As the COVID-19 pandemic recedes, it’s time to turn attention back to the slow-moving and devastating epidemic caused by America’s opioid crisis. For the last 10 years, around 15,000 annual deaths have been ascribed to prescription opioid overdoses. Add in deaths from all opioids, whether obtained by prescription or on the black market, and the total reaches almost 50,000. Black market fentanyl has played a big role, as well as a now notorious pharmaceutical called OxyContin, which is manufactured and sold by Purdue Pharma. The company’s dysfunctional culture combined with complacent oversight by the US Food and Drug Administration (FDA), the research community, and the medical community led to this perfect storm—one we must learn from so that we can avoid a similar tragedy in the future.
Much outstanding reporting has been done about the OxyContin saga and the role of Purdue Pharma and the Sackler family, which owns and runs the company. Most recently, Patrick Radden Keefe has written a compelling version of the tale in his new book, Empire of Pain. The book centers mostly on the horrific business actions of the Sacklers, but given Keefe’s detailed reporting, I asked him to help me understand why the scientists and physicians in the company couldn’t stop the crisis earlier. “One of the real oddities of this story,” he told me, “is the absence of whistleblowers. You would expect precisely what you describe, people to come forward, to quit in protest, to try and alert the authorities—and there’s not a huge amount of that along the way.” Keefe says the fact that Purdue was not a public company and that there was a high premium placed on loyalty to the Sackler family were key considerations. But he also cites an idealistic belief among company scientists that with OxyContin, they had cracked the code on managing pain. “These are drugs that we’ve known for thousands of years to have important therapeutic benefits but also really significant downsides,” he said, “and I think that the hope and the ambition of Purdue was that they’d hacked it.” Keefe was referring to the time-release aspect of OxyContin, which allowed Purdue to deliver much higher doses of opioid.
One telling episode in the company’s history involves a chemical explosion at a Purdue manufacturing facility in New Jersey in 1995 that killed five people and injured dozens of others. All kinds of corners were cut in the interest of profits, creating a hazard that should have been foreseeable. Keefe said, “The family that owns the company and that was driving that push for profits accepts no responsibility whatsoever. They don’t go to any funerals. They don’t even make any expressions of regret… to me that was in a nutshell a story of the ways in which a relentless drive for profit can blind people to the seriously dangerous consequences of some of the risks that they’re undertaking.” This lack of safety culture at Purdue’s factory apparently carried over to the whole organization.
The FDA also failed to address the situation. Though the drug was approved in 1995, it was not until 2009 that the FDA started warning about its dangerously addictive properties. David Kessler, who was the FDA commissioner when OxyContin was approved, was later quoted as saying that the destigmatization of opioids is “one of the great mistakes of modern medicine.” Nevertheless, Keefe says that the FDA casually took Purdue at its word both in terms of the science and the marketing of the drug. It was 14 years after the drug was approved when FDA Commissioner Margaret Hamburg finally began to hold hearings and issue warnings about the dangers of the drug. Joshua Sharfstein, who was FDA’s deputy commissioner at the time, said to me, “The FDA has to remember that it is the last line of defense against something horrible happening, and for a variety of reasons, the agency didn’t play that role.”
The OxyContin story is first and foremost a story of greed and hubris. But science bears some responsibility for failing to come forward but also for acceding to the view that science can solve anything. As Keefe surmised, “The original three Sackler brothers in the 1950s had this, I think, very American sense that if the chemistry is good enough, there’s no human problem that cannot be fixed with a pill.” For many scientists, this view can be just as intoxicating as an illicit drug.
