The Clinical Trial from Hell

A number of British papers are reporting on a drug trial gone horribly wrong in London:

Friends and relatives of six men left seriously ill after a clinical drug trial went wrong yesterday spoke of their horror. The girlfriend of one of the victims said he looked "like the Elephant Man" after he and the five other medical guinea pigs had a violent reaction to the drug on Monday.

One of two medical test volunteers who escaped unscathed after being given a placebo also described the horror of watching those given the real drug go "down like dominoes". Two of the men remain critically ill and the other four are still in a "serious" condition in the intensive care unit of Northwick Park Hospital, Harrow, north-west London, following the leukaemia treatment trial.

Fellow volunteer Raste Khan, 23, said: "First they began tearing their shirts off complaining of fever, then some screamed that their heads felt like they were going to explode. "It was terrifying, because I kept expecting it to happen to me at any moment." Last night the drugs company involved apologised to the families of the six men who developed potentially life-threatening side-effects while taking part in the trial.

But questions were raised as to whether all six victims had been given the experimental TGN1412 drug at the same time - against guidance in the Textbook of Pharmaceutical Medicine, which says such practices can be "difficult to manage" and "put subjects at unnecessary risk". Professor Gary Slapper, of the Open University law programme, said that even though the drug-trial participants had probably completed consent forms, that did not mean they had signed away their rights to sue if there had been negligence.

The six men were admitted to the ward from an independent medical research unit on the hospital's campus after taking part in the trial, for which they were reportedly to be paid £2,000. The drug, known as TGN1412, is made by pharmaceutical company TeGenero AG, based in Wurzburg, Germany. It is intended to fight leukaemia, rheumatoid arthritis and multiple sclerosis.

TeGenero AG's chief scientific officer, Thomas Hanke, said the firm was "devastated" at the "shocking developments" in tests of a medicine which had shown no previous safety problems.

Have we learned anything from Gelsinger?
- Art Caplan