NYT Exposes Unreported Deaths in Genetic Engineering
"Gene Therapy" Experiments on Humans

Death Raises Questions about Gene Therapy's Safety
The 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 didnít 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 didnít 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.

The story includes reports from the Associated Press.