This post is part of Outward, Slate’s home for coverage of LGBTQ life, thought, and culture. Read more here.
If a company controls an important tool in fighting a decadeslong epidemic, what are its obligations to share it?
Activists in New York City are pressing this question. Over the past few months, members of ACT UP New York, a group founded in the 1980s to confront societal and governmental indifference to the AIDS crisis, have staged protests against Gilead Sciences, a California-based pharmaceutical company. In April, members rushed the stage at an industry exposition in Manhattan to disrupt the proceedings in order to bring attention to their grievances against the company.
At issue is the price of Truvada, a medication manufactured by Gilead, and for which it holds the patent. Truvada is currently the only medication approved by the Food and Drug Administration for pre-exposure prophylaxis, or PrEP, a regimen that is highly effective at reducing the risk of HIV infection if taken regularly. According to ACT UP, the medication costs about $6 a month to manufacture—but a month’s worth of the prescription can run as high as $1,500. For many people who lack insurance coverage for the drug, the price makes it inaccessible.
It is common for pharmaceutical companies to retain the patent on drugs they develop for a limited time, arguably to get a return on the investment made in researching those medications. In this case, Truvada was previously approved for the treatment of patients already infected with HIV. The new indication for use of the medication for prevention of new infections allowed the company to extend its patent.
Compounding the group’s complaint against the company is the issue of how research into the use of Truvada for PrEP was funded. According to documents provided by ACT UP, the initial application for FDA approval to use the medication for the purposes of HIV prevention cited three studies, all of which were heavily funded by federal agencies (the National Institutes of Health and the Centers for Disease Control and Prevention), as well as the Bill & Melinda Gates Foundation. Gilead’s role in supporting the studies was limited to donating the medication itself. A report put out by AVAC (formerly the AIDS Vaccine Advocacy Coalition) showed that between 2005 and 2014 public and philanthropic investment in PrEP research and development vastly exceeded that of commercial entities. Public funding got as high as $33.8 million in 2010, and philanthropic spending reached $28.7 million the next year, but commercial investment never exceeded $2 million over that span, and dipped as low as half a million in 2012.
“The taxpayer is the initial investor in development of [medications] that we then end up being charged top dollar for,” ACT UP told me. “There’s a disconnect between what they represent as their true cost, and what we’ve already paid into the system.”
“Such a high price for the only drug that’s available is beyond dangerous. It eliminates our opportunity to prevent new infections,” a representative for the group said during a recent phone call.
While wider use of PrEP would not eliminate new infections with HIV entirely, ACT UP maintains that making it more affordable, and thus more accessible, would slow the rate of new infections such that HIV would no longer be considered an epidemic. By keeping the price higher than many people can afford, the organization believes, Gilead stands in the way of that effort.
“Truvada is a vital tool in the fight against HIV, and there are tens of thousands of people across the United States who are utilizing it as a prevention option,” said Ryan McKeel, a representative for Gilead, when I asked about ACT UP’s criticism. According to McKeel, there were about 167,000 people in the United States taking Truvada as PrEP at the beginning of this year.
He also noted efforts the company has made to increase accessibility for those who may not have insurance coverage for it and funding to support programs to fight the epidemic in underserved populations.
“Effective Jan. 1, 2018, Gilead raised the annual benefit cap for the Truvada copay coupon program from $3,600 to $4,800,” he said. (The coupon program is a benefit the company provides to help patients recoup some of the cost of their prescription copay for the medication.) “The Truvada benefit increase is for both PrEP, as well as use in a treatment regimen. By increasing the annual benefit cap, we hope to help additional eligible people access and adhere to their prescribed therapy.”
McKeel went on to mention an initiative the company is calling COMPASS, “a $100 million commitment over 10 years to support organizations working to address the HIV/AIDS epidemic in the Southern United States,” which would be “focused on capacity building and shared knowledge in community-based, underfunded organizations; wellbeing, mental health and trauma-informed care; and awareness, education and anti-stigma campaigns.”
All of that sounds eminently laudable, and doubtless $100 million to support local organizations fighting the HIV epidemic in the South will be welcome. However, none of the responses I received spoke to the particular criticisms about basic affordability that ACT UP is raising. Presuming the accuracy of the numbers I was given, a coupon program capped at $4,800 annually may not go very far for a drug priced at $1,500 every month. Awareness and education are great, but the benefit is limited if you can’t afford the preventive care after you’ve been made aware of it. (Gilead did not provide alternate figures in response to my specific questions about the cost to manufacture the medication or the price per month, nor did it rebut criticisms based on PrEP’s research.)
It is difficult to credit the beneficence of a company that marks up the price of a medication 250 times what it costs to make, particularly when it is the only such medication approved for the prevention of an epidemic infectious disease.
During our conversation, ACT UP representatives were intent on keeping the focus on Gilead. However, the company’s actions are part of a more systemic problem.
“It’s not just Gilead. The government does not provide any guidance as to the percentage of profits that a company is required to give back to the public when it receives taxpayer money for development,” Celia Fisher told me. Fisher is the Marie Ward Doty University Chair in Ethics at Fordham University and director of both its Center for Ethics Education and its HIV and Drug Abuse Prevention Research Ethics Training Institute.
“I think public funding does uniquely obligate companies, and that obligation must be further defined by regulation,” she continued. “It’s a failure of the government, to abandon its responsibilities to make critical medicines available to the public after taxpayer money contributes to the development of the drug.”
Fisher also noted the incentives Wall Street puts in place for companies to maximize profitability.
“We also have a stock market that only rewards companies if profit keeps skyrocketing, so there’s no reward for simply maintaining profitability for companies like Gilead,” she said. “Responsibility shouldn’t just lie with Gilead or other pharmaceutical companies. The system itself is not working.”
As it stands, however, making the most effective method of prevention available only to those who can afford it is innately discriminatory. Both Fisher and ACT UP also noted that expecting those who can’t afford PrEP to use condoms exclusively overlooks those in relationships where they do not have the capacity to insist that their partners use condoms, including victims of domestic abuse.
But ACT UP is one of just a few groups within the LGBTQ community drawing attention to the discrepancy between how much Gilead spends to manufacture Truvada and how much it charges for it. The company generates a great deal of goodwill by supporting LGBTQ advocacy—for example, as corporate sponsor of the AIDS Walk and the GLAAD Awards, among others. That makes potential critics hesitant to press the subject of access to PrEP. By protesting at a pharmaceutical industry event, ACT UP brought its criticisms to those within the industry who are already well aware of how little it costs to make the medication. Other protests outside the Broadway revival of Angels in America sought to bring broader attention to the issue with the community.
“Angels in America isn’t a period piece. We’re not memorializing it, because it still exists,” ACT UP told me. “AIDS is still political. … We don’t need Gilead to be the sponsor of the AIDs Walk. We need affordable and free PrEP.”
Fisher does credit Gilead for its outreach and notes that there needs to be some allowance for profitability. There is also no guarantee that generic versions would be priced so affordably that they would be as universally accessible.
Even with those caveats, though, it’s hard to look at the differential between how much Truvada costs to make and how much it costs to buy, and not see a serious problem. It’s great to have corporate sponsors for events and programs that support the LGBTQ community. But Gilead controls the sole medication that provides the pre-emptive protection against HIV, a disease that does ongoing harm to that community—and its monopoly is built on research funded at taxpayer expense. The company seems to be forgetting a chief lesson of the AIDS crisis: In the midst of an ongoing epidemic, access to medication must be valued over profit.
