ad info




CNN.com
 MAIN PAGE
 WORLD
 U.S.
 LOCAL
 POLITICS
 WEATHER
 BUSINESS
 SPORTS
 TECHNOLOGY
 SPACE
 HEALTH
 ENTERTAINMENT
 BOOKS
 TRAVEL
 FOOD
 ARTS & STYLE
 NATURE
 IN-DEPTH
 ANALYSIS
 myCNN

 Headline News brief
 news quiz
 daily almanac

  MULTIMEDIA:
 video
 video archive
 audio
 multimedia showcase
 more services

  E-MAIL:
Subscribe to one of our news e-mail lists.
Enter your address:
Or:
Get a free e-mail account

 DISCUSSION:
 message boards
 chat
 feedback

  CNN WEB SITES:
CNN Websites
 AsiaNow
 En Español
 Em Português
 Svenska
 Norge
 Danmark
 Italian

 FASTER ACCESS:
 europe
 japan

 TIME INC. SITES:
 CNN NETWORKS:
Networks image
 more networks
 transcripts

 SITE INFO:
 help
 contents
 search
 ad info
 jobs

 WEB SERVICES:

  Transcripts

CNN Today

Experimental Gene Therapy Programs Come Under FDA Scrutiny After Patient's Death

Aired February 2, 2000 - 1:39 p.m. ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

NATALIE ALLEN, CNN ANCHOR: Experimental gene therapy programs are under scrutiny after the Food and Drug Administration shut down all such studies at a major university. One patient died while taking part in a study of a liver disorder.

CNN medical correspondent Elizabeth Cohen spoke with other participants in that study who hope this and other genetic experiments will continue.

(BEGIN VIDEOTAPE)

ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT (voice-over): Eighteen-year-old Jesse Gelsinger died last fall after receiving an experimental treatment called gene therapy. His doctors had hoped the treatment would cure his disorder. Four months later, the Food and Drug Administration shut down the experiment and all gene therapy trials at the University of Pennsylvania, and that makes Tish Simon mad. She has the same disease, called OTC deficiency, for which there is no disease.

TISH SIMON, GENE THERAPY TRIAL PARTICIPANT: The people who live with this disease on a daily basis have nothing to hope for. This was the hope, and they're taking it away.

COHEN: In gene therapy, researchers actually replace the gene that's causing the disease. People with OTC deficiency have a faulty gene that makes ammonia build up in the body, often leading to brain damage and death. The FDA cited several reason for halting the experiments, including the researchers failed the notify the FDA in a timely fashion about the deaths of two monkeys in the study and about some side effects in humans.

Janie Sheedy, another participant in the experiment, also says the trials should continue. Her four sons all had the defective gene, all died before they were three days old.

JANIE SHEEDY, GENE THERAPY TRIAL PARTICIPANT: I'd do it again in a heartbeat. It was -- they took such good care of me there.

COHEN: She doesn't blame the doctors.

SHEEDY: I don't think that they could have in any way predicted what happened to Jesse Gelsinger, and I think it was a complete shock and a pretty big devastation to them.

(END VIDEOTAPE)

COHEN: At the Senate hearing, today, Jesse Gelsinger's father says he feels the researchers acted irresponsibly, adding that before his son entered the study researchers down-played possible risks.

(BEGIN VIDEO CLIP)

PAUL GELSINGER, JESSE GELSINGER'S FATHER: When lives are at stake, when my son's life was at stake, money and fame should take a back seat. The concern should not be on getting to the finish line first but making sure no unnecessary risks are taken, no lives filled with potential and promise are lost forever, no more fathers lose their sons.

(END VIDEO CLIP)

COHEN: Also at the hearing, an official from the National Institutes of Health said that before Gelsinger's death, researchers doing studies similar to the one that the University of Pennsylvania reported that there had been 39 adverse events, in layman's terms, 39 events where something went wrong with patients. But then after Gelsinger's death, researchers said there had in fact been 691 adverse events. The NIH spokeswoman said that's a clear violation of the rules and her agency will be doing an investigation -- Natalie.

ALLEN: Elizabeth Cohen in Washington. Thanks, Elizabeth.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com

  ArrowCLICK HERE FOR TODAY'S TOPICS AND GUESTS
ArrowCLICK HERE FOR CNN PROGRAM SCHEDULES
SEARCH CNN.com
Enter keyword(s)   go    help

Back to the top   © 2001 Cable News Network. All Rights Reserved.
Terms under which this service is provided to you.
Read our privacy guidelines.