CCHR Supports Suspension of NY Psychiatric Institute Research After Suicide

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Mental health watchdog commends halt of New York Psychiatric Institute research following patient suicide, stresses need for reform

The Citizens Commission on Human Rights (CCHR) applauded the recent federal government decision to suspend research on human subjects at the New York State Psychiatric Institute (NYSPI) in the wake of a tragic suicide during a clinical drug trial. The Parkinson’s Disease drug was being tested 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, the withdrawal procedures, and their potential role in the tragic event.[2] The psychiatrist who led the study resigned from NYSPI on June 1, 2023, and is no longer a Columbia faculty member.[3]

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.[4]

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.[5]

This decision to halt all human research follows the removal of a former American Psychiatric Association psychiatrist as the director of NYSPI in 2022. The removal occurred due to public remarks he had made of a racist nature. Subsequently, an interim leader in the field of psychiatry was appointed director. However, that interim leader was then succeeded by yet another psychiatrist in response to the University’s suspension of the clinical trials because of the suicide.[6]

The study received $736,579 in funding from the National Institute of Mental Health.[7]

CCHR joins others in questioning the handling of participants who were taking antidepressants prior to the trial, including how they were withdrawn from these drugs and whether such withdrawals were responsible for the tragic outcome.[8]

A former research assistant 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 were “relaxed.”[9]

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.”[10]

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.”[11]

The lead psychiatrist running the halted study had four previously published studies 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.[12]

Withdrawal effects, as highlighted in a 2019 Epidemiology and Psychiatric Science study, can last weeks to months.[13] Withdrawal symptoms can encompass potentially violent and suicidal symptoms.[14] 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.[15]

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

In the 1950s, NYSPI conducted LSD experiments under the Central Intelligence Agency’s guidance, tragically leading to the death of a patient, Harold Blauer, who was injected with mescaline.[16]

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.[17]

In 1999, the New York Post, through documents obtained under the Freedom of Information Act, exposed that NYSPI researchers conducted tests using an SSRI antidepressant on children as young as six, without fully informing parents or guardians of the dangers involved.[18]

In 2016, then chair of the Department of Psychiatry at Columbia and NYSPI’s director downplayed the severe adverse effects of psychedelic drugs. A 2023 University of London report found serious ongoing negative impacts from the drugs, such as anxiety, fear, existential struggles, and more.[19]

CCHR says 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.

Read the full article here.

[1] www.nytimes.com/2023/08/10/health/columbia-drug-trials-suicide.html

[2] www.dailymail.co.uk/news/article-12395401/New-York-State-Psychiatric-Institute-suicide-Parkinsons.html; www.spectrumnews.org/news/exclusive-shake-up-at-top-psychiatric-institute-following-suicide-in-clinical-trial/

[3] www.medscape.com/viewarticle/995413

[4] www.medscape.com/viewarticle/995413

[5] www.nytimes.com/2023/08/10/health/columbia-drug-trials-suicide.html

[6] www.medscape.com/viewarticle/995413; 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

[7] www.dailymail.co.uk/news/article-12395401/New-York-State-Psychiatric-Institute-suicide-Parkinsons.html

[8] www.dailymail.co.uk/news/article-12395401/New-York-State-Psychiatric-Institute-suicide-Parkinsons.html; www.spectrumnews.org/news/exclusive-shake-up-at-top-psychiatric-institute-following-suicide-in-clinical-trial/

[9] www.dailymail.co.uk/news/article-12395401/New-York-State-Psychiatric-Institute-suicide-Parkinsons.html

[10www.spectrumnews.org/news/exclusive-shake-up-at-top-psychiatric-institute-following-suicide-in-clinical-trial/

[11www.dailymail.co.uk/news/article-12395401/New-York-State-Psychiatric-Institute-suicide-Parkinsons.html

[12] www.spectrumnews.org/news/exclusive-shake-up-at-top-psychiatric-institute-following-suicide-in-clinical-trial/

[13] www.cchrint.org/2021/04/06/antidepressant-withdrawal-warning-vital/, citing www.ncbi.nlm.nih.gov/pmc/articles/PMC8061160/

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

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

[16] nypost.com/2019/09/16/the-mad-scientist-behind-americas-mind-control-quest-with-lsd/; ahrp.org/nypsi-an-early-cia-contracted-academic-institution-under-mk-naomi/

[17] www.psychiatrictimes.com/view/americas-tragedy; www.nature.com/articles/33760

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

[19] journals.sagepub.com/doi/10.1177/0269881116675755; papers.ssrn.com/sol3/papers.cfm?abstract_id=4505228

Source: http://newswire.net/newsroom/pr/00000000-https-www-cchrint-org.html