Procter & Gamble - Let's take the high road

See this article (AAAS Ethics reports 2006 XIX 3 2006) and the rest of this blog for background to this letter. The recipient is Dr Larry M Games, Vice President at Procter and Gamble Pharmaceuticals. The letter is about research misconduct in studies investigating the mechanism of action and clinical monitoring of the osteoporosis drug Actonel.


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

23 November 2006

Re: Actonel Studies/Sheffield Situation - Issue of Raw data

Dear Dr Games

I am writing following our previous correspondence. We have a number of matters to discuss. To maintain clarity I will write separately about each matter. The purpose of this letter is to revisit your earlier refusal to allow the raw data you provided in April 2006 to be made available for public/scientific scrutiny.

I again thank you for your eventual provision in April 2006 of raw data underlying the three intended P&G Publications (Eastell et al. 2003 J.Bone.Miner.Res. 18:1051-6 + the two abstracts/draft publications in my name). I also thank you for your commitment to openness, and for writing the Bill of Rights for researchers. All of this is good.

Unfortunately the Eastell 2003 publication (J.Bone.Miner.Res. 18:1051-6) has not yet been retracted.

As stated, the main purpose of this letter is to revisit your earlier refusal to allow the data provided in April to be scrutinized in an open manner. Your refusal to allow the data to be transmitted to a journal editor accompanying a properly corrected manuscript is not appropriate. A journal editor can request raw data from an author at any time, and such refusal (particularly under the circumstances of this case) would be inappropriate.

The raw data you sent me by E-mail in April is attached exactly as sent (PGData.zip - web downloadable data is encrypted in the online letter). The CD-Rom and paper versions of the data you sent are retained by my legal representative.

Obviously the refusal to supply the raw data to authors in the first place has caused some international consternation. There is also the entirely separate matter concerning the potential mis-analysis of data by P&G in the ghost-analyzed/ghostwritten material. I believe the data was mis-analyzed - and quite obviously so. Two statisticians agree with me.

Certainly data must be transmissible to journal editors. This whole matter could be settled most easily by making the full data as attached available for open scrutiny. Secrecy has no further place in this, and I am asking you to allow this. Any other approach is I am afraid not going to satisfy anyone.

You also make the unusual comment in your last letter that the Eastell 2003 article is somehow separate from the other two intended publications and abstracts in terms of data. Obviously you must know that this is not true. You yourself provided me with the data underlying the Eastell 2003 paper (PGData.zip - encrypted). One of the two manuscripts in my name includes the entire Eastell 2003 data (for NTX and fractures) as a subset since it was based on a combined analysis of the HIP and VERT studies. The related abstract in my name involving the Eastell data (as a subset) is referenced below (1). I am sure you have the draft publication of 2003 relating to this abstract.

You will also no doubt be aware of (and have seen) the statistical reports which attempt to reconstruct Figure 1 and related statistics in the manuscript by Richard Eastell (2003) from the data. One of these reports is here ( Professor Martin Bland). Obviously there were several other problems with the analysis in all manuscripts but for the moment I will keep things simple.

There is a high road Dr Games, and I hope that we can work together to take it.

Kind wishes

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


Reference:

1. A. Blumsohn, IP Barton, A Chines, R Eastell Relative Contributions Of The Early Changes In Bone Resorption And Later Changes In Hip Bone Mineral Density To The Reduction In Vertebral Fracture Risk With Risedronate. J Bone Miner Res 2003;18(S2):S157 Abst#SA337

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Comments on: Procter & Gamble - Let's take the high road

 

Anonymous Anonymous said ... (November 27, 2006) : 

Data downloaded as suggested.

 

Anonymous DW said ... (November 27, 2006) : 

Data downloaded as suggested

 

Anonymous Anonymous said ... (December 03, 2006) : 

Great blog, keep it going !

JS
http://www.mymathforum.com

 

Anonymous Patricia said ... (December 12, 2006) : 

I see you wrote a fantabulous front page feature in PER. It is worth looking at the secrecy feature in PER of Winter 1999 and the conference to which it relates.

Sigh.....

http://www.aaas.org/spp/sfrl/per/per16.htm

"While academic freedom and the integrity and accountability of the research process are fundamental issues in the debate over secrecy in science, the issue of scientific responsibility to the public is critical. The sensitive nature of human subjects research, whether individuals or entire communities, makes it desireable that some scientific data be handled as confidential in order to protect privacy. Thus, there was a call by some at the colloquium to replace secrecy with privacy as the threshold for restraining information. The task of safeguarding privacy rights of vulnerable individuals and populations in genetics and other research, while working to preserve academic freedom, is of paramount importance if the research community is to avoid violating public trust in science."

 

Blogger CL Psych said ... (December 31, 2006) : 

The suspense is killing me (and others, I'm sure). Did you hear back from Larry within the week? Allow me to venture a wild guess that one of three things happened:
1. You did not hear from him
2. You did not receive a reasonable response -- more bureaucrat-speak was issued
3. You were threatened with legal action

 

Anonymous Maureen said ... (January 01, 2007) : 

You should try to contact some of the good people at radstats
http://www.radstats.org.uk/

 

Blogger Fiddy said ... (January 06, 2007) : 

Moral excellence comes about as a result of habit. We become just by doing just acts, temperate by doing temperate acts, brave by doing brave acts.

ARISTOTLE

I salute you

 

Anonymous Anonymous said ... (January 08, 2007) : 

Well.... where is Dr Games - or did they threaten you. Please let us know.

 

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