All human research trials at New York State Psychiatric Institute are halted while federal regulators investigate possible violations of clinical drug trial protocols following patient suicide.

By CCHR International
The Mental Health Industry Watchdog
August 23, 2023

The federal government has suspended the New York State Psychiatric Institute (NYSPI)’s research on human subjects following a patient’s tragic suicide during a clinical drug trial using a Parkinson’s drug to treat depression.[1] Concerns are now raised about the institute’s safety protocols and research practices, specifically relating to the management of participants on antidepressants during the trial and the withdrawal procedures, and their potential role in the tragic event.[2]

The Department of Health and Human Services’ Office for Human Research Protections (OHRP) initiated the suspension of research funding to NYSPI, affiliated with Columbia University, citing the need to thoroughly investigate the circumstances surrounding the patient’s suicide and the institute’s overall safety measures.[3]

According to The New York Times, “It is unusual for the U.S. regulatory office to suspend research, and this suggests that investigators are concerned that potential violations of safety protocols occurred more broadly within the institute.” The NYSPI, which shares buildings and staff with Columbia University and the University’s hospital, has been conducting nearly 500 research studies with a budget of $86 million—of those, 124 receive federal funding.[4]

The Office of Mental Health is also currently conducting an audit of NYSPI, according to Carla Cantor, the institute’s director of communications.[5]

This decision to stop all human research comes in the wake of the removal of former American Psychiatric Association psychiatrist, Jeffrey Lieberman as NYSPI’s director in February 2022 due to racist comments he made publicly about a model. He was replaced by psychiatrist Helen Blair Simpson, who was named interim chair of psychiatry and interim NYSPI director. However, she was then succeeded by another psychiatrist in July 2023, after the University stopped clinical trials led by Bret Rutherford, an associate professor of psychiatry at Columbia University.[6]

Dr. Rutherford was leading the study in which the patient committed suicide. The study was testing the use of a Parkinson’s drug, Levodopa, to treat late-life “depression.”[7] The Daily Mail reported that the study, which received $736,579 in funding, was temporarily suspended by the National Institute of Mental Health in January 2022.[8]  Rutherford resigned from NYSPI on June 1, 2023, and is no longer a Columbia faculty member, Cantor said.[9]

The circumstances surrounding the suicide during Rutherford’s study have raised questions about the handling of participants who were taking antidepressants prior to the trial, including how they were withdrawn from these drugs and whether such withdrawals were responsible for the tragic outcome.[10]

Emily Roberts, a former research assistant in Rutherford’s laboratory and who managed the clinical trial in its first year, told Spectrum that recruiting was challenging—and in a bid to get enough people enrolled, some criteria was “relaxed.”[11]

According to Spectrum, “Participants who met all the enrollment criteria but were taking an…antidepressant were supposed to undergo a study-supervised taper of that medication and complete a washout period, though that was not explicitly written into the publicly available study protocol.”[12]

While Daily Mail reported that it is not yet confirmed if the deceased person was taking antidepressants, it said, “Issues became apparent after it was reported that some of the human subjects had only just finished taking their antidepressants days earlier, which goes against the study’s protocol. As well as this, stopping antidepressant consumption is linked to an increased risk of suicide.”[13]

Subsequently, four of Rutherford’s published studies were retracted or corrected for issues related to how participants taking antidepressants at enrollment were handled. One retraction notice published in February 2023 indicated that tapering could be challenging and that the researchers did not always stick to the protocol. One-third of the participants taking antidepressants were unable to successfully taper off them.[14]

Withdrawal effects, as highlighted in a 2019 Epidemiology and Psychiatric Science study, can last weeks to months.[15] Withdrawal symptoms can encompass potentially violent and suicidal symptoms.[16] The UK Royal College of Psychiatrists has also cautioned about experiencing anxiety, “sometimes in intense ‘surges,’” rapidly changing moods, anger, suicidal thoughts and a feeling of inner restlessness and inability to stay still (akathisia), with the latter capable of leading to violence.[17]

A History of Scrutiny: NYSPI and Columbia University’s Complex Past

Columbia University’s research history is marred by the findings of investigations into its practices and that of NYSPI.

In the 1950s, NYSPI’s Paul Hoch conducted lethal LSD experiments under the CIA’s guidance, tragically leading to the death of a patient, Harold Blauer, who was injected with mescaline.[18]

In 1998, NYSPI-Columbia faced an inquiry for subjecting vulnerable youth to hazardous fenfluramine (a drug normally used to treat seizures) trials as part of the “Fen-Phen” diet drug combination, where children were subjected to unethical and damaging experiments.[19]

In 1999, the New York Post, through documents obtained under the Freedom of Information Act, exposed that NYSPI conducted tests using Prozac on children as young as six, without fully informing parents or guardians of the dangers involved.[20]

In 2016, Jeffrey Lieberman, then chair of the Department of Psychiatry at Columbia and NYSPI’s director downplayed the severe adverse effects of psychedelics, though a 2023 University of London report contradicted this, revealing ongoing negative impacts such as anxiety, fear, existential struggles, and more.[21]

Also in 2016, Columbia settled a $9.5 million civil fraud case for mishandling National Institutes of Health (NIH) grants, improperly seeking inflated cost recoveries, and diverting funds from vital research.[22]

These instances and the ongoing investigations into potential protocol breaches underscore a problematic culture that persists despite previous controversies. They highlight the need for robust oversight, accountability, and substantial penalties for NYSPI and Columbia University’s psychiatric research violations.

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[1] Ellen Barry, “U.S. Watchdog Halts Studies at N.Y. Psychiatric Center After a Subject’s Suicide,” The New York Times, 10 Aug. 2023, https://www.nytimes.com/2023/08/10/health/columbia-drug-trials-suicide.html

[2] Claudia Aoraha, “New York State Psychiatric Institute has ALL human research trials suspended by watchdog after person taking part in Parkinson’s drug trial kills themselves,” Daily Mail, 10 Aug. 2023, https://www.dailymail.co.uk/news/article-12395401/New-York-State-Psychiatric-Institute-suicide-Parkinsons.html; Brendan Borrell, “Exclusive: Shake-up at top psychiatric institute following suicide in clinical trial,” Spectrum, 31 July 2023, https://www.spectrumnews.org/news/exclusive-shake-up-at-top-psychiatric-institute-following-suicide-in-clinical-trial/

[3] Alicia Ault, “Feds Suspend Research Support at New York State Psychiatric Institute,” Medscape, 14 Aug. 2023, https://www.medscape.com/viewarticle/995413

[4] Ellen Barry, “U.S. Watchdog Halts Studies at N.Y. Psychiatric Center After a Subject’s Suicide,” The New York Times, 10 Aug. 2023, https://www.nytimes.com/2023/08/10/health/columbia-drug-trials-suicide.html

[5] Brendan Borrell, “Exclusive: Shake-up at top psychiatric institute following suicide in clinical trial,” Spectrum, 31 July 2023, https://www.spectrumnews.org/news/exclusive-shake-up-at-top-psychiatric-institute-following-suicide-in-clinical-trial/

[6] Alicia Ault, “Feds Suspend Research Support at New York State Psychiatric Institute,” Medscape, 14 Aug. 2023, https://www.medscape.com/viewarticle/995413; Brendan Borrell, “Exclusive: Shake-up at top psychiatric institute following suicide in clinical trial,” Spectrum, 31 July 2023, https://www.spectrumnews.org/news/exclusive-shake-up-at-top-psychiatric-institute-following-suicide-in-clinical-trial/; “After reported suicide of participant, human research studies suspended at psychiatric institute affiliated with Columbia University,” CNN, 11 Aug. 2023, https://www.cnn.com/2023/08/11/us/columbia-university-psychiatric-research-suspended/index.html

[7] Claudia Aoraha, “New York State Psychiatric Institute has ALL human research trials suspended by watchdog after person taking part in Parkinson’s drug trial kills themselves,” Daily Mail, 10 Aug. 2023, https://www.dailymail.co.uk/news/article-12395401/New-York-State-Psychiatric-Institute-suicide-Parkinsons.html

[8] Claudia Aoraha, “New York State Psychiatric Institute has ALL human research trials suspended by watchdog after person taking part in Parkinson’s drug trial kills themselves,” Daily Mail, 10 Aug. 2023, https://www.dailymail.co.uk/news/article-12395401/New-York-State-Psychiatric-Institute-suicide-Parkinsons.html

[9] Alicia Ault, “Feds Suspend Research Support at New York State Psychiatric Institute,” Medscape, 14 Aug. 2023, https://www.medscape.com/viewarticle/995413

[10] Claudia Aoraha, “New York State Psychiatric Institute has ALL human research trials suspended by watchdog after person taking part in Parkinson’s drug trial kills themselves,” Daily Mail, 10 Aug. 2023, https://www.dailymail.co.uk/news/article-12395401/New-York-State-Psychiatric-Institute-suicide-Parkinsons.html; Brendan Borrell, “Exclusive: Shake-up at top psychiatric institute following suicide in clinical trial,” Spectrum, 31 July 2023, https://www.spectrumnews.org/news/exclusive-shake-up-at-top-psychiatric-institute-following-suicide-in-clinical-trial/

[11] Claudia Aoraha, “New York State Psychiatric Institute has ALL human research trials suspended by watchdog after person taking part in Parkinson’s drug trial kills themselves,” Daily Mail, 10 Aug. 2023, https://www.dailymail.co.uk/news/article-12395401/New-York-State-Psychiatric-Institute-suicide-Parkinsons.html

[12] Brendan Borrell, “Exclusive: Shake-up at top psychiatric institute following suicide in clinical trial,” Spectrum, 31 July 2023, https://www.spectrumnews.org/news/exclusive-shake-up-at-top-psychiatric-institute-following-suicide-in-clinical-trial/

[13] Claudia Aoraha, “New York State Psychiatric Institute has ALL human research trials suspended by watchdog after person taking part in Parkinson’s drug trial kills themselves,” Daily Mail, 10 Aug. 2023, https://www.dailymail.co.uk/news/article-12395401/New-York-State-Psychiatric-Institute-suicide-Parkinsons.html

[14] Brendan Borrell, “Exclusive: Shake-up at top psychiatric institute following suicide in clinical trial,” Spectrum, 31 July 2023, https://www.spectrumnews.org/news/exclusive-shake-up-at-top-psychiatric-institute-following-suicide-in-clinical-trial/

[15] https://www.cchrint.org/2021/04/06/antidepressant-withdrawal-warning-vital/, citing: Michael Pascal Hengartner, John Read, James Davies, “Antidepressant withdrawal – the tide is finally turning,” Epidemiology and Psychiatric Sciences, Aug. 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8061160/

[16] https://www.verywellmind.com/antidepressant-withdrawal-4172110; https://www.madinamerica.com/2022/10/antidepressant-withdrawal-linked-suicide-attempt-case-study/

[17] https://www.rcpsych.ac.uk/mental-health/treatments-and-wellbeing/stopping-antidepressants

[18] Larry Getlen, “The mad scientist behind America’s mind-control quest with LSD,” The New York Post, 16 Sept. 2019, https://nypost.com/2019/09/16/the-mad-scientist-behind-americas-mind-control-quest-with-lsd/; “NYPSI an early CIA-contracted academic institution under MK-NAOMI,” Alliance for Human Research Protection, https://ahrp.org/nypsi-an-early-cia-contracted-academic-institution-under-mk-naomi/

[19] https://www.psychiatrictimes.com/view/americas-tragedy; https://www.nature.com/articles/33760

[20] Greg Birnbaum, “Science or Abuse? State Testing,” New York Post, 31 Jan. 1999

[21] https://journals.sagepub.com/doi/10.1177/0269881116675755; Jules Evans, et. al, “Extended Difficulties Following the Use of Psychedelic Drugs: A Mixed Methods Study,” Social Science Research,” 21 June 2023, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4505228

[22] “Manhattan U.S. Attorney Announces $9.5 Million Settlement With Columbia University For Improperly Seeking Excessive Cost Recoveries In Connection With Federal Research Grants,” U.S. Attorney’s Office, Southern District of New York, 14 July 2016, https://www.justice.gov/usao-sdny/pr/manhattan-us-attorney-announces-95-million-settlement-columbia-university-improperly