2004N-0559 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee
FDA Comment Number : EC61
Submitter : Ms. Micke Brown Date & Time: 02/07/2005 06:02:56
Organization : American Society for Pain Management Nursing
Health Professional
Category :
Issue Areas/Comments
As a nurse for close to 30 years, I have seen many people affected by pain. Whether caring for premature babies or elders from birth to death and in between, I have witnessed a great deal of suffering. I have learned one simple truth, from the pain sufferer to loved ones and their caregivers, pain touches everyone. And the really difficult part is that too much of pain goes untreated.

For some living with persistent pain disorders that may range from arthritis, low back pain to cancer pain, pain relief primarily comes from drug therapy. Many may be fortunate to achieve relief using analgesics not as restricted as opioids or require the assistance of these drugs to enhance the effect of opioids or other adjuvants. Up until recent months, healthcare providers who shied away from providing prescriptions under DEA regulations at least had been more willing to help those in mild to moderate pain, who require analgesics in the NSAID class.

When the COX-2 inhibitors, were introduced on the market, they became a blessing for many pain sufferers who could not tolerate the GI effects of the older NSAID?s such as aspirin, ibuprofen and naproxen (even when medications were taken as an attempt to curb these unwelcomed side effects). I can tell you that many lives have been improved by these newer drugs.

First Vioxx was removed from the market this fall. Only a few months later, Bextra and Celebrex were called into question as concerns about Naproxen and the entire NSAID class was also raised. Most of us are aware of recent reports of various studies that may indicate an increase risk of heart attack and stroke. However, these some of the studies are providing mixed messages.

All medicines have risks as well as benefits. We have known for many years that NSAID?s can cause life-threatening side effects in some individuals. The public needs to decide with their healthcare provider whether the benefit of taking these medications outweighs the risk of exposure over time. They need to be discussing whether they really need to be taking these drugs and if they have considered the range of drug and non-drug therapies that are available. For example, exercise and drugs to help with sleep may be the best therapies for fibromyalgia; other types of pain medicines (yes, this may include the opioid class) may be safer and more effective for some. Regular monitoring by office visits and telephone contacts with their healthcare provider can lower the chance of causing more harm than good.

I think it is most important not to panic and rush to a judgment that may have devastating, unintentional effects on many who need these medications to have a life worth living. Remember the media are always obsessed with the bad news. What is most needed at the present time is the opportunity for our scientists, who are involved in studies with these medicines, to carefully analyze the data they have and use the results of their analysis to develop guidelines for their use.

Physicians are frustrated; the public is fearful and not really clear about what to do. Combine this with current issues facing prescribing doctors as a result of stricter DEA law enforcement of opioids needed for the treatment of severe pain --AND THE WAY IS PAVED toward to a serious
impediment in access to pain care. Pain sufferers who already face many challenges in finding the right treatment or combination of treatments are now facing the challenge of fewer and fewer choices. I am pleading that you consider the full impact of your decision before acting on either restricting or eliminating this drug class.

Micke A. Brown BSN, RN
Public Outreach Manager/American Pain Foundation
Coordinator/Maryland Pain Initiative
Immediate Past President/American Society for Pain Management Nursing