OPEN PUBLIC HEARING STATEMENT
REBECCA BURKHOLDER
NATIONAL CONSUMERS LEAGUE
BEFORE THE FOOD AND DRUG ADMINISTRATION
JOINT MEETING OF THE ARTHRITIS ADVISORY COMMITTEE
AND THE
DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE 

FEBRUARY 17, 2005

I am Rebecca Burkholder, from the National Consumers League.  In the interest of full disclosure, NCL occasionally receives unrestricted financial support from pharmaceutical companies for consumer education and research projects.  The research cited below is one of those projects.  My expenses for this meeting were not paid by an external organization, and my statement reflects the interests of those NCL represents - consumers. 

NCL urges the FDA to carefully weigh the risks and benefits of COX-2 inhibitors as it decides how best to protect the public.  Whatever action this committee takes, NCL believes it is important to anticipate consumer response in the wake of the publicity surrounding COX–2 drugs. 

Although COX-2 drugs were originally intended for use by those patients who had GI side effects with traditional NSAIDs, a much broader population actually took the medications.   Given recent events, some patients taking COX-2 drugs for arthritis or other pain will now likely turn back to traditional over-the-counter NSAIDs for relief. 

But consumers likely do not understand how to safely use these OTC NSAIDs.   A 2003 survey of over 4000 adults commissioned by NCL on consumer use and attitude toward OTC pain relievers found that:

·             47% of those who take OTC NSAIDs take more than the recommended dose 

·             Nearly half would NOT consult a doctor when taking Nfor more than 10 days

·             Nearly half thought it was more important to control pain - regardless of risk

And the survey revealed the following about arthritis sufferers:

·             85% take OTCs for pain relief, with 60% choosing OTC NSAIDs.       

·             30% take pain relievers on a daily basis, and

·              While arthritis suffers are more concerned about side effects than the general public, 70% do not discuss the risk of stomach bleeding or ulcers with their doctor.

Based on these findings, we believe consumers must be educated about the relative risks and benefits of all medications, OTC or prescription. We call upon the FDA to engage with relevant partners in a broad-based educational campaign that would cover:

-    relative risks and benefits of various pain medications

-         appropriate pain management strategies

-         importance of talking with a health care professional, and

-         the role of direct to consumer advertising on choice and use of medications