Doubts raised over cancer vaccine study

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Drugs: immunological products and vaccines
Cancer:other

BMJ 2001;323:184 ( 28 July )

News roundup

Doubts raised over cancer vaccine study

Annette Tuffs Heidelberg

A prizewinning German study claiming to have found a safe and effective vaccine for kidney cancer has been heavily criticised by doctors who say that the research data may have been manipulated and that the treatment could even be dangerous.

Alexander Kugler, a senior registrar in the urology department of Göttingen University Hospital, and Gernot Stuhler, an oncologist from Tübingen University, treated 17 patients with metastasising kidney cancer with a vaccine made from a hybrid of cancer and immune cells. Their study, published in March last year, reported that after vaccination four patients experienced a full remission and in three others the tumours shrank to half the original size (Nature Medicine 2000;6:332-6).

Hybrid cell vaccination, according to the researchers, is a safe and effective therapy for renal cell carcinoma and may also be helpful in the treatment of other malignancies.

Doubts about the study began to surface earlier this year when a university ombudsman committee investigated whether a picture of the cell hybrid, published in another journal after being submitted by Dr Kugler for a thesis, was valid, and whether this had any impact on the credibility of the results of the study.

The committee did not find any evidence of scientific misconduct, but it said that the picture, which Dr Kugler had declared was his own, had come from the internet and that the authors had not been sufficiently diligent in their clinical practice.

A further investigation into the research, which has so far involved over 100 patients, has been launched by the university ethics committee, and it is also being examined by the German Research Council.

The research has also been strongly criticised by the cell fusion specialist Ulrich Zimmermann from the University of Würzburg. He has written a letter to the Göttingen faculty in which he claims that the cell hybrids used in the research cannot be live and may even be dangerous for patients.

Other specialists have asked why in another study, carried out at Tübingen, the vaccine treatment was unsuccessful and why the treatment results at Göttingen were not confirmed by a radiologist, as is usual for this type of cancer.

Meanwhile Dr Kugler, Dr Stuhler, and Rolf-Hermann Ringert, the director of Göttingen's Urological Hospital, have defended the research, pointing to the number of patients in the study who have survived after the new treatment.

The German medical community is still recovering from the case of Friedhelm Hermann and Marion Brach, two formerly renowned cancer researchers who in 1997 were discovered to have committed a series of forgeries, mainly in papers on leukaemia and the role of cytokines. Both researchers were dismissed from their university posts and had to abandon their academic careers.

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