Bone professor faces GMC probe

Lead author falsely claimed ‘full access’ to data in study funded and co-authored by Procter & Gamble. Phil Baty reports

September 22, 2009

A leading academic faces a General Medical Council (GMC) disciplinary hearing following a 2005 article in Times Higher Education, which reported that he had given his name as lead author of a research paper although he did not have full access to the data on which its conclusions were based.

Richard Eastell, professor of bone metabolism at the University of Sheffield, is due to face the GMC’s Fitness to Practise Committee over his role in a research paper on the effects of Actonel, a drug used to treat osteoporosis. The study was funded and co-authored by Actonel’s manufacturer, Procter and Gamble (P&G).

In November 2005, Times Higher Education reported concerns about the validity of a 2003 paper by Professor Eastell and others, published in the Journal of Bone and Mineral Research (JBMR), “Relationship of early changes in bone resorption to the reduction in fracture risk with risedronate” (Actonel’s generic name).

The journal warns authors that they must disclose “any limitation to full access to all material”, and Professor Eastell states in the paper that “all authors had full access to the data and analyses”.

But Times Higher Education reported that the paper’s data analysis had been carried out by P&G, and the academics had not been given full access to the information.

In 2007, in a letter to the JBMR, Professor Eastell accepts that he had incorrectly signed the declaration stating that he and the other authors had “full access” to the data. He adds that “one of the authors, a statistician working for P&G, Ian Barton, had full access”.

The statistician had “worked closely with all of the authors… on the data analysis”, but Professor Eastell adds: “not all the original authors were given access to the raw data”.

He also concedes that the paper contained “some errors and some poor practice”. An incorrect statistical test had been used, and in particular, a graph in the original paper had been “cropped extensively and in an asymmetric manner”.

In 2007, P&G said that it agreed with the corrections made by Professor Eastell to the 2003 paper, but added that the mistakes did not affect its scientific conclusions. It said that the work was not related to the safety, efficacy or approval of Actonel and did not directly involve clinical research with patients.

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