CEO drilled over profiting on government-patented HIV drug

WASHINGTON — Gilead CEO Daniel O’Day faced scathing questions from Democratic House panel members who demanded answers on how the drug manufacturer could charge $1,700 a month for an HIV prevention drug discovered through taxpayer-funded research.

“How can Gilead do this? How can our system allow a company to take a drug treatment that was developed with taxpayer funds and abuse its monopoly to charge such astronomical prices?” Oversight Committee Chairman Elijah Cummings asked at the top of the hearing. “This lifesaving treatment would not exist but for the research funded by the CDC and the NIH.”

The hearing follows an investigation by the PrEP4All Collaboration into the invention of Truvada. The activist group found that the U.S. Centers for Disease Control and Prevention holds patents on the drug, since federal money funded the researchers who made the discovery.

O’Day contradicted expert researchers on the panel and Democrats on the committee Thursday, downplaying the role of public funds in the discovery of the drug combination’s use for HIV prevention.

“Gilead invented Truvada,” O’Day said. “Prior to 1995, Gilead assisted in studies designed to assess the efficacy of tenofovir for PrEP. Gilead donated all of the drug used in these studies, collaborated in the study methodology design, provided dosing guidance, and participated in analysis of the study results.”

Pre-exposure prophylaxis, commonly known as PrEP, is when people at risk of being infected with HIV take a daily dose of medicine to minimize their risk of contracting the disease. Truvada is a combination of two HIV medicines — tenofovir and emtricitabine — and sold by Gilead.

The patent findings by PrEP4All were first reported by The Washington Post.

O’Day’s Thursday testimony was contradicted by Dr. Robert Grant, professor of medicine at the University of California, San Francisco, who government watchdog group Public Citizen calls “the father of PrEP.” Grant said in his testimony that he devoted 20 years of research to developing PrEP with grants from the U.S. government and nonprofits.

Grant said the pharmaceutical company had been a “reluctant partner” as he researched the use of Truvada to prevent HIV. The company “did not provide leadership, innovation or funding,” Grant said, even as it sought to block competing drugs from coming to market.

That means taxpayers have paid for PrEP twice: by funding the research and development, then paying escalating prices at the pharmacy counter and through public health programs like Medicare and Medicaid, Rep. Alexandria Ocasio-Cortez said in her testimony.

“There’s no reason this should be $2,000 a month. People are dying because of it,” the New York Democrat said. “We developed this drug.”

Cummings thanked Ocasio-Cortez for “leading the charge” to compel the hearing, who in turn credited HIV/AIDS activists and a staffer for raising the issue.

O’Day maintained that the U.S. government’s patent on Truvada for PrEP is invalid.

The pharmaceutical executive was met with criticism from fellow witnesses on the panel.

“Mr. O’Day, what justification do you have for charging $2,000 a month for Truvada as PrEP, when the American people funded the invention of the molecule, invented its use as PrEP and funded four clinical trials to prove its efficacy?” said patient advocate with PrEP4All, Dr. Aaron Lord, who sat next to O’Day.

At issue is whether the patients most at risk for contracting HIV, namely lower-income patients and communities of color, can afford the drug. The list price of Truvada in the U.S. is about $1,700 per month, O’Day testified.

Profits from Truvada have exceeded $36 billion, Cummings said at the hearing.

Meanwhile, just 200,000 of the estimated 1.1 million Americans at risk of contracting HIV currently receive Truvada for PrEP, according to the company’s own estimates.

Activists have turned up the pressure on the CDC to assert its own patent protections. Some activists have also called on the U.S. Department of Health and Human Services to revoke Gilead’s monopoly on PrEP by asserting march-in rights under the 1980 Bayh-Dole Act.

Rep. Jim Jordan, the top-ranking Republican on the Oversight Committee, called PrEP “something of a miracle drug,” and accused some of the Democrats on the committee and activists and researchers on the panel of “demonizing” profit-seeking.

Jordan commended President Donald Trump for progress on HIV/AIDS treatment, citing Gilead’s announcement last week it will donate 2.4 million bottles of Truvada to the CDC to treat lower-income patients.