Now nearly a year after its initial publication, this article remains pertinent to the ongoing US and Canadian public conversation on chronic pain and the so-called \"addiction crisis\". On January 30, 2018, I will speak at a Workshop held by the FDA Opioid Policy Steering Committee on the FDA campus at Silver Spring MD. This group has published eight questions in the Federal Register pertaining to their \"Risk Evaluation and Mitigation Strategy\" for prescription of opioid analgesics in chronic pain. From the phrasing of these questions, it is apparent that the FDA has fallen victim to the mythology that America\'s \"addiction crisis\" has been in some way significantly affected by prescriptions to people in pain. As I have recently written in The Crime Report, FDA is \"chasing the wrong epidemic.\" To attend or speak at this Workshop, participants must register with FDA through their Federal Register announcement before January 16th. I urge pain management physicians who can travel for the event to register and speak on behalf of their patients... and themselves.

The opioid epidemic is harming pain patients across the country because they are being caught up in it. I\'ve been on opioids for 20 years now and because of them I\'m able to stay active so that my condition doesn\'t get worse. I\'ve injured my back 3 times at work and after my 3rd injury, my workers compensation company denied treatment for me for over 5 years. Because of this, I have chronic back and nerve pain. I continued walking after my injuries so that my muscles didn\'t deteriorate further and so that my left leg didn\'t get weaker from the nerve damage. I have been able to do this because of the pain medications I received. Since the opioid epidemic started, two of my doctors have quit because of the new rules and the rules from the pain clinic management. Those doctors knew what my problems were and they knew that I was not a drug seeker. I had been on the same drug and I never abused them. Now I\'m being seen by a doctor who knows nothing about what my injury is and how it has been treated. 5 minutes after seeing the new doctor he said that he didn\'t think I had the problem with my leg that had been documented by 3 doctors and by medical tests. On what basis did he make this decision? He hadn\'t reviewed my medical records or especially the new tests I took to find what was causing the new problems. I\'m being told that I will be rapidly tapered off the drug I\'ve been on and if I can\'t tolerate the other drugs he wants me on, I will be left with no drugs to help my pain. I have been on the drugs he wants me to try twice before and it has been documented that I can not tolerate them. I experience extreme and dangerous side effects from the longer acting opioids and if he insists that I try them again knowing that my blood pressure will go into high levels, that is unethical. Putting me at risk of having a stroke is not something any doctor should do. It has been well documented that the opioid epidemic has been caused by doctors that prescribe medications and then cut those people off from them. Not from people who have been in pain clinics for years. We know very well what the rules are and that if we break them, we will be kicked out of the clinics and possibly won\'t be able to see another doctor. The government needs to get their noses out of people\'s medical treatments because they have not spent years in school learning about this issue.

I am very grateful that someone in a position of responsibility has finally said what those of in the chronic pain community have been saying since the CDC guidelines were first released. Doctors across the country, and not just primary care physicians, have adopting the guidelines like that were brought down by Moses from Mount Sinai. For chronic pain patients like myself this has meant either slowly or more often rapidly being cut back to the 90 MME recommendation. This in spite of the fact that the overwhelming majority of those patients, myself included, have been stable for years and in some cases a decade or more on dosages that are well over that amount. I personally had been stable for over 8 years at twice the amount with no increases (in fact, I had voluntarily dropped from higher dosages TWICE to get to that dosage), no missing pills at the pill counts I was subjected to like a criminal, no failed UAs (also treated worse then an addict, a treatment I fully understand from having dealt for 4 years in the juvenile court system for drug related issues with my now 18 year old recovering addict son), and most importantly for this discussion, ZERO overdoses. Having my pain management regimen disrupted by these reductions has sent my entire world out of control. First, the dosage of the fentanyl patches I relied on for 24-hour pain control was cut in half. My initial concern was for withdrawal since it had been eight years since my last reduction although I remembered that step down being smooth, since it was only a 25% drop. Withdrawal turned out to not even figure at all. Instead, my pain level that usually hovered around 5-6, not great but controlled enough for me to be a semi-effective stay-at-home parent, has now moved to 7-8 with jumps to 10 when I attempt to do the things I need to do. My physician\'s assistant at my pain management clinic then tried to move me to an oral long-acting medication. First we tried MS Contin which didn\'t provide relief either as it continued at the 7-8 level. Next, we attempted Nucynta ER which, after a month of waiting to see if it would be effective, I can definitively state has also not managed to get me constant pain level below 7-8. In addition, due to the increase in pain level I had to leave the pain management clinic I\'d been with for over 4 years because I could no longer make the 45 minute drive there. I have moved to a clinic that is 10 minutes from where I live but have been with them for less than a month. This means I have no rapport with the staff there nor with the doctor. It leaves me in an inferior position when it comes to discussing these issues. In spite of the fact that there is no federal law nor, in most cases, state laws requiring pain management specialist to adopt these guidelines across the board, in many states this is happening at an alarming rate. Why? Because these doctors see what the politicians are doing to primary care physicians and are afraid for their own practices and licenses.Some of these doctors are abandoning the treatment of chronic pain patients without warning, leaving those patients scrambling to find another doctor, which is a Catch-22 because it makes them look like they are drug-seeking addicts. I am aware of patients on dosages similar to mine or higher being dropped cold turkey to go through the double whammy of painful and dangerous withdrawal symptoms and the return of the pain for which they were being treated. This is inhumane treatment that should NEVER be tolerated in our society. To us, it appears that addicts are being treated more compassion than chronic pain patients. The reduction of prescriptions for opioid pain medications will NOT solve the \"opioid epidemic\". Why? Because the opioids in question are overwhelmingly heroin and illicit fentanyl, neither of which are available through prescription. A further complication will be that chronic pain patients under treated or untreated may turn to the illicit street medications in an attempt to get the relief they are currently being denied. Lastly, the suicide rate may also climb as the patients take what they feel may be the only avenue left to them. The time has come for the healthcare community to come to the aid of patients who, through no fault of their own, have conditions that require more than what the flawed CDC guidelines are offering as a blanket recommendation for all patients.

As a chronic pain patient of 40 years plus, I no longer can drive. Yet, every month if I want my limit of 60 Hydrocodon-Acetaminophen 5/325 mg pain pills. Either I or my representative has to appear in person and sign for the prescription, at my doctor\'s office. Then sign for it again at the pharmacy! If I troubled you with all my pain over the past 40 years. You would offer me far more than my wonderful doctor does, so his right to practice medicine doesn\'t end him up in jail for treating my pain as he once swore to do upon graduation from medical school. To him and Red, I again offer my dearest thanks for what they both do in attempt to do what my government should be doing, helping me to live life more fully. Patricia Jean Blosser-Lotfinia

Thank you Mr.Lawhern for your article.Finally,,,someone is willing to speak the truth,,and TRUTH it is.. I see all over the web,,chronic physical pain human beings dieing,,force to choose self termination of their own body to stop their physical pain from painful medical illness\\\'s,because the government has taken away their medicine..I can only image for those of us w/very little medicine left for us now a days,,,we wait in terror,,from our own Government to rip away what little medicines and civil rights we have left to receive effective access and treatments using opiate medicine that factually lessen our physical pain. I too believe this false ,\\\'\\\'epidemic,\\\'\\\' was entirely manufactured by government officials,the cdc,who have a fiscal interest in literally selling snake oil to our government,ie,profits in addiction centers,and our government bought it hook,line and sinker,,For example,,if u have 1,mill,,diabetic,and u forcible take 500,000 off of their insulin,,So 500,000 diabetics go the streets to find their insulin,,or die trying,,Do u call them addicts to insulin,or Long Term Insulin users,,and force them to see shrinks instead of just giving them their MEDICINE,,, Or label them insulin abusers so u can get that ,\\\'\\\'label\\\'\\\' on them to forcible admit them to some psychiatric facilty against their will,,instead of just giving them their dang insulin..This is exactly the collusion klondyn and freidmen planned,,,to fill up their pockets w/these addiction centers on OUR DIME,, IT HAS ALL BEEN 1 BIG LIE,, paid for on our dime,,and the literally life,lives of the medically ill,,Who now their only option to stop physical pain from medical conditions is to ,\\\'\\\'self terminate ,\\\'\\\' the body that is the source of their medical condition causing physical pain,,because their medicine has forcible been taken by the federal government...LIKE IT OR NOT,,SINCE IT FACTUALLY IS A GOVERNMENT ENTITY,FORCIBLE DENYING THE MEDICAL ILL MEDICINES,,THAT DEFINES TORTURE AND GENOCIDE,LEGALLY!!!!!maryw

Thank you Doctor Lawhern, for your bravery and succinct clear mindedness in explaining the harmful condition of today\\\'s pain management. I have suffered over 40 years with chronic pain with an average pain level ranging from 5-8 on the so called pain scale only to have my medications reduced by half for fear of the DEA. I am angry that my treatment and so called well being is determined and directed by the DEA. My Doctor asks me every time I see him if my medications are helping me and I respond by saying I would be bedridden without them. After 12 surgeries, I went from being 6-1 to 5-6. I can barely walk or do anything physically. I suffer constantly and yet the DEA in their infinite wisdom dictates to my doctor what my treatment should be. So thank you again, Dr. Lawhern for speaking up.

I appreciate the message of this article. It has always concerned me that the word \"addiction\" is used when \"habituation\" would better describe what occurs when treating chronic pain with opiates.

I concur with the article and I am glad that someone has had the courage to say so. I am providing a copy of a letter that I wrote to the CDC on 01 / 09 / 2016, over one year ago. I was very concerned by their jump to many poorly formulated conclusions and the fact that they just reiterated the concept of \"Universal Guidelines\" that have been touted by many pain specialty physicians over the last decade. PRESENTED TO THE CDC WEBSITE REGARDIANG THEIR RECENT CREATION OF GUIDELINES FOR THE USE OF OPIOID MEDICATIONS IN TREATING CHRONIC PAIN IN THE U.S. I Consider myself to be a dedicated pain management physician. I have found treating 1) chronic pain and the potential for development of 2) medication addiction to be two of the most challenging areas of modern medicine in the United States today. Despite the Hippocratic Oath declaration to “reduce pain and suffering” unfortunately, fewer and fewer physicians are treating chronic pain today due to: 1. Increasing risk of opioid overdose deaths, 2. Government and DEA / Medical Board regulations regarding the prescribing of opiates, 3. Hassles with the medication authorization process required by insurance companies and workers compensation administrators, 4. The time commitment required in treating chronic pain because it is such a complex and difficult disorder to monitor and treat, 5. Inadequate medical school training in the treatment, diagnosis, and monitoring of chronic pain and addiction disorders 6. Extensive patient education, monitoring, providing patient informed consent, and the risks of addiction, and potential risks of medication abuse, misuse, and diversion that may occur with long-term therapy, One of the major issues is that the symptom of chronic pain is one of the most common disorders at office presentation and it is a symptom that is so complex that it is a problem that is found in literally every single clinical specialty of medicine from pediatrics to geriatrics, from gynecology to orthopedics, from rheumatology to dermatology, and every other ABMS specialty in between other than pathology. Add to this the major risks of accidental opioid overdose as well as the worsening abuse and misuse of opioid analgesic medications that leads to the heartbreak of addiction, and we have a recipe for developing the potential for unending pain, deaths, suffering and despair. One in four Americans, or over 100 million Americans suffer with a painful condition, and chronic pain is now more difficult than ever to treat because of poor physician training in pain management, physician desire to steer away from complicated patients, and over-reaction by the government regarding the actual causes of pain medication misuse, and the misguided paranoia and judgment that has caused many medical groups, emergency rooms, and pharmacies to refuse patient access to pain treatment and medication management. I practice in the trenches of the war on pain and it is currently a battle that we are losing, and it is the people who suffer in pain or run the risks of becoming addicted who are the casualties. The current recommended limits on total milligram strength of morphine equivalents is not an exacting science, and will not stop the overdose deaths because there are other reasons involved with this problem as the heroin epidemic has shown. In addition, some people have metabolisms that reduce serum levels substantially, so by limiting the doses of medications arbitrarily, there will be groups of patients who will suffer in pain arbitrarily, and many will begin to turn to smoking illicit heroin. I have treated patients who required 1000 mg of METHADONE DAILY who had serum peak and trough levels in the sub-therapeutic range. I have treated “soccer moms” from Palos Verdes who were previously treated for chronic pain with doctor prescribed pain medications who later became hooked on heroin because their doctors wouldn’t prescribe Vicodin or OxyContin or their insurance companies refused to authorize continuation of their medications for treatment of their chronic pain. So what is the answer? I believe that the answer is in the narrative and explanation that follows below. I hope that those who read it will have an open mind and, as you read about what I have successfully done clinically begin to look outside the box for answers. Just limiting the milligram strength of morphine equivalent strength is inadequate and potentially a problem itself because I have already had insurance companies and workers comp administrators quote that buprenorphine at doses of 2 mg is equivalent to > 200 mg of morphine and have denied authorization for continued use of buprenorphine to prevent relapse towards opioid dependence in the previously opioid dependent pain patient. This concept is misguided because it negates the use of BUPRENORPHINE at higher doses to treat opioid addiction. In addition: MTUS GUIDELINES :CHRONIC PAIN MEDICAL TREATMENT GUIDELINES Chronic Pain Medical Treatment Guidelines 8 C.C.R. §§9792.20 - 9792.26; MTUS (Effective April 2014) Page 27 of 127 (McNicholas, 2004) (Helm, 2008) \"Recently, Buprenorphine was recommended for use in the treatment of opiate addiction, but since the inception of DATA 2000, BUPRENORPHINE is now recommended as an option for the treatment of chronic pain, especially after detoxification in patients who have a history of opiate dependence because of its many ideal attributes as an analgesic medication in individuals who would normally rely on chronic opioid therapy but who are at risk of developing opioid dependence. BUPRENORPHINE is a schedule-III controlled substance, and is classified as an opioid partial agonist / antagonist at the Mu receptor or endorphine receptor, and a antagonist at the Kappa receptor, which is the receptor that is thought to produce alterations in the perception of pain, including emotional response. According to the Chronic Pain Medical Treatment Guidelines (MTUS April 2014).” COMMENTARY: In CALIFORNIA, the following attributes allow BUPRENORPHINE to be used long-term in treating chronic pain in previously opioid dependent pain patients (>100 million Americans or 1 person in 4 suffer with chronic pain) with very few drawbacks: 1. No Analgesic effect \"Ceiling,\" meaning respiratory depression is not seen with buprenorphine, even at maximum doses thus the \"Ceiling effect.\" Respiratory depression is the cause of death in opioid overdoses. 2. A good safety profile because of the \"ceiling effect\" on pulmonary or respiratory depression makes it an ideal drug to transition patients who have been on opioid maintenance therapy for pain. 3. Buprenorphine has a Markedly diminished abuse potential (no change in mental function.). In Heroin addicts there have been IV misuse, but the majority of the time it is not used to get high but rather to prevent withdrawal. In chronic pain patients, it is even less likely to be abused in this manner. Arguing against buprenorphines widespread us really negates the fact that NOT ONE INDIVIDUAL PRESCRIBED BUPRENORPHINE BY A CERTIFIED PHYSICIAN AND STRICTLY MONITORED HAS EVER ACCIDENTL OVERDOSED. 4. Suppression of opioid withdrawal symptoms PREVENTS CRAVING which is the trigger in relapse. 5. An apparent anti-hyperalgesic effect and reversal of tolerance partially due to the effects at the Kappa receptor also stabilizes chronic pain best in the opioid dependent pain patient. Buprenorphine causes many negative symptoms in the opioid naïve patient at higher doses (>2 mg) and it’s complex pharmacology makes it a less likely drug for opioid addicts to understand and results often in their becoming ill and, as you read further, regular use prevents opioid use triggers that instigate opioid addiction. 6. The 4 abstracts below support it’s use for Long-term pain management without escalation in dose. 7. It has a Bimodal effect resulting in a long 1/2 life which allows for > 24 hours of level effect, but because there is a shorter dose response related peak buprenorphine provides additional pain relief at 90 to 100 minutes, declining over 6 hours so that if given in divided doses TID OR QID spread out as each dose taken every 4 to 6 hours sublingually, chronic pain patients benefit throughout the day, however after 6 hours the decline slows pain relief but the long 1/2 life allows the dose to last >24 hours thus providing patients being treated for opioid addiction the option for once a day dosing. That is why an addict may take BUPRENORPHINE ONCE DAILY and stop opioid relapse, however for use in chronic pain patients using it TID to QID makes more sense to control chronic pain. 8. Withdrawal off of buprenorphine is easier for the most patients then those on full agonist opiates. It is important to emphasize that buprenorphine is NOT A FULL AGONIST like methadone. Even physicians do not understand the difference and it is this ignorance that unfortunately misleads opioid addicts into believing that there is an effective treatment available. 9. Patients on chronic BUPRENORPHINE medications report feeling mentally \"NORMAL,\" in other words NO ALTERED MENTAL STATE, no high. Buprenorphine patients are fully functional and are not restricted from any activity.. Buprenorphine\'s pharmacological and safety profile makes it an attractive treatment for pain patients addicted to opioids. Buprenorphine\'s usefulness stems from its unique pharmacological and safety profile, which encourages treatment adherence and reduces the possibilities for abuse.. Studies have shown that buprenorphine is more effective than placebo and is equally as effective as moderate doses of other full agonist opioids used in chronic pain maintenance therapy. In fact, of the almost 39,000 accidental overdose deaths in pain patients in 2012, NOT ONE DEATH OCCURRED DUE TO THE USE OF doctor prescribed and monitored sublingual BUPRENORPHINE THERAPY because it is not possible to overdose on BUPRENORPHINE sublingual treatment due to the “ceiling effect.” In 2012 more pain patients died than people killed in automobile accidents. Also 10-13,000 deaths resulted from MOTRIN LIKE DRUGS or NSAIDS, and 5000 deaths resulted from TYLENOL And over 100,000 people were hospitalized as a result of the side effects due to NSAIDS, So in reality, BUPRENORPHINE treatment of chronic pain in previous opioid treated individuals is EXTREMELY safe and very EFFECTIVE. As an independent consultant to the DEA and the Medical Board of California and I have reviewed many of the most notorious physicians in California who unscrupulously prescribed opiates, benzodiazepines, stimulants, and many other controlled medications which resulted in large numbers of overdose deaths. I have reviewed over 70 doctors over the last decade and they have been responsible for more than 100 overdose deaths of patients ages 16 to 50. One physicians care resulted in > 24 deaths, another for >18 overdose deaths. I have reviewed every physician report that I wrote and it was clear to me that arbitrary limits on milligram strength of opioid medications was not the primary factor. These physicians (many trained at U.S. Medical Schools) committed heinous acts due to greed, uncaring attitudes, poor training, and unscrupulous acts of care. Many of these physicians have since been sentenced to prison, one physician was sentenced to a term of 24 years and another for 12 years in the penitentiary. The California medical board has guidelines that spell out exactly what approach physicians should take in caring for chronic pain patients. Every state has model guidelines written by the federation of medical boards of the U.S. I am hopeful that the CDC will review these board guidelines so as not to reinvent the wheel. They are very clear and well written. Preventing overdose deaths requires a more in depth analysis of the problems facing us today. Just limiting milligram strength is misguided because of the metablic differences between individual pain patients and insurance companies, workers comp managers, and pharmacists will just end up denying care by sticking rigidly to not exceeding a specific milligram dose. Also, more and more mainstream pain patients will go out and find illicit heroin to smoke. Generally, it is the rare chronic pain patient who will begin use by injecting if they have been primarily on tablets. Opioid overdoses may actually increase if we don’t think through this issue carefully. Before I explain how I have successfully approached treatment clinically, there are several other important points to discuss. Based on review of the many physician reviews that I have done, the following findings may help guide the authors of the guidelines. FACTORS THAT ARE “RED FLAGS” FOR CLINICIANS SEEING PAIN PATIENTS PRESENTING TO THEIR OFFICE: 1. THE age the patient is a very important factor. Generally patients under the age of 35 do not require multiple large amounts of short acting controlled drugs. In addition, it is not common to see people under the age of 45 requiring more than 1 long-acting opioid. 2. The use of short acting controlled drugs over long-acting controlled drugs is a red flag because short acting drugs are easily abuse, misuse, and diverted. 3. Mixtures of multiple medications of varying pharmacology should be a red flag as well. My review of the thousands of patients that were taken care of by these physicians noted that short acting drugs like HYDROCODONE, ALPRAZOLAM 2 mg bar, RITALIN, MORPHINE sulfate, OXYCODONE, CARISOPRODOL (SOMA), amphetamine salts, FENTANYL, HYDROMORPHONE, METHADONE, and CODEINE cough syrup along with HYDROCODONE cough syrup with the most commonly prescribed. While long-acting drugs like OXYCONTIN ER, and OPANA ER WERE STILLPRESCRIBED BUT DUE TO THEIR INCREASING DIFFICULTY TO BE USED AS SHORT ACTING DRUGS THEY WERE LESS LIKELY TO BE PRESCRIBED. 4. THE OTHER RED FLAG WAS IRREGULAR DOSING. Generally, PAIN PATIENT’S MUST BE SEEN REGULARLY. IN MY OFFICE, I SEE THEM EVERY MONTH, NO EXCEPTIONS. And SINCE THEY ARE ON A 28 DAY SCHEDULE THEY ONLY RECEIVED 28 DAYS WORTH OF MEDICATION. I DO PILL COUNTS AND BOTTLE REVIEWS AT EVERY VISIT AND REVIEW C.U.R.E.S. AND DRUG SCREENS AS REGULARLY AS I CAN ORDER THEM. It IS IMPORTANT TO NOTE THAT THE INSURANCE COMPANIES OFTEN REFUSED TO PAY FOR URINE DRUG SCREENS. Some INSURANCE CARRIERS RESTRICTED DRUG SCREENS TO ONCE A YEAR. Obviously IT IS IMPORTANT TO CHECK URINE DRUG SCREENS REGULARLY AS WELL AS RANDOMLY, AND IF THE DRUG SCREEN IS NOT COVERED BY INSURANCE IT MAKES PAIN THERAPY USING OPIOIDS VERY DIFFICULT FOR THE TREATING PHYSICIAN. 5. ANOTHER RED FLAG ISSUES USE OF MULTIPLE PHARMACIES AT VARYING DISTANCES FROM THE PHYSICIAN’S OFFICE AND THE PATIENT’S HOME. Always CHECK THE HOME ADDRESS AND THE LOCATION OF THE PHARMACY. Always CHECK CURES FOR DOCTOR SHOPPING. Cures WILL ALSO PROVIDE INFORMATION AS TO WHAT DRUGS WERE PREVIOUSLY PRESCRIBED, HOW OFTEN THEY WERE PRESCRIBED, HOW MANY TABLETS WERE PRESCRIBED, AND IRREGULARITY WITH WHICH THEY WERE PRESCRIBED. Anyone WHO IS TREATED FOR CHRONIC PAIN MUST BE SEEN REGULARLY. Most OF THE PATIENTS WHO WERE MISUSING DRUGS OR HAD OVERDOSED GETTING DRUGS AND VARYING TIMES AND NOT UNDER RATIONAL PHARMACOTHERAPY. 6. PATIENT’S AND PAIN DO NOT TRAVEL LONG DISTANCESJUST TO GET CERTAIN MEDICATIONS. IN ADDITION, MULTIPLE PROVIDERS, WITH VARYING SPECIALTIES SUCH AS PHYSICIAN’S, DENTIST, PODIATRIST, EMERGENCY ROOM AND URGENT CARE, VARYING SPECIALTIES ARE RED FLAGS. 7. Multiple FAMILY MEMBERS AND FRIENDS RECEIVING SIMILAR PRESCRIPTIONS IS ANOTHER RED FLAG. Frequently I SAW THAT GRANDPARENTS, PARENTS, CHILDREN, SPOUSES, SIBLINGS FROM THE SAME FAMILY, OR FRIENDS LIVING AT THE SAME ADDRESS WOULD COME IN TO SEE THE SAME PHYSICIAN AND ORDER SIMILAR DRUGS. 8. Often charts were inadequate (medical board guidelines spell out specifically how a pain patient should be evaluated and the important parts of the history (including previous addiction history and family history of addiction problems) must be done before beginning treatment. 9. How many times the patient had been through drug rehabilitation or been treated for addiction since adolescence through adulthood. 10. Reviewing the previous consults, specialty evaluation, diagnostic studies, hospitalizations and surgery, list of medications previously try, outcome with therapy, and results and current functional status. Continued working or on disability. 11. Must review previous physicians names, addresses, and telephone. 12. C.U.R.E.S data COMORBID CONDITIONS, TOBACCO USE, ALCOHOL USE, DRUG USE, MARIJUANA USE, AS ALREADY DOCUMENTED. 13. The TREATMENT OF CHRONIC PAIN REQUIRES A FULL UNDERSTANDING OF THE TYPE OF PAIN, THE TYPE OF PAIN GENERATORS, INTENSITY LEVELS AT REST, WITH ACTIVITY, DURING THE NIGHT, AND WHETHER ON MEDICATION OR NOT. 14. Review OF USE OF NON-CONTROLLED AND NON-OPIOID MEDICATIONS AND ALTERNATIVE THERAPIES. Another RED FLAG IS A PATIENT ONLY ON CONTROLLED DRUGS AND NOT USING OTHER ADJUNCTIVE DRUGS LIKE gabapentin, amitriptyline, flexeril, voltaren SHOW, lidocaine PATCH OR CREAM, AND MANY OTHER MEDICATIONS THAT ARE NOT CONSIDERED DRUGS OF ABUSE. 15. Review OF QUALITY OF LIFE, FUNCTIONAL STATUS, WORK STATUS, HOBBIES, MARITAL STATUS, DIFFICULTY WITH CHILDREN, 16. Informed CONSENT, AND OFTEN A MEDICATION AGREEMENT TO MAKE SURE THAT THE PATIENT IS AWARE OF THE REQUIREMENTS TO BE ACCEPTED FOR TREATMENT. 17. Appropriate LAB AND END ORGAN FUNCTION. 18. A Psychologic EVALUATION RED FLAGS PER CALIFORNIA PHARMACY BOARD: The “red flags” that should give a pharmacy and pharmacist the inkling of a potential problem with prescriptions and invoke in them a duty of inquiry include: 1. Irregularities on the face of the prescription itself 2. Nervous patient demeanor 3. Age or presentation of patient (e.g., youthful patients seeking chronic pain medications) 4. Multiple patients at the same address(es) 5. Cash payments 6. Requests for early refills of prescriptions 7. Prescriptions written for an unusually large quantity of drugs 8. Prescriptions written for potentially duplicative drugs 9. The same combinations of drugs prescribed for multiple patients 10. Initial prescriptions written for strong opiates (e.g., OxyContin 80mg) 11. Long distances traveled from the patient’s home to the prescriber’s office or pharmacy 12. Irregularities in the prescriber’s qualifications in relation to the medication(s) prescribed 13. Prescriptions that are written outside of the prescriber’s medical specialty 14. Prescriptions for medications with no logical connection to diagnosis or Treatment THE CALIFORNIA MEDICAL BOARD GUIDELINES PROVIDE A FULL DISCUSSION OF THESE FACTORS. In ADDITION, MOST OF THIS DATA IS OBTAINED OVER MULTIPLE VISITS, SOMETIMES NOT FULLY AVAILABLE UNTIL THE FOURTH OR FIFTH VISIT. Physicians WHO BELIEVE THAT IT IS NOT POSSIBLE TO GATHER THIS DATA PROBABLY SHOULD NOT BE PRACTICING PAIN MEDICINE BECAUSE MUCH OF THIS IMPORTANT DATA CAN BE GOTTEN FROM PATIENT QUESTIONNAIRES PRIOR TO EVEN THE FIRST VISIT. I EXPLAIN TO PATIENTS WHAT IS REQUIRED OF THEM AND VERY FEW WILL DISAGREE BECAUSE THEY ARE MOTIVATED. Those THAT DO NOT ADHERE TO THE TREATMENT CONTRACT POSSIBLY ARE NOT REALLY INTERESTED IN GETTING THE RIGHT TREATMENT OR PERHAPS ADDICTION IS THE MAJOR FACTOR OVER CHRONIC PAIN. ANOTHER VERY IMPORTANT QUESTION GENERALLY FOR THE CDC PANEL IS TO PUT OUR CURRENT SITUATION IN PERSPECTIVE. WHAT BOTHERS ME IS THE FOLLOWING: 1. Many OF THOSE WHO DIED FROM ACCIDENTAL OVERDOSE OR WERE MISUSING OPIOID AND OTHER CONTROLLED DRUGS HAD GONE THROUGH REHABILITATION BETWEEN 1 AND 4 TIMES. As SOON AS THEY LEFT REHABILITATION, AT SOME POINT THERE CRAVING FOR OPIATES WAS TRIGGERED AND THE OPIOID ADDICTION WAS RE KINDLED. We HAVE TO ASK OURSELVES WHY? 2. CURRENTLY IN THE U.S. WE HAVE THE MOST DRUG REHABILITATION HOSPITALS AND PROGRAMS IN THE WORLD (5000-10000). We ALSO HAVE THE MOST METHADONE PROGRAMS IN THE WORLD. We HAVE THE MOST AA / NA / CA GROUPS IN THE WORLD. AND, AS MENTIONED EARLIER, WE HAVE THE MOST ACCIDENTAL OVERDOSE DEATHS IN THE WORLD. 80% OF ALL THE OPIOID DRUGS IN THE WORLD TO THE U.S. WHICH REPRESENTS 4% OF THE WORLD’S POPULATION AND IT IS ESTIMATED THAT 80-90% OF ALL ADMISSIONS FOR DRUG ADDICTION FAIL. 3. Every OTHER CHRONIC MEDICAL CONDITION TREATED IN THE United STATES today IS Either LEVEL / STABLE, OR IMPROVING in outcome. Addiction treatment outcome has failed miserably. Clearly WE ARE DOING SOMETHING WRONG. 4. ADDICTION IS one of THE ONLY MEDICAL CONDITIONS TREATED where we rely on NON-PHYSICIANS who had personal experience with addiction previously TO COUNSEL AND TREAT ADDICTS PREDOMINANTLY RELYING ON THE AA / NA PHILOSOPHY. While THIS IS AN APPROACH THAT IS GOOD FOR SOME PEOPLE AND NO ONE SHOULD TAKE THIS AWAY AS AN OPTION in treatment. However, it is not the only approach. Unfortunately, AA philosophy often encourages patients to discontinue medications, even though clinicians who use BUPRENORPHINE, have found it to be one of the most effective approaches to treat opioid addiction when used correctly. In the rest of the world (France, Britain, Australia) BUPRENORPHINE is properly used as a maintenance drug. Yet treatment in the U.S. encourages physicians to prescribe it in subtherapeutic low-dose therapy, and the goal is to taper patients off rapidly. There is no rationale for this approach, but AA / NA philosophy often does not consider an individual to be “clean” and in control of their addiction until ALL medications are discontinued. BUPRENORPHINE is clearly a maintenance drug and in my experience, patients are often on it for a minimum of 1 year, if not more and some of my patients have been on it for up to 10 years or more. As long as the individual is functional, in less pain, able to work, and feels better than they have ever felt, why should they be criticized for being on maintenance treatment. Patients who have repeatedly failed rehab go through a revolving door of readmissions until they finally “make it” or die from overdose. One individual, the actor PHILIP SEYMOUR HOFFMAN comes to mind as an example of someone who might have survived if proper therapy had been offered. 5. Does it make sense to treat heart attack victims by having them monitored and treated by previous survivors of heart attacks and told that they were not truly in control until all medications were stopped? Or treat diabetic patients by counselors who had diabetes previously with the goal of getting off of their diabetic medications or insulin? Or to treat cancer by relying on previous cancer victims to make treatment decisions? The answer is No. Of course, individuals who have diabetes, hypertension, previous heart attacks, cancer, may participate in treatment by providing supportive, emotional, and psychologic support. That is not the question. But no one should guide treatment based on their philosophy or belief system regarding medication therapy. If cardiac care units had counselors running treatment and ordering the approach to treatment and making suggestions like stopping medications because of their experience, would we have better outcomes with heart attacks? I don’t think so. 6. To be clear, there is definitely a place for AA/ NA philosophy, but recommendations to treat addiction with BUPRENORPHINE should be between the physician and the patient and their families. AA / NA TREATMENT PHILOSOPHY should criticize patient treatment with medications, anti-depressants etc. I HAVE HAD MANY PATIENTS RELAPSE JUST BECAUSE SOMEONE AT An AA/ NA meeting TOLD THEM THAT THEY WERE NOT “CLEAN” UNTIL THEY STOPPED ALL OF THEIR MEDICATIONS. This ATTITUDE IS A MAJOR CAUSE OF RELAPSE AND UNFORTUNATELY this can lead to accidental opioid DRUG OVERDOSE. I have found that up to 75%-80% of all of my opioid dependent chronic pain patients (see abstracts below) who have been on chronic opioid therapy for chronic pain for a minimum of 6 months or more, were able to transition successfully to BUPRENORPHINE because many of these patients had developed opioid tolerance, and opioid induced hyperalgesia (see research and abstracts) so that in effect, the longer full agonist opiates were used to treat their pain, the more likely they ended up suffering with more pain. Paradoxical but true. Why? Some had started a cycle of daily withdrawal due to inadequate doses of opiates, often waking up in severe pain due to the long interval at night between doses. Others had forgotten what the initial pain felt like and assumed that the bad feelings felt due to inadequate dosing was the same as their original pain when in reality their pain had slowly had changed over the years. And others due to tolerance and hyperalgesia development. Medical science still does not fully understand the physiology of chronic pain and what really happens at the ENDORPHIN or Mu receptor where opioid drugs attach. Pain is a very real but complex condition, yet some clinicians choose not to trust the patient’s need for treatment and often label patients as “drug seeking,” or “exaggerating,” and some even go so far as to accuse the patient of having generated the pain “in there head.” The sad thing is that patients, who are suffering terribly are often mistreated because of the pharmacist’s or physician’s misguided suspicions. Never-the-less, since pain is a true medical condition for which there is NO CURE, I have found that about 75% to 80% of patients that are able to transition (see abstracts) to BUPRENORPHINE due very well on BUPRENORPHINE ALONE. HOWEVER, the remaining 20 to 25% of these pain patients on BUPRENORPHINE still have persistent severe pain that BUPRENORPHINE alone does not adequately control their pain. Although, usually the pain is never more severe than when they were on their doctor prescribed opioid analgesic for their condition. The first concept that is important to understand is that BUPRENORPHINE is one of the safest drugs developed because of the pharmacology of this unique medication. We know that if one is on < 2 mg of BUPRENORPHINE daily, it acts more like a full agonist opiate and that is why drugs like Temgesic, and Butrans, etc are dosed in smaller doses of BUPRENORPHINE. But as the BUPRENORPHINE dose is increased above > 4-12 mg per day, it moves away from being a full “agonist” drug and begins to become an “antagonist” drug as well. The changes and effects at the MU receptor are paradoxical and not fully understood, but because it’s effects change its function to not only acting like an opioid agonist, it also functions as an antagonist. BUPRENORPHINE begins to take on similar characteristics as the antagonist naloxone, in that the Mu receptor does not activate further but remains blocked. Naloxone does not stimulate the receptor while BUPRENORPHINE does both, and that is why NALOXONE does not stop opioid craving and is not very successful in preventing opioid addiction, which is the primary issue in treating opioid addiction. At 12-18 mg per day, > 88-94% of Mu receptors in the brain are filled with BUPRENORPHINE and that dose successfully stops opioid craving but, since it does not activate the receptor completely like a full agonist opiate would, it in effect “resets” the MU RECEPTOR system in a unique and beneficial way. In general, one cannot get regularly “high” or suffer mind altering effects after stabilization on sublingual buprenorphine after several days. Overdose is virtually impossible on 24 mg daily. Not one person on doctor monitored sublingual buprenorphine has ever died from an accidental overdose of BUPRENORPHINE because the Mu receptor cannot be stimulated beyond “the ceiling effect,” no matter how much buprenorphine is ingested. (note: all values I have discussed are estimates only, because the point is to understand the concepts) It is important to note that if a full agonist opiate like HYDROCODONE, OXYCODONE, FENTANYL, OR METHADONE ETC. were to fill > 40% of MU receptors, the individual would likely die from a respiratory arrest. However, as I said, not one person has ever died from sublingual buprenorphine overdose because even if 98% of the receptors are filled, the receptors do not increase activity due to the concept of something called a “ceiling effect,” which prevents respiratory depression. The next concept to understand is “precipitated withdrawal.” If an individual is given BUPRENORPHINE without having discontinued their full agonist opiate, the individual undergoes precipitated withdrawal because BUPRENORPHINE is extremely adherent to the MU receptor and “knocks off” the full agonist opiate off of the Mu receptor causing the patient to go into acute drug withdrawal and severe distress. But, the opposite is not true. That is Adding a weaker full agonist opiate to the individual on currently on maintenance BUPRENORPHINE does not result in precipitated withdrawal. And surprisingly, nothing happens as long as the patient continues maintenance BUPRENORPHINE. In my 14 years of treating patients who suffer with chronic pain and chronic addiction issues, I have found various unique approaches in treating the suffering individual who despite transitioning from a full agonist opiate to buprenorphine, still suffers with severe pain. These individuals have the double whammy of possible addiction or dependence to opiate medications, and severe chronic pain. The question is how to safely treat these patients. In my view it is inhumane to NOT treat these individuals. However, there is the danger of accidental overdose in some patients as well. Well, it turns out that once a patient is on maintenance BUPRENORPHINE, we can add back a full agonist opiate like HYDROCODONE, OXYCODONE, ETC. Why? You may ask? Well, it turns out that once a patient is on maintenance BUPRENORPHINE and >85-95% of the MU receptors are blocked with BUPRENORPHINE, only 5-15% of MU receptors are open to the added full agonist opiate and the opiate filling in the remaining 5-15% of Mu receptors continues to provide pain relief. Not only that, it does not trigger “craving”and not only that, but the person cannot get “high.” As you can see, if you read the abstract from the state university of new York, their findings concur with what I have found to be true. (see abstract below) So by monitoring patients every 2-4 weeks and doing urine drug screens at every visit and monitoring C.U.R.E.S data, I have patients who suffer with chronic pain who I have transitioned to BUPRENORPHINE from chronic opioid therapy and because of persistent severe pain, added back an opiate with the result of better control of pain. The added benefits are that they are safer from accidental overdose, safer from re-igniting any potential for opioid dependence or addiction, and they can safely get off of the opioid pain medication without fear of withdrawal symptoms. This approach can be done with all opioid agonists except methadone and fentanyl. The pharmacology of BUPRENORPHINE is often misunderstand. I have had patients who suffers with chronic pain and have found that 24 mg of buprenorphine has changed their lives. However the workers comp group that advises the insurance carrier have stated that their physician advisors have stated that since 24 mg was equivalent to more than 200 mg morphine, that they would no longer cover its use. The patient was forced to go back onto morphine and now is rapidly declining. No matter how much I tried to explain to them that their rationale was wrong and irrational they refused to allow the use of BUPRENORPHINE. So now the risk of accidental overdose is a major issue, and the patient’s chronic pain is worse again and deteriorating. The pain patient is now back on the cycle of escalating opiates and increasing risk of accidental overdose. I hope that the CDC guidelines explain fully that no one should compare buprenorphine to morphine or methadone without a full explanation of why it is a different type of drug. PLEASE make it clear in the guidelines that BUPRENORPHINE cannot be compared to full agonist opioid medications. At low doses <2 mg it is a good pain killer in some patients, but at high doses it acts to protect against overdose and as my abstracts demonstrate can help many previously opioid dependent non-opiate naïve patients stabilize their pain, regain function, and get back to living normally. It does all of this and does not affect mental or physical function. 1. BUPRENORPHINE alone can help an opiate dependent or addicted pain patient improve 50-80% of the time (see abstracts). 2. I have also explained how pain meds can be given to buprenorphine maintained individuals and help reduce pain safely, have surgery, and resolve acute pain problems without having to stop BUPRENORPHINE OVER THE SHORT TERM. 3. Paradoxically, buprenorphine maintained individuals, contrary to previous beliefs, are able to take full agonist opiates while they are on maintenanace buprenorphine. Pain Patients are monitored monthly, undergo urine tests monthly for both buprenorphine and opiate, and are monitored by C.U.R.E.S., and every one of the hundreds of patients I currently treat have done exceptionally better than when they were on full agonist opiates alone, and the risk of accidental overdose on buprenorphine has dropped to zero. In 14 years, not one accidental overdose and no development of tolerance or hyperalgesia. The S.U.N.Y. study mirrors my observations clinically and they found that pain relief was observed as well, also contrary to previous physician assumptions. 4. This approach of treating chronic pain with opiates for 6 months or more first, and then transitioning to BUPRENORPHINE if the patient desired to do so was very successful and should always be considered. The second more controversial approach of treating intractable pain with a combination by adding back opioid therapy in those that still suffer with severe pain on buprenorphine should only be done by physicians who understand the pharmacology and are committed to the strict monitoring required. Pure opioid addiction would not be a reason to use this combination. This approach should only be used when treating complicated chronic pain patients. Addiction is primarily manifest by aberrant behavior as part of the definition. Pure pain patients who suffer with pseudo addiction or inability to control pain benefit greatly from this approach. Unfortunately, there is very little in the literature to match my results, but the SUNY study matches what I see clinically. Any patient who does not see me regularly, sign a contract, fails to understand the importance of NEVER, NEVER, EVER stopping BUPRENORPHINE, fails urine drug screens for illicit drugs, doctor shops as seen on C.U.R.E.S. is not allowed to continue treatment, no exceptions. I demand that ALL patients on this protocol understand it fully and never compromise or run out of their medications. I do bottle checks and pill counts on everyone. It is difficult to treat someone who suffers with both an opioid addiction or dependence AND chronic pain. Which came first? And people treating their chronic pain do get physiologically addicted or dependent as well so differentiating is based on aberrant behavior. One is not addicted if they are taking doctor prescribed opiates as prescribed and meeting all other doctor/patient expectations. The term pseudo-addiction refers to the individual who is suffering with so much pain that in desperation they end up using more pain meds then prescribed. Does that mean that they can’t be treated? Isn’t that a judgement call? And isn’t it inhumane if we refuse treatment? These are difficult questions clinically, and I don’t have all of the answers. I spend a great deal of time trying to help these people and I certainly want to be as safe as possible but also able to relieve pain. What I do know is that chronic pain patients will follow directions and adhere to the protocol because they simply do not have any other provider who will treat their pain condition in this manner. The pain is REAL, and providers who do not treat them with compassion probably will not go to this much intervention. So, what is the diagnosis for prescribing SUBOXONE? By the way I prefer using GENERIC BUPRENORPHINE, but SUBOXONE is what is covered by a majority of plans. In my 14 yrs of utilizing BUPRENORPHINE, I have never had a well monitored pain patient ever intravenously inject opiates. Naloxone in SUBOXONE is an inactive agent sublingually and is not absorbed significantly sublingually. There is no reason why a middle class pain patient would inject SUBOXONE, IT JUST DOESN’T HAPPEN. Also, there are a few patients who are hypersensitive to naloxone and have either an allergy to it or to the dye in the film and, they cannot continue on SUBOXONE, but do well with generic BUPRENORPHINE. My patients who do well on SUBOXONE were treated with suboxone to get them off of doctor prescribed opioid analgesics originally given to them for their chronic pain. I have about 5 % HEROIN addicts, and they never ever are given a combination treatment, only SUBOXONE unless, of course, if they switched to HEROIN because their primary care physician refused to treat their chronic pain with opiates. The diagnosis to use BUPRENORPHINE is always DUE to opioid dependence, pseudo addiction or addiction. If I have to add back an opiate, then the patient also has the additional diagnosis of chronic pain. But that does not negate the fact that they did suffer with opioid dependence, pseudo-addiction, or addiction. Removing buprenorphine and leaving them on an opiate alone would cause escalation of opiates in many patients due to tolerance and/or hyperalgesia and put them at risk for problems with opioid dependence, addiction, pseudo-addiction, and the added risk of overdose. I cannot emphasize that drug overdose is prevented by using BUPRENORPHINE and the dose is on average 16 mg. Many physicians still try to titrate the dose down below 8 mg. The literature is clear that this actually increases the risk of relapse and possibly overdose. REMEMBER low doses are for treatment of pain, and higher doses are for the antagonist component as well as pain and probably prevent tolerance and hyperalgesia. Giving a patient 16 mg or more a day is protective and giving less than 8 mg is risking relapse. Doctors have to change their attitude that less is better when using BUPRENORPHINE. If we alter this attitude, we will see a drop in accidental overdoses amongst opioid addicts. Remember, there has never been an accidental overdose using sublingual BUPRENORPHINE monitored regularly by a physician. Misuse of BUPRENORPHINE is generally seen in IV HEROIN ADDICTS and it is usually used to bridge the patient to their next dose of illicit opiates and prevent withdrawal symptoms. Most addicts state that IV buprenorphine is of limited value to get high. So the next concept is using buprenorphine does not lead to the same risks seen with full agonist opiates. The more we confuse the DEA, federal government, and physicians the more likely we will see overdoses. Even addictionologists who adhere to the AA / NA mentality of not using medications in therapy and using buprenorphine as a short-term treatment and rapidly tapering off of the drug are actually a detriment to treatment. Had many of the rock stars and actors like Philip Seymour Hoffman been treated with high doses on BUPRENORPHINE, many of them would be alive today. Even if they tried to inject HEROIN while on BUPRENORPHINE it would protect against overdose. My chronic patients have been referred to me because no one knows how to treat their chronic pain. I get the worst of the worst. I believe that the patient deserves the best care that medical science can offer. Most patients have had multiple surgeries, many epidural injections, many procedures costing a great deal of money. Such a waste of money, and many patients are crippled by unnecessary surgery. Many of these pain patients have been to the ER repetitively and have been through rehab programs multiple times, and have been hospitalized many times. I treat doctors, lawyers, CEOs, teachers, nurses, engineers, students, housewives and soccer moms, oh and yes . . . pharmacists too. We have a epidemic of pain, and addiction, and no one seems to care. Marijuana does not treat severe pain, so that suggestion is hooey. ¼ of high school seniors smoke marijuana regularly, and kids who smoke regularly between age 14-25 can lose up to 8 IQ POINTS PERMANENTLY, AND increases the risk of schizophrenia by 100% (doubles). Sorry I digressed, but I am passionate about treating pain and addiction. I have many patients who I have treated for more than 10 years without another visit to the ER or hospitalization. Many that didn’t need to undergo surgery, all because of the approaches I have discussed. I am not sure that what I have described is understood by many physicians, but I do hope that my explanation will be evaluated by the authors of the CDC guidelines. Diagnosing Addiction in Patients on Chronic Opioids is often Difficult because it Requires 3 or more criteria occurring over 12 months that can also be seen in chronic pain patients who are pseudo addicted: 1. Tolerance – YES 2. Withdrawal/Physical dependence – YES 3. Taken in larger amounts or over longer period - MAYBE 4. Unsuccessful efforts to cut down or control - MAYBE 5. Great deal of time spent to obtain substance - MAYBE 6. Important activities given up or reduced - MAYBE 7. Continued use despite harm - MAYBE (From American Psychiatric Association DSM IV-TR 2000) LITERATURE RESEARCH: SUNY findings: Neuropsychopharmacology (2011) 36, 411-422; doi:10.1038/npp.2010.172; published online 27 October 2010 The Subjective, Reinforcing, and Analgesic Effects of Oxycodone in Patients with Chronic, Non-Malignant Pain who are Maintained on Sublingual Buprenorphine/Naloxone Jermaine D Jones1, Maria A Sullivan1, Jeanne Manubay1, Suzanne K Vosburg1 and Sandra D Comer1 1Division on Substance Abuse, New York State Psychiatric Institute/College of Physicians and Surgeons, Columbia University, New York, NY, USA Correspondence: Dr SD Comer, New York State Psychiatric Institute/College of Physicians and Surgeons, Columbia University, Division on Substance Abuse, 1051 Riverside Drive, Unit 120, New York, NY 10032, USA, Tel: +1 212 543 5981, Fax: +1 212 543 5991, E-mail: jermainedjones@gmail.com Received 23 March 2010; Revised 18 August 2010; Accepted 30 August 2010; Published online 27 October 2010. Abstract Some sources suggest that significant misuse of opioid drugs exists among patients with chronic pain. However, the risk factors and motivation behind their abuse may differ from those of other opioid abusers. This study sought to examine the abuse liability of oxycodone among patients with chronic, non-malignant pain who met the DSM-IV criteria for opioid abuse. Eighteen opioid-dependent patients with chronic pain lived on an in-patient unit of the New York State Psychiatric Institute during the 7-week study. Participants were given oral oxycodone (0, 10, 20, 40, and 60mg/70kg) while maintained on various doses of sublingual buprenorphine/naloxone (Bup/Nx; 2/0.5, 8/2, and 16/4mg/day). Doses of both medications were administered under double-blind conditions. Oxycodone produced an overall positive, but less robust, subjective profile than previously reported in recreational opioid users without pain. Furthermore, unlike our findings in recreational opioid users and more similar to effects in non-drug-abusing individuals, oxycodone failed to serve as a reinforcer. As for the maintenance drug, Bup/Nx produced a dose-related reduction in some of the effects of acutely administered oxycodone. Neuropsychopharmacology (2011) Studied the Subjective, Reinforcing, and Analgesic Effects of Oxycodone in Patients with Chronic, Non-Malignant Pain who are Maintained on Sublingual Buprenorphine/Naloxone Eighteen opioid-dependent patients with chronic pain lived on an in-patient unit of the New York State Psychiatric Institute during the 7-week study. Participants were given oral oxycodone (0, 10, 20, 40, and 60?mg/70?kg) while maintained on various doses of sublingual buprenorphine/naloxone. The following are my analysis of S.U.N.Y. Findings when compared to clinical observations at The P.A.I.N. Institute (The Pain & Addiction Integrated Network, Inc.) CLINICAL STUDY OBSERVATIONS WHEN COMPARED TO THE P.A.I.N. INSTITUTE EXPERIENCE: Furthermore, unlike previous findings in recreational opioid users and more similar to effects in non-drug-abusing “doctor prescribed opioid analgesic” using chronic pain patients, OXYCODONE failed to serve as a reinforcer. Most, if not all significant studies to date on Opioid use and abuse and buprenorphine have used data from individuals who were heroin and other opioid addicts Based on my experience, pain patients are different and studies need to be done on this cohort. As for the maintenance drug, it was observed that Bup/Nx produced a dose-related reduction in some of the effects of acutely administered oxycodone, but most important is the observation that the combination did prevent pain, as I have observed as well. ANALYSIS: This study, as in my clinical observations, also showed the Safety & Effectiveness of adding an opioid agonist to treat acute or chronic pain in individuals already on an opioid agonist/antagonist like BUPRENORPHINE with the results of: 1. Suppressing the acute triggers and reinforcers involved in re-igniting opioid craving and addictive behavior is one of the remarkable observations. Being able to treat acute pain due to surgery or trauma without having to discontinue buprenorphine was seen in the S.U.N.Y. study and has been seen clinically on hundreds of patients that I have treated over the last decade. 2. Increasing the safety of opioid therapy in treating pain by diminishing the likelihood of accidental opioid overdose is the other observation seen in buprenorphine maintained patients. 3. Adding opiate therapy to maintenance buprenorphine therapy (>8 mg daily) does not result in the concept of precipitated opioid withdrawal because buprenorphine adheres to the Mu receptor so strongly. 4. the ease with which opioid therapy can be withdrawn without causing symptoms of opioid withdrawal in buprenorphine maintained patients. 5. Understanding that patients on maintenance buprenorphine therapy get benefit from opioid therapy when treating acute pain due to surgery, trauma, etc without having to discontinue BUPRENORPHINE first. 6. Chronic pain is also successfully treated long-term in patients on BUPRENORPHINE maintenance therapy and the risk of accidental overdose is reduced dramatically. Rick Chavez, M.D. ABSTRACTS (done with renowned BUPRENORPHINE researcher LESLIE AMASS, Ph.D.) Buprenorphine Treatment as an Alternative to Orthopedic Surgery in Patients on Prescription Opiates with Lumbosacral or Cervical Spine Disc Disease R Chavez, W. Dillin and L. Amass The P.A.I.N. Institute, Inc., Redondo Beach, CA and Kerlan-Jobe and Friends Research Institute, Inc. Los Angeles, CA, 2006 Presented at the 67th Annual Conference of College on Problems of Drug Dependency, Scottsdale, Arizona, 2006 INSTITUTIONS The P.A.I.N. Institute, Inc., Redondo Beach, CA, USA. Kerlan-Jobe, Los Ángeles, CA, USA. Friends Research Institute, Inc., Los Angeles, CA, USA. ABSTRACT BODY: Buprenorphine’s analgesic properties are well known, but using the sublingual tablet (Subutex/Suboxone) pre-operatively to stabilize pain in opiate dependent chronic pain patients awaiting orthopedic surgery is unique and novel. Worsening pain in these patients may be due to opioid induced hyper-algesia and mistaken as a signal to proceed with surgery. Buprenorphine’s anti-hyper-algesic effects may benefit these patients by reducing pain and enabling surgery to be postponed or cancelled. This report describes results with 18 opioid tolerant patients taking prescription opiates for severe pain due to lumbosacral (n=16) or cervical spine (n=2) disc disease. All patients were preoperative and referred before scheduling surgery by orthopedic and neuro surgeons to The P.A.I.N. Institute for buprenorphine treatment. Patients (11 male; 7 female) averaged 48 years old (range 33-69) and were mostly white (89%), insured (83%), working (95%) and college educated (95%). Patients had been maintained on prescription opiates for a mean of 4.9 years (range 1-15), 12 had none and 6 had between 1 and 5 prior surgeries. After treatment with Subutex (n=13) or Suboxone (n=5), 89% (16/18) no longer required surgery. Surgery is being considered for 1 patient after 13 months on Subutex and another had surgery and has since returned to Subutex. To date, 89% (16/18) have continued buprenorphine maintenance at a mean daily dose of 19.1 mg (range 1-32) for a mean of 16.7 months (range 2-31). No patient has become tolerant to buprenorphine, nor has there been any medication misuse, diversion or safety issues. Pain ratings on a 10-pt scale averaged 6.9 before and decreased to 2.7 during treatment. These clinical findings support using Subutex/Suboxone for pain reduction in preoperative, opiate dependent chronic pain patients. The potential medical and economic benefits of buprenorphine treatment for avoiding surgical complications, time and work lost, and monetary costs to society are tremendous IMPROVEMENT IN PAIN LEVELS AFTER TREATING OPIOID DEPENDENT CHRONIC PAIN PATIENTS WITH BUPRENORPHINE. Rick Chavez, M.D.1,2, Leslie Amass, Ph.D.3, Jonathan B. Kamien, Ph.D. 3 and Lynette Prucha2 1UCLA School of Medicine, Los Angeles, CA, 2The Pain Institute at Little Company of Mary, Redondo Beach, CA, and 3Friends Research Institute, Inc., Los Angeles, CA Presented at 3rd World Congress, World Institute of Pain, September 21-25, 2004 “Pain Advances in Research and Clinical Practice,” Barcelona, Spain. AIM OF INVESTIGATION: Managing opioid dependent patients with chronic pain is challenging and hampered by limited treatments. We explored buprenorphine sublingual tablets (BUP) for treating 65 opioid-dependent patients (34 male) with chronic severe pain at a multidisciplinary pain management center in Redondo Beach, CA. METHODS: Patients received medical and psychological assessment at entry. Open-label treatment included maintenance or medically-supervised withdrawal using BUP over varying periods of time, urine drug screening, on-going pain assessment using a 0-10 rating scale, monitoring of adverse events and centralized case management. Concomitant medications were prescribed according to medical and psychiatric disorders. Patients averaged 47 years old (range 18-87), 6.4 years of opioid dependence (range 0.25-30) and prior treatment attempts for opioid dependence had been unsuccessful. To control pain, all patients used prescription Opioids (legally and illegally) and 5 also used heroin. Pain ratings at initial evaluation averaged 6.5 ± 0.2 (SEM). Common co morbid disorders included depression, anxiety, and musculo-skeletal maladies. All patients had stopped using Opioids before starting BUP 2 mg and BUP 8 mg tablets, two to four times per day, were prescribed according to patient need. Maintenance doses averaged 14.7 ± 1.1 (SEM) mg/day and maintenance are ongoing in 81% of patients. RESULTS: Average pain ratings declined to 2.9 ± 0.3 (SEM) on maintenance BUP, and ongoing medical and non-substance abuse-related psychiatric problems were stabilized. CONCLUSIONS: BUP therapy safely and effectively managed opioid-dependent Pain patients with co morbid chronic severe pain and reduced their pain ratings. Additional controlled research is needed to evaluate BUP for treating these opioid addicted patients. Buprenorphine Tablet Treatment for Opioid Dependence in Patients With Co morbid Chronic Severe Pain Rick Chavez, M.D. 1,2, Leslie Amass, Ph.D. 3, Jonathan B. Kamien, Ph.D. 3, and Lynette Prucha, MA 2 1UCLA School of Medicine, Los Angeles, CA, 2The Pain Institute at Little Company of Mary, Redondo Beach, CA, 3Friends Research Institute, Inc., Los Angeles, CA Oral Presentation at The 66th Annual Meeting of The Conference on Problems in Drug Dependence (CPDD), San Juan, PR 6/04 AIM OF INVESTIGATION: Managing opioid dependent patients with chronic pain is challenging and hampered by limited treatments. We explored buprenorphine sublingual tablets (BUP) for treating 65 opioid-dependent patients (34 male) with chronic severe pain at a multidisciplinary pain management center in Redondo Beach, CA. METHODS: Patients received medical and psychological assessment at entry. Open-label treatment included maintenance or medically-supervised withdrawal using BUP over varying periods of time, urine drug screening, on-going pain assessment using a 0-10 rating scale, monitoring of adverse events and centralized case management. Concomitant medications were prescribed according to medical and psychiatric disorders. Patients averaged 47 years old (range 18-87), 6.4 years of opioid dependence (range 0.25-30) and prior treatment attempts for opioid dependence had been unsuccessful. To control pain, all patients used prescription Opioids (legally and illegally) and 5 also used heroin. Pain ratings at initial evaluation averaged 6.5 ± 0.2 (SEM). Common co morbid disorders included depression, anxiety, and musculo-skeletal maladies. All patients had stopped using Opioids before starting BUP 2 mg and BUP 8 mg tablets, two to four times per day, were prescribed according to patient need. Maintenance doses averaged 14.7 ± 1.1 (SEM) mg/day and maintenance are ongoing in 81% of patients. RESULTS: Average pain ratings declined to 2.9 ± 0.3 (SEM) on maintenance BUP, and ongoing medical and non-substance abuse-related psychiatric problems were stabilized. CONCLUSIONS: BUP therapy safely and effectively managed opioid-dependent Pain patients with co morbid chronic severe pain and reduced their pain ratings. Additional controlled research is needed to evaluate BUP for treating these opioid addicted patients. Buprenorphine Treatment for Opioid Dependence in Patients With Co morbid Chronic Severe Pain: An Open-Label Case Study Analysis R Chavez and L Amass. UCLA School of Medicine, Los Angeles, CA and The Pain Institute at Little Company of Mary, Redondo Beach, CA; and Friends Research Institute, Inc., Los Angeles, CA Poster presentation at “6th Annual Conference on Pain and Chemical Dependency in New York City, February 13-15, 2004” Buprenorphine-only and buprenorphine-naloxone sublingual tablets became available for treating opioid dependence in the US in March 2003. Managing opioid dependent patients with multiple chronic pain issues is challenging and has been hampered by limited or non-existent effective treatments. Objectives/aim: We explored using buprenorphine tablets for treating 13 opioid-dependent patients (8 male, 5 female) with chronic severe pain seeking treatment at a multidisciplinary pain management center in Redondo Beach, CA. Methods: Patients received medical and psychological assessment at treatment entry. Open-label treatment included either maintenance or medically-supervised withdrawal using buprenorphine-only tablets over varying periods of time, urine drug screening, and ongoing pain assessment using a 0-10 rating scale, monitoring of adverse events and centralized case management. Concomitant medications were prescribed according to medical and psychiatric needs. Results: Patients averaged 44 years old (range 34-68); 5 years of opioid dependence (range 2-10) and prior treatment attempts had been unsuccessful. To control pain, all patients used prescription Opioids (legally and illegally) and one patient also used heroin. Twelve patients requested addiction treatment; one patient became aware of her addiction after physician counseling. Pain ratings at initial evaluation averaged 7.4 (range 5-9). Common co morbid disorders included depression, anxiety, non-opioid substance dependence, and muscular-skeletal maladies. Two and 8 mg buprenorphine-only tablets, two to four times per day, were prescribed according to patient need. All patients were offered, but declined, once per day dosing. Maintenance averaging 12.7 mg/day (range 4-24) is ongoing in all but one patient who has since discontinued buprenorphine. All patients successfully withdrew from prescription Opioids within 5 days of starting buprenorphine, average pain ratings declined to 2.8 (range 0.5-7), and ongoing medical and non-substance use disorder psychiatric problems became stable. The most common side effects were extreme sleepiness, fatigue, migraine headaches, dizziness, disorientation and nausea, but reports were few, appeared dose dependent and eventually resolved. Conclusions: Buprenorphine-only tablet therapy safely and effectively managed opioid-dependent patients with co morbid chronic severe pain and reduced their pain ratings. Additional controlled research to evaluate buprenorphine’s role in treating this sub-population of opioid addicted patients and examine the role of other factors on their treatment outcome is needed. THANKYOU FOR ALLOWING ME TO PROVIDE YOU WITH THIS INFORMATION regarding my experience clinically. WHAT I AM TRYING TO GET ACROSS in this discussion IS THAT WE NEED TO CREATE GUIDELINES WHICH actually are not a reiteration of what state boards have already written. The RECOMMENDATIONS need to include HOW TO TREAT CHRONIC PAIN and ADDICTION effectively. Also, we should not forget the DATA AVAILABLE regarding those PHYSICIANS who have been convicted of contributing to opioid abuse, misuse, and diversion along with many patient deaths due to accidental opioid overdose. Reviewing THE MEDICAL BOARD data to GET A BETTER IDEA OF WHAT MISTAKES WERE MADE AND HOW WE CAN PREVENT THOSE MISTAKES FROM REOCCURRING will help to improve the CDC guidelines. In ALL HONESTY, THE MAJORITY OF DEATHS THAT I SAW IN MY EVALUATION OF PHYSICIANS for the DEA AND THE MEDICAL BOARD OF CALIFORNIA WOULD NOT HAVE CHANGED HAD THE CDC’s draft GUIDELINES BEEN COMPLETED and in place. The reason being BECAUSE THE MEDICAL BOARD GUIDELINES ARE JUST AS THOROUGH AND DESCRIPTIVE AND CURRENTLY AVAILABLE TO THE TREATING PHYSICIAN. THANKYOU RICK CHAVEZ, M.D. Medical Director Santa Clara County Valley Medical Center & Health System 777 E. Santa Clara St. Downtown Site, 3rd Floor Rick.chavez@hhs.sccgov.org Board Certified, American Board of Family Medicine (ABFM) Board Certified, American Board of Pain Medicine (ABPM) Board Certified, American Board of Addiction Medicine (ABAM) Former Assistant Clinical Professor of Family Medicine, UCLA Geffen School of Medicine (2002-2012) Independent Consultant to the Medical Board of California, the DEA Dept. of Justice, and the California Attorney General.

Strike 2 against the CDC\\\\\\\'s mission statement to \\\\\\\"save(s) lives and protect(s) people from health threats\\\\\\\". The story that Dr. Lawhern recounts is similar to the CDC\\\\\\\'s falsified data in their study of the causal relationship between the MMR vaccine and autism. Physicians and caregivers rely on clinical guidelines for care plans and if the care plan is based on garbage, how much harm is being done to patients? We\\\\\\\'re left with conscientious whistleblowers being the voice of truth for what otherwise somewhat amounts to government cover ups. This is not right, folks!

I am a neurologist. I agree 100%. My metric for using opioids was always whether the patient was able to participate in life and have less pain. This policy has harmed an enormous number of patients.