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January 31, 2006

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

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.


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
****************************************************
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.

--------------------------------------------
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.

Link to comments page

To your health,

Julian Whitaker, MD


See also:

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...

Synthetic Hormones Put Millions Of Women At Risk For Cancer And Other Deadly Diseases -- Part 1 of 2

Synthetic Hormones Put Millions Of Women At Risk For Cancer And Other Deadly Diseases -- Part 2 of 2

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:
http://www.communicationagents.com/sepp/2006/01/31/wyeth_asks_fda_prohibit_bioidentical_hormones.htm

 


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Readers' Comments


I took Premarin for 2 years and I can tell you right now come hell or high water I WOULD NEVER TAKE IT AGAIN even if the FDA was ignorant enough to take away our right to decide what drug of choice we want in OUR BODIES.

I would help fight this every step of the way. My health and body and mind are much more important to me then to stick horse urine in my system ever again. The Bio Identical Hormones are the best thing I have ever taken, it has truly given me my life back.

Posted by: Patricia Hoffer on February 7, 2006 03:17 PM

 


this issue is not just about women as I am a 49 year old male and have the same problems with hormone replacment therapy,as my testoterone levels have dropped I found myself at home on the couch for 1.5 years in pain , no energy, no sex life, unable to work even the most mundane job.
The doctors went thru another year of tests and I finally talked them into giving me andro gel, and with in a week I was back to work and felt fine. after a year and a half, doctors wont give me anymore
androgel as there worried about the side affects, which in trials have been very few. Iam going for the
sottopelle treatment for men which is the testosterone pellet implants that are bioidentical and have no adverse side affects,and last for 4 to 6 months.
I WOULD BE SCREWED IF NOT FOR THIS TREATMENT!!
it is also avaliable for women to

Posted by: kevin golike on February 24, 2006 04:47 AM

 


I have been on Bio-Identicals for over a year now. I finally have my life back and feel in control of it. Before the bio identicals I was placed on Paxil and birth control pills and sleeping pills for weepiness, hot flashes and insomnia. I was told I was too young to be having these symptoms, so I must have been depressed. My anxiety levels were through the roof and my moods almost got me a divorce. A friend told me about the Bio identicals so I did some reading. Wihtin the first week of being on them I flet great, the hot flashes are gone my modds leveled out and for the first time in years I am resting. I encouraged my mother to get on them as well, she has suffered for 30 years with severe symptoms. Now she is doing great and no longer has to use a walker to get around. I hope the people involved in making these discions look at the whole picture and not just the almighty dollar.

Posted by: Ann Haworth on March 9, 2006 05:50 AM

 


I am so appalled, why is it we can abort a entire person out of our body but we can't decide what we want to put in it. We are also told we have to buckle up, yes I feel anyone in my car under the age of 18 should be but an adult should be able to decided things for themselves I thought that was my constitutional right, as long as it isn't illegal.

I took HRT for almost 20 years for what to end up more of a basket case with aches and pains then I would have if I had just left it all alone. I found out about a wonderful natural progesterone 5 months ago sure wish I had known about it 20 years ago I feel great and I feel like what I am putting into my body is safe. If any thing should be shut down it is the dispenseing of these harmful drugs just to make someone rich doesn't matter what it does to women just pat that pocket book of a drug company

Posted by: Becky Baucum on March 12, 2006 07:26 PM

 


I got off Combi-Patch with my gynocologist's support and am very successfully using a natural progesterone that I love. We are both very pleased. I am not happy with the side effects of HRT as I am one who has repeatedly had cysts in my breasts. I want to be able to chose, what I view as a safer alternative-natural progesterone!! Please keep it on the market so I have an option.

Posted by: Mary Hendrickson on March 13, 2006 07:59 PM

 


My Dr. took me off of Prempro a few years ago right after the scare came out.
I found this compounding pharmacy close to where I live and with my Drs. help I have been on these natural hormone creams for several years now.
I have felt great ever since.
So please give all women the choice to choose what is best for them.
Thank You

Posted by: Susan J. Lewis on March 16, 2006 03:07 AM

 


your taking away my right tohave compounding pharmacy fill a prescripton for hormones identical to those made in the human body because wyeth is losing money on horse estrogen and synthetic progesterone. i am appalled and strongly oppose this and will continue todo so for as long as need be to maintain my freedom of choice in the public marketplace. j. thrasher

Posted by: j. thrasher on March 16, 2006 08:27 PM

 


BHRT has made my life worth living.I can't think of going back to life the way it was before.I feel alive again.I can sleep,my joints dont ache,I no longer have night sweats and hot flashes that kept me from sleeping,I can think straight again,my skin is comfortable again and I'm happy again.The very thought of losing all of this because of the greed of Wyeth and others like it makes me sick.Don't let them take away our right to choose BHRT.

Posted by: lynn towne on March 22, 2006 11:42 AM

 


"A prescription for disaster" is what I call it if the FDA were to comply with Wyeth's request to prohibit the production of bio-identical hormones. Does the FDA need to be made aware that there are already more than enough ill people in this country - and that we don't need anymore. And Wyeth's Premarin and Prempro (and synthetic Progesterones as well) are certainly not the answer to hormone replacement. Regardless, what ever happened to our freedom of choice. Isn't that the underlying reason for which our country was founded?

But if anything should be prohibited it is Wyeth's Premarin and Prempro. These mass produced prescription hormones are given out like candy and even worse are being prescribed for the wrong reason. Premarin and Prempro are poorly made and make people ill. Instead of even considering to eliminate bio-identical hormones, the FDA should have Wyeth Pharmaceuticals take a taste of their own medicine, make it known that Premarin and Prempro are a mistake and a disaster, and just remove them from the market, and, that should have been done long ago.

I am a 41 year old woman who learned first-hand about the horrors of Wyeth's Premarin when I was put on it a few years ago. Luckily for me, I did not have a stroke or get cancer, or die from it for that matter, but I had another kind of nightmare: After suffering for many many years from a hormone imbalance (that was not diagnosed), and living in a fog and from exhaustion that was growing worse all the time, I tried to get this health problem resolved but could not. In my late 30's an incident woke me up to the fact that I truly was dealing with a hormone problem, and it absolutely had to get resolved. But getting any conventional doctor to understand this was impossible.

Finally, when I did get some of the attention I needed, I was prescribed PREMARIN, at first a .25 mg tablet - even though my Estrogen level was normal. But this only resolved my symptoms for about four hours until I fell back into a state of exhaustion. I needed someone to help me figure out why I only had the relief for such a brief amount of time. Eventually I learned about a "specialist" who claimed he could help me. He put me on PREMARIN as well, but, a very high dose, a total amount of 5 (five) mgs a day, or, the equivalent of 10 (ten) estrogen patches at a time (which we also tried.) This science experiment was a disaster and eventually made me very very ill. When that happened it caused me to feel as though my adrenal system stopped working and I could barely walk. I literally felt like a block of cement.

The doctor who was "helping" me assured me he was the only doctor in our state who could treat me. And I had already called all over the U.S. to try to find help.

Eventually I found my way into the offices of holistic doctors, where I learned the following: there was absolutely no reason for me to be on Premarin. Instead, I had a severe deficiency in my PROGESTERONE level that was easily determined through a simple blood test. My hormone imbalance had nothing to do with a need for PREMARIN.

What was determined was that I was going through Peri-Menopause and by then it was severe. What I needed was natural Progesterone Cream, a Compounded Hormone called Estriol, and years of Acupuncture. **NOT PREMARIN** Besides getting to the bottom of that, I found out that I was in severe need of Digestive supplements for Digestive Imbalances that had plagued me since I was two years of age.

The very low Progesterone level that caused me such debilitating symptoms is called Peri-Menopause and had also begun at a very young age.

More often than not, Peri-Menopause and Menopause are caused by a Progesterone deficiency, but unfortunately our conventional gynecologists and reproductive specialists do not know this. Of course, always, both hormones need to be tested to get the correct diagnosis and provide the correct treatment.

For sound information on women's hormones, I highly recommend this on-line article by Dr. I. Michael Borkin, called Women's Hormones 101 at www.mercola.com/2000/nov/12/womens_hormones.htm and the newsletters available through
http://www.womenshealthconnection.com the educational division of Women's International Pharmacy (http://www.womensinternational.com/). Another very informative website is www.saundramckenna.com.

I've created this 8.5 x 11 poster to create awareness so that many people can reply to the petition - so we may keep our rights to choose what's best for our hormonal health. Please feel free to download it, print it out, make cuts in between the strips at the bottom, and pin it up where there is interest. So far, it is getting a lot of attention on the bulletin board at my local natural food store. I have given some to my doctors' offices too. But I am only one person, and cannot hang enough on my own. Please help me to distribute them! Thank you!

Download poster to put up in a public place

I will do anything else it takes to help fight for this cause. Thank God for my holistic doctors!

(S. Hoffman March 27, 2006)

Posted by: S. Hoffman on March 23, 2006 11:50 AM

 


Keep bio-identical hormones on the market. They are much safer that the synthetic forms which I personally cannot take because they made me seriously ill.If you take them off the market it will be very clear that the FDA is not concerned with public safety.

Posted by: Carol Berman on March 29, 2006 04:46 AM

 


Comment filed with the FDA by "vitamin lawyer" Ralph Fucetola (www.vitaminlawyer.com)

... my comments submitted to FDA below:

As an attorney at law in NJ for 34 years, specializing in dietary supplements I am aware of the wording of DSHEA and the Court decisions stating that dietary substances are foods. I am aware that dietary supplementation to support normal hormone function, especially for "change of life" circumstances, is well within the intent of the statute and the letter of the Structure and Function Rule. Since such use existed prior to the approval of dangerous drugs to "treat" such normal change of life, the use is grandfathered.

It is wrong for the FDA to ban therapies that may benefit individuals (see AMA Code of Ethics Opinion 3.04) and contrary to public policy. Compunding Pharmacies are authorized by State Law to provide the health care services they provide and the compounding of natural dietary substance remedies to support normal hormone function, if not protected under DSHEA (as I believe they are) are well within the scope of "therapies that may benefit."

The proposal appears to be an obvious attempt by special interests to abuse the legal system to the manifest harm of the public. FDA officials who assist in this endeavor are engaged acting beyond the scope of their official status may be personally responsible for the resultant harm. As public officers your obligation is to deny the propsal.

When the authority of FDA was extended in the middle of the last century, Compounding Pharmacies were offered significant Congressional protection. That protection was recently extended by the US Supreme Court in Thompson v Western States Medical Centers.

It is simply false science - the typical voodoo science of the pharmaceutical cartel - to allow dangerous drugs while denying the public access to truthful information and access to natural alternatives.

No doubt if the FDA insists upon acting as a shill for the pharmaceutical cartel, the Supreme Court will once more need to remind the Agency that the Law is intended to serve the People, not special interests. Perhaps even Congress will feel the need to act, as it did unanimously in 1994, when it protected the public's right to access dietary substances that support normal structure and function.

Posted by: Sepp on March 29, 2006 10:42 AM

 


"YOU ARE TAKING AWAY MY RIGHT TO UTILIZE BIO-IDENTICAL HORMONES BECAUSE WYETH IS LOSING MONEY ON HORSE ESTROGEN AND SYNTHETIC PROGESTERONE IS UNCONSCIONABLE. I VIGOROUSLY OPPOSE YOUR ATTEMPSFOR AS LONG A NECESSARY TO MAINTAIN MY FREEDOM OF CHOICE IN THE MEDICAL MARKETPLACE".

Posted by: D L STARK on April 4, 2006 02:06 AM

 


I think it is an absolute crime for the United States Government is even concidering taking away mine and every persons right to choose between a natural choice vs ones given to us by the phamaceutical companies. Seems to come down to a money issue when it really should be about our health and what works best.

Posted by: C J Walbran on April 4, 2006 02:41 PM

 


I highly oppose Wyeth's complaint to the FDA to take away my right to take to take bio-identical hormones. I cannot and will not take the synthetic version. It made me greatly ill. BHRT has been my savior. This is the best I have felt in years. The people making the decision need to think about if this were their mothers, daughters, or even themselves, what would they want. Better health and a long life, or a fat pocket!!

Posted by: Shelly Wiggs on April 5, 2006 05:58 AM

 


I have had excellant results with these products. The action being taken against alternative medicine and it's products is just another death blow to females. How dare you take more from us. It is the ultimate disrespect for WOMANKIND. And for what...who will benefit most?...WOMEN....NO...THINK ABOUT WHAT YOU ARE DOING!

Posted by: Deborah Ulm on April 12, 2006 10:36 PM

 


I have been using this product for a very long time, I know it has helped me in many ways, My doctor said to keep using it.. She said many of her patients are taking it and that we have her blessings..................................

Posted by: Diana A. Boesch on April 13, 2006 01:27 AM

 


I have read the many testimonials for BHRT and I agree. I had to switch from Premarin to bio-compound for myself when I was diagnosed as having Major Depression when it was actually Menopause that I was going through. BHRT helped relieve all of my symptoms.

But I want to address what is happening to the beautiful horses----female, the horses that are kept for breeding, and kept pregnant repeatedly for Wyeth's pregnant mare's urine which is the major ingredient for Premarin and Prempro.

It is ethically, morally, spiritually wrong to use these horses just to make money and to keep populations of women all over the world believing that Wyeth's products are the only and best for a woman when she is being challenged with the changes that come with age.

Women will reach for anything that will give them relief and when their doctor's prescribe a synthetic for their symptoms the doctors should tell each women what is going into her body and how it is made. Also, each doctor needs to tell each woman that there is an alternative to using pregnant horse's urine, a more natural and better compound that is nearer to a human female's hormonal composition than Premarin and Prempro.

But the underlying deception which happens continuously in our contemporary western cultures about women's issues and what women put into their bodies, makes money for those huge companies that are not thinking about each individual and helping each woman and man get the best help. Wyeth and other huge companies are at a crucial point in their financial survival where they have to do whatever they can to cover their losses when instead they could get creative and re-think of how to join the alternative health system and make better and healthier solutions for all human beings and become a real hero instead of the villain who is on the constant prowl for a new kill.

Stop using the animals and the women for greedily gain and the world will become a better place, a more sentient place for all beings to live harmoniously with the Earth, our home. That's all....just re-think and get creative, Wyeth! Take your losses and get creative, join the alternative medical forces which will always turn to the naturals for cures, healing, and relief especially when your products stop working and make life worse for us and often kill us instead of helping us. Just stop using the animals, let them be free as they are supposed to be, as all beings are supposed to be free, not used for the superiority of mankind!

Posted by: Gaye Bennett on April 13, 2006 04:12 PM

 


I can not believe, this is even a consideration. It is NOT a safety or health issue. This is a selfish, deceitful, GREED issue. The possibility of outlawing bioidentical hormones is very upsetting and frightening to me. This would be a direct violation of our women's rights. I have been on bioidentical hormones, prescribed by my primary care physician through a compounding pharmacist, for 10 months. Previous 18 years, I was on the premarin products with very little success. And was a mess, emotionally and physically. Since I have been on the BHRT, I am and feel better than I have in 20 years. Also, a very important fact is, I no longer need a hypertensive drug, have been able to avoid bladder control, antidepressant and sleep drugs, which I needed, but refused. I no longer need these drugs. Can you see why Wyeth wants to outlaw the natural hormones? It is all about the money. And I hope and pray you will see that, and make the decision for the women's rights and wellbeing, vs the drug company's greed. Thank you.
Hilda Holbrook

Posted by: Hilda Holbrook on April 21, 2006 01:42 AM

 


According to the science on the comments page, there is NO science-based evidence that so-called "bio-identical" hormones are safer than pharmacologically created hormones. Anecdotal evidence (with its notorious flaws) aside, it's a well-established fact that ALL bio-active compounds have side-effects, so claiming that a so-called "natural" hormone doesn't have side effects that a brand-name hormone does, is disingenuous.

Additionally, it seems that these compounders are up the same old tricks that the vitamin supplement manufacturers routinely play: they don't always give you the substance you pay for; in fact, sometimes the substances they provide are downright dangerous.

On the flip side, the compounds are much, much cheaper than the brand-name versions, but it's unknown whether the cost reduction is worth the potential risk to life and health from what is essentially an unlicensed practice of medicine.

After reading the comments -- complete with a dozen non-profit women's health orgs urging support for the measure, I don't believe that those claiming that it's all about profit have a leg to stand on. Sure, profit is involved -- you'd have to be incredibly naive to believe that Wyeth isn't going to do whatever they can to protect billions of dollars of revenue. Frankly, maybe this could be the tip of the iceberg of a discussion -- carried out nation-wide -- about the merits of generics versus brand-name drugs, and of lessening the pharma companies death-grip on so-called "intellectual property."

Posted by: Tom C on June 7, 2006 11:36 AM

 


So interested in this subject. Would like to find a doctor who believes in bio-identical hormone in my area, Central NJ. Thank-you

nshapanka (at) hotmail (dot) com

Posted by: Nancy Shapanka on October 15, 2006 06:32 AM

 


I know I'm way too late for the petition. Does anyone know how it turned out?

Personally, I'd rather base my decision to use BHRT on personal testimonials and my doctor than on FDA testing and those horrible "here's everything that can happen to you if you take this drug" inserts. We all have to make decisions for our own selves, but I really resent the BIG drug companies trying to take away one of my choices.

Tom C.: It IS about profits!!!

I stopped taking the FDA approved drugs a few years ago when I was enlightened about where these products come from and learned about the terrible conditions in which these beautiful animals are raised, kept and ultimately destroyed.

DITCH PREMPRO & PREMARIN and ADOPT A HORSE!!!

Posted by: Helen C on November 10, 2006 11:32 PM

 


It is obvious that the FDA has been waging a war against bioidentical hormones because of a citizen's petition from Wyeth. Wyeth makes the synthetic hormone, prempro, a drug found to cause cancer and heart disease in the WHI study published in JAMA July 2002. Wyeth has lost 2 billion in sales since millions of women have switched away from the Wyeth product to compounded bioidentical hormones, a safer and more effective alternative. Wyeth wants to use the FDA to eliminate its competition. The problem is that the FDA does not regulate compounded bioidentical hormones, the states do the regulation. And the FDA's actions have only demonstrated that the agency is completely inept and corrupted by special interest groups in the drug industry. To read more about this Click Here Jeffrey Dach MD

Posted by: jeffrey dach md on January 12, 2008 10:40 PM

 


Wyeth makes Premarin and Prempro pushing everyone to use this Horse Hormone drugs which causes cancer and Heart Disease and Stroke in the WHI study Published in Jama July 2002.

WYETH and FDA have lost lot of money in revenue.

Interestingly the FDA still allows this drug being sold despite the Medical Evidence against it. In any other country it would have been BANNED, but in AMERICA. God bless American WOMEN.

This is the conspiracy against AMERICAN WOMAN dying of Cancer Blood Clots and Strokes due to Premarin Prempro but the Money Hungry Drug Company Wyeth is ready to sell American Women lives for their financial benefit.
What is going to happen NEXT>......keep reading and use your common sense....save your sister mother and ladies of the house and friends and families....Become aware...of plant based natural bio=human body identical hormones and demand. may be go to http://www.iacprx.org/site/PageServer?pagename=P2C2 website to learn what you can do...

Go to wyeth.com website read yourself about the drug side effects.


Posted by: KUMAR on January 17, 2008 05:16 AM

 


i had a tah ,bilateral salpingo oophorectomyi in may.tried numerous hrt medication,but all made my joints really bad.my gp prescribed premarin 2.50 mg it has made me so ill.my joints are now so bad they feel like their going to crack.joint and neck pain is unbearable, and im sleeping day and night,i have seized up.please could someone help me.im living on pain killers and anti inflamatories. but nothings helping me.reading this information on this web site i think i should stop the premarin.please, please can you help.

Posted by: karen espley on January 22, 2009 09:48 AM

 


Thank you very much for sharing this wonderful information with us.

Posted by: Compounding Pharmacy on August 1, 2012 02:42 AM

 















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