Drug trial horror

A very special case of a drug trial where a terrible adverse effect was not observed in animal testing under even higher dosage:

A catastrophic drug safety trial which left six healthy volunteers fighting for their lives was the result of “a powerful pharmacological effect of the product in humans”, the UK government agency charged with investigating the incident said on Wednesday. The novel drug, called TGN1412, caused multiple organ failure in the six men injected with it at a Northwick Park Hospital, London, UK, on 13 March.

The severe patient reaction in the first human phase I safety trial of the drug was not due to a dosing error, product contamination or manufacturing problems, and the trial was conducted properly according to the agreed protocol, the Medicines and Healthcare products Regulatory Agency (MHRA) said, announcing its interim findings.

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One thought on “Drug trial horror

  1. MHRA – In whose Interests?

    The recent TeGenero drug trial debacle was an accident waiting to happen. As long as the Pharmaceutical Industry continues to suppress clinical trial data the MHRA (Medicines and Healthcare products Regulatory Agency) will walk blindly and feed the British public false information.

    News this month that GlaxoSmithKline knowingly withheld clinical trial data from the MHRA regarding the top selling anti-depressant drug Seroxat will add further fuel to the fire and hopefully push for an independent review into how the MHRA could be duped into believing that a drug they have reviewed on numerous occasions was safe.

    The MHRA are made up of medical experts, some of whom are former employees and shareholders of the pharmaceutical companies they grant licenses to. Surely this is wrong and at the very least there is the suspicion of a conflict of interest?

    For too long now the MHRA have been hoodwinked by the Pharmaceutical Industry. Lawsuits for damages in respect of harm caused to patients are popping up all over the place, but avoid media and public scrutiny because they are usually settled out of court on the proviso that evidence is not made public.

    A public enquiry is needed to examine how the MHRA is run and why former Pharmaceutical Industry directors are allowed onto the board. Would a convicted drink driver be allowed to adjudicate on a road safety panel?

    The MHRA need to pull the plug NOW on their close associations with the Pharmaceutical Industry. The British public expects and naively assumes impartiality and not a regulatory authority whose main interest seems to be one of ‘delivering jobs for the boys.’

    Mr Robert Fiddaman (Group Moderator of the Online Seroxat Support Group)

    Birmingham, UK

    http://fiddaman.blogspot.com/

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