“Catch me if you Can” crook Sami Anwar defrauded clinical trial sponsors of millions, put patients’ lives at risk, and tainted the hard-earned stature of many innocent doctors. TrialSite News provides an introduction to this ongoing inquiry here.
“Beginning at a date unknown, but no later than on or about July 20, 2016”—is how the timeline of Sami Anwar’s criminal spree is initially chronicalized in the transcript of his hearing filed Nov 7, 2018. By looking at the official court documents, we were able to put together a rough timeline of Anwar’s 47-count indictment. We invite you to see below to get a break-down of a story no one wants to hear but everyone needs to know.
乐动体育Just to be clear, prosecutors state that “At no time relevant to this Indictment was Sami Anwar ever licensed to practice medicine in the United States.”
- Between at July 6, 2017 and the present, Defendant Mid Columbia Research LLC was a Washington State for-profit, limited liability corporation and research site with its place of business in Richland, Washington. During the entire course of the Conspiracy, beginning at least on or about July 20, 2016, Sami Anwar used Mid Columbia Research’s name, and close derivations thereof, on applications to CRO’s sponsors, and the Drug Enforcement Administration.
- On July 20, 2016, Sami Anwar submitted a “Pain Clinical Trial Questionnaire” to Medpace and Braeburn setting forth its intent to participate as an individual research site as part of the CAM 2038 Study.
- On or about November 8, 2016, Sami Anwar entered into a Clinical Trial Agreement with Medpace, with Braeburn as the intended third-party beneficiary, to perform a study regarding CAM 2038.
- The Clinical Trial Agreement with Braeburn and Medpace was falsified and forged bearing Dr. Doe’s purported signature, dated November 8, 2016.
- Defendants (Anwar), and other conspirators known and unknown to the Grand Jury, knowingly and intentionally created and submitted to Braeburn and Medpace a false and forged form FDA-1572, Statement of Investigator, bearing Dr. Doe’s signature, dated November 9, 2016.
- In December 2016, Medpace and Braeburn requested from Mid Columbia Research the mobile number for Dr. Doe, whom they believed to be the investigator. Instead of being provided the legitimate number for Dr. Doe, they were given the number for one of Sami Anwar’s cellular phones.
乐动体育It appears that Anwar and Medpace went into agreement pretty quickly, right? Especially for a study involving morphine and hydrocodone—Schedule II controlled substances. And this wasn’t the only study to involve controlled substances—in 2016, the FDA permitted Flamel Technologies (Flamel) to proceed with a study involving the use of a form of GHB on subjects suffering from narcolepsy, a sleep disorder. Flamel then contracted with INC Research, a CRO located in Raleigh, North Carolina, to conduct the GHB Study.
- On or about May 12, 2017, Mid Columbia Research submitted an application to DEA to conduct the GHB Study.
- Despite the inclusion and exclusion criteria being changed by Braeburn in August of 2017, documents were falsified and forged bearing dates between May 29, 2017, and September 20, 2017, affirmatively and falsely stating that these subjects met all of the inclusion criteria of the Braeburn Study.
- In September 2017, after Dr. Doe first became aware that Sami Anwar used his name and forged his signature on the GHB Study application, Dr. Doe withdrew the application.
- In September 2017, a routine monitoring visit by Medpace revealed certain inconsistencies in subject binder and other study documentation.
- In addition, in September of 2017, Medpace received an anonymous call from an employee of Mid Columbia Research who advised that, among other things, subject diaries were being forged, subject medical records were being falsified, and rescue medications and CAM 2038 shots were not actually being dispensed as represented.
- Medpace and Braeburn announced to Mid Columbia Research that they would be conducting a for-cause audit on October 11 and 12, 2017.
- When Braeburn and Medpace became aware of the false representations through a for-cause audit performed by Braeburn and Medpace personnel at the location of the Defendants’ business in October 2017, they terminated Mid Columbia Research’s participation in the Braeburn Study.
- In January of 2018, pursuant to the execution of a search warrant, the DEA found a sealable reusable baggie in Sami Anwar’s desk drawer in his office containing 590 hydrocodone pills.
Anwar’s trickery continued until at least on or about January 24, 2018. For a detailed timeline of the, shipments, payments and falsified information made throughout Anwar’s spree, see the court document.
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