12/01/2020
Photo by Tingey Injury Law Firm on Unsplash
On October 1, a man from Richland, Washington was pronounced guilty of 47 counts of fraud and drug-related charges. Sami Anwar faces more than 28 years in federal prison according to the U.S. Justice Department’s Eastern District of Washington.
Back in November, Anwar was found guilty of defrauding pharmaceutical companies out of over 5 million dollars for his supposed research on testing experimental drugs. His list of crimes includes mail fraud, wire fraud, conspiracy, supplying false information to the Drug Enforcement Agency (DEA), and fraudulently obtaining controlled substances.
Anwar created companies to feign legitimate clinical research trial sites and provided false data regarding drug efficacy and safety to pharmaceutical companies and to the Food and Drug Administration (FDA) between the years of 2013 and 2018. As part of the plan, Anwar would pose as a medical doctor and also forged signatures of doctors he employed. His employees were threatened and stalked to prevent them from cooperating with investigating authorities.
In 2013, a monitor from one of Anwar’s sites familiar with the Seattle area noticed there was an address that did not exist in a subject’s medical records. An investigatory monitor was then deployed to determine if there was any hard evidence of fraudulent activities. Between the monitor’s findings and those of the sponsor’s Quality Assurance department, there was sufficient evidence to close the site. The closure triggered an Institutional Review Board (IRB) investigation which led to an FDA investigation. Eventually, enough evidence was found to lead to a criminal investigation ending in an arrest.
Anwar violated numerous U.S. laws and regulations covering good clinical practice (GCP). His false safety data concerning dozens of different drugs infiltrated the public health system and thereby endangering lives.
Proper monitoring protocols shed light on the fraudulent behaviors of a clinical site and also contributed to apprehending a criminal. Following GCP and proper monitoring guidelines is paramount to ensuring data integrity and subject safety in clinical trials. Clinical Pathways offers various trainings on GCP which can be accessed in our store, linked here.
-The Clinical Pathways Team
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