Docket Management
Docket: 01N-0256 - Use of Opiate Analgesics in Various Patient Populations, Including Pediatric Patients
Comment Number: EC -204

Accepted - Volume 4

Comment Record
Commentor Mr. JAY STEFFLER Date/Time 2001-12-04 07:19:16
Organization Chronic Pain Patient
Category Individual

Comments for FDA General
1. General Comments I am one of the very rare non-malignant chronic pain people who have beengranted a second life through the treatment of opioid therapy. I want tofocus on the misconceptions of addiction and abuse of opioids in chronic painpeople. I have suffered from Reflex Sympathetic Dystrophy since October 6th,1992. RSD is rated as the most painful non-malignant chronic pain diseaseknown to the human race according to the McGill Medical University painscale. In my case, the pain from the disease is invisible to the naked eye. Very few Doctors will even believe or acknowledge the amount of pain youmust endure. It is impossible for anyone, Doctors or otherwise, tounderstand the horror that now encompasses your entire life. My Doctors suffered from their inability to help, trying every modality,tested and untested, to no avail. The unrelenting intensity or your paincan not be comprehended or relieved, let alone seen. My Doctors cared deeply andmany went beyond the call of duty, wracking their brains and learning much inthe process. Sadly, to no avail. The use of opioids as a permanenttreatment was never a consideration. However, the failure of the countlessattempted modalities pushed their compassion to ease the constant tortureswith small, inadequate amounts of opioids. Fear of addiction which is symbionic with abuse constrained their opioidtreatments. Is a patient whose suffering cannot be eased with acceptedtreatments worth risking their license to help others? Not to mentionacceptance among their colleagues. After all modalities have failed and youare left with a person imprisoned in a live of unbearable pain that can onlybe relieved briefly, the Doctor is left with no choice but to accept thatthey have done all that modern medicine has to offer. Attempts to refer thepatient to anyone but them (out of sight, out of mind) is the last resort.The frustration of the Doctor blinds them to the fact that the temporaryRelief treatments are, in fact, causing more harm and increased pain to thepatient Countless Sympathetic Lumbar blocks over the years produces myofacialsyndrome and arthritis. And attempts to keep the opioid medications atinsufficient levels result in anxiety attacks and depression in the patient. After almost eight years of suffering the tortures of the damned, I wasblessed by finding a Doctor who understood the horror that was my life anddid not fear the repercussions from the ignorance of the Drug EnforcementAgency who focus too much of their time on those who truly need thesemedications instead of the healthy who abuse and, hence become addicted whichresult in increased crime. The American Heritage Dictionary states that the word addict comes fromthe Latin addictus, given over, one awarded to another as a slave. dependence, on the other hand is defined as Unable to exist or functionsatisfactorily without the aid or use of another. And abuse is defined asTo use wrongly or hurt or injure by maltreatment. Any and all chronic pain people know very well that the only addiction isto the pain. (...One awarded to another as a slave.) However, we also feelwe are treated as slaves/prisoners because even if we are fortunate enough tofind an educated, compassionate Doctor, we are still slaves to the insurancecompanies who would prefer to keep us hidden, writhing in pain than to payfor the over-priced opioid medications we need to return to becoming aproductive member of society. It is impossible for a truly chronic pain person to be addicted to theirmedication. The only way one could use their medicine wrongly or improperlywould be to give it to someone whom it is not prescribed. To become addictedto a medication you would first have to abuse it. Every chronic pain personwill testify that when you suffer from constant, unbearable pain and you takeyour opioid medication that the opioid goes right to the pain path and blocksthe gate which sends the pain signals to the brain. There is no euphoriaat all when you suffer from such pain. To abuse or ...use wrongly hurt or injure... would only cause the pain person to fallasleep, no euphoria exists. Every PROPERLY treated pain person has a lifethat they would do anything to keep. Under medicated pain patients are theones who are at risk for abuse but not in the sense that I was referring to.They are at risk because their pain is not properly relieved or treated.Therefore, they will search for anything and go to more than one Doctor totry to receive the amount of pain relievers they need to ease their agony.This can cause mixing of medications and unregulated, mixed doses can ...hurtor injure. or even kill the person. With one Doctor monitoring each medication and amount needed to end thesuffering, the abuse stops. Many Doctors fear the physical damage that canaccompany long term opioid therapy. However, the pure opioid narcotic doesno harm to body tissue or brain function or cells. It is the binder andfiller used in some opioid medications that have added acetaminophen,aspirin, etc. that damages the body. Using the pure opioid does no damage. I found that after being taken off the muscle relaxers,antidepressants, etc. and then titrated with opioid analgesics I actuallyfelt as though I had awakened from a horrible nightmarish coma. My memoryreturned. Ambition and productivity increased. I rediscovered creativityand original thought including the ability to walk without a cane for thefirst time in almost eight years. All due to the opioid therapy treatment.My only anxiety and feelings of enslavement come from my fear that the lawswill change and I will lose the new life I have just regained. I am nowworking through the Office of Vocational Rehabilitation and plan on returningto college to obtain my second degree. I now have the ability to become acontributing member of society! I must admit, I will never lose my faith that someday a cure will befound and I will no longer be a slave to the regulations and availabilityof the medication. The medication that has returned my love and zest forlife. I lost far too many years due to fear and misdirected laws that wecontinue to fight today. Yes, I am still a prisoner of the HMO and the Federal Laws. I cannotleave my home for more than ten days at a time due to the amount ofmedication permitted to be dispensed at once. And I am ...unable to existor function satisfactorily without.. my medication. Therefore, although Iknow I am extremely lucky to be one of the very few who have received thisnew life, only when the laws are changed so that we chronic pain suffers areno longer treated like addicts nor judged as abusers because our pain isinvisible will this emotional pain stop. Jay Steffler 146 O'Neil Lane Pittsburgh, PA 15237 (412) 369-4989

EC -204