Consumer Beware in Biomedical Research and Women's Health

Lost amidst the flurry of changes is a pervasive health care policy issue that significantly affects all of our health outcomes as well as our health care dollar: gender inequity in medical research.
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U.S. Health care is undergoing a transformation with a magnitude that may only be realized with the advantage of history. Our health care investment has skyrocketed at the same time our system is rapidly evolving to extend care and to meet the shifting needs of our population. Lost amidst this flurry is a pervasive health care policy issue that significantly affects all of our health outcomes as well as our health care dollar: gender inequity in medical research.

As a cardiologist, a woman, and a professor of medicine, I have a unique view of just how significant this problem is, which is not to say I thoroughly understand how underreported the issue remains within the medical science community and the general public. When I ask even highly informed people if they are aware that medical research is conducted predominantly on male lab animals, the response is consistently shock and disbelief. Sadly, it is true, as are these dynamics:

Women and men are biologically different far beyond their reproductive organs. Indeed, every cell has a sex, making the impact of sex differences critical in detecting and treating disease. Yet acknowledging sex differences is still not the norm in medical science which means that women are receiving recommendations from their doctors for prevention strategies, diagnostic tests and medical treatments based on research that has not adequately included or reported results on women.

This occurs at the early stages of research, when females are excluded from animal and human studies or the sex of the animals isn't stated in the published results, making the entire process -- ending in translation into practice and measurement of outcomes -- inequitable because sex and gender differences are so often not embedded within it.

What these findings tell us is that even as we spend trillions on health care, and on the world's most advanced technology, we are still leaving women's health to chance. In addition, we are tolerating a poor return on our health care investment when we don't demand accuracy in science.

A new report, entitled, "Sex-Specific Medical Research: Why Women's Health Can't Wait," (link to report) co-authored by The Connors Center for Women's Health and Gender Biology at Brigham and Women's Hospital and The Jacobs Institute at George Washington University, provides the public with specific evidence of these practices and recommends a number of strategies going forward. Recommendations include: holding federal agencies accountable; promoting transparency and disclosure regarding the absence of sex- and gender-based evidence; and expanding sex-based research requirements. These regulatory efforts are gaining traction but as the health care system continues on its seismic shift, the most important voice in all this is you, the patient, regardless of your sex.

Consider Linda's story. Linda is a middle-aged woman who had a stent placed in one of the arteries to her heart. When her symptoms returned, she went back to her doctor who performed the gold standard test, a cardiac catheterization. It showed no blockages.

That's when Linda came to see me. We performed another cardiac catheterization, which gave us clues; but we needed another test to make the diagnosis. We then did an intracoronary ultrasound, a test that gives us pictures of the artery from the inside out. That's when we discovered her heart disease looked different from what you might see in a man.

In a typical man, you see a clear blockage like this. In Linda, as with many women, the plaque is laid down more diffusely along the entire artery and is harder to see. For Linda, as for so many women, the so-called Gold Standard Test wasn't "gold." Linda received the right treatment, she returned to her life, and she's doing well.

But Linda was lucky. She found us and we found her heart disease. For many women, that is not the case. They accept the treatment they receive because they have no reason to think it would not have been accurately researched. Women (and men) need to think again.

Part of the reason Health care reform now dominates the American policy stage is because consumers questioned the product -- be it the coverage and/or the cost. Consumers need to do the same with the science. As a consumer, demand that drug and medical device companies disclose, through warning labels, whether their products were adequately tested on females. Ask your doctor if the recommended prevention strategies, diagnostic tests and medical treatments he or she is giving you are based on research that included women. If you don't like the answers, join a growing movement of men and women who are doing something about it.

History will judge how well we navigated the opportunity to change the American health care system. Let's make correcting the science on which health care is based a good part of that story.

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