Sigh. I had hoped we would not have to fight this fight ever again. But it seems we will need to stand up for our rights. Bioidentical hormones literally saved me during my menopause transition. It’s not that we all need them, it’s that we (and our physicians or nurse practitioners) have a right to choose treatment that has been around safely for decades. Read this important post by Gretchen DuBeau and click the link to write Congress and the FDA today!
Threat to Bioidentical Hormones for Women’s Health
by Gretchen Dubeau
Millions of women rely on hormone replacement therapy to manage the symptoms of menopause. Unfortunately, the Food and Drug Administration (FDA) is poised to eliminate women’s access to alternative medications that are often safer and more effective than the conventional treatments.
Hormone replacement therapy (HRT) is meant to give women the proper balance of hormones to stay healthy. There are a number of HRT drugs on the market, but these hormones are not chemically the same as the ones the human body produces. One product is even made from pregnant mares’ urine. Another contains peanut oil, a potential allergen.
Many doctors, though, swear by bioidentical hormone replacement (BHRT) therapy, the treatment of choice for roughly 2.5 million women. The difference is that bioidentical hormones are, as the name indicates, chemically identical to the hormones produced by the body.
The difference is crucial. A number of studies have indicated that BHRT is not only safer but superior to the alternatives. According to a 2009 review of published studies, “Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious” than standard HRT.
This is also borne out in the experience of patients. Over and over, we hear patients who switch from HRT to BHRT say that they feel like themselves again, that they are no longer tired all the time, or suffering from night sweats and hot flashes, and that their sleep is better. They feel like they’ve gotten their lives back. No premium can be put on such extraordinary outcomes.
Bioidentical hormones are usually made, pursuant to a doctor’s prescription, at a specialized pharmacy—called a compounding pharmacy—which makes medications tailored to a patient’s individual needs. This is one of the great advantages of BHRT; it’s not one size fits all, but can be customized to a patient’s unique needs.
This isn’t to say that BHRT is the answer for everyone. But women deserve choices, especially when conventional HRT leaves many women still feeling the worst effects of menopause.
This is where the FDA comes in. After a tragic incident where 76 people were killed as a result of a meningitis outbreak linked to a single compounding pharmacy, Congress passed a law to increase federal oversight over these pharmacies. To implement this law, the FDA is in the process of finalizing a list of substances that cannot be made at compounding pharmacies. Bioidentical hormones like progesterone, estradiol, and estriol have been nominated to this list, despite having been compounded safely for decades.
It’s also worth noting the FDA’s conflict of interest. Bioidentical hormones compete with FDA-approved HRT drugs. Drug companies pay user fees to the FDA to get their products approved, and these user fees fund the FDA. The resulting bias in favor of the pharmaceutical industry has been apparent throughout the implementation of the compounding law, with the FDA routinely advising that safe, natural medicines—which compete with FDA-approved products—be off limits to these specialized pharmacies.
We at the Alliance for Natural Health USA are spearheading a grassroots campaign to protect consumer access to bioidentical hormones. Patients, in consultation with their doctors, have a right to choose the treatment options that work best for them. Click the link below, which will allow you to send a message to your representatives in Congress and the FDA, urging them to protect access to bioidentical hormones. If enough concerned patients speak up, the FDA will have to think twice about eliminating patient access to crucial bioidentical hormones.
About Gretchen DuBeau
Gretchen DuBeau, Esq. is executive and legal director of Alliance for Natural Health-USA (ANH-USA), an international organization dedicated to promoting natural and sustainable health and consumer freedom of choice in health care.
Note: There is not an actual bill in Congress. This action alert urges FDA to take these bioidentical hormones off the list of substances nominated to not be allowed to be compounded. We are also working on a letter from members of Congress to the FDA with the same message, which is why we’ve included Congress in our action alert as well. FDA and their Pharmacy Compounding Advisory Committee (PCAC) could make this change without Congressional action, but having Congress members push them to do so will likely help.