The Food and Drug Administration has rejected Institue for Human Gene Therapy Director James M. Wilson's letter of explanation concerning the alleged violation of safety procedures in the widely-publicized clinical trial that led to the death of 18-year-old Jesse Gelsigner.
Wilson was called on by the FDA to adequately explain alleged safety problems in the 1999 trial.
"This most recent letter is a continuation of the administrative procedures that were begun by the FDA two years ago," Wilson said in a statement provided by a Penn Medicine spokeswoman. "I will continue a dialogue with the FDA in an effort to reach a resolution satisfactory to all parties."
According to The Associated Press, the FDA sent a letter to Wilson informing him that the various explanations of alleged safety problems he provided in his letter were insufficient and that proceedings to bar Wilson from conducting further research on humans will continue.
The AP also reported that the FDA letter gave Wilson two options -- request a hearing on the charges or consent to a decree barring him from conducting tests on human beings.
"I don't know that Wilson can come to a resolution for all parties," said Paul Gelsinger, Jesse's father. "Ultimately, I think he will find himself barred from ever conducting research on humans again."
Jesse Gelsinger had a mild form of a rare liver condition that is usually fatal to infant boys. In 1999, he enrolled in a study lead by Wilson and his colleagues at Penn's Institute for Human Gene Therapy, hoping to help find genetic therapies for the disease. During the trial, after receiving a high dose of experimental treatment, the teenager died.
The FDA found that Jesse Gelsinger's death was a result of the genetic injection and began an investigation.
In the fall of 2000, the FDA sent Wilson a letter notifying him that its investigations into the death had uncovered several violations of federal policy in experiments involving human subjects. The FDA's letter also cited the IHGT's alleged failure to properly manage the testing facility.
Wilson was then informed that proceedings would begin to prevent him from ever conducting genetic testing on human subjects again.
"There is no justification for the protocol violations or for not reporting pertinent animal data to the oversight authorities," Paul Gelsinger said.
Paul Gelsinger was referring to a series of experiments conducted on animal subjects prior to the trial involving his son. Paul Gelsinger has previously alleged that the IHGT failed to report that monkeys, who were given smaller doses of the same treatment later given to Jesse Gelsinger, either became ill or died and exhibited similar symptoms to Jesse Gelsinger's when he died.
However, Wilson has said that Jesse Gelsinger's death could not have been predicted from the animal trials.
While Paul Gelsinger believes Wilson should be penalized for the violations that may have lead to his son's death, he also sees the need for more widespread, systematic reforms to prevent future accidents.
"It wasn't just the University of Pennsylvania, everyone had culpability. Penn should have been stopped. Our system enabled this to happen, and that needs to be changed," he said.
