ISMP: Avandia at Top in Drug Deaths
Type 2 diabetes drug rosiglitazone (Avandia) accounted for 1,354 patient deaths in 2009, more than any other prescription drug, according to a June report from the Institute for Safe Medication Practices. However, the institute blamed publicity about the drug's cardiovascular risks in part for the large number of fatalities reported to the Food and Drug Administration (see page 1 article for more on Avandia). “The manufacturer, GlaxoSmithKline, told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company,” the report said. The institute excluded reports it knew involved legal claims but said it couldn't rule out the bad publicity as the reason for some other reports of cardiovascular events and deaths associated with rosiglitazone. Other drugs tied to large numbers of deaths last year include deferasirox (1,320 deaths), digoxin (506 deaths), and fentanyl (397). Almost 20,000 medication-associated deaths were reported to the FDA, a 14% increase over 2008 and a threefold increase over 2000, according to the institute. The report attributed the drug-related mortality increase to three factors: increased awareness of drug risks, lack of progress in managing drugs with known risks, and reports of discontinued treatment and death stemming from increasingly common direct company-consumer contacts. The full report is available at
www.ismp.org/quarterwatch/2009Q4.pdf
CMS Reconsiders MRI Coverage
The Centers for Medicare and Medicaid Services is taking another look at its decision to bar coverage of magnetic resonance imaging for people who have cardiac pacemakers or metallic clips on vascular aneurysms. Dr. Robert Russo, director of the cardiac MRI program at the Scripps Clinic in San Diego asked the CMS to reopen the issue of coverage for those patients. He is seeking to have it approved if the MRI is performed on people bearing the devices as part of an FDA-approved, prospective trial to determine the risk of the procedure. Comments on the proposal were being accepted through July 28, and the CMS said that it expected to issue a preliminary decision by Dec. 28.
FDA to Share Drug-Risk Findings
The FDA will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population, including previously unidentified risks and known adverse events that occur more frequently than expected. The initial reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, and depression, the agency said.
J&J Discloses Physician Payments
Following in the footsteps of Pfizer, GlaxoSmithKline, and, most recently, Medtronic, Johnson & Johnson said that it is disclosing how much it pays physician speakers and consultants, at least for a number of its pharmaceutical subsidiaries. Unlike at other companies, however, the data cover only J&J divisions that were subject to corporate integrity agreements with the federal government, according to a company spokesman. Those divisions are PriCara, Ortho-McNeil Pharmaceutical, Ortho-McNeil Neurologics, Janssen, and McNeil Pediatrics. Payment disclosures are listed at those units' individual Web sites, such as
www.janssen.com/transparency.html
Men Less Likely to Get Care
Men are much less likely than are women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as were those with private insurance to make a routine care appointment, the agency said.
State Expands Medicaid to Adults
Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, which could previously be covered only under Medicaid waivers. Connecticut said it initially will cover childless adults who make up to 56% of the federal poverty level, or $6,650 per year, estimated to be about 45,000 extra people. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early.