturer than those who did not recommend its use.
A study reported in the Journal of the American Medical Association described how it was possible to predict the outcome of studies on passive smoking by whether or not the authors had financial ties to the tobacco industry.
It is suspected that the University of Toronto withdrew its job offer to Dr David Healy because its Centre for Addiction and Mental Health receives funding from Eli Lilly, the company that makes the anti-depressive drug, Prozac, which Healy has publicly accused of raising the suicide risk among patients for whom it is prescribed.
back to spring 2002 CivAb