Poor Quality Malaria Drugs Causing Problems

Kaiser Daily Global Health Policy Report reported that between 26 percent and 44 percent of artemisinin-based malaria drugs sold in Madagascar, Senegal and Uganda “failed quality testing” because of impurities or insufficient amounts of active ingredient, the Associated Press reports. The study, which was conducted by the nongovernmental U.S. Pharmacopeia program and received funding from USAID, adds to concerns about growing resistance to artemisinin, which is currently the most effective treatment for malaria.

Malaria, nearly eradicated by the early 1970s, began a resurgence after the US EPA banned DDT because, the EPA alleged, it caused bird’s eggshells to become too thin. Subsequent research casts doubt on this allegation. Nevertheless, other nations followed the USA’s lead and within a few years Malaria had once again reached epidemic proportions in many poor nations of the world, particularly in the tropics. The numbers are truly staggering. According to the CDC

• Forty-one percent of the world’s population live in areas where malaria is transmitted (e.g., parts of Africa, Asia, the Middle East, Central and South America, Hispaniola, and Oceania).
• Each year 350–500 million cases of malaria occur worldwide, and over one million people die, most of them young children in sub-Saharan Africa.
• In areas of Africa with high malaria transmission, an estimated 990,000 people died of malaria in 1995 – over 2700 deaths per day, or 2 deaths per minute.
• In 2002, malaria was the fourth cause of death in children in developing countries, after perinatal conditions (conditions occurring around the time of birth), lower respiratory infections (pneumonias), and diarrheal diseases. Malaria caused 10.7% of all children’s deaths in developing countries.
• In Malawi in 2001, malaria accounted for 22% of all hospital admissions, 26% of all outpatient visits, and 28% of all hospital deaths. Not all people go to hospitals when sick or having a baby, and many die at home. Thus the true numbers of death and disease caused by malaria are likely much higher.

Quality issues only exacerbate the problem of controlling this vicious, often fatal, illness. “The study is the first part of a 10-country examination of antimalarials in Africa by the U.S. and the World Health Organization. It follows evidence from the Thai-Cambodian border that artemisinin-based drugs there are taking longer to cure malaria patients, the first sign of drug resistance,” the news service writes.

“The experts subjected 200 samples of anti-malaria drugs to quality-control testing in a U.S. laboratory. They found 44% of the drugs from Senegal failed the testing, followed by 30% from Madagascar and 26% from Uganda. Patrick Lukulay, director of the U.S. government-funded Pharmacopeia programme, said it was a ‘disturbing trend,’” the BBC writes.

He said, “It is worrisome that almost all of the poor-quality data that was obtained was a result of inadequate amounts of active [ingredients] or the presence of impurities in the product”.

According to the AP, the “three-country report also found bad drugs in both the public and private health sectors, meaning governments – some buying medicines with donor funds – are not doing enough to keep poor-quality pills out. All of the drugs tested from the public sector in Uganda, however, passed the quality tests. But 40 percent of the artemisinin-based drugs in Senegal failed.” The study also notes that the same drug brands generally had similar results across all sectors, which could help governments that are trying to eliminate substandard drugs.

While the study is not the first to assess the quality of antimalarials in Africa, it is the most rigorous and complete, according to the AP, which notes that similar failure rates were found in previous work that did not focus specifically on artemisinin-based drugs. The WHO has examined malaria treatments in Cameroon, Ethiopia, Ghana, Kenya, Malawi, Nigeria and Tanzania, the AP reports, adding that while the results have not been made public, “Clive Ondari, who worked on the study for the WHO in Geneva, said failure rates in three of those countries were also significantly high. Ghana has already withdrawn more than 20 drugs from the market after receiving the initial results, Lukulay said”