快猫短视频

HUNDREDS of cases in which patients became ill or died during gene therapy
trials have not been reported to the US National Institutes of Health as
required鈥攁nd now Congressional leaders are demanding to know why.

After the death of 18-year-old Jesse Gelsinger during a gene therapy
experiment related to his liver disorder, NIH officials began investigating
other gene therapy trials
(快猫短视频, 13 November 1999, p 15).

They have learned that scientists told the NIH of only 39 of 691 鈥渁dverse
events鈥� during seven years of trials using the same type of modified virus that
killed Gelsinger, according to Amy Patterson of the NIH鈥檚 Office of
Biotechnology Activities, who testified at a Congressional hearing in Washington
DC last week.

Some of these problems may have been related to gene therapy itself, rather
than to underlying illnesses. In one trial at Harvard Medical School in Boston,
for example, a 74-year-old woman with advanced colon cancer experienced
gastrointestinal bleeding eight hours after receiving an infusion of genetically
altered cells. She died four days later.

Though scientists did not tell the NIH about this and other incidents, they
did inform the Food and Drug Administration, which carries out confidential
reviews. Jay Siegel of the FDA says that only Gelsinger鈥檚 death can be
definitively blamed on gene therapy. He also points out that FDA officials stop
clinical trials if they find evidence of harm to patients.

Still, NIH guidelines require public disclosure, says Bill Frist, a senator
from Tennessee who chaired the hearing. 鈥淚nformation has been hidden. Clearly
the oversight system is failing.鈥� NIH and FDA officials are now planning a
computerised database to monitor adverse events, and site visits to investigate
ongoing clinical trials.