Pay No Attention to the Bloody Corpse in the Bathroom
Imagine for a minute that you work in a medical school.
Imagine for a minute that you work in a medical school. Your job is to make sure that human subjects in medical experiments are protected from harm. Then imagine that you learn there has been a horrific, unexpected death in a psychiatric study. Five months after a young man was signed up for the study over the objections of his mother, his body was found in a blood-soaked bathroom. His head has been nearly decapitated. A box-cutter is frozen in his hand, which he apparently managed to jam into a gaping wound in his abdomen before he died. What do you do?
Here at the University of Minnesota, the answer seems to be: “Nothing special.” If you don’t believe me, have a look at this testimony by Richard Bianco, the university official responsible for overseeing human research. The young man whose body was found in the bathroom was named Dan Markingson.
Q: Has the IRB (the university’s research ethics board) done any investigation into the death of Dan Markingson?
A: Not a formal investigation, no.
Q: Has the university done any investigation into the death of Dan Markingson?
Q: To the best of your knowledge, did anyone at the IRB, at the University of Minnesota, or anyone under your office investigate this case, actually look at the records and see the court documents that I’m describing, and if so, could you give me the name of that person?
A: Not to my knowledge.
Q: Nobody did that.
For the record, let me make sure this is clear. The bloody corpse of a young research subject is found in the bathroom of a halfway house; he has mutilated himself violently with a box-cutter, nearly severing his own head; and the university’s research oversight body decides there is nothing worth investigating. What could possibly explain this choice?
Nobody’s talking, but it’s a good guess that university officials thought it would all blow over. And to be honest, that wasn’t a bad bet. Minnesotans don’t like to make a fuss. By the time Markingson killed himself in 2004, the Department of Psychiatry had already staggered through several spectacular research fiascos without anyone much noticing, even as local news reports made the university psychiatry ward look like a cross between One Flew Over the Cuckoo’s Nest and Fargo.
For, example, there was the psychiatrist who was “disqualified” by the FDA for recruiting unwitting Hmong opium addicts into a trial of a powerful, potentially dangerous CNS depressant called GHB — a drug that is illegal in many countries, is commonly used as a date rape drug, and goes by street names such as “Easy Lay” and “Georgia Home Boy.”
Then there was the psychiatrist who was sentenced to federal prison for research fraud — but only after a nearly 4-year cover-up by the university in which the Dean of the Medical School inexplicably signed a written agreement with the psychiatrist to keep the fraud secret.
Perhaps most alarming of all was the case of Dr. Faruk Abuzzahab, a clinical faculty member and former professor in the department who was investigated by the state medical board and found to be responsible for the deaths and injuries of (count them ) 46 separate patients under his care. Many of these unfortunate people were psychotic, drug-dependent and suicidal — in other words, perfect candidates for pharma-sponsored drug studies. One study subject left the ward on a day pass and plunged off a bridge into the Mississippi River.
Yet even against this spectacularly lethal backdrop, the case of Dan Markingson stands out. This 26 year-old man was so floridly delusional when he was admitted to the psychiatry ward that he reportedly thought his mother was a lizard. A county court placed Markingson under a civil commitment order that legally required him to obey the recommendations of his psychiatrist. Unfortunately for Markingson, that psychiatrist turned out to be Dr. Stephen Olson, the director of the University of Minnesota schizophrenia program and a paid researcher and speaker for the pharmaceutical company AstraZeneca. Olson promptly recruited Markingson into a scientifically dubious, AstraZeneca-funded study of antipsychotic drugs — despite the fact that Markingson had been repeatedly judged incompetent to make his own medical decisions.
His mother, Mary Weiss, tried desperately to extricate her son from the study, repeatedly warning Olson and Dr. Charles Schulz, the Chair of the Department of Psychiatry, that her son’s condition was getting dangerously worse. In mid-April of 2004 she left a message with the study coordinator, asking, “Do we have to wait until he kills himself or someone else before anyone does anything?” Three weeks later, Markingson’s mutilated corpse was found in the shower, along with a note that said, “I left this experience smiling.”
In the years since the suicide, the behavior of university officials has hardly been reassuring. In fact, had you tried to draw a caricature of a guilty man — defensive, sweaty, fake smile frozen in place like Nixon with the camera on – you could hardly do better. First university attorneys tried to block Mary Weiss from seeing her son’s medical records. Later, when they managed to get her lawsuit thrown out on grounds of statutory immunity, they proceeded to file a counter-action against her, demanding $57,000 in legal costs. (Yes, you read that correctly: the university demanded $57,000 from a mother whose son had committed suicide in a university research study.) University officials have repeatedly claimed to have been investigated and exonerated by various legal and regulatory bodies, but those claims have fallen apart. A few years ago, when Mary and her friend Mike Howard tried to hand-deliver a letter of complaint to the university president, they were escorted out of the building by security officers.
In fact, with each damning new revelation over the years — a $520 million fraud settlement against AstraZeneca, newspaper reports linking Schulz to manipulated AstraZeneca studies, evidence of faked study documents at the university — the university has steadfastly refused to discuss the issues. Instead, it has played rope-a-dope, hoping that its attackers would exhaust themselves.
They did not count on the stamina of a mother who has lost her only son, or that of Mike Howard, a determined, Patton-like figure with the demeanor of a blunt instrument. Together they have hammered the university relentlessly for over nine years: filing suits, writing letters, submitting endless complaints to oversight bodies, and most recently, starting an online petition to the governor, asking for an external investigation.
The petition has attracted some influential supporters: former New England Journal of Medicine editors Marcia Angell, Arnold Relman and Jerome Kassirer; Richard Horton, who edits the venerable British journal The Lancet; Daniel Callahan, the pioneering bioethicist who co-founded The Hastings Center; Richard Smith, the former editor of the British Medical Journal; Susan Reverby, the Wellesley historian who uncovered the Guatemala syphilis studies; and a roster of over 250 bioethicists, physicians and other scholars.
The university is not budging, of course. But the more attention the petition attracts, the greater the institutional embarrassment. Over 2700 people have signed it, many of them University of Minnesota alumni who are rightfully ashamed of their alma mater. The petition may not succeed, but one thing is certain: the opposition is not going away.