McGee Faces FDA Censure
By OMER GILLHAM World Staff Writer and JEFF MARTIN World Assistant City Editor
The U.S. Food and Drug Administration is taking action that could ban Dr. J. Michael McGee from the kind of research he did with experimental melanoma vaccines, which has been his life's work.
The FDA sent McGee a June 21 letter alleging that the researcher broke numerous rules and regulations during a University of Oklahoma study conducted in Tulsa and five other sites.
"We believe that you have repeatedly or deliberately violated regulations governing the proper conduct of clinical studies involving investigational new drugs," the letter states. The letter says the FDA "proposes that you be disqualified as a clinical investigator. "The letter is the beginning of a process that could take months or years, an FDA spokeswoman said. McGee could also reach an agreement with the FDA that would allow him to continue research under certain conditions.
Nationwide this year, only two other clinical investigators have received similar notices, according to FDA records. "It's a death sentence for his chances to ever conduct research again," said Okmulgee attorney Robert Seacat, who represents several cancer patients who took part in the study and are now suing McGee, OU President David Boren and others. "He can fight it and lose and be barred from ever doing research again or he can enter a consent agreement, which is basically admitting guilt, and be placed under years of probationary supervision. But to be honest, who would want to work with the guy knowing how he conducts his research?" Seacat said.
When the FDA bans a clinical investigator from doing research on humans, the action extends only to research in the United States, FDA spokeswoman Lenore Gelb said.McGee's lawyer, Lynn Mattson, could not be reached Wednesday or Thursday.
However, McGee has responded to the FDA's accusations and portions of his responses are included in the FDA's 12-page letter. McGee's responses dispute some of the allegations, but not others, the letter indicates. The FDA's letter to McGee states that "you failed to adequately protect the safety and welfare of subjects.
"Among other things, the FDA maintains that McGee enrolled subjects who were not eligible for the study. The letter cites one case in which McGee allegedly submitted a form to "waive" such eligibility requirements nine months after the patient's death. Some patients, whose identities were not revealed by the FDA, "were dead by the time you submitted an `Eligibility Criteria Waiver' request form to the IRB for these subjects," the letter states.
The IRB -- short for Institutional Review Board -- is charged with overseeing the safety of humans in research projects.
McGee reportedly administered experimental drugs to 11 cancer sufferers ineligible for the study months before obtaining special waivers to allow them in, the letter states.
"Four of these subjects were dead by the time you submitted the waiver requests" which could allow them into the study, the letter states. The FDA states that some patients had been in the study more than a year before waivers were granted.
Such ineligible subjects -- mostly those having highly advanced cases of melanoma -- were administered experimental drugs in 1997, well before McGee sought waivers in February 1998, according to FDA records.
"Your response explains that you submitted "Eligibility Criteria Waiver" request forms to the IRB when you `became aware' of the requirement to do so," the FDA's letter states. "We do not accept your explanation because, as the author of the protocol, you established those requirements. "The FDA's letter also accuses McGee of failing to monitor effects of the drug in subjects.Additionally, the FDA maintains that McGee improperly allowed patients to self-inject drugs.
For example, drugs were shipped to a patient in California who then self- administered them without proper supervision, the FDA alleges. IRB approval to allow self-injections was obtained two years after the fact in some cases, the letter states.
McGee also is cited for shipping doses of the experimental drug to a patient in Tennessee, who was allowed to store it at home in a refrigerator, according to the FDA.
More than 90 patients participated in the three-year study, which was conducted in Tulsa and at sites in Newport Beach, Calif.; Springfield, Mo.; Knoxville, Tenn.; Nashville, Tenn., and Bloomington, Ind. McGee, a former OU professor, was fired in the wake of the melanoma study.
The FDA's letter to McGee can be viewed on-line at cf,fgc www.fda.gov/foi/nidpoe/n16l.pdf
Omer Gillham, World staff writer, can be reached at 581-8301 or via e-mail at firstname.lastname@example.org. Jeff Martin, World assistant city editor, can be reached at 581-8413 or via e-mail at email@example.com.