Stanford University tests of a psychiatric drug on 61 teenage inmates may have violated state law banning medical research on inmates, officials said Monday August 16, 1999. The study also raises some troubling ethical issues.
Imprisoned youths were subjected to a eight week long experiment with the drug Depakote in 1997, conducted by Stanford psychiatrist Hans Steiner. Sixty one male inmates, aged 14 to 18 were given varying dosages of the drug, which is used to control epileptic seizures and episodes of mania, to determine if it made them less aggressive. All of the youth were serving prison sentences at the Stockton facility of the California Youth Authority for violent offenses.
The Behavioral Science Unit of the Stanford Medical Research Center has been known for conducting research of new drugs used to treat mental illness. While this is not the first time Stanford has been investigated for research done at the research center, it is the first time that California Attorney General has been asked to step in and investigate.
California Gov. Gray Davis is notably upset by the study, and has "slammed the door on any future such experiments." "We are not going to put up with wards being used as guinea pigs," said Hilary McLean, the governor's spokeswoman.
In a written statement, the university said Stanford officials took several steps to make sure the study complied with state and federal laws, and posed a "low risk and direct benefit" to the imprisoned youth. Those efforts included a review by the Stanford Human Subjects Committee, consultation with the Food and Drug Administration, and written consent from the California Youth Authority, as well as the inmates themselves and their parents.
However, while all the inmates volunteered for the study, not all of their parents gave consent. In some cases, when the parents took longer than 30 days to give their consent, the California Youth Authority consented on their behalf. This has prompted an investigation on whether the obtained consent was legal.
The federal and state laws regulating medical experiments on youth and inmates are unclear. One law clearly prohibits biomedical research on state prisoners. But another law, intended to help HIV/AIDS victims, says prisoners can be given experimental drugs if it is in their best interest. But is giving minors a psychiatric drug for experimental purposes beneficial? Many medical experts disagree, and are appalled by the study. "I'm not against research in prisons, but you just can't do it that way," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania Medical Center. "When you involve young people who are not competent (to give consent), you've got to be extraordinarily careful. (Stanford) was clearly in there without appropriate consent."
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