[MOL] Controversy arises over study deaths.... [00181] Medicine On Line

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[MOL] Controversy arises over study deaths....

  NOVEMBER 04, 1999

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.

Warmly, lillian
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