A crisis within a crisis

As daily COVID-19 cases, hospitalizations, and deaths break daily records in the United States, the nation's sweeping opioid epidemic rages on, claiming a record number of lives as well.

In Cook County, opioid overdose deaths have already surpassed 2019 numbers by 17%, and 70% to 80% of the office's 600 pending cases are expected to be attributed to opioid overdoses after examination, according to the county's chief medical examiner. Washington, D.C., saw its deadliest year on record for opioid overdoses this year, with April seeing the highest number of opioid deaths in the District in five years. After Virginia issued stay-at-home orders to curb the rising transmission of COVID-19, the state saw 67% more fatal drug overdoses.

In total, more than 40 states have reported increased opioid deaths since the beginning of the coronavirus pandemic.

But this year also saw the largest ever settlement by a pharmaceuticals company for its role in fueling the opioid crisis. Purdue Pharma, the manufacturer of the opioid drug OxyContin, pleaded guilty on Nov. 24 to felony charges that included paying illegal kickbacks to physicians who prescribed unnecessary or excessive doses of the drug. As part of the settlement, Purdue Pharma agreed to pay $8 billion to the United States and to dissolve the business to form a public benefit corporation, which would continue manufacturing drugs but steer profits from future opioid sales toward programs aimed at alleviating the addiction crisis. The Sackler family, which owned Purdue Pharma and served as company directors and board members before the company dissolved, agreed to pay $225 million in civil penalties and is battling an ongoing cascade of additional civil lawsuits.

For more information about the Purdue Pharma settlement and the ongoing crisis within a crisis of rising opioid deaths during the coronavirus pandemic, the Johns Hopkins Public Health On Call Podcast recently spoke with Caleb Alexander, a professor of epidemiology and medicine at the Bloomberg School of Public Health and the School of Medicine. Alexander discussed the advantages and flaws of the criminal case against Purdue Pharma, the challenges of combating a drug crisis during an infectious disease crisis, and what programs should be funded to support addiction services and prevent further harm.

So today we're going to talk about opioids and a recent settlement announced by the federal government. They announced an $8.3 billion settlement with OxyContin maker, Purdue Pharma. So among other things, the company paid doctors to drive up prescriptions and hid the addiction dangers of what they were selling. While the settlement is historic, is it enough to bring the opioid crisis to heel?

I think it is, no doubt, really big news and has been watched very closely by many different parties. It's important to keep in mind while there has been enormous scrutiny regarding Purdue's actions, Purdue is just one of many manufacturers that are being pursued in litigation. And indeed, other parties in addition to manufacturers—mainly wholesalers and distributors of prescription opioids—are also defendants to much of this litigation. So Purdue has often been viewed as one of the primary drivers of the opioid epidemic and their bankruptcy is further along in the process of litigation than [the bankruptcies of] many other parties.

Whether or not $8 billion is the right number, or is enough, I think depends upon who you ask. As with many issues in pharmaceutical policy, where you stand depends on where you sit. There have been many individuals and groups of individuals, especially those that have been directly harmed by the opioid epidemic, as well as some individuals representing states—for example, states attorneys general—that have spoken out with concern about the settlement, namely that the amount of the settlement is not sufficient and that the way that it's been structured is not ultimately going to generate the resources that are needed in the fairest and most efficient way possible.

I guess one question that comes to mind as you're talking is how big a role do you think manufacturers play in the opioid crisis?

That's a great question. And ultimately it will be up for the courts to decide. And it's important to note that there is litigation that's ongoing in many different cities and states, counties, and tribal communities as well. Manufacturers again represent one of the key groups of defendants, but this is a multifaceted epidemic, and the ultimate way that it's played out is not a function of one single party alone.

I think some of the concern and liability in the case of the Purdue bankruptcy has had to do with specific allegations of behavior that have been publicly aired. For example, the payment of providers or incentivizing of providers to prescribe opioids in settings when it may not have been clinically appropriate. And I think if you talk with individuals about the contours of the epidemic, one point that's often raised is that, well, if we look at addiction as one of the key ways that individuals have been harmed, because of the ways that increasing opioids have contributed to soaring rates of opioid use disorder or addiction, the issue is that addiction is a function not just of access alone, but access is one important component of addiction.

In other words, addiction isn't just driven by one's genetics or one's environment—it takes access as well. And I think that's where claims have been made that the role of manufacturers has been so important in generating that access. Keep in mind, at the peak of opioid prescribing—say 2011, 2012—enough opioids were dispensed in the United States to provide every adult a three- or a four-week, round-the-clock supply of pills. So we're talking about, in some cities and some counties, millions and millions and millions of pills flooding the market.

As a result of the settlement, Purdue will dissolve and be reformed as a public benefit company under government control and will still manufacture opioids. Some critics, including several state attorneys general, say the government should not be in the business of making and selling addictive substances. What's your view? Given what we've learned about the corporate bad actors, is it safe to have government control here?

Well, this is one of the sticking points of the terms of the bankruptcy that has been particularly controversial. So there's the question of whether the $8 billion number is the right number, there's an issue of whether or not the Sackler family that profits so much from ownership in Purdue is being held appropriately accountable, and then there's the issue of this public benefit trust. And some individuals have argued that the notion of the government being involved in the manufacturing of opioids is just ludicrous. It's a complicated and controversial matter.

The notion that part of the future payout to abate opioid-related harms will come from future opioid sales may be distasteful to some. I believe that the tobacco settlements were not structured completely dissimilarly. Now, I don't believe that there was a public benefit trust that was structured in the same way, but some of the payments as part of the tobacco litigation have arisen from continued tobacco sales. It's an area that I think will continue to be debated, and we'll see. I don't think any final determinations have been made as to whether and how this trust would be structured.

My understanding is that drug treatment or drug abatement programs may be funded through the settlement. I'm curious which ones you'd like to see funded.

Well, it's an excellent question. There was a remarkable piece in The New York Times probably 18 or 24 months ago that asked 20 or 30 different experts how they would spend $100 billion or some figure on abating the opioid epidemic. And it was remarkable to see the differing opinions of a police officer and a paramedic and a public health professor and a judge. I think treatment for opioid addiction is an outstanding place to spend a very considerable amount of abatement dollars, what the exact numbers should be I think requires more careful calculations. But when you look over time at what the major legacy of the opioid epidemic will be, it's going to be in the range of 2–5 million Americans, depending upon your definition, who have opioid use disorder.

This is a chronic disease. This is a lifelong disease. Now it happens to fortunately be a disease that's treatable, and for which we have FDA-approved therapies. So it's not a disease that one needs to suffer from lifelong, but there are many hundreds of thousands of individuals who are likely to have active opioid addiction for years and years to come. And so I think that the notion that a considerable fraction of abatement dollars would be spent on treating those with opioid use disorder is quite smart.

It is important to keep in mind though that there are other ways that these monies can be expended as well. And individual cities, counties, and states will be left with having to decide how best to distribute these monies across different evidence-based approaches. Here I'm talking about things [including] Naloxone distribution and training; primary prevention and social marketing campaigns—media campaigns that help reduce the overuse of opioids and de-stigmatize opioid use disorder; treating women who may be pregnant; treating children who may have a neonatal abstinence syndrome; and so on.

This settlement sort of comes about during a pandemic of huge proportions. And reports indicate that at least 40 states have seen a rise in opioid-related deaths since the coronavirus began. So how can governments respond to these two overwhelming public health crises at the same time, or are people ignoring what's still going on with the opioid crisis?

There was a remarkable body of work done in the 1970s by an economist who coined the term "the issue attention cycle," which refers to this phenomenon that all too often, the public attention and focus on a particular matter—whether seatbelts, or drunk driving, or obesity, or disparities in care—waxes and wanes in ways that may have very little to do with the degree to which the underlying problem has resolved. And I think what we've seen with the COVID pandemic is that it's sucked all the oxygen out of the room. In other words, it's COVID all the time.

And the big concern over time is that the pandemic has affected the way that the opioid epidemic has evolved and progressed. There are several different lines of evidence suggesting the pandemic has disrupted local drug markets. It has potentially increased the lethality of illicit opioids by introducing greater unpredictability into those markets. Individuals with opioid use disorder may be at heightened risk of getting COVID, and many are at increased risk of severe COVID or death or other severe outcomes if they do get infected. And then of course there are all the ways that the pandemic has affected the treatment infrastructure. There are police departments that have that at least temporarily stopped administering Naloxone due to concern about potential COVID transmission, leaving that task to first responders. There are treatment facilities that decreased their operating function. And fortunately we've seen at local, state, and also federal levels many different efforts to try to mitigate or buffer some of the unintended consequences. There's increased use and provision of telemedicine to provide addiction treatment and increased ability to share information across providers so that care may be less fragmented in the context of the pandemic.

I think this is an opportunity for us to, as a community, rally around those that have been impacted by the opioid epidemic and to ensure that we are putting in place and also evaluating the impact of these types of measures to ensure that individuals who have opioid use disorder or who have otherwise been impacted by the opioid epidemic don't incur even greater potential harms from the COVID-19 pandemic.

Public Health On Call is produced by Joshua Sharfstein, Lindsay Smith Rogers, Stephanie Desmon, and Lymari Morales. Audio production by Spencer Greer, Nial Owen McCusker, Cian Oatts, and Matthew Martin with support from Chip Hickey. Distribution by Nick Moran.