The controversy really began in April 2004 when the results from the Women's Health Initiative (WHI) became public. The purpose of this study was to evaluate the long term benefits and risks of hormone replacement therapy. The hormone replacement used in the study consisted of conjugated equine estrogen (CEE), in other words, conjugated estrogens from horse mare urine, and medroxyprogesterone acetate (MPA), which is a synthetic progestin. The estrogen-progestin portion of the clinical trial was stopped in 2002 after results showed that a synthetic hormone combination containing conjugated equine estrogen (CEE) plus medroxyprogesterone acetate (MPA) increase a woman's risk of developing invasive breast cancer, heart disease, stroke and pulmonary embolism. The “estrogen–only” portion of the WHI study was halted in March 2004 after analysis of data suggested that synthetic CEE alone had no impact either on heart disease, which was the main focus of the study, but may increase the risk of stroke.
So, of course, the major headlines and media reports of the day announced that “estrogen and progesterone” are terrible for you and every woman needs to stop her hormone therapy. And many women did stop hormone therapy. They went “cold turkey” and suffered with their menopausal symptoms not knowing that they had an alternative.
In reality, the news media should have reported that taking conjugated horse mare urine and synthetic progestins for hormone replacement increases your risk for side effects and complications. Personally, I don't think we were ever intended to consume estrogens from pregnant horse mare urine. So, the results of that study make sense. But what doesn't make sense is to continue to promote synthetic and artificial hormones for hormone replacement therapy.
What does make sense is to replace the hormones that identically match what your body makes. Hormones are little messengers that travel around the body. The attachment of a hormone to a cell is similar to inserting a key into a lock. The bio-identical hormones are the perfect match. The synthetic hormones may fit the lock, but they won't open the lock. Because the synthetics do not fit perfectly, side effects develop. And you can read the potential list of side effects from these drugs in the PDR (Physician's Desk Reference).
Now the politics enters into the equation. Bio-identical hormones are specifically produced in compounding pharmacies. Bio-identical substances cannot be patented. Only patented drugs can be mass produced and be profitable to the pharmaceutical companies.
Wyeth Pharmaceuticals, makers of the conjugated horse estrogen and the synthetic progestin used in the WHI study, filed a Citizen's Petition with the Food and Drug Administration (FDA) asking the FDA to impose harmful restrictions on the compounding and dispensing of bio-identical hormone replacement therapy (BHRT). Then Senators Kennedy (D-MA), Burr (R-NC) and Roberts (R-KS) among others were considering legislation (Safe Compounding Drug Act of 2007) that would severely restrict and possibly deny access to critical medications. On the download page of my web site I have a copy of the testimony of T.S. Wiley before the Special Committee on Aging in United States Senate on April 19, 2007. Many experts testified and along with a grass roots efforts, that bill died in commitee.
Please, members of Congress, with all the issues we have to face in our nation and the world, restricting a person's choice in medical therapy should not be on your list of priorities. Haven't you heard the saying “If Mama ain't happy, then nobody's happy”. Please continue to allow women and men a choice in hormone replacement therapy. As we struggle to achieve peace in the world let's, at least, allow a little peace at home.
Dr. Milinda