It's "the biggest blow to the war on drugs to date," said Kassandra Frederique, executive director of the Drug Policy Alliance.
- Oregon voted to decriminalize possession of small amounts of all drugs, including heroin, cocaine and methamphetamine.
- The state also legalized the therapeutic use and sale of psilocybin mushrooms.
- As the laws go into effect, other U.S. states will be watching to see how the experiment plays out, influencing future votes across the country.
Arrest and incarceration rates<p>Reduced arrest and incarceration rates for drug possession are likely to be the most obvious changes. The Oregon Criminal Justice Commission <a href="https://www.opb.org/pdf/IP44%20-%20REI%20Statement%20Supplement_1602708982790.pdf" target="_blank">estimates</a> that the new laws will reduce convictions for drug possession by about 90 percent, from 4,057 convictions in 2019, to a projected 378 in 2021.<br></p><p>The commission's report also estimates that drug convictions among Black and Indigenous Oregonians may drop by 94 percent, and that racial disparities in drug arrests could drop by the same amount.</p><p>If more Oregonians stay out of the criminal justice system, it could help more people find employment, housing, addiction services and student loans, all of which can be harder to access with a drug conviction on your record. </p><p>It's also conceivable that the new initiative will reduce contentious interactions between Oregonians and law enforcement, which, potentially, could lead to lower arrest rates for other infractions, and create fewer opportunities for police interactions to turn violent.</p><p>Alternatively, if the initiative frees up time and resources for Oregon law enforcement, the state could see arrests rise for other types of crimes. That may include arresting more dealers and traffickers, considering the new laws only apply to users carrying small amounts. If police focus on the suppliers, it will likely change the dynamics of Oregon's illegal drug trade.</p>
Drug use rates<p>How will removing the threat of jail and steep fines change drug use and overdose rates? It's hard to say for sure, but Portugal's 2001 decision to decriminalize drugs provides some clues. In the years following decriminalization, the nation's drug overdose deaths and <a href="https://www.scientificamerican.com/article/portugal-drug-decriminalization/" target="_blank">HIV infection rates dropped significantly</a>, while <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1464837" target="_blank">drug usage either stayed constant or decreased</a>.<br></p><p>That drug use remained constant or decreased may be because Portugal only decriminalized drugs, meaning drugs weren't legally available for purchase at something like a marijuana dispensary. But it's also worth noting that Portugal invested money in addiction treatment services, as Oregon <a href="https://ballotpedia.org/Oregon_Measure_110,_Drug_Decriminalization_and_Addiction_Treatment_Initiative_(2020)#How_is_the_drug_addiction_treatment_and_recovery_program_funded.3F" target="_blank">plans to do with tax revenues from marijuana sales and savings on correctional services</a>.</p><p style="margin-left: 20px;">"Most accounts of the Portugal experiment have focused on decriminalization, but decriminalization was part of a broader effort intended to encourage treatment," <a href="https://www.cambridge.org/core/journals/law-and-social-inquiry/article/uses-and-abuses-of-drug-decriminalization-in-portugal/1F68DA5A8F0369F3FBA6B2B04E454BBE" target="_blank" rel="noopener noreferrer">Hannah Laqueur</a>, an assistant professor in the Department of Emergency Medicine at the University of California, Davis, <a href="https://www.nytimes.com/2020/10/05/upshot/portugal-drug-legalization-treatment.html" target="_blank" rel="noopener noreferrer">told</a> <em>The New York Times</em>.</p><p>Oregon will be a particularly interesting case study for decriminalization's effects on drug usage, considering the state ranks among the worst for <a href="https://www.wweek.com/news/state/2019/10/02/nobody-can-beat-oregon-for-drug-use-and-abuse/" target="_blank" rel="noopener noreferrer">rates of addiction, use, and overdose</a>.</p>
Treatment rates<p>Although Oregon plans to expand investments in treatment programs for drug users, some are worried the new initiative will discourage people from seeking help.<br></p><p>John Kitzhaber, a former E.R. physician in Oregon, called for Oregonions to reject the measure, writing on his <a href="https://blog.johnkitzhaber.com/vote-no-on-measure-110/" target="_blank">blog</a>:</p><p style="margin-left: 20px;">"Measure 110 would eliminate this invaluable tool by reducing the possession of highly addictive drugs like heroin, cocaine, methamphetamine and oxycodone to a "violation," which means the court will no longer have the ability to offer people the choice to pursue treatment. It also means that a teenager caught in possession of heroin or meth will only receive a ticket, which in many counties means that parents won't be informed of their child's drug use."</p><p>Still, even if Oregon's measure reduces the number of people who get treatment, that wouldn't necessarily be an indictment of decriminalization writ large, but rather the specific way the state is allocating funds. Kitzhaber concluded his post with a sentiment shared by both drug reform advocates and some of the measure's opponents: "Incarcerating people who suffer from addiction should not be tolerated."</p>
While many people don't think its all that bad, a new study suggests you should lay off while expecting.
- A new study suggests that smoking weed during pregnancy reduces birth weight and gestational age.
- The study follows on the heels of several others suggesting that marijuana has a variety of negative side effects.
- Despite this, many people still consider marijuana to be harmless.
What happens when you smoke for two<p>The study worked with 5628 pregnant women in Australia, New Zealand, Ireland, and the United Kingdom who were also part of a separate study investigating the relationship between marijuana use and pregnancy complications. These women had their demographic information, lifestyle characteristics, and medical history collected by a midwife.</p><p> All participants were asked if they ever smoked marijuana and, if so, if had they smoked it at any point during their pregnancy. Those who did smoke were further asked how many times a week they partook. Similar questions were asked for alcohol and tobacco usage. The midwives also recorded socio-economic data, noted if the test subject had used other illicit drugs during their pregnancy, and administered tests checking for depression and anxiety. After the test subjects gave birth, the midwives recorded infants' size and weight. </p><p> The babies born to women who smoked past the 15-week point in their pregnancies had lower birth weights, head size, body length, and lower gestational age. The reductions were comparable to the known effects of an expecting mother smoking nine cigarettes a day. These effects were more dramatic for children born to mothers who smoked more frequently. The risk of infant death and the rate of severe infant morbidity increased with the frequency of smoking as well. </p><p>Women who stopped smoking before the 15<sup>th</sup> week gave birth to babies with similar measurements to those born to women who did not smoke. </p><p> The evidence behind these findings remained even after factoring for tobacco and alcohol usage. While those lower on the socio-economic scale were more likely to continue smoking during pregnancy than others, their lower social standing was found to have no direct relation to birth outcomes.</p><p>The study was not without limitations. The number of women who reported continuing to smoke throughout their pregnancy was comparatively low, though not so small as to reduce the validity of the findings.</p><p>The researchers only looked at the number of times a person smoked and not at the potency of the marijuana or how it was consumed. They also looked at the effects of taking other illicit substances, but the number of women taking them was low enough to make serious investigation impossible during this study. </p><p>Perhaps most importantly, the study did not investigate what mechanism is at work. It could be simple carbon monoxide production by the act of smoking cutting down on oxygen that is getting to the fetus, as with tobacco smoking. Or it could be that the chemicals in marijuana were affecting the <a href="https://theconversation.com/using-cannabis-during-pregnancy-could-be-bad-news-for-your-baby-new-research-140443" target="_blank">fetus</a>. This is an area where further research is needed.</p>
So, what does this mean for me?<div class="rm-shortcode" data-media_id="uOrxqasD" data-player_id="FvQKszTI" data-rm-shortcode-id="5fb1fc085ecf9ca63355b4e0bc632e25"> <div id="botr_uOrxqasD_FvQKszTI_div" class="jwplayer-media" data-jwplayer-video-src="https://content.jwplatform.com/players/uOrxqasD-FvQKszTI.js"> <img src="https://cdn.jwplayer.com/thumbs/uOrxqasD-1920.jpg" class="jwplayer-media-preview" /> </div> <script src="https://content.jwplatform.com/players/uOrxqasD-FvQKszTI.js"></script> </div> <p>The first take away here is that you shouldn't smoke weed while pregnant. The second is that it might not be too late to stop.</p><p>Previous studies have suggested that a lower gestational age at birth is associated with lower <a href="https://fn.bmj.com/content/102/5/F409" target="_blank">literacy later in life</a> and that children in families with lower social standing start behind their wealthier peers in literacy <a href="https://www.apa.org/pi/ses/resources/publications/factsheet-education.pdf" target="_blank">tests</a>. The finding here that lower-income women are more likely to smoke during pregnancy suggests that their children may be subject to particular difficulties.</p><p>The study is yet <a href="https://www.sciencedaily.com/releases/2020/02/200204094730.htm" target="_blank">another</a> one suggesting that marijuana isn't as harmless as many people suppose. The drug is known to cause memory trouble, anxiety, and increase the risk of psychotic symptoms. Previous studies similar to this one already hinted at the effects of smoking on the newly born. This one didn't break new ground so much as remove hidden variables in previous experiments on the same subject. <br> <br> Despite this, up to a <a href="https://pubmed.ncbi.nlm.nih.gov/28252456/" target="_blank">third of women think marijuana can't harm a gestating fetus</a>, and the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5550346/" target="_blank">popular conception of the drug</a> has yet to incorporate notions of its <a href="https://en.wikipedia.org/wiki/Cannabis_(drug)#Adverse_effects" target="_blank">various adverse side effects.</a><u></u></p><p>Perhaps the take away for those who are not or cannot become pregnant is that marijuana isn't completely harmless and should be interacted with as such. <u></u></p>
A new study on rats suggests that using marijuana as an adolescent "reprograms the initial behavioral, molecular, and epigenetic response to cocaine."
- In the study, adolescent and adult rats were first given a synthetic cannabinoid and then cocaine.
- The results showed that the young rats' brains were more sensitive to the effects of cocaine, but these effects weren't observed in the adult rats.
- The researchers suggest that research like this can help to develop better treatments for substance abuse disorders.
Fig 1. Cross-sensitization between WIN and cocaine in adolescent rats is associated with histone hyperacetylation in the PFC.
Scherma et al.<p>The results showed that young rats who had been exposed to WIN were more sensitive to the effects of cocaine. This early exposure "reprograms the initial behavioral, molecular, and epigenetic response to cocaine" in young rats. These changes were not observed in adult rats.</p><p>Past research has shown that young rats that have been exposed to cannabinoids become "cross-sensitized" to cocaine, and that cross-sensitization can alter the extent to which rats crave cocaine and experience withdrawal symptoms. </p><p>The new study took a close look at how cannabinoids prime bodily systems for cocaine. </p>
Changes in the prefrontal cortex<p>One such system is the endocannabinoid system, which is impaired by the use of cannabis or cannabinoids. Studies have linked impaired endocannabinoid signaling with increased stress responsivity, negative emotional states, and drug craving. </p><p style="margin-left: 20px;">"The endocannabinoid system has a modulatory role in brain reward and cognitive processes," the researchers wrote. "It has been hypothesized that repeated interference with endocannabinoid signaling (e.g., through abuse of cannabis or synthetic cannabinoids) can remodel the adolescent brain and make it respond differently to more addictive substances, such as cocaine. In the present study, we demonstrate that a history of synthetic cannabinoid exposure in adolescent animals results in distinct molecular and epigenetic changes following initial exposure to cocaine."</p><p>In addition to affecting the endocannabinoid system and (potentially) the glutamatergic system, the study found that early cannabinoid use seems to cause epigenetic changes in the prefrontal cortex. This area of the brain controls executive functions like long-term planning and self-control.</p><p style="margin-left: 20px;">"Our findings suggest that exposure to psychoactive cannabinoids during adolescence primes the animals' prefrontal cortex, so that it responds differently to cocaine compared to animals who had been given cocaine without having previously experienced cannabis," study co-senior author Philippe Melas told <a href="https://www.sciencedaily.com/releases/2020/04/200420165718.htm" target="_blank">Science Daily</a>.</p><p>One consequence of priming the prefrontal cortex in this way seems to be that cocaine becomes more enjoyable.</p><p style="margin-left: 20px;">"This study suggests that teenagers who use cannabis may have a favorable initial reaction to cocaine, which will increase their likelihood of engaging in its repeated use so that they eventually become addicted, especially if they carry additional environmental or genetic vulnerabilities," Kandel told Science Daily.</p>
Limitations<p>The researchers noted several limitations in <a href="https://www.pnas.org/content/early/2020/04/16/1920866117" target="_blank">their study</a>, including:</p><ol><li>The use of experimenter-administered drug regimens instead of self-administration procedures</li><li>The use of synthetic cannabinoids instead of Δ9-THC</li><li>The assessment of neurobiological changes in bulk tissue instead of cell type-specific analyses</li><li>The lack of in vivo causality experiments rendering the molecular data correlational in nature</li></ol><p>They also noted that someone won't necessarily develop an addiction if they happen to have a good first experience with a drug. Still, they suggested that research like this can help to develop better treatments for substance abuse disorders.</p><p style="margin-left: 20px;">"These and other experiments are key to understanding the molecular changes to the brain that occur during drug use," said Dr. Eric Kandel, who is also University Professor and Kavli Professor of Brain Science at Columbia. "This knowledge will be crucial for developing effective treatments that curb addiction by targeting the disease's underlying mechanisms."</p>
Check out the curriculum for the nation's first cannabis-focused bachelor's program.
- Colorado State University-Pueblo will offer the first undergraduate weed degree in the U.S.
- The program will include intensive coursework focused on chemistry and advanced biology.
- Cannabis has become one of the fastest-growing job markets.
A budding industry<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="8deb8acdb60b8a68565aaafb1d9bb22a"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/PtzodN8zSxU?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>The ban on weed, which was outlawed in the 1930s, has only recently started to lift. Though it's still federally illegal, cannabis is now recreationally legal in 11 states plus Washington, D.C. It's also legal for medical usage in 33 states. As a result, cannabis has become one of the fastest-growing job markets. <a href="https://www.forbes.com/sites/kevinmurphy/2019/05/20/cannabis-is-becoming-a-huge-job-creator/#13e2a5d649bf" target="_blank">Forbes</a> estimates that the industry is responsible for the employment of around 300,000 full-time workers.</p><p>"We kind of looked at the industry, and the sector as a whole, and what was needed for students to get jobs," said Lehmpuhl <a href="https://qz.com/1802904/heres-colorado-state-universitys-weed-degree-curriculum/" target="_blank">to Quartz</a>. "We have a lot of businesses in the area that are clamoring for workers." In fact, CSU-Pueblo is also home to the state-funded Institute for Cannabis Research. </p><p>The new degree is intended to prepare students for opportunities to work in chemistry, biology, or natural products labs. That could mean jobs ranging from CBD extraction to analyzing soil chemistry.</p>Though perceptions of marijuana and hemp have evolved over the last decade, the cannabis plant is still shrouded in cultural and political controversy. CSU-Pueblo's bachelor's program is not intended to be political or an attempt to legitimize cannabis consumption. It's rigidly focused on the scientific aspects of the weed plant. <a href="https://www.wbur.org/hereandnow/2020/02/18/colorado-state-cannabis-degree" target="_blank">WBUR reports</a> that Lehmpuhl wants the students to study the plant from an unbiased, scientific viewpoint that is neither pro- or anti-weed usage. He said that studying cannabis in relation to the human body, the industrial world, and the environment will bring new insights into the field, potentially revealing new "creative applications of the cannabis plant."
What the CBC program looks like<p>There's a cluster of U.S. schools that offer similar courses, certificates, and master's degrees in cannabis-centric studies for students looking to pursue the up-and-coming industry. Northern Michigan University, for instance, offers a degree in Medicinal Plant Chemistry with a capstone course named <a href="https://www.nmu.edu/chemistry/ch420-and-research-curriculum" target="_blank">CH420</a> (haha). What's unique about CSU-Pueblo is that it is the first undergraduate program in the country to put the word cannabis in its name, which has resulted in media attention and a flood of inquiries from prospective students.</p><p>The major will offer two tracks students can choose from: one is "natural products," which places more emphasis on biological aspects of weed, while the "analytical" track focuses on chemistry. The <a href="https://www.csupueblo.edu/cannabis-biology-and-chemistry-bs/index.html" target="_blank">program overview</a> states that through the degree, "students will understand cannabis physiology and growth, the pharmaceutical implications, and the practical applications for the industry."</p><p>The CBC program will officially start in the fall semester of 2020 with courses that include Cannabis Physiology and Growth, Medicinal Chemistry and Pharmacology, Medicinal Plant Biochemistry, and Natural Products Extraction and Analysis. You can check out the program's full curriculum <a href="https://www.csupueblo.edu/cannabis-biology-and-chemistry-bs/_doc/course-offerings.pdf" target="_blank">here</a>.</p>
Clinical studies are underway. How we treat them moving forward matters.
- Michael Ehlers, a former executive at Biogen and Pfizer, has assumed an advisory role with Field Trip, a psychedelics research organization.
- Ehlers has followed the science of psychedelics for more than a decade and is excited by the potential for therapeutic applications.
- MDMA and psilocybin have been granted breakthrough therapy status by the FDA, signaling a shift in the future of mental health treatment.
Photo courtesy of Michael Ehlers<p><strong>Derek</strong>: You have an accomplished career in the pharmaceutical industry. Now you've taken on an advisory role with a company specializing in psychedelics. I would love to know when you first became interested in psychedelics as a potential therapeutic tool. </p><p><strong>Michael</strong>: I've followed this area for quite some time. I've been intensely involved in different aspects of drug discovery and development, particularly, although not exclusively, within CNS or neuroscience drug discovery, including neuropsychiatric disease. I've followed more peripherally some of the efforts both in standard pharmacology and then some of the emerging work, whether it was more acute, high-dose psychedelics or microdosing psychedelics in neuropsychiatric disease.</p><p>At the same time, I was following a lot of the work on some of the core receptor biology and neurobiology, which was really advancing in systems neuroscience. Following this field and some of the early indications of potential clinical efficacy were some of the things that really got me quite excited. I was particularly close with aspects of what's been done over the past 10 years with ketamine, which is a very different agent but also in the class, initially leading from small trials on ketamine for acute, anti-depressive actions, now to Janssen and J&J using a variation of this, esketamine, to get full-on FDA approval for the first new mechanism in depression in 20 years. The combination of these things indicated to me that there could be a new paradigm change or highly-active psychopharmacology to potentially treat some of these otherwise fairly intractable types of neuropsychiatric disorders.</p><p>There are some other things that were also on the horizon. The history of CNS drug development, particularly in neuropsychiatric disease, has been one where the empirical observations in human patients have really guided efficacious therapeutics by and large. Even though I know we like to talk a lot about rational drug discovery and development, at least in the field of neuropsychiatry, because there's still so much that is not known that we've had to rely a lot more on empirical observations in humans. </p><p>There's probably no more profound CNS pharmacology out there than that with psychedelics like psilocybin or LSD or ketamine. I've actually long thought it was just a matter of figuring out what a treatment paradigm could look like—how maybe when you dose it could you alter aspects of its dose exposure and distribution and then in what exact disease or syndrome.</p><p><strong>Derek</strong>: You have a history of working with rare diseases. Field Trip is going to tackle a wide range of studies, but the ones that are really on everyone's mind (in terms of what psychedelics could potentially help) ranges from PTSD to treatment-resistant depression and anxiety. These are much more common diseases. Do you have any background in those diseases and, in the advisory role, what will you be doing for them?</p><p><strong>Michael</strong>: I've got a lot of background in that. I worked for nine years in large biopharma, six years at Pfizer. I started in neuroscience and pain, but ultimately ran several divisions of Pfizer R & D, that did include rare disease, but included a bunch of other things. Then I ran R & D advising for three-and-a-half years. I've done clinical trials in depression, schizophrenia, PTSD, generalized anxiety disorder, Alzheimer's disease, and Parkinson's disease. I've done both rare diseases and a lot of common disorders: hemophilia, genetic disease, and some of the rare diseases as well. I've done stroke trials. I've had experience across a range.</p><p>One thing I like is about what Field Trip is doing and the prospect of these diseases is that they're incredibly common. Roughly 25 percent of people will have some experience with major depression in their lives. One percent of the world has schizophrenia. These are serious and significant disorders. I really love the fact that this field—and Field Trip is really part of that in a leadership role—is looking to take some of these on. </p><p>Although the lore has been that there hasn't been that much innovation, I actually think that's not true. I think we're just at the beginning of a whole new era of advances in neuropsychiatric disease. I can point to several things that indicate that. I have a feeling that if we really understand that the best way to dose and conduct trials with psychedelics like psilocybin and be able to segment patients who are the most likely to benefit, this can become quite important.</p>
The future of psychedelic-assisted psychotherapy | Rick Doblin<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="408bb22b4a049f39ed1c070282deb3c5"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/Q9XD8yRPxc8?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p><strong></strong><strong>Derek</strong>: You mentioned that pharma companies stepping away from neuropsychiatric disease. There is obviously a problem with SSRIs over the long-term. Efficacy rates tend to be high in the short-term, but over the long-term prove problematic. When you're stepping into substances that potentially could help treatment-resistant mental health diseases in one dose (or just a couple of doses), how do you think that companies are going to be able to monetize this, especially given the incredible amounts of money that have to go into R & D and clinical trials?</p><p><strong>Michael</strong>: It's a very good question. I think we haven't solved that problem yet. There are a lot of open questions. Will some of these therapies really be single dose or short regiments and you're done? Will it have to be that there's some degree of maintenance where there's some regularity in the need for therapy? Will it really be like antibiotics or gene therapy? We don't know. </p><p>A lot of these neuropsychiatric diseases, although they're complex, have genetic features that are polygenetic but they're related. Whether you're talking about, schizophrenia, autism, bipolar disorder, ADHD, there's a complex genetic architecture that has shared features across all of those. The risk of relapse and occurrences will be there in a given population. I tend to think the likelihood of things like ketamine or psychedelic treatments for depression will be one of periodic needs. </p><p>The question you raised is an excellent one, which is what ultimately is the commercial model for that? Certainly, the hope is that it doesn't go down the road of antibiotics for which the commercial incentivization for real R & D and drug development has been catastrophic. I don't see that in this space. I just don't think it's going to be quite as simple as "one and done." The prevalence alone will be a strong incentive for investment when there's real efficacy potential. </p><p><strong>Derek</strong>: Please correct me if I'm wrong; I'm fascinated by neuroscience, but not having an academic background my knowledge is limited. That's why I love talking to people about this. From my understanding, SSRIs work in a much different manner in terms of the serotonin release then psychedelics. Do you see any potential benefits or dangers in the ways that psychedelics deal with the serotonergic system?</p><p><strong>Michael</strong>: It is quite different. From a simple pharmacology point of view, SSRIs are, as their name indicates, selective serotonin reuptake inhibitors: they block serotonin transporters that would normally release serotonin back up into nerve cells so that it increases serotonergic tone. Once released, it stays released in the extracellular space for longer, acting on all the different receptors in the places that it does. </p><p>The psychedelics typically act directly on serotonin receptors within serotonin transporters, but their action at different receptors has different potency. It's not a clean pharmacology. People will talk about 5-HT-2A receptors and they're clearly important, and there's been a lot of study on that, but we also know that if you just give a pure 5-HT-2A receptor an agonist you do not reproduce the effects of psilocybin or LSD. </p><p>The pharmacology is complex; it's clearly different than SSRIs. Obviously, the behavioral and therapeutic groups are very different. It just highlights that we really need to understand it better. It's going to reveal I think very important things about psychiatric disease and fundamental neuroscience.</p>
A shaman gathers the raw materials to make ayahuasca in the jungle outside of Iquitos.
Photo by Andrew Lichtenstein/Corbis via Getty Images<p><span style="background-color: initial;"><strong>Derek</strong></span>: One of the criticisms of the way that the industry is right now is that, why would a doctor spend an hour talking to a patient when you can see six patients in an hour and write a script? Efficacy rates are different for different people, dealing with the microbiome, for example, and the way that their gut processes drugs. It's a very complex issue. One thing I believe is going to be important is that psychotherapy is going to be tethered with psychedelics, especially if people have never done them before. Will that coupling provide a sustainable model?</p><p><strong>Michael</strong>: Here's an aspect of what's important to understand: the field has understandably taken a cautious approach, which I think is warranted in this whole guided therapy concept and that will probably be required for certain dosing regimens. I would personally like to see this converted into what is a very standard thing in a lot of drug administration in practice or trials, which is more about medical monitoring. Change it from the notion of it's guided therapy to monitoring like you would for a lot of things. People go to IV infusion centers to get their IV drug. It's different, but there's nothing that unusual about the notion of having a monitored pharmaceutical or pharmacological drug intervention even in standard practice. This will likely be part of that.</p><p>If you're a neurologist treating MS and you've got MS patients on Alemtuzumab or Natalizumab as your IV drugs. They come in, you've got your IV clinic. They come in regularly, every month or every quarter depending on the drug, and they get their IV infusion. They get monitored while it happens because they can have an immune response. I see a future for some of these psychoactive therapeutics where you have something similar.</p><p>Now the question will be to what extent does the guided as opposed to monitoring aspect of that influence the degree of efficacy? That's something which really would need to be studied. To the extent it really requires some special type of guided activity that will be a little bit more of a limitation. To the extent that it can be ultimately the design in a more monitoring approach with education, the more widespread this can become.</p><p>Does that analogy make sense to you? There's a lot of precedence for this in other areas. The way this has gotten utilized now is still a remnant of causing people to have profound hallucinations and behavioral stuff and paranoia. Some people get afraid of that, so we need to have some monitoring.</p><p>We need to understand doses. We need to know the extent to which those experiences are part and parcel to a therapeutic response or not associated with a therapeutic response.</p><p><strong>Derek</strong>: How much do you think anecdote is going to matter? One main issue I have with the whole cannabis legalization process is the extraction of <a href="https://bigthink.com/culture-religion/is-cbd-legal" target="_self">CBD being sold for every possible ailment</a> out there when the actual evidence is almost nothing at this point, besides epilepsy. At the same time, dealing with mental health disorders, how much are we going to rely on anecdote? If people think they're getting better, there's placebo, and it actually helps them get better.</p><p><strong>Michael</strong>: I hope we moved beyond anecdotes, and I think that you're right about CBD, but it's interesting the way you put that because of the fact that rigorous trials have been done in rare epilepsies, like Dravet and Lennox-Gastaut syndrome, nobody disputes that. Patients in need can get insurance companies or health systems in other countries to reimburse for that. That's what I mean by saying real location impact is going to require that component of it too. You'd like to be able to generate the evidence because nothing comes without safety concerns. The nice thing about putting this all through the lens of drug discovery and development is that it allows the community—and here I mean the medical community, policymakers, others —to have a much clearer view of the benefit-risk, and where the benefit-risk is positive, in which case that's usually a required element for real access for patients. </p><p>Of course, you could argue and say, "well, if it's just out there, people can try it, we'll see and that's fine," but this doesn't allow us from a clinical scientific vantage point to really know when and where we are going to provide benefits. That's what we really need to work toward. There's enough anecdotal evidence out there to justify rigorous evaluation.</p><p>--</p><p><em>Stay in touch with Derek on <a href="http://www.twitter.com/derekberes" target="_blank">Twitter</a> and <a href="https://www.facebook.com/DerekBeresdotcom" target="_blank">Facebook</a>. His next book is </em>Hero's Dose: The Case For Psychedelics in Ritual and Therapy.</p>