Clinical Trials

It is difficult to say what is impossible, for the dream of yesterday is the hope of today and the reality of tomorrow - Robert H. Goddard

Clinical Trials

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In the past year, Hollywood’s uncomfortable look in the mirror has shown a place where inequity is profound, sexism is rampant, and gender bias and the subjugation of women are the norm. Women have not been equals in the entertainment industry, and the reckoning is now.

However, the passion for equity that I have carried throughout my life extends into the world of science and discovery, particularly when it comes to the inequitable research funding and treatment of cardiovascular disease in women. Just as women have been undervalued in Hollywood, we aren’t adequately represented in the lab, or in research, when it comes to heart health. Today in America, women are being sent to early graves because our country has failed to combat a disease that kills more of us annually than all forms of cancer combined.

Some sobering numbers are worth considering: Cardiovascular disease claims the lives of nearly 400,000 women each year. One in 3 women die of heart disease and stroke, whereas one in 32 women die of breast cancer. Sadly, but a point that should give us great hope, about 80% of heart disease and stroke in women is preventable or manageable.

I’ve come to Washington this week to implore lawmakers and those who allocate funding to meet this moment with urgency and action. A quarter-century after a bipartisan group of legislators wisely recognized and acted upon a significant gender gap in research, inequity is still pervasive. I’ve been working for years on women’s heart health, specifically, because the need is so great. Only a movement can shake us from this slumber.

Gaps in awareness, diagnosis and treatment of cardiovascular disease cut short too many women’s lives. Sometimes, their names make the headlines: Debbie Reynolds, Carrie Fisher and Florence Henderson. Yet, behind the scenes, a woman in America dies of cardiovascular disease about every 80 seconds. Just as we know what Hollywood must do to rectify historic wrongs, we know how to change the way cardiovascular disease in women is studied and treated. We must:

  • Raise awareness among women before they find themselves in the hospital.
  • Use the knowledge about sex differences to save women’s lives.
  • Drive policy change at every level.
  • Fund more sex-specific research to remedy the blind spots in our knowledge, and apply those breakthroughs to improve prevention, care, treatment and ultimately outcomes.
  • Translate new discoveries into everyday practices.

For too long, cardiovascular disease has been perceived as a “man’s disease” from the patient perspective and in the scientific community. Most of the research has been conducted on men, and most treatments and therapies were tested on men. Sex-specific differences have been neglected all the way from the lab to the ER — even though women’s bodies and biology are different, from the size of our hearts, to our vascular systems, to the impact of risk factors.

We’ve seen progress in fits and starts. A new FDA study on women’s participation in clinical trials that support FDA approval of cardiovascular drugs illustrates that women are well represented in some types of heart disease research but still underrepresented in others. Of 57 clinical trials supporting 36 new drug applications, only 1 in 3 study participants were women.

An accompanying editorial thoughtfully lays out why such research inequity is so significant. It suggests that the inadequate representation of women could lead to sex-biased outcome measurements, deficient data analysis and missed opportunities to transfer the results into clinical practice. My hope is that continued scrutiny like this will lead to women being equally represented in research, and that countless lives will be saved because of it.

The Yentl Syndrome

We’ve known about the disparities in cardiovascular disease treatment in women for decades — since Dr. Bernadine Healy, then director of the National Institutes of Health, published The Yentl Syndrome in the July 1991 New England Journal of Medicine. Named after the movie I directed about a young woman who has to pretend she’s a man to get an education, Yentl Syndrome was Healy’s way of describing a disturbing inequity she had found: Women with heart attacks were not getting the same quality of care as men.

Unless a woman’s symptoms looked like a man’s — the classic crushing pain in the chest — too often she would be misdiagnosed and undertreated. Maybe she’d be told she was having a panic attack, or simply given an antacid and sent home. And maybe she’d never recover and would be found dead the next day.

Women are no longer content to be hidden figures. Like men, we are demanding to be valued as creators, innovators and human beings. Women are finally being heard.

Today, there’s much more to be done so every American has an equal chance to lead a healthy life. This means that the incremental and uneven progress in the research and treatment of cardiovascular disease in women must become a formidable and well-funded movement. The time is ripe for a great leap forward on behalf of gender equity, whether in health care, in science, in Hollywood or throughout American culture.

Source: Barbra Streisand, Heart disease research and treatment neglects women, and it's killing them, USA Today, May 15, 2018.

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Last Updated : Monday, January 7, 2019