FDA Declares War on Bioidentical Hormone
One of the Nation’s Leading Bio-Identical Hormone Doctors and the Natural Hormone Institute Co-Founder Speak Out on FDA’s Attempts to Crack Down on Natural Hormones
The health, well being, and freedom of hundreds of thousands of pre-menopause and menopause women is at stake.
Jacksonville, Florida (PRWEB) January 16, 2008 — “The Food and Drug Administration’s (FDA) new policy about bio-identical hormones could potentially deny hundreds of thousands of women access to bio-identical hormone therapy,” urges C.W. Randolph, Jr., M.D., R.Ph, one of the nation’s leading bio-identical hormone physicians, and Genie James, M.M.Sc., his co-founder of The Natural Hormone Institute of America. “We want people to know that this is an egregious example of a multi-billion dollar pharmaceutical giant (Wyeth) wielding financial and political power in an effort to regain an eroding market share and female healthcare consumer trust.”
Last week, the FDA announced that there’s no evidence that “bio-identical” hormones therapies (BHRT) mixed by individual pharmacists are any safer than prescription hormones made by drug companies such as Wyeth. They warned seven pharmacy operations about misleading safety and effectiveness claims of BHRT products. The FDA stopped short of taking immediate action to stop the practice of mixing hormones or compounding them by individual pharmacists as Wyeth has sought since it filed a petition with them in 2005.
Dr. Randolph, who is the best selling author of “From Hormone Hell to Hormone Well” and “From Belly Fat to Belly Flat,” originally practiced as a compounding pharmacist before returning to medical school. He established his OB/GYN practice in Jacksonville, Florida in 1986 and - like most physicians at that time - prescribed synthetic hormone therapies such as Premarin, Provera and later Prempro. Dr. Randolph stopped prescribing these pharmaceutically manufactured synthetic hormones because of the side effects experienced by his patients.
“Long before the output of the Women’s Health Initiative (WHI) validated the health risks associated with synthetic hormone replacement [such as an increased risk of breast and uterine cancers, heart attack, stroke and increased risk of dementia I was concerned,” says Dr. Randolph. “I drew on my background as a compounding pharmacist to research safe and effective alternatives. For more than a decade, I have prescribed bio-identical hormone therapies (BHRT) for literally tens of thousands of patients. Not only do my patients report that they ‘feel like themselves again’, they also remain side effect free. My clinical experience validates the medical research substantiating the safety and efficacy of BHRT.”
Why is the FDA attacking BHRT? “Money, politics and power,” Ms. James, the co-author of Dr. Randolph’s books, responds. “There are currently close to 38 million women in the U.S. entering pre-menopause or menopause. This is a huge market. When the results of the WHI study were first released in 2002, the sales of synthetic hormone therapies dropped almost 50% immediately. It is worth noting that synthetic hormone formulations are patentable. Bio-identical formulations can not be patented because their molecular structure originates in nature, e.g. the human body.”
“The issue here is not the safety of women who are choosing BHRT as their treatment of choice for menopausal and pre-menopausal symptoms, it is dollars. Wyeth’s financial reports, which are available online at www.wyeth.com, suggest an ongoing and significant decline in the sales of the Premarin synthetic hormone family of products; e.g. from over $2 billion in 2002 to $880 million in 2004; a 68% decline in sales.”
“Many women who stopped taking synthetic hormones therapies began to do their homework and research alternatives,” continues Ms. James. “The result is that in the last five years there has been a significant upsurge of women choosing (and physicians prescribing) BHRT as an effective alternative that is formulated to match the structure found in the human body, a common practice in other medical treatment areas such as in the treatment of the thyroid.. No wonder Wyeth is worried. And, for anyone doubting the influence that a multi-billion pharmaceutical company might have on a government regulated agency such as the FDA, I would suggest that they read the book by Marcia Angel, M.D. (former editor in chief of The New England Journal of Medicine) The Truth About Drug Companies: How They Deceive Us and What To Do About It.”
Last week, when the FDA issued the warning to compounding pharmacies across the nation, they stated that they should halt the compounding of medications containing estriol. “The FDA is way out of bounds here,” says Dr. Randolph. “Like many commonly prescribed drugs (e.g, Phenobarbital, quinine, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP), but is not currently a component of an FDA-approved drug. When it passed the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could be compounded. In addition, the practice of medicine and pharmacy is legislated at the state level. The FDA officially does not have jurisdiction in this area.”
“As Ms. James stated, the fundamental issue at stake is much more critical,” says Randolph. “The larger issue is the health and well being of millions of American women who, with their physicians, want safe and effective hormone replacement therapy. The big pharmaceutical muscles are working to do away with BHRT, despite medical studies and clinical evidence validating it as a safe and effective solution for women suffering from symptoms of hormone imbalance.”
“There is now real data linking a decreased incidence in U.S. breast cancers with a decrease in the number of prescriptions written for synthetic hormone therapies. Now think about this: during these same years, we have seen lock-step increases in the number of prescriptions written for BHRT. Why isn’t the government funding a study examining the inverse relationship between the rise in the popularity and use of BHRT and the decline in the incidence of breast cancer?” asks Ms. James.
For more information on bio-identical hormones, go to www.hormonewell.com. For media inquiries, contact Nanette Noffsinger at nanette@burkehollowmedia.com or 615-776-4230.
Will Wyeth Bully You out of Your Estriol?
The FDA has begun 2008 by forbidding compounding pharmacists to use estriol in their natural hormone formulations because the agency doesn’t have a specified approved use for it. They took this action because Wyeth complained about it.
In case you’ve forgotten, Wyeth is the giant pharmaceutical company that makes Premarin and PremPro, synthetic hormones found to cause heart disease, strokes and cancer. If we do some rough calculations based on statistics from the Women’s Health Initiative (WHI), Wyeth’s hormone replacement drugs have killed tens of thousands of women over the past few decades. Sales of these dangerous drugs have plummeted since the WHI results were announced, and women who were injured by them and sued, are winning millions in damages in courtrooms around the U.S. (You go girls!)
Estriol is a Safe Alternative
Estriol, on the other hand, is a mild (natural) estrogen that’s primarily used in cream form for vaginal dryness and urinary tract problems in menopausal women. It’s been in common use in Europe for well over a decade, and its safety and effectiveness are well established. Many doctors in the U.S. who use natural hormones prescribe tri-est and bi-est, estrogen cream formulations made by compounding pharmacies that contain estriol. These formulations appear to be what Wyeth perceives as its competition. If you’d like to know more about estriol, Dr. David Zava wrote an entire chapter on it in What Your Doctor May Not Tell You about Breast Cancer.
The doctors and pharmacists can take the estriol out of the formulas and they’ll still work well because they also contain estradiol, but ironically they probably won’t be quite as safe. Estriol may have some protective properties that balance estradiol’s cancer-promoting effects. In fact, estriol is so safe that it’s the primary estrogen of pregnancy—the fetus is bathed in it.
The Bully in the Neighborhood
It’s shameful of Wyeth to use its clout and money to bully and beat on the competition through the FDA, but by now we expect that behavior from them. The real shame is that the FDA can’t seem to stop itself from being bullied. You can bet there was some major arm twisting going on to push the FDA into this action, because they just have to know that it’s been proven safe and effective in Europe, and that thousands of annoyed menopausal women are going to be sending them e-mails. We can only hope that the FDA responds by quickly reviewing the body of excellent research available on estriol and taking action to assign it some specific and approved uses.
Many for profit and nonprofit groups interested in defending a womens’ right to use estriol are putting together a unified message to send to the FDA. If they call for a petition I’ll be sure to let you know.
In the meantime, if big bad Wyeth succeeds in taking your estriol away, and you can’t have sex because of vaginal dryness, send your partner to Washington to march on the FDA’s doorstep. Just kidding. This is an especially poignant issue for women with breast cancer or who have had breast cancer, because estriol is a safe alternative to estradiol. The estrogen-blocking drugs such as tamoxifen that are used to treat breast cancer can cause terrible vaginal dryness and urinary tract problems, and even without the drugs, these are serious problems for many menopausal women.
Estradiol cream is an effective, albeit less safe, treatment for vaginal dryness and urinary tract problems. Please use the lowest dose possible that relieves symptoms and use progesterone cream for balance. For details I recommend that you read Hormone Balance Made Simple.
Keep it natural,
Virginia Hopkins
Editor, Virginia Hopkins Health Watch
http://www.virginiahopkinshealthwatch.com
Inept FDA Declares Misguided War on Bio-Identical Hormones, and Promptly Shoots Own Foot
Acting as agent for drug maker Wyeth this week, a dysfunctional and inept FDA fired the opening salvo in a misguided war on bio-identical hormones. Using typical Orwellian DoubleSpeak, the FDA issued a series of nonsensical and contradictory statements intended to serve the financial interests Wyeth, maker of synthetic hormones Premarin and Prempro, found to cause cancer and heart disease in the 2002 NIH sponsored Women’s Health Initiative Study.
Since the study’s release, millions of women have switched to the safe and more effective bio-identical hormones, currently prescribed by thousands of physicians, available as FDA approved products at local drug stores and compounding pharmacies. Wyeth has lost market share and suffered financial loss as synthetic hormone profits have declined from 4.4 to 1.2 billion annually from 2001 to 2006.
Click HERE to read full article
Coalition of Doctors Condemn FDA Decision to Deny Women Access to Bioidentical Hormones
A coalition of gynecologists, internists, allergists, ER physicians and general practitioners responsible for treating thousands of women today criticized the Food and Drug Administration (FDA) for taking action that threatens to deny hundreds of thousands of women access to customized medications they take for symptoms of menopause.
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FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones
In a series of warning letters to compounding pharmacies across the country, the Food and Drug Administration (FDA) has asserted a policy that would deny hundreds of thousands of women access to many commonly compounded bioidentical hormones, substituting its judgment for that of doctors.? Wyeth Pharmaceuticals, the number one manufacturer of synthetic hormone products, petitioned the FDA to do so in October 2005.? More than 66,000 doctors, patients, and pharmacists filed comments with the FDA opposing Wyeth’s petition.
“Under this policy, patients will suffer while Wyeth profits,” said L.D. King, executive director of the International Academy of Compounding Pharmacists (IACP).? “Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate, sometimes because Wyeth’s products are found to be ineffective or produce side effects.? This is a decision that should be left to doctors.”
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Wyeth’s War on Women and Bioidenticals
The Food and Drug Administration has declared war on bioidentical hormones and plans to eliminate the compounding and availability of estriol.
This disgraceful action is the direct result of an intense lobbying petition by Wyeth, the leading manufacturer of synthetic hormone products, even though more than 60,000 doctors, patients and pharmacists filed comments with the FDA opposing Wyeth’s petition.
The lesson here: When Wyeth speaks, the FDA listens.
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FDA’s New Release
FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs
FDA Cracks Down On Custom-Made Hormones
