Patient-Focused Drug Development on Opioid Use Disorder; Public Meeting; Request for Comments
2018-86
2018-05-18 2018-06-20 2018-06-20 2018-04-25 2018-04-18 2018-04-18 2018-06-20 2018-06-20 2018-06-20 2018-06-20
FDA-2018-N-0987-0025 FDA-2018-N-0987-0052 FDA-2018-N-0987-0062 FDA-2018-N-0987-0016 FDA-2018-N-0987-0008 FDA-2018-N-0987-0010 FDA-2018-N-0987-0038 FDA-2018-N-0987-0069 FDA-2018-N-0987-0060 FDA-2018-N-0987-0059
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-0987-0025 https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0052 https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0062 https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0016 https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0008 https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0010 https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0038 https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0069 https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0060 https://api.regulations.gov/v4/comments/FDA-2018-N-0987-0059
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
The rules regarding opioid use are getting ridiculous.  You are hurting chronic pain patients!  Every month, we must see our Pain Management Doctor and pray that he isnt going to try to wean us off our medications.  I take a 12 hour in the morning and at night, with two breakthrough pills inbetween.  I am barely able to function with my pain but there is no way I can try to request my dosage to be upped during this current climate, and I have been on the same dose for 3 years following a very large tumor removed from my spinal canal that has now become arachnoiditis.  Opioids are the ONLY thing that seems to let me have halfway of a life currently.  If I did not have them, I would not be able to function AT ALL due to my pain and limited ability to move throughout my day.  Please, when you start putting these restrictions on paid meds, you MUST think about the chronic pain community.   We have NO OTHER OPTIONS for pain management, especially living in a State where marijuana and even kratom are illegal.  If I had to live with this pain and no opioids at all, I would probably just kill myself.  This is barely a life, but taking my meds allows me to make coffee for my family, shower, and do minimal cleaning.  I wouldnt be able to do anything without my meds, and by making this so difficult, I am totally afraid to ask for something stronger even though my condition is even worse than it was three years ago.  Why are we not exempt from any kind of restrictions if we have pain that is never going to go away and are permanently disabled?  Dont we have a right to try to be as normal and pain free as other people?  Im tired of feeling ashamed every time I go to my appt and have to do demeaning things like drug tests, fill out pages of paperwork, etc.  This is not right!!!  If we go to pain management, we are obviously complying and will comply so dont make us suffer for those who are straight up drug users and oding on stuff that they dont legitimately need.  The people who are seeing their doctors each month are complying so please...enough with the restrictions!  And bring us MORE choices on pain pills!  Or medical marijuana! Or both preferably!  Its inhumane this current climate for me and fellow pain sufferers!!!  Its our bodies and we are not children! Id love to put my name on here but I dont need to be flagged!!!  One day, you will all see why we are scared.  If you get in a car accident or something and have pain like we do, you will understand why we need to be able to keep getting our medication. This whole meeting seems to be on the effects that opioids have on a person using these pain medicine.  However, you are not taking into consideration the many people who take these for many years to have some quality of life.  When a person is injured with permanent pain or has a medical condition where pain is constant, these opioids give them a little quality of life. To live with constant pain without these medications, life is not worth living. Yet, you expect those people to stop a drug cold turkey.  That is impossible.  These people are not drug addicts but depend on these drugs to survive through the pain. We were originally told that anyone on this medication before 01/2018. that they could continue their meds.  Now, the dose has been cut and another drug has been ordered,which was tried in the past and did not relieve the pain.If you want to stop people from O.D.ing, go to the Police Departments and get a list of all the people who have been arrested for the use and selling of these drugs and deny them!  Dont take away the only hope we elder people have of any quality of life. My understanding was if you do not increase the mgs or the dosage, you may be dependent but not addicted.  Now you want us to go to a pain clinic, we have, did not work! It now takes 6 months to get an appointment and another 2 months for shots, so in the meantime, are we going to have withdrawals?  It looks to me like we may have to become alcoholics to numb the pain!  Just consider what you are doing to the legitimate opioid users. Thank you. I am a father of a 37 year old son who has been diagnosed with a neurological disease called RSD/CRPS from a car accident he had when he was 17 in highschool.  RSD/CRPS is rated on the McGill Pain Index as the highest known pain, above removal of a finger, or even childbirth.  He describes it as having gasoline poured on his skin and set on fire when it is not in control.  Over the last 20 years, we have tried everything we could find to stop the pain including hyperbaric oxygen treatment, anti-inflammatory drugs, tens units, hypnotic therapy, chiropractic therapy, physical therapy, too many to remember them all. For the first 10 years after the accident my son had absolutely no life, bed ridden or chair ridden in our living room.  Getting out of the house to go to the doctor was the majority of his life. About 10 years ago we found a pain management doctor who placed him on high dosages of long acting morphine and fast acting opioids. 1900MME daily plus 8mg daily of klonopin. After 4 months on the drug, he began regaining his life back.  6 years ago, even though he was legally disabled, he went to work full time for 4 years.  In August 2016 the government arbitrarily imposed its 90 MME rule, the one treatment fits all mentality. He no longer can work.  It took my son 10 years to reduce his pain medications by 65%. In January of 2017 he was on 960MME daily. Since the government intervention beginning in February of 2017, he has been forced to reduce his pain medications by another 65%, and in the process he lost his pain management doctor he had for 10 years.  He is now on 280MME and with this new pain management doctor will continue to be reduced on his pain medications. It took 6 months to find a new pain management doctor due to the 90MME regulation. To complicate matters, 10 years ago (by the same pain management doctor) he was also placed on a long acting benzodiazepine (klonopin) to combat nerve pain and the anxiety related to it. Now there has also been a restriction made that patients are not supposed to have both morphine/opioids and benzodiazepines.  It took my son 10 years to reduce 50% of his benzodiazepine.  He was expected to remove himself completely off of the benzodiazepine (4mg daily) in 4 months or completely remove himself off of the morphine and opioids.  He could not complete either task of complete removal of either drug and this is why he lost his pain management doctor of over 10 years,He has been physically tortured for the last 22 months, and is losing his life due to crippling pain again.  Due to these forced pain medication reductions, his heart rate has been exceeding 200 bpm and his blood pressure has gone as high as 230/140. Since the reductions he has been placed on (4) blood pressure medications to keep him from having a stroke.  Being on that many blood pressure medications causes him to feel severely depressed, which prior to these reductions was not the case. The pain could actually kill him.  His sleep cycle is all but non-existent.  The forced reductions has also caused periodic states of mental instability, which he never had issues with before Were all worried that his depression will eventually take his life.   Ibogaine (or 18-MC)Its been ignored long enough to the point of willful negligence.  What is being done at a local level to prevent judges and correctional facilities from discriminating against those seeking or receiving methadone treatment?Methadone being withheld and refused to inmates precipitating withdrawal with INTENT to punish.Judges mandating forced detoxification  from methadone, or incarcerating those who refuse to, and/or fail to do so.Judges sentences including mandated levels of care, as if they are licensed healthcare providers capable to determine best practices.Judges including in probation guidelines that methadone/suboxone treatment programs will not satisfy the requirements for drug treatment to complete probation. Hello: Seems to me, maybe incorrectly... that [both big pharma AND] the FDA do a good job of shoving the Ibogaine topic to the background.  Just 30-days ago, as of April 20th 2018, I was FREED from a literal 30-year dependence (OK, addiction) to prescription opioids!  That freedom was gained within mere hours of a ONE-TIME TREATMENT with Ibogaine Hydrochloride at https://BajaIbobaineCenter.com in Rosarito, BC, Mexico.Either the FDA and big pharma will [eventually] work together and explore via clinical trials the Ibogaine promise, or there WILL BE an uprising within the patient community, Im sure!  Ibogaine, Ibogaine Hydrochloride, norIbogaine and the root of it all, the Iboga plant needs immediate focus!  -Stanley Poe / northwest, Ohio Later I will forward a letter written on behalf of a patient who after 10 years had his buprenorphine discontinued by insurance and we wrote the letter to the insurance commission and they are in process of investigating.In the midst of an opiate death epidemic why would anyone refuse an effective Sched III opioid, Buprenorphine for pain??Most insurance cos. are doing this. Only a few medicaid committees will allow it for pain. Washington St. a positive example. Idaho and other NW states would rather have everyone take opiates. Hmmm, in view of the epidemic, why should this happen?? Talk about a no-brainer. Well rub your fingers together, it is all about money. The drug insert that insists on the use of Suboxone, which is 3x subutex is a problem as well. Subutex is safe and generic. We have been using it off-label for years for pain. Still not cheap, but a lot cheaper than dying. By itself, and no CNS issues, no ODs reported, on buprenorphine. Even ins. companies are still forcing that, even though 30%  GI intolerance is an issue due to the naloxone. Clearly the drug is safe, even when used IV. But, guess what, the drugs pharmacokinetics by itself (agonist/antagonist) give it a ceiling beyond which it blocks itself and can make you sick if you take too much. . This feature makes it unattractive to the majority of abusers. It ceases giving a high and being fun. That is one reason no ODs reported and it is such a great drug for addicts. Insurance cos keep reading the drug handout and refuse to make wise decisions, and even some certified MDs do too.  It is abused and sold, but that is ok for the recipient. They need it to relieve their withdrawal, if they can find a certified doc to rx., which they cant. Docs can learn to do this without a course. They do so for opiates, which are a lot more dangerous to rx. Finally what kind of pain med do you want for your family, a safe one or an opiate that can cause OD deaths, especially if available for theft in your med cabinet? IV drug was approved for pain years ago and my surgeon daughter who used it during residency in 2000 reports it works great and no issues for post op pain. Maybe fentanyl will be needed if you break a leg, especially if you already take it for anything else, including addiction.  Recently 2 opiate use disorder pts had a headon and broke their legs. Ortho called for anesthesia and they used a general with ketamine, which can cause dissociative thinking in adults. A good trade, no?  Good solution, docs. By the way, the vets are way ahead of us, finding it effective for their patients in an oral solution. In a few years the medical community and general public will all realize the safety and effectiveness of buprenorphine, and it will become the go to drug for pain. Cost and insurances that want to cut down allowed doses are the only barriers now.  I saw two patients in the hospital this evening with endocarditis, a life-threatening infection of the heart, due to intravenous injection of buprenorphine-naloxone. One is 29, and was just told today that his heart is inoperable and he should be put on hospice. I asked the other to put her thoughts on paper, and this is what she wrote:Im a mother of 3 beautiful, smart, wonderful children (whom I have lost custody of due to IV drug use). It all really took off 4 years ago when I was introduced to Suboxone. I had been sick, throwing up sick, for a week, with no relief in sight. I was in the bathtub feeling like I was dying when my brother came in and told me he had something to make me feel better instantly. And yes, I wanted relief! He fixed me up a rig full of Suboxone and injected it into my arm. Within 5 minutes I was setting at the kitchen talbe, eating cereal and feeling much better. From that day on I was an IV Suboxone user. Me or my brother neither one had it prescribed, so we bought it off the street. I wish I had never ever ever met Suboxone. I didnt know none of the risks of using it the way I did (IV). It sets up infection in your blood, heart and possibly your brain. It can take a year to fully detox from. I have been in the hospital for 3 weeks and will be here for another three so they can run antibiotics continuously to rid my body of infection. I was on the verge of death when I first got here. but Im grateful for this rock bottom Ive finally hit. Its taken me almost dying to realize my worth and to open my eyes up to how bad drug use is everywhere. If my story can help just one person then Ill forever be happy. Im still very sick but getting better, one day at a time!! Since before my force taper from 450MME for 11yrs I was able to care for myself, my family, my 83 yr old mother, 76 yr old mother inlaw.  Since the beginning of my force taper I am bed bound and unable to care for myself.  My husband has had to cut back on work to care for our whole family.  We are being foreclosures on our home because of my lupus, fibromyalgia, severe DDD with 3 herniated disks, chronic fatigue and other autoimmune diseases.  I dont no what we are going to do now!  I am so scared and in chronic pain 24/7!  Please help me help myself!  My high dose narcotics were helping me live a life.  Still in pain but nothing like this. I beg you to stop this CDC Guidelines, etc so I can get my life back if it not already too late. Thank you for hearing our stories. It is my sincere prayer that you read them with open hearts and minds. I am a 54 y/o woman with spinal stenosis, bulging and herniated disks, fusion and bone spurs in C 3-6 stemming from an accident in 1998. The initial pain was excruciating and I was given opioids for one month. My pain subsided in the weeks to follow and I spent the next 11 or so years in discomfort at times that I would treat with Tylenol or Ibuprofen. The only time I had a thought of opioids was when the subject came up in the news. I mention this to bring light to the fact that my exposure did not cause me to become an addict. I went on to enjoy a full life filled with physical activities that I loved such as running, hiking, spelunking, not to mention raising three kids and owning and operating a very demanding construction company.Fast forward 11 years... My neck began to give me trouble, it was hurting worse and more often. I found myself running less, hiking less and being thankful that the kids were older and no longer needing my role as soccer mom. I began to see a wonderful chiropractor who was adamant about never cracking my spine. While I truly liked him as a person and respected his profession, he was not helping me. I asked him about surgery and was told I was not a good candidate.  My neck was getting worse, and fast. In 2009 my sister was diagnosed with stage 4 colon cancer. With no husband or children to help her I took on the job of caregiver, a job I wouldnt have missed for the world. However, it was during this time that I sought a Drs care once again for my neck pain. I was referred to a pain management specialist in her state of Ohio. He prescribed low-dose oxycontin which afforded me the opportunity to care for my sister without having down time due to my own pain. I saw that specialist for almost a year before I returned home, opioid dependant and had several days of discomfort and thought I would go back to otc medications, which I suffered through for the next couple months (Still not an addict) before seeing a specialist here to treat my pain once again. His treatment had allowed me to enjoy my life as any normal person would. I hiked, worked, enjoyed my grandchildren, etc., etc. I have been with this Dr. since 2011. Over the years my tolerance has risen to my highest dose of 180 MME per day. This was working for me. It was working well.  Due to the CDC recommendations my doctor was bullied into going against best practice and I was tapered by 25%, then most recently, 33% of that for a total of a 50% reduction in medication and what my Primary Care Dr. refers to as a cocktail of other drugs in its place, which includes a 500% increase in Gabapentin  (from 600mg per day to 3000mg per day), 150mg Voltaren, 75mg Soma and Tramidol as needed. This has led to a virtual collapse in my life. I can no longer do the small things that most people take for granted. Things such as my own grocery shopping (4 times out of 5), no thought of going on a hike or planning a day at the zoo with my grandchildren. We have a family reunion planned this summer, which I had to back out of, as the thought of traveling and participating in large functions for a week is a distant dream. I spend most days gingerly counting my steps, careful not to step too hard or try to navigate any uneven terrain - if I can manage to walk at all. I am increasingly isolated from family and friends, which I will admit, depresses me at times.It is baffling to me how the CDC can scare good doctors into stopping treatment for pain patients that gives us quality of life! I implore you to take this power away from them.  I have read that even they say their arbitrary recommendations were not researched, nor do they apply to chronic pain patients.This is the short version of my story. Thank you for taking the time to consider it in your Drug Development Policy.Sincerely,Beckie