FDA Attempts to Ban Products Containing Estriol
A major coalition of informed women and their doctors have launched an all out war on the Federal Drug Administration's (FDA) cynical and corrupt decision to ban compounded hormones containing Estriol.
In a full page ad appearing the New York Times, The Wall Street Journal and other major U.S. newspapers, the HOME (Hands Off My Estrogens) Coalition www.homecoalition.org denounces the FDA for using unfair and dishonest tactics in an attempt to protect Wyeth's synthetic products from the increasing popularity of bio-identicals.
The HOME Coalition consists of concerned citizens and licensed physicians and its message is endorsed by such respected groups as the Bioidentical Hormone Initiative (BHI), the American Academy for Advancement in Medicine (ACAM), the American Academy of Environmental Medicine (AAEM) and the International College of Integrative Medicine (ICIM).
The ad explains to women and their doctors: "The FDA has said stop using bioidentical hormones. Your choice and your doctor's prescription don't matter. Heart and cancer questions raised in 2002 about FDA 'approved' synthetic women's hormones don't matter." The ad goes on to urge us: "Act now to defend your right to bio-identical hormones."
HOME and all of us who support its message say "there is no scientific or anecdotal evidence to the FDA's claim that natural Estriol is unsafe or unproven". In fact, according to multiple reliable sources even Wyeth, the instigator, actually uses estriol in two products it markets and sells in Denmark; Cyclo-Menorette and Estriolsalbe. Hormone treatments that include estriol are commercially available all over Europe. www.compoundingtoday.
Estriol is the safest estrogen. Its safety is well recognized by experts in the scientific community. It is involved in clinical trials for the treatment of women with MS and the results are remarkable (www.neurologyreviews.com ). Estriol is the hormone of pregnancy and pregnant women have extremely high circulating levels of estriol and no negative side-effects to the presence of this natural hormone in their body. Its usefulness in clinical practice has been proven over decades of use and research (Maturitas, 2000, issue 34, pg. 169-177).
So why is the FDA so hostile toward natural Estriol? The HOME Coalition states: "The FDA is worried that natural substances will eat into the sales and profits of its clients, the big drug companies. Fees from them pay for a sizeable share of the FDA's budget and staff." Is this a good reason to attack a safe and useful treatment that serves women well?
The FDA's aggressive and unfounded move against compounded Estriol came in response to a so-called "citizen's petition" penned by Wyeth pharmaceuticals calling for a ban on bioidentical hormones and the compounding pharmacies that make them available to millions of women who use them as prescribed by their physicians. Despite opposition voiced by more than 70,000 women, pharmacists and doctors who, the FDA chose to side with Wyeth and without any scientific foundation move to intimidate compounders, restrict women's access to bioidentical hormones and even question the validity of the term bioidentical.
So far this war for survival of bioidenticals has been waged behind the scenes, out of the public eye because Wyeth and its gigantic publicity machine has stopped and confused the media, women and many physicians from becoming aware of its machinations. To protect their market share on artificial hormone replacement therapy (HRT) in spite of its established and proven dangers made public in 2002, Wyeth has misled the media, the conventional medical establishment and the public with misinformation and a campaign of intimidation and fear.
"The hormone controversy" does not exist.
It was created by Wyeth after the Women's Health Initiative (WHI) study proved Wyeth's drugs to be flawed and dangerous to women. The only dangerous hormones are synthetic or made from horse urine.
Our own human hormones are good for us. The hormones our bodies make when we are young and in balance help us feel great, look young and be fertile. They do not increase the risk for heart attacks, strokes, cancer or blood clots. The drugs that do cause these problems are made by pharmaceutical companies like Wyeth and they are not identical to human hormones; they are birth control pills, Premarin, Provera, Prempro, etc.
Bioidentical hormones are prescription medications created to be identical to the hormones our bodies make and they have been studied and used by scientists and clinicians world wide for more than 40 years (JAMA 171 (12), 11/21/1959, 1637-1642).
Women and men who use them are not complaining about their effects. The only problem with bioidenticals is that because they are molecularly identical to human hormones, they cannot be patented and the big pharmaceutical companies cannot make billions off them.
This is not a good reason to mislead and deprive women and men of the option of bioidentical hormones.
Please join me, www.bioidenticalhormoneinitiative.org, www.homecoalition.org, www.projectfans.org, www.savemymedicine.org, and let our voices be heard without fear, intimidation or doubt.