All NIH-funded human research suspended at Columbia psychiatry

[a;sldkfj]

U.S. Watchdog Halts Studies at N.Y. Psychiatric Center After a Subject’s Suicide (Published 2023)

Human research trials at the New York State Psychiatric Institute at Columbia have been paused while regulators review whether protocols were violated.

www.nytimes.com

Jeff Lieberman's replacement (interim chair Blair Simpson) was replaced. Research staff are being laid off as salary money is running thin. Unclear when human subjects research will be permitted to resume. I DO NOT think this is going to significantly affect the quality of their uber-competitive residency program or day to day clinical training (since the researchers are pretty siloed), but it is still not a good look for the department's character. Tbh, many of us in the research field saw this coming, though I didn't expect the penalty to be so harsh.

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[phonyreal98]

Was just talking with one of my attendings about this earlier today. Yikes.

 

[comp1]

Can someone translate that article's PR speak into what actually happened? I was trying to track and I guess my reading comprehension just isn't high enough. The problem was a study that required a wash out from antidepressants which they presume lead to a patient on placebo killing themselves?

 

[deleted1162863]

Can someone translate that article's PR speak into what actually happened? I was trying to track and I guess my reading comprehension just isn't high enough. The problem was a study that required a wash out from antidepressants which they presume lead to a patient on placebo killing themselves?

The nytimes article is behind a paywall, but this CNN article says the patient was in the placebo arm. There is a link to the clinicaltrials.gov listing.

https://www.cnn.com/2023/08/11/us/columbia-university-psychiatric-research-suspended/index.html

ClinicalTrials.gov

classic.clinicaltrials.gov

 

[StIGMA]

The penalty and resignation make this seem like research misconduct, using a patient death as a cover up for that. Anyone have the real details?

 

[Merovinge]

The penalty and resignation make this seem like research misconduct, using a patient death as a cover up for that. Anyone have the real details?

I agree, seems fishy to have such a big thing happening for a patient in a placebo arm completing suicide.

 

[PikminOC]

I agree, seems fishy to have such a big thing happening for a patient in a placebo arm completing suicide.

I read somewhere that the patient had depression and his antidepressant had been stopped for this trial

 

[a;sldkfj]

As an insider , I can say there was a possible cover-up of Rutherford's doings, exacerbated by the clout of the previous administration (Jeff Lieberman of CATIE trial fame) who had ties to some of the most powerful people in psychiatry and NIH. There were other instances of bad research practice , which is not necessarily research fraud , that was swept under the rug on many instances. When Lieberman was dismissed for his Twitter blowup, it became harder for Columbia to avoid scrutiny, causing widespread research "problems" to be unveiled and leading to a complete seizure of federal funds for human subjects research . Long story short, the biggest problem is inadequate funds right now to pay and retain researchers, support staff, and layoffs. There is no timeline in place for when human subjects research will be permitted. Again I don't think this will significantly impede their stellar psychiatry residency program but tells you about some of the personalities high up in that department.

 

[tr]

I agree, seems fishy to have such a big thing happening for a patient in a placebo arm completing suicide.

Really?? I think it's a pretty bad look. They took a volunteer who was being treated for depression, tapered them off their medication, replaced it with placebo, and the patient completed suicide? That's... pretty darn bad don't you think? At the very least it would indicate stopping the trial to reassess protocols for participant safety monitoring.

 

[tr]

The penalty and resignation make this seem like research misconduct, using a patient death as a cover up for that. Anyone have the real details?

From what I've read (I'm not an insider), it seems like the scientific misconduct is more like fudging inclusion criteria to get people into a trial that is really hard to recruit for.

It's a pretty tough sell to tell people they have to come off their medication for a 50% shot at trying an experimental treatment that may or may not be as effective as what they were taking. It sounds like they were far behind recruitment targets and also had enrolled people who didn't do the 1 month washout period prior to starting the study drug.

Unclear if that issue is related to the participant suicide, but it does sound like they fell down on the job regarding human subjects protections. Replacing active antidepressant with placebo for a research trial is a risky endeavor for which you would need really tight safety monitoring protocols.

 

[G Sheb]

Can someone translate that article's PR speak into what actually happened? I was trying to track and I guess my reading comprehension just isn't high enough. The problem was a study that required a wash out from antidepressants which they presume lead to a patient on placebo killing themselves?

I think they were hinting that the group had difficulty recruiting subjects, so they cut corners and jeopardized the safety of one of their subjects to include them in the placebo arm.
This is a pretty big deal and a big blow to the department. I can't imagine this will have no effect on their recruitment for both residents and faculty in psychiatry research for a while.
I mean, psychiatry with no human subjects isn't going to get you far.

 

[ObsequiousAplomb]

Really?? I think it's a pretty bad look. They took a volunteer who was being treated for depression, tapered them off their medication, replaced it with placebo, and the patient completed suicide? That's... pretty darn bad don't you think? At the very least it would indicate stopping the trial to reassess protocols for participant safety monitoring.

I mean, isn't that a structural problem with nearly all psychiatry trials? Because they require washouts in general all placebo arms usually end up like this. If anything, it makes it suspicious that this was supposed to be a study for mild to moderate depression.

 

[tr]

I mean, isn't that a structural problem with nearly all psychiatry trials? Because they require washouts in general all placebo arms usually end up like this. If anything, it makes it suspicious that this was supposed to be a study for mild to moderate depression.

The obligation to protect study participants from harm is a bedrock principle of clinical research ethics (Belmont Report 1976).

All psychiatry trials (that's a broad spectrum) do not require washouts. But if researchers are going to wash people out of their medication, it's incumbent on them to make sure that there are procedures in place to prevent foreseeable harms.

 

[whopper]

A patient of mine is involved with research (I intentionally did not ask him for specifics) where he told me the principle investigator is knowingly misleadingly manipulating the presented data. This stuff happens. Probably won't affect Columbia Psychiatry but just recently a Columbia GI doctor was found drugging his patients and raping them while sedated. I'd usually say this is an allegation but seriously it's on video. The guy was stupid enough to record several of his sexual assaults and collect the videos as trophies. The reason why I mention this is cause the institution is accused of allegedly knowing this GI doctor was doing this but looking the other way.

 

[throwaway2099]

Columbia alum here: I don’t think what happened with that GI doc is directly generalizable to the Jeff Lieberman regime . I’m sure this bs happens at many other institutions too. But yeah, i think we can say this is evidence of failed leadership at Columbia. Also don’t forget this (Doctor Who Abused Women Sentenced to 20 Years Imprisonment) and this (Columbia University Drops Out of U.S. News Rankings for Undergraduate Schools — their fudged of US news rankings which involved claiming $$$$$ spent on patient care at the teaching hospital was part of money spent on undergrads).

In the end of the day, this all sheds light on some of the true reasons as to why they got rid of lieberman, as his tweet was just the tip of the iceberg to unethical leadership at CUIMC. I’m sure there are more stories to come out of this debacle, as Lieberman had connections to some of the most powerful people in academic psychiatry allowing the Rutherford disaster (and MANY other sketchy research-related things at Columbia) to be kept quiet . That’s the real story that’s hopefully going to come out one day

 

[ObsequiousAplomb]

The obligation to protect study participants from harm is a bedrock principle of clinical research ethics (Belmont Report 1976).

All psychiatry trials (that's a broad spectrum) do not require washouts. But if researchers are going to wash people out of their medication, it's incumbent on them to make sure that there are procedures in place to prevent foreseeable harms.

right, which is why I said "nearly all."

I know it's incumbent on them to make sure that there are procedures in place. This doesn't mean that suicide isn't inevitable given enough patients.

It seems like the suicide was just an excuse to go after the other, actually egregious things. I'm all in favor of the reaction NIH had here.

 

[whopper]

Columbia alum here: I don’t think what happened with that GI doc is directly generalizable to the Jeff Lieberman regime . I’m sure this bs happens at many other institutions too. But yeah, i think we can say this is evidence of failed leadership at Columbia

You're likely right. The issue with the GI doctor likely has nothing to do with the psych department.

I will say, and it's likely just the coincidence of being a major institution, lots of scandals have gone on in the last few years. Dr. Oz for example and Columbia doing nothing against his fraudulent panacea recommendations. They only decided to take make some space with him when he left his TV show and (I don't know this for sure but I bet this was going on), Columbia might've been taking a slice off the profits of the show cause most educational institutions take a slice of any media done by a professor. I remember every time I or my wife was in an institution we'd see something in the contract where the institution was to get some of the money if we ever published anything.

The irony to me is that IMHO Columbia should've done something with the fraudulent medical recommendations of Dr. Oz and they did nothing, but when he went political then they distanced themselves from him. While I disagreed with Oz's politics, a medical institution should just stay out of politics and remain neutral, but that's when they took action. Again IMHO showing it was really for Columbia about the money. TV show over? Money's gone. Then they take action.

 

[whopper]

The Lieberman thing was stupid on so many levels. He was an idiot for tweeting nonsense, but the reaction was idiotic overkill. Add to that there were already trolls who wanted his head on a platter and they predictably exploited the situation to further add to the histrionics.

What's going on inside Columbia, I don't know and I certainly don't consider the Lieberman situation a true barometer of what's going on inside the department, but the institution had a number of possibly coincidental (or connected?) problems happening in short timepsan that does lead to worsened public perception of the institution.

 

[Celexa]

In case anyone (i.e., resident applicant) is wondering, things are getting worse here. No HSS-funded studies involving human subjects, which have been suspended since June, have been allowed to resume. Tom Smith is somehow still in charge (the benefits of being a government stooge) and clearly does not know what he's doing. He also refuses to take responsibility for his massive failures. Lieberman in some sense created this mess as described above, and Blair had her failures, but until Tom Smith is replaced this will continue to be a disaster.

The interim chair is trying but his hands are tied. Unclear when a permanent chair will be hired.

To be clear, however, clinical services and residency clinical training are not affected. If residents want to do research NOT involving human subjects they still can.

Interesting. Are they allowing projects that involve older datasets, or de-identified data, or minimal risk (ie, insurance claims data, aggregate medical record data, etc)? Most residents with a casual research interest, not planning to pursue grant funded careers, get involved in those types of projects.

 

[StilgarMD]

I don't know the degree to which people staying at an institution following graduating is a reliable indicator of its health, but it sounds like of the current PGY4 class, most if not all are staying as faculty or going into fellowships.

 

[HemeOncHopeful19]

I’m curious why y’all even do trials against placebo in depression, wouldn’t you want to compare a new drug to whatever the current standard is (SSRI unless I’m super behind the times)?

 

[Celexa]

I don't know the degree to which people staying at an institution following graduating is a reliable indicator of its health, but it sounds like of the current PGY4 class, most if not all are staying as faculty or going into fellowships.

It's either an indicator of the health of the leadership most relevant to junior faculty OR an indication of a high need to engage in safety behaviors related to the existential fear of leaving the twisted but predictable embrace of medical training for the uncertainties of the actual job market....

 

[tr]

I’m curious why y’all even do trials against placebo in depression, wouldn’t you want to compare a new drug to whatever the current standard is (SSRI unless I’m super behind the times)?

Because "Significant separation from placebo!" looks much better on a pharma ad for your latest copycat patented med of choice than "No worse than $5/month generic Prozac!"

 

[mistafab]

I don't know the degree to which people staying at an institution following graduating is a reliable indicator of its health, but it sounds like of the current PGY4 class, most if not all are staying as faculty or going into fellowships.

As others said, it could be a good or bad sign. The good is that at least this is the devil they know, and they are willing to stay. The bad is maybe they felt they couldn't hack it in the real world after graduation.

It's often better to see a spread, but sometimes a cohort is just all-in on research/academics and this pattern appears benignly.

 

[Stagg737]

Because "Significant separation from placebo!" looks much better on a pharma ad for your latest copycat patented med of choice than "No worse than $5/month generic Prozac!"

This plus the FDA only requires meds to separate from placebo for approval. Why risk failing to beat the gold standard or even perform worse when it's not necessary to get approved and can cost your company billions?

 

[SmallBird]

Because "Significant separation from placebo!" looks much better on a pharma ad for your latest copycat patented med of choice than "No worse than $5/month generic Prozac!"

Medications that do as well as SSRIs might not have been better than placebo under those study conditions; SSRIs also have a small effect size and don't represent a good 'gold' standard; the comparator arm requires decision about dose/escalation study and without a placebo control it's difficult to know if superiority of the experimental drug isn't an artifact of a suboptimal dosing strategy; other stats things I don't understand; it's not just about money, there are theoretical reasons why placebo controlled studies are important.

Head to head studies are important as well and it is good that we are seeing more for existing drugs. Network meta-analysis is interesting and offers the ability to compare effect sizes for different treatments without doing head to head studies.