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WHO DETERMINES HOW YOUR PAIN IS CONTROLLED?
6/18/01 -from Ron Griffin:
PAIN MANAGEMENT
WHO DETERMINES HOW YOUR PAIN IS CONTROLLED
Chances are that if you are reading this article, you suffer from at least some measure of pain emanating from some form of arthritis. In addition, chances are that you take or have taken a pain medication that had been prescribed by your Rheumatologist or maybe by your Orthopedics Doctor. You take these strong medications primarily for two reasons; they help you establish a better quality of life by dulling or eliminating your pain and you trust the physician who prescribed them for you to be aware of your needs and prescribe only the medications needed.
Well, hang on kiddies, because if the DEA gets its way, your trusted physician may not be in charge of how your pain is treated. Currently, the DEA is considering limiting the amount of one medication (OxyContin) that your doctor can prescribe for your pain and even the amount that can be produced. I have to wonder if this is not just the tip of the iceberg.
Currently, the drug OxyContin is under attack by the DEA. OxyContin is an analgesic pain medication that has oxycodone as its primary active ingredient. The benefit that OxyContin offers that is not offered by other similar analgesics is that it is a time-released medication that allows the drug to work for 12 hours; twice the normal range. The Food and Drug Administration approved the drug in December 1995 for the treatment of moderate to serious pain in a number of medical conditions. (Many of the pain medications that chronic pain sufferers take are hydrocodone based, including vicodin, lorcet, and lortab and others.)
Unfortunately, like other pain medications, OxyContin is also a favorite street drug. On the street, abusers can crush the pills and snort the powder or inject a solution. For this reason, the DEA requires pharmacies to maintain detailed records on OxyContin and other drugs with strong potential for abuse, and forbids refilling such prescriptions. Further, restrictions are placed on supplies provided to manufacturers.
Recently, many articles have appeared concerning the evils and dangers of this drug (in the wrong hands) in particular and of opioids in general. I cannot dispute that the abuse of OxyContin may be on the rise, or that some deaths may have occurred because of the use of this drug. What I do dispute is the insertion of prohibitive regulations for those who both receive and use the drug legally and responsibly. As one who has legally used opioids (Fentanyl) for chronic pain, I object to the characterization that either I am an abuser, or that I am going to become an abuser, or that I am going to pass drugs illegally to an abuser.
I happen to be one of the fortunate individuals who lives in a mid-sized city which has an excellent pain clinic with doctors who are trained in pain management. The medication worked for me and I voluntarily discontinued the drug when I felt a lesser drug could control my pain.
At the time opioids were prescribed for me, I was recovering from an attempted suicide attempt brought about primarily by the chronic pain from rheumatoid arthritis, osteoarthritis, chronic degenerative disks in the lumbar spine, and degenerative disks in the cervical spine along with other causes. Under the current DEA scenario, I probably would not have been able to get the medications that helped break or mitigate the pain cycle. I have to wonder what might have happened to me if these medicines had not been available to me.
I am not going to point any fingers here because I don't know where the blame lies. Once again though, the ones who are responsible and honest in their use of medications are being punished (having some or all of their pain medication withheld) through a governmental mandate. The legitimate users of these drugs are causing the problems cited by the DEA. Studies have repeatedly show that individuals who take analgesic drugs for pain relief generally do not become addicted, yet, this is the group from whom the DEA proposes to withhold or limit their use.
The Food and Drug Administration has announced a Hearing in its "Anesthetic and Life Support Drugs Advisory Committee"
Date and Time: September 13 & 14, 2001 8:00 a.m. - 5:00 p.m.
Location: University of Maryland, Shady Grove Campus, Multi Purpose Room, Building 9630, Gudelsky Drive, Rockville, MD 20850
Agenda: On days the Committee will discuss the medical use of opiate analgesics in various patient populations, including pediatric patients and patients with chronic pain of nonmalignant etiology, as well as the risk to benefit ratio of extending opiate treatment into these populations. It will also address concerns regarding the abuse potential, diversion and increasing incidence of addiction to opiate analgesics, especially to the modified release opiate analgesics (OxyContin).
Public Participation: The entire meeting is open and the public is invited to attend without pre-registration. In addition, a portion of the meeting, the open public hearing, is set aside so that the public may present relevant views to the Committee. This portion of the meeting will be held from approximately 1 p.m. to 2 p.m. each day.
If you wish to speak at the open public hearing:
Please submit a statement of your position and how we might contact you before the meeting. Pleasee-mail the statement to topperk@cder.fda.gov or fax the statement to (301) 827-6801. The statements must be received by August 17, 2001. Please limit your presentation to 3 minutes. Any statements received after the deadline will be posted to the docket but will not be sent to the Committee nor will you be scheduled time go speak. FDA DOES NOT pay for Open Public Hearing Speaker travel expenses.
If you wish to send a statement for the record:
All the letters already received will be posted under docket number 01N-0256. If you wish to send in a statement to be posted, please go to
http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm
and select "Submit electronic comments" and follow the prompts.
Letters/statements may be mailed to:
Kimberly Topper
Food and Drug Administration, CDER,
Advisors and Consultants Staff, HFD-21
5600 Fishers Lane
Rockville, MD 20857
Due to the overwhelming interest in this meeting and time constraints - no statements will be read into the transcript by the FDA staff. All statements received before the August 17th deadline will be available to the committee in advance.
I would point out that this hearing deals not with one particular drug, but with all opiate analgesics. The background information for the hearing will be posted shortly after it is sent to committee members. All information available for the meeting will be posted on the FDA web site at
http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
Also listed on this site will be minutes, transcript, and slides from the meeting. The material is generally posted about three weeks after the meeting.
I am sure that most of you are tired of reading this and want me to get to the point. OK, here it is. Your voice is needed to assure that those who NEED this type medication can get it. How can you do this? You can let the FDA, The DEA, and your Congressional members know that we are here and that we count; that we have a story to tell and that we want them to listen, that we are not criminals, that we have legitimate and life preserving needs and that we do not want to be the innocent sacrificed for the guilty.
If ever there was a time to make to make the effort to call or write the DEA, the FDA and our representatives on capital Hill, now is the time. A few brief tips regarding writing or calling:
· Keep the letter short (1 page if possible, 2 page maximum)
· State your bottom line message in the first sentence. "I oppose ---------- because--------.
· Make it personal. Explain how the problem personally affects you and people like you.
· Do NOT exaggerate. It kills your credibility.
· Request that the legislator respond with a specific statement of his/her position. "Please tell me exactly where you stand on issue ---------"
· It is better not to use a model letter where possible, because customized letters have more impact.
· Phone calls are much more effective than letters IF the caller speaks directly to the aide handling the issue, NOT the receptionist (who merely tallies calls), AND the caller can explain the issue in a succinct and accurate way. Call the House and Senate switchboard and the operator will transfer the caller to the correct legislator's office.
Click here to find your Representatives
and Senators
names and addresses.
To write to the DEA, address your correspondence to:
Donnie R. Marshall
Administrator
Drug Enforcement Administration
Room 12060 LP-2
Department of Justice
10th Street and Constitution Avenue NW
Washington, DC 20530
To write the FDA, address your correspondence to:
Kimberly Topper
Center for Drug Evaluation and Research (HFD-21)
Food and Drug Administration
5600 Fishers Lane,
Rockville, MD 20857
Tell us how you feel about this! Speak
Out!!!
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