Doctors have been agreeing to be named as authors on studies written by employees of the pharmaceutical industry, giving greater credibility to medical research, according to new evidence.
The Guardian has learned that one of Britain's leading bone specialists is facing disciplinary action over accusations that he was involved in "ghost writing".
The wider phenomenon has come to light through documents disclosed in the US courts which have revealed a culture in which doctors agree to "author" studies written by employees of drug firms. The doctors may have some input but do not have access to all the evidence from the drug trial on which the paper's conclusions are based, the documents showed.
The General Medical Council will call Professor Richard Eastell in front of a fitness to practice committee. Eastell, a bone expert at Sheffield University, has admitted he allowed his name to go forward as first author of a study on an osteoporosis drug even though he did not have access to all the data on which the study's conclusions were based. An employee of Proctor and Gamble, the US company making Actonel, was the only author who had all the figures.
The disciplinary move in the Eastell case comes after he admitted that a statement he signed declaring that all six authors had access to all the statistical data was wrong.
In a letter published in the Journal of Bone and Mineral Research, which carried the original study, he stated: "In the original paper one of the authors, a statistician working for P&G, Ian Barton, had full access to all the data." The authors had full access to all the analyses of the data that they requested, he said – but those analyses were carried out by the company.
The letter, published in 2007, also acknowledged flaws in the study. A later independent analysis of the data "identified some errors and poor practice", he wrote. The study was designed to show the strengths of Actonel which was in fierce competition with a rival bone-strengthening drug called Fosamax, made by Merck.
Eastell's paper concerned a study carried out on behalf of Proctor and Gamble, comparing the bone density of women prescribed Actonel with others who were not. Only the company knew which women were on the drug and which were taking something else.
Eastell's colleague, Dr Aubrey Blumsohn, wanted the codes which would say which of the patients who suffered fractures had been on the drug. The company refused. Blumsohn took his concerns to Eastell, but in a conversation which Blumsohn says he taped , Eastell said he was concerned that persistent requests might damage the relationship they had with the company. Eastell is said to have told him: "The only thing that we have to watch all the time is our relationship with P&G. Because … we have the big Sheffield Centre Grant [from P&G] which is a good source of income, we have got to really watch it." .
Tim Kendall, joint director of the National Collaborating Centre for Mental Health, says the problem is the close relationship between doctors and the industry. "Some doctors don't seem to see the relationship … as problematic."
A study of 4,000 physicians found that 96% received money from drug companies, and yet "the majority did not see it as a conflict of interest", he said.
"I do think there needs to be a national debate in this country about the interpenetration of medicine and the pharmaceutical industry."
Ghost writing was one manifestation of a bigger problem which he believed was the institutional bias of doctors who work closely with and for drug companies. "In mental health 85% of all published trials are funded by the drug industry," he said. Allowing for the unsuccessful trials the industry does not publish, the figure is probably nearer 95%, he said. Studies have shown that drug company-funded trials are five times more likely to come out with a positive result for the drug than independent trials.
Jane O'Brien, head of standards and ethics, said that their research guidance specified the importance of honesty in the attribution of authorship. "We would see that as an important issue. If somebody's name is on something it gives research a credibility that it wouldn't otherwise have. If somebody had not been involved, we would see that as misleading people as to the credibility of the research."
She added that the GMC felt it important to play a role in ensuring good conduct in research. About a year ago, she said, they took soundings of bodies that regulate and support research, such as the Medical Research Council, asking whether the GMC should be involved. "The response was yes, because we are the people who can strike doctors off in the end."
Eastell declined to discuss the hearing. "I do not wish to comment on the case. The proceedings have yet to commence," he told the Guardian in an email. A spokesperson from the University of Sheffield, where Eastell is professor of bone metabolism, said they were aware of the investigation. "We will be informed by the GMC of any outcome and cannot comment further until we receive this."
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