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The Pulse of the Pharmaceutical Industry

WHO Removes Controversial Opioid Guidelines Following Scathing Congressional Report

Written by: | | Dated: Monday, June 24th, 2019


WHO_Editorial_Martin Good

Martin Good / Shutterstock


After accusations of being influenced by Purdue Pharma, the World Health Organization (WHO) has withdrawn two guidelines for opioid medications following criticism from U.S. lawmakers.

In a statement, WHO said it was discontinuing two guidelines that have been in place since 2011 and 2012 “in light of new scientific evidence that has emerged since the time of their publication” regarding the dangers of opioid abuse. The agency added that its decision should address any “issues of conflicts of interest regarding its experts” that were raised in a May report released by two members of Congress who claimed the company influenced the health agency in order to open up international markets for its opioid, OxyContin.

Reps. Katherine Clark (D., Mass.) and Hal Rogers (R., Ky.) released a report called “Corrupting Influence: Purdue & the Who” that raised allegations the company was practicing the same kind of aggressive marketing tactics to sell its powerful and addictive opioid OxyContin across the globe. The report raised questions about “the integrity and accuracy of the WHO’s opioid prescription guidelines” and also raised concerns about the influence privately-held Purdue may have had on the health agency. The lawmakers said Purdue was able to “insert their marketing strategies into the WHO by creating and funding front organizations, who participated in research that acted as the foundation for the WHO’s guideline documents.”

The lawmakers said they issued a letter to the WHO in 2017 expressing concern over the company’s international intentions and noted that the WHO did nothing about it. The members of Congress pointed to the WHO guidances that indicated the medication was safe and that there was “no need to fear accidental death or dependence.” Furthermore, the lawmakers noted that the guidelines also indicated that there was no maximum dose limit for opioid use in children. The lawmakers’ report said if the WHO guidelines are followed, “there is a significant risk of sparking a worldwide public health crisis.”

“It’s no secret that Purdue Pharma, fueled by greed, relentlessly and recklessly marketed OxyContin in the United States, even when it became clear the drug was fueling addiction and overdose deaths,” Rogers said in a statement following the release of the report. “While the findings in this report are tragic and alarming, they are unsurprising given this company’s unscrupulous history. The WHO must take action now to right the ship and protect patients around the world, especially children, from the dangers associated with chronic opioid use.”

Opioid addiction in the United States has become an epidemic. According to the U.S. Centers for Disease Control and Prevention, from 1999 to 2017, there were nearly a quarter of a million deaths caused by prescription opioid overdoses in the U.S. In 2017, the Department of Health and Human Services officially recognized the crisis and declared a public health emergency. In April, a poll unsurprisingly revealed that a significant number of people in the U.S. blame the opioid-manufacturing pharmaceutical companies for the addiction crisis. According to the poll, 63 percent say the pharmaceutical companies bear direct responsibility for the crisis and related deaths.

Purdue, which has become the bad boy company of opioid addiction due to its aggressive marketing schemes, denied the claims raised in the congressional report.

Purdue’s aggressive marketing of OxyContin earned it billions of dollars. But in the wake of the opioid crisis in the United States, the company has become the subject of more than 1,600 lawsuits. The state of Massachusetts has attempted to place blame on the company for 670 opioid-related deaths in the state since 2009. The lawsuit against Purdue has also made sure to emphasize how critical the success of OxyContin sales was to the company’s bottom line. That lawsuit revealed that Richard Sackler, a former Purdue president, called for a “blizzard of prescriptions” during a launch party for OxyContin shortly after the drug had been approved by the U.S. Food and Drug Administration. Sackler, according to reports, predicted that the number of paper prescriptions for OxyContin would be “deep, dense and white.”

In March, Purdue agreed to pay $270 million to settle a lawsuit brought against the company over the marketing of OxyContin. The state of Oklahoma had been seeking more than $20 billion in damages from Purdue, as well as other opioid manufacturers, such as Teva Pharmaceutical and Johnson & Johnson. Teva also agreed to settle the lawsuit for $85 million.

In its announcement this week, WHO said it remains committed to ensuring that people suffering severe pain have access to effective pain relief medication, including opioids. WHO noted the threat of addiction to the pain killers but also expressed a concern over “very low access” to medications that treat moderate and severe pain, particularly in low and middle-income countries. Additionally, the international health agency said it recognizes that the “need for access to pain relief must be balanced with concerns about the harm arising from the misuse of medications prescribed for the management of pain, including opioids.”



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