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| O'Brien Pharmacy > RX Compounding > HRT for Women > Hormones in the News |
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Hormones in the News January 2008 Recently the FDA has announced a policy restricting the use of Estriol, an estrogen produced by the human body. At the same time, no reason for this capricious policy has been cited. However, in recent years the FDA has tried to adopt other strange policies restricting patient access to compounded medications, and has lost in both the Federal and Supreme Courts. The FDA’s position is especially strange because of a lack of evidence to support any such decision, and might be related to pressure from drug companies. Synthetic hormone manufacturer Wyeth has been involved in previous attempts because of decreasing sales of drugs like Premarin. Furthermore, it is important to remember that Estriol is only used under the care and prescription of a physician. Symptoms of menopause are attributed to a decline of the human estrogens, which includes Estriol. Decades of studies published in JAMA, the New England Journal of Medicine and other prestigious journals around the world document the benefits of Estriol and the other natural hormones. In addition, Estriol has a recognized monograph in the United States Pharmacopeia, the compendium used by the FDA to set the standards and regulations related to all areas of pharmacy, medication and drug manufacturing. In fact, the FDA approved the use of Estriol in 1977! Unable to monitor simple foods like spinach and dog food, it is curious that the FDA would focus money and energy on a long-established, long-used natural hormone like Estriol, especially without documentation to support their position. This is clearly unacceptable governmental intervention that will not be tolerated by patients, physicians, pharmacists and public advocate groups supporting medical choice. Equally bizarre, the FDA would like to stop the use of the medical chemistry term “Bio-identical.” Since the hormones used in natural hormone replacement are exactly the same as hormones used in the body, the term is simply indisputable, and the restriction almost comical. Other headlines about hormone replacement are both accurate and deceptive. It is accurate to report that the drugs Premarin and Provera are poor medication choices based on their risks and benefits. It is deceptive to suggest the same risks and benefits apply to natural or bio-identical hormone replacement. The stories are old news to those who understand the differences between bio-identical hormones and synthetic hormones, and in fact confirm popular convictions: Premarin and Provera and other non-human hormones are not safe for humans. Worldwide research, studies, experience and the drug manufacturers’ own warnings long ago demonstrated the negative effects of these drugs. Many published clinical trials have already reported that the risk of breast cancer is increased by long-term use of Premarin, and increases even more when Provera is added to the regimen. [J Natl Cancer Inst 1997 Aug 6;89(15):1110-6] Many patients intuitively know something is not right with these synthetic hormones. Now the Women’s Health Initiative Study affirms these convictions. It is important to understand that the study was not conducted using human (bio-identical) estrogens and progesterone. The study used only Premarin and Provera (Prempro). In addition, it is documented that all hormones, when administered in an oral tablet like this study, stress the liver and gall bladder, produce carcinogenic metabolites and have other negative effects on the body. The situation is analogous to the history of insulin use in diabetes. Until the early 1980s, the only insulin hormone available to give to diabetics was from cows and pigs. While this complex molecule from these animals is almost identical to human insulin, it differs by one or two amino acids. This seemingly small difference is enough to cause critical long-term problems in human beings. When drug companies were able to manufacture the exact human insulin molecule in large quantities, it was proclaimed a major breakthrough in health care. Now, every patient prescribed insulin is given the exact same molecule that is unique to human beings. Why should hormone replacement be approached any differently? It only makes sense to use the exact same human molecule (bio-identical). And every day more and more evidence supports the use of bio-identical hormones and the restricted use or elimination of synthetic or non-human hormones. In addition, unlike mass-produced hormones, bio-identical hormones can be custom-made to match the exact needs of the individual. Individualized dosing, bio-identical hormones and drug delivery systems that bypass the liver and digestive tract allow for maximized benefits without side effects. An estimated two million women are now benefiting from bio-identical estrogens and progesterone. The news reports also neglect the reason 90% of all women take hormone replacement: to relieve menopausal symptoms like hot flashes, vaginal thinning and dryness, loss of libido, osteoporosis, forgetfulness, anxiety, thinning hair and bladder disorders. Evidence continues to support bio-identical hormone replacement as a safe and effective option for symptoms of menopause, and is most effective when coupled with dietary, nutritional and lifestyle changes. |