An Opportunity to Make Ourselves Heard
/By Richard “Red” Lawhern, Guest Columnist
Many kinds of chronic pain are represented by the readers of Pain News Network -- among them, several forms of peripheral neuropathic pain. PNN readers might not be aware that a public meeting was recently held by the U.S. Food and Drug Administration on “Patient-Focused Drug Development for Neuropathic Pain Associated with Peripheral Neuropathy.”
You can watch and listen to the June 10th meeting by clicking here.
The FDA maintains a public gateway for comments on the meeting and its goals. I urge anyone who wishes to influence this issue to submit their comments. The public comment period ends August 10th.
As of July 2nd, only 27 comments have been received!
To get any notice at all, we need 2,700 -- or better yet, 27,000 comments -- not 27. Silence will almost certainly be maliciously interpreted by the FDA to mean that pain patients are doing okay with presently available remedies, which all of us realize we most decidedly are not.
To make a comment, the FDA gateway may be reached by clicking here.
The following was the questionnaire filled out by meeting attendees. Follow-up comments may be more effective if focused on these areas:
Topic 1: Disease symptoms and daily impacts that matter most to patients.
1) How would you describe your pain associated with peripheral neuropathy? What terms would
you use to describe the most bothersome aspects of pain? (Examples may include stabbing
sensations, electric shocks, burning or tingling, etc.)
2) Are there specific activities that are important to you but that you cannot do at all or as fully as
you would like because of your neuropathic pain? (Examples may include sleeping
through the night, daily hygiene, participation in sports or social activities, intimacy with a
spouse or partner, etc.)
3) How does your neuropathic pain affect your daily life on the best days? On the worst days?
4) How has your neuropathic pain changed over time?
5) What worries you most about your condition?
Topic 2: Patients’ perspectives on current approaches to treatment
1) What are you currently doing to help treat your neuropathic pain associated with peripheral neuropathy? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies such as physical therapy). How has your treatment regimen changed over time, and why?
2) How well does your current treatment regimen control your neuropathic pain? How well have these treatments worked for you as your condition has changed over time? Would you define your condition today as being well managed?
3) What are the most significant downsides to your current treatments, and how do they affect your daily life? (Examples of downsides may include bothersome side effects, going to the hospital or clinic for treatment, time devoted to treatment, restrictions on driving, etc.)
4) Assuming there is no complete cure for your neuropathic pain, what specific things would you look for in an ideal treatment for your neuropathic pain? What would you consider to be a meaningful improvement in your condition (for example specific symptom improvements or functional improvements) that a treatment could provide?
5) If you had the opportunity to consider participating in a clinical trial studying experimental treatments for neuropathic pain, what things would you consider when deciding whether or not to participate? (Examples may include how severe your neuropathic pain is, how well current treatments are working for you, your concern about risks, etc.)
Mine was one of the first comments submitted. After summarizing my background as a chronic pain patient advocate, I offered several inputs. Two seem particularly aligned with the concerns of PNN readers:
1) Despite the legal restrictions still placed on medical marijuana, there is ample evidence in patient reports that several strains of this natural plant can be used effectively in pain management for a wide variety of chronic pain conditions, including peripheral neuropathy. Federal funding is needed to bring marijuana research out of the shadows and integrate it into mainstream medicine. If legislative changes are needed, then seek them soon.
2) The most important near term outcome that this public meeting can reinforce is recognition that legally prescribed opioid medications play an indispensable role in present treatment of chronic neuropathic pain which is refractory to other therapies. In this context, the recently published CDC “voluntary” guidelines on prescription of opioids in adult chronic non-cancer pain need to be withdrawn immediately and rewritten to make this role clear -- for both peripheral neuropathic pain and many other chronic pain conditions.
In their present form, the CDC guidelines have become a de facto restrictive practice standard that is driving doctors out of pain management and thousands of patients into unmitigated agony. The basis for the guidelines is also scientifically weak and may have reflected professional or financial self-interest bias on the part of some participants in the “Core Expert Group” that supported the guidelines.
Insofar as I can determine, the working group did not include a SINGLE practicing board certified pain management specialist who is actively treating patients. Revisions of the guidelines need to reflect a much more patient-centered frame of reference, with explicit recognition that dose levels must be tailored to the individual patient and that effectiveness is highly variable between patients due to genetic factors which make some people poor metabolizers of this class of medication.
Richard “Red” Lawhern, PhD, became a patient advocate 20 years ago after his wife developed trigeminal neuralgia, a chronic facial pain disorder. He presently supports 20 groups on Facebook with a membership of over 15,000 patients and family members.
Pain News Network invites other readers to share their stories with us. Send them to: editor@PainNewsNetwork.org.
The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.
