In 2012, Gilead Sciences Inc.’s Truvada became the first drug ever approved to prevent HIV, the virus that causes AIDS. It was a public health triumph that was spurred by years of government-funded research.
Seven years later, efforts to prevent HIV in the U.S. have stalled. Only a fraction of U.S. patients who could benefit from the treatment — known as PrEP — are getting it.
AIDS activists and some doctors blame Gilead’s $21,000 annual price for Truvada. They say the U.S. government should leverage patents held by the U.S. Centers for Disease Control and Prevention to push down the price, perhaps by seeking royalties from Gilead.
The furor over PrEP spilled over onto Capitol Hill on Thursday when the House Committee on Oversight and Reform held a hearing that pitted AIDS activists and doctors against Gilead’s new chief executive officer, Daniel O’Day.
“We are suffering under the weight of your company’s pricing,” said Aaron Lord, a neurologist and co-founder of the PrEP4All Collaboration, which has petitioned the Trump administration over Truvada’s cost. He said infection rates have hardly budged since Truvada was approved. “Why not lower the price of Truvada to $15 a month?” he said.
O’Day, who took the helm of the biotechnology giant in March, said Gilead is working hard to make Truvada more accessible. The company is donating free drugs for uninsured patients and providing assistance for insured patients who can’t afford their copay. Gilead spent $1.1 billion to develop the drug, which was first approved in 2004 for treatment of patients who already have the HIV virus.
“Gilead invented Truvada, no one else,” O’Day told lawmakers. The CDC’s patents are invalid, he said.
While Gilead created the drug, the U.S. government was heavily involved in making the use of it for prevention a reality. The CDC did early experiments on monkeys that suggested that the two compounds that make up Truvada were more effective than one for prevention. The federal government also obtained patents on the use of the compounds in Truvada for HIV prevention. Those patents weren’t widely known until AIDS activists discovered them recently.
“Gilead seems to be using the CDC’s technology for free without compensating the CDC, without compensating the taxpayer,” Christopher Morten, a patent attorney and research scholar at Yale Law School, said in an interview. He reviewed the CDC’s patents at the request of the PrEP4All Collaboration and concluded they were valid and enforceable.