A major pharmaceutical company lied and misrepresented its powerful opioid product for profit, putting people at risk in the worsening opioid epidemic, according to a new bombshell report by Sen. Claire McCaskill (D-MO).
The report, which McCaskill’s office has described as the first round of an investigation into opioid companies, details the workings of Insys Therapeutics, which manufactures the fentanyl drug Subsys. According to the report, Insys misrepresented Subsys to get insurers to pay for it, letting the company sell its product to people who didn’t need and shouldn’t have access to such a powerful drug.
“In the case of Subsys patient Sarah Fuller, an audio recording reveals that an Insys employee repeatedly misled representatives of Envision Pharmaceutical Services to obtain approval for her prescription,” the report found. “The result, in the case of Ms. Fuller, was death due to allegedly improper and excessive Subsys use.”
McCaskill’s report provides a grim snapshot of one reason the opioid epidemic became the deadliest drug overdose crisis in US history: Driven by a quest for profit, opioid makers and distributors misled doctors, insurers, patients, and the general public about their drugs — claiming that they are safe and effective for conditions that they would turn out to be neither safe nor effective for. The drugs proliferated across the US, and tens of thousands of people have died annually for years as a result of opioid overdoses.
What McCaskill’s office found
In 2012, Insys found that Subsys got reimbursement approval from insurers in only about 30 percent of cases — a pretty low rate. So the company set up a special unit, known as the Insys Reimbursement Center (IRC), to try to get that number up.
There was a lot of pressure to do this, according to McCaskill’s report: “Led by an Insys employee named Elizabeth Gurrieri, IRC employees reportedly received significant financial incentives and management pressure — including quotas and group and individual bonuses — to boost the rate of Subsys authorizations.”
At the same time, an internal document uncovered by McCaskill’s team found that IRC failed to maintain “even basic measures” to make sure staff weren’t lying and misleading insurers so they would pay for Subsys when patients didn’t really need the drug. The unit took part in a lot of shady behavior as a result, even allegedly falsifying patients’ medical records to help them attain prescriptions.
Here’s the problem: Subsys is a very powerful drug. It is highly potent and addictive. That’s why it’s meant for cancer pain patients. These patients typically need end-of-life care, meaning the risk of addiction isn’t as big of a concern, and many have already developed a tolerance to opioids from previous use.
So when Insys representatives misled and in some cases flat-out lied about a patient’s needs, they helped push a dangerous drug to people who didn’t need it. The results are often misuse, addiction, and death.
Insys was apparently aware of this, McCaskill’s report found: “According to a class action lawsuit, Insys management ‘was aware that only about 10% of prescriptions approved through the Prior Authorization Department were for cancer patients,’ and an Oregon Department of Justice investigation found that 78% of preauthorization forms submitted by Insys on behalf of Oregon patients were for off-label uses.”
And the company allegedly knew, based on internal documents, “that the IRC lacked formal policies or monitoring procedures to ensure proper communication between Insys employees and healthcare professionals.”
In short, the company allegedly knew its very dangerous product was being used for unintended purposes — yet it continued pushing more prescriptions for higher profits anyway.
McCaskill’s report points to the story of Sarah Fuller as an example: Based on an audio recording, the team found that an Insys employee misrepresented herself as “with” the office of Fuller’s doctor to representatives for a pharmacy benefit manager. The Insys employee then suggested — albeit with careful wording to avoid the use of the word “cancer” — that Fuller, who did not have cancer, needed Subsys for “breakthrough pain.” The prescription was approved. Fuller later died “due to an adverse reaction to prescription medications.”
Insys did not respond to a request for comment. But the company told McCaskill’s office that it had “completely transformed its employee base over the last several years,” and has “actively taken the appropriate steps to place ethical standards of conduct and patient interests at the heart of [its] business decisions.” And in June, Gurrieri, the former head of IRC, pled guilty for conspiring to defraud insurers.
McCaskill’s office said it intends to “continue to evaluate whether these efforts have resulted in a true transformation of the Insys corporate culture.” And this is just one part of her office’s efforts to hold opioid makers accountable in the middle of the US’s overdose crisis.
This isn’t the first report to reach these types of conclusions
Perhaps no single data point makes the connection between drugmakers and the opioid epidemic clearer than the following chart from an analysis published in the Annual Review of Public Health, which shows how increases in opioid sales went hand in hand with increases in opioid overdose deaths and drug treatment admissions:
Much of this was the result of misleading marketing by major drug companies.
As an extensive Los Angeles Times investigation found, Purdue’s opioid OxyContin was marketed for its supposed ability to provide 12 hours of pain relief. But as Harriet Ryan, Lisa Girion, and Scott Glover reported, “Even before OxyContin went on the market, clinical trials showed many patients weren’t getting 12 hours of relief. Since the drug’s debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research.”
This was critical to Purdue’s competitive advantage: If it really didn’t provide 12-hour relief, then it wasn’t more effective than other similar painkillers on the market. In the face of the evidence, though, Purdue stood by its claim for years. And it told doctors that if patients weren’t seeing the promised results, then the problem was that doses were too low.
These efforts, it seems, were in the name of profit. One sales memo uncovered by the Times was literally titled “$$$$$$$$$$$$$ It's Bonus Time in the Neighborhood!”
This is alarming for public health: As the Centers for Disease Control and Prevention warned, higher doses significantly increase the risk of overdose and addiction.
The Los Angeles Times investigation found, “More than half of long-term OxyContin users are on doses that public health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times.”
Opioid makers’ claims that their drugs are an effective treatment for chronic pain are similarly faulty. There’s simply no good scientific evidence that opioid painkillers can effectively treat long-term chronic pain as patients grow tolerant of opioids’ effects — but there’s plenty of evidence that prolonged use can result in very bad complications, including a higher risk of addiction, overdose, and death. In short, the risks outweigh the benefits for most chronic pain patients.
Yet opioid makers were highly influential in perpetuating the claim that their drugs can treat chronic pain. Several public health experts explained the recent history of opioid marketing in the Annual Review of Public Health, detailing Purdue Pharma’s involvement after it put OxyContin on the market in the mid-1990s:
Between 1996 and 2002, Purdue Pharma funded more than 20,000 pain-related educational programs through direct sponsorship or financial grants and launched a multifaceted campaign to encourage long-term use of [opioid painkillers] for chronic non-cancer pain. As part of this campaign, Purdue provided financial support to the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards, the Joint Commission, pain patient groups, and other organizations. In turn, these groups all advocated for more aggressive identification and treatment of pain, especially use of [opioid painkillers].
As a result of the misleading claims, Purdue and several of its chief executives paid more than $600 million in fines in 2007.
But based on McCaskill’s report and other investigations, that kind of shoddy behavior has continued — likely making America’s deadliest drug overdose epidemic even worse.
The opioid epidemic, explained
In 2016, more Americans died of drug overdoses than any other year on record — more than 64,000 people in one year, based on preliminary figures from the National Center for Health Statistics. That’s higher than the number of Americans who have ever died from car crashes, gun violence, or HIV/AIDS during any single year.
This latest drug epidemic, however, is not solely about illegal drugs. It began, in fact, with a legal drug.
Back in the 1990s, doctors were persuaded to treat pain as a serious medical issue. There’s a good reason for that: About 100 million US adults suffer from chronic pain, according to a 2011 report from the Institute of Medicine.
Pharmaceutical companies took advantage of this concern. Through a big marketing campaign, they got doctors to prescribe products like OxyContin and Percocet in droves — even though the evidence for opioids treating long-term, chronic pain is very weak (despite their effectiveness for short-term, acute pain), while the evidence that opioids cause harm in the long term is very strong.
Painkillers proliferated, landing in the hands of not just patients but also teens rummaging through their parents’ medicine cabinets, other family members and friends of patients, and the black market.
As a result, opioid overdose deaths trended up — sometimes involving opioids alone, other times involving drugs like alcohol and benzodiazepines (typically prescribed to relieve anxiety). By 2015, opioid overdose deaths totaled more than 33,000 — close to two-thirds of all drug overdose deaths. (The figures for 2016 aren’t added up just yet.)
Seeing the rise in opioid misuse and deaths, officials have cracked down on prescriptions painkillers. Law enforcement, for instance, threatened doctors with incarceration and the loss of their medical licenses if they prescribed the drugs unscrupulously.
Ideally, doctors should still be able to get painkillers to patients who truly need them (and they can work for some individual chronic pain patients) — after, for example, evaluating the patient’s history of drug addiction. But doctors, who weren’t conducting even such basic checks, are now being told to give more thought to their prescriptions.
Yet many people who lost access to painkillers are still addicted. So some who could no longer legally obtain painkillers have turned to illegally obtaining the cheaper, more potent opioids: heroin and fentanyl, a powerful synthetic drug.
Not all painkiller users went this way, and not all opioid users started with painkillers. But statistics suggest many did: A 2014 study in JAMA Psychiatry found 75 percent of heroin users in treatment started with painkillers, and a 2015 analysis by the Centers for Disease Control and Prevention found that people who are addicted to painkillers are 40 times more likely to be addicted to heroin.
So other types of opioid overdoses, excluding painkillers, also rose.
That doesn’t mean pulling back on the number of painkiller prescriptions was a mistake. It appeared to slow the rise in painkiller deaths, and likely prevented doctors from prescribing opioids to new generations of people with drug use disorders.
But it must be paired with more access to addiction treatment. According to a 2016 report by the surgeon general, just 10 percent of Americans with a drug use disorder obtain specialty treatment. The report found that the low rate was largely explained by a shortage of treatment options.
So federal and state officials have pushed for more treatment funding, including medication-assisted treatment like methadone and buprenorphine.
Some states, like Florida and Indiana, have taken a "tough on crime" approach that focuses on incarcerating drug traffickers. But the incarceration approach has been around for decades — and it hasn’t stopped massive drug epidemics like the current crisis.