The government declared an opioid epidemic because people were dying at rates that no prior drug crisis in American history had produced, in communities that had not historically been associated with drug abuse, from medications that had been marketed as safe by pharmaceutical companies and prescribed at escalating rates by physicians who were told that addiction risk was minimal.
The declaration was the public health and political response to a mortality trend that had been accelerating for more than a decade before it received that formal designation. The CDC had been tracking overdose death rates since the late 1990s and had observed a consistent upward trajectory that correlated with the expansion of opioid prescribing initiated after the introduction of OxyContin in 1996 and the subsequent promotion of opioid therapy for chronic non-cancer pain as a legitimate and appropriately managed treatment approach.
The Origins in Pharmaceutical Marketing
The prescription opioid epidemic’s origin is traceable to a specific period of pharmaceutical industry marketing that promoted opioid therapy for chronic pain with representations about addiction risk that subsequent investigation, litigation, and prosecution revealed were inconsistent with the company’s internal knowledge. Purdue Pharma’s marketing of OxyContin beginning in 1996 emphasized the medication’s extended-release formulation as a feature that reduced abuse potential, a representation that the company’s own scientists had identified as inaccurate at the time it was being made to prescribers.
The pharmaceutical industry’s marketing efforts, combined with continuing medical education programs funded by opioid manufacturers, advocacy organizations funded by the same manufacturers, and clinical guidelines developed with industry involvement that recommended opioid therapy for a broader population of pain patients than prior practice had supported, produced a dramatic expansion of opioid prescribing during the late 1990s and early 2000s. That expansion created a population of opioid-dependent individuals at a scale the healthcare system had not previously produced.
The Mortality Data
The Centers for Disease Control and Prevention began tracking drug overdose deaths as a distinct mortality category in the mid-1990s. The data revealed three successive waves of the opioid epidemic, each with its own primary driver and each with a mortality toll greater than its predecessor.
The first wave, beginning in the late 1990s, was driven by prescription opioid overdose deaths. The second wave, beginning around 2010, was driven by heroin overdose deaths as individuals who had developed opioid dependence through prescription medications transitioned to heroin when prescription access was restricted. The third wave, beginning around 2013, was driven by illicitly manufactured fentanyl and its analogs, which displaced both heroin and pharmaceutical opioids in the illicit drug supply and produced overdose death rates substantially higher than either predecessor wave.
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(212) 300-5196By 2016, when President Obama formally declared the opioid crisis a public health emergency, more than forty thousand Americans were dying annually from opioid overdoses. That number has since increased, with the fentanyl wave driving annual overdose deaths above one hundred thousand by 2021. The mortality data is the most powerful driver of the political and law enforcement response that produced the enforcement environment described throughout this series.
The Public Health Emergency Declaration
The declaration of the opioid crisis as a public health emergency, made under Section 319 of the Public Health Service Act, permitted the federal government to deploy emergency authorities and funding to address the crisis, to expand access to addiction treatment medications including buprenorphine and naloxone, and to coordinate a federal response that involved multiple agencies including HHS, SAMHSA, the CDC, and the DEA.
The declaration also provided political and institutional impetus for the enforcement response. The combination of public health resources directed at treatment and the law enforcement resources directed at the supply chain, the prescribers, and the distributors that had produced the epidemic was the dual-track federal response that the emergency declaration authorized and that has defined the federal approach to the opioid crisis since 2016.
Todd Spodek
Lead Attorney & Founder
Featured on Netflix's "Inventing Anna," Todd Spodek brings decades of high-stakes criminal defense experience. His aggressive approach has secured dismissals and acquittals in cases others deemed unwinnable.
The Enforcement Response’s Relationship to the Epidemic
The DEA’s escalation of opioid prescribing enforcement, the OIG’s expansion of healthcare fraud investigations targeting opioid prescribing, and the coordinated national enforcement actions of the type described in earlier articles in this series were all responses to the mortality data that the public health emergency declaration cited. The enforcement was not primarily a response to the pharmaceutical marketing practices that had created the epidemic’s preconditions; those were addressed primarily through civil litigation and some criminal prosecution of company executives. The enforcement was directed primarily at the practitioners and distributors whose prescribing and distribution had served the population of opioid-dependent individuals that the marketing had created.
The opioid epidemic was declared an emergency because the data demanded it. The deaths were real, the numbers were unprecedented, and the communities affected had not expected to find themselves in the center of a drug crisis. The enforcement response that followed the declaration was as real as the deaths that generated it. The practitioner who prescribes controlled substances in the environment the epidemic created operates under scrutiny that is proportional to the scale of the harm that scrutiny is designed to address.
The Current State of the Epidemic
The opioid epidemic in its current form is primarily a fentanyl epidemic driven by illicitly manufactured opioids rather than diverted pharmaceutical products. The prescription opioid prescribing that drove the first wave has declined substantially from its peak, partly through enforcement and partly through the prescription drug monitoring programs, clinical guideline updates, and prescribing restrictions that the epidemic generated. The death toll from fentanyl, however, has not declined proportionally with the reduction in prescription opioid availability; the fentanyl supply chain has proven more resilient and more lethal than the prescription opioid supply chain it has largely displaced. The enforcement environment for healthcare practitioners reflects the epidemic’s pharmaceutical origins even as the current mortality is driven primarily by a supply chain that healthcare practitioners do not control.
