Breaking into new medical territory: Will the psychedelic renaissance find its way into policymaking?

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In recent years, one drug policy phenomenon present in the media has been the way in which many parts of the Western world are changing their views regarding the legalization of cannabis. Examples include the legalization of cannabis in a handful of states in the United States, Canada, and also recently Luxembourg. This shift in policy focus could be explained by a change in the public’s perception of cannabis or how problems associated with cannabis should be handled. In turn, this change of public perception started with a heightened medical interest in cannabis. In the US, for instance, a major positive shift in public perception towards cannabis can be observed starting with the issuing of state medical marijuana laws in 1996.[1]

While other stronger psychedelic substances have also experienced a surge of research into medical applications in the last years, this phenomenon was not present in the media, especially outside of the US. Defying legal and political obstacles, different organizations have been pushing into the abandoned field of psychedelic medical research. The question arises if these efforts will eventually also shift the public perception of psychedelics and overturn the no-tolerance stances of many policy-makers on psychedelics. A frontrunner of this so-called “psychedelic renaissance” is the non-governmental organization Multidisciplinary Association for Psychedelic Studies, or MAPS for short, whose work will be further presented in this article.

Psychedelics or “mind-expanding drugs”, are substances that can cause effects on the mind, such as feelings of deep understanding or unusually strong sensory experiences.[2] These substances have been consumed in various communities across the world since the formation of early human cultures.[3] Well-known examples of psychedelics that have been used in the western world are: LSD, in hippie communities; MDMA (the original compound of ecstasy) in the techno rave culture; and psychedelic mushrooms, in communal gatherings in ancient Greece. Likewise, ayahuasca and peyote are used in shamanic ceremonies by native Latin and North American people, and iboga bark is used in spiritual ceremonies in West Africa. Cannabis has also been proposed to be classified as a psychedelic.[4]

In recent western culture, psychedelics have become prominent with the discovery of LSD by Albert Hofmann in 1943. Hofmann immediately recognized that his discovery could be beneficial to the field of psychiatry.[5] In the middle of the twentieth century, psychedelic research flourished all over the world. However, due to particularly widespread use of psychedelics by the counter- culture and the anti-Vietnam War movement, it has been said that political conservatives felt threatened by the emergence of LSD, which many saw as promoting civil rights protests, feminist ideologies, environmentalists and anti-war protests that went against preserving the status-quo[6]. In short, the US government began criminalizing all uses of LSD in 1966 and other psychedelics and began shutting down all psychedelic research. Soon the rest of the world, as well as the United Nations, followed. The UN Convention on Psychotropic Substances of 1971, which guides national legislations, manifested this no-tolerance stance by classifying drugs such as cannabis, LSD, MDMA as Schedule I drugs, stating that these substances have a high risk of abuse, posing a serious risk to public health and have very little or no therapeutic value.[7]

Some drug researchers object to this view, saying that almost all substances, which fall under the description of “recreational” drugs, have medical uses as well.[8] Regarding this, David Nutt[9], one of the world’s leading drug researchers, has pointed out the potential of MDMA for the therapeutic treatment of post-traumatic stress disorder (PTSD), one of the most widespread psychiatric disorders. PTSD can affect people who experienced a traumatic event (e.g. war, sexual or childhood abuse), which leads to intense disturbing thoughts and feelings related to the experienced trauma. Common occurrences are reliving the event through flashbacks or nightmares. Affected people may feel sadness, fear or anger and they may feel detached or estranged from other people. Approximately one in eleven people will be diagnosed with PTSD in their lifetime, while women are twice as likely as men to have PTSD.[10] According to David Nutt, if one had to invent a drug for the therapeutic treatment of PTSD specifically, it would have the following properties:

  • be short-acting enough for a single session of therapy,
  • have no significant dependency issues,
  • be non-toxic at therapeutic dosages,
  • reduce feelings of depression that accompany PTSD,
  • increase feeling of closeness between the patient and the therapist,
  • raise arousal to enhance motivation for therapy,
  • increase relaxation and reduce hyper-vigilance and anxiety,
  • stimulate new ways of thinking to explore entrenched problems. MDMA, he points out, is a drug that combines all these [11]

In a 2011 study sponsored by MAPS, Michael Mithoefer[12] et al. explored the application of MDMA-assisted psychotherapy, confirming the promising properties of the drug for this therapy. The study showed an 83% success rate of treating PTSD with MDMA, compared to only a 23% success rate with a placebo.[13] More importantly, a follow-up study four years later showed that the success rate was maintained over time.[14]

Following these promising findings, MAPS started research to seek state approval for offering MDMA-assisted psychotherapy, overcoming the research obstacles which have been imposed upon psychedelics and making it available for people in need. While MAPS had initial problems getting acceptance from ethics boards in the US (who admitted their rejection was not based on science, but rather politics)[15], they completed in 2016 a series of six Phase-2 clinical trials, moving onto Phase-3 clinical trials and the potential for marketing authorization if everything goes well with the Phase-3 trials.[16]

The trials so far have been quite successful and well received by the Federal Drug Agency (FDA). They not only led to the approval by the FDA of the US to start final Phase 3 studies for market authorization, but also the granting of a Breakthrough Therapy designation by the FDA. This designation acknowledges the vast potential for health benefits of this therapy method and grants MAPS an accelerated development and review process compared to other applicants. Furthermore, the FDA granted MAPS Expanded Access for MDMA-assisted psychotherapy for PTSD for people with a serious or life-threatening condition, who cannot take part in the Phase-3 studies. With this exemption, a small number of people in need can get access to the MDMA-assisted psychotherapy offered by MAPS before they receive the marketing authorization by the FDA.[17]

While a marketing authorization from the FDA (potentially by the end of 2021) would mean an automatic marketing authorization in Israel and Canada,[18] MAPS has also expanded to Europe. Marta Mazur, former clinical trial leader of MAPS Europe, told The Bulletin that Europe’s medicine authorization systems, however, pose special challenges. The European Medicine Authorization Agency (EMA), Europe’s counterpart to the FDA, demands that MAPS conducts clinical trials in different member states, going through different national regulatory bodies, who each have slightly different requirements regarding the clinical trials (only one of the challenges being different language requirements). Two other challenges for MAPS in Europe are the stricter privacy laws compared to the US and that EMA asked MAPS to account for cultural diversity in their studies, e.g. by including refugees. Nevertheless, MAPS work in Europe also encountered some opportunities. Since EMA has accepted all the data MAPS has gathered for the FDA for review, overall costs for the clinical trials in Europe are significantly lower. According to Marta Mazur, MAPS Europe also not encountered any discrimination so far connected to the stigma of psychedelic substances, judging from their encounters with regulatory agencies and ethics committees.[19]

At the same time, MAPS is working on multiple other fronts of psychedelic research. They have conducted successful studies with MDMA-assisted psychotherapy for anxiety or alcoholism or studies with other psychedelic substances.[20] A handful of other non-profit and for-profit organizations have also joined the efforts in scientifically exploring the benefits of psychedelics for therapy and, in September 2019, the first of its kind psychedelic research center debuted at Johns Hopkins University.[21]

Many of these psychedelic researchers hope to have an impact that goes beyond science and medical applications. Being an advocate of the use of psychedelics in general, “it felt like science was the way into the culture that was freaked out by the 60s”[22], Rick Doblin[23], the founder of MAPS has commented. Since the stigma connected to psychedelics created a barrier for conventional political advocacy for legalization or even just the abandonment of the current no-tolerance policy on psychedelics (responsible for many research barriers), Doblin hopes that legalization will eventually follow medicalization.[24] In accordance, Marta Mazur told The Bulletin that “changing the political view and approach to all psychedelics comes first with facts, data and also awareness and education. Then the mindset of people is changing […]”.[25]It might be possible that this commitment of psychedelic researchers achieves what the psychedelic advocates of the 60s failed to achieve. Some of these advocates did not use the most convincing strategy, saying that everybody should just take LSD to open their minds and to reach world peace.[26] While some of these current psychedelic researchers still hope to promote global human understanding with psychedelics[27], they shift the attention focus on science-based insights.

MAPS research into the MDMA-assisted therapeutic treatment of PTSD might just as well be a gate-opener in this regard. MDMA has a relatively low chance of adverse events occurring.[28] More importantly, the therapeutic area of PTSD has a big strategic advantage. Firstly, PTSD is a serious widespread mental disorder, in which conventional psychotherapy often falls short and symptom- treatment with antidepressants has many negative side effects. Secondly, PTSD is especially widespread among veterans. In the US, for example, the Veterans Administrations spends about 10 billion dollars in mental disability payments for veterans.[29] This number is so high because about 10 to 20 percent of soldiers coming back from war suffer from PTSD[30], which not only raises war costs, but also lowers the public acceptance of military deployments. The 6,000 veteran suicides occurring every year in the US due to PTSD do not help create a positive image for military interventions.[31] The member states of the EU and other countries will have similar problems, which leads to the need for more effective therapy methods for PTSD overall and therefore might even be able to convince people with a conservative political opinion. Indeed, support for MAPS’ PTSD- work has been bipartisan and included for example psychedelic enthusiasts from Silicon Valley and the Open Society Foundations, but also people from the conservative spectrum in the US like parts of the Mercer and Koch families.[32]

Therefore, the current research into the medical use of psychedelics seems very promising. If the current “renaissance” of psychedelic research leads to a generally more open stance towards psychedelics by policy makers remains to be seen in the next few years. The decriminalization of psychedelic mushrooms in the cities of Denver and Oakland in the US in 2019 might have been one of the first indications of this.[33] For the future, Rick Doblin already has an ambitious vision. Over the next several decades, he anticipates thousands of psychedelic clinics established by MAPS all around the world, where therapists can administer different psychedelics, hopefully covered by insurance. These clinics could also evolve, according to his vision, into centers offering psychedelic therapy for personal growth, for couples therapy or spiritual and mystical experiences.[34]

 

“The views represented in this opinion piece do not necessarily represent those of the Willy Brandt School of Public Policy.”

 

References:

[1] See Andrew Daniller, „Two-thirds of Americans support marijuana legalization,“ Pew Research Center, last modified November 14, 2019, accessed April 4, 2020,

https://www.pewresearch.org/fact-tank/2019/11/14/americans-support-marijuana-legalization/.

[2] „Psychedelic,“ Cambridge Dictionary, last modified July 5, 2017, accessed April 4, 2020, https://dictionary.cambridge.org/dictionary/english/psychedelic.

[3] David E. Nichols, „Psychedelics,“ Pharmacological Reviews 68, no. 2 (2016), 264.

[4] E.g., Andrew Brodwin, „Some psychiatrists think cannabis can be considered a psychedelic drug like shrooms – here‘s why,“ Business Insider, accessed April 4, 2020, https://www.businessinsider.com/cannabis-marijuana- psychedelic-drug-why-2017-7?r=DE&IR=T.

[5] David Nutt, Drugs without the hot air: Minimising the harms of legal and illegal drugs (Cambridge, UIT Cambridge, 2012), 250.

[6] Ibid, 253.

[7] „Classification of controlled drugs“, European Monitoring Centre for Drugs and Addiction, accessed April 04, 2020, http://www.emcdda.europa.eu/publications/topic-overviews/classification-of-controlled-drugs/html_en.

[8] David Nutt, Drugs without the hot air: Minimising the harms of legal and illegal drugs (Cambridge, UIT Cambridge, 2012)

[9] David Nutt is also famous for being sacked from the Advisory Council on the Misuse of Drugs in the United Kingdom in 2007 after having compared the threats of MDMA with horse riding as well as comparing the threats of Cannabis with the threats from alcohol. The Home Secretary of the United Kingdom justified the decision of sacking him by saying he crossed the line from science to policy. Source: David Nutt, Drugs without the hot air: Minimising the harms of legal and illegal drugs (Cambridge, UIT Cambridge, 2012), 2-4.

[10] „What is postraumatic stress disorder?,“ American Psychiatric Association, accessed April 04, 2020, https://www.psychiatry.org/patients-families/ptsd/what-is-ptsd.

[11] David Nutt, Drugs without the hot air: Minimising the harms of legal and illegal drugs (Cambridge, UIT Cambridge, 2012), 25.

[12] After Mithoefer received approval for his study by the Federal Drug Administration he had to leave the university he was working at, because the university did not approve of the study due to political reasons. Source: Rick Doblin, „Updates from the Frontlines of Psychedelic Science,“ MAPS, last modified January 26, 2020, accessed April 4, 2020, https://www.youtube.com/watch?v=bzBcE207O9Q.

[13] Michael C. Mithoefer, Mark T. Wagner, Ann T. Mithoefer, Lisa Jerome and Rick Doblin, „The safety and efficacy of ±3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study,“ Journal of Psychopharmacology 24, no. 4 (2011), 439-452.

[14] Michael C. Mithoefer, Mark T. Wagner, Ann T. Mithoefer, Lisa Jerome, Scott F. Martin, Berra Yazar-Klosinski, Yvonne Michel, Timothy D. Brewerton and Rick Doblin, Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine- assisted psychotherapy: a prospective long-term follow-up study,“ Journal of Psychopharmacology 27, no. 1 (2013), 28-39.

[15] Rick Doblin, „Updates from the Frontlines of Psychedelic Science,“ MAPS, last modified January 26, 2020, accessed April 4, 2020, https://www.youtube.com/watch?v=bzBcE207O9Q.

[16] “Research: Current Focus,” MAPS, accessed April 04, 2020, https://mapseurope.eu/.

[17] „Press release: FDA Agrees to Expanded Access Program for MDMA-Assisted Psychotherapy for PTSD, MAPS, last modified January 17, 2020, accessed April 4, 2020, https://maps.org/news/media/8008-press-release-fda- agrees-to-expanded-access-program-for-mdma-assisted-psychotherapy-for-ptsd.

[18] The Federal Drug Adminstration of the US also regulates Phase 3 clinical trial sites of MAPS not only in the US but also in Canada and Israel. Source: „Phase 3 Trials: MAPS meets with European Medicines Agency (EMA)“, MAPS, accessed April 04, 2020, https://maps.org/research/mdma/ptsd/phase3/timeline/7274-phase-3-trials-maps- meets-with-european-medicines-agency-ema?pk_campaign=2018-06-Newsletter-June-Web&pk_kwd=intro- scientificadvice.

[19] Marta Mazur (former clinical trial leader, MAPS Europe), in discussion with the author, December 2019.

20] For example, they have conducted a conflict-resolution study with Israelis and Palestinians who took ayahuasca together in cooperation with the Imperial College London. Source: Natalia Lyla Ginsberg, „Can ayahuasca promote peace in the Middle East? Conversations with Palestinians and Israelis,“ MAPS, last modified February 26, 2020, accessed April 04, 2020, https://www.youtube.com/watch?v=arw3yzr5erY.

[21] Rick Doblin, „Updates from the Frontlines of Psychedelic Science,“ MAPS, last modified January 26, 2020, accessed April 4, 2020, https://www.youtube.com/watch?v=bzBcE207O9Q.

[22] „Joe Rogan Experience #782 – Rick Doblin,“ PowerfulJRE, last modified April 07, 2016, accessed April 04, 2020, https://www.youtube.com/watch?v=Prxam5Lp4S4&t=7s.

[23] Doblin is a fellow public policy alumni, having received a doctorate in Public Policy from Harvard‘s Kennedy School of Government.

[24] Rick Doblin, „Updates from the Fronlines of Psychedelic Science,“ MAPS, last modified January 26, 2020, accessed April 4, 2020, https://www.youtube.com/watch?v=bzBcE207O9Q.

[25] Marta Mazur (former clinical trial leader, MAPS Europe), in discussion with the author, December 2019.

26] Probably the most famous example is the activism by the Harvard psychologist and „hippie-guru“ Timothy Leary.

[27] Rick Doblin, „Updates from the Fronlines of Psychedelic Science,“ MAPS, last modified January 26, 2020, accessed April 4, 2020, https://www.youtube.com/watch?v=bzBcE207O9Q.

[28] In a multi-criteria decision analysis of 20 different „recreational“ drugs by the Independent Scientific Committee taking into account such factors as mortality, addictivity, impairment of mental functioning, loss of tangibles, harms to the users environment and other factors MDMA scored an overall harm value of 9 (for comparision: heroin 55, crack 54, cocaine 27, tobacco 26, cannabis 20, benzodiazepines (antidepressants) 15, LSD 7, psychedelic mushrooms 6). Source: David Nutt, Drugs without the hot air: Minimising the harms of legal and illegal drugs (Cambridge, UIT Cambridge, 2012), 43.

[29] „Budget in Brief,“ U.S. Department of Veterans Affairs, accessed March 05, 2020, https://www.va.gov/budget/docs/summary/fy2021VAbudgetInBrief.pdf.

[30] „PTSD: National Center for PTSD,“ U.S. Department of Veterans Affairs, accessed March 05, 2020, https://www.ptsd.va.gov/understand/common/common_veterans.asp.

[31] VA National Suicide Data Report 2005-2006, 2018,“ U.S. Department of Veterans Affairs, accessed March 05, 2020, https://www.mentalhealth.va.gov/docs/data-sheets/OMHSP_National_Suicide_Data_Report_2005- 2016_508.pdf.

[32] Rick Doblin, „Updates from the Frontlines of Psychedelic Science,“ MAPS, last modified January 26, 2020, accessed April 4, 2020, https://www.youtube.com/watch?v=bzBcE207O9Q.

[33] Samantha Maldonado, „Oakland becomes second U.S. city, after Denver, to decriminalize magic mushrooms“, The Denver Post, last modified June 05, 2019, accessed April 04, 2020, https://www.denverpost.com/2019/06/05/oakland-magic-mushroom-decriminalization/.

[34] Rick Doblin, „The future of psychedelic-assisted psychotherapy | Rick Doblin,“ TED, last modified August 09, 2019, accessed April 04, 2020, https://www.youtube.com/watch? v=Q9XD8yRPxc8&list=PLu1gZqytReTH6vo4Qu_2lWjY7TGBVOS8y&index=4.

 

Follow Robin Schultz:

Robin Schultz came from Franconia, the neighboring Region of Thuringia, to the Willy Brandt School to continue his previous studies in the field of political science. Currently, he serves as the president of the Student Government of the Brandt School. Until now he gathered work experience in the area of event management, in federal politics and party political foundations in Germany and abroad. Robin is a passionate pro-European, especially interested in the fields of agent-based modeling, drug policies, local politics, and research on the German reunification. After finishing his academic training at the Brandt School he looks forward to working in the area of public administration or political advocacy.