Will Wyeth Bully You Out of Your Estriol Cream?

The FDA has begun 2008 by forbidding compounding pharmacists to use estriol in their natural hormone formulations because the agency doesn’t have a specified approved use for it. They took this action because Wyeth complained about it.

In case you’ve forgotten, Wyeth is the giant pharmaceutical company that makes Premarin and PremPro, synthetic hormones found to cause heart disease, strokes and cancer. If we do some rough calculations based on statistics from the Women’s Health Initiative (WHI), Wyeth’s hormone replacement drugs have killed tens of thousands of women over the past few decades. Sales of these dangerous drugs have plummeted since the WHI results were announced, and women who were injured by them and sued, are winning millions in damages in courtrooms around the U.S. (You go girls!)

Estriol is a Safe Alternative
Estriol, on the other hand, is a mild (natural) estrogen that’s primarily used in cream form for vaginal dryness and urinary tract problems in menopausal women. It’s been in common use in Europe for well over a decade, and its safety and effectiveness are well established. Many doctors in the U.S. who use natural hormones prescribe tri-est and bi-est, estrogen cream formulations made by compounding pharmacies that contain estriol. These formulations appear to be what Wyeth perceives as its competition. If you'd like to know more about estriol, Dr. David Zava wrote an entire chapter on it in What Your Doctor May Not Tell You about Breast Cancer.

The doctors and pharmacists can take the estriol out of the formulas and they’ll still work well because they also contain estradiol, but ironically they probably won’t be quite as safe. Estriol may have some protective properties that balance estradiol’s cancer-promoting effects. In fact, estriol is so safe that it’s the primary estrogen of pregnancy—the fetus is bathed in it.

The Bully in the Neighborhood
It’s shameful of Wyeth to use its clout and money to bully and beat on the competition through the FDA, but by now we expect that behavior from them. The real shame is that the FDA can’t seem to stop itself from being bullied. You can bet there was some major arm twisting going on to push the FDA into this action, because they just have to know that it's been proven safe and effective in Europe, and that thousands of annoyed menopausal women are going to be sending them e-mails. We can only hope that the FDA responds by quickly reviewing the body of excellent research available on estriol and taking action to assign it some specific and approved uses.

Many for profit and nonprofit groups interested in defending a womens' right to use estriol are putting together a unified message to send to the FDA. If they call for a petition I'll be sure to let you know.

In the meantime, if big bad Wyeth succeeds in taking your estriol away, and you can’t have sex because of vaginal dryness, send your partner to Washington to march on the FDA’s doorstep. Just kidding. This is an especially poignant issue for women with breast cancer or who have had breast cancer, because estriol is a safe alternative to estradiol. The estrogen-blocking drugs such as tamoxifen that are used to treat breast cancer can cause terrible vaginal dryness and urinary tract problems, and even without the drugs, these are serious problems for many menopausal women.

Estradiol cream is an effective, albeit less safe, treatment for vaginal dryness and urinary tract problems. Please use the lowest dose possible that relieves symptoms and use progesterone cream for balance. For details I recommend that you read Hormone Balance Made Simple.