Alternative & Complementary Treatments

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Update: This post has been edited and updated to reflect current changes in legislation which affect regulation and oversight of compounding pharmacies in 2016

Recently, while searching around on the Internet for a list of FDA approved bioidentical hormones for one of my readers, I ran across an article at The Huffington Post written by a fellow women’s health writer and advocate, Staness Jonekos, entitled “10 Hormone Therapy Facts that Every Woman Should Know.

I have had the good pleasure of meeting Staness during a short trip to NYC last fall.  I’ve also had an online relationship with her for a few years now.  She is a sweet and wonderful woman who, like me, is very passionate about women’s health issues. So when I ran across her article I naturally stopped to read it.

It was a good article, written and published in 2010, with some well researched information on hormone replacement therapy.  Much of what Staness had to say I agreed with.  However, there was some of it I did not.  But, it was the comments in response to the article which I actually found to be the most compelling. Not only were they impassioned, but some were just downright hostile.

So what was it exactly in Staness’ article which set off such a comment section firestorm?  She challenged the credibility of Suzanne Somers’ work, and the safety of compounded bioidentical hormones based on her negative personal experience with them.

According to her article, compounded bioidentical hormones are not FDA regulated, therefore they are unsafe and shouldn’t be taken. She also quoted several “reputable” medical organizations like NAMS (The North American Menopause Society) and The Endocrine Society to support her position.

Now look, I’m not a Suzanne Somers devotee.  Truth be told, I’ve never even read any of her books, though I do sell some of them here at The Perimenopause Blog. So I’m not going to jump to her defense.  I’m also not going to call into question Staness’ personal experience with compounded bioidentical hormones.  I believe Staness (and every woman) owns the copyrights to her personal experience, and I’m not going to tell her it is false.

What I have a problem with, however, is what I always have a problem with.  Statements which draw hard lines and which also presume to own all of the science and facts to back-up a specific position.  This attitude, which pervaded most of Staness’ article, seems to be what upset so many people, several of them medical professionals and physicians themselves.

What Does FDA Approved Mean?

If something is FDA approved, it means clinical studies have been done and have shown that the drug or product is “more helpful than harmful” for a specific disease or condition. FDA approval does not guarantee that the product or drug is 100% safe and effective.  It only means that it is “sufficiently safe and effective.” But only if it is used within the defined limits indicted by the product’s testing, side effects, and contraindications.

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So what does all of this mean in layman’s terms?  It means that a product or drug is “sufficiently” safe and effective.  Nothing more. Which is why so many drugs which are FDA approved can still turn out to be very dangerous and life-threatening.  So while it may sound officially safer to call something FDA approved, it is not a guarantee that the product or drug you are using or taking is 100% safe or healthy.

Here’s Another Important Fact

There are equally credible, competent, and highly educated physicians and medical professionals on both sides of every medical debate. Why do you think they’re called “debates?”  For every medical study used to support a particular position, there is another medical study which can be used to support an opposite position.

So while I respect the science and medical facts that Staness used to make her case, I have to disagree with her over-arching point, that unless something is FDA approved, it is not safe and therefore should not be taken.

Critics of compounded bioidentical hormones and alternative remedies for symptoms of perimenopause, often point to the fact that they are not FDA approved or regulated.  There was a time, when this may have been true. However, much of that has changed over the last 5 years.

The FDA does currently have regulatory oversight of compounding pharmacies.  But, even before legislation was passed allowing them federal oversight, compounding pharmacies have been regulated by state regulatory boards for decades upon decades.

And they have been legally required to abide by standards set forth by the USP Pharmacopeial for decades as well. So, the notion that compounding pharmacies live in a medical world under the rules of the Wild, Wild West, is simply misleading at best, and a flat out lie at worst.

It is true, many complementary and alternative treatment products do not meet standards of quality, and are not regulated.  In fact, many OTC products which are marketed as bioidentical progesterone, for example, often do not contain much progesterone at all.

However, this does not mean that all bioidentical hormones which are compounded are not FDA approved, or that they are not subject to any type of regulation, or held to standards of quality, because they are.

The FDA is Not Infallible

It’s important to recognize that if something is claimed to be “FDA approved” this is not an infallible standard of quality which rises above all other standards.  Neither does it mean if something is not FDA approved, that it is unregulated and therefore unsafe.

I do not subscribe to the notion that nothing should be regulated at all.  What I am trying to say, however, is that just because something is, does not mean it is 100% safe for human consumption.  And just because something isn’t, that’s it’s not. Clearly, educating ourselves and making the best informed decision for our health is the best way to go in my opinion.

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