A day rarely goes by without opioids making headlines in the national news. With overdoses still at staggering highs (the Centers for Disease Control and Prevention estimates that 115 Americans die every day from opioid overdose), it has become one of the most devastating health problems in U.S. history.
Recently, however, the front lines have shifted from the doctor’s office to the streets as illicit fentanyl — a potent opioid that’s often made in China
and smuggled into the U.S. — becomes the prime source of overdose and death.
But that doesn’t mean the pharmaceutical industry is done grappling with this crisis. In fact, by many measures, the legal, regulatory and market fallout has just begun.
Years ago, the U.S. Food and Drug Administration took calculated steps to address the situation. Now, the agency is in a full-on gallop towards the goals of preventing addiction, curbing abuse, and expanding treatment for opioid addicts — all while attempting to protect the needs of chronic pain patients.
Meanwhile, several key industry players have launched other programs to help — from educating healthcare professionals about prescribing opioids to adjusting formulations to deter abuse. R&D teams have also sprung into action to develop alternative painkillers or new opioid medications that carry fewer addiction risks. Dozens of new drugs to treat pain and addiction are also on the horizon and could soon be in reach.
While opioid lawsuits continue to play out in the legal system, outside the courtrooms, focus has shifted towards mitigation strategies, as regulators, manufacturers and researchers help pick up the pieces of the opioid storm.
The Blame Game Continues in the Courts
The history of the rising prescription rates for narcotics and addiction have been well documented, and despite the changing patterns of drug abuse, pharmaceutical companies are still taking the brunt of the blame. The American legal system is fast becoming the main theater for the ongoing drama.
What began as a handful of local governments suing major opioid manufacturers such as Purdue Pharma and Johnson & Johnson a few years ago, has turned into an avalanche of litigation. Currently, drugmakers and distributors are staring down more than 250 lawsuits from states, counties and even hospitals.
Many of the plaintiffs are hoping to recoup the various costs associated with the rising needs of addiction treatment. Even though many opioid abusers are now hooked on heroin or fentanyl, the plaintiffs accuse manufacturers of misleading the public about the addiction risks associated with prescription painkillers and often point to Purdue’s marketing of Oxycontin as the prime trigger of the epidemic.
More than a decade ago, executives from Purdue pleaded guilty to charges that they misled the public about Oxycontin’s risks and agreed to pay $634 million in fines that were divvied up between private parties, and state and federal agencies.
But Purdue has also netted about $35 billion in sales from Oxycontin since it began marketing the drug in 1996, and many of the plaintiffs claim that the company hasn’t paid its fair share for the medication’s impact.
The company is certainly facing a mountain of legal costs now and finds itself in a tricky conundrum: If Purdue settles any cases, it could lead others to sue. For this reason, the company is reportedly hoping instead for a global settlement — similar to the settlement that was made with tobacco companies in 1998. A U.S. district judge in Cleveland reportedly has the same goal, and has been in talks with manufacturers and various agencies about coming to an agreement before all of the parties involved become entangled in years of costly litigation.
Critics point out that manufacturers may not be willing to pay a sum even close to the estimated $500 billion a year opioid addiction costs the country. Pharma companies could also make a strong case that they shouldn’t be forced to financially compensate for addiction now that the epidemic is more closely linked to street drugs.
Because these talks just began this winter, it remains to be seen if manufacturers will walk away with a settlement deal or be stuck in the long, legal shadow Oxycontin has cast for years to come.
The Industry Response
Like many industries, the pharma world has never been without some controversies. And after any disaster, there’s always a period of introspection when the dust settles, the damage is assessed and the hard lessons are learned, so that mistakes won’t be repeated.
In the case of opioids and other potentially addictive medications, the tone of the conversation throughout the industry has taken a dramatic shift in recent years according to Ed Elder, the director of the Lenor Zeeh Pharmaceutical Experiment Station and a professor at the UW-Madison School of Pharmacy.
“For a long time, the industry focus was on providing the benefit [of painkillers] and not mitigating the risk,” he says. “Now there’s a been a lot more focus on...finding mitigation strategies to address that.”
Even though many in the industry have been accused of causing the epidemic, they are now stepping up to show they have some of the best solutions, too.
Among the dozens of opioid manufacturers in the U.S, you’d be hard pressed to find one that has taken more of a leading role on that front than Purdue. So far, Purdue has expressed support for limiting the length of first opioid prescriptions, the use of prescription monitoring programs, switching to abuse-deterrent formulations for opioids and most recently, promised to stop its sales force from touting the benefits of opioids to doctors.