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.

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 are quietly tucked
away so nobody will see them — sometimes call the "file drawer
effect" — has been around for years.

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

"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.

REWRITTEN STUDIES

However, only three of the 36 studies with negative or
questionable results, as assessed by the FDA, were published
and another 11 were 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 authors.

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. A fourth
study, ruled 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 is committed to the communication of results of all
registered clinical studies, regardless of outcome. More
specifically, we have committed to disclose clinical trial
results within one year after study completion for all of our
marketed products," Pfizer spokesman Jack Cox said in an
e-mail.

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

Via Yahoo