By Hannah Cleaver

BERLIN (Reuters Health) - A programme in which more than a million babies were screened for cancer has ignited a controversy in Germany after initial reports suggest it has done more harm than good.

The newspaper "Sueddeutsche Zeitung" carried a report on the test programme, which involved 3.5 million babies around 12 months of age. More than a million of the infants were tested for early signs of neuroblastoma, a quick-growing cancer that arises in nerve tissue and is more common in infants and children than in adults.

The report, compiled from several abstracts due to be presented at a cancer conference in Berlin but which have not been published, concluded that all fatalities in the test group were connected with therapy rather than cancer.

The early signs of neuroblastoma can be detected in urine. The parents of 1.5 million children in six German states were asked to send a urine sample to researchers for testing while urine from a further 2 million or so was collected for comparison ("controls").

Analysis of the tests, which were conducted between 1995 and 2000, showed that there was a tendency to over-diagnose the tumours. Of those given positive results from the urine tests, around two thirds, or 100 infants, were cases where the cancerous cells would have disappeared without treatment.

"While these children and their parents would have lived a carefree life without the early diagnosis, they were labelled with this verdict of 'cancer,' with all the psychological consequences it brings," ran the article published on Tuesday.

"Apart from that, the children often had to undergo operations and chemotherapy which they would have been spared without the early diagnosis. For some children, the therapy was more dangerous than the tumour itself," it said.

In his abstract leaked to the newspaper, Dr. Freimut Schilling of the Olga Hospital in Stuttgart wrote, "We were able to show that a considerable over-diagnosis was observed." He concluded that, "At the moment, neuroblastoma mass screening cannot be recommended as a general health measure."

His colleague, Claudia Spix, a statistician at Mainz University, wrote in her conclusion, "The ethical dimension of this result is highlighted by the fact that all deaths observed so far in the screen-detected group were in localised stage at diagnosis and therapy related."

When approached for further explanation or comment after the article was published, none of those involved in the study would comment.

Reuters Health was told that some of the figures had to be corrected slightly and that all would be revealed at a press conference next month.