 Hello, welcome to this project briefing about the opioid industry documents archive, a joint initiative between the University of California San Francisco and Johns Hopkins University. I will be speaking today, along with my co presenter and Seymour director of the Welsh Medical Library at Johns Hopkins University. And I'll be joined by Kate Tasker industry documents library managing archivist at the University of California San Francisco. Before we get started with our presentation, we would like to first acknowledge and thank the teams at UCSF and Johns Hopkins and members of our external national advisory committee for their ongoing work and expertise in developing and supporting the opioid industry documents archive. We'd also like to acknowledge the significant work done by state attorneys general, private plaintiffs and counsel, the courts and community activists and advocates to call for truth and accountability about the opioid crisis, and to demand public disclosure of opioid industry documents. I'd like to provide some brief background in context about the opioid epidemic, and the opioid documents. As many of you know the US is struggling with the opioid crisis, a major public health catastrophe, which has been called an epidemic, and has resulted in the deaths of over 500,000 people since 1999, according to the latest figures from the CDC. The epidemic's first wave began in the 90s with a massive expansion in the market for prescription opioids, and a second and third wave soon followed. As new consumers initiated prescription opioids, which can be highly addictive, others moved from opioid pills to heroin, and then to even stronger synthetic opioids such as illicitly manufactured fentanyl with each wave of the epidemic building upon the previous one. The opioid crisis has devastated communities across the country and is often reported in the media as mostly impacting a major white population in rural and suburban areas in regions such as West Virginia and Ohio. The crisis has undeniably taken a huge toll on these communities. However, there has also been a huge surge in opioid overdose, overdose deaths in urban minority communities, and many scholars and public health experts have called out the responses from governments, organizations, and law enforcement as yet another example of racial disparities in the healthcare and criminal justice movements. These numbers from the National Survey on Drug Use and Health from the National Center for Health Statistics further illustrate the catastrophic impact of the opioid epidemic. A further challenge is that significant information relevant to understanding and addressing the opioid epidemic has been inaccessible. Millions of internal corporate documents related to drug development, marketing, promotion, sales, and lobbying has been kept behind closed doors of opioid and drug companies or have been sealed under protective court orders. Other documents are available to the public but are scattered across different courthouses and in multiple different websites, making them difficult to discover, access, and analyze. So this is where the digital library and archives community comes in. Colleagues at UCSF and Johns Hopkins, including librarians, digital archivists, technologists, scientists, historians, and community members are building the opioid industry documents archive to preserve and provide public access to these documents. This digital archive will promote accountability and transparency about the causes of the opioid epidemic and can be used to take action to protect public health. So far documents have come from lawsuits against Johnson and Johnson, Incis Therapeutics and Malincrot Pharmaceuticals, and from investigative journalism by Kaiser Health News, Stat News, and the Washington Post. The archive currently contains over 131,000 pages in 14,000 documents. An additional one to two million documents will be added by the end of 2021, with much more to follow. The goals of the opioid industry documents archive are to consolidate information into an easily accessible state of the art, open digital archive for use by researchers, journalists, policymakers, community members, and other stakeholders. Maintain the archive for long term preservation and public use, and to increase support for scholarship on subjects such as commercial determinants of health, pain management addiction conflicts of interest in the pharmaceutical and healthcare industries and health policy. The archive can help epidemiologists, social scientists, historians, policymakers, journalists, community advocates, and many others investigate key questions about the opioid epidemic, such as how pharmaceutical companies drove the epidemic, how marketing and promotional practices deviated from standards set by the FDA, and what changes in policy are needed to prevent another health crisis in the future. And now I'm going to turn it over to my co-presenter Kate Tasker. Thank you, Ann. The opioid archives work is expanding on efforts at UCSF and its industry documents library. The IDL is a digital repository of more than 15 million documents, which illuminate corporate influences on health. The IDL team works to preserve free access to the documents and to enable researchers to investigate industry tactics in order to improve public health. The documents library began as the legacy tobacco documents library in 2002, which was established at UCSF to house millions of documents which were publicly disclosed in historical litigation against the tobacco industry. The archive was initially funded with a gift from the American Legacy Foundation, now called the Truth Initiative, and with funds made available from the 1998 master settlement agreement. UCSF has since expanded the collections to include documents from other industries impacting health, including the drug, chemical, food and fossil fuel industries. UCSF's Archives and Special Collections Department also houses the Tobacco Control Archives containing papers and materials from individuals and health advocacy organizations involved in the tobacco control movement. The opioid documents can be cross-searched with these other collections, providing unprecedented insight into previously confidential corporate records documenting activities and decisions related to governance, sales, marketing, lobbying, internal scientific research, product development and regulation. In addition to their significant value for public health research and policymaking, these materials are also a rich data set for historical research, digital health humanities and other computational analyses. The Truth tobacco industry documents have been cited in more than 1,000 publications and have supported significant scientific and investigative research, which has facilitated efforts to reduce smoking and related diseases and to improve health around the world. Two major developments at the national and international level, which relied on research done with the documents, are the US Family Smoking Prevention and Tobacco Control Act of 1999, which gives the FDA authority to take action to protect public health regarding tobacco production, sales and use, and the World Health Organization's Framework Convention on Tobacco Control, or FCTC, which developed in response to the globalization of the tobacco epidemic. There are hope that the opioid industry documents archive will have a similar impact on national and international public health policy development and help all of these types of communities deal with this crisis. There are many complex and intertwined roots of the opioid crisis, which public health and legal experts are best qualified to discuss so we provided a short list of resources at the end of this presentation, if you'd like to find out more information. However, it is widely recognized that opioid manufacturers such as Purdue Pharma have played a major role in contributing to the epidemic through profit driven aggressive marketing and sales of prescription opioids like OxyContin. There are thousands of these ongoing lawsuits across the country seeking to hold opioid manufacturers, distributors, pharmacies and other parties responsible. Huge settlement and settlement amounts have been reported in the media, including a $1.6 billion settlement in the Mallincloth bankruptcy, and a $4.5 billion settlement in the Purdue Pharma bankruptcy. These settlements will only provide a fraction of money that is needed to compensate devastated families, towns and healthcare systems to support treatment programs and to rebuild communities. But thanks to enormous efforts by state attorneys general, other plaintiffs lawyers and community advocates, many of the settlements also require that opioid companies publicly disclose internal documents in order to shine a light on the corporate decisions and actions that contributed to the crisis. As Anne mentioned, as of today, November 10, 2021, the opioid industry documents archive contains more than 131,000 pages in more than 14,000 documents, and we've collected these from a range of public records investigative journalists and from litigation disclosures. Our team is currently processing another 25 million pages in about one to two million documents and will be making these publicly available as soon as possible. This diagram illustrates the current document processing workflow and open source tools which currently underlie the UCSF industry documents library. We're assessing this architecture and planning for significant upgrades, including a website redesign interoperability with other data repositories and exploration of linked open data and community annotations or enabling crowd sourced metadata tagging using the international image interoperability framework or triple IF. In addition to the uses of the archive we previously described, we're also planning on how to make the documents more accessible and useful for digital humanities and digital health humanities research. The archive contains an extensive corpus of data with rich potential for computational analysis to enable this we're working on improving performance for scalability and interoperability, creating opportunities for researcher and community engagement and expanding machine learning capacity for additional forms of discovery. Some of the many challenges in this project relate to digital preservation. For example, the scale of the archive is very large, the collections may potentially include 10s of millions of documents or several terabytes of data. We need to understand and apply best practices for cloud storage backups file fixity and managing original and use copies. We're working under an ethos of open source development and are trying to use open platforms and tools wherever possible. And last but not least, we are assessing the best available options for preserving and providing access to a wide variety of file formats from outlook email files to Word documents to Excel spreadsheets to audio visual materials. Another critical aspect of the project is managing metadata. Metadata questions include using item level versus collection level description for access discoverability and context, the reuse of any existing metadata that is provided to us through the legal discovery process. The application of computational methods such as natural language processing or named entity recognition, the crowd sourcing or community annotations, and how to support or implement linked open data. Another really significant challenge is privacy and legal issues. As the documents are arising from opioid litigation. They were created internally by pharmaceutical companies. And there's high probability that the data contains personally identifiable information or protected health information. It's imperative that we understand the extent of this protected data where it's found, and how it can be screened and redacted to fully comply with state and federal privacy laws before we make any documents public. In addition, our team is also in taking and managing the metadata records for documents which have been held withheld from public disclosure due to attorney client privilege or confidential trade secrets. We're also focusing on sustainability and accessibility. Our goal is to maintain the archive in perpetuity but in reality no one really knows exactly how long that will be. We need to consider environmental sustainability and how to responsibly steward electronic resources over a long period of time. We need to meet web accessibility standards and best practices and enable the documents to be accessed from multiple kinds of devices by users in different countries, speaking different languages. And of course we need to plan for long term funding to support staffing data storage digital preservation software and hardware upgrades and many other costs. Another side of these challenges is opportunity and we are so excited to be in a position to advocate for digital archives as a vital public health and health justice resource. We are developing internship opportunities and a post doctoral fellowship program to support students and early career researchers. We want to support open source technology development and contribute to digital preservation and access initiatives through this project. This has a huge potential to support digital humanities work and computational research and to increase public engagement and knowledge. Having recently attended the digital library federations 2021 forum, I was again reminded that digital archives is never a solo endeavor. It really does take a village. The industry documents archive began in March 2021 as a collaborative initiative by UCSF and Johns Hopkins University, but we welcome participation and input from other expert colleagues across the digital library sector and beyond. We're working to connect with library and archives students and practitioners with digital humanities groups public health researchers, investigative journalists community advocates, people with lived experience of the opioid epidemic, and anyone who has an interest in contributing to the success of the project. As Anne mentioned, we've also convened a national advisory committee with people from a variety of backgrounds with different perspectives who can help us guide the development of the archive. Here are just a few of the links to the additional resources mentioned earlier for further reading about the opioid crisis and its impact on communities. To find out more about how to get involved with the project, please get in touch with us through our email addresses provided here. We thank you so much for your interest in this work and look forward to engaging with your comments and questions.