Medical Research
Fraud: Professors Go Unpunished in Glaxo $3 Billion
Guilty Plea Over Paxil
The head of the UCLA hospital, Dr. David Feinberg, and
twenty-one other academics are going unpunished despite their role in
perpetrating a healthcare fraud that has resulted in the largest fine ever paid
by a pharmaceutical company in US history.
On July 3 GlaxoSmithKline pleaded guilty
to criminal charges and agreed pay $3 billion in fines for promoting its
bestselling antidepressants for unapproved uses. The heart of the
case was an article in a medical journal purporting to document the
safety and efficacy of Paxil in treating depression in children. The article
listed more that twenty researchers as authors,
including UCLA’s Feinberg, but the Department of
Justice found that Glaxo had paid for the
drafting of the fraudulent article to which the researchers had attached their
names.
The study, which, according to The Chronicle of
Higher Education, had been criticized because it “dangerously
misrepresented data” and had “hidden information indicating that the drug
promoted suicidal behavior among teenagers,” was published in 2001 in The
Journal of the American Academy of Child and Adolescent Psychiatry. The
lead “author” was Martin B. Keller, at the time a professor of psychiatry at
Brown University. He retired this month. The article had been exposed as
fraudulent in a 2007 BBC documentary and in the 2008 book Side Effects: A
Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, by
Alison Bass. Glaxo’s guilty plea, according to the Chronicle,
included an admission that “the article constituted scientific fraud.”
Paxil went on sale in the US in 1993 and, according to Bass, prescriptions
for children “soared” after the study appeared, even though research showed
Paxil was not more effective than a placebo. But in 2004, the Chronicle
reports, British regulators warned against prescribing Paxil to children, after
a study reported that children taking Paxil were nearly three times more likely
to consider or attempt suicide. Then the US FDA issued a similar warning. Paxil
sales totaled more than $11 billion between 1997 and 2005.
Brown University officials said they had no plans to take action against
Keller. At UCLA, Dale Triber Tate, a spokesperson for
the medical center and Dr. Feinberg, had no comment. The journal that published
the fraudulent research has failed to retract it, and editor-in-chief Andres S.
Martin, a professor of psychiatry at Yale, told the Chronicle he had
no comment on the options the journal might take.
Feinberg and Keller were among twenty-two people listed as “authors” on the
fraudulent article. Others included Karen D. Wagner, now professor and vice
chair of psychiatry at the University of Texas Medical Branch at Galveston;
Boris Birmaher and Neal D. Ryan, professors of
psychiatry at the University of Pittsburgh; Graham J. Emslie,
professor of psychiatry at the University of Texas Southwestern Medical Center
at Dallas; and Michael A. Strober, professor of
psychiatry at UCLA.
Although Glaxo pled guilty and paid $3 billion in
fines, none of the academics have been disciplined by their universities for
their roles in perpetrating research fraud. Moreover, according to the
Chronicle, several continue to receive federal grants from the National
Institute of Health.
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