Pfizer retracts third figitumumab study citing data discrepancies
According to a notice published last Sunday in Clinical Cancer Research (CCR) the US drugmaker asked for a 2010 Phase II study of the monoclonal antibody to be retracted in light of concerns about the data.
This is the third figitumumab study to be withdrawn at Pfizer’s request behind one pulled by the Journal of Clinical Oncology (JCO) in 2012 and a second paper in the British Journal of Cancer (BJC) that was retracted in the same year.
A Pfizer spokeswoman told BioPharma-Reporter.com that: “The Retraction issued by CCR relates to a Phase II study of figitumumab, known as Study 1002.
“Efficacy results and biomarker data from Study 1002 were reported in two previously retracted articles, one of which was published in the JCO and the other in the BJC.”
Pfizer asked for the JCO and BJC studies to be pulled after discovering discrepancies caused by “inaccurate clinical data analyses that were performed outside of Pfizer’s standard operating procedures and were not the result of problems arising from study conduct.”
The retractions prompted investigation of other figitumumab-related publicaitons, including the paper published in the CCR which discussed data derived from tumor biopsies provided by a subset of patients from Study 1002.
The spokeswoman said: “Pfizer has been unable to verify certain data reported in it [study 1002] and…requested that CCR retract the 2010 article” adding that “since the discovery of the errors, Pfizer has made continuing efforts to correct the scientific record.”
Big pharma publication practices are under the spotlight at the moment, particularly in Europe where transparency advocates, industry and the European Medicines Agency (EMA) are debating how to comply with recently passed laws calling for all trials to be disclosed.
The debate has focused on drug industry claims that full data publication would give rival developers access to commercially sensitive information and breach patient confidentially rights, which are arguments that advocacy groups like AllTrials reject.
With this in the background, Pfizer is clearly mindful that the timing of the latest figitumumab-related retraction may generate negative publicity.
The spokeswoman told us that: “As always, public health and safety are Pfizer’s first priority, and it is important to reiterate that the errors identified do not alter the safety profile of figitumumab. Pfizer is committed to ensuring that accurate clinical study results are disclosed to medical professionals, patients and the public.