AUTH/3449/1/21 - Complainant v Small Pharma

Alleged misleading press statement

  • Received
    05 January 2021
  • Case number
    AUTH/3449/1/21
  • Status
    Breach ruled, no undertaking provided. Small Pharma withdrew its agreement to comply with the ABPI Code and accept the jurisdiction of the PMCPA.

Case Summary

Small Pharma is not a member company of the ABPI. On being notified of the complaint it agreed to comply with the Code and accept the jurisdiction of the PMPCA and the complaint was processed and considered by the Code of Practice Panel. Following notification of the Panel ruling, Small Pharma did not appeal the Panel’s rulings nor provide the requisite undertaking and assurance. It withdrew its agreement to comply with the ABPI Code and accept the jurisdiction of the PMCPA. As the complaint was also copied by the complainant to the Medicines and Healthcare products Regulatory Agency (MHRA), the complainant and the MHRA were informed of the position.

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An anonymous contactable complainant complained about an article which appeared in the Guardian entitled ‘Psychedelic drug DMT [dimethyltryptamine] to be trialled in UK to treat depression’. The article, published in December 2020 included quotations attributed to a senior employee at Small Pharma, the company running the trial in collaboration with a named university.

The complainant alleged that Small Pharma appeared to be misrepresenting a medicine it was developing for use in mental health indications. The complainant referred to misleading statements attributed to the senior Small Pharma employee and noted that he/she had stated that dimethyltryptamine ‘breaks up all of the ruminative thought processes in your brain – it literally undoes what has been done by either the stress you’ve been through or the depressive thoughts you have – and hugely increases the making of new connections’. The complainant alleged that there was no evidence to support that claim. The complainant noted that Small Pharma had a financial incentive in representing that type of (unproven) efficacy.

The complainant subsequently submitted that some of the most compelling evidence for this assertion came from the fact that, in some cases, DMT had been reported to induce psychosis. The complainant referred to an extract from a peer-reviewed article discussing DMT-induced psychosis.

The complainant submitted that, furthermore, press coverage of Small Pharma’s recent approval to conduct clinical studies evidenced a major flaw in the employee’s assertion that ‘[DMT] literally undoes what has been done by either the stress you’ve been through or the depressive thoughts you have,’ in response to announcements that Small Pharma was prepared to conduct the first trials that would test the efficacy of DMT for depression.

The complainant submitted that the assertions about how/why DMT affected depression prior to conducting the ‘world’s first patient clinical trial using the psychedelic drug N,N-dimethyltryptamine (DMT) to treat depression’ begged significant questions as to how the employee could make assertions about the efficacy of the medicine for unstudied applications, and what evidence he/she was using to make those assertions.
Given that this was the world's first clinical trial examining the efficacy of DMT for depression, and given that there was such little understanding as to the mechanisms and mental effects of DMT on the human psyche, the Small Pharma employee’s claims that ‘[DMT] literally undoes what has been done by either the stress you’ve been through or the depressive thoughts you have’ appeared to be unsupported by scientific evidence. There were no studies in the peer-reviewed literature that offered evidence for the assertion that ‘[DMT] breaks up all of the ruminative thought processes in your brain – it literally undoes what has been done by either the stress you’ve been through or the depressive thoughts you have – and hugely increases the making of new connections’, and quite a bit of evidence to the contrary.

A glance through anecdotal ‘trip reports’ of DMT users evidenced a wide range of experiences, ranging from the ineffably beautiful to agonizingly hellish (including instances in which extreme DMT experiences appeared to contribute to psychotic breaks).

The complainant alleged that the above provided sufficient evidence as to the degree to which the Small Pharma employee’s comments should be understood as irresponsible and inappropriate, particularly given his/her company's financial stake in promoting the efficacy of DMT for understudied psychiatric indications.

The detailed response from Small Pharma is given below.

The Panel noted that the complainant referred to an article in the Guardian and alleged that Small Pharma appeared to be misrepresenting N,N-dimethyltryptamine (DMT) which it was developing for use in mental health indications. The complainant referred to a quote from a senior employee of Small Pharma within the article that dimethyltryptamine ‘breaks up all of the ruminative thought processes in your brain – it literally undoes what has been done by either the stress you’ve been through or the depressive thoughts you have – and hugely increases the making of new connections’ and alleged that this misrepresented the medicine and could not be substantiated.

The Panel noted that, in addition to sharing a press release with the Guardian after the approval of its Phase I/IIa clinical trial evaluating the effects of N,N-dimethyltryptamine (DMT)-assisted therapy in psychedelic naïve healthy volunteers and it’s efficacy in patients suffering with major depressive disorder, the Small Pharma employee spoke with the Guardian for an introductory briefing about the company ahead of the clinical trial approval. The Panel noted Small Pharma’s subsequent submission that the Guardian article was based on a broader interview with the employee which was wide ranging and covered different aspects of Small Pharma’s business. In the specific quote, the employee was talking to the hypothesis behind DMT-assisted therapy treatment based on accumulating evidence to date. The Panel noted that there was no evidence before it of what was said during this interview.

The Panel noted that the quotation at issue did not appear in the press release shared with the Guardian by Small Pharma, although Small Pharma appeared to accept that the quotation at issue had been made by its employee and the Panel’s ruling was made on this basis.

The Panel noted Small Pharma’s initial submission that the quotation was based on unpublished and published research conducted by the Centre for Psychedelic Research at Imperial College London and reported in various papers in the literature including Timmermann et al, 2019. The Panel had to make a judgement based on the evidence provided.

The Panel noted that Timmermann et al presented results from the first ever placebo-controlled investigation of the effects of DMT on spontaneous human brain activity in thirteen healthy volunteers. The Panel noted that the primary aim of the study was to determine how a bolus intravenous injection of DMT affected the power spectrum and signal diversity of EEG recorded brain activity. Further, that the study analysed the subjective effects of DMT.

The Panel noted that the EEG results showed that compared with placebo, DMT markedly reduced oscillatory power in the alpha and beta bands and robustly increased spontaneous signal diversity. The Panel also noted that the emergence of oscillatory activity within the delta and theta frequency bands was found to correlate with the peak of the experience.

The Panel noted that Timmermann et al concluded that the present results might shed light on the mechanisms underpinning the antidepressant potential of DMT and DMT-related compounds. Increased alpha power and decreased delta power had been found in populations of depressed individuals and associations had been observed between signal diversity and fluctuations in mood including depressive states. Timmermann et al stated that it was reasonable to consider that the massive effects observed here under DMT might have implications for modelling, and perhaps treating, psychopathology.

The Panel noted the positive data in healthy volunteers presented in Timmermann et al, particularly in relation to the change in alpha and delta power. The Panel also noted the study’s qualified reference to antidepressant potential.

The Panel further noted Small Pharma’s submission that in the specific quote at issue, the employee was talking to the hypothesis behind DMT-assisted therapy treatment based on accumulating evidence to date.

The Panel considered, however, that the quotation at issue was strong and unqualified. It was not qualified by other quotations in the article which were not the subject of the complaint but were, nonetheless, relevant and referred to the treatment of a number of depressive disorders besides major depression. The Panel noted that when providing quotations to the press, the ultimate audience should be borne in mind; the Panel noted the audience was the general public rather than the medical press and thus the weight to be attached to the evidence should have been made especially clear. In this regard, the Panel noted that although the press release did not contain the quotation at issue, it, nonetheless, referred to DMT as a ‘potentially revolutionary treatment’.

The Panel considered that the quotation in the lay press that ‘DMT broke up all of the ruminative thought processes in your brain, literally undoing what had been done by either the stress one had been through or the depressive thoughts one had and hugely increased the making of new connections’ implied a clear and unequivocal clinical benefit in relation to the treatment of stress and depression and that the evidence provided was insufficient to substantiate that implication. The Panel, noting its comments above, considered that on the evidence before it, the unqualified quotation was incapable of substantiation and thereby misleading. Breaches of the Code were ruled.