FDA’s Ridiculous Stand on Bioidentical Hormones

Ever since the Journal of the American Medical Association (JAMA) reported on the dangers of conventional hormone replacement therapy (HRT) in the July 17, 2002 issue of the journal, women have been scrambling to find a safer, yet still effective treatment for menopause symptoms.

In case you are not familiar with the study, JAMA reported on the findings from one part of the Women’s Health Initiative, an 8.5 year project funded by the National Institutes of Health. According to the findings, menopausal women taking estrogen/progestin for five years or more had an increased risk for blood clots, coronary heart disease, strokes, and breast cancer. In fact, researchers felt so strongly about the negative implications of long-term combined HRT, especially the unacceptably high risk for breast cancer, that they ended the study three years early! Participants were contacted and instructed to stop taking the drug—immediately.

As you can imagine, the pharmaceutical companies have been in a panic ever since, as hundreds of thousands of women have stopped taking their medication and look to natural medicine for answers…answers that many have found in bioidentical hormones.

Dr. Lark has written about and prescribed bioidentical hormones for more than 20 years. In fact, in our book Hormone Revolution, we have devoted several pages to the topic. And when it comes to using bioidentical hormones to treat menopause symptoms such as night sweats, hot flashes, and other signs of menopause, the most commonly prescribed hormone is estriol.

Given the sudden drought in conventional HRT usage (and therefore loss of money to pharmaceutical companies), as well as the increased interest and media attention surrounding the usage and efficacy of bioidentical hormones—namely estriol—it shouldn’t come as a surprise that the FDA is now cracking down on these natural options.

According to the FDA’s Web site, the “use of ‘bio-identical’ as a marketing term implying a benefit for the drug, for which there is no medical or scientific basis.” They even go so far as to state that estriol “is not a component of an FDA-approved drug and has not been proven safe and effective for any use.”

This is simply ridiculous and just plain outrageous. Estriol is the weakest, and therefore safest, of your three main types of estrogen. It has been studied in various animal and human studies and has been shown to be less likely to promote excessive tissue growth, and even helps prevent breast and endometrial cancers.

To me, that seems to contradict the “not been proven safe” part of the FDA’s statement. And, as for the “not been proven effective for any use,” I cannot help but wonder if the FDA is familiar with the JAMA study that found that estriol was particularly effective in treating vaginal atrophy, mood swings, and hot flashes. Or, how about study from Alternative Medicine Review, which found that estriol provided the protection of conventional hormone replacement therapy without the risks. Plus, estriol was found to ease menopause symptoms, including hot flashes, insomnia, vaginal dryness, and urinary tract infections.

Don’t be fooled by the FDA’s “concerns.” Sadly, in this arena, their main concern seems to be with the pharmaceutical company’s checkbooks, not your health. Keep yourself informed by reading blogs, newsletters, and informative emails from trusted sources and doing research for yourself. And fight for your right to natural alternatives to all your health concerns.