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Results of inquiry into allegations of research fraud remain secret

BMJ 2003; 327 doi: (Published 04 September 2003) Cite this as: BMJ 2003;327:519
  1. Caroline White
  1. London

    The Department of Health has still not announced the outcome of an investigation into claims that one of its leading medical experts may have produced fraudulent research more than 20 years ago.

    The chief medical officer's silence on the matter comes despite his having received an investigative report into the matter six months ago.

    Now an expert on research fraud says that the department has a duty to make the investigation's findings available.

    The man at the centre of the allegations, Dr David Jefferys, is a former director of the Medicines Control Agency and, latterly, chief executive of the former Medical Devices Agency. Both organisations merged in April to become the Medicines and Healthcare Products Regulatory Agency. Dr Jefferys is currently head of the devices sector at the new agency.

    He is also visiting professor of medicine at the University of Newcastle and was the UK representative on the European Union Committee on Proprietary Medical Products between 1995 and 2000.

    Dr Peter Wilmshurst, a consultant cardiologist at the Royal Shrewsbury Hospital, contended: “The findings should be made public because the allegations are very serious. Jefferys is a very important person and in a position to influence policy affecting thousands of patients. It is essential that people know the truth one way or another.”

    The Department of Health has confirmed it is investigating allegations that resurfaced last summer that, while at London's Guy's Hospital between 1978 and 1983, Dr Jefferys faked research that formed part of his MD thesis at the University of London and some of which also appeared in peer review articles.

    Among the allegations investigated in the past are suggestions that the number of patients treated was implausibly high and that there were unusual patterns in the data. Dr Wilmshurst has calculated that “at least 850” patients were reported in the thesis, while a former colleague said he had been “staggered” by Dr Jefferys' productivity.

    It is understood that Dr Wilmshurt raised concerns about Dr Jefferys and the thoroughness of previous inquiries into the allegations—including one in 1992 by the Department of Health—with the chief medical officer, Professor Liam Donaldson, in November 2000.

    The department concluded in 1992 that the allegations against Dr Jefferys were “unsubstantiated.” Dr Jefferys was also reported to the General Medical Council in 1999, which did not proceed with the complaint, citing the age of the research and insufficient corroborative evidence.

    The continuing concerns prompted Professor Donaldson to set up a further investigation, with Dr Jefferys' agreement, to resolve the matter “once and for all,” according to a Department of Health spokesman.

    Professor Donaldson convened a confidential inquiry under the aegis of the Academy of Medical Sciences last autumn. The resulting report was submitted to him before the end of February.

    The department denies that it is deliberately sitting on the report, pointing to the complexity and time frame of the issues involved. “This matter is still under active consideration. Any suggestion to the contrary is wholly inaccurate,” insisted a spokesperson.

    But the department would not be drawn either on the nature of its current deliberations or on what grounds it would consider making its findings public. Asked whether the inquiry's report would be made public, another spokesperson said: “It is too early to say.”

    Dr Jefferys has denied the allegations, which have surfaced several times throughout his career, and has attributed them to professional jealousy. But he has declined to comment to the BMJ about them, and former colleagues have been reluctant to talk openly or at all to the BMJ.

    In 1992 Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, was one of three statisticians commissioned by the BBC's Public Eye television programme to review Dr Jefferys' thesis.

    Professor Evans sent his report to the University of London in 1993. After conducting its own investigation the university found “no prima facie case for taking the matter any further.”

    The Public Eye programme was never broadcast.

    Professor Evans describes as “astonishing” a claim attributed to Dr Jefferys in an article in the Observer (“Top doctor accused of faking research,” 21 July 2002, that Professor Evans would have been unable to appreciate the “biological nature” of Dr Jefferys' research.

    Last week the health department announced that Kent Woods, professor of therapeutics at the University of Leicester and director of the NHS Health Technology Assessment Programme, had been appointed to head the Medicines and Healthcare Products Regulatory Agency.

    The department would not say whether Dr Jefferys, thought to be a serious contender, had applied for the post when it was re-advertised in May. But a spokesperson added that “no one was barred from applying.” An earlier advertisement had not, according to the department, resulted in an appointment.

    When approached in June, before the appointment was made, Dr Jefferys told the BMJ that he had “nothing further to add,” when asked whether he wanted to be considered for the job.

    The BMJ contacted Dr Jefferys again before going to print. He said, “I have no further comments to make at this stage.”

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