Munich

A university investigation has found the lead author of a contentious German cancer study guilty of gross negligence, but has cleared his 14 co-authors of misconduct.

The study, led by Alexander Kugler, formerly of the University of Göttingen, was published two years ago in Nature Medicine (A. Kugler et al. Nature Med. 6, 332–336; 2000). It claimed that kidney cancer could be treated using a vaccine made from tumour cells fused with healthy dendritic cells from the immune system.

But the university launched an investigation into the paper after allegations that Kugler and another co-author had included a picture downloaded from the Internet in another paper submitted for publication (see Nature 412, 8; 2001).

In a statement issued on 12 November, the University of Göttingen said that the Kugler paper “fails to meet the requirements of good scientific practice”. It added that data in the study were handled incorrectly, and that information relevant in judging the vaccine's efficacy — such as whether the patients had received alternative treatments — was missing from the study.

Among other problems that were identified by the university's task force was the false claim that the vaccinations had been carried out under a clinical trial approved by an ethical committee. In fact, they were individual treatments which were later subsumed into a study for publication.

But the task force firmly apportions the blame to Kugler, who has since left research, and whose whereabouts is unknown. The 14 co-authors, including the heads of the university's institutes of urology and nephrology, Rolf-Hermann Ringert and Gerhard Müller, received only mild reprimands in the university's statement. The task force's full report has not been released publicly, pending comment from Kugler's co-authors, but the university says that a copy is being sent to Nature Medicine.

“I am taking this very seriously,” says Beatrice Renault, editor of Nature Medicine, adding that she will need to read the report in full before deciding what course of action to take over the paper.

Despite doubts about the initial study, at least 400 patients have since been treated with the vaccine by Ringert and Müller. The results of these treatments have not been made public — but according to an unpublished analysis obtained by Nature, there were no significant tumour regressions among the 100 or so patients treated in Müller's department. Ringert, who has treated more than 300 patients, declines to comment on the vaccinations, saying that the results have not yet been fully analysed.

Ulrike Beisiegel, vice-dean for research and ombudswoman at the University of Hamburg, criticizes the slow release of information about the case. “It is urgent that all relevant information be revealed,” she says. Beisiegel adds that the episode reflects deep-seated ethical problems in German clinical research.

Meanwhile, the DFG, Germany's main research funding agency, has announced its own investigation into the Kugler paper. Reinhard Grunwald, the agency's secretary general, says that it will seek to build on the university investigation and establish both the vaccine's therapeutic effects and the degree of responsibility borne by all of the authors of the paper.

The Göttingen research was supported by Fresenius, a biotechnology and healthcare company that is based in Bad Homburg, Germany, which is expected to obtain approval shortly for a fresh study of the vaccine's efficacy.