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SWHR Calls on the New Administration to Safeguard Women’s Health

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The Society for Women’s Health Research (SWHR®) offers support to both the President Trump administration and Congress and will actively build on the progress made in advancing women’s health in the U.S. and worldwide.

Approximately 157 million women live in this country; accounting for 50.8 percent of the U.S. population. For more than 25 years, our organization has brought attention to the variety of diseases and conditions that disproportionately or predominately impact women, and we are dedicated to transforming women’s health through science, advocacy, and education. With a new administration in the White House, it is crucial now more than ever to remember why women’s health is important and why it must remain a high priority on the national agenda.

For a century or more, the U.S. has paved the way in scientific research and medicine. Our leadership must continue. As an organization, SWHR looks forward to working with the incoming administration and Congress on championing continued research and funding of the study of sex and ethnic differences in the prevention, diagnosis, and treatment of disease; expanding access to healthcare coverage for preventive care services, including well-woman visits; ensuring proper mental health services and screenings by healthcare providers; and other important health policy issues that disproportionally affect women. Accelerating our progress in understanding the science of sex differences will benefit the health and longevity of both women and men.

Our tireless advocacy efforts for over a quarter-of-a-century have resulted in the passage of notable legislation, including the Women’s Health Office Act that mandated the offices on women’s health within the Department of Health and Human Services, and the authorization for offices and positions of women’s health among five federal agencies, including the Office on Women’s Health, the Office of the Director of the Centers for Disease Control and Prevention, and the Office of the Commissioner of the Food and Drug Administration. We anticipate the new administration will continue to appropriately staff and fund the offices on women’s health.

SWHR is hopeful the Trump administration will make the promotion of women’s health a prominent component in its national agenda, and that Congress will appropriately fund a federal research agenda that is inclusive of women’s health and sex differences research, which will ultimately improve the lives of all Americans.

ABOUT SWHR

The Society for Women’s Health Research (SWHR®) is a national non-profit based in Washington D.C. that is widely recognized as the thought leader in promoting research on biological differences in disease and is dedicated to transforming women’s health through science, advocacy, and education. Founded in 1990 by a group of physicians, medical researchers and health advocates, SWHR aims to bring attention to the variety of diseases and conditions that disproportionately or predominately affect women.

For more information, visit www.SWHR.org. Follow on Twitter at https://twitter.com/SWHR.

 

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SWHR Thanks House Appropriators for NIH Support

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The National Institutes of Health (NIH) serves as the America’s premier biomedical research agency and many of the health-related advances in recent decades are direct results from bipartisan investments in the agency. The Society for Women’s Health Research (SWHR®) thanks the House Appropriators for their continued support of the Agency. SWHR believes that Congress has a duty to appropriately fund a federal research agenda that is inclusive of women’s health and sex differences research, which will allow us to achieve the goals outlined in the President’s Precision Medicine Initiative, and ultimately improve the health and well-being of all Americans.

One of the federal government’s primary responsibilities is to protect the public health, and to invest in basic biomedical research that leads the way for the next generation of cures and therapies. For over 25 years, SWHR has been widely considered the thought-leader in promoting research on biological differences in disease and we are dedicated to transforming women’s health through science, advocacy, and education.

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SWHR Supports Dr. Robert M. Califf’s Confirmation to Lead FDA

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Dr. Robert M. Califf, distinguished cardiologist and medical researcher, has been confirmed by the U.S. Senate as the next U.S. Food and Drug Administration (FDA) Commissioner. President Barack Obama nominated Dr. Califf in September 2015.

The Society for Women’s Health Research (SWHR®) congratulates Dr. Califf. Having strongly supported his nomination and urged the Senate to confirm him, SWHR is pleased that he has been presented with this leadership role.

Dr. Califf joined the FDA as deputy commissioner earlier this year from Duke University in Durham, NC, where he had served as the vice chancellor of clinical and translational research and the director of the Duke Translational Medicine Institute (DTMI). In addition, he was a professor of medicine in the Division of Cardiology at the Duke University Medical Center, and the founding director of the Duke Clinical Research Institute (DCRI).

“Dr. Califf is a widely respected leader in the field of clinical research and will do an excellent job leading the FDA during this critical juncture,” said Phyllis Greenberger, MSW, SWHR President and CEO. “We congratulate Dr. Califf on his confirmation and look forward to working with him and the FDA to ensure that medical products are safe and effective for both women and minorities.”

 

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SWHR Supports HELP Committee’s Califf Approval; Urges Confirmation by Senate

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Washington, D.C., January 12, 2016  The United States Senate Committee on Health, Education, Labor and Pensions (HELP) unanimously approved Dr. Robert Califf’s nomination to serve as U.S. Food and Drug Administration (FDA) Commissioner, moving the process to the full Senate for a final vote.

The Society for Women’s Health Research (SWHR®) strongly supports the HELP Committee’s approval and urges an immediate confirmation by the full Senate. SWHR, one of 50 organizations supporting Dr. Califf’s confirmation, believes he will provide strong leadership and direction to improve FDA’s drug approval process, while ensuring that safety and effectiveness are not compromised.

Dr. Califf, a distinguished cardiologist and medical researcher, was nominated to the post in September by President Barack Obama. Dr. Califf joined the FDA as deputy commissioner after serving as the vice chancellor of clinical and translational research at Duke University in Durham, NC, where he also was director of the Duke Translational Medicine Institute (DTMI). In addition, he was a professor of medicine in the Division of Cardiology at the Duke University Medical Center, and the founding director of the Duke Clinical Research Institute (DCRI).

“He is a widely respected leader in the field of clinical research and has the perspective and experience to lead the FDA during this critical juncture,” said Phyllis Greenberger, MSW, president and CEO of SWHR. “We thank the Senate HELP Committee for their quick approval and urge the full Senate to confirm him to the post. We look forward to working with him and the FDA to ensure that Americans have access to the latest medical treatments and that these treatments are safe and effective.”

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About SWHR

The Society for Women’s Health Research (SWHR®), is a national non-profit based in Washington D.C. that is widely recognized as the thought-leader in promoting research on biological differences in disease. SWHR is dedicated to transforming women’s health through science, advocacy, and education. Founded in 1990 by a group of physicians, medical researchers and health advocates, SWHR aims to bring attention to the variety of diseases and conditions that disproportionately or predominately affect women. For more information, please visit www.swhr.org. Follow us on Twitter at @SWHR.

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SWHR Congratulates Sen. Barbara Mikulski for Earning Presidential Medal of Freedom

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Longtime supporter of women’s health research Senator Barbara A. Mikulski (D-Md.) will be awarded a Presidential Medal of Freedom, the nation’s highest civilian honor, on November 24th at a ceremony at the White House.

Senator Mikulski, who will retire at the end of her term in 2017, is the longest-serving woman in the history of Congress. She has worked tirelessly on issues, including equal pay for women, college affordability, healthcare, and science research and funding.

It is for her dedication to issues of women’s health and research that the Society for Women’s Health Research (SWHR®) is proud to commend Senator Mikulski on this achievement.

“We applaud Senator Mikulski and her longtime commitment to ensure that women’s health receives the attention it deserves, and that all women have access to the best treatment possible,” said Phyllis Greenberger, MSW, president and CEO of SWHR. “Senator Mikulski has a long legacy of accomplishments and is incredibly deserving of this prestigious award.”

SWHR honored Senator Mikulski with the Women’s Health Research Legacy Award at our 25th Anniversary Gala Dinner last March.

 

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The Society for Women’s Health Research strongly urges Congress to pass the Bipartisan Budget Act of 2015

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While no deal is perfect, the Bipartisan Budget Act of 2016 replaces sequestration equally for both defense and nondefense over the next two years. Failure to pass this critical legislation will hinder scientific discovery, compromise public health programs, and delay patients’ access to innovative medical treatments.

As a member of NDD United, an alliance of more than 2,500 national state, and local organizations working to protect investments in core government functions, SWHR believes that the deal provides a path towards a bipartisan agreement on appropriations to fund the federal government for the remainder of fiscal year 2016, avoids a government shutdown, and provide increases for the federal health and research agencies.

SWHR strongly supports the Bipartisan Budget Act of 2015 and urges Congress to avoid the addition of any policy riders that would hinder the bill’s passage.

 

Arzt impft Patient gegen Krankheiten uns Grippe.

GAO Finds NIH Has Made Progress Including Women in Research, But Improved Reporting And Analysis Needed

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Last week, The Government Accountability Office (GAO) released a report, showing that more work needs to be done in reporting and analysis policies to further ensure women and minorities are being accurately represented in clinical trials.

Since 1990, the Society for Women’s Health Research (SWHR ®) has worked to increase equality in healthcare research, recognizing biological sex differences between women and men, and that these differences matter.

“We are pleased that this report shows progress in increasing the number of women in clinical trials. However, clearly more work needs to be done to increase inclusion in studies that include both women and men, and to ensure that biological differences are analyzed and reported,” said Phyllis Greenberger, MSW, president and CEO of SWHR. “Analysis and reporting of this data is critical to fostering innovative research that meets the goal of tailoring treatment to the individual patient.”

To learn more about sex differences in health and science, visit www.swhr.org.

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SWHR Supports Dr. Robert Califf’s Nomination to Lead FDA

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President Barack Obama has nominated distinguished cardiologist and medical researcher Dr. Robert Califf to be the next U.S. Food and Drug Administration (FDA) Commissioner. The Society for Women’s Health Research (SWHR®) strongly supports his nomination to this post and urges a quick congressional confirmation.

Dr. Califf joined the FDA as deputy commissioner earlier this year from Duke University in Durham, NC, where he had served as the vice chancellor of clinical and translational research and the director of the Duke Translational Medicine Institute (DTMI). In addition, he was a professor of medicine in the Division of Cardiology at the Duke University Medical Center, and the founding director of the Duke Clinical Research Institute (DCRI).

“He is a widely respected leader in the field of clinical research and has the perspective and experience to lead the FDA during this critical juncture,” said Phyllis Greenberger, MSW, SWHR President and CEO. “We congratulate Dr. Califf on his nomination and look forward to working with him and the FDA to ensure that medical products are safe and effective for both women and minorities.”

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SWHR Supports FDA Decision to Approve Female Sexual Dysfunction Treatment

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The Society for Women’s Health Research (SWHR®) applauds the Food and Drug Administration (FDA) on the approval of Flibanserin, the first ever medical treatment option for Hypoactive Sexual Desire Disorder (HSDD). Known as the most common type of female sexual dysfunction, HSDD affects one in ten American women each year.

Sexual health is an important component to a healthy life. For many years, it was a taboo topic and even today, many women are still hesitant to discuss their sexual health with their healthcare providers.  Last year, SWHR, along with a number of patients and women’s groups, addressed the need for FDA-approved treatments for female sexual dysfunction. At that meeting, the FDA heard directly from patients on how HSDD, along with other types of female sexual dysfunction negatively impacts their health and well-being. Many patients spoke candidly about their use of products off-label to try to treat their condition and with their frustration about the lack of options available to them.

“The Society for Women’s Health Research is pleased that the FDA has approved the first ever treatment for HSDD, a type of female sexual dysfunction. This condition can severely impact a woman’s quality of life,” said Phyllis Greenberger, MSW, SWHR President and CEO. “We believe this is a good first step in addressing this need and hopefully this approval will generate more research into safe treatment options for HSDD in women.”

SWHR applauds the FDA on its leadership in treating HSDD with the same priority as other sexually related disorders. This is an important step toward health equity and will have a positive impact on the lives of millions of women and men.

To learn more about SWHR, the thought leader in transforming women’s health research, visit www.swhr.org.

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SWHR Applauds NIH’s New Inclusion Of Sex As A Biological Variable

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The Society for Women’s Health Research (SWHR ®) supports the National Institute of Health’s (NIH) move to include sex as a biological variable in future research. Since 1990, SWHR has been working to increase equality in healthcare research, knowing that there are biological sex differences between women and men, and that these differences matter.

According to a release from NIH, accounting for sex as a biological variable begins with the development of research questions and study design and will also include data collection, analysis of results, and reporting of findings.

This change was largely influenced by the work of Janine Clayton, MD, Director of the NIH Office of Research on Women’s Health. For years, she has championed NIH’s policy change initiative, requiring scientists to include female animals and cells in preclinical research design. We applaud her efforts and are delighted to see these changes taking shape.

Consideration of sex is crucial to the interpretation, validation, and generalizability of research findings. Balanced consideration of both sexes in experiments and disaggregation of data by sex allows for sex-based comparisons and could inform clinical interventions. “I am delighted to see the announcement of the new guidelines from NIH, ensuring the transformation of preclinical research to include sex as a variable,” said SWHR President and CEO Phyllis Greenberger. “This policy change will transform science and, as has been advocated by SWHR, will result in greater understanding of sex differences earlier in research, directly and positively impacting scientific discoveries going forward.”

To learn more about sex differences in health and science, visit www.swhr.org.

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