The FDA
has told women and their doctors: stop using bioidentical hormones. Your choice
and your doctor’s prescription don’t matter. Heart and cancer
questions raised in 2002 about FDA “approved” synthetic women’s
hormones don’t matter. Act now to defend your right to bio-identical
hormones!
Countless women currently rely on replacement hormones
that are prescribed by their doctors and compounded in local pharmacies. These
compounded hormones are biologically identical to the ones produced in the
human body. The formulas include bio-identical, naturally occurring estrogen
hormones such as estriol.
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Nevertheless, on January 9, 2008, the U.S. Food and Drug
Administration ordered pharmacies to stop providing bio-identical estriol.
Even though 80% of bio-identical hormone replacement therapy prescriptions use
it, and estriol is manufactured by the human body, the FDA makes the outrageous
and nonsensical claim that estriol is “a new and unapproved drug” and
that “the safety and effectiveness of estriol is unknown.”
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Bio-Identical Estriol is Safe
In a press
conference, the FDA admitted that no adverse event involving compounded
bio-identical estriol has ever been reported. 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.
Every woman who has
ever had a menstrual cycle or been pregnant knows that natural estriol is both
safe and effective. Estriol is a major estrogen throughout a woman’s
reproductive years, and soars to enormous levels (up to a thousand times)
during pregnancy.
How can bio-identical estriol, identical to every
woman’s natural estriol, be unsafe or ineffective? And how can the FDA
claim that a substance present in our bodies from the dawn of humanity is a
“new and unapproved drug”?
Speaking the Truth is Not a
“False Claim”
The FDA is also ordering pharmacies to stop
using the terms “bio-identical hormone replacement therapy” and
“BHRT” on the grounds that these terms represent “false
claims.”
False claims do exist in any field and should not be
allowed. But describing these hormones accurately is not a false claim.
What’s Going on Here?
For decades the FDA has
called any claim about a natural substance, no matter how accurate, a
“false claim” if it is not specifically FDA “approved.” But
there’s a big “Catch-22”: It costs up to a billion dollars to
achieve FDA approval. As a general rule, companies cannot afford to spend these
huge sums unless their drug is patent-protected. And again, as a general rule,
natural substances such as bio-identical hormones cannot be patent-protected.
As a result, the FDA has “approved” only a very small handful of
natural substances, sometimes only after being sued and ordered to do so by a
judge.
Bottom line: The FDA says that natural substances must be
“approved” to make any claims about them, but knows full well that,
under the current FDA system, there is no way to get most natural substances
“approved.”
Why is the FDA So Hostile to
“Natural” Medicine?
“Alternative,”
“natural,” and “integrative” medicine is booming today. A
growing number of doctors and patients believe that natural substances are
often safer and more effective than synthetic, hyperexpensive but
“approved” patent medicines (drugs). So why is the FDA so hostile?
A possible explanation: the FDA is worried that natural substances will
eat into the sales and profits of its clients, the big drug companies. Fees
from the big drug companies pay for a sizeable share of the FDA’s budget
and staff. There are many other financial ties as well.
In October
2005, Wyeth, a large patent medicine (drug) company, filed a
“citizens’ petition” demanding that the FDA ban bio-identical
hormones that compete with Wyeth’s synthetic hormones. Sales of
Wyeth’s hormones had plummeted as more and more women and their doctors
turned to bio-identical hormones. (Recently Wyeth has faced layoffs and
facility closings for this and other reasons.)
Over 70,000 women,
pharmacists, and doctors wrote to the FDA, the overwhelming majority asking the
Agency to reject Wyeth’s attempt to shut down the competition and preserve
access to bio-identical hormones. The FDA sided against the women and with
Wyeth.
Are the FDA “Approved” Drugs Safe?
And
what do we know about the “approved” patent medicines (drugs) from
Wyeth and others that the FDA wants you and your doctor to use for hormone
replacement? These once-bestselling 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 precisely
identical to those found naturally in her body?
Studies have also
raised questions about possible heart and cancer risks from these hormones.
(See the Journal of the American Medical Association 288 [3], pp. 321-333; [7],
pp. 872-884). This is why these drugs currently have Black Box Warnings on
them.
Why Shouldn’t Women and Their Doctors Have a Choice?
It’s time to take action again!
We are the
HOME (HANDS OFF MY
ESTROGENS!) Coalition, a coalition of licensed doctors and concerned
citizens. Please contact your congressional representative, senators, and the
White House immediately.
Or contact your elected officials directly.
You can use these numbers to obtain an address or to leave your comments:
The U.S. Senate and the House of Representatives:
(202) 224-3121
(switchboard)
The White House:
(202) 456-1414 (switchboard); (202)
456-1111 (comments)
—Jonathan V. Wright, MD Tahoma Clinic, Renton,
Washington A.B., Harvard University (1965) M.D., University of Michigan (1969)
First North American prescriber of bio-identical hormones for clinical use,
1983
For the HOME Coalition: American Academy for Advancement in
Medicine (ACAM) American Academy of Environmental Medicine (AAEM) International
College of Integrative Medicine (ICIM) The Bio-identical Hormone Initiative
(BHI)
Index of Herbs for
Health
Index of
Herbs
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