Is the FDA looking out for Women or Wyeth? A Physician’s Point of View
I recently had an opportunity to interview Dr. Marsha Nunley, a San Francisco-based physician, about bioidentical hormone replacement therapy and her opinion about the FDA’s recent action against certain compounding pharmacies. She made several compelling points that I want to share with you on this blog.
Dr. Nunley is the medical director of Optimum Health, a new, integrative medicine practice in San Francisco, that is focused on prevention, wellness and lifestyle interventions. Previously, she served as Medical Director of the Women’s Health Resource Center at the California Pacific Medical Center in San Francisco. In addition to her board certifications in Internal Medicine, Geriatric Medicine and Hospice and Palliative Medicine, Dr. Nunley completed an Associate Fellowship with Dr. Andrew Weil at the University of Arizona.
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Q. Are Bioidentical hormones safer and more effective than FDA approved hormone therapy drugs?
No, but synthetic hormones, such as premarin, provera, etc. are clearly NOT safe. I no longer prescribe these to women because I believe the data is clear that they are dangerous for women.
Q. Have there been any definitive studies showing the safety and efficacy of bioidentical hormones?
Bioidentical hormones are substances found in nature and therefore cannot be patented so no company stands to get rich from them unlike the synthetic hormones. Also, since most drug research is funded by pharmaceutical companies, no one is willing to finance large scale studies. There are a number of studies in Europe but there are no clear randomized trials to document the safety of Bioidentical HRT and it is not likely that there will be.
Q. I’ve read that bioidentical hormone therapy can prevent or even cure heart disease, Alzheimer’s and breast cancer. Is there any truth to this?
No, however there are a number of studies that show that estrogen deficiency may be associated with a number of chronic conditions including these. Again, no studies that replacement will change this but some do show benefit. What the FDA doesn’t say is that synthetic estrogen and progestins (not progesterone – they are different) are definitely associated with increased risk for blood clots, cardiovascular disease and breast cancer. The synthetic estrogens and progestins are not the same as the bio- identical hormones but they are referred to in the literature as if they are interchangeable. The biochemical structure is clearly different and would not necessarily be expected to have the same biochemical effect and could certainly have unexpected effects.
Q. Is the estriol found in bio-identical hormones safer than FDA approved estrogen products?
Estriol is a very weak estrogen and is biochemically an end metabolite of estrogen. This means that when estradiol (the most potent) is metabolized and it gets to estriol, it is done. The metabolites of estradiol are strone and estriol and estrone is metabolized to possible carcinogenic metabolites. There are studies that show that women with higher estriol levels have a lower incidence of breast cancer and women with breast cancer with higher estriol levels do better. Estriol has been used extensively in Europe for years and is currently being used in a study of Multiple Sclerosis in the U.S. and there are no untoward side effects and the study is ongoing.
Q. Does this mean that estriol is safe?
No. Again, there are no randomized trials and there are unlikely to be any. Estriol has been around a long time and its use is well supported in medical literature. Estriol has a USP monograph. Congress specifically recognized and approved the use of active ingredients that have a USP monograph as appropriate for use in compounding.
Q. Do you think bioidentical hormone replacement therapy is safe? There are no reports of bad side effects.
We have no long term studies showing that BHRT is safe. Pharmacies are not required to report adverse events. Again there are no long term studies to assess risks associated with bioidentical hormones…BUT we do know that synthetic hormones are dangerous and the FDA continues to support their use.
Q. Can bio-identical hormones be made especially for an individual based on saliva samples? Some doctors believe they are a waste of money.
Saliva testing has tons of data to support its use. It can fluctuate just as serum and urine can, but it is well validated in the literature and can be used to follow a women’s hormonal levels. Who uses saliva testing? Well, NASA in evaluation of astronauts for one and the US Military for another. It is true that it can be difficult to adjust levels based on the numbers, and individual symptom assessment is probably as useful as saliva testing to adjust hormone levels.
Q. What is your opinion about the FDA’s recent action concerning compounding pharmacies?
I believe the FDA is speaking out of both sides of their mouth when they continue to allow Wyeth to produce and prescribe drugs that we know are unsafe for women.
The bottom line is the FDA has approved menopausal therapy that causes blood clots, heart attacks, strokes, breast cancer or gall bladder disease.
While there are no convincing data that there is less risk of the above with bio- identicals, there is substantial data that synthetic HRT does increase the risk for all of the above.
See website just recently up…www.optimumhealthsf.com
Unfortunately Deb, your story is not unique. After going through similar problems myself and not being able to find a colleague or doctor who knew how to help, I began looking for solutions outside the lines of traditional medicine. Adrenal fatigue and subsequent sub clinical hypothyroidism is further compounded by the onset of menopause, and even the healthiest and strongest finally succumb. Usually one ends up on antidepressants and or synthetic hormones. My doctor told me that I would probably need to be on antidepressants the “rest of my life”. In my search for solutions, I discovered Functional Medicine. See http://www.functionalmedicine.org
Medicine has become far too reliant on pharmaceuticals to treat our patients. For every problem, there is a medication. But in my 25 years of practice, I have seen many medicines that were billed as the next greatest answer that with time were not only shown to be ineffective, but actually harmful. An article came across my desk this AM that CHANTIX, the antismoking medication released about 2 years ago has been associated with significant neurotoxic and neuropsychatric problems. Vioxx – heart attacks, Premarin – breast cancer and thromboembolic disease, Zelnorm ischemis colitis, (dead bowel), Nifedipine – increased risk for stroke, propulsid – fatal cardiac arrhythmias, and the list goes on and on. I decided that I could no longer in good conscious practice medicine in this way.
The best way to deal with disease is to concentrate on returning us to health by combining the innate wisdom of the body with current and emerging medical science including science that is outside the traditional medical journals such as nutrition. exercise and international journals. We also need to restore government funding for areas of research so that there is money to look into areas other than pharmaceuticals as a solution to diseases.
There are doctors out there. The Functional Medicine Web site lists doctors who have gone through their program and they are in the process of seeking approval to become a sub specialty . Keep looking until you find someone that can help you.
Thanks for your comment, Deb. You’re so fortunate to have found the right doctor and the right combination of medicines. We can’t count on our regular physicians for this kind of guidance. It takes a lot of experimenting, perserverence and in the end, trial and error to find just the right combination (and timing) of drugs (whether they’re natural or synthetic).
Another practitioner you may want to seek out is Saundra McKenna who trained as an MD and now is prescribiung bio-identical hormone solutions.
http://www.saundramckenna.com
In addition to getting sleeplessness and hot flashes under control, she was very helpful in getting thyroid and adrenal functions back in balance. In ten years of seeing endrocrinolgists for thyroid nodules (later diagnosed as Hashimoto’s Disease) no MD had ever bothered to test more than TSH (which always tested “normal” btw) when there are at least 3 other thyroid hormones produced. I was completely out of T3 and my adrenals were shot. I now think this had everything to do with a clinical depression I experienced 2000-2004.
My LA psychopharmacologist never tested more than TSH either and then put me on Synthroid as well as a couple other anti-depressants. I am now off all anti depressants as of August 2005 (which I did very slowly with large doses of Omega- 3 (recommend mail order OmegaBrite by MD on East Coast who wrote a very compelling book about depression and fatty acids) and Saundra had prescribed an herbal adrenal booster called Adapt plus bio-identical T-3 and hydocortisone in very small dosages to give my body a rest so I could then produce them again. It worked! I now need none of those.
She also prescribed bio-identical estrogen and progesterone in sub-lingual form from a NYC based compounding pharmacy. from time to time. I no longer need those so things have evened out. Oh, and I’ve lost the 20-25 lbs that accumulated over the last 7-8 years—I never had a weight problem before.
I think many of these symptoms I experienced were related to changes related to menopause.
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