By Mason Marks
The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.
Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below).
The rising death toll reflects the urgent need for innovative solutions to the opioid crisis. However, few can agree on the best approach. On March 29, 2017, President Trump issued an executive order that created the Commission on Combating Drug Addiction and the Opioid Crisis. Trump chose New Jersey Governor Chris Christie to lead the Commission, which included two state governors, a former Congressman, a state attorney general, and a Harvard professor of psychobiology. Only one member of the Commission, Professor Bertha Madras, has a formal scientific education. In its final report released on November 1, 2017, the Commission made several recommendations that are supported by scientific evidence or at least not contraindicated by it. For instance, the Commission concluded that patients should receive more education regarding the risks, benefits, and alternatives to opioids. Because alcohol and benzodiazepines are often implicated in opioid-related deaths, increased patient education could help decrease fatal drug interactions. The Commission advocated for increased screening for substance abuse by healthcare providers, improved access to medication assisted treatment (MAT), and increased reimbursement for opioid alternatives such as acupuncture and physical therapy. Randomized controlled trials suggest that MAT-assisted behavioral interventions are more effective than behavioral interventions alone, and epidemiologic data suggest that increased access to MAT may decrease opioid consumption, opioid-related deaths, criminal activity, and disease transmission. The Commission also recommended that drug courts be established in all judicial districts. Though drug courts are controversial, data from criminal justice and public health research suggests that drug courts may reduce crime, drug-use, and the cost of running the criminal justice system.
Despite the Opioid Commission’s justifiable recommendations, it drew many conclusions that lack empirical support or are contradicted by scientific evidence. Several of its proposals are one-sided and do not fully evaluate the risks of implementing each recommendation. For example, the Commission criticized aspects of the Centers for Medicare & Medicaid Services’ (CMS) Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS). This 32-question survey is administered to a random sample of patients when they are discharged from hospitals. Implemented in 2006, it is the first standardized national survey to evaluate patient satisfaction with medical care. Since July 2007, some hospitals must administer the HCAHPS survey in order to receive full reimbursement from Medicare. The link between patient satisfaction scores measured by HCAHPS and hospital Medicare payments has led to concerns that doctors could feel pressured to prescribe opioids inappropriately to raise patient satisfaction. The original survey contained three questions related to pain management. However, on November 1, 2016, CMS announced that in response to healthcare provider concerns, it would remove the link between pain-related questions and Medicare reimbursement. In 2017, CMS proposed changing the focus of pain-related questions from “pain management” to “communication about pain.”
Despite these changes, the Opioid Commission was convinced that pain-related questions are driving inappropriate prescriptions. In its final report, the Commission cites a 2016 study published in the Journal of the American Medical Association as evidence that “savvy providers have figured out that opioids are a way to manipulate satisfaction.” The Commission recommends complete removal of HCAHPS pain-related questions “so that providers are never incentivized for offering opioids to raise their survey score.” However, the cited study did not reach this conclusion. Instead, it reports a mere correlation between a hospital’s rate of new post-discharge opioid prescriptions and patient reports that their pain was well-managed (as measured through the HCAHPS survey). This result is not surprising, and does not necessarily reflect excessive or inappropriate opioid prescribing.
One potential explanation for the observed association is that opioids were appropriately prescribed, which prompted patients to report that their pain had been addressed. Alternatively, there may be no direct link between new post-discharge opioid prescriptions and patient satisfaction; the study identifies only a moderate correlation between data points and makes no claims that they are causally related. Throughout the cited article, the authors emphasize their inability to distinguish between appropriate and inappropriate opioid prescribing. They advise readers to use caution when interpreting the observed correlation between satisfaction scores and new opioid prescriptions. Nevertheless, the President’s Opioid Commission ignored this advice and conjured up an unconfirmed causal connection between these variables. In an ironic twist, the authors conclude that due to the modest observed association, reducing incentives for doctors to prescribe opioids would be unlikely to have a significant impact on opioid use. Thus, in efforts to support its proposal to eliminate pain related questions from CMS patient satisfaction surveys, the Opioid Commission selected an article that argues against its proposal. Others studies found no correlation between prescriptions for pain medication and patient satisfaction. However, these studies were omitted by the Opioid Commission’s report.
The Commission’s conclusion that healthcare providers prescribe opioids to manipulate patient satisfaction is also contradicted by statements of the Department of Health and Human Services (HHS) and public health professionals. In a 2016 New York Times article, a spokesman for HHS stated there is no known evidence linking satisfaction survey scores to improper prescribing. In that article, Dr. Paul Clearly, a former Dean of the Yale University School of Public Health said “Overprescribing of opioids is egregious and it is a national problem, but it is not caused by patients’ being asked some questions about their experience with medical care.”
The Opioid Commission’s misinterpretation of study data is careless and could negatively impact public health. According to CMS, its patient satisfaction surveys are intended to increase accountability and transparency with respect to the quality of medical care. Removing questions related to pain management would reduce transparency and equates to throwing the baby out with the bath water. A more reasonable approach would be to commission research to improve the data collected from HCAHPS. During the opioid crisis, we need more information on how well doctors are managing pain, not less.
In another section of its final report, the Commission recommends the use of enhanced prescription drug monitoring programs (PDMPs), yet it makes no mention of potential privacy and public health risks associated with these systems. The use of PDMPs has been linked to reduced opioid prescribing by physicians. Yet, there is growing concern that law enforcement access to patient prescription information through PDMPs constitutes an unreasonable government search under the Fourth Amendment. Police departments and federal agencies could access the information without establishing probable cause or obtaining a warrant. Unrestricted law enforcement access to prescription records could affect the quality of care received by patients.
In a recent federal court case, the Oregon State PDMP sued the U.S. Drug Enforcement Agency (DEA) to determine whether it was obligated to comply with DEA-issued subpoenas for prescription data presented without a search warrant. Oregon pharmacies that dispense Schedule II-IV controlled substances must electronically report prescription data including information that identifies patients and the prescribers. Under state law, the PDMP was prohibited from releasing records to law enforcement without a valid warrant. The American Civil Liberties Union (ACLU) intervened in the case on behalf of several anonymous patients who routinely use legally prescribed controlled substances. In the District Court opinion, Judge Ancer L. Hagerty concluded, “It is difficult to conceive of information that is more private or more deserving of Fourth Amendment protection. He concluded that the subpoenas violated the Fourth Amendment because they demanded records without obtaining a warrant based on probable cause. However, on appeal, the 9th U.S. Circuit Court of Appeals reversed Judge Hagerty’s ruling. A three-judge panel concluded that the ACLU and the five anonymous plaintiffs lacked standing to bring the complaint. Because the case was reversed without reaching the merits of the plaintiffs’ Fourth Amendment claim, whether the DEA subpoenas violate the Fourth Amendment remains an open question. However, the Court argued that the U.S. Controlled Substances Act (CSA) preempts the Oregon law prohibiting the PDMP from sharing sensitive patient data without a warrant.
The American Medical Association, and the medical associations of eight U.S. states, filed an amicus brief in the Oregon case. They emphasized that the primary purpose of PDMPs should be to inform healthcare not law enforcement decisions. Their brief advised the Court that unlimited access to PDMP data could adversely impact public health. Specifically, “with unsupervised law enforcement access to their prescription care records, patients may fear to fill prescriptions [sic] and thereby compromise their care.” Yet the Opioid Commission advocated for expansion of state and federal PDMPs without discussing the risks to public health.
How could the Commission misinterpret the results of numerous studies and make recommendations without discussing the associated risks? One potential cause is the conspicuous lack of healthcare professionals on the Commission. Professor Madras was the only member with a formal scientific education. However, even she lacks clinical training or experience treating patients with substance abuse. To ensure that solutions to the opioid crisis are based on the best available evidence, the Commission should have been filled with scientists, physicians, and public health professionals. With hundreds of American lives at stake each day, the public deserves only the most careful and responsible use of data. Without more scientific voices anchoring the conversation, the Commission may have succumbed to less rational forces.
In Part II of this three-part series, I will discuss how the Opioid Commission ignored medical interventions used successfully in other countries (despite receiving thousands of public comments urging it to consider them). These potential solutions include using medical marijuana as an alternative to opioids for treating chronic pain, evaluating the West African plant Tabernanthe iboga as a means of curbing opioid cravings, and studying the Southeast Asian plant Mitragyna speciosa, also known as kratom, as a tool to ease symptoms of opioid withdrawal. These treatments for pain and opioid addiction are administered in numerous countries, and there is growing scientific support for their use. However, the Opioid Commission either dismissed them or ignored them completely.