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, 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.
I want to thank everyone who fought so hard to maintain our rights. Not being able to choose the medicines that work best for us would be a terrible loss.
It's in the best interest of public soundness,” 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, both economically or time-wise, for the needed medications to be subjected to the FDA approval process.”
This is good news for all us women who choose new alternative therapies such as compounded bio-identicals. There are 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.
It all started when last October of 2006, out of the blue, Wyeth (WYE), filed a disease 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.
As some experts pointed out, the WHI in no degree 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.
Let's all revel in this victory.
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