THE FDA, HORMONES AND CELEBRITY ADVICE

“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.)
• Bioidentical hormones are prescribed by doctors just like so called "commercial" hormone therapies.
• When hormone replacement therapy was black labeled to make sure women were aware of the risks associated with HRT, prescriptions decreased.  Drastically.  That was in 2002.
• In 2002, bioidentical hormones (BHT) hit the shelves using a marketing strategy that they are safer because they are more natural.  My friend Lori had plenty to say about natural substances in a blog post entitled So Is Hemlock.
• There has never been a head to head comparison of HRT and BHT so there is no evidence based research to support the idea that they are, indeed, safer.
• BHT which comes from yams goes through many layers of processing in a laboratory in order to be a usable product. In other words, slathering a yam all over our bodies isn't going to do a damn thing.  The yam is PROCESSED and changed so it resembles HRT.  The act of processing sort of negates the whole natural thing.
• Enter Suzanne Somers and sex.  We see the way breast cancer is sexualized so we already know the power of Sex Sells.
• Somers pushed BHT as the fountain of youth, the way to regain a great sex life and went a step further, pronouncing this would be achieved without ANY of the risks associated with traditional, commercially available HRT.
• In 2009, Somers hit the Oprah show and its 6.2 million viewers and a big business was born.  While many are convinced of the upside of BHT, few have questioned the scientific evidence.  (Where is it?  Does it even exist??  And that answer would be a resounding NO.  And I'm not talking about science evidence on a site that is trying to sell a product, I'm talking comparative head to head studies.)
• The premise of BHT is that it is customized for our unique needs based on bloodwork.  The only problem, until many years after menopause, our hormones are all over the place.  I see you nodding in agreement.  Want to know WHY you were a raging bitch at 10AM and then mom of the century for the afternoon carpool?  Not only do hormone levels change depending upon the time of the month, they change throughout the course of a single day.
• That begs a question?  Upon what basis is Somers statement in her recent book that BHT specifically formulated for her allows her to be like Goldilocks, not too much, not too little but just right.  Which Goldilocks?  The 9AM version, the 2:15PM edition, the 10PM raring to go vamp.....
• The thing is.... there are now FDA approved biodienticals on the market but they aren't customized.  A niche market. Custom compounds being sold by a company that ... wait for it ... Suzanne Somers is the spokesperson.  (I thought I read she was a partner but since I can't find that information, I'll go with she's the face of the company and she's undoubtedly making a boatload of money)
• The MORE article had 12 identical prescriptions sent to 12 different compounding pharmacies.  The returned products were analyzed by an independent lab.  The results were all over the charts and not one of the compounds would have passed FDA requirements for prescription drugs.  Remember, these ARE prescriptions and the FDA mandate states that the finished product must be between 90 and 110% of what was ordered by the physician.  Even with my math challenged brain, I'd say an error margin of 10% is mighty generous (a discussion for another day....).

The take away?  First, despite the length of the article, it really is a must read.  It explains the risks associated with any HRT or BHT if the right type of estrogen isn't used and the consequences (uterine cancer) if there isn't sufficient progesterone. Second, if you are a fan of BHT, it is recommended that your doctor is affiliated with the North American Menopause Society. Understand what you are subjecting your body to by speaking to a trained doctor who specializes in these issues.

Ms. Ramin points out in her blog post that many of the doctors "were furious about the way in which Somers had brainwashed their patients...." seeking the " 'safe' and 'natural' hormones (to) restore them to premenopausal pizazz."  As an aside, my oopherectomy threw me into instant menopause and I am still on estrogen suppressant treatment.  An attentive partner, a patient partner who is willing to master the art of "making out" as a prelude, followed by a slower pace than perhaps what may have occurred pre-menopausal can be pretty damn hot.  I'm just sayin' ......  BHT is not the prerequisite for a "rockin' libido."

And most importantly, if you love Suzanne Somers, stick to her work as an actress.  I've said it before and I'll repeat it forever. Celebrities have no business using their celebrity to dispense medical advice.  And in this case, the celebrity is reaping some hefty financial rewards.  I call that a conflict of interest and a disservice.  And seriously, what's up with the references to Goldilocks and the Seven Dwarfs.  I think it's time to realize we are being told a bunch of fairy tales.

And while I'm at it, I think Katie Couric should have a do over and include Cathryn Jakobson Ramin in the conversation, too.

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