Aegis

Since the time of Classical Greece, the term aegis has been associated with protection, as it was often depicted as either Zeus or Athena's mythological shield. Over the past 5,000 years, the concept of being "under someone's aegis" has now evolved to mean being under the protection of a powerful or knowledgeable source. Unfortunately, patients have not always had such clear protectors as the gods of Olympus; and therefore, the healthcare industry relies on regulatory powers and the integrity of the individual caregivers.

This week, a new report revealed nearly half of all U.S. hospitals fail to report to the National Practitioner Data Bank (NPDB) when a physician's admitting privileges have been revoked or restricted for more than 30 days, despite the federal laws requiring these actions.

Upon discovering these failures, consumer watchdog group Public Citizen wrote a letter to HHS Secretary Kathleen Sebelius suggesting that the failure of providers to adequately discipline doctors or to report cases of physician discipline to the NPDB deprives state medical boards of critical information needed for regulatory oversight and creates the potential for patient harm. The firm concluded that the hospitals need more oversight to protect patient care.

In an interesting role reversal, an investigator involved with the early TRITON-TIMI trials is attempting to caution the FDA about reviewing prasugrel too hastily. Dr. Victor Serebruany, a Johns Hopkins professor, wrote a letter to new FDA Chief Dr. Margaret Hamburg, petitioning the agency to halt its ongoing regulatory review of the anticoagulant, and requesting that new studies with a lower dose be launched. Serebruany expressed concern that the 10 mg dose could lead to bleeds and potentially cancer.

Also, wielding its regulatory sword this week, the FDA rejected two drugs, stating that more data are needed before they were deemed safe enough to administer to patients. ACRA biopharma's heart failure drug and Ortho-McNeil's anticoagulant Xarelto are the two drugs under the FDA's microscope.

While patients do not have one source to seek out for their protection, many different forces are at work to provide the proper aegis for their safety, including governemnt agencies, professional organizations and consumer groups.

On these topics, or any others, feel free to send me your comments.

Justine Cadet
News Editor
jcadet@cardiovascularbusiness.com