2004N-0559 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee
FDA Comment Number : EC73
Submitter : Dr. Christopher Grubb Date & Time: 02/07/2005 07:02:23
Organization : Womack Army Medical Center
Federal Government
Category :
Issue Areas/Comments
COX-2 Selective Inhibitors are Essential Assets to the U.S. Armed Forces and the Global War on Terror
-- As a pain specialist in the U.S. Army Medical Corps, I am commissioned to 'preserve the fighting force' by treating acute and chronic pain conditions in our active duty soldiers and returning them to the battlefield. Like our civilian pain medicine colleagues, we find COX-2 selective inhibitors (COXibs) useful in treating pain. However, military medicine presents some unique issues, which make this class of drugs more advantageous than traditional NSAIDs. The uniformed men and women fighting abroad who are currently benefiting from the COXibs should not be disenfranchised in this public discussion. As a physician and fellow soldier, I have no other interests at heart but their health and safety.
-- Many of our providers (including field combat medics) will not send soldiers into harm's way on NSAID therapy due to their anti-platelet effects and the potential for worsened outcomes after trauma on the battlefield. The COXibs provide an essential alternative for soldiers with pain.
-- If we recommend that patients withhold NSAIDs prior to surgery, is it ethical for us to send our brave troops into battle on the same anti- platelet agents?
-- Indeed, most of our soldiers are already fearful of the bleeding risk with NSAIDs and ask specifically for COXibs at the Battalion Aid Stations.
-- Since the average service member is 26 years old, engages in daily physical training, and maintains strict weight standards, the Armed Forces constitutes one of the lowest cardiovascular risk subpopulations of our society. Thus, the recent COX-2 risk data was of very little concern to the military medical community.
-- In this discussion of drug safety, we warn against using a broad brush when painting the overall portrait of risk. The recent publicized COX-2 inhibitor studies of Alzheimer's and colon cancer patients clearly focused on older populations. It is fallacious to generalize this data of higher risk patients to most other COXib consumers, including military personnel.
-- Due to the strenuous physical nature of military activities and daily strength training, men and women in the armed forces suffer frequent injuries and have a higher incidence of chronic pain syndromes than the general public. We consequently require the use of COXibs more than our civilian counterparts.
-- We generally avoid narcotic analgesics at all costs in the military due to the importance of vigilance in defense operations. The COXibs offer non-opioid therapy that returns soldiers to duty without side effects.
-- The COXibs have allowed the worldwide deployment of countless numbers of soldiers previously disabled from low back pain. These soldiers were initially referred to our pain clinics because they were deemed incapable of performing their assigned duties. They are now back in Iraq and Afghanistan on 6-12 month missions on stable regimens of COXibs.
-- Without the availability of these drugs, we will likely face a deluge of requests for medical discharge from the military. This would then have costly implications for our Veterans Affairs Disability System.
-- The evaluation of COXibs for chronic pain is in its infancy. Though efficacy data for COXibs versus NSAIDs may be equivocal for arthritis conditions, the same should not be assumed for other types of pain. Military medicine will soon conduct trials of its own to compare these two drug classes head-to-head in the treatment of low back pain. Low back pain continues to be the most prevalent chronic pain condition among our troops (among civilians as well).
-- In conclusion, our finest Americans on the front lines of the Global War on Terror are reaping many benefits from the COXibs with no drug adverse events. This very large population, though often unseen, should not get neglected when making drug policy decisions; good drug products help to 'preserve the fighting force.'