A coalition of gynecologists, internists, allergists, ER physicians and general practitioners responsible for treating thousands of women today criticized the Food and Drug Administration (FDA) for taking action that threatens to deny hundreds of thousands of women access to customized medications they take for symptoms of menopause.
The FDA last week announced that the hormone estriol can no longer be used in estrogen medications customized for women by compounding pharmacies. Estriol is a component of 90 percent or more of these customized preparations.
The FDA action is in response to a "citizen petition" filed by the giant drug maker Wyeth Pharmaceuticals. Wyeth is the maker of Premarin and Prempro, two hormone treatments for women that have been linked to cancer, heart disease and stroke by the Women's Health Initiative, NIH study. Millions of women have discontinued taking Wyeth's hormone products as a result of the WHI study, which was halted because of the serious health risks that were discovered in 2002.
"The FDA has succumbed to pressure from Wyeth in its attempt to clear the market of safer alternatives to its unsafe products," said Erika Schwartz, M.D., a co-founder of BHI, the Bioidentical Hormone Initiative (
www.bioidenticalhormoneinitiative.org), a not-for-profit medical organization comprised of conventionally trained, practicing physicians who have successfully treated patients with bioidentical hormones for years. "The FDA should protect the interest of women, not the profits of Wyeth."
Estriol has been used by women for decades as a component of customized estrogen hormone drugs, most commonly known as Biest and Triest. It occurs naturally in the human body and, according to the FDA, has never been associated with adverse events or other health and safety issues. Estriol is also in a phase II/III clinical trial pending FDA approval for treating women with Multiple Sclerosis (MS). It is approved for use and widely used in Europe and is a component of medications that have been commercially available in the U.S.
"There is no evidence that anyone has been harmed by estriol," said Kent Holtorf, M.D., also a co-founder of BHI. "The FDA has even admitted that safety concerns are not the reason behind their decision to try to remove estriol from the market. Instead, they are responding to Wyeth's blatant attempt to remove medicines that provide an alternative to their flawed horse hormones that are foreign to a woman's body."
"FDA's actions are clearly misguided," said David Brownstein, M.D., another founder of BHI. "They have no legitimate reason or even the legal authority to limit a licensed physician's use of a safe and effective bioidentical hormone. There are numerous positive studies and countless successful outcomes with estrogen treatments containing estriol."
The FDA claims that it is taking estriol off the market because it is not a component of any FDA approved drug, despite the fact that the hormone has been used for decades without problems. Estriol has a long standing United States Pharmacopoeia monograph, an accepted standard for drug ingredients absent significant health risks. Other common drugs that are not components of FDA approved drugs include aspirin.
"There are no legitimate medical, scientific or legal reasons for the FDA to take this action," said Dr. Schwartz. "It would require countless women to return to their doctors and alter the medications they have used both safely and effectively for years. If the FDA has its way, since estriol is available in Europe, a woman will need a passport, not a prescription to get her medication."
The citizen petition filed by Wyeth with the FDA requested that estriol be removed from the market, along with other requests to remove customized medications that compete with their flawed products. The petition created a tremendous backlash from women, doctors and pharmacists. Over 77,000 comments, a near record, were filed with the FDA in response to the petition, all but a handful opposing Wyeth's request.
"The few comments in support of the Wyeth petition were filed mostly by organizations with substantial financial ties to Wyeth," said Dr. Schwartz. "The FDA has chosen to protect Wyeth's wealth rather than women's health. This is a shameful act for this agency to take."
For more information on the Bioidentical Hormone Initiative, visit
www.bioidenticalhormoneinitiative.org.