Pharma giant Gilead sued for ‘withholding’ safer HIV drug
Gilead-branded Truvada, a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) taken by HIV patients (Jeffrey Beall)
A lawsuit has alleged that pharmaceutical giant Gilead Sciences is “intentionally withholding” a safer drug used for HIV treatments.
The company holds a patent on Tenofovir Disoproxil Fumarate (TDF), an antiretroviral drug sold as part of medications routinely taken by people with HIV to regulate their viral load.
However, a lawsuit filed in US federal court on November 17 alleges that the company is withholding a safer version of the drug with less side-effects to exploit patent laws.
Antiretroviral drugs like Truvada can prevent the spread of HIV (Justin Sullivan/Getty)
The lawsuit, filed in federal court by Morgan & Morgan, Ben Crump Law and Hilliard Martinez Gonzales, alleges that Gilead plans to roll out a safer version of the drug—with fewer side effects—called Tenofovir Alafenamide Fumarate (TAF) when the patent on TDF expires in 2021.
Patent expiration would usually allow others to produce cheaper generic versions of drug cocktails, but timing the rollout of TAF to the date of expiration would allow Gilead to continue to charge premium rates for the new drug.
“Gilead’s chosen path of inaction is causing tremendous harm to persons with HIV, particularly black and LGBT minorities.”
— Ben Crump
The lawsuit claims that the company is “intentionally withholding [TAF] …from hundreds of thousands of patients in order to extend the profitability of the patent.”
The attorneys highlight that more than 70 percent of all new HIV diagnoses in 2017 were in gay and bisexual men or transgender women, while African-Americans and Latino Americans are also disproportionately impacted by the drug policy.
“We believe the evidence will show that Gilead withheld the equally effective but safer medication for one primary reason—billions in profits.”
— Bob Hilliard
The lawsuit alleges Gilead’s actions have “unjustly affected patients in the black, minority, and LGBT communities,” alleging that people were left at risk to “life-threatening side effects such as bone demineralization and kidney toxicity.”
Gilead received FDA approval in November 2016 for the successor drug TAF.
Gilead stance harms minorities, lawsuit claims
Ben Crump, a civil rights attorney who previously represented the family of Trayvon Martin, said: “Gilead’s chosen path of inaction is causing tremendous harm to persons with HIV, particularly black and LGBT minorities, by keeping drugs that would reduce deadly symptoms off the market and unavailable to those who need them the most.
“This lawsuit is a major step in the right direction toward racial equity in communities unevenly affected by HIV and exploited by pharmaceutical goliaths like Gilead.”
Civil rights attorney Benjamin Crump (Andrew Burton/Getty)
Crump added: “This new lawsuit seeks justice for underrepresented communities, providing a voice to those who may not have ever received one otherwise.
“As long as Gilead continues to cravenly value profits over people, people living with HIV/AIDS will suffer from a lower quality of life. This must stop.”
Attorney Bob Hilliard said: “For nearly two decades, Gilead has been raking in billions of dollars each year from the sale of the TDF-containing drugs that are the subject of our lawsuit—medications used primarily for treatment of people living with HIV.”
He explained: “Gilead openly markets TAF as a safer alternative to TDF. We believe the evidence will show that Gilead withheld the equally effective but safer medication for one primary reason—billions in profits.
“If Gilead withheld TAF during its patent exclusivity with regard to TDF, Gilead could maximize its profits by monopolizing the market during the exclusivity period, releasing TAF prior to expiration of TDF exclusivity, and encouraging prescribers to switch patients from TDF to the safer TAF medications before entry of generic TDF into the market.
“This is what Gilead did do, and people living with HIV paid the price.
“Our lawsuit seeks recovery for those hurt by Gilead’s greed, and to hold Gilead accountable for choosing profits over people.”
PinkNews has contacted Gilead for comment.
