-Caveat Lector-

Six Gene Therapy Deaths Unreported

WASHINGTON (AP) - 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 Jeffrey Isner of Tufts University in Boston told The Washington Post they
believe the six patients died from underlying illnesses and not from the gene
therapy.

Last month the Food and Drug Administration ordered Schering-Plough Corp. to
temporarily halt two gene therapy studies after a teen-ager in a similar
experiment died on Sept. 16. University of Pennsylvania scientists had placed
healthy genes in his liver to combat a rare metabolic disease.

The researchers in the blood vessel study said they did report the deaths to
the FDA, 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.

The Post quoted NIH officials in its editions Wednesday as saying that even
deaths first appearing unrelated to gene therapy should be reported and made
public because the cause of death may not be determined until later.

``It may take five, six, seven patients ill, or 20 patients, before you find
out, 'Hey, this is also happening in other people's trials,''' said Amy
Patterson, who heads the NIH office that oversees gene therapy studies.

Isner told the Post not reporting the deaths was an oversight and he was
unclear about whether he had to.

Crystal said he supported telling the NIH, but he didn't consider it a legal
requirement. He said Parke-Davis, which sponsored his study, has become
responsible for reporting deaths to the agencies involved.

Parke-Davis spokeswoman Carol Goodrich told the Post that the company had
sent the NIH details of the deaths on Oct. 20.

The deaths had been discussed in scientific journals and meetings, both
researchers said.

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