Documents obtained in lawsuits by insurers and consumers against the “world’s biggest drug maker” Pfizer
have given rise to a report to be published today in the New England Journal of Medicine (NEJM), indicating the company “altered or omitted unfavorable study findings to expand its epilepsy drug Neurotonin’s market.” (Sound familiar?)
Regardless…even more audacious, the report comes on the heels of Pfizer being “fined a record $2.3 billion—including an unprecedented $1.2 billion criminal fine—for illegally marketing other blockbuster drugs.”
“In eight of the 12 published studies, the main outcome listed in internal documents differs from the one later given in the published report. In half the cases, a new primary outcome was substituted and in others, the original main outcome was instead reported as a secondary measure or wasn't disclosed at all.”
Dr. Sidney Wolfe, who founded Public Citizen’s Health Research Group and is now also on the FDA’s Drug Safety and Risk Management Committee, called the NEJM report the first in-depth examination of “studies in which a company and people working for it so maliciously manipulated the data to make a drug look more effective than it actually was.” "In every instance, the published article made the drug look better than it would have," said Wolfe.
Regardless…even more audacious, the report comes on the heels of Pfizer being “fined a record $2.3 billion—including an unprecedented $1.2 billion criminal fine—for illegally marketing other blockbuster drugs.”
“In eight of the 12 published studies, the main outcome listed in internal documents differs from the one later given in the published report. In half the cases, a new primary outcome was substituted and in others, the original main outcome was instead reported as a secondary measure or wasn't disclosed at all.”
Dr. Sidney Wolfe, who founded Public Citizen’s Health Research Group and is now also on the FDA’s Drug Safety and Risk Management Committee, called the NEJM report the first in-depth examination of “studies in which a company and people working for it so maliciously manipulated the data to make a drug look more effective than it actually was.” "In every instance, the published article made the drug look better than it would have," said Wolfe.
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