Bioidentical Hormones

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In January of this year, I wrote an article that NAMS (The North American Menopause Society) declared that compounded hormones are unregulated, and therefore, unsafe.  In that article I called NAMS a liar.  And they are. You can find that article here if you wish to go back and read it.

The Endocrine Society is following in the footsteps of NAMS, and has issued a new scientific statement advising clinicians to avoid the use of compounded hormones to treat symptoms of [perimenopause] and menopause. The statement specifically addresses bioidentical hormones.

The article, which is published by ScienceDaily.com (PDF copy here), states that “compounded hormone medications can be unsafe when inappropriate practices are used.”  The Endocrine Society then backs up the statement by referencing the 2012 case (though the article said it happened in 2010 which is incorrect), where the New England Compounding Center of Massachusetts dispensed thousands of vials of contaminated steroid injections which exposed 14,000 patients to meningitis, and actually killed 64 people. I wrote about that incident here. 

I find it interesting that both NAMS and The Endocrine Society reference the 2012 compounding pharmacy incident to support their claims that bioidentical hormones are unsafe.  But, they do not provide any actual cases where compounded bioidentical hormones have caused deaths or other health issues as the result of being compounded in compounding pharmacies.

But that is because there ARE no cases to report.

It should be noted that the compounded bioidentical hormone market generates approximately $1 billion dollars in sales per year.  The article makes note of this fact, and also notes that the $1 billion dollars in sales is roughly equivalent to 1/3 of the sales of hormone therapies which are FDA approved.

Do they think that we might miss the suggestion that perhaps money is the primary motivating factor behind this so called “statement” against compounded bioidentical hormones?

The article also goes on to state that there is “no scientific evidence or medical reason to use a custom-compounded treatment that could have an unknown effect on the body, when there are numerous FDA-approved options for treating menopausal symptoms.”

So, does The Endocrine Society expect us to believe that if something is FDA approved, it is safer? That it does not carry with it the risk of an “unknown effect on the body?”  Seriously???? I went to the FDA’s website.  And I found on the site a set of data published in November 2015. The data describes the outcomes of patients after using either a product or drug approved by the FDA.

Please also note that this is a report published by the FDA itself regarding these outcomes.  This is not a watchdog group or some other organization gathering this data.  It is data gathered and collated by the FDA itself.

And here are some of the numbers:

Year Deaths Serious
2006 37,309 264,227
2007 36,689 272,324
2008 49,699 318,536
2009 63,830 373,471
2010 82,704 471,243
2011 98,469 572,992
2012 117,202 656,613
2013 116,388 707,593
2014 123,927 807,270
2015(Q1) 44,693 253,017

You can go to their site and read more about this data here.  

You may have noticed as I did, that the number of deaths resulting from FDA approved drugs and/or devices and products, increased each year from 2006 to 2015.  The number of deaths quoted in 2015 represents the 1st quarter only.  With the exception of 2013, when there was a slight dip in the number of deaths, each year, deaths have increased.  The same can also be said for the number of “serious outcomes” which did not result in death.  But, they were still considered “serious.”  In 2014 alone, there were nearly 1 million “serious outcomes” as a result of someone taking or using an FDA approved drug, product, or device.

And The Endocrine Society wants us to believe that compounding pharmacies are less safe than FDA approved therapies? I just don’t even know what to say.  The gall of these people never ceases to amaze me.

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Study Says Estrogen Therapy Protects Against Dementia

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Well, the title of the study actually said that estrogen “supplements” may protect against dementia. But, given that the study is published in the journal of Neurobiology of Aging referencing a doctoral thesis of a Norwegian doctoral student, we will overlook the nomenclature and focus on the findings of the study instead. Shall we? Facts About Dementia Globally one person […]

March 1, 2016 CONTINUE READING →

Stay Young & Sexy with Bioidentical Hormone Replacement – A Book Review

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Okay, ladies.  I’m back with my book review for Stay Young & Sexy with Bio-Identical Hormone Replacement: The Science Explained by Dr. Jonathan V. Wright & Lane Lenard, PhD. with a foreword by Suzanne Somers. First of all, I want to give kudos to Suzanne Somers.  Yeah, I know, we all remember her as the […]

February 29, 2016 CONTINUE READING →

35 Symptoms of Perimenopause: Loss of Libido

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As if perimenopause doesn’t cause enough grief, it can also kill your sex drive. It seems awfully cruel too, especially if you’ve enjoyed a healthy and satisfying sex life until then. I distinctly remember panicking when I realized that my desire for sex would diminish – or at least, that’s what I was expecting to happen.  […]

February 22, 2016 CONTINUE READING →

Estrogen Protects Women Against the Flu?

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Here’s a study worth crowing about!  According to a study published in the American Journal of Physiology, estrogen has anti-viral effects against the influenza virus. Given that we’re smack in the middle of flu season, this is good news for us estrogen users, eh? In order to conduct the study, researchers examined nasal cells from both men […]

February 3, 2016 CONTINUE READING →

Are FDA Approved Bioidentical Hormones Better Than Compounded Hormones?

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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 […]

January 29, 2016 CONTINUE READING →

NAMS Claims that Compounded Hormones are Unregulated and Unsafe: NAMS is a Liar

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In December 2015, The North American Menopause Society (NAMS), published a report in their journal, Menopause, citing the dangers of unregulated compounded hormones.  These so-called unregulated hormones, according to the article, reach an estimated 26 to 33 million patients [primarily women] per year. The story implies that hormones compounded by compounding pharmacies are unsafe and extremely risky, […]

January 27, 2016 CONTINUE READING →

Dear Magnolia…..Nobody Really Understands….What Can I Do?

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Today’s “Dear Magnolia” installment is from a reader who posted her question a few weeks ago.  “Angie” has been experiencing the typical perimenopause symptoms, though that in no way diminishes how she is feeling! It is only to say that her symptoms are “normal” even if they are making her feel as if she is […]

January 1, 2016 CONTINUE READING →

Does Estrogen Cause Breast Cancer? Part III

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This is the final post in Dr. Joseph Mazzei’s series on the relationship between estrogen therapy and breast cancer.    If you wish to contact Dr. Mazzei or any of his colleagues in the Body Logic medical group, please see his byline at the end of the post.  As always, the views expressed in this post […]

October 23, 2015 CONTINUE READING →

Does Estrogen Cause Breast Cancer? Part II

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Today’s post is a continuation of  Dr. Joseph Mazzei’s post on the relationship between estrogen therapy and breast cancer.  The views expressed in this post are not necessarily the views held by The Perimenopause Blog and are for informational purposes only. Please see your physician or healthcare provider for personal medical evaluations.  Let us continue our conversation from […]

October 19, 2015 CONTINUE READING →

Does Estrogen Cause Breast Cancer? Part I

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Today’s post is a guest post by Dr. Joseph Mazzei, a Chicago based doctor for BodyLogicMD, a medical group which sponsors The Perimenopause Blog. I asked Dr. Mazzei if he could give his opinion on estrogen therapy since it is starting to make its way back into the news once again.  In this post, Dr. Mazzei […]

October 13, 2015 CONTINUE READING →

Hormone Therapy in Perimenopause: The Truth behind the Women’s Health Initiative Study

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In 2002, the now infamous Women’s Health Initiative study sent the medical professionals prescribing hormone replacement therapy for their patients in menopause, into a bona-fide tail spin.  Terrified of putting their patients at risk for coronary heart disease, stroke or breast cancer, physicians abandoned HRT all together, advising their patients to do the same. Few […]

October 12, 2015 CONTINUE READING →

The Importance of Estrogen for Sleep in Perimenopause & Menopause

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I started using the Vivelle Dot Patch, a transdermal, bioidentical estradiol, about two years ago.  You can read a couple of posts I did on it when I first started using it here  and here.  I started using it because I had been diagnosed with fibromyalgia.  was experiencing debilitating joint and muscle pain, was lost […]

April 24, 2015 CONTINUE READING →

Are Compounding Pharmacies Safe?

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Thanks to the recent outbreak of fungal meningitis in the United States, which is now responsible for 25 deaths across the country, compounding pharmacies are now in the cross-hairs of federal regulators, and questions are being raised about their safety. The New England Compounding Center, (NECC), located in Massachusetts, shipped thousands of vials of a […]

April 1, 2015 CONTINUE READING →

Food as Medicine: Omega-3s & Zinc For Itchy Skin and Scalp in Perimenopause

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This is the first post in a new series I’m entitling “Food as Medicine.”  After several years of reading and writing about perimenopause, I’ve come to the conclusion that food is as important in managing the symptoms of perimenopause, as I believe bioidentical hormones are. In fact, I would likely say that food is even more important. Now, […]

March 3, 2015 CONTINUE READING →

Looking for Resources for Perimenopause? Look No Further!

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A lot of my readers ask for help in locating physicians, pharmacies, and recommendations for bioidentical progesterone (which I promote a lot here).  I almost always forget to direct them to my  Resources Page.  And unless you take the time to click through on some of my pages, you might not locate it either, though […]

February 15, 2015 CONTINUE READING →

Estrogen, Uterine Polyps & Me

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UPDATE: A reader left a comment pointing out that this article wasn’t entirely accurate.  She herself had undergone a procedure to have uterine polyps removed and informed me that hers were so deeply embedded in her uterus, that there was no possible way for a routine gynecological exam to discover them. She also noted there […]

January 30, 2015 CONTINUE READING →

Bioidentical Progesterone for Insomnia: It Works for Me!

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I’ve been taking Prometrium, an FDA approved bioidentical progesterone, for the past month to help me with sleep, and to help with my night sweats and hot flashes. I told you all I would share my experience with you, and the jury is in: it works. I am taking 200 milligrams about 2 hours before […]

November 18, 2014 CONTINUE READING →

So Exactly “WHAT” are Bioidentical Hormones?

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I’m going to come clean and tell you that until the last couple of years, I really didn’t understand the difference between bioidentical hormones and what we call synthetic hormones. I also didn’t know that bioidentical hormones have actually been around for a very long time – like, nearly 100 years. Surprised?  I was too. […]

October 22, 2014 CONTINUE READING →