By Terri Lewis, Ph.D.

As many of you know, there’s suddenly a lot of interest in the opinions of chronic pain patients. Dr. Terri Lewis has been an advocate for the chronic pain patient—her own father and son fall into that category—and she writes tonight on the importance of the chronic pain community contributing to a number of surveys that are underway.

There are multiple data collection activities underway that are related to the July 9 meeting in Silver Spring Maryland at FDA headquarters.

The first Is their link that allows you to directly submit comments to FDA. I encourage you to submit comments to this link which is located here:

https://www.regulations.gov/document?D=FDA-2018-N-1621-0001

The second is a link to a survey tool that allows you to submit comments that will be aggregated and compared across the states in relationship to a body of experiences related to the provision of pain care and disease management – insurance, pharmacy, clinical interactions, diagnosis, suicide, care partner supports, and the impact of changes to your medical routines. The goal is to assess how these changes are interacting to affect real people and develop targets for advocacy, tools, communications, and policy conversations. This link is located at the red tab to the right of your screen. Nearly 1000 persons have submitted a wide range of comments to the second link. If you haven’t already, you might want to learn how your experience compares to that of your peers across the nation.

Why is this important to you? Consider the news this week:

On May 24, 2018, Pain Management News online published a report on a case of a woman who had a childbirth epidural injection that went way wrong. It was later learned that she had had multiple lumbar epidural steroid injections for lumbar pain in the period prior to her pregnancy and delivery and the article author concluded there was a relationship between the two medical events and their success or lack thereof. In our survey responses, multiple women have reported that epidural injections figure prominently in their path to disability and similar difficulties with childbirth epidural injections – in some cases, steroid injections were employed for back pain prior to the childbirth epidural – and in other cases the childbirth epidural produced a catastrophic birth result that was followed by the administration of additional epidural injections for arachnoiditis that subsequently developed.

Some of you are aware that more than 60 amendments to manage the opioid crisis are before the House of Representatives for their consideration. Among these is HR5408 which is promoted by ASIPP.org which alleges that the reason that opioids have become so troublesome is because epidural steroid injections are being withheld or reduced. There is no evidence for this, but this bill is buried in this bundle of responses to the opioid crisis and in this case, the goal is to ensure that people with chronic pain receive and fail interventional procedures as a matter of public policy. Importantly epidural steroid injections are not FDA approved, and further, the manufacturer of the primary steroid utilized – Depo Medrol™ – has requested that FDA stop authorizing the use of this material for epidural injections. FDA has yet to honor this request even though other countries have done so.

Among the concerns expressed by respondents to my survey are those of availability of medications when needed. Respondents report significant problems filling prescriptions for pain medicines from CVS, Walgreens, and Walmart. As reported by Forbes on May 22, 2018, persons who utilize Medicare Part D are seeing a rapidly shrinking marketplace of pharmacy plans as consolidation sweeps the health insurance and drug benefit management industry. According to Kaiser Family Foundation in a report issued May 17, 2018, if these acquisitions go through – health insurer Cigna successfully completes its acquisition of the PBM Express Scripts and CVS Health pulls off its purchase of Aetna – nearly three in four seniors will have drug benefits controlled by just four companies. These four firms plus UnitedHealth and Humana will cover 71% of all Part D enrollees and 86 percent of stand-alone drug plan enrollees, based on 2018 enrollment. How this will affect persons with multiple chronic conditions is unknown and will remain unknown unless you share your experience. This will be a central issue as FDA considers drug development and availability.

The Department of Health and Human Services has appointed their new advisory group to help craft pain policy. Pain policy should not be constructed in a vacuum without the participation of those who are most affected by the decisions. It remains important that the pain community remain vigilant and self-aware enough to understand the importance of balanced reporting of the overall patient experience in this challenging environment. Further, we have to make sure that the most marginalized of populations affected by pain have a seat at this table and that their voices are heard – this includes persons of color, persons with developmental disabilities, the rare disease community, and persons who claim gender and ethnicity affiliations that are different than the majority population of health care users.

The inaugural meeting of the Pain Management Best Practices Inter-Agency Task Force will be held on Wednesday, May 30 – 31, 2018, in the Hubert H. Humphrey Building, 200 Independence Avenue, S.W., Washington, D.C. Members of the public are invited to participate in person or by webcast. During the inaugural public meeting, the Task Force will discuss updates to best practices and issues that address gaps or inconsistencies for managing chronic and acute pain. The public is encouraged to provide oral or written public comments. For submitting written comments, please visit regulations.gov and search docket # 2018-09379.

Please take advantage of your opportunities to comment. We know this takes a huge commitment of time and energy. Disclosure is a challenge because you fear retribution. But nobody can tell your story like you can. From these response tools, themes will be extracted and summaries made available to you to use for your personal self-advocacy applications. If we persist, we have an increasing chance of being heard.

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