The U.S. is the only industrialized nation to allow drug ads on TV. These advertisements focus more on what can go wrong with synthetic drugs then on how people may benefit. The odds are that one day viewers will actually pay attention to these commercials, and when they do, drug sales will plummet.
To counter the eventuality of an awakened public, the pharmaceutical industry is hard at work along with their colleagues the American Medical Association, to ensure that natural medicines are outlawed in the US. A prime example of this is their attempt and near success in outlawing the prescription and sale of natural hormones.
Despite the fact that countless women and men rely on natural compounded hormones which are identical to those produced in the body, the Food and Drug Administration (FDA) on January 9th ordered pharmacies to stop providing bio-identical estriol. Estriol is used in about 80% of natural hormone formulations. Even though estriol is made in the human body, the FDA contends that it is a “new and unapproved drug” and the “safety and effectiveness of estriol is unknown.”
The FDA does admit that there has never been an adverse event reported with estriol. In fact, one study of 15,000 women found a significant decrease in the incidence of breast cancer in those whose natural estriol levels were the highest.
The FDA is ordering pharmacies to stop using the terms ‘bio-identical hormone replacement therapy” and “BHRT” on the grounds that the terms present false claims.
I don’t think that describing these hormones accurately should be construed as false claims. The FDA believes that any claim about a natural substance is false no matter how accurate if they haven’t approved the claim. The catch 22 is that there is little incentive to spend upwards of a billion dollars to achieve FDA approval to make a health claim for non-patentable substances.
The FDA is concerned that the booming health care industry will erode the profits of their most profitable client: the pharmaceutical industry. Drug companies fund a large share of the FDA’s operating budget and staff. In October 2005, Wyeth, a large patent based drug company, petitioned the FDA to ban bio-identical hormones which compete with their synthetic hormones. Due to adverse publicity of synthetic hormones many doctors and patients have been turning to bio-identical hormones as a sensible alternative. Despite receiving some 70,000 requests by doctors, pharmacist and citizens to preserve access to natural hormones the FDA sided with Wyeth.
The synthetic hormones which Wyeth produces have shown clear risks for heart disease and cancer and thus carry black box warnings on their labels. A black box warning is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. The name comes from the black border that surrounds the text of the warning. A black box warning means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. It is the strongest warning that the FDA requires.
U.S. Representatives Mike Ross (Arkansas) and Jo Ann Emerson (Missouri) along with other co-sponsors have presented a Sense of the Congress Resolution (H. Con. Res. 342) challenging the FDA’s new anti-natural hormone policy. We can help them by contacting our legislative representatives. Now. It is easy. If you don’t know who they are go to:
www.womensinternational.com website. Just follow the information under critical action alert. There’s even a sample letter.
Attempts to limit or eliminate access to natural medicine are not new, are on-going and world wide in scope. Codex Alimentarius is a prime example of the international effort which is already being implemented in Europe limiting access to and strength of natural medicines. You can do an online search to quickly find more information on Codex.
I often say that the medical system is a reflection of the society in which it lives: let’s provide our legislators a healthy reflection. Please contact me with any questions or feedback.
Jon Dunn, ND