The Fox Guarding Your Hen House

Health Alert 10

You may be shocked to learn this. The federal agency that you have put your trust in to ensure that your medications are safe no longer operates independently. It has recently become dependent on the multibillion-dollar drug industry that you thought it was policing.

The Food and Drug Administration probably has your trust. Because it is FDA approved, you believe that pill you’ve been given is safe. You know this because the FDA is an impartial watchdog set up to keep you informed. It protects you from an aggressive industry that would otherwise put profits ahead of your health. Right? Not anymore.

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With virtually no public debate, Congress has passed a law that dramatically increases the FDA’s dependence on large drug companies for its funding. It’s an expansion of a law passed in 1992 intended to speed up the approval process for new AIDS medications.

The emergency now is of a different sort. The FDA was running out of money to keep these new employees. Going before Congress and asking for more money amidst a war on terrorism was going to be a tough fight. The drug companies offered an easier solution. Negotiate a deal in secret, attach it to the widely popular bioterrorism bill, and they would pay for the new employees and more.

* The Fence between the Fox and the Hen Is Getting Harder to Find *

The details of discussions leading to this “solution” were never made public. According to The Washington Post, “The program was crafted in private meetings between the industry and the FDA, was never debated or voted on in either chamber before going to the negotiators, and is moving forward before a General Accounting Office review of the current program can be finished and made public.

“… The user fees from pharmaceutical and biotechnology companies would add almost 500 employees to the FDA centers that review proposed new drugs … bringing the FDA workforce funded by industry to at least 1530. That would constitute more than 55 percent of the FDA staff involved in reviewing drug applications.”

How much money are we talking about? 1.2 billion dollars over the next five years.

I don’t know what this General Accounting Office report will say about how well the public has faired under the current smaller program of drug company support of the FDA’s drug approval process. If I were writing it ….

? Over the last 10 years, the FDA has approved nine drugs that proved to have deadly side effects forcing their withdrawal under multiple lawsuits from the families of victims.

• The Journal of the American Medical Association estimates that 125,000 Americans continue to die each year from the side effects of FDA approved drugs.

• The FDA approved the sale of Baycol later found to cause fatal rhabdomyolysis and continues to approve the use of other “statin drugs” to lower cholesterol also associated with this deadly side effect. (Members were warned of this in Health Alert 4)

• The FDA has used its muscle (beefed-up by drug company funds) to aggressively suppress natural alternatives to drugs. In 2001, for instance, the FDA sided with Merck, the manufacturer of Mevacor and began enforcing a ban on the sale of red yeast rice in the US. Red yeast rice is a safe natural alternative to cholesterol lowering drugs like Mevacor.

* What You Can Do Now *

1) Write your congressional representative. Tell him you have concerns over Drug Company funding of the FDA without public debate.

2) The next time you are offered a drug, ask questions. Why do I have to take it? Are there alternatives? What are the side effects? How can I get more information?

3) Keep reading Health Alerts. Gradually you will learn more and more alternatives to drugs. Keep yourself healthy and you will be less dependent on a suspect drug approval process.

In your next letter, you will learn how to use your most powerful health insurance policy.

Al Sears, MD