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.
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.”