1.4 million opioid industry documents now public for all the read at UCSF

Fourteen state attorneys general, in collaboration with UCSF and Johns Hopkins University just made 1.4 million previously secret opioid documents (8.1 million pages) publicly available at the UCSF Industry Documents Library.

The AGs’ statement is worth quoting in full because it is important not only as a model for future opioid settlements and document disclosures, but as a model for rapid complete disclosure of the Juul documents in that litigation.

State AG Perspective: Exposing the Truth

Guest post by California Attorney General Rob Bonta, Colorado Attorney General Phil Weiser, Connecticut Attorney General William Tong, Idaho Attorney General Lawrence Wasden, Iowa Attorney General Tom Miller, Maryland Attorney General Brian Frosh, Massachusetts Attorney General Maura Healey, Minnesota Attorney General Keith Ellison, New Hampshire Attorney General John Formella, New York Attorney General Letitia James, North Carolina Attorney General Josh Stein, Oregon Attorney General Ellen Rosenblum, Pennsylvania Attorney General Josh Shapiro, and Virginia Attorney General Jason Miyares

Today’s disclosure of more than a million documents from Mallinckrodt Pharmaceuticals, one of the country’s most prolific opioid sellers, is an important step to expose the truth and prevent a manmade crisis like the opioid epidemic from ever happening again.

Drug companies profited by pushing dangerous prescription opioids, and Americans have become the biggest users of opioids in the world. Communities across our nation suffered the consequences as a result: addiction, overdose, and death.

Families most impacted by the crisis have led the way in advocating for justice. Parents whose own children died because of the opioid crisis have dedicated years of their lives to protect others. They demanded that lawbreakers be held accountable, failed systems be reformed, and urgent investments be made for harm reduction, treatment, recovery, and prevention.

State Attorneys General heard the calls for action and acted. Working together, across party lines and across the nation, our teams conducted a searching investigation of illegal conduct throughout the opioid industry. We filed lawsuits and won verdicts from judges and juries, forcing companies to pay tens of billions of dollars that will be dedicated to address the crisis.

An essential part of justice is exposing the truth. Our teams pursued that truth for years. Our efforts resulted in the public disclosure of millions of documents and of the critical facts revealed by witnesses ranging from drug sales reps to company presidents.

We rejected the companies’ attempts to keep the evidence sealed, or to hand it back to the perpetrators. Instead, we posted it online.

For the first time in a generation, since the landmark tobacco cases, an industry’s secrets are being turned over to the public. Under orders entered by courts throughout the nation, millions of opioid industry documents will be posted in a free public archive, in perpetuity.

The families who suffered in this crisis will be able to see for themselves the evidence that we uncovered – the company emails, board minutes, and business plans that changed so many lives.

Journalists, filmmakers, artists, and scholars will tell the story of this epidemic using the real words and actions of the people who drove the opioid business.

Policymakers throughout the country will be informed by what went wrong.

Executives, directors, and employees in every industry will know that, if they break the law and endanger the public, the whole world may see what they did.

Today is a step toward justice. We are grateful to the advocates who demanded action in the face of a devastating crisis, to our staff who work every day to serve the public, and to the archivists at the University of California San Francisco and Johns Hopkins who will preserve this evidence for the public good. [emphasis added]

It is also worth noting that the settlement paid the costs of making the documents available.

And there are more on the way.

These documents have been added to UCSF/JHU’s existing smaller collection of opioid documents (KHN OxyContin Collection, Insys Litigation Documents, Kentucky Opioid Litigation Documents, McKinsey Litigation Documents, National Prescription Opiate Litigation Documents, Oklahoma Opioid Litigation Documents, Washington Post Opioid Collection). All the opioid collections can be searched at once as well as with the tobacco, chemical, drug, food and fossil fuel collections.

The Washington Post has already run a big stroy using the opioid documents.

Here is the UCSF/JHU press release that provides more details on the new documents:

Opioid Industry Archive Releases 1.4M Documents from Leading Opioid Maker Implicated in Drug Crisis

Largest Acquisition of Litigation Documents to Date is Made Available Free to Public Within the UCSF-JHU Opioid Industry Documents Archive

By Laura Kurtzman

UC San Francisco and Johns Hopkins University have announced the addition of 1.4 million documents to their Opioid Industry Documents Archive from Mallinckrodt, a leading generic opioid manufacturer now in bankruptcy. The company is one of many in the opioid industry currently implicated in the deaths of hundreds of thousands of people due to misleading marketing, sales, distribution, dispensing, and governance practices.

The archive, launched by the two research universities in March 2021, is a digital repository of publicly disclosed documents arising from ongoing opioid litigation brought by local and state governments and tribal communities against opioid manufacturers, wholesalers, and pharmacies. The Mallinckrodt company agreed to release documents produced during litigation as part of their settlement in recent legal cases with the plaintiffs. Starting May 10, the documents in the archive are available to and searchable by the public, including families impacted by the opioid crisis as well as the media, health care practitioners, students, lawyers, and researchers.

Documents in the archive reveal the many ways opioid litigation defendants sought to increase sales of drugs they knew to be addictive and deadly. Defendants’ tactics included using misleading marketing materials, enlisting health care providers as lobbyists, casting doubt on the drugs’ addictiveness, ignoring or downplaying health risks, and overlooking evidence of opioid oversupply and unsafe use.

The new Mallinckrodt company materials – the archive’s largest acquisition to date – will expand the archive’s collection of 15,000 opioid industry documents by more than a hundredfold. The archive’s documents are full-text searchable and include an array of relevant materials, including company emails, memos, presentations, sales reports, budgets, audit reports, Drug Enforcement Administration briefings, meeting agendas and minutes, expert witness reports, and depositions of company executives.

“We are glad these documents will now see the light of day, thanks to this initiative. It is so important that the public have an opportunity to study, analyze, and act upon this information,” said G. Caleb Alexander, MD, MS, professor of Epidemiology and Medicine at the Johns Hopkins Bloomberg School of Public Health and co-founding director of its Center for Drug Safety and Effectiveness. Alexander, who has provided expert testimony on behalf of plaintiffs in federal and state opioid litigation, added, “We invite anyone interested in the roots of the opioid epidemic, and the role that manufacturers like Mallinckrodt played, to delve into and search and study these materials.”

The release of these 1.4 million documents coincides with the announcement of the Opioid Industry Documents Archive National Advisory Committee. Members include bereaved family members and others directly impacted by the epidemic, as well as investigative journalists, legal and addiction experts, archivists, historians, and health policy analysts. The archive is designed to accommodate new documents from future settlements or judgments as part of opioid litigation.

Founded in 1867 in St. Louis, Missouri, Mallinckrodt was an early producer of codeine, morphine, and photographic chemicals. The company eventually came to dominate the generic opioid market through a subsidiary, SpecGx, at a time when addiction and overdose rates were spiking across the United States. According to DEA records, the company provided nearly 40% of all opioid pills sold in U.S. pharmacies from 2006 to 2012.

In 2011, Mallinckrodt company came under investigation by the DEA for failing to meet its requirements to track and report suspicious and excessive orders of controlled substances. The company was later named as a defendant in thousands of lawsuits consolidated through Multidistrict Litigation (MDL 2804). Plaintiffs accused the company of trivializing and hiding the risks of addiction, as well as failing to use its data to identify and report suspicious orders of opioid supplies.

“It’s so rare for us to have a full window into the strategies and tactics used by industry to increase use of a product that has and continues to have such deadly consequences,” said Kirsten Bibbins-Domingo, MD, PhD, Vice Dean for Population Health and Health Equity and professor and chair of the department of Epidemiology and Biostatistics at the UCSF School of Medicine. “Open-access archives such as these play a critical role in ensuring we learn from the past to help avoid such crises in the future.”

According to the Centers for Disease Control and Prevention, the first wave of opioid overdose deaths in the U.S. began with increased opioid prescriptions in the 1990s, with overdose deaths involving prescription opioids increasing since at least 1999. Nearly 841,000 people in the U.S. have died from an overdose involving opioids, including prescription and illicit opioids, since 1999, according to the CDC. The economic costs have also been colossal. The White House Council of Economic Advisers’ most recent analysis estimates that the opioid epidemic cost $696 billion in 2018, and more than $2.5 trillion between 2015 and 2018.

“We can’t accept the toll of the opioid crisis and move on,” said Joshua Sharfstein, MD, the Johns Hopkins Bloomberg School’s vice dean for Public Health Practice and Community Engagement and director of the Bloomberg American Health Initiative. “We must learn. The opioid archives are an essential resource for understanding what happened and how we can prevent such disasters.”

The opioid archive is modeled after UCSF’s groundbreaking Truth Tobacco Industry Documents archive, which has fostered scientific and public health discoveries shaping tobacco policy in the U.S. and around the world.

“Archives are sources for truth,” said Kate Tasker, MLIS, UCSF Industry Documents Library’s managing archivist. “We are collecting and preserving these documents for long-term public access so that anyone who wishes to examine them can do so freely – now and in the future – to understand and address one of the biggest public health crises in the United States in the 21st century.”

For access to the archives, go to: https://www.industrydocuments.ucsf.edu/opioids/

About UCSF: The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes UCSF Health, which comprises three top-ranked hospitals, as well as affiliations throughout the Bay Area. Learn more at https://www.ucsf.edu, or see our Fact Sheet.

About JHU: Johns Hopkins is America’s first research university. For more than 140 years Johns Hopkins has been a world leader in both teaching and research, with nine academic divisions—the Krieger School of Arts and Sciences, the Whiting School of Engineering, the Bloomberg School of Public Health, the Carey Business School, the Peabody Institute, the Paul H. Nitze School of Advanced International Studies, and the schools of Medicine, Nursing, and Education—plus the Applied Physics Laboratory, a nonacademic division that supports national security and pursues space science.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

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