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Originally published November 6 2004

Reputation of the FDA in shambles after Vioxx scandal; calls for wholesale FDA reform gain momentum

by Mike Adams, the Health Ranger, NaturalNews Editor

"...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

Another FDA researcher, Dr. Andrew Mosholder, was censored and not allowed to testify in February, 2004 about his study that found antidepressants increase the risk of suicides in children. There was a war within the FDA between the scientists who recognized the clear health risks of drugs like Prozac and Vioxx, vs. the top administrators who wanted to keep pushing drugs to the public regardless of their health risk. As Dr. David Graham explained, "the review and clearance process had been turned into a battleground, full of contention and intimidation because our managers, the people who fill out our performance evaluations, had created a system where it was taking a great risk to stand firm in our scientific beliefs."

That's how the FDA operates: censor any scientists who speak out against prescription drugs. Better yet, just fire them and blackball the whole lot. Only positive information about drugs is accepted by the FDA, and if you work for the agency, you're encouraged to understand that message as quickly as possible through a system of intimidation and censorship.

Today, the FDA's reputation is in shambles. Finally, the world is getting the picture: the agency cannot be trusted. It has now proven, yet again, that it will co-conspire with drug companies to distort the truth, lie to the American public, and blatantly promote dangerous drugs that it knows are killing people.

Blatant criminal behavior at the FDA

These actions are not mere "administrative oversight," folks. These actions represent a pattern of criminal behavior on the part of FDA employees and drug company executives. Promoting these toxic drugs, distorting the clinical trials, and burying the negative evidence are criminal actions and should be treated as such. In a sane world, the FBI would march into the FDA offices tomorrow and arrest these white-collar felons for the crimes they have committed. Executives at Merck should do prison time -- plus pay billions in fines -- for the pain, suffering and death they have unleashed upon the population.

Quite clearly, Big Pharma is a highly corrupt industry, and it is backed and promoted by a federal agency that needs to be wiped clean and rebuilt from scratch (along with a new office of Internal Affairs that would investigate FDA employees for precisely these sort of crimes).

Regardless of what happens next, it's evidence that the public trust in the FDA has been destroyed. "...the most important legacy of this episode," writes Dr. Horton, "is the continued erosion of trust that public-health institutions will suffer. Failure to act decisively on signals of risk might minimize short-term political criticism for regulators, or shareholder unrest for company chief executives. But the long-term consequence of prevarication is a tide of public skepticism about just whose interests drug makers and regulators truly represent."

That's a very polite way of saying the FDA is in bed with the drug companies -- a fact that's as obvious as the fingers on your hand to anyone who has actually been following the FDA's actions over the last few years. There's no question about it: the FDA knowingly and willingly places the financial interests of Big Pharma as its highest priority. And in doing so, it is causing the needless death and suffering of American citizens.

By any definition, that is criminal.

Action Items:

1) Support the movement to charge FDA officials and drug company executives with the crimes they have committed against humanity. If they are not held responsible for their actions, there's no reason why they won't keep repeating them.

2) Write your political representatives in Washington and demand real reform at the FDA.

3) Steal this article and post it on your website or send it to your friends via email. Spread the word about so that more people can get involved in our leading effort to call for FDA reform and the prosecution of drug company executives for their crimes against the people.


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