Academic made ‘untrue’ declaration about ‘full access’ to research material, GMC finds

Lead author who had not seen all of Procter & Gamble’s raw data about osteoporosis drug was ‘negligent’ but not ‘deliberately dishonest’. Phil Baty reports

November 10, 2009

A senior academic made an “untrue” and “misleading” declaration about his access to research data in a paper co-authored with a pharmaceutical company, the General Medical Council (GMC) has found.

After a hearing of its Fitness to Practise Committee, the GMC concluded that Richard Eastell, professor of bone metabolism at the University of Sheffield, wrongly stated in a paper on the osteoporosis drug Actonel that he had been given “full access to the data and analyses” on which his conclusions were based.

The data had been retained by the drug’s manufacturer, Procter & Gamble, which funded the study and co-authored the paper.

The GMC concluded that Professor Eastell’s failure to correct the statement before its publication was “negligent”.

But because his action was “not deliberately misleading or dishonest”, there was no finding of misconduct, and no warning has been issued.

Professor Eastell said this week that he was “pleased that the GMC has exonerated me of any intentional wrongdoing”.

Times Higher Education first reported concerns about the validity of Professor Eastell’s paper in November 2005.

The paper, “Relationship of early changes in bone resorption to the reduction in fracture risk with risedronate”, was published in the Journal of Bone and Mineral Research (JBMR) in 2003.

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

In 2007, in a letter to the JBMR, Professor Eastell accepted that he had incorrectly signed the declaration in the 2003 paper and said that one of the authors, a statistician working for P&G, Ian Barton, had “full access”.

He also accepted that the 2003 paper included “some errors and some poor practice”.

In its findings, the GMC committee said that the statement by Professor Eastell in the 2003 paper “was untrue, since you did not have full access to the raw data from the study upon which the article was based”.

It said: “The panel found that your failure to correct the statement before its publication in the JBMR was misleading because the statement was untrue and subsequently required public clarification.”

Professor Eastell had argued that he did not give “much consideration” to the statement about access to data when the article was in draft form because he “believed it to be accurate”.

The GMC panel said that it “took account of the approach in 2002 to potential conflicts of interests and the availability of raw data to researchers”, and was aware that there was at the time “an evolving understanding of access to data”.

On that basis, it concluded: “While your failure to give the statement due consideration may have been negligent, it was not deliberately misleading or dishonest.

“The panel has noted the documented examples in which you have specifically requested access to raw data for studies you have been involved in since concerns were raised regarding your article in 2003.

“It is satisfied that you have acknowledged the issues raised in this case and have adapted your practice accordingly.”

Professor Eastell said: “The GMC recognised that there was never any intention on my part when I wrote the paper along with others in 2002 to deliberately mislead about our access to the raw data used in the study.

“I have spent the past 30 years conducting research into the cause, diagnosis and treatment of osteoporosis, and over that time I have published about 295 papers.

“I am committed to continuing with medical research and to working on new treatments for osteoporosis. Hopefully, this work will hasten the development of better treatments for patients with osteoporosis.”

Aubrey Blumsohn, who worked with Professor Eastell on the project at Sheffield and who raised initial concerns about the lack of access to Proctor & Gamble’s data, said: “The GMC has done an important job in helping to define the meaning of data and the responsibilities of scientific authors… The council has determined that access to data to authors means proper unfettered access to raw data so that authors can check findings reported in their names. Scientists would otherwise be indistinguishable from clowns.”

phil.baty@tsleducation.com

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