New Studies Reveal Frequent Failures Among World Health Organization-Approved Drugs Sold in Africa
Consistent under-dosing of antimalarial drugs due to
poor manufacturing could accelerate parasite resistance
July 10th, Washington, D.C. - Two new studies published in Research and Reports in Tropical Medicine reveal significant quality problems with World Health Organization-approved drugs sold in Africa, sometimes through Western donor-funded programs.
In one study, 2,652 drugs to treat malaria, tuberculosis and bacterial infections were collected off-the-shelf in low- and middle-income countries and assessed for basic quality. 13 percent of drugs not approved by a stringent regulatory authority or the World Health Organization failed quality tests.
Among those approved by the World Health Organization, 7 percent failed. Notably, 18 percent of these were manufactured in China.
"Perhaps half these failures may be fakes," said Dr. Roger Bate, Resident Scholar at the American Enterprise Institute and lead author on the studies. "The other half are substandard, but legal, medicines. Many drugs purchased from the same locations did not fail quality tests. This suggests that shoddy manufacturing, as opposed to product degradation, is the more likely cause of these failures."
In another study, nearly 8 percent of antimalarial drugs approved by a stringent regulatory authority or the World Health Organization and sold in Accra, Ghana and Lagos, Nigeria failed quality tests because they contained too little active ingredient. None contained too much active ingredient. These results did not appear to be due to chance events, indicating that these failures were the result of systemic poor manufacturing practices.
Under-dosing fuels drug resistance. If a medicine contains insufficient active ingredient, some of the parasites or bacteria will be killed but the strongest will survive, mutating and evolving into more resilient strains.
"Deliberately counterfeiting of drugs is dangerous to patient health but often is not a criminal act," said Bate. "Sloppy manufacturing, or cutting corners, yields substandard products but remains a woefully unaddressed offense. Many of these manufacturers are capable of making high-quality drugs, but they are not doing so consistently and people may be harmed as a result."
Many of the public health programs through which these drugs are distributed - such as the $225-million Affordable Medicines Facility for malaria - aim to combat resistance by subsidizing high-quality drugs. If these programs are distributing substandard drugs, they may in fact accelerate it.
Donors only purchase drugs that have been registered with a stringent regulatory authority or approved by the World Health Organization. Quality control testing in the after-market, however, is often non-existent. Regulatory authorities in low-income countries like Angola have few resources to pick up the slack.
"These results again remind us that essential medicines can be compromised through negligence or criminality of suppliers," said Professor Amir Attaran, Canada Research Chair in Law, Population Health and Global Development Policy, Faculties of Law and Medicine at the University of Ottawa and co-author of the studies. "What is particularly disturbing is that even world's leading buyers of malaria medicines, like the Global Fund, are unable to avoid that problem, which calls for a radical rethinking of laws and regulations."
"The WHO will report failures when it finds them, but its meager budget rarely allows that," said Bate. "Donors must step up post-market surveillance and increase penalties for repeat offenders. If three product failures occur from the same manufacturer in a given year, that company should lose its WHO prequalification status for all of its registered products. If we took drug quality control as seriously in poor countries as we do in the West, we could save lives and dramatically increase the impact of our public health programs."