Asparaginase is used to treat acute lymphoblastic leukemia (ALL) in children.
One of the alleged substandard brands of asparaginase is Leuginase. A spokesperson for Beijing SL Pharmaceutical, the manufacturer of Leuginase, said the drug is tested by Chinese regulators and assessed in-house. The spokesperson claimed that quality results have stayed within statutory limits over the past decade.
However, analysis by the Bureau of Investigative Journalism showed that poor-quality brands of asparaginase, including Leuginase, made their way to more than 40 countries across Europe, South America, Asia, Africa and the Middle East. Shipping data also found that 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.
Experts estimated 70,000 children with ALL are at risk globally, as contaminated and ineffective asparaginase brands are able to pass through global safety nets. "What's happening here is a disaster," said Vaskar Saha, director of the Tata Translational Cancer Research Center in Kolkata, India, pointing out that the vast majority of children with all are in low-income countries. "This is an issue of money, resources and equity."
In 2018, a court ordered the Brazilian government to remove this particular brand from hospital shelves. Silvia Brandalise, a Brazilian child's oncologist, had long been suspicious of Leuginase. She had tested the drug in mice and came under fire for speaking up when she found it was dangerously defective.
But the China-based manufacturer of the specific brand disputed this, saying that doctors in China and around the world have been using its products and "none of them, other than these individuals in Brazil, has ever reported any quality-related problems." (Related: Warning: Chemo may be linked to cancer relapses in patients with leukemia.)
According to a study back in 2013, 80 percent of children with cancer live because low- and middle-income countries had access to cheaper and good-quality asparaginase. However, major manufacturers have increased their prices or stopped making asparaginase altogether.
Drug makers are increasingly focused on modified products that are less likely to cause allergic reactions, but carry heftier price tags up front. Most of the more expensive brands consistently passed quality tests. The cost of these "gold-standard" products has ballooned well beyond what lower-income countries can afford.
One example is the Oncaspar. Published data shows that a single vial of Oncaspar cost $1,700 in the U.S. in 2015. The following year, when one company merged with another, that price surged to $18,000. Now distributed by the French company Servier, one vial costs as much as $24,000 in U.S. websites.
Another modified brand, Spectrila, is said to cost $500 per vial in Chile, and roughly the same in the United Kingdom.
Countries with low to medium income are already losing hope as the two most affordable brands have been discontinued since 2012 due to "ongoing manufacturing challenges."
None of the leading manufacturers of asparaginase have stepped in to produce an affordable native form. A market analysis from 2021 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.
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