Opioid Analgesic Drugs:  Considerations for Benefit-Risk Assessment Framework; Draft Guidance for Industry; Availability 
2018-551 CDER Guidance for Industry Opioid Analgesic Drugs Considerations for Benefit-Risk Assessment Framework Open
2019-08-20 2019-08-27 2019-07-15 2019-07-15 2019-07-15 2020-02-26 2019-07-15 2019-08-13 2019-08-15 2019-08-14
FDA-2019-D-1536-0022 FDA-2019-D-1536-0026 FDA-2019-D-1536-0004 FDA-2019-D-1536-0013 FDA-2019-D-1536-0010 FDA-2019-D-1536-0036 FDA-2019-D-1536-0011 FDA-2019-D-1536-0017 FDA-2019-D-1536-0021 FDA-2019-D-1536-0019
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https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0022 https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0026 https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0004 https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0013 https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0010 https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0036 https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0011 https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0017 https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0021 https://api.regulations.gov/v4/comments/FDA-2019-D-1536-0019
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Hello,I am another chronic pain patient who is paying the price for people who recreationally use opioids and become addicted. By now you know it is not those of us who are prescribed pain medicine and take it as directed by our physicians who become addicted. There is a very small chance of that, and it is not that the opioid is addictive, it is the persons genetics and social, economic, and personal history factors that determine this. This is why denying pain medicine for the population in general does not defeat addiction. The addict will find a replacement drug on the black market, meanwhile law abiding citizens are left to suffer.What I am asking the FDA to do, please emphasize that opioids are essential medicines, that the benefits outweigh the risks for most patients. The so called opioid epidemic has spread the false narrative that opioids only have risks but no benefits, this needs to be made clear that this is an overdose epidemic involving illicit substances, and polypharmacy. It is reckless use of taking opioids with alcohol, sedatives, cocaine, and multiple other substances that are killing people. Responsible people are paying the price for the recklessness of others. Opioids are valuable, and desperately needed, extremely beneficial medications for the majority of citizens. Again, please emphasize this!Sincerely, Donna Johnson Collegium written response to June 2019 FDA draft guidance Opioid Analgesic Drugs Considerations for Benefit-Risk Assessment FrameworkCollegium Pharmaceutical is a specialty pharmaceutical company committed to being the leader in responsible pain management. For nearly two decades, Collegium has been focused on developing and commercializing new medicines for pain management that reflect our core values and our commitment to people suffering from pain, providers and our communities.  As an integral part of our overall strategy we strongly believe in leading with science.  The result of those efforts is a portfolio consisting of Xtampza ER, Nucynta and Nucynta ER, three meaningfully differentiated medications to treat moderate to severe pain.  Collegium Pharmaceutical appreciates the FDAs recent actions in relation to the opioid crisis. These included the recent issuance of Draft Guidance to describe the benefit-risk assessment framework that the Agency uses in evaluating whether applications for opioid analgesic drugs meet the standard for approval under section 505 of the Federal Food, Drug, and Cosmetic Act.  In particular, we agree with the Agency that, in light of the ongoing opioid crisis in the U.S., an assessment of opioid analgesic drugs should take into account the broader public health impact of such drugs, including consideration of risks related to misuse, abuse, opioid use disorder, accidental exposure, and overdose.  In doing so, it is equally important that the Agency take into consideration the legitimate need of millions of Americans for meaningful relief for their moderate to severe pain when alternative treatments are inadequate.  Collegium understands that opioid analgesics carry substantial risks.  We are dedicated to supporting responsible pain management that meets the needs of patients, healthcare professionals, and society.  We support FDAs conclusion that it is appropriate when making drug approval decisions to consider the benefits and risks of a product relative to other available analgesic therapies indicated for a specific condition.  We acknowledge that FDA has not historically required a showing of superiority to available therapies as a condition of approval under section 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.  355.  Although such superiority is not an express requirement for approval under section 505 and would not in most cases necessarily be warranted, we believe the language of the Act provides the Agency with adequate authority to require that sponsors of New Drug Applications (NDAs) for opioid drug products include comparative data in appropriate cases.  Specifically, Section 355(d) of the Act provides that FDA should deny approval of any NDA when the application does not include reports of investigations that establish whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof.  It is well established that the term safe does not refer to absolute safety but rather requires the Agency to determine that the benefits of a drug product outweigh its known risks.  This determination cannot be made in a vacuum but implicitly requires consideration of, among other things, the public health landscape into which every proposed product will be launched.  Because of the substantial risks that opioid medications present not only to individual patients but also to their household members and their larger communities, it is reasonable for the Agency to conclude that new opioid medications that do not provide a meaningful clinical improvement over existing therapies cannot be viewed as sufficiently safe to merit approval.  Such a position would be entirely in keeping with FDAs mission to protect the public health.  Adopting such a position would strengthen the Draft Guidance (i.e., lines 155-157), enable the application of the benefit-risk framework, and provide clarity to sponsors. Collegium Pharmaceutical welcomes the opportunity to discuss these issues regarding the new Draft Guidance further with the FDA.  In closing, and as an organization dedicated to leading in responsible pain management, we strongly support the Draft Guidance and we believe that it will provide direction to industry in relation to the development of meaningfully differentiated opioid analgesic drugs.    Guidance to industry on criteria for risk-benefit assessment certainly seems called for in the review and approval process for opioid analgesic drugs.  But several fundamental problems are evident in the present draft phrasing of that guidance. The following issues require reconsideration in light of emerging knowledge.For existing opioid analgesics, todays medical patient is rarely tomorrows non-medical abuser. [1] Risk of opioid use disorder among actively managed medical patients is so low as to be difficult to measure.  Large scale studies of post-surgical patients prescribed opioids for the first time reveal incidence of Opioid Use Disorder (OUD) diagnoses of 0.6% or less for follow-up periods averaging 2.5 years. [2] This number is likely a maximum, since many diagnoses are recorded by GPs who lack current training in evaluating patient behaviors that define OUD.  Incidence of protracted opioid prescribing for 13 weeks or longer in post-surgical patients is also less than 1%.  Such prescribing may be more closely related to procedure failure than to properties of opioid analgesics per se.  Procedures where chronic prescribing is most often observed are also among those in which procedure failures and emergence of chronic pain are highest (e.g. total knee replacement).[3]There is no reliable relationship between rates of opioid prescribing by physicians versus rates of opioid overdose-related mortality from all sources (legal prescriptions, diversion of prescriptions, or illegal street drugs).  There has never been a relationship during the past 20 years.  CDC prescribing and demographics directly contradict any such relationship.  People over age 55 are prescribed opioids for pain two to three times more often than youth and young adults under age 25; but, age-adjusted overdose related mortality in seniors is the lowest of any age group and has been mostly stable for 20 years, while mortality in youth and young adults has skyrocketed to levels now six times higher than in seniors. [4],[5]A major missing dimension in the draft Framework must be addressed substantively if drug approvals are to be safe and reliable for the public.  Due to naturally occurring genetic polymorphism in six key liver enzymes, there can be no one size fits all minimum dose or risk threshold that applies to all patients. Some patients are natural hyper metabolizers of specific opioids, while others are poor metabolizers.  Thus there may be a broad natural range in minimum effective dose levels. [6]Finally, medical practice and ongoing drug approvals for both established and new opioid formulations must come to grips with emerging evidence that risks of opioid use disorder on short term exposure may be elevated among a small fraction of patients due to effects of an abnormality in the A118G gene.  [7]Emerging evidence of genetic factors in metabolism and mu-receptor response to all opioids has clear implications for the drug approval process.  To ensure patient safety, larger and longer trials are clearly needed, with more rigorous documentation of the variations in patient outcomes.  Approval of drugs based on 90 day trials in populations of less than 200 patients must become a thing of the past.  This change in policy must become explicit in Benefit Risk Frameworks which drive Industry investment in trials. References:[1] Singer JA, Sullum JZ, Shatman ME,  Todays nonmedical opioid users are not yesterdays patients; implications of data indicating stable rates of nonmedical use and pain reliever use disorder, Journal of Pain Research 2019:12 617620[2] Brat GA, Agniel D, Beam A, et al. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018;360:j5790.[3] Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and risk factors for chronic opioid use among opioid-naive patients in the postoperative period. JAMA Intern Med. 2016;176(9):1286-1293.[4] Lawhern RA.Over Prescribing Did Not Cause the Opioid Crisis. Blog of Dr. Lynn Webster. Last updated April 5, 2019. http://www.lynnwebstermd.com/over-prescribing/.[5] Lawhern RA, Tucker JA. Analysis of US Opioid Mortality and ER Visit Data. Last updated April 2019. Available at: http://face-facts.org/atip/analysis-of-us-opioid-mortality-and-er-visit-data-v15-april-2019/. [6] Richeimer SH, Lee JJ,  Genetic Testing in Pain Medicine  The Future Is Coming , Practical Pain Management, Volume 16, Issue #8, August 8, 2017. Available at:  https://www.practicalpainmanagement.com/treatments/genetic-testing-pain-medicine-future-coming [7] Kline T, Opioid Facts  Are We Getting the Whole Picture?  - A Physicians Perspective,   Medium, June 14, 2019, https://medium.com/@ThomasKlineMD/opioid-facts-are-we-getting-the-whole-picture-a-physicians-perspective-67cc7e3b0d2e?fbclid=IwAR1uYeo1OXS2lVo0--IKFx5fP_BwmytUExjI65ZbJ2tfqGMvbjLHzHboDsc  Patients with intractable pain are careful with their meds or else they have no pain relief. Thats what gives us a life, not euphoria. We must sign a lengthy contract and if we violate it, we have no pain doctor. The addiction rate is proven to be 1%. The people overdosing on opioids are using heroin and illicit fentanyl. Thats been proven too. How do you explain the major decrease in prescriptions and continued increase in opioid overdose deaths? Its been found patients with chronic/intractable pain who are undertreated or not treated adequately with pain medication will eventually get so desperate due to the pain that they will seek out some type of pain relief whether prescription meds or street drugs. They are then labeled as drug seekers or addicts when they are not. They exhibit symptoms similar such as doctor shopping, stealing others prescriptions, lying or buying illegal street drugs. Even if these patients are prescribed medication in dosages that dont provide them adequate relief, they will still seek out relief. Many patients have had their lives ruined because doctors either dont believe them or dont treat their pain adequately with an appropriate dosage. It happened to me after my first cervical fusion surgery. My surgeon didnt believe me that my pain was worse after the surgery and documented in my medical records that I was a drug seeker even though I was his patient 8 months and never abused my medication. He never mentioned anything about addiction until I told him the pain was worse. I was accused of drug addiction for five years and forced into a detox/rehab program in order to save my RN/Nurse Practitioner license. However, once I completed it, I still wasnt believed and my pain wasnt treated at all. So for seven years , I was either untreated or under treated and I started doctor shopping. Finally a pharmacist intervened and recommended a physician who literally saved my life. I was started on a compounded pain medication with 40mg hydrocodone plus naloxone every six hours. I had adequate pain relief for the first time in eight years. I was finally able to go back to work. I eventually had three more neck surgeries and now have three fusions and another bulging disc. All the years of the rest of my spine working extra hard led to spinal arachnoiditis down my entire spine. My pain gradually increased over the years as did my medication dosages. I now have two neurostimulators and three years ago I had a fentanyl pain pump implanted. Ive also taken tizanidine, a muscle relaxant, it has ruined my teeth. I also had to quit working in 2007 which was devastating. I loved my career and I was one of the first Neonatal Nurse Practitioners licensed in the state of Texas. Anyone who truly knows about intractable pain knows that our brain works different than a drug addict in that we DO NOT experience euphoria, our pain receptors are busy concentrating on pain relief from the pain medication and not euphoria. The last comment about me Ill add is that Im pretty certain if my pain meds were stopped, I would definitely have a heart attack or a stroke because my blood pressure elevates to stroke level anytime my pain is excessive. Either that or Im sure Id consider suicide because I know I cant live like that....pain has already taken everything I ever loved. With intractable higher doses allow us to at least have a life, nothing compared to what we used to have though. Its better than laying in bed in extreme pain all the time. FDA states that they hear frequently from patients and providers about the need for higher doses. The patients need it for a decent life and the doctors feel like they cant do their job and treat their patients adequately. Statistics show complications in intractable pain patients is extremely low. There is a small amount of diversion, but we are very careful about our medication. The past three years of the patients horrific suffering, deaths and suicides should be enough to answer your questions. A lot of patients feel the CDC and DEA both are responsible with blood on their hands. Im including two short articles written by Red Lawhern PhD. He has dedicated his life to advocating for us. Please read them. https://www.statnews.com/2019/06/28/stop-persecuting-doctors-legitimately-prescribing-opioids-chronic-pain/ http://face-facts.org/lawhern/congress-clean-up-this-mess/ Heres my story, short-version:I first started having chronic pain when I was 4 months pregnant with my son back in 2007. I toughed it out at first but I ended up seeing my PCP and rheumatologist  getting some treatment for RA  fibromyalgia.Then in 2009-2010, things got REALLY bad: it was eventually discovered that I had a 9-inch long benign hemangioma tumor going from the spinous process of T4 to my left shoulder blade, which was unbearably painful, but only one neurosurgeon believed me and did a T4 laminectomy  tumor resection. He said this tumor ended up eating away part of this protective coating around my spinal cord and that I would always be in pain from it. Well, the surgery was a success because it took care of most of the pain.Anyway, fast-forward to today:Ive got another aggressive vertebral hemangioma at T10, but once again, no doctor will believe that Im one of the rare 1% of patients with symptomatic vertebral hemangiomas! Ive been red-flagged, black-listed, called many different names (besides the usual drug-seeker  addict). Ive been screamed at by ER nurses (among other verbal abuse), verbally and even physically abused by EMTs (cant prove it, so theyve told me...), etc. The forced tapering off of very effective high dose opioid medications caused me to have a stroke in my early 30s. Afterwards, I lost my successful career and my life has spiraled downhill ever since this started 3-4 years ago.Today Ive got an OK pain doctor, but hes injection  procedure happy and has expressed fear of going to jail and such to me in the past. Hes reduced my meds to the point they barely touch the pain. 2 of my former pain doctors left pain management out of fear of DEA persecution and I dont blame them.Like Ive said before, I could write a book! This is just a basic outline of my story. If it werent for Kratom, I would already be dead because the constant pain I would feel without it just isnt compatible with life!I left out a lot, but I didnt want a ridiculously long post. My basic diagnoses not listed above: OA, DDD, possible CRPS/RSD (disputed by current PM doc), seizure disorder, hx of mild strokes, PE  other blood clots.It also took doctors 2 years to realize I needed a hysterectomy and a cholecystectomy...but they were too busy accusing me of drug-seeking to actually diagnose the real problems I was having. I almost died of sepsis from my gallbladder as they were wheeling me into an emergency cholecystectomy!No one deserves to be in unbearable pain, especially when patients like me were stable on them (opioids) for a very long time. Its inhumane and it directly goes against my Constitutional rights to life, liberty, and the pursuit of happiness.We desperately need to find a middle ground in which to prescribe and take opioids, and without government overreach and interference. Our physicians know what theyre doing!Thank you for listening!Sincerely,Christina Leann Nunn7108 Hardwood TrlDallas, TX 75249214-402-3319jarednunn10@gmail.com Can the FDA please compile a list of FDA approved drugs that are approved for the treatment of pain, especially post-surgical pain, that are NON-opioids and make this available to both physicians and patients so that informed decisions can be made regarding options for treating pain? A useful list would be one that lists all non-opioid FDA approved drugs that have an indication for the treatment of pain and a short explanation of what type of pain they can be used to treat.  Ladies and gentlemen,Thank you for taking my comments, Im a pain patient dad has almost committed suicide four times because of the misapplication of the CDC guidelines.I think we must ask ourselves some questions when considering benefit risk assessment. Heres my take.Q. Is there an epidemic of opioid overdose death?A. Not really. They actually increase from 2014 to 2015 was in the line with years past a 0.001% increase. These are street overdose deaths in addiction communities, not in the general public. No particular year was significantly higher than the other.Q. Is addiction rare?A. Yes, the rate for the last hundred years has been steady at 0.5% ( today CDC reports 1 million heroin-addicted/320 million u.s. population = 0.5%).Q. Why are addiction rate staying the same with so many prescriptions we hear about?A. Opiate addiction ( not addiction to marijuana, cocaine or amphetaminesl) needs two things to trigger it: an opioid and the gene for addiction. No genes, no genes, no addiction.Q. Can a person become addicted by taking too much pain medication or for taking it for a long time?A. No, FDA scientist ruled both of these fears as being unfounded. Google FDA 2011-P-0818 to see the report. Once on the pain medicine, without becoming addicted immediately, you have virtually no chance of addiction from then on. No cases have been reported of addiction occurring in patients already taking opioid pain medication.Q. Do doctors prescribe too much opioid medicine per patient?   Shouldnt the number of prescriptions be limited? NoA. No, the concern is, higher doses cause more overdose deaths and addiction. The FDA has already ruled that this is not true (FDA 2012-P-0818).Q. Opioids given longer than 90 days dont work and can cause more pain, addiction and overdose.A. Not true. FDA review these arguments and found all three faults in 2013 (FDA 2012-P-0818) these scary assumptions are made up by Lunatic Fringe groups, such as Physicians for Responsible (reduction) of Opioid Prescriptions, commonly known as PROP, a group with the goal to stop the use of opioid pain medications as both ineffective and dangerous, are not true. *** in the words of an ex FDA senior official.Q. Are prescription opioid deaths increasing at an alarming rate?A.NO (False) they have been the same for six years. Heroin deaths have been increasing, and important difference thats conveniently forgotten in many reports thank you. Google (NIH overdose deaths September 2017) and see the graphs for yourself. Prescription opioid deaths or not increasing, just more FOA thinking and actions.With all due respect, the FDA has already investigated all the things you are talking about, there is no reason to reinvent the prescription opioid wheel. It is well known that the CDC guideline has no reliable scientific data in it.The bottom line is prescription opioids are safe for 99.5% of the population. If you want to stop addiction, then test people for the gene that makes them addicted.Please consider making chronic / intractable pain patients a endangered species as we are dropping like flies in a bug spray Factory. All of these rules and regulations for pain patients are doing nothing to help addiction. As you know we have the lowest prescription rate in 25 years, however we have the highest drug related deaths in 25 years. That should tell you everything that were doing to stop addiction is doing nothing.Please, for god sakes stop making it hard on pain patients oh, were dying.Thank you for your time I know this is going to be a difficult task.Sincerely,David Cole Yes, I am a chronic pain patient living in Florida. As a disabled senior, I have been adversely affected by the CDC guidelines. Even though there has been a retraction, most doctors here have made no adjustment to their their new practices of prescribing an insuficent amount of pain medications. I was doing as well as could be expected on a regime that addressed my intractable pain by a regular dosage, that exceeded the 90MME with my doctor of 20 years. As of January, I lost my doctor and, after going to several pain management doctors, realized that there was not much hope that I would be treated with an appropriate dosage and, dare I say compassion. My dosage has been decreased by 2/3rds- my mobility so compromised that I am bed ridden. I must go to the store occasionally and that, has become a nightmare. These draconian methods are absurd.I have severe cervical and lumbar degenerative disc disease, inoperable , along with a myriad of other physical problems associated. I have tried all modalities, massage, chiropractic, injections, accupuncture, and more. (these were when I was ambulatory) The only thing that gives me relief is my narcotic medication which is being lowered each month, according to my present doctors theory. I find it deplorable that a citizen of these united states is being subjected to  inadequate treatment going along with a one size fits all  idea of treatment.I was led to this forum by a piece written by Red Lawhern, a blessed advocate for chronic pain patients. He has done extensive research into this problem and statistically and humanely written a draft that is comprehensive and unflinching in the truth.. The AMA, Human Rights Watch, and others, which Im sure you are  aware,  agrees with his assesment of the wrongs being inflicted on people who are already suffering, without having their care disrupted and medication reduced.Please address this situation. There are so many who have been abused from withdrawral of comprehensive treatment and many have resorted to suicide, a number of our veterans among them. This is not a case of kids getting high from the street dealer, but a unacceptable epidemic full of fallacies that has been spoon fed to the general public, while those of us who suffer are miscategorized and ignored! Please dont punish pain!! August 15, 2019Ned Sharpless, MDActing CommissionerFood and Drug Administration U.S. Department of Health  Human Services 5630 Fishers Lane, Rm. 1061Rockville, MD 20852RE: Docket No. FDA-2019-D-1536Dear Dr. Sharpless, On behalf of over 34,000 orthopaedic surgeons and residents represented by the American Association of Orthopaedic Surgeons (AAOS), we are pleased to have the opportunity to offer the U.S. Food and Drug Administration (FDA) comments on the draft guidance, Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry. The AAOS has observed the implementation of the benefit-risk framework within the Centers for Devices and Radiological Health. We are struck by the deliberate and thoughtful process of the FDA in expanding their understanding of safety and effectiveness to include a more individualized consideration of how patients evaluate the risks and benefits of treatments. The AAOS supports the Agencys continued efforts to incorporate these factors in the regulatory schema of its centers.Benefit-Risk AssessmentThe AAOS wishes to share our approbation of the FDAs expressed intent to give greater scrutiny to key questions regarding the benefits and risks of opioid analgesic drugs. We are pleased to note the clear emphasis placed on the provision of evidence in support of efficacy claims, as those claims apply to specific populations and duration of use. The AAOS is further encouraged by the Agencys request for information about risks associated with abuse-deterrent properties and any indications that new compounds or formulations may increase the risk and/or severity of adverse events.The AAOS recognizes that addressing the questions outlined in this guidance may require larger, longer studies to satisfy the FDAs requirements for safety and effectiveness data. Given the economic, social, and health consequences of placing a higher priority on pain alleviation that supports public wellness, we believe the cost and inconvenience of any delays to market are far outweighed by the benefits of a more deliberate regulatory approach. To ease these potential regulatory burdens, we suggest the FDA assess the appropriateness preapproval incentives to better support and encourage development of all therapeutics  opioid or non-opioid drugs, biological products or devices  intended to treat pain or addiction. Access to alternative pain alleviation modalities should lead to a reduced reliance on opioid analgesics.Broader Public Health Effects and Risk ManagementWe share the FDAs interest in receiving information from both traditional and non-traditional data sources from applicants in support of their descriptions of the ways in which their product might be misused or abused in the post-market setting. We believe those data and considerations of how abuse deterrent formulations may influence routes of abuse will provide the Agency and clinicians with a broader picture of the potential harm a product may pose to certain patients. A greater understanding of factors impacting misuse and abuse, as well as populations that could be at increased risk of diversion and abuse, will support shared decision-making and may reduce adverse events related to those practices.The AAOS supports the FDAs Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain. In reviewing the contents of this resource during the preparation of these comments, we noted the lack of educational goals related to transitioning patients from opioid to non-opioid pain alleviation strategies in the required education. We encourage the FDA to revisit this document and consider amending it to include this material.ConclusionThe AAOS thanks the FDA for describing the benefit-risk assessment framework that they intend to use in the evaluation of opioid analgesic drugs. We hope that the comments we have provided will be useful to the Agency in the finalization of their recommendations. If you have any questions or comments, please do not hesitate to contact William Shaffer, MD, FAAOS, AAOS Medical Director, by email at shaffer@aaos.org.Sincerely, Kristy L. Weber, MDPresident, American Association of Orthopaedic Surgeonscc:  Joseph A. Bosco III, MD, First Vice-President, AAOS Daniel K. Guy, MD, Second Vice-President, AAOSThomas E. Arend, Jr., Esq., CAE, CEO, AAOS William O. Shaffer, MD, FAAOS, Medical Director, AAOS Ive been a pain patient for over 36 years with the last 25 of those years as a chronic pain patient. In 1991 I had my 5th and 6th surgeries on my spine, until that time I had 4 previous surgeries that started in 1982 from a work related injury. I did not think of myself as a chronic pain patient because I was able to manage my pain and function using alternative methods of pain management such as Physical Therapy, Pool Therapy, TNS unit, NSAIDS, Meditation, exercise and diet. After my 5th and 6th surgeries I spent 2 years trying to get well enough to return to work, or at least part time work. I was told by 3 doctors I was not going to get better from my injury and I could expect to get worse over time, at the same time I was told I should not return to my previous type of work and to retrain into something that did not require physical labor. After trying to retrain for a different career I noticed I was unable to function nor able to concentrate due to pain. I told my doctors what was going on so they suggested opioid therapy and I was warned of the possibility of addiction. Only after I had exhausted all other means of pain management available to me, I decided to try opioid therapy. That was not something I wanted to do, for a lot of reasons. In fact I spent a year soul searching and trying to make up my mind if opioid therapy was the right direction to go in. Things got to the point where I needed to at least try opioid therapy and see if it would work out. I ended up trying the opioid therapy and I was put on a low dose but had to up the dose a couple of times to get to the point I could function better and concentrate more. I was able to start a new career. I started training and was hired on as a State Employee. I thrived the first year, and earned an Employee of the year certificate, along with several certificates of achievement over five and a half years, until 2003 when I needed another surgery on my spine. I was unable to return to work due to pain, however in 2014, and after years of hard work from my doctors and myself and the aid of exercise, diet and complimentary alternative pain management and opioid therapy,  I felt well enough to try to return back to work.  In July, 2014 I was excited about a doctor appointment I had that day because I was finally going to tell my pain specialist that all of the hard work he, my PC doctor and myself had done was going to pay of after such a long time of being off work.  Well, the time came for me to tell my pain specialist of my plans, at the moment I informed him of my plans, and at that instant, he informed my that he is cutting my pain medication in half! I was shocked, especially after telling him I felt as if I was ready to return back to work. Thats when it all came to a huge, screeching halt and ended with a crash to a brick wall. I asked why would he was dong that to me. He replied, he is following the new CDC Opioid Guidelines and every doctor and health insurance company including State Accident Industrial Insurance are going to be on board by the end of Sept 2014. He said his hands were tied and didnt have a choice! I have never misused my pain medication, have never had any problems with my doctor, have always passed every U.A. screening done, always had the right amount of pain meds at the end of the month. Never a problem to justify my doctor cutting my medication. After a couple of months of tapering, I found out my doctor lied to my when he said he was cutting my meds in half, he tapered me down by eighty five percent of what I was getting for pain. Now, I am in intractable pain, home ridden, in more pain than I have been in, in over 36 years and trying to live on Social Security. What a waste! I could have been working over the last 5 years. I could have had a functional life and not just existing in a shell of pain. I could have been a functioning contributing member of my community. If you dont think opioid pain therapy works for long term chronic and intractable pain patients, then you really need to start doing research on long term chronic and intractable pain patients. Start working with us, beside us, start asking us what is happening with us and the opioid pain medication. One of the many problems with this issue is, no one has asked the chronic/intractable pain patients how they are dealing with the so-called opioid crisis. We are under the assumption no wants to hear or see the truth were it comes to the disabled chronic pain patients in this country. It appears everyone (FDA, DEA, Lawmakers) have closed off all communication with the AMA, Pain Advocacy Groups, and most of all the disabled pain patients in this country. Lets be clear, opioid pain medication is the last resort to a functioning life most of the pain community has and by taking away the medicine, you have literally taken away the lives of Disabled Chronic Pain Patients. You need to start listening to your Disabled American Citizens in pain!  Wake up!    