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Bipartisan Stabenow Measure to Ensure New Medications are Tested and Safe for Women to Become Law

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A bipartisan measure authored by Senator Debbie Stabenow to help ensure that medical treatments are safe and effective for women is on its way to becoming law. Following House passage last week, the U.S. Senate passed legislation containing Senator Stabenow's today, sending the bill to the president's desk. President Obama has said he will sign the bill and Stabenow's legislation, known as the HEART (Heart Disease Education, Research and Analysis, and Treatment) for Women Act, will become law.

Accurate information on the safety and effectiveness of new drugs and medical devices is often not available to women and their doctors because women and men are not equally represented in the testing of medical treatments-even though women can react differently than men to certain treatments. Senator Stabenow's bipartisan HEART for Women Act requires the Food and Drug Administration to help make sure women are better represented during clinical trials to determine whether new medical treatments are safe and effective for women.

"Women and their healthcare providers must be confident in knowing whether medical treatments are safe and effective," said Stabenow. "Women sometimes react differently than men to certain medications, so adequate research of a drug's effect on women could mean the difference between life and death. We need to make sure women and their doctors have the information they need to make the best medical decision possible."

Recent reports, including one conducted by the Institute of Medicine, showed a lack of women in clinical trials on drug and device safety and inadequate enforcement of requirements that clinical trials include representation of men and women. In another example, a 2007 study found that 75 percent of cardiovascular disease clinical trials do not report gender-specific results. This lack of information puts women's lives at risk.

Senator Stabenow's measure requires the Food and Drug Administration to develop a plan to address the extent to which women are represented in clinical trials. This plan will also include recommendations to improve the public availability of important safety and effectiveness information regarding gender, age, and race to patients, health care providers, and researchers. It will also address the possibility of including more of this information in drug and device labeling.

Last month, Sen. Stabenow held a media call with Kelly Huhn, a Grand Rapids resident with a congenital heart defect, who was prescribed a medication called digoxin when she was thirteen. She took the medication for two years before undergoing open heart surgery after which the digoxin was no longer needed. Kelly found out years later that digoxin was associated with an increased risk of death among women but not men. Situations like this occur too often when clinical trials focus disproportionately on a drugs' effect on men without adequately testing the effect on women.

Kelly Huhn said: "I was shocked when I found out that the medicine I was prescribed years ago could have killed me because no one knew at the time that digoxin was life-threatening to women. There is simply not enough research being done on the affects that drugs have on women versus men. I am thankful that Senator Stabenow is leading the charge to solve this problem which will help save women's lives."

Dr. Pam Macrovitz, Director of the Ministrelli Women's Heart Center at Beaumont Hospital said: "Heart disease kills about one woman each minute in the U.S. It is crucial that we recruit and retain enough women for gender specific analysis in all clinical trials of heart disease therapies. In the absence of this, physicians will be forced to use drugs and devices that may not be safe and effective for half the population with heart disease in the U.S. - namely women."

Dr. Gordon Tomaselli, President of the American Heart Association said: "Forty two million American women live with some form of heart disease or stroke. They deserve to know as much as possible about the safety and effectiveness of new therapies for different populations. Through this legislation we can ensure that such important information is consistently available to patients, families and their physicians."

First introduced in 2006, Stabenow's bipartisan Heart Disease Education, Research and Analysis, and Treatment (HEART) for Women Act ensures that women and their doctors are better equipped to fight cardiovascular disease, which is the number one killer of women in the country. Cardiovascular disease claims the lives of more than 422,000 American women each year-one every 60 seconds, and more than the next four causes of death combined. While there has been success in combating heart disease in men, reducing death rates for the disease among men by more than 15 percent over the last thirty years, there has been almost no reduction in the death rate for women.

Sen. Stabenow's measure was included in the Food and Drug Administration Reauthorization bill which passed the house last week and the Senate today, and now goes to the President for his signature.


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