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The drug was meant to save children’s lives. Instead, they’re dying.

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By Rosa Furneaux , Laura Margottini. It was a week before Christmas, and she and her husband had taken their children to visit family. Her youngest daughter, Isadora, had been feverish and listless, unwilling to play or take a bottle. Something was very wrong. The doctor urged Emily to take her daughter to a hospital as soon as she could. Back home in Porto Alegre in southern Brazil, Emily watched as doctors hurried her daughter through medical tests. The lumps had grown. That night, Isadora was lying on a stretcher beside Emily when a doctor told her the news. Isadora had an aggressive type of leukaemia, a cancer that affects white blood cells. Acute lymphoblastic leukaemia ALL is the most common kind of childhood cancer, and Isadora was one of roughly 3, children in Brazil to be diagnosed with it in Her treatment would be gruelling: a cocktail of chemotherapy drugs that would leave her skeletal, vomiting and lethargic. One cancer doctor described this process as a fine art: to almost kill a child, but not quite. Isadora, usually a bubbly baby, began to suffer side effects. Emily took hope from the idea that, although the drugs were making her daughter sick, they were also curing her. It stops cancer cells from dividing and growing. Without it, patients face a dramatically reduced chance of survival. But in Brazil, the drug was already at the heart of a national scandal. Unbeknownst to Emily, her daughter would be the last child in the hospital to receive a particular brand called Leuginase. Later that year, Brazilian doctors — including some looking after Isadora — would confirm that Leuginase was nowhere near as good as it should have been. Eventually, the Brazilian government was ordered to remove Leuginase from hospital shelves. Reporting by the Bureau of Investigative Journalism, in partnership with STAT, reveals that at least a dozen brands of asparaginase have been proven to be poor quality, with ten still on the market. In some cases brands fell well below the standard needed to treat cancer. Many have also been found to contain contaminants such as bacteria that could be harmful to patients. In the past five years these poor-quality brands have been shipped to more than 90 countries. Many receiving the drugs are low- and middle-income nations without strict regulatory authorities, but in several instances substandard drugs have been imported into Western Europe and given to patients in Italy. At least seven manufacturers have continued to sell their products despite being warned that they do not meet minimum manufacturing quality standards. Experts estimate 70, children around the world are at risk, as contaminated and ineffective asparaginase slips through global safety nets. The vast majority of children with acute lymphoblastic leukaemia are in poor countries. As a global shortage of the drug continues, experts fear that high-income countries may also be compelled, like Italy, to buy untested products. Across the world, doctors may have no idea if they are prescribing poor-quality asparaginase — or what else could be lurking within those vials. In , shortly after Brazilian courts banned Leuginase, the substandard brand of asparaginase, Professor Silvia Brandalise received a package from Haiti. She had tested the drug in mice, and came under fire for speaking up when she found it was dangerously defective. It contained a single vial of asparaginase. In Haiti, Dr Pascale Gassant saw only 15 or so patients a year in her department; a fraction of the children with the disease in her country. Nonetheless, she had had good success with her patients. That was until her hospital switched its brand of asparaginase. Children she would once have been optimistic about — children who were otherwise healthy, and who had arrived early enough that treatment could save them — were dying. Her worst fears were confirmed: like the Brazilian Leuginase, the Haitian drug was contaminated with byproducts that could cause side effects and even impede treatment. Her patients did not stand a chance. If poor-quality asparaginase had spread to Haiti, how many more countries had it reached? She had no way to know it, but bad asparaginase had already begun to flood the world. In alone, analysis by the Bureau of Investigative Journalism shows, poor-quality brands made their way to more than 40 countries across Europe, South America, Asia, Africa and the Middle East. Worse, in the past five years substandard asparaginase has spread to almost countries, from Armenia to Zimbabwe. Shipping data suggests that countries including Nepal, Ecuador and the United Arab Emirates have received the most shipments of these brands. Nearly half the countries of Africa have received substandard drugs. A representative from Beijing SL Pharmaceutical said the company has produced asparaginase for a dozen countries over the past decade. He added that the company had never sold its asparaginase in Haiti, and offered several theories on how it could have ended up there: it could have been counterfeit, expired, or sold on by South American distributors. But in the past decade, major manufacturers have increased their prices or stopped making asparaginase altogether. There are several different types of asparaginase. Turning the bacterium into medicine is complicated and costly, and even good-quality asparaginase can cause side effects, including severe allergic reactions. For this reason, doctors prefer to use modified versions of asparaginase. These are less likely to cause allergic reactions, but are much more expensive up front. Both have consistently passed quality tests. For patients who experience serious reactions to these forms, there is another type: Erwinia asparaginase. However, only two companies make trusted brands and supplies have frequently been short since Asparaginase is an enzyme, a type of protein produced by living organisms to speed up chemical reactions inside the body. For asparaginase, this reaction is breaking down an amino acid called asparagine. Cells need asparagine to survive. White blood cells can normally make their own asparagine, but acute lymphoblastic leukaemia white blood cells cannot. When asparaginase breaks down asparagine, there is less asparagine in the body for the cancer cells to use. Without it, the cancer cells stop dividing and growing. As such, asparaginase is a crucial drug for patients with the most common kind of childhood cancer, acute lymphoblastic leukaemia, or ALL. Patients are given asparaginase over several months at the start of their treatment, either into a vein or as an injection into a muscle. Read a full explainer here. Manufacturers are increasingly focused on their higher-priced modified products. Take Oncaspar. Takeovers and mergers mean that the drug has passed through five different pharma companies in the last 15 years, with corresponding price hikes. Unable to access these products, hospitals in low- and middle-income countries often use cheaper, native asparaginase. Until recently there were at least two good, affordable brands. The second was discontinued in , after the sole manufacturer in Japan had its certification of quality revoked. None of the leading manufacturers of asparaginase have stepped in to produce an affordable native form. A market analysis from found that global demand for the drug was too small to motivate companies to improve their quality, or to encourage other manufacturers to begin producing it. Professor Carmelo Rizzari had never experienced a shortage of asparaginase until autumn , when a pharmacist at his hospital in Milan, Italy, told him they could not get hold of Oncaspar. Could they get some vials from another hospital? Could they find an alternative product? Not long after, the drug arrived in the pharmacy — but Rizzari had never used the Indian-made brand, Aspatero, before. Rizzari gave it to his patients. As chance would have it, the 12 children were part of international studies that meant their treatment was being closely monitored. Two children experienced side effects. The pharmacist soon found a supply of Oncaspar, and Rizzari swapped his patients back to the gold-standard brand. All survived. But when data from the studies revealed what had transpired, Rizzari was disturbed. The Italian drug regulatory agency denied it had authorised the import of Aspatero from India. The Bureau has found that at least ten other Italian hospitals have purchased poor-quality asparaginase in the past five years. It is unclear how many patients have been affected. Italian doctors were shocked to learn that the brand of asparaginase they have been administering to their patients, Celginase, has been found to be substandard. Hospital documents show it purchased Celginase in and The hospital said it had bought Celginase in compliance with relevant regulations. Five young patients had developed a high fever after taking an Indian-made asparaginase. One died. This had never happened when the hospital was using a US-made brand, the professor, Tariq Madani, reported. He had run tests on the new drug. First, to stop using the brand and to find an alternative source. And finally, to alert the manufacturing company so that they could recall bottles from any other countries. It is not clear if all of these recommendations were followed. Neither King Abdulaziz University Hospital nor the Saudi health ministry responded to requests for comment. Contamination of asparaginase with harmful bacteria is potentially deadly. Cancer treatment leaves children with significantly weakened immune systems, making them more prone to infections and other serious complications. Infections hit harder on a paediatric oncology ward, often requiring intensive care. If a child receiving chemotherapy gets an infection, the cancer treatment stops until they are better. Pegapar is not the only brand that has been found to be contaminated with bacteria. In August and October , the Chilean health ministry issued two alerts against Onconase in quick succession. Both batches were found to contain bacteria after patients suffered fevers. Even so, shipping data analysis shows Onconase has been imported into Chile at least nine times since its health ministry alerts. Government records show the brand has been distributed more than 70 times to over a dozen different hospitals since late Some were still receiving Onconase as recently as last October. India and its pharmaceutical industry plays a vital role in ensuring people across the world can access affordable medicine. The majority of its products are safe and work well. But for decades, the Indian generics industry has been dogged by quality scandals. Asparaginase, though, is a biologic: a drug made from a living organism. Biologics and their generic versions known as biosimilars have much more complex and expensive manufacturing processes than most small molecule drugs. In recent years, a complex network of Indian suppliers have sought to capitalise on chronic shortages of gold-standard asparaginase and the increasing desperation for affordable products. Saha was working at Tata Medical Centre, a specialist cancer hospital in Kolkata, when he began to examine the quality of brands available on the Indian market. He tested seven products. Not a single one met minimum manufacturing quality standards. In five brands, drug strength was lower than expected. All seven had purity problems. Saha was deeply concerned. He was also keenly aware of the inequalities between his patients in India and those in his second home, the UK. In lay terms: sick children in poor countries could be dying in large part because of bad drugs. Saha alerted all the manufacturers to what he had found. Just three replied, saying they wanted to do better. All seven products remain on the global market and were sent to countries around the world in Which brands of asparaginase are substandard? The Bureau has found at least a dozen brands of asparaginase, including ten still on the market, have been proven to be poor quality. Nonetheless, according to a national database, the 11 Indian asparaginase manufacturers investigated by the Bureau have received important, WHO-backed quality-assurance certifications. While the WHO sets the framework for these schemes, responsibility for assessing facilities and issuing the certification lies with national governments: in this case, the Indian health ministry. The FDA refused an import from the company in , and has not inspected their manufacturing plants or authorised their products. Virchow Biotech and United Biotech did not respond to a request for comment. The Indian-made asparaginase investigated by the Bureau sells for just a fraction of the price of gold-standard brands. One senior oncologist from Latin America said Onconase was marketed at one-tenth the price of Oncaspar. How they establish that is not known to anyone. He thinks that the Indian government should review and strengthen its drug approval process, particularly for biologics, to ensure strict standards are being met. The Indian Ministry of Health and Indian drug regulatory agency did not respond to a request for comment, and so far, little appears to have been done. Without proper checks before the drugs are sold, a greater burden falls on purchasing governments to improve quality checks at home. He thinks that local regulators need more support to improve their ability to assure the quality of medicines, from licensing through to laboratory tests and patient monitoring. Cost-cutting may be driving wealthier governments who could secure more expensive, trusted brands to choose low-cost alternatives. Since its asparaginase scandal, the Brazilian government has changed regulations to allow its Ministry of Health to buy drugs that have not been proven safe and effective, even if approved products are available in the country. Experts have questioned whether that decision was driven by anything other than reducing costs. The Brazilian Ministry of Health did not respond to a request for comment. But the high price of gold-standard products puts them out of reach for much of the rest of the world. In one instance, the team was alerted to potential defects in their asparaginase. After weighing the risks, they stopped giving their patients the drug and replaced it with another chemotherapy. But gold-standard asparaginase was not an option. Neither of the major manufacturers of gold-standard asparaginase offer programmes to help poorer governments afford their products. Servier, which makes Oncaspar, did not respond to a request for comment. Given the global nature of the crisis, and the fact that asparaginase is listed as essential by the WHO, some have suggested the organisation should do more to boost access to good-quality asparaginase. The WHO hosts a global monitoring system for fake and substandard drugs, and provides technical support in emergencies. However, while it can issue medical product alerts, it does not have the power to reprimand countries for exporting poor-quality medicine, or close down manufacturers. The WHO relies on countries to report incidents to its monitoring system, and some are more willing to do that than others. Thakur suggested that reported cases in India were just the tip of the iceberg. In October, the deaths of nearly 70 children in Gambia were linked to an Indian-made cough syrup. Last month, 18 children died in Uzbekistan after taking another Indian-made cough syrup. Fixing the systemic issues that have allowed poor-quality asparaginase to spread could help patients far beyond child cancer wards. Stemming the tide of poor-quality asparaginase will take global cooperation, money and willpower. While long-term solutions may feel out of reach, a handful of measures to help children who need the drug now are taking shape. A new platform will act as a purchaser on behalf of low- and middle-income countries, giving quality manufacturers a reliable source of demand. In turn, they may be more willing to offer competitive prices for bulk orders. The result should benefit everyone. St Jude predicts approximately , children could benefit by the end of For those still relying on untested brands, one short-term solution could be to assess asparaginase as patients are being treated with it in hospitals. Her team has trained researchers at eight centres in Brazil and one in Colombia so far. In India, Vaskar Saha is working with the three manufacturers who responded to his research to help improve their asparaginase products. He hopes that a collaborative approach will help spur Indian manufacturers to create an affordable asparaginase on par with gold-standard brands. The fastest solution to the crisis could be to convince quality manufacturers to lower their prices — at least for countries who cannot afford them. While this may seem like a non-starter, one leading oncologist said he had argued with both Servier and Medac that selling their products at a price only rich countries could pay limited their profits. But the companies refused. Servier did not respond to a request for comment. For now, doctors will have to continue to use what they can get, and parents and children will continue to suffer the consequences. A few months ago, outside a small house in the hills of southern Brazil, Emily was holding her daughter. Isadora had survived. After receiving eight doses of Leuginase and responding badly, doctors had been able to switch her onto a gold-standard product. She completed her treatment last spring. Some 6, miles away, in Barcelona, a group of child cancer specialists met for their annual conference. On the first morning, they heard about data collected by Professor Federico Antillon, a Guatemalan oncologist. The research detailed the survival rates of children at his hospital who had received three different treatments: a gold-standard brand of asparaginase, asparaginase from India, or no asparaginase at all. The results were stark. It features only a small number of children, and his findings are not yet peer-reviewed or published. Not far from the auditorium where Barr had spoken, a gaggle of eager sales people were gathering. They worked for a Colombian pharmaceutical company and were in Barcelona to sell asparaginase. With smooth sales patter and glossy leaflets, the sales reps explained how they could provide native, modified or Erwinia asparaginase. They said their products were marketed in countries including Argentina, Brazil, Colombia, Mexico and Peru, although they hoped to expand. Given the turbulent history of this crucial drug, you might expect them to be eager to share proof that their products are safe and effective. The company had given conference organisers paperwork showing their drugs had been authorised for import into Colombia, and that their asparaginase products were made in India and China. The Bureau asked the Colombian company to provide evidence that their product works and is safe. Their response was a letter threatening legal action if we published this story. Subscribe to the Bureau newsletter, and hear when our next story breaks. Rosa reports on global health issues, particularly access to healthcare. Her coverage of Covid vaccine inequity won a number of awards. Laura is an award-winning journalist based in Italy, exploring health, environment and science policy. This story was published in partnership with:. It should have been the end of the scandal. Instead, it was just the beginning. Fight for survival In , shortly after Brazilian courts banned Leuginase, the substandard brand of asparaginase, Professor Silvia Brandalise received a package from Haiti. Professor Silvia Brandalise was the first to raise the alarm over Leuginase in Brazil, when she tested the drug in mice and found it was dangerously defective. How does asparaginase work? Short supply Professor Carmelo Rizzari had never experienced a shortage of asparaginase until autumn , when a pharmacist at his hospital in Milan, Italy, told him they could not get hold of Oncaspar. The price per vial an Italian hospital paid for Celginase, a substandard brand. Find out more Which brands of asparaginase are substandard? Find out which, and more on the research behind these discoveries, here. No qua lity control Without proper checks before the drugs are sold, a greater burden falls on purchasing governments to improve quality checks at home. Facing the future Stemming the tide of poor-quality asparaginase will take global cooperation, money and willpower. Emily with Isadora now. Isadora wants to be a cancer doctor when she grows up. The Bureau newsletter Subscribe to the Bureau newsletter, and hear when our next story breaks. Name: Email: Comment:. E-mail address. About The Authors Rosa Furneaux Rosa reports on global health issues, particularly access to healthcare. Laura Margottini Laura is an award-winning journalist based in Italy, exploring health, environment and science policy More by Laura Margottini Email. More From Global Health.

Porto Alegre buying Heroin