Richland researcher found guilty of stealing millions, endangering patients in fake clinical trials

Over a five-year period, pharmaceutical companies provided Richland-based researcher Sami Anwar with millions of dollars in exchange for the promise he would use that money to help test potentially life-saving experimental drugs.

But on Friday, a jury found Anwar guilty of doing the opposite; court documents show he instead exploited the system to enrich himself and endangered the lives of patients.

In addition to the 47-count indictment against Anwar in federal court, prosecutors have also detailed numerous incidents wherein the researcher attempted to obstruct justice by threatening witnesses and intimidating them into silence.

KAPP-KVEW examined hundreds of pages of court documents filed in this case to break down the crimes Anwar was convicted of and the impact on the patients, doctors and employees caught in the crossfire.

The scheme

In the years prosecutors say Anwar spent defrauding pharmaceutical companies, he followed a similar pattern. First, he’d create a medical research company and impersonate a real doctor to apply for clinical trials.

Anwar would then use those trials as a money-making scheme, enrolling as many patients as possible to rack up the payments, regardless of whether they were eligible or if it was even safe for them to participate, court documents said.

Court documents describe an intricate fabrication of research; Anwar directed his employees to falsify drug tests, lab work, vital signs, patient visits and even diary entries by patients.

Some trial patients would receive the experimental drug, while others would not. To hide the evidence of unused drugs, Anwar reportedly directed employees to empty syringes into the drain, squeeze tubes of medication into the trash and hoard controlled substances in desk drawers or the attic.

Prosecutors say Anwar’s fraud began in 2013, when he applied to run two clinical trials at his company, Zain Research: one to help adolescents stop smoking and another to lower cholesterol.

When Anwar submitted the applications to Pfizer, Inc. — the pharmaceutical company behind the studies — he did so using the identity of his business partner at the time, Dr. Cheta Nand. He repeatedly forged his signature and impersonated him via phone, email and in person, according to court documents.

Unbeknownst to Dr. Nand, he was listed as the principal investigator for numerous studies between 2013 and 2016, including trials covering asthma, diabetes, Alzheimer’s, multiple sclerosis, liver cirrhosis and scabies.

When Pfizer eventually became suspicious of inconsistencies in the research, they terminated all studies with Zain Research and Dr. Nand.

That’s when Anwar allegedly set up a new company in the same location, Mid Columbia Research, and found a new person to pass off as the principal investigator: Dr. Lucien Megna. Using the doctor’s name, he applied for an opioid drug trial with Braeburn Pharmaceuticals.

“Like the many studies that [Anwar] controlled before it, the Braeburn study was rife with fraud from top to bottom,” court documents said.

At the same time he created the new company, Anwar sought to expand geographically. He created another company, Bracket Trials, with another physician, Dr. Danish Jabbar, in Festus, Missouri.

“[Anwar] created Bracket Trials to essentially replicate the fraudulent scheme … in another geographic location,” court documents said.

Court documents show he repeated the same pattern again and again, skirting potential investigations and covering up evidence before audits.

At one point, he used Dr. Megna’s credentials in an attempt to get Gamma Hydroxybutyrate — commonly known as GHB or the “date rape drug” — for a separate sleep disorder study, but was unsuccessful.

It was only through an employee’s tip-off that authorities learned what Anwar had been doing and announced an audit into the Braeburn study, court papers said.

“The lead up to this audit was an active time for the conspiracy as study binders, drug accountability logs, and other documents, were altered and forged en masse at Sami Anwar’s direction in an attempt to fool the auditors,” court documents said.

But unlike other times when officials had gotten close to the truth, the employee made sure officials knew where to look for falsified documents and other irregularities.

Despite the investigation, Anwar tried to continue with a new company, GS Trials, and attempted to enlist the unwitting help of another licensed physician, Dr. Gopinath Sunil.

However, his plans fell through as federal authorities gained enough evidence to indict him and his companies on multiple charges, leading to his arrest in November 2018 and his conviction Friday.

Danger to patients

By conducting fraudulent clinical trials, prosecutors argued that not only did Anwar effectively steal millions from drug companies, but threaten the lives of the patients entrusted to his care.

Because the trials weren’t run by a licensed physician, the patients weren’t examined by a doctor prior to or during the studies to see if they were healthy enough to participate or how the drug might affect them.

In one study done by Zain Research involving diabetes, Anwar admitted people who were already taking multiple anti-diabetic medications, something that should have disqualified them.

“The study coordinator responsible for this study was concerned one of these subjects would die because [Anwar] had enrolled them in the study while they were on other anti-diabetic medication,” court documents said.

Anwar reportedly frequently enrolled subjects in multiple trials at once, not taking into account how someone might react to being on several experimental medications designed to treat different conditions, all at the same time.

One employee confronted Anwar about this, to which he reportedly replied, “If a general goes out to battle, will the soldiers let him die?” Prosecutors said that meant Anwar expected employees to lie and conceal fraud to protect him.

One patient, referred to as “W”, was enrolled in three clinical trials at Zain Research: one for Alzheimer’s, one for cholesterol and yet another for diabetes. Not only was this a violation of every clinical trial agreement, court documents say, it was also dangerous.

“W had never been properly assessed by a licensed physician regarding the extent to which he was eligible to or could safely participate in any of the studies, let alone all of them at the same time,” court documents said.

W died in March 2015 from kidney disease, which is a common complication of diabetes. At Anwar’s direction, W’s death was not reported to the study’s sponsors, according to court documents.

By faking test results used to determine if a drug is safe and effective, prosecutors argued Anwar risked putting a harmful drug on the streets or preventing a life-saving one from getting approved by the FDA.

If an adverse event happened, Anwar directed employees not to report it to the drug companies, so they could keep getting money for that patient, court documents said.

In one case, a woman in a clinical trial for a drug to treat liver cirrhosis had a menstrual period for an entire month and broke out in hives. Anwar directed staff not to report the event and to keep the woman in the trial, court documents said.

Negative impacts on the doctors

Along with the damage to unwittingly involved doctors’ reputations came problems with their abilities to conduct their own research and alleged harassment by Anwar.

After the Pfizer studies were terminated and the consequent federal inspection, Dr. Nand received a warning letter from the FDA.

“In the world of clinical research trials a warning letter from the FDA is sufficient to prevent a doctor or a site from ever obtaining another study from a sponsor again,” court documents said.

Not only was Dr. Nand disqualified from all future studies with Pfizer, other study sponsors reportedly terminated Zain Research and Dr. Nand from ongoing studies when they learned about the FDA inspection and warning letter.

On Aug. 29, 2017, Anwar reportedly confronted and physically threatened Dr. Nand, leading to his arrest.

Several days later, three of Anwar’s female employees submitted complaints –nearly identically worded — to the Washington State Department of Health claiming Dr. Nand had sexually harassed them.

At the same time, prosecutors say Anwar coerced one of the employees, A.C., to file a restraining order against Dr. Nand, which Anwar then paid for, according to court documents.

When Dr. Jabbar grew uncomfortable with the arrangement for the Bracket trials, Anwar reportedly threatened him with a false complaint and investigation as well as the loss of his medical license. He said he would prevent Dr. Jabbar from ever doing another clinical trial.

[Anwar] made good on his threat by filing a false complaint with FDA, posing as another individual … and then alleging that Dr. Jabbar was perpetrating the very fraud that [Anwar] was himself perpetrating,” court documents said.

Anwar reportedly intimidated Dr. Megna into not meeting with the DEA for several months during the investigation.

Harm to employees

An integral part of the scheme, prosecutors argued were Anwar’s employees; he reportedly targeted people who had ongoing financial difficulties, or who were less educated, single parents, had potential immigration concerns or were otherwise vulnerable.

“To accomplish his fraud … [Anwar] recruited, trained, and managed a rotating cast of well over a dozen co-conspirators and employees of his companies,” court documents said.

Anwar would train employees in a particular aspect of the fraud like “auditing”, which was really reviewing for missing documentation to be later falsified, court documents said.

“Often the employee was placed in a position that was wholly unfamiliar to them and for which they had to rely on the on-the-job training provided by [Anwar] and his co-conspirators,” court documents said.

To ensure compliance, Anwar reportedly had audio and video recording devices installed in all areas of the workplace and monitored all employee emails.

“During their employment, [Anwar] attempted to exert extreme control over every facet of the employee’s work life,” court documents said.

When employees realized what was happening, prosecutors say many wanted out. At first, Anwar would try to up the incentives to get them to stay, sometimes offering to nearly double their salary, before taking other measures, according to court documents.

“Anwar would resort to threats, frequently intimating or saying outright to unhappy employees that if they left, he would make their lives miserable and make sure they never worked in the field again,” court documents said.

Finally, if an employee was able to get out successfully, they faced retaliation, including false complaints to various regulators or to the police, threats of deportation, violence, stalking, vexatious litigation, and property destruction.

“As the investigation progressed and [Anwar] became aware that he was the target of a criminal investigation, the intensity of these threats and retaliatory actions increased exponentially,” court documents said.

Prosecutors say Anwar ratcheted up his efforts to corruptly persuade as well as intimidate those whom he assumed were or might assist law enforcement, including:

Employees L.D. & Y.R.

In February 2016, employee L.D. resigned from Zain Research over concerns about the fraud they were being asked to participate in.

Reportedly too fearful of Anwar to return to the workplace, L.D. asked another employee — Y.R.– to retrieve their personal items: a framed picture drawn by their child, a plaque from their military service and a military deployment patch.

Instead of helping in the process, Anwar called the Richland Police Department and falsely reported that confidential documents had been stolen from his business.

Anwar then confronted Y.R., the employee he’d accused of theft. L.D. explained to officers that Y.R. had just grabbed their personal items at their request. The investigating officer found Anwar’s theft claim was unfounded.

Employee J.H.

In December 2017, employee J.H. resigned from the company. Anwar responded by attempting to collect false complaints against J.H. from patients and staff.

In one case, Anwar reportedly cornered a patient who suffers from anxiety in a room with her husband and two-year-old child for 45 minutes, refusing to let them leave unless they agreed to submit the false complaint.

On the day the DEA executed its first search warrant, Anwar reportedly told another employee he was going to blame everything on J.H.

Employees J.B. & H.E.

By Jan. 4, 2018, Anwar had learned the identities of two cooperating DEA witnesses — J.B. and H.E. — after intercepting and reviewing their text messages.

A week after the search warrant was executed, the HR manager for Anwar’s company called the Richland Police Department to report that a stolen binder and prescription pills were found in J.B.’s car.

No arrests were made and no charges were referred to a prosecutor. Then, J.B. was notified by the Washington State Department of Health that a complaint had been filed against him.

“The allegations in the complaint, which placed J.B.’s license to continue practicing as a medical assistant in jeopardy, was based in part on being terminated by [Mid Columbia Research] for allegedly stealing medications,” court documents said.

A few weeks after the search warrant, H. E. had their car tires slashed. This happened six times between February 2018 and June 2018, despite H.E.’s efforts to avoid the issue by parking in different locations and even driving a different car.

Employee A.C.

After a second warrant was executed by the DEA in September 2018, Anwar went to A.C.’s new place of employment as a bank teller.

A.C. at that point, had terminated their earlier cooperation with the DEA out of fear of Anwar. Anwar asked A.C. if the DEA had contacted them.

With no answer, Anwar showed A.C. a list of five people he suspected of cooperating with authorities.

Employee D.G.

In March 2018, longtime employee D.G. resigned. D.G. had worked on multiple clinical trials in multiple capacities and had detailed knowledge of the conspiracy. Anwar showed up to D.G.’s home, entered uninvited and threatened D.G. Anwar said if he went to jail, D.G. would too.

The verdict

Anwar was found guilty Friday of conspiracy to commit wire fraud, conspiracy to commit mail fraud, 23 counts of wire fraud and 15 counts of mail fraud in connection with the payments he fraudulently elicited from pharmaceutical companies.

He was also found guilty on six counts of fraudulently obtaining controlled substances for ordering drugs for the fake clinical trials, and furnishing false or fraudulent material for falsifying the research.

Anwar is scheduled to be sentenced early next year.