On May 1, the House Energy and Commerce Subcommittee on Health held a hearing on the Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act (H.R. 1014). The measure, sponsored by Rep. Lois Capps (D-CA), would require all drug applications submitted to the Food and Drug Administration (FDA) to stratify their safety and efficacy data by race, ethnicity, and sex. The Agency for Healthcare Research and Quality would be required to issue an annual report on quality of and access to care for women with health disease, stroke, and other cardiovascular diseases (CVDs). The bill also would establish an educational program targeted at women aged 65 and older, physicians, and other health care professionals, related to the prevention, diagnosis, and treatment of CVD and expand the Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWoman) program from 14 to 50 states.
In his opening statement, Chair Frank Pallone (D-NJ) said, “There is a common misperception that exists today that heart disease is a ‘man’s disease.’ But this simply is not true. In reality, heart disease has a deadly impact on both men and women. In fact, I think most people would be surprised to learn that heart disease is the number one killer of women in the U.S., followed by cancer and stroke. One in four American women dies of heart disease each year, while one in 30 dies of breast cancer.” He concluded, “I want to thank Ms. Capps for all her efforts in this area and for leading the charge on so many women’s health issues. As a husband and father of two girls, I know how important it is that we tackle this issue.”
Echoing Rep. Pallone’s sentiments, Ranking Member Nathan Deal (R-GA), said, “As a husband and father of three girls, I am very interested in what we can do about women and heart disease.” Rep. Deal noted that of the 450,000 annual deaths related to heart disease, 220,000 were women. Rep. Deal said he supported the bill but had concerns regarding the requirement that all data submitted to the FDA be stratified by race, ethnicity, and sex. Specifically, he was concerned that the bill did not exempt applications for the manufacture of generic drugs; Rep. Deal said he would support the provision as long as it “does not delay the availability of drugs, device, and other medical products to consumers.”
Rep. Capps said, “I think it is appropriate timing that we hold this hearing just before Mother’s Day. What greater gift can we give to mothers and daughters this holiday than the tools to combat the number one health crisis for women in the United States?” Rep. Capps noted “that this legislation is on the Women’s Caucus priority list for the 110th Congress, boasting the cosponsorship of over 50 women members of the House and all 16 women senators.” She urged her colleagues to support the measures, saying “too many women are unaware of the symptoms for heart disease as they manifest themselves differently in women than in men. And then when women present these symptoms to a health professional, they too often go unrecognized.”
Santa Barbara County Supervisor Janet Wolf testified about her heart attack and subsequent recovery. In 2004, at age 50, Ms. Wolf suffered a heart attack related to a 100 percent blocked artery. She described her experience as beginning with “extremely painful heartburn which felt like a hole was burning in my esophagus.” Even after treatment with antacids, the heartburn continued intermittently for the next two days. “By Monday morning, the pain was worse and I noticed that it become more intense after slight exertion. I became concerned that it was more than just heartburn and that it might be cardiac related,” Ms. Wolf said. Early the next morning, Ms. Wolf and her husband went to the emergency room where she learned that she was having a “massive heart attack”; after being admitted, she underwent an angioplasty (a procedure to open the blocked artery) followed by a cardiac rehabilitation program. Since her heart attack, Ms. Wolf has modified her lifestyle: “I currently work out at my local gym at least five times a week. I stopped drinking coffee and I have altered my eating habits by adopting a version of the Mediterranean diet, and I have cut my portion of food in half.”
“In 1984, women achieved equality and then surpassed men in one area where they don’t want it, heart disease mortality,” said Susan Bennett, a cardiologist and director of the Women’s Heart Program at The George Washington University. She continued, “The latest American Heart Association [AHA] survey tracking women’s awareness of heart disease, published in February 2007, found that 43 percent of women still are not aware that heart disease is the leading cause of death of women. Women of color are significantly less likely to know about heart disease as their leading killer, despite being at greater risk for CVD…Even more alarming is the pervasive lack of awareness about heart disease among physicians. According to an AHA-sponsored survey published in 2005, fewer than one in five physicians surveyed recognized that more women than men die of heart disease and other cardiovascular diseases each year. Astoundingly, only eight percent of primary care physicians knew this fact.” Dr. Bennett said the stratification of data by sex will help clinicians and researchers tailor medication regimens to individual patient needs and may help encourage the enrollment of women in clinical trials.
During questions, Rep. Deal asked Dr. Bennett why it was necessary for the bill to require the FDA to stratify data by race, ethnicity, and sex when the Code of Federal Regulations already requires the practice. Dr. Bennett said that including the requirement in a statute would bring more attention to the need for sex-specific data. At present, she said, women comprise only slightly more than one-third of clinical trial participants and only about one in four cardiovascular trials published in medical journals report sex-specific results.
Rep. Hilda Solis (D-CA) asked Dr. Bennett why it was necessary to expand the WISEWoman program. She told Rep. Solis that the program targets the woman at greatest risk of heart disease women of color, un- and underinsured woman, low-income women, and women using tobacco products. The WISEWoman program reaches these women with culturally and linguistically appropriate education programs around tobacco cessation, nutrition, physical activity, and stress management, Dr. Bennett said.