I’ve written extensively on CardioBrief about Sanofi’s promotion of Multaq (dronedarone). John Fauber, a reporter for the Journal Sentinel in Milwaukee, tackles the topic from an important perspective that often gets ignored or neglected. He focuses on ATHENA, the drug’s pivotal trial, and notes that all the trial authors had financial ties to Sanofi. Further, the authors were unable to perform an independent analysis of the data.
Fauber’s takes a local Wisconsin angle on the story and asks some hard questions about Richard Page, a well-known electrophysiologist who is the chairman of the department of medicine at the University of Wisconsin School of Medicine, a past president of the Heart Rhythm Society, and an ATHENA co-author. Writes Fauber:
But in putting his name on the influential paper, Page allowed Sanofi-Aventis to dictate the terms. He vouched for the accuracy and completeness of the study despite not seeing the raw data. The company, which paid for the study, collected that information and performed the analysis without an external audit for accuracy or completeness.
Page says it comes down to trusting the drug company.
“These companies, if they were falsifying data, wouldn’t be kept in business if that were found out,” he said. “I was satisfied and remain satisfied that the study was conducted in an appropriate way.”
Fauber notes that JAMA will no longer publish trials for which an independent analysis of the data has not been performed. ATHENA was published in the New England Journal of Medicine, which Fauber notes does not have a policy similar to the JAMA policy.
Fauber quotes Sanjay Kaul, who describes several limitations of ATHENA, including a decision to add to the number of patients enrolled in the study, presumably because of a lack of significant benefit after the original number of patients were enrolled.
Fauber also asked Page about the now infamous Prystowsky lecture posted on Afibprofessional.org, the ACC/HRS website funded by Sanofi (and written about extensively on CardioBrief here, here, and here). Writes Fauber: “Page said he supported the creation of the website but was not aware of its content, which was managed by the staffers.”
I strongly recommend you read the full story on the Journal Sentinel website. The story is a part of Fauber’s extraordinary series of articles, Side Effects, which is “examining doctors, drug companies and conflicts of interest.”