Thursday, October 2, 2014
This week several groups called for the resignation of FDA Commissioner Dr. Margaret Hamburg in a letter to HHS secretary Sylvia Burwell. Why? Because of the agency’s stance on opioid drugs, as reflected in their statement, “preventing prescription opioid abuse and ensuring that patients have access to appropriate treatments for pain are both top public health priorities for the FDA.” Keep in mind, the agency has not been idle on the issue of preventing untimely deaths related to opioids. For example, hydrocodone products were recently rescheduled from schedule III to schedule II and the Risk Evaluation Mitigation Strategy (REMS) program was instituted last year. But in the fog of moral panic in response to untimely opioid related deaths, there is little room for moderate stances that factor the wellbeing of all patients in public policy.
It is tragic if even one person dies after taking too many opioids; the uptick over the last decade is an important public health issue. It is a public health issue precisely because people are dying prematurely. The most basic principles of public health research require root cause analyses of the issue, a scarce commodity in this case. In fact, most of the attention has focused on ideas based on the fundamental confusion of correlation with causation and which characterizes the harm as use of prescription opioids rather than preventable death.
Most are left with the impression that these deaths are from purely accidental, prescription opioid only overdoses in people who received the drugs via prescription. This is not the case. Here are some of the facts:
- Most of the deaths involve opioids mixed with other drugs, such as benzodiazepines, and alcohol. Of the 16,651 deaths in 2010 attributed to prescription opioids, only 5,000 involved opioids alone.
- More than half of the individuals did not obtain the drugs through a prescription.
- The deaths are automatically classified as opioid overdoses if there is any evidence at all of opioid use, regardless of other blood levels.
- There is no standardized definition or measurement for opioid toxicity or overdose.
- A third of the deaths involve methadone although it only represents 5% of prescribed opioids (it has unique potential for life threatening arrhythmia and respiratory depression).
- The CDC groups suicides and homicides together with accidental opioid poisoning in counting overdoses. This is a significant problem because living in chronic pain roughly doubles the rate of suicidal thoughts, plans and attempts as compared to the general population.
- In context, each year, an estimated 80,000 deaths are attributable to excessive alcohol use and an estimated 10,000 deaths are attributed to non-steroidal anti-inflammatory drugs.
Unfortunately, these facts escaped many policy makers to their peril as policies that did little to reduce the morbidity and mortality for drug use proliferated. For example, states with the most aggressive and blunt responses have succeeded only in decreasing the number of overdose deaths attributable to prescription drugs because other drugs, such as heroin, have filled the void. At the same time, patients in chronic pain who rely to some extent on opioids to function are collateral damage as providers are disincentivized from prescribing opioids to anyone.
These tensions are explained beautifully in Judy Foreman’s recent book, A Nation in Pain. The book describes how patients navigate a medical climate that disproportionately values the smallest potential prevention of drug diversion and criminalization of substance use disorder over the basic obligation to care for patients. One patient story she tells is illustrative of the complexity of overlapping comorbidities that often accompany chronic pain, including disproportionate rates of serious mental illness and suicidality. In contrast, the rate of substance use disorder in this population mirrors the general population. Yet clinical practice research and guidelines in pain management are disproportionately focused on drug diversion and abuse with little to no attention paid to assessing patients for suicidality and serious mental illness. Foreman writes, “Hyrum Neizer would be dead today if his wife hadn’t walked in on him with the gun in his mouth. He was in unremitting pain…his life was ruined not just by his chronic physical pain but by the very people who were supposed to be helping him-doctors.”
Niezer was in chronic pain from relentless headaches, actively suicidal, and in serious mental distress: all problems that were ignored while doctors focused on his requests for medication and accused him of lying about his pain and diverting drugs. They even convinced him he was an addict: he understood he was not only after entering a substance abuse program. Finally, a doctor listened to Niezer and engaged in the complexity of his condition: the cause of his pain was multiple cerebral aneurysms. Treatment resolved his severe pain and suicidality.
The very real harm an oversimplified approach to all patients, including patient in pain, is less sensational but no less substantive than the harms associated with opioid overdoses. This is just another example of the limited ability and willingness of those in power, including many providers, to engage in the difficult and nuanced approaches required for substantial harm reduction. Admittedly, complexity is at its peak with patients who present in severe pain without an obvious cause: providers need well developed skills of mental flexibility and attentiveness to do them justice. Dr. Kate Scannell has advanced that complexity “should be considered another condition altogether” because of what it demands from the provider and the harm to the patients when complexity is disregarded. Nonetheless, providers owe all their patients respectful treatment and referrals for care, including those whose underlying issues might include complex neuropsychiatric issues such as substance use disorder, chronic pain, serious mental illness, and suicidality. Why? Because as Kate Scannell so beautifully explained, “patients who are not seen within the wholeness of their experiences of suffering are people rendered invisible.”