Risks of Biotherapeutic Agents

Abstract

The appeal of biotherapeutic agents is the use of naturally occurring organisms to combat specific illnesses. The benefits of biotherapeutic agents include direct and indirect reduction of health care concerns. Direct benefits arise from their use in prevention and/or treatment of specific diseases. Indirect benefits may include a reduction in the frequency of antibiotic use when biotherapeutics are used as an alternative to antibiotics, a reduction of medical care costs (since biotherapeutic agents are less expensive than most antibiotics), and with the reduced frequency of antibiotic use comes the theoretical reduction in the frequency of antibiotic resistance. Justification for medical use must balance the benefits and the potential risks. Potential risks include bacterial translocation, septicemia, mutation of microorganisms, changes in metabolic activities owing to bacterial interactions, immunomodulation, and transfer of genetic material, including genes for antibiotic resistance. These potential risks have been hypothesized to be associated with the use of any biological agent, but large, well-controlled clinical trials must be done to determine if any of these potential risks are actually observed with the use of specific biotherapeutic agents. To date, only isolated case reports have been published linking the use of biotherapeutic agents and adverse reactions.