What spurred the boom in bioidenticals
For years, compounding pharmacies were few and far between. But during the early 2000s, the backlash against HT presented an opportunity for compounding pharmacies to greatly expand their business by offering bio-identicals. (Bulk compounders, which make large quantities of supposedly sterile drugs, began their exponential growth around the same time.) The bioidentical drugs fit nicely into the zeitgeist, which was characterized by the public’s distrust of big pharmaceutical companies, an urge to go organic and the conviction that natural is better. No wonder women have often been willing to pay more for compounded hormones (about $58 for a month’s supply and rarely reimbursed by insurance) than commercial ones ($80 or more but usually covered by insurance carriers and so ultimately cheaper).
Many mom-and-pop compounders, eager to increase sales, began offering free seminars and consultations on bioidenticals to walk-in patients who were confronting signs of menopause, such as vaginal dryness, hot flashes and reduced libido. Compounders also learned to do business online, filling prescriptions and shipping the drugs all over the country.
The consumer move to bioidenticals was also a huge boost to physicians engaged in what is called anti-aging medicine. For two decades, many anti-aging clinics—often associated with compounding pharmacies—treated healthy patients with human growth hormone (HGH). After an FDA crackdown on HGH in 2003, many anti-aging clinics switched to providing individualized hormone therapy.
Of course, nothing sells like sex, and that, in the form of actress turned hormone activist Suzanne Somers, was a major kickstarter for the bioidentical movement. In 2004, Somers published The Sexy Years: Discover the Hormone Connection, which immediately became a sensation, selling nearly half a million copies that year. The book—along with similar titles by Somers as well as some by doctors (such as The Hormone Solution: Naturally Alleviate Symptoms of Hormone Imbalance from Adolescence Through Menopause by Erika Schwartz, MD, and Natural Hormone Balance for Women: Look Younger, Feel Stronger, and Live Life with Exuberance by Uzzi Reiss, MD)—claimed that customized compounded BHT would help women regain their libidos and youthful bodies. The clincher was that BHT would do all that without making them vulnerable to the many risks described in the WHI study. Somers found a big audience: In January 2009, a reported 6.2 million television viewers watched while she promoted the benefits of BHT on The Oprah Winfrey Show.
But while thousands of women have become convinced that compounded
bioidenticals can deliver on these promises, very few have delved into whether there is strong scientific evidence behind their hopes.
The illusion of safety
According to the FDA, there is no reason to believe that the risk profile of compounded hormones is different from that of other hormones on the market. This means that in the agency’s view, compounded BHT is as likely to increase a woman’s risk of heart attack, stroke, blood clots and breast cancer as commercial HT is. Yet none of our filled prescriptions arrived with any product literature warning consumers about those risks. “Every FDA-approved estrogen product carries a black-box warning and also explains the risks in nontechnical language, but no such warning is required to appear on compounded estrogens,” says Larry D. Sasich, PharmD, chair of the department of pharmacy at Lake Erie College of Osteopathic Medicine.
Women can easily draw the wrong conclusions from this omission. “My patients frequently have the impression that because [compounded BHT] comes without any mention of adverse reactions, that means there are none,” explains James A. Simon, MD, clinical professor of obstetrics and gynecology at the George Washington University School of Medicine.