Last June, Star Tribune reporters uncovered yet another medical research scandal in Minneapolis. This time it was Hennepin Healthcare. At the direction of researchers in the Department of Emergency Medicine, paramedics were testing a risky anesthetic called ketamine on agitated patients without their consent. As many as 47 percent of the patients forcibly injected with ketamine had breathing problems so severe they wound up on a ventilator.
Hennepin Healthcare leaders insisted they had done nothing wrong. “We are following all the rules and regulations that govern research at all the other U.S. academic medical centers,” Chief Medical Officer William Heegaard told the Hennepin County Board on June 26.
The U.S. Food and Drug Administration disagrees. According to an inspection report obtained by Public Citizen, Hennepin Healthcare has known since August that the FDA found serious ethical and regulatory violations. It is now clear there has been a systemic breakdown in research oversight at Hennepin Healthcare, yet its leaders have repeatedly refused to release information about the study or how it managed to get ethical approval by its Institutional Review Board.
Why does unethical research take place so often in Minnesota? These forced ketamine studies and the suicide of Dan Markingson in a University of Minnesota drug study are only the most visible cases in a string of research scandals dating back to the 1990s.
In the University of Minnesota’s Department of Surgery, the ALG transplant drug scandal ended with a five-year NIH probation, a $32 million federal settlement and the departure of 86 faculty members in the Medical School.
Scandals in the Department of Psychiatry resulted in a federal prison sentence for the head of child psychiatry and the FDA disqualification of the director of the chemical-dependency unit.
In 2007, the New York Times reported on the quiet rehabilitation of a Minneapolis psychiatrist responsible for the deaths or injuries of 46 patients, 17 of them in research studies.
Yet to many people, these scandals barely seem to register. Often they are forgotten as soon as it they are reported. At most, the issues simmer quietly for years as attorneys and regulators fight over a face-saving settlement. Almost never are any real lessons learned.
Things could be different. Consider the recent case of Paolo Macchiarini, a celebrated transplant surgeon at Sweden’s Karolinska Institute, home of the Nobel Prize in physiology or medicine. Macchiarini and his colleagues purported to have developed an experimental synthetic trachea that could save the lives of desperately ill patients. In 2011, Macchiarini performed the world’s first synthetic-trachea implant on an Eritrean graduate student with cancer. Claiming success, Macchiarini soon went on to perform similar implants on patients around the world, including a 2-year-old girl in Illinois.
The procedure made Macchiarini internationally famous. There was only one problem. It didn’t work. All of the patients with synthetic tracheas were either dead or barely hanging on to life. Macchiarini had lied to the press about his results and had falsified his scientific publications.
In 2013, four whistle-blowing surgeons at the Karolinska Institute began raising alarms. In response, Karolinska Institute leaders threatened to fire them. Later, when the surgeons refused to back down, Karolinska leaders reported them to the police and had them charged with illegally accessing patient records. In 2015, when an external review corroborated the misconduct claims made by the surgeons, Karolinska leaders held a news conference and publicly declared their confidence in Macchiarini.
This strategy of denial and discrediting might have worked indefinitely if not for the efforts of investigative reporter Bosse Lindquist, who tracked Macchiarini for nearly a year. His remarkable three-part documentary, “The Experiments,” was broadcast on Swedish television in January 2016. Armed not only with the graphic testimony of the whistleblowers but also footage of Macchiarini and his colleagues deceiving patients, Lindquist produced a devastating indictment that could not be brushed aside.
Public outrage was swift. Within a month, Macchiarini had been fired from his job and charged with manslaughter. The vice chancellor of the Karolinska Institute was forced to resign. So were the secretary of the Nobel Committee for Physiology or Medicine and the chancellor of the Swedish university system. Sweden’s scientific review board later found misconduct by Macchiarini and his co-authors in six papers and recommended that they be retracted.
Rarely does anything this dramatic happen when a research scandal is exposed. The usual response to an investigative report looks much like Heegaard’s response when the Star Tribune exposed the forced-ketamine experiment: denial and stonewalling while everyone waits patiently for the issue to go away.
What made things different in Sweden? To answer this question, the Minnesota Center for Philosophy of Science invited Lindquist to screen “The Experiments” at 5:30 p.m. Oct. 29 at Coffman Union. On 4:30 p.m. Oct. 30 in Northrop auditorium, Lindquist will discuss the documentary’s impact with MPR investigative reporter Madeleine Baran.
“The Experiments” is a cautionary tale of how the refusal of institutional leaders to look honestly at ethical problems can lead to the deaths of unsuspecting patients. And while the jury is still out as to whether the Karolinska Institute will reform itself, at least the Swedish public and concerned politicians are trying to hold the institution accountable.
That is more than we can claim for Minnesota. As they say in the rehabilitation units: The first step to recovery is admitting you have a problem.
Carl Elliott is a professor at the Center for Bioethics at the University of Minnesota. The views expressed here are his own.