(5 of 9)
In the Oklahoma case, it may have been a nobler motive that tripped up McGee. "McGee is a good surgeon and a decent man," maintains his whistle-blowing research nurse, Mathias. "But he became a biased investigator. He thought he had found the cure for cancer. He really wasn't interested in running a clinical trial; he wanted to administer his drug"--even if that meant breaking the rules to get there. Although McGee said he had tested his drug properly on animals, he had not; the data he submitted in his original protocol came from animal studies of a different drug. McGee promised the FDA that he would test each lot of the new vaccine on animals for safety before injecting it into humans. The FDA's subsequent investigation found that such testing had not been done adequately.
Then the university review board dropped the ball. Despite federal rules requiring it to conduct "continuing review" of ongoing studies, the board met just once a month, typically for an hour, and then went out to dinner. Among other things, the board approved McGee's consent form, which contained numerous errors. McGee later got permission to add more subjects than the original 25 he had applied for. According to the OHRP investigation, 11 of McGee's first 18 subjects didn't meet eligibility criteria. Like most of the key oversight decisions, this one actually came directly from the IRB chair, Daniel Plunket, who often did a one-man "expedited review" without consulting the rest of the board. James Robinson, Plunket's lawyer, insists "there is no evidence" his client "took any action on his own."
Mathias reported substantial protocol violations to Plunket and told Dr. Harold Brooks, dean of the university's College of Medicine in Tulsa, as well. They finally agreed to hire an outside consulting firm to audit the experiment. The finding: deficiencies "so severe that it is beyond the scope of this report to advise corrective actions." This finally persuaded Brooks to put the trial on hold. But according to the investigation, Brooks and Plunket decided not to share the report with the IRB; instead, Plunket filed an annual report that stated, "There are no significant safety issues related to the vaccine." That gave cover to McGee's letter lying to patients about why the trial was being halted.
That's when Mathias wrote her whistle-blowing letter. On the basis of its investigation, the OHRP shut down all federally funded human research at the university. The university, meanwhile, did its own digging and came to the same conclusions. It disbanded the Tulsa IRB, suspended and later fired McGee, and terminated Plunket and Brooks as well. And on July 7, 2000, it sent a new letter to McGee's subjects. This one admitted that "in fact, the trial was closed because of possible safety concerns."