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gilead sciences
Will Big Pharma Greed Consume Promise of 'HIV-Ending' Shot?
"This moment calls for bold public funding, strong private sector leadership, and a shared commitment to making HIV prevention accessible, affordable, and a cornerstone of our national response," said one campaigner.
Jun 18, 2025
While joining Gilead Sciences in welcoming the U.S. Food and Drug Administration's Wednesday approval of a six-month shot that CEO Daniel O'Day said "offers a very real opportunity to help end the HIV epidemic," public health advocates this week have expressed concern that Big Pharma greed could impede access to lenacapavir.
Gilead announced that the FDA has approved lenacapavir—which will be sold under the brand name Yeztugo—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 77 lbs., "making it the first and only twice-yearly option available in the United States for people who need or want PrEP."
Responding in a statement, Save HIV Funding campaign manager Maxx Boykin said that "the FDA's approval of lenacapavir for HIV prevention has the potential to be a pivotal moment for the broader fight to end HIV. It's a reminder that prevention must be a national priority, backed by serious investment and political will."
"Ending the epidemic requires equal focus on prevention and treatment, delivered through equitable, community-driven systems," Boykin continued. "This moment calls for bold public funding, strong private sector leadership, and a shared commitment to making HIV prevention accessible, affordable, and a cornerstone of our national response."
"If lenacapavir has any chance of becoming a viable choice for people who could benefit from PrEP, the price will have to be low enough that safety net providers can afford to procure it."
The Save HIV Funding campaign was launched in 2023 by multiple groups, including PrEP4All, to fight proposed cuts to federal funds. PrEP4All senior policy consultant Amy Killelea and executive director Jeremiah Johnson wrote Tuesday at Health Affairs that "lenacapavir's PrEP approval comes four years after the first long-acting injectable product for PrEP—a once-every-two-month injection made by ViiV and sold under the brand name Apretude—hit the market. Despite a lot of fanfare about its ability to change the HIV prevention landscape, Apretude sales have been fairly anemic since its launch."
"This likely reflects the many barriers to PrEP access, including provider willingness to prescribe PrEP, individual awareness about HIV risk, and complicated procurement and financing considerations for provider-administered products," they explained. "Whether the fact that lenacapavir requires far fewer provider visits than Apretude will make it a better option for people remains to be seen. But regardless of whether lenacapavir truly disrupts the PrEP landscape, it provides another important tool in the HIV prevention toolbox and an option that could help anyone who might struggle with adherence to a daily pill regimen."
The FDA approval comes as congressional Republicans push a budget reconciliation package that would deprive millions of Americans of health insurance, and "given the anticipated high price tag of lenacapavir, any coverage losses could impede access," Killelea and Johnson warned. "The launch of lenacapavir also comes amidst an intentional hollowing out of governmental public health programs by the Trump administration."
"Gilead's charitable assistance programs cannot alone ensure that PrEP is available and accessible to the people who need it most," they stressed. "If lenacapavir has any chance of becoming a viable choice for people who could benefit from PrEP, the price will have to be low enough that safety net providers can afford to procure it. This is particularly true for provider-administered products, which are often covered as a medical benefit."
Given the challenging last few months, this is a bright spot - the approval of lenacapavir twice yearly to prevent HIV. Unlike past PrEP meds, it was found t be 100% protective in cisgender women.But it will only work if gets to people, especially those communities that need it most.
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— Oni Blackstock, MD MHS (@oniblackstock.bsky.social) June 18, 2025 at 3:54 PM
The Guardian reported Tuesday that Gilead "has not yet made the price of the drug public, but it has been estimated... that it is likely to be on par with current preventive medications at about $25,000... a year. As a treatment for people already living with HIV, it costs about $39,000 annually."
However, the "HIV-ending" injection could "be made for only $25... a year—including a 30% profit margin," the newspaper noted, citing an analysis from the University of Liverpool and others. The researchers found that "lenacapavir could be mass produced for $35 to $46 a year, if there was annual demand for 2 million doses, falling to $25 at scaled-up production of 5 million to 10 million doses each year."
The watchdog Public Citizen also highlighted that study in a Wednesday statement:
The closest drug to an HIV vaccine, lenacapavir has shown 99% efficacy in preventing HIV infection, but its manufacturer, Gilead, is overcharging for the drug and gripping tightly to its patents in certain countries.
Patented in many Latin American countries, lenacapavir as an HIV treatment is priced at more than $40,000 (U.S. dollars) per year, but experts estimate lenacapavir's production (plus a margin for profit) could price the drug as low as $25 with process improvements and an increase in demand...
Public Citizen has been working with 100 health groups across Latin America to overcome the patent barrier, issuing multiple compulsory license requests and calling on governments to take action to make long-acting PrEP more accessible.
Public Citizen Access to Medicines Director Peter Maybarduk said that "the world has an historic opportunity to end AIDS," a condition caused by HIV, but "that requires confronting the triple threat of funding cuts, stigma, and pharma power."
Reporting on the FDA approval Wednesday, The Associated Press pointed out that "global efforts at ending the HIV pandemic by 2030 have stalled. There still are more than 30,000 new infections in the U.S. each year and about 1.3 million worldwide."
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Gilead's ESG Awards Are Worthless. What About Drug Prices?
Diversifying your workforce represents a worthy goal. Yet, corporate social responsibility awards distract from what really matters to pharmaceutical company customers: whether or not they can afford life-saving medicines.
Feb 24, 2024
Corporate “Environmental and Social Governance” (ESG) performance ratings are less than worthless. Yet, companies cannot wait to show off when they make the cut.
Giddy communications shops rush out press releases boasting their inclusion on lists that purportedly showcase a commitment to ethical business practices. Many variables determine the gold star awardees that peacock for the public and shareholders. The common-sense metrics include how well a corporation treats its employees and customers. Others weigh how well companies reduce carbon emissions or strive for diversity in hiring practices.
While monitoring the carbon emissions of a natural gas company seems worthy, does it matter how much a pharmaceutical giant commits to climate change initiatives? What if the drug maker went all-in on diversity, but raised many of its drug prices 30 percent or more in under a year? In the end, who cares how much a drug company “greens” its production if sky-high price hikes make its products unaffordable to many Americans.
People living with HIV likely care more about sticker shock at the pharmacy counter than the diversity of Gilead’s sales force and research & development team.
Take Gilead Sciences as one example. In 2022, the California-headquartered drug maker cleaned up at the ESG awards ceremony. Gilead took home the Best Diversity, Equity & Inclusion (DE&I) Prize at Corporate Secretary and IR Magazine’s ESG Integration Awards. The company also earned the nod from the Association of Corporate Citizen Professionals as its first Corporate Social Impact Team of the Year designee. Fierce Pharma, a news outlet dedicated to reporting on the drug industry, ranked Gilead #2 on its Big Pharma list for corporate DEI efforts. Finally, JUST Capital and CNBC recognized Gilead as one of America’s most just companies, ranking it fifth overall in the pharmaceuticals and biotech industry. Paeans to DEI pay dividends.
Diversifying your workforce represents a worthy goal. Yet, corporate social responsibility awards distract from what really matters to pharmaceutical company customers: Can they afford their prescriptions, often in Gilead’s case, for life-saving HIV therapeutics?
The awards committees must have missed Gilead’s recent unsavory business practices. A 2023 New York Times story revealed how Gilead gamed the patent system, keeping Americans living with HIV on the less effective and not as safe Truvada to maximize profits before its patent expired. Gilead had already started researching the safer and more effective design of tenofovir (tenofovir alafenamide), but shelved it in favor of monopolistic profits for the older version. Then, just before the patent expired, Gilead brought the successor drug Descovy to market.
The shenanigans with Descovy don’t stop with mere patent profiteering. In under two years, Gilead doubled the price of its HIV-prevention drug. In the third quarter of 2020, Gilead charged healthcare safety net providers $445.11 for the PrEP medication; by the second quarter of 2022, the price hit $987.55. Pandemic-related inflation caused price hikes for innumerable goods and services, but inflation did not double pharmaceutical ingredient and manufacturing costs.
2022 marked a banner year in charity claw-backs from one of America’s supposed “most just” companies. According to its most recent financial report, Gilead generated over $27 billion in revenue, netting $4.59 billion in profit. Domestic sales of HIV medications accounted for $13.8 billion in sales. Despite beaucoup revenues with healthy profits for the year, Gilead made drastic changes to its Advancing Access Medication Assistance Program, a vital patient assistance program. Gilead reduced reimbursements to nonprofit healthcare providers that rely on the program for their low-income, uninsured patients living with HIV.
What if the drug maker went all-in on diversity, but raised many of its drug prices 30 percent or more in under a year?
The drug maker announced the changes would “support the long-term sustainability” of the initiative—code for trimming expenditures so the company generates greater profits. Just as troubling, the Gilead Foundation—the drug maker’s philanthropic arm—made substantial cuts to its charitable giving from the prior year. In 2021, Gilead donated equity securities to the foundation totaling $212 million. The following year, the drug maker slashed such donations by 59 percent, providing only $85 million in funds. The drop-off came despite no change in revenues.
ESG awards for corporate culture and commitment to diversity disregard the real ethical concerns in the pharmaceutical industry. People living with HIV likely care more about sticker shock at the pharmacy counter than the diversity of Gilead’s sales force and research & development team. The following metrics for drug companies make much more sense: Monitor patent manipulation that emphasizes profits at the expense of health outcomes; evaluate whether the company made it harder to access patient assistance programs; and, above all, highlight the affordability of prescription drugs. Have prices increased beyond inflation and costs from the previous year?
When an ESG award for the pharmaceutical industry focuses on these standards, then the recipient drug maker will actually have something to brag about.
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Sanders-Led Panel Exposes Big Pharma for 'Ripping Off' Americans With Publicly Funded Meds
"It is unacceptable that half of new prescription drugs invented with the help of NIH scientists now cost more than $111,000," said the HELP Committee chair, urging action by the Biden administration to cut prices.
Jun 12, 2023
"What makes the greed of the pharmaceutical industry so reprehensible is the fact that the American people are paying twice for some of the most expensive prescription drugs on the market: First through their taxes and a second time at the pharmacy counter."
That's according to U.S. Sen. Bernie Sanders (I-Vt.), who chairs the Senate Health, Education, Labor, and Pension (HELP) Committee and on Monday released a report revealing how Big Pharma is "ripping off" Americans with medical treatments that publicly funded experts helped create.
Sanders' staff tracked the prices—generally set by private corporations—of medical treatments developed with the help of scientists from the U.S. National Institutes of Health (NIH) over the past two decades.
"It is unacceptable that half of new prescription drugs invented with the help of NIH scientists now cost more than $111,000," said Sanders, a longtime advocate of policies to reduce healthcare costs, including a nationwide shift to Medicare for All—the focus of a bill that the senator introduced last month with Reps. Pramila Jayapal (D-Wash.) and Debbie Dingell (D-Mich.).
\u201cEssential reading from @SenSanders @HELPCmteDems on US taxpayers' immense contributions through @NIH to the development of new treatments; despite this, median price is $111,000 & US taxpayers almost always pay more than other countries for these publicly-funded treatments.\u201d— Reshma Ramachandran (@Reshma Ramachandran) 1686604987
The new report states that "U.S. taxpayers virtually always pay more than people in other countries for treatments that NIH scientists helped invent."
For example, a trio of Johnson and Johson's HIV treatments—Prezcobix, Prezista, and Symtuza—cost from $25,000 to $56,000 annually in the U.S., while patients in various other countries can get them for $4,000 to $10,000 per year.
"The price of some of these taxpayer-funded drugs is now over $1.9 million," Sanders highlighted, referring to Myalept, which is manufactured by Amryt Pharma to treat leptin deficiency and costs $580,000 a year in France.
Tecartus and Yescarta, manufactured by Gilead Sciences to treat cancer, both cost $424,000 in the United States, while the price for Tecartus in Germany is $306,000 and Yescarta is $212,000 in Japan.
Yescarta is one of two case studies included in the report. The other is Hemgenix, used to treat hemophilia B. As the document details:
The world's most expensive medicine—with a $3.5 million price tag—is the culmination of major scientific breakthroughs led by researchers at St. Jude Children's Research Hospital and NIH. However, NIH appears to have handed over taxpayer technology while obtaining vanishingly little in return. Licensing agreements reveal that NIH negotiated royalties of around 1% on sales, without any pricing constraints. Meanwhile, the company behind Hemgenix, uniQure, quietly disclosed that the price was "significant" and "most patients and their families will not be capable of paying for our products themselves."
"Congress provided nearly $54 billion for biomedical research across the U.S. government this year" and NIH alone has a $47.5 billion budget, "making it the largest biomedical research funder in the world," the report notes, stressing that "the federal government sets the stage for new medicines with its substantial investments."
"At the earliest stage, the federal government plays a role in pushing forward research for virtually all new medicines," the publication explains. The U.S. government also "directly funds the invention of some medicines," and sometimes helps with testing.
There are even cases in which the government financially backs getting medicines through the Food and Drug Administration approval process and scaling up manufacturing, the report adds, pointing out that "many Covid-19 products developed as part of Operation Warp Speed benefited from this kind of support."
\u201cNow is the time for the Biden Administration to take executive action to substantially lower the price of prescription drugs and to take on the corporate greed of the pharmaceutical industry.\u201d— Bernie Sanders (@Bernie Sanders) 1686606120
The report draws from U.S. history to offer a solution, highlighting that "after a pharmaceutical company launched an AIDS drug developed with the help of NIH scientists at $10,000 per year, NIH responded in 1989 by inserting a 'reasonable pricing clause' into contracts when taxpayers supported new drugs. The clause was withdrawn six years later after industry pressure."
"The average price of new treatments that NIH scientists helped invent over the past 20 years is now more than 10 times the price that led NIH to first introduce a reasonable pricing clause in 1989," the document continues. "The federal government should reinstate and strengthen a 'reasonable pricing clause' in all future collaboration, funding, and licensing agreements for medical research."
Sanders argued Monday that "now is the time for the Biden administration to take executive action to substantially lower the price of prescription drugs and to take on the unacceptable corporate greed of the pharmaceutical industry."
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