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Posted on: Wednesday, November 3, 1999
Gene Therapy Deaths Hidden
planetc1.com-news email to the editor
Test Deaths Weren’t Reported to NIH
(AP) - Two researchers trying to grow new blood vessels around blocked ones failed to report to the National Institutes of Health that six people 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 in today’s editions that they believe the six patients died from underlying illnesses and not from the gene therapy.
The Food and Drug Administration ordered Schering-Plough Corp. to temporarily halt new enrollments in two gene therapy studies last week after a teen-ager in a similar experiment died 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.
Source: ABCNews, click here for entire article

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