Editor’s Note: Ford Vox is a physician specializing in rehabilitation medicine. He is also a journalist whose work ranges from investigations to analysis, including his frequent contributions to CNN Opinion. Follow him on Twitter @FordVox. The opinions expressed in this commentary are the author’s own. View more opinion at CNN.
If this week’s $572 million opioid liability verdict in Oklahoma is any indication of a trend to come, the nation’s automakers should be worried. Johnson & Johnson just got retroactively punished for the consequences of conducting its business legally according to the regulations of the time. When legal commerce generates results we don’t like, it’s worth asking who designed the marketplace, and who sets the rules. Those folks weren’t defendants in this trial.
Automakers are well aware that fossil fuel emissions are contributing to climate change. For that matter, the auto company is aware tens of thousands of people have died in accidents involving its vehicles, and that deaths will continue so long as their products keep rolling off the assembly line.
The auto business is far from perfect, but because of its vehicles, millions of folks get back and forth to work every day, make the PTA meeting, or take to the open road, vacationing at beaches and mountains with their families, renewing spirits, forging bonds, living happier and healthier lives.
Similarly, Johnson & Johnson made drugs – Fentanyl patches and Nucynta pills – that successfully treat pain and have improved many lives. It also manufactured the base active drug sold to many other pharmaceutical companies who make riskier drugs, like oxycontin – that also brought relief, but more in the way of death and destruction. So far society hasn’t insisted that automakers eliminate all emissions or prevent all deaths. The current NHTSA safety and emission standards it’s forced to meet must be barbaric compared to what we’ll expect in 2050.
Just how far in advance of the rules actually changing should automakers predict the future? At what point should J&J have pulled out of the poppy-growing business?
The science of pain treatment is a moving target, and the cavalier conclusions about the side effects and addictiveness of prescription drugs in the mid-1990s through the early 2000s are no longer acceptable.
Norms change – and not just for big pharma. Increasingly, auto manufacturers are facing market pressure to transition out of the internal combustion engine toward electric vehicles. One day it likely won’t be acceptable to put gas guzzling Jeeps out on the streets. When that day comes, should automakers pay out for their share of global warming?
Maybe so, in Oklahoma, where years of legal business conduct can later be declared a public nuisance.
The opioids at issue are prescription-only products that can only be doled out by licensed medical professionals who make their own judgment as to the appropriateness of the drug in any given case. Where those professionals get their information and whether they are up to the job at hand is actually the state’s job to determine, not any pharmaceutical company’s.
Some of the biggest factors in the opioid epidemic have to do with a confluence of bad policies and bad regulation, which Oklahoma and other states should have attended to more closely. The state could do more about climate change, too.
To get opioids to market and keep them there in one of the most regulated industries in the United States, manufacturers had to navigate a thicket of federal and state regulations. Why didn’t regulators at the state and federal level cut down on supply as data began to show that far too many opioid prescriptions led to dependency and addiction, or were diverted into the black market – and ultimately cost countless lives?
Other big pharma players have also been hit with legal consequences for Oklahoma’s opioid crisis, but settled their more damning cases for far less money. Purdue Pharma has already seen its executives plead guilty to hiding addiction risks; internal documents show the company knew OxyContin was being abused while the company doggedly kept to the line that the product was highly abuse deterrent. Purdue settled with the state of Oklahoma for $270 million, followed by Teva Pharmaceuticals, which also made highly abused opioids including hydrocodone, settling for $85 million.
Only J&J was left holding the bag in court. The state’s prosecutor slammed J&J’s field representatives and literature for encouraging opioid usage for chronic non-cancer pain. While J&J and other companies incestuously helped create the medical culture in the late ’90s and early 2000s that normalized liberal opioid prescribing, the now-scandalous intersection of business, scientific publication and medical practice was legal at the time.
J&J’s representatives understandably spoke about its drugs being safer than other opioids: they were safer. Duragesic (a brand of fentanyl patch) is a slow-release skin patch which has never been the favorite of prescription opioid drug abusers. It is possible to abuse this patch, but is the answer to say that the manufacturer shouldn’t have put the drug on the market for the many more patients who have benefited from it?
Nobody’s concerned about “patch mills” – the concern is pill mills. Then there’s the J&J drug Nucynta (generic name tapentadol). This is a dual-action opioid that stimulates additional pathways in the brain in the hopes of delivering more effective pain treatment at lower doses of opioid. It’s not a primary target of abuse.
If anything, many doctors think tapentadol should be used more often in place of other pure opioids on the market due to its superior risk profile. I’m one of them. One of the biggest problems with tapentadol is that insurance plans often won’t cover it, preferring that a doctor prescribe more dangerous but cheaper opioids like hydrocodone or oxycodone.
The liabilities for any individual case of opioid misuse dissipate as you step further away from the patient-doctor relationship. Yet the pockets grow deeper the further up the chain you get from that interaction.
The big money in medicine is housed with the pharmacies, the distributors, the insurers, and the pharmaceutical companies. The key legal maneuver for Oklahoma and others who hope to mount similar cases is to demonstrate that those with the deepest pockets recklessly influenced the doctor-patient relationship in ways that made them party to the bad prescribing.
We know that pharmaceutical marketing can influence doctor’s behaviors, which is why these for-profit companies spend their money on the practice. It’s also why, as the problem of pharma’s influence on medical practice has been increasingly recognized, medical centers, universities and professional societies have started to clamp down on those interactions. The oddity of Oklahoma’s case is that these activities were legal and normal at the time – J&J made clear that the content of its communications was legal.
Everyone involved in the chain of prescription opioid abuse, save for the patient, is a licensed professional or entity, and various state agencies and boards are responsible for policing them. How does the manufacturer of a product that can be used for good or ill get stuck with the bill for the entirety of harms to which it may have been only a minor party, if at all? Courts previously rejected the same nuisance prosecution of the gun industry, which makes a product that kills by design.
The state’s mantra in this case was “if you have an oversupply, people will die,” but that slogan oversimplified the fact that the supply is controlled by the federal and state governments at every level, and only made its way to users through a state-licensed professional.
Meanwhile, the state of Oklahoma knew who the overzealous prescribers were but didn’t take appropriate action against them while the crisis was developing. It’s also hard to fault auto dealers for selling cars to drivers with active licenses, despite DUIs they don’t know about.
Bigger trends in health care, especially in red states like Oklahoma, play a role in how vicious any state’s effort to curb the opioid crisis might be. Oklahoma resisted the Affordable Care Act’s offer of Medicaid expansion, which could have offered low-income residents alternative treatment options to quick-fix opioids, and helped the addicted get effective treatment.
A misguided movement to promote pain as a “fifth vital sign” in hospitals and clinics was the culmination of a decade of overly-heady opioid promotion with organic sources in the medical profession – and symbiosis with the pharmaceutical industry’s interests as well. Today it’s widely recognized that elevating pain to such prominence, via omnipresent questioning, fosters overtreatment.
The states are responsible for policing the medical profession, including requirements about opioid education, and how providers utilize drug monitoring systems to screen for patients who may be diverting pills by getting them from multiple sources. While Oklahoma was one of the first with a drug monitoring database, it didn’t require prescribers to check it until 2015.
The states are also responsible for regulating their respective insurance industries, an option more laissez-faire governments like Oklahoma’s don’t seem to exercise enough when it comes to fixing public health priorities like the spiraling opioid addiction crisis.
Highly profitable insurance companies have stood in the way of effective medication-assisted treatment with buprenorphine, a drug that both helps get people off of deadly opioids and can be used as an alternative first-line pain treatment in high-risk populations. Insurers routinely thwart clinician’s efforts to use the drug by restricting coverage of it, something that’s happened to me many times. Recently a trio of medical societies are trying to push back by advocating the necessity of the life-saving medication.
We know that rehabilitation interventions can be highly effective alternative treatments to pain meds or surgery for a variety of painful musculoskeletal conditions, the kind that lead many people to their first prescription opioid exposures. Yet too often insurance companies deny these opioid alternatives. States don’t have to let that happen.
Laying the blame in the opioid crisis is complex. I sympathize with Oklahoma’s desire to gain funds to cope with the current situation. I can understand why a judge who knows he’ll go down in history as the “opioid judge” and could be thinking about re-election settled on this tortured legal reasoning. Structural change is required. Courts won’t solve climate change either. Voters and our representatives share responsibility for a better future.