Dr James Schaller
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Dr. Graham Toasts the FDA
He Beats Up "Big Brother"

Dr. David Graham, associate director in the FDA's Office of Drug Safety, called the FDA's approval of arthritis drug Vioxx, "The single greatest drug safety catastrophe in the history of this country or the history of this world." Graham went on to cite the following statistic: A staggering 88,000 to 139,000 Americans suffered heart attacks and strokes as a result of taking Vioxx.

Graham's other health disaster drugs include:

  • Meridia
  • Crestor
  • Accutane
  • Serevent
  • Bextra

Graham stated that the FDA's inability to protect Americans from another case similar to the Vioxx case was clear evidence that massive changes need to be implemented for the future protection of the public.

One of the regulatory changes Graham proposed was granting the Office of Drug Safety independent regulatory authority. Presently, safety officers are faced with a conflict of interest in the event they have to convince the Office of New Drugs that a drug is causing side effects. The conflict arises because the very group that approved the drug in the first place is also responsible for taking regulatory action against any post-marketing activities.

According to USA Today, [Graham's reward] is to "be exiled from work reviewing drugs and put to work in the office of the commissioner," said Devine [Graham's attorney], adding that Graham has no legal recourse against such a move. "He'll be paid to fill space under the watchful eye of a babysitter." Devine's non-profit group is a public-interest organization and law firm that defends whistleblowers.

Graham knows he is needed just where he is in keeping the misguided FDA from more serious errors. But he is not naive.

"I'm going to be transferred, and I don't want to go," said Graham, who told a Senate committee on Nov. 18 that the FDA is "virtually defenseless" against another "terrible tragedy and a profound regulatory failure" like Vioxx, an arthritis drug pulled off the market over concerns that it increased the risk of heart attack, stroke or sudden cardiac death.

USA Today also reported that:

BMJ, a British medical journal, reported this week that a caller to Devine's group, who claimed to be another FDA whistleblower, described Graham as a bully whose research might reflect scientific misconduct. The call was found to have come from an FDA manager trying to discredit Graham. [Italics and bold mine].

For the full story: www.usatoday.com/news/health/2004-11-25-fda-graham_x.htm

I have a dream. Someday the FDA will not attack:

  • Tailored medications from thousands of genius compounders.
  • High quality Canadian medications and prevent their importation.
  • Allow American's to choose what risks they want to take with clear labeling.
  • Make it so America does not get the best drugs after eighty other counties have them for a decade.
  • Stop acting as the anti-nutrition force of the land.

But then you wake up, and they are a waste of taxpayer money, and they are abusing their super power status.

Dr. J

From an undisclosed location :)

Bank Towers, Tamiami Trail, Naples, FL
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