Unfortunately, the New York Times article provides no evidence or numbers just opinion.
Here is my take on TPA when looking at the evidence. I’m primarily using the following reviews to make these comments and ignoring authors conclusions and just looking at the data Forest Plots myself
Small numbers - agree but that is one reason we do meta-analyses
Use of secondary outcomes - not sure what they really mean by this - a study should have only one primary outcome (not necessarily the most important one) and we still have to look at the secondary outcomes as they are often clinically relevant
Definitions of outcome - I think the reviews above did a pretty good job of teasing out consistent outcomes when it comes to disability - not perfect but not too bad
Baseline imbalance - I didn’t see any baseline imbalances that I thought would be responsible for the results seen
Other sources of potential bias - agree some trials are unblinded - but many good trials are unblinded
Confounders - definitely an issue but difficult to manage when you have a stroke team dealing with all the other aspects of care
External validity - agree
Influence of pharmaceutical sponsorship - always a concern BUT I have similar concerns with people or groups of people whose job it seems is to discredit every study and treatment - I believe they have an academic bias almost as powerful as the
industry bias
Given the above I still think the “best available evidence” - with all its warts etc suggests the following numbers - these numbers are taken from both the independent review and the Cochrane review
1) If you use TPA within 1-3 (maybe 4.5) hours you get a 5-10% absolute benefit in the number of people with a residual disability
2) intracranial hemorrhage goes up by about 5% BUT not sure how relevant this is given that the number of overall people with a residual disability is reduced
3) overall mortality is unchanged
So is TPA a good or bad drug - neither - but if I had a stroke and was in a stroke unit within 2-3 hours I would want TPA.
Hope this helps
James
I haven't reviewed this data for a long time, but do vaguely remember that there is some evidence of somewhat better functional outcomes, but the trade-off is bleeding risk. Kolata minimized bleeding risk in her story, suggesting that somehow it is going away.
So far, I haven't seen any pushback from the skeptics, so the story unopposed suggests once again the nasty pharma-scolds are preventing people from getting miraculous therapy.
Did I miss something?
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Roy M. Poses MD FACP
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