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Retraction Watch

Tracking retractions as a window into the scientific process

Another retraction for Pfizer’s experimental cancer treatment figitumumab

with 5 comments

6794 BJC_newblue_V1.qxdLast month, we brought you news that Pfizer had retracted a paper in the Journal of Clinical Oncology

purporting to show a benefit of their experimental drug for lung cancer figitumumab after discovering that its clinical lead on the project had done analyses improperly.

There’s been another retraction, of a related paper, in the British Journal of Cancer, “Pre-treatment levels of circulating free IGF-1 identify NSCLC patients who derive clinical benefit from figitumumab.” Here’s the notice:

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.

The co-authors have been informed of this decision.

Dr Gualberto sincerely apologises for any inconvenience this may have caused the readers of the BJC.

The paper has been cited 27 times, according to Thomson Scientific’s Web of Knowledge.

Pfizer, which is no longer developing the drug following two failed Phase 3 trials, tells Retraction Watch that the retraction followed a company investigation:

As you know based on our discussion in early November, Pfizer became aware that final data from a Phase 2 study of figitumumab, known as the 1002 study, and certain biomarker analyses performed in connection with the figitumumab program differed from the results that had been reported previously to regulators and published in medical journals.

We conducted a proactive, thorough and comprehensive review to determine how this may have occurred, and enlisted the services of independent experts to assist with this review. Based on our review, we believe that the publication of results from the inaccurate biomarker analysis was primarily due to the actions of the former Pfizer clinician, who operated outside our approved systems for data management and publication.

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 left Pfizer in September 2010, and is now at Millennium: The Takeda Oncology Company. He did not respond to a request for comment.

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5 Responses

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  1. There are 14 publications on figitumumab by Antonio Gualberto.

    http://www.ncbi.nlm.nih.gov/pubmed/?term=figitumumab%20Gualberto

    Two have been retracted. One of the 14 is a retration notice, but how many of the others are going to stand?
    Some of them are clinical.

    fernando pessoa

    December 13, 2012 at 1:41 pm

  2. Adam and Ivan, I have though for some time as I have read Retraction Watch, what is the follow on effect of retractions (such as these) on the patent applications/patents that correspond to or have relied on the retracted data/manuscripts?

    As a patent attorney, I am well aware that fraud in front of the USPTO may have serious consequences for the parties involved. If appropriate, should any corresponding patent applications/patents be withdrawn?

    It would be simple, but time consuming, to go through the relevant authors in the relevant patent databases to look for corresponding applications by the author/inventor and see what has happened to the related IP.

    M

    December 13, 2012 at 6:41 pm

  3. M, I am not a patent person – but I am a scientist involved in the biopharm industry – but if these retractions are regarding clinical trials, then I wouldn’t think that it would have much to do with patents. I believe (possibly naively, I only have 1 patent) that the patents/patent applications for the molecules, which likely include expression, genetic code, protein structure, protein function etc happen well before things go to clinical trial. Just because it didn’t work in people does not mean that the molecule’s premise is not valid. If it binds IGF-1 it binds IGF-1, its just that in a test tube it worked fine, in a person it didn’t.

    DME

    December 14, 2012 at 5:06 pm

    • Who know what the patents are about?
      This issue is also about other clinical trials.
      I do understand that some papers are not about clinical trials.
      The fact is that the molecule does not work in people.
      You might expect a reassessment from front door to back door.

      “Just because it didn’t work in people does not mean that the molecule’s premise is not valid.” could be turned on its head. Just becasue it didn’t work in people does not mean that the molecule’s premise is valid”.

      What about some house-cleaning, not distance-running?

      fernando pessoa

      December 16, 2012 at 7:03 am

  4. Great answer, DME: I think that fact nullifies any repercussions for a substance’s patent.


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