How FDA Failures Contributed to the Opioid Crisis

Andrew Kolodny, MD

AMA J Ethics. 2020;22(8):E743-750. 

doi: 10.1001/amajethics.2020.743.

Abstract

Over the past 25 years, pharmaceutical companies deceptively promoted opioid use in ways that were often neither safe nor effective, contributing to unprecedented increases in prescribing, opioid use disorder, and deaths by overdose. This article explores regulatory mistakes made by the US Food and Drug Administration (FDA) in approving and labeling new analgesics. By understanding and correcting these mistakes, future public health crises caused by improper pharmaceutical marketing might be prevented.

Introduction

In the United States, opioid use disorder (OUD) and opioid overdose were once rare. But over the past 25 years, the number of Americans suffering from OUD increased exponentially and in parallel with an unprecedented increase in opioid prescribing. Today, OUD is common, especially in patients with chronic pain treated with opioid analgesics, and opioid overdose is the leading cause of accidental death.

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Oversight Recommendations

While fewer clinicians are initiating long-term opioids, overprescribing is still a problem. According to a recently published report, more than 2.9 million people initiated opioid use in December 2017. The FDA’s continued approval of new opioids exacerbates this problem. Each time a branded opioid hits the market, the company, eager for return on its investment, is given an incentive and, in essence, a license to promote aggressive prescribing. The FDA’s continued approval of new opioids pits the financial interests of drug companies against city, state, and federal efforts to discourage initiation of long-term opioids.

To finally end the opioid crisis, the FDA must enforce the Food, Drug, and Cosmetic Act, and it must act on recommendations from the NAS for an overhaul of its opioid approval and removal policies. The broad indication on opioid labels must be narrowed, and an explicit warning against long-term use and high-dose prescribing should be added. The label should reinforce, rather than contradict, guidance from the CDC, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and other public health agencies that are calling for more cautious prescribing.

The information is here.

New York’s Met museum to remove Sackler name from exhibits

Sarah Cascone

artnet.com

Originally posted 9 DEC 21

The Metropolitan Museum of Art in New York has dropped the Sackler name from its building. The move is perhaps the museum world’s most prominent cutting of ties with the disgraced family since their company Purdue Pharma’s guilty plea to criminal charges connected to marketing of addictive painkiller OxyContin in 2020.

The decision, which came after more than a yearlong review by the museum, was reportedly mutual and made “in order to allow the Met to further its core mission,” according to a joint statement issued by the Sackler family and the institution.

“Our families have always strongly supported the Met, and we believe this to be in the best interest of the museum and the important mission that it serves,” the descendants of Mortimer Sackler and Raymond Sackler said in a statement. “The earliest of these gifts were made almost 50 years ago, and now we are passing the torch to others who might wish to step forward to support the museum.”

Institutions have faced increasing pressure to sever relations with the Sacklers in recent years as part of a growing push to hold institutions and other cultural groups accountable over where their money is coming from. (Other donors that have come under fire include arms dealers and oil companies.)

Seven spaces at the Fifth Avenue flagship bore the Sackler name. The biggest was the Sackler Wing, which opened in 1978, and includes the Sackler Gallery for Egyptian Art, the Temple of Dendur in the Sackler Wing, and the 1987 addition of the Sackler Wing Galleries.

The day of the announcement, Patrick Radden Keefe, the author of Empire of Pain: The Secret History of the Sackler Dynasty, visited the museum to find that the family’s name had already been removed.

The information is here.

U.S. judge tosses $4.5 B deal shielding Sacklers from opioid lawsuits

Brendan Pierson & Mike Spector, Maria Chutchian

Reuters

Originally posted 16 DEC 21

A federal judge overturned a roughly $4.5 billion settlement that legally shielded members of the Sackler family who stand accused of helping fuel the U.S. opioid epidemic, a decision that threatened to upend the bankruptcy reorganization of their company, OxyContin maker Purdue Pharma LP.

U.S. District Judge Colleen McMahon said in a written opinion on Thursday the New York bankruptcy court that approved the settlement did not have authority to grant the Sacklers the legal protection from future opioid litigation that formed the linchpin of Purdue’s reorganization.

Purdue said it would appeal the decision.

"While the district court decision does not affect Purdue’s rock-solid operational stability or its ability to produce its many medications safely and effectively, it will delay, and perhaps end, the ability of creditors, communities, and individuals to receive billions in value to abate the opioid crisis," Purdue Chairman Steve Miller said in a statement.

The Sacklers had insisted on the legal shields, known as nondebtor releases because they protect parties that have not filed for bankruptcy themselves, in exchange for contributing $4.5 billion toward resolving widespread opioid litigation.

The Sacklers threatened to walk away from the settlement absent the guaranteed legal protections.

Representatives for the Sacklers did not immediately respond to a request for comment late on Thursday.

Attorney General Merrick Garland said in a statement he was pleased with the ruling.

"The bankruptcy court did not have the authority to deprive victims of the opioid crisis of their right to sue the Sackler family," Garland said.

The info is here.

Note: If you have not watched Dopesick on Hulu, please do.  Excellent portrayal of the level of harm and psychopathology with members of this family.