FDA ‘highly culpable’ for opioid crisis, says ‘Empire of Pain’ author

·5-min read

Amid the COVID-19 pandemic, the opioid crisis has turned into a deadly drug overdose epidemic, impacting nearly every state in the country. Over the past decade, nearly 500,000 people have died from an opioid overdose, involving either prescription and/or illicit drugs. On average 38 people died every day in 2019 from prescription opioid overdoses, amounting to more than 14,000 deaths.

There is arguably no name more synonymous with the nation’s opioid epidemic as that of Sackler, one of the richest families in the country, with an estimated net worth of $10.8 billion. The Sackler family owns Purdue Pharma, the company which manufactures OxyContin, the highly addictive opioid painkiller. OxyContin is one of the most commonly abused prescription drugs in America.

Almost every state in the country has filed lawsuits against Purdue Pharma. The company declared bankruptcy in 2019. In March, Purdue Pharma proposed a bankruptcy restructuring plan, in which the Sacklers would pay roughly $4.25 billion to states, tribes, and municipalities to help them address the opioid crisis, but the family would admit to no wrongdoing.

Big Pharma’s role in enabling the opioid epidemic has been dubbed the “Crime of the Century” by filmmaker Alex Gibney, in his new HBO documentary which explores the origins, extent, and fallout of the public health crisis.

A pharmacist holds prescription painkiller OxyContin, 40mg pills, made by Purdue Pharma L.D. at a local pharmacy, in Provo, Utah, U.S., April 25, 2017. REUTERS/George Frey
A pharmacist holds prescription painkiller OxyContin, 40mg pills, made by Purdue Pharma L.D. at a local pharmacy, in Provo, Utah, U.S., April 25, 2017. REUTERS/George Frey

While the glaring national legal spotlight remains on Purdue Pharma’s role in manufacturing and promoting OxyContin which many lawsuits allege laid the foundation for the opioid addiction crisis and deadly overdoses, new questions are being raised about the U.S. Food and Drug Administration’s responsibility in the opioid epidemic.

The FDA “is highly culpable,” Patrick Radden Keefe told Yahoo Finance. Keefe is the author of the recently published book “Empire of Pain,” which explores the history of the Sackler dynasty.

In 1995, the FDA approved OxyContin, the highly addictive painkiller, which Purdue Pharma then marketed and sold. (Purdue has twice admitted to illegally marketing OxyContin in 2007 and 2020 plea deals with the U.S. Department of Justice.)

In “Empire of Pain,” Keefe details the FDA’s role in enabling Purdue Pharma to cash in on OxyContin.

“When Purdue Pharma was originally submitting OxyContin for approval by the FDA, the top official at the FDA in charge of approving the drug for sale but also of approving the way in which it could be marketed was a guy named Curtis Wright,” Keefe said.

OxyContin turned out to be a blockbuster drug, bringing in over $30 billion in revenue from sales for Purdue, according to the House Committee on Oversight and Reform. Curtis Wright ended up leaving the FDA and took a job at Purdue Pharma – about a year after the drug’s 1995 approval, according to Keefe’s book.

FILE - In this Sept. 11, 2019, file photo, medications slated for destruction are shown in a locked storage area of the police department in Barberton, Ohio. The tentative settlement involving the opioid crisis and the maker of OxyContin, Purdue Pharma, could mean that thousands of local governments will one day be paid back for some of the costs of responding to the epidemic. (AP Photo/Keith Srakocic, File)
In this Sept. 11, 2019, file photo, medications slated for destruction are shown in a locked storage area of the police department in Barberton, Ohio. The tentative settlement involving the opioid crisis and the maker of OxyContin, Purdue Pharma, could mean that thousands of local governments will one day be paid back for some of the costs of responding to the epidemic. (AP Photo/Keith Srakocic, File)

“He ends up taking a job at Purdue Pharma, the company that makes the drug that he’s just approved for roughly three times his government salary. I think his starting compensation was somewhere in the neighborhood of $400,000,” said Keefe. “That’s not a suitcase full of money getting slid under a table, but it raises questions in my mind about corruption, conflicts of interest and how much we can trust the judgment of the FDA in having given such a green light to Purdue Pharma early on.”

David Kessler, former commissioner of the FDA from 1990 to 1997, acknowledged the agency’s role in enabling the opioid epidemic. "This has been one of the great mistakes of modern medicine," Kessler said in a CBS News interview in 2016. The “FDA has responsibility, the pharmaceutical companies have responsibility, physicians have responsibility."

Although Kessler absolved himself personally from any responsibility for the opioid crisis as the former head of the FDA by saying that the pandemic took hold after he left the agency in 1997, he did admit that he should have pushed for stricter prescription practices during his tenure, according to CBS News.

A spokesperson for members of the family of the late Dr. Mortimer Sackler issued the following statement to Yahoo Finance regarding Keefe’s book: “Our focus is on concluding a resolution that will provide help to people and communities in need, rather than on this book.”

In response to a request for comment about Keefe's book, a lawyer for the Raymond Sackler family said in a statement that Keefe "refused to correct errors in his past reporting" and refused "to meet with representatives for the Sackler family during the reporting of his book." The lawyer also said that "documents being released in Purdue’s bankruptcy now demonstrate that Sackler family members who served on Purdue's board of directors acted ethically and lawfully." (Brothers Mortimer and Raymond Sackler co-owned Purdue Pharma, and have both passed away.)

The FDA did not respond to a request for comment.

Note: This article was updated on May 13 with additional comments from a representative for Raymond Sackler.

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