Select Committee on Health Appendices to the Minutes of Evidence


Memorandum by Sir Iain Chalmers, Director, UK Cochrane Centre (NC 22)


  There is a need for greater transparency in the data available to the National Institute for Clinical Excellence. All the data that have informed NICE's judgements should be made public.


  1.  I am the Director of the UK Cochrane Centre, which forms part of the infrastructure supporting the Cochrane Collaboration—an international organisation, registered as a charity in England, which prepares, maintains and makes accessible systematic reviews of research evidence on the effects of health care interventions. The NHS Research and Development Programme and the Chief Scientist Office in Scotland have provided very important support for this Centre and other elements of the Cochrane Collaboration. The output of the Collaboration's work—the reviews of evidence published electronically in The Cochrane Library—have been used extensively by the National Institute for Clinical Excellence, and by other national and international organisations responsible for developing guidelines and policies.

  2.  Within this work, one of my specific interests has been the extent to which reporting biases have distorted publicly accessible evidence about the effects of health care interventions. Studies with "positive" results are more likely than others to be selected for presentation at scientific meetings; more likely to be reported in print; more likely to be published promptly; more likely to be published as full reports; more likely to be published in journals that are widely read; more likely to be published in English; more likely to be published in more than one report; and more likely to be cited in reports of subsequent, related studies. Under-reporting research is scientific and ethical misconduct. At best, it results in resources being wasted on interventions that have no important beneficial effects; at worst, it can result in avoidable suffering and death of people using health services.


  3.  It is possible to understand the demand for commercial confidence of information about the effects of drugs that have not yet been licensed by the Medicines Control Agency or the European Medicines Evaluation Agency. In contrast, withholding information about the effects of drugs (and other health care interventions) that have been licensed is indefensible. Patients, prescribers and policy makers should have access to all the information about the effects of the drugs and other health care interventions they may wish to consider. (Roberts I, Li Wan Po A, Chalmers I. Intellectual property, drug licensing, freedom of information, and public health. Lancet 1998; 352:726-729).

  4.  NICE is currently expected to serve the interests of patients, the public more generally and the NHS (i) without knowing the extent to which it is being provided with all relevant information (and not a biased subset of it); and (ii) without being able to make public all of the information that has informed its judgements. While this state of affairs persists, NICE cannot be expected to achieve the credibility that is essential for it to earn the trust of the public.

  5.  Speaking at NICE's annual conference at the end of last year, Lord Hunt stated that NICE's work is transparent. Although the Institute's work is commendably transparent in some respects, as indicated above, it is anything but transparent in some crucially important respects. Even though it might be difficult to encapsulate in publicly available documents the series of judgements leading to the appraisal decisions made by NICE, making public the data informing these decisions would help to promote greater trust in the process.

  6.  Under current arrangements, NICE cannot be certain that the information that it receives in confidence from industry is all of the relevant information it should take into account, nor can some of the information it does receive be made publicly available to those who wish to understand the background to NICE's appraisals and guidelines. Some of the people working on analyses relevant to NICE have told me that they are aware of important data having been withheld from NICE by companies whose interests would not be served by submitting it.


  7.  The most appropriate response to these causes for concern would be for NICE to insist that it receives all of the information relevant to a particular judgement, and that this information would be made public once the appraisal or guideline was released. I gather that Ministers rejected this at an early stage in the life of the Institute, but the Health Committee could recommend that this should be required.

  8.  Short of this desirable level of transparency, other steps can be taken to improve the current situation. First, those companies that declare that they have submitted all relevant information to NICE should be openly credited for having done so. I gather from staff at GlaxoSmithKline, for example, that it is the company's standard practice to submit all the data of which they are aware.

  9.  Second, even if the results of controlled trials are not made public, NICE should require companies to make basic details of the relevant trials publicly available through registration and the metaRegister of Controlled Trials, and for an international Standard Randomised Controlled Trial Number to be assigned (see Not only does the NHS Research Governance Framework now require registration of all controlled trials, but also, over a year ago, the Association of the British Pharmaceutical Industry recommended that all of its member companies should follow Glaxo Wellcome's lead in registering their trials.


  Although I am confident that these views are shared by many others, this memorandum has been submitted on an individual basis. If the Committee wishes me to give oral evidence, I would be willing and able to do this after 17 February.

January 2002

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