Comment Wider problems in how to design tests (Score 2) 109
The article made good points: the issues are even wider. There is much more besides the type of test-animal strain that can make for problems in effective testing.
Nowadays some new pharmaceutical product-candidates are designed and intended to work by specifically interacting with some very human-specific features of materials present in the eventual treated patients. Sometimes product-candidates of this kind are not expected to interact with non-human animal substances in a corresponding way at all.
An example lies in the specificity of human-antibody-related products (some of them intended for use against types of cancer). Their effects may be hard to mimic and test in any non-human animal subject whatever.
This makes for much harder problems in test design than in the more straightforward old days of (for example) testing candidate antibiotics. That involves checking that the material does kill the target bug and does not damage the treated animal or human subject, and in the past, observations of tested animals often gave very good indications of what would happen next when the substance was given to humans. (Caution is still needed, and clinical trial regimens accordingly have to include careful human safety testing as a follow-up to successful and careful animal safety testing.)
But when the product candidate is supposed only to interact in a special way with very human-specific substances, somehow its safety and efficacy has to be effectively tested before it gets to humans -- but how? -- when no non-human animal can be expected to show the same type of effects whether wanted or unwanted.
This new twist to the problem of test design has not always been addressed successfully. A tragic example occurred a few years ago, when a modified antibody with a design incorporating very unusual and specifically human-human interactions passed the animal safety testing that was decided on, but then went on to injure severely the first few human test volunteers by causing major acute iflammatory effects not seen in the animal tests.
The issues go well beyond selection of strains of test animals and sometimes the solutions may have to be developed on a case-by-case basis..
-wb-