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American Morning

Interview with Dawanna Robertson, 'Time's' Michael Lemonick

Aired April 15, 2002 - 07:21   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.
JACK CAFFERTY, CNN ANCHOR: Clinical trials of new drugs can offer hope, and in some cases the prospect of a medical breakthrough. But the current issue of "Time" magazine points to some potentially fatal flaws in our nation's clinical trial system. For those who participate, the risks can outweigh the benefits.

Joining us with more now from Princeton, New Jersey is Michael Lemonick. He is the co-author of the "Time" cover story on this subject. And from Tulsa, Oklahoma, Dawanna Robertson, who took part in a clinical trial that turned into a living nightmare -- welcome both of you to AMERICAN MORNING.

Michael, let me start with you. Based on the reporting you did for this story, would you volunteer to participate in a clinical trial of a new drug?

MICHAEL LEMONICK, "TIME": I might, but I would look very carefully at the consent form that I signed. I would ask questions about the safety of the trial and exactly what they were trying to do.

CAFFERTY: Tell us a little about what's wrong with the system. Obviously people, at least in some cases, sign up for these trials out of desperation. They have been diagnosed with a fatal illness. They are seeking some sort of, you know, treatment that might work as a court of last resort. Are they misled? Is there enough regulation? Where is the system broken?

LEMONICK: They are usually not misled. I want to emphasize that most clinical trials are pretty safe and pretty responsibly done. The problem is that the oversight, the regulatory system that we have in place is very, very inadequate. So those few cases where the trial isn't done carefully, where the doctor has maybe a financial interest in the drug or just a belief that he or she has invented some great new medicine outweighs the responsibility to be careful with patients.

CAFFERTY: Is it something that in your opinion, based again on your reporting on your story, that it is manageable, that it's fixable, and if so, how? You know, it's a huge process. The drug companies have numerous products undergoing all kinds of testing. There are several phases for these things. The approval process can be complex. How do you provide adequate oversight of all of this?

LEMONICK: Well, what you really have to do is fund the oversight agency so that, for example, today -- first of all, we don't even know how many clinical trials there are. There are so many different overlapping oversight boards. The other thing is that those regulatory agencies that do exist are under funded, so you've got two or three inspectors for the entire country overseeing hundreds, in fact, thousands of clinical trials with hundreds of thousands of patients.

CAFFERTY: All right. You mention that the vast majority of these tests are fine. They are above board. They are responsibly done. They are, you know -- et cetera. Nevertheless, we've got a full screen that I want to throw up here. And we'll just run over if people watching the program are thinking about perhaps participating in one of these things that they should do before making a decision to go ahead. And if we can put that up and, you know, people might want to make note of this.

But you can run through these for us. What's the purpose? Know the risks, et cetera.

LEMONICK: Right. I mean, knowing what the purpose of the trial is really important, if you are suffering from a disease, for example, and this is a phase I clinical trial to establish the safety of a new medicine.

CAFFERTY: All right.

LEMONICK: That means they don't even know whether the medicine is effective. They are just trying to find out if it's going to hurt people. And only after that, do they go at a trial to test the effectiveness. So you have no idea really whether the drug is going to help you if you have a serious medical condition.

CAFFERTY: All right. Michael, I am told that we are about to lose the satellite to Princeton, New Jersey, so I am going to have to say goodbye to you and recommend to the people watching the program that they check out the "Time" magazine cover story. Michael Lemonick is the reporter.

I want to switch now to Dawanna Robertson who joins us from Tulsa, Oklahoma, and she is an example of clinical trials gone awry -- good morning to you and welcome. Tell me a little bit about what happened in your case. You got pregnant, among other things, partly through this thing, right?

DAWANNA ROBERTSON, FORMER CLINICAL TRIAL PARTICIPANT: Correct.

CAFFERTY: And what happened then? You went to the doctor conducting the test, said I am pregnant, what happened from that point forward?

ROBERTSON: When I told Dr. McGill (ph) I was pregnant, the exact same day he gave me my injection. He told me there was minimal harm, that it would not reach the fetus, because she would be protected by the placenta. After I went home, I started having severe side effects. Swelling, my throat had swollen up so I couldn't swallow. I couldn't breathe. I had rashes on my arm. My arm went numb. Vomiting -- it was like a bad case of the flu, depression set in. I just -- my hair started to fall out.

CAFFERTY: And you originally had signed up for the trial because of a melanoma condition that you had. Do you still have the melanoma?

ROBERTSON: Yes.

CAFFERTY: So it obviously didn't cure the disease. What about the baby?

ROBERTSON: We believe that she had some problems with her immune system. I have two other children, and she seems to be a little bit more sickly than them. She always has an ear infection, a runny nose, a cough. I believe that she is underweight. She is only about 24 pounds, and she is two-and-a-half years old.

CAFFERTY: Obviously based on what you have been through, if somebody called you tomorrow and said, would you like to sign up for a clinical trial, I bet I know the answer.

ROBERTSON: No.

CAFFERTY: All right. Dawanna, we've got to run. Thank you very much for being with us this morning.

ROBERSON: Thank you.

CAFFERTY: And good luck to you -- hope it works out well for you and your baby.

ROBERTSON: Thank you.

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