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Using Inmates as Medical Guinea Pigs

The New York Times today reports on recommendations for loosening federal regulations on using experimental drugs on prison inmates made in June by the Institute of Medicine of the National Academy of Sciences at the request of the the Department of Health and Human Services' Office for Human Research Protections.

Under current regulations, passed in 1978, prisoners can participate in federally financed biomedical research if the experiment poses no more than "minimal" risks to the subjects. But a report formally presented to federal officials on Aug. 1 by the Institute of Medicine of the National Academy of Sciences advised that experiments with greater risks be permitted if they had the potential to benefit prisoners. As an added precaution, the report suggested that all studies be subject to an independent review.

This is a sensitive area, particularly for those who recall what happened at Holmesburg prison in Philadelphia between 1951 and 1974 and even worse, the Tuskegee syphilis studies, both of which prompted the current regulations.

[at Holmesburg] ....inmates were paid hundreds of dollars a month to test items as varied as dandruff treatments and dioxin, and ....were exposed to radioactive, hallucinogenic and carcinogenic chemicals.

....In addition to addressing the abuses at Holmesburg, the regulations were a reaction to revelations in 1972 surrounding what the government called the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930's and lasted 40 years. In it, several hundred mostly illiterate men with syphilis in rural Alabama were left untreated, even after a cure was discovered, so that researchers could study the disease.

The Institute of Medecine report makes it sound like a loosening of regulations is all for the benefit of prisoners...where else can they get experimental AIDS drugs? But a larger reason may be that drug firms are running out of subjects for testing and prisons provide a new human laboratory

The discussion comes as the biomedical industry is facing a shortage of testing subjects. In the last two years, several pain medications, including Vioxx and Bextra, have been pulled off the market because early testing did not include large enough numbers of patients to catch dangerous problems.

....From 1951 to 1974, several federal agencies and more than 30 companies used Holmesburg for experiments, mostly under the auspices of the University of Pennsylvania, which had built laboratories at the prison. After the revelations about Holmesburg, it soon became clear that other universities and prisons in other states were involved in similar abuses.

The synopis of the report, Ethical Considerations for Research Involving Prisoners, is here. (pdf) In a nutshell, the report recommends current federal regulations be changed to:

1. expand the definition of "prisoner;"
2. ensure universally and consistently applied standards of protection;
3. shift from a category-based to a risk-benefit approach to research review;
4. update the ethical framework to in-clude collaborative responsibility; and
5. enhance systematic oversight of research involving prisoners.

One problematic area is consent.

Daniel S. Murphy, a professor of criminal justice at Appalachian State University in Boone, N.C., who was imprisoned for five years in the 1990's for growing marijuana, said that loosening the regulations would be a mistake.

"Free and informed consent becomes pretty questionable when prisoners don't hold the keys to their own cells," Professor Murphy said, "and in many cases they can't read, yet they are signing a document that it practically takes a law degree to understand."

And with the drug companies throwing money at the inmates, it's a powerful allure:

During the Holmesburg experiments, inmates could earn up to $1,500 a month by participating. The only other jobs were at the commissary or in the shoe and shirt factory, where wages were usually about 15 cents to 25 cents a day, Professor Hornblum of Temple said.

Another is this:

Dr. A. Bernard Ackerman, a New York dermatologist who worked at Holmesburg during the 1960's trials as a second-year resident from the University of Pennsylvania, said he remained skeptical. "I saw it firsthand," Dr. Ackerman said. "What started as scientific research became pure business, and no amount of regulations can prevent that from happening again."

Then there's the financial state the pharmaceutical companies have in the research trials.

"It strikes me as pretty ridiculous to start talking about prisoners getting access to cutting-edge research and medications when they can't even get penicillin and high-blood-pressure pills," said Paul Wright, editor of Prison Legal News, an independent monthly review. "I have to imagine there are larger financial motivations here."

Also, there's no regulation of drug company trials not receiving federal funding:

The report also expressed worry about the absence of regulation over experiments that do not receive federal money. Lawrence O. Gostin, the chairman of the panel that conducted the study and a professor of law and public health at Georgetown University, said he hoped to change that.

So wouldn't the prudent thing be to impose regulations on all and once that's in place, come back and seek a change in the regulations?

And how did this guy get stay on at a prominent medical school?

Dr. Albert M. Kligman, who directed the experiments at Holmesburg and is now an emeritus professor of dermatology at the University of Pennsylvania Medical School, said the regulations should never have been written in the first place.

"My view is that shutting the prison experiments down was a big mistake," Dr. Kligman said.

While confirming that he used radioactive materials, hallucinogenic drugs and carcinogenic materials on prisoners, Dr. Kligman said that they were always administered in extremely low doses and that the benefits to the public were overwhelming.

His examples of great studies....those for Retin A and a poison ivy drug. In all the years I've been representing prisoners, not once has one complained of wrinkles or acne or told me of any fellow prisoner suffering from poison ivy.

If you are still on the fence after reading the NY Times article, read this one:

Perhaps most shocking was a Phase I study, ongoing since 1997, that used prisoners to test a radically experimental approach to treating lung cancer. In that study, the prisoner was anesthetized and then connected to a machine called the BioLogic-HT System. According to the consent form, the test subject would agree to be heavily sedated and then to have tubes inserted into veins in the leg and neck to obtain blood. The blood removed from the volunteer would then be heated by the machine and returned to the body, inducing a dangerously high body temperature of 108.5 degrees and resulting in a sustained "hyperthermia" for two hours. (Dr. Joseph Zwischenberger did not respond to a list of questions about the study he directed.)

The consent form for the study cites a long list of serious potential side effects, including brain and spinal cord damage, loss of limbs, heart attack, hallucination, memory loss, burns at body pressure points, congestive heart failure, internal bleeding, seizures and death. While consent forms for experimental studies typically do list a wide array of possible complications, this form carried the additionally disturbing warning that the university would not compensate a research subject in case of injury. Participants in the study signed a form that read: " I understand that I cannot ... receive financial remuneration for any injuries resulting from my participation in this project."

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    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#2)
    by jondee on Sun Aug 13, 2006 at 02:41:11 AM EST
    Spaking of Mengele's bastard children, The C.I.A's MK-Ultra program also "utilized" inmates and even mental patients as part of it's chemical crusade to keep non-confined members of society safe.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#3)
    by jondee on Sun Aug 13, 2006 at 05:07:19 AM EST
    Spaking..That's my Irish brogue sneaking in again.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#4)
    by jen on Sun Aug 13, 2006 at 05:19:09 AM EST
    Just to chime in on a cold blooded note: I have to wonder about the scientific soundness of using such an iffy (healthwise) population as a pool for research studies. There can be little point in using someone who can't read or write. A prison is also not the kind of environment that normal people live in. The differences might be important - depending on what you are researching. When I played guinea pig for a vaccine at work, we had to keep a diary, keep track of how we felt physically, what medications we took, do prisoners take them?. They were very picky about who they allowed to participate, too. We not only had the stack of papers, we were given a plain language lecture by one of the researchers and shown a video; although I can't vouch for how informative it was to outsiders - I already understood when I volunteered. Any company given lab space in a prison to do research should also be required to provide overall health care to the population. Human use rules should STILL be observed. There is a good reason for them. Researchers too easily begin to forget their test subject in the heat of a study.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#5)
    by Talkleft Visitor on Sun Aug 13, 2006 at 05:42:08 AM EST
    Thank you, eniarku99 and Jen; my sentiments EXACTLY. This is chilling though not at all surprising. This is fascism, folks. Pure and simple. Allow government to use the dregs of society for ethically-bankrupt business practices masquerading as "science" and the chances more "law-abiding" folk will go along with it increase accordingly. After all, they're criminals dontcha know! Who cares what is done to criminals! Is it starting to sound familiar? Paging Doctor Mengele. Can you say "slippery slope"? Sure, I knew ya could!

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#6)
    by Talkleft Visitor on Sun Aug 13, 2006 at 06:46:00 AM EST
    the article also does not put forth the Vioxx/Bextra debacle truthfully. They totally neglect the suppressed evidence of heart problems. That's just a side note, but important nonetheless. I find the "need" to use prisioners in trials similar to Francis Fukuyama's human experimentation advocacy, on a smaller scale.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#1)
    by eniarku99 on Sun Aug 13, 2006 at 07:28:56 AM EST
    Dear Ms. Merritt: Please don't forget to mention the horrible Western State sterilization program in Virginia, which almost everyone has forgotten about: Actually, Ms. Merritt, you might be shocked to find out that the no coverage for medical problems arising from experimental treatments has been going on for some time now. While I worked as a secretary in a medical school, I had to prepare consent forms in which the subjects consented to have only problems sufficient to require hospitalization to be paid for, and nothing else. And these are for the healthy, literate people on the outside of prisons. While the treatments were nothing like what you mentioned above, still such stringent denials of possible association with possibly debilitating low-grade problems gave me pause. Evidently, corporate medicine thinks that playing Dr. Mengele is fine so long as you have a signed waiver.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#7)
    by roy on Sun Aug 13, 2006 at 08:01:13 AM EST
    These people are sentenced to imprisonment, not infantilization. So long as fraud is addressed -- which I admit is iffy -- then adult prisoners should be treated like adults, allowed to make decisions on what they do or allow others to do to their bodies. Doesn't "my body, my choice" apply to prisoners, too?

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#8)
    by jen on Sun Aug 13, 2006 at 08:15:02 AM EST
    "informed" consent is always the catch. The key. The most easily juggled part of a study. They are talking about loosening up the normal human use rules. Just how loose?

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#10)
    by Talkleft Visitor on Sun Aug 13, 2006 at 09:33:03 AM EST
    It's not true that these proposed experiments will not be subject to federal regulations. If they are sponsored by drug companies then they are being done to support marketing applications to the FDA, which means they have to follow FDA regulations which impose conditions very similar to those used for federally supported research. That said, the extent to which these regulations are followed faithfully is quite variable and even the regulations leave wide gaps in protection. Two examples from your comments so far: the regulations require that consent forms and the consent process be in language and format understandable to the subject. This should always include a plain language explanation, a consent form written in plain language and any other aids to understanding that are necessary. Nevertheless, many researchers still write (and Institutional Review Boards approve) dense consent documents written at graduate level readability with a lot of medical jargon which are then thrown at prospective subjects with the instructions "Here, read this and sign it." Second, as other commenters have pointed out, most research institutions do not accept any liability for providing either medical cae (except perhaps emergency care) or compensation to subjects who are injured in their research. Subjects can always sue of course, but the documents are written so as to discourage it. This is perfectly legal. This means that the essential language of many consent forms is "This experiment could badly hurt you or even kill you, but we won't take care of you if it does." Is it any wonder there is a shortage of medical research volunteers? The response of the drug companies is not only to attempt to access prisoners, but also to ship a great deal of the research overseas, preferably to developing countries where people may agree to anything just to have access to medical care or small payments for participation.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#11)
    by aw on Sun Aug 13, 2006 at 10:13:59 AM EST
    Slippery slope, yes. Maybe they could start arresting people that would make even better test subjects based on DNA or something? Maybe they could emulate the Chinese and sell their organs? Trumped up charges, shadowy crimes against the state, secret trials. That's where slippery slopes lead.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#12)
    by Talkleft Visitor on Sun Aug 13, 2006 at 10:26:10 AM EST
    Two men who fell seriously ill following a clinical drugs trial remain in a critical condition but four others are showing signs of improvement. If things like this occur in the out, makes a fellow wonder just how much publicity a similar event inside would attract.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#13)
    by Talkleft Visitor on Sun Aug 13, 2006 at 10:32:38 AM EST
    Roy
    Doesn't "my body, my choice" apply to prisoners, too?
    Prisoners are captives of the State. They are told what to do and when to do it. Under these circumstances the chances of a prisoner making a truly conformed consent is tenuos at best and the Drug Cos. know it. If your so interested in giving prisoners individual rights I would suggest you start with supporting giving them The right to Vote first!

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#14)
    by Talkleft Visitor on Sun Aug 13, 2006 at 10:56:26 AM EST
    And who is to say a scenario could not exist where the screws are paid a bonus for every "volunteer" they recruit. If army recruiters can sign up halfwits and deadbeats for shipping out as cannon fodder then it's not inconceivable that a screw with unbridled power might apply a "little coercion" after all inmates are expendable trash, not to mention the bucks that a few dead wouldn't save

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#15)
    by lilybart on Sun Aug 13, 2006 at 10:56:54 AM EST
    I think it's ok IF an inmate is in for life with no parole and if they get something in exchange, like, if it were me, I would want a daily Starbuckstriple Grande Latte. My quality of life would improve in exchange for something that might effect my health, but prison is doing nothing for my health anyway. AND the doctors doing the clinical trial might take better care of me than the prison medics!!

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#16)
    by Talkleft Visitor on Sun Aug 13, 2006 at 11:08:35 AM EST
    Lilybart. This is not a personal attack, but you're mad.
    AND the doctors doing the clinical trial might take better care of me than the prison medics!!
    The doctors on the outside won't look even look after you, unless you front the wedge, what kind of treatment do you think an inmate will receive? Who will protect the vunerable, the metally challenged, the illiterate? I can't think of anything so open to abuse as what is being proposed here. Have you not realised yet, America doesn't give a goddamn about its people, not forgotten Katrina allready?

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#17)
    by HK on Sun Aug 13, 2006 at 12:18:09 PM EST
    Doesn't "my body, my choice" apply to prisoners, too?
    Erm, in a word, no. While a Federal Judge in Missouri recently upheld the right of female prisoners to have abortions (as reported by TalkLeft here), prisoners don't really have that much control over what happens to their bodies. They often have substandard medical care, waiting months to see a doctor and in between visits their medication frequently runs out. They have no control over the standard of food they are offered, which is generally poor and can exacerbate existing medical problems and cause new ones. And those on death row are forbidden from offering their organs for transplant in the event of their execution. The current Katrina Prisoners thread here on TalkLeft shows that even in dire, emergency circumstances, prisoners have little control over what their body is put through. So, while "my body, my choice" should apply to prisoners, in reality it really doesn't.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#18)
    by HK on Sun Aug 13, 2006 at 12:47:55 PM EST
    Thanks for the link, eniarku99. I never knew that eugenics had been so widely practiced in the US.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#19)
    by Sailor on Sun Aug 13, 2006 at 03:04:41 PM EST
    The discussion comes as the biomedical industry is facing a shortage of testing subjects. In the last two years, several pain medications, including Vioxx and Bextra, have been pulled off the market because early testing did not include large enough numbers of patients to catch dangerous problems.
    3 points 1) If that was true, the drug industry has the highest profitibility of any industry, including oil, if they couldn't get enough subjects, then just pay them more. Free market at work right? 2) It wasn't true, they did have eough subjects to determine the dangers, but the drug co's along with the FDA suppressed the evidence. 3) prisons control all info in and out to prisoners. Family, press, newspapers, magazines, even atty visits. How would anyone know if the protocols were followed? I might be able to see it if the studies were NIH funded, but once the obscene profit margins and financial stakes of corporations are involved this is a terrible idea.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#20)
    by BigTex on Sun Aug 13, 2006 at 03:09:21 PM EST
    The idea is troubling in how it looks to be carried out, but this should be allowed, withouth the finincial compensation to the inmates. In fact, this type of informed concent, high risk high reward treatment should be an optiono available to everyone, prisoner or not. Europe regularally uses treatments that are apparantly safe long before we adopt them here. The apparantly bit is important because sometimes down the road problems creep in. However, the patient should be given the option of using expirmental treatments to cure their ailments. While the thought of throwing money to lure in subjects is disturbing, if this was done on a voluntary basis with the only reward being the ailment is cured, this is a big step in the right direction.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#21)
    by Sailor on Sun Aug 13, 2006 at 04:30:58 PM EST
    but this should be allowed, withouth the finincial compensation to the inmates.
    Performing medical experiments on a captive population is what megele did.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#22)
    by Talkleft Visitor on Sun Aug 13, 2006 at 05:20:41 PM EST
    How would we react if the commision recommended using
    Repuglicans as Medical Guinea pigs.
    most of them are criminals anyway.

    Re: Using Inmates as Medical Guinea Pigs (none / 0) (#23)
    by phat on Mon Aug 14, 2006 at 12:12:40 AM EST
    We know that large percentages of the people in prisons suffer from some form of mental illness. Expecting them to be able to make reasonable decisions about their future is problematic at best, criminal at worst. The post above about rehabilitation should help make that clear. The medical testing industry in this country has serious problems as it is. Finding guinea pigs in the prison system is liable to cause more problems. Once again, we see certain interests attempting to throw away the past 30 years of progressive policy. This push towards shortsightedness is getting very, very old. If this program were allowed to go forward I would put money on the research that comes from it to be debunked eventually just on a strictly scientific basis. Nevermind the strictly ethical problems involved. phat