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NIH and FDA Announce New Clinical GuidelinesAired May 23, 2000 - 2:23 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: Clinical trials may bring new hope to patients who have exhausted all other forms of medical treatments. But they can also be very risky. The National Institutes of Health, and the Food and Drug Administration are announcing new guidelines today to increase patient safety.
CNN medical correspondent Eileen O'Connor joins us from Washington with more about this -- Eileen.
EILEEN O'CONNOR, CNN MEDICAL CORRESPONDENT: Well, Natalie, citing recent problems in several gene therapy trials, the Clinton administration is taking these measures and says it will: improve training of researchers and review boards; increase oversight to guarantee patients are informed of all risks; review monitoring plans, even for small, early phase trials; and develop new policies requiring that researchers' financial interests in the trials be disclosed to participants.
In addition, they're going to pursue legislation that would allow the FDA to impose civil fines for violations. The secretary of Health and Human services, Donna Shalala, says the measures are designed to reassure patients and the public about the integrity of the research.
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DONNA SHALALA, SECRETARY OF HEALTH AND HUMAN SERVICES: These clinical trials are going to be more numerous in the future, as more products come on line, and to continue this extraordinary effort that we've had in science, we need people to feel comfortable going into clinical trials. They're not at risk. We are strengthening the system, we're putting more protections in place, as we get more and more clinical trials and more complexity in those clinical trials.
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O'CONNOR: Gene therapy involves transferring a healthy gene into the cells of a patient to replace or repair genes that are causing disease. But to get past the body's defenses, the genetic material is delivered by way of a virus. It is the virus that most often causes illness, and in one case, death.
Some researchers say that only patients with no other hope should be allowed into these trials and that even these latest measures are not enough to ensure safety. But those suffering from diseases that could benefit from the development of gene therapy disagree, saying a moratorium would hurt more patients more than it would help -- Natalie.
ALLEN: All right, Eileen O'Connor in Washington, thanks.
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