FOI release
Access to Documents Regarding Biological Evidence
Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.
Case reference FOI2026/00111
Received 3 February 2026
Published 23 March 2026
Request
I am writing to request access to information under the Freedom of Information Act 2000 regarding the evidence base for psychiatric diagnoses and pharmacological treatment as classified in: * ICD-10, Chapter F00-F99 (Mental and Behavioural Disorders) * ICD-11, Chapter 06 (Mental, Behavioural or Neurodevelopmental Disorders) * DSM-5 (where applicable) To avoid unnecessary document production and ensure clarity, I am requesting only clear YES/NO answers to the questions below, along with - where relevant - document titles, dates, and document types. I am not requesting document delivery at this time. A. EVIDENCE BASE (Causation and Causal Treatment) 1. Measurable Biological Cause Does MHRA possess documentation of measurable biological causes (e.g., biomarkers, laboratory measurements, neurochemical indicators, or imaging diagnostics) that can diagnose one or more psychiatric disorders in ICD-10/ICD-11/DSM-5 on a biological basis? Answer: YES / NO If YES, please provide: Document title, date, and type 2. Causal Treatment Does MHRA possess documentation that pharmacological treatment used for psychiatric disorders corrects or normalizes a demonstrated biological cause of these disorders? Answer: YES / NO If YES, please provide: Document title, date, and type 3. Clinical Threshold Values Does MHRA possess documents with clinical normal or threshold values for biological parameters (e.g., neurotransmitters, hormones, or other measurable substances) that are used to define disease thresholds for psychiatric diagnoses in ICD-10/ICD-11/DSM-5? Answer: YES / NO If YES, please provide: Document title, date, and type 3B. Prescription Thresholds for SSRI/Psychiatric Medication Does MHRA possess documentation establishing minimum and/or maximum threshold levels (biological markers, severity scores, or measurable parameters) that determine when SSRI or other psychiatric medication should be: * Initiated (minimum threshold for prescription) * Discontinued (maximum/recovery threshold) * Adjusted in dosage Answer: YES / NO If YES, please provide: Document title, date, and type Supplementary question: If no measurable thresholds exist, does MHRA possess documentation explaining the clinical decision-making criteria used to determine when medication is indicated versus when it should be discontinued? Answer: YES / NO If YES, please provide: Document title, date, and type 4. Correction Documented by Measurements Does MHRA possess documentation that psychiatric medication corrects a demonstrated biological abnormality, documented by measurements before and after treatment, for diagnoses covered by ICD-10/ICD-11/DSM-5? Answer: YES / NO If YES, please provide: Document title, date, and type 5. Children's and Adolescents' Neurobiology Does MHRA possess documentation of what psychiatric medication does to a normal, developing brain in children and adolescents, including any long-term neurobiological consequences, in relation to psychiatric diagnoses in ICD-10/ICD-11/DSM-5? Answer: YES / NO If YES, please provide: Document title, date, and type 5B. Rationale for Not Testing Before Prescribing Does MHRA possess documentation or scientific rationale explaining why serotonin levels (or other relevant neurotransmitter levels) are not measured or tested before prescribing SSRI, SNRI, or other psychiatric medications that are purported to affect neurotransmitter function? Answer: YES / NO If YES, please provide: Document title, date, and type Supplementary question: If such testing is deemed unnecessary, does MHRA possess documentation explaining how treatment can be considered causal or corrective without baseline measurements? Answer: YES / NO If YES, please provide: Document title, date, and type 5C. Treatment Duration and "Cure" Criteria Does MHRA possess documentation establishing: * The expected duration of psychiatric medication treatment required to "cure" or resolve the underlying biological abnormality * Criteria for determining when the biological cause has been successfully corrected and medication can be safely discontinued * Evidence-based protocols for distinguishing between "treatment completion" and "lifelong treatment requirement" Answer: YES / NO If YES, please provide: Document title, date, and type 5D. Dependency, Tolerance, and Withdrawal Does MHRA possess documentation addressing: * Whether psychiatric medications (particularly SSRI/SNRI) create physical dependency or neuroadaptation * Documented withdrawal syndrome profiles and their distinction from "relapse" or "return of original symptoms" * Guidelines for differentiating between: (a) withdrawal symptoms, (b) rebound effects, and (c) return of underlying condition * Expected timelines for neurobiological normalization after medication cessation Answer: YES / NO If YES, please provide: Document title, date, and type 5E. Diagnostic Stability and Medication Effect Does MHRA possess documentation examining: * Whether psychiatric diagnoses remain stable or change when patients are medication-free versus medicated * Studies tracking whether the same patients receive different diagnoses when assessed off-medication versus on-medication * Evidence for whether psychiatric medications affect the diagnostic process itself (i.e., whether medicated brain states create different symptom profiles that lead to different diagnoses) Answer: YES / NO If YES, please provide: Document title, date, and type 5F. Comparative Efficacy: Medication vs. Natural Recovery Does MHRA possess documentation comparing: * Long-term outcomes (5+ years) for medicated patients versus unmedicated patients with the same initial diagnoses * Natural recovery rates without pharmaceutical intervention * Studies examining whether early medication intervention improves, worsens, or has no effect on long-term outcomes compared to delayed intervention or no medication Answer: YES / NO If YES, please provide: Document title, date, and type 5G. Mechanism of Action Verification Does MHRA possess documentation demonstrating: * The actual mechanism by which SSRI/SNRI medications produce clinical benefits (if the serotonin deficiency hypothesis is not supported) * Alternative explanatory models for how these medications work if not through correcting a measurable biological deficiency * Evidence distinguishing between "mechanism of drug action" (how the drug affects the brain) and "mechanism of therapeutic effect" (why that action produces symptom reduction) Answer: YES / NO If YES, please provide: Document title, date, and type 5H. Placebo-Controlled Long-Term Studies Does MHRA possess documentation of: * Placebo-controlled studies extending beyond 12 weeks for psychiatric medications * Long-term (1+ year) randomized controlled trials comparing medication to placebo * Studies examining whether initial placebo-medication differences persist, diminish, or reverse over extended treatment periods Answer: YES / NO If YES, please provide: Document title, date, and type 5I. Informed Consent and Biological Uncertainty Does MHRA possess documentation or guidelines addressing: * How clinicians should inform patients about the absence of biological testing before psychiatric medication prescription * Required disclosures about the unproven nature of the biological basis for psychiatric diagnoses * Standards for informed consent when prescribing medications that alter brain chemistry without prior measurement of brain chemistry * Guidance on explaining to patients that psychiatric medications are prescribed based on symptom reports rather than biological measurements Answer: YES / NO If YES, please provide: Document title, date, and type 5J. Polypharmacy and Drug Interactions Does MHRA possess documentation regarding: * Evidence base for combining multiple psychiatric medications (e.g., SSRI + antipsychotic + mood stabilizer) * Studies demonstrating that combined psychiatric medications are more effective than monotherapy for specific measurable biological abnormalities * Guidelines for determining which biological markers indicate need for polypharmacy versus monotherapy * Long-term neurobiological effects of psychiatric polypharmacy, particularly in developing brains Answer: YES / NO If YES, please provide: Document title, date, and type 5K. "Treatment-Resistant" Patients Does MHRA possess documentation explaining: * Why some patients are labeled "treatment-resistant" if the medication is supposed to correct a biological deficiency (i.e., why would correcting a deficiency fail in some patients?) * Whether "treatment resistance" indicates the absence of the purported biological abnormality in those patients * Biological markers that distinguish "treatment-resistant" from "treatment-responsive" patients before treatment begins * Whether "treatment resistance" might indicate that the underlying causal model is incorrect Answer: YES / NO If YES, please provide: Document title, date, and type B. TREATMENT PROTOCOLS AND TREATMENT STANDARDS 6. Diagnosis-Specific Treatment Protocols Does MHRA possess standardized treatment protocols, treatment pathways, algorithms, flowcharts, or instructions linked to specific ICD-10 and/or ICD-11 diagnoses? Answer: YES / NO If YES, please provide: Document title, date, and type 7. Pharmacological Treatment Protocols Does MHRA possess documents describing initiation, dosing, dose adjustment, monitoring, treatment duration, and discontinuation of psychiatric medication per diagnosis? Answer: YES / NO If YES, please provide: Document title, date, and type 8. Age-Differentiated Protocols Does MHRA possess separate treatment protocols or instructions for children, adolescents, and adults? Answer: YES / NO If YES, please provide: Document title, date, and type 9. Combination Treatment Does MHRA possess protocols or standards for combining pharmacological and psychological treatment? Answer: YES / NO If YES, please provide: Document title, date, and type 10. Treatment Follow-up and Effect Monitoring Does MHRA possess documents describing how treatment effect, side effects, deterioration, and dropout are monitored and documented? Answer: YES / NO If YES, please provide: Document title, date, and type 11. Update and Revision Basis Does MHRA possess documents specifying when and on what professional basis existing treatment protocols are revised? Answer: YES / NO If YES, please provide: Document title, date, and type REQUEST SPECIFICATION I am requesting only a clear confirmation of whether the above documentation exists or does not exist in MHRA's possession, in accordance with Freedom of Information Act 2000. If documentation does not exist, I request an explicit confirmation of this fact. I prefer to receive the response in electronic format. BACKGROUND AND PURPOSE This request is part of research into the evidence base for psychiatric treatment recommendations across different national health authorities. The purpose is to understand what documented biological evidence exists for psychiatric diagnoses and whether current pharmacological treatments have documented causal mechanisms.
Response
See attached
Documents
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