The FDA notified Dr. James M. Wilson of the University of Pennsylvania on Nov. 30 that the agency was starting a proceeding “to determine whether you should be disqualified from experimental drug research on human subjects.

Larry Bachorik, an FDA spokesman, said Monday that the process could result in Wilson being barred for life from conducting human subject research in this country.

Wilson was in charge of a gene therapy experiment that last year resulted in the death of Jesse Gelsinger, 18, of Tucson, Ariz.

Death a Direct Result of Injection
　　Gelsinger suffered from a liver disorder. He died in September 1999 after being injected with a genetically altered virus that was designed to deliver a gene that would treat the liver condition.

An FDA investigation concluded that Gelsinger died as a direct result of the injection. He is the first patient die in a gene therapy experiment.

The notice to Wilson charged a series of violations in the gene therapy experiment and said the FDA “asserts that you have repeatedly or deliberately failed to comply with the cited regulations and it proposes that you be disqualified as a clinical investigator. /p>

The notice gave Wilson up to 30 days to respond. It offered him the chance to answer the charges in writing or in a personal conference with FDA officials.

According to the letter, an FDA investigation found these violations:
　　Enrolling patients, including Gelsinger, who were not eligible for the study.
　　Failure to stop the study after some patients developed elevated liver enzymes, fever and anemia.
　　Failure to follow the experiment plan in conducting monitoring medical tests on the patients.
　　Submitting “misleading and inaccurate statements in an annual report on the experiments, including claims that there were no “significant toxicities experienced by the patients.
　　Failure to warn patients enrolled for the tests that two monkeys used in the experiment had to be put to death after the animals experienced serious side effects.

University of Pennsylvania representatives could not be reached for comment, but a story on The Washington Post’s Web site Monday quoted university officials as saying: “This is obviously a very serious matter and we know that Dr. Wilson understands its importance, is reviewing the letter carefully and intends to respond in a timely way. /p>

Following Gelsinger’s death, the FDA ordered the Institute of Human Gene Therapy, which Wilson heads at Penn, to halt human drug trials. The university later announced that Wilson would limit his research to animals.

Gelsinger’s family last month settled a lawsuit against Wilson and the university. The terms were not disclosed.

(From ABCNews.com)