Valery Javiana Fernández Rivas was only six years old when she died. She had been diagnosed with an aggressive form of leukemia in the summer of 2018 and began chemotherapy at a hospital in northern Colombia a few months later. “Even with the illness, she was a very cheerful girl,” says her mother, Yohana, while showing a video of Valery, with very short hair, happily dancing to the rhythm of an old Latin rumba hit.
Valery’s medications, which included a drug called methotrexate, had to be injected into her spinal cord every two weeks. “It was very strong,” Yohana recalls. “When I was about to start crying, she would say to me: ‘I’m not going to cry, mommy.’”
At the end of January 2020, after more than a year of treatment, Valery arrived at the Medical Duarte Clinic in Cúcuta for a routine injection. The aggressive approach was working, and the plan was for her to soon switch to a less intensive treatment with pills.
The injections had always been tough, but this time something was different. Valery screamed in pain and vomited in the hospital bed. Four days later she went into a coma. Just over two weeks later, she had died.
Valery was not the only one. Three more children died after receiving the medication, while more than 100 patients suffered reactions that doctors suspected were related to the contaminated drug. Six years later, despite calls for justice for the children and their families, there has been virtually no progress. The company that manufactured the drug, Naprod Life Sciences, an Indian pharmaceutical specializing in oncology drugs, has not faced sanctions in Colombia and its drugs continue to be exported worldwide. Naprod did not comment on the details at the time nor respond to TBIJ’s questions for this report.
Furthermore, investigations into the deaths have yielded no results, and questions about how the Colombian regulatory body, the National Institute for Food and Drug Surveillance (Invima), did not act more swiftly remain open.
More than two-thirds of countries worldwide cannot guarantee that the medicines reaching patients are of quality and safe. Claudia Martínez, from the Access to Medicine Foundation, states that this problem is representative of a global supply chain that too often allows substandard medicines to pass safety checks. “It is a systemic problem,” she points out.
“Access to guaranteed quality methotrexate is critically important in cancer treatment worldwide,” Martínez explains. “In many [resource-limited] countries, it may be one of the few affordable and consistently available chemotherapy options.” “Approximately 90% of children with cancer live in low- and middle-income countries. Therefore, access to safe and guaranteed quality products is essential,” she adds.
Access to guaranteed quality methotrexate is critically important in cancer treatment worldwideClaudia Martínez, Access to Medicine Foundation
For Yohana, the consequences are clear: “If they hadn’t sent the contaminated drug, I would be here with my daughter.” This mother calls for “justice for whoever caused the harm.”
A present bacteria
Valery’s autopsy revealed the presence in her blood of a bacterium called Pseudomonas aeruginosa. It is especially dangerous for people with weakened immune systems, such as cancer patients.
Tests performed on samples of Naprod’s methotrexate by the Colombian regulator Invima at that time (including some from before Valery’s death) found it contained the same bacterium.
The company conducted two internal investigations into the contaminated drugs, exonerating itself on both occasions. The first concluded that the bacterium came from hospitals, but an independent team of epidemiologists from the Colombian National Institute of Health found no possible sources of contamination in the medical centers and suggested the problem was in the drugs.
Experts consulted as part of a Bloomberg Businessweek investigation in 2023 indicated that the circumstances left little doubt that the contamination occurred during the manufacturing process. Naprod did not make statements about the details at that time nor respond to TBIJ’s questions for this report.
Experts consulted by TBIJ made similar arguments. “The contamination of sealed medicines with bacteria and fungi clearly points to the need for urgent investigation of the production processes at the factory by epidemiologists, microbiologists, and quality control experts,” says Paul Newton, head of the medicine quality research group at the University of Oxford.
After the deaths of Valery and the other children, Naprod faced no sanctions. But when the Bloomberg report was published three years later, regulators in India began questioning the company. Around the same time, Naprod’s methotrexate triggered three alerts in the country. As in Colombia, the drug was found to be contaminated.
Bhushan Patil, deputy commissioner of the Indian regulatory body, stated that Naprod’s license to manufacture methotrexate was eventually canceled. Shri Singh, a criminal lawyer who has handled cases under Indian pharmaceutical law, describes this type of sanction as “a slap on the wrist” and adds that license cancellation is reversible if the company reapplies.
Since Valery’s death, Naprod has exported hundreds of thousands of vials of methotrexate worldwide: to Algeria, Cambodia, Chile, Jamaica, the Philippines, Peru, and Thailand. Speaking to TBIJ last year, Bhushan Patil from the Indian regulator noted that the company has not manufactured methotrexate injections in “the last two or three years.” However, even during that period, the company has exported tens of thousands of vials to Algeria.
“They have not taken responsibility for what they did here in Colombia,” says Yohana. “And they continue selling freely as if nothing happened.”
Warning signs
Substandard cancer drugs are a significant and under-documented threat worldwide. “Many of the most affected countries are the least prepared to detect and document the problem,” Martínez says.
In fact, the Colombian regulator Invima had already detected problems with Naprod’s drugs. Throughout 2019, the year before the tragedy, more than 70 cases of severe reactions suspected to be linked to Naprod’s methotrexate were reported in hospitals across the country. Most of those affected were children.
Substandard oncology drugs represent a significant and under-recognized threat worldwide
In January 2020, Invima completed an analysis of a sealed sample of the drug, which revealed the presence of bacteria. But despite this warning sign, no action was taken. A week later, Valery received the injection that would end her life.
Over time, analyses of three different batches would reveal the presence of the bacterium. On February 8, with Valery in a coma, Invima issued orders demanding the withdrawal of two batches of Naprod’s methotrexate. Less than two weeks later, the regulator ordered the total withdrawal of Naprod’s methotrexate.
But it was not enough. Valery had died. So had three other children. And since then, questions remain about why Invima did not act more quickly. “There has not been a single news report acknowledging that Invima allowed contaminated medicines to pass inspections,” says Yohana. “There has been no statement from them explaining what happened or where they failed.” “The damage they have caused,” Yohana adds. “Not only to me, but to so many other families here in Colombia.”
Naprod has not faced long-term consequences in the country. Invima has the authority to impose sanctions but is hamstrung until its own investigations conclude. Its responses to TBIJ’s questions about the timelines, scope, and results of those investigations were confusing and unclear.
“Patients must be protected,” says Angela Caro-Rojas, a pharmacist and former president of the International Society of Pharmacovigilance. “That is the role of the regulatory agency.” She adds that urgent measures are needed. Invima is limited by lack of resources, she says, pointing to recent staff cuts. Sometimes it relies on third-party reports when approving foreign manufacturers instead of conducting its own inspections.
Eight million vials
In practice, Naprod can continue selling drugs freely in the country. Last year, the company shipped nearly eight million vials of drugs to Colombia, including injectable chemotherapy drugs. Some of these drugs cost less than a dollar per vial, a price hard to refuse in a country where access to medicines can be limited. “Someone has to be more attentive to this,” says Yohana. “If [Naprod] keeps putting drugs on the market, it’s because no one has stopped them.”
Naprod previously said it “complies with internationally recognized Good Manufacturing Practices and follows rigorous quality and compliance protocols.” It stated that it “remains committed to maintaining the highest standards of product quality, patient safety, and regulatory compliance.”
The Pan American Health Organization told TBIJ that, in Colombia and other countries, it provides support to strengthen authorities’ capacity to detect and respond to substandard medicines, as well as to promote regulatory standards and good practices. However, this does not seem to be enough.
The judicial process in Colombian courts does not offer immediate justice. Like the regulatory process, it seems stalled. The Attorney General’s Office told TBIJ reporters that it is still gathering evidence.
Lawyer and regulatory specialist Carolina Gómez says proving causality in cases like Valery’s can be difficult. And the sad reality in Colombia is that justice can take a long time to arrive. However, in Yohana’s case, she notes that the time elapsed without justice is “unacceptable… it shouldn’t take this long and it outrages me.”
Meanwhile, affected families remain without answers and unable to close this chapter. “Time passes and they say nothing,” says Yohana. “It’s as if they are not investigating, as if they are not getting to the bottom of what happened.”
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