-Caveat Lector-

Researchers didn't report six gene therapy deaths

WASHINGTON (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.

The Post quoted NIH officials 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.

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.

DECLARATION & DISCLAIMER
==========
CTRL is a discussion and informational exchange list. Proselyzting propagandic
screeds are not allowed. Substance—not soapboxing!  These are sordid matters
and 'conspiracy theory', with its many half-truths, misdirections and outright
frauds is used politically  by different groups with major and minor effects
spread throughout the spectrum of time and thought. That being said, CTRL
gives no endorsement to the validity of posts, and always suggests to readers;
be wary of what you read. CTRL gives no credeence to Holocaust denial and
nazi's need not apply.

Let us please be civil and as always, Caveat Lector.
========================================================================
Archives Available at:
http://home.ease.lsoft.com/archives/CTRL.html

http:[EMAIL PROTECTED]/
========================================================================
To subscribe to Conspiracy Theory Research List[CTRL] send email:
SUBSCRIBE CTRL [to:] [EMAIL PROTECTED]

To UNsubscribe to Conspiracy Theory Research List[CTRL] send email:
SIGNOFF CTRL [to:] [EMAIL PROTECTED]

Om

Reply via email to