Why Did the FDA's Advisory Committee Recommend Rejecting MDMA as a PTSD Treatment and What Does This Mean for Ukraine?

Author: Oleh Orlov, PhD, Head of NGO “UPRA”, Deputy Director for Research and Experimental Work at the Mykola Yarmachenko Institute of Special Pedagogy and Psychology, NAES of Ukraine

About a month ago1, the advisory committee of the U.S. Food and Drug Administration (FDA) issued a recommendation to reject the application for the use of MDMA for treating post-traumatic stress disorder (PTSD).

This decision came as a surprise to many in the scientific and medical communities, as all previously published research results show the high effectiveness of MDMA-assisted therapy for PTSD. MDMA-assisted therapy had even received “breakthrough therapy” designation from the FDA due to its superior outcomes compared to traditional treatments. Therefore, Lykos Therapeutics, formerly known as MAPS PBC and now continuing MAPS’s nearly 40-year research legacy, was confident in a positive outcome from the vote. However, the members of the advisory committee almost unanimously voted against introducing MDMA into widespread clinical practice. In their opinion, the scientific data collected by Lykos Therapeutics was insufficient to determine the safety and efficacy of MDMA conclusively.

The committee’s recommendations are not binding. The FDA must make a final decision by August 11. There are essentially two paths forward: either allow the use of MDMA now and collect data on adverse reactions through specially monitored clinical practice, or delay its introduction and require Lykos Therapeutics to conduct additional research.

In the vast majority of cases, the FDA follows the recommendations of its advisory committees. In our opinion, the remarks are quite serious and it is likely that the wide implementation of MDMA in the U.S. will be postponed. However, many patients with PTSD are still hoping for a positive decision. Between 40% and 60% of patients suffer from treatment-resistant PTSD.3 4 5 Moreover, the FDA has not approved any new medications for PTSD in the last 25 years. So for many, MDMA is the only real hope for healing. As veteran John Lubecki said in his speech before the vote, this hope is the only thing that keeps many of his fellow veterans alive6.

Why should Ukrainians understand what happened at the FDA advisory committee meeting?

In Ukraine, unlike the United States, the introduction of MDMA into widespread practice is not currently being considered. No scientific research on MDMA is being conducted and has never been conducted here before. Moreover, the FDA's decision is an internal matter for the U.S. and does not impose any obligations on Ukraine. So, from a formal standpoint, these events shouldn't affect us. However, at UPRA, we have been closely following the developments in the U.S. and believe it is necessary to provide professional commentary — and here’s why.

Immediately after the FDA advisory committee meeting, Ukrainian media outlets such as Babel,7 Dzerkalo Tyzhnia,8 Ukrainska Pravda,9 and others published articles covering the event, as is expected from journalists who are attentive to global events. But, perhaps due to the complexity of translation or simply because the topic is inherently difficult to grasp, these articles contain numerous inaccuracies. Individually, they are not important, but together they can create a misleading picture — both of what happened in the U.S. and of MDMA-assisted psychotherapy as a whole. And we cannot allow this to happen, because a misunderstanding of the situation can lead to poor decision-making.

For the widespread implementation of psychedelic-assisted therapy (PAT) in Ukraine, several foundational components are needed: domestic clinical research, pharmaceutical manufacturers, approved therapeutic protocols, trained professionals, licensed mental health institutions, regulatory mechanisms, state health guarantee programs, and — most importantly — legislation to govern this critical field. Once these elements are in place, PAT could take its rightful place among psychotherapy methods, complementing today’s recommended approaches like cognitive-behavioral therapy and antidepressants to contribute to Ukraine’s recovery. But today, even scientific research on MDMA and other psychedelics is impossible in Ukraine, even though it is legal. Since the 1990s, the Cabinet of Ministers of Ukraine has not established the procedures for conducting such studies — likely because, until now, no one found it necessary.

Now the situation can change radically. At UPRA (Ukrainian Psychedelic Research Association), together with like-minded individuals and partners, we have made a lot of efforts to start a public discussion about the introduction of PAT in Ukraine. In May 2023, we held Ukraine’s first conference on psychedelic-assisted therapy together with international partners and specialists from the “Lisova Polyana” Center for Mental Health and Veteran Rehabilitation of the Ministry of Health of Ukraine.10 In October of the same year, a roundtable was held under the Committee of the Verkhovna Rada of Ukraine on public health, medical care, and health insurance, discussing the potential for introducing PAT in Ukraine for PTSD treatment. During the discussion, the participants came to the conclusion that PAT can be considered as one of the most promising methods for overcoming the negative impact of war. And that it is worth starting with research and control mechanisms. In February 2024, the Temporary Special Commission of the Verkhovna Rada of Ukraine on the Legal Status, Social Support, and Medical Care of Veterans supported a pilot project on MDMA-assisted psychotherapy at Lisova Polyana.11 In May 2024, the abovementioned committee approved the recommendations of the roundtable held in October and asked the Cabinet of Ministers of Ukraine and the Ministry of Health of Ukraine to streamline the rules for conducting research with psychotropic drugs from Table 1.12 A draft of the relevant regulatory document has already been developed, and if the Ministry of Health of Ukraine manages to review and adopt it quickly enough, the first patients with treatment-resistant PTSD could undergo MDMA-assisted therapy in a Ukrainian hospital as early as 2024.

Of course, we’re not yet talking about full-scale implementation or therapy for everyone who needs it. First, we need our own scientific research under strict government supervision, because Ukraine’s healthcare system has its own unique characteristics, and we cannot simply copy Western practices. Moreover, even the research itself remains uncertain, as the necessary regulatory decisions have not yet been officially adopted. All the progress we have made today can easily be reversed. The decision is being made right now.

So, if there are questions about MDMA, as Babel writes,13 maybe we should just wait until they are resolved in the United States? In five to ten years, the Americans will (probably) figure everything out and tell us whether we should implement MDMA therapy or not. So Ukraine does not need its own research. And accordingly, there is no need to regulate anything. True, we wouldn’t advance scientific progress or access to cutting-edge treatments — but we also wouldn’t bear any responsibility.

Such thoughts would be permissible and even correct, from the point of view of a cautious Ukrainian official, in peacetime. But in wartime, the largest since World War II, mental health cannot simply wait. The scale of the problem will not allow it. Ukrainian society will have to actively seek solutions. At UPRA, we believe it won’t be impossibly difficult — because those solutions already exist. But first, we suggest clarifying whether there truly are any unresolved “questions” about MDMA.

What is the FDA advisory committee and how do its meetings work?

The FDA's advisory committee is a group of advisors consisting of experts in various medical fields, as well as representatives of patients, manufacturers, etc. The committee’s goal is to provide the FDA with an independent assessment and recommendations on certain decisions. It may issue opinions on approving new drugs, developing rules, standards, guidelines, and so forth.14 The composition of the committee is reviewed and approved every two years. Any U.S. citizen can become a member of the advisory committee. However, in order to qualify as an expert, one must have the relevant education and professional experience. The committees meet several times a year, and the meetings may last multiple days.

There are several different FDA advisory committees, such as those on food products, tobacco, digital health, and human medicines, etc. Their meetings are open to the public and are usually broadcast online. Information about the date, time, topic, and agenda are posted in advance on the FDA website. Typically, scheduled presentations are made at the meeting. There is also a time for speeches, where any person can provide any information regarding the topic of the meeting. Information can also be provided in writing, including anonymously. After the discussion, a vote may be taken on pre-determined issues. Alternatively, the meeting may be held without voting.

Overall, the purpose of the FDA advisory committee is similar to that of other federal advisory bodies in the United States: to give all interested citizens a chance to be heard and to offer independent expert opinions to federal agencies. These recommendations are advisory in nature — government bodies may choose to follow them or not. However, in the majority of cases, such recommendations are taken into account.15

Usually, FDA department directors typically convene advisory committee meetings in special cases, when they need to make decisions on fundamentally new technologies or discuss complex, controversial topics that do not have a simple answer. As noted by former FDA Advisory Committee Management Director A. Sherman, the primary role of these committees is not necessarily to approve or reject medical products, but to discuss certain unique aspects of their safety, efficacy or clinical use. In fact, the FDA advisory committee meetings are often the setting for the first broad public debates on new medical technologies.16

Analysis of the FDA advisory committee meeting on the introduction of MDMA-assisted therapy for PTSD

To evaluate the potential approval of MDMA-assisted therapy, the FDA convened its Psychopharmacologic Drugs Advisory Committee. This council, along with patients and government representatives, includes experts in psychiatry, neuroscience, statistics, and more. The FDA convened the council simultaneously with the publication of a petition17 submitted by Neşe Devenot, a lecturer in literature, ethics, and rhetoric at Johns Hopkins University, though there does not appear to be a direct causal link between the petition and the committee's convening.

Neşe Devenot asked for an extended meeting for several reasons. Firstly, approving MDMA-assisted therapy for PTSD would set a precedent in the U.S. — it would be the first time a new class of psychoactive substance (an entactogen) was approved for clinical use. Theoretically, this could affect how easy it will be to introduce other similar substances in the future. Another fundamentally new thing is the consideration of a psychotropic drug and a psychotherapy method in one application. This has never been done before. Therefore, the author of the petition noted that a broader discussion would be appropriate. Secondly, according to the author, Lykos Therapeutics behaved unethically in its research, hiding information about adverse effects and generally strongly influencing the results of the studies. Thirdly, the petitioner referred to a report by the independent research organization ICER (Institute for Clinical and Economic Review), which, according to her, described in detail the criticism of Lykos Therapeutics' research methodology.18 Later, Neşe Devenot further clarified her position: "I think MDMA has potential as a therapeutic agent, and psychedelics have positively changed my life. In the context of the upcoming FDA decision on MDMA-assisted therapy, I argue that the MAPS/Lykos psychotherapeutic approach increases the risks of MDMA use that have not been reported and responsibly managed. I am working to educate the public about these risks, and to encourage researchers to take safer and more rigorous approaches."19

According to the plan, the meeting was to consist of a report by Lykos Therapeutics on the research and its results, a report by the FDA on the problem, and a public discussion. At the end of the meeting, two questions were voted on: "Does the available evidence support the efficacy of the drug in patients with PTSD?" and "Do the benefits of MDMA, along with the FDA's proposed risk assessment and mitigation strategy, outweigh its risks for treating patients with PTSD? "20

The presentations from Lykos and the FDA were fairly standard. They presented the well-known data that had previously helped Lykos to obtain the status of a breakthrough treatment for MDMA-assisted therapy of PTSD, as well as more recent studies with almost the same results. The most interesting things happened during the free discussion. Usually, such a discussion takes about 60 minutes. But this time, the entire meeting, including the discussion, lasted almost 10 hours. And after that, the council members almost unanimously voted for a negative decision on both issues.

As noted above, an open discussion allows to highlight the complex and ambiguous aspects of a particular therapeutic method. So let's look at the main issues that were raised. This will be useful to consider when planning potential trials in Ukraine, regardless of the final decision made by the FDA.

Concerns Regarding Effectiveness.

As the voting showed, members of the advisory committee had doubts about whether the data presented by Lykos truly allow for an assessment of the effectiveness of MDMA-assisted therapy for treating PTSD. These concerns arose due to the impossibility of complete "blinding" of participants (i.e., participants in the experimental group could guess that they had taken MDMA), the inclusion of participants who had previously experienced recreational use of MDMA (which may affect both expectations of therapy and "blinding"), the non-standard psychotherapy protocol, and accusations that Lykos selectively presented information and attempted to influence study participants to give positive feedback on the treatment. Allegedly, all of this together has such a strong impact on the results of the study that it makes it impossible to assess the effectiveness of MDMA-assisted therapy.

As for blinding,, there are several things wrong with it. First of all, blinding is done to avoid the placebo effect. It is believed that if research participants and/or researchers expect a certain outcome of the experiment, they will unconsciously tend to see this outcome even where it does not exist. That is why experiments are often set up in such a way that neither participants nor researchers know which group they are working with - the experimental group (which receives the real medicine) or the control group (which receives an inert substance that looks the same as the medicine under the same conditions). If the experimental group performs better than the control group at the end of the experiment, it is believed that the substance is responsible for the successful outcome. In addition, if research participants learn that they are in the control group, they are more likely to withdraw from the experiment before it is completed, which can also affect the outcome.

In the case of MDMA and psychedelics in general, the very nature of the substance's effect is such that the person who has taken it will know exactly what it is. This problem has been known for a long time and also applies to a number of other medical fields where drugs that affect the mind are used. Blinding of both participants and researchers is mostly impossible to achieve in trials of antidepressants, anti-anxiety drugs, antipsychotics, strong painkillers, etc. In fact, only in 4.7% of cases researchers, for example, of antidepressants additionally evaluate and take into account the effectiveness of blinding.21 And the FDA apparently did not particularly prevent it from evaluating the effectiveness of the recently approved antipsychotic clozapine and the dissociative anesthetic esketamine. In their response to the expert panel's comments, Lykos noted that they were aware of the problem and had taken appropriate measures to reduce the impact of the placebo effect (for example, by involving independent "blinded" diagnostic specialists to assess the outcome of treatment). They also noted that the studies were originally planned in close cooperation with the FDA. Therefore, the research methodology, including blinding, is the best of what the joint work of experts from the FDA and Lykos has produced.22 This means that although incomplete blinding may indeed have influenced the data, it is not necessarily a sign of poor research quality on Lykos’s part23.

Regarding previous recreational experience with MDMA, it could have influenced the study in several ways. Since 40% of study participants had previous experience with MDMA, they may have been more likely to guess which group they were in, potentially affecting the quality of blinding. Also, previous experience with MDMA could theoretically affect the results of therapy (but it is not known whether it would improve or worsen them). In addition, the tendency to use illicit MDMA could theoretically affect the willingness to stay in the study, the sustainability of long-term effects of treatment, and many other study parameters. In the response to the comments quoted above, Lykos noted that they analyzed the differences between participants who had experience with MDMA prior to the study and those who did not. In both the experimental and control groups, prior MDMA use had no effect on PTSD baseline severity, study outcomes, or the frequency of side effects. Nevertheless, it is an open question whether people with negative reactions to illicit MDMA may have simply not responded to the offer to participate in the study. Lykos argued that they did not account for this because in “real life,” a certain percentage of people do use illicit MDMA, so including them in the study was considered natural. Still, the actual percentage of such individuals “in the wild” is likely lower than 40%

Regarding the psychotherapy protocol, used in combination with MDMA, concerns were raised about its non-standard nature and the absence of a study group that received only MDMA without psychotherapy. In other words, according to the advisory committee, the data presented do not allow for an assessment of the effect of MDMA alone, independent of psychotherapy. Nor do the existing research results allow for a comparison of the effectiveness of Lykos’s MDMA-assisted therapy with other recognized psychotherapy methods.

Lykos’s psychotherapy protocol does indeed differ somewhat from generally accepted methods. We recently translated it into Ukrainian, and it is publicly available on UPRA’s website.24 The very essence of psychedelic-assisted psychotherapy is to use psychotherapy simultaneously with the effect of psychedelics. The psychedelic facilitates the psychotherapy, but the latter is what actually delivers the therapeutic effectsuch a therapy session must last four to eight hours, as this is the duration of the drug’s effect. In their response to the advisory committee, Lykos stated that their goal was to study the effectiveness of MDMA in facilitating psychotherapy. Therefore, they used the same psychotherapy method in both groups — experimental and control. Replacing this method with one of the standard approaches was not possible, as there is no standard therapy involving eight-hour sessions. Also, there was no experimental group receiving MDMA without therapy, because the researchers believed it would be of no benefit to the patients.

The method of Lykos is an eclectic combination of techniques from different therapeutic approaches. According to the protocol, its only significant difference from other psychotherapy methods is that it is relatively less directive and structured. Lykos claims that they ensured the method was applied uniformly across all experimental sites, which is confirmed by the consistency of results across clinics. They also claim that the method is effective on its own, since many participants in the control group showed some improvement even without MDMA. At the same time, public hearing materials available on the advisory committee’s website include criticism of the method. Several people have sent letters to the FDA's public mailbox accusing Lykos/MAPS PBC of allowing too much freedom for therapists. The authors of these letters also argue that concepts such as “inner healing intelligence” and “trusting the process,” which Lykos employs, are unscientific and contradict the latest findings in the field of trauma therapy. According to critics, on the contrary, the goal should instead be to “ground” patients with PTSD, help them build boundaries, and regain a sense of control.

It should be noted that the FDA does not have the authority to regulate methods of psychotherapy. Therefore, the FDA applies its experience in evaluating the effectiveness and regulation of drugs to psychedelic-assisted psychotherapy. And they approach MDMA as a medicine. And the community of developers of psychedelic-assisted therapy emphasizes that it is the combination of the drug and psychotherapy that should be used and not otherwise. At the same time, there is controversy about the Lykos version of the therapy. Some experts consider it unscientific, while others, on the contrary, support it. For Ukraine, this presents a potential problem, since in the U.S., professional associations of psychotherapists have the authority to regulate psychotherapy practice, whereas in Ukraine — they do not. Therefore, the risks associated with the potential use of ineffective or even harmful psychotherapy methods are higher for us. This is another example that points to the need to introduce licensing of psychotherapy practice in Ukraine.

In this context, it is also worth emphasizing one obvious but very important point. The results of the Lykos’s study do not allow us to state whether MDMA-assisted therapy is more or less effective than other standardized methods, because such comparative studies have not been conducted. There are also very few experimental studies comparing even standard psychotherapy methods. Therefore, in order to be able to speak confidently about the relative effectiveness of MDMA-assisted psychotherapy compared to standard methods, experiments need to be conducted. In the meantime, the success of different methods can only be compared with some degree of confidence based on results from unrelated studies.

As for the bias of the researchers, the accusations also come from the above-mentioned opponents of the Lykos\MAPS PBC psychotherapeutic method. The authors of the letters accuse Lykos of "psychedelic evangelism" - that is, an uncritical belief in the benefits of psychedelics and the necessity of their broad use, including attempts to deliberately distort research results to make them appear better than they really are. However, no evidence of this is provided, except for personal testimony. Lykos responded that they submitted all data to the FDA in full and that the FDA conducted regular inspections regarding this. Therefore, they consider the accusations unfounded.

Finally, regarding the overall effectiveness indicators,they are very high (the effect size, Cohen's d25, in the experimental group was 1.9 units, whereas an effect size above 0.8 is already considered large). This allows the results to retain their significance even if all the mentioned distortions did, in fact, influence the final outcome.

Concerns Regarding Safety.

During the discussion, members of the advisory committee expressed doubts about whether the data presented by Lykos truly allow for an assessment of the safety of MDMA-assisted therapy for treating PTSD. In particular, the members of the public hearing expressed concerns that MDMA, due to its stimulant effect, may pose a risk to individuals with cardiovascular problems. It was also noted that currently there is insufficient data regarding MDMA's hepatotoxicity. Special attention was drawn to the potential for MDMA abuse. And most importantly, Lykos was once again accused of bias, insufficient disclosure of adverse side effects, and unethical behavior. For example, it was noted that in one of the studies, several participants allegedly had suicidal thoughts after using MDMA, which Lykos did not report in their study results. Additionally, participants in the discussion emphasized that MDMA temporarily reduces people's critical thinking and increases their level of trust, which could be exploited by unscrupulous therapists. One case, in particular, was mentioned — from 2015 — in which a married pair of therapists involved in a phase 2 Lykos/MAPS study were accused of sexually harassing a patient.

Regarding potential problems with the cardiovascular system, Regarding potential problems with the cardiovascular system, MDMA, being a central nervous system stimulant, has a number of sympathomimetic (stimulatory) effects, such as increased heart rate, elevated blood pressure, faster breathing, pupil dilation, nausea, appetite suppression, muscle tension, increased body temperature, excessive sweating, agitation (psycho-emotional arousal), insomnia, and so on. These effects are mostly mild to moderate and last until MDMA is eliminated from the body (about 4-8 hours). After that, the patient's condition returns to normal. The long-term cardiovascular risks mentioned by Babel in the previously cited publication were not discussed — this is a translation error.

That is, due to the increase in blood pressure, the use of MDMA may pose a danger to individuals with serious cardiovascular issues. Apart from MDMA, these individuals are also contraindicated for other medications with stimulating effects (such as ADHD medications, certain antidepressants, some cough medicines, nonsteroidal anti-inflammatory drugs, alcohol, strong coffee, and intensive exercise). So this should be taken into account when prescribing MDMA- assisted therapy. Alternatively, MDMA’s sympathomimetic effects may potentially be neutralized by using adrenergic receptor antagonists, such as carvedilol.26

Lykos believes that the cardiovascular risks are minor and well controlled in clinical settings, and therefore not a sufficient reason to delay the introduction of MDMA to the market.

Regarding hepatotoxicity, the concerns arose because MDMA's effects on the liver were not separately monitored. Lykos responded that the data from previous clinical trials27 should be sufficient to assess this risk as low and well-controlled. However, Lykos says it is ready to work with the FDA to re-analyze the existing data in detail and find out if new data is needed.

Regarding the increase in suicidality and the potential for addiction, Lykos stated that such problems were not observed in the group undergoing MDMA-assisted therapy. However, the advisory committee still had doubts. Once again, this brings us back to the issue of researcher bias and, more broadly, the level of trust in MAPS/Lykos, which has already been discussed above.

It is worth noting here that MDMA does not cause physical dependence. It is also not taken continuously but used only a few times during the entire course of therapy. At the same time, it can cause quite strong emotional experiences. Therefore, some experts believe that MDMA has no potential for addiction in clinical use. As an example, they recall the use of opiates, such as fentanyl, in surgical procedures. Patients do not seek repeated use of fentanyl after surgery, although it is the most potent drug and can cause physical dependence. Other experts are still concerned that patients may hypothetically seek to repeat the emotional experience of using MDMA and buy it on the illegal market, and the MAPS\Lykos data on such use does not satisfy them.

The story of sexual harassment in a phase 2 study deserves special attention. The events in question took place in 2015, but they gained wide publicity only relatively recently, after video recordings from one of the MAPS/Lykos experimental sites in Canada were released to the media.

All experimental sites of MAPS/Lykos were required to video record every psychotherapy session to ensure oversight procedures. Access to the recordings was granted only to authorized MAPS/Lykos personnel. Upon request, study participants could also be given access to video recordings of their therapy sessions.

In 2021, one of these videos was submitted by research participant Meaghan Buisson to the producers of New York Magazine's Cover Story podcast for publication: Power Trip.28The video shows psychiatrist Donna Dryer and her husband Richard Yensen — both holding the status of "therapist-researchers" — hugging the patient in an overly “intimate” manner while she was evidently reliving traumatic memories. There are also questions about the "therapeutic" nature of other actions. It is important to note that the patient had a history of psychological trauma related to sexual violence. Therefore, as she herself stated, the issue of touch and physical contact was generally very sensitive for her. A significant number of mental health professionals consider what was recorded to be a clear violation of professional ethics. MAPS/Lykos themselves also described the use of physical contact seen in the footage as an unacceptable deviation from protocol, which only allows for touching the patient’s hand or back to show support — and only with prior written consent.

Meaghan Buisson herself regards the actions of Donna Dryer and Richard Yensen as sexual harassment. Although she had previously spoken positively about the couple's actions, she filed a lawsuit in a Canadian court in 2018. In response, MAPS/Lykos terminated all professional relations with Dryer and Yensen and paid compensation to Buisson.29 In their response to the expert panel's comments, which we have mentioned several times, Lykos described the case as a "horrific and damaging example of a breach of professional ethics." They stated that they had reported the incident to Canada’s Ministry of Health, the FDA, and the ethics committees at the relevant institutions, ended all cooperation with the above-named therapists, and implemented stricter measures to ensure that patients' rights are respected. However, the fact that at least four years passed between the events in question and Lykos/MAPS’s reaction clearly did not increase the advisory committee’s trust in the organization.

Conclusions

As we can see, there are no “questions about MDMA” — if we interpret this phrase to mean known issues with MDMA as a chemical substance — neither from the FDA, nor even from the initiators of such an in-depth discussion about its implementation in the U.S. There are certain problems with the credibility of Lykos\MAPS PBC and controversies about their approach to psychotherapy. There are also specific safety concerns related to the fact that many aspects of MDMA-assisted therapy have not yet been thoroughly studied. Overall, the members of the FDA's expert council believe that "this therapy is new territory that requires caution," that many aspects of MDMA use have not been studied in scientific research, and for that reason, they do not recommend introducing MDMA into widespread practice at this time.

In general, it’s always possible to say that some aspect of therapy (or any other phenomenon) hasn’t yet been fully researched. Any high-quality scientific publication ends with a section on “research limitations” and a description of areas for further research, as science never claims to have complete and perfect knowledge, recognizes its own limitations, and always sees prospects for development. The real question is how much research will be enough for regulatory authorities to allow the use of MDMA for medicinal purposes. As PTSD researcher and professor of psychiatry Rachel Yehuda notes, it is important to be aware both of the fact that we may not fully understand all the risks of psychedelics, and also of the fact that while scientists are conducting further studies, patients with treatment-resistant forms of PTSD and other disorders are forced to wait, because no alternative therapies exist.30 It is also interesting to know whether the need for additional research is actually dictated by rationality and care for patients, or, for example, by the stigma around psychedelics, or something else entirely.

We will know what the FDA thinks in about a month. But even if the FDA requires additional studies, this should not be seen by Ukrainian experts who recognize the potential of PAT as an entirely negative outcome. First of all, PAT is being studied not only in the U.S. We can refer to the model of Australia, which has already begun implementing MDMA-assisted therapy, or the Netherlands, which approved such therapy shortly after the FDA meeting, based on the same scientific data.31 Secondly, Ukrainian scientists can also conduct research and share the results with their American colleagues. It is only necessary to take into account the shortcomings described above in advance and be especially attentive to scientific methodology, accurate documentation of results, ethical behavior, protection of patients' rights and external control over the course of research. We also shouldn’t forget about stigma — any complicated or ambiguous situations will, for some time, continue to be interpreted unfavorably toward psychedelics.

Finally, we would like to address Ukrainian journalists with a small request. We urge you to interpret scientific data clearly and impartially, and to be careful when translating foreign sources. This is important because you shape public opinion, which influences important decisions. Incorrect interpretation or inaccurate translation can lead to misinformation and incorrect conclusions. We also ask that you do not use the terms "MDMA" and "ecstasy" interchangeably, and do not link the medical use of psychotropic drugs to "entertainment" in any way. MDMA was created for psychotherapy, and the fact that it was used for recreational purposes before it was introduced into medical practice (because it obviously does not require long-term research) is a tragedy that led to the ban of this drug and the halt of scientific progress for decades. Also, creating such associations is also harmful for patients with PTSD, as illicit use has nothing to do with treatment and, as the examples mentioned in this article show, it can be very harmful. Moreover, we at UPRA are always open to communication with journalists and help them interpret scientific sources to ensure the accuracy and reliability of the information you publish.