News: August 09, 2007

Conflicts of Interest on FDA Advisory Panels. The House appropriations bill including FDA’s budget that was passed last week includes an amendment that would end all conflicts of interest on FDA panels.  The provision would bar anyone with any financial ties to drug or device companies from sitting on FDA advisory panels.  This would sharply reduce the pool of qualified experts in the device industry.  FDA had already proposed a measure to curb egregious conflicts.  Those receiving more than $50,000 from industry in the past year will not be allowed to serve, and those receiving between $1 and $50,000 may serve on the panels but not as voting members.  It remains to be seen if the proposal survives when the chambers’ bills are combined.  Additional information is available at  http://www.boston.com/business/healthcare/articles/2007/08/07/
bill_calls_for_fda_to_end_all_conflicts_of_interest.

Diagnostic Devices Need to be Made Disaster-Ready.  At the American Association of Clinical Chemistry annual meeting, professor and director of the clinical chemistry program at UC-Davis, Gerald Kost, said that “industry needs to develop more robust diagnostic equipment and supplies so that patients can be appropriately treated in the event of a devastating hurricane, earthquake or other type of disaster.”  Many existing diagnostic products are not designed for use in a point-of care field setting, and are not guaranteed to produce accurate results in poor environmental conditions.  Devices and reagents should be specifically tested and certified for use in disasters; e.g., should be able to withstand high temperature, freezing, long-term humidity, dust exposure, strong vibration and altitude changes.  Equipment should also be standardized to allow interchangeability and compatibility of components among devices from different manufacturers, e.g., glucose meters and test strips.  Additional information is available at http://www.thegraysheet.com (paid subscription service).

Success of Destination Left Ventricular Assist Device Depends on Patient Selection.  A study of destination LVAD showed that the pump itself is not the only important variable in outcome.  Pump improvements should also be paralleled by patient selection improvements.  In Thoratec’s HeartMate XVE 309 person clinical trial, one and two-year survival rates following implantation were 56% and 33%, respectively.  A high rate of in-hospital mortality (26.8%) was caused by complications unrelated to the device, such as sepsis, right heart failure, and multi-organ failure.  If patients are too sick, operative risk outweighs survival benefit from the treatment.  Additional information is available at http://www.thegraysheet.com (paid subscription service).

MedApps Implements 'Healthcare Anywhere' Program Using Angel.com Interactive Voice Solutions Application.  MedApps, Inc., a provider of remote patient monitoring systems, implemented an enterprise-level interactive voice response (IVR) and intelligent call routing solution from Angel.com. In conjunction with MedApps FDA-cleared wireless medical devices, the Angel.com IVR system will help MedApps implement its "Healthcare Anywhere"(TM) ubiquitous healthcare solution for patients managing chronic diseases, such as diabetes.  Remote patient monitoring devices collect and transmit daily readings to MedApps servers for storage and review by healthcare professionals.  If a reading occurs outside of a pre-set threshold, an alert is triggered through the Angel.com IVR solution, and the patient will receive a call.  Additional information is available at http://dialog.newsedge.com.