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  Vol. 294 No. 20, November 23/30, 2005 TABLE OF CONTENTS
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Conflicts of Interest and Independent Data Analysis in Industry-Funded Studies—Reply

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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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RELATED LETTER

Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies—Reply
Catherine D. DeAngelis and Phil B. Fontanarosa
JAMA. 2008;300(8):905-906.
EXTRACT | FULL TEXT  

RELATED ARTICLES

Conflicts of Interest and Independent Data Analysis in Industry-Funded Studies
Caroline J. Loew
JAMA. 2005;294(20):2575.
EXTRACT | FULL TEXT  

Conflicts of Interest and Independent Data Analysis in Industry-Funded Studies
Geert Molenberghs, Peter Imrey, and Christiana Drake
JAMA. 2005;294(20):2575-2576.
EXTRACT | FULL TEXT  

Reporting Conflicts of Interest, Financial Aspects of Research, and Role of Sponsors in Funded Studies
Phil B. Fontanarosa, Annette Flanagin, and Catherine D. DeAngelis
JAMA. 2005;294(1):110-111.
EXTRACT | FULL TEXT  


THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals
Hirsch
Mayo Clin Proc. 2009;84:811-821.
FULL TEXT  

Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies
Lachenbruch and Wasserstein
JAMA 2008;300:904-904.
FULL TEXT  

Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies--Reply
DeAngelis and Fontanarosa
JAMA 2008;300:905-906.
FULL TEXT  





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