Right To Consent?
Prison Experimentation Has a Dark Past That Weighs On Future Research Involving Inmates
After some years on the back burner, the question of using prisoners as subjects in biomedical and behavioral research heated up again in 2006 with the publication of the Institute of Medicine report, Ethical Considerations for Research Involving Prisoners. The IOM had been asked by the federal Office for Human Research Protections of the Department of Health and Human Services to review federal regulations on prisoner research, last updated in 1978.
The basic federal rules for protecting research subjects, known as The Common Rule, are contained in Subpart A of Title 45 Part 46 of the Code of Federal Regulations (45 C.F.R. 46). Subsequent subparts spell out more specific rules for protecting vulnerable populations, such as children, fetuses, pregnant women—and prisoners, whose protections are detailed in “Subpart C”.
Subpart C’s regulations are highly restrictive, but they only apply to federally funded research carried out by three federal agencies under the jurisdiction of OHRP, excluding 14 others, including the Department of Justice’s Bureau of Prisons (BOP).
Redefine the term prisoner to expand the reach of human subjects protections. (4.1)
Ensure Universal, Consistent Ethical Protection
- Establish uniform guidelines for all human subjects research involving prisoners. (3.1)
- Maintain a public database of all research involving prisoners. (2.1)
- Ensure transparency and accountability in the research enterprise. (6.7)
Shift from a Category-Based to a Risk-Benefit Approach to Research Review
- Apply a risk-benefit framework to research review. (5.1)
Update the Ethical Framework to Include Collaborative Responsibility
- Use a collaborative research approach. (5.2)
- Ensure adequate standards of care. (5.3)
- Support critical areas of correctional research. (5.4)
Enhance Systematic Oversight of Research Involving Prisoners
- Strengthen monitoring of research involving prisoners. (6.3)
- Modify institutional review board considerations for independent ethical review of research protocols. (6.4)
- Enhance the Office for Human Research Protections’s capacity to provide systematic oversight of research involving prisoners. (6.5)
- Establish systematic oversight of all research with prisoners. (6.6)
- Ensure voluntary informed consent. (6.1)
- Protect the privacy of prisoners engaged in research. (6.2)
At the outset, the IOM report acknowledges that “[p]risoners have been exploited in the past, carrying a heavier burden of the risks of research than the general population.”
The IOM report argues for jettisoning Subpart C’s categorical restrictions on research with prisoners, favoring the adoption of new regulations permitting prisoner research to proceed. The proposed new regulations would clarify when such research might be appropriate (see sidebar). Such clarity would come, says the IOM, from better defining what is meant by “prisoner” and by adopting regulations for all sorts of prison research, regardless of the source of funding.
Arguing that categorically shutting prisoners out of research merely compounds their vulnerable status, the IOM would have regulators decide the appropriateness of including prisoners in research protocols on a case-by-case basis, weighing the risks and benefits in each instance. To assist in such calculations, the IOM calls for bolstering oversight mechanisms and including prisoners’ representatives in the deliberations.
At the outset, the IOM report acknowledges that “[p]risoners have been exploited in the past, carrying a heavier burden of the risks of research than the general population.” (p. 2) “Throughout its deliberations, the committee was well aware of the dark history of research involving prisoners.” (p. 3)
Temple University’s Allen Hornblum, whose writings are among those cited at the end of each of the forgoing sentences, has spent much of his academic life illuminating this dark history. His overview of the sorry history of prison research appeared in the British Medical Journal. He focused on the scandalous and shameful use of prisoners in decades of research at Philadelphia’s Holmesburg prison in his 1998 book, Acres of Skin. In his latest book, Sentenced to Science: One Black Man’s Story of Imprisonment in America, Professor Hornblum returns to Holmesburg to zero in on the story of a single prisoner’s life as an experimental subject.
In an epilogue to Sentenced to Science and in this Science Progress interview with Jeff Stryker, Allen Hornblum explains why he “begs to differ” with the IOM report and how he reads the lessons of history differently.
(Full disclosure: Jonathan Moreno, Editor-in-Chief of Science Progress, was a member of the IOM report committee, and is the author of Undue Risk [Routledge 2001], a history of human experiments conducted for national security purposes. The committee heard testimony from both Allen Hornblum and Anthony Edwards during its deliberations.)
Science Progress: This is a story about one man’s imprisonment. Could you summarize Edward Anthony’s criminal career before we get into his experience as a research subject?
Allen Hornblum: Eddie Anthony grew up in the Village, a tough Black neighborhood in North Philadelphia. He grew up in a large family, with hard-working, church-going parents. But he went in another direction. He got into alcohol, was introduced to pills and codeine, and by the time he was a teenager, he was shooting up heroin. He started to commit various low-level crimes to pay for the drugs. He wasn’t out to hurt anybody. He would steal packages of beef or meat and then sell them on the street, just enough to get another hit or two of heroin. He was about 20 or 21 when he ended up in Holmesburg Prison and first saw the clinical trials taking place there.
It looks pretty forbidding, just from the aerial photo you have in the book.
Yeah. It’s a pretty scary place. It was built in the classical spoke-and-wheel design back in the 1890s and there’s a good many horrendous stories of things that happened there. One of the longer-running ones was the use of the facility to become what I would call the “Macy’s of human experimentation.”
Others said that they had put so many things in their veins already, so being exposed to something else was no big deal.
I first walked into Holmesburg about 1971-72 as an adult literacy teacher. It gave me a shot in the solar plexus to see dozens and dozens of inmates wrapped in bandages and gauze pads and all sorts of medical tape. It looked like they had just had a gang war or some really nasty knife fights in the prison yard. I asked the guard. He said, “Oh, that’s nothing, just the perfume experiments for the University of Pennsylvania.” I just could not fathom that these men, who were pretty nasty and smelly, were testing perfumes. I continued to pepper the guard with questions. “This is a way the inmates make money, they give their skin up,” he said. “You and I wouldn’t do it, but these inmates are crazy. They’re desperate for money, and they rationalize that the University of Pennsylvania and the doctors involved are top-notch.” He said the experiments had been going on for twenty years. I was new, not the experiments.
Everybody took them for granted. I asked the inmates. “What kind of test are you on? How does it affect you? Does it burn? Does it hurt? How much money do you get? How many days?” Some of them were quite frightened of the tests, wanted nothing to do with them. Others said that they had put so many things in their veins already, so being exposed to something else was no big deal. There were all gradations of faith and logic.
The vast majority of experiments were patch tests where all sorts of chemicals and potions were being applied to the inmates. Others were being injected with things. Others were wearing little metal cubes on their foreheads, their armpits, their groins. All sorts of things were taking place in there. It really was a pretty bizarre experience. And that went on from 1951 until about mid-1974.
And these were all hosted or facilitated by the University of Pennsylvania?
You have to understand that Holmesburg Prison probably was the largest human experimentation facility in Cold War America. The doctor in charge, [now retired] Penn dermatologist Albert Kligman was doing Phase One experiments with all sorts of chemicals and potions. He took contracts from all sorts of private and public sector entities: Dow Chemical, the CIA, the Army, and R. J. Reynolds are just a few examples. It was a three-ring circus of investigatory opportunity for doctors and organizations wanting to test on prisoners. Penn and Holmesburg had developed a national reputation in the field of clinical trials. This was the place to come, particularly if you had something that was very potent, unsavory, or dangerous.
And this was basis for your first book on prison experimentation, Acres of Skin?
I spent five years tracking down inmates, doctors, medical assistants and technicians—anybody who had some involvement with the Holmesburg experience. The book got a lot of publicity when it came out in 1998. Former inmates came out of the woodwork, including many I wasn’t able to track down during my initial research. These guys started meeting, initially as a self-help group. Eventually they organized their own campaign to try to achieve justice.
I would periodically bring one or two of them into my classes at Temple. Edward Anthony was someone who had a particularly chilling story to tell. He wasn’t a trained public speaker, but his story really resonated with the students. Eventually I realized I could reach more people if I focused on one person as a narrative, in contrast to Acres of Skin, which is more of an academic overview.
Your descriptions of prison conditions are harrowing. They seem to aimed at explaining why, after literally being burned as an experimental subject, he opted to get involved a few more times.
Edward Anthony’s first test was a skin patch test. He wasn’t getting money from his family. So, needing cash for commissary items and toiletries, but afraid of the tests, he asked his cellmates about the safest test. They encouraged him to get on a skin patch test for—I think it was Johnson & Johnson shampoo or bubble bath.
It didn’t seem like bubble bath.
Not from the reaction he had. He went down to H Block where they turned a cell block into a facility for experimentation. They took off six patches of skin, using scotch tape to take off the first layer of skin. They applied medication on a piece of gauze pad and then they taped that to his back. Almost immediately, Anthony felt and tasted this chemical that they sprayed on his back to hold this large tape mechanism, and he gradually got very dizzy from that. By the time he got back to his cell, he passed out completely, smashed his head on the ground and was eventually revived by his cellmates.
The pain got progressively worse, and by the next day he had these blisters on each of these six sites, these puss-filled blisters. Over the course of the next 24, 48 hours, as he says, he turned into a Black man who looked like a strawberry. His became very, very red and inflamed, with pain and itching in his armpits and his groin. He couldn’t kill the pain. And this went on for a couple weeks. He was all broken out now with little white puss bumps all over his body. He couldn’t sleep at night and was moaning constantly. It got so bad that he was threatened when he went to the chow hall because he looked like he had some sort of bubonic plague. The other inmates said that if he got too near, they would beat the hell out of him.
He was finally visited in the middle of the night by a doctor who took him back to H Block and shot him up with something very potent, I’m presuming morphine, bathing his body in some sort of medication until gradually the situation receded.
Mr. Edwards’ involvement raises questions of medical ethics about payment and inducement and coercion and whether it’s ever possible to do a proper experiment in a prison setting. But for most readers, the biggest question would be, why on earth would he go back for more?
Oddly enough, yes, he subsequently went back for other tests. You have to realize what goes on in a maximum-security urban jail like Holmesburg. There was a tremendous amount of violence, with threats, fear, stabbings, periodic killings, a lot of rape and other sexual assaults. The men felt that having money on the books was one way to be protected. So, he was talked into doing another test and another and another. Some were pretty innocuous, but others really wrecked him, such as the psychotropic drug study for the Army.
What were the Army experiments?
Some of the more serious things were kept secret, not only from the inmates, but from the other people who were employed as medical staff.
Prison jobs paid maybe 15 to 25 cents a day. But being a guinea pig for the University of Pennsylvania could get you a dollar a day, a dollar and a half a day, possibly more for the Army experiments. These started in 1963 and lasted into the 1970s. They were basically a continuation of the U.S. Army’s Chemical Corps work at Edgewood Arsenal, Maryland. For years the Army had been doing experiments at Aberdeen Proving Ground using all sorts of chemical concoctions on inmates. They were looking for chemical incapacitants, things they could spray or give to a foreign enemy that would knock them out of commission.
The Army contacted Dr. Kligman in 1963 about collaborating. As usual, Dr. Kligman said, sure, why not, especially when he heard that there could be some serious money procured from it. Eventually the Pentagon spent hundreds of thousands of dollars, setting up three metal trailers between G and H Block to perform psychotropic drug tests on the inmates.
Edward Anthony was one of the test subjects. And he only went through a very initial phase of it. But it affected him greatly. Whatever the drug was—and it is not clear exactly what he got—did have serious impact on him. He went into a very striking depression, becoming extremely paranoid. He no longer communicated with his cellmates or anybody else on the cell block. Formerly a very upbeat, outgoing guy, he withdrew. He became afraid of people. He attacked another inmate because he thought he was going to be attacked. Eventually he became such a strange character the inmates dubbed him Outer Limits. His acting out on the drugs got him thrown in solitary.
And you never found out what the specific drug was?
No, the inmates were not always told, or what they were told turned out to be inaccurate or downright deception.
I obtained government documents showing that inmates received injections of radioactive isotopes as well as dioxin in experiments for Dow Chemical. It’s the only case I know of where humans purposely had dioxin applied on their faces, foreheads, and backs. Yet not a single inmate I interviewed ever knew about either the radioactive isotopes or dioxin. Some of the more serious things were kept secret, not only from the inmates, but from the other people who were employed as medical staff.
Did the inmates sign consent forms?
Early in the ‘60s there were no consent forms or at best they were merely waivers, signing away the rights to sue the prison, the university, or Dr. Kligman. As human subjects protections evolved in the outside world, by the late ‘60s and early ‘70s, there were more extensive declarations about medical experiments. But remember that most of these men had dropped out of high school and often had an abbreviated vocabulary. If you told them they were getting an analgesic, for example, they wouldn’t even know what that was.
I take it that their efforts to sue were pretty much unavailing?
When you go through some of the things he did, you know, for all your efforts you can’t jettison it.
Their first attorney tried unsuccessfully to cut some kind of deal with the city, the University of Pennsylvania, Dr. Kligman, and a couple of big corporations. But it came to naught and she didn’t even file a lawsuit. Subsequently, when another attorney did file suit, it was barred by the statute of limitations. There were hearings before city and state legislators and talk about helping the prisoners, but it never amounted to more than lip service. This whole experience gave the prisoners a sour perspective on the judicial system in this country to go along with their tremendous distrust of doctors and hospitals.
How’s Mr. Anthony today?
He occasionally is hearty and seemingly robust, but he’s got lots of medical problems. His hands blow up periodically on him. Other days he’s tremendously weak and has difficulty getting out of bed or functioning. He was recently diagnosed with prostate cancer. He’s been going to a mental health center facility for many, many years, diagnosed as paranoid schizophrenic. And it’s a shame, because when he’s feeling good, he wants to work and really can put in a hell of a day. But there are many days where he’s just really strung out physically and emotionally.
When you go through some of the things he did, you know, for all your efforts you can’t jettison it. That was one of the problems initially when I started bringing him to my classes. It brought back such bad memories. He couldn’t sleep before a class; he couldn’t sleep after a class. He really didn’t want to do it. But he realized people needed to hear his story.
Now that his story has been told, what does it mean for those concerned about research on prisoners today?
Going back into prison is a problematic venture. I would not only caution those leaning that way, but vociferously argue that we should follow the Nuremburg Code. As I read it, it basically states that if you are in a confined, constrained environment such as a prison you shouldn’t be used as a test subject for invasive medical procedures and experiments.
I suppose the folks behind the IOM report might say that line of reasoning denies the prisoners’ autonomy and takes away their choice to participate. How do you feel about research that involves prisoners’ actual medical problems, especially conditions more prevalent than in the public at large, say HIV or hepatitis C?
I believe that doing experiments in prisons is a risky, dangerous initiative. It should not be done. In theory, on paper, it looks viable. But as somebody who has spent years working in prisons, who has been in prisons all over the world, it is not something you want to risk doing in that sort of environment.
Take them out of the prison and put them in a hospital. What’s holding them back from doing that?
If people are so interested in protecting and safeguarding the health of prisoners, take them out of the prison and work with them in some other facility, such as a hospital. To think they want to do these cutting-edge medical research projects in prison really does not pass the smell test with me, because the vast majority of these prisons have absolutely putrid medical operations. These prisoners can’t even get aspirins. You mentioned hepatitis. There are cases where prisons just stopped doing tests for hepatitis C—they were finding too many inmates testing positive and it just cost too much. So they decide: don’t look; don’t find; don’t do; don’t spend. When I hear all of a sudden that researchers want to do cutting-edge experimental procedures, it does not ring true to me. There may be some people who have some altruistic goals and motives, but my experience of working in prisons and researching this issue lends me to believe it probably should not be done.
What about better oversight, including having prisoner representatives on the review boards?
The notion that you could have a series of safeguards—running the gamut from having a prisoner on the IRB [institutional review board] to making sure that no one knows who is HIV positive or a study subject—these just don’t not work in the prisons that I have been. Information travels very quickly through a prison.
Are you heaping more on the Holmesburg experience than it can bear? It seems to be the very worst of the prison experimentation experience. Could it be a mistake to extrapolate too far from the Holmesburg situation into the present day?
For those people who want to get research back in prisons, obviously, it is. From my perspective, no. You have the same population in prisons now as you did a quarter century ago.
What about the arguments from the AIDS era that access to clinical trials is itself a human right? What about inmates who are ill and have problems that can only be addressed by experimental therapies?
Take them out of the prison and put them in a hospital. What’s holding them back from doing that? Money. Money.
So, it still all comes back to money?
Absolutely. This is an ongoing story. Money drives this train.
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