Ageology: Dr. Paul Savage. July 1, 2013. Photo by Andrew Collings.I am a board-certified physician who specializes in integrative metabolic medicine.  This means that I have made it my life’s work to help people overcome the health challenges that increasingly confront them as they age.  The goal? To support every patient in the quest for wellness and quality of life – however that is defined by the individual.

Integrative medicine doctors are physicians who take a whole-person wellness approach to treatment.  As part of our treatment regimen, we may use bioidentical hormone therapy (BHT) – very successfully – to combat debilitating symptoms of menopause suffered by millions of women every year.  Bioidentical hormones are an exact copy of the hormone molecules produced in the human body. Some are made by the same FDA-regulated pharmaceutical companies that produce most other drugs prescribed by doctors. Some prescriptions for bioidentical hormones must be compounded (manufactured) at smaller-scale compounding pharmacies to match individual needs. In my practice, I provide prescriptions primarily for compounded hormones.

It was therefore both distressing and frustrating for me to read the recent article published in the popular women’s magazine MORE. While hormone therapy has, for decades, yielded highly vocal advocates on both sides of the story, the MORE missive is disturbing in its one-sided quest to prove two points: that the safety of BHT itself is questionable, and that compounding pharmacies can’t be trusted.

The arguments the article’s author, Cathryn Ramin Jakobson, makes about compounding pharmacies are based on a flawed “study” performed by the magazine. The arguments made by Jakobson against BHT are outdated and not supported by either medical literature or clinical experience. My response to Ramin’s article is meant to help women achieve a more balanced perspective so that they can choose for themselves whether BHT and compounding are reasonable options for coping with symptoms of menopause.

Ramin opens her article with a discussion of a fungal meningitis outbreak caused by a compounding pharmacy’s injectable drug, leading to 749 illnesses and 63 deaths. Although this scary and eye-opening tragedy merits exposure, it is a rare occurrence and does not properly represent the safety of compounded medications as a whole—at least, not any more than the millions of deaths due to FDA-approved drugs represent the safety of FDA-approved medications as a whole. Even major pharmaceutical companies are rightfully forced to suspend manufacturing of products when safety is called into question.

She then presents “findings” of an experiment conducted by the reporter of a BHT product (based on a single prescription) from 12 compounding pharmacies. These “findings” offer no foundation for the validity of her conclusions.  She cites the results of an anecdotal experiment that contains no defined parameters, no identification of the pharmacies she used and no explanation around the methods of analysis.  (See the point-by-point flaws in More’s “study” that I mention below.) She does this in an attempt to eviscerate, in one fell swoop, the positive and life changing impact BHT – most of which is manufactured by responsible and reputable compounding pharmacies – has on millions of women every year.

Her story is particularly disturbing in that is entirely one-sided.

Here’s how I see it:  Any attempt to take a position on the therapeutic impact of a drug category carries with it an obligation to provide a balanced perspective both for and against.  This allows patients to evaluate their options in an analytical manner and not an emotional one.

Discussions around the benefits and risks of hormones carry with them a special obligation given the volatility of the category across the decades.

I am writing this response to the MORE article because I feel duty bound to offer patients and perspective patients the other side of the BHT story.

In support of compounding pharmacies:

Physicians support processes that ensure and monitor the quality of products which we prescribe to our patients.  We don’t want to do harm to anyone—indeed, aside from our desire to do right by our patients, we’re liable to be held accountable if we don’t dedicate ourselves to ensuring that anything we prescribe to patients will be administered by a pharmacy that adheres to high standards of quality control.

By way of background, compounding pharmacies were originally created to make medicines to order for those who, for example, could not swallow pills, or could not take a standard medication because of an allergy to one of its components.

Boiled down:  these companies were founded on the idea that individualized medicines could and should be made available for the benefit of patients who truly need them. In many cases they serve relatively small patient populations and must ensure their facilities are flexible and nimble enough to meet the needs of the individual.  These companies, therefore, sit far afield from the mass pharmaceutical manufacturers who accommodate the many but offer no option for the few.

I am the first to admit that there is a need to regulate compounding pharmacies. A previous article published in the Journal of Integrative Medicine, titled “Ensuring the Safe Use of Compounded Hormones,” found that regulation in the form of the Pharmacy Compounding Accreditation Board (PCAB) works, and works well.  Just because there are bad actors out there, trying to take advantage of a BHT boom, doesn’t mean we should throw the compounding baby out with the bathwater.

Compounding pharmacy is a crucial part of individualized care, and there are plenty of terrific and trustworthy compounding pharmacies out there. The compounding pharmacies we use at Ageology have been validated by PCAB. They do frequent quality control testing. We wouldn’t use them if they didn’t.

Point-by-Point: Flaws in MORE’s “Study”

More collected 12 identical prescriptions for BHT, through a physician “concerned about the use of unregulated hormones.” All were filled by compounding pharmacies, 10 of which were online and two of which were “brick-and-mortar stores.” Those 12 prescriptions, which the author states were all for Tri-Est and progesterone, were sent to Flora Research, a lab in Oregon, for analysis.

Nothing is said about how these pharmacies were chosen from the 7,500 or so possibilities. Were they selected randomly? Were they all local to the magazine’s offices? Was any effort made to choose pharmacies accredited by the Pharmacy Compounding Accreditation Board (PCAB), which the article eventually recommends as good compounding pharmacy choices?  Experienced physicians use compounding pharmacies that routinely perform skip lot testing and obtain a Certificate of Analysis on their compounded products (a requirement of PCAB).

The weight of each prescription’s contents was found to vary from 80 to 102 milligrams, suggesting that the contents were not uniform for prescriptions that were supposed to be the same. As most compounded products contain varying amounts of fillers dependent on capsule size, we are left uncertain as to the composition of the samples being tested. Fillers would certainly create variations in weight between samples. How much of each comprised active ingredients? That information is not included.

Mass spectrometry revealed that levels of estriol in the samples varied from 67.9-89.5% of the labeled amount—making it subpotent; levels of estrone were 58.4-272.5% of what was prescribed, and levels of estradiol were 95.9-259% of the amount prescribed. Amounts of progesterone were found to be less than what was prescribed. Giving ranges of hormone content and weight makes the results seem more extreme than they would if the individual values were given, or even a mean or a mode. The statement about 90-110 percent and FDA acceptability is also unclear. Is she referring to the weights? Levels of individual hormones? I couldn’t tell.

It appears, from the article, that the Tri-Est may have been delivered in a single capsule and the progesterone in another capsule. But when oral progesterone is used, it’s almost always FDA-approved Prometrium; micronized progesterone contained in that bioidentical formulation is the kind that is best absorbed into the GI tract effectively.  Most prescriptions for progesterone that are sent to compounding pharmacies are for transdermal creams. The article does not clarify this point, which further calls into question the conclusions drawn by the author.

In support of BHT:

Ramin mentions the 2002 Women’s Health Initiative (WHI) study, which was stopped early because of findings that Prempro (Premarin, or estrogens derived from horse urine, plus non-bioidentical Provera, a form of progestin) slightly increased the risk of breast cancer and heart attack. Use of that form of standard hormone therapy (HT) plummeted in the years that ensued. Yet, the facts are that in the decade before that result, many studies found that even this traditional form of HT had significant benefits, and demonstrated little to no risk. That’s why the WHI was mounted—because HT seemed to have so much promise not only as a therapy for menopausal symptoms, but as preventive medicine against osteoporosis, colon cancer and loss of sexual function and libido.

Since then, studies of safer forms of HT have quietly continued. Based on the evidence gathered in those studies, transdermal patches containing bioidentical estrogen plus Prometrium (oral bioidentical progesterone) or Crinone (vaginal progesterone gel) are generally accepted as the safest forms of HT available to women. Testosterone therapy is increasingly accepted as safe and effective for women whose levels are low and who wish to reverse the loss of libido that often comes with menopause.

Test-tube, animal and human studies indicate that bioidentical progesterone is either neutral to or protective of breast tissue. Orally administered estrogens create increased blood clotting in the body, which is why it has been linked to higher heart attack risk. Estrogen given transdermally (through the skin) bypasses this so-called first-pass effect.

This reduces heart attack risk to nil and allows the use of very small doses to achieve therapeutic impact. Provera and other progestins increase blood vessel constriction and block estrogen’s healthy impact on cholesterol counts, which adds to the threat of heart attack with Prempro. Use of bioidentical progesterone circumvents this issue too—it relaxes blood vessels and does not block the well-established heart health benefits of estrogen.

Although we can’t say that BHT is more effective than traditional HT, we can say that it is safer. Women who need menopause symptom help can trust that it will relieve their symptoms without increasing risk of heart attack or breast cancer. The research is there to support this point, and more is in process at this writing.

What’s the net/net here?  Millions of women suffer debilitating and life-altering symptoms associated with hormonal change as they age.  The medical practice of hormone balancing helps alleviate and potentially eliminate those symptoms.  These patients get their lives back.  These patients, in many cases, come to embrace a program of whole body wellness that supports an extended healthspan across the years.  The one-sided presentation of danger and discrepancy may turn many women from even exploring BHT as a therapeutic option.  Effectively they will acquiesce to reduced quality of life years, even decades, before they might otherwise need to confront this issue.

BHT represents an evolution of traditional HT that reduces risks and offers greater benefits. There is a substantial amount of research to back me up on this (see list of references below).

In closing:

  • Physicians experienced in prescribing compounded medications understand the risks and benefits of utilizing this form of therapy when needed. We freely share this information with our patients.
  • We acknowledge that fewer than 2 percent of compounding pharmacies are accredited by PCAB, and we support regulation that would require all compounding pharmacies to have this accreditation.
  • We support education of physicians in the art and science of prescribing compounded medicines—this should be part of any credential that allows them to do so.
  • We do not support sensationalized, fear-invoking articles without a fair and balanced viewpoint.

It is my sincerest hope the sensationalistic article published in More doesn’t cause too many women to forego a therapy that could make a dramatic difference in their health, their quality of life, and their healthspan (the number of years they get to experience great health without disability).

Partial List of References

Benefits and Risks of Postmenopausal Hormone Therapy

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