Health Freedom Under Attack!August 2006
By Dave Tuttle
New Heights of Hypocrisy
Wyeth and its lawyers submitted a citizen's petition seeking FDA actions to counter what Wyeth calls “flagrant violations of the law by pharmacies compounding bioidentical hormone replacement therapy drugs that endanger public health.”12 Wyeth's attorneys went out of their way to produce a document that appears reasonable on the surface. Who, after all, would oppose restrictions on drugs that endanger the public health? However, a review of Wyeth's petition shows that the company's arguments do not hold up under scrutiny.
According to Wyeth, American women are being duped by compounding pharmacies, which do not put the same “black box” warnings required for Wyeth's drugs on the labels of their compounded bioidentical hormone formulations. Wyeth maintains that these pharmacies allegedly violate the law by not informing women that all estrogen-containing hormone therapies present the same health risks. Wyeth further maintains that compounding pharmacies even advertise the availability of bioidentical hormone alternatives, resulting in the illegal “manufacture” of these “drugs” in violation of FDA rules for pharmaceuticals. Wyeth also claims that these bioidentical products are misbranded and adulterated. In its petition, Wyeth states that “the public interest requires that this activity, which is putting women's health and safety at risk, be stopped.”12
The Wyeth petition then requests that the FDA initiate enforcement actions in the form of seizures, injunctions, and/or warning letters against the offending compounding pharmacies. It demands that a package insert be included with each product sold, informing consumers that bioidentical hormone replacement products are drugs that lack FDA approval, are not manufactured in accordance with FDA requirements, and have not been demonstrated to be safe or effective for any use, or to be safer or more effective than FDA-approved hormone therapy products (such as Premarin® and Prempro®).
In addition, the petition demands that this package insert be mailed retroactively to all physicians and consumers who have prescribed or used bioidentical hormone replacement therapies in the previous 12 months. Wyeth's petition also requests that the FDA issue an alert or paper outlining the new regulations, including the stipulation that health care professionals and pharmacies can lawfully compound hormone replacement formulas only when a patient's needs cannot be met by an FDA-approved hormone therapy product.12
Remarkably, the Wyeth petition was endorsed by 11 non-profit health organizations, including the National Black Women's Health Project, the National Association of Nurse Practitioners in Women's Health, the North American Menopause Society, and the Society for Women's Health Research.13 While these various groups purport to represent the public interest, a telling analysis by the International Academy of Compounding Pharmacists suggests they may be more concerned with their own financial interests.14 In fact, all these groups have financial or professional ties to Wyeth. The National Black Women's Health Project, for example, has received sponsorship money from Wyeth for various events.15 The president and CEO of the National Association of Nurse Practitioners in Women's Health serves on both the Wyeth advisory board and its speakers' bureau.16 Wyeth underwrites three separate North American Menopause Society award programs for physicians and nurses,17 and serves as a member of the corporate advisory council for the Society for Women's Health Research.18
According to Eldred Taylor, MD, assistant clinical professor of OB/GYN at Emory University and director of the Women's Wellness Group, “Wyeth has all these organizations backing them that are financially supported by them. It looks impressive, but most of the members are financially tied to these people—so the only motive they have is maintaining that financial source.”
By contrast, members of the public without any financial ties to Wyeth—including thousands of women with first-hand experience using bioidentical hormone replacement therapy during menopause—have deluged the FDA with more than 40,000 comments on the petition. The vast majority of these letters and email messages submitted through the agency's website vehemently oppose the proposed restrictions.7,19 The FDA recently told Wyeth that it will need more than six months to review and respond to both the petition and the public comments it has received.
More Problems with Wyeth's Petition
While many Americans have contributed thoughtful critiques of the Wyeth petition, one of the most detailed, legally supported rebuttals was authored by the International Academy of Compounding Pharmacists (IACP).14 Apart from its flawed reasoning, Wyeth's request appears to be unlawful on its face, since by law, citizen's petitions cannot be used to request FDA enforcement actions such as seizures and injunctions.20 The FDA could therefore deny the petition on these grounds. However, the IACP critique demolishes Wyeth's arguments one by one.
For example, Wyeth's petition invokes statutory provisions that the FDA has never indicated apply to compounding pharmacies. As a result, the company's attempt to apply regulations designed for off-the-shelf, one-size-fits-all pharmaceuticals to the practice of compounding custom-made medications would, as the federal government and Supreme Court have already acknowledged, effectively deny patients access to these medications. That, of course, is Wyeth's intention.
Wyeth's petition suggests that compounding pharmacies are selling bioidentical hormone products directly to ignorant patients. The petition even states that the pharmacies “are simply trying to dupe an unsuspecting patient population.”12 Conveniently ignored is the fact that a licensed medical doctor must write a prescription for a patient to obtain a bioidentical hormone formulation, just as a doctor does when he or she prescribes Prempro®.
According to Wyeth, pharmacies that compound bioidentical hormone formulations are somehow involved in “manufacturing,” and must therefore be brought under FDA jurisdiction. However, bioidentical hormone preparations are customized for each patient—there is no wholesale manufacturing involved, as is implied by the Wyeth petition. Wyeth also suggests that anyone who advertises their services in compounding hormones must therefore be a manufacturer. The Supreme Court has already reviewed this issue, concluding in 2002 that the First Amendment precludes the FDA from using advertising as a factor in its regulations.21 This decision protected the right of pharmacies to advertise the availability of their compounding services. Pharmacies would be “manufacturing” only if they produced large batches of standardized hormone preparations for sale to the public, which they do not.
As if this were not enough, Wyeth's arguments grow even more curious. On the one hand, the company asserts that its drug Premarin®—which is derived from the urine of pregnant mares—is unique and unable to be copied generically.
For more than a decade, Wyeth has fended off generic competition to Premarin® by claiming that an unknown compound found only in horse urine might be a “concomitant component” that is partially responsible for its effectiveness.14 Incredibly, the FDA has accepted this “secret ingredient” argument. At the same time, Wyeth claims that all estrogen drugs hold the same risks and must therefore carry the same black box warnings and other package inserts.
In fact, not all estrogen preparations are alike. By petitioning that all estrogen drugs should carry black box warning labels, Wyeth is essentially implying that the findings of the Women's Health Initiative study apply to all estrogen-based therapies, including bioidentical hormone preparations. In fact, the WHI study examined only Wyeth's products—and not bioidentical hormone replacement therapies.4,5
Moreover, the study was halted in 2002 after the data conclusively demonstrated that using Premarin® (conjugated estrogen) raised stroke risk, while the use of Prempro® (Premarin® plus synthetic progesterone) elevated risk for stroke, breast cancer, heart attacks, and blood clots.4,5 The FDA's own record suggests that if use of a natural product presented even a fraction of these risks, the product would be taken off the market in the blink of an eye. Four years after the WHI study exposed the potentially lethal side effects of Wyeth's hormone products, these dangerous drugs are still widely used.
The FDA's ruling on the Wyeth petition will have wide implications not only for compounding pharmacies, but also for millions of aging women and men who recognize the important role that customized hormone formulations can play in enhancing health and alleviating the effects of aging.
To date, bioidentical hormone replacement has not demonstrated the same health dangers that the WHI study attributed to Wyeth's hormone drugs. While bioidentical hormone therapies have not been subjected to randomized, prospective clinical trials to assess their risks, many doctors and patients are convinced that bioidentical hormones are both safer and more effective than hormone drugs, since they contain hormones that are identical to those found naturally in the human body. Many women who commented on the Wyeth petition felt compelled to share personal stories about how bioidentical hormones helped alleviate their menopausal symptoms and greatly improved the quality of their lives.
As Dr. Taylor of Emory University points out, “I don't need a double-blind study to simply bring hormones back to their normal levels. We know what progesterone does to the body. We don't have to prove what a bioidentical hormone does, because it is not foreign to the body.”
Until conclusive scientific evidence demonstrates that bioidentical hormones carry the same risks as commercial hormone drugs, the FDA should reject Wyeth's request that bioidentical hormone formulations carry the same warnings required of its own disease-inducing drugs. Furthermore, given the wealth of clinical and anecdotal studies demonstrating the life-enhancing benefits of optimal hormone balance,1-3 ensuring that Americans continue to have access to compounded bioidentical hormones should be a top priority for all who seek optimal health and well-being.
1. Head KA. Estriol: safety and efficacy. Altern Med Rev. 1998 Apr;3(2):101-13.
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4. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women’s Health Initiative randomized controlled trial. JAMA. 2002 July 17;288(3):321–33.
5. Anderson GL, Limacher M, Assaf AR, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA. 2004 Apr 14;291(14):1701-12.
6. Available at: http://www.medaus.com/ p/208.html. Accessed May 10, 2006.
7. Parker-Pope T. New controversy over menopause hormones. Wall Street Journal. May 6, 2006.
8. Hertoghe T. The “multiple hormone deficiency” theory of aging: is human senescence caused mainly by multiple hormone deficiencies? Ann N Y Acad Sci. 2005 Dec;1057:448-65.
9. Cosman F. The prevention and treatment of osteoporosis: a review. MedGenMed. 2005 May 11;7(2):73.
10. Available at: http://www.fda.gov/womens/ menopause/mht-FS.html. Accessed May 11, 2006.
11. Available at: www.wjla.com/news/stories/ 0406/321139.html. Accessed May 19, 2006.
12. Available at: www.fda.gov/ohrms/dockets/ dockets/05p0411/05p-0411-cp00001-01-vol1.pdf. Accessed April 21, 2006.
13. Available at: www.fda.gov/ohrms/dockets/ dockets/05p0411/05p0411.htm. Accessed April 21, 2006.
14. Available at: www.fda.gov/ohrms/dockets/ dockets/05p0411/05p-0411-c000009-vol1.pdf. Accessed April 21, 2006.
15. Available at: www.blackwomenshealth.org/ site/News2?page=NewsArticl&id=6388&JServSessionIdr011=t2lyv0bu91.app2a. Accessed April 21, 2006.
16. Available at: www.npwh.org/CE-Transdermal/article1.htm. Accessed April 21, 2006.
17. Available at: www.menopause.org/ awards.htm. Accessed April 21, 2006.
18. Available at: http://www.sourcewatch.org/ index.php?title=Society_for_Women’s_Health_Research. Accessed April 21, 2006.
19. Available at: www.fda.gov/ohrms/dockets/ dockets/05p0411/mostrecent.htm. Accessed April 21, 2006.
20. Available at: http://www.cfsan.fda.gov/ ~lrd/FCF10-k5.html. Accessed April 21, 2006.
21. Available at: http://www.oyez.org/oyez/ resource/case/1462/. Accessed May 5, 2006.