Waiting for Febuxostat

The annual meeting of the American College of Rheumatology, San Francisco

Here at the annual meeting of the American College of Rheumatology, the talk between investigators is about how the Food and Drug Administration has stopped approving new drugs. This case of regulatory paralysis makes no sense, according to people who talked to me on the subject. FDA advisory panels have recommended approval of drugs like febuxostat for gout and tocilizumab for rheumatoid arthritis. Rheumatologists are not by nature a cynical bunch but no one I spoke with expected either of these agents to be approved in 2008. Why?


Like everything in rheumatology, the answer seems to be multifactorial. The FDA has been diagnosed here with a case of post-Vioxx PTSD. The agency seems terrified of making a mistake of that magnitude again. The other factor is more practical: FDA is awaiting the results of the presidential election, with its attendant new administration and eventual appointment of a fresh FDA commissioner.


The exhibit floor is jammed with booths, some large to promote approved agents and others describing agents that are hanging fire in the approval process. I felt relieved by the sight of products that do not require FDA approval-such as equipment for office–based ultrasound, fluoroscope of small joints, and DXA scans. My favorite booth promoted the large handled kitchen products of OXO. How clever to market these thick gripped peelers and ergonomically responsible lettuce spinners (priced rather steeply as all fans of Williams and Sonoma know) to rheumatologists and physical and occupational therapists who will in turn recommend them to patients whose hand pain makes it difficult to grip smaller kitchen tools. And who is to say that the pain relief offered by these thoughtfully designed gadgets does not make a significant improvement in the quality of life of patients with rheumatic diseases of the small joints?


—Sally Koch Kubetin


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