By Stephen Ziegler, PhD, Guest Columnist
JAMA Internal Medicine has published a research letter that purports to be an examination of the relationship between funding from opioid manufacturers and opposition to the prescribing guidelines issued by the Centers for Disease Control and Prevention (CDC) in March of 2016.
The authors examined the written comments made to the CDC during the open comment period, asserted that those who had received funding were more likely to oppose the CDC guidelines, and concluded that their “findings demonstrate that greater transparency is required about the financial relationship between opioid manufacturers and patient and professional groups.”
The following commentary, while critical of information contained in the article written by Caleb Alexander, Andrew Kolodny and others, nevertheless concludes with some positive suggestions for the future.
Illicit Opioids: The Harms Associated With Conflation of Data
The research letter, like many articles authored by those who are rightly concerned about addiction and overdose, begins by asserting that an association exists between increases in opioid prescribing and “large increases in addiction and overdose deaths in the United States.”
However, there are several problems with such a statement. First, association is not causation. For example, while a positive association exists between the size of a fire and the number of fire engines on the scene, fire engines for the most part do not cause fires -- they are only associated with it. Further, it is misleading and harmful to lump all opioids, prescription and illicit, together.
While conflating the two may help create better headlines and fuel the hysteria, such conflation is misleading because studies continue to indicate that two opioids, illicit fentanyl and heroin, are major drivers in the alarming increase in addiction and overdose, not prescription opioids.
Moreover, lumping all opioids together can be harmful because it ignores the size and complexity of the problems associated with the use and abuse of illicit and licit drugs. Because drug abuse remains a moving target, it is important to draw distinctions between a variety of factors and sources so that solutions can be tailored and refined. One size does not fit all.
Unclear Methodology Used to Classify Comments
Another problem with the JAMA article was the lack of measurement clarity regarding content analysis and how the authors categorized (coded) the comments that were submitted to the CDC during the open comment period.
According to the authors, the comments were classified as belonging in one of four mutually exclusive categories: “supportive, generally supportive with recommendations, generally not supported with recommendations, and not supportive.”
While it is unclear whether the coding occurred before or after the comments were reviewed, one section of the paper the authors pointed out that about 6% of the comments “were coded as supportive by 1 reviewer and not supportive by the other; a third reviewer adjudicated these cases.”
The first question that comes to mind is: who was the reviewer? Since it is likely that the authors were not randomly selected, it remains unclear what criteria was used to adjudicate disputes related to coding, especially when we know that two reviewers were at opposite ends of the spectrum and the coding scheme was central to the study.
Along these same lines, what constitutes opposition to the CDC guidelines? Was opposition binary (yes/no), was it mixed (and if so, where was the line), or did opposition exist along a range (strong or weak)?
When dealing with qualitative data (words as opposed to numbers), there are tendencies in terms of direction, but the devil is in the details. This is notable because there were likely many different reasons commentators and organizations were not supportive of the CDC prescribing guidelines, such as, but not limited to:
- The secretive nature of the entire process
- The short time frame the CDC allotted for public comments (initially less than 24 hours)
- Allegations that the process violated the Federal Advisory Committee Act
- Strong recommendations based on weak evidence
- Committee membership that lacked balance and broad stakeholder involvement
- An anti-prescription opioid agenda or bias by some committee members
- The fixation on dosing limits ignored the problems associated with converting dosage from one opioid to another, the differences in patients, and the potential for unintentional overdose at any dosage level
- The lack of balance and selective nature of the literature cited in the guidelines
- The failure to recognize that non-pharmacologic therapy and alternatives to opioids may not be effective or covered by insurance
- An ironic lack of transparency and full disclosure concerning potential conflicts of interest among those involved in the guidelines at various levels from start to finish
While the reduction of harms associated with the use of prescription drugs and illicit opioids such as heroin remains essential to improving the public health, it serves no laudable purpose to continually lump all opioids together.
Drug abuse is a highly complex bio-psycho-social phenomenon that requires recognition that not all people, nor problems, are the same. We must also not lose sight of the fact that millions of Americans are suffering from chronic pain, alternatives to opioids may not be as effective or covered by insurance, and the overwhelming majority who take prescription opioids use them responsibly.
In regards to the conflicts of interest issue, while the authors eventually admitted that the “CDC did not prompt or require organizations to disclose their financial associations as part of their comments,” I agree that disclosing real or potential conflicts of interest in the future is good for all involved. However, such disclosure should not be limited to just the pharmaceutical industry. It should also include government agencies and those in the substance abuse community.
I have and continue to provide consultation to government and the pharmaceutical industry about the need for balanced solutions that help ensure appropriate access, while at the same time prevent abuse. I care about the under-treatment of pain, as I am sure that those in the substance abuse community care about those suffering from addiction.
Consequently, what both the pain community and the substance abuse community need to focus on is finding common ground and forging balanced solutions, since finger pointing, bullying or taking a zero-sum game approach only impedes progress.
Stephen J. Ziegler, PhD, is a Professor Emeritus of Public Policy at Indiana University-Purdue University in Fort Wayne, Indiana.
Dr. Ziegler conducts research, provides continuing medical education, and consults on the topics of opioid risk management and the impact of drug regulation and enforcement on the treatment of pain. He has been published in several peer reviewed journals and serves as a reviewer for several journals such as the Journal of Opioid Management, Pain Medicine, Cancer, and the Journal of Medical Ethics. Prior to obtaining his law degree, Dr. Ziegler worked as a police detective and as a Task Force Officer for the U.S. Drug Enforcement Administration.
The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.