Steve Eaton, the former Aptuit employee convicted of manipulating data from hundreds of drug safety studies, has been ordered serve three months in jail, the first such sentencing under the U.K.'s tightened research regulations.
Eaton's sentencing follows the revelation that he had been selectively reporting study results since 2003, forcing Aptuit to re-examine trials for sponsors like AstraZeneca ($AZN) and Roche ($RHHBY). For years, Eaton made results look better than they were by picking and choosing data on drug concentration and analytical efficacy, according to prosecutors, and the resulting clean-up process forestalled drug approvals, the U.K.'s Medicines and Healthcare Products Regulatory Agency said.
The U.K. is using the case to reaffirm its commitment to good laboratory practice laws, the BBC reports, and Eaton's sentencing came alongside a strong rebuke from Sheriff Michael O'Grady.
"You failed to test the drugs properly--you could have caused cancer patients unquestionable harm," O'Grady said at a hearing, quoted by the BBC. "Why someone who is as highly educated and as experienced as you would embark on such a course of conduct is inexplicable."
MHRA Director Gerald Heddell told the news service the conviction sends a message that the U.K. will not tolerate CROs and pharmas that run afoul of GLP in the interest of speeding along regulatory processes or pleasing shareholders.
While Eaton's case is isolated and was only discovered because of an Aptuit internal review, the underlying worry that CROs lack oversight is widespread. Last year, a Access to Medicine Foundation survey found that very few sponsors could cite instances in which they'd disciplined CROs for violating ethics standards. For its part, industry group ACRO says the worry is overstated, pointing out that reputable CROs have too much to lose to be lax about ethics enforcement.
- read the BBC story