By: Brandon M. Macsata, CEO, ADAP Advocacy Association
Baseball Hall-of-Fame legend Yogi Berra coined the infamous phrase, "It's deja vu all over again". For the HIV community, it finds itself once again confronting the sad reality that antiretroviral (ARV) therapy isn't immune from counterfeit and tampered medicines. The latest counterfeit warning - involving products manufactured by Gilead Sciences - represents the second such ARV-related counterfeit scheme in less than one year.
Earlier this year, we raised similar concerns over fake Symtuza® entering the U.S. drug supply chain. It came in response to Janssen Pharmaceutical Companies of Johnson & Johnson issuing a drug warning alert in late 2020 about the counterfeit HIV drug. There were no reported adverse events related to the use of the counterfeit product, but it nonetheless sounded the alarm over fake HIV medications potentially reaching medicine cabinets in American households.
Fast-forward to August 2021, Gilead Sciences alerted the U.S. Food & Drug Administration (FDA) that fake meds for its once-daily single tablet HIV treatment regimen Biktarvy® (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and its HIV treatment and prevention medication Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) were within U.S. drug distribution networks.[1]
“The safety of individuals taking Gilead medication is always our first priority,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We are taking aggressive action to ensure that healthcare providers and people who rely on our medicines can confidently distinguish authentic Gilead products from counterfeit drugs.”[2]
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| Photo Source: Gilead Sciences |
According to Gilead Science, "counterfeit and tampered medicines can bring serious and sometimes life-threatening health risks to individuals." It is also important to note that these medicines are:
- not the same as authentic medicine in terms quality, safety, and/or efficacy;
- not guaranteed to contain the correct drug or active ingredients;
- not likely to meet purity standards; and
- not inspected for unsafe manufacturing conditions or secure supply chains.[3]
Gilead Sciences' full statement is available online here: https://www.gilead.com/news-and-press/company-statements/gilead-warns-of-counterfeit-hiv-medication-being-distributed-in-the-united-states.
Fortunately, it appears that there have been no reported adverse events related to the use of the counterfeit product. Advocates credit the U.S. drug supply chain's internal safety protocols.
Shabbir J. Safdar, Executive Director of the Partnership for Safe Medicines, summarized, "U.S. licensed pharmacies are the safest in the world. They're so safe we often go years without seeing a fake medication in the legitimate supply chain like this. But the consequences of a fake medication in a licensed pharmacy is serious and life threatening, given the numbers of patients that could be affected. We're grateful to see how fast both Gilead's security team and the FDA have responded."
Any patient who fears they may have received counterfeit Gilead medications should immediately report the medicine to their doctor and pharmacy and Gilead Product Quality Complaints at 1-800-445-3235 or QualityComplaints@gilead.com.
People living with HIV/AIDS, or any chronic condition, need to have confidence that they're getting a safe prescription medicine. The assurance in knowing that the product has been rigorously tested with a safety-seal as appropriate for treatment is vitally important for the patient advocacy community. Forty-years into the epidemic it is clear that drug manufacturers, government agencies, and patients must remain vigilant to combat threats to the nation's drug supply chain.
[1] Gilead Sciences (2021, August 5). Gilead Warns of Counterfeit HIV Medication Being Distributed in the United States. Retrieved online at https://www.gilead.com/news-and-press/company-statements/gilead-warns-of-counterfeit-hiv-medication-being-distributed-in-the-united-states.
[2] Gilead Sciences (2021, August 5). Gilead Warns of Counterfeit HIV Medication Being Distributed in the United States. Retrieved online at https://www.gilead.com/news-and-press/company-statements/gilead-warns-of-counterfeit-hiv-medication-being-distributed-in-the-united-states.
[3] Gilead Sciences (2021, August 5). Gilead Warns of Counterfeit HIV Medication Being Distributed in the United States. Retrieved online at https://www.gilead.com/news-and-press/company-statements/gilead-warns-of-counterfeit-hiv-medication-being-distributed-in-the-united-states.
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.
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