Whistleblower wins the praise of minister

August 25, 2006

Health Minister Andy Burnham has praised the whistleblower who raised the alarm about the conduct of a study of Procter and Gamble's osteoporosis drug Actonel.

He said Aubrey Blumsohn, a doctor and former senior lecturer at Sheffield University, had highlighted "weaknesses in the verification of academic research". Dr Blumsohn raised doubts about the validity of conclusions that his research team at Sheffield's Bone Metabolism Research Unit had made about the effects of Actonel.

Dr Blumsohn revealed in The Times Higher last year that research findings had been published in the name of the Sheffield academics although the university researchers had not carried out their own analysis of the firm's drug-trial data. All analysis and interpretation of data had been left to P&G, which had funded the study.

Subsequent access to the relevant data led Dr Blumsohn to conclude that earlier published conclusions were incorrect.

In a letter to Dr Blumsohn's MP Nick Clegg, Mr Burnham, Minister of State at the Department of Health, says that Dr Blumsohn has raised "useful"

questions "about the reliability of exploratory research published in academic" outlets. He writes: "Cases such as this may make the academic community more aware of the importance of ensuring that such work can be verified."

Dr Blumsohn confirmed this week that he would publish all his evidence and scientific analysis in a blog - www.scientific-misconduct.blogspot.com - after the minister conceded that the drug regulatory authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), was powerless in this case.

The MHRA was asked to look into the concerns, but Mr Burnham says in the letter: "The research was of an exploratory nature... The laboratory analysis of samples... was not recorded in a way that allowed verification of the data produced... it means that the results would not be acceptable to regulatory authorities." The work "was never intended to be used in submissions to the MHRA for licensing purposes and... is outside the legislative powers and responsibilities of the MHRA".

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