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Today on The Pulse View All

FDA Announces Plan to Help Improve Health Equity for Women and Minorities

A new action plan released by the Food and Drug Administration (FDA) to increase the participation of women, minorities, and the elderly in research trials was welcomed today by four leading health organizations as taking an important step toward closing the health care disparities gap.  The groups called on the agency to implement the plan swiftly.

The American Heart Association, National Women’s Health Network, Society for Women’s Health Research, and WomenHeart: The National Coalition for Women with Heart Disease said the “FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data” will not only help boost representation of these population groups in clinical trials, but also will lead to more analyses on how medical drugs and devices affect women and men differently.

The groups particularly applaud the FDA for finalizing its guidance on the evaluation of sex-specific data in medical device studies and for establishing a steering committee and website to oversee and track progress on implementing the action plan. The groups, however, urged the FDA to do even more.  

The FDA’s Action Plan was required by the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July 2012.  The act directed the FDA to review medical product applications to determine the extent to which data on how new drugs and devices affect certain subpopulations is being collected, evaluated and released publicly. By taking the actions outlined in the plan, the FDA will emphasize the need to look for sex, race, ethnicity and age-based differences through medical research, allow subgroup-specific data to be more widely available for use in medical practice, and improve the participation of women and minorities in research trials.

“Guaranteeing greater diversity in research trials will help ensure that patients and their health care professionals have the most up-to-date information needed to make the best decisions about care and treatment,” said the four organizations. “By carrying out the actions recommended by the FDA plan, we can advance our nation’s efforts to achieve the high quality health care that women and minorities want and deserve.”

While the organizations applauded the FDA’s work to address the many issues they highlighted in testimony before the agency earlier this year, they called on the FDA to:

  • Establish and clearly spell out for application sponsors the consequences of not collecting or analyzing subgroup data;
  • Take action to address concerns related to the under-inclusion of women, minorities and the elderly in early phase trials; and
  • More aggressively move forward with additional, standardized subgroup information in the labeling of medical products.

“Gender, race and age play a decisive role in how heart disease, stroke and other forms of cardiovascular disease affect us. Yet, these key populations are often left out of the research necessary to better understand the diverse impact of these diseases,” said Nancy Brown, CEO of the American Heart Association. “That’s why the FDA must not allow this new plan to just gather dust on a shelf. It’s critical that these actions be carried out rapidly and aggressively, and we look forward to working with the FDA to implement this plan.” 

“Women and their health care providers need complete and accurate information about the medical products available to them, particularly the specific benefits a drug or device might offer and the risks it might pose to her because she is a woman,” said Cynthia Pearson, executive director of the National Women’s Health Network. “The current lack of information exposes women to harm that could be avoided by more inclusive requirements for clinical trials. While the FDA Action Plan is a step in the right direction, the agency must do more than remind and encourage industry to include women and minorities in trials and analyze the data. The FDA must require that companies do this to ensure that that the products women use are safe and effective for them.”

“The Society for Women’s Health Research is pleased that the FDA heard our call for the need to release demographic data and establish training for all reviewers to look for sex differences. One of SWHR’s key priorities for more than 20 years has been making sure this data is appropriately analyzed and reported by the FDA,” said Phyllis Greenberger, president and CEO of the Society for Women’s Health Research.  “Still, the Action Plan falls short in several important areas. The FDA should do more to prioritize finding out how medical products affect women and men differently and report that information to patients and health care providers, especially since there have been significant discoveries of sex differences from biomedical research in the last two decades.”

“Women and their health care providers are tired of waiting for access to data demonstrating whether drugs and devices are safe and effective for their use. The FDA has studied this problem for decades, yet
the problem has not been fixed,” said Lisa M. Tate, CEO of WomenHeart: The National Coalition for Women with Heart Disease. “Implementation and enforcement of these recommendations would go a long way toward assuring that providers can recommend appropriate treatments for 51 percent of the U.S. population, including the 43 million women living with or at risk for heart disease.”

In the coming months, the organizations will submit additional comments and recommendations about the FDA Action Plan and work with the agency and Congress to address continuing areas of concern vital
to the health of women, minorities and older Americans.

Read what FDA Commissioner Margaret Hamburg had to say about this important step.

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Introducing 'Life is Why'

Here at the American Heart Association/American Stroke Association we’re excited about our new brand Life is Why and we hope you are excited too! Life is Why was developed to capture the momentum of our growing organization, the passion of our people, and to communicate our mission to one day realize a world free of heart disease and stroke.
 
A celebration of life, Life is Why offers a simple, yet powerful answer to the question of why we do what we do. Simply put, we want people to experience more of life's precious moments. To do that, we all must be healthy in heart and mind. I’ll personally share that my Why as the Director of the You’re the Cure program is YOU! Volunteers are Why I come to work every day. Your stories, your passion, your commitment to create change motivate me.

We know a brand is built by its supporters which makes you a critical part of our brand success. We thank you for helping to make our brand so meaningful by your commitment, achievements and passion. Take a moment to watch our new video that captures the essence of our new brand, Life is Why and let us know what you think!

(Please visit the site to view this video)

 

Clarissa Garcia
Director, Grassroots Advocacy
American Heart Association
Heart Disease and Stroke. You're the Cure.

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Upcoming Event View All

  • Sep
    18

    Rally for Medical Research Virtual Hill Day!

    Thursday, 7:00 AM – 5:00 PM

    On September 17th and 18th, the American Heart Association will be joining over 80 organizations in our nation's capital to meet with our elected leaders! Our message will be simple: Prioritize funding for medical research done at the National Institutes of Health (NIH). Even if you are not in Washington, you can still participate from your own home. Below are a few was to get involved!

     

    • Get Social: Follow our You’re the Cure Facebook page to see which You're the Cure advocates will be representing the American Heart Association during the Hill Day!

     

    • Stay Tuned: As we approach the Rally for Medical Research Hill Day, keep an eye out for emails asking you to contact your member of Congress asking them to prioritize heart and stroke research.

     

     

     

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Watch You’re the Cure advocates and get the latest AHA advocacy updates.

Advocate Stories View All

Ariel Walker Ohio

At 19, my life was totally normal for a college student.  Eat, sleep, class, repeat.  And then one day, my heart quit beating.  I was giving a final presentation in front of a class full of people when everything went dark.  When I woke up, I was on the floor with a paramedic looking at me.

It took almost 4 years to diagnose what had caused me to pass out.  I was lucky.  I had a mother who had worked in a hospital for 25 years, and a supportive partner who drove me four hours each direction every couple of weeks for tests.  For such a dramatic event, it was extremely difficult to convince doctors that anything was wrong with me.  I passed every test.  Most appointments ended with the explanation that I was probably passing out because I was thin and therefore probably not eating enough. 

However, with my mom’s stubbornness and understanding of the heath care system, I was able to get an appointment with a cardiologist who was willing to send me for a tilt-table test.  I laid strapped flat to a table for an hour and then they flipped me vertically to see what would happen.   As everyone waited to see if I would pass out, the surgeon suggested that if I switched my snacks to salted peanuts and Gatorade, I would probably be fine.  I don’t remember much after that because I did pass out, and my heart stopped beating. 

I had cardio-inhibitory vasovagal syncope and I would need a pacemaker to keep me from passing out in the future.  A million things raced through my mind, the first of which was relief… I finally had a diagnosis.  The second was, would I ever look good in a bikini with a pacemaker implanted in my chest.  A month later, I was in surgery: the only 24 year-old on the cardiology schedule. 

My surgery was not easy.  It was supposed to be less than 24 hours in the hospital and I ended up there for three days.  My body was going into shock every time the pacemaker tried to pace my heart.  I was sent for x-rays in a wheelchair and brought back in a gurney because I kept losing consciousness.  It was terrifying.  Not for me so much, I was just exhausted. But for my family who had to watch helplessly, it was a nightmare. 

What I didn’t realize at the time, and what is impossible to explain to someone who has never been in such a situation, is that I not only became aware of a problem that day, I also lost the ability to trust that my heart would ever beat the way it was supposed to.  We don’t think about our lungs allowing us to breathe or our heart pumping our blood. It just happens.  I can’t explain the sense of loss, or the fear that develops of your own body, but I can encourage people not to take it for granted. 

I am now on my second pacemaker and, although that surgery wasn’t easy either, I live a healthy and active life with my amazing husband and two dogs.  To give back, I also joined the Board of Directors for my local American Heart Association so that I can encourage others to live well and take care of their hearts.  A coronary event can happen to anyone, at any stage of life.  It is important to pay attention to what your body is telling you and seek a doctor’s care whenever your heath circumstances change.  Treat your heart with care and never take it for granted.

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