Throughout its 26-year history, the Life Extension Foundation has worked tirelessly to educate the public about novel, scientifically supported ways to prevent the diseases of aging and to halt and even reverse the aging process itself. As part of this mission, Life Extension has relentlessly challenged the FDA, drug companies, and others who would limit or abolish access to these lifesaving therapies.

Today, one of the world's largest drugmakers is asking the FDA to deny Americans access to bioidentical hormone replacement drugs. As Life Extension readers know, levels of life-sustaining hormones plummet in aging adults. The debilitating health effects of depleted hormones are perhaps most acutely felt by women undergoing menopause. Restoring these essential hormones to youthful levels confers health benefits to aging women and men alike, including relief from depression, insomnia, and other miseries associated with hormone deficiencies, such as migraine headaches, low energy, low libido, and mental fatigue.1-3

Last fall, multibillion-dollar drug giant Wyeth Pharmaceuticals—the manufacturer of the hormone replacement drugs Premarin® and Prempro®—filed a “citizen's petition” with the FDA, asking the agency to deny consumers access to compounded bioidentical hormones. Prepared by compounding pharmacies and available only under a doctor's prescription, these custom-made preparations combine individualized doses of hormones that are chemically identical to those found in the human body. Bioidentical hormone replacement therapy has soared in popularity in the last four years, after a landmark government study found that Wyeth's Premarin® and Prempro® drugs pose grave health risks to menopausal women.4,5

FDA approval of Wyeth's request would jeopardize access to compounded bio-identical hormone therapies not only for millions of menopausal women, but for all aging adults.6 Since Wyeth filed its petition, the FDA has been buried by an avalanche of more than 40,000 letters and emails, most of them urging the agency to reject the petition and protect Americans' access to compounded bioidentical hormone therapies.7

In this article, we examine this threat to Americans' health freedom, why Wyeth's petition should be rejected, and what you can do to preserve access to life-enhancing bioidentical hormone therapies.

Benefits of Bioidentical Hormone Replacement Therapy

As men and women grow older, their levels of life-sustaining hormones drop precipitously.8 This marked decline has been linked with conditions as varied as hot flashes, diminished libido, and decreased bone mass, among many others.3,9 As more and more studies documenting the dangerous side effects of prescription hormone drugs come to light, aging adults increasingly are seeking safe, effective therapies to achieve optimal hormone balance. In recent years, growing numbers of doctors and patients have turned to bioidentical hormone replacement therapy. In contrast to conventional hormone replacement therapy with drugs such as Premarin® and Prempro®—which contain altered forms of hormones that differ chemically from those naturally found in humans—bioidentical hormone replacement utilizes hormones such as estriol, estrone, estradiol, progesterone, testosterone, dehydroepiandros-terone (DHEA), and pregnenolone that are molecularly identical to those found in humans. Physicians who utilize bioidentical hormone replacement know that each patient has unique needs and thus requires an individualized prescription and treatment regimen. These doctors usually measure their patients’ hormone levels with specific blood tests before recommending an individualized course of therapy. They then write a prescription for the appropriate hormone treatment, which is dispensed by a pharmacy that offers specialized compounding services. Since each patient’s needs are different, the pharmacist freshly prepares each prescription according to the requirements set by the patient’s physician. Bioidentical hormone replacement preparations from a compounding pharmacy have certain advantages and disadvantages compared to conventional hormone drugs. Unlike prescription hormone products such as Premarin®, many compounded products are not covered by health insurance. However, bioidentical formulations can be made without additives and dyes commonly found in conventional, one-size-fits-all prescription drugs. Moreover, the use of compounded hormones allows for specialized, flexible dosing strategies. This is consistent with the most recent FDA Menopause and Hormones Fact Sheet (issued in July 2005), which recommends that menopausal hormone therapy should be used at the lowest doses for the shortest duration needed to achieve treatment goals.10 Christopher Turf is a registered pharmacist who serves as director of compounding and medical outreach for Pharmaca Integrative Pharmacy, a national chain of pharmacies based in Boulder, CO. In an interview with Life Extension, Turf noted, “Several hundred thousand women use compounded hormones every day. Many have previously used manufactured hormone products, but found that they were inadequate, because they did not control symptoms effectively or had unacceptable side effects. Women seem to need very specific doses of hormones that cannot always be met by conventional hormone replacement therapy products. When the patient, doctor, and pharmacist work together to find the precise blend of compounded hormones that a patient needs, the results are tremendously successful.”

Wyeth's Response to Falling Sales?

Wyeth is the world's largest manufacturer of prescription meno-pause hormones. In 2002, the massive Women's Health Initiative (WHI) study demonstrated that hormone replacement therapy using the company's menopause drug Premarin® increased the risk of stroke, while treatment with its Prempro® product not only raised stroke risk, but also increased the risk of breast cancer, heart attacks, and blood clots.4,5 As a direct result of the WHI findings, Wyeth saw its revenues from these drugs decline dramatically. Sales of Prempro® and Premphase®, which combine estrogen and progestin, and Premarin®, an estrogen-only pill, fell by more than 57% in just three years, from $2.07 billion in 2001 to $880 million in 2004.11

“Wyeth is the largest manufacturer of animal-derived hormone,” according to Steven Russell, RPh, president and CEO of Medaus Pharmacy, Inc., of Birmingham, AL, one of the leading compounding pharmacies in the country. “What is occurring now is that Wyeth's sales have plummeted over the years, because there has been more of an outcry from the public since the Women's Health Initiative and many physicians have investigated the use of bioidentical hormone therapy.”

In October 2005, Wyeth petitioned the FDA, requesting that it completely ban the bioidentical alternatives that women have been using in ever-increasing numbers to achieve optimal hormone balance. With bioidentical replacement therapy clearly reducing its market share, Wyeth asked the FDA to outlaw all compounded bioidentical hormone formulations that compete with its own discredited drugs. If Wyeth is successful, then menopausal women will have no choice other than to take potentially life-threatening hormone drugs or to forgo hormone replacement therapy altogether, thus enduring the physically and emotionally debilitating effects of menopause-induced hormone depletion.

Russell notes several significant differences between Wyeth's hormone drugs and bioidentical hormones. “First off, Premarin® is a brand-name product derived from pregnant horse urine,” explains Russell. “Bioidentical hormones, on the other hand, are identical to what the human body produces. Premarin® is not identical and has numerous side effects. Bioidentical hormones are non-patented, they can be compounded by a licensed pharmacist, and they are derived from plant sources. The end product is 100% identical to what the ovaries produce, and is usually less expensive than hormone drugs.”