Integrative groups offer guidance for FDA on pain, opioids

by John Weeks, Publisher/Editor of The Integrator Blog News and Reports

Last spring, the U.S. Food and Drug Administration (FDA) joined the chorus of agencies weighing in on pain treatment and opioid prescribing policy. At the time, I wrote a column for Integrative Practitioner, FDA pain draft promotes alternative medicine, offers chance for influence. Among the respondents seeking to influence the powerful agency were two policy-active organizations in the integrative health community: the interprofessional Integrative Health Policy Consortium (IHPC) and the specialty-focused Acupuncture Now Foundation (ANF).

Acupuncture Now Foundation

The Acupuncture Now Foundation (ANF) offered its guidance via a 38-page white paper, Acupuncture in Pain Management: Strengths and Weaknesses of a Promising Non-Pharmacologic Therapy in the Age of the Opioid Epidemic. The co-authors are Matthew Bauer, LAc, president of the ANF, and John McDonald, PhD, the vice president of research for ANF. The first two pages are an executive summary leading to the following core recommendations:

1. Guidelines for healthcare providers (HCPs) managing patients with pain should unequivocally recommend acupuncture as an evidence-based therapy for common pain conditions.
2. HCPs should not let the concern over limits in insurance coverage for acupuncture services prevent them from recommending it.
3. The existing paucity in the number and the current disproportionate distribution of acupuncture providers should be addressed to meet rising demand.
4. Comparative cost effectiveness studies should be undertaken to help guide treatment protocols and determine where acupuncture is both most and least cost effective.
5. Governmental and philanthropic financial support grants should be established to support unbiased research into integrating the most promising non-pharmacologic pain management therapies into the practice of mainstream healthcare. This research should include pragmatic clinical effectiveness and workforce capabilities studies and lead to the development of guidelines that HCPs could utilize to aid their decision-making with regard to those therapies.

The authors make clear that, while they are focusing on acupuncture, they are not asserting that it is better than other non-pharmacologic approaches. They cite the lack of comparative effectiveness trials, which they address in their recommendations.

Integrative Health Policy Consortium

The Integrative Health Policy Consortium (IHPC), the consortium of a robust set of 22 “Partners for Health”, submitted a five-page paper entitled IHPC Recommends Education Critical for Adoption of Non-pharmacologic Pain Treatments: Response to FDA request for public comment. The document, submitted under the name of IHPC chair Len Wisneski, MD, was coordinated by long-time IHPC policy leader, Bill Reddy, LAc, DiplAc, a Virginia-based acupuncturist and writer.

The IHPC letter starts by thanking the agency for its “recommendation of non-pharmacologic pain management.” The organization then quickly argues that the shift toward non-pharmacologic approaches will require additional education of practitioners on the application of such approaches. “The present document does not substantially provide guidance to practitioners in these areas. The bulk of your current document focuses on non-opioid drug interventions. Our core recommendation is that the FDA dedicate a like amount of educational power and authority to teaching practitioners how to begin making this transition to non-pharmacological approaches.”

The IHPC document then lists roughly 15 specific disciplines and therapies to which they call the FDA’s attention as potential non-pharmacologic contributors. They draw the list mainly from prior documents from the Joint Commission, the Veterans Administration, the American College of Physicians, and other conventional sources.

IHPC recommends specific additions to the document. One is a set of links to resources that can connect conventional practitioners with nationally-certified integrative practitioners. IHPC further recommends a section of self-care. The statement calls the FDA’s attention to the National Pain Strategy segment on “Prevention and Care” noting that it “invites collaboration with ‘licensed complementary and integrative health fields’ in their goal to develop ‘nationwide pain self-management programs.’”

IHPC’s urges the FDA instructions to include practitioner education on how to develop SMART (Specific, Measurable, Attainable, Relevant, Timely) goals with patients.

Other sections of the document guide the FDA to value non-pharmacologic approaches not only as preventive strategies, but as collaborative factors in co-management methods and as agents that can be useful in helping the toughest patients who are in the throes of significant addiction.

Comment: We are witnessing a pattern in final documents from major federal and non-governmental agencies on pain and opioid guidance in which they erase lists of specific complementary and integrative therapies that are visible in the drafts. The 2016 CDC Guidance and the recent Joint Commission document, for instance, elected the sparse “non-pharmacologic” umbrella term. Doing so is akin to assuming that every land-locked and culturally challenged U.S. citizen who uses the term “American” is including the residents of Mexico or Chile, much less the indigenous of the upper Amazon, in that umbrella term.

If these agencies are serious about non-pharma approaches, they need to get their readers accustomed to the diversity of all the options at the table. To not take the space to educate and direct, given the evidence for present integrative strategies and of the morbidity and mortality associated with opioids, is to have blood on their hands. The good work from ANF and IHPC point them in the right direction.