Rep. Alexandria Ocasio-Cortez grilled Daniel O'Day, the CEO of Gilead Sciences, the pharmaceutical company that manufactures the pre-exposure prophylaxis (PrEP) medication Truvada, about the drug's inflated costs in a hearing before the House Oversight and Reform Committee.
AOC pointed out that the current list prize of Truvada is nearly $2,000 (It's $1,780 according to O'Day) in the U.S. and asked O'Day why the drug is $8 in Australia.
Said O'Day: “Truvada still has patent protection in the United States and in the rest of the world it is generic. I can't comment on the price in Australia of the generic medicines. … It will be generically available in the United States as of September 2020…one year early.”
Replied AOC: “I think it's important that we notice here that we the public, we the people, developed this drug, we paid for this drug, we led and developed all of the grounding patents to create PrEP, and then that patent has been privatized despite the fact that the patent is owned by the public. We refuse to enforce it. There is no reason this should be $2,000 a month. People are dying because of it. And there's no enforceable reason for it. We own the core intellectual property for it and as a result people are dying. For no reason.”
O'Day had told the committee earlier: “Our well-supported view is that the U.S. government does not hold valid patents on the use of Truvada for pre-exposure prophylaxis (‘PrEP'), nor does it hold any patent for Truvada itself.”
The Washington Post reports: ‘The panel called the hearing after The Washington Post reported in March that the government had opted not to file an infringement suit to enforce a 2015 patent on Truvada from the Centers for Disease Control and Prevention. The use of the drug to prevent HIV infection was discovered in federal labs in Atlanta, according to the government. Since the article appeared, members of Congress have written letters to the Department of Health and Human Services demanding to know why the patent has not been enforced. The Justice Department has opened a review of the patent, which would be an initial step toward more aggressive enforcement.'
The Department of Health and Human Services last Thursday announced that Gilead would provide PrEP for up to 200,000 individuals each year for up to 11 years.
HHS wrote: The agreement between the U.S. Department of Health and Human Services and Gilead will last until at least December 31, 2025 and possibly through December 31, 2030, and will provide medication to treat individuals who are at risk for HIV and who are uninsured. This donation will deliver Gilead's PrEP medication Truvada, which currently carries a list price of more than $20,000 per patient per year, to up to 200,000 people per year, including in the states and counties identified as priority areas in the Trump Administration plan – PDF to end the HIV epidemic in America.”
HHS added: “Gilead will donate Truvada until its second-generation HIV preventative medication, Descovy, becomes available. At that time, Gilead will donate Descovy. The agreement would end after 11 years, or when a generic version of Descovy becomes commercially available, whichever comes first. The government has agreed to cover costs associated with distributing the drugs.”
Said HHS Secretary Alex Azar: “Securing this commitment is a major step in the Trump Administration's efforts to use the prevention and treatment tools we have to end the HIV epidemic in America by 2030. Under President Trump's leadership, HHS worked with Gilead to secure preventative medication for individuals who might otherwise not be able to access or afford this important treatment. The majority of Americans who are at risk and who could protect themselves with PrEP are still not receiving the medication. This agreement will help close that gap substantially and deliver on President Trump's promise to end the HIV epidemic in America.”
The NYT reported: “H.I.V. activists and experts had mixed reactions to the news. While some felt the donation was a good start, they said it filled only one-fifth of the need in the United States. The high cost of Truvada has been called a major barrier to stemming the spread of H.I.V. among low-income Americans, critics say, and part of the reason the AIDS epidemic has persisted for so long. A deep price cut for Truvada — and the Gilead drug slated to replace it, Descovy — would do far more to protect Americans at risk, they said. Truvada now costs about $20,000 a year in the United States.”
Activist Peter Staley pointed out to the NYT that the DOJ is investigating whether Gilead failed to pay the CDC royalties for work it did developing Truvada: “Neither Azar's announcement nor Gilead says whether this is part of some settlement of that Justice Department investigation. Also, this won't cut into Gilead's sales at all, and it's a very cheap marketing program for Descovy.”
The news comes in the wake of Gilead's announcement that it had reached an agreement with Teva Pharmaceuticals to release a generic version of Truvada one year earlier than expected.
NBC News reported: ‘Activists who have been pushing Gilead to #BreakThePatent hailed the news Wednesday, calling it “a victory for the LGBTQ+ community, for HIV activists, and for U.S. taxpayers,” but also tamped down expectations. In a statement from the PrEP4All Collaboration, Dr. Aaron S. Lord said allowing just one generic manufacturer, Israel-based Teva Pharmaceuticals, to make generic PrEP “will do little to reduce the price in a way that will increase access, and PrEP4All remains suspicious of the terms and lack of transparency surrounding the Teva settlement.”'
In related news, a study of nearly 1,000 serodiscordant couples using antiretroviral therapy found no transmission of the HIV virus during condomless sex.
CNN reported: “A European study of nearly 1,000 male couples, where one partner with HIV was taking antiretroviral therapy (ART) to suppress the virus, has found that there were no new cases of transmission to the HIV-negative partner during sex without a condom. HIV can lead to AIDS. While 15 men were infected with HIV over the course of the eight-year study, genetic testing showed that it was a result of sexual relationships with someone other than their partner.”
