June 02, 2006 MHRA investigation into 'elephant man' drug trailOrganisation: Parexel
Analysis and commentary by Echo Research. Click here for full-size graph Last week's publication of the official report into the 'elephant man' drug trials brought scant comfort to Parexel, the organisation behind the "disastrous" (Guardian, 26/5) testing of drug TGN1412. Finding that the negative effects of the drug, which left six healthy adults with mutiple organ failure and swelling, were due to an unexpected biological effect rather than any error by Parexel, the report criticised sloppy administration procedures, a lack of adequate training and experience of staff, no 24 hour cover, inadequate insurance cover and a delay in appropriate counter treatment. Damming, but not enough for the claimants' solicitors, who branded the investigation a sham and claimed the next day's headlines: "Victims fury over elephant drug 'whitewash" (Daily Mirror, 26/5); "Drug test review is 'whitewash'" (Daily Telegraph, 26/5). Central to criticism was that the investigation had been undertaken by the MHRA, the drug industry's own watchdog, with inevitable question marks over its impartiality. "Today's report is inadequate and completely misses the point" was an independent drug expert's view (bbc.co.uk, 25/5). With calls for an independent review of the MHRA, it seems that the side effects from this ill-fated drugs trial will be felt by victims and industry alike for some time to come. |
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