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Report: Studies revealing negative drug results are not printed

Submitted by Samia Sehgal on Thu, 01/17/2008 - 10:27. ::

Studies that reveal the negative effects of anti-depressants are kept veiled, according to researchers. An article in the New England Journal of Medicine alleges that studies on antidepressants that have positive results are more likely to be published than the ones which happen to show that the drug being tested did not work or disclose the adverse effects.

Unfavorable results are sometimes manipulated in publications 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. The team wrote that even if not deliberate, this can be bad news for patients.

"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," the researchers wrote in their report. "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."

The team referred to Food and Drug Administration registry in which companies log details of their drug tests before experimenting. Out of the total 74 studies for 12 antidepressants, only one of the 38 that showed positive results was not published.

Whereas of the 36 studies with negative or questionable results, according to FDA, only three were published and some 11 were written as if the drug had worked.

The published literature suggested that 94 percent of studies were positive, but the actual figure was close to 51 percent.

Such tendency for articles to get published to reflect chiefly positive findings about drugs and medical devices is called ‘publication bias’ by the researchers who assert that it gives doctors and patients a distorted view of the drug value.

“We know publication bias exists,” said Jeffrey Drazen, editor-in-chief of the New England Journal of Medicine. The article “shows that what's reported is really a much more rosy situation than actually exists.”

According to Erick Turner, Publication bias can either occur because companies don't offer negative studies for publication or because editors are disinterested in publishing negative results.

London-based GlaxoSmithKline spokeswoman Mary Ann Rhyne said in an e-mail that the comapny “agrees that public disclosure of clinical trial results for marketed medicines is essential.”

Also, Pfizer said, it is committed to disclose results within one year of their completion for all its products.

Such claims make it difficult to find that who should be blamed for the manipulated or curtained outcomes of drug experiments.

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