- Lawmakers sparred Thursday with Gilead CEO Daniel O'Day over the company's pricing of its HIV prevention therapy Truvada, citing the role played by government-funded research in the drug's approval for that use in 2012.
- "This life-saving treatment would not exist but for the research funded by the CDC and NIH," said Maryland Democrat Elijah Cummings, chairman of the House Committee on Oversight and Reform, in an opening statement at the hearing.
- The origins of Truvada's use for prevention, or pre-exposure prophylaxis, is newly in focus, after reports the Justice Department was reviewing patents held by Gilead and the U.S. government on Truvada for PrEP. Last week, Gilead announced it would donate 2.4 million bottles of Truvada annually to the Centers for Disease Control and Prevention, intended to treat up to 200,000 uninsured Americans at risk of infection.
Truvada, a combination of the HIV antiviral therapies emtricitabine and tenofovir, is one of Gilead's top-selling drugs and, since its original approval for treating existing infections in 2004, has earned roughly $36 billion for the California biotech.
Not all of that revenue stems from PrEP, the focus of Thursday's hearing. But lawmakers and HIV activists charged Gilead has hindered access to the drug by steadily raising its price.
Truvada costs $1,780 per month in the U.S. at list price, more than double what Gilead charged per month when the drug debuted in 2004. Most recently, Gilead raised Truvada's price by 4.9% in March, along with many of its other HIV medications.
"Price is not the only barrier preventing people from using PrEP," said Aaron Lord, co-founder of the PrEP4All collaboration and an advocate, in testimony to the committee Thursday.
"These barriers can and must be mitigated," he added. "But we cannot do it if our healthcare system spends over $20,000 a year on Mr. O'Day's drug instead of spending those precious resources on fighting these barriers."
Research from the CDC suggests more than 1.1 million people in the U.S. could benefit from PrEP. Yet the drug's only been prescribed to less than 150,000 people since it became available for that use.
"Even if it was free, PrEP is difficult," said Rochelle Walensky, head of Massachusetts General Hospital's division of infectious diseases, at the hearing. "But right now, the biggest problem with PrEP is access."
Incensing some lawmakers, such as Cummings and Rep. Alexandria Ocasio-Cortez, D-N.Y., is the contribution made by government-funded research to an approval that has earned Gilead billions of dollars.
In the mid-2000s, CDC scientists conducted research on the efficacy of PrEP treatment in monkeys. Later, in-human studies funded by the National Institutes of Health demonstrated the benefit of a combination regimen of tenofovir and emtricitabine.
Gilead supported some of that work, donating Truvada and providing technical assistance to researchers, according to O'Day.
But testimony from Robert Grant, a professor at the University of California, San Francisco and a long-time PrEP researcher who led key studies of Truvada, suggest a more complicated relationship between the biotech and government-supported scientists.
"Gilead proved to be a hesitant partner in PrEP research," Grant said Thursday
Testifying to Congress members, Gilead's CEO strongly rebutted claims the government, not Gilead, is responsible for demonstrating Truvada's use in prevention.
"Gilead invented Truvada. No one else," said Gilead CEO Daniel O'Day at Thursday's hearing. "Gilead developed the two drugs that are combined in Truvada, invented the combination that allowed these drugs to be taken as a single pill and invented the drugs used to treat HIV in combination with other antiretroviral drugs."
According to O'Day, Gilead has spent $1.1 billion developing Truvada, although the CEO declined to break out how much of that figure was for PrEP research and how much was directed at other uses.
The NIH invested roughly $50 million in PrEP research, while the Bill & Melinda Gates Foundation contributed upwards of $80 million, O'Day indicated.
Gilead believes the patents held by the government on Truvada are invalid but, according to O'Day, hasn't initiated a legal challenge because of the value it places on its relationship with the CDC.