FDA Extends Comment Period on Bid to Ban Natural Hormones

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The FDA has extended the comment period on the Citizens Complaint filed by pharmaceutical giant Wyeth (Docket: 2005P-0411) against the sale of natural hormones ("bioidentical") by special pharmacists. Wyeth filed their complaint in October, 2006 claiming that both the bio identical hormones and the pharmacisits who filled the customized prescriptions posed a health hazard. After receiving 37,000 written responses, the FDA will accept comments until May 4, 2006.

The FDA announced that it would allow comments on the Citizens Complaint against bio identical hormones until May 4, 2006 although the original comment period expired on April 4, 2006. Wyeth filed their complaint (Docket: 2005P-0411) on October 6, 2006 asking the FDA to impose significant restrictions on consumer’s access to bio identical hormones. These natural molecules are prescribed by physicians in amounts and delivery systems which are customized to the need of each patient. The prescription is then filled by special pharmacists who are trained in the compounding of these individualized formulations.

Comments may be sent to the FDA at http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=3356.

Consumers, compounding pharmacists, physicians practicing bio identical and health freedom advocates are up in arms over this action by Wyeth. States, not the federal government have jurisdiction over compounding pharmacies. Health freedom advocates characterize Wyeth's move as seeking an extension of federal power on its behalf and attempting to eliminate a competitor in a failing market.

Health freedom advocates also fear that this is merely another step in the restriction of the consumer's right to make their own health choices whether or not they add to the pharmaceutical or medical coffers. Physicians and patients who have experienced the benefit of bio identical hormones fear that they will loose a powerful, gentle and effective option to drugs when they need to replace and regulate their hormone levels. During the final days of the comment period, the traffic was so heavy that the FDA's electronic comment system was reportedly overwhelmed.

Hormones are biologically active molecules which have body-wide effects at very low concentrations. Women's bodies make reproductive hormones throughout their reproductive lives but the levels fall sharply, changing their balance, during and after menopause. Natural hormones cannot be patented because they occur in nature so they are less expensive than prescription drugs despite the effort involved in compounding them individually. Synthetic and conjugated hormones, on the other hand, are patented and thus carry a higher cost to cover the expenses involved in developing and marketing the drug.

Small changes in molecules which render them patentable may also render them toxic or difficult for the body to process. Hormone receptors and enzymes are powerfully impacted by slight differences in molecules and many women find that their bodies react with difficulty to altered molecules leading to increased side effects and dangerous consequences to synthetic hormones. Bio identical hormones are exactly like the ones that a woman's body has processed over the years of her reproductive life and, when customized for her individual needs, are often accepted by the body with little or no discomfort and, supporters believe, without the risks posed by pharmaceutical, patented hormones. The long-term safety of the use of bio identical hormone replacement therapy for more than five years has not been established although several smaller studies reported positive results without adverse outcomes (http://www.consciousliving.net.au/articles.htm?74&PHPSESSID=e02c491567b54227173e785227262ef7).

Hormone replacement therapy (HRT) is frequently prescribed for women to alleviate symptoms associated with menopause (hot flashes, night sweats, memory problem, mood changes, wrinkles, weight gain, etc.) and to prevent serious diseases (breast, colorectal and uterine cancer, heart disease, senility, osteoporosis, strokes, etc.).

HRT was studied by the NIH because of its anticipated benefits in over 161,000 women in a large 15 year study which began in 1991. The study, called the Women’s' Health Initiative (WHI) was an observational study designed to examine the effects of Premarin (conjugated estrogen derived from PREgnant MARes' urINe) or Prempro (Premarin plus synthetic progesterone or"progestin"). Because the WHI found that the women taking either Premarin or Prempro we at increased risk of breast and colorectal cancer, stroke, blood clots, heart disease, osteoporosis and a host of other serious disease, the study was halted years early (May, 2003) and women in the study who were taking either Premarin or Prempro received letters telling them to stop the medication. Wyeth provided both Premarin and Prempro to the WHI although it was not involved in the analysis or conclusions of the study.

Critics of Wyeth's challenge to bio identical hormones contend that the action is designed to bolster flagging sales of the "Premarin family" of drugs. According to Wyeth (http://wyeth.com), profits for the synthetic hormones declined by 68% between 2002 and 2004 ($2,072,000,000 in 2002, $1,275,000,000 in 2003, $880,000,000 in 2004).

Total profits for Wyeth in the same period have declined by 72% (2002:$4,447,000,000; 2003:$2,051,192,000; 2004: $1,234,000,000).

Since the only significant non pharmaceutical competitor for the HRT prescription dollar is bio identical hormones, industry watchers link the move with an attempt to regain lost sales and profits. L. D. King, Executive Director of the International Association of Compounding Pharmacists, a professional association of special pharmacists notes, "Wyeth's aims are clear: to restrict the ability of physicians to prescribe and patients to use customized BHRT following studies that have raised serious health concerns with the company's own products," (http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/10-27-2005/0004197725&EDATE=)

Wyeth maintains that its actions are motivated by concerns about the safety of the natural substances and the way the prescriptions for them are filled. In its complaint it alleges that compounding pharmacists state that natural hormones are safer than synthetic, patented ones and that some have been "illegally" mass produced, rather than individually compounded. Wyeth also asks the FDA to regulate compounding pharmacists although they are regulated by the states, not by the federal government. (Supreme Court Decision - Thompson et al. v. Western States Medical Center et al., U.S. Supreme Court Case No. 01-344, Decided April 29, 2002m http://www.fda.gov/cder/pharmcomp/supremeCourt.pdf.)

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Rima Laibow, MD
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