Officials Depart, Dismissed amid Scandal at OU's Medical School

Article excerpt

A scandal involving a cancer study at the University of Oklahoma's medical school in Tulsa has brought the departure of three top officials and the dismissal of the prime researcher, OU President David Boren said Friday.

The university began steps Friday to terminate Dr. Michael McGee. Safety and oversight concerns involving McGee's melanoma vaccine study brought federal suspension last month of government-sponsored research programs in Tulsa.

Harold Brooks, dean of the college of medicine in Tulsa; Edward Wortham Jr., director of the Office of Research at the Health Science Center, and Daniel Plunket, who chaired the school's research oversight board also have resigned or retired, Boren said.

"I think we have no choice but to demonstrate we're making a fresh start," he said. "We simply have to send a very strong signal for the sake of all our research programs."

McGee's attorney, Tom Mason, said Friday he had no comment on the dismissal.

Boren also outlined new requirements the university is putting in place to ensure compliance with federal regulations meant to protect patients participating in medical studies. A task force set up after the suspensions recommended the changes.

"I don't believe there will be a university in the United States with procedures as tough as ours or as comprehensive as ours," Boren said.

The university stopped the cancer study in March after an outside audit revealed problems with the manufacturing of the vaccine and patient monitoring. Twenty-six of the 94 participants who received the vaccine in the 3-year-old study died, although officials found no evidence the study contributed to the deaths. Regulators with the federal Office for Human Research Protections shut down enrollment in five government-sponsored studies on the Tulsa campus in June. The university voluntarily suspended enrollment in 70 other clinical trials.

Last week, federal health officials lifted suspensions. The university said it would resume all research except for the cancer study. Many of the patients who received the vaccine, however, asked that it be continued.

"We want to take a very very close look at that before we even make any requests for resumption of it," Boren said. …