The Current Standards of Human Medical Testing

Show: FRESH AIR
Date: JULY 28, 1998
Time: 12:00
Tran: 072801NP.217
Type: FEATURE
Head: Acres of Skin
Sect: News; Domestic
Time: 12:06

TERRY GROSS, HOST: This is FRESH AIR. I'm Terry Gross.

You know the anti-wrinkle cream Retin-A? According to the new book "Acres of Skin," the early tests of this cream were conducted on prisoners who voluntarily rented out their bodies in return for modest payments.

"Acres of Skin," written by Allen Hornblum, focuses on the use of inmates at Holmesburg Prison in Philadelphia for testing new creams, toothpastes, deodorants, foot powders and shampoos.

The testing program expanded to include mind-altering drugs, dioxin, and radioactive isotopes. The architect of the prison testing program was the dermatologist who invented Retin-A, Dr. Albert Kligman (ph). He was also a professor at the University of Pennsylvania.

Holmesburg was one of the many prisons around the country that allowed its inmates to be used as medical guinea pigs. This practice was outlawed in 1974 after congressional hearings led by Ted Kennedy.

Author Allen Hornblum has served on the Board of Trustees of the Philadelphia Prison System and the Pennsylvania Crime Commission and now teaches criminal justice and urban studies at Temple University.

He first found out about the medical experiments in the early '70s when he was teaching at the Philadelphia Detention Center, which was part of Dr. Kligman's testing program.

ALLEN HORNBLUM, CRIMINAL JUSTICE EXPERT, AUTHOR, "ACRES OF SKIN: HUMAN EXPERIMENTS AT HOLMESBURG PRISON": I walked into the Philadelphia Detention Center on a very hot September morning in 1971 to begin teaching adult literacy program. And one of the first things that struck me were the scores of inmates who were walking around with bandages, gauze pads, adhesive tape on their arms and chest and back.

I had never seen a large-scale clinic experiment. So I thought it could have come from a cellblock riot, some sort of gang warfare in the prison yard. And the next day, I asked the guy what was the story here. And he said, "Oh, that's nothing. That's just the perfume tests for the University of Pennsylvania."

And I was dumbfounded by this and very skeptical. But that's what everybody told me.

GROSS: How did you find out that these tests were also being run at Holmesburg Prison?

HORNBLUM: I was told immediately that what we had at Philadelphia Detention Center was mild in comparison to Holmesburg. They told me that three out of four prisoners were on one experiment or the other.

And the guards were equally dubious. But it had been going on for years. And they grew tired of my questions, quite frankly, because I was the one who was new in the prison system, not the experiments. By the time I had walked into the prison in 1971, those experiments were two decades old.

GROSS: Give us the big picture what kinds of medicines or products, ingredients, were being tested on prisoners at Holmesburg?

HORNBLUM: You could find any and everything at Holmesburg that you would find in your medicine cabinet. They were testing hair dyes, soaps, deodorants, detergents, athlete's foot medication, skin creams of every kind. It really was a marketplace that the pharmaceutical companies and the chemical companies were attracted to because there were so many prisoners who were cheap and available at the time.

GROSS: And there were other studies too that were done?

HORNBLUM: Yes, in later years, the program took on such wide acceptance by people in both the private and public sector that you had tobacco companies asking to have their protocols operationalized there. You had major chemical companies, like Dow Chemical was testing dioxin on the prisoners. You even had chemical warfare studies for the Army and the CIA that went through the 1960s.

GROSS: Tell us something about the doctor who was the architect of the program, Dr. Albert Kligman.

HORNBLUM: Dr. Kligman is still with us today. He's 82 years old. And he's arguably the most famous dermatologist in the country. He has a worldwide reputation. Many people know him because he's the father of Retin-A, the very successful anti-acne, anti-wrinkle cream.

Dr. Kligman was a fascinating physician in the post-war period. Many young scholars and students came to Penn just to train under him.

He was a great raconteur. He was a spellbinding lecturer. In his private life, he was a horseback rider. He was a balloon enthusiast. He flew planes. He played tennis. He was a gymnast in college. He was very colorful compared to most of the stayed men in the field.

GROSS: Now how did Dr. Kligman end up using prisoners as people to test products on?

HORNBLUM: Well, he first walked into the prison, as I understand it, in 1951 to take a look at an outbreak of athlete's foot, which periodically occurred in the prison. Some of the medical people in the prison had caught notice of a couple of articles on fungi written by this University of Pennsylvania professor. So they contacted him. And he decided he would go up there and take a look at it.

But when he walked through the front doors, he was just amazed. As he said, he felt like a farmer seeing a fertile field. He did not see people. He did not see prisoners. He saw acres of skin, which is where the title of the book comes from. These are his own terms.

And he said that they were an anthropoid colony that was perfect for dermatologic study. And from that day on, he was in there for nearly the next quarter-century.

GROSS: Allen Hornblum is my guest, author of the new book "Acres of Skin" about medical testing on prisoners.

How were prisoners recruited for these medical tests?

HORNBLUM: In many cases, they were directed there by other prisoners who told folks, "This is where you could earn some money." Some of the social workers told the prisoners, "If you're desperate for money, this is where you can go. And you can be on an experiment, and they will pay you."

There could have been some items placed on billboards. But basically, it was word of mouth. And it got around very substantially. And the men who were in the prison were desperate to earn a few bucks. If you were lucky enough to get a prison job -- selling clothes, making shoes, cleaning a cell block -- you would get all of 15 cents a day, 25 cents a day. It was really a pittance.

However, if you were an experimental guinea pig, you could make a buck a day, $1.50, $2.00, depending upon the experiment that you embarked on. So it was really princely wages compared to what the history of the prison paid out.

GROSS: A lot of people wonder, why do prisoners need money when they're locked up?

HORNBLUM: What people don't understand is wherever you are in society, and basically whatever country, you are better off if you have money. And that includes prisoners.

You have to understand that Holmesburg Prison, then as it was throughout its 100 years, it was a county facility where overwhelmingly the people who were there were unsentenced, untried. They were technically innocent. So if you could raise a few bucks, you may be able to pay your bail. Or you may be able to hire an attorney to represent you, or just to go down to the commissary and buy some Tastee Kakes (ph), some cigarettes, some other candy food items, things like that. So if you had money, you'd be in a better position.

GROSS: So the prisoners got money in return for loaning their bodies to science?

HORNBLUM: They were not doing it for altruistic reasons or patriotism or anything else.

GROSS: Were there consent forms that they had to sign?

HORNBLUM: There were consent forms or waiver forms. I have a couple of them, one from the mid-'60s and one from the early '70s. And they basically state that, "I the undersigned give up any legal right to sue the doctors, the University of Pennsylvania, or the prison system if anything untoward should occur in the experiment."

GROSS: What were the prisoners told by the doctors who were running the tests?

HORNBLUM: At most they would be told that maybe you're going to be testing an analgesic and it may have this effect. And if anything goes wrong, we'll be here to take care of you. It was very brief, very superficial.

You have to also understand that the prisoners were unsophisticated, uneducated. By the time I was there, they were overwhelmingly African American. And they were not particularly well-adept at handling such questions or even raising them. You know, you could tell them they're testing an analgesic and they wouldn't have any idea, you know, what you were talking about.

I was there to teach. So I knew their education level. Very few had graduated high school. Most had dropped out of school in 9th or 10th grade, which meant they were basically on a sixth-grade reading level.

GROSS: What were some of the typical side-effects that the prisoners testing the drugs experienced?

HORNBLUM: Well, what I saw when I interviewed them were lots of scars and discolorations. One inmate I tracked down at Holmesburg took off his shirt and showed me all sorts of scars and discolorations on his back. He also showed me two large incisions, scars, on each side of his abdomen where he was brought in for a test, two doctors laid him down on a gurney. They cut him open on each side. They then packed him with gauze pads and some medication. They sewed him up and sent him on his way.

This was without, according to the inmate, any anesthesia or anesthetic. They brought him back 10 days later. And they reopened one wound and took out the packing, sewed him up again and sent him on his way. Ten days later, they did the same thing on the other side.

He never knew what the test was about. He never knew what they put in him or why it was done. All he knows is he got 10 dollars for each slice.

GROSS: Now when it came to the dermatological tests, the patch tests, to see how your skin would react to different ointments and chemicals, one prisoner gave you this comment. The comment was basically, you know, "Big deal, so I'm rubbing some ointments on my back. You know, maybe it will blister. I spent half my life shooting heroin into my veins. So why should I worry about, you know, a few creams and ointments and some itching."

Was that a typical comment?

HORNBLUM: Many told me that. This one particular prisoner was up in years who was a very wily con, and in fact, was my age through many of the early years there. But there were other inmates who were genuinely fearful of the tests and did it only under duress. They needed money. And this was the only way to get it.

But yes, there were many inmates who felt that the doctors were wearing white coats. They were well-educated. They were from a prestigious university in the city. They said that these tests would not harm them. They believed them, and they took part in the experiments.

GROSS: You point out in your book that prisoners, some of the prisoners, were the most ardent advocates for keeping the system in place because it was helping them get money which they very much wanted to get.

HORNBLUM: Absolutely. In fact, when the experiments were curtailed in Philadelphia in 1974, the prisoners signed a petition. Overwhelmingly, they wanted them back. And they were upset with the individuals who tried to stop the experimentation. These prisoners were willing to gamble on the health risks to make a few dollars.

GROSS: If you're just joining us, my guest is Allen Hornblum. We're talking about his new book "Acres of Skin: Human Experiments at Holmesburg Prison."

This is the story of how prisoners were used in the '50s, '60s and '70s for experimental medical research. And it happened not just in prisons in Pennsylvania but really in prisons all around the country.

Let's take a short break, and then we'll talk some more. This is FRESH AIR.

(BREAK)

My guest is Allen Hornblum. His new book is called "Acres of Skin." And it's about how prisoners in the '50s, '60s and '70s were used as human guinea pigs.

How did the FDA ban medical testing on prisoners?

HORNBLUM: Well, you had it arise in the early '70s a universal recognition that maybe we were doing the wrong thing. There were doctors in the medical community that started to bring up the red flag that doctors were committing some heresy here in treating people as animals. You had some exposés taking place, such as the Tuskegee Syphilis study was exposed in 1972. That alarmed a great many people. There were a lot of hearings taking place.

You had the rise of lawsuits coming about. So there were a number of things happening by the early '70s that sensitized folks in different areas that these experiments on retarded children, on prisoners, on other vulnerable populations, should not take place any longer. And the FDA and other government agencies finally had to put their foot down.

The Federal Prison System said no more testing of federal prisoners. Individual city and states were doing the same thing. And the FDA and the Department of Health and Human Resources came up with their own guidelines that precluded the use of prisoners.

GROSS: Did you come across any prisoners who were still suffering with long-term consequences from the medical tests?

HORNBLUM: I had prisoners tell me that they had rashes and they had blackouts and they weren't thinking properly. But quite frankly, there's no way to tell if that emanates from the experiments.

The prisoners were used literally as guinea pigs. They were pulled out of a cell or a cage, they were monitored and examined for a short period of time. But after the study was over, they were forgotten about.

Getting back to Dr. Kligman's, you know, response to this investigation, there was no long-term study. There was no longitudinal study as to what the effects would be over a period of years.

Twenty, 25 years have gone by now, more in some cases. Nobody has followed the progression of these individuals. The dioxin study, for example, we know that there were, you know, several dozen prisoners. It may be the only case on record where the scientific community purposely applied dioxin, a known carcinogen, to the faces and backs of prisoners. What's the long-term effect of that? What's the long-term effect of having radioactive isotopes injected into you, or being exposed to these incapacitants.

We do not know, because when the prisoners were released from Holmesburg, either because they were sent to another prison or they were found innocent and sent home, nobody bothered to follow up on them.

GROSS: What happened to Dr. Kligman's medical records, the doctor who ran many of these tests?

HORNBLUM: The doctor has said over time that some of them were destroyed in a prison fire. Some, he got rid of. Some were lost. He says he no longer has any records from that period.

GROSS: Now I know you used the Freedom of Information Act to get files that would be helpful in your research. What did you learn through the Freedom of Information Act?

HORNBLUM: Well, I learned that it was invaluable. If I did not have that, this book would be a very cursory tale just based on the recollections of the doctors, the medical technicians, the guards and the inmates. The documents showed me basically what took place there. They showed me, for example, in the way of radioactive materials that I got from the Nuclear Regulatory Commission what radioactive isotopes Dr. Kligman was bringing into the institution.

It shows me, with regard to the Army documents, how they ran the program, what their concerns were. They themselves were upset with Dr. Kligman's operation and told him he'd better come up to speed, he'd better hire certain people.

They tell me what chemicals were being brought in, what dosages were being used. So they were really invaluable to me.

And I had to really apply a full-court press on many different government agencies because, as I said before, there were so many different, varying experiments that Dr. Kligman was doing. It was not just dermatological studies. They were doing psychotropic drugs. They were doing internal medicine studies.

Therefore, I had to put out FOIAs to the Nuclear Regulatory Commission, the Department of Energy, the Environmental Protection Agency, the Food and Drug Administration, the Pentagon, the CIA. So many things were happening there that there are some people who feel that I still maybe have only covered the tip of the iceberg.

GROSS: Allen Hornblum, thank you very much for talking with us.

HORNBLUM: Thank you. It's been my pleasure.

GROSS: Allen Hornblum is the author of "Acres of Skin." He teaches at Temple University in Philadelphia.

This is a rush transcript. This copy may not
be in its final form and may be updated.

Dateline: Terry Gross, Philadelphia
Guest: Allen Horblum
High: "Acres of Skin," written by Allen Hornblum, focuses on the use of inmates at Holmesburg Prison in Philadelphia for testing new creams, toothpastes, deodorants, foot powders and shampoos.
Spec: Health and Medicine; Prisons; Crime; Environment; Testing

Please note, this is not the final feed of record
Copy: Content and programming copyright 1998 WHYY, Inc. All rights reserved. Transcribed by FDCH, Inc. under license from WHYY, Inc. Formatting copyright 1998 FDCH, Inc. All rights reserved. No quotes from the materials contained herein may be used in any media without attribution to WHYY, Inc. This transcript may not be reproduced in whole or in part without prior written permission.
End-Story: Acres of Skin
Show: FRESH AIR
Date: JULY 28, 1998
Time: 12:00
Tran: 072802NP.217
Type: FEATURE
Head: Testing Back Then
Sect: News; Domestic
Time: 12:35

TERRY GROSS, HOST: This is FRESH AIR. I'm Terry Gross.

Substances ranging from toothpaste to hallucinogens were tested on prisoners until this practice was outlawed in 1974. Holmesburg Prison in Pennsylvania is one of the many prisons that participated in such medical and product testing.

The architect of the Holmesburg testing program was the dermatologist who invented Retin-A, Dr. Albert Kligman (ph). My guest, Dr. Bernard Ackerman, was a student of Dr. Kligman's at the University of Pennsylvania and in that capacity, helped conduct the prison experiments.

Dr. Ackerman now directs the Institute for Dermatopathology at Jefferson Medical College in Philadelphia. As a student, Dr. Ackerman came to the University of Pennsylvania specifically to study with Dr. Kligman. I asked why.

BERNARD ACKERMAN, DERMATOLOGIST, PROFESSOR OF DERMATOLOGY AND PATH DIRECTOR, INSTITUTE FOR DERMATOPATHOLOGY, JEFFERSON COLLEGE: Well, most people in university life are not highly flavorable (ph). Some are scholars, some are not. But most are pretty ordinary in terms of personality. Dr. Kligman was just the reverse.

He was, and still is in some ways, a very vibrant, exciting, excitable, flamboyant, dramatic thinker, had lots of ideas, was spawning ideas all the time. And for a person who was a novice as I was, this was very appealing. And so that's the reason.

GROSS: Did you know anything about the prison medical testing when you got to Penn?

ACKERMAN: Only that Dr. Kligman told me when he knew that I was going to be working with him, that he encouraged me to do that because he had acres of skin and said that there was a prison in which they did their research.

GROSS: What were you told about the prison research before you actually started working on the project?

ACKERMAN: Well I was told by Dr. Kligman that it was a model for what should go on in research because something was being done there that wasn't done anyplace else. Namely, the prisoners were being paid; that many of them, after they were released from prison, got jobs in laboratories or as technicians; that the prisoners loved it; that this was a big distraction from the quite terrible routine of prison life. So before I ever stepped foot in that prison, I had a rather glorified notion of what went on at Holmesburg.

GROSS: So you were working on studying dandruff?

ACKERMAN: That was my project.

GROSS: What did that entail? What was the actual research that you used the prisoners for?

ACKERMAN: Right. We took biopsies by a technique termed a "punch." And the punch is about the size of the rubber eraser on the end of a pencil. And if you can imagine taking that rubber out, there is a metal, or there used to be a metal rim. And that is used as a core in this punch biopsy technique.

And one first puts on anesthesia, one goes down to the subcutaneous fat, out pops the piece of tissue. Then one puts it in formalin. And one has it processed, and then one looks through a microscope at the changes and tries to make assessments about what's going on here. What's the process?

GROSS: Was this painful or at all dangerous for the prisoners?

ACKERMAN: No, this is not painful anymore than an injection of penicillin or anything else, or anesthesia of any kind. Very little anesthesia is put in, and once it's in it's no longer a painful procedure.

GROSS: When you started using prisoners as research subjects, did you have any qualms about it?

ACKERMAN: At the outset, I didn't because I thought in the spirit of what Dr. Kligman had told me that we were doing something very beneficial. That was my initial impression.

I've come to see it very differently. But in answer to your question, I had no qualms at the outset.

GROSS: Well, while you were still comfortable with it, what kind of questions would the prisoners ask you that you were either free or not free to answer?

ACKERMAN: Well, most of the subjects asked nothing. The person who was assigned to me as the person who was helping me with the things that I was doing was a prisoner. And he was a guy who had passed bad checks. And he was a sociopathic character.

And he used to say to me, "Doc, go slower. I want to watch the technique because when I get out of here, I'm gonna to do this to." So that was the kind of colloquy I would have with a person like that.

But for the most part, the prisoners who were the subjects, engaged in banter with me. They had some interesting colorful names. And I had very good rapport with them. But they didn't ask hardly any questions about what was happening.

GROSS: Were you ever worried about the possible damaging effects of anything that you tested on the prisoners?

ACKERMAN: Only one material. And that was what was called Tritium Labeled Thimadine (ph)." It was radioactive material that was used in those days for assessing the turnover time of epithelial cells, and in this instance, the epidermis.

And I specifically asked Dr. Kligman about the propriety of it because I was concerned about it. And he assured me that there was a government agency that had given permission, it was written permission, to the university and to him for doing these very studies.

That's not verified in Mr. Hornblum's book. But that's what I was told. So that was the only thing that I had any qualm about.

GROSS: When did you start getting reservations about the ethics of the prison research?

ACKERMAN: Well, it began clearly one Saturday when my brother, my younger brother, who was then Chairman of the Department of Orthodontics at the University of Pennsylvania, came to visit me at the prison at my request. I wanted to show him what I was doing. And he took a very brief look around and asked me, "Haven't you ever heard of the Nuremberg Code"?

And I hadn't, and he sent it to me. And at that juncture, I realized that this really might not be all that proper.

But in truth, my thinking changed slowly over time. And by the end of my year at the University of Pennsylvania, I realized very well that this was improper and should not be done.

But in truth, as time has gone on, it's 33 years since I was a second-year resident at the University of Pennsylvania, I have come to really view it in much clearer perspective, at least from my vantage. And it was improper in every respect.

And the University of Pennsylvania shouldn't have been there. Dr. Kligman shouldn't have been there. And I shouldn't have been there.

GROSS: Have you ever been involved in other research that you felt was ethically questionable?

ACKERMAN: After my year at the University of Pennsylvania, I never did experimentation of that kind ever again. And my work deals with microscopy.

And from the time I went Harvard on, except for a little clinical exposure there, I've been a histopathologist, a dermatopathologist, and there's been nothing that comes close...

GROSS: But you work in the lab most of the time?

ACKERMAN: I work at a multi-gated microscope, 21 heads. So there are 20 students with me at least all the time and sometimes many more because we have videos. It's an entirely a different circumstance.

But the experience at Holmesburg, especially as time went on, was searing, and, I think, in many ways had a very salutary effect upon me because, by virtue of that, I determined that I wanted to lead a professional life of a different kind.

GROSS: Did you ever take your doubts, once you had ethical concerns, to Dr. Kligman and talk them over?

ACKERMAN: Well you know, that's a perfectly reasonable question, and the answer is no. And the reason is that Dr. Kligman was not a person who one could have colloquy with in a very easy way. He was very opinionated and could also be very aggressive and could behave in a way that was extraordinarily unpleasant.

And if one raised this kind of issue with him, his response could either be something like, "What are you some kind of Boy Scout?" or be very aggressive. And so there was really no point in doing that.

GROSS: Dr. Kligman is, for the most part, not speaking to the press about the subject. But he did make this statement. He said, "My use of paid prisoners as research subjects in the '50s and '60s was in keeping with this nation's standard protocol for conducting scientific investigations at that time. To the best of my knowledge, the result of those experiments advanced our knowledge of the pathogenesis of skin disease. And no long-term harm was done to any person who voluntarily participated in the research program."

What are you're thought's about that statement?

ACKERMAN: Well, I...

GROSS: Let's start with the standard research protocols of the time.

ACKERMAN: ... Well, I think that when the prison work began under the auspices of the University of Pennsylvania and Dr. Kligman, it was in the early 1950s. And that was shortly after the Nuremberg Code had been set forth. So there was a standard, and that was the standard. And it really was the standard for research after that.

So I don't think it's accurate to say that, that was not the standard of the United States. It was a universal standard.

GROSS: What did the Nuremberg Code say that is relevant to the research you were doing?

ACKERMAN: Well, the Nuremberg Code makes it utterly clear that prisoners are not to be used as research subjects. It could not be more clear.

GROSS: Even if it's voluntarily and they're getting paid for it?

ACKERMAN: Under no circumstance because, first of all, they are really not volunteers in a sense. They're in prison. And once you're in prison, you're not a volunteer.

Secondly, there's an emphasis on informed consent. And there was no informed consent at Holmesburg. The prisoners hadn't the slightest idea what was going on in the research. And no attempt was made to instruct them.

So if the Nuremberg Code was the standard, and in my estimation it was and should have been, and certainly in a university, then this was a violation of that code.

GROSS: When you were involved in the prison research, you were at the University of Pennsylvania, do you think that the University of Pennsylvania was exceptional in it's participation in this research? Or do you think that was basically the standard at the time?

ACKERMAN: It surely wasn't the standard, and this is not to say that no other university did it. But they were very few. And this is not the rule.

And I think that the University of Pennsylvania was derelict in it's duty then because it was the beneficiary, certainly the medical school, the Department of Dermatology, of monies that were made at Holmesburg.

I guess that the vast majority of those monies went to Dr. Kligman. But certainly a percentage of it went to the Department of Dermatology. Well, that department had a responsibility. And I think that that's a shame for the University of Pennsylvania because the University of Pennsylvania is a great university.

And it seems to me that this is the kind of thing, this issue of Holmesburg Prison, that should be part and parcel of a teaching program. Medical students should learn about this, residents in dermatology especially, but residents of all kinds.

This is the kind of thing that should be debated and discussed. This is what universities are for. This is what universities are about.

And my concern is that too few of my colleagues in dermatology see anything wrong with what happened at Holmesburg. That's what has to be changed.

They have to understand that it was wrong and it had no place in a civilized society. And it is contrary to the Hippocratic Oath and to the Nuremberg Code.

GROSS: Dr. Ackerman, I want to thank you very much for talking with us.

ACKERMAN: Thank you for inviting me.

GROSS: Dr. Bernard Ackerman directs the Institute for Dermatopathology at Jefferson Medical College in Philadelphia.

Coming up, how the protocols of medical testing have changed. This is FRESH AIR.

This is a rush transcript. This copy may not
be in its final form and may be updated.

Dateline: Terry Gross, Philadelphia
Guest: Bernard Ackerman
High: Substances ranging from toothpaste to hallucinogens were tested on prisoners until this practice was outlawed in 1974. Holmesburg Prison in Pennsylvania is one of the many prisons that participated in such medical and product testing. Dr. Bernard Ackerman helped conduct the prison experiments.
Spec: History; Prisons; Politics; Government; Health and Medicine; Testing

Please note, this is not the final feed of record
Copy: Content and programming copyright 1998 WHYY, Inc. All rights reserved. Transcribed by FDCH, Inc. under license from WHYY, Inc. Formatting copyright 1998 FDCH, Inc. All rights reserved. No quotes from the materials contained herein may be used in any media without attribution to WHYY, Inc. This transcript may not be reproduced in whole or in part without prior written permission.
End-Story: Testing Back Then
Show: FRESH AIR
Date: JULY 29, 1998
Time: 12:00
Tran: 072903NP.217
Type: FEATURE
Head: Changing Research Methods
Sect: News; Domestic
Time: 12:50

TERRY GROSS, HOST: The architect of the medical testing program at Holmesburg Prison in Pennsylvania was dermatologist Dr. Albert Kligman (ph) who was then a professor at the University of Pennsylvania and is now retired. The practice of using prisoners for medical testing was outlawed in 1974.

We invited Dr. Richard Tannen of the University of Pennsylvania to talk with us about how the protocols of medical testing have changed. Dr. Tannen is the former vice dean for Research and Researching Training, and is now the senior vice dean at the university's school of medicine. He's been at the University of Pennsylvania since 1995.

What is your reaction and the university's reaction in retrospect to the research that was conducted on prisoners?

RICHARD TANNEN, DERMATOLOGIST, FORMER VICE DEAN FOR RESEARCH AND RESEARCH TRAINING, UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM: Well, you have to put that into the context of what goes on currently and what was going on at that point in time. At the present time, really ever since 1974, research on prisoners was no longer considered to be ethical because they were felt to be a vulnerable population.

And since that time, neither we at Penn nor anybody else, does research on prisoners. However, prior to 1974 within that time frame of the 1950s to the 1970s, it was common practice to be doing research using prisoners as a population to do that -- to do research on of all sorts with informed consent. But it was considered to be the standard at that point in time.

GROSS How informed was the informed consent at the time?

TANNEN: Well, we really don't -- we don't know that because we don't have access to the records in terms of these specific experiments. Informed consent on everybody, prisoners or non-prisoners, has become much better since that period of time.

Now in part because institutional review boards, and institutional review boards are those bodies that have to review and approve any form of research that's going to be carried out in humans, carefully review consent forms. So if you're going to do a study in this day and age on a human, the consent form is carefully reviewed by the institutional review board.

And the things that they look for are that it is full informed consent and that it's written in a way that a layperson could really understand what somebody is saying. Though standards have -- are much more rigorous than they were back, again, in the '50s and '60s.

GROSS There's a new book out about the tests that were done on prisoners through the University of Pennsylvania. And I think that's kind of reopened the discussion about those tests. And I'm wondering if it has reopened discussion at the university, or if it's having any impact on the university and its public image?

TANNEN: Well, the book is new. But the story is pretty old. And it's been in the news media and published previously so that it's not something that has just come to light.

The studies were done so longer ago they are very -- and the records are no longer available. So most people who are at the University of Pennsylvania at the present time really don't have any first-hand knowledge about what transpired. We know that those studies, however, did lead to a lot of important discoveries that were useful for treating individuals with varying types of skin diseases.

So there clearly is some benefit that came from those studies. And to view them totally in a negative light I think would be inappropriate.

GROSS Well, new drugs and new cosmetics still have to be tested. And there are still debates about what the ethics of that testing are. What are the protocols now for testing cosmetics and drugs on people?

TANNEN: Well, I can speak better to drugs because I'm more aware of that. Again, in order for a drug to be tested on people, one, if it's a new drug -- that is one that hasn't been approved -- it first has to have FDA approval to actually go into the human testing phase. That's based on there being enough animal experimentation to demonstrate that it's at least believed to be safe so that with drugs the initial testing is carried out utilizing animals.

If it passes muster in terms of animal experimentations, and the FDA feels that sufficient investigation has been done to demonstrate that the drug seems to be safe, then it goes into a human testing phase. And humans could be paid volunteers. They could be non-paid volunteers. Usually, the initial phases of testing drugs in most instances are on healthy individuals. And then it goes into the next phase of testing in individuals with disease. And the people have to be appropriately informed as to what they're taking and what the known risks, or potential known risks, of the compound are.

GROSS Your university advertises in the weekly papers here looking for people willing to participate in research trials, in drug trials. And let me read one of the ads: "Acne. Females may be eligible to participate in a research study to test a new birth control medicine for facial acne. A $300 compensation is available for those who complete the study. For more information, call the department of dermatology at the hospital."

So what are the -- how do people decide in research how much money to pay people who are willing to basically rent their bodies for research?

TANNEN: Well, one is to try to make a judgment in terms of how much time somebody will have to involve in going through a study and what may be the -- a level of discomfort that might be involved in going through a study.

The other thing is the institutional review boards do look at how much subjects are going to be paid. And they're interested that it not be so large that it would be inappropriate for what the individual is going to undertake in terms of time and effort and so forth.

GROSS If the product has more side-effects, are you likely to get more money?

TANNEN: If there's more risk?

GROSS Yeah.

TANNEN: But really the institutional review boards also try to sort out before they permit anything to be tested on humans whether or not the benefits are going to outweigh the risks, that is the benefits more generally to what the value of the drug would be to society. In terms of cosmetics, in those instances, if one view that there might be significant side effects, you probably would not approve testing such a compound because the benefits are much more marginal.

GROSS Would it be a fair argument to say that there's still a class system when it comes to testing that we're asking people like students who don't have a lot of money to rent out their bodies to test new drugs?

TANNEN: Well, to some extent. But sometimes testing goes on, for example, when you get to people who have illness -- sometimes testing goes on at the level where somebody has a serious illness where they really wish to do something that they think would be valuable for society. And they recognize -- or sometimes there are people that do it for altruistic purposes as well.

That tends to obviously be more typical in drugs that are new and that look like they may have an important, you know, beneficial effect in certain significant illnesses.

GROSS What are some of the biggest dilemmas you have faced in your years as a researcher regarding how to test new drugs and who to test them on?

TANNEN: Well, I've done some human investigation where -- and most of it has actually not been directed toward testing drugs -- so I'm not perhaps the best person to ask that question to from my own personal experience. But the dilemmas that are always faced are if you believe there is risk, does the risk -- is the benefit going to outweigh the risk?

More typically that occurs at the phase where you're utilizing drugs in people with illness. Some of the hard, difficult problems, for example, are sometimes you think you have a drug that's really going to be remarkably effective. And usually when you do appropriate studies, you have to have a control group that doesn't get the medication. And it has to be a random selection process so that somebody volunteers for the study knowing that they may get the drug and they may not get the drug.

In some instances, not giving the drug might be viewed as more of a problem than getting the drug because you may have a very serious illness where the drug may be valuable. But the difficulty is, unless you do those kinds of studies, you really don't ever know for certain whether the drug does work in the way it's predicted that it's going to work when you reach that phase of investigation.

GROSS Well, Dr. Tannen, thank you very much for talking with us.

TANNEN: Oh, you're quite welcome.

GROSS Dr. Richard Tannen is the senior vice dean of the University of Pennsylvania School of Medicine.

This is a rush transcript. This copy may not
be in its final form and may be updated.

Dateline: Terry Gross, Philadelphia
Guest: Richard Tannen
High: We invited Dr. Richard Tannen of the University of Pennsylvania to talk with us about how the protocols of medical testing have changed. Dr. Tannen is the former vice dean for Research and Researching Training, and is now the senior vice dean at the university's school of medicine. He's been at the University of Pennsylvania since 1995.
Spec: Health and Medicine; Ethics; Prisons; Testing

Please note, this is not the final feed of record
Copy: Content and programming copyright 1998 WHYY, Inc. All rights reserved. Transcribed by FDCH, Inc. under license from WHYY, Inc. Formatting copyright 1998 FDCH, Inc. All rights reserved. No quotes from the materials contained herein may be used in any media without attribution to WHYY, Inc. This transcript may not be reproduced in whole or in part without prior written permission.
End-Story: Changing Research Methods
Transcripts are created on a rush deadline, and accuracy and availability may vary. This text may not be in its final form and may be updated or revised in the future. Please be aware that the authoritative record of Fresh Air interviews and reviews are the audio recordings of each segment.