FDA bans clinical trial co-ordinator who faked patient samples and stole funds
pharmafile | March 22, 2016 | News story | Manufacturing and Production, Medical Communications | FDA, HIV, clinical trials, faked, forgery, mcquerry, prison
The US Food and Drug Administration has permanently banned a clinical trial co-ordinator who was found to have falsified patient consent forms, forged doctors’ signatures and pocketed more than $2000 in the process.
According to the Chicago Sun-Times, Wesley McQuerry was jailed for three years for his crimes last October but the FDA’s announcement of his debarment from any further participation has highlighted new aspects of the case.
The FDA report states: “Specifically, between January and October 2008, Mr McQuerry created fifteen to twenty fictional patients, whom he claimed were participants in the clinical trial. [He] falsified signatures of those patients on consent forms and falsified doctors’ signatures on medical evaluations for those patients. He provided his own blood, stool, and EKG results, which he claimed were provided by the fictional patients.
“He also transmitted false data and information to the administrator regarding these fictional patients and made and caused to be made false statements regarding their participation in the study and attendance at office visits, all of which he knew would be provided to the pharmaceutical company and to FDA.”
McQuerry’s fraud caused a great loss for the pharmaceutical company at the centre of the trial according to the FDA. The report continues: “As study coordinator, Mr McQuerry was responsible for disbursing gift checks, which were provided by the pharmaceutical company to patients at various points during the patients’ participation in the clinical trial. Mr McQuerry falsely and fraudulently claimed to have disbursed gift checks when, in fact, no checks were disbursed.
“Instead, between approximately July 11 2008 and September 3 2008, [He] deposited over $2300 of gift checks into his personal bank account. He additionally used the gift checks to make direct purchases at various retailers. Mr McQuerry’s fraud resulted in a loss of approximately $200,098 to the pharmaceutical company.”
The prosecutor in the clinical case noted that had the flawed drug study not been uncovered, it would have tainted the data that the FDA would have based their decision on.
In addition to his prison sentence and debarment, McQuerry was also ordered to pay $200,000 in restitution, according to the Chicago Sun Times.
Sean Murray
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