STOCKHOLM, Dec 30 (IPS) - While the U.S. Food and Drug Administration (FDA) is supposed to safeguard the nation's medical products, drawing upon the substantive expertise of its drug scientists in vigilant dedication to the public's health, that is not the case today.
Documentation, interviews and recent drug debacles depict a brutally different reality, with the Vioxx scandal alone estimated to have resulted in 30,000-55,000 U.S. deaths.
"You have an agency in denial -- the FDA still maintains it made no mistake in the approval or regulation of Vioxx," says the agency's associate safety director, Dr David J Graham.
Vioxx was voluntary withdrawn by its manufacturer, Merck and Co, on Sep. 30, 2004 due to substantively increased risk of heart attack and stroke. Since then, questions have been raised regarding similar problems in other pain medications like Celebrex and Aleve.
Graham, who provided the figures on the Vioxx deaths, also told IPS that -- despite the recent linkage between some antidepressants and suicide -- the FDA is in the process of "misleading the public in their (antidepressant) labelling ... taking care of business rather than patient safety."
Graham, whose November testimony before the U.S. Senate Finance Committee rocked the FDA's leadership, warned that while the agency's proposed new label for the class of antidepressants known as SSRIs cites a "suicidality" rate of one-two percent, a senior FDA official acknowledged in September that number was based upon drug trials that "failed to capture most of the reactions of suicidality."
A 20-year FDA veteran, Graham then noted that an alternative trial found "the actual rate was somewhere around seven or eight percent," an incredibly substantive difference from the proposed FDA numbers.
Investigation reveals that dangers of drugs are being deliberately downplayed, the public misled.
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