Pain Management Task Force Meeting - May 9-10, 2019
2019-05-15 2019-05-15 2019-05-15 2019-05-15 2019-05-15 2019-05-15 2019-05-15 2019-05-15 2019-05-15 2019-05-15
HHS-OS-2019-0003-0388 HHS-OS-2019-0003-0387 HHS-OS-2019-0003-0071 HHS-OS-2019-0003-0080 HHS-OS-2019-0003-0078 HHS-OS-2019-0003-0327 HHS-OS-2019-0003-0245 HHS-OS-2019-0003-0149 HHS-OS-2019-0003-0400 HHS-OS-2019-0003-0087
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/HHS-OS-2019-0003-0388 https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0387 https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0071 https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0080 https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0078 https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0327 https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0245 https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0149 https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0400 https://api.regulations.gov/v4/comments/HHS-OS-2019-0003-0087
Kristen Kristen Kelly Iris Christy Carrie Cathy Anonymous Anonymous Natalie
Ogden Ogden Howard Ayala Ashford J Kean Anonymous Anonymous B
Families for Intractable Pain Relief (FIPR) recommends adding a section to 2.7 to address the overlooked condition of constant severe intractable pain.  Individuals who have such pain do not experience remissions  frequent relapses.  The pain level is extremely severe  it is constant with no remissions.  Many of these patients have been treated for long periods of time with opioid pain medications at high doses  have experienced great harm since 2016 due to reduction or cessation of their opioid medications.2.7.9  Constant Severe Intractable Pain Constant severe intractable pain is defined as an excruciating, constant pain state without remissions that is not curable by any known means, causes adverse biologic effects on the bodys cardiovascular, hormone,  neurological systems, and leads to a bed- or house-bound state  early death if not adequately treated.  This category of pain differs from chronic relapsing pain (addressed in 2.7.5) in that there are no remissions at all; the pain is both very severe  constant.  Constant severe intractable pain can be caused by rare illnesses including adhesive arachnoiditis, some autoimmune diseases, Reflex Sympathetic Dystrophy (RSD) (also called Complex Regional Pain Syndrome (CRPS)),  genetic connective tissue disorders such as Ehlers-Danlos Syndrome  Marfan Syndrome.  Gaps and RecommendationsGap 1:  The existence of such pain is not widely accepted, which contributes significantly to its under-treatment.  Lack of awareness often makes these patients the victims of stigma  disbelief on the part of physicians.  These patients require comprehensive, compassionate palliative care which will likely require opioid pain medications, often at high doses, in addition to adjuvant treatments and therapies.  The goal of treatment is to provide life-long pain relief sufficient to normalize physiologic and mental function and enable the patient to independently carry out activities of daily living to the maximum extent possible.  Patients with constant severe intractable pain are often met with great hostility and resistance because they are, by definition, incurably disabled and will have to take opioids for a long period, probably for the rest of their lives.  In the absence of clarifying guidance about what to do with these seriously ill patients who have already tried and failed standard treatments, pain practitioners accepting such patients for care will be likely to tell them they must lower their opioid doses and essentially start over, requiring them to jump through hoops already tried and failed.  Recommendations:1a:  Educate physicians, pharmacists, law enforcement, and regulatory agencies at all levels to the fact that pain of this nature exists, is totally debilitating, and leads to early death if not adequately treated.  Endorse the long-term use of immediate or extended release opioid medications at whatever dose is required to manage the pain, when all efforts at standard care have failed.  Practitioners should continue successful treatment protocols for long-term stable legacy patients who have demonstrated that benefits exceed risks.  Practitioners should avoid mandating changes to treatment regimens that are succeeding, as changes in medication protocols, once a patient is stable, are frequently destabilizing and very harmful to these complex, often frail patients.1b:  Emphasize the following in educational efforts to combat stigma against these patients:oPatients who request a specific opioid medication almost certainly know what works best to manage their pain.  Such requests should not be construed as drug-seeking behavior.  Also, physicians should believe patients who report that a medication isnt working or intolerable side effects are being experienced.oSuccessful pain care of these patients is best measured by 3 outcome metrics:  1) pain control, 2) functional capability, and 3) quality of life as reported by the patient with confirmation by a family member.  A focus on MME is inappropriate as many of these high-dose outlier patients are limited in their ability to metabolize medications due to genetic variance, gastrointestinal malabsorption from diseases and surgeries, or dysfunctional receptors.oFor successful patients, months or years of effort have likely gone into developing the personalized treatment protocol that works.  In these cases, the best practice is to keep doing what works.  For these patients, the current protocol represents the pinnacle of individualized, patient-centered care.  Forced tapering or forced change in regimen brings about unnecessary suffering, disruption of life, and loss of quality time for patients who have already suffered greatly before finding their successful regimens.  Such forced change not only disrupts the lives of these patients during the transition, but may never result in outcomes as good as those produced by the regimen from which the patient is being forced to change.  May 5, 2019Re:  HHS-OS-2019-0003Subject:  Public Comment for the Pain Management Best Practices Inter-Agency Task Force  Thanks you for this final opportunity to comment on the Task Force draft report.  Dr. Singh, I read somewhere that you were encouraging patient and advocate input regarding patients lived experiences.  Our lived experience as a couple living with long-term debilitating illness was overall very good for many years.  However, unless something changes to remedy our current situation, our lived experience in the future will be unsatisfactory and quite bleak.  When my husband, Louis Ogden, and I wrote to the Task Force on April 1, we were about 6 weeks into the unfortunate and ill-advised process of trying to transition from his former regimen of high-dose OxyContin to an opioid regimen using injectable hydromorphone.  Now, at 11 weeks, we are both very dissatisfied, and we feel angry that this change has been forced on him.  The hydromorphone does not relieve his pain nearly as well as OxyContin, and the constant experience of pain up, pain down, pain up, pain down, all day every day is destroying his quality of life.  For 8  years, he enjoyed remarkably consistent pain relief 24/7 with no dose escalation.  This medication protocol, while considered extreme by some, gave him excellent pain relief with no significant side effects, greatly improved function, and a hugely improved quality of life.  We were able to travel (with accommodations, of course), he was able to do chores around home, and for the last few years he spent a lot of timing playing music and improving his skill playing guitar and electronic keyboard.  At this point, his ability to do almost anything enjoyable is greatly reduced.  He spends most of his waking hours sitting on the couch in a reclined position with his head propped on a pillow to try to minimize his head and neck pain.  Traveling even a short distance has become much more difficult and more painful for him.  He isnt really able to participate in chores or light yard work any longer.  While he used to enjoy playing his guitar or keyboard for 2 or 3 hours in a day, he can now only play for a few minutes at a time.  The personal satisfaction he gained from playing music, from being able to learn and progress in this creative outlet surely isnt important to the DEA or the Virginia regulatory agencies that have prevented us from being able to fill prescriptions for pain medications here in our home state.   He had found an extremely effective care regimen with the help of Dr. Forest Tennant, had accepted the limitations associated with his illness, and found music and other activities that made his life good despite the illness.  For now, at least, those days are over.Many among the current generation of pain care practitioners do not know nearly as much about treating severe intractable pain as the elder generation, and those older, experienced doctors are now being dismissed as out-of-date purveyors of improper care  because the well-funded anti-opioid groups, the CDC, the DEA, and state legislators say soeven though prescriptions written and treatments provided were totally legal and the results were very successful in the opinion of the patients and families affected.  It is a sad state of affairs when truly gifted physicians are deliberately discredited by the DoJ and DEA in attempts to reduce their influence.  We, and many other families in our situation, need your help!  Please adopt the proposed section 2.7.9 submitted by Families for Intractable Pain Relief that addresses constant severe intractable pain.  The failure of your draft to address such pain will mean that these patients will continue to lack credibility and will continue to suffer from inadequate care or reversal of their prior highly effective pain care regimens. You will have failed to thoroughly address gaps and inconsistencies in pain care policies and best practices, because you will have failed to acknowledge the existence of those who suffer the worst pain of all.  My husbands future quality of life will largely depend on the output of this Task Force and the actions Congress will take to implement the recommendations.  Please dont allow our lives to be ruined by failure to acknowledge constant severe intractable pain.  My husband and I, as well as thousands of other families, deserve better!Sincerely,Kristen D. OgdenCo-Founder/Co-Leader, Families for Intractable Pain Relief (FIPR) There is an astounding amount of misinformation, disinformation,  flat out lies going around about the so-called opioid crisis. The actual numbers are lower than what frequently appear in headlines; and for all the hysteria  hype, ALL drug deaths combined kill fewer than medical errors, influenza,  far, far fewer (orders of magnitude) than heart disease, cancer, tobacco, hypertension, and many other conditions (CDCs own data). Prescription opiate pain meds do not, and have not, caused the crisis; the number of prescriptions have plummeted since 2011, but the number of opioid deaths has gone up considerably. This is because the overwhelming majority of ODs are due to illegal drugs, NOT prescriptions. And unlike alcohol  tobacco, pain meds play a vital part in allowing millions of pain patients to work, function, and live decent lives. The primary actors in creating the hysteria were the members of PROP; their lying PROPaganda campaign has led to the destruction of millions of lives, caused post-surgical  injured patients to be literally tortured, and millions to die in unnecessary agony. They created this hysteria because they have earned vast amounts of money --and power-- from it. I have multiple chronic pain conditions,* one extending back to the 70s. I was first advised to apply for disability by my long-term neurologist in 1988; I was able to continue working until 2011 with responsibly prescribed pain meds. I have never abused them, sold them, or done anything nefarious with them. I now have ZERO pain meds; my doctor cut me off because of the opioid hysteria, not because of anything I did wrong or any negative impacts I had from the pain meds. I now am nearly completely unable to function or care for myself. Merely changing the sheets can put in me bed for days. I worked in basic medical research for many years: I can read and evaluate medical and scientific journal articles and facts. And the facts are, there is no scientific, medical, or simply sane reason for this witch hunt of pain patients. There is no opioid epidemic outside of the minds of hysterics and PR-hungry, greedy liars, like Andrew Kolodny, Jane Ballentyne  their ilk. The CDC has been silent for far too long about the impact of the supposedly voluntary guidelines. The guidelines have become weaponized. The DEA is attacking  closing down the few remaining clinics and doctors who are still willing to treat pain patients, probably because its a great deal easier to look up a doctors office in the phone book than it is to track down illegal drug dealers. Plus the doctors have all that money sitting in easy-to-access banks, again unlike the drug dealers. This has become an Age of Institutionalized Sadism. Millions have been forced into unspeakable, unnecessary agony. This trend MUST be stopped. This illegal, immoral, and cruel national crusade to torture this countrys own innocent citizens will go down as one of the most shameful periods in our history. I hope it will be history soon, because thousands of pain patients are killing themselves because their doctors have abandoned them. Also, the suicide rate among veterans is appalling, at least partially due to them losing their pain medications --again, FOR NO REASON other than GREED.My mother was forced to die in unspeakable, untreated agony when she died of leukemia. No doctor would give her any pain relief even though there was absolutely no question she was dying. Her monstrously hideous death did not save one single recreational drug user from using a drug, or from ODing, or from anything else. This story is being repeated daily. Please, stop this madness and reverse the diabolical trend of the torture of innocent civilians  veterans; because it IS pure torture. *intractable migraines, CRPS (post-surgical), SI joint deterioration, upper back injury, severe carpal tunnel, congenital leg deformity, fibro, severe GI attacks.  I benefited  greatly from the Opioid medication my Nurse Practitioner Primary Care Provider prescribed me. I chose Tylenol/Codeine instead  of Hydrocodone due to abdominal sensitivity, voluntarily.  For the short time I was approved  a prescription.  She withdrew the prescription from me.  Due to the pain contract rules.  The pharmacy did not fill the complete amount of  pills to cover the months supply. Having run out of medicine and in agonizing  pain.  I used a an old prescription of Hydrocodone. I was given at the Hospital Emergency Room prior to the new pain Prescription..  When given the random U A at my clinic.  although I informed the technician.  Due to this my pain contract was terminated. This happened nearly three years ago.  Although i appealed it I was denied.  I had to endure at the time seven months of agony with screaming pain.  While my right hip deteriorated into mush.  I was at the verge of suicide.  Believing in a greater power that i was what kept me alive.  And i made it through a total hip replacement.  even though I endured the torture I had to go through.  I am still to this day living the torture of no relief for my double form of chronic pain. Arthritis on every joint the cause of hip joint disintegration.   and Fibromyalgia the cause of chronic pain on every fiber nerve and muscle of my being.  I am a self sustaining person.  i cant help but think.  How much longer can I hold on?  How much longer will i be able to continue earning my own living?  Managing my Chronic pain with no help  means bearing with it for me!  How much longer can i live with pain before I totally brake?  Speaking for my self and the millions of people through out our nation suffering chronic pain.  In some cases, the only thing that allows us to experience a somewhat normal life is Opioids. Let our doctors treat our pain without fear of retaliation by the DEA! CDC Guidelines should be just that...Guidelines! Not the law... so dont treat them as such! Establish clear guidelines for Chronic Pain Patients that allow us to be treated by out Pain Management Physician and not by the government!  Please take away patient restrictions such as contracts which treat us like we have commited crimes and are on probation or parole.We are not ADDICTS! Our doctors are not DEALERS!  I have had two failed back surgeries,  had breast cancer and chemo, the chemo has played havoc on the nerves in my legs.  Without pain medication I would be in a wheelchair.  I have also been getting injections in my back and neck for the last 12 years, along with the pain meds I can walk.  Some days are still worse then others.  Basically  I feel the government is getting involved where they shouldnt.   They should not be able to make a decision on my medical care or the medication that I take.  That is between me and my doctor.  Period.  I am not addicted,  I use my medication to get me through my life and I dont feel that is unreasonable, I do not feel anyone besides my doctor should have a say so on my care.  We pain patients should not have to suffer because you guys cant get control of the illegal drugs coming from other countries.  We should not be treated with disrespect either because of our medication.   You are treating us very unfairly and its not right.  Im a 39 year old female with Ehlers Danlos Syndrome. Im currently fighting for my life because I have intractable pain thats  under-treated. I was barely able to do normal day to day activities before I began opioid therapy 10 yrs ago. I have both c and l spine disk herniations with nerve compression in 2 areas. I systematically tried every non opioid medication and alternative therapy before deciding to take long-acting oxycodone. It literally saved my life and I began to actually function like a normal person! I did some substitute teaching, was able to finally be active with my family, made and sold my artwork, etc. For Joint-type EDS,   PT strengthing exercises are the main treatment and I am proud to say I did so well with these during opioid therapy, I was asked by 2 ppl if I was a trainer! A year and a half ago, my trusted pcp was told to refer me to a pain specialist b/c of the cdc guideline. Once in pain mgmt, I was force-tapered down to 1/5 of my therapeutic dose, again, due to the cdc guidelines. I am down to 95 lbs and have been struggling to do basic housework and self care. My joints are dislocating more frequently due to destabilization as I cant do my pt strengthing exercises due to pain. My specialist can not safely do injections as the nerve compression is in the thoracic area, making it a high risk for lung puncture.  My life felt full of potential and hope, now I actually wonder if Ill be able to continue. I have little energy left after continually dealing with relentless pain. I am a 58 year old divorced mother of 4 adult children and 7 grandchildren. I will never be able to come even close to performing, functioning or have the mindset I once did prior to the implementation of the 2016 CDC guidelines! Im experiencing abandonment of care! I no longer have access to the instrumental tools, medications that I need for functionality and any semblance of quality to my life! I have called well over fifty different pain management clinics and cannot get into one!This has been horribly debilitating painful illness not being able to have access to the medications that wants help me function  and  engage in life the pain causes me extreme depression, frustration, sadness among a gambit of other issues!I suffer and endure incurable deep-rooted, ceaseless, recurrent, obstinate,  ever-present, incessant, continual, lasting persistent, deep-seated  AGONIZING, pain, miser, torture, torment,  tormenting, hurtful stiffness, soreness, burning, agony, throbbing, piercing, Sharp severe caustic extreme intractable/chronic pain due to arachnoiditis, stiff person syndrome, fibromyalgia, lupus, Parkinsons disease, arthritis, anxiety, depression, insomnia...This journey this path is incomprehensible for individuals who do not have intractable/chronic pain, 24/7,  365 days a year to understand!My life and standards of living are incredibly compromised!In addition, the collateral damage that occurs due to our inability to function, perform, engage in normal tasks/functions  that a parent, grandparent or employee should  functioning member of society would do our children our grandchildren our workplace do not get the quality and quantity of care and attention that they should!The individual I once was no longer exist the person that was able to go to work, engage with family, friends, interact with life and sustain a sense of normalcy is goneI suffer with cognitive difficulties or fibro fog, headaches, sensory sensitivity, exhaustion, muscle tightness, digestive issues, and disabling pain, anxiety and depression I never feel good, lack of control, grief and worry, immune dysfunction, chest pain, inflammation, insomnia, memory loss, my body is now overly sensitive to, well, pretty much everything! Its not that I am emotionally over-sensitive its a psychological thingSince the implementation of the 2016 CDC guidelines my life has literally declined 98%. In all respects financially, health related, depression and biggest loss is the quality and quantity of time I was able to spend with family is all but gone!I no longer can work, engage outside my home in any capacity! My standard of living is well beneath the poverty standard now and Im in the process of potentially losing my home of 32 years! All of this because I am not able to have access to the essential tools/medications that I need for functionality and any semblance of quality to my life!The pain is so bad I isolate in my room as not scare my family to the horrible struggles I am going through! This is not living its barely just existing! In such a short amount of time my life went from being engaged and happy in life, and being a functional member of society giving to thy fellow man advocating for individuals with autism... to barely existing and living in a painful tortuous hellthis is not living!I would in a hot second absolutely waive any liability in any way shape or form to receive my lifesaving, life-enhancing and life enriching tools/medications back! It is worth any kind of side effects or consequence to my health! Not having my tools/medications is a death sentence! My organs are starting to shut down, being in constant, continual pain leads to depression and premature death! When drug addicts use/take drugs their lives declinespiral out of controlWhen a intractable pain patient uses their tools/medicationsTheir functionality and semblance of quality returns to their lives!Huge difference!Can not compare the two!Intractable pain definition, Intractable pain, also known as Intractable Pain Disease or IP, is a severe, constant pain that is not curable by any known means and which causes a bed or house-bound state and early death if not adequately treated, usually with opioids and/or interventional procedures.Intractable pain - Wikipedia, 2017I currently have a list of suicides due to pain of 300 + more in the realm of 400 these individuals took their lives because of the Insidious, constant, never ending, tortuous pain they felt 24 7, 365 days a year every minute of every day! Data from the CDC itself reveals that there is no relationship between rates of opioid prescribing and rates of opioid overdose-related mortality... and there never has been.  Yet the CDC is refusing to analyze its own data or to conduct an outcomes study for the horrendous results of their deeply flawed and biased 2016 guidelines.  Pain is relentless Pain is cruel It doesnt discriminate It can happen to you!Everyone is just one car accident, surgery, illness away from living the rest of their lives in torturous, stabbing, burning, caustic, incessant intractable pain!Believe me this is a Journey you do not want it is literally hell on earth!In memory of those in the intractable pain Community who could not handle their pain anymore due to the 2016 CDC guidelines! Please give us back our tools, medications that give us functionality and any semblance equality to our lives! Without are medications it is a death sentence and torture!Suicide due to pain videos I have 7 more plus I have to make so many morehttps://youtu.be/CSkxF1DMQwshttps://youtu.be/0ACgV0aLIAkhttps://youtu.be/hRGECrgVPskhttps://My story published in pain News Network describes my journey!www.painnewsnetwork.org/stories/2018/7/13/living-with-a-beast This is my story of how the opiate hysteria has effected my life.My story is twofold. I lost my husband to suicide 5 years ago due to untreated pain. Every day of my life and others who loved him have been affected. I couldnt save him. I hate myself for not doing something to somehow help him but I went through every legal avenue I had before me.During the time following his death, I have had such a difficult time finding a doctor who would prescribe my anxiety/seizure medicine, I was in the ER with seizures and have had increased psychiatric issues. I developed PTSD after witnessing my husbands suicide. Then further traumatized by lack of treatment over the last 5 years.I have an autoimmune disease, peripheral neuropathy, Fibromyalgia, Pernicious anemia, Hashimotos, among other conditions. Long qt, (but still given medicine that is dangerous with this condition)The straw that broke the camels back for me and beginning to standing up for pain patients started a few months ago.I suffered 2nd  3rd degree burns over 5% of my body. I was taken by ambulance from my local hospital to a special burn unit. I was treated by having it scrubbed without adequate pain relief, given some Bactitracin and bandages and told how to care for it.I didnt realize I was released without pain meds until half way through the 2 hour ride home. I began to have pain again after the meager relief I had in the hospital. I looked at my paperwork and saw take Ibuprofen for pain.I immediately sent a message to my concierge doctor whom my family paid an extra 175$ a month for specialized treatment. She already knew about my accident and  I was going to be driving past her office.She refused to see me or prescribe anything besides Ibuprofen. No advocacy at all. I felt abandoned.I got home and cried almost non-stop. I contemplated suicide.I didnt sleep more than 5 minutes at a time.I have never experienced this level of pain. I have nightmares about it.After a week of this my fiance called the burn unit and was irate. The nurse who he spoke with was apologetic for releasing me without pain medicine. She told us to come back and she would personally advocate for me. I sat in the ER for 2 hours but was admitted to the special burn unit.I couldnt walk on that leg. I hopped to the bathroom for week.I was apologized to and treated well by the nurses at the hospital. I was released with a weeks worth of pain meds.I went back a week later to be lectured by the doctor that I couldnt be in that much pain and if I was still taking pain meds it was in my head. To be clear I had only had opiates a few times in my Iife. After my C-sections and a few times over the years for a kidney infections. I never went back. I fired my doctor and on top of it all, I was charged for another month of concierge medicine !I dont leave my house, I am pain most of the time over a 7 and rarely get below a 6. I cant walk very far. I gave up my drivers license. My agoraphobia which had been getting better since my husbands suicide is worse than it ever has been.And I still dont have a family doctor.The photo is a day after the burn injury. My buttocks, thighs and pernium were also burned. I have to say 1st how miserable my life has become. Jan 2019 started out to be the best year. It was supposed to be my year to get back to work. Started off after getting 2major health concerns dealt with. Then onto Going back to work. I left the work force in 2018to care for a parent after a full health crisis in 2017 where my attention was focused on my mom and 1of my children. 2018was spent developing a care system for parent and getting back on top of my health. Even after 2016 guidelines were in place, my doctor working with me agreed to a treatment plan. One which included pain medication. I had always been active and daily did every aspect of physical therapy I was taught. Had previously tried every aspect of alternative treatment. Not helpful , at least not without also using pain meds in conjunction. I have spent more money out of pocket for failed treatments,braces,and devices. I was stable on meds. Then February came and new insurance. From day 1of this new insurance, BCBS, its been hell to continue my prior treatment. But worse has been the sudden shift in treatment by my doctor. Not once had I actually been told why my treatment was changing. For3 months I have suffered and been lied too. This opiod hysteria caused good doctors to now become liars. And good forbid 1shred of honesty come out. My doctor and I had a plan, was completely fine, then 1,pill a day was gone. Then 2pills a day are gone. My quality of life now so low. Ive not been able to keep up with housework, let alone go back to work. Open communication with my doctor is gone. Cdcs recommendation of making sure patient is stable during pill reductions, a joke. My doctor now does not care. Not even when I called daily for 2 weeks worried about my blood pressure. Only after reaching out to a different Dr. Did I get attention from my doc. Even STIll she take my concerns seriously and hastly choose a BP med that I cant take. The only sane and rational help has been from my pharmacist! Meanwhile my life and health decline do to under treatment and everything is passing me by. And my doctor doesnt care, because its easier to not deal with BCBS. Oh but our pain MGMT doc who abandoned pain PTs will now treat SUD, and my doc will manage with MMJ, both of which will be cash only. Insurance needs to be charged endangerment of patients. And doctor needs to be told to give me back some quality! I Need To Go Back To Work!  I still cannot believe this was allowed to happen, since when does insurance company have the right to tell a doctor how to or not to treat. Please, hear me. Please Help.