The basic criterion that the FDA uses in approving a pharmaceutical is that it must be shown to be safe and effective. The maker of a pharmaceutical demonstrates that a drug is safe and effective by conducting clinical trials—the so-called gold standard for biomedical research. Until the 1970s, about 90% of those clinical trials were conducted on prison populations.

Revelations of horrifying abuses such as those of the Tuskegee Study of Untreated Syphilis in the Negro Male brought the practice to a halt. Currently, clinical trials using prisoners are permitted only when risks are minimal. But that would all change if the recommendations of the National Academy of Sciences Institute of Medicine are adopted. The National Prison Project of the American Civil Liberties Union is on board because the emphasis of the Institute’s report is on research that would benefit prisoners and that is wrapped in a wide range of protections against abuse and coercion.

I had an immediate revulsion at this news. Some of my revulsion is captured by an MD who, as a resident in the 1960s, had witnessed prison experiments. He said, “What started as scientific research became pure business, and no amount of regulations can prevent that from happening again.” Finding people as subjects for clinical trials has become a very big business, $7 billion worth last year.

The Institute of Medicine, the Prison Project, and others who advocate changing the rules use the logic of risk assessment: experiments should be allowed, with protections, when the benefits outweigh the risks. And the benefits are not just the “greater good” kind with all the risks dumped on the prisoners. These advocates actually see what they’re proposing as of benefit to the prisoners directly. If you’re wondering, the pharmaceutical companies don’t seem to have been involved in any of this, although I have yet to look at the resumes of the panel’s participants.

There’s so much wrong with this that I don’t know where to start. But this is one place it sent me.

The basic benefit to opening up prisons to biomedical research is improved medications. A recent article in Environmental Health Perspectives reviewed toxicology research demonstrating that lab animals in restrictive habitats are more sensitive to toxins than animals in pleasant habitats. I don’t mean animals that are intentionally stressed out, but simply live, for example, with more crowding. The results from experiments on these lab animals are different from those on happier animals. Prisons are very crowded and unpleasant places. Those conditions will affect the outcome of any clinical trials conducted on the prisoners. So the science that comes out of these clinical trials is likely to be junk. But good enough to get approval from the FDA.

Typically, the social and environmental conditions of the subjects in a clinical trial are not factored into its design and analysis. In clinical trials, a body is a body. Which is yet another reason for me to question the worship of clinical trials as a method. But that’s another matter.

The New York Times article that carried this story cites nameless critics who “also doubt the merits of pharmaceutical testing on prisoners who often lack basic health care.” Yet more reason to believe that the science that comes from such experiments is of questionable value because the subjects’ health is compromised.

The scientific and business environment that informs the Institute’s recommendations is a shortage of human subjects combined with the quadrupling of the prison population—a match made in heaven for some, in the other place for me. It’s obvious to me that the problem here isn’t some mythical benefit denied to prisoners but the pharmaceutical juggernaut that dominates medicine. If you want to benefit prisoners’ health, don’t take advantage of their vulnerability. Give them a humane living environment, real health care, and the opportunity for a better future. Come to think of it, that’s not a bad idea for the rest of us.

The issues in this article are developed (with references) in issue #4 of the Progressive Health Observer in a review article titled “Fit to Print? A review of The Truth About the Drug Companies and Critical Condition.”

Related resources are available on the Health Politics page.