AMA on Wed 5/6: psychedelic medicine legal & business expert

We are very lucky to welcome Ziv Shafir, JD, MBA, MS to our next AMA (Ask-Me-Anything) on Wednesday, May 6th from 4:30-6pm PT.

Ziv is an expert on the legal and business side of psychedelic medicine.

Ziv Shafir studied molecular and cellular biology at UC Berkeley before moving to Stanford, where he obtained a M.S. in molecular immunology. Ziv then obtained an MBA from Stanford Business School and a JD (Doctor of Law) from Stanford Law School. He is licensed by the State Bar of California.

For the past eight years, Ziv has helped teach a well-regarded seminar at Stanford Business School entitled “Leading Strategic Change in Healthcare” alongside Dr. Robert Pearl, former CEO of The Permanente Medical Group, and Robert Burgelman, Professor of Strategy. Ziv blends together science, business and law, having performed immunology research as a graduate student at Stanford, worked as a medical device reviewer at the FDA, advised numerous healthcare startups as an attorney at Fenwick & West, and worked at various other reputable law firms.

Ziv has taken a professional interest in psychedelic medicine after seeing first-hand how powerful psychedelic medicine can be in creating transformations. His expertise in psychedelic medicine is augmented by his rich background in healthcare law and experience at the FDA.

Suggested topics:

  • Business & industry trends in psychedelic medicine
  • Different players in the space, from pharmaceutical companies to underground guides
  • Legal and regulatory considerations, including off-label use
  • The qualitative differences between psychedelics and the experiences they engender

We are very lucky to have Ziv and are grateful for his time. We’re posting this thread early to field questions, so fire away! Please add any questions you have to this thread and stay tuned for the actual event – Wed May 6 from 4:30-6:00pm PT .

Format: Ziv will post written answers to questions/comments directly on this thread during the event time.

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thanks for doing this!

what do you think is the best way to get psychedelics broadly used again? to go through FDA regulated pathways or decrim or both? what are the pros and cons of each?

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How do we walk the line between ethical/broad access and going through the FDA process? How do we avoid what has happened decades ago with psychedelics gaining momentum and showing promising research before a huge political and cultural backlash and stigmatization?

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Could you talk a bit about the underground guides? Maybe a brief intro about it? I’m not familiar with it, I’ve only seen the FDA-sanctioned clinical trials on MDMA and psilocybin. Thank you so much - appreciate your time!

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Hello! Thanks for your time:) I am curious about how it could be possible for the average person to change the mentality that many law enforcement officials and agencies have regarding psychedelics. Coming from the more legal perspective, what are effective approaches for convincing and showing people whose job is to enforce the law, that psychedelics are not harmful to society as a whole? I feel that the psychedelic movement needs to work to change many legal frameworks through causing the people who work for those frameworks to question those rules themselves, too.

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how can legal professionals best advocate for psychedelic legalization?

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Do you suspect any pushback from traditional pharma companies that occupy the same sphere of mental health medicine?

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how are multiple organizations pursuing psilocybin, e.g. usona and compass? what are the differences in patents that are allowing both to conduct trials?

in general how is new IP being formed if many of these substances are known or naturally occuring?

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Hey, thanks for doing this! I was wondering if you could talk more about the regulation side of things. I don’t really know about what goes into the legal considerations for whether a medicine or treatment becomes approved for use. What are current standards surrounding that? And what are ways we could change them? Thanks!

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Wooo! let’s get started on this AMA!

Proof:

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Thanks so much for your time Ziv!

I’m also curious about what @caligirl asked about how IP works for substances like psilocybin or ayahausca that are natural, and MDMA or LSD which have been around for a long time. Can organizations really just patent a particular way to produce the compound? That will be robust enough to function like a patent that traditional pharma companies use for their drugs?

Could you talk a bit about what happens with decriminalization on a local level - we’ve started to see a few cities like Denver and Oakland move to decrim but federally it is still illegal. I’m sure there are some interesting legal and conlaw questions here? Would be curious for your thoughts

And if I may ask one more quick one - do you see any similarities or differences to what has happened with cannabis over the past few years? Thanks again!

I don’t think we’ll see broad use like there was in 50s or 60s before many substances were scheduled, at least not for a while. In terms of pathways, each has a different purpose but they work synergistically. FDA regulated pathways legitimize psychedelics as a medical treatment from a legal perspective, and also would provide an avenue for off-label use (so if psilocybin was approved to treat depression, a doctor could conceivably prescribe it off-label for smoking cessation). As a medical treatment, it will take many years until these substances can actually make it on the market, and they may be prohibitively expensive for many people.

Decriminalization is tricky - businesses do not want to operate under that framework since there’s still too much risk. Akin to cannabis, you’ll see more public offerings when something is actually made legal on the state level. What decriminalization does do is introduce the issue to the public, hopefully de-stigmatize it and allow folks who are currently using psychedelics or otherwise acting as guides to feel a bit safer, and thus give them confidence to offer their services more widely. I imagine there will always be a black market for psychedelics, and accessing substances through that will be cheaper and provide an alternative for a segment of the population.

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A lot of people in the psychedelic community are nervously cheering decriminalization efforts: on one hand, getting psychedelics FDA-approved is the strongest endorsement for psychedelics as a legitimate medical treatment, and decriminalization has the potential to derail that careful medical campaign. On the other hand, the reason so many people are such zealous advocates for psychedelics is that they’ve had profound experiences with them in non-medical setting, and they want more people to have those experience, whether for healing an ailment or expanding one’s consciousness.

MAPS strikes a good balance between championing psychedelics more broadly while trying to protect the gains that have been made on the medical front - I’d look to them to see how they approach the issue.

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Sure - there’s a wide variety. Some may be licensed therapists or psychiatrists whom have decided to work with psychedelics incognito, others are non-licensed individuals who have gone through extensive, formal training that is arguably more rigorous than what a therapist signing up for above-ground training would currently receive, and some are psychonauts that have decided to dedicate part of their working lives to holding space for people.

Instead of going to a clinic, one would go to someone’s house (usually) that has a room that’s been decorated and set up to hold journeys, and they would provide the substances. The experience on the psychedelic is arguably the same (there’s variability in the dose when providing the pure, synthesized compound versus a handful of mushrooms, in the case of psilocybin), but there’s more flexibility as to what goes on in the actual session.

Preparation and integration would be largely the same as what participants in the clinical trial are receiving. The guide should also do an extensive screening, akin to what you’d see in a clinical trial, to ensure that the client or someone in their family does not have a history of schizoprenia (as one example), and check to see what other substances they may be taking.

It’s all accessed through word of mouth and referrals - since these are Schedule III substances, there could be serious ramifications if one was caught.

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I believe that the FDA track is a very strong endorsement for the healing power of psychedelics. It also depends on how on their perspective on drugs as a whole and where they fall on the spectrum in the war of drugs paradigm - some may be more open to changing their views than others. And there is the prosecutorial priorities of both law enforcement and prosecutors - so making sure to vote on initiatives and for certain lawmakers will help.

Perhaps the most effective way is to point out the benefits. Take MDMA for example - the treatment that is currently undergoing FDA review can cure people of PTSD. So many of our veterans have mental health needs regarding PTSD, and I’d be hard pressed to find law enforcement that wasn’t sympathetic to helping that cause. I’ve also heard researchers talk about how these treatments are not necessarily fun - they can be really difficult experiences for the people undergoing treatment.

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Check in with organizations such as MAPS that strike a good balance between advocacy on this front and protecting the gains for FDA approval. Like any political campaign, it takes a lot of strategy and any initiative should be carefully orchestrated and written. One could check in with current initiatives for decriminalization or legalization and see where they need assistance.

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On the contrary, I think pharma is actually waiting to see smaller companies gain traction in the space and then investing in or acquiring them. For example, in the latest round of funding for Compass Pathways (seeking FDA approval for using psilocybin for treatment-resistant depression), one of the funders was Otsuka, which is a large pharmaceutical company that makes drugs targeting mental health issues.

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It can be hard for me to distinguish as well. One is the indication - Usona is getting approval for major depressive disorder, while Compass is getting approval for treatment-resistant depression, which technically falls under major depressive disorder. While the mission is ostensibly the same for both companies, I imagine they will act differently in terms of how they decide to commercialize and provide access to treatment, given Usona is non-profit while Compass is for-profit.

One doesn’t need a patent to pursue a clinical trial - it’s independent of the FDA approval process. For the first company that brings a product to market for an indication, the FDA gives varying amounts of exclusivity before they will consider other manufacturers whom want to provide a generic version, which in a way functions similarly to patents. See below for more on the IP front!

In rare cases, such as with designer molecules that are similar to current compounds, one could get a patent on the actual compound, which would be considered a “composition of matter” patent, which is what biotech and pharma companies usually seek out when they patent drugs. One could take the approach that Compass took and try to obtain a patent on process for producing a compound (psilocybin), or a patent on a process of using a product to treat a particular condition (will be curious how this plays out).

Otherwise what many are banking on is the exclusivity that the FDA offers companies presenting new chemical entities, which is currently set at five years. This functions independently from the patent process - the FDA has a good explanation on this:

We will see in a few years if another company wants to produce a generic psilocybin, for example, and which patents they may challenge and what approach they will take. Also, the therapists and medical practitioners that are trained and approved by the companies to actual administer these compounds may act as another roadbump - it’s unclear if the FDA will allow these practitioners to administer generic compounds, or if they need additional training.