Latest news with #lowIncomeCountries
Zawya
5 days ago
- Business
- Zawya
Briefing Highlights: How the African Development Fund is Financing Africa's Future in a Shifting Global Landscape
The African Development Fund, the African Development Bank Group's ( concessional financing arm, was the focus of a special edition of the African Transformation Briefing co-hosted by the African Center for Economic Transformation (ACET) and the Global Strategic Communications Council. Moderated by ACET Communications Manager Belinda Ayamgha, the session was held virtually on 29 July 2025. The media-focused event convened development partners, journalists, and policymakers for an in-depth conversation on the Fund's role in financing economic transformation across 37 low-income African countries, nearly half of which are classified as fragile states. Valerie Dabady, Manager of Resource Mobilization and Partnerships at the African Development Bank, delivered a keynote presentation outlining the Fund's catalytic impact, financing structure, and evolving strategic direction. She underscored the Fund's ability to channel investments in areas such as climate resilience and regional integration through concessional resources tailored to country-specific needs and highlighted plans to expand its resource base. 'With 37 member countries and over $45 billion in investments since inception, the African Development Fund is a cornerstone of Africa's development financing architecture,' Dabady said. 'As we look toward the future, innovations like market borrowing and expanded donor engagement will be critical to increasing our impact.' The briefing also featured a country perspective from Joseph Chanda, Assistant Director for Economic Management and Planning in Zambia's Ministry of Finance. Chanda highlighted how Zambia is leveraging African Development Fund resources to accelerate infrastructure development, build climate resilience, and deepen regional integration. 'ADF financing has played a transformative role in Zambia,' he noted. 'By allocating just 10% of our national resources to the Lobito Corridor, we were able to leverage over $330 million in regional window co-financing. These are the types of investments that build real economies and regional prosperity.' The Lobito Corridor, a strategic rail and road project connecting Angola, the Democratic Republic of Congo, and Zambia, is among the largest regional integration initiatives currently under preparation with support from the African Development Fund. With a $500 million commitment, the Fund is helping to finance and de-risk the project, which is expected to catalyze investment in logistics, agriculture, and mining, particularly in critical minerals vital to the global energy transition. Chanda also referenced the Kazungula Bridge Project, a regional integration initiative co-financed by the Fund with an investment of $68 million. Completed in 2021, the 923-meter-long bridge spans the Zambezi River, connecting Zambia and Botswana and replacing a long-standing ferry service. The project also includes One-Stop Border Posts on both sides of the bridge, significantly streamlining customs procedures and reducing transit times along the North–South Corridor. It supports intra-African trade, enhances regional logistics efficiency, and has become a key node for trade between Southern and Central Africa. Participants raised questions on donor engagement, capital market access, and the future structure of the Fund. Dabady reaffirmed the Bank's ongoing efforts to attract non-traditional partners and finalize approvals that would enable the Fund to access capital markets. 'The ADF has long flown under the radar,' she said. 'But this is a pivotal moment to raise its profile, demonstrate impact, and unlock greater investment for Africa's most pressing priorities.' The session concluded with a call to action from Kerezhi Sebany, Africa Director for Economic Opportunities at the ONE Campaign. 'We must shine a light on the African Development Fund,' she said. 'When people know what the Fund is and what it delivers, it fosters transparency, trust, and partnership. Now is the time to tell the ADF story and tell it boldly.' The African Development Fund is currently undergoing its 17th replenishment cycle (ADF-17). The next consultative meeting with development partner representatives will be held virtually on 18-19 September 2025. This will be followed by a meeting in Lusaka, Zambia in October, where Zambia government representatives will share results and country-level experiences. The final pledging session for ADF-17 is scheduled for December 2025. Watch the briefing: Distributed by APO Group on behalf of African Development Bank Group (AfDB).
Yahoo
09-07-2025
- Health
- Yahoo
Gilead, Global Fund finalize plan to supply HIV prevention drug to poor countries
By Deena Beasley and Jennifer Rigby (Reuters) -Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis and Malaria said on Wednesday they had finalized plans to supply a long-acting HIV prevention drug to low-income countries, despite the absence of funding from a key U.S. initiative aimed at addressing the global HIV/AIDS epidemic. Under the agreement, Gilead said it will supply, at cost, enough doses to reach up to 2 million people over three years in countries supported by the Global Fund. Both parties said price terms are confidential, and the Global Fund declined to comment further on how many doses would be ordered immediately. The U.S. Food and Drug Administration last month approved Gilead's lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents. The World Health Organization and other regulators are currently reviewing it. Last year, Gilead signed royalty-free deals allowing six generic drugmakers to make and sell low-cost versions of the drug in 120 low- and middle-income countries, but those supplies will take time to get up and running. Some AIDS experts have said the new drug could help end the 44-year-old epidemic that infects 1.3 million people a year and is estimated by the World Health Organization to have killed more than 42 million. The Global Fund said it will prioritize access based on HIV incidence and prevention strategies, including countries in sub-Saharan Africa that have expressed strong interest - notably South Africa, which will be among the first to roll out the drug among around 10 other nations. The partners aim to have the first delivery reach at least one African country by the end of this year. "For the first time, a tool to prevent HIV infection is coming available in low and middle-income countries at the same time as in high-income countries," Peter Sands, executive director of the Global Fund, said in an interview with Reuters. In the past, this has taken years, he added. Gilead, the Global Fund and the United States President's Emergency Plan for AIDS Relief had announced the plan in December. However, the administration of U.S. President Donald Trump, who took office in January, has pulled back on PEPFAR funding, limiting global HIV prevention programs to pregnant and breastfeeding women. In response to questions about the impact of the cuts on HIV programs worldwide, a U.S. State Department spokesperson told Reuters: "PEPFAR-funded programs that deliver HIV care and treatment or prevention of mother-to-child transmission services are operational... All other PEPFAR-funded services are currently being reviewed." They did not respond to questions on lenacapavir specifically. Gilead CEO Daniel O'Day said he is still hopeful that U.S. aid spending to fight the epidemic will resume. "We want to be spending less over time on HIV because the incidence is lower ... we should put resources toward things that actually reduce the burden of disease over time." Gilead is also working with middle-income countries, many of which are in Latin America, to make lenacapavir accessible as soon as possible, he said. The drug, which has the brand name Yeztugo, has an annual list price in the United States of $28,218. The Children's Investment Fund Foundation pledged $150 million to the Global Fund earlier this year, including money for the lenacapavir initiative. Sands said more donors were also needed.
Yahoo
09-07-2025
- Business
- Yahoo
Gilead Finalizes Agreement With the Global Fund to Accelerate Access to Twice-Yearly Lenacapavir for HIV Prevention for up to Two Million People in Primarily Low- and Lower-Middle-Income Countries
– Strategic Partnership Agreement is Part of Gilead's Commitment to Provide Lenacapavir at No Profit in High-Incidence, Resource-Limited Countries Until Licensed Generics Can Fully Meet Demand – FOSTER CITY, Calif., July 09, 2025--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced a strategic partnership agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) to supply lenacapavir—Gilead's twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP). Through the agreement, Gilead will supply enough doses to reach up to two million people over three years in countries supported by the Global Fund, at no profit to Gilead. In October 2024, Gilead signed non-exclusive, royalty-free voluntary licensing agreements to manufacture and supply high-quality generic versions of lenacapavir in 120 high-incidence, resource-limited countries, which are primarily low- and lower-middle-income countries (LLMICs). Until licensed generic versions are available and can fully meet demand in LLMICs, Gilead also committed to providing Gilead-supplied lenacapavir for PrEP at no profit. Under this strategic partnership agreement with the Global Fund, countries supported by the Global Fund that are among the 120 high-incidence, resource-limited countries can access lenacapavir for PrEP. The Global Fund will prioritize early-access countries based on HIV epidemiology, national prevention strategies, and available resources. Gilead looks forward to partnering with other global aid organizations to further accelerate access to lenacapavir for PrEP in LLMICs. "The agreement between Gilead Sciences and the Global Fund is based on our shared intention to benefit as many people as possible, as quickly as possible with this breakthrough in HIV prevention," said Daniel O'Day, Chairman and Chief Executive Officer, Gilead Sciences. "We are providing the medicine at no profit to Gilead, and in enough supply to reach up to two million people in low- and lower-middle-income countries ahead of generic lenacapavir becoming available. This is all part of our unprecedented approach to access for a medicine that could help end the HIV epidemic." "This is not just a scientific breakthrough — it's a game-changer for HIV/AIDS," said Peter Sands, Executive Director of the Global Fund. "For the first time, we have a tool that can fundamentally change the trajectory of the HIV epidemic — but only if we get it to the people who need it most. Our ambition is to reach 2 million people with long-acting PrEP. But we can only do that if the world steps up with the resources required. This is a pivotal moment — not just for the fight against HIV, but for the fundamental principle that lifesaving innovations must reach those who need them most — whoever they are, and wherever they live." This collaboration is one of several actions Gilead is taking to help ensure supply until licensed generic versions of lenacapavir are available in countries covered by its voluntary licensing program, which is the earliest and most geographically expansive ever developed for an anti-HIV agent. Gilead's voluntary licensing agreements were finalized well before any regulatory filing or decision, to enable these countries to quickly introduce generic versions of lenacapavir for PrEP, if approved. Gilead hopes to secure approvals in key high-incidence, resource-limited countries as quickly as possible following the recent U.S. and potential EU approvals. To that end, in February 2025, the European Medicines Agency (EMA) validated Gilead's EU-Medicines for all (EU-M4all) application for lenacapavir for PrEP. Through the EU-M4all procedure, national regulatory authorities in LLMICs can leverage the EMA opinion to expedite their review processes, potentially accelerating access to lenacapavir for PrEP. Gilead is actively consulting with global aid organizations, including the Global Fund, to understand product demand and collaborate on distribution. Gilead has contracted at-risk manufacturing capacity to produce vials of lenacapavir for PrEP and corresponding oral initiation doses for up to two million people in the countries covered by the licensing agreements until generics fully meet demand, with the ability to produce additional supply to fulfill the needs of countries and global procurers. Extending Access Across More Countries In other middle-income countries, including many in Latin America with a high burden of HIV that are not covered by this agreement and the voluntary licensing program, Gilead is pursuing multiple strategies to support access to lenacapavir for PrEP, including tiered pricing and potential public-private partnerships, and is working with payers to establish fast, efficient pathways to help reach those who need or want PrEP. Gilead will continue to provide updates on regulatory filings and other steps aimed at expanding access to lenacapavir for HIV prevention. The company remains deeply engaged with stakeholders around the world, including community-based organizations, governments and multilateral organizations, to help ensure that its access efforts address the needs and preferences of the people and communities that stand to benefit from PrEP. Lenacapavir for HIV prevention is not approved by any regulatory authority outside of the United States. There is currently no cure for HIV or AIDS. Gilead's U.S. Access Strategy In the U.S., where lenacapavir for HIV prevention is approved as Yeztugo®, Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage. Additionally, for eligible commercially insured individuals, Gilead's Advancing Access® Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars for many. Gilead is also committed to helping to ensure that people without insurance in the U.S. will be able to benefit from Yeztugo. For those who are eligible, Gilead's Advancing Access medication assistance program will provide Yeztugo free of charge. About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg who are at risk of HIV acquisition. Please see below for the U.S. Indication and Important Safety Information for Yeztugo® (lenacapavir), including Boxed Warning. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 "Breakthrough of the Year." U.S. Indication for Yeztugo Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (>35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen. Contraindications Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status. Warnings and precautions Comprehensive risk management: Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. Potential risk of resistance: There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Long-acting properties and potential associated risks: Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously. Adverse reactions Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea. Drug interactions Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers. It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors. Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo. Dosage and administration HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection. Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose. Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate. Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to realize the anticipated benefits from the collaboration; difficulties or unanticipated expenses in connection with the collaboration and the potential effects on Gilead's earnings; Gilead's ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Yeztugo, including Boxed Warning, is available at Advancing Access, Yeztugo, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company's website at follow Gilead on X/Twitter (@GileadSciences) and LinkedIn (@Gilead-Sciences). View source version on Contacts Ashleigh Koss, Mediapublic_affairs@ Jacquie Ross, Investorsinvestor_relations@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
09-07-2025
- Health
- Reuters
Gilead, Global Fund finalize plan to supply HIV prevention drug to poor countries
July 9 (Reuters) - Gilead Sciences (GILD.O), opens new tab and the Global Fund to Fight AIDS, Tuberculosis and Malaria said on Wednesday they had finalized plans to supply a long-acting HIV prevention drug to low-income countries, despite the absence of funding from a key U.S. initiative aimed at addressing the global HIV/AIDS epidemic. Under the agreement, Gilead said it will supply, at cost, enough doses to reach up to 2 million people over three years in countries supported by the Global Fund. Both parties said price terms are confidential, and the Global Fund declined to comment further on how many doses would be ordered immediately. The U.S. Food and Drug Administration last month approved Gilead's lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents. The World Health Organization and other regulators are currently reviewing it. Last year, Gilead signed royalty-free deals allowing six generic drugmakers to make and sell low-cost versions of the drug in 120 low- and middle-income countries, but those supplies will take time to get up and running. Some AIDS experts have said the new drug could help end the 44-year-old epidemic that infects 1.3 million people a year and is estimated by the World Health Organization to have killed more than 42 million. The Global Fund said it will prioritize access based on HIV incidence and prevention strategies, including countries in sub-Saharan Africa that have expressed strong interest - notably South Africa, which will be among the first to roll out the drug among around 10 other nations. The partners aim to have the first delivery reach at least one African country by the end of this year. "For the first time, a tool to prevent HIV infection is coming available in low and middle-income countries at the same time as in high-income countries," Peter Sands, executive director of the Global Fund, said in an interview with Reuters. In the past, this has taken years, he added. Gilead, the Global Fund and the United States President's Emergency Plan for AIDS Relief had announced the plan in December. However, the administration of U.S. President Donald Trump, who took office in January, has pulled back on PEPFAR funding, limiting global HIV prevention programs to pregnant and breastfeeding women. In response to questions about the impact of the cuts on HIV programs worldwide, a U.S. State Department spokesperson told Reuters: "PEPFAR-funded programs that deliver HIV care and treatment or prevention of mother-to-child transmission services are operational... All other PEPFAR-funded services are currently being reviewed." They did not respond to questions on lenacapavir specifically. Gilead CEO Daniel O'Day said he is still hopeful that U.S. aid spending to fight the epidemic will resume. "We want to be spending less over time on HIV because the incidence is lower ... we should put resources toward things that actually reduce the burden of disease over time." Gilead is also working with middle-income countries, many of which are in Latin America, to make lenacapavir accessible as soon as possible, he said. The drug, which has the brand name Yeztugo, has an annual list price in the United States of $28,218. The Children's Investment Fund Foundation pledged $150 million to the Global Fund earlier this year, including money for the lenacapavir initiative. Sands said more donors were also needed.
Mail & Guardian
26-06-2025
- Health
- Mail & Guardian
‘It's heartbreaking': bad cancer drugs shipped to more than 100 countries
The burden of cancer is growing, particularly in low- and middle-income regions. In sub-Saharan Africa, for example, instances of cancer have doubled in the last 30 years. (File photo) Vital chemotherapy drugs used around the world have failed quality tests, leaving cancer patients in more than 100 countries at risk of ineffective treatments and potentially fatal side effects, The drugs in question form the backbone of treatment plans for numerous common cancers — including breast, ovarian and leukemia. Some drugs contained so little of their key ingredient that pharmacists said giving them to patients would be as good as doing nothing. Other drugs, containing too much active ingredient, put patients at risk of severe organ damage or even death. 'Both scenarios are horrendous,' said one pharmacist. 'It's heartbreaking.' Doctors from multiple countries told TBIJ of the drugs in question not working as expected, leaving patients suddenly unresponsive to treatment. Other patients suffered side effects so toxic that they could no longer tolerate the medicine. The variance found in the levels of active ingredient was alarming. In some cases, pills from the same blister pack contained different amounts. These findings expose huge holes in the global safety nets intended to prevent profit-seeking manufacturers from cutting corners and to protect patients from bad drugs. All the while, patients and governments with stretched resources are paying the price for drugs that don't work. A global killer Cancer is one of the biggest killers worldwide, linked to around 10 million deaths every year — roughly one in six. The burden of cancer is growing, particularly in low- and middle-income regions. In sub-Saharan Africa, for example, instances of cancer have doubled in the last 30 years. Much of the global demand for treatment is met by so-called generic drugs. These are versions of a drug that can be made once the original maker's exclusivity rights have expired and are typically made far more cheaply. The bad drugs described in this investigation were all generics. Generics are widely used in all countries but are most crucial in those with fewer resources, where costlier treatments might be beyond reach. If generics were not available in sub-Saharan Africa, for instance, 'any cancer treatment would be likely inaccessible to most of the population', said Claudia Martinez of the Access to Medicine Foundation*, an NGO. In chemotherapy drugs, the active ingredient — which fights cancer cells — is also highly toxic. Patients need to receive enough of it to treat the cancer but not so much that they overdose and suffer damaging side effects. As such, hospital pharmacists calculate doses carefully and, in doing so, rely on the amount of active ingredient being exactly what's stated on the label. Research from a Working with collaborators in Cameroon, Ethiopia, Kenya and Malawi, researchers at the University of Notre Dame, Indiana in the US, analysed drug samples from the four countries. Of 189 samples that had not expired at the time of testing, about one fifth failed. This consisted of 20 different brands of generic drugs made by 17 manufacturers (see a full list of the brands that failed 'We were all taken aback when we saw the results,' said Marya Lieberman, the professor who led the research. More than 30 manufacturers made products to a good standard. But for patients receiving the poor-quality drugs, the effects could be devastating. 'Once a person has been diagnosed with cancer, there's a limited window of opportunity for treatment to work,' said Lieberman. 'And if someone is treated with an ineffective product, they can lose that precious window.' The majority of failed drugs had too little active ingredient (for most this meant less than 88% of the amount stated on the label) while some contained too much (more than 112%). Both thresholds were decided by researchers based on international standards. 'Both scenarios are horrendous in my eyes,' said Shereen Nabhani-Gebara, vice chair of the British Oncology Pharmacists Association. 'It takes a lot of courage for someone with cancer to accept a diagnosis, but then to be short-changed like this when they are trying their best is heartbreaking — because this is someone's life.' Tracking the threat Over the past six years, these brands of drugs have been shipped to more than 100 countries in every populated continent on the planet. They range from low- and middle-income nations like Nepal, Ethiopia and North Korea, to wealthy countries such as the US, UK and Saudi Arabia. The worst-performing drug in the study is made by Indian manufacturer Venus Remedies. It is a drug called cyclophosphamide, which is often used to treat cancers including lymphoma and breast cancer. All eight samples of this Venus Remedies drug failed, with six containing less than half the amount of active ingredient claimed by the manufacturer. One contained just over a quarter of the stated dose, which according to several cancer pharmacists would be as effective as no treatment at all. The drug has been shipped to six countries, with its largest importer being Ethiopia. Wondemagegnhu Tigeneh, a clinical oncologist in the Ethiopian capital Addis Ababa, told TBIJ that he has treated patients with chemotherapy drugs he believes did not work. 'I have a suspicion that the active ingredient was lower than expected,' he said, remembering a drug he gave to a recent patient who had responded well to the first three rounds of treatment. But on the next round, their progress suddenly stopped. Because he has no means to test them, Tigeneh can never be sure of the quality of a given drug. But in his 20 years treating cancer, he has learned to notice tell-tale signs. Sometimes, for instance, there is a complete absence of side-effects such as nausea or hair loss. 'That makes it difficult to trust that particular drug,' he said. Then there are the patients whose disease he struggles to get under control, such as a patient whose response to treatment halted without warning. Rather than reducing the size of the tumour enough to enable surgery, his team has been forced to move onto a second-line treatment. If that fails, the next stage is palliative care. 'It's very sad,' said Tigeneh. 'We didn't used to see things like this.' Cancer patients in Ethiopia have far better access to treatment facilities now than they did 20 years ago. It doesn't seem, however, that the standard of medicines has kept pace. A 2020 study of cancer drugs in Ethiopia included 20 samples of cisplatin which were all found to be substandard, averaging just over half of the stated content. One researcher who tests the quality of drugs in the country told TBIJ that they find bad medicines wherever they go. Venus Remedies told TBIJ that the study results were 'not scientifically plausible' given the company's 'validated manufacturing systems and quality controls'. It said it has received no complaints or concerns about the batches in question and shared the results of its own testing that indicated they were of a good standard. It said storage conditions in the supply chain, which can affect drug quality, might have affected the researchers' test results. However, the absence of similar quality issues across the entire data set suggests this is not the case. Venus Remedies is one of three companies or regulators that queried the methodology used by the lab, saying it deviated from international standards or could give erroneous results. However, Lieberman said that, although her results are not intended for regulatory purposes, her researchers' methods are based on those used by regulatory labs and were verified for suitability, accuracy, and precision. Both the findings and methods have been scrutinised by independent academics. Toxic effects About 3 200km south of Addis Ababa, in Malawi, specialist cancer care has only been available for around 15 years. In one of the poorest countries in the world, patients depend on healthcare being free at the point of need. That means clinics have to rely on generic drugs. A pharmacist specialising in cancer care in central Malawi told TBIJ of seeing patients at his hospital overdose on methotrexate, a drug used to treat leukaemia and lymphoma. Malawi has also imported two of the brands of methotrexate the researchers in this investigation found to contain too much active ingredient: Zuvitrex, made by Zuvius Lifesciences, and Unitrexate, made by United Biotech. Neither company responded to multiple requests for comment. This sort of excess can be just as harmful as a deficit. A bad overdose can leave a patient with lifelong side effects or even kill them. As Nabhani-Gebara said: 'More is not better.' The Malawian pharmacist said patients at his hospital have suffered severe vomiting and nausea after overdosing on methotrexate, while others had to be moved onto a second-line treatment, which might not be as effective. For some patients, the side effects were so severe that they had to pause treatment entirely — giving the cancer a chance to grow. When a sample of the methotrexate in question was tested as part of a research project taking place at the time, it was found to be too high in active ingredient. 'It's very worrying,' the pharmacist said. He told TBIJ that he and his colleagues have on occasion had to stop using an entire batch of chemotherapy medicine and send samples to the national drug regulator after the medicine changed colour — a sign something is wrong with it. 'We had patients scheduled for clinic,' he said, 'and then we had to break the news to them that we don't have medicines.' Failing safety nets Countries all over the world have systems in place to stop bad drugs reaching patients. However, there are huge disparities in their effectiveness. According to Chaitanya Kumar Koduri of the US Pharmacopeia, an organisation that sets standards for medicines in the US and internationally, '70% of countries cannot take care of their own medicine quality'. Most governments have a national regulator — but their remit and resources vary hugely. And even the better-funded regulators are far from foolproof. The US Food and Drug Administration (FDA), for instance, is struggling to keep up with inspections of manufacturing plants domestically and in India and China, and has admitted that its inspections have not been a reliable indicator of drug quality. The FDA recently announced it would expand unannounced inspections at foreign manufacturing facilities, saying this would help expose those who falsify records or hide violations. It told TBIJ 'that inspections and reviews will continue to ensure [drug] safety and efficacy'. One of the countries where medicine regulation ranks the lowest, according to the WHO, is Nepal. It is also one of the biggest importers of the failed chemotherapy brands in this investigation. Despite there being more than 20 000 brands of medicine on the market there, the country's drugs regulator has set a target of testing just 22 drugs in the next 12 months — and none of them chemotherapy drugs. Narayan Prasad Dhakal, the regulator's director general, told TBIJ that its lab cannot currently test cancer drugs and admitted that the situation around quality-testing is 'a concern'. He also said that while his department has the power to recall cancer drugs based on external evidence, it has never done so. The issue is especially fraught for patients who may have travelled from remote, rural areas to get treatment that then may not even work. Laxmi Kumari, whose two-year-old son is being treated for cancer in Kathmandu, Nepal's capital, has had to procure chemotherapy drugs from private pharmacies. The treatment has cost the family nearly two lakh rupees (R30 000), equivalent to several months' average salary in Nepal, and yet they have no reassurance that it will be effective. 'We have no way of knowing the quality of the medications being used in his treatment,' said Kumari. 'We rely entirely on what the doctors recommend.' 'Neither patients nor their families have any way of knowing the quality of these drugs,' said Smriti Pokharel of the Wish Nepal Foundation, which helps children from low-income families access cancer treatment. 'Even doctors face challenges in verifying their quality. No one seems willing to take responsibility for ensuring proper treatment for cancer patients.' Race to the bottom Generic drug manufacturers are operating in a global market that healthcare professionals and experts agree is driven by one thing: price. It's a market in which those operating under a less watchful eye can find ways to undercut their competitors. This could mean scrimping on the amount or quality of the active ingredient — the most expensive component — or using cheap or outdated machinery. Research shows that the majority of substandard drugs occur due to problems with manufacturing, quality control, packaging or storage. The results can be fatal. Four children died in Colombia after being given contaminated cancer drugs in 2019. Three years later, another batch of bad medicine caused the deaths of at least 10 children in Yemen who were being treated for leukaemia. The price-driven market creates a dangerous dynamic in which the number of companies making a particular drug shrinks and shrinks until global supply is precariously dependent on just a handful of manufacturers. Should one company slip up, thousands of patients can be left without the drugs they depend on. It's a situation that played out in the US recently. Between 2018 and 2022, Intas Pharmaceuticals — the parent company of Accord Healthcare, which made the worst-performing cisplatin tested in this investigation — grew its market share of cisplatin from 24% to 62%. It also increased its share in methotrexate fivefold in the same time period. All the while, prices of both these chemotherapy drugs dropped. Then, at the end of 2022, a surprise inspection by the US drug regulator revealed a 'cascade of failure' at an Intas factory in India, where staff were seen shredding and pouring acid on quality records. The shutdown that ensued sent shockwaves across the US, with nearly every major cancer centre reporting shortfalls in chemotherapy drugs during 2023, Accord Healthcare said the batch of cisplatin that failed our testing had met all established quality standards, and shared data from internal and external studies indicating its quality. It said it has not received any market concerns related to this batch. In India, the world's largest producer of generic drugs, questions have been raised over whether manufacturers are properly punished for producing drugs that aren't fit for purpose — and whether foreign regulators have proper oversight. 'The Indian government's interest is in trying to protect the industry,' said public health activist and former Big Pharma whistleblower Dinesh Thakur. Sixteen of the 17 manufacturers identified in this investigation are based in India and five have been previously flagged by a regulator for producing substandard batches of drugs. One of them, Zee Laboratories, has been flagged 46 times since 2018. India's drug regulator told TBIJ that Zee Laboratories has been audited and given a 'stop production order', which was lifted after the company resolved the problems in question. It did not give details about when this was, which issues it pertained to or whether the company faced any consequences. It's also unclear whether the manufacturers exposed in TBIJ's previous investigation into substandard asparaginase have faced any repercussions, despite 70 000 children with leukemia being at risk. Three of those companies — Getwell Pharmaceuticals, United Biotech and VHB Medi Sciences — also made some of the substandard drugs revealed by this investigation. Thakur said there's only one way to explain the production of weak drugs by big companies: 'Somebody's cutting corners.' Meanwhile, these medicines continue to fill pharmacy shelves. Zuvius Lifesciences and GLS Pharma have supplied their failed brands to over 40 countries. And in the past two years, Venus Remedies — which made the drug that pharmacists said wasn't worth prescribing — has been awarded a series of contracts and licences, including from the Pan American Health Organization to supply several essential cancer drugs to Latin American countries. India's drug regulator defended the oversight system, saying that failing drugs are recalled and manufacturers face 'either administrative penalties or legal prosecution in court'. Getwell Pharmaceuticals, GLS Pharma, VHB Medi Sciences and Zee Laboratories did not respond to multiple requests for comment. Shortage of resources In order to ensure that people across the world have access to safe, effective drugs, the WHO has put in place a series of steps. It has compiled a list of 'essential medicines', to help countries with limited resources know what to prioritise. It checks certain drugs, active ingredients and their manufacturers to create a pre-approved list that countries can trust. The WHO also oversees a set of standards for manufacturers and drugs that many countries refer to when importing medicines. However, these measures have their own limitations. The list of recommended medicines, for example, only expanded to include cancer drugs in 2019 and experts say WHO should include more of them on the list. Shalini Jayasekar-Zürn of the Union for International Cancer Control, a global membership organisation dedicated to taking action on cancer, says it currently only encompasses two cancer drugs, rituximab and trastuzumab. 'It would be great if the list was expanded to include more essential medicines, especially for cancer,' she said. While the WHO oversees standards for manufacturers and drugs, it's up to the countries buying medicines to make sure those standards are met — which is no easy task given the resources of national regulators. Meanwhile, Thakur said that one WHO scheme — a certificate system that says a given drug meets various standards — has been undermined by companies that have found 'workarounds' to get hold of the paperwork without improving quality. 'It's not worth the paper it's written on,' he said. The upshot, experts say, is that without the comprehensive oversight seen in countries like the UK, the WHO's processes don't stop substandard medicines making their way onto shelves. Reflecting on TBIJ's findings alongside his own experience, Thakur said that the WHO was 'clearly not' delivering on its stated purpose: to promote health, keep the world safe and serve the vulnerable. The WHO did not respond to several requests for comment made by TBIJ. A high price The cruel irony is that in this race to the bottom, it is the cancer patients who are often left to foot the bill. And those who have the least pay the most. In low income countries, the cost of 58% of essential cancer medicines is paid by patients, compared with 1.8% in upper-middle-income countries. One cancer pharmacist in Ethiopia estimated that it could take over a year for a patient to save for cancer treatment. If that medicine then turns out to be faulty, they simply might not be able to afford to pay for another. 'Most people believe cancer is incurable,' they said. 'When they end up with a medicine that won't cure them, that's another tragedy.' 'For me, it's a question of fairness,' said Lieberman, the lead researcher. '[Patients] have the right to be treated with a medicine that actually is what it says it is. One that has the correct ingredients in it, that hasn't degraded, and that doesn't have things in it that will hurt them. It's too important.' * The Access to Medicine Foundation is part-funded by the Bill & Melinda Gates Foundation, one of TBIJ's funders. India, where about 20% of the world's generic drugs come from, plays a pivotal role in ensuring people everywhere can access affordable medicine. Sixteen of the 17 manufacturers of failed drugs in this investigation are based in India. While the majority of India-made drugs are safe, the country's generics industry has long been dogged by scandal. In 2013, Indian manufacturer Ranbaxy agreed to pay a fine of $500 million after its US subsidiary pleaded guilty to the improper manufacturing, storing and testing of drugs. In 2022 and 2023, Indian-made cough syrups were linked to the deaths of children in Gambia, Cameroon and Uzbekistan. And as recently as August 2024, it was reported that the regulator had found more than 50 drugs on the market to be substandard or fake, including some paracetamol and antacids.
