Wall Street Journal examines debate over alternative HRT to treat menopausal symptoms

November 19, 2015

"A Safer Prescription for Menopause?": Women take a "litany of drug regimens" -- including antidepressants, osteoporosis drugs, sleep aids and prescription anti-inflammatories -- to handle symptoms of menopause that previously were treated with traditional HRT. According to the Journal, physicians are beginning to worry whether the "shift away from hormones [has] made women safer or ... just subjected them to a whole new set of drug risks." After results from the Women's Health Initiative study showed that women using estrogen and progestin appeared to have a higher risk of breast cancer and heart disease, use of HRT has dropped. According to IMS Health, sales of menopause hormones declined by 33% from 2001 to an estimated $1.9 billion in 2005, and sales of estrogen-progestin combination therapy decreased by 8% in the first half of this year from the year-earlier period. Sales of estrogen therapies dropped by 4%. Shari Lusskin, director of reproductive psychiatry at New York University Medical Center, said, "People are saying, 'If it's hormones we won't take it, but I'll take anything else you'll hand me.'" She added, "But there's no medical treatment that has only benefits and no risks. Patients have to be educated consumers and think carefully about what drugs they're going to take" (Parker-Pope [1], Wall Street Journal, 10/21). "Treatments: The Debate on Compounded Hormones": A debate is "raging" about what to call hormones that are custom mixed by pharmacists and whether they are any safer than commercial hormone preparations or prescription drug alternatives. The treatments are called "bio-identical hormones" and have the same molecular composition as hormones produced by a woman's body. They often are promoted as "natural" hormones that do not have the same risks as hormones sold by drug companies, the Journal reports. FDA has said that women should assume that all hormone treatments have the same risks and benefits, though commercial hormone products have that warning, while compounded treatments do not. Critics say that the terms "bio-identical" and "natural" are misleading to women who think their bodies will respond differently to the treatments than to commercial hormone drugs, the Journal reports. There is no is published evidence that compounded hormones are safer or more beneficial that tradition HRT, according to the Journal. "The argument is not against the use of compounded hormones," Wulf Utian, executive director of the North American Menopause Society, said, adding, "The argument is that women aren't being informed" (Parker-Pope [2], Wall Street Journal, 10/21). This article is republished with kind permission from our friends at the The Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery of in-depth coverage of health policy developments, debates and discussions. The Kaiser Daily Health Policy Report is published for Kaisernetwork, a free service of The Henry J. Kaiser Family Foundation. 2006 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

A multivariable analysis that took into account age, estrogen receptor-negative status, primary tumor size, and whether the disease had spread to the lymph nodes, showed that African-American race is an independent factor in reduced overall survival rate.

The researchers note they could not take into account factors that might have influenced the patients' care before they entered the clinical trials. And their analysis did not include socioeconomic factors because that information was not available for patients. However, they doubt socioeconomic factors could fully explain differences in survival rate because Hispanic and African-American women have similar socioeconomic status in M. D. Anderson's patient referral area.

"We interpret these data as suggesting that intrinsic biological differences in the disease and response to treatment among racial groups contributed to the poorer overall survival rates seen in the African-American cohorts," the researchers conclude.

"It's important to note that African-Americans, and people in all self-reported racial groups, are genetically and culturally diverse," Woodward says. "Not all African-American women will have worse survival prospects for breast cancer, but there are probably subsets of patients for whom we could be doing something better.

"The tools and technology are emerging that will allow us to understand how one person's tumors differ from another and how we can more effectively assign people to treatments," Woodward says.

The paper notes that explaining the association of African-American race with more aggressive breast cancer will be challenging, and suggests analysis of genetic variation and regulation of genes by environmental factors as two potential areas of research.