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

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4.1 The cause – the Lancet article

In December 2005, Camilla Stoltenberg, Division Director at the Norwegian Institute of Public Health, read an article published by a group of Norwegian and foreign researchers in the internationally highly respected journal The Lancet in October the same year:
Sudbø J, Lee JJ, Lippman SM, Mork J, Sagen S, Flatner N, Ristimaki A, Sudbø A, Mao

W, Evensen JF, Reith A, Dannenberg AJ. Non-steroidal anti-inflammatory drugs and the

risk of oral cancer: a nested case-control study. The Lancet. 2005 Oct 15-21;366:1359-66.
While reading the article, Stoltenberg became aware of certain cited factors which she was not able to see agreed with actual facts. This was discussed with other researchers at the Institute of Public Health. The Cancer Registry, which had been stated as supplier of the cancer cases, was also contacted. The Cancer Registry further contacted Professor Lars Vatten, MD, of the Norwegian University of Science and Technology (NTNU). Vatten is among other things a member of the management group for Cohort of Norway (CONOR), to which a reference was also made in the article. CONOR is both the designation of a collection of health data and blood samples, and a collaboration between the Public Health Institute and the universities relating to regional health studies. In addition, Vatten is involved in HUNT (the Nord-Trøndelag health study). Vatten read the article and reacted to several of the discrepancies in relation to actual facts. He brought this up in an email which was sent to the first author, Jon Sudbø, on January 5, 2006. On January 10, a meeting was held with Jon Sudbø and Albrecht Reith at the Cancer Registry, at which Vatten among other persons was present. On January 12, Jon Sudbø admitted to his superiors at the Radiumhospitalet that he had fabricated the data file on which the research results presented in the Lancet article was based. This means that the alleged patients from whom the analyzed data originated, were fictitious. Jon Sudbø has later on confirmed this to the Commission. Jon Sudbø has also stated that there are deficiencies in two other articles:
Sudbø J, Samuelsson R, Risberg B, Heistein S, Nyhus C, Samuelsson M, Puntervold R, Sigstad E,

Davidson B, Reith A, Berner A. Risk markers of oral cancer in clinically normal mucosa as an aid in

smoking cessation counseling. J Clin Oncol. 2005 Mar 20;23:1927-33
Sudbø J, Lippman SM, Lee JJ, Mao L, Kildal W, Sudbø A, Sagen S, Bryne M, El-Naggar A, Risberg B,

Evensen JF, Reith A. The influence of resection and aneuploidy on mortality in oral leukoplakia. N Engl J

Med. 2004 Apr 1;350:1405-13.

The Lancet article has subsequently been retracted. Journal editors have issued so-called expressions of concern regarding the articles in Journal of Clinical Oncology 2005 and New England Journal of Medicine 2004, as well as two articles by Sudbø et al published in the same journals in 2002 and 2001 respectively.28

On this background, the Commission found reason to investigate the entire scientific activity and production of Jon Sudbø. The Commission also found reason to investigate the role of all the coauthors and other players.

The Commission’s primary task has been to map the material which forms the basis for the publications. Important questions have been:

  • Are the patients who allegedly have been studied real or fictitious?

  • Have patient data been manipulated?

  • Do serious methodological flaws exist?

  • Are there evident and serious flaws in the research reporting?

  • Are there other serious breaches of scientific practice/good research practice?

In line with these points of departure, the Commission started its work by mapping the data basis which is the foundation of Jon Sudbø’s first big scientific project, the PhD degree project. The background for this choice is that the raw material collected in connection with the PhD degree project, as well as the results thereof, has been used in and forms the basis also for Sudbø’s subsequent research.

Jon Sudbø has been presented with the draft report, i.e. what corresponds to Chapter 4 through section 7.2.1 of the prevailing report on two occasions. In a letter of May 30, 2006, he submitted a series of comments to the first draft report which the Commission has compared with information which otherwise has come to light during the investigation. The Commission has corrected the draft on points where one found a factual basis for taking account of Sudbø’s comments. However, the Commission would emphasize that these comments have not entailed any significant changes in the Commission’s assessment of the validity of Sudbø’s research work. A substantial part of Sudbø’s objections are linked to the relationship between him and his supervisor, Reith, in that Sudbø alleges that the supervisor had a much more key role in the research project than the impression the Commission has got through the investigation otherwise. The Commission

will at some places comment on diverging perceptions of the facts where this is deemed necessary. Sudbø chose not to comment on the revised draft report, sent to him subsequently.

4.2 The PhD degree project relating to oral cancer

      1. Introduction

Jon Sudbø is educated as a dentist (cand. odont.) from 1985 and medical practitioner (cand. med.) from 1994 with the very best grades. In his odontology study he came best in his class. In 1993 Sudbø, in cooperation with Professor Albrecht Reith, MD, at the Radiumhospitalet applied to the Cancer Society of Norway for funding of his PhD degree project. The study concerned finding methods to predict oral cancer. Sudbø has stated that it was Albrecht Reith who took the initiative to the project at issue. This took place by Reith making contact with Associate Professor T.Ingar Leidal at the Faculty of Odontology at the University of Oslo, to ask him to recruit a candidate to a research project on oral premalignant diseases, which Reith had been planning for some time. After this first contact in February 1993, Sudbø was contacted by Leidal, who thought Sudbø might be suited for such a project. However, Sudbø had not previously worked with this problem, which he found interesting. The first contact between Sudbø and Reith took place in February or early March 1993. The Cancer Society granted Sudbø a three year stipend, with Albrecht Reith as main supervisor. Sudbø was then from 1994 paid a salary as a recruitment fellow by the Cancer Society.

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