Bioidentical Estriol Still Under Threat

Nurses in Oregon may soon lose their ability to prescribe estriol, the safe and effective bioidentical estrogen hormone. Meanwhile, an FDA-approved menopause drug is killing women at twice the usual mortality rate.

A new study published in the Journal of the American Medical Association (JAMA) shows that women who take the synthetic estrogen replacement product Prempro^®—a combination of a potent estrogen derived from pregnant mares’ urine and a synthetic progestin—are twice as likely to die from breast cancer. (This confirms the research we reported to you in 2008.) This month’s Archives of Internal Medicine shows that women taking Prempro^® or Premarin^® are also 21% more likely to develop kidney stones over five years. A study published last year in The Lancet showed that Prempro^® raises the number of lung cancer deaths. And the government-sponsored Women’s Health Initiative study was halted in July 2002 because long-term Prempro use was found to raise the risk of breast cancer, heart attack, and stroke.
Despite these manifold dangers, and despite the fact that the FDA has been unable to substantiate a single adverse event for estriol, the FDA is still working diligently behind the scenes to remove it from the market. This makes no sense to anyone other than those making a profit from the synthetic, dangerous alternatives to estriol—the same drug companies which have enjoyed large profits while keeping their competition (estriol) at bay.
The Oregon State Board of Nursing will meet on November 18 to finalize draft changes to the Nurse Practice Act, which as currently drafted will restrict nurses’ ability to prescribe non-FDA-approved drugs. This includes estriol and, we believe, is specifically designed to remove all access to estriol.
Keep in mind, as we often point out, that FDA approval costs an average of $1 billion, and nobody will pay that for non-patentable substances including estriol. So to keep repeating that only FDA-approved drugs are safe or effective is total nonsense.
Estriol is naturally occurring and is a part of every human body. This bioidentical estrogen is approved in Europe for treatment of menopause, and is the standard of care in most of the developed world. It is the weakest estrogen and generally accepted to be the safest estrogen treatment. But because it cannot be patented and it is not as profitable as synthetic alternatives, US drug companies have not taken it through the FDA’s drug approval process.
We are asking residents of Oregon to take action by emailing the Nursing Board and telling them to allow nurses to continue to prescribe estriol. We are also asking our members in other states to let us know if there are similar processes pending in any other states.
The attack on bioidentical hormone replacement therapy all started with a petition from the drug giant Wyeth (since bought by Pfizer) to ban estriol, a natural form of their synthetic drug, from the market. Ironically, when it filed the petition Wyeth was marketing its version of estriol in Europe as the “ideal therapy” for women.  The FDA seemed to grant the petition, but then backpedaled in part because of the huge public outcry as we got the word out about this latest blatant example of crony capitalism. Efforts were made to shut down compounding pharmacy sales and to threaten doctors who prescribed estriol, then largely abandoned it in favor of a so-called public awareness campaign about the risks and benefits of hormone therapy for the treatment of menopausal symptoms and other conditions.
As we told you in August, an oral Multiple Sclerosis drug that contains estriol, Trimesta, is currently undergoing FDA trials. If Trimesta is approved, some of our concerns go away, because it would then be a component of an FDA-approved drug. But it could take years for Trimesta to make its way through the process, and approval is by no means certain.