On July 9, 2018, the Federal Drug Administration (FDA) held a public forum focusing on the patient’s perspective on drug development for chronic pain. The FDA invited members of the public, including the Foundation for Peripheral Neuropathy’s (FPN) President, Lou Mazawey, to attend to give their perspectives on living with chronic pain and treatment approaches currently available to patients with chronic pain. Mr. Mazawey, as a patient with peripheral neuropathy, was able to share his viewpoints as well as represent FPN in this important discussion.
The Foundation for Peripheral Neuropathy (FPN) surveyed its members on their experience with chronic pain and its treatment. FPN will submit the survey results to the FDA as a follow up to the public meeting. The results of our survey generally mirror the issues and concerns raised by the 1000 patients in attendance either in person or virtually for the FDA forum. We present our summary of the key points below.
Is Chronic Pain a Problem in the US?
According to the FDA, chronic pain affects approximately 100 million adults in the US. Chronic pain greatly contributes to national rates of morbidity, mortality and disability. It has a major impact on the livelihoods and well-being of those affected. The economic cost of chronic pain is estimated to be $560-$635 billion a year. The FDA confirmed that the medical needs of patients with chronic pain are largely unmet, representing a large health concern in the US. One of the major types of chronic pain included in these statistics is neuropathic pain, such as peripheral neuropathy.
Symptoms and Daily Impacts of Chronic Pain that Matter Most to Patients
Chronic pain can manifest itself through a number of symptoms and vary in severity. Of those attending the forum, 74% described their pain as always being present but with intensity that changes over time. Patients indicated that, with medication, they often accept moderate pain levels rather than complete pain elimination. Patients in our survey also said that even with medication their pain was in the moderate to significant pain levels.
Nonetheless, chronic pain has a significant impact on the quality of life for patients overall. In our survey, respondents agreed that chronic pain has had an impact on their day-to-day lives. Many patients find their mobility impacted. They also find that chronic pain affects their overall feeling of well-being. Other impacts described by patients during the meeting included an impact on relationships, the ability to care for oneself and family, and stigma or embarrassment related to chronic pain.
Many patients raised the issue of fatigue as a wide-spread but little recognized impact of chronic pain. Fatigue could be caused by disrupted sleep or the sheer energy it takes to battle chronic pain on a daily basis. One patient described battling chronic pain as a full time job. Another describe chronic pain as ‘stealing’ her life. These comments, sadly, drew applause from the audience at large.
Current Approaches to Treatment of Chronic Pain
Both the patients at the forum and the respondents of FPN’s survey have tried a wide range of medicinal and non-medicinal therapies to address their pain. According to our survey, 45% of patients took gabapentin and found it somewhat or very effective relative to other treatments. Other popular treatments include lidocaine and other nonprescription creams. In terms of non-medicinal treatments, patients in our survey found diet and exercise to be by far the most utilized and most effective of all treatments.
Nonetheless, our survey indicated that these treatments were only moderately effective in managing pain. It was fairly universally agreed that no one treatment completely managed the chronic pain of patients. In our survey, in some cases, patients chose to give up taking certain medications due to the side-effects being worse than the benefit of the pain relief.
Patient Concerns about Treatment Options
A major concern among the participants of the forum and our survey respondents was the cost of treatments. For those with insurance, the cost of treatments was less of an issue. However, not all insurance plans cover physical therapy or many other potentially useful treatments. For patients who are not able to work full time or do not have insurance, the cost of treatments are often prohibitive. Patients are not able to access the best treatments available due to this cost.
Many patients were concerned about being able to continue to get prescriptions for certain treatments. They were also concerned about the added scrutiny that doctors are under in writing these prescriptions.
In summary, there was a consensus that much more needs to be done to ensure safer, more effective and more affordable treatments for chronic pain. The FDA took note of all comments during the session. The FDA encouraged all patients to submit comments through the public docket on their website. The public docket will be open through September 10, 2018.
For More Information
A recording, transcripts and slides from the July 9 FDA Patient-Focused Drug Development Meeting on Chronic Pain can be found on the FDA website. This is one of a series of meetings on the subject including a 2016 meeting focused on neuropathic pain.
More information on available treatment options for chronic pain and other symptoms related to peripheral neuropathy can be found on the Foundation for Peripheral Neuropathy website.