More Data Sought on Vytorin
It's the controversy that won't die. The House Energy and Commerce Committee and its Oversight and Investigations subcommittee are seeking more information on why the Data Safety Monitoring Board asked two other DSMBs to unblind data for their major Vytorin trials before their conclusion. In a letter to the chief executives of Merck and Schering-Plough, Committee Chairman Henry Waxman (D-Calif.) and Subcommittee Chairman Bart Stupak (D-Mich.) requested “all minutes, records, communications, and other documents” related to the DSMBs for the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis), SHARP (Study of Heart and Renal Protection), and IMPROVE-IT (Examining Outcomes in Subjects with Acute Coronary Syndrome: Vytorin vs. Simvastatin) trials. A Schering-Plough spokesman says that the company is “aware of the current letter from the Energy and Commerce Committee, and will cooperate with the request for information.”
MRI Blood Flow Coverage Sought
The American College of Radiology, American College of Cardiology, North American Society for Cardiovascular Imaging, and the Society for Cardiovascular Magnetic Resonance have asked the Centers for Medicare and Medicaid Services to cover the measurement of blood flow by magnetic resonance imaging. The current CMS policy—established in 1985—states that blood flow measurement, imaging of cortical bone and calcifications, and procedures involving spatial resolution of bone and calcifications are not reasonable or necessary. The groups asked the CMS to specifically consider national coverage of the blood flow indication. The comment period closed on Feb. 19. The CMS expects to issue a proposed decision in late July and take final action by mid-October.
EMS Delays for Women?
Women may be getting the short end of the stick when it comes to rapid response for cardiac conditions. A study in the January issue of Circulation: Cardiovascular Quality and Outcomes finds that women complaining of cardiac symptoms to 911 dispatchers were 52% more likely than were men to experience delays in care from emergency medical services. Researchers reviewed data on 5,887 calls made in 2004 for suspected cardiac symptoms to 911 for Dallas County, Tex. Half of the patients were women and half were white. The median time in EMS care—which included at the scene and transport to the hospital—was 34 minutes; times of 49 minutes or longer were considered to be a delay. The researchers found no serious delays in getting to the scene, but women had 52% higher odds of being delayed. They could not speculate on the reasons for the delays, but in an accompanying editorial, Dr. Joseph Ornato of Virginia Commonwealth University, Richmond, said possible explanations included a need for extra time to place 12-lead ECGs in an effort to preserve a woman's modesty. But, he said, the study provides insufficient data to assess whether a gender bias exists. “Nevertheless, it is a critical issue and deserves follow-up study,” said Dr. Ornato.
FDA Device Enforcement Lax
A nonprofit watchdog group says that the Food and Drug Administration is not properly enforcing its own rules on monitoring manufacturers' testing of medical devices. The Project on Government Oversight reviewed FDA enforcement of quality assurance standards for medical devices such as implantable cardiac defibrillators, pacemakers, aortic valves, and stents. Device makers have to satisfy requirements for good laboratory practices before a product can be tested in humans. The Project, known as POGO, said that agency inspections have been dropping—from 33 labs in 2005 to just 1 in 2008—and that there is a laissez-faire culture at the FDA's Center for Devices and Radiological Health. The group said that internal FDA documents show that many CDRH scientists have challenged management on its lack of enforcement, but that they have been rebuffed. POGO called on Congress to investigate what it alleges is a deliberate decision not to enforce FDA rules by CDRH senior management.
FDA on High-Risk List
The FDA faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said, adding the agency to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address internal mismanagement. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.