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Adeline Siew is the editor of Pharmaceutical Technology Europe. Adeline Siew joined the editorial team of Pharmaceutical Technology and BioPharm International in 2012. She has a pharmacy degree from the University of Strathclyde and a PhD in Pharmaceutics (Drug Delivery) from the School of Pharmacy, University of London, where she also did her post doctorate research. She previously worked as an editor at IMS Health and BioMed Central before joining Advanstar’s Pharm Sciences group.
Steven Eaton, a scientist working for Aptuit, a US pharmaceutical company, has been jailed three months for falsifying preclinical safety data on experimental anticancer drugs due for clinical evaluation.
Steven Eaton, a scientist working for Aptuit, a US pharmaceutical company, has been jailed three months for falsifying preclinical safety data on experimental anticancer drugs due for clinical evaluation. Eaton, 47, who worked at the company’s drug discovery and development site in Riccarton, near Edinburgh, Scotland, is the first person in the UK to be jailed under the country’s scientific safety laws. He was found guilty at the Edinburgh Sheriff’s Court in March following a prosecution under the Good Laboratory Practice (GLP) Regulations, introduced in the UK in 1999. This marks the first time the Medicines and Healthcare Products Regulatory Agency (MHRA) has successfully used GLP regulations to bring a prosecution.
Eaton, from Cambridgeshire, had been conducting preclinical studies in animals to investigate the safety and efficacy of new treatments for several drug companies, including AstraZeneca and Roche. Aptuit had been carrying out the work on their behalf.
Eaton performed liquid chromatography analyses to determine drug concentration in the blood. The results would be used to define the appropriate doses that can be safely administered to subjects during clinical trials. The court heard that Eaton had manipulated the data so that his experiments were deemed successful when they had in fact failed. Eaton’s actions could have potentially harmed cancer patients who took the drug if they had been given the drug based on his data.
“I feel that my sentencing powers in this are wholly inadequate. You failed to test the drugs properly-you could have caused cancer patients unquestionable harm. Why someone who is as highly educated and as experienced as you would embark on such a course of conduct is inexplicable,” said Sheriff Michael O’Grady in The Telegraph’s news. O’Grady said that a three-month prison term was the longest sentence he could give Eaton under the GLP regulations.
Irregularities were noticed when Eaton’s work was scrutinised and his supervisors at Aptuit alerted the watchdogs at the MHRA. The subsequent investigation found that over the six-year period from 2003 to 2009, Eaton had been selectively reporting research data and manipulating calibrations, which caused his analyses of blood samples to be flawed. He may have persuaded his colleagues that drugs were suitable for clinical trials when they were actually not.
Aptuit has stopped work on the projects that Eaton was involved in. As Eaton’s actions could lead to wider consequences, the MHRA reviewed hundreds of drugs tested by Aptuit assessing the impact of the data manipulation to ensure that the compromised data was not used in future submissions to relevant authorities without their knowledge.
Jim Stephenson, who is Eaton’s defence solicitor advocate, said that his client had been under tremendous pressure at the time apart from having trouble with his personal life. BBC news reported that Eaton had given up working as a scientist and is unlikely to return to this type of work ever again according to his solicitor. Stephenson said that Eaton had not gained financially but the court was offered no motive for why Eaton had falsified the data.
“Mr. Eaton’s actions directly impacted on the validity of clinical trials and delayed a number of medicines coming to market,” Gerald Heddell, director of inspection, enforcement and standards at the MHRA, said in The Telegraph. “This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health.”
Sir Paul Nurse, president of the Royal Society, said, “Good science is based on reliable observation and the data can only be relied upon if scientists are open and honest. People in the UK generally trust science because they know that experimentation is the most reliable route to knowledge. Anything that could be seen to jeopardise both the process and the trust it engenders is dangerous and needs to be rooted out.”