Headlines: November 18, 2010
by Meg Larkin
Today was a big news day for the federal government. First, in regulatory news, an FDA advisory committee has voted in favor of approving a new Lupus drug. In spite of lackluster data on the drug’s efficacy, strong safety findings and a dearth of available treatments for lupus persuaded the committee to vote 13-2 in favor of the drug. The drug, Benlysta, was developed by Human Genome Sciences with the aid of GlaxoSmithKline. The FDA is scheduled to decide on whether to approve the drug by December. Although the agency is not bound to follow the panel’s recommendations, it usually does. Lupus is an autoimmune disease affecting approximately 1.5 million Americans, many of them young women. The last treatment approved for Lupus was developed 1958 and has since fallen out of use. According to the New York Times, the drug “reduced symptoms in two clinical trials. But about 11 patients would have to be treated in order for one to benefit.” However, doubts about the drug’s effectiveness were outweighed by the positive showings that it may help some patients who otherwise face a severe lack of treatment options in the face of a crippling disease.
In other government news, the health reform law will close a gap in the availability of maternity care by 2014. At present, most individual insurance plans do not cover medical expenses typically associated with a normal pregnancy and delivery. Furthermore, if a woman is pregnant when she applies for health insurance, it is often considered a preexisting condition, and is often either used as grounds to deny coverage entirely or not covered by the insurance company. Furthermore, while large employers who offer insurance are required to cover maternity services, small employers are not required to do so. This framework will be completely changed by the implementation of the new health care law, which will require policies sold on the exchanges and new individual and small group plans to cover maternity care as an essential health benefit. Insurers will also be barred from using any preexisting condition, including pregnancy, to deny coverage.
Medicare’s new chief has called for a major push on patient safety. Don Berwick, the current Medicare head, and former head of the Institute for Healthcare Improvement has called for better patient safety standards for hospitals. Dr. Berwick’s announcement followed the publication of a government report that said one in seven hospitalized Medicare patients is injured during their stay. Of the patients injured, 1.5 percent suffered a complication that ultimately contributed to their death. The Centers for Medicare and Medicaid Services unveiled an “innovation center” on Tuesday that is designed to find ways to improve quality and reduce costs in health care. It is one of many similar projects funded by the new health care law. According to the Boston Globe, initial projects undertaken by the center will focus on improving primary care coordination among other things.
Finally, in global health news, Haitian officials are defending their focus on the treatment of Cholera instead of the origins of the outbreak. The outbreak has killed more than 1,000 Haitians, and has sparked violent protests against UN peacekeepers from Nepal that some believe to be the source of the outbreak. So far two people have been killed in the protests, and the UN claims that the protesters were using the cholera outbreak as an excuse to encourage political instability. Anger towards the UN peacekeepers escalated after scientists identified the strain of cholera as one originating in Southeast Asia. The US Centers for Disease Control and Prevention has said that it is unlikely that it would pinpoint where the Haitian outbreak began, and that doing so would not be a good use of resources. Right now, the focus in Haiti is on treating patients and preventing the further spread of the bacteria.
Meg Larkin is a third year law student at Boston University. Please feel free to email her with any questions, comments, suggestions or concerns.