Posted on 03/22/2013 3:34:20 PM PDT by neverdem
A UK court has found a man guilty of illegally altering pre-clinical trial data. Steven Eaton, a former employee at drug discovery and development firm Aptuit’s Riccarton site in Scotland, produced flawed data over six years. This is the first case of someone being successfully prosecuted under current Good Laboratory Practice (GLP) Regulations. A spokesman for the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) underlines how unusual this is. ‘This type of activity is very rare and, based on the results of a significant number of inspections, we have no evidence to indicate the problem is widespread,’ he tells Chemistry World.
The MHRA started its investigations in February 2009, after Aptuit told it that a supervisor at the Riccarton site had noticed serious irregularities with Eaton’s liquid chromatography analyses. His studies provided information on drug concentrations in blood, to determine the dose given to subjects in clinical trials that assess safety and efficacy. Eaton added extra blank washes during calibration, but removed them when running analyses on test samples. That meant his analytical methods and systems appeared to be operating properly when they might not have been. Eaton's motives for fudging the calibration remain unclear. A two-and-a-half year investigation followed, reviewing hundreds of safety studies.
The investigation found Eaton’s illegal actions began in 2003, before Aptuit’s 2005 purchase of the now-closed Riccarton site from Quintiles. The MHRA and Aptuit worked to limit damage to the affected trials, and ensure bad data will not harm future medicine submissions. Eaton’s tampering meant an experiment was considered successful that had actually failed, but did not overturn any of the affected clinical trials’ results. However, trials were held back, at significant cost.
‘Mr Eaton’s actions directly impacted on the validity of clinical trials and delayed a number of medicines coming to market, including one to treat depression,’ says Gerald Heddell, MHRA director of inspection, enforcement and standards. ‘This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health.’
David Holt, who runs Analytical Services International, a GLP laboratory in St George's, University of London, stresses that it’s hard to alter data from today’s instruments. ‘For example, our LCMS tools have built in audit trails, so I would think this is a pretty isolated problem,’ he says. ‘It’s encouraging that this didn’t make a large enough difference to materially affect the clinical studies.’
Eaton will return to court in Edinburgh for sentencing on 17 April 2013.
This is crazy that this would be a criminal issue.
There is not enough info to really know what happened.
For example this article does not state if he deviated from the SOP.
If technicians are going to be criminally charged for making mistakes, that is a chilling draconian trend that will not help the pharmaceutical industry at all.
If he was knowingly doing something outside of the SOP purposefully to deliberately manipulate results, that would be fraud and criminal.
But this article doesn't state that and it implies it was criminal because GLP was not compromised.
Last sentence in 2 should be GLP was compromised.
Eaton added extra blank washes during calibration, but removed them when running analyses on test samples.
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