Headlines: April 19, 2011
by Meg Larkin
New guidelines allow for an earlier definition of Alzheimer’s disease. The guidelines, issued on Tuesday by the National Institute on Aging and the Alzheimer’s Association reflect the latest medical evidence in the field. In recent years research has shown that Alzheimer’s disease begins to affect patients’ brains long before symptoms and dementia become apparent. As the New York Times reports, the guidelines, “divide the disease into three stages: a phase when dementia has developed, a middle phase in which mild problems emerge but daily functions can still be performed, and the most recently discovered phase, in which no symptoms are evident but changes are brewing in the brain.” While Alzheimer’s cannot currently be diagnosed until patients are symptomatic, the new guidelines reflect an awareness of the latest developments in research on early diagnosis of Alzheimer’s disease through the use of biomarkers and seem to contemplate the availability of such diagnostic tools in the future.
In patient safety news, a powerful blood clotting drug has been found to pose significant risks when used off-label. Factor VIIa was approved by the FDA in 1999 for use in patients who lack a gene to make a certain blood clotting factor, and for some hemophilia patients. However, those patients make up only 3 percent of patients who are given Factor VIIa. Ninety-Seven percent of the time, Factor VIIa is used off-label in patients with other reasons for excessive bleeding. Recent studies have found that while Factor VIIa is effective in stopping bleeding in those patients, it may dramatically increase the risk of patients suffering a blood clot in the heart or the brain. Factor VIIa is also frequently used by trauma surgeons to control bleeding, but its use by those doctors has fallen in recent years after a study showed no survival benefit for patients from the drug. Factor VIIa takes a year to produce, and each dose of the drug costs $10,000. The author of both recent papers on the off-label use of Factor VIIa was quoted by the New York Times as saying that the research reflected the dangers of using drugs for unapproved uses can be risky because doctors are operating without full knowledge of the risks and benefits.
In other safety news, the Joint Commission has announced a new initiative to combat alarm fatigue. The Joint Commission, which accredits hospitals, plans to meet with FDA officials in the next few months to develop a plan of action. The initiative follows on the heels of a Boston Globe investigation that found, “at least 216 deaths nationwide between January 2005 and June 2010 linked to alarms on patient monitors that track heart function, breathing, and other vital signs.” In a number of cases hospital staff didn’t respond to the alarms, or didn’t notice them. Because hospital staff work in an environment with numerous alarms, many of them false, going off for a number of reasons all day, they may become desensitized to the alarms and not respond appropriately when a patient is in urgent need of care. Possible approaches to the problem include redesigning or integrating the alarms on different medical devices and bringing together health care workers and medical device designers to work on mutually beneficial solutions.
Finally, in research news, studying astronauts’ hearts in space may be able to improve cardiac care back here on earth. Because gravity doesn’t exert the same force in space, Astronauts’ heart muscles don’t have to work as hard, and the heart appears to shrink as blood volumes decrease. The decrease in heart size and blood volume can lead to abnormally low blood pressure and an inability to stand up. The research on the astronauts found that seated exercise, such as using a rowing machine, can be beneficial for treating the condition. The Wall St. Journal reported that, “About 25% to 30% of astronauts may have trouble maintaining their blood pressure when they return from trips lasting less than 30 days, while 80% have low blood pressure and experience symptoms like tunnel vision and cold sweats after six-month missions.” The recent research both confirmed that Astronauts do lose heart mass in space, and that exercise may be able to counteract the problem. Here on earth, the results have been used to help treat patients with similar problems of small heart size and hypotension.
Meg Larkin is a third year law student at Boston University. Please feel free to email her with any questions, comments, suggestions or concerns.
