Two Sentenced To Prison For Falsifying Clinical Trial Data
As if there weren’t enough reasons to be afraid right now, a recent criminal case against two Florida nurses alleges that they falsified clinical trial data related to a specific drug. While it may not sound like a crime, maybe just a breach of professional ethics, it is, in fact, fraud to forge data that will be used by the government to make key decisions on consumer health and safety.
In this case, the nurses were accused of fabricating patients for their clinical trial and submitting patient reports from patients who did not exist. One nurse has been sentenced to 46 months in prison while another will serve a 30-month sentence. The defendants will also be required to pay over $2 million in restitution.
The incident was investigated by the Justice Department at the behest of the FDA.
Wow, that’s a crime?
Yes, as a matter of fact, the FDA takes it personally when researchers attempt to move a drug through the clinical process without using the proper safeguards. Clinical trials are necessary to determine the safety of a drug, its efficacy, and any potential side effects that could occur.
If doctors cannot anticipate the side effects of a drug, what would happen? Well, in a case like this, one or several people might suffer serious side effects that their doctor could not foresee. They get sicker and their doctors may not even know why. Eventually, on a long enough time scale, the deaths and injuries related to the drug become the subject of personal injury lawsuits. The drug company is taken off guard by lawsuits related to their drugs for potential dangers that were not uncovered during clinical trials.
So, what exactly is the crime?
The crime is forgery or uttering forged documents. Making a fake Honus Wagner baseball card is not forgery. Selling the fake baseball card as real, however, that is forgery. In this case, the faking of dating and then the submission of that data as real is a basic, if rare, form of forgery. Mostly when we think of forgery, we’re thinking of counterfeiting money, fake checks, or identity theft. But you can also forge scientific documents and it constitutes a crime, especially when the results are going to be submitted to the FDA.
In that regard, forgery is no different than submitting false information on a loan application to secure a loan for which you would otherwise not be entitled. The forgery here was conducted to expedite the FDA’s approval of the drug.
While you don’t hear many cases of this type of forgery in the news, perhaps because it’s a fairly boring news article, you have to wonder how often it happens and whether or not it was just plain luck that caught the defendants.
Talk to a West Palm Beach Criminal Defense Attorney
If you’ve been charged with falsifying your scientific data, you should know that you’re in deep trouble. Call the West Palm Beach criminal attorneys at The Skier Law Firm, P.A. today to schedule an appointment to discuss your situation in more detail.