Sami Anwar was arrested on November 8, 2018. Prior to that, on November 6, 2018, the Grand Jury returned a 47-count Indictment charging the Defendant with, inter alia, devising and perpetrating a fraudulent scheme and artifice, referred to in the Indictment as the Mid-Columbia Research Fraud Conspiracy, to enrich himself by falsifying research data for human clinical trials, including a clinical trial for a medical study designed to prevent and lower opioid use and addiction. Below we summarize the court documents and exhibitions of this shocking case, which were accessed via publicly available sources as well as unpublished exhibits sent to TrialSite News directly from the United States District Court Eastern District of Washington.
This story is not one being readily covered by industry news sites. We first introduced the matter here and here and have also provided a timeline of the fraudulent clinical research operation. Our concern centers on the possibility of similar schemes occurring elsewhere in the United States and beyond.
Extreme Obstruction of Justice
In a desperate attempt to keep this illicit operation going, as detailed in the indictment (filed November 8, 2018), the Defendant repeatedly attempted to obstruct justice. His obstruction included the “intimidation of multiple cooperating witnesses and therefore is part-and-parcel of the danger he poses to the community.” Since Anwar became aware that he was being investigated by the Drug Enforcement Administration (DEA), he engaged in “multiple and repeated attempts to obstruct justice designed to manipulate and intimidate those who cooperate with the investigation.” These, as outlined in the indictment, include:
- Attempting to frame his then employee and cooperating witness for theft and possession of prescription medication after learning the identity of that cooperating witness;
- Instructing his employees and former employees to not cooperate with the investigation, to provide false information, and to change phone numbers to evade being contacted by law enforcement;
- Threatening the lives of certain of his current and former employees by claiming to have close ties to known international drug lords and terrorists in his native Pakistan.
Anwar’s threats and intimidation have had real consequences and placed multiple people in fear of their lives and the lives of their families. Thankfully, bail was denied as he attempted multiple times to flee the country and is deemed a danger to the public. The U.S. Marshals have him in custody until his March 11, 2020 sentencing before Senior Judge Ed Shea. Anwar faces a maximum of 20 years in prison for each of the 47 fraud counts.
The full extent of the consequences of Anwar’s action may be incalculable. Some, however, are certain and are listed in the indictment as below:
“The Defendant continues to engage in the ongoing falsification of research data for human clinical trials in order to enrich himself. The precise breadth of this ongoing fraud is not fully known to the investigation and includes multiple different human clinical trials presenting the danger of loss to multiple research sponsors. Even more concerning, because these unwitting and to some extent unknown research sponsors rely on the fraudulent data to justify FDA approval of various drugs, the fraud presents a particularly acute danger to the public at large regarding potential FDA approval of various different prescription drugs. Moreover, it is highly likely that this ongoing suspected fraud, just as with the fraud charged by the Grand Jury, includes falsifying medical records of actual patients. This aspect of the Defendant’s ongoing fraud also poses a significant, insidious, and ongoing safety risk to the community as most if not all of the patients are believed to be unaware that their medical records are being falsified and therefore are unreliable for use by any future medical provider attempting to treat them. In addition, the Defendant’s ongoing fraud facilitates the unlicensed practice of medicine at his medical clinic. This, of course, poses a grave and ongoing danger to the public.”
We should all be relieved to hear that, as declared in the indictment, “the weight of the evidence against the Defendant as charged is substantial and involves multiple cooperating former employees with direct knowledge of the fraud. In addition, the voluminous materials seized from the Defendant’s business by the DEA fully corroborate their statements in particular and the Defendant’s fraud in general.” There is no way someone like Sami Anwar should ever be able to get away with this grand and dangerous of a scheme.
Even more terrifying was our discovery that in United States v. Hir, the court was concerned that the defendant had previously sent his brother money knowing that he had affiliation with terrorism and violence. In addition, The Defendant’s past conduct shows that lying to authorities in order to get his way, including retribution against former colleagues, is part of his standard operating procedure.
In the indictment, the court considers the nature and seriousness of the danger to any person or the community posed by the Defendant’s release. While the concept of danger certainly includes potential violence, and typically focuses on crimes of violence, in fact, white-collar crimes pose serious dangers. We couldn’t agree more. It is a precarious thin line that separates street crimes from white-collar crimes, and this Defendant transcended the lines.
Call to Action: In contacting the United States District Court Eastern District of Washington where this case was tried, we were able to access witness names and other unpublicized information. For any pharmaceutical sponsors that would like to learn from this experience, understand how to detect fraud and any other illicit activities associated with clinical research sites, this case provides valuable but painful lessons.