Are the recent psilocybin studies that bad?

[drseltsam]

Probably most of you read about the psilocybin studies from NYU and John Hopkins. They made a big fuzz about it in the media. The fuzz was too big for my liking but as I am not American, it is hard to judge for me that is odd and what are just cultural differences I can not comprehend.

I stumbled across reviews about the studies in a blog of a professor from the Netherlands.
http://blogs.plos.org/mindthebrain/...patients-who-are-not-depressed-the-nyu-study/
http://blogs.plos.org/mindthebrain/...for-2-rcts-of-psilocybin-for-cancer-patients/

To me the arguments made in the blog sounds very convincing. What do you think?

 

[serotonin2A]

If these had been phase III trials then his criticisms would make more sense, but this was phase II. Phase II trials are intended to look for evidence of efficacy in small samples, to determine whether larger phase III trials should be attempted.

The author also seems not to understand that terminal patients sometimes exhibit psychological distress that is not easily treated. The incidence may be low, but so what? There is definitely evidence that psychedelics may relieve some of their suffering, so I don't understand why he is so dismissive of the idea of investigating this as a potential treatment. Criticism of the study design is not unreasonable, but his criticism of the underlying rationale and motivations of the studies and the investigators is not valid IMHO.

 

[Solipsis]

It seems very strict and like a convention-stickler to judge this for 'the desire to pull existential / spiritual matters into psychiatry'. This is obviously not similar to just some anti-depressant study, but meant to target those who have serious trouble with facing their mortality, even though it is perfectly fine to be able to face it naturally as a part of life. Not even going into what is 'normal' in that department.

It sounds convincing if you compare it to strict scientific study conventions like he does and I must admit it is not worded badly at all, but it seems wrong to dismiss this for being set up the way it is. I'm not too sure if it's trouble with recruiting participants, it's probably just a bit more difficult / complex to approach this 'mental issue'. Which by the way also explains why patients were in different stages of cancer - you can be in stage II and still have distress from being confronted with your mortality. You don't have to be a day away from dying. It's one of many things that reveal lack of understanding the particulars. Not just about the type of trial but also the type of issue and treatment.

 

[iksaxophone]

The author's mistake is revealed when he states that "There is no evidence that treating depression increases survival rates or slows progression.".
Psilocybin was never supposed to treat cancer. It treats psychological discomfort.

 

[drseltsam]

Solipsis, the author doesn't state that psilocybin might not effective. It might be but with this design it is very hard to tell. There is no double blinding for the long term effects and it is not clear why. The patients take other drugs, like Cannabis, this make it even harder to make statements about long term benefits.
The other point where the author is right is that the marketing is questionable. They market the study as double blind but only parts of them are.

Serotonin2A, I think the author states very clear that the claims made by the study are not backed by literature- and this is what counts in science.

My hunch is that three factors made this study so low quality:
1. There is a conflict of interest: Roland Griffiths is on the Board of Directors of the Heffter Research Institute.
2. The people who made the study really wanted to show what they believe in. This is the opposite of how science works. This is how building a business works
3. The authors are lacking knowledge on how to do these studies properly and lacking resources to do them right. Studies done by the pharmaceutical industry are much more expensive and done by professionals. Even then a lot of them are utterly ridiculous and only some of them are good.

 

[iksaxophone]

Drseltsam, yeah that makes a lot of sense. The presence of other drugs in patients' systems is an important factor. And the fact that they weren't trying to prove the null hypothesis is indeed unscientific.
However, a double blind psychedelic study seems definitively impossible. One, placebos are obvious. Two, there are huge psychological risks in having 'blinded' researchers collect data on individuals who are tripping.

 

[Solipsis]

Not really, placebos may sometimes be obviously different in effect but that can always happen and the point is more that compared to milder doses placebos could still produce like a +1 which should be compared in the calculations of efficacy. Placebo therapy can still be quite efficacious.
There are psychological risks involved but as long as everyone is always prepared that they got psilocybin rather than a placebo, it should be well supported and safeguarded.

About the study design - yes it had already been said there are flaws. I don't think necessarily the results are worthless and I find it meriting self-congratulations just to carry out a study like this to look into the effects. It's a shame it is not set up better and I hope that future studies have many improvements on this, but it should be encouraging that this field is explored... not completely burned to the ground for where it is lacking. I imagine it can be tricky to start with this sort of research again after decade bans on all of it. Let's not be too cynical.

Maybe results should be taken with a grain of salt but let's just hope it encourages much much more research in the field so that it can develop well again.

 

[drseltsam]

I agree that using a low dose of the compound is probably the best way to go. Still not perfect but probably the best you can do.

I do not think that the results are useless but it sheds a bad light on the renaissance of psychedelic research. The blog author compares the study with a study about homeopathy. That hurts.

 

[Sir Ron Pib]

Only scanned through this but tbh the criticisms sound pretty fair at a glance. I totally welcome the resurrection of psychedelic research and it seems blindingly clear to me (which isn't to say it is fact) that psychedelics (not psilocin specifically) could be very useful in end of life cancer care and other situations but it’s pragmatic more than cynical to want the the highest standard of science. It is important that we don’t blindly accept any research that strokes our preconceived hopes or notions of what psychedelics can or might achieve. People to some degree have thrown out some of the spiritual baggage (seen recent discussion here of previous elitism on that front) but the area isn’t without it ideologies and politics. Ok that’s a very complex area to discuss and obviously there is the counter of hostile politics and perceptions. We have clearer motivations for therapies with MDMA and Ibogaine I feel and how we move forward with treatment and how presented and within what rubric with ‘pure' psychedelics isn’t entirely clear to me they are so broad; my own positive experiences have been self directed and (being objective) self perceived, it is a difficult one - of course this subscribes to the notion that justification for these drugs needs a ‘worthy' context - concurrently we need a more libertarian approach to personal freedom in this area both for individual harm reduction and the greater harms of the war on drugs. Certainly we should be looking for uses beyond neurological research but much of the 60s ideas in this area are pretty fuzzy frankly. There are questions of bias in all studies and criticism is a necessary tool and not just for those we disagree with in the broadest sense; In the longterm it maybe a long haul but it will be an own goal and counterproductive if studies are not of very high quality. As such this criticism should be taken very seriously.

 

[PriestTheyCalledHim]

How can I sign up for a study to take it?

 

[Sir Ron Pib]

The author's mistake is revealed when he states that "There is no evidence that treating depression increases survival rates or slows progression.".
Psilocybin was never supposed to treat cancer. It treats psychological discomfort.

This isn't the authors mistake - he says this after quoting the study which says;
"These symptoms are associated with a variety of poor outcomes, including medication non-adherence, increased health care utilization, adverse medical outcomes, decreased quality of life, decreased social function, increased disability, hopelessness, increased pain, increased desire for hastened death, increased rates of suicide, and decreased survival rates (Arrieta et al., 2013; Brown et al., 2003; Jaiswal et al., 2014)."
You have selected a quote free of it's context;"These correlations are not established as causal, and mostly come from cross-sectional studies. Residual confounding and reverse causality are highly likely. Patients with more debilitating physical symptoms inadequately controlled pain register more distress." before the bit you quote.
The study claims to be treating anxiety and depression in an undiagnosed population and linking these clinical symptoms which it is purporting to treat to poor outcomes. That rather implies the outcomes would be less poor if these symptoms were treated with psilocybin otherwise what the point beyond some nice colours? The more I look at this the study it doesn't look rigorous enough by far.
Also this isn't the authors only complaint with the study so you singular 'mistake' doesn't address the other criticisms

 

[Sir Ron Pib]

I would suppose that his own existential purpose may have conflicted with the one mushrooms gave his patients. Everybody has their biases, especially older people. This is just some pure speculation.

Not sure what your point is here; one could also speculate that older people can develop critical facility over time. Seems, short of evidence, you betray your own bias more than prove a point pertinent to analysing the study and it's skeptical critique, perhaps because you are a 'young people' and especially have your biases - see how this works?

 

[Orbis]

A better question to ask is what is the true meaning of the word "terminal".