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« Back to Opinion & Analysis
Drug Company Influence at the FDA
Editorial for the Houston Community Newspaper
Steven F. Hotze, M.D.
June 5, 2008
The FDA takes its cues from the pharmaceutical companies which provide it with nearly 30% of its funding, $350 million in this fiscal year alone. The drug companies help fund the FDA by paying drug user fees on any drugs that the FDA approves.
The FDA is dependent upon the sale of drugs for a major portion of its income. Whose interests do you think the FDA will protect, yours or the drug companies'?
Wyeth manufactures Premarin and Prempro, counterfeit hormones derived from pregnant mares' urine. These drugs were studied in the Women's Health Initiative which was abruptly halted in 2002 when they were shown to increase the risk of breast cancer, heart disease, blood clots to the lungs and strokes. Hundreds of thousands of women abandoned Premarin and Prempro causing a dramatic decline in sales for Wyeth amounting to over $500 million per year. This translated into a decline in fees paid by Wyeth to the FDA.
Many women sought a safer, natural alternative in bio-identical hormones, prescribed by their physicians and prepared by their local community pharmacists. A key ingredient in this compounded preparation was the natural female hormone Estriol, which is produced in every woman beginning at puberty and enables women to develop their menstrual cycles. Estriol has been used by physicians for decades to treat problems associated with peri and post menopausal symptoms. There has never been any adverse event reported to the FDA related to the use of Estriol.
In an apparent attempt to destroy its competition, Wyeth filed a "citizen complaint" with the FDA in 2005 asking the agency to ban the use of Estriol. Over 70,000 patients filed responses with the FDA opposing Wyeth's attempt to undermine their right to choose natural solutions for their health problems by restricting the use of Estriol. These patients do not believe that some bureaucrat in Washington knows better than their physician as to what medication is best for them.
In January of this year the FDA issued a policy guideline supporting Wyeth's request for banning the sale of Estriol to community pharmacies which compound preparations. This is another step in the FDA's attempt to destroy the practice of compounding pharmacy which is regulated by the respective state boards of pharmacy.
A battle for patients', pharmacists' and physicians' rights has begun in earnest in Congress. Texas Congressmen Burgess, Carter, Hall, McCaul, Paul, and Thornberry, among others, have introduced House Concurrent Resolution (H. Con. Res.) 342 in Congress which calls upon the FDA to lift its ban on Estriol.
Senator John Cornyn - (R-Texas) has also agreed to sponsor this resolution in the U.S. Senate.
The FDA must not be allowed to be used by drug companies in their plan to destroy the health rights of millions of Americans who choose the benefits of natural bio-identical hormones and other compounded preparations as an alternative to drugs promoted by Big Pharma.
Go to www.projectfans.org to learn more about this issue, and what actions you can take to protect your rights.
About Conservative Republicans of Texas
Steven F. Hotze, M.D. is president of Conservative Republicans of Texas and founder of Hotze Health & Wellness Center in Houston, Texas.
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