“People Are Screaming Out for Alternatives” In Mental Health Care, And Psychedelics May Fill The Gap, Expert Suggests

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Many psychedelics being studied for clinical use are not "magic mushrooms", rather clinical drugs formulated using good manufacturing practice standards.

Mark Bleackley, PhD, the chief scientific officer at Incannex Healthcare Limited in Melbourne, Australia, joins Pharmacy Times for a discussion about the therapeutic potential of psychedelics for mental health. Bleackley addresses the possible benefits associated with the psychoactive component of psychedelics, and debunks the notion that psychedelics all come from magic mushrooms. In addition, he describes how treatment might look in the clinical setting, their economic potential, and the necessity to change clinical perception. You don’t want to miss this discussion.

PT Staff: The psychoactive component of psychedelics considered to be an adverse event, or is that actually part of the therapeutic potential?

Mark Bleackley, PhD: That is a very, very good question. It's something that is still being properly defined. I think there's aspects of the psychedelic experience that may be helpful in promoting the efficacy of the psychotherapy, at a purely molecular level.

There are some studies have been done in animals, where they blocked the pathway which led to that psychedelic effect, and they still have seen anti-depressive effects which would indicate that, at least in some way, it's not entirely dependent on the psychedelic effect. But I think there's a contribution, [and] I think it comes back to this idea that [with] these molecules, it's not a simple sort of lock and key. There's a lot of interactions that are happening, a lot of different pathways that are being activated. They're all working together towards the same endpoint. But my opinion is that it is going to contribute and you're going to have a benefit there.

Whole psilocybin mushroom in a clear medication capsule | Image credit: Zim - stock.adobe.com

Whole psilocybin mushroom in a clear medication capsule | Image credit: Zim - stock.adobe.com

It does make the molecules challenging to work with because it is it can be a very intense experience. Having a psychedelic/psilocybin experience means that the patients have to be in in quite controlled setting [and] under the supervision of medical professionals. But we also think it's a big part of making these molecules as achieving their full potential as therapeutics.

PT Staff: How will this look “in the real world,” where it's a very controlled setting? Are you going to have an expert on psychedelics/psilocybin who's going to walk you through, or would it be your healthcare provider? Who's there with you?

Key Takeaways

  1. Part of the benefit of psychedelics may come from their psychoactive properties, but this complexity does necessitate administration in a controlled settings by specific medical professionals.
  2. Collaboration between specialized clinics, psychotherapists, pharmacists, and providers is necessesary to promote and integrate safe and effective psychedelic therapies into mainstream healthcare.
  3. Psychedelics research and trials are going through the proper regulatory pathways to get approval, and these products are being formulated in a clinical setting with highly controlled ingredients.


Mark Bleackley, PhD: There's a sort of an evolution of how the process will work initially; it is going to be about delivering this in specific clinics or in places where there are specific rooms in a clinic and specific psychotherapists, psychiatrists who are trained and have that specialist expertise in delivering this. [Given] the nature of these molecules, because the effects are so intense, it does need to be in a very controlled environment. I would anticipate that it will there will be still considerable regulation around who could administer this therapy. where it can be administered, and how access is provided.

PT Staff: What can companies, entrepreneurs, and psychedelics researchers do to improve literacy among current health care providers and pharmacists?

Mark Bleackley, PhD: it's about changing people's perceptions. When most people hear psilocybin/psychedelics, they go towards the recreational use, whether it's people using party drugs or hippies using magic mushrooms. So it's about continuing to present good evidence demonstrate that these molecules are now being developed as a pharmaceutical.

All of the pharmaceutical ingredients that we work with at Incannex, these are manufactured chemically that we're not extracting them from mushrooms— it's all done using the same to the same good manufacturing practice (GMP) standard that you would for any other pharmaceutical. There's nobody growing mushrooms and extracting the psilocybin, it's a pharmaceutical product— it's in a gel cap, it's of high-quality (all of those controls and all those measures are there).

As the safety data and the efficacy data continues to build and the regulatory approval start coming through, I think that's when there's a real opportunity. And I think even before that, it's talking to pharmacist talking to patients and saying, “Look, this is being done properly (for lack of a better term). We're doing this through the regulatory pathways that any other drug would be expected to use.”

When you look at over the past 5 to 10 years, [we have] much more appreciation and understanding there is for mental health, [and] there are some drugs out there that work very well. But there's still a substantial number of patients that, for one reason or another, the established drugs either don't work for, or they're not compatible with the patient because of side effects or tolerability.

People are screaming out for alternatives, and I think these psychedelics have a high potential to address that unmet need. But also, there's a real economic opportunity there as well. It’s attractive to investors, it's attractive to entrepreneurs, and that's what drives that's what funds this research. Research isn't cheap. And we need to get those people excited as well that they're willing to put their hard-earned dollars behind companies that can connect to help us continue to pursue generating that high quality evidence to convince the regulator's to get approval. Then also, what you've alluded to, [is to] convince pharmacists and physicians and patients that this is something that is of interest, [that] it could make a real difference to them as well.

PT Staff: It’sironic because, as you said, it's hard to teach people to think differently about [psychedelics] because there is already this notion [of them] in your mind. But then again, as you've discussed, psychedelics are all about developing neuroplasticity in order to learn new things. It's ironic, it’s fun.

Mark Bleackley, PhD: Maybe that's one way to get there. But interestingly, we need to make the general public a little bit more receptive to a change in idea, and that's the whole point of our therapy programs as well—making people more receptive to a shift in in how their brains are processing signals.

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