In an August 30, 2007 ruling by U.S. District Court Judge
Robert Junell, patients and physicians appear to have won
the battle against Big Pharma, and therefore will continue
to have access to vital compounded medicines. This was a
big victory for patients who rely on customized medicines,
especially for women taking bio-identical hormone therapy.
Advocates including small pharmacies and makers of
alternative therapies including T.S. Wiley, developer of
The Wiley Protocol® bio-identical hormone replacement
therapy, patients, doctors, the International Academy of
Compounding Pharmacists (IACP), Patients and Professionals
for Customized Care (P2C2) and other pharmacy associations
stood up to this legislation and fought hard to keep it
from becoming a law, and they won.
"It is in the best interest of public health," ruled
Junell, to uphold the legality of compounded drugs. He also
said that this legislation passed by Congress exempts
compounding pharmacies from such detailed Federal Drug
Administration (FDA) inspections. "It is not feasible,
either economically or time-wise, for the needed
medications to be subjected to the FDA approval process."
This is good news for women on new alternative therapies
such as compounded bio-identicals because this battle over
hormones for women affects a huge market. There are over 40
million women in the U.S. from the age of 40 to 60. About
25 million women worldwide enter menopause annually. It is
estimated that by the year 2030, that number will increase
to 47 million women per year.
Advocates like Wiley, a medical theorist in the field of
environmental endocrinology and a writer and researcher on
the use of hormones, testified on April 19, 2007 before the
Special Committee on Aging at the United States Senate.
Wiley's in depth testimony is available in the Library of
Congress.
This testimony sites those who would have been affected --
menopausal women and andropausal men; the Autistic
community; individuals living with HIV/AIDS; infants and
young children with conditions like gastroesophageal reflux
disease (GERD); hospice and nursing home patients; people
who are extremely allergic or sensitive to fillers, dyes,
and additives in medicines, and head trauma victims whose
lives and minds can be saved by a compounded bio-identical
hormone.
It all started when last October of 2006, out of the blue,
Wyeth (WYE), filed a complaint with the federal FDA to take
action against the small pharmacies making bioidentical
hormones from soy and other plant materials. There was
initially some concern of the dangers of prescription
hormones for women thanks to a major study conducted and
then stopped in 2003 by the National Institutes of Health
(NIH) known as the Women's Health Initiative (WHI). It
suggested that taking hormones made by Wyeth could lead to
increased risk of heart problems and breast cancer.
Recently a new study was published in the Journal of the
American Medical Association, mentioning that the risks
were overstated. Since the synthetic hormones - Premarin
and PremPro were deemed too dangerous, the common
assumption among women using bio-identical regimens is that
they are doing something "safer."
As some experts pointed out, the WHI never looked at
hormones, but only drugs with "hormone-like" effects that
were dosed in a regimen far from that of human replacement.
In summary, the fact that the Court ruled in favor of
patient access to compounded medicines not only ensures
that patients and physicians will continue to have access
to vital compounded medicines including bio-identical
hormones, but also will allow more research and clinical
trials to take place. This could prove that Wiley's
revolutionary discovery is accurate - the fact that it's
the rhythm that matters in the accurate physiological
replacement of hormones without side-effects for women in
the second half of life.
Wiley's findings may have important implications across a
wide range of areas, from the treatment of menopause and
anti-aging to all of the other diseases of aging such as
heart disease and stroke, Type II diabetes, cancer and
Alzheimer's disease.
----------------------------------------------------
Kristin Gabriel is the director of marketing communications
for T.S. Wiley, who is a medical writer and researcher in
chronobiology, environmental endocrinology and circadian
rhythmicity. Wiley is the author of "Sex, Lies &
Menopause," Harper Collins, 2005. She is also the developer
of The Wiley Protocol (http://www.thewileyprotocol.com), a
trademarked patent pending delivery system consisting of
bio-identical estradiol and progesterone in topical cream
preparations dosed in a rhythm to mimic the natural cyclic
hormone levels replicated in serum blood produced by a
twenty year-old woman.
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