Editor's Corner: Investigations into opioid marketing could bring second wave of billion-dollar settlements

 

When something goes wrong, we look for someone to blame. A kid fell into a gorilla habitat? Blame the parent; or the zoo--whichever you prefer.

The opioid abuse crisis offers several enticing avenues for blame: Physicians overprescribed addictive medication; the healthcare system ignored signs of addiction; heroin dealers capitalized on a cheaper product; law enforcement didn't crack down hard enough on drug dealers; The Joint Commission created obscure pain standards; and, while we're at it, toss the patients in the ring for succumbing to an addiction.

It feels good, doesn't it? There's a visceral satisfaction in being able to point to point the finger and say, "They did it." Problem solved.

Like opioid addiction, most of the world's controversial issues are so muddled and tangled it's hard to untie the knot completely. But as we untangle the impossibly complicated knot of opioid addiction, more evidence is pointing to pharmaceutical manufacturers as the group that laid the ugly foundation for the addiction epidemic.

Just to reiterate: It takes more than one party to create a problem this size. Drug companies are not wholly to blame for the 1.9 million Americans who were addicted to prescription painkillers in 2014, or the nearly 19,000 who died as a result. But at the risk of mixing metaphors, they were the match that started the fire. Then they added a steady stream of gasoline in the form of questionable marketing practices.

In some cases, pharmaceutical companies have already faced legal action for marketing tactics surrounding opioids. In 2007, Purdue Pharma pleaded guilty to misbranding OxyContin, suggesting that it was less addictive than other painkillers. The company settled for nearly $635 million, but continues to write checks to other states seeking to recover damages, such as Kentucky, whichreceived a $24 million settlement from Purdue in December, more than 50 times what the state was originally offered in 2007.

As the addiction crisis has peaked, more lawsuits and federal investigations are exploring pharma's role in pushing opioids into the hands of doctors and patients. Following an in-depth investigation by the Los Angeles Times into Purdue Pharma's shaky claims that OxyContin relieves pain for 12 hours, Sen. Edward Markey (D-Mass.) has called on the Justice Department to intervene, arguing "Purdue's aggressive-- illegal--marketing efforts" played a key role in the addiction epidemic purely for the sake of profit.

Driven almost exclusively by the need to combat "serious generic competition" following an expired patent of another pain medication, Purdue essentially reverse engineered OxyContin, marketing the drug as 12-hour pain relief, despite evidence that showed it didn't last that long. No matter. A sales force of 600 drove sales up to $3 billion by 2010 by pushing the 12-hour dosing.

I know. You've heard this story before. The industry's largest fraud settlements--totaling billions of dollars--have largely been linked to unsavory and illegal marketing tactics for other drugs, not unlike the ones laid out by the LA Times. Except this time, the drugs they were peddling just so happened to ignite an addiction epidemic.

In 2012, the Senate Finance Committee launched an investigation into the relationship between several pharmaceutical companies--including Purdue Pharma, Endo Pharmaceuticals and Johnson & Johnson--and seven different medical groups, including the American Pain Society. Last year, dozens of organizations urged the Senate to release the findings of the investigation, which have still not been made public.

Cities and states are getting into the legal mix, as well. The City of Chicago is going after six drug makers for downplaying the addiction risks tied to opioids. A case filed in 2014 by Orange County and Santa Clara County against five pharmaceutical companies has been put on hold until the FDA completes its investigation, the LA Times reports. The Mississippi Attorney General is preparing to bring claims against eight pharmaceutical companies, as reportedby Legal NewsLine, and New Hampshire has reignited its investigation into opioid marketing practices.

Settlements with drugmakers have dropped precipitously over the last two years, but perhaps a second wave is cresting. If so, it would serve as the ultimate test for the DOJ's recent emphasis on individual accountability. And maybe it would allow us to start leveling blame against the organizations that deserve it most. - Evan (@HealthPayer)