The UK’s regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that Steven Eaton, a former Aptuit employee, received a three-month sentence for selectively reporting analytical data over a number of years.
“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, MHRA Director of Inspection, Enforcement and Standards in a press release.
“The sentence sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health.”
The case came to the attention of the MHRA when Aptuit noticed a series of irregularities in preclinical data.
Following an MHRA-led inquiry, it was concluded that Eaton had changed or provided false data used to assess whether analytical methods were working properly or to assess the concentration of the drug in blood in a number of trials, to the extent that a failed experiment was deemed successful.
In an official statement released by Aptuit, the company said it "recognizes the importance of data integrity and remains committed to delivering the highest quality of data and services to its clients." It also pointed out that "the MHRA investigation was concluded years ago at a former site and has no effect on current operations."
Though this incident has led to delays and costs to Aptuit, as reported last month trials will not need to be redone as was the case in 2011’s fraud debacle at Cetero’s laboratory in Houston, Texas.
Furthermore, examples of manipulation of trial data are rare, according to the MHRA, and this is the regulator’s first successful prosecution under the Good Laboratory Practice Regulations of 1999.