Animal testing
A more important contribution to safety assessment was probably my
10-year crusade to get rid of animal-based genotoxicity assays for
assessment of medical devices, usually an in vivo micronucleus assay.
This was well before the ground swell against animal testing, and might
be seen as prescient, but the truth was that medical devices themselves
or device extracts could not reach the OECD guideline dosimetry
requirements for a valid assay. Thus, there were hundreds of invalid
assays, usually using 90 animals per test. Of course they were always
negative. I recall starting even earlier to eliminate the
carcinogenicity tests, first their occurrence and then the option for
performing them under any circumstances. As practiced, they were even
farther removed from the requirements for any sort of scientifically
reasonable carcinogenicity assessments, based not only on dosimetry but
also on the numbers of animals used. I remember reviewing one test on a
sum of 5 animals. The use of animals for medical devices was an
incredible waste with no benefit.