JOHANNESBURG, South Africa — Many of Africa’s anti-malaria drugs are fake or of poor quality, weakening a crucial battle against the world’s deadliest disease, a new investigation has found.
Many of the drugs — even those approved by the World Health Organization — are Chinese fakes or low-quality variants that failed quality tests, according to two new studies released today.
Instead of fighting malaria, the bad-quality drugs may actually be accelerating the disease by causing drug resistance, according to the researchers.
Dr. Roger Bate, lead author of the studies and a scholar at the conservative American Enterprise Institute, warned of “unthinkable” public health consequences from drug resistance.
“This has the potential to render entire classes of medicines useless, making malaria or TB untreatable with currently available medicines,” Bate wrote in an opinion piece published today in Business Day, a South African newspaper.
More than a million people, most of them young African children, die from malaria every year.
In one of the studies, 2,652 samples of antimalarials, antibiotics and tuberculosis drugs were purchased in 11 African cities, three cities in India and five middle-income cities, including Beijing and Bangkok.
Up to 15 percent of the all the drugs bought in Africa failed basic quality testing. Of the drugs that had received approval from the World Health Organization (WHO), 7 percent failed the quality tests.
The investigation found that 18 percent of the made-in-China medicines approved by the WHO failed quality tests – a far worse result than with the non-approved Chinese products.
Some of the medicines were counterfeit, while others were of substandard or degraded quality, containing too little of the active ingredient for the patient to recover. This can lead to parasites or bacteria surviving treatment and mutating into stronger strains.
The second study found that nearly 8 percent of antimalarial drugs approved by the WHO or another “stringent” regulatory authority, and sold in Accra, Ghana and Lagos, Nigeria, failed quality tests because they contained too little of the active ingredient.
In treating malaria, artemisinin-based drugs are now the only effective treatment that is widely available. But a spike in global prices of sweet wormwood, the main natural source of artemisinin, may be contributing to the quality problems.
“Rumors are it’s watered down in the grey market of active ingredient trade,” Bate said during a conference call with journalists.
Western donor-backed programs, including the Global Fund’s Affordable Medicines Facility for malaria, only stock drugs approved by the WHO or another regulatory authority.
But quality control testing of drugs in the after-market is often non-existent in African countries because regulatory authorities have too few resources.
Dr. Amir Attaran, co-author of the studies and a Canada Research Chair at the University of Ottawa’s faculties of law and medicine, said it is “particularly disturbing” that even global health organizations are unable to avoid the problem of fake drugs.
Attaran told journalists that in some countries, including Nigeria and Ghana, local authorities can’t keep substandard medicine off the market, despite best efforts, and so it is “negligent” for international health agencies to rely on them to monitor post-market quality.
A separate study published in May by the US National Institutes of Health said that poor-quality antimalarial drugs are leading to drug resistance in Southeast Asia and sub-Saharan Africa, posing an “urgent threat” to at-risk populations and jeopardizing gains made in fighting malaria in the past decade.
In that study, researchers found that 20 to 42 percent of malaria drugs available in those regions are either of bad quality or fake.
The WHO, in an apparent response to the new studies, said that every year millions of people receive life-saving drugs through international health agencies because of the WHO’s medicine pre-qualification program, intended to reassure these agencies that they are buying good-quality drugs.
Drugs that are pre-qualified undergo regular tests and inspections, and experts are working with countries to improve local regulatory capacity, a statement posted on the WHO website said.
“If quality issues are identified in relation to a pre-qualified product, WHO intervenes swiftly,” the statement said.
Bate told reporters in a conference call that the WHO has launched an investigation on the basis of his studies.
In describing the research, he wrote that Western-funded donor programs must improve post-market surveillance of drugs and increase penalties for drug companies that repeatedly produce sub-standard 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,” he wrote.