WHO confronts Chinese company over malaria drug

British Medical Journal | March 17, 2007

The World Health Organization is asking a Chinese pharmaceutical company to stop making a malaria drug that earns millions of dollars annually in revenues.

The move is part of a campaign to combat increasing resistance to antimalarials and to promote use of combination treatments. The drug’s manufacturer, Kunming Pharmaceutical, which is owned by the Holley Group and publicly traded on the Shanghai Stock Exchange, is refusing to halt sales, which amounted to $5m (£2.6m; €3.8m) in 2004, according to the Wall Street Journal (http://online.wsj.com, 6 Mar, “China’s pride on line in malaria clash”).

The confrontation may prove awkward for Margaret Chan, the newly elected director general of WHO, who is from Hong Kong. One of the questions raised about Chan’s candidacy was whether or not she would be able to stand up to China when necessary.

Complicating matters is the fact that a huge market for malaria drugs exists in Africa because 90% of the world’s deaths from malaria occur in the sub-Saharan part of the continent. Most drugs sold in Africa come through the private sector, which is beyond WHO’s remit. Although public health systems in many countries purchase only drugs that are approved by WHO this is not the case in Africa, where over the counter sales are common.

The relationship between China and Africa is burgeoning, and one of the factors in Dr Chan’s winning of the WHO directorship was support for African countries. After taking office in January she appointed Anarfi Asamoa-Baah, of Ghana, as her deputy director general, a post that WHO has not always had on its organisational chart.

Kunming’s drug is based on artemisinin, which is derived from a plant used in Chinese traditional medicine for centuries. Chinese scientists developed the drug, and Kunming introduced its product in the 1980s.

“This is not fair to China,” Yu Zelin, general director of international trade at Kunming, told the Wall Street Journal. “We have developed the drug ourselves. We have made so much effort.”

But with resistance to malaria drugs such as chloroquine, sulfadoxine-pyrimethamine, and amodiaquine on the rise, and between 300 and 500 million cases of malaria (and a million deaths) a year, WHO’s malaria chief, Arata Kochi, has stepped up the campaign to stop drug companies selling monotherapies, which WHO believes lead to drug resistance.

In meetings with drug company executives in Washington, DC, and Geneva Dr Kochi has been threatening to boycott all drugs produced by companies that continue to make products based on artemisinin monotherapy. The only situations in which monotherapies are still recommended are in cases of severe malaria or in pregnant women.

Coartem (arthemeth and lumefantrine), made by Novartis, is the sole artemisinin based combination treatment to have received WHO approval. Kunming also makes its own combination therapy, Arco (naphthoquine phosphate and artemisinin), which is just starting to penetrate the African market and does not have WHO approval.

If resistance to artemisinin drugs rises, the public health situation could deteriorate. “We rely absolutely on these drugs,” said Nicholas White, of Mahidol University in Bangkok and author of a 2005 study of malaria drugs that found artemisinin drugs more effective than quinine. “We don’t have an alternative.”

Dr White, who is also head of WHO’s antimalarial treatment guidelines committee, thinks the solution lies in persuading Kunming to work towards developing combination treatments. “If Chinese and Indian pharmaceutical companies can come up with high volume, high quality combination drugs for less than 50 cents for an adult treatment, it would have a highly beneficial effect. International donors could get enough to treat everybody in the world,” he said.