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published on Friday, December 31, 2004 by the Inter Press Service
by Ritt Goldstein
STOCKHOLM - 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.
It's more than manipulation -- they (the FDA and NIH) put their seal of approval on things that they knew were false, were wrong ... they've betrayed the trust. Instead of servants of the public, they became truly agents and promoters of the Industry.
renowned drug industry critic
"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Vioxx was voluntary withdrawn by its manufacturer, Merck and Co, on Sep. 30, 2004 due to substantively increased risk of heart attack and stroke.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) labeling ... 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, and the public misled.
Notably, a March 2003 report by the U.S. Department of Health and Human Services Inspector General (DHHS-IG), Janet Rehnquist, found that just 12 percent of FDA scientists were completely confident that "labeling decisions adequately address key safety concerns."
In his most recent congressional testimony on Nov. 18, Graham named five drugs as candidates for market withdrawal: Accutane, an acne treatment; Bextra, the pain medication; Crestor, which lowers cholesterol; Meridia, a weight reduction drug; and Serevent, an asthma medication.
All of the preceding drugs' manufacturers were reported declaring their medications safe, paralleling similar pronouncements made by Merck and Company prior to its withdrawal of Vioxx.
At the same time, the Senate Finance Committee chairman, Iowa republican Charles Grassley, expressed his belief the FDA was "too cozy" with the drug industry.
Graham urged Congress to pursue legislation separating the FDA offices that address drug safety from the drug review and approval structure, arguing that creating an independent body to review drug problems would avoid the need to seek action on problem medications from the very individuals who had approved them, which is now what happens.
Both the FDA and the National Institutes of Health (NIH) have come under increasingly strong criticism for alleged distortion of research, their "cozy" relationship with the drug industry said to be at the root of the problem.
'The National Institutes of Health: Public Servant or Private Marketer?' headlined the Dec. 22 'Los Angeles Times', which revealed that while physicians have relied on the NIH to draft medical standards, the agency's researchers ac
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