An alarming number of people across Africa may be taking cancer drugs that don't contain the vital ingredients needed to contain or reduce their disease.
It's a concerning finding with roots in a complex problem: how to regulate a range of therapeutics across the continent.
A US and pan-African research group published the findings this week in The Lancet Global Health. The researchers had collected dosage information, sometimes covertly, from a dozen hospitals and 25 pharmacies across Ethiopia, Kenya, Malawi and Cameroon.
They tested nearly 200 unique products across several brands. Around 17% — roughly one in six — were found to have incorrect active ingredient levels, including products used in major hospitals.
Patients who receive insufficient dosages of these ingredients could see their tumors keep growing, and possibly even spread.
Similar numbers of substandard antibiotics, antimalarial and tuberculosis drugs have been reported in the past, but this is the first time that such a study has found high levels of falsified or defective anticancer drugs in circulation.
"I was not surprised by these results," said Lutz Heide, a pharmacist at the University of Tübingen in Germany who has previously worked for the Somali Health Ministry and has spent the past decade researching substandard and falsified medicines.
Heide was not part of the investigative group, but said the report shed light on a problem not previously measured.
"I was delighted that, finally, someone published such a systemic report," he said. "That is a first, really significant systematic study of this area."
Causes need addressing, but it's not straightforward
"There are many possible causes for bad-quality products," Marya Lieberman of the University of Notre Dame in the US, the investigation's senior researcher, told DW.
Those causes can include faults in the manufacturing process or product decay due to poor storage conditions. But some drugs are also counterfeit, and that increases the risk of discrepancies between what's on the product label and the actual medicine within.
Spotting substandard and falsified products can be difficult. Usually, a medical professional or patient is only able to perform a visual inspection — literally checking a label for discrepancies or pills and syringes for color differences — to spot falsified products.
But that's not a reliable method. In the study, barely a quarter of the substandard products were identified through visual inspection. Laboratory testing identified the rest.
Fixing the problem, Lieberman said, will require improving regulation and providing screening technologies and training where they're needed.
"If you can't test it, you can't regulate it," she said. "The cancer medications are difficult to handle and analyze because they're very toxic, and so many labs don't want to do that. And that's a core problem for the sub-Saharan countries where we worked. Even though several of those countries have quite good labs, they don't have the facilities that are needed for safe handling of the chemo drugs established."
Not only cancer treatments are affected
Nearly a decade ago, the World Health Organization found around one in 10 medicines used in low and middle-income countries were substandard or falsified. Independent research conducted since has backed those figures up, sometimes finding rates that are potentially twice as high.
"This could lead to treatment failure, adverse reactions, disease progression," health economist Sachiko Ozawa told DW. Ozawa contributed to the investigation on anticancer drugs and has separately researched other cases of defective medicines.
"For the community, there's also economic losses in terms of wasted resources,” she said. “So countries may be spending a lot of money on medications that are not going to be effective."
While high-income countries can monitor supply chains and have stringent regulatory systems in place to identify and withdraw suspect products, the infrastructure to do that is far from common in other regions.
In those places, poor access to affordable medication often drives patients to less-regulated marketplaces. Inadequate governance and regulation, as well as a scarcity of surveillance and diagnostic equipment to test pharmaceuticals, are all contributing to the problem in Africa.
"In high-income countries, I think there's a much more secure supply chain where you know the manufacturers are vetted, it has to go through very stringent regulatory processes to get approval...it gets tested more frequently," said Ozawa.
The WHO told DW that following the report's findings, it was working with the four affected countries to address the problem.
"We are concerned with the findings the article has highlighted. WHO is in contact with national authorities of four impacted countries and obtaining relevant data," it said in a statement. "We expect to assess full information to evaluate the situation, which often takes time and capacity. But we're committed to address these issues working with the relevant countries and partners."
The WHO also reiterated its ongoing call for countries to improve their regulatory frameworks to "prevent incidents of substandard and falsified medicines, including in settings of cancer programs."
Prevention, detection and response
In 2017, the WHO's review of substandard and falsified medicines offered three solutions based around prevention, detection and response.
Stopping the manufacture and sale of those medicines is the primary preventative measure, but where defective products make it to market, surveillance and response programs can prevent poor quality medicines from reaching patients.
But regulatory reform sought by experts and authorities takes time. More immediate solutions are being developed in the form of better screening technologies.
Lieberman is working on a "paper lab" — a type of test that can be used by trained professionals to chemically test the quality of a product before it's administered to a patient. Other laboratory technologies are also under development.
One comforting point is that while a significant proportion of the medication circulating in medical facilities in the four African countries was defective, the majority of the products tested met required standards.
"[With] two-thirds of the suppliers, all the products [were] good quality, so there are good quality suppliers," said Heide. "But a few of them really have a suspiciously high number of failing samples."
Edited by: Derrick Williams