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



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5.4 Questions are raised in relation to the ploidy classifications


In the summer 2005, Jon Sudbø was contacted by Bjørn Risberg who wanted to use the raw material on which Jon Sudbø’s PhD work was based in another study. In this connection, Risberg repeated parts of the ploidy classifications. It appeared that these in no way agreed with the classifications on which Sudbø had based his work. Risberg, together with Eva Sigstad, pointed this out to Sudbø in a letter dated August 3, 2005, at the same time as they asked to be delivered the data material used as basis. In the letter is stated:
“We have now made up the results from our automatic measurement of your previous M41 study (on oral mucosa biopsies) and compared with the results you arrived at by automatic measuring. The results are as follows:




Manual

Automatic

Same ploidy result

Diploid

29

36

18

Tetraploid

15

14

6

Aneuploid

13

7

1

Unsuited/no block no.

24

24




Total

81

81

25

There is a large discrepancy between the results. The cause of this can be several:



  1. wrong rendering of the data in the data bases

  2. measuring errors; degenerated (“old”) material in the automatic measurement

  3. differences of method between manual and automatic

It is essential to find the cause of the discrepancy. Further automatic measurements will otherwise be without value. We would appreciate hearing your views on this problem.”
The Commission will comment to this that Risberg’s and Sigdal’s measurements are in harmony with the Commission’s previous findings under section 4.2.7, in the sense that Sudbø’s measurements do not agree when they are checked. In the Commission’s opinion, Risberg’s and Sigdal’s letter is striking, by showing conformity in only 25 out of 81 measurements. It is obvious that this was a very serious and dramatic accusation against a research colleague in spite of the neutral wording of the letter. In the Commission’s conversation with Risberg it appeared that by going further into the raw material for ploidy analyses, it appeared that there was an acceptable conformity between the automatic and manual measurements (which was the original purpose of Risberg’s investigation) and that any discrepancy would have to be explained by an exchange of patient identification. According to Risberg, the latter was never clarified.

According to Risberg, Sudbø tried to explain away all of this, and said he would put things straight, but this never happened. Risberg brought this up with the department manager, Jahn Nesland, but nothing came out of it. At this time, the Radiumhospitalet was busy with a very demanding merger with the Rikshospitalet.

Jon Sudbø contests this presentation, and asserts that it was a joint evaluation by himself, Risberg and Reith which led to the reclassification. The Commission does not believe Sudbø’s explanation on this point. Also Reith has confirmed that, when Risberg wanted to reclassify the material, it proved difficult to obtain the material from Sudbø. After several reminders, Reith suggested that Risberg wrote a letter to Sudbø to make him give priority to obtaining the material. Finally, Reith did obtain agreement from Sudbø for a meeting, a meeting that Sudbø nevertheless did not attend. The letter from Risberg and Sigstad of August 3, 2005, was unknown to Reith until the case was discovered in 2006.

As regards the choice and involvement of coauthors to works produced in a later phase, where Sudbø was more established as an independent researcher, it is, like in the first phase, typical that these coauthors have had marginal knowledge of the raw material. At the same time, Sudbø surrounded himself with a sufficient number of persons for his project to appear as legitimate. It seems to the Commission as if the coauthors to a large extent were used to legitimize what Sudbø did. It is also typical that the coauthors have had little or no contact among themselves; it is Jon Sudbø who had the full control of what each of them knew, and to what each of them had access. In several cases, the coauthors did not see the final draft of articles, and many of the coauthors were very little involved in the writing of the manuscript itself.


5.5 External factors


In compliance with its terms of reference, the Commission has examined and evaluated whether external causes can have contributed to the breaches of good scientific practice that have been discovered. It may be a question of several causes, as for example the relationship to external cooperating research institutions, including the pharmaceutical industry.

The Commission has evaluated such factors, but has not found grounds for believing that external factors of this nature contributed to the breach of good scientific practice. Nor has the Commission discovered actual facts which have provided reasons to implement more extensive and in-

depth investigations on this point. For example, the Commission does not find it likely that Jon Sudbø produced research data and results commissioned by the pharmaceutical industry.

However, the Commission cannot entirely disregard as a possible cause that Jon Sudbø may have been driven by a wish to satisfy express or unspoken needs, wishes or such like from international cooperation partners, including the pharmaceutical industry, with ensuing honor and recognition, as well as financial support to new research projects. The Commission cannot exclude that interests of this nature to some extent may be an explanation (motivating factor) on the background of the NSAID findings, i.e. the cardiovascular results in the Lancet article. These were results that were sensational and potentially useful to several international main players within the development and manufacture of medicines.

Moreover, there is reason to point out that the type of dishonesty that manifests itself in, i.a., the NCI application and the Lancet article is possible precisely because one cooperated with external institutions with insufficient knowledge of the situation in Norway.

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