Replies to post #148211 on Biotech Values

[iwfal]

Modern anti-coags and bleeding risk.

Thanks for the paper - hopefully at some point they find SNPs/genes associated with excess bleeding. Comments in general (all presuming that the stats I cited earlier are real):

1) Given that in the stats I quoted Warfarin actually had fewer bleeds despite much higher script rate in the US, there is some 'splaining to do - why so different than the clinical trials?

2) The only explanations I can think of off-hand for the higher apparent rate of bleeding events for Pradaxa are:

2a) that Pradaxa bleeds are reported more frequently to the FDA because they are novel and/or scarier for the physician (e.g. they are more likely to cause extensive medical care because they cannot be reversed).

2b) that Pradaxa is being used where it should not be - e.g. in older patients who experience significantly more bleeding than those same patients on Warfarin. For instance there is are lawsuits now against the manufacturer for patient families suing - and some of those patients are well in excess of the age cutoff.

3) Pradaxa related deaths vs Warfarin related deaths - I'd guess at least some of that is due to the novelty of Pradaxa resulting in more assigning-to-drug and reporting-to-FDA. But I'd also guess that there is some substantial amount of inappropriate usage.

4) Finally, note the stat sig difference between the ratio of deaths to bleeding events. For Pradaxa deaths are more than 20% of bleeding events, while for Warfarin it is about 10%.

All told I think there is some work involved to vet the numbers - but, if the stats I cited are even close to real then Pradaxa may have real problems until they can find a reversing agent or ensure that the drug is used as per label.