Wyeth Asks FDA: Prohibit Bio-Identical Hormones
There 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.
- - -
Bio-identical Hormones - FDA
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.
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
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.
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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
February 07, 2006
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.
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.
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 with synthetic and bioidentical therapies.
"I have been on a variety of hormone replacement options over the years. Regardless of what I tried, I had many unwanted side effects (acne, sweating, fluid retention, etc. etc.). After reading up on bio-identical estrogen, I asked to be switched to a bio-identical tri-estrogen compound. All side effects I experienced with other therapies went away almost immediately.
"I have been very happy with the results whereas I had been miserable for years with other therapies. My doctor prescribes these bio-identical hormones through a compounding pharmacy called Women's International Pharmacy. They mail me both the estrogen and testosterone each month."
A compounding pharmacy prepares customized medications, following specific guidelines prescribed by doctors. According to a press release from the International Academy of Compounding Pharmacists (IACP), the Wyeth petition inaccurately charges compounding pharmacies with "trying to dupe an unsuspecting patient population." And the press release adds: "To suggest that pharmacists who prepare customized medicines based on doctors' orders are duping patients is an insult to all physicians, patients and pharmacists."
Leading the way
In April 2006, FDA officials will make a decision on how to proceed with the Wyeth petition. Until then, the agency will accept comments from interested parties on the bioidentical hormone issue.
If you're a doctor or a woman who's had an experience with bioidentical hormone use and would like to submit an opinion with the FDA, you can do so until April 4, 2006. Use this link to file comments
For more information about bioidentical hormone therapy, you can visit the web site for Dr. Wright's clinic: tahoma-clinic.com.
- end of HSI Baltimore article -
From: Julian Whitaker, M.D.
Sent: Saturday, March 11, 2006
Subject: Stop Wyeth and the FDA
Stop Wyeth and the FDA: Your Hormones Are in Danger
Bio-identical hormones are in danger, and we must act quickly to protect your right to use these safe, effective, natural therapies.
Wyeth, one of the world's pharmaceutical giants, filed a Citizen Petition with the FDA requesting that compounding pharmacies be prohibited from providing natural hormones - and we only have until April 4, 2006, to stop them.
Show Me the Money
For years, Wyeth counted Premarin (conjugated estrogen) and Prempro (Premarin and synthetic progesterone) among their bestselling drugs. However, since 2002, when a large, well-publicized clinical trial showed that these drugs increased risk of breast cancer, blood clots, heart attacks and strokes, sales have plummeted from more than $2 billion in 2002 to $880 million in 2004.
The petition, which is rife with inaccuracies, is supported by a number of medical societies and patient advocacy groups that have financial ties to Wyeth. In fact, even the FDA has financial ties to Wyeth, reaping in the form of "drug user fees" required by the agency. Folks, this isn't about protecting women from the "dangers" of natural hormones. It's about protecting Wyeth's bottom line.
Let's Fight Back
We must hold off this threat to freedom of choice in the medical marketplace. Voice your opposition to the Wyeth petition at the FDA website. Simply fill in the required information, followed by your comments. Here's what I wrote:
"You taking away my right to have a compounding pharmacy fill a prescription for bio-identical hormones (hormones identical to those made in the human body) because Wyeth is losing money on horse estrogen and synthetic progesterone is unconscionable. I vigorously oppose your attempts to do so and will oppose them for as long as necessary to maintain my freedom of choice in the medical marketplace."
Act today. The comment filing period ends on April 4, 2006.
To your health,
Julian Whitaker, MD
Hormone Battle: Big Pharma vs. Small Biz
The debate surrounding prescription hormones for women has pitted drug company Wyeth against small pharmacies and makers of alternative therapies ... "The FDA has yet to rule on Wyeth's complaint, but the huge corporation has stirred up a hornet's nest of opposition from women and doctors around the country, who see it as a classic case of Big Pharma throwing its weight around against small businesses and seeking to remove an important element of choice for suffering patients.
This article on the Business Week website has a comment facility for readers to add their 2 cents...
Download poster to put up in a public place
A small poster that can be printed out and put up in public places. It is available at this above in PDF format, ready for you to print. Cut the strips on the bottom so people can take one if they like, and distribute...
Hormone replacement dispute rages
Wyeth Pharmaceuticals has filed a petition with the FDA to restrict the plant-based compounds.
March 18, 2006
There's a new conflict brewing over hormone replacement therapy. At the center of the debate: Bioidentical hormones — custom-made, plant-based prescriptions women use as alternatives to synthetic hormone therapies.
Popular Menopause Treatment Comes Under Fire From Drug Company
'Bio-Identical Hormones' Are Custom-Made by Compounding Pharmacists
By ARTHUR DELANEY
Her doctor had first prescribed an estrogen patch, but it didn't help for long. In 2000, after hearing about "bio-identical" hormone replacement therapy from a friend, she requested a measurement of her hormone levels from the Wisconsin-based pharmacy Women's Health America. Women's Health then sent the results of a saliva test to her doctor, who wrote a prescription for progesterone cream, which Women's Health custom-made for her. "Within two weeks, I knew that there was hope," Danielewicz said. She now feels like she did before menopause and credits her customized medication with saving her when manufactured drugs didn't work as well.
April 2007: Health Freedom Foundation - Act Today on Compounded Medicines Bill !
(link no longer active)
Legislation threatens to halt drug customizing
"At AstraZeneca, we recognize that compounding of medications by pharmacies, when medically necessary and done at the direction of a physician, may be beneficial to some patients. However, patient safety is a key priority for AstraZeneca, and products manufactured by pharmacies under the guise of compounding are not subject to FDA oversight, including rigorous testing to ensure the safety, potency and efficacy of the drugs. With pharmacy manufactured products, there is no guarantee patients receive the exact medication prescribed by their doctor."
How moving, their concern for patient safety. No word about the many people who die from the correct administration of their registered drugs. Perhaps a reason for Astra Zeneca's support for this legislation is a fear that compounding of bio-identical hormones cuts into their business with useless and often dangerous hormone-replacement drugs.
January 2008: Hot Flash: FDA Warns About BHRT Drugs
The agency sent warning letters to seven compounding pharmacies operations that their claims about the safety and effectiveness of their allegedly bio-identical hormone replacement therapy, or BHRT products, are unsupported by medical evidence, and are considered false and misleading. The move comes, partly, in response to a citizen's petition filed by Wyeth, which wants to stop compounding pharmacies from making bioidentical versions of Prempro.
The FDA Attacks Women – Declares Estriol Illegal
In a shocking and blatant attack on women, the FDA has declared estriol illegal. This move is designed to stop compounding pharmacies from making bio-identical hormone creams and will also stop over-the-counter estriol-containing creams from being sold to women. The FDA has no report of any problem from these creams. It is acting on a complaint from Wyeth (the makers of estrogen-containing horse urine extract and Centrum vitamins). Millions of women are adversely affected.
Wyeth & Pfizer Unit Must Pay $27M In Hormone Case
The jury ruled today that Donna Scroggin should receive $19.3 million from Wyeth and $7.7 million from Upjohn in punitive damages. Jurors ruled in favor of Scroggin last month and decided that Wyeth inadequately warned her that its Premarin and Prempro drugs carried an increased risk of breast cancer. The lawsuit also named Upjohn, which made Provera. Wyeth plans to appeal.
Pfizer And Wyeth Sued By Nevada Attorney General
Attorney General Cortez Masto claims Nevada consumers and doctors were misled about the safety of Wyeth's Premarin, Prempro and Premphase, and Pfizer's Provera.
"When drug companies purposefully misrepresent the safety and efficacy of their drugs, or promote their drugs in a deceptive way, everybody loses," Masto says in a statement. "We're confident we have the facts necessary to prove this case, and we hope this lawsuit and its outcome will deter improper drug company practices in Nevada."
Wyeth Paid Ghostwriters To Boost Prempro
Wyeth paid ghostwriters to produce medical journal articles favorable to its Prempro hormone replacement therapy, according to Congressional letters seeking more info about the drugmaker's involvement in medical ghostwriting, The New York Times reports, adding that at least one article was published even after a federal study found the drug raised the risk of breast cancer.
posted by Sepp Hasslberger on Tuesday January 31 2006
updated on Tuesday December 21 2010
URL of this article:
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