New York Times | November 4, 1999
Washington - Six weeks after an 18-year old Arizona man died unexpectedly in a gene therapy experiment, the field's safety record is coming under increasing scrutiny and new information is coming to light about patients who may have been harmed in other clinical trials.
In another matter, two researchers competing to be the first to grow new blood vessels around blocked ones say they didn't report to the National Institutes of Health that six people have died during their gene therapy studies.
Ronald Crystal of the New York Hospital-Cornell Medical Center in Manhattan and Jeffery Isner of Tufts University in Boston said they believe the six patients died from underlying illnesses and not from the gene therapy.
The researchers in the blood vessel study said they did report the deaths to the Food and Drug Administration, which doesn't release the information. But they said federal regulations didn't require them to tell the NIH because gene therapy didn't directly cause the deaths.
Isner said not reporting the deaths was an oversight and he was unclear about whether he had to.
Of particular concern to federal health officials are studies that employ an inactivated cold virus, called adenovirus, as what scientists call the vector that carries new genes to the proper cells. The Arizona patient, Jesse Gelsinger died four days after doctors at the University of Pennsylvania injected a corrective gene, encased in a deactivated adenovirus, into the hepatic artery, which leads to the liver.
Leading scientists and government officials said Gelsinger was the only person known to have died as a direct result of receiving gene therapy.
On Wednesday, a spokesman for Schering-Plough Corp., the drug manufacturer, said that three liver cancer patients who had been treated the same way as Gelsinger had experienced serious side effects.
The spokesman, Robert Consalvo, would not disclose details, except to say that the Food and Drug Administration and the National Institutes of Health had been notified.
In the wake of Gelsinger's death, the FDA temporarily halted two Schering-Plough gene therapy experiments using adenovirus, one for the treatment of liver cancer and another for colorectal cancer that had spread to the liver.
