A recent opinion from an appeals court in Manitoba, Canada sheds new and more favorable light about the CanadaDrugs-related wholesale drug importation case that was first covered a decade ago in the Wall Street Journal. The case pertained to an indictment of CanadaDrugs, Ltd. for sales of mostly misbranded (but not counterfeit drugs) and two batches of counterfeit drugs. Journalists, policymakers, and other interested parties who were led to believe that CanadaDrugs.com, its owners, and affiliates purposely trafficked in counterfeit, or any dangerous drugs should read this to understand what actually happened. It’s important because this case was wrongly used as a pretext to oppose safe personal drug importation and international online pharmacies, which help Americans afford prescription drugs.
The crux of the Manitoba court’s decision is that CanadaDrugs’ founder and CEO, Kris Thorkelson, gets his pharmacist license back after it was revoked in 2019. The Winnipeg Free Press has an excellent story on that. The focus of this post is to simply show that the accused parties did not disregard patient safety in the manner that the pharmaceutical industry sought to portray.
For the record, CanadaDrugs.com was never found or even accused of selling a counterfeit drug to its online pharmacy customers while it operated from about 2001 to 2018, but the pharmaceutical industry wanted people to believe otherwise. Kris Thorkelson never pled guilty to selling counterfeit drugs. Its affiliate company in the UK, River East, however, did, according to the Manitoba court, unknowingly sell two counterfeit batches of Avastin to several U.S. clinics in 2011. Instead, Thorkelson pled to misprision, which means failure to report a crime: but did he fail? I don’t think he did. Here’s what the judge in Manitoba said:
“The evidence before me is that no one at River East knew or had reason to believe that the Avastin was defective. River East’s management acted quickly and appropriately as soon as it learned there was a problem. While the appellant did not take steps to notify MHRA [FDA’s counterpart in the UK], he was told River East and CareMed [FDA’s counterpart in the Netherlands] agreed that CareMed would do so. That CareMed followed through is clear from subsequent events. It seems that the appellant was also told that MHRA would notify the FDA of the situation. Clearly it did so. Thus, while he failed in a legal obligation to notify an authority that the Avastin was defective, it seems fair to say that he believed that both the U.K. and American authorities were notified, and in fact they both were notified.” (Emphasis added).https://www.manitobacourts.mb.ca/site/assets/files/1042/thorkelson_v__the_college_of_pharmacists_of_manitoba_et_al__2022_mbqb_29.pdf
Pharma-industry-funded forces have heavily relied on this case in their opposition to prescription drug importation. While the online pharmacy’s operation, CanadaDrugs.com, was not responsible for the cause of action in the case, it was the largest safe international online pharmacy, making itself a target of the industry.
Looking soberly at the matter: The FDA was right in investigating and going after those companies and people they believed were responsible for a counterfeit drug in the U.S. supply chain. That’s its job. On other hand, the federal indictment cast the most sinister shadow over this case, in a manner now appearing more vindictive than ever. They made it seem like the accused never did anything to notify authorities or others about the accidental counterfeit in their supply chain, and, apparently, they did notify the authorities.
As part of Thorkelson’s plea deal, his company agreed to shut down its retail online pharmacy operations, which I believe the industry saw as mission accomplished. After its plea, it’s noteworthy that the FDA granted CanadaDrugs.com a few months to operate while it served U.S. patients that relied on it for more affordable drugs, notifying patients about the plea deal and being forced to shut down. The agency, ironically, must have known that it was safe for Americans to get their prescription drugs that way and didn’t want them to be abruptly cut off from their treatments.