TeGenero Clinical Trial
In March 2006, a PAREXEL-run trial on behalf of TeGenero, the now bankrupt German biotechnology firm, on its anti-inflammatory drug TGN1412 to treat rheumatoid arthritis, multiple sclerosis or leukaemia, unexpectedly caused severe inflammation and multiple organ failure in six healthy volunteers at a facility based at Northwick Park Hospital in London. The drug had been tested on animals but this was the first test on humans.PAREXEL became the target of legal proceedings from lawyers representing the injured volunteers after the insurance policy of TeGenero was unable to provide sufficient compensation. When the liable company subsequently declared bankruptcy, lawyers for the volunteers initiated legal proceeding against PAREXEL and the two parties later entered into talks; the results of this meeting have not been made public.
A documentary shown in the UK on 28 September, 2006 featuring journalist Brian Deer as part of Channel 4's Dispatches series exposed uncertainty about the existence of data that should mandatorily have been submitted by TeGenero to the Medicines and Healthcare products Regulatory Agency (MHRA) prior to the trial indicating whether TGN1412 had been adequately tested on human blood in vitro. Concerns were also raised about whether a safe human dosage was properly obtained by TeGenero. The MHRA however concluded that none of the companies involved could be held responsible for the outcome of the test and that the adverse events that occurred were most likely caused by an unpredicted biological action of the drug in humans .
Adapted from the Wikipedia article Parexel, under the G. N. U. Free Documentation License. Please also see http://en.wikipedia.org/wiki
