Two Ukrainian nationals pleaded guilty last week to conspiring to smuggle and distribute counterfeit versions of cancer drugs pembrolizumab (Keytruda) and nab-paclitaxel (Abraxane) as well as hepatitis C drug sofosbuvir/velpatasvir (Epclusa) into the United States, according to the US Department of Justice.
Maksym Nienadov, 36, owner of Healthy Nation, an online nutritional supplements company, and employee Volodymyr Nikolaienko, 33, admitted to conspiracy, trafficking in counterfeit drugs, and smuggling goods into the United States.
Neither of the arrested pair is a doctor, pharmacist, or licensed pharmaceutical wholesaler in the United States; they did not have authorization to sell the drugs, according to authorities.
In 2018, undercover federal agents purchased via the mail purported pembrolizumab and nab-paclitaxel from Nienadov and, later, fake sofosbuvir/velpatasvir from both men. Merck, Celgene, and Gilead (the manufacturers of these drugs) performed analyses and confirmed that the packaging and drugs were counterfeit.
The Ukrainian pair were arrested in April 2019 when they arrived in the United States to discuss future shipments of counterfeit pharmaceuticals and have been in custody since then. US Magistrate Judge Christina Bryan took their guilty pleas on July 17.
The Ukrainians sold two boxes of 50 mg fake pembrolizumab and two boxes of fake nab-paclitaxel 5 mg/ml to undercover agents for a total of $3400. They also sold two boxes of fake sofosbuvir/velpatasvir tablets for $6000.
The counterfeit prices were drastically lower than retail prices. For example, in the US at a retail pharmacy, a single box (quantity 8 vials) of 50 mg pembrolizumab is about $17,000; thus, two boxes would be more than $30,000.
Healthy Nation, the mail-order supplements company owned by Nienadov, still has a functioning website (healthynation.com.ua) and apparently sells company-branded supplements, including omega-3, pumpkin seed oil, flax seed oil, fish oil, and hemp seed oil. Their products are also available on at least one other website, Rozetka.ua, a large consumer goods portal that additionally sells well-known health supplement brands such as Solgar.
Healthy Nation says it was looking to grow: “We are always evolving and looking for new scenarios for partnership.”
The Problem of Drug Counterfeiting
The World Health Organization claims that 10% of all drugs in low- and middle- income countries are substandard or falsified and that the global market for these agents is worth around $200 billion.
The US Food and Drug Administration in 2003 initiated an internal task force to address drug counterfeiting. In 2012, a spate of counterfeit versions of bevacizumab (Avastin) that did not contain the active ingredient circulated in the United States, as reported by Medscape Medical News. In 2014, a Kentucky oncology practice pleaded guilty to charges that it purchased and sold unapproved and improperly labeled chemotherapeutic agents, including counterfeit bevacizumab.
Last year, the European Union implemented a new system to fight counterfeit drugs, which was 4 years in the making, according to Euronews.
Nick Mulcahy is an award-winning senior journalist for Medscape. He previously freelanced for HealthDay and MedPageToday and has had bylines in WashingtonPost.com, MSNBC, and Yahoo. Email: nmulcahy@medscape.net and on Twitter: @MulcahyNick