A while ago, I read this shockingly disturbing article titled “Panel Suggests Using Inmates in Drug Trials“. I was taken aback by the information thus presented and grabbed a couple of more readings, in an attempt to clarify the suffocating atmosphere this news created. The post below is the result of these readings.
In Aug 2006, a group of federal medical advisors recommended to loosen the rules and regulations surrounding the limit of testing of pharmaceutical products on prison inmates, during clinical trials.
The current regulations passed in 1978, require that prisoners may participate in federally funded clinical research given that the experiments pose no more than minimal risk. However, a report made in June 2006, by the Institute of Medicine of the National Academy of Sciences at the request of Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP), recommends the following: “clinical research involving greater risk be allowed on prisoners given that the research has the potential to benefit the prisoners. There should be an independent review ”.
The proponents of this recommendation, such as Dr. Ernest D. Prentice, suggest that prisoners should have access to medical care that is usually not available in the prisons. The pharmaceutical companies are willing to provide that access to health care given that the prisoners enroll in clinical trials that involve greater risk. The critics of this recommendation note that the prisoners are not in a capacity to make un-coerced decisions. In her article, Cheaper than Chimpanzees, Vera Sharav, a strong critic of the above mentioned recommendation notes the following:
Those who want to loosen restrictions on the use of prisoners and children in medical and behavioral high risk experiments argue that it would be detrimental to these vulnerable populations to “deprive” them of the benefits of experimental treatments that would be – or might be – beneficial to their health. When examined closely, this rationale always, or almost always, fails. The number of patients enrolled in a study of an investigational treatment is always a tiny fraction of the potential patients who may derive a benefit – IF – big if – the drug is shown to be safe. But what if the drug turns out to be lethal? Given prisoners’ fewer avenues of redress, it is not hard to see who has the most to gain from using prisoners. Investigations are continuing into a series of phase I AIDS drug and vaccine trials conducted on infants and children who were wards of the state, in foster care – some of the infants were merely “presumed” to be HIV-infected.
In the past, a lot of clinical research was conducted on prisoners. However, such research was reduced immensely in 1974, after the public found out about Holmesburg incident as well as the Tuskegee Study of the Untreated Syphilis.
The reason why this recommendation was put forward was that there was a shortage of volunteers available for clinical studies. Furthermore, the prison population has increased by 2.3 million over the last 30 years. A lot of these prisoners suffer from incurable diseases such as H.I.V. and Hepatitis C. Proponents of this recommendation think that it would be better for such prisoners to enroll in clinical trials that have a potential to benefit them. However, the critics fiercely disagree. Dr. Leodus Jones, warns us against this recommendation by reminding us of the incidence with Mr. Jones, who participated in the experiments at Holmesburg in 1966.
In my opinion, research on prisoners may only be allowed if it involves minimal research and if it is necessary to do so. It would be best to avoid conducting any kind research on prisoners.
1-Prisoners are not in the capacity to make any sort of informed and voluntary consent.
The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. Source.
In the article “Cheaper than Chimpanzees” author Vera Sharav, founder and president of the Alliance for Human Research Protection (AHRP) notes that voluntary, informed consent is impossible to get in a prison setting.
The reason prisons are shrouded in a veil of secrecy is they hide a world of institutionalized brutality and abuse-both physical and psychological. No one outside of prison walls knows what happens in a prison. Visiting outsiders – such as public officials, Congressional subcommittees, or advisory committees – have no inkling about the level of fear, intimidation that prisoners are subjected to. Prisoners are not rehabilitation centre; they are places that breed hardened criminals. Source
2-The history of prison abuse by pharmaceutical companies just shows that it is impossible to conduct any sort of clinical research on prisoners without rudely overriding certain legal and ethical regulations.
One only needs to look at the Holmesberg incidence to figure this much out. Anybody who intends to decide otherwise, must read”Acres of Skin: Human Experiments at Holmesburg Prison” by Allen Hornblum, before making any sort of decisions.
Chapter 1: “The Money was Good and the Money was Easy”
They marched six of us, three blacks and three whites, all the same age, late twenties-early thirties, into this one room of the trailer. They told us to strip down and put on these white, cotton pullovers with three-quarter sleeves and elastic bands around the waist. Some of us were getting pretty nervous now, especially when we saw the syringes on the table.
I never did drugs, it wasn’t my thing. I was into chasing women and crime, but no drugs. Good looking women and nice cars, that’s how I got my high.
The attendants all looked professional in white smocks and stethoscopes. They lined us up and gave us our shots. I learned later that the shot I got was based on my height and weight. One of the doctors told us to go into the rec room and relax. I went in and sat down on some plastic furniture. There was heavy padding under the shag rug on the floor. I felt fine. I picked up a pack of playing careds that was on the table and asked another guy, “Do you want to play some gin rummy?” He said, “Okay, “and as I dealt the cards I could feel it coming on. The room started to spin around. I looked at my hand, and it looked like there were 30 or 40 cards there.
It was only three to five minutes after the shot, but I was on a real trip. I started to see double and triple, and the room was really spinning pretty good. I went back to when I was four or five years old and playing with little kids. Then I was about seven years old and going to school and I was in a classroom with all the other little children I sued to know. All the old faces came back to me. Then I went from 7 to 14 o r 15 and my first serious girlfriend. We were going to dances, making out in the back seat of the car. I took me right up until my twenties. I t was a good trip….
….In 1963, Zabala was imprisoned again, this time in Philadelphia. Jobs in jail were rare, competition for them was tough, and the pay was poor. “My first jail job was as a good in OBS (the Psychological Observation Unit). I put straightjackets on the patients in the Holmesburg’s psych unit. I soon heard about the UofP (Universtiy of Pennsylvania) studies and the good pay they offered. They had all kinds of tests-foot powder tests, eye drop tests, face creams, underarm deodorant, toothpaste, liquid diets, and more. It was easy money. You could make $10 to $300 a test depending on how long it lasted.”….
….”Lots of men were burned or scarred and wanted to sue, but they had signed releases and waivers and thought they couldn’t.” Zabala says. He, too, came away with a prominent scar, a permanent reminders of his days as a “Chemist” in the UofP research unit. His account fo that incident is interesting for the light it sheds on the wide latttitude given to inmates workers in the clinical research program. He quotes “We were given jars marked A, B, C, D…with percentages of 2%, 8%, 4%…We had to mix the creams together and then put them on the inmates. This one time, I got the job to mix the chemicals for the test and I wasn’t paying attention to what I was doing. But I still had the sense to test it on myself (before I used it) and it burned a hole the size of a thumbnailin (the skino f) my right forearm. It hurt like hell. If I (had) put hat stuff on an inmate, he would have come back at me with a pipe or a shank”.
….”I was scared of other tests,” recalls Zabala, “medications and eyedrops (with) no labels on them. They looked nasty. “Zabala put aside his reluctance to try anything other than topical ointments whtne he heard talk around the prison that a special study for the Army was starting and that the pay would dwarf anything the subjects had sense so far. A volunteer could make somewhere between $10000 and $1500. Zabala decided to check it out.
He was given a “15 minutes interview (in which) white-coat professionals from the University of Pennsylvania asked questions about his age, place of birth, family history of mental illness or health problems”. A couple of weeks later he was asked to fillout a three age questionnaire and was surprised to received $25. That was followed by a second interview with a psychologist and psychiatrist and an additional $50. Zabala felt he was making out pretty well and he hadn’t done anything yet. “They were sucking (e) in with all the money,” he says.
3-The scientific information collected by running clinical trials on prisoners will not be valid enough.
Prisoners admitted that they were not always passive “guinea pigs.” They cheated with “patch tests,” which they could easily take off upon return to their cells, and with liquid diet tests, which they could supplement with contraband food. Yet, surprisingly, no one seemed to care about these insults to study protocol, nor did scientists ever question their “trust” in confined subjects, which is necessary for the conduct of valid and reliable research. Prisoners could also bargain for more pay. For example, when they were offered $50 for having their nails pulled out, they demanded (and obtained) three time more per nail after experiencing excruciating pain. Source
4-Given the conditions the prisoners live in, the compensation granted to the prisoners will always be considered as a lottery and hence coercive.
For example, Holmesburg inmates tell us of the endless financial opportunity that prison research offered: “Everyone wanted to get on the gravy train.” One inmate recalled that he could not remain immune to the lures of the testing program despite potential danger: “It was something to do, the best game in town. The money was good and the money was easy.” First, he tried a deodorant test and chose the one he thought had the least chance of harming him. He went on to test hand and body lotions and began to realize the full financial potential of the test program: “You could be making $300 to $400 a month.” He ultimately volunteered to a special study conducted by the US Army: “I was given ‘a talk’ that described a test of “experimental stuff,” but nothing too specific. I believe I received an injection of a substance ‘ten times stronger than LSD.’ Except for the “trip” he has no recollection of his actions during that period. He explained that despite occasional “strawberry rashes,” overall, he felt fine, helped by the fact that he walked out of Holmesburg “$1,500 richer because of the drug study.” Compared with the 15 cents a day prisoners were paid to make shoes, knit socks and shirts, sew trousers, and work in the plumbing shop, the appeal of big research money was enough “to tempt and convert anyone, including those opposed to human experimentation.” Apart from money, inmates also expected better food, cleaner, safer and more comfortable living conditions, a brief reprieve from the eternal boredom of prison confinement and from threats of violence, and a sentence reduction. There were also altruistic feelings of doing something worthwhile. Source.
5-Even the current research regulations adopted in 1978, are not enough to prevent prisoner abuse. Just imagine what will happen if the current regulations are loosened! We should be working towards making the current regulations and oversight more stringent, not loosening them.
Vera notes in her article “Cheaper than Chimpanzees”, that a four part investigation series by Mike Ward and Bill Bishop in the Texas Statesman, revealed that the University of Texas Medical Branch was conducting abusive and coercive clinical trials on the Texas prisoner population. During this clinical research, UTMB violated the federal research regulations pertaining to both prisoners and children as well as basic human research protection laws.
A four part investigative series, “Sick in Secret: The Hidden World of Prison Health Care,” by Mike Ward and Bill Bishop in the Texas Statesman (December 2001-2003) uncovered a covert, interlocking system of abuse in the Texas prison health care system operated by the University of Texas Medical Branch (UTMB) since 1993. UTMB is charged with providing care to 80% of the 146,000 inmates in the prison system, Texas Tech is responsible for the remainder. UTMB continues experimenting on prisoners, apparently ignoring the federal prohibition on the use of prisoners in medical experiments unless they “have the intent and reasonable probability of improving the health or well-being of the subject.” Absolute, impenetrable secrecy surrounds the Texas prison health-care system. Texas law (1999) precludes anyone from monitoring the quality of care provided by the universities. This insular, publicly financed health care system has become a $297-million-a-year business that is immune from any public scrutiny. UTMB is accountable to no one, it is essentially free to cover its tracks and bury its failures as well as its dead bodies with complete impunity.
The Texas Statesman series provided documented evidence of how UTMB operated a two track health care system of vastly unequal quality. UTMB’s two track system of care ensure that prisoners will seek better care at the University’s Galveston branch to avoid being maltreated in sub-standard prison clinics, where their lives are put at risk. But to gain access to UT hospital care there was a hitch: prisoners had to become human subjects in experimental drug trials. Advertisements at UTMB’s public hospital in Galveston promised free treatment to those who enroll in research trials. UTMB has run thousands of clinical research trials and its Office of Clinical Trials boasts that one of the “special features” available at UTMB is the prison hospital, and the tens of thousands of Texas inmates who look to that hospital for medical care. Texas Tech University does fewer. The Statesman reported that until late 2000, “UTMB conducted dozens and possibly hundreds of trials without telling state prison officials what it was doing – violating a longstanding prison system rule.”
In 1998, doctors retained by plaintiff lawyers reviewed the medical charts of inmates who had died and others who suffered from chronic conditions such as HIV, diabetes and cancer. The doctors found that that 20 of the 59 inmates whose charts they examined who died received “poor” or “very poor” care. And 16 of those 20 deaths were either “preventable” or “possibly preventable.” As recently as March, 2001, a prison review found that half of the prisoners discharged from prison clinics and hospitals had incomplete documentation, and one in every 10 required “emergency, acute care or readmission following discharge.”
An investigation of UTMB in January 2000 by OHRP found that in 220 protocols prisoners were included – among these 95 were federally supported projects. In a letter of determination, OHRP ordered UTMB to “Suspend immediately involvement of prisoners in any federally supported research subjects that have not satisfied all requirements of HHS regulations.” It is clear from OHRP’s letter of findings that UTMB violated federal research regulations pertaining both to restrictions on the inclusion of prisoners, and those involving protections for children, as well as basic human research protections. The UT IRB summarily approved inclusion of prisoners in research involving greater than minimal risk not intended and with no evidence to demonstrate “reasonable probability of improving the health and well-being of the individual subject.” The IRB failed to meet its legal responsibility by failing to review research it approved, and failing to ensure and document that informed consent had been obtained. Some consent documents included exculpatory language which stripped prisoners of their legal rights, and UTMB attempted to renounce its regulatory responsibility to provide follow-up care necessitated by participation in research. A follow-up letter, September 14, 2000, expanded in greater detail on the IRB’s failings. Source.
In conclusion, it would be retarded to loosen the regulations on clinical research involving vulnerable populations such as prisoners. There is a strong need to increase oversight and tighten the original regulations, not loosen them. As we can see from the above mentioned post, oversight by the IRB and government has not been enough to protect both the safety of human research subjects. I agree with the recommendation offered by AHRP IF the current regulations are not loosened.
AHRP offers the following recommendation to fill the gap in the current system. What is missing in the current research oversight system is a mechanism to ensure independent checks and balances. Our recommendation follows from the model proposed in 1973 by the Department of Health Education and Welfare,[28] but never adopted. We recommend that for each medical trial in which vulnerable populations such as prisoners and / or children are sought as research subjects, a court-appointed, independent Research Protection Committee (RPC) should be provided to serve as advocates for such subjects throughout the process. The RPC would have authority to decide whether the trial was in the individual subject’s best interest, monitoring the selection of subjects, assessing their uncoerced willingness to participate – in the case of children, assessing the reasonableness of parental permission to ensure no extraneous enticements have been offered. The RPC would assess the adequacy of disclosure in informed consent documents, and monitor the well-being of the subject and his / her continued willingness to participate. Source
References:
1-Acres of Skin—An Excerpt. By Allen Hornblum. Routledge; 1 edition (April 12 1999)
[URL:http://www.amazon.ca/gp/reader/0415923360/ref=sib_fs_top/186-3927384-1005121?ie=UTF8&p=S00P&checkSum=liqVIfQYQ%2FfkOpgIuKuQrrdOqlbK2uUER4OnIarLRNw%3D#reader-page]
2-Cheaper than Chimpanzees. Statement before the Committee on Ethical Consideration for Revisions to DHHS Regulations on Protection of Prisoners Involved in Research. By: Vera Hassner Sharav. Alliance for Human Research Protection. 2005.
[URL: http://www.ahrp.org/testimonypresentations/CheaperThanChimpanzees0705.php]
3-Involving Prisoners in Drug Trials. Health Law Prof Blog. 2006
[URL: http://lawprofessors.typepad.com/healthlawprof_blog/2006/08/prisons_and_hum.html]
4-Review of Acres of Skin: Human Experiments at Holmesburg Prison. By Allen M. Hornblum. 1998. Journal of Criminal Justice and Popular Culture, 6(1) (1998) 4-9
[URL: http://www.albany.edu/scj/jcjpc/vol6is1/shuster.html]
5-Using Inmates as Medical Guinea Pigs. By Jeralyn. TalkLeft, the Politics of Crime. 2006.
[URL: http://www.talkleft.com/story/2006/08/13/382/14475]
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