UK Man Sentenced to Prison after Falsifying Trials Data and Delaying Hundreds of Drugs
UK regulators said Wednesday that they had, for the first time ever, gotten a man sentenced to prison for his role in falsifying pre-clinical data that was meant to support the regulatory approval of several drug products.
The man, Steven Eaton, was sentenced on 17 April 2013 following an investigation by the Medicines and Healthcare Products Regulatory Agency (MHRA) into the practices of Eaton. The investigation was triggered after Aptuit, an international drug development and testing firm, approached the agency with major concerns about serious irregularities in some of the pre-clinical data in their possession.
That data is used to support regulatory determinations that a drug product is safe enough to be tested on humans in Phase I clinical testing. However, MHRA said that the irregularities in the data appeared to show that the analytical data for the medicines' concentration had been tampered with and was no longer accurate.
MHRA's statement explains that it then launched an investigation into what other studies might have been affected and by whom.
"The investigation concluded that Mr. Eaton had selectively reported analytical data over a number of years, dating back to 2003," MHRA said in a statement. "During this period he selectively reported data which was used to assess whether analytical methods were working properly or to assess the concentration of the drug in blood. The data manipulation ensured an experiment was deemed successful when in fact it had failed."
That review wound up involving hundreds of safety studies, MHRA said, resulting in significant delays for several new medicines, costing their sponsors an enormous amount of money.
"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," said Gerald Heddell, director of inspection, enforcement and standards for MHRA. "The sentence sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health."
Eaton was sentenced under the Good Laboratory Practice Regulations (GLPRs) of 1999, and is the first time MHRA had ever successfully used the regulations to prosecute someone for fraud.