Hollywood could have not created a worse character: a crooked, manipulative sociopath that established elaborate schemes to defraud clinical sponsors of millions, place patients at grave risk and ruin the reputations of innocent doctors. Sami Anwar represents a real-life fusion of “the Goodfellas” and “Catch me if You Can” in the world of clinical investigation. The Richland, WA-based clinical investigator received millions of dollars during a multi-year run where he established what amounted to fraudulent clinical centers to illegally run trials involving in some cases life-saving drugs, not to mention controlled substances. Last Friday, a jury found Anwar to be a guilty—fleecing the sponsors out of their money, endangering the lives of patients, and destroying reputations of the physicians he used. How can sponsors and CROs prevent this from happening again?

47-Count Indictment Plus

Prosecutors have detained incidents wherein the clinical investigator sought to obstruct justice—even threatening witnesses. Recently, the United States Attorneys’ Office, Eastern District of Washington published an announcement of Anwar’s guilty verdict.

What Happened?

A criminal named Sami Anwar posing as a clinical investigator went on a five-year run defrauding biopharmaceutical sponsors. The con was familiar from operation to operation. Anwar would set up shell operations with names such as Zain Research, Mid Columbia Research, and Bracket Trials. Anwar would find real doctors that he would dupe, manipulate or even just steal their information, so that he could sign up with biopharmaceutical companies to participate in their clinical trials. Anwar would then recruit as many patients as possible and, at times, even threaten their health by not following any protocol inclusion and exclusion criteria.  He had employees fraudulently fake documents—from trial binders to patient records. He was finally stopped after three years as employee tipsters notified authorities who first demanded an audit and later secured enough incriminating evidence to prosecute. His sentencing is forthcoming.

The Zain Research Story

Based on investigative journalism from YakTriNews (KAPP-TV/KVEW-TV)

Anwar started this twisted investigator’s tale under the banner of Zain Research. By using the name of a licensed doctor, Dr. Cheta Nand, the fake clinical investigator was able to forge that doctors signatures, even impersonating them on the phone and email, and secured business with Pfizer to conduct their studies. This deceitful operation tricked the sponsors investigator qualification process. According to KAPP-TV/KVEW TV the sponsor was Pfizer. To the sponsor’s credit, it began to notice anomalies with reporting outcomes and ultimately terminated the contact. But the damage was done—the prominent American company had been ripped off and some of the trial participants were undoubtedly put in an unethical and possibly even dangerous position.

CAM 2038 Opioid Study

Anwar moved on to another scheme—this time he launched a venture called Mid-Columbia Research; he found another unsuspecting doctor to use for expropriation and identify theft, Dr. Lucien Megna, and found his next victim: Braeburn Pharmaceuticals. First, they duped the clinical research organization Medpace, according to court documents, into thinking they were a legitimate clinical investigative site. Among many other things, the sponsor entrusts the CROs to source and qualify high-quality sites to the study.

The clinical sponsor was in need of sites to recruit patients for an opioid study called CAM 2038. Anwar eagerly signed up and was accepted—duping the CRO’s investigator recruitment process as he (Anwar) falsely stated the investigator application was signed by a physician. Once he inked a deal with Braeburn via Medpace, the con continued. He illegally obtained a controlled substance license as the CAM 2038 study involved opioid alternative buprenorphine. Once the site qualification process was complete, study start up commenced and Anwar ran an efficient shop—enrolling and treating patients efficiently, with ease and in line with the commitments made to the CRO. Anwar’s operation violated informed consent principles and failed to follow the study protocol—adhering to inclusion/exclusion criteria—endangering patients along the way. The site deceptively entered data into the CRO’s electronic data capture (EDC) system and submitted documents falsely declaring that patients signed informed consent when they did not in many cases. Of course, Anwar accelerated the entire process, illegally, to obtain payment from the sponsor via the CRO, which totaled $274,642.80.

Employee Tipsters

This three-year clinical investigative fraud was ultimately stopped by mindful and caring employees that tipped off authorities to the racket. Anwar had closely alluded capture in other scenarios, so the employees made sure to tell authorities where to look for falsified records, such as illicit study binders, falsified patient logs, and the like. Authorities finally conducted an audit, which led to an investigation and ultimately a prosecution. Anwar will be sentenced to prison shortly.

Lessons Learned

Sponsors—accelerating study start-up is important but the most precious of goals include patient safety and quality. Undoubtedly, sponsors such as Pfizer and Braeburn Pharmaceuticals have many smart, dedicated, and talented resources—not to mention quality systems infused with innumerable past lessons learned. These sponsors often count on CROs who have teams of well-trained professionals to conduct clinical trials. This scam wasn’t easy to catch but there were certainly some signals or red flags that could have been considered for further diligence.  

An underlying force is the incredible pressure sponsors and CROs face to meet study start up, conduct and close out timelines. With these studies, many millions of dollars are at stake. But in the rush to get ahead, we can fall terribly behind. 

The industry still maintains multiple silos and manual processes for investigator records and the site qualification process, for example, and crooks and con artists, such as Mr. Anwar, can exploit those gaps to gain confidence of local resources and ultimately pull of their con of CROs and sponsors while seriously endangering patient safety. Most investigators are 100% committed to patient safety, quality and the integrity and purpose of the study. There are only a few bad apples but those surely can make it more difficult for the rest of us. Perhaps sponsors and CROs need to think more about investigator engagement strategies and how mission, process and system can be improved.

Source: Justice.gov

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