Over the last several months, we have been exploring various types of medical-related fraud and the common themes that lead to criminal prosecutions. Clinical research trials of experimental pharmaceutical drugs has recently become a hotbed for fraud, and doctors and test subjects are unknowingly getting caught up in these schemes.
Companies conducting clinical research trials are subject to strict protocols and procedures which must be scrupulously adhered to. Licensed doctors must participate in the trials as the “Principal Investigator” and supervise the administration of the experimental pharmaceuticals and the testing procedures. This doctor will be the one responsible for the accuracy of the research data transmitted to the Contract Research Organization (CRO) which acts as the intermediary between the clinical research lab and the pharmaceutical companies. However, many doctors are lulled into a false sense of security by the clinical research facility operators, who do not strictly follow the required protocols or fabricate data.
Participants in the trials, known as “subjects” are supposed to be located through radio, tv, and digital advertisements. After responding to an advertisement, they must satisfy “inclusion criteria” to determine if they have the specific medical condition which the drug being tested is designed to remedy. If accepted into the clinical research trial, they are compensated for their participation. Many of these individuals, similar to other frauds we have covered in the past, are approved despite not genuinely qualifying under the terms of the trial. In other cases, a patient is informed they did not qualify, but their identity is fraudulently used and fabricated test data is submitted to the CRO. The more participants the clinical research facility enrolls in the study, the more money the research facility can receive.
Whether it is a doctor or subject, participants can unknowingly participate in a fraudulent scheme involving manufactured or inaccurate research data in exchange for money. This can subject them to a criminal investigation and possible criminal charges being filed against them.
This type of fraudulent scheme has garnered attention from prosecutors and law enforcement due to public safety concerns. If clinical research data is false, medicines can conceivably be approved and prescribed to the general public which are ineffective or possibly dangerous. It is no wonder that clinical research trial fraud is a priority of law enforcement.
This blog is simply an overview of this type of fraudulent scheme, which is far n=more complex than described here. If you are involved in clinical research trials, or are under investigation for possible criminal responsibility, Contact Barry M. Wax, Attorney at Law, and get the legal advice you need.