This week’s big story: How fake Gilead HIV drugs ended up with patients

Gilead has uncovered an unauthorized network selling counterfeit versions of its HIV drugs worth more than $US250mn

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Leila Hawkins
Leila Hawkins
01/20/2022

Assorted colors pills and gel capsules

Gilead Sciences Inc has announced that a criminal network had made it possible for counterfeit and tampered Gilead HIV medication to reach patients in the US.

As part of an ongoing investigation with US law enforcement, Gilead uncovered an unauthorized network of distributors that sold pharmacies counterfeit versions of its HIV drugs worth more than US$250mn in total over a period of two years.

Thousands of bottles of Gilead-labeled medication including the HIV medicines Biktarvy and Descovy have been seized at 17 locations in nine states. Many of the counterfeits originated from suppliers who purchased Gilead HIV medication from individuals after it was dispensed to them, often exploiting individuals with low incomes who were experiencing substance use or homelessness.

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Suppliers then unlawfully resold the medication on the secondary market with fraudulent supply chain documentation, as though they were legitimate Gilead medicines.

Lori Mayall, Head of Anti-Counterfeiting and Brand Protection at Gilead Sciences, said: “Based on our actions, we believe that we have successfully stopped these defendants from distributing additional counterfeit versions of Gilead medication to patients.”

Analysis: pharma must raise awareness and secure its supply chains

The problem of counterfeit medication continues to grow, with an estimated global value of US$4.4bn. While in high-income countries such as the US less than 1 percent of medicines sold are fake, in low- and middle-income countries it is estimated to affect up to 41 percent of the drug supply.

In some cases the drugs do not contain sufficient active ingredients to be effective, however, others may contain harmful ingredients such as paint and arsenic with devastating consequences – more than 250,000 children with malaria and pneumonia die each year after being treated with counterfeit medication.

To combat this, pharmaceutical companies must raise awareness among consumers of the risks of taking fake medication, as well as how to detect scams, such as purchasing medication online from unverified sources.

“The first step is to acknowledge the problem, and then you can move on to risk management and analysis”

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Secondly, distributors must ensure supply chains are secure and visible from end to end. The use of technologies that provide real-time data analysis can facilitate this, such as IoT and blockchain, which can enable monitoring of medicines as they move through each part of the supply chain by scanning a unique data matrix code. 

Also in the news

  • The Medical Technology Association of India (MTaI) has called on the government to lower customs duties on medical devices, cold chain units and parts used in healthcare appliances.  MTaI Chairman Pavan Choudary has said that high customs duties have increased the likelihood of smuggling medical devices from the neighboring countries of Nepal, Sri Lanka, and Bhutan, where customs duties are lower.
  • Merck and Ridgeback have signed a long-term deal with Unicef to deliver 3 million courses of the oral Covid-19 medication molnupiravir to low- and middle-income countries during the first half of 2022. 
  • Catalent is expanding the company’s largest site in Philadelphia by 20,000 square feet to increase its cold-chain packaging capabilities, in anticipation of a rise in gene and cell therapy development.