Posted on 03/20/2006 4:54:15 PM PST by goodnesswins
PROTECT YOUR RIGHT TO CHOOSE COMPOUNDED BIO-IDENTICAL HORMONE MEDICATIONS
THE FACTS: Recently, Wyeth Pharmaceuticals, maker of Premarin & Prempro, (drugs derived from Pregnant Mares Urine – yes, horses pee) filed a Citizen’s Petition with the Food & Drug Administration (FDA) asking the FDA to impose harmful restrictions on the compounding and dispensing of Bio-identical hormone replacement therapy (BHRT). (Bio-identical hormones are manufactured to have the same molecular structure as the hormones made by your own body.) This petition would eliminate the availability of compounded bio-identical hormones, which are prescribed by healthcare providers and prepared by pharmacists, to meet the unique needs of each individual patient.
THE FUTURE: Wyeth’s petition asks for strategic restrictions that, if granted, would put an end to all pharmacy compounding. These restrictions would severely restrict or limit the ability of healthcare providers to treat all their patients, not just women and men on BHRT. Prescribing BHRT is considered “off-label prescribing”, which physicians do routinely with both compounded and manufactured medications. With your help Wyeth can and must be defeated in its attempt to restrict your right to choose “compounded” medication. This is all about “$$” for Wyeth.
WHAT CAN YOU DO? Time is of the essence? We need 20 000 comments filed with the FDA by April 4, 2006. It is also extremely important that you file your comments with your U.S. Congressional elected officials. Please note that your comments should be in written form sharing your personal experience with bio-identical hormones stating the positive impact it has had on you and your quality of life.
HOW DO I SUBMIT MY COMMENTS? You may fill out the accompanying form and either fax or mail it to the FDA Division of Dockets Management. Or you may go online to the International Academy of Compounding Pharmacists (IACP) website (www.iacprx.org) and click on “Wyeth Files Petition Seeking FDA Action Against Pharmacies That Compound BHRT”. This site will give you more information on Wyeth’s action and a way to make your comments online to the FDA.
WE MUST WORK TOGETHER TO FIGHT FOR THE FREEDOM OF PATIENTS, PHYSICIANS and PHARMACISTS TO CONTINUE TO USE THERAPIES ESSENTIAL FOR HEALTH AND QUALITY OF LIFE.
Please forward this information to family, friends, and physicians who would support this effort. Thank you.
------------------- SAMPLE LETTER
FAX # 301-827-6870
Date
Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305 Rockville, MD 20852
RE: Docket 2005P-0411
Dear Sir or Madam:
My name is ______________________________________and I have been taking bio-identical hormones for _________________. It has been the only thing which worked to relieve my symptoms (_____________________________) and keep me able to do my daily activities. Without BHRT I would be unable to live a normal life.
I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them.
Without this medication, I would be unable to do the following: ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
The benefit of BHRT is that it is prepared just for me. I am concerned that Wyeth’s petition (Docket #205P-0411) would limit the ability of my physician and pharmacist to keep prescribing and preparing these individualized doses for me. The FDA should reject Wyeth’s petition.
Sincerely,
I don't take these drugs, but I will bump the thread so that others who do will see it. I will also send a note opposing Wyeth to the FDA, but since I don't take the drug I don't know if it will be considered.
The women of FR need to have a look at this because Wyeth Pharmaceuticals is cutting off a few years to the average woman's lifespan by banning these drugs. Premarin & Prempro can damage the liver in same cases, bio-identical hormones will not damage the liver.
This is no better than the RIAA attacking new technology. Same principle.
THANK you for your info, Paul.......For OTHERS....I was diagnosed with RHEUMATOID ARTHRITIS.....but couldn't believe it....so went looking for alternatives....bio-identical hormones have been a lifesaver.....that and a little levothyroxine, too.....
Anyone know who the "HEALTH" pinger is?????
Thanks, MM.....you're lucky!
At any rate, it goes against my beliefs to let a company pull this trick.
horse pee ping coleus
Um...did you see my post above......I was told I would be on $10,000 a year rheumatology drugs......I didn't buy into it.....but, it's hard to find a good doc these days who will test ALL your hormones and apply what's now known as a "cure" for much of what happens as we age....Good luck.
The reason the drug companies want the bio-identical hormones banned is because they can't be patented, so they can't make money.
Read the books "What Your Doctor Won't Tell You About Menopause" and "what Your Doctor Won't Tell You About Breast Cancer" to see why these drugs are so important and so threatened.
I am not in a more serious condition, and for that I am thankful.
Thank you for the post and the petition. These prescription natural hormone creams are safe and highly effective. I wouldn't be without mine, and I've been using it with great results for about 8 years. It's hard to believe that anyone who believed in promoting good health would want to pull them. But then, the drug companies have much to lose. Imagine, if I used their prescriptions I would need another 3 or 4 just to mask the side effects. Instead, I'm in good health and feel younger than ever, thanks to bio-identical natural hormones.
We took her to the 2001 Inauguration in a wheel chair. She went back in 2005 walking. She'll be walking the March for Life when we can get back there to do it. We pushed her before.
Would you consider pinging people for this? Purty please?
Would you consider pinging your "health and science" list? Purty please.....
Please do not spam the state TOPICS. Those topics serve to help monitor news of interest to specific states.
sorry, but I THOUGHT this would be of interest to the STATES.....but, hey, you make the call...
You're welcome. Interesting. Like I said, there is a court case waiting if the FDA goes ahead with the ban. But such a ban would happen only in the store shelfs of the U.S., not the rest of the world.
Think about it. I trust you'll understand.
Actually herbs did not have enough hormones them to affect the human body to any large degree.
Actually herbs did not have enough hormones in them to affect the human body to any large degree.
whatever.....
I've always wondered why they don't make more human hormones since they can make Humulin Insulin now. The Prempro I was on for 4 months really brought out this AI disease with a vengeance.
Women on birth control pills should also know that our testosterone receptors can be suppressed for up to 6 months after stopping the pills. Believe it or not, we have that hormone as well for the health of our private parts.
I cannot believe docs still prescribe HORSE URINE....it's an idiotic thing to do these days.....glad you're getting helped. Spread the word.
should read....glad you ARE spreading the word....
Here's a link from the International Academy of Compounding Pharmacies:
http://www.iacprx.org/site/PageServer?pagename=home_page
You can click on the front page area on BHRT for a form to send to the FDA.
Thanks, maybe tomorrow you could post a thread with THAT web site in it.....it might get more traffic than this one is getting. :o>
Maybe.
While I was trying to look this up again, it looks like Nader's Public Citizen is saying the FDA has 2 standards for drugs. So there is a big government knows best sort of thing going on.
The group I joined has women from Canada, England and parts of Europe who can't get the proper drugs at all. And the doctors can be awful and your just out of luck for months 'till you get an appointment with a specialist and it maybe an awful specialist.
Thanks....I'm off for the night....and yes, this being a threat to pharmaceuticals it doesn't surprise me what lengths they go to to stop compounding...i.e. "not putting in active ingredients."
The Chinese gave them only a small window of time for the agents to go into this remote mountainous region to look at the "manufacturing " of this compound.
They found open windows with flies going. Their time was up without seeing much. That was it.
Modern medicine is in a terrible state.
No problem. Thank you for clearing that up.
Modern medicine is in a terrible state.
That is true in so many different ways.
Here's a link for a short synopsis of what is proposed.
http://www.smart-publications.com/articles/060302-wyeth.php
I have to bring the kids to our Tuesday appointment. But, this may restart this post.
Nancy
"Bio-Identical Hormone Replacement Therapy is Under Attack !
Wyeth Pharmaceutical, the makers of Premarin® and Prempro®, have seen a 72% decline in sales recently, after the famous 2002 Women's Health Initiative Study had to be halted because the results showed that women taking these popular drugs were at heightened risk for blood clots, breast cancer, heart attack and stroke! These very drugs had—for years—been sold to the public as good protection for bones and heart!
Now Wyeth is using lobbyists to influence the Food and Drug Administration (FDA) to prevent women from using natural safe options for hormone balance. Bio-identical hormones are safe and effective, often relieving the uncomfortable symptoms of hormonal imbalances without the potentially life-threatening side effects of chemical drugs like Premarin. They want to make it illegal for us to use compounded (individually prepared) pills and creams from natural "bio-identical" sources.
At least 20,000 signatures and notes are needed by April 4 to stop this travesty.
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."
This is an Excerpt.
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