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Many unfavorable drug studies aren't published
Some of those that are printed have been recast, researchers say

Reuters updated 6:09 p.m. CT, Wed., Jan. 16, 2008

BOSTON - Nearly a third of antidepressant drug studies are never
published in the medical literature and nearly all happen to show that
the drug being tested did not work, researchers reported on Wednesday.

And in some of the studies that are published, unfavorable results
have been recast to make the medicine appear more effective than it
really is, said the research team led by Erick Turner of the Oregon
Health & Science University.

Even if not deliberate, this can be bad news for patients, they wrote
in their report, published in the New England Journal of Medicine.

"Selective publication can lead doctors to make inappropriate
prescribing decisions that may not be in the best interest of their
patients and, thus, the public health," they wrote.

The idea that unfavorable test results get quietly tucked away so
nobody will see them -- sometimes call the "file drawer effect" -- has
been around for years.

The Turner team was able to study the question because the U.S. Food
and Drug Administration has a registry in which companies are supposed
to log details of their drug tests before the experiments are begun.

They could see which experiments approved by the FDA between 1987 and
2004 were ultimately publicized in the medical literature and the main
criteria the researchers planned to measure success.

"It tells you where they placed their bets before they saw the data,"
Turner said in a telephone interview.

Of the 74 studies that started for the 12 antidepressants, 38 produced
positive results for the drug. All but one of those studies were
published.

However, when it came to the 36 studies with negative or questionable
results, as assessed by the FDA, only three were published and another
11 were turned around and written as if the drug had worked.

"Not only were positive results more likely to be published, but
studies that were not positive, in our opinion, were often published
in a way that conveyed a positive outcome," said the team.

For example, of the seven negative studies done on GlaxoSmithKline's
Paxil, five were never published. The researchers found three studies
for GSK's Wellbutrin SR, but the two negative ones never reached
print.

There were five studies for Pfizer's Zoloft, but the three showing the
drug to be ineffective were not published and a fourth study, ruled as
questionable by the FDA, was written and published to make it appear
that the drug worked.

A Glaxo spokeswoman said the company posts the data from all of its
trials, positive or negative, on the Internet.

"GlaxoSmithKline agrees that public disclosure of clinical trial
results for marketed medicines is essential and fully supports
registration of all trials in progress," she said.

Pfizer was not immediately available to comment.

Turner and his colleagues did not find out who was to blame for not
publishing the studies.

Although the authors and drug company sponsors may not have submitted
the unfavorable results for publication, medical journals and their
editors may have played a role by deciding they would rather publish
favorable results.

"There's an expectation that if you get a positive result, that's what
you're supposed to do, and if you get a negative result you have
failed," said Turner. "The first impulse is to say, 'I was wrong.
Maybe I should move on to something more interesting"' so the results
may never get written up.

Copyright 2008 Reuters. Click for restrictions.
URL: http://www.msnbc.msn.com/id/22690043/

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