John Fauber of the Milwaukee Journal Sentinel reports on outside authors of drug company-funded studies who do not have access to the raw data behind the study.
In the latest installment of Side Effects, a series examining doctors, drug companies and conflicts of interest, Fauber reports that a researcher who co-authored a study of Multaq that led to the drug’s FDA approval “vouched for the accuracy and completeness of the study despite not seeing the raw data.”
The researcher, Richard Page, chairman of the department of medicine at the University of Wisconsin School of Medicine and Public Health, says he trusts the Sanofi-Aventis, the drug’s manufacturer.
Fauber delves into the differing editorial policies of the Journal of the American Medical Association and the New England Journal of Medicine when it comes to studies in which drug company employees perform the data analysis.
In the case of the Multaq trial, published by the New England Journal of Medicine, the FDA got unanalyzed raw data and did its own analysis. Fauber reports that “one FDA panel member questioned differences between the information included in the published February 2009 study and what was submitted to the FDA.”
