FORMER OU researcher could be banned from doing studies
Friday, July 13th 2001, 12:00 am
By: News On 6
(TULSA) - A former University of Oklahoma medical researcher could be banned from the kind of studies he did with experimental melanoma vaccines.
The U.S. Food and Drug Administration sent Dr. J. Michael McGee a letter last month, alleging McGee violated numerous rules and regulations during research 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 June 21 letter stated.
The FDA ``proposes that you be disqualified as a clinical investigator,'' the letter stated.
The letter begins a lengthy process, an FDA spokeswoman said. McGee also could reach an agreement with the FDA that would allow him to continue research under certain conditions.
``It's a death sentence for his chances to ever conduct research again,'' Okmulgee attorney Robert Seacat said. Seacat represents several cancer patients who participated 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,'' Seacat said. ``But to be honest, who would want to work with the guy knowing how he conducts his research?''
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 for comment Wednesday or Thursday. McGee has responded to the FDA's accusations and portions of his responses are included in the FDA's 12-page letter.
His responses dispute some of the allegations, but not others, the letter indicated.
Among other things, the FDA accused McGee of enrolling subjects who were not eligible for the study. The letter cited one case in which McGee allegedly submitted a form to ``waive'' such eligibility requirements nine months after the patient's death.
Some patients ``were dead by the time you submitted an `Eligibility Criteria Waiver' request form to the IRB for these subjects,'' the letter stated. The IRB, or Institutional Review Board, oversees 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 stated.
The FDA also said 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 stated. ``We do not accept your explanation because, as the author of the protocol, you established those requirements.''
The FDA's letter also accused McGee of failing to monitor effects of the drug in subjects and of improperly allowing patients to self-inject drugs.
More than 90 patients participated in the three-year study, which was conducted in Tulsa and 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. He has filed a federal lawsuit alleging OU violated his due process rights and tried to destroy his ability to defend himself or salvage his reputation as a medical researcher.
The FDA's letter to Dr. J. Michael McGee can be viewed online at www.fda.gov/foi/nidpoe/n16l.pdf