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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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Research & Advocacy = Results

In the last decade, U.S. hospitalization and death rates for heart disease and stroke have dropped significantly!  That means our research and your advocacy are paying off!  Let's keep it going to reach the American Heart Association’s 2020 goal — to improve the heart health of all Americans by 20 percent while reducing deaths from cardiovascular diseases and stroke by 20 percent by 2020.  Learn more here:

http://blog.heart.org/study-finds-significant-drop-in-hospitalizations-deaths-from-heart-disease-stroke/

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My Story: Katie Krisko-Hagel

Katie Krisko-Hagel Eagan, MN

I am a registered nurse.  My Ph.D. is in nursing with a specific focus on heart disease, especially in women. My stroke story is about my mother who died from stroke and heart disease six years ago.

 
It was 1995 when she presented to an emergency room after having experienced dizziness, weakness, and loss of consciousness. She had a known history of high blood pressure yet she was admitted for an inner ear disorder. I was told later by the nurse that she was alert and oriented as evidenced by her ability to answer questions about where she lived, living relatives (who, in fact, were no longer alive), etc. Yet, nobody bothered to check to see if her answers were correct; because they weren't. My mother's memory was quite impaired and by this time, the window of opportunity had passed and brain damage had occurred. Her life was never the same since then. She lost her ability to live independently (she was only in her mid-seventies at the time) and eventually needed to live out her final years in a nursing home as she continued to suffer more strokes. Since 1995, much has improved about how people are assessed in an emergency room and treated by receiving tPA once ischemic stroke has been identified. Many brains have been saved; many lives have been uninterrupted and spared. Also, since 1995, a lot has been done about the prevention of stroke. This has all come about because of research. But, the battle isn't over because many people still suffer and die from stroke and heart disease every year. In fact, heart disease is still the number one killer of men and women in the United States. Research needs to continue in order to change these statistics. Without research, many lives like my mother’s will continue to be cut short or so drastically altered that they will never be the same again. Prevention and adequate treatment is key and can mean the difference between life (as well as quality of life) and death. Only through research can we have any hope to change the statistics. Only by continuing to fund that research, we can make it happen.

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J. Antonio G Lopez, MD FAHA

J. Antonio G. Lopez, MD FAHA

The American Heart Association (AHA) has supported and played a pivotal role throughout my career in cardiovascular research, leading to my focus on the prevention and treatment of cardiovascular disease. Presently, I am the Director of Preventive Cardiology, the Lipid clinic, and LDL apheresis Program, and Hypertension Consultation Service at the Saint Alphonsus Regional Medical Center in Boise Idaho. Without the support for cardiovascular research, the understanding of disease processes that lead to important scientific advances would not be possible. Our current knowledge of risk factors (high cholesterol, low good cholesterol (HDL), diabetes, smoking, high blood pressure and family history of premature heart disease) leading to the development of atherosclerosis and coronary artery disease was based on epidemiologic research.  Advocacy is fundamental to continue our progress.

I support advocacy on behalf of the American Heart Association chiefly for the health of our communities. For example, the AHA supports coverage of preventive benefits in private and public health insurance plans and the implementation of policies that provide adequate resources and encourage healthy choices. Locally, the AHA as a member of the Smokefree Idaho coalition is working to make communities across our state smoke free, inspiring more Americans to live in an environment that supports a heart-healthy lifestyle. Moreover, through our education efforts the AHA is reaching at-risk populations with cause initiatives and online tools. Thus, strong advocacy, sustained efforts, and programs such as “You’re The Cure” will significantly impact the reduction of cardiovascular disease.

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Tell Congress WHY you support medical research

We don’t have to think twice about why we support more funding for organizations like the National Institutes of Health (NIH) to research cures for cardiovascular disease and stroke. But unfortunately the funding cuts continue.

We routinely tell Congress that NIH research leads to innovation, jobs, and life-saving medical breakthroughs. But right now they need to hear the personal reasons why research is important from advocates like you!

Tell us, WHY do you support medical research?

For me, I support the NIH because of advocates like Ryley. In 2013, Ryley, just a teenager, unexpectedly suffered from multiple strokes that affected five different areas of his brain. Since then, he has had to endure thousands of hours of physical therapy and testing to relearn to walk, talk, and function like his normal self. But despite the large obstacles he has faced, he has had the opportunity to share his story and help others like him.

Ryley has made tremendous progress in the face of such large obstacles, but doctors still have much to learn about his condition. With more available funding, NIH has the opportunity to find real cures for cardiovascular diseases, giving hope to families like Ryley’s who depend on research to provide clarity and answers.

For me, individuals like Ryley are why.

What about you? Tell Congress today why you support medical research!

Finding a cure doesn’t happen overnight; however, each step takes countless hours of research and manpower, trial and error, and hope and frustration. But each step is an opportunity to bring a new chance at life to families across the country. It’s why the work NIH does is so vital, and it’s why the work we do to protect NIH’s funding is so critical.

Ryley is why. A cure is why. Life is why. Show your support for NIH and tell us: what’s your why?

 

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Our new anthem: life is why

School behavioral specialist Carla Leonard had her hand on her heart during the Pledge of Allegiance when a heart attack nearly killed her. Her doctor didn’t mince words with her family afterward: “If I didn’t have surgery, they should pick out a dress for my funeral,” she said. “Plain and simple.”

But Leonard wanted to live — to see her daughter graduate from high school — so after surgery she started on a new path that continues today. She kicked her soda habit, started visiting her doctor regularly and got healthy enough to experience many important milestones in her life.

Leonard exemplifies the American Heart Association/American Stroke Association’s new brand tagline, “Life Is Why.” The phrase, which began appearing with the logo on Heart.org on Aug. 1, is much more than a slogan. It’s the singular idea that stands behind all the lifesaving work the AHA has carried out for 90  years – and it’s the very basic idea that people should be healthier so they can enjoy their lives more.

“The work we do matters,” American Heart Association CEO Nancy Brown said. “It has mattered to my family and I’m sure it has mattered to your family. Life is why.”

(Please visit the site to view this video)

Brown’s grandfather had a blockage of his carotid artery in the early 1970s. During surgery, he suffered a stroke, and his life was never the same — nor was his family’s. He died a few years later after another stroke. “I missed my grandfather then and I continue to miss him today,” Brown said.

But she pointed out that scientific research and treatment guidelines have led to much better outcomes for many others in the decades that followed. One of those survivors is Brown’s sister, who is thriving despite two recent strokes. She received treatment at one of the AHA’s primary stroke centers, helping her working through rehabilitation and regain her life.

“My sister is why, my grandfather is why — and all of you are why,” Brown told the organization’s volunteers and staff when announcing the adaptation of “Life Is Why” as a focal point of the AHA’s brand.

The American Heart Association is the nation’s oldest and largest voluntary health organization dedicated to fighting heart disease and stroke — the two leading causes of death in the world. The AHA fights these diseases through a wide variety of tactics, yet “Life Is Why” can be attached to every facet of the organization’s work.

Life is why the AHA helps people eat healthier foods and get more active — among the many activities the organization has to help people live healthier lives.

Life is why Roni Noone decided to lose weight so she could enjoy her life with her family.

Noone, a 38-year-old Baltimore mom who struggled with her weight in her teens and 20s, has lost a total of 70 pounds because she wants to be there for those special moments with her family. She has joined a gym and even run a marathon – saying she didn’t want to set a poor health example for her sons Ryan, 9, and Evan, 3.

Roni Noone is motivated by the special moments with her family.

“Last year I took Ryan whitewater rafting, and it was really emotional for me. Now I’m doing all the things I got healthy for,” said Noone, a fitness blogger who’s also writing a book. “I want to run a half-marathon with him when he’s 18. And I want to be able to do all these things that I’m doing in my 30s when I’m in my 50s.”

Life is why the American Heart Association has funded more than $3.6 billion in heart disease and stroke research, more than any other organization outside the federal government. Life is why the association works to develop treatment guidelines that help healthcare providers follow scientifically proven treatment standards.

Life is why the AHA is the nation’s leader in CPR training and science, and why the AHA has helped pass many laws and policies that have improved the public health. In fact, now that 17 states have passed laws requiring CPR as a high school graduation requirement, more than 1 million seniors will leave school every year with this lifesaving skill.

Leonard, 52, has gone on to be an AHA advocate for CPR in schools and screenings to detect heart defects in newborns. And she did get to see her daughter Yasmine finish high school, just one of many milestones she has experienced since her surgery eight years ago.

“The highlight of them all was when I heard that my child had used my life-and-death experience to write her entrance essay for college,” she said. “I want to be able to look back on my life and say that I did not waste the second chance I was given.”

And as 13-year-old Natalia Bascunan of Nutley, New Jersey, will attest, loved ones and special moments are the most important illustration of Life Is Why. Natalia made the Little League all-star team years after facing two open-heart surgeries for a heart defect.

“They loved it because she was the only girl in the state on an all-boys team,” said Natalia’s mom, Roe Corsi. “When they found out she had a heart condition, they loved her even more.”

Another person who has embraced life’s special moments thanks to better health is Bernie Dennis, a longtime volunteer with the AHA who is now the chairman of the board.

Dennis said he didn’t appreciate the risks he was taking with his health until he had three heart attacks in one month, followed by a quadruple bypass. While he recovered, he started realizing some of the things he’d taken for granted.

“I can remember the fact that I was sitting on my porch saying to myself, ‘this is the first time in my life I’ve appreciated the warmth of the sun in May,’” he said.

Getting healthier has meant Dennis has gone on to experience precious family time that he would’ve missed. A high school graduation. A wedding. Playing with his “two beautiful granddaughters.” And dressing up as Santa Claus at Christmas.

“There’s a choice you get to make about living or not living,” he said. “My wife’s hand gave me reason to live. My wonderful family gave me reason to live.”

Learn more at www.lifeiswhy.org 

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New York City Tackles Obesity!

Did you see the news?  New York City recently announced that they've achieved a significant drop in the rate of severe obesity among our city's kids.  A nearly 10% decline of this leading cause of heart disease and stroke is a tremendous achievement!  However, the thing I liked most about this announcement (linked below), is the city's eye to the future.  It's right there in Commissioner's Bassett top quote.  More needs to be done.  Chancellor Farina's quote is an important one as well.  If health and wellness are truly top priorities for this administration - let's work together to pass laws that will serve to protect more kids from the dangers of inactivity and poor nutrition!

http://www.nyc.gov/html/doh/html/pr2014/pr019-14.shtml

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Where Do Your Candidates Stand?

Federal funding for basic research is an essential step towards achieving medical progress for heart and stroke patients. Over the past decades, we have seen remarkable breakthroughs done at the National Institutes of Health (NIH), such as the development of pacemakers and the discovery of a clot-busting drug used to treat stroke.

However, during the last ten years, the NIH has lost more than 20% of its purchasing power. This dramatic downturn has come at a time when other countries are increasing investments in science and when the need for innovation to prevent, diagnose, and treat heart disease and stroke is great.    

But we can change that by exercising our right to vote in November!  To help voters choose candidates whose values on medical research align with their own, the American Heart Association has partnered with Research!America to launch the 2014 Ask Your Candidates! initiative – a national, non-partisan voter education program that empowers voters to be more informed about their candidates’ views on medical progress. If elected to Congress, what will your candidates do to ensure that discoveries of life-altering or live-saving treatments or cures continue?  Will they support funding increases for the NIH?  The answers to these questions is crucial as the nation prepares to go to the voting booth in November.

How can you get involved? Here a couple ways:

1) Visit www.askyourcandidates.org and complete an online form that will assist you in sending a message to your candidates to find out how they view the future of medical progress. It’s easy and only takes a few minutes.

2) Keep an eye out on your candidates' websites, newsletters and social media pages for information about town hall meetings they are hosting in your community! If you decide to attend, go ahead and ask a question of about research. We have provided some sample questions for you to customize.

  • As a stroke survivor, I am very concerned that the National Institutes of Health continues to invest a mere 1% of its budget in stroke research, despite promising research opportunities.  What will you do to secure an increase in funding for stroke, the No. 4 killer and a major cause of permanent disability in the United States?
  • As a heart disease survivor, I am very concerned that the National Institutes of Health continues to invest only 4% of its budget in heart research, despite promising research opportunities.  What will you do to secure an increase in NIH funding for heart disease, the No. 1 killer and a major cause of disability in the United States?
  • The National Institutes of Health (NIH) invests in every state and in 90% of congressional districts, including our own.  In addition to saving lives, NIH is an economic driver, supporting high paying jobs, spurring innovation, and maintaining our Nation’s position as the world leader in medical research.  But, over the last decade, NIH has lost 20% of its purchasing power at a time of heightened scientific opportunity and when other countries are increasing their investment in research—some by double digits. What will you do to reverse this trend?

Medical research done at the NIH is crucial for the future of our country’s health and economy. Let’s see where our candidates stand on this important issue before heading to the polls in November!

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Knowing Which Medical Products Are Best for Each Person -- It Just Makes Sense

Check out American Heart Association CEO Nancy Brown's latest Huffington Post blog post about the need to address health disparities in clinical trials.  

"Turn on your television at any point during the day or night and you will likely run across an ad for a prescription drug, along with a disclaimer about possible side effects. It seems only logical that those side effects are a possibility for anyone who takes the medicine, regardless of gender, race or age.

Unfortunately, that logic is wrong.

Studies of drugs and medical devices do not always report what effects these treatments may have on women, minorities or the elderly. Worse yet, those effects are not always investigated, as members of those populations are often underrepresented in trials -- despite the fact gender, race and age makes people more prone to certain diseases."  Read the full article on the Huff Post Healthy Living Blog. 

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Spring Has Sprung and So Has Budget Season!

It’s that time of year again.  While we wait for the cherry blossoms to bloom in Washington, D.C., budget discussions are heating up between the White House and Capitol Hill. 

On March 4th, the President released his budget proposal for 2015 and now Members of Congress are working to establish their funding priorities to begin the appropriations process and eventually pass a budget.  And that’s where you come in! 

With tight economic times, we need to continue to make the case for heart disease and stroke research and prevention funding that helps drive innovation, cuts health care costs, improves the health of our workforce, protects the health of our youngest generations, and saves lives.  Basically, your lawmakers need to hear from you that the fight against our nation’s No. 1 and No. 4 killers, heart disease and stroke, must be prioritized. 

In addition to funding that would help communities support walking, biking, and recreation, and funding for nutrition programs that would improve access to healthy food and nutrition education, the President’s budget included two key issues that deserve a special note:

  • On the positive side, the budget included a public health ‘win-win’ by proposing an increase to the federal tobacco tax, which would help curb youth smoking rates, to pay for efforts to improve early childhood education, which includes nutrition and physical education for our youngest Americans. 
  • On the negative side, the budget proposed near level funding for the National Institutes of Health, which is disappointing for research-advocates who are continuing to push our nation’s lawmakers to restore significant cuts to the NIH that took place last spring.  As our AHA President Dr. Mariell Jessup said in a statement, “With a meager 1 percent increase over last year, President Obama’s proposed budget for the National Institutes of Health is utterly inadequate.”

But the President’s budget proposal isn’t the end of these decisions.  The work now shifts to Members of Congress to consider these proposals, set their priorities, and negotiate to pass a final budget.  In fact, right now, our legislators are submitting their funding priorities to leadership in the U.S. House of Representatives and U.S. Senate and we need your help to speak-up for heart disease and stroke research!  Will you take two minutes to send a quick message to Congress?  

Without us speaking up- loud and clear- for important funding increases to the NIH, we will see progress and innovation in the way we prevent, diagnose, and treat heart disease and stroke slip backward.  From the jobs it creates to the lives it saves, medical research must be made a priority in the U.S..  Speak-up today! 

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