UK drug trial disaster: dosing was approved by regulator

The March 15 drug trial in London, UK, which left six men severely injured, was cleared not only to proceed, but the sponsors were authorized to initiate the Phase I test on all eight triallists simulaneously, according to local reports. Of the eight who took part in the trial, the two who were given placebo suffered no ill-effects, whilst the six who were given doses of TGN1412, a monoclonal antibody drug developed by German biotechnology firm TeGenero, suffered severe multiple organ failure. After 48 hours two of the men remained sedated. The drug was being tested by Paraxel (Marketletter March 20). Already, the drug indus-try and regulators are concerned as to whether the incident which took place at the Northwick Park Hospital, in north-west London, will lead to major reforms of the way in which clinical trials are carried out, or if the number of trial volunteers will fall for future tests.

Politicians concerned at public confidence in trial safety

Evan Harris, a Liberal Democrat UK Member of Par-liament who had taken part in a Phase I trial for an HIV/ AIDS vaccine in 2000, told the Financial Times that "such trials are a critical step in the generation of new treatments for human diseases." Dr Harris expressed concern that volunteers would be discouraged from taking part in future trials. Brian Iddon, a member of the House of Commons' science and technology select committee, told reporters that a review of the way that animal tests are used before humans would be necessary, given the specificity of the molecules being treated.