Evidence that the World Organization’s Decision to Exclude Methylphenidate from its List of Essential Medicines for Children was Wrong

Although methylphenidate has been used for over 60 years and is recognized for its high efficacy in treating ADHD, the World Health Organization (WHO) has repeatedly excluded it from its list of essential medicines for children.  That decision, which is not consistent with the evidence on methylphenidate limits the availability of this treatment for ADHD, especially in in low and middle-income countries (LMICs). 

The Committee's initial rejection in 2019 was based on doubts about the quality of evidence on the drug's effectiveness and safety, citing a 2015 Cochrane meta-analysis that used a controversial method for assessing evidence quality. Despite a broader evidence base in a second application, supported by numerous professional groups, which showed the drug's benefits in reducing injuries, substance abuse, and criminal acts among ADHD patients, the Committee again rejected its inclusion in 2021. 

They cited the short duration of most supporting randomized controlled trials (RCTs) and their erroneous claim that many methylphenidate RCTs were biased.  That decision was wrong, especially given methylphenidate's proven long-term safety and effectiveness, WHO's own recommendation of the drug for ADHD in another publication and the fact that WHO does not require long-term safety data from RCTs for other medications.  WHO’s decision flies in the face of evidence, harms low-resource families in LMICs, and stigmatizes those with ADHD and the treatments for their disorder.

The application was submitted to the WHO on November 25, 2020 by: 
Stephen V. Faraone, Ph.D.
Tobias Banaschewski, MD, PhD
David Coghill, MB ChB, MD, FRCPsych FRANZCP
Samuele Cortese MD, PhD
Jeffrey H. Newcorn, MD
Patricia Moscibrodzki, MPH 
and Craig L. Katz, MD