Jail for man in data trial
pharmafile | April 19, 2013 | News story | Sales and Marketing | MHRA, Scientist
A British scientist has become the first person to be jailed under the Good Laboratory Practice (GLP) Regulations 1999 for altering pre-clinical trial data.
Steven Eaton, found guilty at Edinburgh Sheriff’s Court last month, was sentenced to three months in prison following his prosecution by the Medicines and Healthcare Products Regulatory Agency (MHRA).
“The sentence sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health,” said Gerald Heddell, MHRA director of inspection, enforcement and standards.
“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,” he added.
The court found that over a number of years from 2003, Eaton – an ex-employee of Aptuit – had selectively reported data used to see whether analytical methods were working properly or to assess the concentration of a drug in blood.
In effect his manipulation of data meant that experiments which had failed were actually deemed to have been successful.
The MHRA was alerted by Aptuit to ‘serious irregularities’ and its subsequent investigation led to the review of hundreds of safety studies in a bid to ensure that compromised data was not used in future submissions.
“Following a full assessment by the MHRA’s inspection team and assessors it was concluded that the data integrity issues did not invalidate the results of the clinical trials that were affected,” MHRA said in a statement.
However, his actions did lead to delays and increased study costs.
Responsibility for adherence to GLP principles is devolved, which means the UK GLP Monitoring Authority (GLPMA) consists of the secretary of state for health, the National Assembly for Wales, the Scottish Ministers and the Department of Health and Social Services for Northern Ireland.
GLPMA sits within the inspection, enforcement and standards division of the MHRA.
Adam Hill
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