Patient-Focused Drug Development on Chronic Pain; Public Meeting; Request for Comments 
Patient-Focused Drug Development on Chronic Pain Notice of public meeting request for comments Meghana Chalasani Chronic Pain CDER OPEN 2018-247
2018-08-07 2018-07-16 2018-07-10 2018-07-10 2018-07-10 2018-07-23 2018-07-23 2018-07-23 2018-07-23 2018-07-23
FDA-2018-N-1621-1507 FDA-2018-N-1621-1311 FDA-2018-N-1621-0663 FDA-2018-N-1621-0671 FDA-2018-N-1621-0674 FDA-2018-N-1621-1414 FDA-2018-N-1621-1409 FDA-2018-N-1621-1410 FDA-2018-N-1621-1402 FDA-2018-N-1621-1405
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1507 https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1311 https://api.regulations.gov/v4/comments/FDA-2018-N-1621-0663 https://api.regulations.gov/v4/comments/FDA-2018-N-1621-0671 https://api.regulations.gov/v4/comments/FDA-2018-N-1621-0674 https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1414 https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1409 https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1410 https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1402 https://api.regulations.gov/v4/comments/FDA-2018-N-1621-1405
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
My mother had severe restless leg syndrome (RLS.) After years seeking help for her overwhelming need to move her legs at night and dealing with dismissive and nearly abusive physicians, we found an M.D. who said that he would not have believed her symptoms had he not had RLS himself!  Her husband, of 50 years, had to move to a separate bedroom because of her constant need to move.  Mother was finally treated with drugs that allowed her to sleep for longer periods without walking about.  Those drugs, first Sinemet and then various dopamine agonists, worked for a few years, but with major side effects that led to severe augmentation.  Her RLS then started earlier in the day and prevented going to a movie, listening to a lecture or traveling despite her determination to live her life fully.  She was exhausted all day and would sometimes just fall asleep in the middle of a conversation because of the impact of the medical regimen.  When she was dying, she was in agony with RLS because she could not get up and move about.  Moving while lying in bed did not alleviate the symptoms or did so only while she continued movement.  When her RLS medications no longer worked, her neurologists had nothing to offer.  Fortunately, once she was in hospice, people actually cared about her comfort and she was provided with opioid pain control which, more importantly to her, helped control her RLS.  It was so sad that mother had to be dying to receive appropriate care.  Fortunately, more physicians now understand that RLS is actually not in ones head, but is a real, not manufactured condition to gain attention.  .  .  25 .  21..    ...  Multiple sclerosis, EDS, mcad..I cant have injections bc of EDS. Professionals should know that. My last resort is going to be learning to buy and do heroin. I have been frustrated by having to even go to pain management to get my pain pills. First I received dilaudid from my eye surgeon that removed my blind eye. Then he no longer wanted to prescribe the 8-10 pills I used monthly and said I had to instead use the time , energy and money to go to a pain clinic for these pills for my blind ennucleated eye neuropathy. Im allergic to codeine and need dilaudid for relief. First the pain clinic said I could come every 3 months and get these pills, then they said CDC guidelines indicated that if they gave me any opiates I had to be seen monthly.  This is costly and I have to drive or be driven ( I have lots of vision issues in the other eye) to a clinic an hour away because the one here in town shut down. This is a racket that is inconveniencing and punishing legitimate patients need for pain control. Also over the past year and a half Ive been to the ER with kidney stones twice. In past years before this opioid epidemic kidney stone patients were regularly sent home with opiates as trying to pass a kidney stone is excruciating. Now they will not give you anything to help. This is cruel! Full disclosure- I never had kidney stones before 16 months ago but my brother had suffered with them off and on for 20 years and was always given pain meds. Anyway, my point continues to be that this crackdown on doctors and pharmacists is causing financial stress, treatment stress and travel stress on patients and is causing Doctors and Pharmacists to be reluctant to provide needed interventions to control pain. If I didnt have the medication for my neuropathy Id be bedridden for 2-5 days a month. The pain is like a knife stabbing me through my eye and into my brain.  With this pain control Im only having to spend 1-2 days per month in the bed and nonfunctional to my family. I do use an ice pack during flares and I use OTC analgesics to manage pain as much as possible.  Topic 1: Symptoms and Daily Impacts of Chronic Pain That Matter Most to Patients1. How would you describe your chronic pain? (Characteristics could include location, radiation, intensity, duration, constancy or intermittency, triggers etc.)muscular, skeletal, neurological; both diffuse and highly localized. I have a condition called Ehlers-Danlos Syndrome.2. What are the most significant symptoms that you experience resulting from your condition? (Examples may include restricted range of motion, muscle spasms, changes in sensation, etc.)Tens of joint dislocations daily, muscle spasms, restricted range of motion, chronic fatigue, mobility problems, inability to lift over a few pounds.3. 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 chronic pain? (Examples of activities may include work or school activities, sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)Sleeping, feeding self, washing self, recreational outings, working fulltime, sex.4. How has your chronic pain changed over time? (Considerations include severity and frequency of your chronic pain and the effects of chronic pain on your daily activities.)Started when I was around 23. I am now 29. Its all day every day but highly variant.Topic 2: Patients Perspectives on Current Approaches to Treatment of Chronic Pain1. What are you currently doing to help treat your chronic pain? (Examples may include prescription medicines, over-the-counter products, and non-drug therapies.)Topicals, heat, PT, trigger point injections, nerve blocks, exercise as much as possible, non-opioids, opioids, mindfulness, therapy.a. How has your treatment regimen changed over time, and why? (Examples may include change in your condition, change in dose, or treatment side effects.)Ive gone through virtually every option offered by any doctor Ive encountered except for prolotherapy (insurance wont pay) and steroid injections (contraindicated for my condition).b. What factors do you take into account when making decisions about selecting a course of treatment?I read the existing literature and also am constrained by provider willingness.2. How well does your current treatment regimen manage your chronic pain? (Considerations include severity and frequency of your chronic pain and the effects of chronic pain on your daily activities.)I would say its moderately controlled due to opioids.3. What are the most significant downsides to your current treatments, and how do they affect your daily life?Biggest issue is things not working well enough and fatigue and stigma from medication.4. What challenges or barriers to accessing or using medical treatments for chronic pain have you or do you encounter?This war on opioids is out of control. Its a terrifying climate. I have intractable pain according to my state laws, but it is still extremely intimidating to even admit I am seeking pain mgmt unless the provider is trusted. I have been diagnosed and in treatment for years, but the strongest thing I have ever gotten prescribed is Tramadol despite the failure of invasive procedures. I went from being a research mathematician with an active social life to fully disabled and no longer active in my field.5. What specific things would you look for in an ideal treatment for your chronic pain?OPIOID ACCESSIBILITY. At the age of 71 and being a retied public official  I find my government jumping the gun on these decanoin rules recommending and justifying an opioid crisis. For years heroin and fentanyl have been corrupting our society from Mexican drug gangs and their local distributors. This is a known fact that has been by panic and misinformation by our own government that has fueled the so called opioid crisis. My story is a 6 year battle with spinal stenosis, degenerative disc disease and spinal cord damage, six major surgeries including a spinal fusion, spinal cord stimulator that has been removed do to no relief and a pain pump that offers very little help. Now for the facts the only medication and I have been prescribed everything known to man opiates offer the best pain relief when managed properly. Yes we have those who have no control over their addictions who need the proper treatment for which lacking, so they are mixed in with us the legitimate people who need their pain medication on a routine basis and we have a so called crisis and the FDA, CDC and DEA swing into action with swiping us all and our doctors off the map. This whole political witch hunt needs to stop and be thought through and just maybe a common sense approach may come of it. To finish my story I am looking at another major surgery to decompress my spinal cord and fuse L-2 and L-3 vertebraes to relief some of the severe pain I deal with, not to mention my pain meds have been cut back by almost half and my pain doctor gave up and quit pain management. Will someone please listen to us and give our God given right to proper medical care and keep political witch hunts out of our medical care.  Hello,When i heard i am being given the opportunity to speak on this matter it gave me pause, I want to speak up however, the complete demonization of chronic pain sufferers and their quest to get some relief to have a semi normal life made me fear coming forward. After reading some of the comments i decided i have to speak. When did it become acceptable to punish all for the crimes or weakness of others? Example of the women who took 35 Vicodin a day! How is that my fault and why should i pay personally for her addiction ? I have been on pain meds for many years, i even took myself off them for awhile to see how i felt and could i cope without. I was off of pain meds for 9 months and i can tell you it was not fun. I tried ibuprofen, it doesnt work and made my stomach ulcers worse, i tried stretching, exercise, diet change, hot baths, ice, aspirin,12 aday! antidepressants. i gave it my all. Finally after days in bed i made an appointment to see my doctor and was immediately put back on my pain meds.I take 2 or 3 a day just enough to take the edge off my pain and be able to be a productive citizen and live a semi normal life.I have spinal and cervical stenosis, I have had one full knee replacement and one that needs replaced, due to arthritis i was also diagnosed with fibromyalgia.Now you want to limit my pain relief because their are people who have addiction problems ? You want me and others to suffer for the weakness of others ? I have even had some doctors try to get me to take Marijuana so they do not have to wright a pain med prescription. ??  Now i am old enough to remember when Marijuana was evil and against the law, now it is like going to the 7/11 store here in Oregon, there is a pot shop on every corner! the world is upside down for me. I have been passed around by my own doctors, who disagree strongly with these new RULES but are in fear, and i can only hope my new doctor stands by me. by the way what ever happen to the medical oath Do No Harm because the doctors are in fear due to the new Rules, in turn harming chronic pain sufferers to avoid reprecission from the FDA.I understand that there are people with drug problems, i understand everyone is different and some cannot help themselves when it comes to misuse of drugs, They will find other drugs as they always have. You will not solve the drug problem in america by restricting those who truly need relief! you will force many to become Illegal users, Suicides will increase and pain suffers will have their quality of life dissolve.Please find another way, please dont take it out on true chronic pain sufferers.Peoples lives are at stake!! not just the over users and abusers but the real chronic pain sufferers who go by the book and are responsible.Thank You  Thank you for the opportunity to give input on the current state of medical care for people with chronic intractable pain.  One issue I would like to call to your attention is the difficulty of just obtaining, or picking up, medication from the pharmacy.  Chronic pain patients often have several other medical conditions in addition to whatever diagnosis (es) are causing their pain.  Some of these are treated with medications that may also be controlled substances that are not either opioids or benzodiazepines.  In fact, the vast majority of these medications have little to no risk for abuse and certainly no value for diversion or other illicit use.  As an example, I am diagnosed with lupus, Sjogrens syndrome, intractable seizures, rheumatoid arthritis, mixed connective tissue disease, peripheral neuropathy / permanent nerve damage secondary to Guillian Barre Syndrome, narcolepsy with cataplexy, generalized anxiety disorder, hypertension, GERD, chronic fever, insomnia, vitamins B-12 and D deficiency, Raynauds phenomenon, begin positional vertigo and severe osteoporosis secondary to long term steroid treatment.  A long list, to be sure, and I take 11 different different medication per month. Of these medications, one is a low dose opioid on which I have been stable for 12 years at the same dose, one is a benzodiazepine prescribed for seizure control, one is a antidepressant used for dual purposes of sleep and anxiety,  one is a eugeroic used to combat narcolepsy, three are anti-convulsants for seizure control, two are for hypertension and two are for vitamin deficiencies.  Of these 11 medications I get each month, 7 are controlled substances.  One is Schedule 2 and the remaining 6 are on Schedules 4 and 5.  All of these require careful attention and planning in terms of refill schedule, physician appointments required, and in arranging transportation to and from both the pharmacy and the physicians as I cannot legally drive due to intractable seizures.This may sound easy - like just run to the pharmacy a couple times a month and all is well.  For me, it isnt.  I live in an extremely rural area and the closet pharmacy is 15 miles away.  Leaving the house is quite difficult due to my existing medical conditions.  All of the pharmacies close to me have a strict policy that they will not refill controlled substances until you are completely out - on the 30th day.  Because of my seizure disorder, I have to plan my life carefully around those 30-day refill dates because missing a dose can be life-threatening. And of course they are all on different days of the month. And of course because of the seizures I cannot drive there myself so that means finding transportation for that long round trip ride. Then there are my other meds so even more different refill dates and trips to the pharmacy to manage.  I expend most of my available trips away from home energy on pharmacy visits - my husband nor friends can drop off or pick up controlled substance prescriptions as they require you to show a valid State ID matching the prescription each time.  Because of this, weve been unable to visit family that live a few states away for years because of my meds. I often say that my best friends are my pharm techs because I see them more than anyone else in my life. I understand the need to address medication diversion and I hate to hear about people overdosing on illicitly obtained meds. I hope that the FDA and the CDC decide to focus their efforts on those who are illegally obtaining Schedule 1 and 2 medications and/ or diverting these for illicit use, and those overdosing on illegal drugs such as heroin and illicit fentanyl.   However, most chronic pain patients are not diverting nor overdosing. Nor using heroin or illicit fentanyl.  We need our medications too badly to divert them.  However, the Federal, State, local, and arbitrary pharmacy rules impact my life so greatly that the pharmacy is the only place I get to go.  I would to be able to visit my mother or my sisters more so I could call them my best friends, not the pharmacy techs.  Respectfully submitted,Sharon E. To whom it may concern, in 2015 with no Rhyme or Reason I woke up and was unable to walk properly, bend over twist or left. I went to the doctor told them what I did the day before you thought maybe a back sprain it was too intense I had an MRI mild disc bulge didnt explain the nerve pain didnt explain the amount of pain I was in or the weakness I was explaining in my left leg the pain was excruciating. I have two children forward 2018 here now still battling to find out what is causing the extreme nerve pain the extreme pain in my neck and lower back the paralysis in my foot and why my left side is not working what I can tell you is that the without my nerves suppressants and my pain management medication I do not know how I would be able to care for my children or myself suffering from migraines constant back pain neck pain and nerve pain is debilitating I have never been flagged I have followed all my doctors orders I have tried stretching I have tried doctor order exercises and Im still trying to do and accomplish those exercises. acupuncture Ive never called in early for a perscription Ive never lost a prescription even when my Dr have wrote me too many prescriptions I have brought back those prescriptions and said I already had a prescription for this month and you wrote me an extra one there are plenty of good patients out there that do not need to be treated as drug Seekers who do not need to be in pain management clinics or severe contract where theyre scared every single time that theyre going to lose their medication. you were taking the right of the doctor away to treat his patient and assess his patient because they become too nervous that the federal government is going to come down on them for writing too many pills too many prescriptions theyre only allotted this many perscriptions of this type of drug how can you put that type of pressure on the people who are supposed to be caring for our health and well-being theyre supposed to treat us as humans and as their patients not worried about upsetting the government over pill counts you want too stop addictions I get that but taking away peoples medication is not going to do do that youre going to drive people to the street you arent going to help them be anyting going to do is cause harm suffering and make people look for something some where they be I not trust the the doctors they should be trusting and talking to. I have refractory RLS (severe Restless Leg Syndrome) and although it is not considered a chronic pain condition, we are still being caught up in the opiod crisis and the overreaction with regulations that can penalize those in real need.  RLS is a movement disorder -- you cannot sit still or sleep because of an awful sensation in your legs or arms (like crawling insects) that is relieved only by walking around or otherwise moving your legs.  When it hits, mostly at night, you cannot sleep. And for those like me, with severe RLS, it hits every single day.  I have had it so bad I couldnt ride in a car, would stand to eat dinner, couldnt work on a computer because I couldnt hold my arms still, couldnt sit down to read a book or take a nap, would pound my legs so hard they would bruise, and at one point was throwing things and ripping magazines at 3 am from frustration and total lack of sleep.  It is not curable.    I have had RLS since I was 13.  I am now 66.  I went through virtually every treatment regimen for RLS, until as a last resort, my doctor put me on a low dose of methadone.  It literally changed my life when my RLS attacks went from every day to none at all.  It is the only drug that has totally worked for me.  This opiod is known to benefit severe RLS patients, yet the  repurcussions from this opiod crisis are causing doctors to decrease or stop dosages; insurance companies to put in place  incentives to NOT prescribe these drugs; and now the feds to try and control things without knowing the unintended consequences.  This is just not right.   I have total sympathy for CPP, and I support them.  Just know that there are other very legitimate reasons for patients to need opiods.   We are not addicts.  We are only trying to live normal lives.   Regulations on opiods need to allow their legitimate use not only for CPP, but for other conditions like RLS as well.   Doctors and patients know best.