University research suspended after government raises patient concerns

Monday, July 10th 2000, 12:00 am

By: News On 6

TULSA, Okla. (AP) -- All government-funded clinical trials at the University of Oklahoma College of Medicine in Tulsa have been halted because of concerns about the safety of patients in one cancer study, officials said Monday.

Federal health officials suspended the 3-year-old skin cancer study after receiving an outside consulting firm's reports recommending it be terminated because patient safety could have been endangered, said Ken Lackey, president of the Tulsa campus.

The university stopped the trials in March because of the same reports, which found problems with the manufacturing of the vaccine used in the study and the monitoring of patients, he said. "We're trying to understand what happened here, why there was a breakdown in communications and monitoring," Lackey said.

A June 29 letter from federal health officials accused university researchers and a research oversight board of repeatedly violating federal regulations, USA Today reported Monday. The newspaper obtained a copy of the letter. The Office for Human Research Protections, set up in the Department of Health and Human Services to protect people who enroll in medical experiments, issued the suspension.

Twenty-six of the 96 patients involved in the University of Oklahoma study died, but Lackey told The Associated Press that there was no indication in the research firm's report or the suspension letter that the vaccine caused the deaths. An internal investigation is under way into the 75 clinical trials at the Tulsa campus, Lackey said.

The university also has disbanded the Tulsa campus' Institutional Review Board, which oversees clinical trials. A new oversight board has been appointed from the university's Norman campus.

In the study, patients who were seriously ill with the deadly skin cancer, melanoma, were injected with a vaccine developed by the principal researcher, Michael McGee. McGee was vice chairman of the Department of Surgery during the trial.

On Friday, the university began notifying patients that they may not have been told the truth about why the study was stopped in March, Lackey said. After the trial was halted, researchers told patients that they had run out of vaccine supplies. "We're going back to tell them factually why the trials were ended," he said.

Lackey said the university hired the outside research firm of Hausmann & Wynne to investigate the trial after other researchers involved raised concerns about incomplete paperwork. Unlike other trials sponsored by outside corporations, the trial was unique in that it was the only one sponsored by the university.

Two reports from Hausmann & Wynne found fault with quality control used in the manufacture of the vaccine and that patient monitoring procedures were not adequate, he said. The trial was discontinued but the information in the reports was not forwarded to the Institutional Review Board, Lackey said .He said the dean of the campus had believed that the IRB was informed. "We don't quite understand what happened here," Lackey said.

USA Today reported that the federal human protections office sharply criticized McGee and the review board. Michael Carome, the chief compliance official, recommended that the chairman of the IRB board, Daniel Plunket, be replaced. Plunket told The AP in a brief telephone interview Monday that the review isn't completely finished. "Everything will come out in the wash," said Plunket, who was removed from his administrative duties at the College of Medicine.

McGee has been removed as vice chairman of the Department of Surgery. Edward Wortham Jr., the director of the Office of Research at the Health Sciences Center, was relieved of his administrative duties. All three men remain employed by the university during the ongoing investigation, Lackey said.

Lackey said the problems in Tulsa are the impetus for a new taskforce created by university President David Boren. In a June 29 letter, Boren called upon task force members to review compliance with research contracts and grants. "We seek to become a national model for our compliance programs..." Boren said in the letter.