Gilead Sciences Discovers $250 Million of Counterfeit Biktarvy and Descovy

By: Ranier Simons, ADAP Blog Guest Contributor

The selling of counterfeit goods is a lucrative market. Expensive, popular, and high-demand items are counterfeited globally. The quality of the fake goods ranges from high quality to poorly made. Counterfeiting doesn’t stop at goods. There is also a large market for counterfeit drugs. Studies estimate that the global illegal drug market has sales between $200 billion and $400 billion annually.[1] Additionally, data shows that 9%-41% of medication sold in low to middle-income countries are counterfeit. The percentage drops to about %1 in high-income countries like the United States.[2]

Irrespective of the lower percentage in the U.S., counterfeit drugs are a serious issue. Unfortunately, expensive HIV medicines are on the list of valuable targets. On August 5, 2021, Gilead Sciences released a press release stating that it had become aware of counterfeit and tampered versions of Biktarvy and Descovy in the supply chain in the U.S.[3] The press release resulted from a sealed lawsuit Gilead filed against the sources of the counterfeit in July of 2021. The U.S. District Court of the Eastern District of New York unsealed the documents on January 18, 2022, revealing the details. 

Photo Source: IP Watch

Gilead reported that at a value of $250 million, about 85,247 bottles of counterfeit Biktarvy and Descovy were sold to pharmacies and patients over two years. The drugs entered the supply chain via distributors not authorized by Gilead, who sold to pharmacies and patients. The counterfeit versions were sold in genuine Gilead bottles. The tampered bottles had fake foil induction seals, fake caps, or improper labels.[4] Some of the bottles contained genuine Gilead pills. Others included other drugs, painkillers, and a powerful anti-psychotic drug with serious side effects. Since the bottles were sealed, pharmacists were not physically filling them. Thus, they were unaware of the contents. The majority of the counterfeit drugs were sold by an organized counterfeit ring that used shell companies to advertise and sell the fake drugs to pharmacies. Several licensed pharmaceutical distributors were a part of the scheme.[4] Some of the drugs were even bought off of homeless people or HIV patients before being resold.[5]

The dangers of counterfeit drugs are catastrophic. Results are poisoning, death, treatment failure, disease progression, and even drug resistance. Improper dosages of unneeded medications poison patients ingesting pills of the incorrect medications. Taking the wrong medications can also cause adverse interactions with other medications people are already taking. Fake drugs affect treatment regimens since physicians base treatment on the outcomes they see from care. If patients take counterfeit medication, their disease progression will not change or worsen. As a result, doctors would change medication or make other decisions based on false results. Improper counterfeit drugs also do not contain adequate levels of medications. In the case of antiretrovirals, that could result in drug resistance lowering a patient's options for treatment pathways. 

Photo Source: YouTube

The dangers surrounding counterfeit drugs was recently addressed in a 90-second public service announcement (PSA). Brandon M. Macsata, CEO of the ADAP Advocacy Association and a long-term survivor living with HIV, shared some important steps patients can take to combat counterfeit drugs. The PSA can be viewed online at https://www.youtube.com/watch?v=VWGUW1AAr_w. 

It is imperative that pharmacists source medications from reliable sources. Pharmacists sometimes seek out alternative suppliers to buy drugs cheaper. Scarcity also steers pharmacists into the hands of counterfeiters when legitimate suppliers of high-demand, expensive medication are unable to supply the market needs.[6] Actively examining medication bottles for suspicious appearances and informing patients about the dangers of buying medicines over the internet are effective ways to combat counterfeit medications. Moreover, pharmacists need to confirm that supplies were purchased directly from manufacturers or reputable sources with their distributors. Unfortunately, this due diligence is sometimes thwarted since source documentation is also faked, as it was, in the Gilead counterfeit case.

[1] Miller, H., Winegarden, W. (2020, October). Fraud in Your Pill Bottle: The Unacceptable Cost of Counterfeit Medicines. Retrieved from  https://medecon.org/wp-content/uploads/2020/10/CounterfeitMed_F.pdf
[2] CDC. (2021, July). Counterfeit medicines. Retrieved from )https://wwwnc.cdc.gov/travel/page/counterfeit-medicine
[3] Gilead. (2021, August 5). Gilead Warns of Counterfeit HIV Medication Being Distributed in the United States. Retrieved from https://www.gilead.com/news-and-press/company-statements/gilead-warns-of-counterfeit-hiv-medication-being-distributed-in-the-united-states
[4] IPWatchdog. (2022, January 19). Court unseals documents in Gilead lawsuit alleging massive counterfeit HIV drug scheme. Retrieved from https://www.ipwatchdog.com/2022/01/19/court-unseals-documents-gilead-lawsuit-alleging-massive-counterfeit-hiv-drug-scheme/id=144591/
[5] Lonas, L. (2022, January 18). Drugmaker says counterfeit versions of its HIV medicines ended up in patients’ hands. Retrieved from https://foxlexington.com/news/health-wellness/drugmaker-says-counterfeit-versions-of-its-hiv-medicines-ended-up-in-patients-hands/
[6] Chambliss, W, Carroll, W., Kennedy, D., Levine, D., Mone, M., Ried, D., Shepherd, M., & Yevligi, M. (2012). Role of the pharmacist in preventing distribution of counterfeit medications. Journal of the American Pharmacists Association. 2012(52), 195-199. doi: 10.1331/JAPhA.2012.11085

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.