Should the study go forward

Malaria is a devastating disease in Africa and in many developing countries. Nearly one million Africans die annually from the disease. Plasmodium falciparum is a protozoan parasite, one of the species of Plasmodium that cause malaria in humans. It is carried by Anopheles mosquitoes. P. falciparum malaria has the highest rates of mortality. Acute malaria in pregnancy is associated with increased mortality, spontaneous abortion, and deformities. The current treatment for malaria is chloroquin and sulfadoxinepyrimethamine. The use of these two drugs has resulted in the development of P. falciparum that is more than 50% resistant to these drugs. Moreover, the two drugs lower the development of acquired immunity to malaria. Therefore, there is a great deal of need to develop a new drug for pregnant women. Another drug, malarone, composed of a fi xed dose of atovaquone and proguanil, is licensed for treatment of malaria and the prevention of malaria for travelers. Clinical trials have indicated that it is fairly safe when used in adults and children. However, there has been no determination of safety of malarone in pregnant women, although there are some studies indicating effectiveness. The proposed trial is to test the drug in pregnant women. The study was approved by the local research ethics committee (REC), a group that is similar to an IRB. The drug is manufactured by GlaxoSmithKline (GSK). Many organizations have approved the study, such as the United Nations, WHO, and UNICEF. The opponents of the study claim that malarone is expensive to the community ($50 per preventive regiment), GSK may be producing it for expatriates, and GSK should guarantee the accessibility of the drug posttrial to the local population. The proponents of the study point out that there is a need for an effective and safe treatment for malaria in pregnant women. It is a high-priority public health problem, and cost can be accommodated later with new sources of funding.

• Should the study go forward?

• If you were a member of the IRB, how would you vote?

• What other conditions, if any, you would require?

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