Testing Subject

Should doctors serve as their own guinea pigs?

by Francesca Heintz


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Published: Apr 18, 2007

bioethics

Would you run a catheter into your own heart? Or inject yourself with polio, rabies or typhoid to test a new vaccine? How about give yourself an infusion with contaminated blood?

Most of us would shy away from such risks, but Dr. Lawrence Altman, senior medical correspondent for The New York Times — speaking at Pennsylvania Hospital on April 10 — said doctors should engage in such behavior as a moral and ethical principle.

"Self-experimentation is an expression of the biblical 'golden rule,'" Altman says. "If a physician asked you to participate in a research experiment, my feeling is that among the questions you would be asking in return is, 'Have you done the experiment on yourself?'"

Altman argued that if the answer is no — barring instances such as testing an experimental drug for a disease the doctor doesn't have — volunteers have every right to object. Though risks in experimental medicine can be substantial, the prevailing view among many bioethicists is that this kind of research is necessary to further science.

"Whatever is standard practice today was once experimental by definition," says Altman. "And what might be the medicine of the future could today be experimental."

Dr. Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics, agrees, noting that the ethics of human testing remains widely debated. While guidelines vary by experiment, research ethics committees and institutional review boards are charged with insuring that no unnecessary risks are taken. "Their job is to make sure that the researcher is telling the truth, that the risk-benefit ratio is not out of line, that the science is sound, and that the subject knows all his options," Caplan says.

These boards are relatively new, showing up gradually in the 1970s after years of doctors picking subjects at their own discretion and sometimes refraining from informing them about the intention of their experiments. Now, says Caplan, research involving human subjects has strict protocols and the constant reevaluation of the ethical principles surrounding the issue by bioethicists. With the federal government and private companies pouring more and more money into research, the opportunity to develop new drugs and treatments has exploded, generating an increasing number of experimental trials that require testing on human volunteers before the drugs hit the market.

The absence of regulatory boards in the past contributed to ethical and moral disasters such as the infamous Tuskegee experiments, which researched the effects of syphilis on poor black men during a 40-year span without offering proper treatment. These men technically gave informed consent, but it was after being lied to and, as Caplan says, "Their informed consent was basically an 'X' on a piece of paper."

Locally, prisoners at Holmesburg in the '50s and '60s were subjects of experiments by Penn doctors testing cosmetic and skin products that former inmates claim have given them persistent health issues including fungus in their nails, skin discoloration and scarring.

Bruce Goodman, a test subject who was incarcerated at Holmesburg in the late 1960s, says compensation was the main motivator. Inmates received $10 to $15 for the patch tests of various creams on their backs or sometimes more than $100 by the conclusion of the experiment.

"Mostly everybody who needed the money thought these were just innocent tests," says Goodman. "They guaranteed no side effects and everybody just thought it was free money."

Leodus Jones, another ex-inmate, is the chairman of the Experimentation Survivors Association, which calls for an apology and reparations from the City of Philadelphia and Penn. Though Jones has testified in front of the City Council, he says no formal apology has come. "They act like we did something wrong by exposing it and talking about it," he says.

He worries such a mess could happen again since, last year, the Institute of Medicine was commissioned to reevaluate 1976 regulations that severely limited testing on prison subjects. It proposed loosening restrictions to allow greater freedom for experiments that may benefit the prison population. Though no changes to the current policy have actually been made, the debate revived a discussion about the ethics involved.

"Prisoners are vulnerable," Jones says. "It's not an environment where you have freedom from fear or freedom from want. These doctors were taking perfectly healthy young men and women and infecting them."

Jones, who maintains that his skin changed after leaving Holmesburg, making him look like a "pinto pony," believes that the zero accountability that existed in prison allowed doctors to say and do anything without consequence. But Caplan says that using vulnerable populations is much harder than it was during the Holmesburg experiments; now, researchers must demonstrate that the subject stands to receive a potential benefit. He offered the example of using prisoners to test new HIV medicine because of the high instance of the disease in the population.

But Jones doesn't buy "all that ethical stuff."

"If the doctors had done it to themselves or done it on someone who was exposed to whatever the test study consisted of, it might be more acceptable," he says. "What happened to all the guinea pigs, mice and chimpanzees?"

(editorial@citypaper.net)