Innovative therapy

In the Oregon case, a physician denied wrongdoing but agreed in the future to inform his patients that he gets what could be construed as a kickback from the medical supply company for implanting a particular brand of pacemaker.

In the Sacramento case, two neurosurgeons resigned from the University of California, Davis, after a controversy over the inadequacy of research subject protections in their trial of a novel approach for treating a highly malignant brain cancer with "probiotic intracranial therapy," or the introduction of live bowel bacteria, Enterobacter aerogenes, directly into their patients’ brains or bone flaps. The doctors theorized that an infection might stimulate the patients’ immune systems and prolong their lives.

Physicians who use medications for off-label uses are well advised to be sure they are obtaining and documenting informed consent from their patients. Informed consent requires the physician to have provided all relevant details that a reasonable patient would want to know before making a decision. IRBs are in place to protect research subjects. There is a problem, however, with having a higher tier of protection and the associated burdensome paperwork. Powell’s 4th rule of medical ethics: If you raise the bar high enough, people walk under it.

Dr. Powell practices as a hospitalist at SSM Cardinal Glennon Children’s Medical Center in St. Louis. He is associate professor of pediatrics at Saint Louis University. He is also listserv moderator for the AAP Section on Hospital Medicine and is a member of the Law and Bioethics Affinity Group of the American Society for Bioethics and Humanities. He said that he had no financial conflicts of interest. Readers can e-mail Dr. Powell at pdnews@frontlinemedcom.com.