A person at Columbia University’s New York Institute of Psychiatry, one of the nation’s oldest research centers, is being tested for safety protocols after a study participant’s suicide, as federal regulators investigate laboratory-wide safety protocols. The included study was suspended.
U.S. Department of Health and Human Services spokeswoman Kate Migliaccio-Grabile said Wednesday that the department’s Office of Human Research Protection is investigating the psychiatric lab and said it would “restrict its ability to conduct HHS-supported human research.” “I am.”
On June 12, about two weeks before the federal order came out, the institute said, “All studies involving ongoing interactions with human subjects will be was voluntarily suspended.” The decision impacted 417 studies, 198 of which are ongoing participants. 124 of them are federally funded.
It was unusual for U.S. regulators to suspend research, suggesting researchers are concerned that potential violations of safety protocols are occurring more widely in laboratories. ing. about 500 studiesResearch is underway with a total budget of $86 million, according to the institute’s website.
The study found that a person who participated in a study led by Columbia University Associate Professor of Psychiatry Brett R. Rutherford, Ph.D., who was testing the Parkinson’s drug levodopa as a treatment for depression and reduced mobility, died by suicide. It was done in response to that. for the elderly.
Dr. Rutherford resigned from the institute on June 1 and is no longer on the faculty of Columbia Psychiatry, Ms. Kanter said. Dr. Rutherford did not respond to requests for comment left at his home or office.
Asked about the reported suicides, Kanter denied that there had been any deaths during clinical trials and said medical privacy laws prevent research institutions from providing information about study participants.
The institute’s “first priority is the health and safety of those involved in its award-winning research programs,” Ms Kanter said in a statement.
She said the institute “seeked to support federal agency audits and then restructured and strengthened the institute-wide research compliance and oversight program.”
The institute, which is run by state departments of mental health, said it is seeking federal approval for a new research safety plan so it can resume federally funded research. It is also conducting a safety review of a non-federally-funded human study, which is expected to be completed next month.
After the Rutherford Institute’s initial audit, the National Institutes of Health requested an external audit of all federally funded research, she said.
NIH spokeswoman Amanda Fine said the NIH is working closely with the Human Research Protection Agency, which is investigating the issue. The NIH cannot discuss matters under review, she said.
of Subject reported suicide Previously on the autism research-focused news site Spectrum, however, the US authorities’ decision to order a broader halt to other research was not previously disclosed.
A clinical trial of levodopa for late-life depression began in 2018 and received $736,579 in funding from the National Institute of Mental Health. Aiming to recruit 90 adults Over 60 years old suffering from mild to moderate depression and slow walking.
Records provided to federal regulators show the team ended up with just 51 members, 20 of whom either dropped out or were disqualified. The remaining 31 were assigned to one of two groups, one receiving levodopa and one receiving placebo.
on the website clinical trials.govunder the heading “Serious Adverse Events,” the researchers reported: person who died by suicide They were assigned to the placebo arm of the study.
Dr. Rutherford and co-authors published several papers based on this study, reporting that levodopa, which increases dopamine levels, led to improvements in mobility, processing capacity, and depressive symptoms in the study population.
promising results Pointed out in a commentary in the New England Journal of MedicineClinicians “may consider levodopa” in patients whose cognitive and motor skills do not respond to standard depression treatments, the paper said.
It is not clear when the suicide occurred, but the records show studies temporarily suspended By the National Institute of Mental Health in January 2022, Ended Three scientific journals were published this year. performed a retraction Identify methodological errors in research in Dr. Rutherford’s lab.
one of them I pointed out certain flaws: Eight subjects recently stopped taking antidepressants rather than waiting 28 days to “wash out” as required by the study protocol. The average number of days these patients were off medication was 10 days. One subject was off the drug for only one day.
A faculty member at Columbia University since 2010, Dr. Rutherford was a prolific researcher. 32 grants received Since 2010, NIMH has raised more than $15.5 million.
Study participants were paid $15 in cash for weekly visits, plus an additional $400 for MRI and PET scans.
Emily Roberts, a former research assistant in Dr. Rutherford’s lab and co-author of his paper, said recruitment to the study was difficult and that some criteria were relaxed to increase enrollment. told to
Roberts, who managed the trial in its first year, said the experience led to her disillusionment and decision to leave the trial. “I was disappointed by the rigor of her studies there,” she said. Roberts confirmed her own comments to Spectrum, but she would not comment further publicly on the matter.
Some studies of psychiatric drugs require participants to “flush,” or stop taking drugs and cleanse their bodies, so that scientists can test the effectiveness of new drugs.
Jeffrey Kahn, director of the Berman Institute for Bioethics at Johns Hopkins University, said the practice is unique to psychiatric research and creates tension about what’s best for patients.
“There is no separate category of drug trials asking people to stop what they are currently taking,” he said. “It’s a violation of standard of care. You can’t tell someone, ‘Please stop chemotherapy because we’re going to compare it to newer chemotherapy.'”
It is rare for regulators to suspend agency-wide research.
In 2015, the University of Minnesota suspended enrollment in psychiatric drug trials. important report In 2004, state auditors announced a 2004 suicide in which a patient participating in an industry-sponsored clinical trial of the antipsychotic Seroquel faced state incarceration.
In 2001, the Human Research Protection Agency asked Johns Hopkins University to suspend nearly all federally funded human medical research following the death of a volunteer who inhaled an unapproved asthma drug. ordered.
In 2000, federal agencies temporarily suspended all medical research on humans at the University of Oklahoma after an investigation found that patients had been injected with vaccines made by unlicensed researchers.
If you are contemplating suicide, call the National Suicide Prevention Lifeline at 1-800-273-8255 (TALK) or visit the link below. SpeakerOfSuicide.com/Resources For a list of additional resources, see
