FOIAengine: A Request Was a Signal, Months Before Bad News Hit
Columbia University’s New York State Psychiatric Institute has a storied research history stretching back to its founding in 1895 as one of the first institutions in the U.S. to integrate teaching, research, and therapeutic approaches to the care of patients with mental illnesses. Its website boasts that the Institute consistently ranks at the top of federally funded mental-health research grants, and calls its research “the leading edge of today’s discoveries in mental health.” Indeed, the numbers speak for themselves. Currently, almost 500 externally-funded studies with budgets totaling $86 million are underway at the Institute, many of them supported by the federal government.
As the award-winning head of an important psychiatric research clinic within the Institute, Dr. Bret R. Rutherford focused on the causes and treatment of late-life depression. He received at least $15.4 million in research grants from the National Institute of Mental Health and the National Institute on Aging since 2010, and was the author of dozens of scholarly articles and book chapters describing his research. As a Columbia associate professor and a researcher, Rutherford was one of the Institute’s stars – until, suddenly, he wasn’t.
That is where we pick up today’s story. It’s a cautionary tale, still unfolding, involving just-revealed research irregularities in Rutherford’s lab, a study participant’s suicide, a resulting federally mandated halt to human research at the Columbia-affiliated Institute – and a FOIA request.
Irregularities in Rutherford’s studies were first revealed by Spectrum, a non-profit autism-focused news website that operates independently of its funder, the Simons Foundation Autism Research Initiative. Breaking its exclusive story on May 9, Spectrum revealed that two of Rutherford’s studies being conducted at the Psychiatric Institute were withdrawn because the researchers violated their own study protocol.
Spectrum reported that Rutherford was testing whether the Parkinson’s drug levodopa could be used to improve mood and mobility in older adults with depression. Initial journal reports of Rutherford’s results, in Biological Psychiatry in 2019 and the Journal of Affective Disorders in 2020, seemed promising. Participants walked faster and had fewer depressive symptoms.
But earlier this year, both journals withdrew the articles and published retractions. The problem was with the study population. Rutherford’s clinic had recruited far fewer participants than the 90 adults, aged 60 and older, that the research protocol called for. Further, according to Spectrum’s reporting, eight of the participants – about a fourth of the cohort, according to a summary published on ClinicalTrials.gov – hadn’t spent the required 28 days “washing out” their system of other antidepressant medications. At least one participant had taken antidepressant medication the day before the study began. Three others had a score so low on a depression survey that they shouldn’t have been included in the study.
The study began in 2018 with $736,579 in funding from the National Institute of Mental Health. Participants could earn up to $520 for their time and were split into two groups, one receiving levodopa, the other a placebo. The study was designated as “quadruple-blind” – that is, neither the participants, their care providers, the investigator, nor the outcomes assessor knew who was getting the real drug as opposed to the placebo. Although a “blind” study is intended to safeguard against research bias, the design also had a known risk requiring careful monitoring: There was, in effect, a one-in-two chance that a participant who needed antidepressant medication wouldn’t be receiving it.
A few weeks ago, on July 31, Spectrum broke a follow-up: One of the placebo recipients in Rutherford’s study had died by suicide. The New York Times soon picked up the story and moved it ahead, documenting for the first time even more troubling news: The Department of Health and Human Services’ Office for Human Research Protections was investigating safety protocols not just in Rutherford’s studies, but in every human-subject study throughout the Columbia-affiliated Institute. As a result, all federally funded research on human subjects at the Institute was on hold. Further, the Times reported, Columbia had “voluntarily” paused all other human-subject research projects.
In all, 417 studies were halted, and Rutherford was gone. The Times reported Rutherford resigned his Columbia position on June 1. Rutherford didn’t respond to an email sent to his Columbia email account, still visible on the web, nor did he respond to earlier requests by Spectrum and the Times for comment.
The fatal event that precipitated the halting of all human-subject research at the Institute had been sitting on the ClinicalTrials.gov website for more than two months, in a posting dated May 22. But the bad news was buried deep in the study results. The suicide was listed as a “Serious Adverse Event: Psychiatric Disorders/Death by Suicide.” For months, that had gone unnoticed by the media.
But apparently not by Redica Systems, a regulatory intelligence company that boasts the largest database of FDA inspection records, “powered by the Freedom of Information Act and web crawling from more than 15,000 individual data sources.”
Redica Systems is a prolific FOIA requester at the FDA. On May 23, a day after the fatal result of Rutherford’s levodopa study was posted to ClinicalTrials.gov, Redica Systems filed a FOIA request with the FDA. Redica asked for a warning letter, called a “Form 483” in FDA parlance, that Redica said resulted from “the Human Drugs inspection of Bret R. Rutherford, M.D.” A Form 483 warning letter is issued by the FDA at the conclusion of an inspection, when an investigator observes violations of laws or regulations under the FDA’s purview. Redica obtained and posted the document, and this week provided us with a copy.
The five-page Form 483, although heavily redacted by the FDA before its release under FOIA, lists three broad categories of “objectionable conditions and practices” – in this case, violations of methodology and oversight – that an investigator discovered at Rutherford’s lab between December 19, 2022 and January 10, 2023. The Form 483 doesn’t state whether the inspection was pre-arranged, or a surprise.
Redica’s FOIA request is significant, because it confirms that the FDA was looking into research protocols at the Columbia-affiliated Psychiatric Institute, and at Rutherford’s laboratory in particular, as much as seven months before the news finally broke in Spectrum and the Times.
The existence of the Form 483 issued to Rutherford hasn’t been previously reported. After checking every publicly available FDA database, we were unable to find any other indication, apart from Redica’s May 23 FOIA request, of human-subject research irregularities at the New York State Psychiatric Institute. An FDA spokesman said it’s the agency’s policy not to comment on interactions between FDA inspectors and regulated entities.
FOIA requests to the federal government can be an important early warning of negative publicity, or of litigation or enforcement action yet to happen. In this case, Redica’s FOIA request was the first signal of bad news that months later would have a profound effect on the operations and reputation of a leading psychiatric research institute.
According to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, Redica and its affiliates have made over 3,600 FOIA requests since October 2020. Redica Systems represents a relatively new breed of highly active FOIA requesters who vacuum up federal data and package the result in potent analytical products – FOIA-powered knowledge, giving an advantage to those who possess it. According to Redica, its customers have access to 917,000 FDA inspection records, compared to 279,000 in the FDA’s free public dataset. “It’s been a fun ride working with industry professionals, hedge funds, law firms, and reporters to track down hard-to-organize information,” the company’s founder posted in 2015, on the fifth anniversary of Redica’s founding. According to Crunchbase, California-based Redica Systems has raised at least $34 million in private-equity funding, most recently completing a $30 million funding round in December 2021.
Next: Democrats, Republicans, and FOIA: The Ins and Outs of Oppo.
John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. His most recent book is The Partisan: The Life of William Rehnquist. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at [email protected].
