In a clinical trial of a new antipsychotic drug done at the University of Minnesota, a man named Dan Weiss was given a choice: be hospitalized in a psych ward or, shockingly, “take part in an industry-funded study of antipsychotic drugs”. The usual choice is between hospitalization or conventional treatment. Weiss chose to be in the clinical trial. During the trial he killed himself.
An FDA investigator named Sharon Matson decided that Weiss had not been coerced into participating! During a trial, Moira Keane, the head of the University of Minnesota Institutional Review Board, which of course is meant to protect human subjects, claimed the purpose of the board was not to protect human subjects. The purpose of the board, Keane said, was “to make sure that Olson and the trial sponsor had a plan to protect subjects.” This is false. IRBs sometimes measure compliance, not just plans.
After Weiss’s mom sued the University of Minnesota and lost,
The university filed a legal action against Mary, demanding that she pay the university $57,000 to cover its legal expenses. Gale Pearson, one of Mary’s attorneys, says that while such suits are technically permissible, she had never seen one filed in her previous 14 years of legal practice. The university agreed to drop the lawsuit against Mary only when she agreed not to appeal the judge’s decision.
The article by Carl Elliott about this case also contains excellent discussion of how drug companies shape clinical trials to get the results they want — and when that fails, hide the results. The effect is that new drugs are approved that are worse than the drugs they replace.
Thanks to James Andrewartha.