Johns Hopkins University helps launch digital trove of opioid industry documents

The University of California, San Francisco and Johns Hopkins University today announced the launch of the Opioid Industry Documents Archive, a digital repository of publicly disclosed documents from recent judgments, settlements, and ongoing lawsuits concerning the opioid crisis. The documents come from government litigation against pharmaceutical companies, including opioid manufacturers and distributors related to their contributions to the deadly epidemic, as well as litigation taking place in federal court on behalf of thousands of cities and counties in the United States. The documents in the archive include emails, memos, presentations, sales reports, budgets, audit reports, Drug Enforcement Administration briefings, meeting agendas and minutes, expert witness reports, and depositions of drug company executives.

The Opioid Industry Documents Archive leverages extraordinary expertise within UCSF and Johns Hopkins University in library science, information technology, and digital archiving. It also relies on scholarship focused on many dimensions of the opioid epidemic, ranging from the history of medicine to pharmaceutical policy to clinical care. Key organizations at UCSF involved include the Philip R. Lee Institute for Health Policy Studies; Department of Clinical Pharmacy; Department of Humanities and Social Sciences; Department of Family and Community Medicine; and Library. From Johns Hopkins University, the project involves the Bloomberg School of Public Health's Center for Drug Safety and Effectiveness; Welch Medical Library; Institute of the History of Medicine; and Sheridan Libraries' Digital Research and Curation Center.

The new archive will provide free public access to anyone who is interested in investigating the activities that have led to the devastating epidemic, which has now contributed to the deaths of nearly 500,000 people. The archive will promptly include new documents as they become available through resolution of legal action against companies that contributed to the opioid crisis. The launch coincides with the universities' efforts to house more than 250,000 documents produced by opioid manufacturer Insys in the course of its bankruptcy proceedings following opioid litigation.

"These documents will provide researchers and scholars valuable insights into how an addiction crisis takes hold in a society. By investigating these documents and making them publicly available, our hope is to prevent a public health challenge like the opioid epidemic from arising in the future," said Ellen MacKenzie, dean of the Bloomberg School of Public Health.

The archive is similar to the groundbreaking Truth Tobacco Industry Documents archive at UCSF, which has fostered scientific and public health discoveries shaping tobacco policy in the U.S. and around the world. This new archive from two top research universities will deliver a wealth of information that experts can analyze to help policymakers prevent another disaster like this from happening again.

"This archive serves a vital public health purpose. Thanks to the efforts of the many parties involved, including the leaders of our communities and states nationwide, private lawyers working on their behalf, State Attorneys General, and the Multidistrict Litigation Plaintiffs' Executive Committee, the archive will shine the bright light of day on previously private documents that help explain the background of how the epidemic arose," said G. Caleb Alexander, professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health and founding director of its Center for Drug Safety and Effectiveness. Alexander, who has provided expert testimony on behalf of plaintiffs in opioid-related litigation, added, "Johns Hopkins University and its Bloomberg School of Public Health bring remarkable expertise and scholarship directly related to the opioid crisis that are vital to this project's success."

Michael Steinman, professor of medicine at UCSF, said, "UCSF's ongoing work, through its Industry Documents Library, to provide public access to millions of documents about the tobacco industry has supported significant scientific and investigative research that have facilitated efforts to reduce smoking and related diseases, saving millions of lives worldwide. This new archive will similarly reflect on the opioid industry, whose actions have led to an extraordinary level of suffering and death across the country."

The archive will be guided by an external advisory committee that will include individuals who have lost loved ones to the opioid epidemic and others who have been directly affected by it.

According to the U.S. Centers for Disease Control and Prevention, the first wave of the rise in 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. From 1999 to 2018, nearly 500,000 people in the U.S. died from an overdose involving opioids, including prescription and illicit opioids. According to the White House Council of Economic Advisors' most recent analysis, the opioid epidemic cost $696 billion in 2018 and more than $2.5 trillion between 2015 and 2018.

"This project will provide much-needed transparency into some of the origins of our recent opioid epidemic, informing policies and practices to prevent another such catastrophe," said Joshua Sharfstein, the Bloomberg School's vice dean for public health practice and community engagement and director of the Bloomberg American Health Initiative.

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America's opioid epidemic

In response to the crisis across the U.S., counties, cities, states, and thousands of municipalities have filed lawsuits against various opioid manufacturers, distributors, and pharmacies, and consulting firms. The lawsuits and document discovery from the litigation—such as the recent settlement by States Attorneys General with McKinsey & Company—have exposed how opioid defendants pursued strategies to increase sales of addictive and deadly products, including producing manipulative and misleading marketing, casting doubt on the addictiveness of these products, ignoring or downplaying health risks, or otherwise overlooking signals of opioid oversupply and unsafe use.

"Public archives promote transparency and accountability," said Kate Tasker, UCSF Industry Documents Library managing archivist. "With the creation of the Opioid Industry Documents Archive, UCSF and Johns Hopkins University commit to preserving these materials—and future documents—in a centralized and full-text searchable database, to make this information freely and openly available to the public."

The archive currently contains 3,300 documents (more than 131,000 pages) in six collections:

• Washington Post Opioid Collection
• KHN OxyContin Collection
• Oklahoma Opioid Litigation Documents
• Kentucky Opioid Litigation Documents
• National Prescription Opiate Litigation Documents
• Insys Litigation Documents