On the surface, it doesn’t really seem that surprising men and women develop heart disease differently or experience different symptoms for the same types of cardiac episodes. However, even though heart disease is the number one killer of both men and women, women have traditionally been omitted from clinical trials and female animals have either not been included in preclinical research studies or the two sexes have been combined1. We just simply weren’t taking half of the population into account at every level of cardiovascular disease (CVD) research for quite some time. I spent my graduate career focused on understanding the baseline differences in the heart between the sexes, and was extremely passionate about this work. Since I spent most of my scientific career working in this field, I wanted to switch it up as a postdoctoral fellow and am currently not researching sex differences. However, when I went to AHA sessions this year, I made it a point to go to any events focused on sex differences and women to get updated on what I’ve been missing this past year. Luckily the “State of the Heart For Women: Top Ten Advances in Gender-Specific Medicine” session provided the perfect summary. After ten great talks focused on a variety of gender specific concerns ranging from heart failure to pregnancy, the take home message was clear: women are still very much at risk, more likely to be misdiagnosed, and are still under-represented in clinical trials. These issues are also worse for women of color.
While this is a widespread issue across disciplines, the cardiovascular field has been particularly biased with regard to including women in clinical trials for drug development, leading to drugs being either not as effective in women or causing different side effects2. The good news is, things are changing. In the early 1990’s, reports from the Food and Drug Agency (FDA) demonstrated that less than 20% of participants in clinical trials were women and recent studies reveal that this number is steadily increasing – even in the cardiovascular field3. Fixing this imbalance is the result of the tireless work from many dedicated researchers over the past several decades. One of the main advocates this field has is Dr. Nanette Wenger, who was the first speaker of this session and actually let me ask her a some questions later during the conference while we were both in the Women in Science and Medicine Lounge. When I asked Dr. Wenger about her strategy for making this issue a priority in our field she explained the key steps to creating change:
- Investigate — people can’t ignore what the data is clearly telling them
- Educate — teach your peers & patients
- Advocate for the change
- Legislate — it took a long time, but we’re slowly transforming the strategic plan of the NIH
Dr. Wenger also stressed that since the emphasis in our field now is personalized care, many researchers and physicians are more supportive of including sex in their experiments and/or trials, but we need to move forward by not assuming that women are a homogeneous group. Other factors such as race are also important and must also be considered.
While progress has been made we still have a long way to go on many accounts. While there are more women in clinical trials than in the past, women still only make-up about 34% of the total participants in cardiac clinical trials3. Hopefully, with the passing of the 21st Centuries Cures act and the NIH policy mandating sex be included as an biological variable in basic research studies in 2016, these numbers will progressively increase. At the session before the talks even began, I immediately noticed that all but one of the ten panelists were women (which is awesome, but strange for the cardiac field) and the majority of people in the audience were also women. We will need to continue to advocate for this issue and we need men to join us and take it seriously for real change to be made. Additionally, while I really enjoyed this unique session, the speakers were only given ~10 minutes each to summarize their extraordinarily complex topics, which just wasn’t enough time. It would be great if gender-specific cardiovascular issues were given more time at AHA Scientific Sessions as well as other conferences in the future. This session reminded me just how pressing making CVD treatment equitable for all truly is and thankful for the researchers making it happen.
- Blenck CL, Harvey PA, Reckelhoff JF, Leinwand LA. The Importance of Biological Sex and Estrogen in Rodent Models of Cardiovascular Health and Disease. Circ Res. 2016;118(8):1294-312.
- Regitz-Zagrosek V. Therapeutic implications of the gender-specific aspects of cardiovascular disease. Nat Rev Drug Discov. 2006;5(5):425-38.
- Pilote L, Raparelli V. Participation of Women in Clinical Trials: Not Yet Time to Rest on Our Laurels. J Am Coll Cardiol. 2018;71(18):1970-2.