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

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The time interval

In New England Journal of Medicine 2001 it is stated that the material originates from the period 1982 to 1995, whereas in the two other articles and in the dissertation it is stated to originate from 1976 to 1995. The correct time interval is unclear. According to the Cancer Registry it is supposed to be 1976 to 1995. In a letter from February 1, 1996 from Sudbø and Reith to Gisle Bang at Gade, it is stated that the material from the Odontology originates from 1984-89. In an undated letter, probably from the beginning of 1996, from Bang to Reith and Sudbø reference is made to the Gade material originating from 1981-95. In a letter from Sudbø to the Cancer Registry dated February 20, 1996, it is referred to the patients having been diagnosed 1984 up to 1995. It is surprising to the Commission that there is no conformity between the years stated. Nor is there any conformity between the stated period of time for collection in New England Journal of Medicine 2001 and the other articles.

Sudbø has denied to the Commission that there are discrepancies and “obvious errors” in the various datings, and has alleged that the total material is from 1976-1995, and that it is probable that some blocks taken before 1982 have been excluded because prior to 1982 it was not usual to use buffered formalin at the fixation of tissue blocks, which are less suited to hydrolysis and Feulgen coloring.

The ambiguities existing in relation to the time intervals are however, in the Commission’s opinion, inaccuracies of such a nature that they are apt to impair the reliability of the publications.

The material from the Odontology

Sudbø states that via Reith he got access to patient material from the Odontology represented by Hanna S. Koppang. Reith has stated that he, as far as he can recall, asked Sudbø to contact professor Kjærheim at the Odontology who is supposed to have advised Sudbø to contact Koppang. According to his statement, Reith did not collect any material from the Odontology. It is somewhat unclear how many patients are involved. Sudbø states that the material was sent in several turns, and comprised patients with leukoplakias as well as erythroplakias. The Commission has not found original copies of cover letters or data lists from the Odontology which can document how many and which patients are involved.

Nor can the Commission see that any participant’s consent or dispensation from the duty of secrecy exist for the delivery of the patient data, although this was a requirement for delivery of patient information subject to secrecy, see section 4.2.4. The delivery thus appears to be contrary to the set of rules enforced at that time. The University of Oslo has not been given the opportunity to comment on this fact, see sections 2.4.6 and 7.3.2.

Hanna S. Koppang, who was responsible for the pathology at the Odontology, cannot remember to have delivered material to Sudbø during the relevant period either. But the Commission can for that reason not conclude that the material was not delivered to Sudbø or Reith, since Koppang’s statement is marked by failing recollection from this period.

Sudbø has asserted that it is surprising that professor Koppang allegedly does not remember to have delivered clinical material to Reith and Sudbø. He has stated that in the offices of Reith and Puntervold there is supposed to be lists sent from professor Koppang which allegedly shall show the number of patients, the number of lesions per patient, grading of dysplasias, transferred to carcinoma in situ as well as the time when these were sent. According to Sudbø, Koppang sent leukoplakias in several turns, then erythroplakias, although in a far smaller number, since these are far more rare than leukoplakias. Sudbø also alleges that he (“we”) has sent the total biopsy specimens from Gade to Koppang for classification/grading of dysplasias, and that lists of this are supposed to exist with Reith or Puntervold. The Commission has submitted this information from Sudbø to Ruth Puntervold and Reith, asking whether they have seen or have had access to files, cover letters and the like which can shed light on what Sudbø has received from the Odontology and Hanna S. Koppang. Puntervold states that she received the blocks with marking of block id., and that this was the basis for the journal L 34 which was established for the preparation of ploidy samples from the Odontology. Apart from this, she has no knowledge of Sudbø’s contact with the Odontology. Reith says that he now cannot find lists,

cover letters or the like. However, it should be noted that Koppang has provided the Commission with access to a list which shows that some patient samples were delivered to Sudbø in 2001. In this respect, the material from the Odontology which allegedly forms the basis for the PhD work, appears as being difficult to check.

However, the letter from Sudbø and Reith to professor Bang at Gade dated February 1st, 1996, states that Sudbø and Reith has from “… Odontology institute for pathology, the University of Oslo, been lent 83 biopsies from 63 individuals, taken in the period 1984-89. About half of these are biopsies sent by dentists from Eastern Norway, Middle Norway and North Norway. The other half is biopsies taken at the Clinic for Oral Surgery and Oral Medicine at the Faculty of Odontology, the University of Oslo …”.

Moreover, Sudbø has stated to the Commission that 63 persons seem to tally. The figure 63 persons from the Odontology seems also to be in accordance with the Commission’s and the Cancer Registry’s own investigations. A list that the Cancer Registry made in 2006 after having themselves obtained and entered personal identification numbers for the patients who had names and dates of birth only, shows 132 observations divided on 62 different persons, which means that 70 of the observations are duplicates.31

Accordingly, the Commission finds that Sudbø originally and basically had access to patient data and material from around 63 different persons from the Odontology in Oslo.

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