Aptuit Employee Busted and Jailed for Clinical Trial Data Scams
April 22nd, 2013 // 3:11 pm @ jmpickett
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Last week, an ex-employee from the clinical research organization (CRO) Aptuit was given 3 months in jail. His crime was altering pre clinical trial data that was part of applications to do various types of clinical trials. This news came from the United Kingdom’s Medinces and Healthcare Regulatory Agency. MHRA stated that this was the first time ever that GLPs were used to conduct this type of prosecution.
As was reported last month, an investigation was started on Steven Eaton when Aptuit found major irregularities in preclinical data and it let MHRA know about it. Going back to 2003, Eaton was selectively reporting data that was utilized to see if analytical methods operating correctly, or to check the concentration of drugs in the subjects’ blood. The manipulation of this data made it sure that the experiment would be seen as successful. In reality, the experiment failed, according to the MHRA.
These criminal actions led to major delays in development for many new medicines and it cost several sponsors millions of dollars in extra costs. Aptuit reviewed several hundred safety studies to check on how the manipulation affected drugs, and to also make sure that the bad data was not used in subsequent submissions without the knowledge of the company.
Eaton’s actions had a negative effect on clinical trial validity and delayed several medicines getting to the European market. One of these drugs is intended to treat depression. The idea behind the sentence, according to MHRA, is to make sure people understand that the agency does not hesitate to prosecute people whose actions have harmed the public health.
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