There are public hearings coming up soon in Congress on gene therapy, one led by the grand inquistor himself, Rep. John Dingle. These are expected to be quite unpleasant and quite damaging to gene therapy, according to a recent Science Mag. Lax safety procedures and the web of commercial interests that most researchers are part of will be scrutinized.
Doc
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ap.tbo.com
May 25, 2000 - 03:35 AM
Penn Gene Therapy Lab Won't Perform Research on Humans
By Michael Rubinkam
Associated Press Writer
PHILADELPHIA (AP) - Researchers at a University of Pennsylvania gene therapy institute are hopeful that stalled experiments will go forward now that studies have been restricted to animals.
The school came under fire last fall when an Arizona teen-ager was killed during one of the clinical trials - the first patient known to have died as a direct result of a gene therapy experiment.
Penn President Judith Rodin said Wednesday the university will also strengthen oversight of research at the Institute for Human Gene Therapy and other clinical trials and review policies on conflict of interest.
"We expect our researchers to adhere to the highest scientific and medical standards. From our perspective, nothing less is acceptable," she said.
Gene therapy attempts to repair or replace abnormal genes in seriously ill patients by transferring synthetically manufactured genes into the body.
The death of 18-year-old Jesse Gelsinger prompted the Food and Drug Administration in January to halt all human studies at the institute, citing serious violations of federal research rules important for patient safety.
FDA Commissioner Jane Henney said Wednesday the agency welcomed Penn's review of its research operations.
"This action underscores the importance of research institutions taking full responsibility for protecting and informing research subjects," said Henney, who is pushing for strict new requirements holding universities more accountable for employees who violate research safety rules.
The FDA would not say how Penn's changes would affect its investigation of Gelsinger's death.
In March, the agency said an inspection showed that Penn researchers failed to properly report serious reactions experienced by patients who had the gene therapy before Gelsinger. The FDA also said Gelsinger didn't meet requirements to be in the experiment, and charged that the university also failed to promptly alert officials to the deaths of at least two lab monkeys in similar experiments.
Dr. William Danforth, vice chairman of the board of trustees at Washington University in St. Louis, led an external review board whose report prompted the changes at Penn. His panel questioned the need for the institute and whether it trained young scientists well enough to handle the demands of testing gene therapy on people.
"Are the risks well enough understood to promote widespread testing in inexperienced hands?" the panel's report asked.
Institute director Dr. James M. Wilson, one of genetic medicine's brightest stars, founded a company in 1992 that had exclusive rights to discoveries made at his institute.
That financial relationship raised additional concern about the fatal experiment and led the panel to conclude that similar relationships "may be ill-advised."
Wilson, who will remain as the institute's director, will not sponsor or participate in future clinical trials, Rodin said.
Penn said it will also create a local medical board with expertise in evaluating gene therapy research and conduct a formal review of the school's other local medical boards.
Other programs have come under close scrutiny as a result of Gelsinger's death.
In April, the FDA sent a sharply worded letter to a gene therapy researcher in Boston. Dr. Jeffrey Isner, a Tufts University scientist who headed the trials at St. Elizabeth's Medical Center, is accused of failing to follow key patient safeguards as well as properly report the death of a volunteer patient.
Federal health officials have since proposed fines of up to $250,000 for scientists who violate medical research rules - $1 million for rule-breaking universities or hospitals - amid criticism that the government hasn't done enough to protect thousands of patients involved in clinical trials.
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On the Net: U.S. Food and Drug Administration fda.gov
Institute for Human Gene Therapy med.upenn.edu
AP-ES-05-25-00 0330EDT
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