In conclusion, they write, “the sex disparity in ADRs does not merely reflect body mass masquerading as an effect of sex,” and so while administering drugs on a milligram/kilogram basis might be an improvement on the current default male dosing regimen, it wouldn’t fix the overall problem.
There’s something in their tone here that makes me suspect that the authors have got a bit bored of having to go over this ground. Or maybe it’s just that I personally am bored of having this debate. I find it both bizarre and disheartening that some people – and we’re often talking smart people here – remain invested, in the face of all the evidence, in insisting that all sex differences can be boiled down to men being on average bigger than women. Or maybe it’s not so bizarre since if all that we need to do is adjust the default male research by size and weight, nothing much needs to change and we can carry on merrily default male-ing to our heart’s content. After all, scaling down the default male dummy has worked so well for car safety hasn’t it…
Still, I suppose we should look on the bright side: at least these people are not pretending there are no differences at all and that we should continue to give women the “standard” for which read default male dose.
The same cannot be said for the FDA:
One survey of clinical pharmacology data for 300 new drug applications (NDAs) evaluated by the FDA between 1994 and 2000 [10
] indicated that 31% of studies showed a possible sex effect based on pharmacokinetic (PK) sex differences greater than 20%. In the same report, 11 drugs showed a > 40% difference between males and females in PK measures, yet no dosing recommendations to consider sex were issued, implicitly based on the unsubstantiated grounds that these differences were not clinically relevant.
looks over glasses at the FDA
This, Zucker et al. point out, is daft:
In many cases, [sex-based dosing recommendations] can be implemented at little cost. As demonstrated below, the data required to implement these procedures already exist for a number of drugs but have been ignored.