Small Business and Patients Duke it Out and Win Against Big Pharma

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. And there are over 40 million women in the U.S. from the age of 40 to 60. Around 25 million women annually go into menopause. 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; young children with gastroesophageal reflux disease (GERD); hospice and nursing home patients; people who are very sensitive to dyes and additives in medicines, as well as head trauma victims whose lives can be saved by compounded bio-identicals.

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. Initially there was concern of the dangers of prescription hormones for women thanks to a major study 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. As synthetic hormones known as Premarin and PremPro were deemed dangerous, the assumption among women using bio-identical regimens is that they are actually 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.

The fact that the Court ruled in favor of patient access to compounded medicines ensures that patients and physicians will continue to have access to vital compounded medicines. This will also will allow more research and clinical trials to take place on bio-identical hormones. 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.

Article Source: http://www.a1-articledirectory.com

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.

Please Rate this Article

5 out of 54 out of 53 out of 52 out of 51 out of 5 

Not yet Rated