Six linked to CanadaDrugs.com face extradition to US

Six Canadian men, including the head of the Internet pharmacy CanadaDrugs.com, face extradition to the US after being arrested in connection to an alleged racket distributing counterfeit drugs.

The six men – Thomas Haughton, Ronald Sigurdson, Darren Chalus, Troy Nakamura, James Trueman, and CanadaDrugs.com founder Kristjan Thorkelson – were arrested under the Extradition Act. They have since been released on bail pending a court appearance in July.

CanadaDrugs.com – which is licensed by the College of Pharmacists in Manitoba, Canada, and is still operating – along with affiliated companies and associates in the UK and Barbados are accused of illegally importing and selling $78m-worth of unapproved, misbranded and counterfeit drugs, including fake cancer drugs, to US doctors between 2009 and 2012.

According to court documents: "Canada Drugs [allegedly] purchased its inventory from questionable sources and ultimately sold counterfeit versions of the drugs Altuzan and Avastin to physicians in the United States."

The Internet pharmacy and other US companies have also been accused of not meeting safety requirements to keep drugs refrigerated, while the UK affiliate River East Supplies, has been accused of falsifying customs documents in order to allegedly smuggle the pharmaceutical products.

"Thorkelson orchestrated and profited from the Canada Drugs criminal enterprise," the court documents allege.

Four bank accounts in Canada, the UK and Barbados, have also been put on hold as potential funds in the case that penalties arise from a conviction.

An extradition hearing is now required to view the evidence against the men and establish criminality, and justice minister Jody Wilson-Raybould will make the final decision on whether the defendants can be extradited to the US to face trial.

The arrests follow a wider investigation into a counterfeit scam involving the smuggling and distribution of fake drugs via internet pharmacies. CanadaDrugs.com and Kristjan Thorkelson have been accused of spearheading the activities.

It is alleged that the Internet pharmacy bought non-FDA authorised and mislabelled drugs overseas to sell to US doctors at a fraction of the cost of the legitimate medicines. Money was allegedly funnelled through affiliates overseas.

The US Food and Drug Administration began an investigation of the online pharmacy and its alleged distribution of fake cancer drug Avastin in the US in 2012 after it was revealed that nearly 100 physicians in the US, mostly in California, had purchased bogus cancer drugs.

Fake versions of Avastin were found to contain corn starch and acetone, and no active ingredient. CanadaDrugs.com denied it was connected to the counterfeit Avastin, claiming it didn't sell the drug. Later a manager acknowledged shipping and distributing Avastin but said he didn't know the drug was fake.

In 2014, American authorities laid charges against CanadaDrugs.com and its affiliates of smuggling goods into the US, conspiracy and international money laundering. The following year, CanadaDrugs.com's offices in Winnipeg were raided and the assets in one bank account were seized.

Also in 2015, one man linked to the racket – Ram Kamath, from Illinois, US – pleaded not guilty for his involvement in conspiring with CanadaDrugs.com to smuggle and store the fake drugs.

Health Canada suspended CanadaDrugs.com's Drug Establishment Licence in 2014, citing "significant concerns" over its manufacturing practices and barring the firm from selling prescription drugs to pharmacies. The licence was reinstated in August last year following a Health Canada Good Manufacturing Practices inspection.

The arrests come at a time when the US is debating the exorbitant price of drugs where law makers have proposed legislation to allow cheaper drug imports into America from Canada, and eventually from Europe.

Critics of the proposals – including the pharmaceutical industry, US pharmacy groups and former FDA commissioners – claim the move could jeopardise the integrity of the drug supply chain and allow counterfeit drugs to enter the US. They have pointed to the alleged CanadaDrugs.com scandal as a case in point.

In a recent report on the potential impact of the drug importation proposals on law enforcement, law firm Freeh, Sporkin, and Sullivan, along with risk management firm Freeh Group International Solutions, concluded that, should the legislation go ahead, it "would deplete and overburden already limited resources. In particular, importation proposals would force law enforcement agencies to make tough prioritisation decisions that leave the safety of the US prescription drug supply vulnerable to criminals seeking to harm patients."

The report also adds that the legislation would worsen the opioid crisis in the US where fentanyl-laced counterfeit painkillers and anti-anxiety meds have resulted in hundreds of overdoses and deaths.

The report recommends: an assessment on how to improve the current inspection system of suspicious packages; enhance intelligence collection and sharing; review the current penalties for convictions and whether they are sufficient deterrents; give more power to the FDA Office of Criminal Investigations; ensure adequate funding to strengthen the US drug supply; and a review of prescription drug wholesalers.

"This research should serve as a call to action to redouble the focus on improving and enhancing existing law enforcement capacity to prevent counterfeit drugs from entering the US drug supply in the first instance, and ensuring law enforcement has sufficient resources, expertise, and authority to protect the public health and ensure the integrity of the US drug supply," it states.