invincible summers

in the middle of winter I at last discovered that there was in me an invincible summer. (albert camus)

unfavorable drug studies rarely published January 16, 2008

Filed under: antidepressants,big pharma — clementine @ 1:13 pm
Tags: , , ,

this story is not at all surprising but it still angers me…

from reuters:

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.

REWRITTEN STUDIES

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.

Paxil

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