DRUG CHEATS: ANTIDEPRESSANT COMPANIES ONLY PUBLISH MAINLY POSITIVE REPORTS
January 24th 2008 01:46
DRUG CHEATS: ANTIDEPRESSANT COMPANIES COOK THE BOOKS AND ONLY PUBLISH MAINLY POSITIVE REPORTS
Here’s something to get depressed about: according to Australia’s Biotech Daily, an article published in the New England Journal of Medicine says that negative trial results on anti-depressants tend not to be published.
The January 17 article said that selective publication of clinical trials and the outcomes of those trials can lead to unrealistic estimates of drug effectiveness and alter the apparent risk to benefit ratio.
The authors obtained reviews from the US Food and Drug Administration for studies of 12 antidepressant agents involving 12,564 patients. They identified matching publications and for trials that were reported in the literature, they compared the published outcomes with the FDA outcomes.
Of 74 FDA-registered studies, 31 percent (accounting for 3449 study participants) were not published.
“Whether and how the studies were published was associated with the study outcome,” authors said.
A total of 37 studies viewed by the FDA as having positive results were published; one study viewed as positive was not published.
“Studies viewed by the FDA as having negative or questionable results were, with three exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies),” the authors said.
“According to the published literature, it appeared that 94 percent of the trials conducted were positive. By contrast, the FDA analysis showed that 51 percent were positive”.
“Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients,” the authors said.
Here’s something to get depressed about: according to Australia’s Biotech Daily, an article published in the New England Journal of Medicine says that negative trial results on anti-depressants tend not to be published.
The January 17 article said that selective publication of clinical trials and the outcomes of those trials can lead to unrealistic estimates of drug effectiveness and alter the apparent risk to benefit ratio.
The authors obtained reviews from the US Food and Drug Administration for studies of 12 antidepressant agents involving 12,564 patients. They identified matching publications and for trials that were reported in the literature, they compared the published outcomes with the FDA outcomes.
“Whether and how the studies were published was associated with the study outcome,” authors said.
A total of 37 studies viewed by the FDA as having positive results were published; one study viewed as positive was not published.
“Studies viewed by the FDA as having negative or questionable results were, with three exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies),” the authors said.
“According to the published literature, it appeared that 94 percent of the trials conducted were positive. By contrast, the FDA analysis showed that 51 percent were positive”.
“Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients,” the authors said.
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