Shedding Light on How Pharma Does Business

When I started reporting on the Insys Therapeutics saga in late 2016, for a feature published much later in The New York Times Magazine, the story was still unfolding. Some senior executives of the company had recently been indicted, but the founder and majority owner, John Kapoor, was still untouched. His arrest was still to come. It was unclear where it would all lead.

What was clear, however, was that the story would deliver new revelations, the lifeblood of journalism. For me, the draw was not just for more insight into the incredible human drama inside Insys and at the pain clinics its sales force descended on to sell their fentanyl drug (though admittedly there was plenty of curiosity about that). The hunger was also for something bigger—for an unprecedented access to insider knowledge about how powerful opioid painkillers are marketed and sold in America, in the midst of a national health crisis.

When drug companies come under investigation for their marketing and sales practices, as they routinely do, the Justice Department’s tried-and-true strategy is to pursue the company in a probe that looks more like a negotiation among colleagues; it involves packs of lawyers, many of them billing unbelievable amounts, who talk things over. The result is a settlement years later—a dollar figure that, for the company, puts the whole ordeal in the past. Whether the company admits to wrongdoing or not (and more typically it doesn’t), the unsavory details never get a full airing.

In the Insys case, prosecutors broke new ground by criminally charging the top executives as individuals. That brought a new level of accountability into play. Perhaps even more important, it pried open a window onto how the industry works on a granular level: the executives faced trial (pleading guilty carried too high a price), and there is nothing like the public reckoning of a trial. The internal strategies and tactics, the dossiers about the physician “targets,” the bonus schemes that invited corruption, the pretextual “advisory boards” and “speaker bureaus,” the cheat sheets to deceive the insurers, the emails full of code words and infighting—it was everything we would never have seen in a settlement. I felt privileged to be there, attending every hour of a 10-week trial (and the agonizing four-week wait for the jury to return a verdict).

This release from the Opioid Industry Document Archive, adding up to approximately a million pages of newly public internal records, will take the public’s insight to a still deeper level. Scholars and reporters will be able to pursue new angles, focus their searches, and delve deeply into exactly how the opioid epidemic became big business. One lesson I drew from the Insys story was that the company’s methods were more brazen and careless — worse‚ in almost every way — from those of their peers, and that shouldn’t get lost in the discussion. But they were more different in degree than they were in kind. New dives into this archive will shed light not only on Insys — which was just one company, and not a very big one — but on how pharma continues to do business to this day.

New Insys and Purdue Pharma Documents Posted

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 Purdue Pharma Bankruptcy Transcripts Collection consists of 51 public volumes of hearing transcripts dated September 2019 to April 2022, and includes transcripts of the Bankruptcy Court confirmation hearings, the hearing before the District Court, and the hearing before the Second Circuit.
• The Purdue Pharma House Oversight Committee Investigation Collection consists of select documents produced by Purdue to the HOC as part of the HOC’s investigation into Purdue and the Sackler family, as well as the transcript from the HOC hearing on December 17, 2020. The documents consist primarily of emails and sales data. Also included are reports to the Purdue Board of Directors, Compensation Committee reports, and compliance reports, as well as reports and presentations from consulting firm McKinsey & Company. The House Oversight Committee released these documents to the public in 2020 and 2021.

Over 17,000 New Food Industry Documents Posted

• Carriedo A; Pinsky I; Crosbie E; Ruskin G; Mialon M. The corporate capture of the nutrition profession in the USA: the case of the Academy of Nutrition and Dietetics. Public Health Nutrition, October 24, 2022.
• Starks, Tricia. Cigarettes and Soviets; Smoking in the USSR. Cornell Press. October 1, 2022.
• Yakubi H; Gac B; Apollonio D. Industry strategies to market opioids to children and women in the USA: a content analysis of internal industry documents from 1999 to 2017 released in State of Oklahoma v. Purdue Pharma, L.P. et al. BMJ Open; 12. October 29, 2022.
• Zaltz DA; Bisi LE; Ruskin G; Hoe C. How independent is the international food information council from the food and beverage industry? A content analysis of internal industry documents. Global Health 18. October 29, 2022.

Telling Stories to Promote Change

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.