Testing a low-cost approach to giving eRIG for rabies PEP: Ethical issues

Ethical concerns in using a lower dose of equine rabies immune globulin (eRIG) to irrigate wounds from dog bites to prevent rabies are discussed. A lower dose of eRIG was used because of a general shortage of eRIG and the high market cost in the Himachal Pradesh state of India. The cost and availability of drugs in low- and middle-income countries (LMIC) often necessitates testing a lower dose of a vaccine or treatment than that recommended by international organizations (eg WHO). It raises the issue that recommendations may be designed for higher income countries without taking into consideration issues of supply and cost. Secondly a case-control design to compare dosages or delivery systems is usually not an option so investigators must often use historical data for comparison or other study designs. The ethical issues in the testing of drugs and vaccines in LMIC must be continuously reviewed by the international community.