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American Morning

Government Suspends Federally Funded Research at Johns Hopkins

Aired July 20, 2001 - 11:30   ET

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

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
LEON HARRIS, CNN ANCHOR: The government is suspending federally funded human medical experiments at Johns Hopkins University. This is a serious blow to this prestigious Baltimore school. This move follows the death of a healthy volunteer during an asthma study.

Our medical news correspondent Christy Feig joins us from our Washington bureau with more on this -- Christy.

CHRISTY FEIG, CNN MEDICAL CORRESPONDENT: Good morning, Leon.

This move by the government comes just days after Hopkins officials held a press conference in Baltimore detailing what they found went wrong in a study that left a 24-year-old healthy volunteer dead. Now, the decision does not stop the funding of these trials, it actually stops the trials themselves. All the trials that receive federal funds at Johns Hopkins are stopped for right now.

It's the Office of Human Research Protections at HHS that did this. They are the ones that oversee all federal-funded trials and make sure that humans in those trials are being safely protected. And they wrote a letter to Hopkins detailing the concerns that they had. Most of them had to do with the institutional review board.

Now, this is a term that you hear tossed around a lot as this story is being told, but it's important to understand what the institutional review board does. It is the place that every institution that runs clinical trials has; and this institutional review board is the one that first approves these trials, and then oversees these trials and makes sure that they're done right.

So when the HHS Office found a lot of problems in the institutional review board, that was a big red flag. Some of the problems were things like, you know, there weren't meetings -- there weren't minutes from many of the meetings that they were discussing some of these studies. And they were really afraid that maybe some of these studies weren't getting adequate review.

(BEGIN VIDEO CLIP)

DR. EDWARD MILLER, JOHNS HOPKINS HOSPITAL: What they have said in their release, anyway, makes it sound like there aren't people reviewing this -- that these are paper reviews. Everybody on the IRB -- every member of the IRB sees that and discusses that at the meetings. So it's a very thorough review of these. Our IRBs are excellent. The people who are on it are excellent. They do a very good job. And to make it sound like we are not reviewing these things, I don't understand where they're coming from.

(END VIDEO CLIP)

FEIG: Now, although the death of 24-year-old Ellen Roche was the catalyst that prompted this, there's been kind of a trend across the country from the government towards clinical trials and institutional review boards ever since the death of Jesse Gelsinger. You'll remember he was in the clinical trial with gene therapy in Pennsylvania. He died in 1999.

And ever since then there's kind of been an increased scrutiny of clinical trials and institution review boards. They're really cracking down to make sure the right things are happening there.

We talked to someone today that said, you know, this may be just a little bit of precedent setting with Hopkins. But if there's problems at Hopkins, one of the top institutions in the country, there's problems across the country -- Leon.

HARRIS: Well Christy, is there universal agreement that this is the correct step to take, or is there any thinking at all that this may be overkill here?

FEIG: Well, it depends who you ask on that. Both sides have two different answers to that question. A lot of people say that this is, you know, a little bit of overkill; that there was one healthy volunteer who died here. But Hopkins officials yesterday said, this comes back from an investigation that started late last October. HHS officials did a review then of some of the institutional review boards. They sent a letter to Hopkins at that time. Hopkins officials answered their questions in late December, and then Hopkins officials say they did not hear anything back from HHS until this week.

HARRIS: Interesting. Christy Feig in Washington, thank you very much.

Well, let's talk about what the federal government's decision may mean for patients in the real world. Carolyn Aldige is president of the Cancer Research Foundation of America, and she is also in our Washington bureau.

Good morning to you. What's your thoughts about this? I want to ask you the same question I just asked Christy. Is -- in your mind, is this overkill, to go ahead and shut down everything this way, or was this the proper move to make?

CAROLYN ALDIGE, CANCER RESEARCH FOUNDATION OF AMERICA: Good morning, Leon.

I believe that this is actually overkill. I would compare it to shutting down an airline because one passenger, sadly, died of what we call economy class syndrome. We didn't shut down that airline, and I don't believe we should shut down the entire research enterprise as Johns Hopkins. It is a very fine research institution; highly regarded. The best hospital in the country year after year in certain surveys.

Clinical research is imperative for bringing new treatments and new preventatives for disease to patients. And if we shut down a research enterprise such as the one at Hopkins it will take years to recreate that enterprise.

HARRIS: All right, so what will be lost then, in this case?

ALDIGE: What will be lost will be the ability to monitor the patients who are already on trials. What will be lost will be the possibility of a breakthrough treatment for cancer. We just experienced that with the approval by the FDA, in record time, of a particular drug to treat a certain kind of leukemia. This is just exciting, wonderful new technology, and brings us great hope for the future for cancer and a host of other diseases.

HARRIS: Let me ask you about that, then. In your mind, then, are you sure that there is something, perhaps, that could be, right now, on the threshold that may be in jeopardy?

ALDIGE: Oh, absolutely. I believe there are many new treatments and preventatives for cancer patients and other kinds of patient -- patients who have other life threatening diseases that very much may be in jeopardy if clinical research is, in fact, impeded.

I think there has to be appropriate monitoring. No one would argue with that. But I think that we need to go in and take a careful look, perhaps there need to be tightened-up procedures at Hopkins and any number of other institutions. But I just don't believe we should shut down the entire research enterprise at any institution.

HARRIS: Now, I know you can't speak for all the other foundations that may be doing work there, but for the Cancer Research Foundation, do you have any other recourse, or is there any other plan of action to enact now that this is actually happening?

ALDIGE: We support research all over the country, and we are satisfied -- our scientific review panel is satisfied that appropriate monitoring procedures are in place when human subjects are used.

HARRIS: Were you consulted at all in this?

ALDIGE: We respect to this particular case, no. This was completely unrelated to the field we are in, which is cancer, and specifically cancer prevention.

HARRIS: No, I just mean in the shutdown of all of the operations, period.

ALDIGE: No; no we were not. This was an HHS decision, and I don't believe they go out and consult with patient advocacy groups before they do this.

HARRIS: All right, Carolyn Aldige, we thank you very much for your time. We'll be following this story as it develops.

ALDIGE: Thank you.

HARRIS: We hope the future's not quite that dire.

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