Save Access to Bio-Identical Hormones

[Guest guest]

Save Bio-Identical Hormones

Dear Arnold Gore,

 

Now is the time to act! Preserve our access to bio-identical hormones and

protect the right of the consumer to choose and the practitioner to practice

without unwarranted interference by the FDA.

 

On January 9, 2008, the FDA sent numerous pharmacies, large and small, an

order to stop using Estriol, and the term “bio-identical†in their hormone

replacement formulas. This is an unprecedented attack on compounders, patients

and physicians because until now NO compounded drug component with a USP

monograph has been withdrawn from circulation unless there has been evidence of

harm to patients. Yet that is what the FDA is doing! If they can do it to

Estriol, they can do it to anything they wish to!

 

The FDA admitted in their press conference that there is no evidence of harm

to any patient from the use of Estriol in compounds. It has been used

since 1980, is available throughout the world in numerous prescription

compounds

approved by other nation’s FDAs, and there is even an investigational new

drug application, approved by the FDA, that uses much higher doses of Estriol

than is used in any BHRT formula.

 

What You Can Do

_Read the timeline and Draw Your Own Conclusion_

(http://ga4.org/ct/671BQHK1XmQ6/) – is the FDA doing Wyeth’s bidding?

_Contact Congress and the President_ (http://ga4.org/ct/611BQHK1XmQg/) of

the US and let them know that you want the FDA to stop attacking compounding

medicine.

Personalize your letter. Tell your story, edit to reflect your points of

interest (this is VERY important, please take the extra time!).

_Spread the word!_ (http://ga4.org/ct/6d1BQHK1XmQb/) We need the loudest

voice possible – let your contacts know of this threat, _send an email._

(http://ga4.org/campaign/bioidentical/forward/kswie54l7j68wt3?) Tell people

to

visit _www.healthfreedom.net_ (http://www.healthfreedom.net/)

.. Download, print, and distribute our flyer (_click here_

(http://ga4.org/ct/6p1BQHK1XmQO/) ) and if you don’t have a printer, let us

know how many you

need.

_Join AAHF_ (http://ga4.org/ct/Od1BQHK1XmQI/) so we can continue to lobby

on this and other important issues.

Make a _tax-deductible donation_ (http://ga4.org/ct/O11BQHK1XmQW/) to the

Health Freedom Foundation so we can continue educational efforts and fund a

lawsuit to block the FDA’s assault on bio-identical hormones.

 

 

(http://ga4.org/campaign/bioidentical/kswie54l7j68wt3?)

Send a letter to the following decision maker(s):

Your Congressperson

Your Senators

Below is the sample letter:

Do Women Need FDA-approval Before They " Manufacture " Estriol?

Dear [decision maker name automatically inserted here],

On January 9, 2008, the U.S. Food and Drug Administration sent warning

letters to pharmacies to stop providing Estriol in their bio-identical hormone

preparations for post-menopausal women and were ordered to stop using the term

" bio-identical hormone. "

 

Countless women currently rely on replacement hormones that are prescribed

by their doctors and compounded in local pharmacies.

 

Estriol is the weakest of the three types of estrogen (the other two are

estradiol and estrone) and is derived from a plant source and therefore

unpatentable in the US. Estriol is utilized throughout Europe and other places

in

the world as a component of prescription drugs, including by some of the

manufacturers of FDA " approved " synthetic hormones. Yet the FDA claims that

Estriol is " a new and unapproved drug " and that " the safety and effectiveness

of

Estriol is unknown. " That is directly contradicted by the fact is has approved

an investigational new drug application at UCLA that uses Estriol to treat

MS patients at many times the level of Estriol found in bio-identical hormone

prescriptions.

 

Estriol is used in 80% of bio-identical hormone replacement therapy

prescriptions and is made by the human body. Research indicates it is a very

protective female hormone. In a recent press conference, the FDA admitted that

no

adverse event involving compounded bio-identical Estriol has ever been

reported even though doctors and hospitals have to report adverse events.

 

Research involving 15,000 women funded by the Department of Defense and

conducted at Kaiser-Permanente Oakland found that women who produced the most

Estriol during their first pregnancy had 58% less breast cancer over the next

forty years. Estriol has had a USP Monograph since 1980. In the Food and Drug

Administration Modernization Act of 1997, Congress acted to stop the FDA's

claim that compounded drugs were somehow " new drugs. " The law passed clearly

stated that items with a USP monograph could be compounded.

 

At the same time , the FDA continues to support synthetic hormone

replacement drugs offered by the big drug companies, even though studies have

raised

questions about possible heart and cancer risks from these hormones - a fact

the FDA knows full well, since they have placed their own Black Box Warnings

on each of them.

 

These drugs come from horses or are imprecise versions of natural human

hormones. Why would any woman prefer horse hormones or imprecise-yet-patentable

copies of human hormone molecules to ones chemically identical to those found

naturally in her body?

 

The FDA is ignoring the 70,000 responses from the public urging them to not

restrict access to bio-identical hormones and appears to be in acting in the

best interest of synthetic hormone manufacturers who have made it well known

that they wish bio-identical hormones would be banned as it would open the

market for their dwindling products' sales.

 

I urge you to take action immediately to preserve congressional intent in

the FDA reauthorization bill in 1997, and stop the FDA from denying women the

right to choose their own hormone replacement therapy, and denying the right

of physicians to practice medicine within their scope, training and

expertise. There is no valid scientific or medical reason for this new action

by the

FDA.

 

I urge you to stop the FDA's usurpation of power. I hope you will help to

preserve our access to bio-identical hormones.

Sincerely,

 

Arnold Gore

 

cc:

President George W. Bush

(http://ga4.org/campaign/bioidentical/kswie54l7j68wt3?) Take Action!

Instructions:

_Click here to take action_

(http://ga4.org/campaign/bioidentical/kswie54l7j68wt3?) on this issue or

choose the " Reply to Sender " option on your email

program.

Tell-A-Friend:

Visit the web address below to tell your friends about this.

_Tell-a-Friend!_

(http://ga4.org/campaign/bioidentical/forward/kswie54l7j68wt3?)

What's At Stake:

On Monday, February 4th, Dr. Jonathan Wright and others sponsored an ad

supporting bio-identical hormones in numerous papers across the nation.

Therefore, the time to write your member of Congress and the President is right

now. If the FDA wins on this issue, compounded medicines will be a thing of

the past, and personalized medicine will be lost to a “one-size-fits-allâ€

synthetic drug world where unpatentable medicines like natural hormones, IV

vitamins, and many other medications we take for granted will be lost to us.

So join the fight today and preserve the right of the consumer to choose

and the practitioner to practice.

In addition, we have discovered that for $100,000 we can file a law suit to

enjoin the FDA from taking further action. Unfortunately the compounding

pharmacy industry is strapped because of the legal costs involved in answering

the latest FDA complaints, fighting the Midland case, and other assaults by

the FDA these past few years so we really need the practitioners and patients

to step up to the plate. Remember the FDA’s goal is to end compounded

medications and they have been at it for years. Because your tax dollars pay

for the lawyers they use to harass health care professionals like compounders,

the FDA simply plans to run our side out of money.

The FDA has really gone out on a limb, especially with the smoking gun

memorandum discovered under the Midland case, a memo that states that the FDA

does not have authority under the law to do this, but with a little

“creativeâ€

interpretation, they can get at these pesky compounders. At this point,

help the Health Freedom Foundation to saw that limb off from the other side,

since they have started already.

Join the American Association for Health Freedom and help us reach your

elected officials and educate them about the importance of protecting your

right

to access bio-identical hormones.

Provide your tax-deductible donation to the Health Freedom Foundation so we

can help fund the law suit to block the FDA’s assault on bio-identical

hormones.

Together we can win. Thank you for joining in this vital effort!

 

Campaign Expiration Date:

April 30, 2008

 

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[Guest guest]

This already happened in California a number of years ago (around 3 or so?), and

I've not been able to determine the whys and the wherefores of it. To my

knowledge, the supposedly uber-liberal Nancy Pelosi was the one who pushed the

bill through (although I could be mistaken about that). California has

determined that bio-identical progesterone is a threat to the environment and a

carcinogen. It cannot be sold here, PERIOD. --Or ordered online from an

out-of-state supplier. However, if someone wants to purchase a Rx

progesterone-type hormone for the purpose of hormone replacement therapy, then

that's perfectly legal. Excuse my French--as they say--but WTF is UP with

that?! REAL progesterone is verboten, and phony progesterone is OK?! It bogles

my mind that this could have taken place in California, of all places! It's so

nighmareisly 1984-ish.

 

Cyn

 

 

 

Never miss a thing. Make your homepage.

 

 

[Guest guest]

cynthialstern1 (Cyn Stern) wrote:

 

>California has determined that

> bio-identical progesterone is a threat to

> the environment and a carcinogen. It

> cannot be sold here, PERIOD. --Or

> ordered online from an out-of-state

> supplier.

 

Thanks for explaining this. I live in MA. The last time I ordered

progesterone cream from Vitacost.com, I noticed a notation on the

product page about the California ban on it. I believe it said

something to the effect that the " the state of CA has determined that

progesterone is a carcinogen. " I couldn't believe it. Ironically, CA

was the home of the late Dr. John Lee, I believe, who was a leading

natural progesterone advocate.

 

How in the name of heaven could natural progesterone cream be a threat

to the environment? It's not like you take it orally and excrete it

into the sewer system like all the toxic drugs people ingest.

 

If anyone has more information about how this ban on progesterone cream

in CA came to be, please post it.

 

Cathy B.