Guest guest Posted September 17, 2004 Report Share Posted September 17, 2004 > SSRI-Research > Thu, 16 Sep 2004 19:34:10 -0700 (PDT) > [sSRI-Research] FDA needs its own warning > label > > FDA needs its own warning label > > Published on: 09/12/04 || The Atlanta Journal > Constitution > > The U.S. Food and Drug Administration's policy on > warning labels for > antidepressants that are prescribed for children and > adolescents is more > than bizarre; it's downright dangerous. > > During congressional hearings last week, agency > officials admitted they had > urged drug makers on several occasions not to inform > doctors or their > patients that products such as Paxil and Zoloft, > while helpful for adults, > weren't proved to be any more effective than inert > sugar pills in treating > childhood depression. Even more startling is that > they made those > recommendations despite knowledge that some of the > drugs increased " suicidal > thoughts " in young people. > > This is truly strange behavior for an agency that's > supposed to be looking > out for consumers who lack the expertise to protect > themselves from unsafe > drugs. In 2002, nearly 11 million antidepressant > prescriptions were written > for children, including 2.7 million for children > under 12. Despite their > popularity, more than two-thirds of all studies of > antidepressant use among > depressed children showed they didn't work. > > Drug trials and studies are typically conducted at > public expense but often > represent billion-dollar windfalls for drug makers > by enabling them to > extend the useful life of profitable patents. The > hearings included > testimony from all the heavy hitters of " Big > Pharma " : Pfizer, Wyeth and > GlaxoSmithKline. > > But the most troubling revelation was that the FDA > advocated suppressing or > diluting warnings about some antidepressants for > kids, often over drug > makers' repeated objections. Wyeth, for example, > wanted to alert consumers > that the antidepressant Effexor had been linked to > suicidal thinking, > hostility and self-harm. But the agency demurred, > saying the company's > suggested warning was " not understandable. " > > Earlier in the hearings, Rep. Joe L. Barton > (R-Texas), who chairs the House > Energy and Commerce Committee, accused top FDA > officials of stonewalling. > > " The FDA's lack of cooperation with the committee in > obtaining relevant and > responsive information in a timely fashion on a > matter that involves the > safety of our children leaves me wondering whether > this is sheer ineptitude > or something far worse, " Barton said. > > An industry trade group has offered to voluntarily > publicize the results of > all clinical drug trials on the Internet, but that's > not nearly enough. The > only way to begin fixing the current system is for > Congress to pass > legislation making such disclosures mandatory. After > that, a shakeout of FDA > officials who have shamefully abdicated their > responsibility to protect the > public would be just the right medicine. > > ========================= > > http://tinyurl.com/4sogc > > -- > Alex Chernavsky > alexc > http://www.astrocyte-design.com/ Quote Link to comment Share on other sites More sharing options...
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