An August 30, 2007 ruling by U.S. District Court Judge Robert Junell is a big victory for patients and physicians who have won the battle against Big Pharma. They will continue to have access to vital compounded and customized medicines, including bio-identical hormone therapy. Advocates including small pharmacies and makers of alternative therapies like 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 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. And 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; men and women with HIV or AIDS; young children with 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.
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pharmacy question?Which of the following periodicals publishes pharmacy practice information for managed care settings?
A. American Pharmacy
B. Managed Healthcare News
C. Journal of Managed Care Pharmacy
D. Pharmacy Times
About Author
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, 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. Wiley’s in depth testimony is available in the Library of Congress.