OBG MANAGEMENT: What are the risks of compounded bioidentical hormones?
DR. PINKERTON: According to FDA guidance for industry, in the absence of data about these hormones, the risks and benefits should be assumed to be identical to those of FDA-approved hormone therapies, with the caveat that we don’t know from batch to batch what a woman is receiving. However, they are not regulated or monitored by the FDA, so we are lacking testing for purity, potency, efficacy, and safety. When the FDA did analyze compounded bioidentical hormones, a significant percentage (34%) failed one or more standard quality tests.3 In comparison, FDA-approved drugs fail analytical testing at a rate of less than 2%.3
The problems with compounded hormones
BRUCE PATSNER, MD, JD
Dr. Patsner is Research Professor of Law at the University of Houston Law Center in Houston, Tex. He served as Senior Medical Officer at the US Food and Drug Administration (FDA), where he was one of the agency’s experts on pharmacy compounding of prescription hormone drug therapy for the treatment of menopausal conditions.
The FDA has nothing against compounding pharmacies per se. Individualized preparation of a customized medication for a patient, based on a valid prescription, is an essential part of the practice of pharmacy. However, some actors in the pharmacy compounding business have taken the practice to a different level, not just in terms of the volume of business they do, but in the way compounded hormones are advertised and promoted. The courts aren’t necessarily interested in intervening in cases involving high volume alone. And when it comes to unsubstantiated claims of benefit, the FDA has found it difficult to assert jurisdiction over pharmacy compounding in general, making it hard to assert control over the advertising claims these pharmacies make on behalf of compounded drugs.
The result? The FDA has been unable to rein in claims that compounded prescription drugs are safer or better than commercially prepared medications. These drugs are probably as safe and effective as their manufactured counterparts, but there are no data to confirm this assumption.
What’s in a name?
“Bioidentical” isn’t a bona fide term. There is no definition of it in any medical dictionary; it’s just a name the industry cooked up, a catchy one at that. And when bioidenticals are advertised and promoted, the term “natural” is usually in close proximity. Most patients equate the word natural with plant-derived substances that have not been chemically altered. The fact is, many compounded prescription drugs are derived from plants—but they are also chemically altered.
Some applications are legitimate
A number of women use compounded medications because they make it possible to obtain hormone combinations that are not readily available in cream form. For example, if a patient wants testosterone as part of a cream of estrogen and progesterone, a compounded product is the only option.
Show me the data
No studies have compared compounded drugs with commercial drugs—and such studies are exceedingly unlikely. Compounding pharmacies have no incentive to conduct or participate in such studies. The pharmaceutical compounding industry is a multibillion-dollar enterprise in this country, and compounded prescription drugs for menopausal conditions are probably the biggest product outside of the oncology arena. Proponents of compounded hormones have a captive audience, so to speak, made up of women who don’t like commercial drug manufacturers or who prefer products that appear to be natural, or both.
The problem is that these women receive no package insert or prescription drug label with their hormones. Warning labels are not required because compounded drugs are not regulated by the FDA. Consumers are basically at the mercy of whatever claims they read on the Internet or in the lay literature, which tends to be written by people who have a financial interest in affiliating with the compounding industry. It’s a very frustrating situation for a lot of people.
Unintended consequences of the WHI
The Women’s Health Initiative (WHI) stirred demand for bioidentical hormones by casting the safety claims for some commercial hormone therapy products in a less than favorable light. That wasn’t the investigators’ intent, of course, and some of the findings of the WHI have since been questioned.
The goal of the WHI was to critically evaluate some of the touted health benefits of commercial hormone therapy prescription drugs, but, by questioning some of these claims, it inadvertently pushed a significant percentage of patients toward compounded prescription drugs—and we have no safety data on them.
No one knows exactly how many women were swayed, but the consensus is that they were, and no one’s been happy about that.