Pain management, prescription opioid mortality, and the CDC: is the devil in the data? – J Pain Res. Oct 2017; 10: 2489–2495.
Transparency, freedom from bias, and accountability are, in principle, hallmarks of taxpayer-funded institutions. Unfortunately, it seems that at least one institution, the Centers for Disease Control and Prevention (CDC), continues to struggle with all three.
What began with a prescribing guideline created in secrecy has now evolved to the use of statistical data and public statements that fail to capture not only the complexity of the problem but also the distinction between licit and illicit opioids and their relationship to the alarming increase in unintentional overdose.
For instance, when the CDC was in the process of drafting guidelines for the use of long-term prescription opioids to treat chronic pain, the identities of the project’s Core Expert Group members remained a secret until they were leaked
When its members were eventually identified, many were concerned that the group’s composition was not balanced and had an inherent bias against the use of prescription opioids to treat pain.
Following the webinar, allegations of unlawful behavior by the CDC in the creation of the guideline were made, specifically that the CDC had violated the Federal Advisory Committee Act.
The United States Congress eventually stepped in, and the CDC caved under pressure and permitted a 30-day open comment period during the Christmas holidays. Although the new open comment period yielded several thousand comments in the Federal Register, there was little change between the draft guideline and the final guideline.
Remarkably, the actions of the CDC in the creation and publication of the prescribing guideline appears to violate every single standard that the Institute of Medicine recommended whenever clinical practice guidelines are created.
Consequently, the authors of this commentary fear that the CDC’s earlier lack of transparency, freedom from bias, and accountability in the creation of a prescribing guideline has now infected the way they characterize statistical data to the public regarding the relationship between opioids (licit and illicit) and unintentional overdose.
Simplicity and data conflation is making the problem worse
While accurate measurement of the degree by which various actors or variables have contributed to the initiation and prolongation of the current crisis remains challenging, it is fair to say that prescribers, policymakers, patients, non-patients, the pharmaceutical industry, the insurance industry, regulators, illicit opioids, prescription opioids, dosage, and the addiction community have all played a role, whether in isolation or in combination with the above
there is understandably one universal contributor to the increase in unintentional overdose that continues to be singled out by policymakers and the CDC: opioids.
But the more important question becomes: about what opioids are they speaking?
All opioids in general, some opioids in particular, illicit opioids such as heroin and illicitly manufactured fentanyl, or prescription opioids? These distinctions matter. According to the CDC, the “majority of drug overdose deaths (more than six out of ten) involve an opioid,”12 and “as many as 1 in 4 people who receive prescription opioids long term for noncancer pain in primary care settings struggles with addiction.”
The following commentary examines some of the recent statistical claims asserted by the CDC and argues that not only are these statements inaccurate, but they also impede the ability of the public and policymakers to understand the complexity of the problem and create solutions that are balanced and effective
Prescribing: is the problem under-or over-prescribing?
Pain is individualized, and so should be its treatment.
This is the inescapable truth about pain: a person’s pain and their treatment cannot be standardized.
Right now, guidelines seek to treat pain, not the people who are feeling the pain. To them, pain is a disembodied entity to be vanquished, or lately, merely “counseled” to be less terrifying and catastrophic.
Opioids can be effective in treating pain, and while there may be a variety of alternatives to opioids, some may not be as effective or covered by insurance reimbursement
Yet despite the millions of people who suffer from chronic pain in the United States, there is scant evidence that the CDC considers chronic pain a serious public health problem.
But whether pain is treated with or without prescription opioids, one thing seems clear: it has been undertreated for decades.
So, what amount of prescribing is appropriate? This represents a difficult question since one size does not fit all.
A particular type or dose of one medication may be appropriate for one patient and condition and wholly inappropriate for someone else.
Yet despite the medical necessity of tailoring treatments to the individual, the tendency today is for an across-the-board reduction in prescription opioid availability.
But is prescription pain medication the driving force in today’s overdose epidemic, and if not, does an across-the-board reduction in opioid availability and prescribing make sense?
According to the CDC and several states’ Departments of Health, less opioids are being prescribed, which in turn indicates that there may be something other than just prescription opioids that are contributing to the escalation in unintentional overdose.
Data from the CDC indicate that between 2010 and 2015, the amount of opioids prescribed in the United States actually decreased by more than 18%, with a 13.1% decrease reported between 2012 and 2015 alone
Survey data also suggest that more than half of physicians in the United States have reduced their opioid prescribing, with nearly 10% having stopped prescribing opioids altogether
Consequently, there is little doubt that the amount of opioids being prescribed is decreasing dramatically, so it would be disingenuous to suggest otherwise.
Measuring and reporting prescription opioid mortality
What constitutes “a prescription opioid death?”
It appears that there is some disagreement and controversy regarding this issue, a disagreement that may be agenda-driven or subject to bias.
In 2009, to its credit, the CDC reported that the tremendous variation between states’ rates of prescription opioid overdose deaths “should be interpreted with caution as there is some variation in the reporting of substances on death records.”
Determining therapeutic levels and causes of unintentional overdose can be challenging, and postmortem drug redistribution has been described as a toxicological nightmare.
many states utilize death certificate data, which often do not include
- the source of a drug,
- the purpose for which the drug was used,
- the level of opioid tolerance in the decedent, and
- even the specific type or the name of the drug(s) that were involved.
In order to more accurately assess the actual number of prescription opioid analgesic deaths, it was necessary for the first author (MES) to go to individual states’ Departments of Health (DOH). Looking at the data from Illinois, what were listed as deaths due to “Opioid Analgesics” reportedly increased from 589 to 1233 between 2015 and 2016
This dramatic increase was almost completely driven by illicit fentanyl and its potent analogs, not by legitimate pharmaceutical opioids used to treat pain.
Furthermore, he noted that irrespective of the number of dangerous substances that are found in toxicology reports, the state’s death certificate data categorize any death in which even an iota of a prescription opioid (or a nonpharmaceutical fentanyl product) is found as a “prescription opioid death”
The role of polypharmacy in “prescription opioid over-dose deaths” was recently elucidated empirically.
The investigators determined that more than half of decedents with an opioid-positive toxicology had alcohol in their systems, and the average number of drugs identified in the toxicologies was six.
Yet another cause of the unfortunate overestimation of opioid mortality in the United States (and its link to prescription pain medication) relates to difficulties in distinguishing between heroin and morphine in postmortem samples
Heroin is twice as potent as morphine, has a half-life of only 6–25 minutes prior to its metabolism to morphine in the liver, resulting in studies suggesting that heroin deaths are also underestimated while morphine deaths are overestimated in their prevalence.
Given that the prescription opioid epidemic of the past is progressively being replaced by a surge in heroin use, the negative implications for inaccurate reporting that misidentifies a commonly prescribed opioid that has analgesic efficacy when used appropriately are clear
The deliberate conflation of illicit and prescribed opioids seems almost criminal, like hiding a guilty suspect from the law. If we aren’t allowed to see which opioids are causing overdoses how can we correct the problem?
If PROP is deliberately hiding the real cause of overdose deaths to make people believe its opioid prescriptions that are causing deaths, it’s like harboring a guilty suspect and telling law enforcement “they went that way”.
Wouldn’t this make them an “accessory to a crime” for all the overdoses caused by street drugs, not prescriptions?
in order to force more people to be diagnosed with an SUD and need their recovery services,
Nevertheless, despite the data and their shortcomings, the CDC continues to claim that we are in the midst of a prescription opioid crisis.
The necessity of balance
In medicine, as in life, there are risks and benefits.
Prescription opioids can bring enormous benefits to those who are suffering from acute or chronic long-term pain. Prescribed appropriately, prescription pain medication has provided relief to millions of Americans; it has increased their quality of life, improved their function, provided an option to those for which other analgesics are contraindicated due to certain medical conditions, and reduced their suffering
The proposed solution by policymakers to this complex problem has often been simple: just say no to drugs, and those who are struggling with addiction simply need to be enrolled in a substance abuse program so that they can become clean again. But things are not so easy
Despite decreases in the prescribing of prescription opioids, we continue to see an increase in the rates of unintentional overdose. While there is clear evidence that this increase is driven by the use of illicit opioids such as heroin or illicitly manufactured fentanyl derivatives, this particular fact continues to get lost in the shuffle
People who are not adequately treated for their pain will seek out alternatives, often harmful alternatives that can lead to addiction, unintentional overdose, or even suicide.
It is easy to demonize and point fingers at industry, prescribers, or anyone who calls into question the newest battle in the never-ending war on drugs.
Prescription opioids are not the panacea, but they have medicinal benefits, unlike tobacco.
In contrast to appropriately prescribed and administered opioids, we are unaware of any legitimate medical treatments involving the use of cigarettes, a product that continues to be available to anyone over 18 years without a prescription.
First, we would suggest that the CDC refrain from making alarmist statements that cite statistics that are not supported by the evidence without qualification.
Is there anything that can be done to help solve the opioid crisis? We believe so
Second, the CDC should recognize that chronic pain impacts millions of people in the United States and should, at a minimum, create an entry for pain on their website’s A–Z index. We are concerned that the absence of information about the millions of Americans who suffer from chronic pain sends the message that pain does not “have critical importance to CDC’s public health mission.”
Creating the link and providing information on this serious health problem will go a long way to bringing about balance.
Finally, we need to find ways to work together, instead of against each other, emphasizing civil discourse instead of finger pointing.
We are concerned that some people who are intent on blaming prescribers, patients, and the pharmaceutical industry for the problem without offering solutions (other than perhaps eliminating prescription opioids) are making it more about them than the people they are actually trying to help.
We have many problems, but there are also many solutions.