The claim that doctors (and the regulatory/medical establishment) knew about the risks of sodium valproate during pregnancy, while patients were not informed, is well-supported by multiple official and independent sources. **Key evidence:** 1. **MHRA's own official documentation** states: "Since the general marketing of valproate in 1974, the product information for doctors has included a warning about the possible risk of birth defects after in utero exposure (in pregnancy)." (Source: MHRA/GOV.UK report on valproate safety) 2. **The Cumberlege Review ("First Do No Harm", July 2020)** — Baroness Cumberlege stated: "Sodium valproate has been licensed in the UK since 1972. It was known from the very beginning that it is harmful to unborn children. No one disputes that." The review also found that "Health professionals do not inform them of the risks, regulators have not done enough to make them do so." 3. **The IMMDS Review timeline** shows that from 1973, the Committee on Safety of Medicines (CSM) communicated teratogenic risks to doctors through "Dear Doctor" letters and data sheets. Crucially, in 1973, the CSM explicitly decided warnings should "not (go) on the package inserts, so that there would be no danger of patients themselves seeing it" — to avoid "fruitless anxiety." 4. **The Guardian (September 2017)** reported: "Birth defect risks of sodium valproate 'known 40 years ago'" and that regulators deliberately kept warnings from patients. 5. **Patient group submissions to the IMMDS Review** note that while clinicians received more information than patients, there were also "significant omissions in the information provided to clinicians over time," and the full extent of risks evolved over decades. However, the basic teratogenic risk was known and communicated to doctors from the 1970s onward. **Nuance:** While the core assertion is accurate — the medical and regulatory establishment was aware of the risks from the early 1970s and information was communicated to doctors through official channels, while patients were deliberately not informed — there is some qualification: the full extent of the risks (particularly neurodevelopmental effects) became clearer over time, and patient groups argue that clinicians themselves were not given complete information by the manufacturer and regulator. However, the fundamental claim that doctors knew about the risks while patients were not informed is well-supported by multiple official and independent sources. Sources: - MHRA/GOV.UK, "Valproate: review of safety data and expert advice on management of risks," https://assets.publishing.service.gov.uk/media/65660310312f400013e5d508/Valproate-report-review-and-expert-advice.pdf - IMMDS Review, "Sodium Valproate Timeline – Key Events," https://www.immdsreview.org.uk/downloads/Annexes/Annex-C-Valproate-timeline.pdf - IMMDS Review, "First Do No Harm" (Cumberlege Review), https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf - IMMDS Review, Patient Groups submission on Sodium Valproate, https://www.immdsreview.org.uk/downloads/Evidence/FOR%20PUBLICATION%20-%20Patient%20Groups%20-%20Sodium%20Valproate.pdf - The Guardian, "Birth defect risks of sodium valproate 'known 40 years ago'," https://www.theguardian.com/society/2017/sep/26/sodium-valproate-birth-defect-risks-known-40-years-ago-campaigners - Patient Safety Commissioner, "The Hughes Report," https://www.patientsafetycommissioner.org.uk/our-work/redress/ - House of Commons Library, "Pelvic mesh and sodium valproate," https://commonslibrary.parliament.uk/research-briefings/cbp-10487/