In this New York Times’ Well blog post, the gist of the text is supporting the idea that old fears about the health risks of hormone replacement therapy for women have been rethought and new conclusions should reassure the public about its safe use–especially in short-term (fewer than 5 years) relief of menopausal systems.
The post mentions that HRT has been used in two ways: to treat menopause symptoms, and to prevent chronic disease. But the information is relayed in a somewhat confusing, incomplete way. For example, there was no discussion of where the U.S. Preventive Services Task Force falls on the idea of using HRT to prevent chronic disease. (They recommend against it.) When clinical research is mentioned, no specifics are given on the measured benefits or harms.
Women have been subjected to plenty of confusion in the past decade over the safety of HRT. Once touted as a potential relief for symptoms of menopause, these drugs were also later criticized for potential harms (2002) that outweighed their benefits for some women. New research in this area is certainly of interest to many women, and incomplete information will likely be noticed by sharp-eyed consumers tired of the back and forth.
Costs are not discussed.
This story is about risks and benefits, and about the misunderstandings that can result. But we did not find the absolute risk and benefit numbers that would have helped to clarify.
Here is a benefit statement, which we found incomplete. We would have preferred some absolute numbers.
“In a Danish randomized controlled trial of 1,006 women entering menopause, among those given hormones for 10 years, “there was a reduction in cardiovascular disease and breast cancer — a clear benefit with nominal risk,” Dr. Hodis said. These benefits persisted after 16 years of follow-up, according to the study, which was published in 2012.”
How big was the “clear benefit?” What does Dr. Hodis consider a “nominal risk?” Readers may look at these issues differently than Dr. Hodis does, so it’s important to clarify.
The story is trying to compensate for bad communication in years past, and so we believe it should meet a high standard when communicating the perspective it says is “new.”
Here is one harms statement that could use more careful writing and more numbers. The italics were added by us:
“In an analysis in 2013 in the American Journal of Public Health, Dr. Philip M. Sarrel and his co-authors calculated that, based on reduced death rates among women taking only estrogen in the W.H.I. study, avoiding hormone replacement resulted in the premature deaths of 18,601 to 91,610 women in the decade after the study’s release.”
There is a lot of leeway between 18,000 and 90,000. The claim of deaths due to misinformation begs for a more accurate description of the equation used in the 2013 paper, as well as limitations of the analysis. It would also be important to explain why this recommendation differs from that of the independent U.S. Preventive Services Task Force, which still recommends against the use of HRT for the prevention of chronic diseases. Their recommendation includes a detailed description of harms and benefits on their web site.
The entire story is about the “harm” possibly done by the warning years ago that hormone replacement therapy had been hyped inaccurately as a cure-all. But the story is remarkably silent on the potential “harm” that still exists from hormone replacement for some women under some circumstances. The point that every woman should calculate her own personal risk versus benefits with her physician seemed buried.
The story states early on that “new studies” are invalidating the original Women’s Health Initiative. However, the two research studies cited in the story are from 2012 and 2013, years that don’t qualify as “new.” And the quality of those studies and their potential limitations isn’t addressed in any detail.
Beyond the 2016 guidelines referenced in the story, the only other relatively “new” item seems to be the debut of a mobile app, released in 2014. But the story gives us no evidence or discussion of research to establish its credibility as a health-care decision tool. Here is the mention. Italics added by us:
“To help women and their doctors assess H.R.T. options and select the best treatment for women 45 and older with menopausal symptoms, the North American Menopause Society has developed a mobile app, MenoPro, for iPhone/iPad and Android devices.”
The editorial written about the app contains this disclaimer language. The boldface added by us:
“Disclaimer:This Application is intended for informational purposes only and is not intended as a substitute for professional medical judgment, diagnosis, or treatment. Users of the app are asked to read and accept an End User License Agreement, available on the app.”
We think readers of the news story will be confused, because it seems as if the app is being offered precisely to help them make a health-care decision about the use or non-use of hormone replacement. But the disclaimer seems to say “don’t use this for diagnosis or treatment.”
There was no disease mongering.
The Danish trial referenced in the study was partially funded by drug companies and the authors disclose a long list of drug company affiliations not mentioned in the story. In addition, the first author of the 2013 study showing harm from avoiding hormone therapy has served as a consultant Noven Therapeutics, which makes hormone therapies.
The two experts quoted in the story are JoAnn Manson and Howard Hodis. Manson is one of the authors of the editorial about the mobile phone app, and the paper says she has no conflicts. Hodis is a member of the board of the North American Menopause Society. The NAMS receives support from a long list of pharmaceutical companies. Links to some of them here.
The story tried to cover so much ground in revisiting old ideas and explaining new ideas, it did not take the time to set up a comprehensive list of alternative ways for women to deal with menopausal symptoms. It listed the traditional hormone replacement and then discussed what it labeled “custom compounded” products without much explaining of what they are.
Regular exercise, for example, is among many non-drug approaches listed routinely for menopausal symptoms.
All of the therapies in the story are widely available, and the story establishes this with this sentence: “There are also lots of products now available and different ways to use them that enhance the safety of hormone replacement.”
The story was confusing. The beginning implies that there is new research on the value and safety of hormone replacement, but the only clinical research studies quoted are years old.
The story did not rely on a news release.