| The Court's ruling for patient access to compounded | | | | affected -- menopausal women and andropausal men; |
| medicines ensures that patients and physicians will | | | | the Autistic community; men and women with HIV or |
| continue to have access to vital medicines including | | | | AIDS; young children with gastroesophageal reflux |
| bio-identical hormones.This was a big victory for | | | | disease (GERD); hospice and nursing home patients; |
| patients who rely on customized medicines, especially | | | | people who are very sensitive to dyes and additives in |
| for women taking bio-identical hormone therapy. | | | | medicines, as well as head trauma victims whose lives |
| Advocates including small pharmacies and makers of | | | | can be saved by compounded bio-identicals. |
| alternative therapies including T.S. Wiley. | | | | It all started when last October of 2006, out of the |
| A ruling by U.S. District Court Judge Robert Junell in | | | | blue, Wyeth (WYE), filed a complaint with the federal |
| August indicate that patients and physicians have won | | | | FDA to take action against the small pharmacies |
| the battle against Big Pharma, and therefore will | | | | making bioidentical hormones from soy and other plant |
| continue to have access to vital compounded | | | | materials. Initially there was concern of the dangers of |
| medicines. This victory for patients who rely on | | | | prescription hormones for women thanks to a major |
| customized medicines, is especially sweet for women | | | | study by the National Institutes of Health (NIH) known |
| taking bio-identical hormone therapy. Small pharmacies | | | | as the Women's Health Initiative (WHI). It suggested |
| and makers of alternative therapies including | | | | that taking hormones made by Wyeth could lead to |
| developers like T.S. Wiley (the Wiley Protocol) | | | | increased risk of heart problems and 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, to | | | | the assumption among women using bio-identical |
| uphold the legality of compounded drugs. He also said | | | | regimens is that they are actually doing something |
| 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 feasible, | | | | at hormones, but only drugs with "hormone-like" |
| either economically or time-wise, for the needed | | | | effects that were dosed in a regimen far from that of |
| medications to be subjected to the FDA approval | | | | human replacement. |
| 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 to |
| this battle over hormones for women affects a huge | | | | 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 47 | | | | the rhythm that matters in the accurate physiological |
| 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 across |
| researcher on the use of hormones, testified on April | | | | 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 is | | | | of aging such as heart disease and stroke, Type II |
| available in the Library of Congress. | | | | diabetes, cancer and Alzheimer's disease. |
| This testimony sites those who would have been | | | | |