AIMS vs DEA: Right to Try Psilocybin for End of Life: Court hearing of DEA’s denial on petition to reschedule psilocybin, Friday Oct 20, 2023, 9 am Phoenix,
Lakshmi Narayan: I’m interviewing Dr. Sunil Aggarwal, the co-founder of the Advanced Integrative Medical Science Institute. He is suing the DEA for the right of end-of-life patients to have access to psilocybin. We’ll talk about the October 20 trial that will decide the issue..
Sunil Aggarwal: I’m joining you from Seattle, Washington. We started a case here from my clinic three years ago in the fall of 2020. In the course of my practice as an integrative palliative care doctor, I wanted to find a way to give psilocybin-assisted therapy to my patients who are dealing with advanced cancer. The Right to Try Act (2018) allows access to drugs that are not fully approved by the Food and Drug Administration, but have gone through Phase One trials, called safety testing. And so, it was a matter of simply asking for access based on the law, and then we–I worked with a lawyer, Kathryn Tucker, who had already thought about it–decided that this was the right way to do this.
But the DEA repeatedly told us no, that there was no way to access this medicine through the Right to Try Act. Access had to come through a researcher with a Schedule One license, which is fine if you’re doing research. But if you’re not doing research, if you’re trying to take care of patients who don’t have a lot of time, you have a right to try according to the law. And that’s the whole point of the law–to cut out a lot of red tape and get directly to the supplier as long as there’s a supplier willing to give it to you. We had a supplier lined up, but there was just no way for them to transfer it to us without a license. So we took the DEA to court.
That was in 2021. We had a lot of briefings and many amicus briefs from the State of Washington Attorney General’s office, attorney generals from multiple other states, an entire health system like professional psychology associations at the state level, the ACLU, Goldwater Institute, Cato Institute. It was quite an array of interested parties that recognized that this was an important case for the practice of healthcare and medicine, compassion, human rights, drug policy, and palliative care.
Despite supposedly having the process expedited, we waited and waited. Finally the court heard our case and then waited four months before they gave us a decision, which was, “We’re not going to decide the case. You must go back to DEA and make sure you’ve exhausted all possible avenues that you should have exhausted.” For some time, the court was saying, “We recognize this as a special interest case, because of the health conditions of these parties, so we’ll speed it up”. But then they just slowed it down and then slowed it down even further by asking us to go back to DEA, which we did right away.
We filed again, a formal waiver, and then a psilocybin rescheduling petition, which the DEA suggested we do. We said classify psilocybin at the very least as Schedule 2 because it has accepted severely restricted medical use and treatment in the United States. We didn’t want to argue the scheduling level; that’s their decision, but at the very least, it should be at the same level as oxycodone or morphine, among many other drugs. These drugs have some danger, some risk, but they’re medically safe for use under medical supervision. That’s how the government regulates those drugs, so we thought psilocybin met the criteria. And not just thought; leading researchers have published papers on just that. We cited Matthew Johnson’s paper from Johns Hopkins extensively.
We submitted our nine-page petition and then the waiver. Both came back over the next couple of months. Regarding the waiver, the court basically said, “Hey, you guys asked the same question last year. Our answer is still no”, which proved the point that we really had done everything that the Court said that we didn’t do, and the DEA was still saying “This is our final decision.” As to the rescheduling petition, which they asked us to submit to them, they said, “Oh sorry, this has not been approved by the FDA. We can’t do anything with it.”
Lakshmi Narayan: Basically, they threw it back into the FDA’ s court, although the power to actually change the scheduling lies with the DEA, correct?
Sunil Aggarwal: The DEA is responsible for those decisions. It’s been given that authority by the Attorney General of the United States. But the medical and scientific decisions are delegated to the Department of Health and Human Services. If there’s a question requiring a medical/scientific review, the DEA is supposed to send it to the FDA, which is under HHS, and ask them for their review.
Lakshmi Narayan: These two government bodies are supposed to work together to do the right thing for the American people?
Sunil Aggarwal : That’s right. But they just decided they were not even going to work on it. The DEA says that they have some degree of choice whether to even enter into the process, and they say no. Then they basically say the reason they won’t grant access is because the FDA has not given its final approval to psilocybin. So we can’t do anything. It’s kind of like they did a Catch-22, with very circular reasoning,
I got their letter in September of 2022. I was like what is this? Just a few lines? They simply said thank you very much, but you know, we can’t do anything with this. I was pretty bummed. I thought that’s ridiculous after all of that waiting. But the attorneys looked at it, and they said, this is great; this is really good grounds for appeal. Legally, they made the wrong decision. We can really challenge this, because this is not the way the law is supposed to work. So that is now the case that we’re going to be arguing on Friday in Phoenix,
Lakshmi Narayan: What does success look like with this case? What are the grounds of the case?
Sunil Aggarwal : We will be arguing, basically, number one that the DEA has been acting in bad faith. The Ninth Circuit Court will hear the case, and they’re one step before the Supreme Court. They cover a large part of the western United States. We are basically asking the court to review their denial of our petition to reschedule psilocybin. Oral arguments will be live streamed, so people can tune in to Sandra Day O’Connor U.S. Courthouse, Phoenix Arizona on the 20th.
It’s going to be argued by Matt Zorn from the Houston firm Yetter Coleman. A Columbia Law graduate, Zorn has significant expertise in federal jurisdiction and procedure. He’s a brilliant attorney who’s done a lot of work challenging the DEA on their transparency, their processes. Our case is that the DEA has attempted to usurp the authority that Congress gave to the HHS. We want the court to recognize that we’ve presented sufficient evidence to require the DEA to seek HHS’s medical/scientific opinion on our petition.
Lakshmi Narayan: How long have you known about psychedelic medicines for end of life? What is the argument or reason given by the DEA keeping it scheduled as Schedule 1? Don’t we deserve to get a reason back at this late stage when we’ve known about these medicines since the 1960s? And if the objection is that psilocybin is a psychedelic drug, isn’t morphine, which people get at end of life, also a mind-altering substance? It comes from the poppy, it is also a plant medicine. Other medicines, like Levodopa, create altered states of consciousness. There is a lot of literature and studies about the spiritual and existential paradox of death. What is the case that the DEA gives us for not allowing psilocybin to be reconsidered and made accessible?
Sunil Aggarwal: Beautifully said, I mean, first of all, regarding morphine and all of that, I should say, these laws that we’re dealing with are from the administration of Richard Nixon. He’s the one who signed the Controlled Substances Act in 1970. That’s what the DEA is relying on 50 years later. I have listened to a lot of and read the Nixon tapes transcripts where he’s discussing in private his ideas about drugs. I’m interested in it as a researcher and I’ve published articles about his references to marijuana and the politics of it.
Significantly in those tapes, Nixon talks about the plight of patients with cancer and their need to have pain relief. He’s talking to some confidante, and he says “It’s really terrible that patients will endure this, And they shouldn’t be able to have any morphine or any painkillers that they want just to relieve them”. This was not a heartless person, you know, he did have some ideas like that. So it’s ironic that now his own law is being interpreted to deny people relief. PLEASE CHECK THE QUOTE.
In the Controlled Substances Act, Nixon’s administration created a different category of harmful drugs for substances like psilocybin and LSD. They were associated with the political unrest of the 1960s and early 70s over the Vietnam War. Many of the activists who fought against the war, the mobilization, the draft, also enjoyed psychedelics. Acid, pot, shrooms were part of their lifestyle, part of how many dealt with the trauma of being asked to fight a war they didn’t believe in, or adjusting to the dominant culture growing up in the 50s and 60s. Psychedelics were a part of their culture, part of their customs, and they had a role in their well-being.
The Controlled Substances Act was used as a political tool to get those people who opposed Nixon and the Vietnam War. And that’s not just my opinion. A Seattle lawyer, John Ehrlichman, became Nixon’s chief domestic advisor. He told an interviewer in 1994 what the law was truly meant to accomplish (see sidebar).
And there were promising studies of psychedelics to relieve pain as far back as 1964, when the first study was published by Eric Cast, a University of Chicago MD, psychiatrist, and internist. He gave 100 micrograms of LSD 250, to 50 terminally ill cancer patients, severely burned patients, and those with other painful illnesses or injuries. And he showed that he could actually reduce pain better compared to Delottid or Demerol.
Lakshmi Narayan: And then the other thing Nixon says is that it allows them to alter their pain, attention, and perception, right? So that’s a really important function of how psychedelics work to change your consciousness, change your relationship with the pain, and your perception of death and dying and what it is, and you have less or no fear of these things.
Sunil Aggarwal: Exactly. If you have a lot of anxiety around your mortality, which, of course, is a universal human experience, but the sort of the kiss of death or that terminal diagnosis that you get. Those kinds of things really can create so much anxiety for some people– existential distress, we call it, it actually makes pain worse. Dr. Cast was just interested in relieving pain from tumors or burns. But in later studies, he began to see that there’s a lot more going on than just taking a painkiller.
Lakshmi Narayan: Then the other question I have, and forgive me if I’m being naive, but what I think is, okay, so in the 70s, we, as a people, we as a government made all these laws, and it was a reaction or a response to what was going on then whether it was political, or socio-political, or whatever it was. But here we are. Now, it’s 2023, 53 years since that, and when are we going to reassess our decisions of the past which don’t serve the present? I find the reasons offered insufficient, in the face of how many people could benefit from these medicines, and how many people are dying because of lack of access to them or are dying less peacefully than they might.
Sunil Aggarwal : I think in terms of how health care and access to medicines has become more and more a corporate issue, special interests versus the sort of ethics of humanitarian life, liberty, and the pursuit of happiness. Happiness has a kind of a constitutional approval; you have a right to have some kind of happiness in your life here. That doesn’t mean you have rights at the expense of Pfizer. It’s like you just have this right period. And the government’s job is to sort of ensure that your enshrined privilege is protected, but over the last 60 years with the way that we have allowed healthcare and Big Pharma to prevail, They have the top-spending and one of the most powerful lobbies in the nation. They get so many billions of dollars from these insurance companies, hundreds of billions per year in revenue and profits from the way that they run things. The whole field has become extremely corporatized in a large wave.
When the corporations get that kind of power, so much influence, they literally get to write the laws. Look what’s happened to the FDA and HHS, and maybe even DEA too. We do things as long as the people, the corporations that we’re working with.are happy with the way things are going.
Right now, because of all this established sector, several companies are developing psilocybin, They say, “We’re gonna raise some money, put it through clinical trials, and then wait for our return. The return means a monopoly on exclusive distribution. After they’ve done all their R and D and after a period of time, they get exclusivity. They get to sell their drugs, and they make lots of money. That’s the model of drug development. I can’t say that it has nothing to do with what’s happening right now, in our case.
Lakshmi Narayan: Exactly. So I’d love you to comment on this thing. So the plant medicines, psilocybin, for example, as a whole plant that’s evolved over billions of years has been used for hundreds of 1000s of years, we know that it was there were mushroom drawings on the cave walls. We know that’s how old mushrooms are, right? So it’s evolved its core relationship with human beings, compared to isolating a molecule or two, so that you can patent it and have exclusivity. So we’re reducing the effects of this highly developed plant medicine to a couple of molecules, and just a few years of research to fast track it. And while at the same time, the plant medicines legal access to people is being suppressed, there is something very evil going on in this scenario that affects human health and happiness.
Sunil Aggarwal: Absolutely. Papers from anthropologists and evolutionary biologists suggest that psilocybin played a role in developing the human socio-cognitive niche, which is the term they use. It’s the reason that people are more likely to get into a group and trust each other a little bit more, look at their faces and say, “Okay, you’re not a threat, You’re more of a friend. Let’s get along together.”
Scientists are arguing that psilocybin actually helps people work more collaboratively in groups, Laws have led to so much development of our species. If we were all very much mistrusting each other and broke into enclaves and factions, we wouldn’t have been able to make the progress we’ve made in so many things. So there’s an evolutionary element at work also. That’s the current scientific theory, supported by archaeological evidence and other reasons to believe that these substances have played a key role in human culture for many millennia and continue to do so.
So yeah, it’s I don’t even think the whole idea that you would then prohibit so you know, we’re kind of operating on this prohibition is a sort of the first strike when we just started saying no to all these things, and we were going to ban these because we that’s groups we don’t like and even before the 60s and the Vietnam era protesters, there’s also a lot of history. In that same article on Nixon, I looked into this to about the, the Federal raids on pod in the Native American reservations across the United States, like in in Arizona, New Mexico, other places, they would simply just, you know, that was another tactic they were using to suppress the, you know, to arrest and, you know, they didn’t like the politics of native folks. And, you know, there’s a long standing war anyway. These substances were associated with groups, like indigenous people, and the, protesters that they didn’t like, and so that’s really why they, you know, they were first banned and, and so and then if you even trace that even further back to the 1500s, when the Spanish conquistadores came to North America, and you can look at the journals of the missionaries and they say, “Oh, they’re taking a diabolical mass”, they call it a satanic mass to eat the flesh of the mushroom rather than the flesh of the wafer.
So that was the lens that they were operating in. You guys are doing a sort of foreign religion to us, and we’re going to stop it. They actually that’s why the whole thing went underground for for four or 500 years, the whole framework which the Spanish Inquisition, which they brought over here was an idea. We need to stamp out heresies we need to stamp out what is the devil lurking and all that we know is also was tied into sort of kind of shadow work that people didn’t want to do about like women healers, and witches and all that stuff. And, you know, there’s all kinds of Jews, there was a lot of like fear about anti semitism, that the first Inquisition, but there was other heresies as well in Spain. So there was there was there was mistrust, fear, fear of nature, I think there was also authority control, who’s going to have access to powerful things to heal your soul. Is it going to be the clergy, which are males? Or is it going to be women,
Lakshmi Narayan: I think you hit upon something here. And maybe it did get divided into this gender men or women. But I don’t like to go there so much, because I find that it just creates another gender split that we don’t need right now. It’s more about power, and external power, or the power of access. So it’s the same thing that happened when the church came between a person and their communion with God and said, We’re the intermediary. Just the same thing, when the priests in India said you got to pay us to do the puja for you to get what you want.. Right? Same thing, again, with saying that you have to go through a medical body or whatever. And, you know, I know that that’s the direction the whole psychedelic movement is going. But honestly, it will go that way, Many people will prefer to go to a doctor, or are too ill to do it any other way or whatever, but there will always be others who will also access psychedelics and heal themselves.
Sunil Aggarwal: That’s why I’m very much in favor of really having any and all systems and they can all live side by side. I was talking to somebody about water, you know, like, we have all this municipal system of water to drink tap water, you know, there’s all these testing that goes on chemical testing at the plant processing, etc, etc, your pipes, you drink it, but then you can also have Holy Water, where you think it’s blessed and holy, and you can send it on the internet to other people, because it’s been touched or Ganges water, if you want to talk about India, you know, none of nobody is saying that water is like has to go through all those channels. It’s like no, people have a look deeper relationship with water. It’s very fundamental elements. And there’s so many emotional ties to it. But the same way entheogens the fact of nature that we have these kinds of substances that humans have formed a special bonds with over the eons, across culturally, so we have to just find a place for that. So you gave the example of the Catholic Church mediating the relationship with God. And then the big change of that was the Lutheran revolution, or the Protestant Reformation, they say, you know, where the the Protestants said, No, we were going to, you know, put the Bible in our own language, we don’t, we’re not going to go to the priest, we’re going to do our own direct connection. And that was a huge shift, you know, and that led to a lot of changes actually, in culture. Even the foundation of like hospitals for the poor, things like that, apparently was I’ve been reading it was tied to that. So for the poor
Lakshmi Narayan: It is a great thing to bring up. Because, at one time, hospitals were created by churches, and they were charitable organizations where people could come to heal, and the spiritual component of it was completely integrated because it was inside the church. Then health became part of the secular state. And if religion is in this camp, it is separated. So all the arguments about the metaphysical, existentialist, spiritual dimensions that psilocybin opens up become irrelevant it seems,
Sunil Aggarwal: Right. Thankfully palliative care, the field that I’m in, has made more strides than any other branch in the field of medicine, to reintroduce those elements into our system. I believe in integration; that’s why I practice integrative medicine, I want to bring the various elements together, I think there’s a way that they can function best together. Traditional medicine has always been part secular, part religious. Like it’s together, it’s going to be okay, as long as we really try to make a universe where everybody’s beliefs are respected. Everybody has a consciousness, and I’m just saying, like the revolution involving accessing divinity, whether it’s mediated through a church or experienced directly had huge impacts on culture, and society, overall.
Jonathan Ott has talked about the Entheogenic Reformation, how we may be going through a phase where these substances will force larger changes in terms of organization around how we handle spiritual issues or access to nature, access to healing, All of these prohibitions really came from that original zeal to separate, to do the power thing which was was all about access and then went underground. It wasn’t until 1955 that Valentina and Gordon Wasson went to Mexico and sat with Maria Sabina in an underground midnight ceremony. They were recognizing already that this can be really helpful for people facing terminal illness.
In a fascinating example of how we have a really broken system, our government has chosen to ignore what we know or pretend like it doesn’t matter, and I just don’t think that’s going to last too long. Earlier this year Anthony Amour, a DEA agent, was fired from his job. He’d been an “outstanding”agent for 16 years. He had some serious pain issues, and wanted to avoid using opiates. So he bought CBD, cannabis-derived CBD, whole plant extract. Congress removed controls from CBD hemp under the 2017 Farm Bill, and you can get it without any kind of scheduling issue.
The DEA randomly tested Amour and he was positive for THC, Even if you read the FDA-approved label for Epidiolex, a CBD product that you can get for epilepsy,l it says that you might test positive for THC because that’s just that’s just the way it works with cannabis. But Amour lost his job because of this, and the DEA told him, “You should have known better’. The decision to fire Amour was recently affirmed after Amour appealed.
Lakshmi Narayan: Basically the DEA is saying is that the wisdom of all these researchers, all this anecdotal evidence, all the people who are being helped with CBD — all this evidence is foolish. That’s really what they’re saying.
Sunil Aggarwal :Yeah, even if it’s true, you’re not allowed. I haven’t read the briefs enough to see. But it was interesting to me to see this because this is not just this is an actual human being that works for the DEA as a career veteran, Senior Agent. So even there, I think the system is so big and confusing. The people in the system also don’t know what to do about it. They feel like we’ve created a sort of a Frankenstein monster, Even they who are supposed to be enforcing these laws can’t actually follow them themselves. They’re human beings, and the evidence is mounting as to the benefit of these medicines.
Lakshmi Narayan: I think that’s what I’d like to end. What we all need to focus on is the benefit of these psychedelic medicines that have been mistakenly scheduled as harmful drugs with the potential for recreational abusers. Sure, some of them do have that potential but some, like Ibogaine, don’t. So that’s really what we should focus on. Even for those people in the DEA, these plant medicines can help their evolution. They can speed the evolution of your personality, of your being, your relationship with the world, your intelligence, your creativity, and your health, of course. That is the main reason we’re here, but that’s the beginning of the stair step of things that it opens up.
Sunil Aggarwal: Very strong evidence. Absolutely. I mean, and it’s not like there’s also evidence of risk, everything has risk. So, you know, like you said, and I think it’s like, it’s okay to know those risks, and take a calculated risk for a benefit. You know, and that’s what freedom and being a human being is all about and sometimes and as long as you do have, in the case of medical stuff, somebody advising you who’s an expert, that’s great. And I don’t think everything has to be medically advised. But if, let’s just say, if we were in that category, that’s really a fundamental right. And we’ve really just lost that by this prohibition thing. It just turned into oh, there’s no way, you can just only research these, you can never try them.
Lakshmi Narayan: Well, speaking of this, all these pharmaceutical ads that I see for medications and then they talk about the side-effects, well, a lot of times the risk of the side effects seems worse than the actual thing that’s being treated. So, it’s a hypocrisy to say that there is a risk to these plant medicines.
Sunil Aggarwal: I think that’s again the way in which we’re one of the only countries in the world that does this direct to consumer advertising of drugs like this. Many countries have banned this. There’s just no reason. Nobody can make a decision about their stage four rare tumor type. They have ads for all kinds of things now and it’s just because we have completely given up on any kind of social agreement around what is the role of our government in helping us have accurate health information if that’s what it’s going to be or filter us from the predatory actions of people that wanna just make a buck and actually monopolize– this is a monopoly.
I see this as basically this, the governments have lassoed these natural compounds,like psilocybin, they roped them up and it’s a monopoly. You’re monopolizing a natural germ plasm plant, a genetic resource or fungal genetic resource. And then you’re selling it off to the highest bidder. That’s really what this is. It’s a monopoly game, and we need to break those for the benefit of people, That’s where this becomes a people’s right.
Lakshmi Narayan: People have to get educated and then experience it themselves and then understand what it is and what it’s not, and wake up. We really have to wake up, and I wish the people in the DEA and the FDA a speedy awakening so that they can understand that having access to these medicines is going to help their loved one someday who’s going through cancer. Or it’s not just for some of us, It’s for all of us.
Sunil Aggarwal: And I think that is a very beautiful place to remember. We’re not doing this for ourselves. We’re doing this for the benefit of all. Everybody faces illness. Everybody faces death. Everybody faces mortality.
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