Clinical trials were missing from regulatory documents of extended-release methylphenidate for ADHD in adults: A case study of public documents: author's reply

• Published in: Journal of clinical epidemiology Vol. 145; pp. 183 - 184
• Main Authors: Boesen, Kim, Jørgensen, Karsten Juhl, Gøtzsche, Peter C
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2022; Elsevier Limited
• Subjects: ADHD; Attention deficit hyperactivity disorder; Case reports; Clinical trials; Documents; Drug authorizations; Drug dosages; Epidemiology; Methylphenidate; Population studies; Psychiatry; Regulatory agencies; Systematic review; Drug authorizations; Clinical trials; ADHD; Regulatory agencies; Psychiatry; Methylphenidate
• ISSN: 0895-4356; 1878-5921
• DOI: 10.1016/j.jclinepi.2021.12.021

[...]we refer to the two rejected applications assessed in our study [2]: The Dutch regulator raised concerns over the diagnostic validity (p. 35 and 37) [3] as the pivotal trial participants’ diagnoses had not been “corroborated by a third party”, i.e., confirmed by family members, and the British regulator stated, “There is a major concern over the robustness of diagnosis of ADHD in the population recruited to the studies” (p. 68) [4]. Surveys of adult ADHD patient preferences [5–7] have reported that functional outcomes, i.e., social life and ability to function in school and at work, were ranked most important. [...]we are concerned about Jaeschke's remark about regulatory ‘gate keeping’ and ‘cruelty’ regarding the authorization of ADHD drugs.