May 25, 2012, 10:30 a.m.
Although there has been considerable progress made in malaria control over the past 10 years, these global efforts are now under threat due to increasing drug resistance and inadequate treatment.
According to the researchers, approximately 42% of malaria drugs examined in Southeast Asia were fake, while around 33% of antimalarial drugs in sub-Saharan Africa contained either too much or too little of the active ingredient.
The study is published in The Lancet Infectious Diseases. Lead researcher of the study, Gaurvika Nayyar from the Fogarty International Center at the National Institutes of Health (NIH) in the USA, said:
"3.3 billion people are at risk of malaria, which is endemic in 106 countries. Between 655,000 and 1.2 million people die every year from Plasmodium falciparum infection. Much of this morbidity and mortality could be avoided if drugs available to patients were efficacious, high quality, and used correctly."
The researchers analyzed data from antimalarial drugs in Southeast Asia and sub-Saharan Africa and found that in seven Southeast Asian countries, about a third of the 1,437 samples of 7 malaria drugs analyzed were fake, over a third failed chemical testing, and almost 50% were not packaged correctly.
In 21 sub-Saharan countries, around a fifth of the 2,500 samples tested were found to be fake, and over a third failed chemical testing.
"Despite a dramatic rise in reports of poor-quality antimalarial drugs over the past decade, the issue is much greater than it seems because most cases are probably unreported, reported to the wrong agencies, or kept confidential by pharmaceutical companies.
No reliable global estimates are available about the frequency of poor-quality antimalarial drugs because of no internationally accepted definitions of different types of poor-quality drugs; no globally standardized or statistically robust sample schemes, testing protocols, and requirements for drug content; a dearth of funds; and no recognized international forum to provide technical and scientific guidance and oversight."
According to the researchers, in order to define and eliminate criminal production, poor manufacturing and distribution, several parallel interventions are required. They explained: "Currently, only three of the 47 malarious countries in Africa have laboratories that are equipped to chemically analyze antimalarial drugs."
In an associated comment, Michael Seear from British Columbia Children's Hospital, Vancouver, Canada states that further research is required in order to clarify the magnitude and cause of poor drug quality: "Drug quality is dependent on the overlapping effects of poor manufacturing standards, criminal counterfeiting, adulteration with inactive or toxic fillers, relabeling or time-expired drugs, and degradation during storage. Reliable research concerning counterfeiting is limited, and almost no information is available about the other four factors."
"Construction of a balance between protection of intellectual property and the maintenance of drug quality has plagued the relation between WHO and the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). Hopefully, public health will be given more priority than are intellectual property rights and WHO will develop a clearly defined and widely accepted mandate in this area."