The federal Office for Human Research Protections (OHRP) has taken the unusual step of suspending all federally supported research at the New York State Psychiatric Institute (NYSPI), which is affiliated with Columbia University.
The suspension — first reported by The New York Times — is the latest setback for Columbia’s psychiatry program.
In February 2022, the university suspended psychiatry department chair Jeffrey Lieberman, MD — who was also director of the NYSPI — after a racist tweet. Lieberman was also, until his suspension, ibuprofen reaction with sodium hydroxide an advisory board member and columnist for Medscape Psychiatry.
Shortly thereafter, Columbia appointed Helen Blair Simpson, MD, PhD, as interim chair of psychiatry and interim director of the NYSPI, which is part of the New York State Office of Mental Health but shares staff with Columbia.
According to the autism publication Spectrum, in late July, Simpson was abruptly replaced by Jeremy M. Veenstra-VanderWeele, MD in the wake of the university stopping clinical trials conducted by Columbia psychiatrist Bret Rutherford, MD.
Rutherford was exploring whether levodopa might be used as a treatment for mobility and cognition issues in older people with depression. Spectrum reported that an individual in the placebo group died by suicide in 2019 and that the study was suspended before it was completed.
In a statement to Medscape Medical News, NYSPI director of communications Carla Cantor said she could not comment on the individual who died.
“Due to state and federal health information privacy laws, NYSPI is unable to provide information that identifies or may lead to the identification of any individual receiving treatment and cannot provide specific details about any individual involved in a research study,” said Cantor.
Rutherford resigned from NYSPI on June 1 and is no longer a Columbia faculty member, Cantor said. Spectrum reported that two of Rutherford’s papers on the levodopa studies had been retracted and that the National Institute of Mental Health had ended his studies and has not renewed funding for his grants.
NYSPI “voluntarily paused all research studies involving human subjects in early June,” Cantor said, adding that 2 weeks later, the OHRP restricted US Department of Health and Human Services (HHS)–funded research involving human subjects at the Institute.
“OHRP takes very seriously the protection of people who volunteer for research studies and has procedures to ensure that those protections are in place,” said Kate Migliaccio-Grabill, a spokesperson for the HHS.
The OHRP, part of HHS, “is investigating New York State Psychiatric Institute and has restricted its ability to conduct HHS-supported human subject research,” she said, adding, “More details will be shared when possible.”
National Institutes of Health (NIH) spokesperson Emma Wojtowicz told Medscape Medical News that “NIH is working closely with the HHS Office for Human Research Protections” on its investigation, adding that, “NIH does not discuss matters under review.”
In the meantime, Cantor said that the NYSPI is “working with its federal partners to create a research safety review plan for HHS-funded studies, and out of an abundance of caution has begun a safety review of currently paused studies not funded by HHS.”
The NYSPI reports on its website that “500 externally funded studies with budgets totaling $86 million are underway, most of them supported by the federal government.”
The NYSPI safety review of research that is not funded by HHS “is expected to be completed sometime next month,” said Cantor.
Alicia Ault is a St. Petersburg, Florida–based freelance journalist whose work has appeared in publications including JAMA and Smithsonian.com. You can find her on Twitter @aliciaault.
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