Training for Opioid Analgesic Prescribers--Exploring the Path Forward
2017-76 Training for Opioid Analgesic Prescribers
2017-07-12 2017-05-05 2017-05-12 2017-07-07 2017-05-18 2017-05-18 2017-05-19 2017-05-19 2017-07-11 2017-07-12
FDA-2017-N-1094-0251 FDA-2017-N-1094-0018 FDA-2017-N-1094-0050 FDA-2017-N-1094-0183 FDA-2017-N-1094-0086 FDA-2017-N-1094-0095 FDA-2017-N-1094-0099 FDA-2017-N-1094-0100 FDA-2017-N-1094-0197 FDA-2017-N-1094-0209
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https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0251 https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0018 https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0050 https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0183 https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0086 https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0095 https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0099 https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0100 https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0197 https://api.regulations.gov/v4/comments/FDA-2017-N-1094-0209
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Dear Dr. Throckmorton,Lets go back in time for a minute and recognize that FDAs ineffective warning, regarding the dangers of corticosteroids used to treat back pain, continues to result in unsustainable numbers of catastrophic injuries throughout the country - and the legitimate need for opioids for adhesive arachnoiditis patients (including misdiagnosed cases of Fibromyalgia).  As we both know, the topic of pain is complex (and not what it appears) as underlying profit motives have skewed accurate statistics.    On the National debate: Federal OWCP is willing to authorize reimbursement for repeated, high risk epidural steroid injections.  Ron Angel was offered ESI treatment indefinitely for his low back pain (approx. $2000 per injection).   Ron also suffered an OTJ cervical spine injury, now a retired wildland fire fighter: https://www.painnewsnetwork.org/stories/2015/10/21/jumping-from-fire-into-federal-work-comp-nightmare For the record (again), the most commonly used corticosteroid used for back pain is Pfizers Depo-medrol.  Below is the link to Pfizer/New Zealand Depo-medrol datasheet:  http://www.medsafe.govt.nz/Profs/Datasheet/d/Depomedrolinj.pdf Please note top of page 7:  Depo-Medrol may be used by any of the following routes: intramuscular, intra-articular, periarticular, intrabursal, intralesional and into the tendon sheath. It MUST NOT be used by the intrathecal, epidural or intravenous routes (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE EFFECTS). And bottom of page 18:  ADVERSE EFFECTSAdministration by other than indicated routes has been associated with reports of serious medical events including: arachnoiditis, meningitis, paraparesis/paraplegia, sensory disturbances, headache, functional gastrointestinal disorder/bladder dysfunction, seizures, visual impairment including blindness, ocular and periocular inflammation, and residue or slough at injection site. FDAs warning has not changed the harmful standard of care for back pain, or the problem of injured worker coercion to undergo high risk, high cost injections:  https://www.fda.gov/Drugs/DrugSafety/ucm394280.htm We have reason to believe that FDA sold out to the interests of professional medical societies and large corporations (Pfizer).  Arachnoiditis is grossly misdiagnosed for fear of legal liability;  adverse events are under-reported/not reported to FDA for same reason.  Check out the comment written by Dr. Laxmaiah Manchikanti,  Chairman of the American Society of Interventional Pain Physicians in Pain News Network blog:  https://www.painnewsnetwork.org/stories/2015/8/19/experts-say-epidural-injections-overused Laxmaiah Manchikanti, MD 2 years ago Pending Awaiting Moderation  1 likeThis is a very interesting perspective; however, there appears to be significant misinformation. All in all arachnoiditis is a significant problem which has been missed by multiple governmental agencies as well as physician organizations. It will not go away by ignoring it. All parties have responsibility. It can be avoided by utilizing alternate techniques, alternate drugs, and finally patients must also share responsibility. In the United States, no one can force anyone to have a procedure. Further, each and every patient should be educated about and understand the risks and benefits of any and all procedures and physicians should explain to them that steroids are an off-label use. When you add up the error rates and multiply the estimated numbers of ESIs administered annually, you start to realize the magnitude of the problem.  This cumulative trauma impacting the American public is not sustainable  -- and little is being done to address medical malpractice taking place across the country.  Both FDA and CDC are disregarding this public health crisis. Lets face it:  these agencies are run by politically appointed administrators.  Dr. Tennant should be leading discussions on long term intractable pain conditions at FDA.  Instead, the view is lop-sided, thanks to the likes of PROP, Ballantyne, and Sullivan:    https://www.painnewsnetwork.org/stories/2015/12/10/controversy-grows-over-journal-article-on-pain-treatment  On the Montana Front - please familiarize yourself with these egregious cases: https://www.painnewsnetwork.org/stories/2017/5/26/patient-suicide-blamed-on-montana-pain-clinic https://www.painnewsnetwork.org/stories/2017/5/18/patients-allege-mistreatment-at-montana-pain-clinic https://www.painnewsnetwork.org/stories/2017/5/19/montana-urine-tests-sent-to-bankrupt-drug-lab http://mtpr.org/post/pain-helped-him-pull-trigger Unsuspecting back pain patients are pushed into harmful procedures then end up with permanent injuries and chronic pain for the remainder of their lives.  Corporate decision makers deny these injuries and abandon them in their time of need.  Weve been here done this. Submitted on behalf of Arachnoiditis Awareness and Prevention A.S.A.P.  Please start over with appropriate CDC guidelines. Doctors need reassurance that it is safe to help chronic pain patients,Preventing suicides in opiate refugees. We must help patients who have become dependent on opiates over the last two decades. Some cannot wean off opiates. In my home state of Montana, there is a hostile regulatory environment for doctors who help pain patients.   This is crony capitalism!  Why are we attacking law abiding citizens using narcotic pain killers with government intervention?  If the pain patients dont get their treatment from a doctor they will get it from a dealer.  Heroin use will go up if we restrict pain medication for patients.  Great for big government jobs for all the law enforcement involved in the war on drugs but terrible for the patient.  This is just like gun control where overzealous idiots try to take guns from law abiding citizens to reduce gun ownership by criminals and it NEVER WORKS!  Get big government out of the doctors office; these people went to school for YEARS and they know better than government agencies what their patients need.  If you support restrictions on patients pain medications I hope you die a slow and painful death yourself so that you become a victim of your own legislature.  Doctors and patients dont need the government counting their pills. Hi again.  The past few months I have been slowly buying things to make artisan soaps.  I have been on SSI for years with my autistic daughter.  I want to DO THINGS!  BE PRODUCTIVE and give back!   If I have to sit in a chair and cry all the time, how could I possibly live?  No human wants to do nothing and be in constant pain.  This kind of pain never goes away.  No, I would never kill anyone, but this kind of pain is relentless.Brodericks neighbors told the Review Journal that he was a husband and father of two, who mostly kept to himself but had a friendly wave. One neighbor called Broderick a really nice gentleman who complained of back pain.He used to talk about taking pain pills, said Welborn Williams. He couldnt get any sleep at night.Brodericks Facebook page reveals a man who loved fishing and was a gun enthusiast. Ironically, in 2012 Broderick recommended without comment on his page a story about an employee at a Las Vegas medical clinic who was shot during an armed robbery.The Review Journal reported that Broderick had a concealed weapons permit and five firearms. Williams said Broderick had offered to teach him about firearms.I hate to see anyone in pain like that, Williams said. But there should have been another way for him.https://www.painnewsnetwork.org/stories/2017/6/30/patient-shoots-two-at-las-vegas-pain-clinichttp://www.pharmaciststeve.com/An email received this week from a chronic pain activist: We just lost another intractable member of our support group two nights ago. She committed suicide because her medications were taken away for interstitial cystitis (a horribly painful bladder condition) and pudendal neuralgia, both of which she had battled for years. The nerve pain is equivalent to end-stage cancer pain, but the CDC and doctors in Colorado were merciless. She just couldnt hang on any longer without hope. She was just 30 years old.http://globalnews.ca/news/3571142/commentary-a-deeply-disturbing-email-begins-to-tell-the-opioid-story-for-chronic-pain-patients/Theres a difference between the people (who) need them and the people who are abusing them, Kain said.The CDCin 2016 released new guidelines that discourage primary care doctors from prescribing opioids for chronic pain. The guidelines were meant to curb the rampant over-prescribing practices of the past but may have also created unintended consequences. I dont walk with a cane. I dont have an open wound. Im not in a wheelchair, Kain said, adding that looks can be deceiving. Most of the time, shes stuck in her Pleasant Hill home trying to get through the day with excruciating back pain.http://www.kcci.com/article/has-opioid-epidemic-vilified-chronic-pain-patients/9970531 I am a chronic pain patient and it took over 8 months to officially diagnosis me.  I agree with training those prescribing pain medication both on pain and addiction signs.  I also agree with go slow and low but not making it LAW because think about my situation I have Complex Regional Pain Syndrome CRPS and if you make limits on pain medication a law by state I have to go every week to the doctor to get a new prescription, pay co pays every week, go to the pharmacy every week until officially diagnosed with chronic pain. This puts burdens on the doctors time and the patients time and money.  Most chronic pain patients take medication responsibly to ease the pain.  We arent taking it to feel good. There must be some subjectivity when dealing with pain.  The 30 day to now 3-7 days has been rectified, urine screens happen monthly, we go every month to the doctor as implemented.  The focus needs to be on illicit drugs on the street. Evidence has proved that prescriptions have declined while overdoses have increased.  Some insurances dont cover investigational treatments so your options are limited by insurance.  You cant put real pain patients into one box and you cant scare doctors so much they abandon patients because of too much oversight.  They are trained and if they arent get them to take an online course and if a patient needs to be in pain management get them to a specialist.  We must find a way to stop hurting real pain patients because we deserve care just like someone with cancer does and we also need to find a place for those suffering side effects of taking pain medication and get them help.  Stop hurting and start helping.  Id love for CDC and politicians making black and white rules to live just one day in my shoes.  Talk to the different chronic pain support groups, rare disease groups.  You must hear both sides and bring the pendulum back that has swung way to far in err of hurting pain patients.   Note I have RA, OA, fibromyalgia, degenerative  herniated disk (lumbar  cevical). Been on opioid 20 yrs this yr. I want to increase my meds from 4 to 5 a day. Instead I was given a stronger med 4 sa day. Stronger is not as effective as the one I was taking. Ive protested but Drs say cant prescribe more than 4 a day, so I suffer in silence. Afraid to upset the apple cart. Sirs, I have been in pain management since 2003.  I have Osteoporosis which has caused scoliosis of my spine.  I also have spinal stenosis and herniated discs along with other spinal diagnoses.  Last year the doctor cut back on my fentanyl and the year before they cut my oxycodone for break through pain.  Now they want to cut my medication again because government knows better than my doctor.  Without my medication, I will be bed ridden.  In my lower back, my spine at L1 has completely disappeared. For those who dont know, your spine holds up your entire body.  With medication I can at least dress myself and do a few activities such as walking my dog.  Without it, I can do nothing.  I have never abused my meds nor given any away.  They are too precious to me.  I have always passed my drug tests.  I pray that none of you have to suffer the pain I have experienced but if you do, you better hope someone is there to help you.  Because well people abuse drugs, you are going to punish those who are helped by them.  This is so unfair.  Im afraid you will see suicide rates go up and you will probably see another epidemic of older people soliciting black market drugs to alleviate their pain.  I would much rather be healthy and drug free but since Im not I am so grateful for the doctors who understand my chronic pain and can help.  I ask you to reconsider the people like me who need these drugs to have some semblance of life.  One size doesnt fit all and the government isnt all knowing. I have been suffering from degenerative joint disorder from the age of 23- I am now 47.  I have had 4 separate corrective surgeries on my spine- one repeat.  I have had three corrective knee operations.  I have Carpal Tunnel syndrome, bursitis in four joints, and OA in many.  I have neuropathy in my limbs and torso.  I have pinched nerves in or near my S/I joint.  As my pain increases, the dose and frequency of my pain meds decrease because my doctor is terrified of losing his license.  my teeth are worn down from gritting my teeth.  I get migraines that make me vomit.  I spend days and weeks in bed in too much pain to chew food.  but the doses and frequency continue to go down for fear of prosecution.  I have the scans of a woman twice my age, and still my doses go down.  They want to remove me from all opiates now.  I am on 10 mg of methadone a day (2 doses of 5 mg).  I have planned my suicide.  I have scheduled 6 surgeries this year.  if they do not remove all pain (they cannot, as half of it is from spinal trauma) I will follow through.  I plan on dying on your lawn.  It is time to stop this.  pain management is necessary for much more than just cancer and hospice.  I am traumatized.  I am not depressed.  I am merely incapable of continuing an existence no one would allow a dog to live.  I scream myself awake every night for months on end.  they cannot give me enough sleep medications to keep me out during the spasms.  please stop torturing me and people like me.  it is enough. The FDAs draft curriculum is a step in the right direction and away from the corrupt and biased recommendations from the CDC. Their guidelines, they prefer to say, call for more cautious prescribing, but are having the effect of creating tremendous fear and panic in pain management practices and in patients, for no good reason. Legitimate and stable patients are being forced off their life-saving medications, and many are being fired from the practices for no other reason other than fear of the CDC guidelines.  Many practices are laboring under the belief that the CDCs recommendations apply across the board and have become the new standard of care. This is not even the stated intention, however,  it has become adopted across the country with draconian measures.  The FDA should reject everything PROP recommends. PROP is a commission, wholly-funded by the Steve Rummel Foundation, which is a completely anti-opioid group. Its leader, Andrew Kolodny, is well-known for his business relationships with Reckitt Benkiser, and their US corporation, Indivior, who is the manufacturer of Suboxone, Subutex, and Bupenorphine.  All of these into relationships show the financial benefit to these corporations and the rehabilitation industry of the CDC guidelines, and suggest such bias and collusion that the FDA must repeal the CDC recommendations and start over with a brand-new, qualified, and unbiased panel. It is well-known that of the three Core Experts, two of whom were epidemiologists and not physicians. Their field of expertise ranged from seat belt safety laws to preventing childhood obesity. Only one physician was considered a Core Expert, and while at least a practicing physician, had no experience in pain management. Their attempts to keep the core panel anonymous, their attempts to avoid open comments, the fact that they were ordered to redo the first set of guidelines and return with a different set of recommendations entirely - but essentially returned the same document - shows that there was a bias and an agenda from the beginning.  Many of their date it was flooded from the beginning as well. When all of the CDCs actions to avoid accountability, their questionable business relationships, and their unqualified experts are all taken into account, they create great suspicion.The entire CDC recommendations on opioid prescribing are tainted by the presence of so many who will benefit from moving patients (who are stable on opioids) onto anti-addiction medications  -  including the entire rehabilitation industry, of which Andrew Kolodny is a major player. This, combined with his relationships with the manufacturers of anti-opioid medications, demonstrates that each of the CDCs recommendation is fruit from a poisoned tree.  The WHOs ladder of pain management has worked in every country in which it has  been adopted.  Conversely, countries such as India, that banned the use of opioids, are now pleading for morphine, as their citizens are suffering  - while Portugal, who has removed all limitations on drugs, has one of the lowest overdose rates in the world. It is well-known by now that our overdose problem is not caused by those who use opioids for chronic conditions. Even the CDC itself admitted in March 2016 that, We dont have an opioid problem. We have a heroin problem. We also have new evidence that the rate of opioid prescriptions have decreased, but overdoses are rising. It doesnt take a panel to see that there is no correlation between legitimate opioid users and illegal drug abuse. This heroin/fentanyl epidemic, caused by the illegal importation of these dangerous drugs across American borders  is the true source of the increasing rate of overdoses. The CDC limited its studies to those studying the use of opioids for three months or shorter, ignoring the body of evidence that supports long-term opioid use for chronic pain.  They then said there was no evidence that supported the use of long-term opioids. This is disingenuous at best.  We are encouraged that the FDA has greater foresight and is planning to look at all the evidence, and not limit their own investigation to those studies that support their already-determined outcome.   Even the data itself is unreliable. From county to county, there are no consistent measures for determining a cause of death. We dont even have the same standards for medical examiners versus coronets. If we want to determine the cause of death, we have to start at the beginning with standardized requirements for suspected overdoses. Only when the original data is reliable can conclusions  be drawn. We urge the FDA to start there and work forwards, instead of allowing secretive panels to create income for special interests.  Also, please examine how the manufacturers of these anti-opioid drugs have engaged in illegal trade practices in the UK  United States, where they are being sued by 35 states for deceptive trade practices.  I am a chronic pain patient and I am 77 Yeats old and have severe adhesive arachnoiditis, I have a pacemakerI have tried everything known to man in the last 30 years. Before starting opiates , they do help keep the pain down to a livable manner. I do depend on a higher level than the CDC has wrote we who have this disease should be put in the cancer pain level. As the pain is noted to be equal to bone cancer