Teenager's Death Prompts Calls For Safeguards Review in Gene Therapy TrialsAired March 10, 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: The death of a teenager in a gene therapy experiment last year and the criticism following it are prompting calls for a review of the safeguards used in selecting patients for such trials. But at what expense?
CNN's Eileen O'Connor has the story.
EILEEN O'CONNOR, CNN MEDICAL CORRESPONDENT (voice-over): Nine- year-old Connor Coyne (ph) has hemophilia, a clotting disorder that means the slightest fall from his bike could mean severe bleeding. A shot every other day of a compound called "clotting factor" helps prevent such bleeds at a cost of $100,000 a year.
His father, Michael Coyne, a doctor, is counting on a cure and says it all depends on the continuation of gene therapy trials despite news of previously unreported complication and the death of one teenager.
DR. MICHAEL COYNE, BERKSHIRE MEDICAL CTR., NATL. HEMOPHILIA FDN.: I consider those isolated and unfortunate instances that shouldn't hold back the progress of science and the hopes for thousands and hundreds of thousands of individuals.
O'CONNOR: Gene therapy involves repairing or replacing the damaged or missing genes by inserting healthy ones into specific cells in the body. Trouble is, the gene has to get past the cell's natural defenses, so scientists attach it to things like cold viruses that are good at getting past those defenses and into the cell. The viruses, though, can make a patient sick; in the case of 19-year-old Jesse Gelsinger, so sick his organs shut down. He died during a gene therapy trial.
Gelsinger's father has been lobbying Congress and the National Institutes of Health to review safeguards. And with only limited success thus far, some critics say these trials should be suspended, or use only terminally ill patients as test subjects.
JEREMY RIFKIN, FOUNDATION ON ECONOMIC TRENDS: We still don't know what these viral vectors will do. We haven't cured a single patient. So it seems to me, at this point in time, it would be irresponsible for the NIH not to impose a moratorium. O'CONNOR: Instead of a moratorium, the FTA is increasing safety monitoring and demanding more independent oversight of gene therapy trials.
As a physician, Michael Coyne likens it to the risks incured in the development of bone marrow transplants; risks that he believes are worth it.
COYNE: I look forward to the day when gene therapy will provide a cure for Connor and many others like him.
Eileen O'Connor, CNN, Washington.
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