Influence of OxyContin maker to be scrutinized
Stamford-based Purdue Pharma faces another round of criticism, with a new Congressional report that accuses the OxyContin maker of unduly swaying the World Health Organization to help deceptively market its opioids abroad.
Largely through its financial connections to a number of advocacy groups and individuals, Purdue influenced WHO prescribing guidelines instituted in 2011 and 2012 that endorsed dubious claims about opioids’ safety — including potentially unlimited dosages of drugs like OxyContin for children — according to the investigation led by Rep. Katherine Clark, DMassachusetts, and Rep. Hal Rogers, R-Kentucky.
The allegations parallel the accusations in hundreds of lawsuits filed against the firm by cities and states across the country.
“We are disturbed that the WHO, a trusted international agency, appears to be lending the opioid industry its voice and credibility,” Clark and Rogers wrote in the report. “Based on the course of events that has taken place in the U.S. over the past 20 years, if the recommendations in these WHO guidelines are followed, there is a significant risk of sparking a worldwide public health crisis.”
Purdue officials denied the report’s allegations, saying that the Stamford-headquartered company is “solely based in the United States with no international operations.”
“The company has never violated any applicable rules or guidelines and no formal complaint or enforcement activity has resulted from Purdue’s financial support or relationship with any third party,” the statement added. “These relationships are transparent and any potential conflicts of interest are fully disclosed.”
A message left for the WHO was not returned. Based in Geneva, Switzerland, the WHO is the United Nations agency that focuses on international public health.
Among its most strident criticisms, the report accuses the WHO 2012 guideline, focused on treating chronic pain in children, of subverting the agency’s model for treating pain. It said the WHO acquiesced to Purdue prescribing recommendations that had been outlined in company planning documents from the 1990s.
In that regulation, “if a child’s pain is assessed as moderate to severe, the WHO recommends skipping step two (a combination of non-opioids) and moving straight from non-opioid medication to strong opioids such as OxyContin,” the report said.
At the same time, the WHO claimed that there was no maximum dosage for opioids like OxyContin, according to the report.
The children’s prescribing guideline showed further bias by referring to “opiophobia,” a term coined by opioid-focused firms and used by Purdue, to describe physicians’ supposedly irrational fear of prescribing strong pain drugs, the study said.
Alleged influence
Clark and Rogers said they were “unable to say with certainty that money flowed directly from Purdue to the WHO,” citing a lack of access to complete financial records.
But their report said “it is evident that Purdue and the wider opioid industry exerted significant influence on the WHO as the organization developed and wrote its guidelines on the use of opioid prescriptions.”
As an example, they point to past Purdue funding for the International Association for the Study of Pain, which they said helped finance the development of the controversial WHO guidelines, including the directive on children’s prescribing.
Clark and Rogers’ report does not mark the first Congressional inquiry into Purdue’s nonprofit connections.
The firm ranked as the top donor among five pharmaceutical companies that gave millions of dollars during the past few years to influential nonprofits supporting large-scale opioid use, according to a report last year by then-U.S. Sen. Claire McCaskill, D-Missouri.
Purdue and four other companies — Janssen, Mylan, Depomed and Insys — provided at least $8.9 million in funding to 14 outside groups working on chronic pain and other opioid-related issues between January 2012 and March 2017, according to the “Fueling an Epidemic” report.
With $4.15 million in payments, Purdue accounted for almost half of the companies’ total contributions. The Lenexa, Kansas-based Academy of Integrative Pain Management comprised its largest recipient, receiving about $1.1 million.
“We’ve seen a continued concern about the business ethics of Purdue,” said Angela Mattie, a professor in the schools of business and medicine at Quinnipiac University. “There’s been a societal backlash against the alleged culprits, including Purdue, of the national public-health problem we face with the opioid crisis.”
Reported international ambitions
While Purdue said that it does not operate outside the U.S., its owners, who are members of the Sackler family, purportedly harbor plans to dominate the prescription-opioid market overseas.
A group of Sackler-owned companies known as Mundipharma has pursued wide use of pain drugs in regions including Latin America, east Asia, the Middle East and parts of Africa and Europe, according to a 2016 investigation by the Los Angeles Times.
The conglomerate has implemented some of the same contentious marketing practices used to cement OxyContin’s dominance in the U.S., The Times found.
A message left Thursday for a Sackler family spokesperson was not immediately returned.
Eight Sackler family members have been sued by a number of cities and states, including Connecticut, for allegedly orchestrating fraudulent OxyContin marketing. The family denies those allegations.