Doctors allege OU used them as scapegoats

<br>TULSA, Okla. (AP) _ Months before regulators suspended research at the University of Oklahoma's medical school in Tulsa, the school's research director said he sought university guidelines

Saturday, December 9th 2000, 12:00 am

By: News On 6

TULSA, Okla. (AP) _ Months before regulators suspended research at the University of Oklahoma's medical school in Tulsa, the school's research director said he sought university guidelines for human testing. But none existed, he said.

And when compliance troubles surfaced with a skin cancer study, Dr. Edward Wortham said he asked administrators at OU's Health Sciences Center in Oklahoma City for help. But he said officials told him their hands were full with compliance issues there.

``There was no system in place that could help in correcting the problems,'' he said.

Wortham alleges that when the government stepped in, he and others became the university's scapegoats for its own failure to provide training and an internal compliance system.

OU officials flatly deny the allegations, including the contact Wortham said he made with them.

Wortham and the Tulsa medical school's former dean, Dr. Harold Brooks, say they'll file a lawsuit Monday to clear their names and get their jobs back.

``If there had been leadership from Oklahoma City, they would have seen this coming and created a formal research and monitoring program for both campuses,'' Brooks said.

But OU officials in Oklahoma City say the Tulsa administrators and researchers bore responsibility for complying with all regulations, regardless of the system in place.

``If you're a dean of a medical school, you should know what the regulations are,'' said Dr. Jerry Vannatta, dean of the College of Medicine in Oklahoma City.

University officials also deny being told about the seriousness of the cancer study problems until regulators took action. Vannatta said Brooks told him in April that ``everything had been taken care of.''

``There was no other indication there was a problem,'' Vannatta said.

Brooks and Wortham resigned after the U.S. Office for Human Research Protections suspended government-sponsored research in June at the Tulsa campus because of safety concerns involving the cancer study.

From the start, Dr. J. Michael McGee's melanoma study was unique.

It began three years ago and unlike other studies at Tulsa, had no outside sponsor, such as a pharmaceutical company, to help monitor it.

Ninety-eight seriously ill melanoma patients participated in Tulsa, Springfield, Mo., Newport Beach, Calif., Nashville and Knoxville, Tenn., and Bloomington, Ind.

In the fall of 1999, McGee told his Tulsa supervisors of compliance problems, according to a statement written by McGee to the chairman of a faculty appeals board and obtained by The Associated Press.

Wortham said he learned on Dec. 15, 1999, those problems included a lack of standard operating procedures.

Wortham said he spoke to Dr. Gary Raskob, OU's associate vice president for clinical research, in general terms about the need for such guidelines on Dec. 8, 1999, but not about the cancer study. In February 2000, Wortham said he asked Raskob for audit assistance related to the melanoma study but was told to hire an outside firm.

Raskob said he doesn't recall speaking with Wortham in February or that Wortham mentioned ``any of these things.'' Raskob said he would not respond to specific allegations by Wortham and Brooks through the media.

The outside auditors found numerous compliance and safety problems with the study. They concluded the researchers lacked the background and understanding to assure the safety of study patients. McGee shut the study down in March.

Brooks said he told OU administrators in April that the study had been halted and he would investigate. Brooks said he wasn't aware of the severity of the allegations made by the audit at the time.

In June, federal regulators took action, citing the audit's findings.

With research in jeopardy and federal officials threatening enormous fines on rule-breaking universities, OU President David Boren responded with a vow to make a ``fresh start.''

He announced the resignations of Wortham and Brooks and the retirement of Dr. Daniel Plunket, chairman of Tulsa's institutional review board, which oversaw research. Boren said McGee would be fired.

``We simply have to send a very strong signal for the sake of all our research programs,'' Boren said, announcing that the university planned to become a model of compliance.

``It was plain from Boren's statements and charges that, according to him, my work was medically incompetent and dangerous, and that I was dishonest and incompetent. None of this was true,'' McGee wrote to the appeals board chairman.

``Boren is trying to ruin me for refusing to be the fall guy.''

McGee has declined to speak to the media while he fights to keep his job.

Wortham and Brooks said university officials threatened to fire them and cut off their pay in less than 24 hours if they didn't offer to resign, an option that gave them several months salary.

They stood accused of dishonesty, incompetence and failure to adhere to policies.

``I went absolutely numb,'' Brooks said.

Brooks, an OU and Harvard-educated cardiologist, left a lifetime endowed chair at the Medical College of Wisconsin to take the dean's job in Tulsa in 1992. He said he found a program in turmoil, with three academic programs on probation.

Brooks said he worked to strengthen academics and expand the school's budget from $25 million to $47 million, an increase funded by outside sources including $2 million in research. OU was preparing to move to a new 59-acre campus Brooks helped obtain just before the scandal broke.

In 1994, Tulsa began its research program, the lack of which had been noted by accrediting agencies.

But Brooks said from the start, getting funding and other assistance from OU administrators in Oklahoma City was an uphill battle. No state dollars went toward research in Tulsa, he said.

``Our major complaint is that the university overall did not have in place protocol and they blamed the Tulsa campus,'' he said. ``I'm not expected to be autonomous and create my own guidelines.''

OU officials say the two campuses can't be compared. The Oklahoma City campus is much larger, encompassing seven separate health-related schools.

Dr. Joseph Ferretti, the senior vice president and provost for the Health Sciences Center, and Dr. Jerry Vannatta, the dean of the medical school in Oklahoma City, denied allegations of unfair treatment.

Funding per student at Tulsa is roughly double that at Oklahoma City, Ferretti said. Brooks called the comparison unfair because of the campus' different makeup. The university was processing a request Friday by The Associated Press for budget data for both campuses.

``It was their desire to have a program of research on the Tulsa campus,'' Ferretti said. ``It was their proposal, not ours.''

OU officials are preparing their responses to an ongoing investigation by the U.S. Food and Drug Administration. A handful of melanoma patients have resumed receiving the vaccine with the FDA's permission.

The university also is in the process of selecting a compliance officer to serve as an independent research monitor. A confidential hot line also is planned to allow employees to report problems.

On Thursday, OU regents approved a plan to spend as much as $190,000 to train hundreds of employees involved in clinical studies on compliance protocol.

McGee's attorney, Lynn Mattson, said that alone ``indicates what training programs were and have been at the university.''

Both Vannatta and Ferretti said researchers have operated on an informal system where they sought out compliance information from their oversight boards or on their own.

``I've done clinical research myself and I knew it was my job to know what the rules and regulations were,'' Vannatta said.