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Six in hospital after clinical trial disaster

UK regulator begins investigation to establish how drug caused such a serious reaction

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Six in hospital after clinical trial disaster
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UK drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) has begun an investigation into why six male volunteers in a clinical trial were rushed to intensive care with multiple organ failure after taking a new anti-inflammatory drug.

Two of the patients were said to be in a critical condition, while the other four's condition was described as ìserious but stableî.

The MHRA will investigate several possibilities such as whether the drug was contaminated, whether there had been a dosing error or whether the men's reaction was simply a side effect of the drug.

MHRA inspectors will visit the independent medical research unit on the Northwick Park Hospital campus, where the trial took place. The agency said it was working with North West London Strategic Health Authority, the Department of Health and the Metropolitan Police.

The phase I safety trial of the drug, TGN 1412, was run by contract research organisation Parexel on behalf of German pharma company TeGenero AG.

It was the first human test of the drug, which is a monoclonal antibody being developed to treat conditions including rheumatoid arthritis and leukaemia.

The MHRA has suspended trials of TGN 1412 and alerted other drug regulatory bodies around the world.

ìAn event like this is quite unprecedented,î said MHRA chief executive officer, Kent Woods. ìThere are several possibilities as to what might have gone wrong. We've had inspectors on siteÖ trying to clarify what exactly the event was that caused this disaster.î

Parexel said its team at the London unit had followed guidelines to the letter and had worked in cooperation with the intensive care doctors to ensure that the volunteers were given the best possible care.

ìSuch an adverse reaction occurs extremely rarely and this is an unfortunate and unusual situation,î said Professor Herman Scholtz, head of clinical pharmacology at Parexel.

TeGenero CEO, Dr Benedikte Hatz described the events as ìcompletely unexpectedî and insisted that they did ìnot reflect the results we obtained from initial laboratory studies which enabled us to progress investigations into human volunteers.î

A section on the website recruiting volunteers for trials at the Northwick Park unit is entitled `What's in it for you?' and answers the question by offering participants a free medical check up, payment, free food for the duration of their stay and telling them they will have 'plenty of time to read or study, or just relax, with digital TV, pool table, videogames, DVD player and now FREE internet access'.

30th September 2008


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