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Commentary: Evidence versus influence in the WHO procedure for approving essential medicines: misoprostol for maternal health

BMJ 2014; 349 doi: (Published 31 July 2014) Cite this as: BMJ 2014;349:g4823
  1. Colin Millard, senior lecturer ,
  2. Petra Brhlikova, senior lecturer,
  3. Allyson M Pollock, professor of public health research and policy
  1. 1Global Health Policy and Innovation Unit, Queen Mary, University of London, London, UK
  1. Correspondence to: C Millard colin.millard{at}

In 2002, the World Health Organization changed its procedures for revising the model list of essential medicines as part of a shift to a more transparent and evidence based approach.1 Barbui and Purgato’s analysis highlights how poor quality applications unaccompanied by a systematic review of evidence may lead to the WHO expert committee prioritising reviews of medicines with limited value. Another problem is that the influence of civil society organisations in the application and review process can apparently trump evidence.

A case in point is misoprostol, a synthetic analogue of naturally occurring prostaglandin E1 that was, after six attempts, added to the essential medicine list in 2011 for the prevention of postpartum haemorrhage when oxytocin is not available or cannot be safely used. However, an application to include the drug for the treatment of postpartum haemorrhage was rejected at the same time because it “could divert the attention from or reduce attempts to implement oxytocin availability, a superior treatment.”

The drug of choice for preventing and treating postpartum haemorrhage is oxytocin, followed by ergometrine, both of which are heat sensitive and require parenteral administration. Because misoprostol is stable at room temperature and can be administered orally, sublingually, rectally, and vaginally it has been presented as an ideal alternative in low resource settings, where most maternal deaths from haemorrhage occur. However, the evidence in support of using misoprostol is weak despite the large number of trials.

Over 10 years, four successive versions of a …

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