OU answers FDA deficiency findings

Monday, October 23rd 2000, 12:00 am
By: News On 6

TULSA, Okla. (AP) -- The University of Oklahoma is preparing answers to each of almost 60 potential deficiency findings by the U.S. Food and Drug Administration involving tests of an experimental drug for skin cancer.

"We're doing everything we can to be in full compliance," said Dr. Gary Raskob, OU's associate vice president for clinical research.

The chief researcher, Dr. J. Michael McGee, declined to meet with FDA officials in July about questions concerning his melanoma trials.

"I respect Dr. McGee as a scientist, and we're talking, and the school is doing everything it can to develop a response that is scientifically and factually sound," Raskob said.

An FDA audit revealed 57 deficiencies involving the manufacturing and dispensing of the vaccine.

McGee was removed from the study but is still a faculty member at the school as he fights efforts to end his employment.

Ninety-eight people participated in the study. The vaccine was administered in Tulsa and sites in Springfield, Mo., Newport Beach, Calif., Nashville and Knoxville, Tenn., and Bloomington, Ind.

In August, FDA officials agreed to allow a handful of melanoma sufferers who had participated in the study to receive melanoma vaccine shots until the supply is gone.

The review board in charge of research projects in Tulsa was disbanded after the study was discontinued earlier this year.

McGee's attorney, Lynn Mattson, said his client declined to answer FDA questions in July because federal auditors tried to "ambush" the researcher during an informal interview.

"The FDA was trying to set him up," Mattson said. "They called him into a meeting and read some kind of Miranda warning, then expected him to answer about twenty questions, which he correctly declined on the advice of counsel."

But Mattson said McGee is cooperating with OU officials who are responding to the FDA's report. Mattson said the FDA's deficiencies are "nitpicky" technical matters that could happen on any research project.

The FDA reportedly found, among other things, that pregnancy tests were not performed appropriately.

Dawanna Robertson of Okmulgee alleges that OU officials did not properly inform her of possible side effects of the experimental melanoma vaccine and an accompanying drug known as GM-CSF.