Religious Use of Psychedelics in the United States

Science has demonstrated that psychedelic compounds “can occasion mystical-type  experiences having substantial and sustained personal meaning and spiritual significance.” Scientific surveys indicate that a statistically significant number of people have a stronger belief in a higher power after taking psychedelics. Science is starting to “prove” these things that practitioners have known for thousands of years, and society is rapidly redefining its relationship to psychedelic sacraments and medicines.  

As more and more people begin taking psychedelics, an ever-growing number of them will start asking spiritual and religious questions that arise out of their experience. Our goal in this class is to open some space for these conversations and to help educate people about the legal risks that such explorations may involve. 

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The Farmer and The Cowman Should Be Friends: Why the Pharmaceutical Industry and Grassroots Reformists Should Join Forces

By Gary Michael Smith Esq.

Our regular contributor on legal matters explains how the nascent psychedelic pharmaceutical industry and grassroots reformist movement could work together to achieve both their goals, read to the majesty of the classic American musical, Oklahoma! 

Interested in learning more about the legal side of psychedelics? Then sign up here to receive info on our upcoming FREE series: Religious Use of Psychedelics in the United States.

In my last article, I introduced the idea of crafting the Uniform Plant and Fungi Medicine Act (UPFMA), which could be employed as a public initiative or adopted by state legislatures as a solution to the local piecemeal reforms and slow and improbable response from the federal government to make traditional entheogens lawful outside of religious use. I am happy to report that a team is assembling to undertake drafting UPFMA.  

This, of course, begs a serious and important question: Who’s going to pay for that? Cue music…

“Oh, what a beautiful morning!” …. it would be to see the burgeoning psychedelic pharmaceutical industry back and support UPFMA. Why? Because, like the cowman and the farmer, the pharmaceutical industry and the grassroots movement can be friends. In fact, they need one another. No need to struggle with your feelings over cowboy Curly McLain and farmhand Jud Fry, Laurey. You can have both!

This is no mere minstrel show; this is serious stuff. Consider: 

Farmers (Played Here by Grassroot Reformists) Need a Friend

UPFMA’s promise is to provide a uniform model body of law, akin to other uniform model laws (e.g., the Uniform Commercial Code) for state reformation and regulation of plant and fungi medicines. Amongst UPFMA’s goals are to promote further options in health care, responsible use, freedom of choice, elimination of the underground market, and personal and public safety, through state adoption of a uniform reformation law that will span the gulf between prohibition and total deregulation via a reasonable regulatory structure. The model we hope to write is intended to be adoptable either by state legislatures, or by public initiative campaigns in the more than a dozen states that allow citizen legislation.   

Even with the volunteers who exist and those who will come, the production and campaign will cost the sort of sums that these sorts of campaigns cost. Let’s just put it out there on the square dance floor: “Purty little surreys” ain’t cheap. UPFMA needs benefactors, sponsors, patrons, supporters, shekels. So, peering over the fence and into the grazing lands, UPFMA’s supporters want to give a loud “Howdy, Neighbor!” to our cowmen friends in the pharmaceutical industry. We cannot help but to notice that supporting UPFMA would be hugely beneficial to your interests. It need not be, “All Er Nuthin.” Can we count on you to be neighborly?   

Cowmen (Played Here by the Pharmaceutical Industry) and Grassroot Reformists Are Not Competitors for Territory  

The psychedelic pharmaceutical industry will derive its revenues by exploiting patents and trademarks. But, aside from modified genetics, the pharmaceutical industry cannot patent or trademark natural medicine in its unrefined state. In contrast, UPFMA would seek only to democratize natural substances and would not be aimed at the same patent-driven and trademark-driven “market” as western industrialized pharmaceuticals seek to create. UPFMA poses no challenge to pharmaceutical patents or trademarks. Indeed, discussed further below, UPFMA might even be able to help facilitate product research. Like the cowmen and farmers from Oklahoma!, pharmaceutical industry and grassroots reformists may occupy overlapping interests, but they are not competitors and do not seek incompatible goals.   

UPFMA Can Help Cowmen Catch Cattle Rustlers

As the existing pharmaceutical industry can tell the future psychedelic pharmaceutical industry, the individual home grower and/or user is no threat. Rather, it is the underground market, where pirate industrializers infringe intellectual property and undercut prices, that are your true “cattle rustlers.” Unfortunately for our cowmen…errr…pharmaceutical companies, the coming FDA approval of their products also brings an increase in public interest in psychedelics, and so too an increase in the illicit market. UPFMA is no friend of the unregulated market. Rather, one of UPFMA’s goals is to reduce illicit trade, and not just in (our metaphorical) Kansas City.  

You Can’t Sell the Steak, But You Can Sell the Sizzle: Pharmaceutical Companies Benefit by Supporting UPFMA

Until FDA approval is given, the psychedelic pharmaceutical industry may not advertise their products or offer them for sale. Psilocybin and MDMA are at Phase 3’s door, and FDA approval looks promising, if not inevitable. But FDA approval is still years away, and pharmaceutical companies continue to burn capital waiting for the FDA’s start pistol to fire. This delay in marketing is a costly lost opportunity. 

Meanwhile, UPFMA can do what no pharmaceutical company may – begin to educate the public and draw national popular interest in natural psychedelics. While pharmaceutical companies vie for rescheduling and for FDA approval, pharmaceutical companies who back UPFMA will receive years of permissible brand awareness and marketing research, in advance of being able to bring their products to market.   

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Support of UPFMA Does Not Risk the Ranch

Natural medicines and their patented counterparts do not typically compete. Instead, they compliment. Because of pricing constraints, a significant population will be unable to afford pharmaceutical industry products. It is significantly that demographic – those who cannot afford these patented medicines – that UPFMA addresses. UPFMA offers an alternative to exclusion. UPFMA does not pull market share away from the pharmaceutical industry. Rather, it addresses “customers” the industry never had or was going to have. In the wise words of Obi Wan-klahoma“These are not the cows you’re looking for.” 

There’s a Bright Golden Haze on the Meadow: Support of UPFMA Grows the Ranch and Buys More Cattle

Just like the nascent psychedelic pharmaceutical industry, UPFMA optimistically predicts the public will warm to psychedelics as an optional (if not preferred) tool to fight all sorts of mental illness. As UPFMA democratizes access, a residual effect will be the encouragement of further investment, thereby enabling pharmaceutical companies to more easily explore varieties of formulations, concentrations, extractions, etc., making their products more varied and more accessible to an ever-increasingly interested market. Again, UPFMA’s focus is on natural non-branded medicines, and has no ambition to occupy the patent market.

Support of UPFMA Allows Industry Cowmen to Better-Protect Fences   

UPFMA intends to consider and to factor traditional use of entheogens, including cultural and environmental interests. UPFMA’s focus is legal access, not promotion of industrialization and scale, and UPFMA resists commoditization. UPFMA can help build fences, to allow the grassroots reformists to sustain themselves while leaving scale as the province of pharmaceutical companies. And don’t forget, pharmaceutical companies will, by virtue of their patents, retain exclusivity to further refine and to sell refined products.  

UPFMA Helps When the Pharmaceutical Industry Brings Its Cattle to Market  

By supporting UPFMA, the pharmaceutical industry invests in itself.  UPFMA helps to popularize and to normalize psychedelics and can do it more quickly than the nascent industry presently may.  Not only might that help to speed FDA approval for the industry’s products, but it might help to speed acceptance by health insurance companies.  In turn, that speeds up and increases revenue that can be paid back to investors or poured back into research and product development.   

UPFMA Gives Cowmen Opportunity to Show the Pharmaceutical Industry’s Human Side   

At the end of Act I of Oklahoma!, an unscrupulous patent medicine peddler sells our heroine actual heroin –  laudanum, to be precise – promising he had her best interests at heart, whilst taking her money. While no one expects the pharmaceutical industry simply to be just a girl who “cain’t say no,” industry support of UPFMA avoids a coming public relations whirlwind over the unavoidable disjunction of the pharmaceutical industry touting the benefits of its patent medicines, while pricing them outside the reach of many. 

Support of UPFMA is consistent with ubiquitous sound public policy of fostering and promoting good mental health and responsible drug use. UPFMA can help give the public an alternative, while allowing the industry a platform to openly share the benefits of supporting humanitarian goals that pharmaceutical companies hold in common with the public. In other words, if the pharmaceutical industry touts its wares as good for everyone, support of UPFMA allows the industry to walk the walk.   

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UPFMA Can Create a Public Health Database   

For public health study, UPFMA may consider inclusion of voluntary and anonymous data gathering provisions. This may include regulatory agency ability to present program users with voluntary questionnaires regarding their experiences and other relevant health data points. Support of UPFMA fosters gathering data and sharing it for study and research.    

I submit that UPFMA and the pharmaceutical industry would be fine partners at the square dance. And, like in Oklahoma!, this would be OK. Besides, UPFMA needs a partner. How about it, cattlemen? Care to two-step?   

Interested in learning more about the legal side of psychedelics? Then sign up here to receive more info on our upcoming FREE series: Religious Use of Psychedelics in the United States.

About the Author

Gary Michael Smith is an attorney, arbitrator and founding member of Phoenix-based Guidant Law Firm. He is also the author of Psychedelica Lex, the preeminent legal manual for individuals and organizations with a vested or growing interest in psychedelics and entheogens, as well as a founding director and current president of the Arizona Cannabis Bar Association, board member of the Arizona Cannabis Chamber of Commerce, and contributing author to Green Entrepreneur. Listen to his episode of Psychedelic’s Today here.

Comparing 18-MC vs. Ibogaine for the Treatment of Substance Use Disorder

By Jeff Kronenfeld

Could 18-MC, a synthetic derivative of Ibogaine, make treatment safer without the psychedelic trip?

With COVID-19 still spreading, mutating, and killing, it’s easy to forget the other health crises ravaging the country. One of the most concerning of these is drug overdose deaths, with opioids representing a large share of such casualties. From 1999 through 2018, nearly 450,000 people fatally overdosed on opioids in the US. While slight decreases in 2018 buoyed hopes that we were past the peak, even then, overdose deaths were four times greater than in 1999. In 2019, such optimism was dashed as the number of opioid overdose deaths climbed to 50,042, an increase of nearly 7 percent over the previous year. But, are there viable treatment options that are overlooked by the medical community and general public?

In the psychedelic community, many would argue yes, and highlight the potential of ibogaine, a psychedelic compound found in the West African shrub, Tabernanthe iboga. But ibogaine comes with more possible health risks than other psychedelic plants and substances that we’ll explore below, and of course, there remains a lingering bias in some parts of the medical establishment against psychedelics. And so, a non-psychoactive alternative, 18-Methoxycoronaridine (18-MC) was developed in the 1990s and is now advancing through the FDA’s drug development process at a steady clip, while research into ibogaine remains virtually frozen. However, the question remains: are the concerns about ibogaine’s risks valid enough to explain the differing fates of these chemical cousins, or are other factors at play?

What is Ibogaine? 

Ibogaine is a plant-derived alkaloid with unique psychoactive properties distinct from those of classic psychedelics, such as LSD, psilocybin-producing mushrooms, or DMT. One of its effects is panoramic recall, often described by patients as watching a movie of their life playing in their head. Sometimes called a dissociative psychedelic, Geoff Noller, a medical anthropologist with a doctorate from the University of Otago’s Department of Psychological Medicine, prefers the term “oneiric” (pronounced ō-ˈnī-rik), which is defined as, “dream-inducing.”

This description of the ibogaine experience was seconded by Dr. Bruno Rasmussen, a physician and researcher based in Brazil who provides ibogaine therapy. “Ibogaine doesn’t make you hallucinate; Ibogaine makes you dream, but you are awake when you are dreaming,” Rasmussen said. “If you do an EKG during the effect of ibogaine, the lines will be like they are in a REM state, the rapid eye movements state, the dream state.”

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How Does Ibogaine Work?

The unique, psychedelic qualities of ibogaine are not the only way it differs from more familiar hallucinogens. Psilocybin, LSD, and DMT all act in a more focused manner on the brain’s serotonin receptors. And while ibogaine does act on serotonin levels in the brain, it also acts on numerous other neural systems. Noller compares its relatively blunt mode of action to cannabis, which also acts on many different receptor sites, and contrasts it with more targeted designer medicines like Prozac. 

While the exact neural systems ibogaine engages are not fully understood yet, studies show it can reduce opioid withdrawal symptoms and help control cravings. This offers a window of opportunity for patients to make changes in their life that would otherwise be more difficult due to the pain, anhedonia, and other symptoms of withdrawal. Once they have weathered this storm, the reduction in cravings increases their likelihood of not relapsing. 

Furthermore, studies have shown that ibogaine reduces the amount of drugs, like cocainealcohol, and nicotine, that animals self-administer, despite the fact that each of these drugs has their own distinct way of influencing neural chemistry. This ultimately suggests that ibogaine acts on multiple regions of the brain. Studying this broad function could lead to new insights into the physiological underpinnings of addiction, which makes the relative dearth of research on ibogaine all the more curious — until you consider its potential hazards. 

Ibogaine Risks

The benefits of ibogaine must be weighed against its potential dangers. An article in the Journal of Forensic Science examined 19 deaths that occurred following ibogaine treatments given between 1990 and 2008. Post-mortem testing revealed that at least 11 of these patients had other drugs in their systems, such as benzodiazepines, cocaine, opiates, and methadone, all of which are known to be dangerous when mixed with ibogaine. 

Prior to treatment, however, a dozen of the patients who died also had one or more comorbidities known to pose risks when using ibogaine, such as obesity, brain neoplasm, and a range of diseases affecting the liver, heart, and other organs. 

Although ibogaine research in the US stalled in the late ‘90s, it continued abroad. Thomas Kingsley Brown, a California-based anthropologist, worked with the Multidisciplinary Association for Psychedelic Studies (MAPS) for a 2017 study in Mexico, where ibogaine treatment is not specifically outlawed. Thirty people with opioid dependence received ibogaine treatment and were evaluated over the following year. After one month, half of the research subjects stated they had not used opioids since their ibogaine session. Further follow-ups showed sustained anti-addictive effects.

“To address the first question of whether or not ibogaine can be used safely and effectively, my short answer is yes,” Brown said. “There are going to be risks with that, but you can also minimize the risk.”

In addition to screening patients for potentially dangerous comorbidities and identifying contraindications, such as the presence of drugs that could cause harmful interactions, Brown explained that genetic tests can determine how quickly people’s bodies break down ibogaine into noribogaine. This helps those administering the treatment determine whether it’s safe for a patient to move forward with ibogaine and how to calculate an optimal dosage.

Noller also worked with MAPS on an ibogaine study, though this one was based in New Zealand, where Medsafe (the country’s equivalent of the FDA) made such treatment legally available as a non-approved medication in 2010. According to Noller, this classification gives doctors the ability to write a prescription for a drug or treatment even if it hasn’t gone through a three-phase trial testing period. 

He points out that ibogaine’s mortality rate is comparable to methadone. A 2008 paper in the Journal of Ethnopharmacology reported 11 ibogaine-related deaths from 1990 to 2006 out of the 3,414 people estimated to have taken it — a mortality rate of 0.32 percent. A 2007 paper in the Drug and Alcohol Review found 283 methadone-related deaths in Australia between the years of 2000-2003 out of an estimated 102,615 episodes of treatment, which yields a mortality of 0.27 percent. 

But Rasmussen believes it can still be safer, attributing the majority of ibogaine-related deaths to preventable failures on the part of caregivers, such as not having qualified doctors present, forgoing the use of cardiac monitors, and passing on testing patients for drugs that could cause harmful interactions. His strongest piece of evidence for the ability to safely use ibogaine is that none of his roughly 2,000 patients have died due to or during treatment. In fact, he hasn’t even had a subject develop complications, like severe heart arrhythmia. In Brazil, doctors can legally prescribe ibogaine therapy in hospital settings, a model Rasmussen champions.    

“I think that the trick here is to face it as a little surgery,” Rasmussen explained. “We make some pre-surgical examinations, lab tests, blood tests, and EKGs. We do it in a big hospital with the emergency team aware that there is an ibogaine patient in the hospital. For anything we could need, we are backed up, but we never needed the emergency team because we do the lab tests, so we can usually prevent the complications.”

18-MC: The Non-Psychedelic Alternative to Ibogaine

Concerns about ibogaine’s psychoactive effects and potential risks led to the development of 18-MC in the 1990s. Dr. Kenneth Alper, a professor of psychiatry and neurology at New York University School of Medicine, explained that 18-MC is a structural analog of ibogaine, meaning they share a common molecular base, in this case the ibogamine ring system. At the microscopic level, even small variations can lead to big changes. 

The general consensus seems to be that 18-MC is not psychoactive or oneiric, though Alper speculated that it could potentially be hallucinogenic at higher doses. 18-MC also does not seem to carry the same cardiovascular risks. MindMed, a new Canadian pharmaceutical company focused on psychedelic and psychedelic-inspired medicines, obtained the patent for 18-MC in 2019 when it acquired the biopharma startup, Savant HWP, for an undisclosed sum. MindMed recently completed Phase I testing on 18-MC. The company declined to share information about their 18-MC trials or comment for this story. 

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18-MC Patent and the Halting of Ibogaine Research

Karen Szumlinski, a neuropharmacologist, neuroscientist, and professor at the University of California Santa Barbara, worked on animal studies for both ibogaine and 18-MC from the mid to late ‘90s—long before Savant HWP or MindMed existed. 18-MC was first developed in 1996 by a group of scientists, one of which served as Szumlinski’s research mentor. Based on her observations, Szumlinski believes 18-MC is not psychoactive. But the bias against psychoactive compounds combined with 18-MC’s minimal cardiovascular risks are likely the reasons why ibogaine research in the US halted when it did.

Another reason ibogaine studies in the US stopped is due to profitability. Ibogaine is a natural product not eligible for a patent, according to Brown. Patenting molecules is how companies make big profits. Somewhat confusingly though, Howard Lotsof, the person credited with discovering ibogaine’s anti-addictive properties, was able to patent the use of ibogaine and related molecules in doses ranging from 1 mg/kg to 60 mg/kg given orally or rectally for treating poly-drug dependency in 1990. The patent covered addiction to one or more of the following: alcohol, heroin, methadone, cocaine, caffeine, amphetamine, desoxyephedrine, and nicotine. However, it’s the patents held by companies like MindMed that cause Rasmussen to express concerns.

“Big pharma, they like molecules that they can register as their intellectual property and make more money on,” Rasmussen said. “So, I think that’s the reason that there’s a lot of money for 18-MC and there’s no money for ibogaine research.”

Is the Ibogaine Experience a Crucial Part of the Treatment?

Ibogaine’s effectiveness for treating substance abuse disorders and addiction is established in human trials and supported by numerous first-person testimonials. We were unable to find data showing the same for 18-MC, likely because the results of clinical research don’t exist on the molecule yet. But when such information is available, it may offer additional insights into whether the consciousness-altering properties of ibogaine are essential to its effectiveness for treating various SUDs.

Alper suspects the new data will be consistent with what is shown in the existing research. “In terms of ibogaine and its effects on self-administration and withdrawal, the animal model and human experience appear to align pretty well,” Alper said. “Effects on reduced drug self-administration following treatment with ibogaine or 18-MC are not likely to be based on the processing of the content of psychoactive experience.”

In other words, Alper doesn’t think that the reduced consumption of addictive substances by lab animals is caused by psychedelic epiphanies. Rather, he believes it’s the physiologic processes induced by ibogaine. He suspects the same is true for humans, though he also accepts that the psychedelic experience could be a useful aid for patients undergoing psychotherapy.  

Other researchers were less optimistic about 18-MC’s relative prospects in human trials. “I think that at least in some cases—not the majority of them maybe, but in a significant number of situations—the psychedelic experience is a key to solving the problem,” Rasmussen explained. “It’s not that I think that 18-MC will not work, but I really don’t understand how it would work as well as ibogaine does without the psychedelic experience.”

Instead of viewing the question as a zero-sum game that promotes one treatment at the expense of the other, the true win-win scenario for patients would be that both medicines become safely available. After all, the need for more effective therapies is paramount. COVID-19 and the policies put in place to contain it have only exacerbated the risks posed by SUDs. The Lancet reports that as of July 2020, drug overdose deaths in the US increased by 13 percent, with rates in some states up by over 30 percent. 

If the end goal is to reduce harm and save lives over the long haul—and not pump up stock prices in the short term—then it’s up to those within the psychedelic movement to continue their decades-long struggle to end the criminalization of these potentially life-saving medicines. Otherwise, the fate of these powerful and potentially transformative substances will be decided by supporters of the failed policies of criminalization and the corporatization of psychedelics.

About the Author

Jeff Kronenfeld is an independent journalist and fiction writer based out of Phoenix, Arizona. His articles have been published in Vice, Overture Global Magazine, and other outlets. His fiction has been published by the Kurt Vonnegut Memorial Library, Four Chambers Press, and other presses.

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