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Freedom of Information Requests to Scandinavian and International Health Authorities:

Documented Absence of Biological Evidence for Psychiatric Diagnoses and Treatment

Thomas Fogh Vinter

Generation-Anxiety.com

March 2026

Correspondence period: October 2025 – March 2026

Abstract

This document compiles the full record of Freedom of Information (FOI) requests submitted by the author to health authorities in six countries: Denmark, Sweden, Norway, the United Kingdom, Australia, and the United States. The central question posed to each authority was whether they possess documentation of measurable biological causes for psychiatric diagnoses classified under ICD-10/ICD-11/DSM-5, and whether pharmacological treatments used for these diagnoses have been documented to correct or normalise a demonstrated biological abnormality.

The requests were submitted between October 2025 and February 2026. Completed responses have been received from Denmark (Ministry of the Interior and Health, and the Danish Health Authority/Sundhedsstyrelsen), Sweden (Socialstyrelsen and Läkemedelsverket), and Norway (Helsedirektoratet). The request to the United Kingdom (MHRA) is pending response, the Australian request (TGA) was redirected due to jurisdictional limitations, and the United States (FDA) declined to process the request.

The consistent finding across all completed responses is that none of the authorities contacted possess documentation establishing measurable biological causes for psychiatric diagnoses, clinical threshold values for biological parameters used in psychiatric diagnosis, or evidence that psychiatric medications correct an identified biological abnormality. Every authority that provided a substantive response answered “No” to these core questions. The Danish Health Authority explicitly confirmed “No” to all six targeted yes/no questions regarding biological evidence. The Norwegian Directorate of Health stated that their guidelines do not establish biological diagnostic markers for psychiatric disorders, nor do they contain biomarker-based criteria for initiating, adjusting, or discontinuing psychiatric medication. The Swedish Medical Products Agency (Läkemedelsverket) confirmed that it does not possess documentation of biological markers for psychiatric diagnosis, that no biological parameters are used to determine when psychiatric medication should be initiated, adjusted, or discontinued, and that there is no legal requirement for approval documentation to show that a medication corrects a biological abnormality. The Swedish National Board of Health and Welfare (Socialstyrelsen) answered “No” to all questions regarding biological evidence and referred medication-specific questions to Läkemedelsverket.

These responses, obtained through formal legal channels and documented in official government correspondence, represent a significant body of evidence regarding the current state of biological evidence underlying psychiatric diagnosis and treatment across multiple national health systems.

 

 

Table of Contents

1. Introduction and Methodology
2. Denmark – Ministry of the Interior and Health
3. Denmark – Sundhedsstyrelsen (Danish Health Authority)
4. Sweden – Socialstyrelsen (National Board of Health and Welfare)
5. Sweden – Läkemedelsverket (Medical Products Agency)
6. Norway – Helsedirektoratet (Directorate of Health)
7. United Kingdom – MHRA (Medicines and Healthcare Products Regulatory Agency)
8. Australia – TGA (Therapeutic Goods Administration)
9. United States – FDA (Food and Drug Administration)
10. Summary Conclusion Table
11. Discussion and Implications

   11.1 The Study Duration Paradox

12. Epistemological Framework: From Institutional Absence to Falsification
13. Methodological Framework for Criterion-Based Literature Review

 

 

1. Introduction and Methodology

Between October 2025 and February 2026, the author submitted formal Freedom of Information (FOI) requests to health authorities in six countries. The purpose of these requests was to establish, through official government channels, whether health authorities possess documentation supporting the biological disease model that underpins current psychiatric diagnosis and pharmacological treatment.

Each request asked fundamentally the same set of questions, adapted to the legal framework and institutional structure of each country. The core questions addressed whether the authority possesses: (1) documentation of measurable biological causes for psychiatric diagnoses; (2) clinical threshold values for biological parameters used to define psychiatric conditions; (3) documentation that psychiatric medications correct an identified biological abnormality; (4) documentation regarding the neurobiological effects of psychiatric medication on children and adolescents; and (5) evidence-based criteria for treatment initiation, duration, and discontinuation based on biological measurements.

The methodology was deliberately designed to elicit clear, binary (yes/no) responses from authorities, thereby minimising the potential for evasive or broadly interpretive answers. Where authorities initially responded with general information rather than direct answers, follow-up correspondence was used to clarify and insist upon explicit responses.

The legal frameworks invoked include: the Danish Public Access to Information Act (§§ 7 and 9), the Swedish Offentlighetsprincipen (Public Access to Information), the Norwegian Offentleglova (Freedom of Information Act), the UK Freedom of Information Act 2000, the Australian Freedom of Information Act 1982, and the US Freedom of Information Act.

 

 

2. Denmark – Ministry of the Interior and Health

Authority Contacted

Indenrigs- og Sundhedsministeriet (Ministry of the Interior and Health), Slotsholmsgade 10-12, 1216 Copenhagen V, Denmark.

Date of Request

14 October 2025 (submitted by email).

Questions Posed

The author requested access to documents pursuant to sections 7 and 9 of the Danish Public Access to Information Act regarding the serotonin deficiency theory as a scientific or clinical basis for the use of SSRIs for anxiety and depression. Specifically, the request sought:

(1) Documentation that the serotonin deficiency theory is included in the official evidence base for the approval, marketing, or guidance of SSRIs in Denmark/EU. (2) The scientific sources supporting the claim that SSRIs correct a chemical imbalance or serotonin deficiency. (3) Any internal or external assessments of the serotonin deficiency theory since the year 2000, including changes in its professional status. (4) An account of whether there are approved methods for measuring serotonin levels in the brain of patients, and how deficiency is diagnosed in the absence of such measurement. (5) Information on the ethical or scientific assessments underlying treatment based on a theory that cannot be individually verified. (6) Copy or reference to national or European guidelines describing serotonin deficiency as a documented or probable cause of anxiety/depression.

Authority’s Response

Date: 20 October 2025. Case number: 2025-10398. Respondent: Nancy Husain, Fuldmægtig (Legal Affairs).

The Ministry conducted a search in its electronic journal system for documents containing information of the nature described in the request. The Ministry’s formal response stated:

“The Ministry of the Interior and Health has not identified cases or documents that are covered by your request for access to documents.”

Sub-conclusion: Denmark – Ministry

The Danish Ministry of the Interior and Health confirmed that it holds no documentation regarding the serotonin deficiency theory as a basis for SSRI treatment. The absence was confirmed through a formal search of the Ministry’s journal system. The author subsequently forwarded this response to Sundhedsstyrelsen for further inquiry.

 

 

3. Denmark – Sundhedsstyrelsen (Danish Health Authority)

Authority Contacted

Sundhedsstyrelsen, Islands Brygge 67, 2300 Copenhagen S, Denmark. Contact: Matilde Bredahl Hansen, Fuldmægtig, Evidens og analyser (EVIA). Later: Katrine Stokholm, Specialkonsulent.

Overview of Correspondence Rounds

The correspondence with Sundhedsstyrelsen comprised the most extensive exchange, spanning from 20 October 2025 to 11 February 2026, involving multiple rounds of requests, clarifications, and a formal denial decision.

Round 1: Initial FOI Request (20 October 2025)

The author forwarded the Ministry’s negative response to Sundhedsstyrelsen, asking whether Sundhedsstyrelsen’s own records contain documentation describing serotonin deficiency as a cause of anxiety/depression, whether the serotonin deficiency theory forms part of the regulatory basis for SSRIs in Denmark, whether methods exist for diagnosing serotonin deficiency, and what considerations the authority has made regarding continued use of a treatment model based on an unverifiable theory.

Response (24 October 2025, Matilde Bredahl Hansen):

Sundhedsstyrelsen stated that it has not dealt with causal mechanisms for the development of anxiety and/or depression in its clinical recommendations. The authority relates to treatment effect evidence, not aetiology. Sundhedsstyrelsen has not developed methods or criteria for diagnosing serotonin deficiency in patients. The author was referred to Dansk Psykiatrisk Selskab, Dansk Psykolog Forening, or Danske Regioner for further information.

Round 2: Expanded Request (11 November 2025)

Since Sundhedsstyrelsen had not addressed causal mechanisms, the author submitted an expanded request covering the full evidence base for all recommended treatments for anxiety and/or depression, including: pharmacological treatment (SSRI, SNRI, TCA), the 4–8 week treatment vacuum, psychological treatment methods, combination treatment, diagnostic basis and causal understanding, international reference material, effects on children and adolescents, evaluation and follow-up data, and public communication.

Response (17 November 2025):

Sundhedsstyrelsen asked for clarification, suggesting that the request might only concern publicly available National Clinical Recommendations (NKR).

Author’s clarification (17 November 2025):

The author clarified that the request encompassed all internal and external documents, reports, analyses, emails, notes, and meeting minutes used in the preparation, interpretation, or updating of the mentioned guidelines, not merely the publicly available NKR documents.

Round 3: Delimitation and Focused Questions (20 November 2025)

Following information that approximately 1,000 documents across 7 cases would need to be reviewed, the author voluntarily delimited the request to focus on: (1) Documentation of a measurable cause of anxiety/depression, (2) Documentation that SSRI treatment dissolves or normalises such a cause, (3) Documentation of the treatment vacuum at 4–8 weeks, (4) SSRI effects on children’s neurobiology, (5) Serotonin measurement standards, and (6) SSRI neurobiological effects on immature, non-deficient brains.

Round 4: Sundhedsstyrelsen Sends Documents (1–4 December 2025)

Sundhedsstyrelsen completed its review and sent an official decision along with a large volume of documents via BlueWhale (a secure file transfer system). The authority noted that its National Clinical Recommendations were “under review” (meaning the literature searches were outdated and new evidence may have emerged).

Round 5: Direct Yes/No Questions (5 December 2025)

After reviewing the initial materials, the author found that the documents sent did not address the core questions. The author therefore posed six explicit yes/no questions:

1. Does Sundhedsstyrelsen possess documentation of biomarkers, laboratory measurements, neurochemical indicators, or other biological tests that can diagnose anxiety or depression?
2. Does Sundhedsstyrelsen possess documents showing measurements before and after SSRI treatment confirming that SSRI corrects an identified biological cause?
3. Does Sundhedsstyrelsen possess documents with clinical standards, normal values, or threshold values for serotonin deficiency in anxiety or depression?
4. Does Sundhedsstyrelsen possess studies or internal assessments showing that SSRI normalises serotonin in patients diagnosed with serotonin deficiency?
5. Does Sundhedsstyrelsen possess documents describing what SSRI does to a child’s brain with a normally functioning serotonin system, including long-term consequences?
6. Does Sundhedsstyrelsen possess internal or external assessments showing that the 4–8 week period without effect does not increase suffering, functional impairment, or deterioration, particularly in children and young people?

Response (15 December 2025, Matilde Bredahl Hansen):

Sundhedsstyrelsen provided explicit answers to all six questions:

Question 1 (Measurable biological cause): NO. “Sundhedsstyrelsen has not dealt with causal mechanisms for the development of anxiety and/or depression in its clinical recommendations.”

Question 2 (SSRI normalises biological dysfunction): NO. “Sundhedsstyrelsen has not investigated whether SSRI treatment corrects a biological dysfunction.” The chosen outcome measures in the NKR for anxiety treatment in adults include degree of anxiety symptoms, functional level, serious adverse effects, quality of life, degree of avoidance, improvement, relapse, adverse effects, and dropout rates.

Question 3 (Serotonin threshold values): NO. “This has not been investigated by Sundhedsstyrelsen.”

Question 4 (SSRI corrects serotonin deficiency): NO. “This has not been investigated by Sundhedsstyrelsen.”

Question 5 (Effects on children’s neurobiology): NO. “This has not been investigated by Sundhedsstyrelsen.” The outcome measures for children and young people include remission, patient-reported anxiety symptoms, parent-reported anxiety symptoms, patient- and observer-reported functional ability, dropout, suicidal ideation, suicidal behaviour, and serious adverse events.

Question 6 (Risk profile in 4–8 week treatment vacuum): NO. “This has not been investigated by Sundhedsstyrelsen.”

Round 6: Expanded Request to All Psychiatric Diagnoses (January 2026)

The author subsequently submitted a broader request covering all psychiatric diagnoses in ICD-10 (F00–F99) and ICD-11 (Chapter 06), with 11 structured yes/no questions covering both evidence base and treatment protocols. This request was submitted on 30 January 2026.

Response (11 February 2026, Katrine Stokholm, Specialkonsulent):

Sundhedsstyrelsen denied the FOI request, stating that the request did not meet the thematic specificity requirement of Section 9(1) of the Public Access to Information Act, as it broadly covered documentation about evidence base and treatment protocols for all psychiatric diagnoses under ICD-10 and ICD-11. However, in supplementary remarks, the caseworker confirmed that a search for “documentation + psychiatry” yielded 7,358 documents, but a search for “documentation of measurable biological causes” only yielded documents from the current FOI correspondence itself. The caseworker further stated: “There are no cases with ‘documentation’ in the title that concern diseases or treatment within the psychiatric and/or child and adolescent psychiatric specialty.”

The caseworker also referenced the earlier (December 2025) decision and document delivery regarding anxiety/depression, and reiterated that Sundhedsstyrelsen has not dealt with causal mechanisms for anxiety/depression in its recommendations.

Sub-conclusion: Denmark – Sundhedsstyrelsen

Across multiple rounds of correspondence spanning nearly five months, Sundhedsstyrelsen provided explicit confirmation that it does not possess: documentation of measurable biological causes for anxiety or depression; clinical threshold values for serotonin or other biological markers; evidence that SSRIs correct an identified biological dysfunction; documentation of neurobiological effects of SSRIs on children’s normally functioning brains; or evidence regarding the risk profile of the initial treatment vacuum. The authority explicitly stated it has not investigated causal mechanisms and relates only to symptom-based treatment effect evidence.

 

 

4. Sweden – Socialstyrelsen (National Board of Health and Welfare)

Authority Contacted

Socialstyrelsen, Sweden. Contact: Anne-Katrin Kantzer, Medical Officer.

Date of Request

2 February 2026.

Questions Posed

The same standardised set of questions was submitted as in all other countries, covering measurable biological causes, causal treatment, clinical threshold values, correction documented by measurements, children’s neurobiology, and treatment protocols (Questions A1–A5 and B6–B11).

Authority’s Response

Socialstyrelsen’s Medical Officer, Anne-Katrin Kantzer, responded that many of the topics addressed were not questions for Socialstyrelsen but rather for Läkemedelsverket or for researchers. Socialstyrelsen provides National Guidelines for decision makers in Health Care, which do not contain detailed treatment guidelines or protocols. The authority’s registers provide diagnoses (ICD-10) and prescription of medication but do not provide detailed data on other parameters or outcomes.

Substantive answers to the core evidence-base questions were consistently “No”: Socialstyrelsen does not possess documentation of measurable biological causes, does not possess documentation that pharmacological treatment corrects or normalises a biological cause, does not possess clinical threshold values for biological parameters, and does not perform research studies. For most medication-specific questions, Socialstyrelsen referred the author to Läkemedelsverket.

Sub-conclusion: Sweden – Socialstyrelsen

Socialstyrelsen confirmed it does not possess biological evidence documentation for psychiatric diagnoses and referred medication-specific questions to Läkemedelsverket.

 

 

5. Sweden – Läkemedelsverket (Medical Products Agency)

Authority Contacted

Läkemedelsverket, Box 26, 751 03 Uppsala, Sweden. Contact: Charlotte, Enheten för Effekt och Säkerhet.

Dates of Correspondence

Initial request: 17 February 2026. First response: 11 March 2026. Follow-up questions: 11 March 2026. Final response: 13 March 2026.

Questions Posed

The same standardised questions were submitted. After receiving an initial comprehensive but non-binary response, the author followed up with three focused questions: (1) Does Läkemedelsverket possess documentation describing biological markers that can be used to diagnose psychiatric conditions such as anxiety or depression? (2) Does Läkemedelsverket possess documentation specifying biological parameters used to determine when psychiatric medication should be initiated, dose-adjusted, or discontinued? (3) Does the approval documentation for psychiatric medicines include evidence that a medication corrects or normalises an identified biological abnormality?

Authority’s Responses

First Response (11 March 2026):

Läkemedelsverket provided a detailed overview explaining that: the approval documentation proceeds from medicines, not from diagnoses; both ICD and DSM are “atheoretical” – they express no assumptions about specific biological causes in their diagnostic criteria (with substance-related diagnoses as exceptions); neither legislation nor guidelines require that the aetiology (causes) of a condition be established; the decisive criterion for approval is that the benefits of the effect outweigh the potential risks; for psychiatric medicines, randomised, placebo-controlled, double-blind studies of 4–6 weeks are generally recommended, followed by longer studies; and that the authority does not possess documentation establishing that the causes of psychiatric conditions must be biologically measurable.

Final Response (13 March 2026):

In response to the focused follow-up questions, Läkemedelsverket provided three explicit answers:

1. NO – Läkemedelsverket does not possess documentation describing biological markers, laboratory values, or other measurable biological parameters that can be used to diagnose psychiatric conditions such as anxiety syndrome or depression.
2. NO – Läkemedelsverket does not possess documentation specifying biological parameters, laboratory values, or biomarkers that are used to determine when treatment with psychiatric medications should be initiated, dose-adjusted, or discontinued.
3. NO – There are no legal requirements for approval documentation to include evidence that a medication corrects or normalises an identified biological abnormality. As stated in the previous response, EMA provides guidelines for pharmaceutical companies on how efficacy and safety should be demonstrated for various conditions. These guidelines are not binding, however, neither for EMA nor for the companies. When an approval application is assessed, all data submitted by the company are reviewed, including laboratory research, animal studies, studies in healthy individuals, and studies in patients with the current condition.

Sub-conclusion: Sweden – Läkemedelsverket

Läkemedelsverket provided the most explicit responses of all Swedish authorities, confirming three critical points: no biological diagnostic markers exist for psychiatric conditions in their possession; no biological parameters guide medication initiation, adjustment, or discontinuation; and there is no legal requirement for psychiatric medications to demonstrate correction of a biological abnormality. The authority further stated that psychiatric diagnostic systems (ICD, DSM) are explicitly “atheoretical” regarding biological causation. This does not mean that biological research is absent in psychiatry, but it confirms that the diagnostic frameworks themselves do not presuppose, require, or incorporate specific biological causal mechanisms. The distinction is important: biological research activity is not the same as biological disease documentation integrated into diagnostic criteria.

 

 

6. Norway – Helsedirektoratet (Directorate of Health)

Authority Contacted

Helsedirektoratet, Postboks 220 Skøyen, 0213 Oslo, Norway. Contact: Tone Kaldestad, Seniorrådgiver, Avdeling for fagutvikling i spesialisthelsetjenesten.

Date of Request

3 February 2026.

Questions Posed

The same standardised set of questions was submitted, covering all areas from measurable biological cause through treatment protocols.

Authority’s Response (9 March 2026)

Helsedirektoratet provided a formal written response (reference: 26/3302-2) signed by Børge Myrlund Larsen (spesialrådgiver) and Tone Kaldestad (seniorrådgiver). The response stated:

The Norwegian Directorate of Health provides normative guidance, including national guidelines within the field of mental health. Such guidelines are provided in areas where there is difference of professional opinion or significant variation in practice.

Guidelines issued by the Norwegian Directorate of Health are based on clinical knowledge, service user experiences and research literature, and describe recommended practice, assessment, treatment and follow-up procedures in the health services. They do not establish biological diagnostic markers for psychiatric disorders, nor do they contain biomarker-based criteria for initiating, adjusting, or discontinuing psychiatric medication. The evidence base is presented within each guideline.

The response further noted that the Norwegian Directorate of Health does not engage in research, and referred the author to the Norwegian Institute of Public Health (FHI) for statistics, research, and public health reports on mental disorders.

Sub-conclusion: Norway

The Norwegian Directorate of Health explicitly confirmed that its national guidelines do not establish biological diagnostic markers for psychiatric disorders and do not contain biomarker-based criteria for initiating, adjusting, or discontinuing psychiatric medication.

 

 

7. United Kingdom – MHRA

Authority Contacted

Medicines and Healthcare Products Regulatory Agency (MHRA), 10 South Colonnade, Canary Wharf, London E14 4PU.

Dates of Correspondence

Initial request submitted: 3 February 2026. Acknowledgement received: 3 February 2026 (FOI2026/00111). Initial response: 3 March 2026 (noting cost limit under Section 12). Refined request submitted: 3 March 2026 (narrowed to Fluoxetine or Sertraline). Acknowledgement of refined request: 4 March 2026 (FOI2026/00246, response due by 2 April 2026).

Questions Posed

The initial request contained the full standardised question set. After the MHRA indicated the original scope exceeded cost limits, the author refined the request to focus on a single representative SSRI (Fluoxetine or Sertraline) with four focused questions: (1) Does the MHRA possess documentation identifying a specific, measurable biological abnormality that the medication is intended to correct? (2) Does the MHRA possess documentation demonstrating the medication clinically normalises or balances a pre-existing, measured neurochemical deficiency? (3) Does the MHRA possess documents specifying normal clinical range or threshold values for serotonin levels? (4) Does the MHRA possess documentation explaining the scientific rationale for why diagnostic biological measurements are not required before medication is initiated?

Current Status

As of March 2026, the MHRA’s response to the refined request (FOI2026/00246) is pending, with a statutory deadline of 2 April 2026.

 

 

8. Australia – TGA (Therapeutic Goods Administration)

Authority Contacted

Therapeutic Goods Administration (TGA), Department of Health, Disability and Ageing, PO Box 100, Woden ACT 2606, Australia.

Dates of Correspondence

Initial enquiry: 3 February 2026. TGA clarification request: 5 February 2026. Author’s confirmation of formal FOI: 6 February 2026. Formal acknowledgement: 10 February 2026 (FOI 26-2704). Scope clarification request: 19 February 2026. Refined scope submitted: 20 February 2026 (limited to Fluoxetine, Sertraline, Escitalopram). Jurisdictional limitation notice: 3 March 2026. TGA states documents are outside FOI scope: 4–5 March 2026. Author withdraws FOI request: 5 March 2026.

Key Findings

The TGA informed the author that the earliest records for the requested SSRIs (Fluoxetine: first evaluated 1998; Sertraline: approved 2002; Escitalopram: approved 2001) fell outside the FOI access period, as documents over 20 years old are subject to the Archives Act 1983 rather than the FOI Act. The TGA explicitly stated:

“Our records do not hold the clinical files you are after.” (regarding Fluoxetine)

“We do not have the clinical documents you are seeking.” (regarding Sertraline and Escitalopram)

The documents sought would all be part of the pre-market clinical data submitted with initial applications, and these records have been transferred to the National Archives of Australia.

Sub-conclusion: Australia

The TGA confirmed it does not hold the clinical files or documents requested. While this is framed as a jurisdictional limitation rather than a substantive answer, the practical result is identical: the regulatory authority responsible for approving these medications does not possess, in accessible form, documentation establishing biological causation for the conditions these medications treat.

 

 

9. United States – FDA

Authority Contacted

U.S. Food and Drug Administration (FDA).

Date of Request

3 February 2026. Acknowledgement received with references: FDA-FOIA-2026-1090 and FDA-FOIA-2026-1666.

Questions Posed

The same standardised question set was submitted.

Authority’s Response (11 February 2026)

On 11 February 2026, the FDA’s Division of Headquarters Freedom of Information responded to request FDA-FOIA-2026-1090-DHFI-1 (submitted 6 February 2026). The response, signed by Charis Wilson, PhD, CRM, Denials and Appeals Officer, stated that the request did not adequately describe the records sought under 21 C.F.R. § 20.40(b). The FDA characterised the submission as containing a series of 16 questions requiring yes/no answers, and stated:

“The FDA is not required to answer questions or conduct research in order to respond to a FOIA request. Accordingly, we will be closing our file on this matter.”

The FDA classified the request as “improper” and declined to process it. The author was informed of the right to appeal within 90 days to the Director, Office of Management and Enterprise Services. The author may also contact the Office of Government Information Services (OGIS) for mediation. A second request (FDA-FOIA-2026-1666) was also submitted and acknowledged but has not yet received a substantive response as of March 2026.

Sub-conclusion: United States – FDA

The FDA declined to answer the standardised yes/no questions, stating that FOIA does not require the agency to answer questions or conduct research. This is a procedural refusal, not a substantive response, and therefore cannot be interpreted as either confirming or denying the existence of such documentation. The refusal stands in contrast to the approach taken by Scandinavian authorities, which engaged substantively with the same questions and provided explicit answers. The FDA’s procedural position does not constitute evidence in either direction and is noted here solely for completeness. A second FOIA request (FDA-FOIA-2026-1666) remains pending.

 

 

10. Summary Conclusion Table

The following table summarises the key findings from all completed FOI responses. “No” indicates an explicit negative response. “Pending” indicates the authority has not yet provided a substantive response. “Declined” indicates the authority refused to process the request on procedural grounds. “N/A (Redirected)” indicates the request was redirected due to jurisdictional limitations.

Country / Authority	Biological diagnostic markers?	Biological thresholds for Rx?	Medication corrects biology?	Neuro effects on children?	4–8 week vacuum risk?	Status
DK – Ministry	NO	NO	NO	NO	NO	Completed Oct 2025
DK – Sundheds-styrelsen	NO	NO	NO	NO	NO	Completed Dec 2025
SE – Social-styrelsen	NO	N/A (referred)	NO	NO	N/A	Completed Feb 2026
SE – Läkemedels-verket	NO	NO	NO (no legal req.)	N/A	N/A	Completed Mar 2026
NO – Helsedir.	NO	NO	NO	N/A	N/A	Completed Mar 2026
UK – MHRA	Pending	Pending	Pending	Pending	Pending	Due 2 Apr 2026
AUS – TGA	N/A (Redirected)	N/A (Redirected)	N/A (Redirected)	N/A (Redirected)	N/A	Withdrawn Mar 2026
USA – FDA	Declined	Declined	Declined	Declined	Declined	Declined Feb 2026

 

11. Discussion and Implications

The findings documented in this paper are remarkable not for what they reveal about individual national health authorities, but for the consistency of the pattern across multiple jurisdictions operating under different legal frameworks, different healthcare systems, and different cultural contexts. Every authority that provided a completed, substantive response confirmed the same fundamental reality: no measurable biological cause has been established for psychiatric diagnoses, no biological threshold values exist for determining when psychiatric medication should be initiated or discontinued, and no documentation exists showing that psychiatric medications correct an identified biological abnormality.

These are not fringe claims made by critics of psychiatry. These are the official, documented positions of national health authorities, obtained through formal legal channels designed to compel transparency. The Danish Health Authority’s explicit “No” to six direct questions, the Norwegian Directorate of Health’s statement that its guidelines “do not establish biological diagnostic markers for psychiatric disorders,” and the Swedish Medical Products Agency’s confirmation that both ICD and DSM are “atheoretical” regarding biological causes – all of these constitute formal, government-verified acknowledgements that the authorities responsible for recommending and approving psychiatric treatment do not possess biological evidence meeting the necessary conditions for a documented disease model.

For a patient who has lived with anxiety for many years without finding help in the disease model, these findings carry a different kind of significance. The authorities responsible for issuing the clinical guidelines that govern psychiatric practice have confirmed that the serotonin deficiency hypothesis does not form part of their evidence base, that no biological measurement precedes diagnosis, that no biological correction is documented through treatment, and that no threshold values exist for the biological parameters the treatment is purported to affect. This means that the systemic framework within which patients receive diagnosis and treatment does not rest on the biological evidence that the disease model, as communicated in clinical practice and public health information, implicitly claims. This is not a statement about what any individual clinician has told any individual patient. It is a statement about what the institutional evidence base contains and does not contain.

The implications extend beyond individual patient experience. If the biological basis for psychiatric diagnoses cannot be documented by any of the authorities responsible for approving and recommending treatment, then the diagnostic labels themselves must be understood as descriptive categories based on symptom reports rather than as identified diseases with known biological aetiology. This distinction is not merely semantic. It fundamentally changes the ethical framework within which treatment is offered, consent is obtained, and alternatives are considered.

This document serves as an evidentiary record. It does not argue for the elimination of psychiatric treatment or the abandonment of patients in distress. It argues for honesty – the kind of honesty that these authorities, when asked directly, have now provided on the record.

11.1 The Study Duration Paradox: Approval Studies Shorter Than the Declared Effect Latency

A structural contradiction emerges from the authorities’ own statements when the standard duration of SSRI approval studies is compared with the clinically acknowledged delay before therapeutic effect. Läkemedelsverket confirmed that for psychiatric medications, randomised, placebo-controlled, double-blind studies of 4–6 weeks are generally recommended as the initial evidence base for approval. At the same time, it is broadly acknowledged in clinical practice, and explicitly referenced in the correspondence with Sundhedsstyrelsen, that SSRI medications typically require 4–8 weeks before a clinical effect can be expected. Sundhedsstyrelsen answered “No” when asked whether it possesses documentation showing that this initial period without effect does not increase suffering, functional impairment, or deterioration in patients, particularly in children and adolescents.

The logical problem is straightforward: if a study lasts 4–6 weeks, and the medication is acknowledged to require 4–8 weeks before producing a therapeutic effect, then the study is measuring, at best, the very earliest onset of a potential effect and, at worst, only side effects and placebo response. The study window closes at approximately the same moment the medication is expected to begin working. Any difference between SSRI and placebo observed within this window cannot confidently be attributed to the pharmacological mechanism purported to produce the therapeutic effect, because that mechanism has not yet had sufficient time to operate according to the treatment’s own declared timeline. This observation is grounded in two authority-confirmed sources: Läkemedelsverket’s statement (11 March 2026) that 4–6 week placebo-controlled studies are the recommended standard for psychiatric medication approval, and the EMA’s own guideline on clinical investigation of medicinal products in the treatment of depression (EMA/CHMP/185423/2010 Rev. 2), which Läkemedelsverket directly referenced in its correspondence. The declared effect latency of 4–8 weeks is documented in standard product information (SmPC/SPC) for all major SSRIs approved in the EU and is routinely communicated to patients at the point of prescription.

Several alternative explanations for apparent efficacy within this window must therefore be considered. First, functional unblinding: SSRI medications produce recognisable side effects (nausea, restlessness, sexual dysfunction, sleep disturbance) that allow patients and clinicians to identify whether active medication or placebo has been administered, thereby amplifying placebo response in the active arm. Second, emotional blunting: SSRIs are known to produce a dampening of emotional responsiveness that can be mistaken for symptom reduction on standardised symptom scales, even in the absence of genuine therapeutic improvement. Third, statistical artefact: the effect sizes reported in SSRI trials are generally small (Cohen’s d of approximately 0.3), and when measured within a timeframe shorter than the medication’s own declared effect latency, even these modest differences may reflect measurement noise rather than genuine pharmacological benefit.

The regulatory implications are significant. Läkemedelsverket stated that the decisive criterion for approval is not causal biological correction but that the benefits of the effect outweigh the potential risks. This means the approval standard does not require demonstration that the medication works through the mechanism it is claimed to work through, nor that the study duration is sufficient to capture the full therapeutic effect. It requires only a statistically significant difference at the study endpoint. When that endpoint falls within or before the medication’s own declared effect latency, the evidential value of such studies is fundamentally compromised.

For the patient, this paradox has direct consequences. A person prescribed an SSRI is told that the medication may take 4–8 weeks to work, that side effects during this period are expected and should be endured, and that the treatment is evidence-based. What they are not told is that the studies constituting that evidence base were, in many cases, no longer than the very period they are being asked to endure before the medication is expected to help. The evidence for the medication’s efficacy was gathered within the window during which, by the medication’s own terms, it should not yet be efficacious. This is a structural inconsistency that the authorities contacted in this study have not addressed, and which Sundhedsstyrelsen explicitly confirmed it has not investigated.

 

Author: Thomas Fogh Vinter, Generation-Anxiety.com

Contact: account.dk@gmail.com

Document compiled: March 2026

All correspondence is held in the author’s personal archive and can be provided upon request.

 

 

12. Epistemological Framework: From Institutional Absence to Falsification of Biological Disease Claims

12.1 The Limitation and Its Resolution

A peer review of the present document correctly identified a central methodological limitation: that the absence of documentation within health authorities cannot, by itself, prove the absence of biological evidence in general. This is a valid epistemological point. Freedom of Information responses demonstrate what authorities possess, not what exists across the entire scientific literature.

However, this limitation does not diminish the findings. Rather, it clarifies their scope and points toward the complementary analysis required for a complete assessment. The present chapter outlines the epistemological framework within which the FOI findings and the published research literature can be jointly evaluated.

12.2 Necessary Conditions for a Biological Disease Claim

A claim that a psychiatric condition constitutes a biological disease requires the simultaneous fulfilment of three necessary conditions:

First: Identification of a specific, measurable biological abnormality. This means a parameter such as a neurotransmitter level, receptor density, genetic variant, or neuroimaging correlate that can be identified in individual patients, not merely as a statistical group average.

Second: A defined normal range and pathological threshold. This means clear boundary values that distinguish the normal state from the pathological state, analogous to blood glucose thresholds for diabetes or TSH thresholds for thyroid disease.

Third: Causal correction through treatment. This means documentation that the prescribed treatment changes the identified biological abnormality and that symptom improvement follows this correction, rather than occurring independently of it.

If any one of these conditions is absent, the biological disease claim is incomplete. This is not an arbitrary or unusually strict standard. It is the standard routinely met in other areas of medicine. In endocrinology, hypothyroidism is diagnosed by measuring TSH levels (measurable abnormality), against defined normal ranges of 0.4–4.0 mIU/L (threshold), and treated with levothyroxin, which normalises TSH (causal correction). In haematology, iron deficiency anaemia is diagnosed by serum ferritin levels, against defined thresholds, and treated with iron supplementation that corrects the deficiency. In cardiology, hypertension is diagnosed by blood pressure measurement against defined thresholds and treated with antihypertensives that lower blood pressure. These are not exceptional cases. They represent the baseline standard of biological disease identification across medicine. The present document does not impose a novel standard on psychiatry. It tests whether psychiatry meets the standard that the rest of medicine already fulfils as a matter of routine, and that psychiatry itself implicitly claims to meet when it presents its diagnoses as medical diseases and its treatments as medical interventions.

12.3 Falsification Method

The proof that biological evidence is absent does not arise from demonstrating that nothing exists. It arises from systematically testing every proposed biological mechanism against the necessary conditions and showing that each one fails at one or more points in the chain.

The method proceeds in three steps:

Step 1: Collect all proposed biological causes for a given diagnosis. For depression, these include the serotonin hypothesis, the dopamine hypothesis, the norepinephrine hypothesis, the HPA axis/cortisol hypothesis, the neuroinflammation hypothesis, the BDNF/neuroplasticity hypothesis, amygdala hyperactivity models, and polygenic risk models.

Step 2: Test each proposed mechanism against the three necessary conditions. For each one, ask: Is there an individually measurable abnormality? Is there a defined threshold? Does treatment correct this specific abnormality, and does symptom change follow that correction?

Step 3: When all known and currently proposed candidate mechanisms fail the same structural requirements, the result is not an argument from silence but a documented failure of the biological disease model to meet its own criteria across every available line of evidence. It is acknowledged that this assessment cannot logically preclude the future discovery of a mechanism that satisfies all necessary conditions. However, the burden of proof for such a claim lies with those who assert it. The present framework tests every mechanism that has been proposed, published, and cited in the scientific literature to date. If a mechanism exists that fulfils all criteria but has not yet been proposed or published, it is by definition not part of the current evidence base and cannot be invoked to defend current diagnostic and treatment practices.

12.4 Elimination Rule

The logical structure can be stated formally: If a condition is claimed to be a biological disease, then there must exist a measurable abnormality, a defined threshold, and a causal treatment correction. If none of these can be demonstrated for any proposed mechanism, then the disease definition is not fulfilled. This is not an argument from ignorance. It is a test of necessary conditions, the same logical structure used throughout evidence-based medicine.

12.5 Where the FOI Document Fits Within This Framework

The present FOI document fulfils one essential component of this falsification structure: it demonstrates that the institutions responsible for approving, recommending, and monitoring psychiatric treatment do not possess the biological evidence that the disease model implicitly promises. This is the institutional layer of evidence.

A complete falsification additionally requires a systematic review of the published research literature using the same criteria. The following chapter provides the methodological framework for conducting such a review.

 

 

13. Methodological Framework for Criterion-Based Literature Review

13.1 Purpose

This chapter presents a standardised evaluation framework for assessing whether published biological research in psychiatry fulfils the necessary conditions for biological disease validation. The framework is designed to be applied to systematic reviews, meta-analyses, umbrella reviews, and primary studies across all proposed biological mechanisms for psychiatric diagnoses.

13.2 Review Method

This review framework is designed as a criterion-based falsification review of biological disease claims in psychiatry. The purpose is not merely to identify biological associations, but to test whether published evidence fulfils the necessary conditions for defining a psychiatric condition as a biologically established disease.

The review question is structured as follows: For a given psychiatric diagnosis, does the literature document, first, a specific measurable biological abnormality; second, a defined normal range and pathological threshold; third, a causal relationship between the abnormality and the diagnosis; and fourth, evidence that treatment corrects the identified abnormality such that symptom change follows this correction?

Each proposed biomarker or biological mechanism is assessed against a fixed evaluation matrix. The following criteria are applied to every included source: biological marker proposed, method of measurement, possibility of individual-level measurement, diagnostic specificity, existence of threshold values, evidence of causality versus association, distinction between state and trait markers, evidence of treatment-induced biological correction, relationship between biological correction and symptom change, replication across independent studies, and clinical implementation status.

The review distinguishes strictly between statistical group differences and clinically valid diagnostic markers. Findings are not accepted as evidence of biological disease merely because a biomarker differs on average between groups. To qualify as evidence of disease in a clinically meaningful sense, the marker must demonstrate individual diagnostic applicability, threshold validity, causal relevance, and treatment-linked normalisation.

Systematic reviews, umbrella reviews, and meta-analyses are prioritised over single primary studies in the overall synthesis. Primary studies are included mainly to assess whether recent claims of biomarker progress fulfil the same necessary criteria. Where studies report associations without threshold values, correlations without causation, or biological changes without evidence of diagnostic specificity, such findings are classified as insufficient for establishing a biological disease model.

13.3 Decision Rule

A biological disease claim is considered fulfilled only if all of the following are simultaneously documented: (1) A specific and measurable biological abnormality exists and can be identified at the individual patient level. (2) A normal range and pathological threshold are defined and validated. (3) The abnormality is causally linked to the diagnosis, not merely associated with it. (4) Treatment corrects this specific abnormality. (5) Symptom improvement follows this correction. (6) The finding has been independently replicated and is clinically implementable. If even one link in this chain is absent, the biological disease claim is not documented in the full sense required for clinical validity.

13.4 Standard Evaluation Formulations

The following standardised formulations are used consistently throughout the evaluation:

When a correlation is found without causality: The finding documents an association but does not demonstrate that the marker constitutes a cause of the diagnosis.

When group-level differences lack individual applicability: The study shows average group differences but does not provide a clinically usable diagnostic marker at the individual level.

When no threshold is defined: The study specifies no validated pathological boundary value and therefore cannot serve as a biological disease criterion.

When treatment studies lack biological correction: The study demonstrates symptom change but does not show that treatment corrects a previously identified biological abnormality.

When clinical implementation is absent: The finding appears scientifically interesting but has not been validated for clinical diagnostics or treatment guidance.

13.5 Proposed Application

This framework is designed to be applied initially to three representative diagnoses: major depressive disorder, panic disorder, and generalised anxiety disorder. For each diagnosis, the literature will be reviewed across the following biological domains: neurotransmitter hypotheses (serotonin, dopamine, norepinephrine, GABA), neuroendocrine findings (HPA axis, cortisol), inflammatory markers (cytokines, CRP), neuroimaging correlates (amygdala, prefrontal cortex, default mode network), neuroplasticity markers (BDNF), and genetic/polygenic risk factors.

The evaluation matrix will be completed for each major finding within each domain, and sub-conclusions will be drawn per category before a final synthesis. The anticipated outcome, based on preliminary assessment of the existing literature, is that while biological associations are abundant, the full chain from measurable abnormality to threshold definition, causal linkage, treatment correction, and clinical validation remains incomplete for all reviewed diagnoses.

13.6 Relationship to the Present Document

The FOI findings presented in Chapters 2 through 9 of this document demonstrate that health authorities do not possess biological evidence for psychiatric diagnoses. The framework presented in this chapter provides the methodology for testing whether such evidence exists anywhere in the published scientific literature. Together, these two lines of inquiry, institutional and scientific, constitute a comprehensive assessment of the biological disease model in psychiatry. If neither the responsible authorities nor the published research literature can satisfy the necessary conditions for biological disease validation, then the conclusion is not that biological mechanisms do not exist in any form, but that the biological disease model, as it has been presented to patients, clinicians, and the public, has not been documented to the standard it implicitly claims to meet.