Docket Management
Docket: 01N-0256 - Use of Opiate Analgesics in Various Patient Populations, Including Pediatric Patients
Comment Number: EC -220

Accepted - Volume 4

Comment Record
Commentor Mrs. Mary Winfield Date/Time 2002-01-13 09:51:17
Organization Platinum Precision Software Inc.
Category Company

Comments for FDA General
1. General Comments To the FDA Hearing Committee January 30 & 31, 2002 Since 2000 I have been under the care of an experienced, compassionate doctor who treats my permanent nerve damage and spinal stenosis condition with opiate therapy. My standard of care from him has been excellent every month had and I spend over 90 minutes reviewing my pain management, my symptoms, effective use of breakthrough medication, effective use of time release medication and the overall improvement in my daily activity. No longer am I confined to my bed lying still in a fetal position because my neck and shoulder injury is causing extreme pain so bad that I cannot even take a breath without exacerbating it. My care is provided with a qualified pain management physician along with the two surgeons who performed the three cervical anterior fusion procedures. I suffer from degenerative disk disease, spinal stenosis, radiculapathy, cervical nerve root damage at multiple levels, bulged disks at C1-2 and C3-4 levels and significant scarring/adhesions at the location where I suffered the injury from a train accident in December 1993. Prior to beginning a successful course of opiate therapy from my pain management specialist I suffered intolerable episodes of acute breakthrough pain that would put my body down from days at a time. I was unable to assist my family with basic home skills, complete simple tasks like dressing and bathing, could not open my eyes to read without resulting stabbing cranial pain spreading up from my right neck, had restricted mobility of neck and shoulder movement. If my prescribed medication (Tylenol #4) did not alleviate and control my injury symptoms from the nerve damage then my husband would bring me to the ER where they would examine me, call my surgeon and dispense an injection of Demerol 100mg. Instead of taking a time release medication during the day to control my nerve pain before it increased intensity through a breakthrough acute episode, I was forced to leave my home, wait 2-3 hours sitting in an ER until a stronger medication appropriate to my pain could be administered to me. Now my days are filled with an easier means of moving about and my family's quality of life, my married relationship and my caregiver, who has been my husband, can have a schedule which is not impacted by the constant weight of my injury's pain. I still have bad days but they are reduced in number. Please listen to the constituents who experience first hand the difficulty of everyday life which is overshadowed by permanent nerve damage which without the benefit of opiate analgesia would stop their quality of living to a halt. The FDA and DEA must not put pain management standards of care back into the dark ages. We are not junkies-we are your co-workers, your siblings, your spouses, your neighbors, the person sitting next to you on the Metro, the person sitting next to you at church. We are human and powerless to change our injuries, disabilities and permanently damaged nerves: at this point in human history there is no cure for nerve damage, no restorative surgery, no regeneration of nerve root physiology. The FDA must protect citizens right to adequate pain management through physician administered opiate therapy as an effective means to analgesia. Our doctors, pharmacists and other health providers utilize the audit capabilities of controlled schedule II and III medications; every player who is part of the DEA and FDA infrastructure for monitoring and tracking maintains written records and information for every prescribed medication that we take. The USA tends to ignore its disabled citizens, put them through bureaucratic hell to obtain Social Security Disability Income which they earned from years of full time work along with insurance companies which force delay tactics around disbursing Long Term Disability ERISA benefits: it has ignored (until recently) patients suffering from intractable, intolerable pain from injuries, diabetes, colitis and other non-cancer conditions. Any request for adequate pain control to allow us to rest has been typically been met with suspicion, negative judgment and shame from paranoid doctors who are fearful of DEA enforcement agents and audits. Change has been made through legislation at the state level through pain treatment rights bills aimed at patients who do not suffer from cancer as in the example of the State of Virginia. Even now there are many hospitals with nursing and physician staff who are unaware of legislative impact assuring the right to adequate pain control for deserving patients. Many of the legislative change has been kept in the dark, out of the media and unfortunately out of the offices for medical providers. Why? Keep opiate analgesia accessible to the USA patients who use it responsibly under the experienced care of pain management specialists! We do not abuse these medications nor are we addicts. We seek an improved quality of living despite our painful disabilities. Thank you for the opportunity to present this statement at your FDA hearing. Mary B. Winfield age 44 permanently disabled 3 Cervical anterior fusion discectomy surgeries 1 laminectomy attempting to correct broken bone graft present at C6-7 level Radiculapathy, spinal stenosis, degenerative disk disease

EC -220