Will the FDA Ban Natural Hormone Treatments?

For the last decade of my young life, I have exhibited some of the many symptoms of Polycystic Ovarian Syndrome (PCOS). Doctors did not know what was wrong with me, but they did feel that I had hormonal imbalances. In 2001, I began taking medroxyprogesterone pills. The medicine did help alleviate many of my health issues, but in late 2006 after five years on the prescription, I started to have terrifying side effects. My heart would pound, I'd feel dizzy, and my heart rate would skyrocket after doing the smallest of physical activities like standing up. My legs were so weak it would take all my strength just to get off the couch. By early 2007, I'd had enough. I quit taking the progesterone pills and my symptoms disappeared.

But the old ones soon came back. I was without health insurance and knew that I had to do something. So I saved my money and visited an endocrinologist who prescribed Metformin. Metformin is designed to regulate blood sugar in diabetics, but for reasons still unclear the drug seems to help balance hormones in women with PCOS. After a month of trying different milligrams of Metformin, I had to give that up too. Maybe it was because my blood sugar was normal, and this diabetic medication threw my sugar off balance, but I was having just as many frightening symptoms with Metformin as I was with the progesterone pills. Every night I would feel like I was going to pass out, my heartbeat was irregular, and I was so dizzy that if I didn't keep my eyes closed I was sure I'd be sick. I talked to two nurses, my doctor, and a pharmacist and all of them told me to discontinue use. They claimed that it would have been normal for me to feel some fatigue and maybe a headache, but my side effects were much too severe to keep taking the drug.

With finances low, still no health coverage, and seeing no more prescription options left, I turned to natural treatments. As of April 2008, I have been using natural progesterone cream. Although it can take several months for natural progesterone to regulate hormones, I am already seeing improvements. Browsing though tons of blogs, sites, and message boards have shown me that many women have also found success with natural progesterone.

Our success may be short-lived if the FDA and the drug company Wyeth get their way. Wyeth, who made billions of dollars on the hormone replacement therapy (HRT) drugs Prempro and Premarin, filed a complaint with the FDA regarding the compounding pharmacies and companies that produce natural progesterone and other bio-identical hormones known as BHRTs. The FDA claims that there hasn't been enough research to show that natural hormones like plant-derived progesterone, which is identical to the produced in humans, is safe.

Most women who buy BHRTs, as well as the doctors who prescribe them, have doubts that Wyeth or the FDA are concerned about women's health. They view the complaints as drug companies trying to eliminate the growing natural health market that has become major competition. After studies revealed that Wyeth's HRT drugs increased the risks of breast cancer, heart attack, and stroke, the company lost billions of dollars in profits. Others see the complaints about bio-identical hormones as the FDA and drugs companies trying to inch ever closer to gaining control of the production of BHRTs. Either way, women who depend on these natural hormones could lose the one thing that helped them overcome their symptoms. L.D. King, the executive director of the International Academy of Compound Pharmacists, told ABC in 2006 that Wyeth's petition would give "a devastating blow to the access women need." He also stated that 38 million prescriptions could be in jeopardy if the FDA or the drug companies succeed.

However, there is hope. Just recently, Congress has asked the FDA to remove the ban it ordered on the use of the bio-identical estriol in hormone therapies. The FDA ordered this ban in 2007 even after admitting that the hormone had no known side effects. This act of Congress is a major accomplishment because if the ban on estriol had continued, bans on other bio-identical hormones like natural progesterone would surely be next. After this blow to the FDA and the drug company Wyeth, it will only be a matter of time before they find other ways to take over the natural hormone market. If you are interested in protecting rights to use BHRTs and you hear of new strategies to go after compounding pharmacies or natural hormone companies, be sure to write to your congressmen and the FDA.