BMJ  2006;332:1290 (3 June), doi:10.1136/bmj.332.7553.1290-a

News

Agency criticises drug trial

London

The first 150 words of the full text of this article appear below.

The failure of a drug trial that left six volunteers fighting for their lives in a London hospital cannot be blamed on the way the drug was made or administered, the final report of a government investigation has concluded. It did, however, criticise aspects of the trial's administrative procedures.

The report by the Medicine and Healthcare Products Regulatory Agency (MHRA) on events in March at the Northwick Park Hospital (BMJ 2006;332: 683, 25 Mar[Free Full Text]) concludes that an "unpredicted biological action" of the experimental antibody treatment TGN1412 caused multiple organ failure in all six previously healthy male recipients. One of the six, a 20 year old, is still in hospital two and half months later.

Despite immediate claims from victims' lawyers of a "whitewash," Kent Woods, chief executive of the Medicines and Healthcare Products Regulatory Agency (MHRA), said: "We are satisfied that the adverse incidents . . . [Full text of this article]

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

Relevant Articles

Firm involved in drug trial fiasco files for bankruptcy

Owen Dyer
BMJ 2006 333: 114. [Extract] [Full Text] [PDF]

Severe adverse reactions prompt call for trial design changes

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

Rapid Responses:

Read all Rapid Responses

Predictable Adverse Reactions in a Drug Trial

Andre E McLean
bmj.com, 9 Jun 2006 [Full text]