Eli Lilly defends itself against assertions in BMJ
Nieuws van: British Medical Journal (BMJ)The drug company Eli Lilly has launched a campaign to refute assertions about its anti-depressant medicine, fluoxetine (Prozac), made in an article in the BMJ ( 2005:330: 7[Free Full Text], 1 Jan) about internal company documents sent to the BMJ by an anonymous source.
Sydney Taurel, Lilly's chief executive, in an open letter published in the Wall Street Journal on 13 January, wrote that the BMJ article and the misleading reports about it in other media have "needlessly spread fear among patients who take Prozac."
In response to the suggestion that Lilly might not have reported negative data to the Food and Drug Administration or the medical community, he said: "In reality, all of the medical issues about Prozac raised in the documents had been addressed in Lilly's data submissions to the US Food and Drug Administration or regulators in other countries, in prestigious scientific journals, or in correspondence with attorneys outside Lilly over the course of more than 10 years."
One of the documents received by the BMJ was called "Activation and Sedation in Fluoxetine Clinical Trials," which recorded that 38% of patients taking fluoxetine developed symptoms of activation, such as nervousness and insomnia, compared with 19% of patients taking placebo.
Lilly has posted on their website an annotated analysis of the documents received by the BMJ, including the finding from the activation and sedation report. The analysis cites five scientific publications and concludes: "Subsequent analyses on activation and sedation for multiple specific studies were published in several peer-reviewed journals and were appropriately referenced in annual reports."
Lilly officials maintain that none of the documents sent to the BMJ "went missing" during a 1994 product liability suit. In a news release on 4 January 2005 entitled "Lilly affirms: No `Missing' Prozac documents and no new scientific information," Lilly asserted that its stamp mark placed on the documents sent to the BMJ show that the documents were "indisputably made available to plaintiffs' attorneys for use at trial."
Mr Taurel said in his open letter that Lilly had addressed "all the medical issues about Prozac raised in the documents" and that doctors should "trust the medical evidence."
Morry Smulevitz, manager, global product communications, neuroscience, at Lilly said: "Lilly is most concerned about erroneous media reports causing unnecessary and unwarranted concern among patients and doctors. Lilly was disappointed that a reputable medical journal would make these allegations without first validating the information they had received. Despite repeated requests from Lilly, the BMJ refused to share the documents, choosing instead to issue a news article referencing incomplete data and lacking appropriate scientific context.
"Lilly felt it was imperative to take this opportunity to set the record straight for patients who rely on our medicines for their daily well-being. As a result, patients, healthcare providers and media have shared our dis-may that the BMJ would falsely allege any documents went missing, and, more importantly, publish scientifically inaccurate conclusions regarding the benefits and possible side effects of Prozac."
Dr Kamran Abbasi, acting editor of the BMJ, said: "The BMJ takes this issue very seriously. We are carefully reviewing Lilly's detailed response."
http://bmj.bmjjournals.com/cgi/content/extract/330/7484/161-a - 22 jan 2005
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