This is the first part of a two part series on clinical trial fraud from Johanna Ryan, with part 2 next week. Jo is RxISK’s clinical trial and shoddy clinical practice sleuth – see The Maintenance Man.
Recently the U.S. Department of Justice called attention to a small but worrisome crime wave. Health care fraud is a familiar feature of American life that may account for up to $230 billion per year, or 10% of health-care spending.
In Florida, it’s been called the unofficial state sport.
This particular crime wave involved medical research fraud. In some cases the subjects never had the disease being studied or took the new drug to treat it. In others, those subjects didn’t exist at all.
I found out about this crime wave, not from the daily news, but from the law firm of King & Spaulding – attorneys for GlaxoSmithKline (GSK) and other major drug companies. K&S focused not so much on stopping the crime wave, as on advising its clients how to “position their companies as favorably as possible to prevent enforcement actions if the government comes knocking.” In other words, to make sure someone else, not GSK, takes the blame.
Here’s a brief roundup:
Miami pediatrician Yvelice Villaman-Bencosme founded Unlimited Medical Research and was the primary investigator for its clinical trials. In November 2020 her study coordinator, Lisett Raventos, pled guilty to health care fraud charges; in January, the doctor herself followed suit.
Dr. Bencosme was sentenced to 63 months, Raventos to thirty. Another employee, Jessica Palacio, was charged in May 2021.
Bencosme and her staff conducted fraudulent research on behalf of “an unnamed pharmaceutical company” by fabricating data in a clinical trial of an asthma medication in children ages 4-11.
The unnamed drug company was GSK and the product was its wildly profitable Advair Diskus inhaler. The study, dubbed VESTRI, aimed to test the safety of Advair Diskus in children.
Unlimited’s subjects were real children – mainly Dr. Bencosme’s own patients at her Sacred Heart family-medicine clinic. Most, however, were not real subjects. Dr. Bencosme simply used their names and identifying data to create fake records of study visits that never happened and meds that were never given.
In August 2020, eight people were arrested for research fraud at Clinical Research Solutions (CRS) outside Cleveland. They included Dr. John Panuto, an allergy and immunology specialist and CRS’ principal investigator; Amie Demming, the CEO; and three of Demming’s relatives in Tennessee and Las Vegas.
The charges involve completely imaginary patients enrolled in at least eight trials for major drug firms. “Roll up your sleeves and get to work” had a whole new meaning at CRS: Rather than recruiting patients who had the diseases being studied, employees allegedly used their own Social Security numbers and middle or maiden names to create fake patient records, backed up with their own blood and urine samples.
They’re also charged with spending the debit cards issued to compensate “subjects” for clinic visits.
Dr. Martin Valdes, 64, ran Tellus along with three non-physicians: Fidalgis Font, Julio Lopez and Duniel Tejada. In March 2021, all four were indicted on federal health-care fraud charges.
Like the Ohio defendants, Font and Lopez allegedly used data from family and friends to create profiles of fictional research subjects. Dr. Valdes, meanwhile, used data from patients at his Hialeah general-practice clinic, Healing Touch C&C, who were not actually enrolled in the trials.
Tellus took part in five trials through July 2016, including two that tested a new buprenorphine implant for opioid addiction and one large trial of a drug for diabetic kidney damage (CARMELINA).
An even more audacious fraud scheme, first uncovered in 2018, was not widely publicized by the DOJ or the media. We’re indebted to the Tri-City Herald in Washington’s Yakima Valley for most of what we do know.
Sami Anwar, 42, was convicted of multiple fraud charges in 2019 and was sentenced to 28 years in prison. Anwar, a medical-school graduate from Pakistan who lacked a U.S. license, operated an outpatient clinic called Zain Medical Center with a few local doctors. His first clinical-trials venture, “Zain Medical Research,” used the name of his partner, Dr. Cheta Nand, as principal investigator.
After gross irregularities were spotted in Zain’s work on two Pfizer studies, Dr. Nand was barred from future research contracts, and Zain Research shut down. Anwar simply re-incorporated as Mid-Columbia Research, borrowing the name of a second doctor, and worked on another half-dozen clinical trials before the racket was discovered.
Some Zain Medical Center patients had actually enlisted in studies and taken the drugs. The results could be scary: A teenaged girl taking Pfizer’s Chantix for smoking cessation was hospitalized for a suicide attempt. A three-year-old suffered permanent scars while testing an ointment for a skin disease she did not have. And several subjects were enrolled in two of Anwar’s drug studies at once, including one man whose death was not reported to study sponsors.
These were not criminal masterminds, or scientific ones either. The fraud schemes were crude, almost clownish. Anwar was perhaps the cleverest – but when the feds finally arrived at his Yakima Valley research center, they found him squeezing injectable drugs down the sink and stuffing his desk drawer with unused opioid painkillers.
Yet all these people were working for multinational drug companies, doing the kind of research that gets published in top peer-reviewed journals. The kind of research that your doctor and mine rely on when deciding what treatments we ought to have.
The frauds went undetected for years: CRS worked for seven companies before the eighth one noticed something wasn’t quite right. Tellus Research hummed along unnoticed until the CEO, Ms. Font, used the company account to buy herself a Range Rover.
When FDA inspections finally closed down Zain Research, Sami Anwar simply opened a new research center, in the same small town, at the same address, and was hired anew.
How the hell did that happen?
Find out next week.
Plus check out the overlaps between this and a post on the Politics of Care Forum this week – Medico-Chemical and Petro-Chemical Twins