An increase in opioid prescribing for chronic, noncancer pain has been associated with large increases in addiction and overdose deaths in the United States. In response, the US Centers for Disease Control and Prevention (CDC) developed guidelines for prescribing opioids for chronic pain.1 When the draft guidelines were released, there was criticism. Some organizations argued that the development of the guidelines was not transparent and the recommendations were based on weak evidence.2,3

Subsequently, the CDC postponed the release of the guidelines and opened them to public comment for a 30-day period. More than 150 organizations formally submitted comments. We analyzed these comments to identify levels of support for the guidelines and whether financial relationships with opioid manufacturers were associated with opposition to the guidelines. The final guidelines were released in March 2016.4

Methods

We extracted data from publicly available comments that 158 organizations submitted to the CDC’s docket.1 Two reviewers independently classified each comment into 1 of 4 mutually exclusive levels of support: supportive, generally supportive with recommendations, generally not supportive with recommendations, and not supportive. Comments from 9 organizations (5.7%) were coded as supportive by 1 reviewer and not supportive by the other; a third reviewer adjudicated these cases. Blinded to level of support, we classified each organization’s financial relationship to opioid manufacturers using their self-reported relationships and public websites, annual reports, and federal tax returns. We used the Wilcoxon rank sum test to assess the association between organizations’ final relationship to opioid manufacturers and their level of support for the proposed guidelines.

Results

Of the 158 organizations, 45 (28.5%) received funding from opioid manufacturers, 25 (15.8%) had funding ties to other companies in the life sciences, 64 (40.5%) received no funding from the life sciences industry, and funding of the remaining 24 (15.2%) was not known (Table 1). Of the organizations that received funding from opioid manufacturers, none disclosed these funding sources in their comments; of the organizations that received funding from the life sciences industry, 6 (24%) disclosed their funding.

Fifty-two organizations (32.9%) were supportive of the guidelines without additional recommendations, 75 (47.5%) were generally supportive with recommendations, 18 (11.4%) were generally not supportive with recommendations, and 13 (8.2%) were not supportive (Table 1). Opposition to the guidelines was more frequent among organizations with funding from opioid manufacturers than those without funding from the life sciences industry, both overall (Table 1) and for recommendations about limits on opioid dosing and the length of opioid treatment (Table 2).

Discussion

Of the 158 organizations that commented on the CDC’s draft guidelines, approximately 80% supported them either with or without recommendations, including many that received funding from opioid manufacturers. However, opposition to the guidelines was significantly more common among organizations with funding from opioid manufacturers than those without funding from the life sciences industry. The CDC did not prompt or require organizations to disclose their financial associations as part of their comments. Disclosure, however, is one means of managing conflicts of interest, and organizations were not precluded from disclosing their revenue sources. In the future, the CDC should request or require such information, just as the US Food and Drug Administration suggests that such information be provided as part of public comments to the agency.

US Senate committees5 and investigative journalists6 have scrutinized the financial associations of opioid manufacturers and patient advocacy and professional organizations. A major concern is that opposition to regulatory, payment, or clinical policies to reduce opioid use may originate from groups that stand to lose financially if sales of opioids decline. Our findings demonstrate that greater transparency is required about the financial relationships between opioid manufacturers and patient and professional groups.

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Corresponding Author: G. Caleb Alexander, MD, MS, Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, 615 N. Wolfe St W6035, Baltimore, MD 21205 (galexan9@jhmi.edu).

Published Online: January 17, 2017. doi:10.1001/jamainternmed.2016.8471

Author Contributions: Dr Alexander had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Kolodny, Alexander.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Lin, Lucas, Alexander.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Murimi.

Administrative, technical, or material support: Alexander.

Conflict of Interest Disclosures: Dr Kolodny was Chief Medical Officer at Phoenix House at the time of this study and is a member of the board of Physicians for Responsible Opioid Prescribing (PROP); PROP also submitted a comment to the CDC docket. Dr Alexander is Chair of the FDA’s Peripheral and Central Nervous System Advisory Committee, serves as a paid consultant to PainNavigator, serves as a consultant to IMS Health, and serves on an IMS Health scientific advisory board. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. Drs Kolodny and Alexander were part of a group of faculty from the Johns Hopkins Bloomberg School of Public Health that submitted a comment to the CDC docket. No other disclosures are reported.

Additional Contributions: Joshua Sharfstein, MD, Johns Hopkins Bloomberg School of Public Health, provided helpful comments on earlier manuscript drafts. No compensation was provided for this input.

References