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Can we measure what is in our hearts and minds, and could it help us end wars any sooner? These are the questions that consume entrepreneur Shawn Guttman, a Canadian émigré who recently gave up his yearslong teaching position in Israel to accelerate a path to peaceusing an algorithm. Living some 75 miles north of Tel Aviv, Guttman is no stranger to the uncertainties of conflict. Over the past few months, miscalculated drone strikes and imprecise missile targetssome intended for larger citieshave occasionally landed dangerously close to his town, sending him to bomb shelters more than once. When something big happens, we can point to it and say, Right, that happened because five years ago we did A, B, and C, and look at its effect, he says over Google Meet from his office, following a recent trip to the shelter. Behind him, souvenirs from the 1979 Egypt-Israel and 1994 Israel-Jordan peace treaties are visible. Im tired of that perspective. The startup he cofounded, Didi, is taking a different approach. Its aim is to analyze data across news outlets, political discourse, and social media to identify opportune moments to broker peace. Inspired by political scientist I. William Zartmans ripeness theory, the algorithmcalled the Ripeness Indexis designed to tell negotiators, organizers, diplomats, and nongovernmental organizations (NGOs) exactly when conditions are ripe to initiate peace negotiations, build coalitions, or launch grassroots campaigns. During ongoing U.S.-led negotiations over the war in Gaza, both Israel and Hamas have entrenched themselves in opposing bargaining positions. Meanwhile, Israels traditional allies, including the U.S., have expressed growing frustration over the war and the dire humanitarian conditions in the enclave, where the threat of famine looms. In Israel, Didis data is already informing grassroots organizations as they strategize which media outlets to target and how to time public actions, such as protests, in coordination with coalition partners. Guttman and his collaborators hope that eventually negotiators will use the models insights to help broker lasting peace. Guttmans project is part of a rising wave of so-called PeaceTecha movement using technology to make negotiations more inclusive and data-driven. This includes AI from Hala Systems, which uses satellite imagery and data fusion to monitor ceasefires in Yemen and Ukraine. Another AI startup, Remesh, has been active across the Middle East, helping organizations of all sizes canvas key stakeholders. Its algorithm clusters similar opinions, giving policymakers and mediators a clearer view of public sentiment and division. A range of NGOs and academic researchers have also developed digital tools for peacebuilding. The nonprofit Computational Democracy Project created Pol.is, an open-source platform that enables citizens to crowdsource outcomes to public debates. Meanwhile, the Futures Lab at the Center for Strategic and International Studies built a peace agreement simulator, complete with a chart to track how well each stakeholders needs are met. Guttman knows its an uphill battle. In addition to the ethical and privacy concerns of using AI to interpret public sentiment, PeaceTech also faces financial hurdles. These companies must find ways to sustain themselves amid shrinking public funding and a transatlantic surge in defense spending, which has pulled resources away from peacebuilding initiatives. Still, Guttman and his investors remain undeterred. One way to view the opportunity for PeaceTech is by looking at the economic toll of war. In its Global Peace Index 2024, the Institute for Economics and Peaces Vision of Humanity platform estimated that economic disruption due to violence and the fear of violence cost the world $19.1 trillion in 2023, or about 13 percent of global GDP. Guttman sees plenty of commercial potential in times of peace as well. Can we make billions of dollars, Guttman asks, and save the worldand create peace? The Ripeness Index Every evening, Didis bots scrape the websites of 60 Israeli and 30 Palestinian media outlets, digesting keywords into its Ripeness Index model. The index, a colorful radar chart resembling a digital version of the vintage puzzle game Simon, aims to distill the complex dynamics of Israeli-Palestinian social unrest into simple categories. These categories indicate when the time may be right to push for peace through grassroots messaging and diplomatic activity. If the center of the index is red, it signals that conditions are not yet ripe for negotiations. In such cases, messaging efforts should focus on shifting the surrounding red sections of the model to yellow. Yellow indicates that both sides are beginning to recognize that the costs of continuing the conflict outweigh the benefits. The Ripeness Index scans news media to indicate when the conditions to start negotiations are met. In early May, Guttman and his cofounder, Keren Winter-Dinur, a doctoral student in conflict resolution, worked with a team of developers to put the system through its biggest test to date. The occasion was the annual Peoples Peace Summit in Jerusalem. This years summit was organized by the Its Time coalitiona network of dozens of grassroots organizations seeking solutions to the Israeli-Palestinian conflictand brought together 15,000 attendees from peace-focused groups on both sides of the border. Many of the summits events are talking about, Hey, Israelis, learn about and understand what Palestinians are going through, Guttman says. See the other. The ripeness theory of negotiation, first introduced by Zartman in 1989, proposes that conflicts become ripe for resolution when two conditions are met. The first is the experience of a mutually hurting stalemate, where both sides are suffering and see no viable, unilateral path to a satisfactory outcome. The second is that both parties perceive a way out of the conflict. At this moment of ripeness, the door to negotiation opens. Political scientist I. William Zartman (top right), now in his nineties, endorsed the ipeness Index, developed by Didi cofounders Keren Winter-Dinur (top left) and Shawn Guttman. More recently, as big datasets around conflict resolution have become more easily available, researchers have tried to quantitatively validate Zartmans theory on past diplomatic negotiations. Still, quantitative studies around ripeness theory remain limited. When they launched Didi in 2022, Guttman and Winter-Dinur began by testing their Ripeness Index model on a different conflict: the Troubles in Northern Ireland in the years leading up to the 1998 Good Friday Agreement. After scraping a decades worth of speeches from the U.K. Parliament, the team found that support for negotiated peace increased on both sides just before key political partnerships formed, while support for continuing armed struggle diminished. Then October 7th happened. Guttman and Winter-Dinur knew they needed to pivot to Israel’s war. They began localizing their training database in Hebrew and Arabic and started scraping regional news. Their dataset now extends back to September 26, 2023. I said, Lets jump into the deep waters and see how we do, Guttman recalls. As it scans the news media, the bot tracks specific terms associated with each section of the Ripeness Index, such as confident in winning or willingness to compromise. At the bottom of the dashboard, graphs plot the frequency of flagged keywords in Israeli and Arabic news outlets over time, aligned with the models criteria. For the Its Time coalition, the model also tracks mentions of affiliated organizations, such as the pro-peace group Women Wage Peace and a recent Israeli-Palestinian memorial gathering. Guttman believes grassroots organizations should be using this data every day to spread pro-peace messaging to the public, alongside documentation of wartime atrocities, and to challenge the belief that military victory is necessary. We should be moving as fast as the news cycle moves, he says. The large timeline view lets users explore Didis full dataset. One promising signal came in January, at the start of a two-month ceasefire between Israel and Hamas, when Guttman and his team observed a surge in Israeli sentiment toward compromise. According to the theory, that moment of ripeness was what gave the Israeli political echelon the legitimacy and the support to say, Okay, we’re going to have a ceasefire, we’re going to give humanitarian aid, we’re going to exchange Palestinian prisoners for Israeli hostages, Guttman says. But that sentiment declined soon after and dropped sharply in March. That same month, citing stalled ceasefire negotiations, Israel resumed its ground war in Gaza. Guttman interprets the public shift as a response to the perceived failure of political efforts to secure the return of Israeli hostages. Then, in the week leading up to the Peoples Peace Summit in early May, the model determined that both Israeli and Palestinian publics saw a potential way out of the war. Still, the moment was not yet ripe for negotiations. On the left side of the index, the confident in winning and impossibility of winning sections had yet to shift into the green zone. Individual graphs show timelines of keyword counts in the news media, grouped by two conditions in Zartmans ripeness theory: mutually hurting stalemate and way out. Alongside the insights Didi gathers from the news media, the Its Time coalition also has been collecting data from social media platforms, including Facebook and X. Social media sentiment analysis is on Didis road map as well, but Guttman and Winter-Dinur caution against using it as a source of ground truth. Guttman and his team are still learning the limitations of their own data, too. Manual validation is important because the AI still misclassifies news articles. And Guttman admits that the models capabilities in Arabic are not yet as good as they are in Hebrew, a problem future datasets will address, he says. What could go wrong? The companys mix of AI and big data will also need to win over skeptics in the world of diplomacy. One concern is that relying on historical data to make predictions and inform decision-making could lead to a repetition of past mistakes. Most of the time, any kind of prediction work, machine-enabled or human-enabled, is going wrong, says Martin Wählisch, associate professor of transformative technologies, innovation, and global affairs at the University of Birmingham. The representativeness of data is a major challenge for PeaceTech, says Wählisch, who founded his own startup in the space, Office for Dreams, which combines digital tools with creative strategies to facilitate decision-making. The currency is the data inflow, he says. Last month, Wählisch joined an interdisciplinary group of technologists, researchers, and peacebuilders at the Stockholm Forum on Peace and Development to define a vision for AI use in large-scale deliberation processes. One system, built at Googles DeepMind, uses large language models to assist with the mediation process itself. In experiments with more than 5,000 participants in the U.K., researchers found the system, named after the German social theorist Jürgen Habermas, outperformed untrained human mediators, with 56% of participants preferring AI-generated statements over human ones. The tool also increased group agreement by about 8 percentage points and incorporated minority views. However, the researchers noted, AI-assisted deliberation is not without its risks. . . . Steps must be taken to ensure users are representative of the target population and are prepared to contribute in good faith. Still, many of these efforts are swimming upstream at a moment when defense startups are seeing increased focus and funding amid surging military budgets. According to Bloomberg, private investors have already spent around $790 million on defense this year. Compare that figure to the investing trend in the past two decades, when private equity spending on defense reached $1 billion in nly five of those years. Private investment in PeaceTech is still nascent. Peacebuilding startups have traditionally been supported by government grants and donors, but these are harder to find now. The U.S. Agency for International Developments Development Innovation Ventures, for instance, typically funded startups like Didi, until it was shuttered by the Trump administration. Didis angel investor, B Ventures Group, exclusively funds tech firms with peacebuilding applications. Other PeaceTech investors include Peaceinvest, which focuses on local, pro-peace projects, and Kluz Ventures, which runs the annual Kluz Prize for PeaceTech. Two years ago, Didi won a Kluz Prize, which came with a $20,000 cash award recognizing the companys achievements in machine learning. Peacebuilding has traditionally been seen as the domain of nonprofits and governments, not a space for venture capital, Brian Abrams, founder and managing partner of B Ventures Group, wrote in a March essay. At the same time, this type of opportunity has been associated with impact investing and lower returns, a trade-off many venture investors are unwilling to make. But PeaceTech challenges those assumptions, offering a model that prioritizes both profit and purpose. Pursuing profits means presenting PeaceTech as useful outside of conflict zones too, the way defense firms typically diversify their business with the sale of dual-use technologies. Palantir, for instanceknown for the AI-powered data tools it sells to military and immigration authoritiesalso works for Fortune 500 companies and develops tools for humanitarian purposes. After its software was used to facilitate Ukrainian refugee assistance, the company was awarded a special distinction by the Kluz Prize for PeaceTech in 2023, the same year Didi won its award. We need to expand the current dual-use framing of technologycivilian and militaryto a triple-use paradigm that includes peace as a third pillar, Artur Kluz, founder and CEO of Kluz Ventures, and Stefaan Verhulst, a research professor at New York University, wrote in a recent Fast Company op-ed. This would mean structuring investments in a way that not only supports battlefield advantage and economic competitiveness, but also actively contributes to conflict prevention, mediation, and resolution. Abrams sees many commercial opportunities in Didis tool: Imagine a private equity firm using the Ripeness Index to time its mergers and acquisitions perfectly, or a public relations firm tuning its crisis management messaging just right. Recent estimates gauge the market size for public opinion and election polling at $8.93 billion in 2025. In any scenario, developers and entrepreneurs must be mindful about the use of personal data, says Abrams. PeaceTech begins, I think, with Hippocratic guardrails. First, do no harm. Make sure the technology is contributing toward peace and not in any way being used for anything counterproductive, he says. That concern is heightened by the use of AI for political influence. Governments throughout history have sought to monitor and police public sentiment during times of war and peace. More recently, governments have used artificial intelligence to identify people for deportation and arrest, sometimes wrongfully. The expanding use of AI and data analysis tools to police social media accounts, and the increasing use of large language models (with their tendency to fabricate), exacerbates these risks. Algorithms already purport to track what millions of people are thinking, but there are few ways of knowing if those are correct. The true test of AI in diplomacy will not be whether it can pass the Turing test, but whether it can contribute to a more cooperative, stable, and just international order, writes Erman Akilli, professor of international relations at Ankaras Hac Bayram Veli University, in a blog post for the SETA Foundation for Political Economic and Social Research. He urges policymakers to regulate the use of AI in diplomacy to prevent the tech from being exploited for strategic manipulation or coercion. Promising trends Two days before the Peoples Peace Summit, Guttman noticed anomalies in the trends he had been seeing in the previous few weeks. Willingness to compromise had been on the uptick, but the double-whammy of Israels Memorial Day and Independence Day events had a notable impact on public sentiment. Everything leading up to Memorial Day and Independence Day, the way that people were talking was very much pro-military: remembering soldiers who died, remembering these tragic stories of heroism and so on, Guttman says. The confident in winning line started to rise, reflecting a perception that a military solution to war is still possible. In this timeline view, events surrounding Israels Memorial Day and Independence Day are superimposed. Meanwhile, the hurt measure in the Ripeness Index has remained green, as it has been for most of the war, reflecting the public sentiment that the price of war is too high. Despite that high price, Guttman says, many Israelis appear to believe that there’s nothing to do but pay it and keep fighting because the military can win. A very big victory would be increasing the sentiment in Israeli society that we can’t win the war militarily, he says. As the U.S. attempts to broker a new cease-fire agreement between Israel and Hamasand as Israel launches a new war against Iranthe Didi team has been tracking a sudden, upward spike in the “Confident in Winning” indicator. More recently, Guttman and his team have offered a new recommendation to the Its Time Coalition and its partners as they push for peace: Link the high cost of war with the fact that military resources are limited and military options will eventually run out. In general, a missing element in Israeli discourse has been the connection between the feeling that the price of this war [in Gaza] is too high with the sentiment that we have exhausted our military options, says Guttman. Making this connection could create a tipping point in Israel discourse that pushes the Ripeness Index to yellow.
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Architects have long complained about the industry’s relatively paltry pay. Given the amount of expensive education architects require (master’s level), and the years they have to put in (many) before qualifying to take a licensure exam (arduous), they have been rightly upset: Architects can barely expect to crack the $100,000 salary mark after more than eight years in the profession. Now there are some numbers to back that up. Compared to every other design descipline Fast Company has studied in our our ongoing analysis of where the design jobs are, architects are underpaid, particularly as their careers progress. Their compensation increases at the slowest rate, based on years of experience. Fixing the problem requires a nuanced understanding of the outside factors that limit pay, according to Evelyn Lee, president of the American Institute of Architects. “Architecture is an industry that’s always been known to work within tight margins,” she says. Part of the reason is that the industry long ago set standardized fee structuresbasically a percentage of overall construction costsand those numbers haven’t changed much. “Our ability to get paid more is tied back to that,” Lee says. Architecture is also tied to economic cycles, and it can be a bellwether of recessions. “When things are good, and people are spending a lot of money on capital costs, we are doing well. But we’re usually the first service to get cut when people start to hold back, and we’re the last to come on board when the economy starts coming back,” Lee says. And because they’re never quite sure when the next project will come around, many architecture firms end up being conservative with their spending and salaries. Also, the highly competitive nature of the architecture industry means that it is governed by antitrust laws that prohibit price fixing. These laws are meant to encourage competition, but they often end up creating a race to the bottom. Firms underbid each other in order to secure commissions, and then rely on underpaid workers and uncompensated overtime to get the job done. “It’s very internalized in the profession, starting at the university level,” says Jennifer Siqueira, an architect at New York-based Bernheimer Architects who helped organize the first union at an architecture firm in the U.S. “You’re taught to work very hard because it’s like these are passion projects. It’s almost an artistic endeavor to do architecture . . . It’s a very exploitative environment.” All-nighters are common in the field, from university through the working world; Siqueira says that she herself worked through the night multiple times in previous jobs at architecture firms, including some that are very prominent. Part of the unionization effort she led at her current firm was centered around improving working conditions and making the level of pay match the level of effort. She and fellow union organizers even negotiated with the firm’s management to set salary floors based on years of experience. “It’s very rare, especially because in a lot of contracts you’ll see a clause saying you can’t even talk about what you make to another coworker,” Siqueira says. “This is a level of transparency that’s really lacking within the profession.” Lee, at the AIA, says that the association conducts its own compensation surveys in order to fill that void, but she explains that the upwind forces that limit architects’ fees and salaries are largely beyond the industry’s control. Still, that doesn’t mean architects should sit back and wallow in low fees forever. She says that the AIA has increased the number of training programs it provides that are geared toward the business side of running architecture firms, and it encourages architects to be more proactive in offering clients more than just the limited scope of a one-off building design. “I do think there’s an opportunity to get more savvy though about how we package and deliver our services in a way that better reflects the value that we bring to the table,” she says. Changing an industry takes time, especially one that is predominantly made up of small businesses. About 75% of the 19,000 architecture firms operating in the U.S. have 10 employees or fewer, and 28% are run by sole practitioners. Architects are “wearing many hats, as the marketer and the operations person,” Lee says. Other types of designers work within “a much bigger ecosystem, where they have business experts that are brought on to support non-project needs. We architects feel like we have to do that all on our own.” Lee, who has worked as a fractional chief operating officer for multiple small and medium-size architecture firms, says that the AIA is “trying to support our architects and tell them that it’s just as important to design their business as it is to deliver design as a practice.” But that may take longer than some architects are willing to wait. In the meantime, Siqueira says there’s a clear path toward improving pay and working conditions for architects: “The only way is to unionize,” she says. This article is part of Fast Company‘s continuing coverage of where the design jobs are, including this year’s comprehensive analysis of 170,000 job listings.
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Four decades after the human immunodeficiency virus was first identified, the end of the epidemic could be in sight. Thanks to treatments and preventive medications, new infections worldwide have fallen dramatically, from 3.3 million at their peak in 1995 to 1.3 million in 2023. Now, with the arrival of a groundbreaking drug from Gilead Sciences, theres serious talk about bringing new cases down to zero. Foster City, Californiabased Gilead is already the leader in HIV prevention. Its daily oral pill Descovy accounts for about 40% of the U.S. market for pre-exposure drugs, known as PrEP (pre-exposure prophylaxis). Sales of the companys portfolio of drugs for HIV prevention and treatment reached $19.6 billion in 2024. Some 75% of the nearly 40 million people worldwide who live with HIV receive a Gilead-branded drug or a generic version, according to the company. But the twice-a-year injectable lenacapavir, which is on track for a June 19 approval as PrEP by the U.S. Food and Drug Administration, has the potential to be a game changer. The first study of lenacapavir to prevent HIV infections, which included more than 5,000 women, showed it to be 100% effectivethe first Phase 3 HIV-prevention trial ever with zero infections. In a subsequent study of more than 3,000 men, transgender people, and nonbinary individuals who had sex with male partners, lenacapavir reduced new HIV infections by 96% compared to background incidence. A twice-yearly injection to prevent the infection could change everything, says Gilead CEO Daniel ODay, putting an end to the epidemic and all the health and economic challenges that come with it. According to one estimate, lenacapavir could avert up to a third of HIV infections in eastern and southern Africa over 10 years, if priced affordably enough. Gilead has trumpeted plans for the rollout of lenacapavir in low- and middle-income countries. But these noble promises sit uncomfortably with some patients in the U.S., where the company makes more than 80% of its HIV revenuesand where Gilead is accused of putting profits over patients interests. Even as the FDA weighs approval for lenacapavir, the California Supreme Court has been considering a liability lawsuit brought by more than 24,000 plaintiffs, who say they suffered bone and kidney damage because Gilead delayed the launch of an HIV treatment two decades ago to maximize profits on an older, more toxic drug. Whats more, Gileads halo-burnishing work in the developing world is increasingly threatened by the Trump administration, as it decimates the funding and infrastructure that would support lenacapavirs rollout. HIV drugs have long been among the most politically charged molecules on the market. At this moment, they are explosive. Since the U.S. approved AZTmarketed as Retrovir by drugmaker GlaxoSmithKlineas the first AIDS treatment in 1987, theres been a drive to develop new drugs that better suppress the HIV virus and are safer, more tolerable, and more convenient to take. The history of HIV [medicines] has been one of innovation and then continued innovation, says Jared Baeten, Gileads senior vice president of clinical development in virology. And Gilead controls many of the most lucrative innovations. In the early 2000s, HIV patients took handfuls of pills daily. Gilead and its partner Bristol-Myers Squibb were the first to combine those medicines into a single tablet: Atripla, which launched in 2006. As drugmakers developed new treatments, they also pursued preventive strategies, based on the understanding that the virus has difficulty establishing itself in people who have antiretroviral drugs in their bodies. The first FDA approval for PrEP medication was in 2012, for Gileads Truvada. PrEP has been transformative. New HIV infections have dropped 39% globally since 2010, and annual new infections are down at least 66% in the 11 African countries that are a focus for the Global HIV Prevention Coalition. Gilead saw an opportunity to increase this progress by developing a treatment that requires less frequent dosing. First approved as an HIV treatment in the U.S. in 2022, under the brand name Sunlenca, lenacapavir emerged from a dozen years of preclinical work. Instead of attacking the viral enzymes that help HIV to replicate, as most antiretroviral medicines do, it targets the HIV capsid protein, which holds the viral genetic information. That offers a different opportunity to address the disease, because you hit the virus at different steps in the life cycle, says Gilead chief medical officer Dietmar Berger. Gilead researchers synthesized more than 4,000 molecules to find one with the potency and duration to allow for dosing twice a year, and potentially even less frequently. If approved for HIV prevention, lenacapavir wont be the first long-lasting injectable on the market. In 2021, the FDA approved Apretude, an injectable form of PrEP that must be taken every two months. Made by ViiV (which is majority-owned by GlaxoSmithKline), it had sales of about $350 million in 2024. But Gilead is betting that fewer shots per year will lead to better adherenceand justify a list price that some experts speculate could surpass $40,000, about twice the annual cost of Apretude. A $40,000-a-year drug hardly seems to be a scalable solution for the most vulnerable populations impacted by HIV. But drug pricing in the U.S. is exceptionally complicated. When it comes to accessing PrEP, an individuals options come down to where they live and what insurance they have. Under the Affordable Care Act, nearly all private insurance plans and state Medicaid plans have been mandated to fully cover PrEP. But if youre uninsured, you may have to piece together support from multiple sources, explains Jeremiah Johnson, executive director of the nonprofit PrEP4All. While someone might get medicines through a patient assistance program, they might not have coverage for related lab tests or provider visits. These coverage disparities are reflected in HIV infection rates, which are rising the fastest in Southern states, many of which didnt expand their Medicaid programs under the Affordable Care Act. Meanwhile, Black Americans, who make up about 14.4% of the U.S. population, accounted for 37% of estimated new HIV infections in 2022. Hispanic/Latino Americans, at 18% of the U.S. population, had 33% of new infections. And because the rollout of PrEP has primarily targeted gay men, women have often been neglected, says Lealah Pollock, a physician at the University of California, San Francisco, who specializes in HIV care for women, transgender people, and nonbinary individuals. In its efforts to engage marginalized populations, Gilead has become one of the largest funders of HIV-related programs globally and in the U.S. It distributed more than 900 HIV-related grants totaling nearly $214 million in 2023 (the most recent numbers the company has disclosed). Its given more than $129 million since 2017 to nearly 490 community-based HIV/AIDS organizations in the U.S. South, and has provided free medicines for more than 550,000 individuals without insurance over the past 25 years. But Gilead has drawn fire for the prices of its drugs. Mark Harrington, executive director of the nonprofit advocacy Treatment Action Group, points to Gileads launch of Truvada for PrEP in 2012. Since the drug had already been on the market as an HIV treatment, many patient advocates hoped Gilead would lower the price of Truvada for PrEPthe companys new R&D cost was minimal, after all. Instead, Gilead set the same price as it had for treatment. Then it started raising the priceby 45% within ive years. The list price for a months worth of Truvada hit $1,800 in 2021the year $30-a-month generics came to market. Gilead was one step ahead, however: It was already rolling out its next PrEP medication, Descovy. The decade after Truvadas launch was a missed opportunity for the U.S. and other countries to roll out oral prep, says Harrington, in part because of the excessively high price charged by Gilead. He and other patient advocates dont hold out much hope that the companys rollout of lenacapavir will be any different. Lenacapavir is a fantastic achievement and broadens options for treatment and prevention, Harrington says. But [Gileads] pricing policies have been outrageous and continue to be outrageous. The lawsuit now before the California Supreme Court has put Gileads pricing strategies in the spotlight and revealed the inherent issues when one company effectively controls an entire category of drugs. The case involves more than 24,000 patients on HIV treatment regimens that contained a molecule known as tenofovir disoproxil fumarate (TDF). First approved in October 2001 and branded as Viread, TDF became a key component in combination therapies like Truvada and Atripla. In 2015, sales of Truvada and Atripla each totaled more than $3 billion, while sales of Viread alone surpassed $1 billion. The plaintiffs allege that as early as 2001, Gilead had developed tenofovir alafenamide fumarate (TAF), a similar but chemically distinct drug that the company knew might have fewer side effects than TDF, which has been linked to bone mineral density loss and kidney damage. Rather than bring this newer drug to market, though, the company intentionally delayed its development to maximize profits on TDF. Internal documents from the time, uncovered by plaintiffs attorneys, outline Gileads strategy of waiting until TDFs patent was close to its 2017 expiration before filing patents for TAF, which was approved by the FDA in 2016, and marketed as Descovy. Gilead then worked aggressively to switch patients to the new, patent-protected drug before a generic version of TDF became available. Called product hopping or evergreening, this practice is common in the pharma industry and is used by companies to maintain extended monopolies in a treatment area. Robert Jenner, co-lead counsel for the plaintiffs, says the lawsuit boils down to a simple question: Does a pharmaceutical company have a duty to release a safer drug when it has one, or can it delay its release just to make more money? He is confident in the case: Courts across the country, including in California, have recognized that a company doesnt need to sell a defective product to be liable. It just needs to have made a negligent choice that caused harm. Gilead has argued that it had no legal duty to release TAF any earlier than it did, and its motion for summary judgment is now being weighed by the California Supreme Court. In the meantime, industry groups, the chambers of commerce of the United States and of California, the National Retail Federation, and more than 40 manufacturers across the drug, medical device, automobile, and consumer goods industries have filed amicus briefs in support of Gilead. They say that finding in favor of the plaintiffs would create a duty to innovate that would effectively force drugmakers and others to bring new products to market. (Gilead declined an interview about the case.) If the California Supreme Court lets the case proceed, lawyers for the plaintiffs have several bellwether cases prepared for trial and hope that a favorable outcome in one of these will convince Gilead to make a broader settlement. (In June 2024, Gilead agreed to pay up to $40 million to settle a separate, federal lawsuit over TDF, involving more than 2,600 plaintiffs.) We want an outcome that is cognizant of the kind of innovation that we want from companies, says Johnson of PrEP4All. Do we truly want to reward companies for making decisions to withhold treatments that may be safer? Gileads reputation abroad is somewhat less complicated. Of the more than 3.5 million people who received PrEP at least once in 2023, more than 75% were in the African region, where Gilead works to make its drugs accessible and affordable. Lenacapavir is meant to be a cornerstone of this public mission.Gilead already has agreements with generic drugmakers to supply low-cost versions of the drug in 120 countriesand to provide whats known as access pricing until these manufacturers get up to speed. The company is also partnering with several foundations to make lenacapavir available to at least two million people within three years. But the effort has lost a key partner in the U.S. government, which has traditionally provided two-thirds of the financing for HIV prevention in low- and middle-income countries. Since taking office, President Trump has paused funding to the Presidents Emergency Plan for AIDS Relief (PEPFAR), an initiative launched in 2003 thats saved 26 million lives, and cut funding to the UNAIDS program. Hes also dismantled the U.S. Agency for International Development, which supports the distribution of HIV drugs worldwide. A Center for Global Development/New York Times analysis estimates as many as 1.65 million people could die within a year without U.S. foreign aid for HIV prevention and treatment. The Global Fund, one of Gileads foundation partners in rolling out lenacapavir, has said it intends to fund the drugs distribution, with or without the help of PEPFAR. But even if Gilead provides huge discounts on medicines, the infrastructure that supports their delivery has been demolished. Lowering the price by itself is not going to open a clinic or restore a data system or restore staff that has been let go, says Harrington. Gilead did not make an executive available to discuss the Trump administrations impact on its global HIV efforts. A spokesperson didnt offer specifics on the companys plans but cited its nearly 20 years of experience of ensuring access to our lifesaving medicines in low-to-lower-middle-income countries. They added, We do not expect these changes to have a commercial impact on lenacapavir. In other words, theres still an opportunity to make money from lenacapavir. But the opportunity to end AIDS around the worldthat may have to wait.
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