The deaths of children are a cause for misery, and new research suggests one of the gravest perils comes in the form of falsified and substandard drugs for treating malaria, pneumonia and other diseases. Hundreds of thousands of children each year are dying due to a surge of poor-quality or outright fake medicines, the report says.
“We’re talking about 300,000 – at least – children who have died because of murder-by-alleged-medicines distributed by criminals,” said Dr. Joel Breman, a co-author of the report and senior scientific adviser emeritus at the Fogarty International Center of the US National Institutes of Health.
The World Health Organization has defined three types of falsified and substandard medical products.
“Falsified medical products” deliberately misrepresent their identity, composition or source. “Substandard medical products” are regulated drugs that somehow fail to meet quality standards or specifications – for example, they have less than needed amounts of an active pharmaceutical ingredients. “Unregistered or unlicensed medical products” are untested and unapproved drugs.
Where is it happening?
The number of falsified and substandard medical products is on the rise, according to Breman and his co-authors on the report, published Monday in the American Journal of Tropical Medicine and Hygiene. In 2008, for example, Pfizer Global Security, the drugmaker’s team working to counteract counterfeit drugs, identified 29 of its products in 75 countries as being falsified. Just 10 years later, Pfizer found 95 fakes in 113 countries.
“Our focus was initially and still is on the poor countries because they have no control and a high burden of disease,” said Breman, who is also president-elect of the American Society of Tropical Medicine and Hygiene.
He said the “impact” of falsified and substandard drugs is estimated to be as high as 10% of all medicines, costing up to $200 billion, in low- and middle-income countries.
One of two primary areas of concern in these countries is antimalarials, which may be responsible for the deaths of more than 150,000 children each year, Breman said. Antimalarials and artemisinin combination therapy (often called ACT) are the best solution for treating malaria.
The ACT-watch program, a division within the health-focused nonprofit Population Services International, monitors these medications in eight African countries. The program found that a full quarter of ACTs available in the field were non-quality-assured. (In fact, the program found 185 manufacturers of non-quality-assured ACTs, compared with just 12 reputable companies making these approved combination therapies.)
A second key concern in low- and middle-income countries is antibiotics for treating childhood pneumonia, Breman said: Each year, antibiotics that are either fake or substandard cause as many childhood fatalities as fake antimalarials.