Intended for healthcare professionals


WHO drops opioid guidelines after criticism of corporate influence

BMJ 2019; 365 doi: (Published 24 June 2019) Cite this as: BMJ 2019;365:l4374
  1. Owen Dyer
  1. Montreal

The World Health Organization is discarding two opioid guidelines after a report by two members of the US Congress alleged that they were tainted by opioid manufacturers.

The bipartisan report accused the opioid manufacturer Purdue Pharma of working, through its international arm Mundipharma, to expand the indications for chronic opioid use and minimise concerns about risks of addiction.1

Mundipharma paid physician opinion leaders and sponsored “astroturf” patients’ groups (set up by industry bodies) to demand easier access to opioids for pain treatment, the report alleged. Purdue Pharma faces extensive legal action in the US, where it has often been accused of leading a campaign to normalise opioid use.2

WHO responded by saying that it would investigate the claims, and three weeks later it has moved to discontinue the two guidelines singled out for criticism by the report: Ensuring Balance in National Policies on Controlled Substances,3 published in 2011, and Who Guidelines on the Pharmacological Treatment of Persisting Pain in Children with Medical Illnesses,4 published in 2012.

In a statement WHO said that it took very seriously the concerns raised in the report but also saw the guidelines as outdated.5 It said, “WHO is discontinuing these guidelines in light of new scientific evidence that has emerged since the time of their publication. This will also address any issues of conflicts of interest of the experts that have been raised.”

WHO remains concerned about the burden of untreated pain, especially in developing countries, the statement says, but recognises a need to balance this imperative against concerns about opioid dependence.

Experts fear that an opioid epidemic in some developing countries, where regulation is weak and many drugs are sold without prescription, could dwarf even the crisis seen in the US.

WHO’s statement notes that recent research “has identified many strategies for managing pain, beyond drug treatment alone. Evaluating this new evidence and establishing best strategies for alleviating pain—both acute and chronic—is an important area of work for WHO.”

To this end, the agency developed a new cancer pain guideline in January,6 and is working on others.

WHO’s decision comes as Mundipharma is embroiled in a sprawling corruption case in Italy, where prosecutors allege that it paid dozens of academics, doctors, and regulators to promote opioid use in guidelines, teaching, hospital pharmacy arrangements, and even national law.

Prosecutors have named Mundipharma and the German opioid firm Grünenthal in a kickback scheme to influence doctors and have also named 75 academics, doctors, bureaucrats, and industry executives as suspects in the case. Some Italian firms have also been implicated by prosecutors, but not yet fined, as members of a group dubbed the “pain league.”

Nineteen people have been arrested, including the alleged ringleader of the conspiracy, Guido Fanelli, professor of anaesthesiology at the University of Parma, who remains under house arrest awaiting trial. Fanelli wrote the 2010 law making opioids more accessible in Italy and was legally responsible for its oversight.

The case is known in Italy as Operation Pasimafi, after Fanelli’s seized luxury yacht. In wiretaps released by the Carabinieri, Fanelli boasted that the boat carries Mundipharma’s logo but has his initials above it, because “I earned them $40m with Targin [oxycodone with naloxone].”

In another wiretap he spoke to his wife, also an anaesthesiologist and a suspect in the case, about the risk from another opioid product. “If 100 people die, no one goes to jail,” he reassured her.


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