An ethicist's commentary on extra-label drug use.

摘要: Drug companies are driven by the need to produce profits for their stockholders. The cost of discovery and validation new drugs safety efficacy is enormous, both in terms money time. For this reason, these unwilling make such an investment if a market big enough justify expenditures does not exist. While certain select veterinary drugs, as ivermectin carbrofen do create huge profits, many not. mouse analgesics, example, limited research animals used painful (usually surgical) protocols. Researchers with thousands mice will pay expensive regimens. tiger analgesics considerably smaller, Food animal producers cannot $10 per daily dose cutting edge antibiotics. As 1997, number doing health on Canada had shrunk from 21 7. According Animal Health Institute United States, only 1 7500 compounds succeeds gaining approval over period 10 12 years, at $250 000 000. Clearly serving markets be forthcoming. Veterinarians who wish use approved particular species interest thus face obstacle; rarely available. It reason that legislatures have granted veterinarians privilege using “off label” way; manner has yet been question. Usually means human species, but it may mean drug licensed cattle pig or water buffalo, dogs cat. Such just shooting dark. Safety tested first before clinical trials; we can extrapolate humans, logic dictates go other direction. In fact, when, mid-1980s, States federal law mandated pain control laboratory animals, extrapolations were basis most analgesic use. Furthermore, understand action clearer way, reasonable established information. know pigs well-controlled opiates, so chances opiate yield dubious results. The point alternative extra-label nothing all. position Canadian Veterinary Medical Association (CVMA) encourage prescribe when states “the extra label must based valid veterinarian/client/patient relationship. Inherent responsibility assure safe application education client contribute wholesomeness foods origin. Veterinarians adhere principles through dedication continuing pharmaceutical issues, obtaining up-to-date information companies, colleges, regulatory agencies” (1). In Use Clarification Act was passed 1994. This specifies off-label veterinarian veterinary/client relationship feed. Certain all food clenbuterol chloramphenicol. Further, Secretary Human Services specify levels residue require method detecting residues; proper labeling record keeping required legislation 1997. Some years ago, cavalier about antibiotics growth promotion feeds. led Congress perilously close banning use, which would virtually destroyed medicine. Thus should careful violate public trust area, lest major tool removed them.