In reply: The response from the Medical Director of Pharmacia to our article highlights some problems for all clinicians and independent scientists seeking to evaluate the balance of risks and benefits of pharmaceuticals and to validate the marketing messages of pharmaceutical companies. On the one hand, we lack the time and statistical resources to trawl through all data related to all trials with a test drug. On the other, our efforts to evaluate data are confounded by the publication and reporting biases associated with company-sponsored studies. In this regard, it is notable that the definitive results of CLASS1 have not been published, although the Food and Drug Administration (FDA) review of the data is available through an FDA website,2 as indicated by Fenn. While this document places data in the public domain, its location is neither within the pathway of MEDLINE search engines, nor is it known to the general body of clinicians.
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- Rheumatology Unit, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000.