[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."