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Authors' Reply

  • Erick Turner mail,

    turnere@ohsu.edu

    Affiliation: Portland VA Medical Center and Oregon Health and Science University, Portland, Oregon, United States of America

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  • Martin Tramèr

    Affiliation: Geneva University Hospitals, Geneva, Switzerland

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  • Published: June 28, 2005
  • DOI: 10.1371/journal.pmed.0020187

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Arcoxia MEDAL study -- deja vu of Vioxx VIGOR study

Posted by plosmedicine on 31 Mar 2009 at 00:07 GMT

Author: Erick Turner
Position: Staff Physician
Institution: Oregon Health & Science Univ; Portland VA Medical Center
E-mail: turnere@ohsu.edu
Submitted Date: April 04, 2007
Published Date: April 5, 2007
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

Reading about the upcoming FDA Advisory Committee meeting about the "son of Vioxx", Arcoxia, it appears that the same mistake is being made all over again.

Once again we have a COX-2 inhibitor being compared to an active comparator only. This time we have diclofenac instead of naproxen, another non-COX-2 and older NSAID. Again we have a conclusion of no difference between the two drugs--with no placebo arm against which we can compare the COX-2 inhibitor--and a conclusion of cardiovascular safety.

What is really needed is a study less like the VIGOR study and more like the APPROVe study, ie. one that also includes a placebo arm. That would allow one to infer conclusions that would be more meaningful to the public health.

Competing interests declared: I am an author of the articles that this replies to.