The misconception that compounded bioidentical hormone therapy is safer than commercial hormone therapy has potentially serious consequences. While most MDs are cautious about prescribing estrogen to women at risk for breast cancer, More had no trouble finding women with a family history of the disease who said they’d been assured by hormone-clinic physicians that the BHT drugs were perfectly safe.
After Julie Johnston turned 50 in 2005, she went to a hormone clinic near her home in Kingston, Tennessee, where a doctor prescribed estrogen, testosterone and progesterone even though Johnston’s mother had developed breast cancer in her sixties. Johnston, who does double duty as an intelligence analyst for the National Nuclear Security Administration and as a strategic intelligence officer for the Army Reserve, had read one of Somers’s books, and it spoke to her issues. She was having hot flashes. She was also involved with a new guy and hoped that hormone therapy would add some oomph to the relationship.
It was important to Johnston that she take a “natural” medication. “I fell for the premise that the hormones are safe because they are exactly what your body makes,” says Johnston. No one at the hormone center, she says, brought up risk factors. “When you’re seeing a medical doctor, you think everything’s all safe and sanctioned.” In late 2010, Johnston was diagnosed with a common form of breast cancer that is fueled by estrogen. It is impossible to prove that the very high doses of estrogen she’d received were a contributing factor, but the normal range of estradiol (a kind of estrogen) for a postmenopausal woman who hasn’t taken hormones is 0 to 30 picograms per milliliter, and in June 2010, according to medical charts that Johnston collected from the hormone clinic, her level reached 523.8 picograms per milliliter. In January 2011, Johnston had a double mastectomy. Last winter the clinic she visited was shut down by the state of Tennessee.
The dangers of poor quality control
It would take a major study to fully examine the effectiveness and safety of compounded BHT. The testing More commissioned is not that study—but it does address a basic, essential question about the quality of BHT products made under unregulated circumstances: Do those pills contain what they are supposed to?
To answer that question, we analyzed the ingredients, potency and weights of a common 30-day BHT prescription we’d sent to 12 compounding pharmacies. The prescription called for three forms of bioidentical estrogen (estradiol, estrone and estriol; the combination is known as Tri-Est) as well as progesterone. The estrogens differ mainly in terms of potency. Estradiol, the dominant estrogen in premenopausal women’s bodies, is 12 times as potent as estrone, which takes over in the body once menopause has occurred, and 80 times as potent as estriol, which is the primary estrogen produced in the placenta during pregnancy. Although estradiol and estrone are approved ingredients, estriol is not FDA approved, because it has never undergone clinical tests in the United States. The FDA has issued official Warning Letters to seven compounding pharmacies that include estriol in medications, telling them to stop. Yet none of the places we contacted declined to include this hormone in the capsules we ordered. Flora Research’s analysis confirmed that estriol was present in each filled prescription.
One important question is whether compounded bioidenticals contain the precise doses of medicine specified by the prescribing doctor. More’s testing shows cause for concern. “The results are astounding and terrifying,” says Wulf H. Utian, MD, PhD, DSc, founder of the North American Menopause Society, who reviewed our findings.
Consider this: Among the 12 prescriptions we filled, estriol was sub-potent in all samples, meaning that the hormone was present in lower quantities than the prescription label indicated. In all but two cases, the other two estrogens in Tri-Est, estrone and estradiol, were superpotent—they delivered a higher dose than prescribed.