From: Robert Gerwin, M.D. [gerwin@painpoints.com]
Sent: Thursday, August 16, 2001 7:01 PM
To: Topper, Kimberly L
Subject: Oxycontin and Opiate therapy for chronic pain patients

August 16, 2001

To: FDA Anesthetic an Life Support Drugs Advisory Committe

From: Robert Gerwin, MD, FAAN
Maryland Medical License D0014507
Medical Director, Pain and Rehabilitation Medicine, Ltd, Bethesda, MD 20814
301 656 0220

Dear Committee Members,
I am writing with regard to the September 13-14 meeting of your 
committee at which time the subject of opiate medications in the 
treatment of chronic non-malignant pain is scheduled to be discussed.
I am a neurologist who has been in private practice for almost 30 years. 
I have been working in the area of chronic musculoskeletal and 
neuropathic pain for 25 years. I have treated and presently treat many 
patients who have a condition that is fundamentally uncorrectable and 
that causes chronic disabling pain. This includes certain painful 
neuropathies (that are initially treated with drugs such as 
antiepileptic drugs and antidepressant drugs) as well as chronic 
musculoskeletal pain. Many of the patients that I see have been treated 
by numerous other physicians and come in to our clinic taking 10-30 
tablets of short acting opiates per day (drugs like hydrocodone/APAP or 
oxycodone/APAP). We generally consider these drugs to have a high 
addiction potential, and to often result in dosage escalation, as well 
as providing relief that is too short (as little as 2-3 hours) resulting 
in a dosing schedule that can be as frequent as every 1 or 2 hours in 
some extreme cases.
The long acting or slow release opiates have resulted in the ability to 
develop effective pain relief programs on stable doses of opiates over 
long periods of time without mental clouding, and with pain relief good 
enough to return individuals to productive lives. Many of my patients 
have resumed their role in the family or community and have gratefully 
thanked us for "giving them their life back".
At present there are only 4 drugs that fit the category of long-acting 
or slow release. They are methadone, morphine sulphate oxycodone and 
fentanyl (given as a transdermal patch). Many patients are either 
allergic to one or another of these drugs, or develops nausea 
(especially to morphine) and cannot take one or several of these drugs. 
It is important to have alternative opiates that we can turn to when the 
choice is limited to just 4 drugs.
That one or another of these 4 drugs is abused is a problem that must be 
addressed, but the solution should not be the removal of useful drugs 
from the physicians armamentarium. It would be dreadful to go back to 
the days when pain that could not be treated led to suicide (as it did 
in some of my patients), or simply to withdrawel from life.

Robert Gerwin, M.D.