The Politics of Bioidentical Hormones
As promised I will spend the next few weeks providing you with focused information on bioidentical hormones and then expand into general issues in women’s health. I will do my best to give you all the information honestly and kindly since the only motivator I have is my burning desire to help women get better health care and take better care of themselves.
What are Bioidentical Hormones?
Before we get down to the specific issues and treatments, I want to clarify the issues surrounding bioidentical hormones.
- Bioidentical hormones are medications, they are not natural products. They are manufactured by drug companies from soy and yam oils. The only natural thing about them is their molecular formula which is identical to the molecular formula of hormones our bodies make. That is a crucial piece of information that unfortunately for all of us, most conventional doctors aren’t aware of.
- Bioidentical estradiol looks like the estradiol your body makes, progesterone looks like the progesterone your body makes, testosterone looks like the testosterone your body makes and estriol looks like the estriol your body makes when you are pregnant (because your body does not make any measurable estriol when you are not pregnant).
- The term bioidentical is not a marketing term, it is a descriptive term. It describes the biologically identical molecular formula born by bioidentical hormones. It is a term that makes the important distinction between bioidentical hormones and non biologically identical hormones.
- Bioidentical estradiol, progesterone and testosterone are FDA approved. Estradiol and testosterone can only be obtained by prescription through a licensed medical practitioner (some states allow nurse practitioners to write prescriptions while others do not). Estriol is not FDA approved.
- Progesterone is the only bioidentical hormone available without prescription in low doses, 50 mg or less per unit dose.
- Bioidentical hormones are commercially available. That means they are available at your local pharmacy in tablet, patch, capsule and gel form . Examples include but are not limited to the following: Vivelle patch, Climara, Estraderm, Estrace, Prometrium, Androgel.
- The way to obtain bioidentical hormones is to ask your doctor for a prescription for one of the above products. The problem is that your doctor usually does not know the above products are bioidentical. Once you help your doctor make the distinction, you can easily get the prescription.
- Commercially available bioidentical hormones cannot have the dose adjusted. They are standardized to specific doses. That is a problem many women and physicians who work with bioidentical hormones find difficult to deal with.
- To circumvent this problem compounding is another viable option for the use of bioidentical hormones. Compounding pharmacies provide individualized preparations of bioidentical hormones in gels, creams, capsules and sublingual troches.
Here’s where all the trouble with the politics of bioidentical hormones starts.
Compounding pharmacies are independent labs which dispense bioidentical hormones along with custom mixed medications for conditions like asthma, pain, hospital intravenous medications, etc. Compounding is the original form of dispensing drugs that existed before the drug companies came into being.
To summarize, bioidentical hormones are an FDA approved form of hormone therapy that is available in both commercial forms and individually compounded forms.
A Brief History of Bioidentical Hormones
Bioidentical hormones have been in use for thousands of years. The first record of their use goes back to Ancient China where the aging female nobility routinely ingested dried young women’s urine to counteract problems associated with menopause.
The reason for this type of therapy was that young women’s urine contains the metabolic waste products of estrogen, progesterone, testosterone. Throughout history you can find references to the use of young women’s urine to help older women with problems of aging.
Fast forward to our times.
In the late 1960s, Wyeth- Ayerst Pharmaceuticals introduced Preparin in the U.S., a patented hormone replacement made from pregnant mare’s urine.
Using young women’s urine, although available and cheap, was not a marketing option for Wyeth because women’s urine cannot be patented and in the 1960s getting a patent became the major driving force for drug production in the U.S. Marketing of patented drugs proved to be the best way to make money and as the drug companies went public, the only thing that mattered was the bottom line.
(An interesting aside is that in the 1970s human insulin came to the market and changed management of diabetes for the better. I guess women in menopause aren’t that important).
For 30 years, Premarin and later on its side-kick the terrible drug Provera were marketed to millions of women as the Fountain of Youth, the best way to eliminate symptoms of menopause and even prevent cancer, heart disease and osteoporosis.
In the early 1990s believing their own marketing data, Wyeth Pharmaceuticals, then treating more than one million women a year with Premarin and Provera decided to partner with the National Institutes of Health to conduct a long term national study to evaluate the long term effects of Premarin and Provera in post menopausal women. The study was conducted in hundreds of academic centers around the country. The premise for the study was based on assumptions without any proof of effectiveness. The NIH proceeded with the study with extensive financial support and free Premarin from Wyeth. The goal of the study was to prove that aging women needed Premarin to protect them from diseases of aging.
In 2002 the study was abruptly stopped because after almost eight years too much data accumulated against Premarin suggesting it increased the incidence of heart attacks, certain types of cancers and strokes in the study participants.
Based on the results of the Women’s Health initiative the following happened:
Little has happened since the summer of 2002. Grumblings against synthetic hormones and pro bioidentical hormones could be heard around the country, but not much more. Initially the doctors were directed to stop writing prescriptions for Premarin and Provera. In time though, the Wyeth marketing machine resurfaced and low dose Premarin and Provera entered the market with the recommendation for use for as short a period of time as possible.
No other research or options for women in menopause appeared available.
Women around the country were learning about bioidentical hormone options from a growing cadre of compounding pharmacists and new medicine doctors.
At the academic levels no one talked of hormones if they could help it.
Books for the public were published on bioidentical hormones but nothing filtered through to academic institutions.
In 2004 a book by Suzanne Somers called The Sexy Years brought the option of bioidentical hormone therapies to the general public. What had been a grass roots movement gained some steam.
By 2005 bioidenticals had reached millions. Wyeth had lost billions of dollars in revenue and had to retaliate. First, there was a petition to the FDA in October 2005. Wyeth submitted a Citizens’ Petition to the FDA asking for stronger regulation and federal supervision of compounding pharmacies that produced bioidentical hormone preparations. Keep in mind that the practice of pharmacy and medicine are now legislated at the state level and Wyeth is now asking for the federal government to step in and protect their special interests.
Without any publicity, tens of thousands of women sent in letters and e-mails to the FDA asking for the Wyeth petition to be rejected. The word was out “ Please let me keep getting my bioidentical hormones from the compounding pharmacies”. Women were asking to keep this viable option for treatment out of the reach of Wyeth and their special interest.
Some media attention to the Wyeth petition precipitated a swift reaction from the drug manufacturer. Website information on menopause promoting the use of Premarin and conventional medical experts bashing bioidenticals as a marketing term caused even more confusion.
Finally, in October 2006, a controversial new book by Suzanne Somers pushed the envelope even further. Even though Ms. Somers is an avid proponent of bioidentical hormones, her new book only served to push bioidenticals further into the fire.
Wyeth and the North American Menopause Society both association heavily sponsored by Wyeth retaliated through the AMA. They claim that bioidenticals are “a marketing term.”
Last week while everyone was arguing, the AMA passed a resolution in support of Wyeth asking for more regulation from the FDA in the area of compounded bioidenticals.
Today, we are standing in the midst of a crisis. Women’s health is at stake.
* We need the option of bioidentical hormones which we know from more than 30 years of scientific research and clinical experience to be viable and safe.
* We need support from our academic centers and the federal government to protect women and side with women’s health, not the big pharma.
* We need to teach our doctors and women about bioidenticals.