By Ed Coghlan.

The results of a robust survey authored by Terri Lewis, Ph.D. and promoted by the National Pain Report have been shared with the U.S. Food and Drug Administration in advance of the July 9th public meeting for Patient-Focused Drug Development on Chronic Pain.

“We received a significant response from not just chronic pain patients, but from doctors and caregivers,” Dr. Lewis noted. “It showed that many people are hurting and are being left out of the conversation. This is the message the FDA needs to hear.”

Nearly 1700 people responded and all 50 states had significant participation. 80% of the respondents were women and most were in the 40-to-65-year-old age category.

“What was notable was there was an average of five comorbidities from people who had been ill for twelve years,” she said. “There are 25,000 lines of comment data where people could tell their own stories.”

We are going to cover Dr. Lewis’ submission in two stories.

In part one- we will review the barriers to care that were revealed in the survey that have been shared with the FDA. (In part two—we will look at some of the recommendations that Dr. Lewis gave the FDA which will be part of the testimony for the July 9 meeting and will become part of the Federal Register.

Here’s what she found (and we added a quote where appropriate from a survey respondent that further describes what she called the barriers).

Barrier 1: Insurance problems figure prominently throughout all systems

“I have no care team. I rely on my primary care doctor for my medications. I am poor, have no-one to help me and my insurance does not cover any extras.”

Barrier 2: Regulatory interference in choice making is destabilizing care and treatment of chronically ill persons with multiple comorbidities

“I would love for my care team to consider my input and needs in my care. But they are now more worried about the CDC guidelines and getting in trouble with the DEA. I’ve had my primary care doctor and my pain management doctor both tell me as much.”

Barrier 3: Physicians are retrenching from traditional roles in providing care

“I tried to educate myself is much as I can and a value doctors who are willing to work with me on my health instead of dictate to me.”

Barrier 4: Risk stratification is now based on determining whether the physician can avoid the DEA by balancing the caseload to serve <90 MME criteria (based on assumptions about addiction thresholds) rather than serving confirmed patient needs for specific disease progressions

Barrier 5: The increase in serving physician administrative requirements has broken communication and the Dr./Patient working alliance creating a polarized environment that has increased adverse patient outcomes.

“I would like ONE computer system so ALL of my Doctors can see my records can communicate with ease & cut down on repeat tests.”

Barrier 6: The practice of pain management has suborned ethical care based on medical necessity to risk avoidance and increased attention to dispensing of procedures designed to increase revenue in a shrinking environment

“In the past at pain management, I received injections of different types as well as my pain meds. I stopped going due to the fact that in order to get my pain meds I was basically required to submit to injections that did not help with pain.”

Barrier 7: Across the nation, physicians are fleeing private practice due to regulatory interference and hospitals are closing, factors which affect affordable, accessible, integrated care – particularly in rural areas.

“I have to travel 450 miles one way for a pain doctor that understands CRPS/RSD. I really wish there were someone closer that could take care of my prescription needs for a quality of life. Making the trip is very hard & puts me in a flare.”

Barrier 8: The acute model of medical care fails persons with multiple chronic conditions and leads to increased allocation of interventions which fail while increasing utilization and costs.

“I don’t have a formal “care team”. My “team” is made up of my family members, my physicians, and my pharmacy. When needed, I can get home nursing care. All of that requires some coordination and we work together to get things done.”

Barrier 9: The persons most affected by the decisions about are excluded from having a seat at this table and design of inputs, activities, results, outcomes, impact measures.

“Affected persons” are persons with multiple chronic comorbid illnesses (2 or more confirmed conditions that require care), their care partners, and family members.

Dr. Lewis pointed out in an interview this week that the voices of the chronically ill are not often heard. She believes this survey is a starting point to gain more information from the field to educate the government, insurance payers, medical providers and patients about what is “really happening to these folks.”

“These are clearly not the people that (Dr. Andrew) Kolodny has targeted,” she said. “These are people who have complex illnesses and often need palliative care and just aren’t getting it.”

In Part Two—we will review Dr. Lewis’ recommendation to the FDA.

To register for Public Meeting on Patient-Focused Drug Development for Chronic Pain, click here.

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