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"...the agency’s senior management is more concerned with external appearance than rigorous science." -- Dr. Richard Horton, editor, The Lancet
The reputation of both the FDA and Merck lies in shambles today after evidence continues to surface that shows the FDA knowingly approved, promoted and refused to recall a dangerous drug that caused an untold number of fatalities among the American population: Vioxx. As readers of this website have long known, the FDA sees its job as promoting drugs and the financial interests of pharmaceutical companies, not in protecting the public health. We've known, all along, that it would take a scandal to reveal the true nature of the FDA and see serious calls for reform. Well, folks, the scandal is here, and the FDA is now under intense fire by the international medical community for its role in covering up the truth about Vioxx for four years.
Perhaps the most relevant criticism of the agency comes from Dr. Richard Horton, editor of The Lancet, a well respected medical journal. After reading the Merck insider emails published in the Wall Street Journal showing how Merck sought to distort drug trials to hide evidence of heart disease, and after reviewing the same clinical trials on the drug that the FDA reviewed before approving it, Dr. Horton was outraged and called for FDA reform:
"In the case of Vioxx, the FDA was urged to mandate further clinical safety testing after a 2001 analysis suggested a 'clear-cut excess number of myocardial infarctions'. It did not do so. This refusal to engage with an issue of grave clinical concern illustrates the agency’s in-built paralysis, a predicament that has to be addressed through fundamental
organizational reform."
But Dr. Horton didn't stop there. He also explained, "...with Vioxx, Merck and the FDA acted out of ruthless, short-sighted, and irresponsible self-interest." In other words, Merck and the FDA were playing the classic "cover your ass" game in trying to hide the destructive health consequences of Vioxx from the public for as long as possible. And they managed to pull it off for four years thanks to the gullibility of conventional doctors and the ignorance of the American public, who continue to believe in prescription drugs as "miracle cures" for just about every symptom or disease, even though the facts reveal that prescription drugs heal no one. More often than not, they actually kill people.
The FDA, godfather of the U.S. drug racket
For decades, the public has blindingly trusted the FDA, despite the growing evidence that the agency acts more like a 1920's Chicago mob than an organization dedicated to protecting the public health. The FDA is far more interested in protecting the profits of Big Pharma, it seems. In a very real sense, the FDA is the godfather of the U.S. drug racket, where dangerous chemicals are hyped, approved and sold to the American people, regardless of their true dangers. I've been shouting this message for years, and now, finally, people around the world are starting to listen.
One thing we've learned with the Vioxx scandal is that the FDA routinely suppresses any information from its own scientists that might have something negative to say about drugs the agency has already approved. One scientist the FDA suppressed was Dr. David Graham, associate director for science in the Office of Drug Safety at the FDA. He had directly warned the agency about the cardiovascular risk presented by Vioxx, and yet his supervisors essentially told him to sit down and shut up. Dr. Anne Trontell, one such supervisor, called the studies showing heart damage from Vioxx, "nothing more than a scientific rumor." That's how the FDA and people in the medical community shut down critics: they just declare anything they don't like to be "unscientific."
The FDA censors its own scientists
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