WHO retracts opioid guidelines after accepting that industry had an influence

The World Health Organization has formally retracted its two main guidelines on the use of opioids for pain control, after its own review lent credence to outside complaints that the drafting process had been unduly influenced by opioid manufacturers, notably Purdue Pharma’s international subsidiary Mundipharma.

The retraction notice was published in the January issue of the Bulletin of the World Health Organization.1 The retracted guidelines are Ensuring Balance in National Policies on Controlled Substances,2 published in 2011, and WHO Guidelines on the Pharmacological Treatment of Persisting Pain in Children with Medical Illnesses,3 published in 2012.

Last May a US congressional report described the guidelines as “marketing materials for Purdue,” a company often blamed in the US for working to normalise opioid use. The report highlighted the role of scientists with ties to Mundipharma, a US company that developed, licenses, and markets drugs worldwide, in drafting the guidelines.4

WHO announced weeks later that it would “discontinue” the guidelines, saying that newer science had rendered them outdated. This would also deal with the concerns raised by the US report, which WHO took seriously, said its secretary general, Tedros Adhanom Ghebreyesus.

But in retracting them WHO is now effectively declaring that they were never valid. The guidelines made several familiar claims first heard in the US public relations campaign led by Purdue in the late 1990s. They used the term “opiophobia,” often used by the industry to describe doctors’ natural caution about the risks of opioid use, and claimed that less than 1% of patients taking opioids for chronic pain became dependent, a figure often cited by industry but not borne out by clinical experience.

WHO remains “concerned that there is very low access to medication for moderate and severe pain, particularly in low and middle-income countries,” the retraction notice says. New guidelines for chronic and acute pain management are in the pipeline, and WHO is evaluating new evidence on non-drug approaches.

Reports from China indicate that Mundipharma is deploying similar tactics there to those used by Purdue to boost prescriptions in the US two decades ago.5

In Italy Mundipharma is at the centre of the “Pasimafi” scandal in which nearly 100 doctors, academics, bureaucrats, and industry executives have been arrested or named by prosecutors as participants in a scheme to increase the use of opioids in everyday medicine.6 The alleged ringleader, Guido Fanelli, professor of anaesthesiology at the University of Parma, wrote a 2010 law that removed many restrictions on opioid use in Italy. Accused of taking millions in bribes from Mundipharma, he awaits trial.