Not only is a woman's body obviously different from a man's, but each cell in a person's body has a sex.1 So it is no surprise that diseases, and the medications and medical devices used to treat them, may affect women differently. Yet the prevention, management, and treatment of many health conditions still often follow the one-size-fits-all approach.
Heart disease is an example where there are sex differences. Women are less likely than men to experience the classic symptoms of a heart attack.2 And traditional diagnostic procedures are not optimal for women — sometimes resulting in a delayed diagnosis or misdiagnosis.3 Also, because women are diagnosed with heart disease 10 years later than men, on average, they are more likely to have other chronic diseases at the same time.4 We are still learning more about the differences between men and women that result in different outcomes from heart attack, stroke, and other cardiovascular conditions.
The federal government began addressing sex differences in health almost 30 years ago, in 1986, when the NIH established a policy to include women in clinical research.5 This allowed researchers to study how medications, procedures, and diseases affect women differently from men. One year later, the FDA published the "Demographic Rule," which required manufacturers to show prior to approval how their drug is safe and effective by sex, age, and race.6
Including women in clinical research has led to new developments benefiting women. One example is the FDA's 2010 approval of a smaller left ventricular assist device.7 This device is used in patients with severe heart failure who are not candidates for a heart transplant. The smaller version of this device was created to address to sex differences in body size, giving more women access to this lifesaving treatment.
FDA's Office of Women's Health has been collaborating with private sector partners on a new Women's Health Curriculum and toolbox for pharmacy educators and students nationwide. Students in the program will study how sex differences affect women's health across the lifespan and how they may influence the safety and efficacy of FDA-regulated drugs and devices.
More information on sex and gender differences in health and disease is available through the NIH Office of Research on Women's Health.
- Straface, E. et al (2012). Sex differences at cellular level: "cells have a sex". Handb Exp Pharmacol; (214): 49-65
- OWH, Signs of a heart attack
- Maas, A., Appelman, Y. (2010). Gender differences in coronary heart disease. Neth Heart J; 18(12): 598-602
- Worrall-Carter, L. et al. (2011). Systematic review of cardiovascular disease in women: assessing the risk. Nurs Health Sci; 13(4): 529-35.
- NIH, ORWH Inclusion of Women and Minorities in Clinical Research
- FDA, Promoting Safe and Effective Drugs for 100 Years
- FDA, FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients