Officials depart, dismissed amid scandal at OU's medical school

Journal Record, The (Oklahoma City), Jul 24, 2000 by Kelly Kurt Associated Press

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.

The changes announced by Boren establish a system of four or five research oversight checks. They include:

* The establishment of a university-wide research compliance office that reports to the general counsel and internal auditor.

* A confidential round-the-clock hotline for reporting of research problems. Employees also will be required to sign a statement the compels them to alert officials to any research problems. Failure to do so could lead to dismissal.

* Mandatory educational sessions on proper procedures and regulations for all faculty, staff and health care officials.

* Unannounced spot checks of research compliance by the internal auditor.

* A new Institutional Review Board in Tulsa, which will be composed of Tulsa and faculty from the university's Oklahoma City campus. The university also is working to have an outside firm accredit the IRB.

* Clearance of new research projects by OU Health Sciences Center Provost Dr. Jospeh Ferretti, in addition to receiving IRB approval.

Boren also announced the appointment of Dr. Dewayne Andrews as interim senior associate dean of the medical school in Tulsa and Dr. Robert Block as interim assistant dean. Andrews currently serves as associate dean for academic affairs at the university main medical campus in Oklahoma City. Block is chairman of the department of pediatrics ad the Health Sciences Center Tulsa campus. Boren praised Brooks' contributions in building the Tulsa program but said the leadership change would aid the campus' efforts to make a new start.

Boren said the scandal reflects a "coming of age" for the university as it seeks to expand research. He pointed to similar research scandals at Duke University and the University of Pennsylvania. He wants the new requirements to serve as a national compliance model.

"No system is 100 percent fail-safe. But if this one is not 99 and 99 one-hundredths percent fail-safe I don't know what kind of system we can devise," he said.