The biggest danger emerges from the shortfall of progesterone that the lab identified in 11 out of 12 prescriptions, says Adriane Fugh-Berman, MD, associate professor at Georgetown University Medical Center. When estrogen is used in hormone therapy, it thickens the lining of the uterus. If a woman with an intact uterus takes the drug, the growth in the lining can become excessive, potentially resulting in uterine cancer. For that reason, a woman taking estrogen in HT or BHT must counter its effects with progesterone, which prevents the lining of the uterus from building up. When a compounding error causes the woman to take less progesterone than has been prescribed, the cancer risk is increased.
In at least nine of the samples More tested, “there is a gross overbalance of estrogen versus progesterone,” Utian notes. In other words: These capsules do not contain enough progesterone to offset the potentially cancer-causing effects of estrogen.
The pharmacies probably weren’t even consistent in their dosing. Although Flora Research did not weigh the specific hormones in each capsule, in a second set of tests, it did determine the total weight of individual capsules. Within each pharmacy’s batch, the weights changed considerably from one to the next, which implies that the doses of hormones also varied from day to day, says Sasich. Such unpredictable dosing can result in hormonal confusion; instead of smoothing things out, the varying hormone levels could make menopause an even bumpier roller--coaster ride.
More’s testing shows that compounding pharmacies have not improved their performance since 2006, when an FDA lab analysis showed subpotent amounts of hormones, including estrogen and progesterone, in compounded products, and significant variation in the medicine’s content from pill to pill.
All hormone therapies carry some health risks to women, but the results of our studyraise the possibility that compounded bioidenticals might actually pose more of a threat than FDA-approved drugs.
The myth of customization
The popularity of compounded BHT has not gone unnoticed by pharmaceutical companies, and since 2008, FDA-approved bioidenticals made by conventional manufacturers have become widely available and do about $2.6 billion a year in sales. But these medicines come in standardized formulations, and for diehard BHT believers, that’s a problem. In Somers’s just-published book, I’m Too Young for This! The Natural Hormone Solution to Enjoy Perimenopause, the writer maintains that commercially manufactured bioidenticals “have one big drawback in my estimation: they are not specifically made to individualize exactly what youmight need . . . I get my hormones compounded so that I get my hormones individualized, just for me. This allows me to achieve a perfect balance, just like Goldilocks...not too much, not too little, just right.”
Typically, doctors at hormone clinics rely on blood tests to customize BHT prescriptions. The tests cost hundreds of dollars and reveal nothing useful. In the body, hormones are secreted in pulses; therefore, levels fluctuate depending on the time of day or month. Customization assumes you have an individual hormone level that doesn’t vary much, when in fact women’s hormone profiles change tremendously from one day to another, and even one time of day to another, until several years after menopause. With these moving targets, it is impossible to truly “customize” a drug.
The dark truth, says Lauren F. Streicher, MD, an OB-GYN at Feinberg School of Medicine, Northwestern University, is that “when women hand me their special prescriptions for compounded bioidenticals, guess what? These different women have all been prescribed exactly the same thing. And then they’re asked to go back and have blood testing every few months.”
FDA-approved bioidentical-hormone products do not call for measuring a patient’s hormone levels because effective standardized dosage levels have been well established during clinical trials. If a patient’s symptoms are not improving enough, doctors can boost the prescribed dose in increments produced by the drug manufacturer.