ALSadvocate - Congratulations on getting your comment posted this time. I think it was because it was directed to @WST and not to admin. Never call admin out. LOL
Take a look at this great clinical trial. The FDA finally got around to taking some action in 2016 even though this happened in 2008. The man involved has a history of fraud and convictions. The FDA won't even release the name of the doctor involved without a FOIA request. Everyday, Retraction Watch has articles about fraud and misconduct in the scientific community. Perhaps, it's time for researchers involved in clinical trials to undergo background checks and get licensed and approved.
http://retractionwatch.com/2016/03/21/fda-bans-trial-coordinator-who-pocketed-patient-funds-and-went-to-prison/
FDA bans trial coordinator who pocketed patient funds and went to prison
The U.S. Food and Drug Administration (FDA) has permanently debarred a clinical trial coordinator from working on drug applications after he swapped patient stool samples for his own, and pocketed the money earmarked for patients — along with forging patient records, lab work, and doctors’ signatures.
The debarment is moot for time being — last year, Wesley McQuerry was sentenced to three years in prison
http://chicago.suntimes.com/news/man-gets-3-year-prison-sentence-for-fake-drug-study/ for his misdeeds, according to the Chicago Sun-Times.
The FDA’s debarment, effective March 18, provides more details:
…between January and October 2008, Mr. McQuerry created fifteen to twenty fictional patients, whom he claimed were participants in the clinical trial. Mr. McQuerry 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.
He pocketed more than $2000, but cost the pharmaceutical company much more, according to the FDA:
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 to patients. Instead, between approximately July 11, 2008 and September 3, 2008, Mr. McQuerry deposited over $2,300 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.
We asked Kenny Shade, in the Division of Enforcement, Office of Enforcement and Import Operations, Office of Regulatory Affairs at the FDA, why pocketing $2000 could cost the company more than $200,000, and he explained it’s because the drug company has to re-gather all the data McQuerry falsified:
Any falsified data cannot be used to approve the drug, but the company still paid and they have to incur that loss.
According to the Sun-Times:
[The prosecutor] noted that had the flawed drug study — which took place at a North Side clinic — not been uncovered, it could have tainted data the Food & Drug Administration uses in its drug-approval process.
The drug McQuerry was testing was intended to help treat HIV-associated diarrhea. McQuerry, himself, suffers from HIV.
McQuerry has gotten himself in trouble before: According to the Sun-Times, he lied on his resume to get the job, and has already been to prison after embezzling more than $350,000 from DePaul University while working in the alumni relations department. And:
McQuerry has a history of fraud that includes convictions for ghost pay-rolling and credit card fraud schemes.
Even though McQuerry apparently told the judge “I just didn’t know what to do, I was under stress . . . I accept responsibility,” he was also ordered to pay $200,000 in restitution.
Here are the specifics from the nature of the ban from the FDA:
The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Wesley A. McQuerry from providing services in any capacity to a person that has an approved or pending drug product application.
The FDA has also apparently taken action against the doctor in charge of the trial, the Sun-Times notes:
The FDA has since taken disciplinary action against the doctor in charge, who was concurrently running about a dozen other studies.
An FDA spokesperson told us we’d need to file a Freedom of Information Act request for further information about the identity of the doctor in charge of the trial, and the nature of the disciplinary action.
Shade told us that McQuerry remains in prison, and is scheduled to be released in 2017.
