Pfizer Pulls Another Paper Involving Failed Drug

Pfizer Pulls Another Paper Involving Failed Drug

December 17th, 2012 // 4:03 pm @

For the second time in as many months, Pfizer has retracted a paper about an experimental treatment for lung cancer, which is no longer being developed. Both papers involved the same study and a former Pfizer scientist was listed as a co-author and clinical lead, according to Retraction Watch.

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“After a thorough review, the corresponding author, Dr. Antonio Gualberto, has concluded that the key results reported in this manuscript are incorrect and cannot be reproduced. As there are no remaining samples that would allow a new analysis, he has therefore recommended the retraction of the manuscript to the Editor-in-Chief of BJC,” reads the notice in the British Journal of Cancer.

Last month, the Journal of Clinical Oncology similarly printed a notice concerning the same compound after the drugmaker conducted its own investigation of the findings and discovered improper analyses. At the time, Pfizer told Retraction Watch that the discovery was made during ‘close-out activities.’ Development ended nearly two years ago after two Phase III trials in non-small-cell lung cancer failed.

The retractions are an embarassment for the drugmaker, which took pains to insist that its own staff took the initiative to investigate the discrepancies and report its findings to the journals, according to a statement given to Retraction Watch, which reported the initial retraction last month (read here). Moreover, a Pfizer (PFE) spokesman tells us other papers are likely to be affected.

At the time, Pfizer maintained “we conducted a thorough and comprehensive review to determine how this may have occurred, and enlisted the services of independent experts to assist with this review. Our review determined that these errors were the result of inaccurately performed clinical data analyses.

“These incorrect analyses were performed outside of Pfizer’s standard operating procedures by the clinical lead, who left the company in September 2010. The problems were not based on study conduct or the work of the external investigators. We expect our employees to adhere to the highest levels of personal and professional integrity. We also expect colleagues to take ownership and accountability, and to understand that failure to do so can lead to serious consequences including termination.”

This week, the drugmaker offered a similar explanation for the latest discovery. “We self identified, analyzed and reported these errors on our own and, at the British Journal of Cancer’s request, the lead author submitted the retraction. It’s important to note that the BJC retraction relates to the same study referred to in the JCO but involved biomarker analyses mentioned above. Corporate integrity is an absolute priority for Pfizer, and we will continue to take appropriate actions to strengthen public trust in our company.”

Gualberto, who now works at Millenium Pharmaeuticals, did not respond to a request for comment.

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