Pfizer Manipulated Study Reports, Experts Conclude
Submitted by Carina Rose on Thu, 10/09/2008 - 08:13
Plaintiffs in a lawsuit against drug maker Pfizer Inc. have said that the company controlled the publication of negative scientific studies to expand sale of its epilepsy drug Neurontin. The tactics employed by them, according to documents filed in the federal court in Boston yesterday included delaying the publication of studies that said the drug did not work for some disorders, “spinning” negative data in order to show it in a more positive light and bolstering negative findings with positive studies.
Kay Dickersin, an epidemiology professor at Johns Hopkins University Bloomberg School of Public Health in Baltimore, who reviewed the documents wrote in a report, ``I observed extensive evidence of `reframing' or `spin' to make negative results appear positive.” This she felt made Pfizer's claims about the drug ``untrustworthy and invalid,'' she said. She concluded that she felt it was “a publication strategy meant to convince physicians of Neurontin’s effectiveness and misrepresent or suppress negative findings.”
Denying reports of manipulation Pfizer issued a statement to say, “study results are reported by Pfizer in an objective, accurate, balanced and complete manner, with a discussion of the strengths and limitations of the study, and are reported regardless of the outcome of the study or the country in which the study was conducted.”
Meredith Rosenthal, an associate professor of health economics at Harvard School of Public Health in Boston, said an estimated 43 million off-label prescriptions were written for Neurontin as a result of the company's promotions. The plaintiffs accuse Pfizer of fraudulently misrepresenting the drug’s benefits and consumers and third-party payers including insurance companies and trade unions want Pfizer to repay them billions of dollars for Neurontin prescriptions.
Pfizer spokesman Chris Loder said the company would reply to the allegations ``at the appropriate time. The notion that Pfizer and Warner-Lambert Co. somehow systematically suppressed negative studies related to bipolar disorder is directly contradicted by Warner-Lambert's support of the publication in the journal, Bipolar Disorders, in September 2000 of an earlier study of Neurontin's use in bipolar disorder that failed to show efficacy,'' Loder said in a statement.
Pfizer lost patent protection in 2004 for Neurontin which generated sales of $431 million for the company and is sold under the generic name gabapentin by numerous drugmakers.
Thomas Greene, a lawyer for the plaintiffs, said, “Pfizer continued with the medical marketing firms and planted marketing messages in journal articles that Neurontin was effective while they knew that their own clinical trials had failed to demonstrate it was effective.”
