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How a Suicide in a Clinical Trial Turned a Bioethicist Into a Whistleblower

<ѻý class="mpt-content-deck">— His advice for other potential whistleblowers: Don't go it alone
MedpageToday
A photo of Carl Elliott, MD, PhD

The case of Dan Markingson was the one that plunged bioethicist Carl Elliott, MD, PhD, of the University of Minnesota (UMN), into whistleblowing.

In November 2003, 26-year-old Markingson was involuntarily committed to Fairview Hospital after UMN psychiatrist Stephen Olson, MD, determined he was psychotic, dangerous, and incompetent to make medical decisions.

But not long after, Olson recommended a stay-of-commitment, which meant Markingson would be released if he followed his doctors' orders.

Olson asked Markingson to sign up for a drug trial, sponsored by AstraZeneca, evaluating three atypical antipsychotics for patients experiencing their first psychotic break, Elliott said.

Markingson was eventually transferred to a halfway house, but his mother, Mary Weiss, continued to raise concerns about his state of mind over the next several months.

In May 2004, Markingson stabbed himself multiple times in the shower and died. It turned out he'd been on quetiapine (Seroquel) at the time.

The study pulled in some $327,000 for the university, and Olson and a co-investigator were paid consultants to AstraZeneca -- as was the head of the institutional review board at UMN that approved the study, Elliott noted.

Elliott relayed the story at a virtual seminar on whistleblowing Wednesday afternoon hosted by the Health and the Public Interest program at Georgetown University in Washington, D.C. He spoke about how the case turned him into a whistleblower, how he investigated other cases of whistleblowing for a recent book, and offered tips for health professionals who want to call out wrongdoing.

Elliott said he learned of the case in 2008, and spent the next 7 years trying to get Markingson's death investigated.

"I filed requests with dozens of different agencies at the university, outside the university, federal government, FDA, everything I could think of," he explained. "I helped organize petitions, vigils, letter-writing campaigns, campus events. Eventually, with the help of a former governor of Minnesota, there was a state investigation."

"It was brutal," he added. "It essentially vindicated everything that I and other critics had said about the study."

The concluded that while it's not possible to know if Markingson's suicide was connected to his participation in the study, the case "raises serious ethical issues and numerous conflicts of interest, which University leaders have been consistently unwilling to acknowledge."

Enrollment in the study was finally suspended that year, Elliott noted.

But during the 7 years he worked on the case, "not a single doctor or nurse on the faculty at the University of Minnesota gave us any support," he said.

That made him question why whistleblowers behave the way they do -- and why bystanders don't act.

The resulting research is chronicled in his book, Lonesome Whistle: Exposing Wrongdoing in Medical Research, in which Elliott profiles six cases where whistleblowers exposed serious wrongdoing, including the:

  • Tuskegee
  • Willowbrook
  • Cincinnati
  • New Zealand cervical cancer ""
  • Fred Hutchinson
  • Paolo Macchiarini

What made the whistleblowers act? Many of them said it was just a part of who they are. "It's about maintaining self-respect by holding yourself accountable," Elliott said. "That's the distinguishing feature. It's about your obligations to yourself."

As for why bystanders stay silent, some research has suggested three things, he noted: a fear of retribution; that whistleblowing is futile; and loyalty to colleagues. But other experiments have shown that people hesitate to report wrongdoing even when they can do so anonymously, he added.

The best answer, Elliott said, can be found in studies by Stanley Milgram, PhD, of Yale University, whose shock experiments concluded that people simply do as they're told by authorities.

"The problem is a reflexive obedience to authority," Elliott explained. "When we're told to do something by a person we see as a legitimate authority, most of us just do it."

But Milgram's experiments offered a solution, he noted: deflating the prestige of the authority. When dissenters were included as part of the experiment, people stood up for themselves and declined to participate in experiments with questionable ethics.

That's what Elliott said he found in his research for his book: rarely is there a single whistleblower. Usually, there are many.

"In New Zealand, there were three," he pointed out. "With Macchiarini, there were four. With Willowbrook, there was an entire activist collective."

He said the concept of whistleblower strength-in-numbers was also true for his case at UMN, where he had another colleague from the bioethics department, as well as a nurse from Fairview Hospital, calling attention to the case, with faculty and student groups eventually joining in.

Still, no one from the medical school joined in, he added: "Even years later, the doctors in the medical school still haven't come around."

Acting alone in a case like this is a "suicide mission," Elliott said, which is why he advises any healthcare professionals thinking about becoming a whistleblower to approach it cautiously and strategically.

In addition to not acting alone, be sure to have corroboration from as many people as possible, and have evidence to support any allegations you're making, he advised.

Also, expect blowback, he added. "As soon as anybody knows who the whistleblower is, if you have a vulnerability in any way, they're going to hit back at you very hard. They're going to claim you're crazy, or that you have a vendetta, or that there's something wrong with you. They're going to dig up anything they can find out about you to discredit you. You need to be prepared for that."

If possible, talk to a lawyer first, he urged. "I think people have some idea that if they work in a university, that there are protections given to them by virtue of academic freedom and tenure that can protect them from retribution. They do protect you in some way, but there are so many different ways that you can be punished that you never thought about."

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    Kristina Fiore leads ѻý’s enterprise & investigative reporting team. She’s been a medical journalist for more than a decade and her work has been recognized by Barlett & Steele, AHCJ, SABEW, and others. Send story tips to k.fiore@medpagetoday.com.