Washington Insider: Paul Thacker
The news coming out of Minneapolis is bad. After a decade spent stalling, denying and attacking critics, the University of Minnesota has finally admitted some complicity in the death of a patient during a clinical drug trial.
The patient, Dan Markingson, was 26 years old and exhibiting signs of mental illness when he enrolled in a clinical trial for antipsychotic drugs in 2003. He did so at the urging of a physician. He committed suicide the following year.
Because the university had to be brought kicking and screaming to this conclusion, the state's former governor has now called for the university's president to resign.
Missing from the controversy is one obvious participant: the federal government. From the very beginning it was obvious that enrolling Markingson in the clinical trial that led to his death was wrong—he was not mentally competent to make the decision, his own physicians were conflicted and his mother warned that he was a danger to himself and pleaded to have him taken out of the project. Nonetheless, he was enrolled in the trial and later killed himself.
Because current policy only allows the Office of Human Research Protection to oversee studies funded by the federal government, it never got involved. That needs to change. The status quo is no longer sufficient, and federal policy needs to change so that the government can step in during any trial when a human life is at risk.
It's tragic that reform always seems reactive to scandal instead of being proactive to obvious future problems. But if the law is changed, that will be one positive outcome from Dan Markingson's completely preventable death.
Paul Thacker is a journalist and adviser to nonprofits.