You may have heard the news that 23 hormone replacement therapy lawsuits filed by women diagnosed with breast cancer were dismissed by a New York judge this week. Judge Martin Shulman granted Pfizer’s motion to dismiss for two reasons: the plaintiff’s delayed filing exceeded the the three-year statute of limitations in New York, and that “the potential risk of contracting breast cancer from taking HRT medication was well known at all times out there in the stream of public information.” Oddly, Judge Shulman simultaneously asserted “that the debate over HRT health problems has not yet been settled.”
I can’t argue about exceeding the statute of limitations, but it’s difficult for a judge to assert that breast cancer risk of hormone therapy is well known public information. The Lancet reported today that up to half of US adults have trouble interpreting medical information, displaying low levels of health literacy. Health literacy, according to The Lancet, is the ability to comprehend and use medical information that can affect access to and use of the health-care system. Health literacy is more than reading and comprehending news reports of medical issues (which are often of poor quality – see Health News Review for sharp analysis of health news); one must also know how to navigate the complexities of the health care system, including knowing how and when to question one’s physicians and pharmacists.
It’s also hard to argue that HT risks are well known when gynecologists, the primary prescribers of HT, refuse to believe the scientific evidence. In 2000 – well after 1990s publication of data from the Heart and Estrogen/Progestin Replacement Study (HERS), a prospective, randomized, double-blind study of 2,763 women with coronary disease which found no benefit of hormones in preventing heart disease – 94.6% of American gynecologists surveyed recommended HT during menopause. Denial continued even after the Women’s Health Initiative (WHI) study – a large, prospective, randomized placebo-controlled trial of estrogen (with and without progestin) in healthy menopausal women – was stopped early in July 2002, because the treated group experienced higher rates of breast cancer, cardiovascular disease, as well as other risks of harm.
WHI was a large, primary prevention trial that contained enough subjects (more than 27,000) to answer the research question; used a design widely acknowledged to be the standard in testing therapeutic efficacy; tested Prempro, the most popular hormone combination; and was monitored by a data safety monitoring board using pre-established criteria. Practitioners should have been satisfied that the question of estrogen as a health-protecting drug had been resolved. Instead, a storm of protest erupted from physicians who could not, or would not, believe the results. Objections to the WHI results (almost exclusively from gynecologists) were so widespread that the media characterized the WHI results as confusing and controversial.
In truth, there was no confusion about the data, which were monotonously consistent with HERS and other randomized controlled studies. [Fugh-Berman & Scialli, 2006]
Why do gynecologists, judges, and others still regard this question as unsettled? Scholars offer several explanations. Paula Derry (board member of the Society for Menstrual Cycle Research) proposed in a 2008 article that faulty decision-making criteria are in play, such as
not valuing rigorous scientific thinking (e.g., ignoring normal rules for judging what counts as scientific evidence, sometimes while claiming to be scientific); not placing a primary value on avoiding harm (e.g., considering heart disease outcomes while not simultaneously considering other risks such as stroke); and basing judgments on a preconception about menopause (i.e., that menopause is an estrogen deficiency disease that causes health problems). [Derry, 2008]
Adriane Fugh-Berman and Anthony Scialli also say the perception of menopause as an estrogen deficiency disease still influences doctors. They speculate that certain features of the unique culture of obstetrician-gynecologists are involved in the continuing promotion of HT. For example, gynecologists are one of few medical specialties that see mostly healthy patients.
Managing medications in healthy women gives a doctor something to do and ensures a continuing relationship with women no longer in need of obstetric expertise.The promise of eternal youth ensures the patients’ consent and gratitude. Healthy women require little or no monitoring and are resilient enough to survive most prescriptions.
Personality factors may play a role, as they cite sources that claim certain types of persons are drawn to gynecological practice. And “reliance on expert opinion and personal experience rather than on evidence from randomized controlled trials may be common among physicians in general.”
Fugh-Berman and Scialli assert that many of those experts are actually sales representatives from pharmaceutical companies. That takes us back to marketing of menopause.
Derry, Paula S.(2008). Update on Hormones, Menopause, and Heart Disease: Evaluating Professional Responses to
the Women’s Health Initiative. Health Care for Women International, 29:7, 720-737
Fugh-Berman, Adriane, and Scialli, Anthony R. (2006). Gynecologists and Estrogen: An Affair of the Heart. Perspectives in Biology and Medicine, 49:1, 115–30