Sunday, March 21, 2010

U.S. House of Representatives passes health care reform legislation

In a historic vote and a major victory for President Obama and Speaker of the House Nancy Pelosi, the U.S. House of Representatives has passed health care reform legislation, giving final approval of the Senate bill by a vote of 219-212. The new legislation is likely to reshape the way Americans deal with medical conditions and prevention measures. It is expected to cost $940 billion and to be implemented over a 10-year period. The measure will provide health insurance for more than 30 million uninsured and will provide protections for millions more against losing their coverage. In a last-ditch effort to kill or stall the bill, there was a Republican motion to recommit the bill to change some language, particularly on abortion, but the move to recommit failed to pass by a vote of 232-199. A reconciliation bill (HR4872)that will allow amendments to the legislation also passed by a slim margin. Republicans have argued that the package is too expensive and promotes excess government powers. Democrats consider the legislation comparable historically to enactment of Social Security after the Great Depression of the 1930s and Medicare in the 1960s. One move that helped secure the victory was President Obama's executive order stating that the healthcare bill would not interfere with an existing ban on federal funding for abortions. That helped change the votes of at least seven pro-life Democrats, led by Rep. Bart Stupak of Michigan. The reconciliation bill now goes to the Senate, where it cannot be filibustered. Acknowledging that the vote was not an easy one for some House members, President Obama said "we proved that the government...still works for the people." He called it a victory of "common sense." One thing remains certain...the debate and disagreement over this legislation is likely to continue for years.

Sunday, March 14, 2010

Let the patient participate in drug-safety reporting, NEJM commentary says

There's an interesting "Perspective" on drug-safety reporting in the March 11 issue of The New England Journal of Medicine. The article, by Dr. Evan Baugh of Mount Sinai Hospital in New York, notes that when a patient wants to know about symptoms related to a prescription drug he is taking, he might consult the information on the label or in the package insert. However, this information on side effects is based mostly on clinical trials and clinicians' impressions of their patients' symptoms, rather than on the firsthand reports of patients taking the drug. Yet,a substantial body of evidence contradicts the assumption that this information is truly representative of the patient experience. Instead, Baugh says, research indicates that clinicians systematically downgrade the severity of patients' symptoms, that patients' self-reports frequently report side effects that clinicians miss, and that clinicians' failure to note these symptoms results in the occurrence of preventable adverse effects. Patient self-reporting offers one solution that would enhance the capture of subjective elements of safety information. Baugh believes patient-reported adverse events provide both clinical and scientific value and arutes that patients are entitled to know the impressions of their peers. Scientist, regulators, and clinicians should have access to patient impressions when evaluating drugs, Baugh says. He also suggests that administrative efficiency might actually improve if patients reported adverse events before clinical interactions. Self-reports, Baugh concludes, are more sensitive to underlying changes in patients' functional status than are clinicians' reports. The patient is more likely to identify symptoms earlier during a course of treatment. It seems like a common sense approach to drug-safety reporting.