Announcer:
Good evening, ladies and gentlemen, and welcome to The Advocates, the PBS Fight of the Week. Tonight's debate is coming to you from Boston's historic Faneuil Hall.
Semerjian:
Ladies and gentlemen, may I have your attention, please.
Announcer:
Moderator Evan Semerjian has just called tonight's meeting to order.
Semerjian:
Good evening, ladies and gentlemen, and welcome to The Advocates. Tonight we look at the ethical problems of medical experiments on human subjects and whether certain groups in our society are, by virtue of their circumstances, less appropriate than others. Tonight we focus on one of those groups, prisoners. And our specific question is this: Should all medical experiments on prisoners be banned? Advocate Tom Bourdeaux says, "yes."
Bourdeaux:
Tonight we'll be discussing a subject that most of us don't know much about. Medical experimentation is conducted in prisons with prisoners in programs that are voluntary in name only. My witnesses are William McCue, a former prison inmate, and Jessica Mitford, author.
Semerjian:
Advocate Crawford Morris says, "no."
Morris:
The abuses to which prisoners are put in human experimentation are extremely rare. The real important problem that we face tonight is whether suffering and disease will ever be cured if we banned experimentation. My witnesses tonight are Dr. John Arnold, Director of the Harry S. Truman Laboratory in Kansas City, and Dr. Monroe Trout, Vice President of the Sterling Drug Company.
Semerjian:
Thank you. I'd like to take this opportunity to welcome back Thomas Bourdeaux for his second appearance on The Advocates. He's an attorney from Meridian, Mississippi. I'd also like to welcome Crawford Morris, who's making his first appearance with us tonight. He's an attorney from Cleveland who has specialized in medicine and the law. We'll be back to these gentlemen for their cases in a moment, but first a word of background on tonight's question.
The issue of conducting medical experiments on prisoners arises most often in connection with the legal requirement that all new drugs be demonstrated both safe and effective before they're permitted to be sold to the consumer. The Federal Food and Drug Administration requires that all new drugs must be tested on healthy human beings to determine possible harmful side effects. This is called Phase I Testing. At present almost 90% of all such medical testing is done on prisoners who volunteer for the experiments and who are paid for taking part in them. Medical students are the main source of volunteers for the remaining 10% of these experiments. The vast majority of medical testing on prisoners involves little or no risk to the health or comfort of the volunteers, but there are experiments which necessarily do carry risks, and disabilities and in rare instances death have resulted. Elimination of all risk is not a possibility, and because risk must be present, the issue of why and under what circumstances prisoners volunteer has become a central one. Critics of the use of prisoners for such experiments argue that the concept of prisoner-volunteer is a contradiction in terms. They have called for an end, therefore, to all medical experiments on prisoners. And now to the cases. Mr. Bourdeaux, why should all medical experiments on prisoners be banned?
Bourdeaux:
Prisoners tell us that they have one overriding concern, and that is to get out. We believe that in considering the prison environment in its totality an inmate can't mentally or legally give the free and voluntary consent that all agree is essential to medical experimentation with the human body. The very nature of prison confinement, the atmosphere of physical and psychological oppression serve to render the prisoner often incapable of making that value judgment before submitting his body to the rigors of unknown results of medical testing. Necessarily, the prisoner is forced to submit to an authority almost absolute during the period of his sentence, and to gain any relief from this sorry state, he submits his body to things that he would not even consider doing if he were on the outside. Therefore all medical experiments in prisons should be banned. To tell something about life in prison and medical experimentation, I call as my first witness William McCue.
Semerjian:
Mr. McCue, welcome to The Advocates.
McCue:
Thank you.
Bourdeaux:
Mr. McCue served eleven years as a prison inmate, but now he is Drug Treatment Coordinator for the Massachusetts State Prisons. Mr. McCue, what is the main concern of a prisoner?
McCue:
I would say from day one that it's to get out of prison.
Bourdeaux:
He has other concerns. What are some of those?
McCue:
The other concerns are to try to survive in the prison, to try to live as comfortably as possible, and to get some of the amenities that he was accustomed to having on the outside.
Bourdeaux:
Well, what is it about prison life that makes a prisoner willing to let his body become a test tube, to become a guinea pig?
McCue:
Well, first of all I would say that the majority of prisoners are people who come from low income neighborhoods, welfare kinds of children, people who don't have means to have money in prison. Little known fact is that there's nothing in prison that's given away except an issue of clothes and three meals a day and . . .
Bourdeaux:
Is money paid to prisoners who participate in these drug programs?
McCue:
After a prisoner is in prison for two or three months, he's classified, given a job, and can make up to fifty cents a day in these prisons, and therefore in the meantime, the first three months, he would do probably anything to get a dollar to buy cigarettes or candy or ice cream.
Bourdeaux:
Well, money is given to prisoners to participate in the drug programs.
McCue:
You're talking about drug experimentation?
Bourdeaux:
Right.
McCue:
I'm aware of that fact, right.
Bourdeaux:
All right. Now, do these testers offer to the prisoner a chance of parole if they participate?
McCue:
Not in Massachusetts. There's no direct promise of parole, hut I think that every inmate—even myself, I can remember hoping for a hurricane to blow the walls down, so I could get out of there—and if undergoing, or submitting yourself to an experiment, even to the point of a terminal disease, there's always the hope that that's going to make you look good and you're going to get out sooner.
Bourdeaux:
Well, are the experiments conducted in the cell block, or is the prisoner removed to some other place, and is this a factor?
McCue:
I think the HEW guidelines require that the persons who are undergoing research, the subjects have to be kept in an area where they can be observed, so that they are confined in one area.
Bourdeaux:
Well, is their condition of living better in the area where the testing is going on than it is in the cell block?
McCue:
Well, in the case of Norfolk Prison, for example, all of this is done in a hospital—we have an accredited hospital—and therefore these people live in the hospital; the conditions are better, they eat better, they have more amenities, they have a chance to look at a nurse once in a while.
Bourdeaux:
What does that do to the space in the hospital for other prisoners that might need it for illness?
McCue:
It's my observation that it deprives prisoners around the prison system from getting medical care. We have a lot of sick and injured people in the other prisons who cannot get to Norfolk for the proper medical care because the second floor of the hospital is taken up by this research project.
Bourdeaux:
Is part of your work with the Massachusetts prisons—are you familiar with the Concord prison?
McCue:
I am.
Bourdeaux:
Is the drug program going on there? Have they one going on there that you're familiar with?
Semerjian:
The Concord prison you're talking about, one in Concord, Massachusetts, is that right?
Bourdeaux:
Yes.
McCue:
We're talking about the Youthful Offenders Prison in Concord where the age grouping is eighteen to twenty-four years old. When you say drug program, I'd like to correct that. We're talking about drug experiment. We have drug programs that are trying to deal with the fact that we have a very high population of drug offenders.
Bourdeaux:
We're talking about testing, experimenting with drugs, at the instance of drug companies and so forth.
McCue:
At the present time there is no drug experiment going and only because some observant people caught a private brokerage firm going into—and I feel that somebody got paid off, I'll say this straight out—to go by all of the different committees, the Shattuck Committee and the Protocol Committees, and almost got this study on Clobizan going there. I'd like to mention that 77% of the inmates at the Concord Reformatory are there either as a direct or indirect result of drug abuse. They are there, they were convicted for using drugs illegally for no medicinal reason, and yet we were prepared to use the same kind of drug, a psychotropic drug, on these inmates for money, and I think that's very hypocritical.
Semerjian:
All right, let's go to Mr. Morris for cross-examination.
Morris:
Mr. McCue, when we develop drugs that really do help, like vaccines for poliomyelitis and some day a cure for cancer, that benefits everybody that possibly can come within the range of that disease, isn't that so?
McCue:
I would say so.
Morris:
And if prisoners come in the range of this disease, it benefits the prisoners too.
McCue:
I would say so.
Morris:
And why is it that you don't want the prisoners to volunteer to help us to develop these drugs which will benefit them eventually if they should come into the range?
McCue:
First of all, I don't think it's volunteerism. There is always the onus of force and coercion. There is no free consent in prison, and I'm talking about the prisons within walls. We have other prisons without walls, and I think people have freer choice there, but we don't do experiments there.
Morris:
Do you think it's fair that a prisoner should not have to take some of the experimentation trials and yet be able to get the benefits of that, whereas everybody out in society who's going to have to fill that gap and go through the experimentation, they have to do that if they want the benefits?
McCue:
The last word that I have from the inmates, as far as speaking for them, is that they would much rather that some research be done on why they're there, not on things that are not relevant to them at the present time.
Morris:
You're familiar, are you not, with some of the drugs that have been developed? Are you familiar with the fact that the drug company—one of the drug companies—developed a drug called Chloroquisine, an anti-malaria drug, and they developed this by testing on prisoners.
McCue:
Yes, prisoners and conscientious objectors during the Second World War. I don't approve of that.
Morris:
All right, and are you familiar with the fact that this drug company, every time it makes it, does so at a financial loss to itself, and it has flown it free out to drug addicts who got malaria from dirty needles in California and flew it free down to the South where a Viet Nam veteran was dying of cerebral malaria and this drug saved his life?
McCue:
Let me say that there are roughly 400,000 prisoners . . .
Morris:
Answer my question: are you aware of that?
McCue:
I'm not aware of that, no.
Morris:
All right. How about the—your particular sphere is the drug abuse part of it, is it? You deal with the people with drug abuse?
McCue:
I represent all . . .
Morris:
Drug addicts that are trying to get cured?
McCue:
I represent all the prisoners.
Morris:
All right. Now, how about the heroine-blocking drugs that have been developed—Methadone and Cyclizine? They were developed by experimentation on prisoners, and they are used to try and help prisoners to try and get over their habit, isn't this so?
McCue:
That's not so. That's a medical opinion that's widely disagreed with. I don't see that Methadone is any better or different than heroin.
Semerjian:
Mr. McCue, let me ask you this to clarify it. Let me ask you this to clarify something. Are you saying that there aren't any prisoners who would volunteer for, or would make it a free choice in these experiments?
McCue:
The only people in prisons who volunteer are people who have no means. We have Mafia types in prison who don't need to submit to this. They have plenty of bread. We have other prisoners who come from wealthy families who don't volunteer. It's always the Spanish, the black and the low income prisoner who has no means to buy toothpaste, candy and cigarettes. We have prisoners who submit to homosexuality merely to get a candy bar or a sandwich or a pack of cigarettes.
Semerjian:
What if you put it to a vote tonight with all prisoners in the country as to whether or not prisoners should be permitted to participate in experiments? What do you think the vote would be?
McCue:
I would say that the vote, being honest, I think it would be split in half.
Semerjian:
Fifty-fifty.
McCue:
I would say, approximately.
Semerjian:
Go ahead, Mr. Morris.
Morris:
Yes. In that regard, the prisoners themselves really do want this right to experiment.
McCue:
I did not say that. I'd like to also say that only 8% of prison populations have a high school education, and that only .14 have a college degree.
Morris:
Are you familiar with, Mr. McCue, with the Lancaster experiment down in the Lancaster County Prison, where they temporarily suspended all medical experimentation, and 60% of the prisoners wrote in and said that—wrote letters to the prison officials and said that—they wanted it, and nobody said they didn't want it? Are you familiar with that?
McCue:
I'm not familiar with that, but in response to that, let me say that I know a lot of prisoners who would like to have Dr. Leary come back and do that LSD experiment again that they did at Concord Reformatory.
Morris:
Yes, but that's beside the point of my question. How about the Connecticut experiment where the Connecticut Correctional Department temporarily suspended it and they had hundreds of prisoners write in and say, "Please start up the experimentation again," and no one wrote in and said no?
McCue:
Probably because Connecticut also pays $25 a day for a man's labor.
Semerjian:
All right, let's go back to Mr. Bourdeaux.
Bourdeaux:
Mr. McCue, you know, of course, that 90% of all drug testing is done in prison, do you not?
McCue:
I just learned that now, and it seemed awful high to me.
Bourdeaux:
Yes, sir. But this cancer cure that Mr. Morris is going to find one of these days is going to be to the benefit of everybody, isn't it?
McCue:
Hopefully, it would be one for the cervical cancer as a result of the morning after pill that research came up with.
Bourdeaux:
All right. Would you agree that everybody ought to participate in testing if they're going to benefit from the cure?
McCue:
I don't necessarily go along with that. All prisoners will hit the streets eventually, and if they want to do it then, that's certainly their choice.
Semerjian:
Okay, Mr. Morris, let's come back to you.
Morris:
Are you willing to let the prisoners decide whether or not they want to have this experimentation on their prisoners by a popular vote in your prison?
McCue:
Based on the knowledge that I have from the inmates, I'd be willing to do that tomorrow morning.
Morris:
You would.
McCue:
I would.
Morris:
And you know it's a fact, don't you, from all of the studies from all over the country that when they do have that right to choose, the great majority of them want this.
McCue:
I'm saying that in the Massachusetts prisons tomorrow I would be willing to take that vote, and I feel confident of what it will be.
Morris:
Well, isn't it a fact that more than half of them do?
McCue:
I don't think it's a fact. I don't think that has been substantiated.
Morris:
You've talked about the coercion among the various prisoners, but we all have coercion in life, we're all prisoners of life, are we not?
McCue:
I would say that some of us in a better circumstance than others.
Morris:
Yes, but nobody's free. Everybody has a coercive factor: he has dependents if he's working, he has children...
Semerjian:
I'm going to have to interrupt. Mr. McCue, I want to thank you very much for being with us tonight. Thank you.
Bourdeaux:
I call as my next witness Jessica Mitford.
Semerjian:
Miss Mitford, welcome to The Advocates.
Bourdeaux:
Jessica Mitford is a noted author. Her latest book is on prisons, and it's entitled Kind and Usual Punishment. Miss Mitford, you have a chapter in your book on drug experimentation in prisons called "Cheaper than Chimpanzees." How did you get interested in drug experimentation programs and other medical experimentation programs in prisons?
Mitford:
Well, as a matter of fact, I ran onto that very much by accident. These experiments were carried out in deepest secrecy. They're very much shrouded from the general public, the fact that this goes on, has been shrouded. I found, for example, in California, where I did most of the research on this, that even very knowledgeable people in the State Legislature were unaware of what was going on in Vacaville Prison right under their nose.
Bourdeaux:
What did you find out was going on in Vacaville Prison when you went there to do research on your book?
Mitford:
Well, to my astonishment, I discovered that this organization with a rather high-sounding name of Solano Institute for Medical and Psychiatric Research, called SIMPR for short and that this organization is a conduit with headquarters within the prison itself for research grants from the giant drug companies that go through medical investigators and work entirely on the bodies of prisoners.
Bourdeaux:
Well, what was SIMPR doing in Vacaville?
Mitford:
That's what I should like to know. In other words, Vacaville is a state prison, and this is called a non-profit organization. When you start looking a tiny bit into it, it's so for profit that you . . .
Bourdeaux:
Was it conducting any experimentation programs in Vacaville?
Mitford:
It exists entirely as a conduit for the drug company experimentation programs on prisoners in Vacaville.
Bourdeaux:
Did you discover any effects of any of the experiments in Vacaville on the prisoners?
Mitford:
Well, I was able to discover a few things that went on there. You've got to understand that it's jolly difficult to learn anything about what goes on in prison. Prison is a very secret place. But I did find out one or two things, and these again—you only learn these things more or less almost by accident. I guess that one of them that struck me came to my attention as a consequence of a lawsuit that was filed by a prisoner who almost died as a result of having a drug called Varidase injected into him. This was an experiment carried out for the Lederle Drug Company.
Bourdeaux:
Well, aren't there supposed to be some safeguards, somebody that oversees these programs?
Mitford:
Precisely.
Bourdeaux:
Did you look into that?
Mitford:
I did. There is . . .
Bourdeaux:
And what did you find out?
Mitford:
I found out that the University of California, the Chancellor of the University of California some years ago established a committee which sounds on paper like the perfect idea to safeguard all subjects, all human subjects, of medical experiments.
Bourdeaux:
Did you appear before that committee?
Mitford:
I went and had a meeting with them, yes.
Bourdeaux:
And what did they tell you about the Varidase program?
Mitford:
They told me that none of these Vacaville experiments—that Varidase and dozens of others that are going on today in Vacaville—none of these have been brought to their attention in spite of the fact that the experimenters, the doctors doing it, are on their own staff at the University Medical Center.
Bourdeaux:
And after you found out what was going on at Vacaville, did you look around for other prisons to see where there was medical experimentation going on? I have particular reference to the state of Iowa. What did you find out there?
Mitford:
Well, in the state of Iowa, for example, a few years ago a number of black convicts were taken out of the prison and into the hospitals on this alleged informed consent, and we were talking about informed consent and volunteering: I just wonder if these prisoners were told what was going to happen to them.
Bourdeaux:
In other words, the rule is that a prisoner has got to be informed as to what is going to happen to him, he has got to consent to it freely and voluntarily, is that it?
Mitford:
That's right. He's supposed to know what the likely consequences will be.
Bourdeaux:
All right. What were they doing in Iowa?
Mitford:
What they were doing was to deliberately cause these prisoners to have scurvy by the simple expedient of withdrawing Vitamin C, which I guess Columbus would probably have known about. I mean, the causes and cure of scurvy have been known for many, many hundreds of years. However, what happened to these men predictably was that they got intensely ill, agonizingly ill. I showed the medical article that was written about this experiment to the man who's the head of the Department of Nutritional Science at the University of California, and he said that the likely consequences to these people would have been that they could have easily suffered cardiac arrest. In fact, in the experiment itself, in the description, the doctor who did it described how their hair fell out, their teeth fell out, one man became unable to walk, they suffered terrible, agonizing swellings and pains.
Bourdeaux:
Well, after . . .
Semerjian:
Okay, I'm going to have to interrupt. Mr. Morris is eager to ask you some questions.
Mitford:
Sorry.
Semerjian:
And here he comes.
Morris:
Miss Mitford, you've told this audience about these horror stories that I call them, these examples that you've just gone through, Vacaville and all the rest, and I noticed that those are also in your article in the Atlantic Monthly and which is a chapter in your book. But these really are the exceptions to the rule, are they not?
Mitford:
I have no way of knowing that because I'll tell you why. As I said, it's really extremely hard, since the experiments are carried on in secrecy, since the—well, there are several reasons for the secrecy. In the first place, the drug companies . . .
Morris:
Let me interrupt at this point. There's no secrecy about the medical literature which you have a chance to read, as we all do, and it's full of all of this. Have you reviewed the medical literature?
Mitford:
Well, I've just told you some of the articles I read, like the one about the scurvy experiment, for example. What I wanted to say was, though, that the secrecy has a very great bearing on it. For example,
Morris:
Well, wait a minute, let's go to my question or we'll never get through.
Mitford:
Let me just explain this. Well, if I can explain my answer.
Semerjian:
Well, make it a very brief answer, Miss Mitford.
Mitford:
All right, it was merely this, that in the Varidase case, for example, the case of that experiment, the only reason it came to light at all was that a lawsuit was filed.
Morris:
You said that before.
Mitford:
Otherwise nobody would have known.
Morris:
Yes, you said that before, but let me ask you this. In the ten year period you studied in your article you only talk about seven cases, and those seven cases, none of them involve the problem that we're here with today. Some of them didn't involve prisoners, some of them didn't involve any testing, and it was only one that involved Phase I testing of drugs . . .
Mitford:
Excuse me, you're mistaken about that. You're mistaken in saying that only some of them involve prisoners. This is all.
Morris:
I say some did not involve prisoners. Isn't that right?
Mitford:
No, that's not right.
Morris:
Now, how about this? In the ten year period where you found seven of these horror stories, in that period of time over 120,000 prisoners were tested on Phase I testing and there weren't any deaths and there weren't any serious side effects, isn't that so?
Mitford:
Well, wait, it doesn't really ... Nobody knows that, you see. I don't know whether you could state that, but, for example, in the sixties . . .
Morris:
I don't state it, but Mr. Stetler it, and he testified with you before Senator Kennedy, isn't that a fact?
Mitford:
That's true, but in the sixties, for instance, the late sixties, a New York Times reporter discovered that—and again, he wasn't able to determine the number of actual deaths, but—numerous deaths and enormous amounts of illness in three or four southern states that occurred as the consequence of this drug testing.
Morris:
If you do the mathematics of this, it comes out that your horror stories are about one-tenth of a whole percent, which is just infinitesimal.
Mitford:
Well, I don't quite agree with this, but I'll tell you why: because, you see, all I—I only lifted a tiny corner of that rug . . .
Morris:
Well, but let's . . .
Mitford:
I just found out these few little things. I'm hoping in fact that Senator Kennedy's committee, that large, metropolitan newspapers and so on with far more resources than I, will start taking up where I left off.
Morris:
Yes, but if it is true, if it is true, that it's just an infinitesimally small amount, these horror stories, you don't want to throw the baby out with the bath, do you? You don't want to stop research because there have been one or two abuses?
Mitford:
But you're the one who is saying there are only a tiny few, and I'm saying that I don't believe you know.
Morris:
Well, I'm saying . . .
Mitford:
Unless you . . .
Morris:
... that I only know what the medical literature shows.
Mitford:
Yes.
Morris:
I only know what the medical literature shows, but you admit you don't know at all because you haven't looked into the medical literature. Let me ask you this: can you name a single prison where a substantial number of the prisoners have voted to stop experimentation in their prison?
Mitford:
I don't believe that prisoners are usually called upon to vote about anything in their conditions of life.
Morris:
Well. There are two answers to that: one that the medical literature is just full—and I've got it all here, hut we don't have the time to go through it—but the medical literature is just full of the prisoners voting and telling about the results of their votes and how they do want this. Now, let me go to another source if you don't want to take that. You're familiar with the Associated Press survey they made recently, when they went out and studied the prisoners, and you're familiar with that and what they said, and I'll quote it: "In the overwhelming majority of cases researchers and the institutions for which they work are reputable and keenly aware of the need to protect their subjects." Now, that's what they said after they made the interview.
Mitford:
Well, okay. May I give a little answer to that then? I think it is not reputable, for example, for the medical researchers to require the prisoners to sign an illegal and fraudulent waiver of their rights, and this is routinely done. I found this in every prison where I looked into the thing. In other words, the prisoner is forced to sign a paper saying that he waives the right to sue if any injuries should result.
Semerjian:
What do you mean he's forced?
Mitford:
Well, in other words, he cannot participate in the experiment unless he will sign this waiver.
Semerjian:
Well, that happens to anyone who is in an experiment, isn't that right?
Mitford:
No, no. In fact, it's against the law. It's illegal, it's against FDA regulations, having the force of law. It is also fraudulent because it's invalid. You cannot, you or I or a prisoner, cannot sign away those rights.
Semerjian:
Now, let's go back to Mr. Bourdeaux.
Mitford:
Yes.
Bourdeaux:
Miss Mitford, Mr. Morris was asking you about looking into this thing a little more. Didn't you go to the Food and Drug Administration which is supposed to pass on these tests to try to find out some facts?
Mitford:
I did indeed, and I thought they're supposed to be the watchdogs of the public health, but in my view the Food and Drug Administration is totally derelict in its responsibility to prisoners and people in these experiments. They simply . . .
Bourdeaux:
Were they able to give you any facts and figures that you asked for?
Mitford:
They were not. They were not even able to give a list of prisons in which the experiments go on. They gave me what they called an "imperfect" list, which indeed proved to be imperfect.
Semerjian:
All right, back to you, Mr. Morris.
Morris:
All right.
Semerjian:
One question.
Morris:
All right. How can you say, Miss Mitford, that these prisoners are coerced when 80% of them don't volunteer? More than half of them don't in the beginning, and some drop out along the way.
Mitford:
Well, I don't know what that proves. It seems to me, you see, that the coercion exists in precisely what Mr. McCue was talking about before, and that is the incredible exploitation of labor in prison to begin with, where you make two cents an hour, so obviously a dollar a day for being in the experiments is riches.
Morris:
But how can you be coerced if you're free to drop out? The choice has to work both ways.
Semerjian:
Make this very brief.
Mitford:
Well, I mean, as I said, I think that the whole situation is totally coercive.
Semerjian:
All right, Miss Mitford, I want to thank you very much for being with us tonight. Thank you. For those of you in our audience who may have joined us late, Mr. Bourdeaux and his witnesses have just presented the case in favor of banning all medical experiments on prisoners. And now for the case against, Mr. Morris, the floor is yours.
Morris:
All right. Ladies and gentlemen, we come now to the other side of the coin, and there are always two sides to every question. I ask you to consider why prisoners are used. You've heard the proponents tell you the horror stories, stories of experiments that are ill-designed, shouldn't have been brought, ended disastrously. On that basis, of that infinitesimally small number out of all of the safe programs that have gone on, they ask you to ban all testing. Before you decide to do that, there are some things I want you to consider. First, consider the miracles of modern medicine. Think of today—and you may have forgotten this, but think of today—when you see the little children running in the playground. Think back when they were crippled with poliomyelitis, and we don't have poliomyelitis around with little children any more, and the reason we don't is the Salk vaccine and the Sabin vaccine, and where did those vaccines come from? They came from testing on human beings, and they came from testing in part on prisoners. If we give those up, what will we do for the diseases of tomorrow? How are we going to cure heart disease and cancer and crippling arthritis? What about the future of all of us? If you stop this testing, then all of that will be gone. Consider also why prisoners are used: because there are no suitable substitutes. We can stop testing. If we stop testing, what are the alternatives? What are we going to do without new drugs, or are we going to take new drugs that have never been tested and thrust them out on an unsuspecting public and have everything go bad? To speak to the importance of drug experiments on prisoners, let me call my first witness, Dr. Arnold, a man who won the Army's Medal of Merit for the role he played in developing an anti-malarial drug during the Korean War.
Semerjian:
` Dr. Arnold, welcome to The Advocates.
Morris:
Dr. Arnold is Director of the Harry S. Truman Research Laboratory in Kansas City and Professor of Medicine at the University of Missouri. Dr. Arnold, what is drug experimentation, and why is it important?
Arnold:
Well, Mr. Morris, we're facing a crisis of medical care, and the crisis isn't truly appreciated because very few people talk about this. We are losing control of many of the diseases that were controlled originally by the miracle drugs of the 1940’s and 1950’s. The second thing is that we're having a new disease pattern. Our life styles has led to a change in disease. We have an epidemic of heart disease in this country, and as I look around here, I can say that one out of every two people in this audience will die of heart disease in this century. There are changes in the age spectrum of our population. There are vastly new medical problems developing because our population is older, and new disease entities have appeared. To solve these problems, it is imperative that we use human volunteers.
Morris:
Have you ever done medical experimentation on human beings?
Arnold:
Yes, Mr. Morris, I have spent twenty-seven years of my life working with clinical studies in human volunteers.
Morris:
Why do you have to test on normal human beings?
Arnold:
First of all it's safety. Second, it's safety. Third, it's safety. It's safety for the general public. Unless we know the adverse effects of drugs before they get on the market, we're forever handicapped in identifying and removing these drugs from the market.
Morris:
Have you ever done any tests on yourself a volunteer?
Arnold:
Yes, I did, as a young man.
Morris:
How do you go about testing with these drugs on humans for the first time?
Arnold:
Well, the primary requirement is control, and the primary reason for control is safety. We must see and monitor every subject of a medical experiment of this sort, and the monitoring requires twenty-four hours sometimes three, four, and six weeks observation. There are very few places in which human beings can be observed so closely. There are very few places where as medical experiments have been so safe. Now, I disagree with Miss Mitford: there has never been—I repeat, there has never been—a fatal accident in Phase I drugs testing in prisons, and, I repeat, there have been fatal accidents in Phase I drug testing in patient volunteers.
Morris:
Why do you choose prisoners as subjects?
Arnold:
Well, the problem is time demand. Most of us in society are busy. Few of us are willing to take two weeks or four weeks or six weeks to go into a hospital, away from family and job, to be observed so closely as is required for human testing.
Morris:
Can these prisoners make a free choice as to whether or not they want to go into experimentation?
Arnold:
Well, after twenty-seven years of work, I believe they have the freest choice of any segment of our society. I have no control over prison volunteering. We send out an appeal, and an answer comes back spontaneously. I have no coercive pressure over volunteers in a prison, but I do have in patients, and I frequently have as a Professor of Medicine over students. There are very few segments of our society which are as free— I repeat, as free—of coercive pressure as prison volunteers.
Morris:
Do these prisoners benefit in any way from having gone through the experimentation?
Arnold:
Well, there's a multitude of effects on a prisoner, and it's very easy to become tangled up in these effects. They do need money, and I think that money has been an enormous help in the lives of many of these people who have no other source of money, but there's something bigger than this involved. A number of these people gain a new self-image. Can you imagine a man who has never done anything—I mean, anything— for social good in his life? Can you imagine the new sense of self-respect that he has when he has contributed to the development of a new life-saving drug?
Semerjian:
All right, let's go to Mr. Bourdeaux for some questions.
Bourdeaux:
Dr. Arnold, the truth of the matter is that what you are really saying is that you as an experimenter have made a judgment that society and the requirements of society offset the moral and ethical implications of prisoner testing.
Arnold:
Well, Mr. Bourdeaux, we're making judgments like that every day. We make cost-benefit judgments about everything we do, and these cost-benefit judgments are made about human experimentation. They really ought to be made about everything else, and I don't make those judgments, Mr. Bourdeaux. They're made by an institutional peer review group. They're made by citizens. The same kind of people that sit in this audience look over these experiments, and they make the judgments.
Bourdeaux:
Do they make the judgments, Doctor, about what motivates a prisoner to submit himself to the experiments?
Arnold:
You bet they do, and they contain people who have been in prison, they contain people who have worked with prisoners, and these committees contain people in every walk of life.
Bourdeaux:
Is there an atmosphere of fear in a prison?
Arnold:
Well, I think this varies widely. Prisons are not a generic species. Miss Mitford may think they are, but there are a great many prisons which are not like the ones she describes.
Bourdeaux:
Didn't you write. Doctor, in 1968 in the New York Scientific Journal that there's a general level of fear that exists in many city, county and state prisons?
Arnold:
You recognize that I qualified that, Mr. Bourdeaux.
Bourdeaux:
Have you changed your mind?
Arnold:
No, I haven't.
Bourdeaux:
Now, Doctor, in testing with a prisoner, the first thing that you've got to do is get that prisoner's informed consent, isn't it?
Arnold:
No, the first thing you have to do is to get his inquiry. He has to ask to be a volunteer.
Bourdeaux:
All right.
Arnold:
The second thing you do is to get his informed consent.
Bourdeaux:
All right, I stand corrected. The second thing you do is get his informed consent. This means that you've got to tell him what you're going to do to him, and what may happen to him, and then he's got to consent to it, is that right?
Arnold:
That's right.
Bourdeaux:
And has it been your experience that these prisoners understand the information that you give them?
Arnold:
Well, let's go through this, Mr. Bourdeaux. It's a very interesting exercise.
Bourdeaux:
Well, just answer my question, Doctor. Do you find that the prisoners understand what you tell them about these drugs?
Arnold:
The prisoner asks the questions he wants, and he talks to the other volunteers, and he makes his judgment the same way all of us make our judgment, on his own particular understanding.
Bourdeaux:
All right. Do you find that the prisoner understands?
Arnold:
He understands a great many things. He understands the things you tell him, he understands the answers to the questions that he asks about . . .
Semerjian:
Well, Doctor, let me see if I understand you. Is there any difference between the understanding of a prisoner and the understanding of a person at large outside the prison?
Arnold:
I think there is no difference. I repeat, there is no difference in the capability of understanding.
Semerjian:
Well then, why is it necessary to use prisoners? Why not use students, for example?
Arnold:
Well, as students are appropriate. I didn't say it was always necessary.
Semerjian:
So in other words, you really don't think it's necessary to use prisoners?
Arnold:
Well, I do because students are not always under close observation. This is a safety problem. If we're going to lose safety in the interest of these dialectic arguments, then we have lost the battle. It is safe to observe people, and it's only safe to observe them closely. Furthermore, there are many complications with people on the outside of prisons. They use marijuana, they use alcohol, they find themselves in dangerous positions during the day, they get involved in all sorts of activities that impair...
Semerjian:
All right, go ahead, Mr. Bourdeaux.
Bourdeaux:
Thank you, sir. Now, Doctor, you mentioned and agreed that it was possible to use students.
Arnold:
Yes.
Bourdeaux:
I believe that you have recommended that under certain circumstances we have a national draft for medical volunteers—I use that volunteer word loosely—for volunteers to participate in programs, we're going to draft them, is that right?
Arnold:
No, you are misconstruing what I have said, Mr. Bourdeaux.
Bourdeaux:
I beg your pardon.
Arnold:
I have said that if volunteers cannot be obtained and if we wish to meet the health hazards of the last part of this century, if volunteers cannot be obtained, there is only one other alternative.
Bourdeaux:
All right. Doctor, there is a considerable amount of opinion nowadays that we shouldn't test on prisoners, is there not? Some of it is pretty respectable too, isn't it?
Semerjian:
Make this brief, Doctor.
Arnold:
Well, the answer is there is an opinion.
Bourdeaux:
You don't think it's respectable.
Arnold:
Well, I respect everybody's . . .
Bourdeaux:
Let me ask you this question . . .
Semerjian:
All right, we're going to have to go back to Mr. Morris.
Morris:
Doctor, 80% of the prisoners do not volunteer, is that correct?
Arnold:
Yes, that's about right.
Morris:
And that's a real choice, is it not?
Arnold:
Really it is.
Semerjian:
All right, back to you, Mr. Bourdeaux.
Bourdeaux:
Doctor, isn't it true that in November of last year that the American Public Health Association resolved at its meeting in San Francisco to oppose further testing on prisoners?
Arnold:
I believe that's true.
Bourdeaux:
And that's an organization with some 100,000 people who work in public health, isn't it?
Arnold:
Well, I don't know that, Mr. Bourdeaux.
Bourdeaux:
You disagree with them, though.
Arnold:
No, I didn't say that.
Bourdeaux:
I see. Thank you, sir.
Semerjian:
All right, I want to thank you. Dr. Arnold, for being with us tonight.
Morris:
My second witness is Dr. Monroe Trout. Dr. Trout, will you take the stand, please.
Semerjian:
Dr. Trout, welcome to The Advocates.
Morris:
Dr. Trout is Vice President and Director of Medical Affairs for the Sterling Drug Company. Dr. Trout, Dr. Arnold has said that prisoners are ideal for experimentation because they're in a controlled environment. Do you agree with that?
Trout:
Yes, I do. I think, first of all, they have the time to participate in such investigations. We talk about students and many of them have to go to class. They don't really have all the time that's necessary. I think that Dr. Arnold put his finger on the really important issue, though, and that is safety. I think with close observation in the prison setup, you have all the safety you need. In our experience in twelve years we have never had a death and never had a serious adverse reaction in any of our testing in prisons.
Morris:
Couldn't we rely on people outside the prison for our testing?
Trout:
Yes, we could, and we do. Medical students have been mentioned. Other students are used: Seminarians, for example. They're not necessarily a desirable alternative, however, and again, we go back to the safety factor. I think that there are many factors with students, such as they're not on a standardized diet which may interfere with the scientific validity of the experiment, which means that you may have to do it over again on another group of subjects. You do not have the close observation of those particular people as you do in the prisons.
Morris:
Why do prisoners volunteer?
Trout:
I think the prisoners volunteer for the same reasons that non-prisoners volunteer: money is certainly one of them. Idealism—people who feel that they really want to contribute something to society and want to get the accolades of society.
Morris:
What do prisoners think about the proposal to ban these medical experiments?
Trout:
I know of no prison group that is interested in banning the experiments. Every group that I've been aware of, starting with the Lancaster County prison system where there was a move to temporarily halt experimentation, 60% of the prisoners wrote in and said, "We want it to continue." Not a single one wrote and said that it should be halted.
Semerjian:
This is in Pennsylvania, is that right?
Trout:
This is in Pennsylvania. The same thing happened in Connecticut in 1967 and 1968, and just recently I spoke with the President of the Fortune Society, which is an organization of ex-prisoners in New York City, and he told me that in the entire existence of that society they have never had a letter from any prisoner objecting to experiments in prisons.
Morris:
Are the prisoners inside the prisons able to make a free choice as to whether they want to volunteer or not?
Trout:
I think prisoners inside of prisons are able to make just as free a choice as anybody on the outside. As a matter of fact, I think if you take away that choice, you're really adding to their degradation. One of the mottos of the Fortune Society is "I think, and therefore I am," and I think we're taking away that choice for the prisoner.
Morris:
What about these abuses, these, as I call them, horror stories that Miss Mitford has related to this audience?
Trout:
Well, I think that there have been abuses. However, if we really examine them closely, there are about a dozen incidents which keep cropping up in all the literature. There the same incidents, many of them dating back thirty or forty years, many of them not even occurring in prisons and certainly not in drug testing. I'm concerned really with the greater abuse of having millions of Americans die or suffer each year from cancer, arthritis, heart disease, malaria and overseas schistosomiasis because there is a time lag in getting the drug to the marketplace or because we do not have volunteers to participate in such experiments. For example, 800 people in the United States alone die of cancer each day, and the President of the American Cancer Society said that one of the reasons for this is because experimenters are afraid to take great risks. You're caught in the middle.
Semerjian:
Make this very brief.
Morris:
Doctor, to sum up all your experiences, would you give the jury your feeling as to what we should do about this problem?
Trout:
I think we need—and I think everybody would agree that we need—to continue to develop new drugs for all of the diseases that have not been conquered up to now, and for the new ones which are going to evolve. I don't think anybody will disagree. I wonder if we ban experimentation in prisons where those volunteers are going to come from.
Semerjian:
All right, Dr. Trout, let's see what questions Mr. Bourdeaux has for you.
Bourdeaux:
Doctor, you've mentioned that some of all of these things that Miss Mitford wrote about and other people talk about occurred back many years ago, or some of them anyway. The Iowa scurvy test was in 1968, wasn't it?
Trout:
I believe she reported that in 1968, but that was not a drug test, as far as I know, sir.
Bourdeaux:
It was medical experimentation, though. That's the title of this program, is medical experimentation.
Trout:
I understand that we're talking about drug experimentation . . .
Bourdeaux:
Only?
Trout:
... in prisoners in Phase I testing.
Bourdeaux:
All right, sir. Well, let me enlighten you a little bit. We're talking about medical experimentation which includes Phase I drug testing. The Varidase experiment in Vacaville took place in 1972, didn't it?
Trout:
No, I believe it occurred in 1962. As a matter of fact, it was reported in 1962 in the literature, and I believe that it occurred prior to that time, and 1962, as you know, was when the new amendments to the Food and Drug Act took place.
Bourdeaux:
Yes, sir.
Trout:
A lot of changes have taken place since then.
Bourdeaux:
Yes, sir. Now, are you familiar with the medical experiment out in Oregon about three years ago, involving the reproduction organs of male prisoners?
Trout:
I have heard about this.
Bourdeaux:
That's where they put radioactive material into the testicles of male prisoners. Are you aware of that?
Trout:
Well, we put radioactive material into patients every day to determine whether or not their thyroids are functioning, whether or not they have a brain tumor. This is not as bad, Mr. Bourdeaux, as it sounds.
Bourdeaux:
Yes, but these prisoners had to have a mandatory vasectomy, didn't they?
Trout:
No, my understanding was that they had a vasectomy before the experiment took place, and it was not any condition of the experiment.
Bourdeaux:
Is that your understanding of it?
Trout:
Yes, sir.
Bourdeaux:
All right, sir.
Trout:
And a lot of people, as you know, have vasectomies today.
Bourdeaux:
Now, Doctor, can you tell us today how many drug experiments are going on in prisons in the United States?
Trout:
Can I tell you how many are going on?
Bourdeaux:
Yes.
Trout:
No, I cannot tell you how many are going on.
Bourdeaux:
All right. Would you mind reminding me what your position is?
Trout:
Yes, sir. My position?
Bourdeaux:
Yes.
Trout:
I am Vice President and Director of Medical Affairs for Sterling Drug.
Bourdeaux:
All right. How many experiments is Sterling Drug carrying on today in prisons?
Trout:
I believe that we have less than a half a dozen.
Bourdeaux:
Less than a half a dozen.
Trout:
Yes, sir.
Bourdeaux:
Doctor, have you ever participated in any of these experiments in prisons?
Trout:
Have I ever participated in an experiment in prisons?
Bourdeaux:
Yes.
Trout:
No, sir, I have not.
Bourdeaux:
Well, how are you in a position to tell us what motivates a prisoner to let himself be made a guinea pig?
Trout:
I believe that there have been at least a half a dozen studies . . .
Bourdeaux:
Sir?
Trout:
There have been at least a half a dozen studies which have been reported in the literature by individuals such as Dr. Arnold, who have spent their entire lives in prisons reporting on this.
Bourdeaux:
I see. You mentioned that it was necessary to test these drugs in order to protect ourselves from all these dread diseases. Now, Doctor, that's not the only testing that's done, is it? Aren't there some testing of what's called the "me too" drugs, or the redundant drugs?
Trout:
Those tests that you're talking about and "me too" drugs or bi-availability tests are in large part not—as a matter of fact, I would say that practically 100% of them are not—done in prisons.
Semerjian:
Now, Mr. Bourdeaux, what's a "me too" drug?
Bourdeaux:
Yes, sir, I'm glad you asked me. A "me too" drug, Doctor, is a drug that one drug company tries to bring out to meet the competition from another drug company, isn't it?
Trout:
A "me too" drug, I think, in large part is what is considered a generic drug which is brought out by a company that does not perform any research whatsoever.
Bourdeaux:
It's also called a redundant drug?
Trout:
No, it's the same drug. Many times it doesn't work.
Bourdeaux:
Doctor, you mentioned something about using students, that this wasn't a satisfactory method of testing. Now, isn't it true that the whole prison population of the United States, outside of the county jails and city jails, is less than 300,000 people, or do you know that?
Trout:
No, I did not know that. It was my understanding that it probably is double or triple that number.
Bourdeaux:
But that's if you include the county jails and the city jails and all that sort of thing.
Trout:
Yes. Total prison population.
Bourdeaux:
Yes, sir. Now, Doctor, that's only a very small percentage of the total population of the United States, isn't it?
Trout:
It's probably about a half of 1%.
Bourdeaux:
Yes, sir. What about using, if time is a problem, what about using students or teachers in the summertime when they're not in school? Have you ever thought about that?
Trout:
Yes, that's certainly a possibility. However, most students in the summertime like to return home and see their families.
Bourdeaux:
Yes, sir, most of them . . .
Trout:
That's my experience; that's what I wanted to do.
Bourdeaux:
Most of them need a little extra money too, don't they?
Trout:
Yes, and they usually go home and find jobs around swimming pools and doing something which—we've got more of a vacation . . .
Bourdeaux:
You've got 13,000,000 teachers out lifeguarding during the summertime. Now, Doctor, the truth of the matter is that the only...
Semerjian:
Make this very brief, please.
Bourdeaux:
Yes, sir, it will be brief. The only difference between the body of a prisoner and the body of any of these folks sitting out here is that in the prisons those bodies are cheaper, isn't that true?
Trout:
No, that's not true.
Semerjian:
All right. Okay, let's go back to Mr. Morris.
Morris:
Doctor, just one or two questions. The other side would have us ban this experimentation in prison, which means then that we have to do it on the outside, as you'd call it. If it's done on the outside and to the extent it already is done on the outside, do abuses occur there too?
Trout:
Yes, I believe that abuses will always occur no matter what you do. Abuses occur in medical practice. Does that mean that we're going to ban all doctors and not permit them to practice medicine?
Semerjian:
All right, back to you, Mr. Bourdeaux.
Bourdeaux:
Well, Doctor, if this is such a wonderful thing, this testing on prisoners, Why has the federal prison system recently stopped it?
Trout:
I was not aware that the federal prison system had stopped it. As a matter of fact, I participated in a conference called by the federal government last August on this very issue, and those representatives were there and no mention of that was made.
Bourdeaux:
They haven't announced it to you yet. What about the American Public Health Association? Why have they voted to ban it and stop it?
Trout:
I think you should go back and really read what the American Public Health Association has said very carefully because I do think that they qualify it, and they were talking about prisoners who were convicted of heinous crimes.
Bourdeaux:
No, sir, let me read you what they say: that "the American Public Health Association take a well-publicized and unequivocal stand against all experimentation in prisons." See if I read it right, Doctor.
Trout:
Well . . .
Semerjian:
Is that what it says?
Trout:
I don't know. I don't have time to . . .
Semerjian:
Doctor, I want to thank you very much for being with us tonight. Thank you. Thank you, gentlemen. That completes the cases, and now it's time for each advocate to present closing arguments. Mr. Morris, could we have yours, please.
Morris:
Yes. Ladies and gentlemen, the miracles of modern medicine you're well aware of. They speak for themselves. You've lived with them. You've enjoyed them, and they've enriched your lives, but without this medical research on human beings we're not going to have these miracles very long. We're not going to have any cure for heart disease, cancer, crippling arthritis. Tomorrow we'll be suffering from the same diseases we are today. Prisoners, because of their unusual stable environment, are ideal subjects, and prisoners are not coerced. The great majority of them don't volunteer, and to say you won't go into it is a sign of not being coerced, just as much as they like to argue that those that do go in are coerced. They're not coerced. They have a free choice. Prisoners have a right to do this if they want to do it, as much right as the medical student has it, for all the variety of motivations and reasons: they have a right to earn some money, they have a right to develop some status and do some good and be looked up to as they are, but you should not take that right from them. Don't let a few misguided horror stories, as I call it, don't let that mislead you into taking the prisoner's rights away from him and taking research away from us all. Research is extremely safe; it has a wonderful track record for safety, and the statistics show it, and the witnesses have showed it. Just because some doctor confesses that he has done thirty-eight unnecessary back surgery is no reason to give up back surgery, and because there are some isolated abuses, and sometimes real horror stories, which we all deplore, that's no reason to give up medical research, and it's no reason to deprive the prisoners of it. Remember: your health is the most important thing in your life, so vote no so that we can keep this medical research and keep ourselves alive.
Semerjian:
Mr. Bourdeaux, could we have your argument.
Bourdeaux:
We have been told that drugs have to be tested on human beings, and we agree with this. But we believe that the prisoner who submits himself to an experiment for cigarette money or to enjoy some hospital food or to escape temporarily from that oppressive guard or that cellmate or in the natural hope that his action will provoke a reaction, and a favorable reaction, from the parole board is not acting freely and voluntarily, and no matter how much we are told about the benefits that society will reap from these experiments, this will not quite wash. The scandal and the disgrace of the Iowa scurvy test, the Vacaville Varidase scandal, and the Oregon testicular program. The only safe way to ensure that we do not continue on this deadly course of believing that the needs of society as a whole give justification to the abuse of the individual is to ban the use of prisoners for medical experimentation. Vote yes.
Semerjian:
Thank you, gentlemen. Now it's time for you in our audience to get involved. What do you think about tonight's question? Should all medical experiments on prisoners be banned? Send us your "yes" or "no" vote on a letter or postcard to The Advocates, Box 1974, Boston 02134. We'll tabulate your views and make them known to your state representatives and others concerned with this problem. Write us tonight; don't put it off; let us know how you feel. Remember the address: The Advocates, Box 1974, Boston, 02134.
The Advocates will not be seen in the last week of February, but will return the first week of March to its regular time slot, so let's look ahead to that program. (PROMOTIONAL MESSAGE)
Now, recently The Advocates debated the question, Should we rely on nuclear power to help supply our future energy needs? Of the more than 6,500 viewers who responded, 42% said yes, that the key to making the United States self-sufficient in energy lay in nuclear power, and 58% said no, that the benefits of nuclear energy do not warrant the risks involved.
And now, with thanks to our advocates and to their able and distinguished witnesses, we conclude tonight's debate.