News roundup

Germany may change drug testing rules after debacle in England

Heidelberg Annette Tuffs

After the catastrophic events at Northwick Park Hospital, in London, last month, when six volunteers became severely ill in a phase I trial, German experts are discussing stricter regulations for trials. The reason for the severe adverse events is unclear, and one of the six male volunteers was still being kept heavily sedated as the BMJ went to press this week (BMJ 2006;332:683, 25 Mar).

Originally, Parexel, the contract research organisation running the study, had planned to carry it out in Berlin but moved it to London because approval from the Medicines and Healthcare Products Regulatory Agency, the UK regulatory authority, came through earlier than approval from the Paul-Ehrlich-Institut, the German federal agency for the use of biological medical products.

Germany is involved, however, because the trial was commissioned by a German company, the small biotech firm TeGenero in Würzburg, northern Bavaria, which was started several years ago by scientists from Würzburg University. The drug was manufactured for TeGenero by one of Germany’s largest drug companies, Boehringer Ingelheim.

Johannes Löwer, head of the Paul-Ehrlich-Institut, which is near Frankfurt, said that like the Medicines and Healthcare Products Regulatory Authority, his institute did not find any indications pointing to the risk of severe adverse effects at the time and that the trial was also approved by the Berlin ethics committee.

The Paul-Ehrlich-Institut is currently considering forbidding simultaneous testing of high risk monoclonal antibodies in phase I trials, in favour of the safer option of administering any product to one volunteer at a time.

Meanwhile, the manufacturer of the administered antibody TGN1412, Boehringer Ingelheim, has issued a statement saying that the antibodies were produced according to specifications given by TeGenero and handed over to the firm for research purposes. Before the trial started, documentation and the release were checked again.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

Related Article

Severe adverse reactions prompt call for trial design changes

Susan Mayor
BMJ 2006 332: 683. [Extract] [Full Text] [PDF]