Valery Javiana Fernández Rivas was just six when she died. She had been diagnosed with an aggressive form of leukaemia in the summer of 2018 and began chemotherapy at a hospital in northern Colombia a few months later.
“Even though she had that illness, she seemed so cheerful,” says her mother Yohana. She shares a video of Valery with close cropped hair, dancing happily to an old Latin rumba hit.
Valery’s medicines, which included a drug called methotrexate, had to be injected into her spine every two weeks.
“She was very strong,” says Yohana. “When I was about to cry, she would say, ‘I’m not going to cry, mommy.’”
In late January 2020, after more than a year of treatment, Valery arrived at Clínica Medical Duarte, Cúcuta, for her next injection. The aggressive approach was working – and the plan was that she would soon be moved to a less-intensive treatment involving pills.
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The injections had always been tough, but this time something was different. Valery screamed in pain and vomited in her hospital bed. Four days later she was in a coma. Just over two weeks after that, she was dead.
Valery wasn’t the only one. Three other children died after being given the drug, while more than 100 patients suffered reactions that doctors suspected were linked to the contaminated medicine.
Despite calls for justice for the children and their families, little has happened in the past six years. Investigations in Colombia have gone nowhere. The company that made the drug, Naprod Life Sciences, has faced no sanction in the country. Its cancer drugs continue to be exported around the world. And it did not answer our questions.
More than two thirds of countries around the world are unable to guarantee that the medicines that reach patients are good and safe. Claudia Martínez of the Access to Medicine Foundation, an NGO, says the issue in Colombia is emblematic of a global supply chain that too often allows bad medicines through its safety nets. “This is a system-wide problem,” she says.
“Access to quality-assured methotrexate is critically important in cancer treatment globally,” she says. “In many [less wealthy] countries, it can be one of the few affordable and consistently available chemotherapy options.
“Approximately 90% of children with cancer live in low-income and middle-income countries … So access to safe, quality-assured versions is critical.”
For Yohana, the consequences are plain: “If they hadn’t sent the contaminated medicine, I would be here with my daughter.”
She wants just one thing: “Justice for whoever caused the harm.”
No penalties
Valery’s autopsy revealed a bacterium called Pseudomonas aeruginosa in her blood. It is particularly dangerous for people with weakened immune systems, such as cancer patients.
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Samples of Naprod’s methotrexate tested by the Colombian regulator around the time (including from before Valery had died), were found to contain the same bacteria.
The company conducted two internal inquiries into the contaminated drugs, exonerating itself both times. The first concluded the bacteria in question had come from hospitals – but a separate team of epidemiologists from Colombia’s National Institute of Health found no sources of possible contamination at hospitals and suggested that the issue was the medicines.
Experts consulted as part of a major exposé by Bloomberg Businessweek in 2023 said that the circumstances left little doubt that the contamination occurred in the manufacturing process. Naprod did not comment on specifics at the time nor respond to our questions for this story.
People we spoke to gave similar reasoning. “Contamination of sealed medicines with bacteria and fungi strongly suggests that the production processes in the factory producing them needs urgent investigation by epidemiologists, microbiologists and quality control experts,” says Paul Newton, head of the medicine quality research group at University of Oxford.
After the deaths of Valery and the other children, Naprod faced no penalty. But when Bloomberg’s story was published three years later, regulators in India started asking the company questions. Around the same time, Naprod’s methotrexate triggered three alerts in the country. As in Colombia, the drug was shown to be contaminated.
Bhushan Patil, a joint commissioner at the regulator in question, says it eventually cancelled Naprod’s licence to make methotrexate.
Shri Singh, a criminal lawyer who has fought cases under India’s drugs laws, described this type of punishment as a “slap on the wrist”. He says the cancellation of a licence is reversible if the company reapplies for it.
Since Valery’s death, Naprod has exported hundreds of thousands of vials of methotrexate around the world – to Algeria, Cambodia, Chile, Jamaica, Philippines, Peru and Thailand. Speaking to us last year, Patil from the regulator in India told us the company has not made methotrexate injections for “the last two or three years”. But even in this time, the company has exported tens of thousands of vials to Algeria.
“They haven’t taken responsibility for what they did here in Colombia,” says Yohana. “And they’re selling freely as if nothing happened.”
Red flags
Substandard cancer medicines are a significant and underreported threat around the world. “Many of the countries that are most affected are the ones least equipped to detect and document the problem,” says Martínez.
Invima, Colombia’s drugs regulator, had in fact found problems with Naprod’s drugs. Throughout 2019, the year before the tragedy, there were more than 70 reports of serious reactions that were suspected to be linked to Naprod’s methotrexate in hospitals across the country. Most of those affected were children.
In January 2020, Invima completed an analysis of a sealed sample of the drug, which revealed bacteria. But despite the red flag, no action was taken. A week later, Valery was given her deadly injection.
Eventually tests of three separate batches would show the bacterium. On 8 February, with Valery in a coma, Invima published orders insisting that two batches of Naprod’s methotrexate be withdrawn. Less than two weeks later the regulator ordered a full withdrawal of Naprod’s methotrexate.
But it wasn’t enough. Valery had died. So had three other children. And questions have hung in the air ever since as to why Invima didn’t move more quickly.
“There hasn’t been a single news report acknowledging that Invima allowed contaminated medicines to pass through,” says Yohana. “There hasn’t been a statement from them explaining what happened, or where they went wrong.
“The damage they’ve done,” says Yohana. “Not only to me, but to so many other families here in Colombia.”
Naprod has not faced any long-term consequences in the country. Invima has the power to impose sanctions, but its hands are tied until its own investigations are concluded. Its responses to our questions about the timelines, nature and outcomes of its investigations were confused and unclear. Its answers about whether processes were ongoing or closed, or relevant to the methotrexate or not, changed each time.
“You need to protect patients,” says Angela Caro-Rojas, a pharmacist and former president of the International Society of Pharmacovigilance. “It is the function of the regulatory agency.” She says urgent action is needed.
Invima is hamstrung by a lack of resources, she adds, pointing to recent staffing cuts. It sometimes relies on third-party reports when approving foreign manufacturers rather than doing its own inspections.
‘They don’t say anything’
The bottom line is that Naprod can still sell medicines freely in the country. Last year, the company sent nearly 8 million vials of medicines to Colombia, including injectable chemo drugs. Some of these drugs cost less than a dollar a vial – a price hard to resist for a country where medicines can be hard to come by.
“Someone needs to be more vigilant about this,” says Yohana. “If [Naprod] continues to release medications, it’s because no one has stopped them.”
Naprod has previously told us that it “adheres to internationally recognised Good Manufacturing Practices and follows rigorous quality and compliance protocols”. It said it “remains committed to upholding the highest standards of product quality, patient safety and regulatory compliance”.
The Pan American Health Organization told us that in Colombia, as in other countries, it provides support to strengthen the authorities’ ability to detect and respond to medicines that aren’t up to scratch – and promote regulatory standards and good practices. However, this doesn’t seem to be enough.
The legal process going through Colombia’s courts offers no imminent justice. Like the regulatory process, it’s at an apparent standstill. The attorney general’s office told our reporters that they are still gathering evidence.
Lawyer and regulatory specialist Carolina Gomez says proving causality in cases like Valery’s can be difficult. And that the unfortunate reality in Colombia is that justice can be a long time coming.
Regarding Valery’s case, though, she says the time elapsed without justice was “unacceptable … it shouldn’t take that long and I am appalled by it.”
In the meantime, the bereaved families are left with no answers – and no closure.
“Time goes by and they don’t say anything,” says Yohana. “It’s like they’re not investigating – like they’re not getting to the bottom of what happened.”
Crime & Courts Correspondent
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