Federal regulators have suspended human subjects research at the Columbia-affiliated New York State Psychiatric Institute, one of the nation’s oldest research centers, while they investigate institute-wide safety protocols after the suicide of a research participants.
A spokeswoman for the US Department of Health and Human Services, Kate Migliaccio-Grabill, confirmed Wednesday that the agency’s Office for Human Research Protections is investigating the psychiatric institute “and has restricted its ability to conduct HHS-supported human subjects research.”
About two weeks before the federal order, on June 12, the institute “voluntarily ceased all studies involving continued contact with human subjects,” according to Carla Cantor, the director. of institute communication. The decision affected 417 studies, of which 198 had ongoing participation. Of those, 124 receive federal funding.
It is unusual for a US regulatory agency to suspend research, and it suggests that investigators are concerned that potential breaches of safety protocols have occurred more broadly within the institute. Almost 500 studieswith combined budgets totaling $86 million, are conducted at the institute, according to its website.
The inquiry followed the death by suicide of someone enrolled in a study led by Dr. Bret R. Rutherford, an associate professor of psychiatry at Columbia University who is testing a drug for Parkinson’s disease, levodopa, as a treatment for depression and reduced mobility in older people.
Dr. Rutherford resigned his position at the institute on June 1 and is no longer a faculty member of Columbia’s psychiatry department, Ms. Cantor. Dr. Rutherford did not respond to requests for comment left at his home and office.
Asked about the reported suicide, Ms. Cantor that a death occurred during a clinical trial, saying the institute cannot release any information about study participants due to health privacy laws.
The institute’s “top priority is the health and safety of individuals engaged in our award-winning research programs,” said Ms. Cantor in a statement.
He said the institute “worked to assist federal agencies in their audit and then restructured and strengthened compliance research and monitoring programs throughout the institution.”
The institute, run by the state Office of Mental Health, is seeking federal approval for a new research safety plan so federally funded studies can continue, he said. It is also conducting a safety review of human research studies not funded by the federal government, which is expected to be completed next month.
After the initial audit of Rutherford’s laboratory, the National Institutes of Health requested an external audit of all federally funded research, he said.
A spokeswoman for the NIH, Amanda Fine, said the agency is working closely with the Office of Human Research Protections, which is investigating the matter. The NIH cannot discuss matters under review, he said.
The reported the subject’s suicide earlier on Spectrum, a news site that focuses on autism research. But the US agency’s decision to order a wholesale halt to other studies was not disclosed until now.
The levodopa trial for late-life depression, which began in 2018 and received $736,579 in funding from the National Institute of Mental Health, aims to recruit 90 adults over the age of 60 who suffered from mild to moderate depression and slow gait.
The team finished with just 51, of which 20 dropped out or were found ineligible, according to records provided to federal oversight agencies. The remaining 31 were assigned to one of two groups, one taking levodopa and the other taking a placebo.
On the website clinicaltrials.govunder the heading “serious adverse events,” the researchers reported that the individual who died by suicide were assigned to the placebo arm of the study.
Dr. Rutherford and his co-authors published several articles based on the trial, reporting that levodopa, which increases dopamine concentrations, led to improvement in mobility, processing and symptoms of depression in the study population.
The results are promising was flagged in a commentary in The New England Journal of Medicinewho said that clinicians “may consider levodopa” for patients whose cognition or mobility have not responded to standard depression treatments.
It is unclear when the suicide occurred, but records show that the study did temporarily suspended of the National Institute of Mental Health in January 2022 and terminated in May 2023. This year, three scientific journals run recoveries identifying methodological errors in studies from the laboratory of Dr. Rutherford.
One of them pointed out a certain flaw: Eight subjects recently stopped taking the antidepressant, instead of waiting 28 days to “wash out,” as the study protocol called for. The average number of days patients were drug-free was 10; one subject was drug-free for only one day.
A member of Columbia’s faculty since 2010, Dr. Rutherford was a prolific researcher, which received 32 grants with a total of more than $15.5 million from NIMH since 2010.
Study subjects were paid $15 in cash for weekly visits and an additional $400 for undergoing MRI and PET scans.
Emily Roberts, a former research assistant in the laboratory of Dr. Rutherford and a co-author on one of his papers, told Spectrum that recruiting for the study has been difficult and some criteria have been relaxed to increase enrollment.
Ms. Roberts, who oversaw the clinical trial in its first year, said the experience left him frustrated and contributed to his decision to leave the field. “I was disappointed with the difficulty of the research there,” she said. Ms. proved Roberts made his comments to Spectrum, but he would not comment publicly on the matter.
Some studies of psychiatric drugs require participants to “wash out” – to remove the drugs they are taking and allow them to clear their system, so that scientists can test the effectiveness of a new one.
This practice is specific to psychiatric research, and it creates tension about what is best for patients, said Jeffrey Kahn, the director of the Berman Institute of Bioethics at Johns Hopkins University.
“There’s no other category of drug testing where you ask someone to get off something they’re obsessed with,” he said. “This is a violation of a standard of care. You can’t tell someone, ‘Stop taking your chemotherapy so we can compare it to a new chemotherapy.’”
It is rare for regulators to halt research at an institution.
In 2015, the University of Minnesota suspended enrollment in psychiatric drug trials afterward a critical report by state auditors into the 2004 suicide of a patient facing commitment to a state institution when he was enrolled in an industry-sponsored clinical trial of Seroquel, an antipsychotic drug.
In 2001, the Office for Human Research Protections ordered Johns Hopkins University to suspend nearly all federally funded medical research involving human subjects after the death of a volunteer who inhaled an unapproved asthma drug.
In 2000, the federal agency temporarily suspended all medical research involving human subjects at the University of Oklahoma after an investigation showed that patients had been injected with a vaccine made by unqualified laboratory workers. .
If you are thinking about suicide, call the National Suicide Prevention Lifeline at 1-800-273-8255 (TALK) or go to SpeakingOfSuicide.com/resources for a list of additional resources.
