By Jo Applebaum
Wednesday, July 17, 2002
The recent end of the study of the effects of hormone replacement therapy raises serious questions about how drugs are approved, promoted and prescribed. The author argues it should also be the end of assumption-based medicine.
(WOMENSENEWS)--For many years, the medical community assumed that long-term use of hormone replacement therapy would decrease the risk of heart disease and osteoporosis, even though no prospective, randomized, placebo-controlled studies--the gold standard of scientific investigation--had been conducted.
Last week--five years into the first long-term, rigorous study in healthy women of the most common estrogen and progestin therapy--researchers halted the trial early because they found that the hormones increase the risk of invasive breast cancer and cardiovascular disease, at a rate that clearly outweighs any benefits. There were fewer cases of hip fractures and colon cancer--benefits not considered worth the risk.
In other words, the assumptions were wrong.
Why did doctors prescribe this therapy to so many women--6 million women currently take the hormone combination--without any proof of its long-term benefits? Heart disease and osteoporosis are real concerns for older women, who face dramatic increases in risk after menopause. Estrogen was reasoned to be a factor and observational studies that look at trends in a given population supported taking estrogen for several years as good prevention. Doctors knew for years that hormones posed an increased risk of breast cancer and were willing to accept that risk for the benefits they assumed the therapy provided.
Yet no form of hormone replacement therapy is approved by the Food and Drug Administration for the prevention of heart disease. While other effective--and proven--treatments, such as drugs that lower cholesterol, are available.
Major health institutions played a role in the scenario. The pharmaceutical industry was eager to take advantage of a growing market; the Food and Drug Administration allowed the promotion of these drugs without the most rigorous science behind them; the medical community was quick with the script. Because health maintenance organizations have reduced contact between doctor and patient to five minutes, women often rely on information from the news media, which often reports medical news out of context.
The study might have stopped the routine use of hormone replacement therapy last week. However, the event illustrates tremendous problems in our healthcare system, as well as fundamental inequities in the study and treatment of women's health.
Hopefully, the magnitude of this news will prompt a hard look at these issues, and initiate changes in the business of medicine. But in the flurry of finger pointing and throwing of hormone pills out the window, issues become blurred and information important to women becomes more confusing. More research is needed, as are more reliable avenues of disseminating results to women (and doctors) so they can make more informed decisions.
For instance, there are many different types of hormones available and different ways the hormones are delivered. Whether the recent findings apply to all hormone regimens is still in question. Scientific studies are designed to answer specific questions, which is why several studies are needed in any area of medicine. The Women's Health Initiative was designed to assess long-term risks and benefits; even after the recent results, it is not clear how long is safe. The risk is such that hormone replacement therapy cannot be recommended for long-term use to the entire population of menopausal women, but individual women with severe symptoms may be willing to accept some short-term risk in exchange for relief. But this one study cannot determine what hormones, in what combinations, are right for what women.
Heart disease kills more women in the U.S. than any other cause of death, including all cancers combined, and cardiovascular mortality in women is on the rise. Prevention and treatment of heart disease and osteoporosis have been well studied, and established, proven treatments are available that reduce risk. However, physicians did not prescribe these drugs to women as readily as they did hormonal treatments.
In science and medicine, paradigms shift as one model is shown to be faulty and another is erected in its place. Yet, for numerous reasons that will be explored as this debate continues, the hormone replacement model has only just been tested by modern standards of evidence. Perhaps as health care consumers we'll be asking more questions in the future. As for the medical community, let this mark the end of assumption-based medicine.
Jo Applebaum is a freelance medical writer covering the pharmaceutical industry and topics in health care. She is also a Stress Management Consultant in health care and workplace settings, and is an instructor for Stress Management teacher training programs.
Women's Health Initiative Participant Website:
The North American Menopause Society:
Also see Women's Enews, July 17, 2002:
"6 Million Now at Higher Risk for Breast Cancer":