Not so fast!
We’re getting close. But we’re not out of the woods yet. The good news is that all women who took a moment to write the FDA to describe their personal experiences with bio-identical hormone replacement therapy (BHRT) have made a huge difference. The bad news is that the FDA still hasn’t torn up Wyeth’s absurd petition.
I tend not to assume the FDA will get it right, but my Magic 8 Ball tells me: “The outlook is good.”
Business – as usual
Imagine a hat shop where all the hats are one-size-fits-all. But right across the street is a shop that carries hats of all sizes. So what are you going to do purchase a hat that may be a terrible fit, or walk across the street for a hat that’s just right for you?
That’s one of the basic differences between pharmaceutical hormone replacement therapy (HRT), and bio-identical HRT. One is designed to treat menopausal women with a one-size-fits-all synthetic treatment, as if all women had the same symptoms and the same hormone levels. The other matches symptoms and hormone levels with the right amount of hormones, derived from estrogen-like plant compounds that are identical to natural hormones in the body.
In the e-Alert “Where’s the Shame?” (2/7/06), I told you about a petition submitted to the FDA by representatives for Wyeth Pharmaceuticals. The petition calls for broad restrictions on bioidentical hormones. This is supposedly a safety issue, but Wyeth just happens to manufacture the synthetic HRT drugs Premarin and Prempro. Bio-identical HRT has become Wyeth’s primary competitor in the wake of numerous studies that have revealed the dangers of synthetic HRT.
Voices being heard
Now for the good news. When the FDA invited comments about Wyeth’s petition, they received well over 2,000 testimonials from women who have used bio-identical hormones with safe and effective results. The response has been impressive enough to extend the deadline for comments. Women now have until May 4, 2006 to submit their personal commentary.
According to an article In Business Week, FDA officials informed Wyeth that they have so far been unable to reach a decision because of “complex issues requiring extensive review and analysis by Agency officials.”
Here’s a sampling of comments received by the FDA, illustrating some of those complex issues:
- “I have been using bio-identical hormones for two years now and it has vastly improved the quality of my life.”
- “My wife has been taking bio-identical hormones for 5 years. Since she went through surgical menopause at a young age, BHRT has been a blessing.”
- “I have been taking bioidentical hormones for more than two years. It has been a tremendous comfort to me as it alleviates a myriad of symptoms associated with perimenopause.”
- “I have been taking bioidentical hormones for approximately 6 months my quality of life is much better on the BHRT than the previous 10+ years that I was on conventional HRT.”
- “I have been taking bio-identical hormones for over 12 years. They have been a tremendous comfort to me as they help to eliminate my hot flashes, and assist with the hormone balance that is so critical in keeping flare-ups from occurring with my CFS and FMS Syndromes. I took Premarin for over ten years. I experienced excessive weight gain and bloating and mood swings.”
- “Without bio-identical hormones, I will suffer agonizing, debilitating migraines several times a month. I did try traditional medications for two years and saw several doctors and a neurologist who specialized in migraines. I found relief from my migraines the first month I used a bio-identical progesterone cream. I have more energy now and rarely suffer from a migraine.”
- “I have been using bio-identical hormones for two years now. I am extremely grateful to these doctors and pharmacists for their knowledge, understanding, guidance and perseverance in helping me to overcome endometrial hyperplasia in a safe, healthy and natural treatment.”
- “We might ask, ‘What will be next?’ We will be told that we cannot take fish oil in place of chemical drugs? Will we be forced to buy drugs to lower cholesterol because oat meal has been declared a ‘banned substance’?”
Time to act
If you’ve used bio-identical HRT and would like to submit a comment to the FDA, you still have more than a week to do so. And it’s easy. You can use the link below, which will direct you to a sample text. Just fill out the form and your message will be e-mailed to the FDA.
Let your voice be heard. And please pass this e-Alert on to any women you know who have stories to share. It’s our best chance to keep this important therapy available and out of the hands of the prescription drug lords.
“Hormone Battle: Big Pharma vs. Small Biz” David E. Gumpert, Business Week, 4/13/06, businessweek.com
“Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs” FDA Docket 2005P-0411, fda.gov