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In Reply: Dr Loew and PhRMA contend that industry-sponsored studies are not at higher risk of bias and thus do not require "special scrutiny" and that "vigorous government oversight . . . ensures the integrity of data and results." Despite these assurances, scientific and ethical lapses involving industry and industry-sponsored studies strongly indicate otherwise, as a few examples illustrate.

In the pivotal celecoxib trial, only 6-month data were reported when 12-month data showing no benefit in reducing gastrointestinal toxicity were actually available.¹ In the key rofecoxib trial, data showing increased cardiovascular toxicity were downplayed and erroneously dismissed as due to a cardioprotective effect of naproxen.² Evidence from the Vioxx litigation suggests that the manufacturer may have failed to disclose information about higher drug-related death rates in 2 other rofecoxib studies.³ Results of trials of paroxetine that demonstrated increased risk of teenage suicide or lack of efficacy were suppressed and only revealed after a lawsuit . . . [Full Text of this Article]

Phil B. Fontanarosa, MD, MBA
phil.fontanarosa@jama-archives.org
Executive Deputy Editor, JAMA

Catherine D. DeAngelis, MD, MPH
Editor-in-Chief, JAMA

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