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Rebuttal From Drs Suissa and RabeRebuttal From Drs Suissa and Rabe

Samy Suissa, PhD; Klaus F. Rabe, MD, PhD
Author and Funding Information

From the Centre for Clinical Epidemiology (Dr Suissa), Jewish General Hospital, Department of Epidemiology and Biostatistics, McGill University; and LungenClinic Grosshansdorf and Department of Medicine (Dr Rabe), University Kiel, member of the German Center for Lung Research (DZL).

Correspondence to: Samy Suissa, PhD, Centre for Clinical Epidemiology, Jewish General Hospital, 3755 Cote Ste-Catherine, H4.61, Montreal, QC, H3T 1E2, Canada; e-mail: samy.suissa@mcgill.ca


Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Suissa attended an advisory meeting for a clinical trial involving roflumilast, the drug discussed in this paper, for Nycomed AG and participated in an expert panel meeting for Forest Laboratories, Inc. Dr Rabe has been and is still involved in several clinical trials involving roflumilast, has presented data on behalf of the sponsoring companies Nycomed AG and Takeda Pharmaceutical Company Limited, received financial compensation for talking at scientific meetings and taking part in the expert panels at European Medicines Agency and the US Food and Drug Administration, by Forest Laboratories, Inc, Nycomed AG, and Takeda Pharmaceutical Company Limited. Drs Suissa and Rabe hold no interest or stocks in any of the companies listed above.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2014;145(5):942-943. doi:10.1378/chest.14-0113
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Extract

Dr Rho and colleagues1 claim that “an appropriate study must answer only one question: Does this drug improve quality or quantity of life beyond the best available therapy?” The authors deem that studies of roflumilast “do not meet this mark.” On the other hand, the Towards a Revolution in COPD Health (TORCH) trial of the fluticasone/salmeterol inhaler is presented as an example of such an appropriate study. We show below that this is not so; had the authorization of this combination inhaler been based on such a mark for the TORCH trial, the drug would simply not have been approved. Indeed, the trial does not satisfy the three criteria set down by Dr Rho and colleagues, namely, quality of life, quantity of life, and best available therapy.

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