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Letters Molnupiravir’s premature authorisation

Imbalance in baseline characteristics in molnupiravir trials

BMJ 2022; 377 doi: https://doi.org/10.1136/bmj.o977 (Published 26 April 2022) Cite this as: BMJ 2022;377:o977
  1. Rokuro Hama, medical doctor
  1. NPO Japan Institute of Pharmacovigilance, Tennoji-ku, Osaka, Japan 543-0043
  1. gec00724{at}nifty.com

Brophy emphasises the dangers of making decisions based on a single prematurely terminated trial.1 The molnupiravir trials have several more problems23:

  • The risk of hospital admission or death associated with molnupiravir was not significant in the all randomised population when adjusted for sex (hazard ratio 0.69, 95% confidence interval 0.48 to 1.01).

  • Molnupiravir may worsen covid-19 outcomes after the interim analysis—simply calculating the rate of hospital admission or death in the population of participants who were included in the final analysis but not the interim analysis shows that the molnupiravir group had a non-significant higher risk (6.2%) …

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