October 14, 2013 at 04:48PM Amid the government shutdown, the House did manage to approve some bills -- including one pretty lame one.
If also passed by the Senate, H.R. 3204, the bipartisan bill will increase FDA oversight of compounding pharmacies -- unconventional pharmacies whose products have been linked to dozens of deaths. But even if it becomes law, the new legislation is too limited. It would give Congress oversight of large compounding pharmacies that produce sterile drugs (the failure of a few large manufacturers to guarantee that sterility is what has resulted in at least 64 deaths and prompted the new legislation). The law as written would not protect a different at-risk population: the approximately 33 million American women ages 45 to 59 who are potential consumers of custom-made bioidentical hormone therapy. And that's a problem: MORE magazine's lab testing of these drugs suggests that their quality is so inconsistent that they are potentially dangerous to women's health. (See the October 2013 issue of MORE, page 134). Wulf H. Utian, MD, founder of the North American Menopause Society, reviewed MORE's findings and called them "astounding and terrifying."
Bioidentical hormones, which better match women's chemistry than synthetic hormones like Prempro, are used to treat menopausal symptoms such as hot flashes, vaginal dryness and reduced libido. While bioidentical hormones can be bought in standardized, FDA-approved forms, some women mistakenly believe that they will get better results if their prescriptions are individualized based on the results of blood tests that gauge their exact hormone levels. Often prescribed by anti-aging clinics (and promoted by fans such as Suzanne Somers, who has just published yet another book on the subject) these custom-made drugs are big business: Some compounding pharmacies fill up to 1,500 bioidentical prescriptions a day, with no requirement that they adhere to FDA manufacturing standards.
MORE magazine set out to determine the quality of the bioidentical hormones produced by compounding pharmacies. After obtaining a prescription from a sympathetic doctor, we sent it out to 12 compounding pharmacies and then tested the pills they sent back at Flora Research Laboratories in Grants Pass, Oregon. The lab determined that most of the samples contained more estrogen and less progesterone than prescribed. This hormonal imbalance is dangerous. Progesterone is necessary to prevent estrogen-driven overgrowth in the uterine lining, so an underdose increases users' risk of developing endometrial cancer.
Thousands of women experience serious discomfort before, during and after menopause, and it's easy to understand why they would search for relief, especially since many doctors are not well equipped to help. Yet MORE's testing shows that women are putting their health at risk when they turn to bioidentical hormones manufactured by companies that are not subject to federal standards. And if H.R. 3204 does become law, Congress won't touch the issue of compounding pharmacies again for years, if ever -- leaving women out in the cold with their hot flashes.
If also passed by the Senate, H.R. 3204, the bipartisan bill will increase FDA oversight of compounding pharmacies -- unconventional pharmacies whose products have been linked to dozens of deaths. But even if it becomes law, the new legislation is too limited. It would give Congress oversight of large compounding pharmacies that produce sterile drugs (the failure of a few large manufacturers to guarantee that sterility is what has resulted in at least 64 deaths and prompted the new legislation). The law as written would not protect a different at-risk population: the approximately 33 million American women ages 45 to 59 who are potential consumers of custom-made bioidentical hormone therapy. And that's a problem: MORE magazine's lab testing of these drugs suggests that their quality is so inconsistent that they are potentially dangerous to women's health. (See the October 2013 issue of MORE, page 134). Wulf H. Utian, MD, founder of the North American Menopause Society, reviewed MORE's findings and called them "astounding and terrifying."
Bioidentical hormones, which better match women's chemistry than synthetic hormones like Prempro, are used to treat menopausal symptoms such as hot flashes, vaginal dryness and reduced libido. While bioidentical hormones can be bought in standardized, FDA-approved forms, some women mistakenly believe that they will get better results if their prescriptions are individualized based on the results of blood tests that gauge their exact hormone levels. Often prescribed by anti-aging clinics (and promoted by fans such as Suzanne Somers, who has just published yet another book on the subject) these custom-made drugs are big business: Some compounding pharmacies fill up to 1,500 bioidentical prescriptions a day, with no requirement that they adhere to FDA manufacturing standards.
MORE magazine set out to determine the quality of the bioidentical hormones produced by compounding pharmacies. After obtaining a prescription from a sympathetic doctor, we sent it out to 12 compounding pharmacies and then tested the pills they sent back at Flora Research Laboratories in Grants Pass, Oregon. The lab determined that most of the samples contained more estrogen and less progesterone than prescribed. This hormonal imbalance is dangerous. Progesterone is necessary to prevent estrogen-driven overgrowth in the uterine lining, so an underdose increases users' risk of developing endometrial cancer.
Thousands of women experience serious discomfort before, during and after menopause, and it's easy to understand why they would search for relief, especially since many doctors are not well equipped to help. Yet MORE's testing shows that women are putting their health at risk when they turn to bioidentical hormones manufactured by companies that are not subject to federal standards. And if H.R. 3204 does become law, Congress won't touch the issue of compounding pharmacies again for years, if ever -- leaving women out in the cold with their hot flashes.
1 comment:
The North American Menopause Society (NAMS) is heavily funded by the makers of Premarin and Prempro. Not only do the manufacturers of these drugs have to abuse horses to make these drugs, Premarin and Provera have both been shown to cause cancer and heart disease.
Natural progesterone doesn't cause cancer, heart disease or osteoporosis (the way that Provera does). There are many head-to-head trials with nicknames such as PROOF and PEPI that prove natural progesterone is both safer and more effective.
There is some limited data comparing bioidentical Estradiol to Premarin - and that also shows bioidentical estrogen to be safer.
Instead of scaring women into using a more dangerous therapy that provides better profits to their underwriters (Big Pharma sponsors exhibit hall booths at their conferences, etc), NAMS should become more objective and ask, "Does this therapy work at alleviating symptoms? How toxic (in real life) are these therapies? What is their cost? On all three measures, bioidentical HRT, whether it be through FDA-approved drugs (e.g. Promethium, Estrace, Vivelle Dot, etc) or compounding pharmacies, handily beats Premarin and Prempro.
Kenneth Woliner, MD
www.holisticfamilymed.com
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