Makers of popular antidepressants such as Paxil, Zoloft and Effexor have refused to disclose the details of most clinical trials involving children taking these drugs. The unpublished data is denying doctors and parents crucial information showing that some of these antidepressant drugs may cause children to become suicidal.
The companies are calling the unpublished studies trade secrets. Researchers familiar with these trade secrets say the majority of the secret trials show children who took the antidepressants did not get any better than those who took sugar pills. Analyses suggest that as many as one percent of children in the United States are treated for depression in any year. Of those, 57 percent are on antidepressants.
Researchers have found that the unpublished studies hide the fact that most antidepressant drugs have little to no affect on the children who take them. Most of the studies’ outcomes have turned out with negative results and these are the ones that doctors and parents do not have access to.
For example, GlaxoSmithKine, makers of the antidepressant Paxil, had conducted three trials on children taking the drug. The results showed that all turned out with negative results, but only one was published. Another drug company, Pfizer, which makes Zoloft, sponsored two trials in children. One of the trials had a negative result, but researchers found out the company pooled it with a positive study and only published the combined result, which was positive.
Some doctors and consumer advocates question the real reasons why the negative results go unpublished, believing they go unpublished only because the trials conducted are funded by the pharmaceutical industry. Scientists believe the only way to ensure that science is conducted in the public interest is for it to be funded with public dollars, as opposed to pharmaceutical industry dollars.
The Food and Drug Administration is evaluating 20 studies, however agency officials have declined to identify which ones.
Washington Post January 29, 2004
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