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The FDA has extended the comment period on the Citizens
Complaint filed by pharmaceutical giant Wyeth (Docket: 2005P-0411)
against the sale of natural hormones ("bioidentical") by
special pharmacists. Wyeth filed their complaint in October, 2006 claiming
that both the bio identical hormones and the pharmacists who filled
the customized prescriptions posed a health hazard. After receiving
37,000 written responses, the FDA will accept comments until May 4,
2006.
Croton on Hudson, NY (PRWEB) April 10, 2006 --
The FDA announced that it would allow comments on the Citizens Complaint
against bio identical hormones until May 4, 2006 although the original
comment period expired on April 4, 2006. Wyeth filed their complaint
(Docket: 2005P-0411) on October 6, 2006 asking the FDA to impose significant
restrictions on consumer’s access to bio identical hormones.
These natural molecules are prescribed by physicians in amounts and
delivery systems which are customized to the need of each patient.
The prescription is then filled by special pharmacists who are trained
in the compounding of these individualized formulations.
Comments
may be sent to the FDA via this link.
Consumers, compounding pharmacists, physicians
practicing bio identical and health freedom advocates are up in arms
over this action by Wyeth. States, not the federal government have
jurisdiction over compounding pharmacies. Health freedom advocates
characterize Wyeth's move as seeking an extension of federal power
on its behalf and attempting to eliminate a competitor in a failing
market.
Health freedom advocates also fear that this
is merely another step in the restriction of the consumer's right to
make their own health choices whether or not they add to the pharmaceutical
or medical coffers. Physicians and patients who have experienced the
benefit of bio identical hormones fear that they will loose a powerful,
gentle and effective option to drugs when they need to replace and
regulate their hormone levels. During the final days of the comment
period, the traffic was so heavy that the FDA's electronic comment
system was reportedly overwhelmed.
Hormones are biologically active molecules which
have body-wide effects at very low concentrations. Women's bodies make
reproductive hormones throughout their reproductive lives but the levels
fall sharply, changing their balance, during and after menopause. Natural
hormones cannot be patented because they occur in nature so they are
less expensive than prescription drugs despite the effort involved
in compounding them individually. Synthetic and conjugated hormones,
on the other hand, are patented and thus carry a higher cost to cover
the expenses involved in developing and marketing the drug.
Small changes in molecules which render them
patentable may also render them toxic or difficult for the body to
process. Hormone receptors and enzymes are powerfully impacted by slight
differences in molecules and many women find that their bodies react
with difficulty to altered molecules leading to increased side effects
and dangerous consequences to synthetic hormones. Bio identical hormones
are exactly like the ones that a woman's body has processed over the
years of her reproductive life and, when customized for her individual
needs, are often accepted by the body with little or no discomfort
and, supporters believe, without the risks posed by pharmaceutical,
patented hormones. The long-term safety of the use of bio identical
hormone replacement therapy for more than five years has not been established
although several smaller studies reported positive results without
adverse outcomes.
(More
info. . .)
Hormone replacement therapy (HRT) is frequently
prescribed for women to alleviate symptoms associated with menopause
(hot flashes, night sweats, memory problem, mood changes, wrinkles,
weight gain, etc.) and to prevent serious diseases (breast, colorectal
and uterine cancer, heart disease, senility, osteoporosis, strokes,
etc.).
HRT was studied by the NIH because of its anticipated
benefits in over 161,000 women in a large 15 year study which began
in 1991. The study, called the Women’s' Health Initiative (WHI)
was an observational study designed to examine the effects of Premarin
(conjugated estrogen derived from PREgnant MARes' urINe) or Prempro
(Premarin plus synthetic progesterone or"progestin"). Because
the WHI found that the women taking either Premarin or Prempro we at
increased risk of breast and colorectal cancer, stroke, blood clots,
heart disease, osteoporosis and a host of other serious disease, the
study was halted years early (May, 2003) and women in the study who
were taking either Premarin or Prempro received letters telling them
to stop the medication. Wyeth provided both Premarin and Prempro to
the WHI although it was not involved in the analysis or conclusions
of the study.
Critics of Wyeth's challenge to bio identical
hormones contend that the action is designed to bolster flagging sales
of the "Premarin family" of drugs. According to Wyeth (http://wyeth.com),
profits for the synthetic hormones declined by 68% between 2002 and
2004 ($2,072,000,000 in 2002, $1,275,000,000 in 2003, $880,000,000
in 2004).
Total profits for Wyeth in the same period have declined by 72% (2002:$4,447,000,000;
2003:$2,051,192,000; 2004: $1,234,000,000).
Since the only significant non pharmaceutical
competitor for the HRT prescription dollar is bio identical hormones,
industry watchers link the move with an attempt to regain lost sales
and profits. L. D. King, Executive Director of the International Association
of Compounding Pharmacists, a professional association of special pharmacists
notes, "Wyeth's aims are clear: to restrict the ability of physicians
to prescribe and patients to use customized BHRT following studies
that have raised serious health concerns with the company's own products,"
(More
info. . .)
Wyeth maintains that its actions are motivated
by concerns about the safety of the natural substances and the way
the prescriptions for them are filled. In its complaint it alleges
that compounding pharmacists state that natural hormones are safer
than synthetic, patented ones and that some have been "illegally" mass
produced, rather than individually compounded. Wyeth also asks the
FDA to regulate compounding pharmacists although they are regulated
by the states, not by the federal government. (Supreme Court Decision
- Thompson et al. v. Western States Medical Center et al., U.S. Supreme
Court Case No. 01-344, Decided April 29, 2002. http://www.fda.gov/cder/pharmcomp/supremeCourt.pdf.)
Press Contact:
Rima Laibow, MD
NATURAL SOLUTIONS FOUNDATION
914-271-6792
www.HealthFreedomUSA.org
More Information: http://www.prweb.com/releases/2006/4/prweb369341.htm
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