Report from the Investigation Commission appointed by Rikshospitalet – Radiumhospitalet mc and the University of Oslo January 18, 2006

Possible harmful consequences regarding the treatment of patients, etc

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6.2 Possible harmful consequences regarding the treatment of patients, etc.

The results from the studies have probably been used by many researchers in their works. When the findings referred to are based on incorrect and misleading data, this has in the best of cases caused much wasted work and resources.

Many of the publications deal with the use of diagnostic methods to determine oral cancer and to discuss prognoses for treatment in relation to the time of diagnosis. This may have consequences for the follow-up and treatment of patients. The Commission has not understood it to be its task to discover specific harmful effects. The Commission is aware that this will be a subject for the Board of Health’s own investigation.

However, the Commission is aware that the results have been used in discussions on the value of medicines, also as documentation in discussions about retraction of medicines. Also here, the results of Sudbø’s research may have had negative consequences, both for the treatment of patients and for the use and sales of medicines. Moreover, the Commission has registered that there are reports in the media that Sudbø’s research results have influenced the diagnosis and treatment of certain persons with white patches in their oral cavities in Germany, the UK and the USA. It is also reported in Norwegian media that individual patients have omitted to use painkilling tablets, and rather chosen to live with pain, because it appears from the Lancet article that the tablets entailed an increased risk of cardiovascular diseases, etc.

Evidently, these are very serious matters, and this obvious danger of misleading patients, health staff and researchers with ensuing disadvantages and harmful effects, must have been evident to Jon Sudbø.

7. Criticizable circumstances

7.1 Introductory remarks

In line with its terms of reference, the Commission in this chapter will make a summary of what it found to be criticizable circumstances. For a detailed description of facts and the Commission’s evaluation of Jon Sudbø’s research, see Chapters 4 to 6. The criticizable circumstances the Commission has discovered are related partly to physical persons and partly to institutions.

The Commission’s investigation entailed that 60 authors of scientific publications and several employees at the institutions in fact have been subject to investigation. Regarding individual persons, the Commission, in line with what is stated in Chapter 2, has applied a relatively high threshold for the circumstances that are to form the basis for criticism of individuals, namely gross and serious breaches of good research ethics perpetrated with intent or gross negligence.

The Commission has not found any grounds for believing that other individuals than Jon Sudbø have contributed to the fabrication of data or committed similar gross and serious breahes of regulations either intentionally or with gross negligence. However, Sudbø’s supervisor and most important partner, Albrecht Reith, must suffer a certain criticism for lack of due care.

The fact that the threshold for criticism of individuals is so high, means that few individuals are subject to direct criticism by the Commission. The investigation has disclosed several less gross and serious cases of failing to comply with authorship criteria and the handling of patient data contrary to regulations which, per se, could have given grounds for criticism against more individuals. As mentioned in Chapter 2, however, such an investigation of less serious circumstances would have become disproportionately demanding. Less gross deviations are also serious to research, in particular if seen in connection (collective and cumulative errors). They are a threat to the quality of research and the population’s trust in research. On this background, the Commission has chosen to identify less gross, but nevertheless serious criticizable circumstances, on a more general basis, without mentioning individual persons by name. As accounted for in the introduction, the Commission has chosen to concentrate its investigation on gross breaches of good research ethics, and therefore it does not have a sufficient basis for naming individuals as regards less serious, but nevertheless criticizable circumstances. Moreover, the errors concerned seem to have a certain general incidence, i.e. that the criticism is more related to systems rather than individuals since the deviations to a certain degree must have been known to and therefore apparently accepted by management. The Commission is of the opinion that identifying individuals in such a situation easily will give a distorted impression. As the Commission sees it, it is the duty of the institutions to ensure an appropriate training, organization and monitoring of the institution’s activities, including the research activity. It must be an unconditional requirement that statutes,

regulations and work instructions are made known among the employees and that a certain regular monitoring that the rules are in fact complied with is maintained. In the Commission’s opinion this would imply simple measures which would not be very cost demanding for the management and not very invasive to the researchers. It should be noted here that an evident improvement of these circumstances has occurred over the last years. The Commission will present more specific suggestions for development measures in Chapter 8.

Where criticism of institutions is concerned, the threshold for critical remarks is thus set considerably lower, both in relation to the gravity and the standard of proof of breaches. As regards the “system criticism” the Commission has elected to voice the impressions that it is left with, although the impressions are based on an incomplete and therefore more uncertain basis. The appointing bodies have, as opposed to individual persons, not been given the opportunity to respond to this criticism either. The Commission will nevertheless point at some systematic errors and flaws, because research institutions, and not only those directly involved, probably have a few things to learn from this case and the circumstances disclosed in its wake.

It is the Commission’s hope that the institutional criticism will be perceived as constructive measures for improvement which may enhance the quality and trust in research in the long term.

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