Woman Wasn't Told of Bad Reaction
Filed at 10:35 a.m. EST
By The Associated Press
PHILADELPHIA (AP) -- A woman who volunteered for a
gene-therapy experiment at the University of Pennsylvania says she found
out she briefly had a bad reaction to the test only after another participant
died.
Dolores Aderman, 36, Patient No. 11 in the tests of a treatment for
ornithine transcarbamylase, a liver deficiency, told The Philadelphia
Inquirer she was never told that enzymes believed to indicate liver injury
had shown up in her body, and that the concentration of those enzymes
was high enough that the experimenters reported them to the Food and
Drug Administration.
Three patients who followed Aderman in the experiment also
experienced liver toxicity, The Inquirer reported today, and the FDA
criticized the university for not reporting two of the ``adverse events'
promptly.
Jesse Gelsinger, Patient No. 19 in the experiment, died in September
after having a severe reaction. The FDA has stopped all trials at Penn's
Institute for Human Gene Therapy, saying there were not adequate
systems to protect patients.
Aderman, who participated in the experiment in June 1998, said she
knew nothing about her liver reaction until she pieced it together from
news accounts of FDA reports in December. Her enzyme levels had
returned to normal by time she left the hospital following the tests, the
Inquirer reported.
``The patient has the right to know everything going on,' she said. ``It's
my body. It's not your body. I lent them my body.'
Officials at Penn did not return telephone calls for comment, the paper
said.
Aderman, who volunteered for the project because her son, Michael,
died from ornithine transcarbamylase deficiency, said she still believes in
helping medical research to find cures for this and other diseases.
``All I ask for is a little respect, a little common courtesy, and the truth,'
she said.
Under federal rules, patients in clinical trials have the right to request
adverse-event reports emerging from the research, according to an FDA
spokesperson, and consent forms are supposed to spell out all possible
risks and complications.
Aderman did not suffer from the disease, but Michael and her other two
sons inherited it from her. In OTC deficiency, the liver is unable to
process ammonia, a natural byproduct of the body's metabolism.
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