Just over a year ago, TrialSite introduced the exploits of the fake principal investigator named Sani Anwar, owner of Zain Research and Mid-Columbia Research, to a much wider audience. Industry publications and online media, for the most part, shunned the story. It’s as if the egregious criminal breach raised a collective industry embarrassment. The 41-year-old finally had justice served: 47 counts of fraud and drug-related charges and 28 years in prison. Back in November, TrialSite reported the defendant was found guilty of defrauding pharmaceutical companies out of several million dollars as they entered into contracts with his deceptive trial site operations for conducting clinical trials. Why the pharmaceutical company sponsors or their contract research organizations (CROs) didn’t identify the red flags earlier to stop this fraud cannot be certain. But suffice to say some very large and sophisticated pharmaceutical companies, and at least one prominent CRO, were completely duped, and in the process, clinical trial participants were put in harm’s way.
“Goodfellas meets Catch Me If you Can” in Clinical Research
TrialSite noted, “Hollywood could not have created a worse character: a crooked, manipulative actor that established elaborate schemes to defraud clinical sponsors of millions, place patients at grave risk and ruin the reputations of innocent doctors. Employees who dared ask questions were bullied and threatened.” TrialSite suggested that Mr. Anwar represented a real-life mix of “the Goodfellas” and “Catch me if You Can” in the world of clinical trials investigation. The Richland, WA-based clinical investigator received millions of dollars during a multi-year run, where he established what amounted to fraudulent clinical trial centers to illegally run clinical trials involving what were, in some cases, life-saving drugs, not to mention controlled substances. That’s right, Anwar even managed to secure himself access to a controlled substance license from the federal government.
As reported recently in the local press by David Mann with Yaktri News, Anwar spent from 2013 to 2018 operating sham trial site operations, including Zain Research and Mid-Columbia Research. The individual, originally from Pakistan, posed as a legitimate trial site operation to manipulate and deceive pharmaceutical companies and their CROs into signing up and conducting clinical trials in this part of Washington State. TrialSite breaks down the criminal spree and ongoing deception here.
A Dangerous Situation the Industry doesn’t Discuss
The evidence presented at trial showed that Anwar and his organizations pushed false safety data directly into the public health system, involving dozens of drugs and medicines associated with cardiovascular, diabetes, asthma, adolescent smoking, cirrhosis, scabies, depression, and opioid addiction, among others. Daniel O’Connor, the founder of TrialSite News, commented, “The scale and breadth of the deception was frankly unbelievable.” O’Connor continued, “The TrialSite received an email requesting that the story be taken down.” The founder declared, “no way!”
“We launched TrialSite News to advance research by introducing a platform that tracks clinical trials, the process, and breakthroughs, or mishaps in an unbiased and impartial way.” Why? “Because the lack of collective public trust in research is a big problem and there needed to be a channel that could be open, engaging, and timely for critical research topics of the times.” He continued, “We were amazed that there was so little reporting in the pharmaceutical industry on this very material and important unfolding situation. Many lives were put at risk by this operation. It evidenced material gaps in the site qualification process. How could this individual have duped so many companies?”
U.S. Attorney General Point of View
William Hyslop, U.S. Attorney General, took the time to provide some clarity on the resolution of the Anwar case noting, “Every day, Americans rely on the data from clinical research trials to keep us safe from deadly diseases and dangerous side effects.” He continued, “The ongoing COVID-19 pandemic, and the vital ongoing clinical trials currently being conducted with regard to therapeutic treatments and vaccines, reminds us every day how critical clinical research trials are and how important it is that they be conducted honestly and reliably. Injecting fraudulent and corrupt data into the system is an egregious breach of the trust and faith that we all place in those who perform these vitally important trials.”
‘Catch me if you Can’
In ‘Catch me if you Can: Poser Investigator Bills Big Clinical Sponsors, Dupes CRO, While Endangering Patient Lives,’ TrialSite drilled down into this situation, speaking with members of the court administration and even reaching out to some of the witnesses.
TrialSite suggested the case raised significant challenges with the current research process. In a competitive race for investigators and patients, not to mention meet aggressive study startup and closeout timelines, hundreds of millions, billions collectively, are at stake. But in the rush to get ahead and prove results, companies and society can fall behind.
Transparency Part of the Answer
The industry still maintains multiple silos and manual processes for investigator records and site qualification processes, exposing openings for crooks and con artists to exploit the gaps, gain confidence, and ultimately pull off the con, such as what happened here in Washington.
Of course, overall, this big fraud is an anomaly, and an overwhelming number of investigators and site operations are committed to patient safety, quality, and integrity, as well as the goal of the underlying study. Unfortunately, it only takes a few bad apples to make for even less trust in the process. But suppressing the information and pretending things like this don’t occur isn’t part of the solution. Transparency must certainly be incorporated into how society’s new medicines are produced and tested.
Call to Action: Check out the latest story in the Yaktri News.