The Neglect of Women's Hearts: Time for the FDA to Step Up

Heart disease affects about 43 million women per year. It's time to demand that the research include women in the proportion to which women exist in our population.
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When a man gets heart disease, he will most likely be treated quite differently than a woman, when she gets heart disease. Never mind that heart disease is the leading cause for both. There are vast and, in my opinion, tragic gender-based disparities when it comes to the treatment of our country's number-one killer. Why, in the 21st century, is this true? As the spokesperson for Go Red for Women through the American Heart Association, I feel it is my duty to explain, as well as call out those who might be able to do something about this.

First of all, at the patient level, there is a problem with awareness. Men know that heart disease is the number-one cause of death for them, but only about 50 to 60 percent of women are aware that heart disease is their number one cause of death. Minority women, who are at most risk according to the research, are the least aware of their risk.

At the next level are the doctors. Doctors also have a gap in their awareness, which naturally leads to fewer accurate and/or timely diagnoses when it comes to women. Doctors also lack knowledge about prevention for women -- only about 50 percent of general doctors and 30 percent of gynecologists (the only doctor many women see regularly) are aware of the preventive guidelines for women and heart disease, and a smaller number are actually implementing them.

Finally, at the top level, from which all the knowledge trickles down, only 25 to 30 percent of the research done on heart disease includes women at all. What's more, many of the FDA-approved devices for cardiovascular use in women have never been studied in the women for which they are recommended. How can doctors know what to do when the research isn't there in the first place? This trifecta of neglect when it comes to women's hearts is a tragic reality, but one we must understand if we ever hope to overcome it.

On whom does the onus lie, then, if we are to fix this problem? I say let's start at the top of the chain. Let's start with something simple to get the ball rolling. I call on the FDA to step up and stop the perpetuation of this guessing game we all must use when caring for women's hearts.

In August 2013, we saw the release of the FDA report on the Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products. In the section denoted "Medical Devices," The working group evaluated original premarket approval applications for medical devices approved in 2011. These are the applications that cite the studies used to justify the approval of a medical device. The premarket approval associated with products for facial wrinkle correction and fecal incontinence both included approximately 90 percent females, because these devices represented the "needs" of women. When endovascular occlusion devices (to stop bleeding in the arteries) were evaluated, only 18 percent had female participation. I am relieved to know that women are part of studies that are used in other areas of health care, such as breast cancer and HPV, but it is not enough. This idea of "bikini medicine" is often how women are treated. Our real knowledge is limited to the few parts of woman that seem, on the outside, to be different than a man. What's missing is respect for the knowledge that our hearts, while seemingly similar, operate very differently.

This is why I am disturbed and frightened to learn that devices used in off-pump beating heart surgery, the investigators chose to study the devices mostly on patients with larger coronary artery size and less diffuse disease. Both of these qualities are much more typical in men with heart disease, and in fact are the antithesis of what we see in women's hearts. Yet, we are using these devices on women, with no knowledge of how well they will work, or even whether they might be dangerous. Other devices, such as pacemakers, had a greater inclusion of women, but even then, only included 30 percent. Yet, the premarket approval has indicated the use of all of these devices for women. We're not talking about facial wrinkles here. We are talking about the organ that keeps us alive.

Fortunately, people are taking notice. As a result of this startling report, several notable organizations have expressed concern, including the American Heart Association, National Women's Health Network, the Society for Women's Health Research, and WomenHeart: the National Coalition for Women with Heart Disease. Supposedly, the FDA listened. In a press release from August 21, 2014, the FDA addressed their action plan, responding to the issues addressed by these organizations. What concerns me, however, is that the plan seems less than clear.

This Action Plan was required by the Food and Drug Administration Safety and Innovation Act, signed in July 2012, which directs the FDA to specifically look for sex, race, ethnicity, and age-based differences in the research, and to have the data more available to the physicians using medical devices. The plan also indicated that women and minorities need to be included in the research. The FDA's response has been to "encourage and remind" industry of the importance of adhering to these guidelines.

Encourage and remind? Since when does that work with profit-motivated companies producing expensive products for a vigorous industry? This is hardly a call to action. It is more like a gentle reminder. This response is inadequate and leaves half the population at the mercy of devices that might not help them, and might even hurt them. I am not impressed. It is time that industry become accountable and these initiatives are enforced. We need rules and laws, not gentle reminders. Women have worse outcomes when it comes to heart disease treatment, and this pattern will continue until we truly understand how best to help them. As a doctor, I consider this our obligation, because awareness leads to accountability, and accountability leads to more effective medicine. This is a simple and straightforward way to begin.

Heart disease affects about 43 million women per year. It's time to demand that the research include women in the proportion to which women exist in our population. Come on, FDA. Do the right thing. It's time to change the world.