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