Bouts and others in his practice have been on the receiving end of many compounders’ prescriptions, including faxes that read, "Based on my discussion with the patient and her specific information, I recommend the following order for this patient. Please fax this document to us after the doctor has signed the prescription so we may begin processing."
The idea of pharmacists practicing medicine, ordering and interpreting lab tests, and making specific recommendations for physicians to prescribe unapproved products without disclosing possible risks alarms registered pharmacist Sarah Sellers, a consultant to the Food and Drug Administration on compounding issues and creator of pharmacycompoundingfacts.org. "I’ve talked to physicians who are shocked to learn that pharmacists are hoodwinking them into signing faxed prescriptions for unapproved drugs," she says.
The Pitch: "Bioidenticals replicate your hormones."
Talk to a doctor who prescribes bioidenticals, and you’re likely to get a crash course in estrogen chemistry. The body produces three types: estradiol, manufactured by the ovaries and the predominant estrogen found before menopause; estrone, which is converted from estradiol; and estriol, also converted from estradiol and produced in large amounts during pregnancy. Most compounded products are a mixture of these hormones; depending on a woman’s symptoms and hormone levels (often measured in her saliva), the compounding pharmacist attempts to supply the ideal ratio in a prescription. But there is no sound medical reason for taking two or three different estrogens.
"The idea of producing some mystical, magical oral formula between the three estrogens is pseudoscience at its worst," says endocrinologist Neil Goodman, MD, professor of medicine at the University of Miami, Florida. "Once ingested, the three hormones are absorbed at different rates and metabolized in the liver at different rates, so you’ve soon lost your magical relationship."
The Bottom Line: "If anything, you should take only estradiol," Goodman recommends. "Once in the body, each tissue will make estrone and estriol in various proportions according to your individual needs at any given moment."
The Pitch: "Bioidenticals are risk-free."
"Your own hormones can’t possibly be bad for you," says Erika Schwartz, MD, a specialist in bioidentical hormone supplementation in private practice in New York City. "When you’re 25 and your hormones are in balance, the incidence of heart disease and cancer is minimal. You’re fertile and healthy and have no wrinkles. Hormones are great for you, and I’d like to eliminate the fear of the word hormone that has been unjustly created because of the problems with synthetic ones."
But is there really such a thing as a harmless hormone? "Even hormones made by your body can hurt you," says Adriane Fugh-Berman, MD, who teaches in the complementary and alternative medicine program at Georgetown University. "There’s lots of data that indicates women with higher natural levels of estrogen are at a higher risk for breast cancer."
Bioidentical hormones have not been studied in clinical trials in the U.S., which frees promoters to claim that, among other things, estriol is not only safe but may prevent cancer because it is weaker than the other estrogens. But any estrogen needs to be taken with caution. For years, oral estriol was prescribed in Europe without the standard progesterone accompaniment to protect against endometrial cancer. Then a study in Sweden revealed that taking one to two milligrams a day of estriol alone doubled the risk of endometrial cancer. In another study in Sweden of 5,000 women, published in February 2006, stronger estrogens increased the risk of ductal and lobular breast cancer. That’s really no surprise, but here’s what was — even low-dose oral estriol (about one milligram a day) doubled the risk of lobular breast cancer in women who took it for fewer than five years. "We need more studies, but at this point, we cannot rule out an increased risk for breast cancer even with the less potent estriol," says lead researcher Lena Rosenberg, MD, of the Karolinska Institute, in Stockholm, Sweden.