The New York State Psychiatric Institute in New York City is undergoing an audit and a leadership change after a suicide occurred during one of its clinical trials.
Autism researcher Jeremy Veenstra-VanderWeele has suddenly taken the helm as interim executive director of the institute and chair of Columbia University’s psychiatry department and is replacing Helen Blair Simpson, Spectrum have 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 communications director.
The audit and turnover in management comes after the suspension of a number of clinical trials conducted by Columbia psychiatrists Bret Rutherfordwhich 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, one participant was assigned to the placebo group committed suicide. This 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Two published reports based on Rutherford’s pilot studies have since been retracted, which Spectrum previously reported. The National Institute of Mental Health has terminated the Rutherfords attempt and did not renew the funding of his research grant or K24 Midcareer Award.
Former members of Rutherford’s lab describe it as a high-pressure environment that often puts 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 library at Columbia University, where he was an associate professor, and the answering machine at his former number says he no longer checks 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 surrounding the suicide remain unclear, and the institute has previously declined to comment on Rutherford’s withdrawals. Veenstra-VanderWeele confirmed that he is the new director, but did not respond to further questions about the situation.
Rutherford’s studies aimed to enroll participants who had a slow gait, had only mild or moderate depression, and were not at high risk of suicide.
“You have to be absolutely sure that you are doing as much as possible to exclude people who are at risk of suicide or violence against other people,” says Carl Elliotta bioethicist at the University of Minnesota who has written widely and critically about a suicide in a clinical trial at his institution. “With this lawsuit, the question I would have is: Were these things taken care of?”
It was often challenging to recruit participants who met all 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’s hard to enroll in, you’re going to stretch the boundaries of who’s eligible,” she says.
Roberts notes that many of the participants she worked with “were not doing well financially” and were likely motivated by the small payments they received.
Rutherford aimed to register 90 participants. To increase recruitment, participants were reimbursed for their transportation costs and paid $15 per visit for eight visits, according to the study protocol. Those who also participated in MRI or positron emission tomography scans would receive up to $400 in additional payments.
Participants who met all enrollment criteria but were taking an ineffective antidepressant were required to undergo a study-supervised tapering of this medication and complete washout period, although this was not explicitly written into the publicly available study protocol.
In January 2022, the study was temporarily suspended by the US National Institute of Mental Health following the suicide. It is unknown whether the participant in question had taken antidepressant medication before the study.
Four of Rutherford’s published studies were subsequently retracted or corrected for problems related to how participants taking antidepressants at enrollment were handled.
One notice of withdrawal published in February indicates tapering could be challenging and that researchers did not always adhere to the protocol. One-third of participants taking antidepressants were unable to taper off successfully.
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 only one day before the study.
Discontinuation of antidepressants has been connected to an increased risk of suicide.
The suspended clinical trial was eventually completed with 51 participants, according to ClinicalTrials.gov. A note attached to the results says: “Data collected in the trial have been presented as appropriate but are considered unreliable.”
Elliott, the bioethicist, says a fundamental problem with the way clinical trials are monitored is that ethics boards will review a protocol but not certify that investigators are following it.
As an author of one of the retracted studies, Roberts is not surprised by the anomalies in the research. “I was disappointed with the rigorous research there,” she says, adding that it was “part of the reason I ended up leaving and being disappointed with the field in general.”