A new study has found that poor quality or counterfeit antimalarial drugs in Africa and Southeast Asia threaten the lives of those infected with the mosquito-borne illness, and sabotage critical efforts to combat the disease.
Researchers with the Fogarty International Center of the National Institutes of Health analyzed 27 studies dating back to 1999. They found that more than one-third of the drugs used to treat malaria in southeast Asia and sub-Saharan Africa are fake, mislabeled or ineffective. Malaria threatens 3 billion people around the world, and the parasitic disease kills as many as 1 million people each year, most of them infants and children in Africa.
Data collected from 21 African countries found that 35 percent of almost 2,300 antimalarial drug samples failed a chemical analysis, 36 percent of 77 samples failed packaging tests and 20 percent of 389 samples were purposely falsified.
A similar analysis of studies from seven Southeast Asian countries found that 35 percent of more than 1,400 antimalarial drugs failed a chemical test, nearly half of 919 samples were improperly packaged and 36 percent of 1260 drug samples were classified as fake.
"And that is an injustice," said Joel Breman.
Joel Breman of the Fogarty International Center, a study co-author, says many of the drugs are no longer effective because they are old and past their expiration dates. He says others contain contaminating fillers such as powders and pollens that might be used to trace the bogus drugs back to their countries of origin. Earlier studies have found evidence that some of these counterfeit drugs are manufactured in China and smuggled into Southeast Asia and elsewhere.
Dr. Breman says that counterfeiters can make drug packaging look surprisingly real.
"They even, in some instances, have put look-alike holograms on these packages," he said.
Ineffective or fake antimalarial drugs can lead to resistance or even death, according to the study's authors, who say the emergence along the Thai-Cambodian border of new forms of drug resistant malaria parasites should be a wake-up call to the public health community.
Michael Seear is head of respiratory medicine at Children's Hospital in Vancouver, Canada. He says many diseases, including tuberculosis, now widely thought to be drug resistant really are not. Rather, Dr. Seear says, the problem is due to ineffective drugs.
"The commonest form of poor drugs is just a drug that's been left on the shelf," said Seear. "So you go into Abu Dhabi, and you buy some drugs off the shelf, they have probably been there for five years and they probably don't work. So the quality of those drugs is important. But it's not counterfeiting. Counterfeiting is an exciting subject, but it's not the commonest cause of poor quality medications."
According to Dr. Seear, there is little or no regulatory oversight of drugs in a third of the countries designated as developing nations by the World Health Organization.
"You need an international authority to take control, set universal standards, have a drug quality institution in each country, and so on, so on, so," he said. "Those things do not exist."
An article describing high percentages of poor quality, counterfeit and ineffective antimalarial drugs in sub-Saharan Africa and Asia, and a commentary by Michael Seear, appears in the June issue of the journal The Lancet Infectious Diseases.