Crisis has a way of opening doors of opportunity for fraud around the globe. The COVID-19 pandemic has brought not only a fresh slew of financial schemes, but pharmaceutical fraud as well.
Crisis has a way of opening doors of opportunity for fraud around the globe. The COVID-19 pandemic has brought not only a fresh slew of financial schemes, but pharmaceutical fraud as well.
The latest bust in the U.S. reports federal agents seizing unauthorized versions of Gilead’s remdesivir, marketed as Veklury, destined for distribution Mexico.
The antiviral drug was approved by the FDA last fall in adults and children 12 and older who have been hospitalized for COVID-19. Veklury was authorized by Mexico’s authorities for emergency use in March.
Counterfeit or generic versions of Veklury have been be arriving as packages in U.S. airports from Bangladesh and India to be smuggled by individuals into Mexico. With a seven-day average of over 3,300 cases a day for the country, patients with means are willing to pay top dollar for the drug. U.S. Customs and Border Protection have stopped more than 100 shipments so far.
It isn’t yet clear if the confiscated vials are counterfeit or merely generic. Counterfeit drugs usually include simply water or a saline solution or a cheap drug labeled fraudulently. The market for these illicit products is valued at more than $200 billion a year.
The seized items are 10-vial packages under generic names, not Veklury, and are labeled as sample or testing kits. Gilead’s antiviral carries a US list price of $520 a vial. A typical course of treatment runs up to $3,120.
Gilead has licensed generic versions of its product in more than 100 countries, using companies in India, Egypt and Pakistan to manufacture. However, use of a generic for Veklury has not yet been approved in the US and Mexico.
In January, Colombian officials seized containers of generic remdesivir from a woman at an airport who claimed the drugs were a COVID-19 vaccine. In India, arrests were made this spring in connection with counterfeit remdesivir. Suspects changed the label of an antibiotic, claiming to be the antiviral drug in one of the cases.
While remdesivir has only shown to provide a modest benefit in clinical trials, due to the limited toolkit available to treat COVID-19 patients it is considered a standard of care in those hospitalized. This week Gilead released positive real-world evidence stating that “in the overall patient populations, patients who received Veklury treatment had significantly lower risk for mortality compared with matched controls.”
Gilead isn’t the only company facing knock-offs of its COVID product. Authorities in South Africa, Mexico and Poland have all identified counterfeit versions of Pfizer and BioNTech’s COVID-19 vaccine. Earlier this month saw Africa’s biggest seizure of fake vaccinations: 2,400 doses of illicit vaccines hidden in plastic containers in a refrigerator. Counterfeit N95 masks were discovered next door.
The fake vaccines discovered in Poland contained not one key ingredient of the real vaccine. One version included an ingredient used in skin care products.
“You’ve got to remember, if you don’t have ready access to a vaccine and your healthcare system is at risk of collapse, you will try anything,” said Shabbir Safdar, executive director of Partnership for Safe Medicines, a U.S. nonprofit group whose members include pharmacist and drug-industry trade groups.
Gilead is working with law-enforcement around the world to address threats that counterfeit products can pose to patients.
“We caution against sourcing Gilead medicine from outside the approved and regulated supply chain, hospitals or pharmacies and will continue to support U.S. law enforcement in taking appropriate actions to protect patients,” the company warned.
The counterfeit pharmaceutical world has long been a moneymaker for criminals. The past three years, nearly $12 billion of illegally smuggled medicines were detained worldwide.
