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



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4.3 After the presentation of the thesis


After having defended his thesis at the University of Oslo on March 9, 2001, Jon Sudbø continued his scientific activity, within the same field, i.e. oral cancer. This resulted in a series of scientific original articles, reviews, readers’ letters and the like, which were published currently in several renowned medical journals.

In connection with the publication of the research results in New England Journal of Medicine 2001, Reith and Sudbø in a letter to the Norwegian Board of Health wrote that the research results should lead to a changed practice as regards screening and treatment of patients with white patches in their oral cavities in Norway. By this, many patients could be saved, was the allegation. They also mentioned the need for a prospective study. The Board of Health replied that they did not have any opportunity to reorganize treatment practice in Norway, due to a lack of resources, among other things. The Board of Health also referred to the fact that support for a prospective study would had to be applied for to other quarters.37

Concurrently with the publication of New England Journal of Medicine 2001, Dagens Medisin [an independent newspaper for the health sector] on April 26, 2001 reported a “Breakthrough in the battle

against oral cancer”. “Between eighty and ninety percent of all cancer developments can be predicted by chromosome analysis” Sudbø is supposed to have stated to the newspaper.

In an editorial written by Scott M. Lippmann and Waun Ki Hong (with whom Sudbø subsequently initiated a collaboration) in New England Journal of Medicine 2001 in the same edition of the journal, the study was called an important progress as regards the assessment of the risk of oral cancer for patients with leukoplakia. The editorial states:

“The new molecular data have important implications for the standard of care of patients with oral

leukoplakia. Local management ranges from watchful waiting to resection with widely varying margin

widths, depending on histologic and clinical features. Molecular information can redefine the assessment of

the risk of oral cancer and even guide treatment, with the one important caveat that the molecular results

involving patients with severe dysplasia in the studies we have discussed may have been confounded by the

small numbers of such patients and the likelihood that they underwent more rigorous surgical procedures

than did the patients with mild or moderate dysplasia. It is time to establish standard molecular assays to

help plan the management of oral leukoplakia. … Confirmation of the completeness of resection, close

monitoring, and chemoprevention trials would be appropriate approaches for patients deemed at high risk

on the basis of molecular assays, including patients with hyperplasia.38
In 2001, Jon Sudbø applied to the Cancer Society for money for the project ”Early diagnosis and treatment (chemo prevention) of early stages of oral cancer” for 3 years. The application was denied.

At the same time he also applied to Health and Rehabilitation [a foundation granting money to voluntary organizations and efforts to improve physical and mental health in Norway] via the Cancer Society for funds to the project “Protocol – prevention of oral cancer”. He obtained funds for this project for the years 2002-2004. He was later on also granted funds for 2005.

In 2001-2002, Jon Sudbø also came in contact with American researchers within the same specialist field. Reith and Sudbø met with Scott Lippmann from MD Anderson personally for the first time in November 2002 during a conference in Frankfurt. According to Reith, it was Lippmann who suggested the collaboration which was initiated. This collaboration led to several publications in leading medical journals, as for example New England Journal of Medicine in 2004 and The Lancet in 2005, see section 5.3.

Thus, in 2001 Jon Sudbø had started the work with what was to become part of a big project application to the National Cancer Institute (NCI) in the USA. The project was granted 10 million dollars, of which most went to MD Anderson in the USA.

The Commission will revert in more detail to this PROTOCOL study in section 5.3, but will first account for the consequence of the main conclusion in 4.2.10 for other publications.

4.4 Other publications


In the following, the Commission will deal with the articles suffering from such substantial defects and doubts that they cannot be considered valid, and for that reason should be retracted. The Commission has reviewed the 38 publications which resulted from an individual search for Jon Sudbø in January 2006 in the PubMed data base,39 see Annex 1. The Commission realizes that this publication list is not exhaustive, but has nevertheless found reason to base itself on the list as it in all probability comprises the most important works. Sudbø has not commented on the draft for this section in particular, but refers to the comments cited above.

The Commission refers to the main conclusion in section 4.2.10 and to the general account of retraction of scientific publications in section 3.6.

In the following, the Commission will deal with the publications in which the Commission has found errors and the like. Of most interest are Sudbø’s original articles, totaling 12. By an original article is meant that the article comprises original research results which are not presented previously. It is such articles that are the most important and most meritorious within the research communities. When reviewing the PhD dissertation which contains 6 original articles, the Commission previously found that three original articles must be retracted, whereas no errors were found in three original articles, cf section 4.2. In this section will be held that a further 5 original articles must be retracted or at least be subject to an expression of concern for their validity. This means that 8 out of 12 works appear as more or less invalid. Out of Sudbø’s original articles there are only the three first articles in the PhD dissertation that are found not to contain errors, see section 4.2.5, as well as a less sensational article published in Oral Disease 2003.40 Accordingly, there is a basis for stating that the essential parts of Jon Sudbø’s scientific production suffers from errors and flaws caused by scientific dishonesty.

The publications which are not found to contain errors, apart from four original articles, mainly concern lesser reviews and letters of less scientific value, as well as works in which Jon Sudbø has only been a coauthor, i.e. publications which mainly have been prepared by others.


• Sudbø J, Warloe T, Aamdal S, Reith A, Bryne M. Diagnostikk og behandling av

forstadier til munnhulekreft [Diagnosis and treatment of oral precancerous lesions]

Tidsskr Nor Laegeforen 2001;121:3066-71. Overview article.
The article is an overview article that summarizes results from Sudbø’s articles included in his PhD degree. The article is therefore based on raw data which the Commission has found are manipulated and partly fabricated, cf section 4.2.

The article must therefore be retracted.


• Sudbø J, Kildal W, Johannessen AC, Koppang HS, Sudbo A, Danielsen HE, Risberg B,

Reith A. Gross genomic aberrations in precancers: clinical implications of a long-term

follow-up study in oral erythroplakias. J Clin Oncol. 2002;20:456-62. Original article.
The article asserts that it is based on analyses of a material that has not been used in previous publications. The PhD dissertation states that material from 263 persons was collected and that 21 of them were excluded from the original study due to having red patches in their oral cavities (erythroplakias). It is persons with erythroplakia that have been studied in this study. In the method part it appears that the material comprises 57 samples with human biological material from 37 patients with erythroplakia collected in the period 1988-2000.

The Commission here refers to the fact that it has not found any indications that these raw data exist.

In its other findings, the Commission has found that so much doubt is linked to whether these raw data in fact exist that it is reasonable to apply a large question mark to this article.
• Sudbø J. [DNA ploidy analysis--a possibility for early identification of patient with risk

of oral cancer] Läkartidningen. 2001;98:4980-4. Review.


The article is a review of Sudbø’s own research results. That means that it is based on the raw material which the Commission has based itself on, cf section 4.2. The article must for this reason be retracted.
• Reith A, Sudbø J. Impact of genomic instability in risk assessment and chemoprevention

of oral premalignancies. Int J Cancer. 2002;101:205-9. Review.


The article is a review which is based on Jon Sudbø’s earlier research results,

which again are based on raw data that are manipulated and partly fabricated, cf

section 4.2. The article must for this reason be retracted.
• Sudbø J, Reith A. Which putatively pre-malignant oral lesions become oral cancers?

Clinical relevance of early targeting of high-risk individuals.

J Oral Pathol Med. 2003;32:63-70. Review.
The article is a review which is based on Jon Sudbø's earlier research results,

which again are based on raw data that are manipulated and partly fabricated, cf

section 4.2. The article must for this reason be retracted.
• Sudbø J, Reith A. When is an oral leukoplakia premalignant?

Oral Oncol. 2002;38:813-4; author reply 811-2. Debate contribution.


The article is a review which is based on Jon Sudbø’s earlier research results,

which again are based on raw data that are manipulated and partly fabricated, cf

section 4.2. The article must for this reason be retracted.
• Sudbø J, Ristimaki A, Sondresen JE, Kildal W, Boysen M, Koppang HS, Reith A,

Risberg B, Nesland JM, Bryne M. Cyclooxygenase-2 (COX-2) expression in high-risk

premalignant oral lesions. Oral Oncol. 2003;39:497-505. Original article.
The study is based on an analysis of the raw data which form the basis for parts of the PhD work and which are manipulated and partly fabricated, cf section 4.2.

The article must therefore be retracted.


• Sudbø J, Bryne M, Mao L, Lotan R, Reith A, Kildal W, Davidson B, Soland TM,

Lippman SM. Molecular based treatment of oral cancer.

Oral Oncol. 2003;39:749-58. Review.
The article is a review based on the raw data collected during the PhD degree work and which are manipulated and partly fabricated, cf section 4.2.

The article must therefore be retracted.


• Sudbø J, Lippman SM, Lee JJ, Mao L, Kildal W, Sudbo 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;350:1405-13. Original article.

The article is based partly on the raw data collected in connection with the PhD degree work and which the Commission has found are manipulated and partly fabricated, cf section 4.2. See in particular under section 4.2.7 in which the Commission accounts for the comparison of the data list used in New England Journal of Medicine 2001 and New England Journal of Medicine 2004. In addition the article is based on a follow-up of the same patients which did not take place. The latter fact is partly admitted by Sudbø to the Commission.

The article must therefore be retracted.
• Sudbø J, Reith A. The evolution of predictive oncology and molecular-based therapy for

oral cancer prevention. Int J Cancer. 2005;115:339-45. Review.


The article is a review of earlier research and based on material used both in New England Journal of Medicine 2001 and New England Journal of Medicine 2004. The Commission has determined that this material is manipulated and partly fabricated, cf section 4.2. The article must therefore be retracted.
• 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;23:1927-

33. Original article.


The article is based on allegedly newly collected material from 275 persons. This material is supposed to have been collected via dental clinics. The Commission has tried to obtain documentation showing that these raw data in fact exist. The Commission has been in contact with, i.a., the dentists that are listed as coauthors because they had assisted in collecting material from their patients. These dentists confirm that they were asked by Jon Sudbø to collect scrapings from patients. However, they only collected 10-20 samples each. It therefore appears as rather unlikely to the Commission that Sudbø can have had a complete data material from 275 patients. The Commission also finds it quite unlikely that these patients were enlisted in a program for smoking cessation with a further follow-up. No indications have been found that such a program was implemented. The cited dentist colleagues have difficulties in understanding that such a program existed. The Commission’s

assessment must also be seen in light of other deviations from good scientific practice which the Commission has detected.

Jon Sudbø has admitted that cotinine level was not measured for all patients that participated in the study. The latter fact alone means that the study cannot any longer be considered valid. The journal has published an expression of concern relating to this article and the editors state that with the exception of Sudbø and Reith, none of the coauthors participated in the preparation of the manuscript and they therefore do not meet the authorship criteria. In the Commission’s view, the article should be retracted.
• Sudbø J. Novel management of oral cancer: a paradigm of predictive oncology. Clin Med

Res. 2004;2:233-42. Review.


The article is a review of earlier research in which reference is made to the original raw data collected in connection with the PhD dissertation and which are manipulated and partly fabricated, cf section 4.2. The article must for this reason be retracted.
• Sudbø J, Lee JJ, Lippman SM, Mork J, Sagen S, Flatner N, Ristimaki A, Sudbo A, Mao

L, Zhou X, Kildal 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;366:1359-66. Original article.


The article is based in its entirety on fabricated raw data and is for that reason already retracted. These facts have been admitted by Sudbø. The Commission has for this reason not spent much time on investigating this article. However, the Commission got access to the correspondence between Jon Sudbø and J. Jack Lee of MD Anderson. Thereby the Commission detected how these new raw data came about, see section 5.3.

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