Drug to Save Children With Cancer Allegedly Doing the Opposite

Approximately 400,000 children and adolescents develop cancer every year. Common childhood cancers like leukemia, brain cancer, and lymphoma, are usually not detectable through screening and most likely not preventable.

As of today, many childhood cancers are treated with medicines and treatments — including a chemotherapy drug called asparaginase. The drug is known for hindering cancer cells from splitting and growing. In Brazil, however, asparaginase has had its share of attention for its national scandal.

According to the Bureau of Investigative Journalism, partnered with STAT, it was allegedly found that more than a dozen brands of asparaginase were of poor quality, with 10 brands still being used in clinical settings.

Some brands failed to meet the standard required to treat cancer, and many were revealed to include contaminants that may be dangerous for patients. Over the past five years, substandard brands of asparaginase were transported to more than 90 countries, and used in low and middle-income countries with more flexible regulatory authorities.

The drugs, however, were also shipped to Western Europe and Italy. Regardless of the poor quality, seven manufacturers proceeded to sell their asparaginase drug even when warned. Experts say around 70,000 children worldwide are now possibly jeopardized by the intake of these poor drugs.

"What’s happening here is a disaster," shared the director of Tata Translational Cancer Research Centre Professor Vaskar Saha. The vast majority of children with acute lymphoblastic leukemia are in poor countries.

"This is an issue of money, resources and equity," said Saha.

Brazil’s negative experience with certain asparaginase manufacturers should have cautioned the rest of the world, but inattentive regulation has instead multiplied the growth of these unsafe drugs globally. With the global drug shortage, experts worry that even high-income countries, like Italy, will obtain untested items. Clinicians worldwide are provided with these drugs, and may not know the quality of asparaginase they prescribe and give to cancer patients.

If the expansion of these poor-quality drugs continues, children with cancer are heavily at risk.

What happened in Brazil after the ban of Leuginase?

Leuginase, a poor-quality brand of asparaginase, was banned in Brazil in 2018. Soon after the ban on Leuginase, Professor Silvia Brandalise of Centro Infantil Boldrini was handed a package from Haiti. Brandalise has always been dubious of Leuginase and tested it in mice to find that it was indeed hazardous. When she spoke up about the potential danger of the drug, she was heavily criticized.

When she opened the package, she found a single vial of asparaginase sent by the head of Haiti’s sole pediatric cancer department. Asparaginase was first launched in the 60s when children’s survival rates for acute lymphoblastic leukemia (ALL) cancer was approximately 90% in wealthier countries.

In Haiti, however, the survival rate was only around 15% in Pascale Gassant’s, M.D., department. Despite the lower survival rate, Gassant had favorable outcomes with her patients until her hospital changed its asparaginase brand.

Ever since the switch, Gassant observed her patients’ recovery dropping rapidly. Her department’s survival rate for ALL was only 3.5%. With the alarming results, the team tested samples and found that the new drug, just like Brazil’s Leuginase, was contaminated. She also noticed that the Haitian product was manufactured by Beijing SL Pharmaceutical, the same company manufacturing Brazil’s Leuginase.

In 2018, substandard brands were spread to more than 40 countries, including Europe, South America, Asia, Africa, and the Middle East.

What can we do to prevent the spread of substandard drugs?

As of now, the quick resolution is to persuade quality manufacturers to reduce the price of their drugs, especially for countries that cannot afford them. Clinicians will also have to carry on with the drugs they receive, even if that means using substandard drugs.

Which brands of asparaginase are allegedly substandard?

Per the Bureau of Investigative Journalism, these are substandard brands of asparaginase:

  • Asginase, manufactured by Sun Pharmaceutical Industries
  • Aspatero, manufactured by Hetero Healthcare
  • Bionase, manufactured by Zydus
  • Celginase manufactured by Celon Laboratories
  • Ecaspar manufactured by Beijing SL Pharmaceutical
  • L-Aspase manufactured by Miracalus/Naprod Life Sciences
  • L-Ginase manufactured by Getwell Oncology
  • Lagicad manufactured by Cadila
  • Leuginase manufactured by Beijing SL Pharmaceutical
  • Leucoginase manufactured by VHB Medi Sciences
  • Oncoginase manufactured by Chandra Bhagat Pharma
  • Onconase manufactured by United Biotech
  • Pegapar manufactured by Virchow Biotech

Asginase, Ecaspar, and Leuginase are no longer manufactured by the supplier.

How bad childhood cancer drugs flooded the world

On February 15, 2023, the Bureau of Investigative Journalism held a webinar to discuss the story behind investigating this case.

Global Health Investigative Reporter Rosa Furneaux, Global Health Editor Chrissie Giles, and Global Health Reporter Laura Margottini shared that they went through many steps to gather information and dispense the story with the world.

"It's a matter, I think, of passion, but also hard work, because you don't have to get discouraged when you don't get to the point at the first page," said Margottini.

From emailing experts to gathering freedom of information (FOI) to release information to the public, the team tried unique ways to share this unfortunate story and make sure substandard drugs are no longer used among patients in the near future.

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