Tuesday, August 24, 2010

A Clinical Trial

A Suicide

And Patient Safety

From Pharmalot:

What happens when a university is bound up in the outcome of an industry clinical trial? What does it say when university researchers are actively recruiting patients for a trial while also accepting consulting or speaking fees from the same drugmaker sponsoring the study? Is the research furthering commercial needs more so than scientific needs? And how are patients protected in such situations?
These are among the questions explored in a sobering piece in Mother Jones magazine by University of Minnesota bioethicist Carl Elliott. He focuses on the sorry plight of Mary Weiss, who lost her 26-year-old son, Dan, while he was enrolled - over her strenuous objections - in a trial at the University of Minnesota (yes, the same school) to compare AstraZeneca’s Seroquel antipsychotic with rival brands.

The circumstances in which Dan was placed in the study go to the heart of the matter. Back in 2003, he suddenly exhibited increasingly troubling behavior and threatened his mother before he was briefly committed involuntarily to a mental institution. Later, he was transferred to a halfway house before being released. But along the way, he was enrolled in the trial by a University of Minnesota psychiatry professor, who was also doing work for AstraZeneca, as was another researcher in the department.

Yet just before that occurred, this same physician indicated in a court petition that Dan was dangerous and mentally incapable of consenting to taking antipsychotics. As his mother wondered: How could her son suddenly be capable of consenting to a participation in a research study while he was in a state mental institution? Elliott goes on to explain the university researchers were under pressure to bolster enrollment in the trial, which was run by Quintiles, the contract research company.

As Elliott notes, the study contained a loophole. “Like other patients with schizophrenia, patients experiencing their first psychotic episode are at higher risk of killing themselves or other people. For this reason, most studies of antipsychotic drugs specifically bar researchers from recruiting patients at risk of violence or suicide, for fear that they might kill themselves or someone else during the study,” he writes. “Conveniently, however, the study only prohibited patients at risk of suicide, not homocide. This meant that Dan - who had threatened to slit his mother’s throat, but had not threatened to harm himself - was a legitimate target for recruitment."

The tale goes on to recount previous ethical lapses at the university, the interlocking interests among academic researchers and drugmakers, and oversight issues raised by the growing number of for-profit institutional review boards. At the end of the day, studies are supposed yield info to improve medical conditions - a Machiavellian prospect, perhaps, for those who say shareholder interests predominate.

But as Elliott posits after combing through product-liability litigation: “The documents…suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to generate commercially attractive messages?”


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