Have Peripheral Neuropathy? Tell the FDA

Have Peripheral Neuropathy? Tell the FDA

By Staff

On June 10th, the FDA is convening a Public Meeting on Patient-Focused Drug Development for Neuropathic Pain Associated with Peripheral Neuropathy. The Agency is holding the meeting to address drug development needs and priorities for neuropathic pain associated with peripheral neuropathy.

Richard “Red” Lawhern, PhD emailed The National Pain Report over the weekend to urge people to participate (click here) and share with our readers what he is prepared to tell the FDA.

  1. For the long term, several experimental drugs or classes of drugs appear to offer potential for enhanced effectiveness in treating chronic pain due to peripheral neuropathy. One of these is CNV1014802, a novel small-molecule Sodium channel blocker specific to the Trigeminal Nerve. The drug was developed by Convergence Pharmaceuticals in the UK and completed Phase II Trials. Convergence was bought by a US company and the status of CNV1014802 is presently unclear. Further work on this agent needs to be accelerated and placed under close NINDS oversight. Authorization for use as an orphan drug should be accelerated.
  2. There are published early reports of effectiveness in pain control from use of Peptides found in spider venoms. Isolation of active agents and testing for safety and effectiveness in humans should receive priority funding.
  3. Despite the legal restrictions still placed on 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. NIH funding is needed to bring this type of research out of the shadows and integrate it into mainstream medicine. If legislative changes are needed, then seek them soon.
  4. 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the recently published CDC voluntary guidelines on prescription of opioids in adult chronic non-cancer pain need to be withdrawn immediately and rewritten to make this role clear — in both peripheral neuropathic pain and many other chronic pain conditions.

In their present form, the CDC guidelines have become a defacto 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 Consultants Working Group that supported the writing. 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.

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Authored by: Staff

There are 17 comments for this article
  1. Mark Nawrot at 4:56 am

    I have had peripheral neutopathy since 1995 due to HIV and Antiviral medications for the virus.Eight years ago had to change antivirals due to treatmant failure. 4 of the 5 meds I was changed to had Diabetes as a side effect, with a year to six months was having sugar problems. This added to the neuropathy pain , making ppainin feet almot unbearable. Havs been on gabapentin and amitryptyline since 1957, those doses were in creased to help increased pain, but going higher in dose onlu made me so tired could bare get out of bed and function. Four years ago started vicodan, was on steady dose, and it helped inmensely. Since jan of this year was, cut off, made to go through a therpist and a psycologist to get to a pain clinic. Felt treated lkke an addict, humiliated. Psycologist suggested lyrica, which had alresdy tried, but gave me mood changes, also two, other antidepressants, one of which ks a FAILED antidepressant, pushing as pain med now. Pain clinic had muscle relaxants or IV lidocaine, pitiful substitutes for vicodan which was working. Biofeed back was also a suggestion, what am I supposed to do tell my body it’s not hurting, when feet feel li, e first layer of skin has been removed and lamon juice poured all over, on top of the thousands of pins sticking and shooting pains like when one has a toothache? My life has been hell since january. I used to garden, work part time two days a week, easily do household chores, now don’t have the energy to even get out of bed and eat, the pain is sucking the energy out of me, not to mention tne tramadol which can take almost max reccomended dose, and it dois nothing to ease pain, tried going higher dose on gabapentin, but am sooo zoned out and spacy, and have no energy ,feel stoned. PLEASE, get the FDA, DEA, and CDC, to STOP making doctors scared to lose license for prescrining opiods. Vicodan was ONLY thing that has worked, and I was at lowest dose,,, 7.5 mg tid.

  2. Paula Sheerin at 5:57 pm

    Will comments from patients outside the US be taken into account? As decisions made by the FDA do influence our lives and our healthcare.

  3. Shannon Greathead at 9:36 am

    Yes I have neuropathy among a list over 39 yes I said it, THIRTY different issues or diagnoses in which five are autoimmune diseases. Lupus, fibromyalgia, Raynauds, sjogrens and Anklyosis spondylitis and Lord knows what has been missed. I have been living this daily 365 24/7 non stop pain for almost 10 years now. Not to mention I have had 5 spinal surgeries that effected L5-S1 diskectomy, C4-C7 diskectomy with titanium rod placement, has a neuro-stimulator implant, revision of it the following week because if leads tearing the same day of surgery, then one year later removal of the implant because during that year in my spine fitness turned on and used maybe a dozen times as they could never get it set right to work and give relief of pain at all instead it created more pain. I have lost 3″ in my height in the past 4 years due to degenerative disc and joint disease, currently seeing neurologist for more possible surgery on both lumbar and cervical spine again, going through the insurance motions and requirements such as therapy, spinal epidural cortisone injections and nerve blocks no help. I also had to have a gastric bypass done so now that really limits anything I can take orally for pain. I see pain management physicians for refills but they are no longer giving me options for relief as the pain patch and hydrocodone no longer work it’s like taking tic tacs and putting on the fake tattoos we used to get out of the cracker Jack boxes as kids. Depression?? SERIOUSLY that is a no brainer, but do I have a life to live the answer is yes but do I live it the answer is no because I can barely move daily from pain that is from my neck to my toes and nothing that I have been given or offered to take has worked. Except about a 30 minute period of numbness that I might be lucky to have after a epidural injection and that’s if I am lucky. PLEASE I beg of whoever speaks or gets heard to know that I suffer all the time, that we as a group of chronic pain sufferers need help and support not government blocking of medicine, surgical or any other form of treatment options blocked. PLEASE help us become productive living people again so we can be happy, somewhat healthy, productive, active with our families especially children again people we still have feelings, we still can do things to be proactive and productive individuals again if we were helped to be pain free. I know I would love to be able to work again, use my mind and body and former skills to help others in need but can’t even help myself get dressed some days, it’s a rare occasion if the stove is turned on, and since I don’t own a dishwasher well let’s just say paper products are my friend. Please don’t ignore us from one human being to another I am begging for help.

  4. I. Hollis at 9:22 am

    Charles,
    I also developed an unusual neuropathy after West Nile Virus in 2014-burning mouth syndrome. I have felt that the medical community isn’t paying as much attention as they should to the after-effects of this virus. I lost 35 pounds in the beginning and could barely eat.
    Six months before I contracted West Nile Virus I had been started on a low dose opioid in the evening for pudendal neuralgia, after 20 years and many rounds of PT and medication trails. By evening it was so painful to sit. I believe that this medication saved my life after the West Nile event as it allowed me to eat comfortably at least once a day. I’m extremely sensitive to many medications including gabapentin, so this has allowed me to eat comfortably at the dinnertime meal and I’ve been able to gain back 20 pounds. The lidocaine mouthwash just made it worse after a bit. What a bummer when your nervous system misfires, it feels like when you have the sore mouth/throat before you are coming down with a cold or flu every day and it never goes away! A cure for neuropathies sure would be welcome! It also makes me wonder how many painful conditions are the result of post-viral issues, esp West Nile ?

  5. Bruce Stewart at 1:53 am

    I will be tuning in to the webcast for the FDA hearing. I have had peripheral neuropathy in my feet for roughly the last 8 years. Opiates are the only thing that work. I do not build up any tolerances and they do not “stop working”. They do the job they are intended to do, and no “high” occurs because the medicine simply attacks the pain. That’s what they’re designed to do. The non-sufferers in charge of making the laws designed to intimidate and threaten pain management doctors and pharmacists have to understand a basic fact – that a majority of us with this disease were, at one point as HEALTHY as any one of them. Perhaps the reason that the lawmakers and law enforcement personnel cannot understand our situation is that this type of pain DOES NOT EXIST ORGANICALLY in the body. There has to be a disruption of the nerves for this to occur. We have acquired the unfortunate acquisition of pain that is so severe, that it can only be explained in cartoon-like terms. When I wake up from a nap during the day, it feels like a thousand bees are stinging me, with the stingers embedded in my skin. This can go on for hours, unmedicated. It also feels sometimes as though a hole is being drilled through the balls of my feet. My arches are ripped like ribbons being shredded. My feet feel severely, completely sprained without any support to enable me to walk. If you have a sprained or broken foot, you wear a cast. We don’t because it would not help. Shoes are torture chambers. Clothespins on my toes. Fractured bones. Don’t believe me? Hey – 20 MILLION people can’t all be wrong. It’s an epidemic of suffering beyond belief. I used to be able to dunk a basketball, I played in college, now I can barely walk, I’m so crippled with this pain. I barely survive. And the chronic fatigue syndrome mimics the flu almost to a T. That’s right- I’ve had the flu for almost 3,000 straight days!

  6. Cynthia at 10:10 pm

    Charles Arkinson, Ed.D….I would be very interested to know what nutrition changes you have found helpful…my email is cindy7227@charter.net, if you’d rather not post here. Thank you, Cindy

  7. kimber applegate at 9:24 am

    Someday , probably not in our lifetime the FDA or the CDC will wake up and realize that those of us who suffer on a daily basis from this awful burning and pain in our feet and legs are serious as well as spinal stenosis and degenerative discs , and there is really nothing left other than the therapies that our Pain Management DR’s are prescribing for us. Those PM, mine included who aren’t cutting my prescription understand the agony that I deal with on a daily basis, I have a spinal cord stimulator implanted , granted it helps somewhat , but it doesn’t take care of all of the burning and pain that travels up my feet to my knees most days , no matter the setting, I have been on a higher dose of Opiates for approx 1 yr after going thru most and buliding up a tolerance, and pretty much run out of options for pain control ,short of my garage. If the CDC and FDA close off avenues for developement of new drugs to the market , for us.whats left . We aren’t asking for much, just listen to us, hear our stories, don’t lump us in with the addicts , we are the people in the grocery stores, the library, sitting next to you at the movies in some cases, sitting on a plane. Is that asking too much ?

  8. Jan Kane at 10:35 am

    I have had neuropathy in my lower legs and feet for around 5 plus years now. Along with this, I also suffer from several other pain debilitations which I am being treated by pain management physicians. The worst pain by far is the neuropathy. It is beyond description, of which nothing offered as treatment has even done one thing for relief. If it were’t for the possibility of fathom pain, I’d head for the garage and do my own amputations. My legs, as it stands (ha), are pretty much useless…either way.

  9. JM Robinson at 6:21 pm

    I have had peripheral neuropathy for the last 10 years. It occurred due to an accident (not my fault). I have had an implant in my spine which was supposed to alleviate the pain-it just takes some of the edge off; I take opioids (am in the monthly care of a pain physician). These meds have to be changed all the time as they lose their effectiveness. In addition, I have Scoliosis and Stenosis. The opioids do not help with my back pain. I try very hard to live a normal life but it is for nought. I can’t take a couple of non opioids because of side effects..is: Neurontin and Lyrics. The worst is the bowel problems. And if and when new meds come out…they will be expensive and probably not covered by my Part D med insurance. Please help us. It is living help.

  10. Judy at 1:54 pm

    I have peripheral neuropathy in feet and small nerve fiber neuropathy in legs. The pills I have taken have done nothing but give me horrific side effects. I have tried alternative medicine as well. The intense burning feels like my feet are on fire. I am mostly bedridden because of pain. I would like to try med cannabis but the state I live in neuropathy is not a condition. Would love to see the politicians suffer through one day of this. Opiods do nothing.

  11. Richard Oberg M.D. at 12:03 pm

    Jeremy Goodwin – why don’t more physicians speak out against CDC nonsense and particularly for those long-term patient relationships many physicians have who are being forced to terminate their care? I’ve found physician silence to be deafening and most physicians (as I’m sure you know well) push back hard against any government limiting of their patient provenance in treating – why is this so different? Are physicians suddenly so afraid of doing the right thing and why? Most physicians know there’s been a ‘divide and conquer’ campaign going on for many decades between government/insurance companies and physician care but this is the first time I’ve seen such physician capitulation on a nationwide scale – perhaps because it’s still in localized regions of the country and not everywhere? I’ve been baffled by this and, if allowed to continue, isn’t going to bode well for physicians in general. Not to mention their patients 🙁 Why are addictionologists being allowed to dictate what internists and other do??

  12. Jan Kane at 11:51 am

    I have fibro, neuropathy, degenerative disc disease, osteoporosis and osteoarthritis. The past 10 years I’ve needed pain management. In the last 5 months I’ve had 2 doctors leave the group I’m in. The other doctors are now over booked and don’t have a clue what my issues are, except they want to lower my dosages . They don’t understand I cannot tolerate anything else and my genetic profile shows that I don’t absorb the opiate I’m left to take, very well. I feel SO lost in this battle, and due to pain and fatigue, I don’t have much fight left in me. (My total battle with pain has been 30 years.)

  13. Hope at 11:49 am

    Diane you can not quit talking about it. I learned something today. I did not realize gastric bypass affected meds! I have been a chronic pain suffer for a long time I have not even tried to figure out the years I just keep on plugging. Most of it is lower back chronic pancreatitis and nerve damage from the car accident 20 years ago. The meds keep changing and I keep changing. Keep on plugging in and talking. Gentle hugs

  14. Linda Donner at 11:18 am

    I also have neuropathy in my feet & NOTHING under God’s green earth can compare to the hell i have suffered.. NOTHING is so tormenting as to have your feet numb, burning like they were set on fire & burning & electric shocks running up your toes & feet1!I wish these iodiots that are trying to stop all the pain meds had it ONE HR they would be begging for laws to be changed…

  15. Charles Arkinson EdD at 11:16 am

    My name is Charles Atkinson EdD and I am an 80 year old survivor of Neuroinvasive West Nile Virus in Cambridge MA with severe peripheral neuropathy since August 1, 2012. I have learned to manage my neuropathy with 300 mg gabopentin and Tylenol PM and heat cold dry wet oil and a variety of conservative management approaches. Also total change in nutrition How do I share my success and learn from other victims?

  16. Jeremy Goodwin, MS, MD at 8:56 am

    Thank you for speaking out. I have been so frustrated to read little in support of patients where pain and opioids are concerned. There have been too few refutations of these politically and non scientifically derived government ‘guidelines’. It has been an intimidation movement and it is still gathering momentum.

    Patients are people. Non human animals also experience pain, emotion and cognition. Clinician’s of all types need to understand that a recipe is but a beginning. The individuality of the person then dictates the course of treatment and plain old care. Cure is not always possible. Care is.

  17. Diane Gracely at 3:43 am

    I am 52 years old and have coped with peripheral neuropathy since I was 5 years old when they diagnosed me with Charcot Marie Tooth disease. I have been up and down the road of alternative therapies and medicines over the years and NOTHING works better than opiates. There are a lot of other things to factor into my health care. I also have had gastric bypass surgery which means I do not absorb medicines like normal people do. So I am on a little higher dose of opiates than some people. I am very lucky to have a doctor who understands all of my health problems and what I cope with on a daily basis.

    I could go on and on hear but I got tired of feeling like I am wasting my breath because NO ONE listens to us chronic pain patients. So I quit now.