“Who among us is going to pick up the ball and run with it?
Challenge accepted. I'll pick up the ball and see how far I can get with it. I have a big mouth and a bit of an ax to grind. If the FDA is concerned with 23andMe (a matter with which I happen to agree) dispensing information, there should be a code red within their offices on the issue of bioidentical hormones. That's the ball and we should all be running with it.
Many thanks to Cathryn Jakobson Ramin for an outstanding piece of investigative journalism in the October 2013 edition of More magazine. And the follow up blog post on the USC Annenberg Reporting on Health.
Bioidentical hormones, also known as, the Suzanne Somers way of life.
Ms. Ramin's article is well researched and thorough. Rather than repackage her words from the stellar More article or regurgitate what she wrote in her blog post, I'm going with my own version of a CliffsNotes guide. (And yes, that's accurate... CliffsNotes... if Wikipedia is to be believed.)
- Custom made bioidentical hormone therapy is NOT regulated by the FDA. They are manufactured by compounding pharmacies and fall under the jurisdiction of state pharmacy boards.
- Until the 1990's, the business of compounding pharmacies was simple. If a person had trouble swallowing pills, a compounder would make the medicine in liquid form. If someone had an allergy to a "filler" ingredient in a drug, a compounder could substitute the offending ingredient.
- Basically, a compounding pharmacy is a drug manufacturer if you break it down into its simplest terms.
- Despite this, the drugs formulated by these establishments are not put through the clinical trial process, or in fact any process, to determine their safety and efficacy. For that matter, they are not required to meet stringent FDA manufacturing standards, either. (Say what you want about the FDA but their role is OUR safety.)
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