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CNN Live At Daybreak

Government Puts a Halt to Human Research at Johns Hopkins Hospital

Aired July 20, 2001 - 08:09   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.
CAROL LIN, CNN ANCHOR: To Baltimore, fallout from the death of a research volunteer at one of the nation's top hospitals. The government cuts off the money, and CNN's Christy Feig reports on reaction to that.

Christy, this is not just any hospital. I mean, Johns Hopkins, which was named by "U.S. News and World Report" as the best hospital in America.

CHRISTY FEIG, CNN CORRESPONDENT: That's right, Carol.

The government has stopped not only that money, they have stopped all trials there involving human participants that receive that money. And this is something that's quite disturbing to Johns Hopkins medical institutions.

(BEGIN VIDEOTAPE)

(voice over): Hopkins officials were outraged at the news of their studies being suspended.

DR. EDWARD MILLER, JOHNS HOPKINS HOSPITAL: Patients that are receiving therapies come here for hope are not going to be able to receive that because of this issue.

FEIG: The suspension came after a U.S. Department of Health and Human Services review of a study volunteer's death revealed what government officials called broad systematic problems at Johns Hopkins medical institutions. Of particular concern were actions of the institutional review boards or IRBs.

In the letter to Hopkins, HHS listed the problems they found with the Hopkins system include, "IRB members and administrators indicate that no review takes place at convened meetings for most protocols." The letter continues, "Minutes of IRB meetings do not yet exist for 18 of the last 21 meetings dating back to October, 2000."

But Hopkins officials defended their institutional review boards.

MILLER: Our IRBs are excellent. The people that 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. FEIG: They also reiterated their history of safe research practices.

MILLER: We have done clinical trials for over 100 years here at Hopkins. We have had one death in all of these years in a human healthy volunteer.

FEIG: That was 24-year old Ellen Roche, a healthy volunteer in an asthma study when she died on June 2 less than a month after inhaling a drug called hexamethonium for the study. Hopkins has taken full responsibility for her death.

(END VIDEOTAPE)

FEIG: Now, the government says there are a few exceptions. They will allow any trial to continue if stopping it will endanger the life of the participant. As for privately funded research at Hopkins, that's not affected by this decision -- Carol.

LIN: Christy, as much as they defend their process there at Johns Hopkins, it still doesn't explain how a healthy 24-year old female went in and volunteered for a clinical trial and ended up dying? What do they say about that? What are some theories?

FEIG: Well, Carol, it was just earlier this week that they released the results of their internal investigation on this, and they still say they don't know exactly what the mechanism is. They don't know exactly why she died, but they do attribute it to that drug that she inhaled, because it was just within days of inhaling that drug that she started getting these symptoms that progressed and progressed and progressed and led to her to be hospitalized. And she died within a month of taking that drug, so they don't know exactly what caused her death. They do know that it's connected to that drug that she inhaled.

LIN: Yes, it will be interesting to find out how Johns Hopkins vets some of these volunteers in their health background. But in the meantime, if they lose -- temporarily lose this federal funding, how does that affect the research that's ongoing there now?

FEIG: Well, basically all the trials that are federally funded or receive any federal funds are stopped right now. They cannot enroll any more patients. They cannot continue with what they have. So everything has been basically put on hold. The officials said yesterday that they were sending out e-mails right and left to all of their doctors saying we have just received this letter, you know, tonight -- this was Thursday night -- and we cannot continue right now. Do not enroll any more patients. Do not continue. They are going to try and resolve it in three to four working days, but it's going to take a lot of work with the government to do that.

LIN: Do you know what Johns Hopkins is going to have to do to get their funding back?

FEIG: Well, there's a whole list of things that the government say that they needed to do. In fact, this started not just with the death of Ellen Roche. That was certainly the catalyst that triggered this. This originally started last October, when HHS officials visited Hopkins or at least looked over some of their stuff and said, "We have some problems with some of the things that are going on here."

Late December, Hopkins responded to that letter. They outlined what they were going to do to fix it. They said they had not heard anything from HHS for seven months until they came back to the campus this week, visited what happened with Ellen Roche and put out this announcement yesterday. And so they do have to do a lot of talking with government officials to find out what needs to go on, and they plan to do that.

LIN: You bet. All right.

Thank you very much, Christy Feig reporting in from Washington.

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