GMC clears research dean of dishonestyBMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b4617 (Published 09 November 2009) Cite this as: BMJ 2009;339:b4617
The former research dean of Sheffield University’s medical school has been cleared by the General Medical Council of dishonesty in allowing the publication of a false statement saying that he had seen all the data in a research study of which he was the lead author.
The GMC held that although Richard Eastell might have acted negligently, he was not dishonest, he was not guilty of misconduct, and his fitness to practise was not impaired.
Professor Eastell, who heads the bone research unit at the university, was in charge of studies into Procter & Gamble’s osteoarthritis drug risedronate (Actonel). The university conducted measurements on blood and urine samples that had been taken during clinical trials in the 1990s for a study comparing the bone density measurements of women who had and had not taken the drug.
The measurements were sent to Procter & Gamble, which performed analyses, but the company refused to give the researchers access to the raw data.
An article outlining the study findings, published in the Journal of Bone and Mineral Research in 2003, contained the statement: “All authors had full access to the data and analyses.” The statement is believed to have been inserted by a Procter & Gamble medical writer.
The company finally agreed to release the data in 2006, and an independent analysis was done. In 2007 the journal published a letter from the authors that acknowledged that only one author, a Procter & Gamble statistician, had seen all the data and admitted “some errors and some poor practice” in the original paper (2007;22:1656-60, doi:10.1359/jbmr.07090b).
The GMC’s fitness to practise panel concluded that there was “an evolving understanding of access to data” at the time and accepted evidence from Professor Eastell that he had amended his practice. The incident was “a single episode in an otherwise accomplished career,” and testimonials showed that Professor Eastell was “still highly regarded in the research community.”
The panel decided not to exercise its power to issue a warning after hearing arguments from Professor Eastell’s lawyer that it could have a detrimental effect on his ability to secure research funding.
After the GMC’s determination, Professor Eastell said: “I am pleased that the GMC has exonerated me of any intentional wrongdoing. The GMC recognised that there was never any intention on my part when I wrote the paper along with others in the Journal of Bone and Mineral Research in 2002 to deliberately mislead about our access to the raw data used in the study. I have spent the last 30 years conducting research into the cause, diagnosis, and treatment of osteoporosis, and over that time I have published around 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 carried out subsequent research on risedronate at Sheffield and raised concerns about Procter & Gamble’s refusal of access to data in two other studies, said: “I agree with the outcome. 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 means proper unfettered access to raw data so that authors can check findings reported in their names.”
Procter & Gamble told the researchers that it was acting in accordance with guidelines issued by Pharmaceutical Research and Manufacturers of America (PHRMA), the lobby group for the US pharmaceutical industry, in refusing to release the data.
Dr Blumsohn, who took a financial settlement to leave the university after publicising his concerns, added: “There are unreconcilable discrepancies between guidance from trade groups and the fundamental requirements of good science.”
Cite this as: BMJ 2009;339:b4617