Corporate cartel logic

For Chris, it started with a trip to a Sacramento emergency room in 2010. Presenting with extreme abdominal pain, he was given the opioid Dilaudid every four hours. Then the doctors sent him home with a bottle of OxyContin. Chris—not his real name—said he got zero advice about possible side effects or symptoms of withdrawal.

Two years later, Chris was slumped in the darkened cab of a car, his arm tied off for a needle, his face turning blue, his heart barely pumping.

Chris avoided the body bag, but many didn’t. According to the California Department of Public Health, 91 people in the Sacramento region fatally overdosed on opioids last year. The National Institute on Drug Abuse estimates that the bridge from legal prescription to hardcore dependency kills 90 Americans every day.

In Chris’ view, those numbers don’t tell the whole story. They don’t show how a patient who’s legitimately given opioids will devolve into an addict with crawling skin, who steals from loved ones to stave off the sickness, and embarks on a double life of owing money to multiple drug dealers or facing a gun in a parking lot.

“I was super depressed and suicidal,” Chris remembered. “I didn’t really know a way out.”

Chris is aware that Sacramento is one of 31 California counties now suing some of the largest pharmaceutical producers in the nation on charges that they violated the Racketeer Influenced and Corrupt Organizations Act, better known as the RICO Act—and better known for being used to go after organized crime. While Chris isn’t part of those actions, he’s paying attention to what happens next. He wants to know if anyone can really reign in Big Pharma.

The lawsuits are all separate, but have been constructed by the same attorney using much of the same evidence. And together they make a case for a massive corporate conspiracy.

The consortium of counties is being represented by San Diego attorney John Fiske, who’s arguing that five of the world’s largest pharmaceutical manufacturers launched a coordinated plan to normalize opioid use while intentionally downplaying the known dangers.

Using everything from letters sent between regulators to affidavits from the Justice Department, Fiske claims he can outline exactly how Big Pharma’s conspiracy worked: By spending millions of dollars on planting misleading articles in scientific journals; by hiring compromised doctors to take part in sham speakers’ bureaus; by creating elaborate fronts that masqueraded as patient advocacy crusaders; and by finding various schemes to pay the majority of doctors serving on the board that wrote widely used guidelines for opioid prescriptions.

The latest county to hire Fiske to file suit in the U.S. Eastern District of California was Amador. A land of old western towns and sprawling ranches, it may not conjure images of opioid and heroin addiction, but leaders there say they’ve been overwhelmed by the unfolding crisis.

State health records indicate that at least 30 people died of opioid overdose between 2014 and 2017. Similarly, Amador’s lone emergency room dealt with overdoses at a rate of 44 per 100,000 residents last year, the third highest rate in the state. County health records indicate that, in 2016, Amador’s opioid prescription rate was 112.3 scripts per hundred people. In other words, more than one opioid script for every resident.

“It impacts public health, the emergency room, behavioral health, social services, probation, child protective services, law enforcement,” said Dr. Rita Kerr, head of Amador’s public health department. “All areas of county services are touching the problem in one way or the other.”

Similar to other suits filed by Fiske, Amador County’s 300-page complaint alleges that Big Pharma conspired to maximize profits off one of the greatest death epidemics in modern American history.

The story, according to the suit, started in the early 1990s, when opioids were mainly prescribed to cancer patients and people recovering from major surgery. Citing the work of investigative reporters, memos from the U.S. Surgeon General and documents from the Food & Drug Administration, Fiske charges that some of the largest pharmaceutical companies began a coordinated “marketing enterprise” to normalize opioids as a standard treatment for chronic pain. Among the biggest players in this sales push were Purdue Pharma, the maker of OxyContin; Janssen Pharmaceutical, the maker of Duragesic, generically called fentanyl; Endo Pharmaceutical, the maker of Opana; Insys Therepeutics, the maker of Subsys; and Cephalon Inc., the maker of Fentora.

The companies began spending millions on advertisements in medical journals, which, according to the suit, shared a misleading “core message” about the safety and proven effectiveness of using opioids for pain management. By the mid-2000s, the Justice Department learned that some of the companies were hiding internal data that showed just how dangerous opioids were.

In 2007, three of Purdue’s top executives pleaded guilty in federal court to charges of criminally “misbranding” products, as well as misleading regulators about the risks of opioids. That same year, Purdue agreed to pay more than $600 million to various states that were suing it for reckless advertisement.

Fiske is prepared to argue that the publicity did nothing to change the companies marketing playbook. Fiske plans to present evidence that defendants spent a combined $168 million on questionable journal advertising, spurious brochures and biased websites as recently as 2014. He says evidence will also prove they deployed scores of sales representatives to make personal visits to doctors and medical staffs in the same time frame.

While the level of direct marketing that continued after Purdue’s criminal trials may have surprised some jurisdictions, the lawsuits from California counties allege there were even more elaborate financial transactions going on. Fiske is on course to be the first in the state to make that case in court.

The terms “unbranded marketing” and “key option leaders” sound benign. According to testimony from a former Insys employee, they were euphemisms for a thinly veiled payoff campaign.

In 2012, Insys whistleblower Ray Furchak claimed the company’s speakers program—ostensibly a way for doctors to educate fellow health professionals at conferences—was actually a ruse to secretly reward physicians for prescribing large amounts of the opioid Subsys. The Justice Department looked into the program and investigators for the state of Illinois began their own probe around 2015.

“The speaker events took place at upscale restaurants in the Chicago area, and Illinois speakers received an ‘honorarium’ ranging from $700 to $5,100, and they were allowed to order as much food and alcohol as they wanted,” Fiske wrote of the investigative findings that resulted. “At most of the events, the ‘speaker’ being paid by Insys did not speak, and, on many occasions, the only attendees at the events were the speaker and an Insys sales representative.”

Insys’ owner is currently being charged with a number of felonies in federal court, and some of the prescribers working for his speakers program have since been sent to prison. Meanwhile, the company made more than $330 million off marketing Subsys in the last four years.

Insys was allegedly not an outlier in its use of unbranded marketing. The counties’ lawsuit claims that by funding special “professional societies,” the pharmaceutical companies were able to advertise opioids in the medical community—and lobby politicians on drug policy—in ways that completely dodged the FDA’s reviewing process. They reportedly did this by financially backing “front groups” like the American Pain Foundation, American Academy of Pain Medicine and the American Geriatrics Society. The suit alleges Cephalon, Endo, Janssen and Purdue all spent millions funding these pro-opioid use organizations, which were publicly claiming to be independent patient advocacy groups.

According to whistleblowers who quit AAPM/APS, the same Big Pharma operators were also channeling research funding, consulting fees and honorarias to many of the doctors involved in those groups, including 14 of the 21 experts who drafted the AAPM/APS guidelines for prescribing opioids.

The pharmaceutical companies’ joint participation in funding these societies is a lynchpin in Fiske’s theory of racketeering and conspiracy. So too is the “core message” they all adhered to in their various marketing initiatives. The counties’ suit claims such actions amount to Cephalon, Endo, Janssen, Insys and Purdue all being part of an “association-in-fact enterprise.” According to Fiske, personal relationships, industry forums and joint lobbying groups all played into it.

“Purdue believes the accusations against the company are without merit and we look forward to the opportunity to present our substantial defense,” Bob Josephson, Purdue’s executive director of communications, told SN&R this week.

Janssen has called the counties’ allegations “baseless and unsubstantiated” in a statement. INSYS declined to comment, citing concerns over pending litigation. Cephalon and Endo did not respond to requests for comment.

Last week, Sacramento County Counsel Robyn Truitt said the purpose of the lawsuit is to recover taxpayer dollars spent on combating opioid addiction and “prevent the proliferation of the crisis.”

Greg Gillott, an Amador County attorney, and Kerr said their foothill jurisdiction’s motivations are the same, though they cite a more immediate need. After next year, funding runs out for the opioid overdose reverse kits public safety officers carry. County officials are hoping a settlement with the pharmaceutical companies could keep the program going.

For Chris, who nearly lost his life to an opioid addiction that started within the medical profession that Big Pharma allegedly manipulated, the lawsuits that Sacramento, Amador and other counties are pressing are important.

“I think they were really trying to push sales—they were pushing their product,” Chris said of the pharmaceutical companies. “They were saying, ‘This is better, this is safer, this is less addictive.’ … I think they should be held accountable.”