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Source: Bloomberg Originals

Untitled episode

Dec 15, 2023 · 8m 6s

https://www.youtube.com/watch?v=3BoQsnqC5zM

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This is Valery. She was 5 years old when she received chemotherapy. Valery would receive chemotherapy treatments here at the Clinica Medical Duarte in the small border city of Ccuta, in Colombia. On Jan. 23, 2020, doctors at the clinic gave Valery a dose of Methotrexate, a drug used to treat cancer. Less than 24 hours later, she was back in the hospital. Days later, she was dead. The

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drug Valery was given, Methotrexate, was made by Naprod Life Sciences, a manufacturer headquartered in India a country that supplies 20% of the worlds generic drugs. But instead of being sterile, the medicine was contaminated with bacteria and had become dangerous. In a months-long investigation, we learned this wasnt an isolated incident. Naprods medicines have been linked to dire quality issues with almost zero consequences. This is the story

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of a drugmaker with a dangerous track record and how it keeps selling medicine, leaving families and doctors to suffer the consequences. Methotrexate is a drug used to treat leukemia and other cancers, and has been around for decades. When given as an injection, the conditions in which the drug is made are always supposed to be sterile. If the raw ingredients arent tested adequately, if a production line

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isnt cleaned properly, if the water isnt filtered thoroughly, the life-saving medicine could become potentially lethal. Naprod Life Sciences plays a crucial, if sometimes unnoticed, role in the worlds drug supply chain. None of its medicines are for sale in the US. Instead, it mostly sells directly to suppliers in low-income countries. Batches of the cancer drug methotrexate, made here in 2018 and 2019 were sent to clinics in

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Colombia. Later, Colombian drug regulators confirmed that a dangerous bacteria was found in the drug. Doctors suspected more than 100 patients had suffered reactions linked to the contaminated medicine. A total of 4 kids died. And the drug was later recalled. My colleague Priyanka Pulla looked into Naprods operations in India. This is a plant that makes many low cost cancer generics for big brand names such as Intas,

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Dr Reddys and Abbott. Former employees of Naprod whom we spoke to told us that the quality control in this company was not up to the mark, and was neglected greatly. The former quality control employee spoke to us on condition of anonymity. He was asked to hurry through quality tests. Indian regulators have frequently failed to detect and clamp down on really dangerous quality issues. State governments are

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very eager to attract the pharmaceutical industry and to get them to set up their manufacturing plants because it helps them generate revenue and jobs. And the state regulators are directly under these state governments. These state regulators are not very well staffed. They are underfunded. if you put these two things together, it's a very dangerous cocktail because this means that India's huge manufacturing industry doesn't get as

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much oversight as it needs. This wasnt the first time quality issues were found at Naprod. In India, 3 separate batches of its cancer drugs failed quality tests in 2017 and 2018. In Ethiopia, researchers tested multiple samples of its chemo drug and found only half of the stated active ingredient. Yet the company has not faced any serious consequences from regulators, the big pharmaceutical companies buying Naprods products,

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or public health warnings from the World Health Organization. Naprod declined to comment on Valery's case or other cases in Colombia, citing ongoing legal proceedings. The company said it has responded appropriately to quality concerns raised by regulators and makes high quality products. So who is to blame for Valerys death? And how can people in low-income countries ensure their drugs are safe? Despite its track record, Naprod continued

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selling medicines around the world, cashing in on growing markets for generic cancer drugs. And Valerys case is stuck in the labyrinth of Colombian government bureaucracy. The attorney generals office received Valery's autopsy report four years ago. It has listed her cause of death as under study. In the years that have passed, there have been few signs of progress in the probe. In recent months, the attorney general's

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office has started interviewing families and others involved. But 2,500 miles away, a researcher in the US is trying to perfect a test to help detect bad quality drugs before they reach patients. The market for chemotherapy products is increasing and it's increasing in locations where often the regulatory agencies are under-resourced, particularly for analysis of highly toxic chemotherapy products. And so it's a very risky situation right now.

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The paper test her team developed is a field lab kit run on a sample of medicine, testing for the amount of active ingredient. It costs as little as $2 and can be done easily by a nurse using a cellphone. These are a field screening device that you can use to check a medicine quickly and see if it looks good or if it looks suspicious. Nearly four

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years after Valery's death, Naprod continues to sell its drugs to customers around the world.

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