Posted by
Rajjpuut's Folly on Saturday, July 11, 2009 4:27:09 AM
FDA = Frequently Disguised Avarice
At the FDA it’s not considered “conflict of interest” if the public doesn’t know
At more than 90% of evaluation and recommendation meetings at least one member has a conflict of interest
American Citizens’ Best Interest
is NO Concern of the FDA
Before a drug is approved for the public the FDA will listen to a presentation by the drug manufacturer and then listen to expert witnesses. Federal law prohibits the FDA use experts with financial stakes riding on the FDA decisions. According to NY Times Best-selling author Kevin Trudeau, however, this is a rule that is quite commonly waived. Trudeau says that the FDA keeps these meetings secret as well as which companies are involved, what the nature of the conflict is, and how much money may be involved. Your tax dollars at work protecting you! Rajjpuut has heard that waiving the conflict of interest rule might happen nine or ten times a month. Reuters and USA Today has run articles that imply a far greater degree of financial involvement than that, however -- that well over half the experts the FDA calls upon for testimony have a direct financial interest in the drugs or subject matter being evaluated. With stock ownerships, grant money, consulting charges or other incentives involved, Rajjpuut believes that if three times in every hundred instances the “expert” testified against his own best financial interests that would be very surprising.
At the FDA what the public doesn’t know, can’t hurt them (“them” being the FDA). According to Trudeau, once the experts have been heard from (and there’s only one side represented in 85% of instances) it’s very rare that the FDA rules against their advice in broad general matters. If a specific drug is the subject of evaluation, the FDA appears far less biased: at these meetings only 30% of the experts on average have financial conflicts.
Does this “unbiased” FDA evaluation process work? Listen to the extensive list of side effects that get mentioned every time some drug is advertised on the air. And what happens when the side-effects are truly dangerous or even deadly? The FDA very seldom “pulls” a drug from the market. Instead they typically recommend including another warning on the packaging. Before 1990 less than 60% of drugs were approved today it’s over 80%. Before 1990 about 5% of the drugs approved by the FDA were brand new to the world. Since 1998 the FDA has made enormous amounts of fees approving drugs, 2/3 of them first-time drugs on the market. It is now also considered part of doing business normally for the drug company to legally bribe** the FDA to conclude it’s business much faster than unbribed examinations take.
The Celebrex story is one of the most infamous of FDA approved drug debacles, Celebrex is still on the market despite a horrendous record with deaths and injuries. Despite this when it was reviewed the FDA recommended it stay on the market. According to Kevin Trudeau virtually every advisory panel member profited from the decision to keep it on the market. Statins (cholesterol lowering drugs) are dangerous, expensive and amount to a virtual life-subscription. Guess what? Only 47% of the people who die from heart attacks have elevated cholesterol readings. The FDA was aware of studies showing that cholesterol had no cause-effect relationship with heart attacks back in 1976. For several years the FDA allowed eggs to be attacked as dangerous causes of high cholesterol and to this day allows drug companies to sell dangerous, expensive statins with utter impunity.
Acid Reflux medicines (proton pump inhibitors) are potions without a real disease. 90% of the time when heartburn strikes, the cause is too little acid, not too much. Acid reflux medicine actually makes heartburn worse.
Rajjpuut wants to puke when he thinks about the FDA and its horrendous corruption, but he’s afraid someone might give him some FDA recommended medicine – oh no!
Live long, strong and ornery,
Rajjpuut
** the correct term is "bribe" but the FDA calls them "expedited evaluations" or "expedited reviews"
Regular readers of Rajjpuut’s little rants will recognize a strong personal antipathy toward the FDA (Food and Drug Administration). That once great organization created in 1906, the very year that Upton Sinclair’s monumental novel/expose` “The Jungle” hit the bookstore shelves, has degenerated into the most corrupt federal organization in America. Rajjpuut, health educator he, believes that only a complete top-to-bottom remake of the FDA will allow any health care plan, now or in the future, any hope of success.