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Breaking News

U.S. Government Announces Crackdown on Gene Therapy Experiments

Aired May 23, 2000 - 12:00 p.m. ET

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

JEANNE MESERVE, CNN ANCHOR: The U.S. government has announced a new crackdown on gene therapy experiments.

CNN medical correspondent Eileen O'Connor joins us with the latest.

Eileen, what are they proposing and why?

EILEEN O'CONNOR, CNN MEDICAL CORRESPONDENT: Well, they are proposing to have new regulation -- not -- a strengthening of current regulations and a strengthening of training for investigators, also for a more independent overview of independent review boards at institutions -- research institutions. They will also monitor and audit some informed consent.

Right now, there's been a problem where investigators are also sponsoring trials, especially in the gene therapy area, where a clinical investigator actually has a financial interest in the drugs or the viruses that they are using.

So what HHS and the FDA want to do is put institutions on notice that they are also responsible for what their investigators do. And, in fact, they're going to go to Congress and actually ask to be able to impose civil fines -- $25,000 for an investigator and up to $1 million per institution.

Donna Shalala says -- the secretary of health and human services -- says that this is all about protecting patient safety and also about reassuring patients that clinical trials, very important for science, are safe.

(BEGIN VIDEO CLIP)

DONNA SHALALA, HHS SECRETARY: These clinical trials are going to be more numerous in the future as more products come online. 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're 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.

(END VIDEO CLIP) O'CONNOR: In fact, one of the things that the FDA is already doing is they are actually looking at the investigative new drug applications, something they haven't really done before, doing on-site inspections of those just to make sure that the clinical trials, the gene therapy trials, are following all the regulations from the very beginning -- Jeanne.

MESERVE: Eileen O'Connor, thanks so much for this breaking story.

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