McKinsey denies illegally hiding work for opioid-maker Purdue Pharma while advising FDA
The head of the influential and secretive consulting firm McKinsey & Company has denied the company illegally hid work for Purdue Pharma, the drugmaker that kickstarted the opioid epidemic, while also advising for the Food and Drug Administration.
But Bob Sternfels, McKinsey’s global managing partner, apologised for the company’s work with Purdue, manufacturer of the powerful painkiller OxyContin that initially drove an epidemic that has claimed more than one million lives over the past two decades.
Sternfels testified to a congressional committee on Wednesday after it released a report revealing how McKinsey’s work for Purdue, including how to “turbocharge” opioid sales even after the drug manufacturer was convicted of federal crimes for illegally pushing OxyContin, was hidden from the FDA.
The report said that over a period of 15 years “at least 22 McKinsey consultants, including senior partners, worked for both FDA and opioid manufacturers on related topics, including at the same time”.
The FDA has said that it did not know until last year that McKinsey was simultaneously working for Purdue. The consulting firm was paid $86m by the drug-maker and $140m by the FDA.
The chair of the House oversight committee, Carolyn Maloney, told Sternfeld that McKinsey’s conduct was “among the worst I have seen in my years in government”.
“At the same time the FDA was relying on McKinsey’s advice to ensure drug safety and protect American lives, the firm was also being paid by the very companies fueling the deadly opioid epidemic to help them avoid tougher regulation of these dangerous drugs,” she said.
Maloney said that McKinsey designed strategies for Purdue and other companies to drive up opioid painkiller sales, paving the way for the explosion of addiction and overdoses.
“Some of the advice McKenzie provided is absolutely shocking beyond belief,” she said.
At one point a McKinsey consultant advised the opioid maker to head off tighter regulation of its drug with a legal claim “alleging FDA impropriety”. The same consultant was later assigned to work with the FDA office responsible for overseeing that regulation.
Another senior McKinsey consultant “worked on three FDA projects from 2014 to 2018 to assess the safety of dangerous drugs through the FDA Sentinel Initiative while simultaneously advising Purdue”.
The committee said that a McKinsey partner who frequently consulted for the FDA also worked with Purdue to prepare for an FDA meeting about one of its opioids.
“In 2016, a McKinsey partner encouraged other consultants to share information with Purdue about ongoing drug safety work McKinsey was doing for FDA, saying they should ‘talk about our work w FDA, specifically sentinel which I think would be v useful for them in opioids’,” the report said.
Maloney suggested McKinsey had broken the law in not disclosing its work for the drug-makers to the federal authorities.
Sternfels said his firm was merely protecting client confidentiality. He denied there was a conflict of interest because he said McKinsey was advising the FDA on “implementing technology solutions” and performance management not drug regulation. He said that McKinsey was therefore not obliged to tell the FDA of its work advising Purdue about how to influence the FDA’s regulation of opioids.
But Sternfels acknowledged that McKinsey should not have advised Purdue to increase OxyContin sales.
“We fully recognise that it fell short
of our standards,” he said. “While our intent was not to fuel an epidemic, in any of our work, I think we failed to recognise the broader context of what was going on in society around us.”
Sternfel’s apology did little to satisfy some members of the committee. Representative Rashida Tlaib said she regarded McKinsey’s consultants as “drug traffickers in suits”. Representative Ayanna Pressley accused the firm of being complicit along with Purdue and its owners until recently, members of the Sackler family, in creating the opioid epidemic.
The Massachusetts attorney general, Maura Healey, also testified as to discoveries made by her office investigating McKinsey’s work for Purdue and the Sackler family.
“We learned that McKinsey consultants worked directly with the Sackler billionaires who controlled Purdue. We found that McKinsey told the Sacklers to target the most dangerous prescribers who put the patients on opioids at the most highest levels and at the highest doses for the longest periods of time,” she told the hearing.
“We found that McKinsey did not want the world to know what it was doing. But when I sued the Sacklers, McKinsey consultants read about my investigation and lawsuit and actually planned to delete their documents and emails. They wrote that they were going to destroy the evidence because ‘someone might turn to us’.”
Healey’s investigation resulted in McKinsey agreeing last year to pay nearly $600m to settle claims by 49 states, Washington DC and five territories that its advice to Purdue and other opioid manufacturers drove the US’s worst drug epidemic.
Purdue Pharma, which is in bankruptcy, pleaded guilty to bribery, fraud and other criminal charges in 2007 and 2020 over its drive to sell OxyContin, including false claims for the drug’s safety.
Members of the Sackler family who owned Purdue have agreed to pay $6bn to settle claims by US states, municipalities and individuals without admitting liability.