Tuesday, August 22, 2006

Guinea Pigs Behind Bars

Most psychiatrists know the story of how lithium was discovered, but for the rest of you here's the story:

Many years ago a fellow by the name of John Cade decided to give lithium to manic patients because he noticed that the substance seemed to calm agitated guinea pigs. (Don't ask me how he could tell the guinea pigs were agitated. As far as I can tell all guinea pigs do is squeak and munch alfalfa pellets, or occasionally chuckle while peeing on the visitor's lap but that's a story for another day.) Anyway, the lithium worked.

In the early '70's lithium was tried on another group of research subjects---prisoners with a history of violence. Researchers found that lithium cut the rate of violent infractions in half---even when the inmates didn't think the medication was working.

But the point of this post isn't specifically about lithium---we already have a nice post about that (Peace and Lithium). The topic of this post is clinical research on prisoners.

When this topic comes up most people have an immediate association to Josef Mengele and other horrors. However in the United States physicians had been doing research on prisoners for at least twenty years before that. In one study done in 1916 inmates on a prison farm were used to study pellagra, a disease caused by a nutritional deficiency of Vitamin B. In exchange for a full pardon they were placed on a four month diet entirely free of Vitamin B. By the end of the study half of them had developed dermatitis, weight loss, loss of strength and nervous system impairments.

By 1948 as a result of the Nuremberg trial America developed the earliest standards for human research on prisoners. Dr. Andrew Ivy, a prosecution expert at Nuremberg, proposed that medical research should be allowed if results were "unprocurable by other methods" and animal experimentation had already been performed. He also suggested that medical personel should serve as subjects along with volunteer prisoners. Although he recognized the potentially coercive influence of pardons or "good time" credit, he fell short of banning it outright as an incentive for participation.

At one time a central issue in correctional research was whether or not inmates truly had the capacity to give informed consent. The nature of the correctional environment was thought to be too coercive for completely voluntary consent given the lack of contact with advocates (including friends and family) or other counsel. Today this is not the prevailing opinion and inmates routinely give informed consent for treatment or research.

Presently correctional research is governed by the Code of Federal Regulations, Subpart C, entitled Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners As Subjects. These regulations permit research on prisoners if it falls within certain guidelines. The research must not give the subject advantages or opportunities within the prison to the extent that the offered reward would impair his ability to weigh the risks of the research. Subject selection must be impartial and free from influence by prison officials. Correctional research is allowed if it involves the study of the causes and effects of incarceration or criminal behavior, or conditions which affect prisoners as a class such as hepatitis or drug addiction. It is also allowed if it involves practices which have a reasonable probability of improving the health and well-being of the individual. All studies require that the research involve no more than minimal risk or inconvience to the inmate and that the decision to participate should not affect eligibility for parole or parole decisions. As with any human research, the study must be approved by an Institutional Review Board.

Now a New York Times article discusses a proposal to loosen Federal regulations for the use of prisoners in clinical drug trials. The proposal has the backing of a consortium of prison advocates, researchers, correctional staff and ex-offenders. Even the ACLU has signed on. But is this a good thing? Read the full story for the viewpoint of ex-research subject-prisoners. Be sure to watch the six minute video clip about the history of prisoner research in one Pennsylvania facility.


You wouldn't believe how long it took to find this guinea pig picture. Along the way I found an unfortunate number of photos of guinea pigs as...umm...food. With apologies to our South American readers: yuck. Then I found this site with guinea pigs dressed in little costumes. How humiliating. Which would I prefer if I were a guinea pig?

Pass the parmesian.


Dinah said...

So you didn't like my pic of the caged guinea pig? And you undid where I colored and highlighted your typographical error (I think you meant 'be sure to watch the video')...fine, be that way!

Fat Doctor said...

I always learn so much here at Shrink Rap!

ClinkShrink said...

Dinah, I never saw your picture. Apparently we were both editing my post at the same time---I got a weird error message when I was trying to upload it. I fixed the typographical error, thanks for pointing it out.

Fat Doctor! Thanks for stopping by. ShrinkRap's been thinking of you. If you're about to go NPO just forget anything I mentioned about guinea pigs and food. Then again, thinking about guinea pigs as food may help you go NPO.

Sarah said...

That guinea pig site is too weird. Ok, I have to admit, I dressed up my pet guinea pig when I was a kid (she couldn't come to the tea party without her hat!) But I didn't treat it like a friggin barbie doll.

I'm guessing you'll get more comments about the guinea pig costumes than lithium.

Dr. A said...

I'm going to take a stab a this testing prisoners topic. This really doesn't sit well with me. There are too many questions.

I think I have a handle of the regulations if it is a federally funded study. But, what if it is a privately funded study, by, say, a pharmaceutical company? Would it still be as stringently regulated? Or, would they have free reign to do whatever they wanted?

The NY Times article had this interesting passage: On the issue of compensation for inmates, the report raised concern about “undue inducements to participate in research in order to gain access to medical care or other benefits they would not normally have.” It called for “adequate protections” to avoid “attempts to coerce or manipulate participation.’’

Good point about informed consent. Can adequate informed consent be obtained from prisoners?

Finally, I see a wide open door for litigation of everyone involved for potential side effects of research. No wonder the ACLU is behind this idea -- more business for them.

ClinkShrink said...

My thought on this is that clinical research is necessary to advance our approach to inmate care. While free society research obviously is relevant, it's also clear that free society research subjects are not the same group of people as who you find in a correctional facility. We have more comorbidity (Axis I and II), more substance abuse, more cognitive impairment, more co-existing medical conditions, fewer social supports and on and on. We have a group of patients that is harder to treat and less "pure" than your basic homogenous free society research pool. This is why the APA set up the Practice Research Network to study 'real world' treatment results.

Also, if you want to learn about the effects of confinement that kind of has to be done in a correctional environment with real inmates. (And no, I don't count the Zimbardo experiment as a real correctional study.)

But yes, external protections and close monitoring of clinical trials are essential. At the risk of sounding like the Wicked Witch of the West, 'these things must be done carefully'.

Sarebear said...

Quick, someone get a bucket o' water.

ClinkShrink said...

Hey Hedberg!! Thanks for visiting the blog. You are officially a ShrinkRap VIP.

I tried getting to your myspace page but it keeps rejecting me when I try to create an account. Maybe I'm not young enough??

Foo, you can hang a sign anytime. I'd even be willing to make you your own special wooden laminated logo...