Stanford University Drug Test on Incarcerated Juveniles 1997-1999

Below a group of press reports about an untehical Stanford University experiment which we presented in our testimony before a panel of the Institute of Medicine 

See:  http://www.ahrp.org/testimonypresentations/CheaperThanChimpanzees0705.php

Contact: Vera Hassner Sharav
veracare@ahrp.org
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http://www.nytimes.com/2006/08/13/us/13inmates.html?_r=1&oref=slogin  
August 19, 1999
Psychiatric Drug Tests May Violate Law
Officials in California said tests of psychiatric drugs conducted on teenage inmates may have violated a state law, the Associated Press reported Aug. 17, 1999.

The tests were conducted in 1997 by Stanford University researchers on 61 inmates ranging in age from 14 to 18 at a California Youth Authority (CYA) correctional center. The teens, who were convicted of violent offenses, were given varying dosages of Depakote, a prescription drug used to control epileptic seizures. The intent of the study was to see if the drug made the inmates less aggressive. According to J.P. Tremblay, assistant director of the CYA, the tests were conducted without the knowledge or approval of CYA Director Greg Zermeno or his legal office.

State law bans medical research on prisoners. But Stanford University officials contend that the research complied with state and federal laws and posed "a low risk and direct benefit" to the inmates.
The matter is being investigated by the state attorney general and inspector general.
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After a Drug Study, Questions
A Stanford study of a powerful psychiatric drug may have violated one of several conflicting laws governing research on prisoners, California Youth Authority officials say. In the 1997 research, conducted jointly with the CYA and led by psychiatry professor Hans Steiner, 61 boys held at the state correctional center in Stockton volunteered to take the drug Depakote. Investigators wanted to know if the drug would make the 14- to 18-year-olds less aggressive. CYA officials now acknowledge that the study was probably "not in compliance" with a state law prohibiting medical research on prison inmates. Stanford says doctors followed thorough procedures to make sure the study was permitted and that the volunteers were safe.

Science, Vol 285, Issue 5432, 1337-1338 , 27 August 8, 1999
News of the Week
RESEARCH RISKS:
California Probes Prison Teens Study
Marcia Barinaga

BERKELEY, CALIFORNIA–A study in California of an antiviolence drug given to incarcerated teenagers, which was recently hailed as a model for work with such a rarely studied population, is now under attack for possibly violating laws to protect inmates involved in medical research. The investigation centers on whether the research met legal requirements that all inmates in a study have a reasonable chance of benefiting from their participation.

http://www.motherjones.com/news/mustreads/1999/08/081699.html
MOTHER JONES
Teen inmates were psych guinea pigs
Aug. 16, 1999

A Stanford University professor was allowed to test a powerful psychiatric drug on young inmates at a state correctional center in California, reports THE LOS ANGELES TIMES. Over an eight week period in 1997, Depakote — an anti-seizure drug often used to treat epilepsy and mania — was administered to 61 male inmates between the ages of 14 and 18 to see if the drug would reduce their aggression levels. The experiment is now being investigated by the California Youth Authority (CYA), the state attorney general, and the state inspector general. California law dictates that "no biomedical research shall be conducted on any prisoner in this state"; a second law, however, states that prisoners can be administered drugs only available through studies if it is in "the best medical interest of the patient." The debate will likely focus on whether the testing was in the teenagers’ "best interest."

All of the juvenile inmates signed a consent form agreeing to participate in the trial, which was partially funded by drug maker Abbott Laboratories. Under federal law, Stanford is responsible for ensuring that their research meets federal and state laws. However, the CYA "admit[s] that their system for protecting the teenagers they imprison broke down," according to the Times. Robert Presley, California’s top correctional officer, said that such testing would not occur again in the state’s prisons without being approved by the governor and codified into law. "In the legal sense, and maybe in the moral sense, we missed the boat on this one."

http://www.motherjones.com/news/mustreads/1999/08/081699.html
Tuesday, August 17, 1999 Laredo Morning Times
Tests on teen inmates eyed
BY DOUG WILLIS
Associated Press Writer
SACRAMENTO, Calif. (AP)

Stanford University tests of a psychiatric drug on 61 teenage inmates may have violated a state law banning medical research on prisoners, state officials said Monday. The tests were conducted over eight weeks in 1997 at a California Youth Authority correctional center in Stockton on inmates ages 14 to 18 who were convicted of violent offenses.

They were given varying dosages of Depakote, a prescription drug used to control epileptic seizures, to determine whether it made them less aggressive. There is no evidence any of the youths suffered ill effects from the experiment, such as vomiting, hair loss, depression or other side effects associated with the drug, said J.P. Tremblay, assistant director of the California Youth Authority. But the tests were conducted without the knowledge or approval of then-CYA Director Francisco Alacorn or his legal office, and the tests may be a violation of state law, Tremblay said.

“The process fell down here. But the idea was not necessarily bad,” added Lisa Beutler, undersecretary of the Youth and Adult Correctional Agency. She said researchers could
find medication to reduce violent tendencies. In a statement, Stanford said university officials took steps to make sure the study posed “a low risk and direct benefit” to the inmates and complied
with state and federal laws. The question of legality is cloudy because there are conflicting laws, Ms. Beutler said.

One says that “no biomedical research shall be conducted on any prisoner in this state.” But a separate law, written for inmates with the AIDS virus, lets prisoners take experimental drugs if they are in “the best interests of the patient.” Gov. Gray Davis has asked the state attorney general and new inspector general to investigate.

Current CYA Director Greg Zermeno, who learned about the tests a few weeks after taking office earlier this year, also said he was taking steps to assure similar tests will “never happen again.”
Also under investigation is how consent was obtained. The teen-agers volunteered for the Depakote study, and officials mailed consent forms to parents. But in some cases in which parents didn’t respond within 30 days, the CYA gave consent on behalf of the parents, Tremblay said.
 
You Can’t Be a Sweet Cucumber in a Vinegar Barrel:
A Talk with Philip Zimbardo in Edge, January 19, 2005

Why Americans Should Care

It’s also very important for me, as somebody who’s been interested in prisons for a very long time, to make sure that we don’t see Abu Ghraib as an exotic Middle Eastern prison that is the only place where these terrible things happen. It may not be as extreme, but terrible things happen in prisons in our own country.
Right now there is an investigation of deaths of American Indians in prisons on Indian reservations. There are a large number of what the media calls "strange" circumstances of death. There’s another investigation at the California Youth Authority concerning adolescents who were put in animal cages and drugged over long periods of time so that it would be easier for the guards to control them. At Pelican Bay, a maximum-security prison in California, prisoners are put in extreme solitary confinement units for 23 1/2 hours a day for five or ten years on end in which they never get to see another human being.

One of the issues that society has to face is, if we ever let any of these people out, are they likely to be more or less dangerous to society than when they were put in? The answer is obvious. If you put kids in animal cages and drug them, when they get out they’re going to be more like animals. If you put people in solitary confinement where they never interact with other people, how are they going to be able to interact on any normal basis when they get out? Prisons have lost any semblance of being places of rehabilitation. They are places of punishment and abuse.

Society never gave guards or prison administrators permission to do these things. Society says that if people break a law, they should be separated from the community for a certain amount of time. Period. That’s what a sentence is. It’s only in capital cases that we go one step further and kill people. We don’t say that convicts should be abused or should be put in places that degrade and dehumanize them, because we want them to come out and not go back. The fact that recidivism rates at most prisons are 60% and higher is evidence that this system doesn’t work. In addition, the second offense is likely to be more severe than the first. This means that prisons are places that breed crime and evil. This is not what society wants.

The bottom line is that nobody really cares what happens in prison. Nobody wants to know. Prisons are the default value of every society. We just want to dump convicts there, and let them come back and be good people. We only care about rapists and child molesters, so we want to keep track of them when they get out. For everybody else we don’t want to know. We assume they go to prison, we’d like to believe they get rehabilitated, and when they come back they work in society. But from everything I know, most prisons are places that abuse prisoners, making them worse. They make them hate, make them want to get back at the injustice they’ve experienced.

All prisons are cloaked in a veil of secrecy. No one knows what happens in a prison. And when I say no one outside the prison knows, I mean mayors don’t know, governors don’t know, presidents don’t know, and Congressional subcommittees don’t know. Prisons are huge places, and if you just walk in you wouldn’t know what to see. They could direct you to one part of the prison where everything is clean and rosy and nice, and the prisoners are eating steak for your visit. Prisons have to lift the veil of secrecy. The media and lawyers have to have access to prisons.

None of that was true in Abu Ghraib. After a while the Red Cross was prohibited from coming in, because the Red Cross issued reports months before any of these exposés. Once you have a prison shrouded in secrecy, everyone in the prison knows there’s no accountability outside. And then again, just as in my study of vandalism in the Bronx, nobody cares. Once you have that mentality as a guard or a prison administrator, you say, "We don’t really care what happens in prison, as long as it doesn’t go too far. We don’t want the prisoners to be killed. We don’t want them to be extremely tortured. And obviously we don’t want pictures of it thrust in our face on the evening news while we’re having dinner. But short of that…"

And it’s true. Now, one of the counter-reactions to Abu Ghraib is that by forcing us to look at these things, the whistle-blower almost becomes the culprit. We knew torture was going on at some level, and we knew it was important to get information from these bad people, but we just didn’t want to know how bad it was, how far the soldiers had gone, and how far over the line they had stepped.
That’s really something that every American citizen has to think about. Prisons are our property. We pay for everything in that prison. We pay all the guards’ salaries, the superintendent’s salary, and the warden’s salary. The whole thing comes out of our tax dollars and we have to care. If the money is not going to rehabilitate prisoners, that means that when these people come out they’re going to be attacking, murdering, stealing from us, doing all these terrible things again and again. Who wants to keep paying for that?

Not only do we have to care about what we do in prisons in America, but we also have to care what Americans do in prisons anywhere in the world, because it sends not only a political message, it sends a moral message. One of the worst things about Abu Ghraib is that we have lost any sense of moral superiority that America ever had. Those pictures will be with the world for decades to come. We can say that we’re bringing freedom and democracy to the world, but when people look at the pictures, they say, "Yeah, and what else are you bringing?"

© 1999-2005, Philip G. Zimbardo

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Prison Research: Does Locked Up Mean Locked Out?
September 6, 1999
by Jeffrey P. Kahn, Ph.D., M.P.H.
Director, Center for Bioethics
University of Minnesota

(CNN) — At a recent professional meeting, a Stanford University researcher discussed the results of a test of the effects of a drug to control aggression. The trouble is that the research was carried out on juvenile inmates in a California prison, raising a host of legal and ethical concerns.
The Stanford research gave groups of juvenile inmates varying doses of an anti-aggression drug and assessed its effect on their behavior. The controversy lies in the fact that the researcher reportedly admitted setting the dose so low as to be a placebo, intentionally denying the subjects any therapeutic effect from the drug.
Federal regulations allow research in prisons under only very limited conditions: when the research is on prison environments, or when there is a prospect of direct therapeutic benefit for the subjects. This means no placebo-controlled trials are allowed, since those in the placebo arm are denied direct benefit.

Protecting the ‘vulnerable’
Research in prisons was not always so limited. Before the early 1980s, many clinical trials for new drugs were carried out in prisons. But a series of cases exposed the exploitation of subjects in biomedical research: poor African-American men deceived and untreated in the Tuskegee Syphilis Study; mentally retarded children intentionally exposed to hepatitis at the Willowbrook State School; and chronically ill elderly patients injected with live cancer cells at the Jewish Chronic Disease Hospital of New York.

At the time of these cases, prisoners were a sought-after research population. Prisons offered a controlled environment: No prisoners would be "lost to follow-up." Prisoners were highly motivated subjects, whether to earn extra money or other forms of payment, make amends for previous behavior, or get better access to medical care. In fact, a study performed in the early 1980s demonstrated that research participation was a popular and prized activity; the most powerful inmates were the most likely to be research subjects.
But such motivation is precisely why concerned regulators moved to limit research participation by prisoners. How can subjects give truly voluntary consent in a setting where freedom is so severely constrained? In the case of the Stanford research, consent is doubly complicated by the fact that the prisoners were juveniles. And even if consent is possible, how acceptable is participation motivated by access to non-research-related benefits such as time out of cell or increased access to medical care? The requirement for potential direct medical benefit — and no placebo use — in all prison research is intended to lessen the concerns about research in the prison environment.

The fine line between protection and access The Stanford researcher has not yet commented on his motives, but he might have found inmates a desirable research population for a number of reasons. For research into ways to control aggression, whom better to study and who more likely to benefit than aggressive prisoners?

Sometimes research is best performed using placebo control groups. Since such research is not allowed in prisons, researchers are faced with finding ways to avoid placebos or forgoing prison research altogether. But misleading research review boards as well as subjects by using inactive doses of drugs does justice to no one.
Research policy must balance preventing the exploitation of subjects against overprotecting groups to the extent that they lose out on the research benefits offered to others. Deceitfully flaunting the rules upsets this balance and runs the risk of exploiting not only subjects and the system, but the future of such research altogether.

A researcher from Stanford University recently reported findings of research on a drug to control aggression, tested on juvenile prison inmates. The research used placebo-like low doses of the drug, but federal regulations prohibit placebos in prisons. But whom better to study and who more likely to benefit from such research than aggressive prisoners? Shouldn’t prisoners be allowed to decide for themselves whether to participate in research?

Visit the "Ethics Matters" Archive where you’ll find other columns from Jeffrey Kahn on a wide range of bioethics topics.