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Ethics professor takes on clinical trials, marketing

Writing for Mother Jones, University of Minnesota medical ethics professor Carl Elliott digs into the Dan Markingson story first covered by St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto. Elliott works at the same institution as the physicians who who administered a Seroquel trial that the 26-year-old was enrolled in when he committed suicide.

Given his teaching field and institution, it’s not surprising that Elliot couldn’t stay away from the Markingson story.

…the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported. The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.

Elliot goes after the idea that the new wave of anti-psychotics was any safer than its predecessors, then explains the clinical trial manipulations he says were used to claim they were.

From there, Elliot takes on the use of clinical trials for marketing purposes. Clinical trials can be dangerous, which is theoretically acceptable if they have the potential to advance medical care. But what if patients are just being exposed to those dangers in an effort to sell more drugs?

Investigation of drug-trial suicide earns award

For a story on ethical issues in a drug trial that may have contributed to a patient’s suicide, St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto earned the Minnesota Journalism Center’s Frank Premack Public Affairs Journalism Award for excellence in investigative or analytical reporting about public affairs in the Twin Cities metro area.

Through the eyes of grieving mother Mary Weiss, Tosto and Olson followed Dan Markingson’s schizophrenia diagnosis, his participation in a University of Minnesota clinical trial for AstraZeneca’s Seroquel and his eventual suicide in 2004. Markingson was diagnosed, treated and enrolled in the study by Dr. Stephen Olson, who also happened to be looking for hard-to-find patients with Markingson’s symptoms for the psychiatric drug trial he was running.

From the judges:

In this piece, Olson and Tosto reported for the first time on schizophrenia patient Dan Markingson’s death and the resulting lawsuit and probes. In the process, they pulled back the curtain on the rarely viewed world of industry-funded clinical research and the financial incentives that can compromise a doctor’s decision-making.

Premack judges in this category said: “Through the eyes of one patient, this story shed considerable light on the complicated and competing interests between the development and path to market of new drugs, funding needs of the University and the integrity of medical research. The judges are hopeful that the new ethics task force implemented at the U of M is resulting in changes in conflict of interest policies.”

Olson and Tosto said Markingson’s death also raised “questions about why the Institutional Review Board, the internal group charged with protecting people in university studies, didn’t intervene.” The reporters also used the the $782,000 paid by drug companies to the two psychiatrists overseeing Markingson’s trial (including $261,000 from AstraZeneca) to highlight national criticism of the conflict of interest inherent in pharmaceutical-company funding of clinical trials and questioned whether study staff would be willing to let the public know if something untoward occurred during a trial.

“Physicians face a difficult choice,” testified Dr. Greg Rosenthal, an Ohio eye specialist. “One path is to go along. With drug company money, you can increase your income, prestige, build your practice or fund a department, research or professorships. The middle ground is to simply look away. The hard choice is to fight back.”