Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions; Public Workshop; Request for Comments
2020-846 CDER Notice Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions; Public Workshop; Request for Comments Open
2021-06-28 2021-06-28 2021-06-28 2021-06-28 2021-06-28 2021-06-21 2021-06-21 2021-06-21 2021-06-21 2021-06-21
FDA-2021-N-0275-0127 FDA-2021-N-0275-0132 FDA-2021-N-0275-0138 FDA-2021-N-0275-0140 FDA-2021-N-0275-0142 FDA-2021-N-0275-0108 FDA-2021-N-0275-0112 FDA-2021-N-0275-0120 FDA-2021-N-0275-0109 FDA-2021-N-0275-0118
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https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0127 https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0132 https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0138 https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0140 https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0142 https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0108 https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0112 https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0120 https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0109 https://api.regulations.gov/v4/comments/FDA-2021-N-0275-0118
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Please remove MMEs.  Its based on flawed information.  Everyone metabolizes medicines differently.  Everyone also does better or worse on different medicines.  Pain is NOT the same for everyone.  There are SO many different types/kinds of pain.  As there are many different levels of pain for different people.  Expecting everyone to do well on the same medicine or same amount of medicine is insane.  The government should NOT be putting restriction on doctors(so then it harms us American people in pain).  The doctor knows his patients the best.  And we(the people) know our bodies  pain the best.( what works best for us).  The opioid epidemic is 90 some percent because of illegal street drugs.  NOT safe  effective prescription pain medicines.  Please STOP harming us(the American people in pain) more then were already hurting.  Its insane that we are now forced to live in excruciating pain  cant get out of bed or out of our homes because of being in SO much pain because of being cut off or cut SO low from the medicines that once gave us quality of life.  Which means now we cant work or take care of our families.  No wonder there are more  more committing suicides.  Or just as bad, turning to illegal street drugs.  Since the 2016 CDC guidelines  mme caps were made, over doses  deaths from illegal street drugs have shot up drastically(way way more then even before 2016).  Because the govt is just pushing more  more right to illegal street drugs since they cant get quality or care or treated humanely because they cant get their pain treated accurately any more.  This HAS to STOP!!!  PLEASE!  Millions of us people in pain are begging you!  PLEASE!!!   Thank you!Prescription pain medicines(opioids) are not harming or killing us.  You have it ALL wrong  are harming us more  even killing us!!!  Its illegal street drugs(opioids) that are causing the over doses  deaths.  Please, Please, PLEASE stop the torture on people in pain who are trying to get their pain treated accurately, legally  humanely.   hopefully with a little compassion.  Which youve taken away, since the doctors are SO restricted now.The opium plant was given to us since the beginning of time to help us with our pain.  Problems didnt start to occur until illegal street drugs came into the picture.  Because illegal street drugs arent controlled  you never know what they will contain or how much.  Plus then people use other drugs or alcohol  thats what causes them to overdose or die.  Speaking of alcohol, people die of alcohol thousands of times more then prescription pain medicines( illegal street drugs) but yet alcohol is legal???  Go figure!!!  Please stop torturing people in pain who just want to get relief(legally)  be able to live a half normal life.  Please get rid of mmes and the cap on prescription medicines.  One day you might find yourself in constant, ongoing pain, day after day, that nothing else helps but prescription pain medicines.  But then YOU wont be able to get relief then either.  How would you like to live your life like that?  Im sure you wouldnt.  Well, we dont want to either.  Prescription pain medicines are approved to help pain.   they work for many many people(who take them responsibly).  We the people should have the freedom to be able to get medicines that help us so we can move around(work, take care of family, etc.).  We should NOT be restricted  pain medicines should NOT be held from us when they greatly help us  give us a much better quality of life.  We should have a say in what our medical care consists of.  We should NOT be restricted.  Nor should things that help us be held back from us.  Nor should we be forced into something were not comfortable with(or that isnt approved like injections).Please help stop the torture people in pain are having to go through now.  Please stop mmes  caps on them.Thank you very much! Imagine living with a rare genetic bone disease that has no cure and causes excruciating pain. Then imagine the medication that effectively alleviated that pain for 29 years is abruptly tapered and you are forced to take only half the dosage your body has become dependent on. Not only is the pain unbearable, but the resulting stress placed on the body prevents you from exercising or participating in physical therapy, which is vital to someone with Ochronosis/Alkaptonuria (AKU) to prevent chronic joint pain and inflammation.AKU is known as Black Bone Disease because it turns bones black and brittle. It is the oldest metabolic disease on earth and has even been found in Egyptian mummies! After being diagnosed with AKU, I was placed on a very high dosage of morphine to stop my body from producing Homogentisic Acid (HGA).  People like me born with AKU are missing an enzyme that prevents them from fully breaking down HGA. At high levels, HGA devours my bones, turning them black and stripping the cartilage and cushions between them. My former physician of 32 years identified morphine as a pain medication that helped without causing  side effects. I was able to function again and live a decent life, in spite of having a debilitating disease. But in 2017, the CDC opioid guideline was adopted in Hawaii as state law, and my doctor was driven out of practice. I cannot find a doctor to replace him. They all see my need for morphine, but they do not want to risk their livelihoods by taking me on as a patient. I am being harmed by the state and no one will do anything to help me! Due to the morphine being reduced to half of my original dosage, the HGA accumulation has eaten two holes into my heart valves, resulting in a life-threatening heart condition. HGA has also spread to my upper cervical spine, my lower cervical spine, along with my liver and kidneys. I have endured irreparable damage by being forced off my old dosage of medication in such an inhumane manner. Every doctor I have been referred to has refused to accept me as a patient once they look over my medical records and see I have a rare genetic bone disease that requires opioids.Only when I was forced on a lower dosage did AKU start to spread. I have had four failed surgeries on a non-operative disease, and no doctor wants to put their livelihood on the line to help keep this disease from hurting me more! I have never abused drugs or alcohol in any form. I have comprehensive medical records, including MRIs and x-rays documenting my illness and treatment history. It will also show that for 29 years on the original morphine dose, my liver stayed strong and clean, compared to a patient who has been on a toxic medicine like Suboxone that is just as addictive.Please help me obtain the help I need before this disease spreads even more than it has. I am totally bedridden and need help to regain my quality of life.I pray that a revision of CDC guideline will allow doctors to do their jobs again without being persecuted, and will give me back my life so that I can grow old with dignity. Legitimate pain patients who had never abused drugs are getting treated like addicts, demonized for taking prescribed medicines from licensed doctors.Please watch this video if you have any questions about my disease: https://www.youtube.com/watch?v=7PpQU3wrdlMt=30sGigi Brandford lives in Hawaii.  As with the entirety of the CDC guidelines and their implementation and cross reference allegedly unintended amongst agencies, private and public, medical facilities, practices, and other clinical locations and policies, the MME standards are not backed by high quality science of the 3,4 or even 2nd level.This is significant because while people who are clinically addicted as indicated by medical manuals have access to MAT including various buprenorphine products which has no defined MME equivalent and is very dangerous when considering the abuse and overdose context, medications more frequently used from chronic pain in the four decades ending through 2010 (many of which are used today but overall opioid prescribing(s) have dived off a cliff declining by roughly 70% since 2011) it makes no sense that narcotics such as hydrocodone, oxycodone, meperidine, hydromorphone, etc have become considered more dangerous and in the context of addiction and overdose, no more than 1% experience these adverse events (refer to BMJ); further, as a chronic pain patient, I can tell you doctors know what they are doing usually and are disgusted with the extreme interference by DOJ (including state DOJs) DEA, BOPs, Med Boards, etc as they seek to cast the addiction spell on all patients experiencing chronic pain from varying sources and diseases (endometriosis, sickle cell, myalgic encephalitis/chronic fatigue syndrome, CANCER) Most doctors already understand the pain medication hierarchy (for example: oxycodone is orally stronger than codeine mg for mg)Most doctors try everything else before narcotics, and most patients are literally scared to death of narcotics. The MME, based on little to zero science, has done nothing but to limit doctors in their individualized treatment. MME use in clinical settings has caused doctors of all shapes, types, and sizes to become scared of these millennia old opium medications and their century plus old derivatives (for example: hydrocodone  oxycodone synthesized around 1918 most likely for war vets which btw whose suicide rates have doubled in the middle of the cutting off of their decades old utilized narcotic  pain meds) To conclude, MMEs are not useful, do not make sense, do not prevent the patient that wants to down a bottle of ANY AVAILABLE pills for suicide(s), and are NOT scientifically backed by any source that has zero COI. Oxycodone is stronger than hydrocodone but as a result of MME use and CDC guidelines, myself as a patient who experiences better analgesia and less side effects with hydrocodone, am unable to get an effective dose of a hydrocodone product (60-90 mg/mme/day) and instead I am left to deal with 45 mg of oxycodone per day because according to MME/CDC guidelines, this equals 67.5 MME (yes, chronic pain patients have careers, can do math, and are also intelligent humans). So in effect, MME has forced me to be on a medicine that I dont feel is as effective. I should not have to feel that I am lucky to get treated at all as I have been made to feel based on all government policy. One more thing: doctors and pharmacists are scared of the number of pills as well as the dosage: Vicodin HP 1 every 4 hours or 180/mo makes sense based on my pain level and represents no increase for five to seven years in my clinical treatment but because of MME, 180 tablets per month is considered too many even though it equals in MME what I receive in oxycodone. I hope this reaches someone sane, intelligent, and not bought off by big pharma like Vanila Singh. Ms Singh will go down in history as the worst USA CMO because she now has a board position at BioDelivery Sciences, Inc and makes a wonderful $450,000 per annum for promoting buprenorphine products as the sole opioid to be used for chronic pain. My final note is that before the 2016 CDC guidelines became implemented into various laws, forced into clinical practice, etc., I was very stable as a patient 62 170 6-10% body fat, exercised 1-2 hours a day 3-4 days a week, could withstand 12 hour work days  my pain was effectively managed because with some diseases SYMPTOM MANAGEMENT IS ALL YOU CAN DO. Preventive measures like food cannot fix genetics, and we are not nazis practicing eugenics. I appreciate my heritage with blonde hair and blue eyes BUT EUGENICS is NOT what America is about.I wish the worst on anyone who doesnt get it, doesnt understand ultra metabolizers, and doesnt have a friend/family member experiencing a disease with pain as a symptom. Based on stats tens of millions of people experience debilitating chronic pain to the point they are disabled. Thats not cool, fun, funny, exciting, or interesting to deal with. Best wishes- You cannot set a limit for opioids or any other medications.  Everyone is different  processes medication differently, just as they do different medications.  We are not robots that can all take the same medicine at the same doses  have the same outcomes.  We as people, our bodies are different  dont work like that.Between the 2016 CDC guidelines  the mmes, people in pain are being tortured. The government is playing doctor  knows nothing about our bodies  our pain(nor does it know our tolerances  how our bodies process pain meds or at what doses helps our pain).  Everyones pain is different  should not be treated the same.  Some people do well with lower doses.  But some people need higher doses  do very well with them.The government needs to quit playing All mighty or All knowing  stop restricting our doctors which in turn stops people in pain from receiving compassionate care  held from medicines that can greatly help them.Restricting doctors from prescribing prescription pain medicines are torturing people in pain  are just forcing then to go to the streets for illegal street drugs(which is the main culprit of the opioid epidemic) or they are committing suicide.Since doctors were forced to cut or drop peoples prescription pain medicines, over doses  deaths( also suicides) have sky rocketed.  Again, its just pushing more  more right to the cause(illegal street drugs).Most people want to do the right thing(legally)  go to a doctor to have their pain treated so they can live a half decent life.  So they can continue to work  take care of their families, etc.  But since the falsified  misleading 2016 CDC guidelines  mmes, its just pushing more  more to illegal street drugs  therefore more  more over doses  deaths, as well as suicides(since we just cant live every day in SO much pain).You have to burn the CDC guidelines  quit using them as law to prosecute our doctors(who are just trying to help us).  Do not make any more guidelines since theyll just be used as law again.   rescind the mmes too.Most of us know our bodies best  what helps us or works best for us.  We should be able to be a part of what our medical care consists of.  We should have a say in what we feel would help us(not forced into or away from something).I thought this was America???  Then why do we not have a choice in our own medical care/prescription care  why are medicines that greatly help us being taken away from us(when weve taken them as prescribed  stored correctly  when they have helped us for many many years)?Stop punishing  torturing people in pain because of illegal street drugs!!!That is not fair at all!!!  People in pain who take prescription pain medicines are being majorly tortured.  We are looked down on  treated like a druggie.  When were nothing like that.  We are given a hard time to get our prescriptions filled(if we can even get a prescription any more).  Our doctors are SO restricted that they dont know what to do so they make things up  make it seem like we are drug seeking or called other things, when its been proven time  time again, how well prescription pain medicines work.  But because the doctors hands are tied, they push us away  cant help us now.  Or are to afraid to.This has to STOP NOW!!!!  It should have never started.The CDC nor PROP(who where the ones who created the guidelines) do NOT have the expertise to be making rules or laws.   again we(American people) know our bodies best  should have a say in our medical treatment.  Not be pushed away or sent for another surgery or injection when those were proven before not to work.Stop this insanity!!!   give us back the meds that once gave us a quality of life!PLEASE!!!  Millions  millions of us are begging you!!!  Stop the insanity on safe  effective prescription pain medicines!  stop ruining our lives  torturing us!!! Docket No. FDA-2021-N-0275 for Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions; Public Workshop; Request for Comments. The workshop had many informative presenters but I wanted to highly endorse Jeffrey Fudin, PharmD  Nabarun Dasgupta, MPH, PhD. As well as Toska Cooper, Liz Jonia-Grant  others in his study. Both Fudin  Dasgupta both stressed NO MME limits  pointed out the numerous flaws in the calculations/conversions themselves. The recommendations must remove current MME limits whether in the guidelines or state laws. It seems daily new federal/ state legislation is proposed to limit prescribing  its literally killing pain patients  Veterans. We have a critical patient care crisis that requires emergent actions. We need help now. Misinformation is rampant  being spread by a group of addiction experts w/o pain mgt experience. For one theyre highlighting common pain/disease signs  symptoms to pain med side effects  calling for forced tapering. This is unacceptable. Many are part of the disease process  are present whether on meds or not. This Propaganda/ opioidhysteria is hurting more people than its saving. Take a look at the current tapering recommendations/scenarios- Patient not functioning by atleast 30% - Taper. (Not every disabled person can reach this goal. Plus ALS, quadriplegics  other compromised pts are being forced tapered. It should NOT matter if they can get out of bed. Patient functioning well- TaperPt NOT functioning well - TaperPain adequately controlled- TaperPain NOT well controlled - TaperPt expresses pain mgt working very well - consider OUD, taper.Pt expresses need for higher pain medication - consider OUD , taper. No pt can succeed with these types of parameters designed to taper in just about every situation. Brain fog/confusion - TaperInsomnia - TaperConstipation- Taper. Look how many other med cause constipation, insomnia, brain fog  they dont call for immediate discontinuation. Plus many of these signs/symptoms continue after discontinuation of meds. Its their disaese/pain causing them. I have these with or without medication but they are extremely worse without adequate pain control. Suicidal ideations are common in both untreated  undertreated pain. A Misconception is pain pts want to end their life. No, we want the unbearable pain 24/7 to lesson- huge difference. Once our pain levels are controlled - the majority stop having these thoughts. Its really that simple. Its about STOPPING THE PAIN. Listed as a potential for harm - 65yo, anxiety/depression or 50MME. BUT Above 65yo is the lowest population of overdoses. Anxiety/depression is often a requirement for SSI/SSDI Disability approval because it is an expected outcome of disability. Chronic pain can be very depressing especially when its uncontrolled. I personally ( many others) didnt develop anxiety until the CDC guidelines were developed. This living in constant fear of losing ones meds returning to that agony is very disconcerting  real. But there are addiction experts now trying to add a new diagnosis that would make this fear similar to OUD. For a condition that they themselves created. Diabetics fear not having enough insulin- no difference. This is literally insane!I am bedbound w/o higher doses of pain medications along with associated meds. I am non functioning  dependent. At 90MME I am stable with much improvec function ability  my quality of life is much much mproved. No suicidal thoughts. I could still benefit from an even higher dose but that is no longer an option with the CDC GL  false narrative that pain meds are causing the opioid crisis. In 2019, per the CDC, out of the 70,000 OD deaths- 12,000 were from pain meds. Unfortunately they dont track how many were from suicides due to forced tapering. Liz Jonia-Grant wrote- It is disheartening, but unfortunately not surprising. Far too often we are the victims of good intentions of those wanting to do something About the opioid overdose epidemic but the something that is done over simplifies the problem  pushes cookbook medicine upon those of us with complicated medical conditions. And while everyone debates whether the MNE limit was the right thing to do,we are forced to live by it, because Medical personnel  others treat guidelines as mandates. So we wait. And we suffer. And we hope it will all get sorted so we can get the care we need. We need individualized care. NO MME limits  help pain pts access to opioid pain medications. In 2019 the 70,000 were mostly illicit made Fentanyl  heroin- street drugs. Yet pain pts  their doctors are the target. This isnt helping. Illegal drug deaths have exploded - thats the problem. Protect the patient. Thank you for your time Placing chronic pain patients on the same dosage of opiate pain medication is not scientifically proven effective. Individual aspects have been ignored. People who have been stable and functional on higher doses are now disabled and suffering. The pendulum has gone too far in the wrong direction. Just because they are an easier population to target than illegal drug traders does not make it right. Government needs to remove itself from the physician/patient relationship and let doctors be doctors again. Stop The Insanity. Remember that commercial? Well here we are. As a nurse (RN, BSN, DON) of over 37 years, havent we learned anything? You are punishing people in chronic, severe pain. We need the 90 MME lifted entirely. Physicians are trained to determine the best dosage, and closely monitor patients. This dosage doesnt even cover daily opioid therapy for most people on one medication, and now theyve been told they can only have one. The cuts have been extreme for chronic patients and they are getting sicker, avoiding hospitals and surgeries, and dying either to their illness or suicide. Some have resorted to street drugs with fatal consequences. Its gone as far as to limit dying hospice patients pain relief! We need this workshop to influence the CDC and actually save us all. NOW. My grandmother died in the 70s, screaming in pain. The doctor refused to give her any more morphine because shell become addicted. She died two days later. True story. You must LEARN and stop this ignorant cycle of patient abuse. Opioids ARE effective in long term, chronic pain. Doctors prescribe any and everything before using them. Let them do the job they are trained and educated to do. Study after study has shown that prescribed opioids are not the culprit with drug overdoses. Wake up and stop this cruel interference now. These CDC Guidelines have become de facto law across the country  they have NO basis in science. It makes no sense that a pain patient might die if given 1mg over, but an addict *starts* MAT at 13 TIMES the MME amount. The guidelines do not take into account personal pharmacology, allergies, nor any other concerns. Its a one-size-fits-none sham of a guide. Also it doesnt matter if the guidelines say exceptions can be made! if the DEA/medical boards are using it as a hard-and-fast rule by which doctors lives are destroyed. Additionally, LTOT has proven to be safe and effective, not creating addiction at all, whereas the addiction reaction is known to happen with the first exposure. Plus, diversion among chronic pain patients is rare, and we know the opioid epidemic is actually an opioid overdose death epidemic, fueled by illicit fentanyl and fentalogues coming from the illegal drug trade, not prescriptions. The under-treatment and non-treatment of pain has led to countless suicides (as noted by the VA) and with post-COVID pain creating even more pain patients, this needs to be fixed RAPIDLY. The Guidelines have even created an international crisis, with one woman in Ontario asking to be euthanized rather than live with her untreated chronic pain. This is a genocide. It has to stop.   I definitely dont believe that using the MME conversion to help stop opioid abuse or OUD is based on any concrete research. Its as if someone just picked those numbers out of thin air. I am a chronic/intractable pain patient and have suffered for over 20 years. After trying almost every alternative I was finally prescribed proper opioid therapy and received monthly trigger point injections and chiropractic manipulations. When the pain flared I iced and used a TENS unit. Due to severe side effects I could not take a long acting medication and was finally prescribed 2 short acting medications. Between the two I was at a very high MME. I was able to work part time, care for my family and play my flute as a gig musician. I attended church weekly and was the music minister. This all came to an end in 2017 when I lost my Dr and the new one cut me off the main medication and left me with just the breakthrough one. In 15 days I was dropped to 40 MME. I became almost incapacitated. The pain was excruciating and left me bedridden. Two years later my Dr finally upped my dose to 60MME. Life is slightly better but I can no longer work nor play my flute. I suffer with flares that can sometimes last weeks. My husband has begged me numerous times to go to the ER. I always refuse. Chronic/intractable pain patients must be treated with individualized patient centered care and our pain is unique to each person. Its past time to repeal the CDC guidelines and put a stop to the MME conversions of opiate pain medication. Chronic intractable pain patients are victims of what has been going on for the war on drugs. Our constitutional right has been taken away from us we are killing ourselves because we cannot stand the pain and I know that that will save money for people who are collecting disability but it is cruel for this country to be doing so. I have been a chronic pain patient for 20 years, have raised three children on my own who went to college my last is just finishing up college. It was very hard and if I had not had my fentanyl patches I would never have been able to do so at all. Im not going to say it was easy but it was doable and I raised those three children not to be drug addicts but to be healthy productive members of society. Now much of my pain medication has been taken away from me and I spend most of my time laying down in bed because my pain is from the neck down. The past year someone in the State of Florida did their job and deemed me disabled by the state because I cannot collect disability I was raising three young children when I became disabled and our system only goes back so many years in determining who is allowed to collect disability. Finally I was given Medicaid and I have had two ablations cervically and two lumbar ablations. My medications have been more than halved and I am suffering every day. I dont have family around who can take care of me I have to be able to function I have to be able to cook for myself I have very little money I do not collect disability I just get child support which will be taken away soon and alimony a very small amount. I need to be able to function I need to be able to drive and all this is slowly being taken away from me. Chronic pain patients are the most responsible people when it comes to their medications we need to be allowed to be given the amount of medications that we need in order to be able to function and not want to kill ourselves because we cannot stand the pain anymore. Most of us because of our pain cannot go and picket the governments in our states and we dont have money for lawyers to get to the supreme Court to make the changes needed. Most of us did nothing wrong but we are in a prison that we will never get out of until death. This does not mean we do not have the right to live please make the changes that are needed youre taking away your civil rights and our right to live.