>How important is the immunogenicity issue (beyond a theoretical one)?<
If someone dies as a result of it, that would be pretty important. The <$100 price differential we have assumed for recombinant vs bovine thrombin is a very small portion of the overall price of the procedures where thrombin is typically used.
>Both groups had similar adverse reactions<
Actually, the SAE rate was higher for the bovine arm (although the difference was not statsig):
>>
Serious adverse events were experienced by 18% of patients exposed to rhThrombin (n=36); and 22% of those receiving bovine thrombin (n=46).
<<
Moreover, the trial did not follow patients long enough to assess if there was a significant longer-term risk from exposure to the bovine product.
>All in all there are alot more important medical issues to solve than replacing bovine thrombin.<
No doubt. The larger issue here is not bovine vs human but rather plasma vs recombinant.
Proteins derived from plasma—whether bovine or human—impose risks on patients that become unnecessary when recombinant products are available. Not only can plasma have known pathogens—such as West Nile—that aren’t tested, but it may have bad stuff we have not even heard of yet.
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