ACC CEO Testifies on FY 2010 Budget

ACC CEO Jack Lewin, M.D., on March 18 testified at the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies on funding recommendations for fiscal year 2010. Within the Department of Health and Human Services (HHS), Dr. Lewin urged the subcommittee to support a 7 percent increase in funding for the National Institutes of Health, for a total of $3.227 billion; a FY 2010 budget for the National Heart, Lung and Blood Institute of $3.277 billion; and a base funding level of $405 million, an increase of $32 million, for the Agency for Healthcare Research and Quality. Dr. Lewin also recommended $74 million for the Centers for Disease Control and Prevention Heart Disease and Stroke Prevention Program and $8.927 million for the Health Resources and Services Administration Community Access to Emergency Defibrillation program. In addition, during his testimony, Dr. Lewin made recommendations for CV research areas. His testimony is available online.

Lawmakers Introduce AFib Resolution

Reps. C.A. Ruppersberger (D-Md.) and Kay Granger (R-Texas) on March 17 introduced a resolution (H.Res. 255) that would designate the month of September at “National Atrial Fibrillation Awareness Month.” The purpose of the resolution is to raise awareness of atrial fibrillation and to draw attention to it as a serious public health problem that warrants greater public education and research. The ACC supports the resolution, and asks that members call or e-mail their representatives to ask him or her to co-sponsor the resolution. To reach your representative by phone, call the U.S. Capitol switchboard at (202) 224-3121 and ask to be connected to your representative’s office. A resolution needs at least 100 cosponsors before it is brought to the House floor for a vote. A vote on this resolution and its eventual passage requires your grassroots involvement!

FDA Panel Recommend CV-Related Drugs for Approval
The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Committee on March 18 voted 10 to 3 to recommend for approval Sanofi-Aventis’ Multaq (dronedadrone) for use in patients with non-permanent atrial fibrillation (AF). If approved, it would be the first new treatment in 25 years. The drug for patients with severe heart failure, nor should Sanofi be able to claim Multaq reduces the risk of death, panel members said. The FDA will make a decision of whether to approve the drug by April 30. More coverage is available from Cardiovascular Business magazine.

Also, the committee on March 19 voted 15 to 2 to recommend approval of rivaroxaban to prevent deep-vein thrombosis and pulmonary embolism for patients undergoing knee or hip replacement. Studies of the drug, developed by Bayer Healthcare Pharmaceuticals and Johnson & Johnson, showed that its benefits of preventing blood clots outweighed its risk of bleed and liver injury. Bayer and Johnson and Johnson also are developing the drug for the chronic use in the prevention of stroke, AF and deep-vein thrombosis. The FDA will make a decision on whether to approve the drug by May 28. Additional coverage is available from MedPage Today.

FDA News Updates
The Food and Drug Administration (FDA) for the second time has expanded its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients that could cause heart problems like hypertension, myocardial infarction or stroke. The FDA has identified additional weight loss products, Herbal Xenicol, Slimbionic and Xsvelten, and new undeclared active pharmaceutical ingredients, fenproporex, fluoxetine, furosemide and cetilistat. Click here for the full list of tainted products.

Bodee LLC and the FDA have issued a recall of all the company’s supplement product, Zencore Plus, after an analysis of samples revealed that the product contains benzamidenafil, a PDE5 inhibitor. The use of Zencore Plus by a patient taking organic nitrates could result in a life-threatening sudden and profound drop of blood pressure. More information is available here.

Welch Allyn and the FDA have issued a Class I recall of two types automatic external defibrillators (AEDs): AED 10 and MRL JumpStart. The recall includes 14,054 AEDs manufactured between Oct. 3, 2002, and Jan. 25, 2007. The devices have been shown to experience low energy shock, unexpected shutdown and a tendency for electromagnetic noise interference to prevent defibrillation during cardiac arrest. The device malfunctions could lead to death. More coverage is available from Cardiovascular Business magazine.

Administration Selects Physician to Lead Health IT Efforts
The Department of Health and Human Services last week announced the selection of David Blumenthal, M.D., M.P.P., as the Obama administration’s choice for National Coordinator of Health Information Technology. As National Coordinator, Blumenthal will lead the implementation of a nationwide interoperable, privacy-protected health information technology infrastructure by 2014, as required by the American Recovery and Reinvestment Act. Previously, Blumenthal served as a physician and director of the Institute for Health Policy and the Massachusetts General Hospital/Partners HealthCare System in Boston, Mass. More information is available from HHS here.

HHS Names Comparative Research Council Members
The Department of Health and Human Services (HHS) recently announced the 15 members of the Federal Coordinating Council for Comparative Effectiveness Research, which will help coordinate research and guide investments in comparative effectiveness research funded by the American Recovery and Reinvestment Act (ARRA). ARRA authorized $300 million for the Agency for Healthcare Research and Quality, $400 million for the National Institutes of Health and $400 million for the HHS Secretary to support comparative effectiveness research. The council, which will not recommend clinical guidelines for payment, coverage or treatment, will hold a listening session on April 14 to include public input in making research decisions. A list of the members can be found here.

HHS Issues Report Summarizing Health Care Discussions

The Department of Health and Human Services on Monday released a report summarizing the comments from thousands of Americans who hosted and participated in Health Care Community Discussions. The report, called “Americans Speak on Health Reform: Report on Health Care Community Discussions,” is a collection of group reports from 3,276 community discussions and surveys of 30,603 participants. The report finds that 55 percent participants said that their top concern is the cost of health care services and health insurance. Participants also cited the lack of emphasis on prevention, pre-existing conditions limiting insurance access and quality of care as key concerns. Participants called for a system that is fair, patient-centered and choice-oriented, simple and efficient, and comprehensive. The ACC supports health care reform through Quality First, which aims to set a new standards for health care reform centered on patient value and access to quality care. To learn more, visit: qualityfirst.acc.org.