Carotid Registry Opened
The Carotid Artery Revascularization and Endarterectomy (CARE) Registry, developed by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions, is open for business. As with other components of the National Cardiovascular Data Registry (NCDR), hospitals that participate will be meeting data collection requirements for Medicare payment. Data can even be retrospectively collected, going back to March 2005. Categories include device and lesion characteristics; adverse event rates, including 30-day outcomes; and patient, provider, and facility characteristics. Currently, data can be collected on paper and submitted via a complimentary data entry service offered by the registry. Beginning in January 2007, data can be submitted online at a new NCDR Web site. Participants will receive quarterly and annual benchmark reports that will give data such as comparisons between stent and endarterectomy complications, and the relative outcomes within the registry population.
CMS Incentive Payment Demo
The Center for Medicare and Medicaid Services is seeking participants for a 3-year demonstration project beginning in 2007 in which hospitals would offer incentive payments to physicians for improved quality and efficiency. CMS said it would give preference to consortiums consisting of up to 12 physician groups and their affiliated hospitals in a single geographically contiguous area. The Physician-Hospital Collaboration Demonstration will be extended to only 72 hospitals total, said CMS. The agency is looking for long-term outcomes such as mortality and readmission rates. Participants must document an episode of care from hospitalization to postdischarge and beyond. Hospitals would, for instance, offer incentive payments to surgeons for lower infection rates and fewer readmissions with complications, said CMS. Those payments would be limited to 25% of the normal pay for those cases. To apply, go to
www.cms.hhs.gov/DemoProjectsEvalRpts/
FDA Advisers: Pushovers?
A report by the Washington-based National Research Center for Women and Families claims that the Food and Drug Administration's outside advisers are pushovers when it comes to challenging drug and device applications. They analyzed voting records of a random sample of six drug advisory panels and five medical device panels from 1998 to 2005, and found a 76% approval rate for new drugs and 82% rate for new devices. The FDA does not have to follow the experts' advice, but it generally does. Of the 38 drugs recommended, all were approved by the FDA except one whose application was withdrawn by the manufacturer. The agency also approved 4 of the 11 drugs that received a negative vote. Only 50% of the reproductive health drugs were backed, compared with 100% of the products that came before the arthritis drugs advisory committee. Sixty-seven percent of microbiology devices were backed, as were 88% of ophthalmic devices. After reviewing transcripts, the researchers found that advisory panel members often expressed strong concerns about safety or efficacy, but voted to recommend approval anyway. Some committee members admitted that their votes may not have been consistent with their concerns. “Whatever the reasons, many of today's FDA drug and device advisory committees are rubber stamps for approval almost every time they meet,” wrote the researchers.
Merck Executives Exonerated
Retired U.S. District Court Judge John S. Martin Jr. has determined that Merck & Co.'s executives did not knowingly mislead consumers or physicians on the cardiovascular safety of its cyclo-oxygenase-2 inhibitor, Vioxx. The judge was hired by Merck's board of directors. Over 20 months, Judge Martin and his staff reviewed the scientific literature and documents submitted in some 14,000 personal injury suits and interviewed 115 witnesses, including 100 former and present Merck employees. After talking with senior scientists, the judge said, “We are satisfied that, prior to receiving the cardiovascular results of the APPROVe trial, none of them believed that Vioxx was prothrombotic.” The scientists urged that Vioxx be promptly withdrawn, which the company did, despite contrary advice from outside advisers, said the report. “This conduct is not consistent with the view that Merck's corporate culture put profits over patient safety,” wrote the judge. Merck's board issued a statement that it “is reassured by the fact that, in reviewing numerous allegations of wrongdoing, the Martin Report concludes that management acted with integrity and had legitimate reasons for making the decision that it made, in light of the knowledge available at the time.” The full report is available on Merck's Web site at