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
omer.gillham@tulsaworld.com. Jeff Martin, World assistant city editor, can be
reached at 581-8413 or via e-mail at
jeff.martin@tulsaworld.com.
