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The New York State Psychiatric Institute in New York City is undergoing an audit following a suicide that occurred during one of its clinical trials, and it has announced a change in leadership.
Autism researcher Jeremy Veenstra-VanderWeele has abruptly taken the helm as the interim executive director of the institute and chair of the Columbia University psychiatry department, replacing previous interim head Helen Blair Simpson, Spectrum has learned.
The New York State Psychiatric Institute is part of the New York State Office of Mental Health, but it shares buildings and staff with Columbia University and the university’s hospital. The Office of Mental Health is currently conducting an audit of the institute, according to Carla Cantor, the institute’s director of communications.
The audit and turnover in leadership come after the halting of a series of clinical trials conducted by Columbia psychiatrist Bret Rutherford, which tested whether the drug levodopa — typically used to treat Parkinson’s disease — could improve mood and mobility in adults with depression.
During a double-blind study that began in 2019, a participant in the placebo group died by suicide. That study was suspended prior to completion, according to an update posted on ClinicalTrials.gov in 2022.
Two published reports based on Rutherford’s pilot studies have since been retracted, as Spectrum has previously reported. The National Institute of Mental Health has terminated Rutherford’s trials and did not renew funding of his research grant or K24 Midcareer Award.
(Ten days after the original publication of this story, a Columbia spokesperson told Spectrum via email that Simpson had announced her departure in a letter to Psychiatry Department faculty on 21 July 2023, the day she left the two posts. “Her departure from these interim roles was unrelated to Dr. Rutherford’s research; indeed, the cessation of Dr. Rutherford’s research protocols occurred more than 20 months prior to Dr. Simpson’s decision to step down.”)
Former members of Rutherford’s laboratory describe it as a high-pressure environment that often put publications ahead of study participants. “Research is important, but not more so than the lives of those who participate in it,” says Kaleigh O’Boyle, who served as clinical research coordinator there from 2018 to 2020.
Although Rutherford’s faculty page is still active, he is no longer listed in the directory at Columbia University, where he was associate professor, and the voicemail at his former number says he is no longer checking it. He did not respond to voicemails and text messages sent to his personal phone or to emails sent to his Columbia email address, and Cantor would not comment on his employment status.
The circumstances around the suicide remain unclear, and the institute has previously declined to comment on Rutherford’s retractions. Veenstra-VanderWeele confirmed that he is the new director but did not respond to further questions about the situation.
Randy Mastro, an attorney representing Simpson, told Spectrum by email weeks after the publication of this story that “Her personal decision to voluntarily step down from her interim leadership posts after 17 months of service was not ‘abrupt’ at all, and it was not related in any way to the clinical trial suicide and subsequent cessation of Dr. Rutherford’s research protocols, both of which occurred before she assumed her interim leadership roles.”
The New York Times reported on 10 August that the U.S. Office of Human Research Protections had “suspended research on human subjects” at the institute in late June, about a month before Simpson announced she was stepping down and about two weeks after 12 June, the date on which the institute says it “voluntarily paused” all such studies.
Rutherford’s studies aimed to enroll participants who had a slow walk, had only mild or moderate depression, and were not at high risk of suicide.
“You need to make absolutely certain that you are doing as much as you can to exclude people who are at risk of suicide or violence to other people,” says Carl Elliott, a bioethicist at the University of Minnesota who has written extensively and critically about a suicide in a clinical trial at his institution. “With this trial, the question I would have is: Were those things taken care of?”
It was often challenging to recruit participants who met all of the criteria set by the researchers and the institutional research ethics board, according to Emily Roberts, a former research assistant in Rutherford’s lab, who managed the clinical trial in its first year.
“In a study that is difficult to enroll for, you’re going to stretch the boundaries of who is eligible for it,” she says.
Roberts notes that many of the participants she worked with “were not well off financially” and were likely motivated by the small payments they received.
Rutherford was aiming to enroll 90 participants. To beef up recruitment, participants were reimbursed for their transportation costs and paid $15 per visit for eight visits, according to the study protocol. Those who also took part in MRI or positron emission tomography scans would receive up to $400 in additional payments.
Participants who met all the enrollment criteria but were taking an ineffective antidepressant were supposed to undergo a study-supervised taper of that medication and complete a washout period, though that was not explicitly written into the publicly available study protocol.
In January 2022, the study was temporarily suspended by the U.S. National Institute of Mental Health, following the suicide. It is unknown whether that participant had been taking any antidepressant medication prior to the study.
Four of Rutherford’s published studies were subsequently retracted or corrected for issues related to how participants taking antidepressants at enrollment were handled.
One retraction notice published in February indicates tapering could be challenging and that the researchers did not always stick to the protocol. One-third of the participants taking antidepressants were unable to successfully taper off of them.
Most of the others began the study in the middle of a planned 28-day washout period. In one case, a participant had taken antidepressant medication just one day prior to the study.
The discontinuation of antidepressants has been linked to an increased risk of suicide.
The suspended clinical trial was eventually terminated with 51 participants, according to ClinicalTrials.gov. A note appended to the results states: “Data collected in the trial have been presented as required but are considered unreliable.”
Elliott, the bioethicist, says that a fundamental problem with the way clinical trials are overseen is that ethics boards will review a protocol but not confirm that investigators are adhering to it.
As an author of one of the retracted studies, Roberts is not surprised by the anomalies in the research. “I was disappointed at the rigor of the research there,” she says, adding that it was “part of the reason why I ended up leaving and being disenchanted with the field in general.”
If you or someone you know is having suicidal thoughts, help is available. Here is a worldwide directory of resources and hotlines that you can call for support.
Cite this article: https://doi.org/10.53053/PUPF4995