“Here’s a rule of thumb; too clever is dumb.” Unfortunately, eight people didn’t follow Ogden Nash’s rule of thumb and are now facing a 19-count criminal indictment for falsifying records of clinical trials of investigational drugs and lying about it to FDA.
The 60-page indictment was returned by a grand jury in the Northern District of Ohio, Eastern Division, and charges the defendants with criminal conspiracy, mail fraud, wire fraud and violations of the Federal Food, Drug, and Cosmetic Act. In plain English the defendants are alleged to have falsified records of subjects in clinical trials and billed pharmaceutical companies for work that was never done. The indictment does not name the seven drug companies that were the victims of defendants’ conduct. Instead, they are identified only as Sponsors 1 through 7.
Several of the defendants are related to each other by blood or marriage. For example, Amie Demming was President of Company 1 (the indictment does not provide the company’s name nor was any company indicted.). Also indicted were Demming’s mother, Debra Adamson who was Vice President of Clinical Operations, Demming’s brother William Adamson, William’s wife Ashley Adamson, and Walter O’Malley who was described as the “romantic partner” of Demming but was not an employee of Company 1. The three other defendants were employees of Company 1 including John Panuto who is a medical doctor and was the Principal Investigator for Company 1.
Reading the examples of document falsification leads one to wonder how these defendants ever thought for a moment they could get away with this conduct. Of course, the defendants are presumed innocent and the government has to prove its case beyond a reasonable doubt but here are a couple of examples alleged in the indictment:
- A woman by the name of “Nicole A. Bockman” was enrolled in a study conducted for Sponsor 1. However, there was no such study subject. According to the indictment, “Bockman” was Ashley Adamson’s maiden name and Nicole is her middle name. In addition, “Bockman” was enrolled in the study using Ashley Adamson’s correct date of birth and social security number. Debra Adamson signed the informed consent form attesting that she had obtained the informed consent to participate in the study from “Nicole Bockman.”
- “Hank W. Bobart” was another subject enrolled in the same study. According to study records he had the same date of birth and social security number as William Adamson. The real William Adamson signed the informed consent form attesting that he had obtained informed consent from “Hank Bobart.”
- The indictment alleges that Sponsor 1 paid Company 1 approximately $760,000 to conduct this study.
There are many more allegations of a similar nature involving the six other Sponsors. The indictment also alleges that the defendants knowingly made false statements to FDA. This is certainly not the first time companies have submitted false information to FDA but thankfully those are rare events. It also appears that in this case no drugs were approved and sold to consumers based on the studies “conducted” at Company 1.
As noted above one of the defendants is named Walter O’Malley. That name brings up memories of a long-deceased man of the same name who was the owner of the Brooklyn Dodgers baseball team which he moved to Los Angeles in 1956. For this treachery O’Malley was despised in Brooklyn . There was a joke at the time about what a person should do if he found himself in a room with O’Malley, Hitler and Stalin and he had a gun with only two bullets. The correct answer was to shoot O’Malley twice to make sure he was dead.