Greetings,
The FDA is strongly considering banning the use of estriol, a naturally occurring estrogen, by compounding pharmacies. The latest “concern” was prompted by Wyeth Labs, maker of Premarin and Prempro, currently collaborating with the FDA on this initiative. A few weeks ago, the FDA asserted that estriol is not a safe alternative to the synthetic hormones made by Wyeth. This is ridiculous. This (compounded) estriol is exactly the same as the estriol produced in abundance in the female body, especially during pregnancy. (Neither Premarin nor Prempro is naturally occurring in the female human body! Provera, the synthetic progestin found in Prempro, isn’t found anywhere in nature!) Estriol has been used in Europe and Japan safely for hormone replacement for many years.
Part of Wyeth’s issue is that the FDA doesn’t regulate the individual hormonal compounds created by pharmacists for a woman’s specific needs. And, to date, the FDA hasn’t tested estriol or approved it for use by pharmaceutical companies. (The reason for this is that hormones such as bio-identical estriol, estradiol, and progesterone, are naturally occurring. They cannot be patented. And so drug companies can’t make money on them.) These hormones, however, have been part of the U.S. Pharmacopeia for decades. In other words, they ARE approved by the FDA for physicians and pharmacists to use!
Typically, drug trials are conducted so that patients can be informed about a drug’s safety, efficacy, and side effects before it can be marketed in the U.S. The FDA and Wyeth are using this as an excuse to scare women into thinking that they will put their health in jeopardy by using any kind of hormone replacement, linking bio-identical hormones with the negative results seen when Premarin was studied as part of the Women’s Health Initiative. But research and years of clinical use have already found that estriol is safe and effective! (To review some of it, visit www.womeninbalance.org.)
I feel very strongly about the use of bio-identical hormones, as you know. And I don’t want the FDA to ban estriol, because once they do this, they’ll start in on bio-identical progesterone, estradiol, and testosterone as well. Then, when women need hormonal support, all they will be left with are synthetic substitutes that are less effective and also more dangerous! Women deserve the right to the best treatment possible. And that treatment is often based on the wisdom of Mother Nature, not father pharmaceutical.
If this is an important issue to you too, please let your Congressman know. You can email your concerns to him or her easily by going to www.projectfans.org. There’s even a sample letter you can use, so making yourself heard will only take a few moments.
Here’s to our health and freedom to choose what’s right for our bodies,
Christiane Northrup, M.D.
