A U.K. court has convicted a former Aptuit employee of manipulating data from hundreds of safety studies, making investigational drugs seem successful when they weren't.
Aptuit ferreted Steven Eaton out through an internal review, The Financial Times reports, and the court found him guilty of violating the U.K.'s Good Laboratory Practice regulations. Eaton had been fudging data since 2003, according to the newspaper, and Aptuit has had to re-examine hundreds of study results for sponsors like AstraZeneca ($AZN) and Roche ($RHHBY).
The Medicines and Healthcare Products Regulatory Agency says Eaton selectively reported results on drug concentration and whether analytical methods were successful, FT reports, making trial results look better than they were. Cleaning up the mess was a time-consuming process, delaying drug approvals, MHRA said.
"Mr. Eaton's actions directly impacted the validity of clinical trials and delayed a number of medicines coming to market, including one to treat depression," MHRA's Gerald Heddell told the paper. "This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health."
The conviction comes on the heels of concern that CROs lack oversight from the sponsors. In December, the Access to Medicine Foundation released a report finding that very few drugmakers could provide evidence that they'd ever disciplined contractors that ran afoul of ethics codes. Industry group ACRO begs to differ, however, saying that the industry model gives contract researchers far more to lose in the event of questionable data.
- read the FT story (reg. req.)