HEART Bill Reintroduced
A bill that might address the shortage of women-specific data on cardiovascular conditions has been introduced again by Sen. Debbie Stabenow (D-Mich.) and Sen. Lisa Murkowski (R-Alaska). The Heart Disease Education, Research and Analysis, and Treatment (HEART) for Women Act would require health data reported to the federal government to be broken down by gender, race, and ethnicity. The bill (S. 438), which the senators have introduced in past congressional sessions without success, would also require the secretary of Health and Human Services to submit an annual report to Congress on women's access to quality care for cardiovascular disease. The government's WISEWOMAN (Well-Integrated Screening and Evaluation for Women Across the Nation) program would be expanded from 20 states to the entire country.
Device Recalls Surge
Food and Drug Administration data indicate a 122% increase in recalls of high-risk medical devices from 2009 to 2010, from 23 to 51 class I devices, according to an analysis by the Gray Sheet. The products in the category defined by the risk of death or serious injury varied from infusion pumps to automated external defibrillators to saline syringes. The Gray Sheet found that class I device recalls in 2010 were the highest number ever and that in all categories, there were 717 recalls, up from 626 in 2009.
MRI-Pacemaker Pay Reconsidered
The Centers for Medicare and Medicaid Services is reopening the question of whether magnetic resonance imaging should be covered when done on a patient with an implanted cardiac pacemaker. The CMS said it was reconsidering its February decision never to cover MRI in that instance, in light of the FDA's approval during the same month of the Medtronic Revo MRI Sure Scan Pacing System, which allows for MRI scans. The approval of the pacemaker came days before the coverage decision but too late for the CMS to weigh the evidence for or against MRIs in patients receiving the new product. The CMS expects to propose a decision in September and make a final coverage decision in December.
Index to Measure Diabetes in U.S.
An online database of 30,000 maps, charts and graphs will give users a new, comprehensive picture of the prevalence and cost of diabetes in the United States, said it sponsors. The U.S. Diabetes Index, available through the Web site USDI Report (
What's in an Oath?
In a mailed survey, most physicians said an oath they took at medical school graduation influenced their practices “somewhat” or less. Researchers at the Mayo Clinic and the University of Chicago's ethics program asked 2,000 practicing physicians under age 65 whether they were given an oath and whether it influenced their professional lives. Just over 1,000 replied, and 80% said an oath, mostly a version of the Hippocratic Oath, was given at their schools. Only 26% said that it had influenced their practices “a lot,” with 37% saying “somewhat,” 24% “not much,” and 13% “not at all.” When asked to cite other sources of moral guidance, only 16% cited the AMA Code of Ethics. Ninety-two percent said their “personal sense of right and wrong” guided them. A third said great moral teachers mattered, and 28% said traditions mattered. Physicians who said they were religious were more likely to assign importance to the oaths and codes. But the authors, who published their findings in a letter in the March 14 issue of Archives of Internal Medicine, concluded that codes and oaths no longer inspire “binding moral identity” in most American physicians.
Court Passes on 'Pay for Delay'
The Supreme Court has refused to consider whether drug companies violate antitrust laws when they pay generic competitors to stay out of the marketplace. The high court's rejection of the case in March allowed companies to continue the practice, known as “pay for delay.” In this case, Bayer AG, which makes the antibiotic Cipro, paid generic competitor Barr Laboratories $398 million to not make a version of the drug. Leading up to the ruling, such deals have come under increased scrutiny. Last year, the Federal Trade Commission condemned the deals, and estimated that they will cost consumers about $35 billion over the next decade. There is also legislation pending in Congress (S. 27) to ban pay for delay.