Controversy Arises
over Study Deaths
Two scientists
racing to be first to grow new blood vessels admit they did not
inform the National Institutes of Health that six people died during
gene therapy studies. They did report the deaths to the Food and
Drug Administration.
The two
researchers, Ronald Crystal of New York Hospital-Cornell Medical
Center in New York City and Jeffrey Isner of Tufts University in
Boston, said the six patients didn't die from the gene therapy
experiments, but from other causes, according to a report in the
Nov. 3 edition of The Washington Post. The NIH oversees
medical research safety, but both researchers said federal
regulations didn't require them to notify the agency of the deaths
because the gene therapy did not cause the
deaths.
But NIH officials
quoted in The Washington Post said that even if the deaths
appear unrelated to experiments being conducted, they should still
be reported because the actual cause of death may not be confirmed
until later.
A spokeswoman
for pharmaceutical giant Parke-Davis, which helped fund Crystal's
research, says the NIH was notified of the deaths Oct.
20.
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