America’s Opioid Epidemic

The national opioid epidemic is now front and center in American media and the government’s agenda because it has exacted a heavy financial and social toll. Its affects have been (1) mentioned in the minutes of the Federal Reserve and in reports by such venerable investment banks as Goldman Sachs, for having shaved off a significant portion of our country’s GDP, (2) was noted by the White House Council of Economic Advisors as having cost the US $504 billion in 2015 alone, and (3) has single-handedly been responsible for a multi-year reduction in the American life expectancy rate. The damage to destroyed families is incalculable.

Our Federal government took note, allocating $1 billion toward the opioid fight in the 21st Century Cures Act, and then added another $12 billion, or so, in the continuing budget bills of January and March 2018. President Trump has additionally earmarked almost $17 billion more as part of his proposed budget for 2019. Funds are to be allocated in a wide variety of ways, ranging from additional treatment, increased law enforcement and the expansion of federal drug courts to provide alternative sentencing options for people whose crimes are clearly more driven by addiction than criminality.

This is all very positive, but my issue with this strategy is that it will take years to fully implement and have an impact.

One obvious way in which the government HAS attained more immediate results is via enforcement against unscrupulous pain clinics. Certainly the treatment of pain is important, but far too many of those clinics began to relax their standards for the sake of greed and came to be known as “pill mills” at which addicts could find doctors and pharmacists more than willing to enable their addiction. The federal, state and local authorities have also taken action against disreputable addiction treatment facilities and sober homes. While, perhaps, this effort has somewhat tarnished the image of addiction treatment in general, it was vital to eliminate those bad actors both for the sake of patients and the reputation of our community as a whole. Those recent specific legal clamp-downs had a major beneficial affect. They eliminated criminally run operations and simultaneously scared away others from doing likewise, while also leading to better prescription practices by doctors. While these are encouraging developments, they have unfortunately not totally eliminated the problem. Mexican cartels have stepped into the void producing and selling large quantitative of heroin, fentanyl and carfentanil in modern production facilities. For that reason, a good portion of the aforementioned additional government funding will importantly be directed towards greater enforcement at the borders and in neighborhood-to-neighborhood combat against the street dealers spreading the disease. However, after having watched the war on drugs fought the same way for decades, I can’t help but feel this is not enough. It has turned into a stalemate in which we are consistently successful in battle but never win the war. That’s why I’m heartened by a potentially even bigger development.

The groundswell of litigation brought against Big Pharma started as a murmur and has grown into a tsunami. It all began with the former Attorney General of Mississippi, Mike Moore, who one spearheaded the fight against Big Tobacco. He persuaded Ohio to bring a similar case against the major pharmaceutical companies and that action has since morphed into 400 lawsuits brought by cities, counties, states and Native American tribes across the country. They are following the model of our nation’s one huge success story in the fight against addiction. This has not only led to a continued decrease in smoking but also secured considerable funding for treatment and education. That is exactly the type of revolutionary pivot point we need in order to get out in front of the opioid crisis.

The vast majority of that litigation has been consolidated into one large class action suit in front of judge Aaron Polster in the Northern District of Ohio. In many ways, Ohio has been one of the hardest hit states and can be considered ground zero in the opioid battle. The claims brought by the plaintiffs detail numerous abuses by several large pharmaceutical companies including: (1) representations that new opioid-based products (such as oxycontin) were safe and non-addictive, (2) financially influencing doctors and medical professionals with excessive speaking fees, honorariums and free meals and vacations (68,177 doctors received more than $46 million between 2013 and 2015 alone, according to research by the Boston Medical Center), and (3) wanton disregard for patients’ welfare even as the representations and practices were clearly wreaking havoc on unsuspecting addicts in the making.

Moreover, many of those same companies were simultaneously spending in excess of $10 million on lobbying groups to encourage the use of opioids, according to a February article in The Guardian. This groundbreaking litigation has since expanded to include retailers who knew, or should have known, based on the growing mountain of public evidence that they were a critical part of the deception. They shipped alarming quantities without notifying authorities and sold obscenely large amounts to individuals, well in excess of what they could have possibly personally consumed. The case is so monumental that the US Justice Department has even weighed in by filing a “statement of interest” because our nation itself has a major stake in the outcome. The claims encompass such legal causes as fraud, racketeering, corruption and public nuisance, among many others. In the meanwhile, defendants are trying to shield themselves behind the cloak of FDA approval, that they were doing nothing more than selling a legally prescribed drug. That argument, however, falls hollow, given the abusive way in which they were pushing the drugs while simultaneously holding back information about its dangers.

City, county and state budgets have been overrun by the damage caused as a result of opioid addiction. Emergency services and hospitals are overwhelmed, with some hard-hit locations reporting 90% of calls on any given night as opioid related. It has also led to more children in foster care and more families on unemployment and welfare. Overdose deaths too have forced some small towns to use refrigerated trucks and warehouses to supplement the local morgue. Yes, we need the additional funds that will come from resolving the litigation just to handle the aftermath, but equally importantly to work towards eradicating the root cause, by getting more money into prevention and treatment.

The Judge himself is trying to fast-track settlement discussions and his methods are being called into question because litigation of this magnitude typically takes much longer to resolve. However, their is considerable logic to his unconventional desire to resolve things more quickly. After all, the clock is ticking. More people are dying every day and there are still an enormous number of pills on the street. The quicker we turn the tide the better, and Judge Polster understands this on a very personal level since a very close friend of his lost a daughter to overdose from her opioid addiction.

The litigation itself already seems to be bearing fruit. Purdue Pharma, for example, no longer markets oxycontin due to all of the pressure and has even begun to dedicate funds toward warning society about the dangers of opioid addiction. Most importantly, there also seems to be a general sense that the parties want to reach an agreement – it’s only a question of what that amount might be.

So what to do with all that money?

The National Institute of Health (NIH) suggests we focus on three specific areas: (1) developing better overdose reversal and prevention interventions to reduce deaths, (2) finding new and innovative medications and technologies to treat opioid addiction and (3) finding safe, effective and non-addictive ways in which to manage pain. These are broad and laudable goals but what about the specifics?

The National Institute on Drug Abuse (NIDA) and President Trump’s commission on the opioid crisis heavily recommend expanding access to and distribution of fast-acting naloxone, approved for use since 2015. Narcan is the most well-known and commonly used, and its manufacturer has recently pledged to offer it for free at schools and universities. Moreover, NIH is working with private partners to create longer acting formulations intended to extend the effectiveness of these life saving treatments. The NIH is also promoting greater use of additional medications for treatment of Opioid Use Disorder, which now relies solely upon naltrexone, buprenorphine and methadone. With respect to that, the Food and Drug Administration (FDA) is currently reviewing several options which might work in conjunction with and improve the efficacy of the three approved medications. It is anticipated that these will be made available in the near future. The NIH and NIDA likewise hold out hope for anti-heroin and anti-opioid vaccines which have been showing great promise. They are primarily designed to create antibodies which prevent the opioids from entering the brain.

As for non-opioid pain reduction, there are several different approaches being studied from advanced pain relievers in the form of a pill to electronic brain stimulation and even gene therapy. Some insurers are also stepping in to do their part, like refusing to cover prescriptions for oxycontin (Cigna), and by modifying internal policies for reimbursing pain relief, which up until recently relied mostly on opioids as the cheapest alternative. An article in the Journal of the American Medical Association goes as far as to suggest that the FDA ban all “ultra-high-dosage” painkillers from the market (Kolodny and Frieden). Roughly 8 million Americans are on long term opioid therapy for chronic pain with as many as a million taking dangerously high doses.

Ideally, the additional federal funding and any settlement with Big Pharma will result in speeding up the timeline for tackling these goals because the opioid crisis is a fast-moving, many headed hydra. It seems that each time we crush one dangerous component, like getting doctors to prescribe fewer pills, another one, like black tar heroin, fentanyl and carfentanil hitting the streets, only rises up to take its place. However, with one big push and infusion of funds, perhaps we can finally get ahead of this epidemic and reverse course just as was so effectively achieved in the fight against smoking.