Alzheimer Disease

Studies from University of Washington in the area of Alzheimer disease described

Published in FDA Law Weekly, May 22nd, 2008

According to recent research published in the Jama - Journal of the American Medical Association, "Sponsors have a marketing interest to represent their products in the best light. This approach conflicts with scientific standards that require the symmetric and comparable reporting of safety and efficacy data."

"Selective reporting of the results of clinical trials can misrepresent the risk- benefit profile of drugs. We summarize how the sponsor represented mortality findings associated with rofecoxib in clinical trials of patients with Alzheimer disease or cognitive impairment. We reviewed documents that became available during litigation related to rofecoxib...

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Source: FDA Law Weekly (2008-05-22)

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