2004N-0559 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee
FDA Comment Number : EC48
Submitter : Dr. W. Hayes Wilson Date & Time: 02/07/2005 05:02:25
Organization : Piedmont Rheumatology
Health Professional
Category :
Issue Areas/Comments
As a practicing rheumatologist, I have a different perspective from a cardiologist. My life's work is trying to relieve patient's suffering from pain, to maintain or improve function; and, to the extent that I can, prevent or reduce disability. I am of the opinion that all therapies have concomitant risks. Lack of treatment has risk too. Just today I had a patient confess to me that, if it were not for his 8 year old son, he would have committed suicide because of his pain. This patient has rheumatoid arthritis. A week ago he had his knee replaced. His surgeon did not allow him to take his arthritis medication post-operatively because of potential complication. This is an example of how we have to consider the risks not only of treating the pain, but also the risk of not treating the pain. I have patients that have told me that the only medication that ever helped their arthritis was Vioxx, now that it is gone they live with pain every day. I believe that the best medication is the one that relieves your pain and does not cause a side effect. My clinical experience is that all medications are not equal and that all patients respond unpredictably; however, patients do not take medications that do not work. Therefore, if a medication is used by millions of patients, that is evidence that it is effective for those patients. In a portion of the patients it may be the only medication that has worked or that they can tolerate. My clinical experience has found the Cox-2 Selective Nonsteroidal Anti-inflammatory to be safe and effective. The studies that have raised questions about these medications have been in older patients with colon polyps, rather than arthritis patients, and largely in doses greater than I use in my clinical practice. If I were to give a person two to four times the dose of medication than I typically prescribe and for an extended period of time (3 years), then it would not be surprising if 1% to 2% of them had a side effect. I would not consider that alarming; however, any adverse event should be examined. We have an opportunity to learn more about this class of medications and we should. We should also not forget the burden of morbidity and mortality from gastrointestinal bleeding. I believe that the Cox-2 inhibitors have provided a safer alternative to conventional Nonsteroidal Anti-inflammatory Drugs. We should first do no harm; however, not treating with effective medications may cause more harm than the 1% to 2% who have a serious cardiovascular event. Likewise we should consider the number saved from death due to gastrointestinal bleeding. I hope that we can preserve this class of drugs and use this opportunity to learn more about their mechanism of action, both wanted and unwanted. With experience I believe that we can learn who may benefit from using Cox-2 drugs and which patients for whom the Cox-2 Drugs are contraindicated. Our understanding has evolved and it continues to evolve, as long as the Cox-2 selective NSAID's remain available for our patients. I strongly support efforts to provide as many opportunities as possible through medications to alleviate suffering for patients with arthritis. To the extent that treatments have risks we should vigorously study these risks so we can minimize any potential side effects to our patients. New understanding will help us counsel our patients, so that they can make informed decisions regarding their own treatment. I have extensive experience with the Cox-2 Selective Nonsteroidal Anti-inflammatory medications and I have found them to be safe, effective and well tolerated in my patients. I hope that I have the opportunity to continue using and learning more about the Cox-2 medications that we have and I hope that we can improve not only our knowlege, but that out knowlege will improve our treatment.
Respectfully Submitted,
W. Hayes Wilson, MD
Chief of Rheumatology, Piedmont Hospital
National Medical Advisor, Arthritis Foundation