Ch. XIII — Synthesis & outlook

Chapter XIII of Post-2010 Psychedelics: An Expert-Panel Review. For the executive summary and full table of contents, start there.

Abstract. This concluding chapter synthesises the twelve preceding chapters of this review. It does not introduce new evidence; it consolidates what they collectively say about the post-2010 psychedelics field as of the freeze date of 13 May 2026. The aim is to fix the field’s current epistemic posture in writing — neither the revolutionary breakthrough promised in 2018 nor the failed paradigm Lykos’s 2024 collapse threatened to make it — and to surface the open questions that the next five-to-ten years of research will need to address.

13.1 Scope statement

This review covered the post-2010 clinical, mechanistic, regulatory and sociocultural development of five compound classes:

• Psilocybin / psilocin (Chs II–VI, IX–XII): the central compound of the modern field; the largest evidence base; the regulatory bellwether through Compass COMP360, Usona PSIL201, Cybin CYB003 (deuterated analogue), Reunion luvesilocin (RE104, O-glutaryl psilocin prodrug), and Filament Health PEX010 (botanical).
• N,N-DMT (Chs II, IV): receptor biology and acute-state imaging; the IV-infusion clinical programmes (atai VLS-01, Small Pharma SPL026, Algernon AP-188) treated only at the pharmacology and pharmacokinetic level, since clinical efficacy data at registrational scale remain pending.
• LSD (Chs II, V, VIII, IX): the Basel pharmacokinetic programme; the Holze 2023 anxiety trial; MindMed MM120 in GAD; microdosing literature; fluoroethyl-lysergamide grey-market analogues.
• 5-MeO-DMT (mebufotenin) (Chs II, III, VII, X): the GH Research GH001 and AtaiBeckley BPL-003 Phase 2b programmes; the distinctive pharmacokinetic envelope; the 1980s neoshamanic origin of contemporary toad-secretion ceremony.
• Fluoroethyl lysergamides (Ch VIII): FLUORETH-LAD, FP-LAD, and the 1Fe-LSD ferrocenyl naming collision; grey-market epistemics; no clinical evidence base.

Four dimensions of emphasis structure the report: clinical evidence (Chs V, VI, VII, IX); mechanism and receptor biology (Chs II, III, IV); regulation and policy (Chs I, XI); methodology, ethics and Indigenous reciprocity (Chs X, XII).

Out-of-scope material. The following received only sidebar treatment and should not be read from this report:

• Ibogaine. Two-paragraph note in Ch VI §6.6, principally on the Stanford magnesium-ibogaine TBI work (Cherian 2024) and the DemeRx development programme; no chapter audits ibogaine’s clinical evidence in depth, and its 5-HT2A independence places it outside the report’s central pharmacological frame.
• Ketamine and esketamine. Sidebar in Ch V §5.6 as a comparator anchor for psilocybin TRD effect size and durability. The independent ketamine literature is large, mature, and beyond this review’s scope.
• Mescaline. One paragraph in Ch I on the historical record; no clinical chapter; the modern clinical pipeline is sparse.
• MDMA and MDMA-AT beyond Lykos. The MAPP1/MAPP2 programme is treated as a clinical-trial case study (Ch VI §6.2), regulatory-process narrative (Ch XI §11.2), and methodology-and-ethics forensic case (Ch XII §12.8–9). The broader MDMA-AT clinical evidence base is not separately reviewed.
• Ayahuasca clinical evidence. Indigenous use, the Brazilian syncretic religions, and the diaspora are treated ethnographically in Ch X §10.6; the clinical literature on ayahuasca-assisted treatment is not separately audited.
• Salvinorin A and the 2C-x phenethylamines. Not covered.

Freeze date. 13 May 2026. Events after this date are out of scope of the body of the report; §13.5 below is the placeholder for added-in-proof material.

These boundaries are real. A reader looking for a comprehensive psychedelic-pharmacology audit will find this report substantial on classical-serotonergic-5-HT2A pharmacology and uneven on adjacent classes. That is the trade-off the scope made.

13.2 Convergent findings

Five findings recur across chapters with mutually reinforcing evidence.

Neuroplasticity has become the dominant mechanistic frame. The intracellular-5-HT2A thesis from the Olson laboratory (Vargas et al., Science 2023) has been adopted across Chs III and IV as the best current account of how classical psychedelics produce effects extending beyond the acute trip. Lipophilic ligands cross the neuronal membrane to engage intracellular 5-HT2A pools on Golgi/ER membranes; serotonin itself, being charged and membrane-impermeant, cannot do this — which is why SSRI-induced 5-HT elevation does not produce psilocybin-comparable dendritic-spine growth. The cascade (TrkB/mTOR/BDNF) is the same cascade implicated in ketamine’s rapid antidepressant action, placing psychedelics within a broader “psychoplastogen” class. The empirical rodent foundation is Ly 2018 (Cell Reports), Shao 2021 (Neuron; single 1 mg/kg psilocybin produces persistent spine remodelling), and Vargas 2023; the human bridge runs through Daws 2022, Doss 2021, Siegel 2024 and Lyons 2026.

Psilocybin’s TRD effect is statistically robust, clinically modest, and replicated. Compass COMP005 reported a placebo-adjusted MADRS reduction of −3.6 points (95% CI −5.7 to −1.5) at Week 6 (June 2025); COMP006 replicated at −3.8 (95% CI −5.8 to −1.8; February 2026). The 25 mg arm’s separation from active control is small on a 60-point scale but durable through Week 26 in responders. The effect is substantially smaller than Phase 2 estimates (COMP001’s −6.6; Davis 2021 and Raison 2023 reporting −12 to −13 in MDD), consistent with regression toward truth under larger and more representative samples. Triangulation against the meta-analytic literature (Metaxa & Clarke 2024, BMJ: g ≈ 0.66, I² ≈ 60–70%) places psilocybin meaningfully above the conventional-antidepressant Hedges’ g of 0.30–0.40 but not in transformative territory.

Master comparison table — flagship trials in mood/anxiety indications.

Notes. (i) NNTs are computed from response-rate differences where the trial reported both arms; “n/r” indicates the comparator response rate is not in the public record. (ii) Several trials report effect sizes in the d > 1 range that are not in this table’s “placebo-adjusted Δ” column because they reflect within-subject pre-post change, not placebo-adjusted between-group differences. (iii) RoB 2 ratings are derived from the §12.1a signalling-question table where available; otherwise from §12.1 narrative. (iv) “Durability” refers to the longest follow-up window with disclosed outcome data; OLE-conditional figures are flagged in §13.2 footnote.

The cross-trial pattern that emerges from the table: NNTs for response cluster in the 2–10 range, with the 5-MeO-DMT IDR (NNT=2), MAPP1/2 MDMA-AT (NNT 3–5), and Phase 2 single-site MDD trials (NNT 2–3) on the favourable end, and the Phase 3 psilocybin TRD effects (NNT 6–9) and esketamine (NNT ~9) on the more modest end. The pattern correlates with effect size and therapy-frame intensity (see Ch XII §12.3 therapy-hour gradient analysis). The Phase 3 readouts for MM120 (H2 2026), CYB003 (PARADIGM), BPL-003 (Q2 2026), and GH001 (post-publication) will test whether the favourable single-site Phase 2 numbers replicate at population scale; the prediction from regression-to-the-mean and the Goldberg-vs-Metaxa heterogeneity literature is that they will shrink toward the COMP360 Phase 3 range.

Functional unblinding is a universal, structural limitation. Across every flagship trial in Chs V, VI, VII, IX and XII, ≥85% of active-arm participants correctly identify their assignment, often within an hour of dosing. Active comparators (1 mg psilocybin; 25 µg LSD; 0.3 mg BPL-003; niacin; diphenhydramine) attenuate but do not solve the problem. Ch XII’s Cochrane RoB 2 assessment rates every flagship study “high risk” on D4 (measurement of outcome) for this reason alone. The implication is not that the evidence is invalid but that published point estimates are upper bounds, with the gap between them and the true pharmacological effect uncharacterised.

Expectancy is a legitimate psychological mechanism in microdosing. Ch IX’s central conclusion — derived from Szigeti 2021, Cavanna 2022, de Wit/Molla 2022, and the Polito & Liknaitzky 2024 synthesis — is that placebo-controlled trials of LSD and psilocybin microdosing have largely failed to dissociate active from placebo on the outcomes that matter to users (mood, cognition, creativity). The honest framing is neither “microdosing works” nor “microdosing is sham.” Expectancy is a real, well-characterised psychological mechanism; observational reports of benefit are not hallucinated. The microdosing case is best read as a structural reminder that drug + context produce a single combined effect, and that controlled designs which strip the context can also strip much of the effect.

Mebufotenin (5-MeO-DMT) occupies a distinctive pharmacodynamic niche. Across Chs II, III and VII, mebufotenin is characterised by an inverted 5-HT1A/5-HT2A affinity ratio relative to psilocin (~1:10 versus ~1:100), an exceptionally fast inhaled/intranasal pharmacokinetic envelope (peak in under two minutes; total subjective duration 15–60 minutes depending on route), and a qualitatively distinct “white-out” non-visual peak. The clinical consequence is operational: a 30-minute experience fits outpatient psychiatric infrastructure more readily than the 6–8 hour psilocybin or LSD experience, but the same compressed window makes inert-placebo blinding essentially impossible. GH001’s −15.5 placebo-adjusted MADRS effect (Ch VII) is the largest reported in any psychedelic depression trial and warrants Phase 3 replication under adequately blinded design before being treated as a population-level estimate.

13.3 Open questions

Five questions appear repeatedly across the chapters and remain unresolved.

Durability beyond six months. Compass has reported COMP005/006 durability through Week 26; Cybin has reported 12-month follow-up in n=12 evaluable patients. No publicly disclosed durability data extend to 18–24 months at population scale (Ch V §5.8). The single-dose paradigm’s pharmacoeconomic case is conditional on this number; if the relapse rate at 18 months approaches the natural-course rate of TRD, the model shifts toward maintenance dosing — which itself raises the chronic-5-HT2B-agonism question (Ch IX §9.7) that is at present unanswered by any prospective human data.

Do non-hallucinogenic 5-HT2A agonists work clinically? — the decoupling-of-experience-from-effect question. Ch III’s central frontier and Ch IV’s closing paragraph both turn on this. IHCH-7086 and IHCH-7113 (Roth lab, β-arrestin-biased), AAZ-A-154 and DLX-001/zalsupindole (Delix Therapeutics, isotryptamine partial agonists), tabernanthalog (Olson lab, ibogaine analogue), and MM402 (R-LSD enantiomer) produce psilocybin-comparable rodent dendritic-spine growth without head-twitch response. DLX-001’s FDA Phase 2 IND clearance with at-home administration design (October 2025) is the most significant translational signal. The decoupling question can be framed sharply: the subjective experience could be (a) mechanistically necessary — the experience is what produces the therapeutic effect; or (b) mechanistically epiphenomenal — the receptor engagement produces both the experience and the therapeutic effect via the same downstream cascade, but only the cascade is necessary; or (c) mechanistically additive — receptor engagement contributes some baseline therapeutic effect; the subjective experience and its psychological-flexibility / predictive-prior-update consequences contribute additional therapeutic effect. The empirical test is whether non-hallucinogenic 5-HT2A agonists replicate clinical efficacy at population scale. If yes (frame b or large-component-of-c), the field’s central decoupling question is resolved in favour of the molecular-plasticity account, and the registrational pathway can in principle proceed without the experiential template. If no (frame a or large-component-of-c on the experiential side), the subjective experience and the set-and-setting frame around it must be mechanistically necessary or substantially load-bearing — and the labelled-therapy-component pathway becomes the only honest regulatory framing. The 2026–2028 readout cycle for DLX-001, IHCH-7086/7113, and the Olson-lab compounds is what will settle this.

How to design trials that survive functional unblinding. Ch XII §12.10 lists the minimum reforms: pre-registered blinding diagnostics; pre-registered expectancy measurement; active comparators; auditable rater blinding; independent ethics oversight; standardised harms reporting; pre-registered ITT on pooled analyses. The next-generation registrational programmes will face this as a binding constraint, not an aspirational note. The regulatory science of psychedelic-specific blinding is itself a research agenda.

How to operationalise Indigenous reciprocity structurally rather than as PR. Ch X §10.7 makes the case that reciprocity is a corrective to a default of asymmetric extraction, not a generous addition to a neutral baseline. The Celidwen 2022 Lancet Regional Health – Americas eight-principle framework (Reverence, Respect, Responsibility, Relevance, Regulation, Reparation, Restoration, Reconciliation), the Chacruna Institute’s Indigenous Reciprocity Initiative of the Americas (IRIA) programme, the Pronovost-Morgan / Aday et al. ReSPCT 2025 Nature Medicine consensus on extra-pharmacological reporting, Journey Colab’s equity allocation, and the Psychae Institute reciprocity protocols are the substantive examples. The commercial-stage developers (Compass, Lykos, atai, GH, MindMed, Cybin) have, to public knowledge, no structural reciprocity commitments tied to revenue rather than philanthropy. The per-molecule structural-obligation accounting in Ch X §10.7 makes the chain auditable: psilocybin’s knowledge derivation through Wasson’s 1955 Mazatec-velada participation and Hofmann’s 1957–58 isolation; ayahuasca/DMT components’ derivation through Schultes’ Amazonian ethnobotany; 5-MeO-DMT’s derivation through both Amazonian yopo traditions and (separately, contested) the 1980s-fabricated Comcáac/Seri toad lineage; peyote/mescaline’s continuous documented NAC and Wixárika use. Closing the gap requires molecule-specific obligations tied to named source communities: enforceable royalty terms (e.g., a percentage of COMP360 net revenue flowing to CIPREPACMA or successor Mazatec community-institutional recipient); reciprocal-licence obligations encumbering patent portfolios; insurer-side or formulary-side leverage requiring documented reciprocity for reimbursement; and community-led governance over commercial uses. The operational definition of “adequate reciprocity” is properly determined by source communities themselves (Ch X §10.7), not by Western analysts. This is an infrastructure-build, not a PR exercise, and is the largest 5–10-year structural priority for the field beyond the four already-named clinical priorities.

Whether chronic 5-HT2B agonism carries real cardiac risk. The fenfluramine and pergolide precedents (Ch IX §9.7, Ch XII §12.6) establish the mechanism in principle. Tagen 2023 and Rouaud 2024 derive in-silico safety margins that are wide for episodic full-dose use and narrow for chronic microdosing. No echocardiographic prospective cohort of chronic microdosers has been conducted. The natural-experiment denominator — millions of self-reported chronic microdosers globally — has not been studied with cardiac surveillance.

13.4 Five-to-ten year research agenda

A defensible 2026 view of the priorities for the next five to ten years, derived from convergence across chapters:

Adequately-powered active-comparator trials. The Compass and MindMed Phase 3 programmes use sub-perceptual or low-active comparators that constrain but do not eliminate unblinding. The next generation of trials will need to compare to credible psychotherapy alternatives (CPT, PE, MBCT) and to active pharmacology (esketamine; conventional SSRI/SNRI baselines) under registrational power, with pre-specified blinding-success and expectancy moderators. Dismantling designs (psilocybin with versus without the standard preparation/integration package) at registrational scale are overdue.

Mechanistic biomarkers for responders. Ch IV §4.7 catalogues the candidate signatures — Daws 2022’s modularity reduction, Siegel 2024’s persistent hippocampal-DMN decoupling, Lyons 2026’s coupled DTI/modularity change at one month. None has yet been validated as a within-subject predictor of clinical response. Ch V §5.8 lists the pre-treatment-predictor questions (baseline severity, suggestibility, prior psychedelic experience, anxious-distress subtype) as similarly open. A consortium-scale precision-functional-mapping programme in the Siegel 2024 framework, with longitudinal biomarker tracking through 12-month outcomes, would be the field-defining design.

Pharma-analog versus naturalistic-use comparative effectiveness. Ch VI’s Bogenschutz AUD signal, Ch X’s ritual-ayahuasca cohorts (Bouso 2012; Jiménez-Garrido 2020), and Ch XI’s Oregon/Colorado/Australia real-world clinic data sit in different epistemological registers from the registrational RCT corpus, but they are increasingly the only way to answer questions about durability at multi-year horizons, equity of access, and effectiveness outside enriched trial samples. The methodological challenge is to design comparative-effectiveness studies that respect both registers without forcing one into the other’s frame.

Legal/regulatory evolution post-Lykos and post-Compass-NDA. Compass’s Q4 2026 NDA submission is the next regulatory inflection point. The “Schedule I-to-prescription” framing of any approval should be read precisely: an FDA NDA approval is one of two sequential regulatory events (FDA approval + DEA rescheduling rulemaking under 21 U.S.C. §811, operating on different timelines and statutory authorities); the prescription pathway becomes available after DEA rescheduling, which historically lags FDA approval by 3 months (Epidiolex) to multi-year (Marinol, 14 years to Schedule III through serial petitions). The “precedent” framing should also be qualified by what is actually precedential. If approved, the FDA will have set a precedent under three specific conditions: (i) Schedule I-substance approval with structured psychotherapy as labelled component (the Lykos pathway minus the conduct concerns); (ii) a Spravato-analog REMS architecture with extended in-clinic observation, certified-setting infrastructure, and facilitator-training requirements (Ch XI §11.2c); (iii) substantial-evidence-of-effectiveness reasoning under §505(d) that engages whether two same-sponsor same-protocol-family Phase 3 trials constitute independent confirmatory replication (Ch XI §11.2b). The precedent’s reach to Cybin, Usona, Reunion, MindMed, atai/Beckley, and GH Research is conditional on whether their own NDA packages map onto the same three conditions. If rejected on grounds analogous to the Lykos CRL (functional unblinding, expectancy, durability, conduct concerns), the field’s registrational pathway is meaningfully narrower than it appears at present.

A second qualification matters here. The “Schedule I-to-prescription pathway” frames the registrational route as the legitimate translation of these molecules into care — a Western pharmaceutical regulatory framing that excludes alternative legitimate translations operating in parallel: the Mexican regulatory accommodation of Mazatec traditional use of Psilocybe under cultural-heritage doctrine; the Brazilian regulatory accommodation of Santo Daime and UDV ayahuasca; the US Native American Church sacramental-use protection under AIRFA 1994; the Oregon Measure 109 and Colorado Proposition 122 state-services frameworks (which are not prescriber-mediated and not Schedule I-to-prescription); Indigenous-community continuous traditional use under ancestral protocols (Ch X §10.6 and §10.4a). The “Schedule I-to-prescription” framing in this section refers specifically to the FDA-regulated route; the broader regulatory landscape for psychedelic molecules includes multiple legitimate translation paths, of which the FDA route is one. The panel should read this section’s regulatory-evolution framing as bounded by that scope.

Indigenous reciprocity infrastructure. Building the operational layer Ch X §10.7 calls for — enforceable royalty terms tied to specific molecules and source communities; reciprocal licence obligations encumbering patent portfolios; insurer-side or formulary-side leverage requiring documented reciprocity for reimbursement; community-led governance over commercial uses of molecules with documented Indigenous provenance — is a multi-year regulatory and contractual project.

Precision functional mapping of dosing response (Siegel 2024 framework). The Siegel et al. 2024 Nature paper’s within-subject precision-functional-mapping design (~18 MRI visits per participant) is, at present, the highest-resolution human imaging method available for dose-response questions in psychedelic neuroscience. Scaling this design to multi-compound, multi-dose, longitudinal designs across responder and non-responder subgroups would substantially refine the candidate-biomarker question.

Regulatory science of psychedelic-specific blinding. The Aday 2022 design checklist, the Muthukumaraswamy 2021 framework, the Szigeti & Heifets 2024 expectancy review, and the Wen 2024 systematic review collectively establish the diagnostic instruments. What is missing is FDA / EMA / MHRA-aligned guidance on what counts as adequate blinding in a substance-class where ≥85% functional unblinding is structurally unavoidable. The regulatory-science research programme on psychedelic blinding is itself overdue.

13.5 Added in proof

This section is reserved for events occurring after the 13 May 2026 freeze date that the user may wish to incorporate at delivery time. Examples that could populate this section, depending on timing: Compass NDA submission (Q4 2026 planned); GH001 Phase 3 initiation; DLX-001 Phase 2 readout; MM120 Phase 3 (Voyage, Panorama) topline (expected H2 2026); EMP-01 Phase 2 readout (Feb 2026 — within freeze); Cybin PARADIGM Phase 3 progress; Reunion luvesilocin Phase 3 launch; further state ballot measures in 2026 cycles; EU EMA actions; UK MHRA pilot evaluation; Czech / German implementation milestones; Indigenous reciprocity programme launches; further Lykos Phase 3 protocol development.

Per the freeze convention adopted in §13.1, the body of this report makes no claim about events past 13 May 2026. Any item added here should be flagged with the date of the underlying event and the source.

13.6 Concluding statement

The honest summary of the psychedelics field as of mid-2026 is the one this report has earned: it is neither the revolutionary breakthrough some predicted in 2018 nor the failed paradigm Lykos’s August 2024 collapse threatened to make it.

What it is, in 2026, is a serious clinical and regulatory enterprise — with two replicated Phase 3 readouts in psilocybin TRD, mature pipelines in GAD, postpartum depression and mebufotenin TRD, mechanistic convergence on a neuroplasticity model with a candidate molecular substrate, and a small but real adult-use regulatory infrastructure across Oregon, Colorado, Australia, Czechia, Germany, and Canada — operating under significant methodological challenges that the field has not yet solved. Functional unblinding remains structurally unavoidable. Effect sizes are real but modest. The molecule-versus-context decoupling question is unresolved, and the non-hallucinogenic-5-HT2A frontier (Olson’s Delix DLX-001 isotryptamine class; Roth’s IHCH-7086/7113 β-arrestin-biased compounds; MM402 R-LSD enantiomer; tabernanthalog) could revise the field’s central premises if it succeeds clinically — if a non-hallucinogenic 5-HT2A agonist replicates psilocybin-class clinical efficacy without the subjective experience, the experiential template is shown to be mechanistically dispensable; if it does not, the experience itself, and the cultural-and-clinical frame around it, must be doing load-bearing therapeutic work and the registrational pathway must price this in. The clinical and regulatory enterprise described in this report rests, demonstrably, on knowledge first developed by Indigenous communities in Mesoamerica and Amazonia — Mazatec, Wixárika, Shipibo-Conibo, the Native American Church communities, and others — and the structural reciprocity gap between the multi-billion-dollar commercial sector and these source communities is, presently, the largest such gap in the field’s short history. Building the reciprocity infrastructure — enforceable royalty terms, reciprocal-licence obligations on patent portfolios, insurer-side leverage, community-led governance — is the 5–10-year priority the field has not yet committed to.

The Lykos episode is correctly read not as the field’s collapse but as a focusing event: it crystallised concerns that had circulated in private correspondence for years and reset the discursive baseline against which subsequent claims would be judged. Compass’s COMP005/006 readouts have advanced under that revised baseline, which is the right way to read both their statistical robustness and their clinically modest magnitude. The bifurcation between the medical pathway and the state-services pathway has hardened; whether it stabilises into productive division of labour or hardens into mutual delegitimisation is the open question against which the next five years should be evaluated.

The posture appropriate to a domain expert in 2026 is sober, evidence-graded, and structurally honest about what the controlled literature does and does not establish. That is the posture this report has attempted, across twelve drafted chapters, to model.

A reflexive acknowledgment on the report’s evidentiary base. This report is a Western academic synthesis, and its evidentiary base is constructed primarily from Western academic and industry sources — the same demographic and institutional composition the report itself critiques in Ch X §10.8. The post-2010 psychedelic-research literature is dominated by a relatively small set of investigators (Carhart-Harris, Olson, Griffiths, Nutt, Doblin, Goodwin, Liechti, Vollenweider, Roth, Davis, Aday, Szigeti, Muthukumaraswamy, Yaden, Reckweg, Hauskeller, Williams, and the journal corpus they publish in), and a 55,000-word synthesis necessarily draws from that domination. The report cites Indigenous-authored work where it exists (Celidwen et al. 2022; Acosta López, García Flores & Piña Alcántara 2020/2021; Williams et al. 2022 in which González Romero is a contributing Indigenous scholar) but the citation density is unavoidably weighted toward Western anthropologists writing about Indigenous practice rather than Indigenous practitioners and scholars writing in their own voice. The report’s structural critique of the field’s demographic composition is thereby made from within sources of that composition. The honest acknowledgment is that the field would benefit from parallel and successor reviews authored by — or substantively co-authored with — practitioners and scholars from the source communities themselves: Mazatec scholars on psilocybin and the velada; Wixárika and NAC scholars on peyote and mescaline; Shipibo-Konibo and other Amazonian scholars on ayahuasca, DMT, and yopo; Brazilian Daimista/UDV scholars on the syncretic religions and their globalisation; and broader Indigenous-studies scholars on the structural-political dimensions of psychedelic commercialisation. Such reviews would reach materially different conclusions on at least the questions of plant-teacher ontology as explanatory frame, community-validation versus clinical-trial validation as evidence standards, the proper governance of post-marketing safety data on molecules with documented Indigenous antecedents, and the framing of “vulnerable populations” beyond the medically-narrow Western category. The scoping choice this report made — to operate within the Western-scientific evidentiary frame for a clinical and regulatory audience — is defensible, but the limitation is inherent to the choice, and the panel should weigh the report’s findings with that limitation in view.

References

This synthesis chapter draws on the full reference apparatus of Chapters I–XII; please consult those chapters for the underlying primary sources. The integrator will merge all chapter references into a master references.md at delivery time. No new citations are introduced in this chapter.

← Ch. XII · Overview · Overview →