Headlines: July 13, 2010
by Meg Larkin
In government news, the Department of Health and Human Services is providing $25 million to purchase medication for low income people with HIV/AIDS. However, patient advocates believe the money will not be enough to deal with the large number of people on medication waiting lists since the recession. The Administration’s actions come after both parties in congress expressed concerns over the availability of antiretroviral medication for low income HIV/AIDS patients without insurance. Although advocates say the funding is a step in the right direction, many had urged the Obama Administration to allocate more funds towards medication purchases. It is unclear where the Department of Health and Human Services is getting the $25 million it has just pledged to support the medication purchase programs.
In regulatory news, a scathing FDA report has cast doubts on the safety of a popular diabetes drug. The New York Times reported that in a report issued after a review of the drug Avandia’s clinical trials, “The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s tally of adverse events.: Dr. Marciniak opined that this indicated potential “serious flaws with trial conduct.” The report is likely to be influential as an FDA panel considers whether to require GlaxoSmithKline to either withdraw Avandia from the market or restrict its sale. Safety questions about Avandia were raised after there were reports and clinical trial findings that it caused heart attacks and strokes.
In other FDA news, the Agency is about to review the applications of three weight loss drugs. Given the high obesity rate in the United States, a successful weight loss drug could generate a significant profit for a pharmaceutical company. Previous weight loss drugs have been plagued by dangerous side effects, and some have been removed from the market after concerns over patient safety arose. The current drugs under review target the patient’s brain to decrease feelings of hunger and increase feelings of satiation. In order to be considered effective, a weight loss drug must lead to a loss of approximately 5 percent of a patient’s body weight. It remains to be seen whether any of the drugs under consideration will be able to achieve this goal without also causing severe side effects.
Finally, new research indicates that it may not always be advisable to use intense antibiotic therapy for pneumonia in elderly patients with dementia. According to the Boston Globe, a new study, “found that using antibiotics to fight off pneumonia, a common illness in late-stage dementia, can prolong patients' lives, on average, by nine months, but that they can suffer increased pain, depression, anxiety, and agitation from the treatment.” In light of the study’s findings, patients are encouraged to assign health care proxies and express their preferences for end of life care in writing before dementia worsens. When in doubt about a patient and his or her family’s wishes, nursing homes often take the most aggressive course of treatment action in order to avoid potential liability. The Globe suggested that a better approach may be to encourage a more open dialogue around end of life care between nursing homes, their residents, and their residents’ families.
Meg Larkin is a law student at Boston University. Please feel free to email her with any questions, comments, suggestions or concerns.