by Lauren Streicher, MD
Frequently, patients ask if I prescribe “bioidentical” hormones. It’s a good question, but unfortunately, the answer is not a quick one. Like many phrases, “bioidentical” means different things to different people. Generally, however, most women inquiring about bioidentical hormones are referring to compounded hormones that are advertised as being safer and better than FDA-approved estrogen and progestogens distributed by commercial pharmaceutical companies.
The North American Menopause Society (NAMS) recently conducted a survey of 3725 hormone users to determine the extent and differences between commercial compounded hormone therapy and compounded hormone therapy. Roughly one of four women who use hormone therapy are using compounded hormone therapy however most are unaware that compounded hormones have not been evaluated or approved by the FDA . Most are unaware that compounded hormones have risks in addition to benefits.
Many promoters of compounded hormones claim that their products reverse aging, enhance sex, prevent cancer and, unlike FDA-approved commercial hormones, have no risks or side effects. It all sounds pretty good. But like most things that sound too good to be true, it’s important to separate fact from the myths propagated by clever marketing.
Myth #1: “Bioidentical Hormones Are Natural.”
The only thing that is natural is to drink the horse urine or eat the soy plant (both are used in the manufacturing of hormones). All plant-derived hormone preparations, whether they come from a compounding pharmacy or a large commercial pharmacy, require a chemical process to synthesize the final product, which can then be put into a cream, a spray, a patch or a pill.
Promoters of compounded plant-derived hormones use the terms “natural” and “bioidentical” because it is appealing to consumers and implies that it is not synthetic.
Myth #2: “Compounded Bioidentical Hormones Are Identical to the Hormones in Our Bodies.”
Plant-derived estrogen from soybeans is molecularly very similar, but not identical to human hormones. That’s why I prefer the term “bio-mimetic” to “bioidentical.”
Furthermore, what you get from the compounding pharmacy (where a compounding pharmacist custom mixes drugs to fit the unique needs of a patient) is not “more human-like” than what you get in an FDA-approved product. In fact, you are actually getting the IDENTICAL estradiol molecule whether you get your hormones from a compounding pharmacy or your mega-pharmacy.
How can that be? This is the interesting part. Compounding pharmacies don’t manufacture hormones – they just mix them. Manufacturing factories are the ones that extract estrogen from plants, synthesize it to a useable form, and then sell the same active ingredients to both commercial pharmaceutical companies and compounding pharmacies. It is then that the active ingredient is used to make lotions, pills, sprays or patches.
It’s basically all the same stuff. In fact, many compounding pharmacies mass produce hormone preparations that are copies of those produced commercially.
Myth #3: “Since Compounded Bioidentical Hormones Are Natural, They are Safer Than Other Hormones.”
First of all, “natural” does not equal “safer.” We can all name many things that are natural, but hardly safe. Arsenic comes to mind. But, in any case, I’ve already dispelled the “natural myth” (see Myth #1).
Let’s forget the word natural and ask if compounded hormones are safer than FDA-approved commercial hormones.
Since compounded alternatives to FDA-approved estrogen and progestogen formulations have the same active ingredient (see Myth #2), they obviously are going to have the same benefits, and the same safety concerns. But unlike commercial hormones, the distributors and promoters of compounded hormones deny these risks. And that’s really misleading. So, how do they get away with it?
Since the FDA does not regulate compounding pharmacies, they can make whatever claims they want. So, they tell women what they want to hear – namely that compounded bioidentical hormones have fewer risks, fewer side effects, and are more effective than standard hormones even though there is no scientific evidence to prove that claim.
While women generally distrust the pharmaceutical industry – which is legally obligated to back up their claims, does testing, and reports all safety risks and negative findings – the general population seems to have little problem placing their trust in companies that have no such efficacy or safety standards. This combined with aggressive advertising and marketing has resulted in women believing that compounded products are safer than standard products.
It’s pretty scary to think that millions of women are using prescription drugs that have never gone through a new drug approval process to substantiate safety, prove efficacy, and ensure quality.
Since it is the same active ingredient, what’s the problem?
It’s the dosages and protocols, which are commonly recommended, that have never been shown to be safe, much less safer or more effective than conventional prescription hormone products. I just saw a woman who was essentially going bald because of sky high levels of testosterone in a pellet that was injected into her hip. Transdermal progestogens from a compounding pharmacy are particularly dangerous since there is no evidence that they prevent the lining of the uterus from developing pre-cancerous or cancerous cells. And in fact, the survey recently published by NAMS showed there were 4 cases of endometrial cancer in the group using compounded hormone therapy compared to zero cases of endometrial cancer in the group using commercial products. No surprise since only oral progestogens have been proven to offer that protection.
So, back to the original question: Do I prescribe bioidentical hormones? I prescribe FDA-approved “bio-mimetic” plant-derived estrogen, produced and distributed by companies that are obligated to tell you not only the benefits, but potential risks as well. I prescribe products made by companies that adhere to strict protocols to assure purity of the product and consistency of dosage. I do use compounding pharmacies when I need a product that is not available commercially but I then inform my patient of all known risks and benefits.
One last thing...an added bonus to commercially available products is that your insurance company will likely cover your prescription.. The non-FDA approved compounded versions will require you to open not only your trust, but also your checkbook.
Edited Oct 22, 2015 Originally posted on doctoroz.com 11/09/2011