Dangerous Drugs: Are We as Safe as We Assume?

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Here’s what a House Democrat determined after his 15- month inquiry into the Food and Drug Administration (FDA): During the Bush Administration, the enforcement of food and drug laws has declined — sharply.

 The FDA, as you know, is responsible for approving drugs that are used to treat serious illnesses — and also for yanking those drugs that may be causing unintended side effects. The FDA keeps drug companies in line, making sure that their marketing carries no false connotations and that pharmaceuticals are being used properly. However, lately it appears that the FDA may not be working so hard at keeping the nation safe from dangerous drugs.

 Back in the year 2000, the agency mailed 1,154 warning letters to drug companies. Fast-forward to 2005 and, according to the House Representative, those warning letters have dropped by 54% to 535. Add onto this the finding that the FDA’s seizure of defective or dangerous products has slipped by 44% and you’ll find some pretty stark evidence that shows enforcement is not so swift or strong as it once was.

Plus, in a day and age where wonder drugs are rushed to the market, only to find five years later that they carry unknown side effects, a lack of enforcement is extremely problematic. (And if you think that this scenario is just an unrealistic anecdote, just think back to what happened with “Vioxx,” “Celebrex,” and “Bextra” in the past two years.)

FDA investigators continue to uncover roughly the same number of problems with drugs, but deep inside the agency, officials are overruling these recommendations from the investigators. (For example, to send a warning letter.) This is a sizable dip to have happen — and it coincides exactly with the term of George W. Bush. FDA enforcements have literally plummeted, leaving doctors and pharmacists across the country relying largely on what drug companies have to say about their own products.

The inquiry began after the Congressman requested thousands of documents from the FDA, in wake of the shortage of flu vaccines in 2004. That’s where they saw the evidence that enforcement had declined in the past five years. During that time, there have been cases of people dying unexpectedly from approved treatments and medical devices.

The New York Times recently quoted a former general counsel of the FDA as saying these slipping numbers are a “tragedy.” “Congress has failed to realize that our single most important government agency is being systematically dismantled,” said Peter Barton Hutt.

Here’s a little food for thought I’d like to leave you with: The FDA receives nearly $400 million a year in fees from drug companies. That fact has prompted some individuals to believe that Americans are getting the kind of FDA that the drug industry is paying for them to get.




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