An open letter to Dr Games about Procter and Gamble research misconduct

Dr Larry M Games
Vice President
Procter and Gamble Pharmaceuticals
Health Care Research Center
8700 Mason-Montgomery Road
Mason, Ohio, 45040
USA

17 July 2006

Dear Dr Games

Re: Actonel Studies / Sheffield Situation

In view of Procter and Gamble's stated intent to now deal with this matter in an open and honest fashion, I am writing to express concern that I have received neither acknowledgement of nor reply to recent correspondences.

My last communication of 26 June 2006 is repeated on the following page for your convenience. Points 1-3 and point 6 required no response. However points 4 and 5 were requests for further information. In particular, although I am happy that P&G has now provided the main data underlying material presented
in my name, I remain concerned over the failure to provide confounding variables and information about non-vertebral fracture.

Clearly these publications (one full paper and three meeting abstracts) have to be retracted.

The correct findings (per the two draft publications already written in my name, but with corrected results) have to be published.

I would appreciate a response at your earliest convenience.

Yours sincerely
Dr Aubrey Blumsohn
MBBCh, BSc (hons), MSc, PhD, MRCPath

[Previous correspondence]

Dr Larry M Games
Vice President
Procter and Gamble Pharmaceuticals
Health Care Research Center
8700 Mason-Montgomery Road
Mason, Ohio, 45040
USA

26 June 2006

Re: Sheffield scenario

Dear Dr Games,

1) Per my last letter/request I am writing to confirm that Professor ------------- and Professor ------------- have been involved in statistical analysis.

2) The interpretation of data previously presented in the Eastell 2003 paper, meeting abstracts presented in my name, and two draft publications intended for submission (with me as first author) cannot be sustained (using any of a variety of relevant statistical methodologies, including simple visual inspection).

2) Professor ------------- has agreed to coauthor the publication, with intent to submit to JAMA. Clearly other involved parties may wish to coauthor. I will forward the manuscript when complete.

3) I have requested (and received) permission from the Journal of Bone and Mineral Research to reproduce Figure 1 of the Eastell JBMR 2003 paper a) as it stands, and b) with overlying data and data analysis, c) on a website.

4) Under the circumstances I would wish to submit via JAMA the raw data underlying the intended manuscript, and for this to be made publicly available. I request your permission to do so, since this relates only to data generated in Sheffield in a subset of the VERT and Hip trials (with accompanying randomisation and fracture codes) I trust that this will be satisfactory.

5) I note that data relating to the two key confounding variables (as previously requested) has not been provided. I would appreciate it if you would reconsider this. Please note my email of the 7th of April with regard to these.

6) I will be making a separate evidence based submission to JBMR with regard only to the procedure in these studies along the lines of my current meeting presentations.

Yours Sincerely

Dr Aubrey Blumsohn
Sheffield

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