Wednesday, August 14, 2013

How to Cover Up Research Abuse and Intimidate Critics. By Carl Elliott

Imagine that you lose your only son to suicide in a medical experiment. When you try to get his study records, the university refuses. When you file suit, the university argues successfully in court that it is "immune." Then it retaliates by filing a legal action against you, demanding that you pay the university $57,000 in legal costs. When you try to deliver a letter of complaint to the university president, his staff calls security guards and has you escorted out of the building.

Believe it or not, these are the actions taken by the University of Minnesota, where I teach medical ethics, against Mary Weiss, a 70-year-old retired postal worker from St. Paul.

The basic facts of the case were first reported in the St. Paul Pioneer Press. In late 2003, a psychiatric research team led by Dr. Stephen Olson, the head of the Schizophrenia Program at the University of Minnesota, used the threat of involuntary commitment to coerce Mary's mentally ill son, Dan Markingson, into a profitable, AstraZeneca-funded drug study -- the so-called CAFÉ study. Dan was signed up for the CAFÉ study over the objections of his mother, and despite the fact that he had been repeatedly judged mentally incompetent to make his own medical decisions.

For months, Mary tried desperately to get Dan out of the study, warning that he was danger of committing suicide, but her warnings were ignored. On April 23, 2004, she left a voice message with the study coordinator, asking, "Do we have to wait for him to kill himself or someone else before anyone does anything?" Three weeks later, Dan's body was discovered in the shower of a halfway house, his throat severed so violently that he was nearly decapitated. He had left a note that said, "I left this experience smiling."

In the years since Dan's suicide, the scandal has only worsened. It has become clear that Olson and his co-investigator on the study, Dr. Charles Schulz, had serious, unaddressed financial conflicts of interest from their work with the drug industry. In addition, documents unsealed in federal fraud litigation against the study sponsor, AstraZeneca, suggested that Schulz had been involved in manipulating research data. Last fall, the state Board of Social Work found that the study coordinator for the CAFÉ study, Jean Kenney, had falsified the initials of doctors on study records, had performed medical tasks far beyond her limited training, and had failed to warn Dan of new dangers of the study drugs.

Yet despite all of these alarm bells, the university has blocked every effort to look into the case, claiming that it has already been exonerated. As those claims have been subjected to further scrutiny, however, they have almost all fallen apart. (The one exception is an incompetent, deeply flawed inspection by a local FDA official, which found no wrongdoing.) In fact, according to the deposition of the University of Minnesota official in charge of research subject protection, the university never even investigated Dan's death. Let me repeat that to make sure it is clear: A subject in a psychiatric experiment committed suicide so violently that he nearly severed his head, and the university did not even think it was worth investigating.

The facts of this case are not a secret. In fact, the behavior of the University of Minnesota has generated international outrage. An editorial in the Medical Journal of Australia has compared the Markingson case to the Tuskegee syphilis study. A petition calling on Minnesota Governor Mark Dayton to investigate has gotten support from leading medical figures from all over the world, including the editor of The Lancet, a former editor of the British Medical Journal, the director of Public Citizen's Health Research Group, a former Health and Disability Commissioner of New Zealand and three former editors of the New England Journal of Medicine. In total, nearly 300 physicians, bioethicists and other scholars have called for an investigation.

This is not surprising. In the 23 years I have been teaching and writing about the ethics of medical research, I have never come across a case of abuse this outrageous. Nor have I ever encountered university officials so aggressive in stonewalling legitimate investigation and intimidating critics. Perhaps most alarming of all is the fact that these tactics have been so successful. Not a single person at the University of Minnesota has been disciplined. If a public university can get away with abuse this egregious, how can any of us have confidence that research subjects anywhere are being properly protected?

Carl Elliott, M.D., Ph.D., is a professor in the Center for Bioethics at the University of Minnesota and the author of White Coat, Black Hat and Better than Well. He wrote about the suicide of Dan Markingson in the August 2010 issue of Mother Jones magazine.

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