Fact Check: Where 60 Minutes Got it Wrong on the Opioid Crisis

July 12, 2018

Over the last year, 60 Minutes, in partnership with The Washington Post, has presented several misleading, inaccurate accounts of pharmaceutical distributors’ role in the opioid crisis, including the subsequent enforcement of The Ensuring Patient Access and Effective Drug Enforcement Act. To understand the country’s opioid epidemic and the solutions needed to reduce diversion and misuse of prescription opioids, we need to separate fact from fiction.

FACT: There is broad recognition among leading public health authorities that opioids have been overprescribed — a trend that began in the 1990s and has only recently received the attention it deserves.

For decades, prescription opioids were the recommended course of treatment for millions of Americans suffering from pain. As a result, Centers for Disease Control and Prevention (CDC) data show opioid prescribing in the U.S. peaked in 2010, with healthcare providers writing 81 opioid prescriptions for every 100 patients. Leading public health experts point to this trend as one of the leading drivers of the epidemic today.

• Scott Gottlieb, MD, Commissioner, U.S. Food and Drug Administration: “Unfortunately, the fact remains that there are still too many prescriptions being written for opioids, and too many prescriptions written for long durations of use that aren’t appropriate for the medical need for which the opioid is being prescribed.” – July 9, 2018 – U.S. Food and Drug Administration
  
  
• Nora Volkow, MD, Director, National Institute on Drug Abuse, National Institutes of Health: “Physicians were taught that those with pain wouldn’t get addicted to pain medication, she said. ‘Unfortunately, those beliefs were completely wrong,’ she said. What it resulted in was ‘an overprescription of opioids’.” – June 23, 2018 – The Atlantic: “An ‘Overprescription of Opioids’ That Led to a Crisis” 
  
  
• Francis Collins, MD, Director, Nationals Institutes of Health: "Eighty percent of the people who are currently addicted to opioids, many of which are now injectors, started with prescription drugs. And it was the medical profession, I'm sorry to say, in the late 1990s that greatly began to increase the prescription of opioids because of a sense that as long as somebody actually was in pain, they couldn't get addicted. Well, we found out that's absolutely wrong." – September 20, 2017 – The Washington Post Live: “Transformers: Health”
  
  
• Marty Makary, MD, Professor of Surgery and Health Policy, Johns Hopkins School of Medicine: “My own aha moment came recently after my father had gallbladder surgery and recovered comfortably at home with a single ibuprofen tablet. Wow. It directly contradicted my residency training 15 years ago, when I was taught to give every surgical patient a prescription for 30-90 opioid tablets upon discharge…The medical community at that time ingrained in all of us that opioids were not addictive and urged liberal prescribing. So that’s exactly what we did.” – August 4, 2017 – USA Today: “How doctors can stop the opioid crisis at its source: Quit overprescribing”
  
  
• Atul Gawande, MD, Surgeon, Brigham and Women’s Hospital; Public Health Researcher, Harvard T.H. Chan School of Public Health: “Above all, however, we cannot sit idly by. We surgeons turn out to be suppliers of the excess prescription opiates fueling addiction and death by overdose. We have to change that. And we now know how we can.” – April 2017 – Annals of Surgery: “It’s Time to Adopt Electronic Prescriptions for Opioids”

The shift in clinical practice around the use of opioids started to change in 2016 when leading public health and medical groups, including the CDC, called for a dramatic change in the way opioids are used to help mitigate the prevalence of overprescribing. While there is still more progress that can be made to stem the prevalence of overprescribing, there is far greater awareness around the need for alternative pain treatments and to engage patients around the safe use of these medicines.

FACT: Distributors play a vital role as logistics experts in the supply chain and ensure the safe and secure transport of medicines to licensed providers, pharmacists and hospitals. Distributors DO NOT make clinical decisions regarding patient care, nor do they prescribe medications or fill prescriptions.

Distributors play a vital role in the healthcare supply chain; however, we do not make, market, prescribe, dispense or in any way have control over which prescriptions are written.

A main tool to prevent abuse of prescription drugs is the prescription itself. Following the updated guidelines released by the CDC, there has been a growing awareness among the medical community and providers about the potential for opioid abuse and misuse. As a result, there has been subsequent changes in pain management and the use of narcotic pain pills.

FACT: The Ensuring Patient Access and Effective Drug Enforcement Act (EPAEDEA/Public Law 114-145) was passed as part of a bipartisan, broad effort to address opioid abuse and misuse.

In 2016, Congress unanimously passed The Ensuring Patient Access and Effective Drug Enforcement Act, marking a dramatic change in information sharing and collaboration among distributors, the Drug Enforcement Administration (DEA) and other stakeholders in the supply chain. The law was designed to improve communication and clarity between the DEA and its registrants (licensed providers, manufacturers, distributors, etc.).

One of the persistent inaccuracies across 60 Minutes’ reporting is the claim that PL 114-145 impeded the DEA’s ability to issue immediate suspension orders (ISOs), pointing to a drop-off beginning in 2011. The reality is that President Obama signed the bill in April 2016 — as such, the law could not have impacted enforcement actions in prior years.

60 Minutes’ false narrative has been discredited numerous times, including by the DEA’s own leadership. For example, after a nearly three-hour hearing before the Senate Judiciary Committee in December 2017, the DEA’s acting administrator, Demetra Ashley, testified that ISOs were one of many tools that the agency had at its disposal, and further, that there was no basis to pursue such an action against a distributor subsequent to the law’s passage.

FACT: Under Public Law 14-145, the DEA remains fully empowered to take immediate action against a registrant if there is “a substantial likelihood of an immediate threat” present.

Under the Controlled Substances Act (CSA), the DEA is able to issue an ISO if there is an imminent danger to public health or safety. However, prior to the passage of the EPAEDEA, there was no federal definition of what constituted “imminent danger.” This lack of formal guidance and transparency did little to serve the best interests of patients, particularly those suffering from cancer, recovering from surgery or facing other serious health issues who had already experienced disruptions to their medicines from misdirected enforcement actions.

In the EPAEDEA, Congress established a definition for “imminent danger” for the first time, a definition that was agreed to by the DEA and Department of Justice (DOJ) as part of the legislative negotiations at the time. Yet, 60 Minutes’ narrative falsely asserts that the DEA was deprived of a critical tool when actually the agency was given clear and transparent guidance.

The law’s authors, including Sen. Orrin Hatch (R-Utah), one of the original co-sponsors of the Senate legislation, has repeatedly reaffirmed that the intent of the bill was to reinforce the DEA’s power to intervene in situations where diversion is suspected. Today, the DEA maintains full authority to take action against a registrant as noted above.

FACT: The DEA has broad authority to assess and regulate the demand and supply of opioids across the country. For nearly a decade, the DEA approved year-over-year increases in production of controlled substances, including a 200-percent increase in oxycodone.

One of the agency’s key regulatory responsibilities includes licensing manufacturers, distributors, pharmacists and doctors who handle controlled substances. In addition, the DEA is the only entity that has a view — via its own ARCOS (Automation of Reports and Consolidated Orders System) database — of the entire prescription opioid supply chain, from manufacturing of the medications to patient delivery. Importantly, the DEA sets the annual production quotas for opioids based on “legitimate medical need” and determines the amount of opioids manufactured each year.

60 Minutes’ misleading reporting relies on the testimony from a former DEA official Joseph Rannazzisi who was responsible for the DEA’s diversion control program and now serves as a consultant to plaintiffs’ lawyers suing the industry. He claims the DEA was powerless in addressing the epidemic, yet 60 Minutes never tells their viewers that the agency had broad authority to regulate the supply and demand of opioids in the market. In fact, Rannazzisi’s office approved the yearly increases to prescription opioids. Between 2004 to 2013, the DEA approved increased production of oxycodone by more than 200 percent. It was only when new leadership took over in 2016 did the DEA unilaterally reduce the overall volume of controlled substances by 25 percent, underscoring the power the agency had maintained all along.

FACT: Distributors are committed to helping solve the opioid crisis.

Distributors recognize the tragic impact the opioid crisis is having on families and communities across the nation. The industry is strongly committed to addressing the challenges that contributed to the opioid epidemic. Distributors support efforts to improve provider and patient education, increase awareness of new clinical prescribing guidelines and recommendations and enhance efforts to reduce and dispose of unnecessary medications. For more information on distributors’ efforts to address the opioid epidemic, click here.