One million pages of records from Insys Therapeutics were added to the Opioid Industry Documents Archive (OIDA) today.
The documents stem from litigation against the Arizona-based company, which specialized in drugs to treat cancer pain. Subsys, a fast-acting and highly potent opioid painkiller, had been approved by the FDA only to treat pain in cancer patients already receiving around-the-clock opioid therapy.
The newest additions to the Insys Litigation Documents collection — about 760,000 documents, mostly emails — show that Insys improperly sold vast amounts of its addictive product for off-label uses like non-cancer neck and back pain. The documents also bring to light how the company pressured doctors and deployed deceptive marketing to increase sales and earn millions of dollars in profits.
Read the press release - December 8, 2022: Archive Shows How Fentanyl Promotion Helped Drive Opioid Epidemic
via UCSF News, via Johns Hopkins University News.
The release of these documents coincides with the USA Today investigation published 12/8/2022 - 'Eat what you kill': How a fentanyl drugmaker bribed doctors, harmed patients and collected millions. The article details the role of Insys Therapeutics in the opioid epidemic.
New Purdue Pharma Collections
The story that became the basis of The Pharmacist originated out of a 2016 fellowship on the opioid epidemic in Baltimore. During one of the lectures, a member of the CDC presented a heat map detailing counties around the country that had experienced the highest rate of opioid overdoses from 1999 to the present. In 1999-2000, most of the country was green or blue, meaning the rates were quite low. But I noticed that St. Bernard Parish, which sits right next to Orleans Parish on the Gulf of Mexico, was dark orange, almost red.
When I got back to New Orleans, where I was covering the opioid epidemic, I scheduled a meeting with the communications director of the St. Bernard Parish sheriff’s office. I wanted to know why the rate of opioid overdose was so high around the turn of the century. To my surprise, I was met by half a dozen sheriff’s deputies and the sheriff himself, whose son had recently died of a heroin overdose. They began regaling me with stories about what was happening in St. Bernard back then.
As they explained it, the opioid epidemic was already out of control. This was largely due to a single pill mill doctor in New Orleans, just across the parish line. Her clinic was open 24 hours a day, they said, and got especially busy in the middle of the night. When I asked what happened to the doctor, they brought up a local pharmacist named Dan Schneider. Dan had lost his son to a crack deal gone wrong in 1999, they said. And when Dan learned that this doctor’s prescribing habits were causing his son’s friends to overdose and die, he made it his mission to shut this pill mill doctor down.
I called Dan Schneider that day, and I kept talking with him for months to make sure his incredible story was true. I published the story in The Times-Picayune in October 2017. The following year, I pitched the story to a documentary production company in Brooklyn, and Netflix approved the concept soon after. That’s how The Pharmacist came to be.
The Pharmacist tells the story of the impact of the opioid epidemic on people’s lives. And while we didn’t address it in the documentary, the Opioid Industry Documents Archive (OIDA) shines a light on the industry that contributed to the epidemic. Through document disclosure, people can access industry litigation documents and understand the corporate behavior that helped trigger the epidemic. By accessing these documents and telling people’s stories, we can bring real accountability and find solutions to make sure this kind of public health disaster won’t happen again.
The UCSF-JHU Opioid Industry Documents Archive added 3 collections this week, totaling over 2,000 new documents.
The documents, based on litigation led by the Florida Attorney General, the Ohio counties of Lake and Trumbull, and the San Francisco City Attorney, show how companies including CVS, Rite-Aid, Target, Walgreens and Walmart repeatedly failed to employ safeguards meant to prevent the over-dispensing and diversion of potentially dangerous controlled substances.Access the Collections:
Read the Press Releases: October 14, 2022: New Industry Documents Highlight Role of Pharmacies in Driving Opioid Epidemic via UCSF News, via Johns Hopkins University News Releases
Read the Stat investigation: Documents detail how pharmacy giants Walgreens, CVS, and Walmart failed patients in the opioid crisis. By Lev Facher, Kate Sheridan, and Ed Silverman. STAT, Oct 14, 2022
If there’s anything most of us living everyday lives never expected, it was to be thrown into the ugly world of opioids. The innocent public knew nothing about these painkillers that were being randomly prescribed back in the 1990s, except of course what was reported by trusted professionals. We naively believed that watchdog agencies like the FDA would never approve dangerous drugs, and that if one slipped through the system, that physicians would immediately report any life-threatening side effects to the appropriate federal, state, and local authorities charged with protecting our health and well-being. Simply put, the trusting public believed our government would never let us suffer decades of deadly abuse from pharmaceutical companies, their supply chain and enablers.
We were dead wrong. And if the past twenty-plus years of opioid deaths, immeasurable societal damage and self-serving and destructive corporate greed have taught us anything, it’s that as citizens, we have very limited means of getting to the truth and even then, sealed documents and lack of transparency work against us. Through our government, courts, and political action, powerful pharmaceutical manufacturers such as Purdue Pharma and their equally culpable supply chain—their co-distributors—have been vested with the power to create, manipulate, and remove from record the damaging documents that expose and inform the public of their criminality. Worse, being restricted from relevant data strips the public of its right to know and handicaps us from proactively defending our rights.
Bottom line, the American public, which has suffered the most from the opioid crisis, was further victimized by a lack of information, transparency, and access that can no longer be tolerated.
Now, for the first time, documents that were once shielded from the public are available in mass quantities and at no charge for access by citizen activists and the general public. Thanks to the negotiations of the state attorneys general, behind-the-scenes corporate enablers like McKinsey & Company are being exposed by including the release of incriminating documents as an integral part of the settlement. As a result, we now have access to previously private communications from among Purdue Pharma, Mallinckrodt, Insys leaders, and many other members of the legal cartel of opioid suppliers. We anticipate access to these documents will better position us against powerful lobbyist influence, improve public awareness, and enable us to be better advocates to prevent such a tragedy from ever happening again.
To do this, OIDA’s National Advisory Committee and the OIDA team have two major challenges. One, educating a beaten down and dismissed public of the direct benefit of a repository that contains vitally important information, and two, understanding and categorizing the formats and types of information, promoting ease of access to archive materials. Our long-term goal is to target and bring attention to opioid-related issues that most threaten the lives of citizens and eventually, set the standard for opioid information access for the public. The materials in the archives give us an opportunity to do this.
The IDL blog publishes a variety of perspectives on the opioid crisis and other matters of public health. Views expressed are the authors' and do not represent the positions of the University of California, San Francisco, or Johns Hopkins University.
Food Industry Documents Update:
New Collection: UC Davis Trade Policy and Health Collection - documents collected via FOIA requests for communications related to food industry influence on global trade policy and health.
3485 new documents posted to the USRTK Food Industry Collection - these materials largely contain communications between the Coca-Cola Company, the Pennington Biomedical Research Center, IFIC, and other related scientists/academics regarding ILSI, obesity, sugar and exercise.
97 documents added to the Fredrick Stare Papers - this batch of new documents completes our collection of Stare Papers. Dr. Stare was an American nutritionist regarded as one of the country’s most influential teachers of nutrition. In 1942, Stare founded the Department of Nutrition at the Harvard School of Public Health, now the Harvard T.H. Chan School of Public Health. In 1978, Stare co-founded and served as chairman of the Board of Directors for the American Council on Science and Health (ACSH). Our holdings now total 14,461 documents.
Opioid Industry Documents Update:
46 deposition videos uploaded to the Mallinckrodt Litigation Documents.
These videotaped depositions of Mallinckrodt employees and executives were taken in the opioid lawsuits and complement the already existing deposition transcripts.
UCSF is now an institutional member of the Qualitative Data Repository!
The Qualitative Data Repository (QDR) is a dedicated archive for storing and sharing data (and accompanying documentation) generated or collected through qualitative and mixed-method research. UCSF researchers can use QDR to discover qualitative data for secondary research, and to share their own research data to satisfy publisher and funder data sharing requirements, including the new NIH Data Management and Sharing Policy. As institutional members, UCSF researchers can deposit their data in QDR for free by signing up with their UCSF email. Learn more about this exciting development.
As a junior associate at a big New York City law firm in the early 2000s, I spent my days—and nights—conducting document review. It was not considered to be a choice assignment, but quickly grew into an obsession. With the latest release of Mallinckrodt and McKinsey documents, journalists and the public have a unique opportunity to further explore the cause of accountability in the opioid epidemic.
The “document review” process, circa 2004, began when the firm received boxes upon boxes upon boxes of company records. We hired contractors to scan them into PDF form, then worked with our tech specialists to devise scanning protocols (indicating how we wanted folders, stapled documents, paper-clipped documents or loose assortments to be represented, as well as the numbers to be stamped at the bottom). These “Bates” numbers, popping up on the bottom right corner of every page through which we subsequently rifled, populated our nightmares. I still think of all this work today: there is so much invisible and essential labor in the creation of an electronic collection of images that are not only relevant but presented in their authentic form.
Once the documents had been uploaded into the software program we used for review, we designed protocols for hierarchical tagging systems, which meant every sheet of paper would be categorized, analyzed and ranked by its content, creator, date, topic, relevance or “hotness.” Senior partners could then review their black binders of critical documents with the knowledge that everything below had been filtered by everyone below. As we made our way through each set of documents, we worked with the tech team to roll out “productions” in paper and electronic form, with accompanying privilege logs and cover letters. The entire process was rife with potential dangers: one missed redaction, one unintended enclosure, and your reputation would be toast. I still tremble at the memory of a few all-caps email messages I received in the middle of the night, on my Blackberry, calling me to task for a Bates number error or unintentionally blank sheet.
My obsession with document review thus originated from self-preservation and fear. It developed into a passion when I prepared my first deposition. The defendant was a former New York State corrections officer who’d been accused of raping a female inmate. Though I had my binder of “hot docs” at the ready, it was my understanding of the body of documents we had obtained—their substance, their deficiencies and their gaps—that allowed me to maintain a sense of direction and achieve our deposition goals.
A few years later, as an Assistant District Attorney in Manhattan, I was working with a junior ADA on an investigation. It was “impossible,” he complained, to get through all the cell phone records we’d obtained in the time we had. It took me a moment to understand that he, unlike me, was not in a state of grateful enchantment before this trove of information.
Before long, I was applying my document review skills to a landmark opioid prosecution. My case—involving a corrupt physician who sold controlled substance prescriptions in exchange for cash—was one of many that followed in the wake of Purdue Pharma’s fraudulent marketing of OxyContin. Without my “BigLaw” document skills, I never would have been able to marshal the volume of documentary evidence we needed to build the homicide, insurance fraud and reckless endangerment angles of the case. And ironically, I’ve since applied those skills—developed at the law firm of Debevoise & Plimpton LLP, which represents Side B of the Sackler family—to support activists fighting against the Sacklers.
Documents are a gift to researchers, justice-seekers and students. Everything and everyone leaves a trace. The truth may not always be what you expect, but skillful, careful and honest document review will allow you to make your peace with it.
The possibilities for research and reporting using OIDA documents are rich, as we’ve already seen with Washington Post, Salon, and New York Times articles. I hope someone will choose to go through these documents with an eye to the contributions of the sales representatives and their supervisors, as well as the middle-level executives and the marketing teams. We—justly—have focused on members of the Sackler family and other high-profile industry leaders in seeking accountability for the opioid epidemic, but where are their foot soldiers now? In which industries are they peddling their skills at selling lies? I’ve taken just a few names and followed them into high-level pharmaceutical positions: who will conduct a more thorough examination? Have any of these individuals been held to task for their choices? Admitted their mistakes? Contributed any part of their ill-gotten gains to victims or any of their time to hard-hit communities?
Documents allow us to verify facts and rebuild a disappeared world: in the case of the opioid epidemic, the OIDA documents may well help us repair the damage and prevent this tragedy from ever happening again.