Systematic review of chimpanzee use in monoclonal antibody research and drug development: 1981-2010

Abstract

This survey examines the extent to which live chimpanzees have been used in monoclonal antibody (mAb) research and the drug approval process. The survey covers 193 scientific articles published during the years 1981-2010, as well as preclinical studies leading to the approval of mAb drugs by the Food and Drug Administration of the United States. The frequency of the articles has decreased by more than twothirds from their highs in the late 1980's, and the aggregate number of chimpanzees used in these studies has decreased by more than 90%. The experimental protocols ranged from single or multiple blood draws to extraction of body fluids and tissue samples, and to multiple, repeated organ biopsies. Many studies involved infecting the chimpanzee(s) with pathogenic organisms and immunization and infusion protocols. Addressing the health history and status of the chimpanzees was an exception rather than the rule, and anesthesia and analgesia were mentioned only in a small minority of the surveyed articles. In the past two decades, the FDA has approved 32 mAb drugs, but only three of those drugs could be determined to involve the chimpanzee in the preclinical stage. Two of those three drugs have been withdrawn from the market due to their severe adverse effects in human patients. Available alternatives, together with ethical and economic reasons, suggest that the use of the chimpanzee in this manner may not be necessary or appropriate.