Assessment of Analgesic Treatment of Chronic Pain; A Public Workshop
cder2011204 CDER Public Workshop Analgesic Treatment
2012-08-07 2012-08-09 2012-07-19 2012-08-09 2012-07-03 2012-07-03
FDA-2012-N-0067-0009 FDA-2012-N-0067-0013 FDA-2012-N-0067-0006 FDA-2012-N-0067-0012 FDA-2012-N-0067-0005 FDA-2012-N-0067-0003
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2012-N-0067-0009 https://api.regulations.gov/v4/comments/FDA-2012-N-0067-0013 https://api.regulations.gov/v4/comments/FDA-2012-N-0067-0006 https://api.regulations.gov/v4/comments/FDA-2012-N-0067-0012 https://api.regulations.gov/v4/comments/FDA-2012-N-0067-0005 https://api.regulations.gov/v4/comments/FDA-2012-N-0067-0003
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
It is my understanding that the FDA is doing everything in its power to make it more difficult and complex for patients, who genuinely suffer from chronic, severe pain syndromes, to access opiod medications.  Having undergone a catastrophic ureteroscopy procedure, seven years ago, which resulted in the loss of my left kidney, permanent paralysis of my left flank muscles, chronic, severe nerve damage pain, and Stage 4 right kidney failure, I object to these actions by the FDA.  The abrupt onset of severe kidney failure, following my surgeons decision to remove my healthy left kidney, rather than repair my left ureter, has left me forever on the brink of requiring kidney dialysis.  There are no pain medications, apart from major opiods, that can adequately control the intense nerve pain I will suffer from, the rest of my life.  All other known pain medications (apart from Tylenol), will damage my already impaired right kidney, so are prohibited.  The obstacles that are already in place, for me to obtain my doses of Fentanyl patches are  extraordinary.  They include: my MD cannot phone in nor fax my prescription to the pharmacy, my MDs DEA number must be on all Fentanyl prescription documents, I must physically sign for the patches if I order them from a mail order pharmacy, and I must hand-deliver the Fentanyl prescription to pharmacy staff during pharmacy business hours, rather than at a time that is convenient for me.Having been a professional RN for more than two decades, I am keenly aware that Im not the only legitimate patient whose sole option for pain control involves major opiods.  I have taken care of hundreds of ill  injured persons whose kidneys and/or other medical conditions or medications, prevented them from using NSAIDS or minor narcotics for pain control, on a long-term basis.  It is cruel  unethical to make our health burdens more difficult than they already are.  I didnt ask to be in this situation, nor did any of my former patients! I think it is wrong to change the rules of my pain medications. I am pusshing 50 years old. I have and still do work very hard manual labor. I am a state certified plumbing contractor. That was in a very bad car accident back in 1980. I have been onPain management successfully for the past three years. Before this i could no longer do my job properly. I now can suport my family and be a successfully bisiness professional. If you take away my pain medication i will loose everything. It is not right to hurt everyone for the actions of a few bad seeds. Please do not mess with my medcation anymore. I already havd a hard time filling my legal percriptions. Please stop this madness and let me and my family live the life we diserve Opioid pain medications are an essential treatment option for acute and chronic pain. I know of many individuals with Ehler-Danlos Syndrome (EDS) who suffer daily from chronic pain and it would be of tremendous benefit to them if they could obtain these medications from their physician.  I respectfully request that any decisions to be be made limiting pain medication be decided by a jury of my peers meaning people who have chronic pain. I contracted MRSA in 2006 on top of Pagets disease and I worked in the concrete swimming pool industry for 25 years as a nozzleman doing shotcrete thus all my joints are destroyed by osteoarthritis with bone spurs thruout my body. Honestly I tell you that without pain medication I cannot get out of bed.It enables me to help care for my grandchildren so please please in the name of God leave the prescribing and care up to my doctor, he is an honorable man.My bone marrow is swollen inside my bones. You can imagine the pain this creates. Again please, please I dont have cancer but my pain is great. Thank you for considering me and my family.Sincerely, Roger K. Cummings 501 S. Mccall Rd. Englewood, Florida 34223 Phone 9416811747 God Bless You I been on pain management since 2008,and finally was considered disabled in aug of 2011, and I currently take oxycodone since being on pm,I take 6 a day,was 7 but due to the problems in florida pharmacies wouldnt allow anymore,Ive been without meds for a few days and i cant even get outta bed,but while taking my medications it allows me to somewhat function as a normal human,shower cook shop and such.. There isnt any other medication out there that will allow me to do those things as Ive tried,I cant imagine life without these, If you take these away you be hurting me and hundreds and thousands of people that depend on them for a better quality of life,and to take that away,would be cruelty as in cruelty to animals, no one deserves to suffer....The dea has played a huge role in are problem in florida,were lucky now to get are legal scripts,but not with out a huge crawl to find them,all your gonna do is force us pain patients to the streets to find a dealer for relief,an as we already are being treated like criminals they mite as well arrest us now,my back has hernated disks,bulging disks one hip bone larger then the other and just gonna get worse, please dont take a away the quality of life we all deserve... Docket No. FDA-2012-N-0067Representatives of The Steve Rummler Memorial Foundation attended the May 30-31 workshop on Assessment of Analgesic Treatment of Chronic Pain.  We told Steves story, a tragic part of the epidemic of prescription drug overdose deaths that is plaguing our country today.  This epidemic is fueled by the tremendous increase in prescriptions of opioids for pain.  15,000 deaths per year are proof that opioids are not safe or effective in the treatment of chronic pain.Steve was a loving son, fianc, brother, uncle, cousin, nephew and friend.  He was smart and excelled in school and in sports.  He was a gifted musician and successful financial advisor.  He loved his family and was loved in return.  We miss him terribly, and our lives will never be the same.Chronic pain, caused by an injury in 1996, changed Steves life.  He immediately sought help from many healthcare professionals.  No treatable diagnosis was found, and he was prescribed antidepressants, benzodiazepines, and in 2005 opioids.  He became addicted and went the Mayo Clinic in Rochester, MN and to Hazelden in Center City, MN.  Until the night of his death, Steve had never taken an opioid that had not been prescribed to him.  After his accidental death we found a note among his belongings, referring to his treatment with opioids that said: At first it was a lifeline; now it is a noose around my neck.The mission of The Steve Rummler Memorial Foundation (www.rummlerfoundation.org) is to heighten awareness of the dilemma of chronic pain and the disease of addiction and to improve the associated care process.  We support change and urge the FDA to:Correct the labeling of opioid drugs to indicate their use for short-term severe pain onlyCorrect the classification of hydrocodone products from Class III to Class IIPlease hear the pleas of the many who have lost loved ones to this epidemic.Judy Rummler, President of The Steve Rummler Memorial Foundation