Headlines: May 14, 2010

by Meg Larkin

           There are two big stories in the news today about defibrillators.  First, researchers are currently testing a defibrillator that is implanted under a patient’s skin, but is not wired to the patient’s heart.  According to the New York Times, “The new version works much like an external defibrillator, but delivers the electrical jolt by means of a sensor implanted under the skin near the chest bone. A power unit is placed under the skin on the side of the chest.”  While the device is already on the market in some European countries, it has yet to be approved for sale in the United States by the F.D.A.  Although the device costs about the same to purchase as a traditional defibrillator, researchers expect it to lower health care costs by reducing the number of surgeries required to correct problems caused by the wires in traditional defibrillators.

            Second, new questions are being raised about whether to deactivate defibrillators as patients near the end of their lives.  Defibrillators can sense an unhealthy heart rhythm and deliver a life-saving electrical jolt in otherwise healthy patients, but when patients are on their death beds, the defibrillator may send a shock when it should not. As patients near death, their heart rhythms may become atypical, triggering the defibrillator, but at that point the shock will just cause pain and suffering rather than stall the patient’s irreversible decline towards death.  According to the New York Times, the Heart Rhythm Society plans to promulgate guidelines on Friday that would help doctors decide when to discuss defibrillator deactivation with their patients.

            In government regulatory news, antifraud efforts have gained $2.5 billion for Medicare.  The government has stepped up enforcement antifraud enforcement efforts in hope of gaining substantial cost savings.  Under new legislation, the government’s oversight powers have been expanded and the penalties for engaging in Medicare fraud have been increased.

            Finally, Walgreens has announced that it will not begin selling genetic tests today as planned.  Although the pharmacy chain had planned on selling the tests by Pathway Geonomics, Walgreens has announced that it will postpone offering the tests until a later date.  The announcement came after the F.D.A. challenged the legality of the test in a letter to Pathway Geonomics that was announced on Wednesday.  The agency has said that it is also investigating similar direct to consumer genetic tests produced by other companies. 

Meg Larkin is a law student at Boston University.  Please feel free to email her with any questions, comments, suggestions or concerns.