AIPM Response to the Senate Report on Relationships with Opioid Manufacturers
Tuesday, February 27, 2018
Posted by: Bob Twillman, PhD, Executive Director
The Academy of Integrative Pain Management is among the fourteen professional and patient advocacy organizations named in Senator McCaskill’s recent report on the potential influence of opioid manufacturers on public policy. We at the Academy are proud of our outstanding record of education, research, and advocacy for patients and professionals of all disciplines who treat persons with pain. The Senate report, which details which organizations utilized industry funds, did not include the logical next step of examining how those funds were utilized. We believe that the work of the Academy clearly demonstrates judicious use of all external funds to provide the most comprehensive integrative educational opportunities for clinicians desiring a positive transformation in how they provide pain care. We are proud of our unique perspective and positioning regarding policy and advocacy, in that we have articulated an integrative approach to pain care for three decades. Far from facilitating ever-increasing doses of opioids, we maintain that an integrative approach actually lessens opioid use in the aggregate, while still providing clinicians the opportunity to utilize their training and expertise to benefit patients in an individualized approach. The following response from our executive director and staff highlights this work, and provides needed context in which to more fully understand the McCaskill report.
W. Clay Jackson, MD, DipTh
President of the Board of Directors, AIPM
Summary of the Report
On February 12, 2018, the United States Senate Homeland Security and Governmental Affairs Committee issued a Minority Staff Report entitled, “Fueling an Epidemic: Exposing the Financial Ties Between Opioid Manufacturers and Third Party Advocacy Groups”. The report, prepared under the direction of Ranking Member Sen. Clair McCaskill (D-MO), reports on payments from five opioid analgesic manufacturers to 14 outside groups between 2012 and 2017. The Academy of Integrative Pain Management (AIPM) was one of the 14 groups included in the report.
The sole request from the Senate Committee to AIPM was for information detailing all payments received from the five manufacturers during the specified time frame, and the intended purpose of each payment. AIPM willingly cooperated with this request and provided the information as requested.
The report criticizes the 14 groups for “fail[ng] to adequately disclose manufacturer contributions”, despite noting that the organizations meet the letter of the law through their current reporting practices. The report also alleges that the groups have contributed to “opioid overprescription and overuse” by minimizing the risk of addiction, lobbying to defeat policy measures to restrict overprescription, criticizing or attempting to undermine the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain, and attempting to limit the government’s ability to prosecute and “punish physicians engaging in opioid overprescription and executives responsible for fraudulent marketing of opioid products.”
Response to the Report’s Findings
Throughout the section of the report alleging improper actions by these advocacy groups, only one or two specific examples of each type of activity are provided, but it is clearly implied that all these groups are somehow involved in these activities. This diverse group of 14 organizations is treated as a monolith that engages in uniform practices regarding education and advocacy. Those who know the organizations well will appreciate the flaw in this overgeneralization. Further, the report alleges that the groups inappropriately promoted the use of opioids to treat pain to sustain their funding streams from these manufacturers. AIPM categorically rejects this characterization of its activities and wishes to correct this misperception.
With respect to disclosure of contributions, AIPM has always been transparent regarding the use of contributions from commercial entities. Every educational program supported by commercial entity grants has prominently acknowledged the source(s) of funding, and every speaker at our Annual Meeting has disclosed his or her ties to commercial supporters (if such ties existed). AIPM’s website includes a page that displays logos and descriptions of companies that have joined its Corporate Council. Companies that have purchased exhibit booths and other items (e.g., attendee bags, lanyards, etc.) at AIPM’s Annual Meeting have been listed in the meeting program and on the website. Advertisers in AIPM’s publications have been self-evident, and it is worth noting that those advertising FDA-approved pharmaceuticals must meet FDA standards for that advertising. Finally, contributions to support AIPM’s policy efforts through its State Pain Policy Advocacy Network (SPPAN) project have been acknowledged on the SPPAN website. The only way in which AIPM could have been more transparent is if it had listed the actual amounts of the contributions, something that is not required by law and that is very much the exception, rather than the rule, among professional societies such as AIPM.
AIPM has always gone to great lengths to represent the risk of addiction to controlled substances used to treat pain. AIPM always strives to present this risk as it appears in the scientific literature, and it has frequently offered courses for prescribers on ways to mitigate this risk while still effectively using opioids to treat pain, when such treatment is appropriate as part of an individualized plan for pain management. The truth is that the scientific literature about risk is no more specific than the literature about the benefits of opioids in treating chronic pain—reported rates of addiction among people using long-term opioid therapy to treat chronic pain are highly variable, ranging from approximately 3% to about 35%. AIPM strives to report this information accurately, based on the preponderance of the evidence, and seeks to educate clinicians on other means of treating pain to reduce the need for opioid analgesics as much as possible.
AIPM, primarily through its SPPAN project, has been the most active of the 14 groups in lobbying on legislation and regulation intended to eliminate overprescribing. The report singles out AIPM’s activity related to attempts to repeal Tennessee’s Intractable Pain Treatment Act (originally passed in 2001 to ensure that people with chronic noncancer pain could access all effective treatments, especially opioids) in 2013 and 2014, relying entirely on one media report to accuse AIPM of having improper motives in so doing. That media report grossly misrepresents the actual situation, in which legislators were misled about what the existing law required. In letters to policymakers regarding Tennessee’s HB 1713 (2014) and SB 1819 (2014), AIPM took pains to point out the factual inaccuracies in statements from supporters of repealing the law, believing that legislators should make their decisions based on the actual language of the law. At the same time, AIPM recognized that the law was confusing, partly because it was poorly written, and encouraged advocates to support alternative legislation (HB 1966 (2014) and SB 1820 (2014)) that would have amended the law in ways that would have resolved repeal supporters’ concerns. None of that was mentioned in the report. It is concerning that Sen. McCaskill’s staff never solicited information from AIPM about this issue, choosing instead to rely entirely on one inaccurate media report.
AIPM has posted a statement on its website describing its approach to advocacy for proposed legislation and regulation related to prescribing of opioids and other controlled substances. Succinctly stated, this approach recognizes that some people with chronic pain need opioids to achieve optimal pain relief. Further, an integrative approach to treating pain requires that clinicians and people with pain have adequate access all available treatments, including opioids. When AIPM advocates for opioid-related legislation and regulation, it is with the intent to prevent access from being unduly restricted, not with the intent to maximize the use of opioids to benefit any pharmaceutical manufacturer. In fact, AIPM often supports efforts to appropriately restrict opioid prescribing, largely supporting legislation intended to limit initial opioid prescriptions to new and/or opioid naïve patients, so long as appropriate exceptions are in place that protect unique patient considerations. AIPM is confident that a review of the actual record, consisting of more than 300 comments on legislation and proposed regulations from 2014-2018, will reflect balanced comments consistent with this approach. Had Sen. McCaskill’s staff sought such a review, that would have been revealed.
With respect to the CDC guideline, AIPM has been critical of the process involved in drafting the guideline, and of the inappropriate and unintended application of the guideline following its publication. AIPM specifically criticized CDC’s decision to exclude all pain management professional societies from the committee that drafted this guideline on how to treat pain. AIPM was invited by CDC to be one of the first 16 stakeholder groups to review the guideline after the drafting process. This review was approached as if it was a rigorous academic exercise, as reflected by the extensive comments AIPM submitted. Such an approach presents constructive criticism, and is completely appropriate, rather than improper; indeed, the nation’s pre-eminent public health agency should expect nothing less.
Subsequently, CDC released a second draft and invited comments from all sources. In reviewing this second draft, AIPM noted that, not only had its first set of comments not been incorporated, but changes had been made that moved the draft farther from AIPM’s recommended construction. This fact is reflected in the 23 pages of comments submitted for the second draft. Again, AIPM took a rigorous academic approach to making constructive comments. AIPM’s intent was to help CDC produce a guideline that provided helpful recommendations supported to the greatest extent possible by the low-quality evidence available, while avoiding pitfalls that could result in inappropriate restrictions on clinicians’ ability to treat pain most effectively.
When CDC issued its guideline, it carefully noted these considerations: 1) the guideline was intended to present recommendations to prescribers, and CDC did not intend for those recommendations to be turned into requirements through legislation or regulations; 2) the guideline was intended to apply to people with chronic pain who were not already using opioid therapy, and not intended to apply to those whose ongoing opioid therapy might fall outside the parameters given in the recommendations; 3) the guideline was intended to apply to primary care providers (not pain specialists or other specialists who often treat pain); and 4) the guideline was not intended to apply to people with chronic pain related to cancer, or to those receiving palliative, hospice, or end-of-life care.
AIPM warned that legislators and regulators, and probably third-party payers, were very likely to violate all of these considerations in service of desperate efforts to combat the opioid overdose epidemic, and that the inclusion of specific numbers in recommendations related to acute pain treatment and opioid doses for chronic pain treatment was likely to result in those numbers being turned from the thresholds represented in the guideline, into ceilings based on new legislation and regulations. Those warnings from AIPM have turned out to be prescient, as legislators, regulators, and third-party payers, including the Centers for Medicare and Medicaid Services, have done exactly that.
To be completely clear, AIPM supports the recommendations in the CDC guideline as they are written. Conscientious adherence to these recommendations is likely to improve the safety of opioid therapy, without unduly restricting access for people who need it. However, in concert with the approach outlined above, AIPM has seen the need to advocate for modification to proposed legislation, regulation, and payer policies to prevent CDC’s clearly stated intent from being perverted in such a way that appropriate access is restricted. AIPM’s criticisms of the CDC guideline have been intended to produce a stronger guideline that would more likely accomplish CDC’s intent, not, as the report implies, to subvert the guideline and eliminate it. Again, a careful review of AIPM’s statements on this guideline and related policy proposals would have revealed this to be true.
With respect to the report’s final accusation, that these 14 groups have acted to prevent prosecution and punishment of overprescription and inappropriate marketing, AIPM is unaware of any specific action it might have taken that meets this description. While it is possible to construe AIPM’s actions related to the Tennessee legislation described above as fitting this bill, the fact that AIPM supported alternative legislation that would have specifically maintained the ability to prosecute or administratively sanction inappropriate prescribing clearly refutes such an accusation. AIPM believes that negligent or reckless overprescribing, especially when it crosses the line from the practice of medicine to the practice of drug dealing, should be prosecuted and sanctioned as appropriate to the case. It is in no one’s interest to allow such practices to go unpunished. That extends to inappropriate and illegal marketing practices as well.
A Call for Greater Interaction
Part of what AIPM finds so distressing about this report is that it believes that an integrative approach to pain management is one of the practices needed to successfully address the opioid overdose and misuse epidemics. By making use of all the tools in the integrative pain management toolbox, people with pain can achieve more and greater benefits, fewer and less severe harms, and greater satisfaction and quality of life, all at reduced cost to the healthcare system. AIPM has steadfastly educated clinicians about these approaches and advocated for policies that remove barriers to accessing them. This has been the mission of AIPM since its founding three decades ago, and that mission is more important now, in the context of the opioid crisis, than it has ever been. Unfortunately, inaccurate accusations such as those contained in this report hinder AIPM’s ability to accomplish this vital mission.
Each year, AIPM surveys stakeholders (i.e., its members and representatives of outside organizations that have congruent missions, but NOT funders) to determine the focus of its advocacy efforts. For the last four years, these surveys have identified increasing access to non-pharmacological pain treatments as the top priority. Advocacy to prevent problematic restriction of access to opioids has consistently been ranked fourth or lower on the priority list. Clearly, if AIPM’s education and advocacy efforts were designed to curry favor with opioid manufacturers, the priority list would be different.
AIPM calls on Sen. McCaskill and all other interested parties to thoroughly and carefully examine the educational offerings and advocacy information available on its website to determine if there is evidence of undue influence by opioid manufacturers, rather than relying on media reports of variable accuracy. Further, if any party has a question about specific educational programs or advocacy efforts, AIPM will be happy to supply materials needed for that party to make an informed decision about AIPM’s motives. Had the individuals developing this report done so, AIPM is confident that different conclusions would have been reached.
AIPM will continue to educate clinicians, policymakers, and payers about the integrative model of pain management, and will continue to advocate for policies that allow its members and other clinicians to practice integrative pain management to the greatest extent possible. AIPM is eager to work with Sen. McCaskill and other policymakers to address barriers to integrative pain management, because it believes doing so is necessary to achieving the goal of successfully resolving three intersecting public health crises in today’s United States: the inadequate treatment of pain, the epidemics of opioid misuse and overdose, and the inadequate treatment of other mental health conditions. Using the interdisciplinary, multimodal, whole-person approach to restoring health reflected in integrative pain care is, AIPM believes, the only way to achieve this goal. Increased cooperation between AIPM, its educational and advocacy partners, and policymakers is urgently needed for this to happen.