Wyeth Asks FDA: Prohibit Bio-Identical Hormones
CategoriesThere is time until 4 April 2006 to comment on a petition to the FDA which aims at removing from the market the natural alternative to pharmaceutical hormone replacement, which has shown to have serious adverse effects. Help is needed.
Wyeth Pharmaceuticals, the maker of Premarin and Prempro, both drugs extracted from the urine of pregnant mares and used in hormone replacement therapy, has asked the FDA to eliminate competition from bio-identical - plant based - hormones, which are a more natural alternative to these drugs.
Dr Steven F. Hotze has the details and asks for help to convince the FDA not to touch the natural alternatives to pharmaceutical hormone replacement.
His call for action - the FDA comments period on the petition closes on April 4, 2006 - is copied in the second part of this article.
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Bio-identical Hormones - FDA
From: DrHotze
Sent: Saturday, January 21, 2006 7:01 PM
Subject: Letter to Stop Wyeth and the FDA from Denying Your Right to Choose Bio-identical Hormones
January 21, 2006 Dear Friends,
Wyeth Pharmaceutical wants the FDA to take away your right to choose safe, effective and natural, bio-identical hormones and regulate your choice of health treatments. We have until April 4, 2006 to stop them.
Wyeth, the maker of Premarin and Prempro, filed a "Citizens Complaint" with the FDA on October 16, 2005, requesting that the FDA effectively prohibit compounding pharmacies from providing bio-identical hormones to their patients. This would mean that you would no longer be able to get your bio-identical hormones from us or from any one else.
Since the 2002 Women's Health Initiative (WHI) which demonstrated that Wyeth's products, Premarin and Prempro, caused a significant increase in breast cancer, blood clots to the lungs, heart attacks and strokes, Wyeth has seen a dramatic decline in the sales of these counterfeit hormones. Wyeth's financial reports, which are available online at www.wyeth.com, indicate the following significant decline in sales of Premarin Family products;
2002 - $2,072,000,000;
2003 - $1,275,000,000;
2004 - $880,000,000.
This represents a 68% decline in sales of Premarin Family products between 2002 and
2004. Wyeth's profits have likewise declined precipitously;
2002 - $4,447,000,000;
2003 - $2,051,192,000;
2004 - $1,234,000,000,
a 72% decline in profits. Tens of thousands of women have forsaken Premarin family drugs for bio-identical hormones. Wyeth is simply trying to stop its losses and regain its market share. Wyeth wants to force women to take their counterfeit hormones by eliminating the competition from bio-identical hormones prepared by compounding pharmacies.
The FDA receives drug user fees, totaling at least $300,000,000 in 2004, from the pharmaceutical companies for the drugs they sell. The less drugs that Wyeth sells, the less money the FDA makes. The FDA collects no drug user fees from compounding pharmacies because they are regulated by the states, not the federal government. So the FDA wants to eliminate compounding pharmacies as well.
Pharmaceutical companies recruit key FDA employees to work for them at huge salaries. This is the dream of many bureaucrats, to get a high paying job with a big drug company. So you can understand why FDA regulators have an incentive to please Wyeth.
Wyeth, like all the major pharmaceutical companies, contributes billions of dollars to various medical societies and patient advocacy organizations. So it is not surprising that many of these organizations have written responses to the FDA in support of Wyeth's complaint. Because of their money ties to Wyeth, these organizations endorse Wyeth's products and do Wyeth's bidding. When an organization supports something which is obviously detrimental to women and men, it is important to follow the money trail.
Wyeth can and must be defeated in its attempt to restrict patients' rights to choose to safe, effective and natural treatments using bio-identical hormones.
You can voice your opposition to the Wyeth Complaint by going directly to the FDA comment link below and telling the FDA your story about the benefits that bio-identical hormones have made in your life. The comment filing period ends on April 4, 2006 at which time the FDA will make its decision. To stop Wyeth and the FDA we need at least 20,000 comments opposing the Wyeth complaint. So write your comment on line today! Please forward this information to any one who will support this effort.
FDA Comment Link for the Wyeth Complaint
The comment period on the Wyeth Petition is open until April 4, 2006. The above is a link where comments can be filed with the FDA on-line.
If you are receiving this information by hard copy then you may go to www.drhotze.com, or www.hotzehwc.com in order to find this link. Otherwise, just click on the above link.
After entering the requested information (zip code, name, etc.), hit the continue button to get the comment screen. Comments can be up to 4,000 characters. Hit the continue button to get to the next screen, where attachments can be filed. Hit the button "save comments" to submit (doesn't make sense, but I tried it with a test comment).
Hard copy comments (which can also be scanned and submitted as an attachment using the above link) can be mailed to:
Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Allow me to recommend for your consideration that you go to the above link and draft your response on the job today. Also please forward this e-mail to everyone on your distribution lists.
Your ability to continue to choose your treatment depends upon our success in blocking Wyeth and the FDA in their plan to eliminate bio-identical hormones.
Thanking you for supporting patients' rights to choose bio-identical hormones, I remain, as always, Sincerely yours, Steven F. Hotze, M.D.
- - -Here is the take of the Baltimore Health Sciences Institute - thanks to Alternative Medicine Forum
HSI e-Alert - Where's the Shame?
Health Sciences Institute e-Alert
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February 07, 2006
Dear Reader,Is it possible to surgically remove the ability to feel shame?
It must be. That's the only reasonable explanation that might account for a recent petition submitted to the FDA by representatives for Wyeth Pharmaceuticals. Wyeth is calling on the FDA to impose broad restrictions on bioidentical hormones.
This is supposedly a safety issue, but Wyeth executives have an obvious motive for trying to curb the use of this natural therapy. Wyeth just happens to manufacture the synthetic hormone replacement therapy (HRT) drugs Premarin and Prempro.
Sales of these drugs have dropped off considerably since the 2002 bombshell study that found they significantly increase the risk of serious health problems, including breast cancer and heart attack. In the past few years, many women have started using bioidentical hormones as a safe and effective alternative to synthetic HRT.
So is this a safety issue, or a business issue? I'll let you make the call on that one. But on this point there's no question: If Wyeth's petition is successful, women may lose their right to choose between a synthetic drug and a natural therapy.
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Finding the balance
--------------------------------------------As the name implies, bioidentical hormones (derived from estrogen-like plant compounds) are identical to natural hormones in the body. The chemical makeup of synthetic HRT is not identical.
Jonathan V. Wright, M.D. was the first doctor in the U.S. to recommend bioidentical hormones to his patients. Since 1982, Dr. Wright has been prescribing this therapy with great success. In the May 2002 issue of his Nutrition & Healing Newsletter, Dr. Wright offered some hormone basics, beginning with three primary types of estrogen that are present in a woman's body between the onset of menstruation and menopause: estrone, estradiol, and estriol.
Dr. Wright explains: "It's been found that estradiol, when prescribed by itself (as sometimes happens in conventional HRT) can raise the risk of cancer after several years. Estriol, on the other hand, is anti-carcinogenic. Healthy women naturally excrete much more estriol than estradiol and estrone. But when hormone production slows down during menopause, it's important to replace all three estrogens in the same proportions your body would produce on its own if it could.
"With natural hormone replacement therapy, these estrogens are used along with natural progesterone in proportions as close as possible to those produced in the body."
As Dr. Wright notes, pharmaceutical progesterone raises the risk of heart problems, whereas natural progesterone provides the same benefits, but virtually no risks. According to Dr. Wright, the natural form also helps rebuild bone mass, another key advantage over using synthetic.
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In her own words
--------------------------------------------Many HSI members are already familiar with bioidentical hormones. In an HSI Healthier Talk community forum thread, a member named Seana shares her experiences w
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