| The Court's ruling for patient access to | | | | been affected -- menopausal women and |
| compounded medicines ensures that patients | | | | andropausal men; the Autistic community; men |
| and physicians will continue to have access | | | | and women with HIV or AIDS; young children |
| to vital medicines including bio-identical | | | | with gastroesophageal reflux disease (GERD); |
| hormones.This was a big victory for patients | | | | hospice and nursing home patients; people who |
| who rely on customized medicines, especially | | | | are very sensitive to dyes and additives in |
| for women taking bio-identical hormone | | | | medicines, as well as head trauma victims |
| therapy. Advocates including small pharmacies | | | | whose lives can be saved by compounded |
| and makers of alternative therapies including | | | | bio-identicals. |
| T.S. Wiley. | | | | |
| | | | It all started when last October of 2006, out |
| A ruling by U.S. District Court Judge Robert | | | | of the blue, Wyeth (WYE), filed a complaint |
| Junell in August indicate that patients and | | | | with the federal FDA to take action against |
| physicians have won the battle against Big | | | | the small pharmacies making bioidentical |
| Pharma, and therefore will continue to have | | | | hormones from soy and other plant materials. |
| access to vital compounded medicines. This | | | | Initially there was concern of the dangers of |
| victory for patients who rely on customized | | | | prescription hormones for women thanks to a |
| medicines, is especially sweet for women | | | | major study by the National Institutes of |
| taking bio-identical hormone therapy. Small | | | | Health (NIH) known as the Women's Health |
| pharmacies and makers of alternative | | | | Initiative (WHI). It suggested that taking |
| therapies including developers like T.S. | | | | hormones made by Wyeth could lead to |
| Wiley (the Wiley Protocol) bio-identical | | | | increased risk of heart problems and breast |
| hormone replacement therapy, doctors, | | | | cancer. |
| patients, and other industry organizations | | | | |
| including compounding pharmacists stood up to | | | | Recently a new study was published in the |
| this legislation and fought hard to win. | | | | Journal of the American Medical Association, |
| | | | mentioning that the risks were overstated. As |
| "It is in the best interest of public | | | | synthetic hormones known as Premarin and |
| health," ruled Junell, to uphold the legality | | | | PremPro were deemed dangerous, the assumption |
| of compounded drugs. He also said that this | | | | among women using bio-identical regimens is |
| legislation passed by Congress exempts | | | | that they are actually doing something |
| compounding pharmacies from such detailed | | | | "safer." |
| Federal Drug Administration (FDA) | | | | |
| inspections. "It is not feasible, either | | | | As some experts pointed out, the WHI never |
| economically or time-wise, for the needed | | | | looked at hormones, but only drugs with |
| medications to be subjected to the FDA | | | | "hormone-like" effects that were dosed in a |
| approval process." | | | | regimen far from that of human replacement. |
| | | | |
| This is good news for women on new | | | | The fact that the Court ruled in favor of |
| alternative therapies such as compounded | | | | patient access to compounded medicines |
| bio-identicals because this battle over | | | | ensures that patients and physicians will |
| hormones for women affects a huge market. And | | | | continue to have access to vital compounded |
| there are over 40 million women in the U.S. | | | | medicines. This will also will allow more |
| from the age of 40 to 60. Around 25 million | | | | research and clinical trials to take place on |
| women annually go into menopause. It is | | | | bio-identical hormones. This could prove that |
| estimated that by the year 2030, that number | | | | Wiley's revolutionary discovery is accurate - |
| will increase to 47 million women per year. | | | | the fact that it's the rhythm that matters in |
| | | | the accurate physiological replacement of |
| Advocates like Wiley, a medical theorist in | | | | hormones without side-effects for women in |
| the field of environmental endocrinology and | | | | the second half of life. |
| a writer and researcher on the use of | | | | |
| hormones, testified on April 19, 2007 before | | | | Wiley's findings may have important |
| the Special Committee on Aging at the United | | | | implications across a wide range of areas, |
| States Senate. Wiley's in depth testimony is | | | | from the treatment of menopause and |
| available in the Library of Congress. | | | | anti-aging to all of the other diseases of |
| | | | aging such as heart disease and stroke, Type |
| This testimony sites those who would have | | | | II diabetes, cancer and Alzheimer's disease. |