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2025-06-18 09:00:00| Fast Company

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.


Category: E-Commerce

 

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2025-06-18 08:00:00| Fast Company

Artificial intelligence is rapidly being adopted to help prevent abuse and protect vulnerable peopleincluding children in foster care, adults in nursing homes, and students in schools. These tools promise to detect danger in real time and alert authorities before serious harm occurs. Developers are using natural language processing, for examplea form of AI that interprets written or spoken languageto try to detect patterns of threats, manipulation, and control in text messages. This information could help detect domestic abuse and potentially assist courts or law enforcement in early intervention. Some child welfare agencies use predictive modeling, another common AI technique, to calculate which families or individuals are most at risk for abuse. When thoughtfully implemented, AI tools have the potential to enhance safety and efficiency. For instance, predictive models have assisted social workers to prioritize high-risk cases and intervene earlier. But as a social worker with 15 years of experience researching family violenceand five years on the front lines as a foster-care case manager, child abuse investigator, and early childhood coordinatorIve seen how well-intentioned systems often fail the very people they are meant to protect. Now, I am helping to develop iCare, an AI-powered surveillance camera that analyzes limb movementsnot faces or voicesto detect physical violence. Im grappling with a critical question: Can AI truly help safeguard vulnerable people, or is it just automating the same systems that have long caused them harm? New tech, old injustice Many AI tools are trained to “learn by analyzing historical data. But history is full of inequality, bias, and flawed assumptions. So are people, who design, test, and fund AI. That means AI algorithms can wind up replicating systemic forms of discrimination, like racism or classism. A 2022 study in Allegheny County, Pennsylvania, found that a predictive risk model to score families risk levelsscores given to hotline staff to help them screen callswould have flagged Black children for investigation 20% more often than white children, if used without human oversight. When social workers were included in decision-making, that disparity dropped to 9%. Language-based AI can also reinforce bias. For instance, one study showed that natural language processing systems misclassified African American Vernacular English as aggressive at a significantly higher rate than Standard American Englishup to 62% more often, in certain contexts. Meanwhile, a 2023 study found that AI models often struggle with context clues, meaning sarcastic or joking messages can be misclassified as serious threats or signs of distress. These flaws can replicate larger problems in protective systems. People of color have long been over-surveilled in child welfare systemssometimes due to cultural misunderstandings, sometimes due to prejudice. Studies have shown that Black and Indigenous families face disproportionately higher rates of reporting, investigation, and family separation compared with white families, even after accounting for income and other socioeconomic factors. Many of these disparities stem from structural racism embedded in decades of discriminatory policy decisions, as well as implicit biases and discretionary decision-making by overburdened caseworkers. Surveillance over support Even when AI systems do reduce harm toward vulnerable groups, they often do so at a disturbing cost. In hospitals and eldercare facilities, for example, AI-enabled cameras have been used to detect physical aggression between staff, visitors, and residents. While commercial vendors promote these tools as safety innovations, their use raises serious ethical concerns about the balance between protection and privacy. In a 2022 pilot program in Australia, AI camera systems deployed in two care homes generated more than 12,000 false alerts over 12 monthsoverwhelming staff and missing at least one real incident. The programs accuracy did not achieve a level that would be considered acceptable to staff and management, according to the independent report. Children are affected, too. In U.S. schools, AI surveillance like Gaggle, GoGuardian, and Securly are marketed as tools to keep students safe. Such programs can be installed on students devices to monitor online activity and flag anything concerning. But theyve also been shown to flag harmless behaviorslike writing short stories with mild violence, or researching topics related to mental health. As an Associated Press investigation revealed, these systems have also outed LGBTQ+ students to parents or school administrators by monitoring searches or conversations about gender and sexuality. Other systems use classroom cameras and microphones to detect aggression. But they frequently misidentify normal behavior like laughing, coughing, or roughhousingsometimes prompting intervention or discipline. These are not isolated technical glitches; they reflect deep flaws in how AI is trained and deployed. AI systems learn from past data that has been selected and labeled by humansdata that often reflects social inequalities and biases. As sociologist Virginia Eubanks wrote i Automating Inequality, AI systems risk scaling up these long-standing harms. Care, not punishment I believe AI can still be a force for good, but only if its developers prioritize the dignity of the people these tools are meant to protect. Ive developed a framework of four key principles for what I call trauma-responsive AI. Survivor control: People should have a say in how, when, and if theyre monitored. Providing users with greater control over their data can enhance trust in AI systems and increase their engagement with support services, such as creating personalized plans to stay safe or access help. Human oversight: Studies show that combining social workers expertise with AI support improves fairness and reduces child maltreatmentas in Allegheny County, where caseworkers used algorithmic risk scores as one factor, alongside their professional judgment, to decide which child abuse reports to investigate. Bias auditing: Governments and developers are increasingly encouraged to test AI systems for racial and economic bias. Open-source tools like IBMs AI Fairness 360, Googles What-If Tool, and Fairlearn assist in detecting and reducing such biases in machine learning models. Privacy by design: Technology should be built to protect peoples dignity. Open-source tools like Amnesia, Googles differential privacy library, and Microsofts SmartNoise help anonymize sensitive data by removing or obscuring identifiable information. Additionally, AI-powered techniques, such as facial blurring, can anonymize peoples identities in video or photo data. Honoring these principles means building systems that respond with care, not punishment. Some promising models are already emerging. The Coalition Against Stalkerware and its partners advocate to include survivors in all stages of tech developmentfrom needs assessments to user testing and ethical oversight. Legislation is important, too. On May 5, 2025, for example, Montanas governor signed a law restricting state and local government from using AI to make automated decisions about individuals without meaningful human oversight. It requires transparency about how AI is used in government systems and prohibits discriminatory profiling. As I tell my students, innovative interventions should disrupt cycles of harm, not perpetuate them. AI will never replace the human capacity for context and compassion. But with the right values at the center, it might help us deliver more of it. Aislinn Conrad is an associate professor of social work at the University of Iowa. This article is republished from The Conversation under a Creative Commons license. Read the original article.


Category: E-Commerce

 

2025-06-18 04:11:00| Fast Company

Gen Zers are putting their money where their mouths are when it comes to shopping. Nearly all Gen Z consumers96%say they shop with intention, and 66% believe their purchases should reflect their personal values, according to the newly released Lightspeed Commerce report, which surveyed over 2,000 North American shoppers. Spending habits have never been more visible, thanks to social media. Todays consumers have more ways than ever to signal their morals and valuesand more platforms to share those choices. Posting shopping hauls and empties videos, or filming a fit check with coffee in hand has become prime social media fodder. In an age where everything is content, more consumers are choosing brands that reflect who they are and what they stand for. A hallmark of Gen Z is coming to age in a hyper-connected world. In this world, every follow, like, repost, and even purchase is a direct reflection of a persons identity and values, Lightspeed CEO Dax Dasilva tells Fast Company. Through this connected world, there is a never-ending exposure to global issues, where activism, accountability, and cancel culture move at the speed of light. Today, the wrong purchase can carry social consequencesnot just from peers, but from the broader judgment of the internet. This pressure is especially strong among Gen Z: Thirty-two percent fear being canceled for supporting the wrong brands, which is more than five times higher than for boomers (6%). In many ways, this fear of being judged or canceled and the understanding of the weight of their buying decisions differentiates Gen Z from older generations, who have traditionally shopped based on things like price or quality, Dasilva says. This trendwhat Lightspeed calls value spendingis part of a broader consumer shift. Nearly all consumers (92%) identify as at least somewhat intentional in their purchases. While price (78%) and quality (67%) remain top priorities across generations, purchasing decisions that align with personal values or identity are close behind, cited by 62% of respondents. In the past six months, 27% of consumers made purchases based on national pride; 18% supported brands tied to charitable or social causes; another 18% chose products for their sustainability impact; and 15% factored in a CEOs political alignment. For 32% of these value spenders, this is a new behaviorbut half believe their spending carries more influence than ever before. Value for money has taken on a new meaning.


Category: E-Commerce

 

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