[BostonCard]

Some thoughts on convalescent plasma:

https://blogs.sciencemag.org/pipeline/ar...e-politics

First, the medical aspects: in my view, for what that’s worth, convalescent plasma is likely to be at least somewhat helpful to hospitalized coronavirus patients. I think that its safety profile is likely to be good as well, and I really have no problem with it being used.

As Goose has noted, this is a stopgap measure until monoclonal antibodies (or cocktails) make it through clinical trials.

All of these considerations are taken care of by dosing monoclonal antibodies instead of the isolated antibody fractions, and as mAbs become more available, I would expect convalescent plasma to become less widely used. There are costs and production aspects to rolling out mAbs, but biologically, they are the perfected version of what convalescent plasma is trying to achieve.

The piece makes a very good point about the scientific drawbacks of being too lose with emergency use authorizations.

The problem is that we still haven’t generated any controlled clinical data on how useful it is. The Mayo-led data that were talked about during yesterday’s press conference had no control group, making that key question impossible to really answer. This shows the perverse danger of being too free with emergency use. If you just turn everyone loose on a bunch of therapies, they will be used under all sorts of conditions and the chances of getting a useful read on any of them go down. Look at our current situation: we have data on over 35,000 patients who have received convalescent plasma, but we still don’t have a good comparison to not receiving it. It shouldn’t have happened this way.

I think I've made this point before, and Mayo holds a lot of the blame here.  But also, the IND shouldn't have been a blank check to enroll thousands of patients in an uncontrolled study.  Maybe you get a couple hundred uncontrolled patients, and then the FDA should have said that it is time to move to a randomized, controlled study.

Finally, that leads us to the political aspect of this, damn it all. Yesterday’s press conference was announced the night before by the White House as concerning “a major therapeutic breakthrough”. The president and his allies echoed this language, with phrases like “historic breakthrough”, “a truly historic announcement”, and so on. It wasn’t. Convalescent plasma has been used for many decades in other infectious diseases, and it was tried very early on in the first countries affected by the coronavirus. Announcing an Emergency Use Authorization this late in the game for it in the US is, as I tried to convey in the above paragraph, closer to being something that we should be vaguely ashamed about.

And... yikes!

Commissioner Hahn’s and Sec. Azar’s obsequious statements yesterday (and the mangling of the statistics to make everything look rosier) were terrible to see. And the FDA’s own web site announcement includes the phrase “Another Achievement in Administration’s Fight Against Pandemic” in the headline, which is a first, to the best of my knowledge, since the FDA is not supposed to be tied to any particular presidential administration and is not supposed to be shining anyone’s shoes. But hey, if you’re going to have someone licking them, someone else has to step in with the rag right afterwards, and they’d better snap the thing so the big guy can hear it.

Sorry for the extensive quoting.

BC

[BostonCard]

Some thoughts on convalescent plasma:

https://blogs.sciencemag.org/pipeline/ar...e-politics

First, the medical aspects: in my view, for what that’s worth, convalescent plasma is likely to be at least somewhat helpful to hospitalized coronavirus patients. I think that its safety profile is likely to be good as well, and I really have no problem with it being used.

As Goose has noted, this is a stopgap measure until monoclonal antibodies (or cocktails) make it through clinical trials.

All of these considerations are taken care of by dosing monoclonal antibodies instead of the isolated antibody fractions, and as mAbs become more available, I would expect convalescent plasma to become less widely used. There are costs and production aspects to rolling out mAbs, but biologically, they are the perfected version of what convalescent plasma is trying to achieve.

The piece makes a very good point about the scientific drawbacks of being too lose with emergency use authorizations.

The problem is that we still haven’t generated any controlled clinical data on how useful it is. The Mayo-led data that were talked about during yesterday’s press conference had no control group, making that key question impossible to really answer. This shows the perverse danger of being too free with emergency use. If you just turn everyone loose on a bunch of therapies, they will be used under all sorts of conditions and the chances of getting a useful read on any of them go down. Look at our current situation: we have data on over 35,000 patients who have received convalescent plasma, but we still don’t have a good comparison to not receiving it. It shouldn’t have happened this way.

I think I've made this point before, and Mayo holds a lot of the blame here.  But also, the IND shouldn't have been a blank check to enroll thousands of patients in an uncontrolled study.  Maybe you get a couple hundred uncontrolled patients, and then the FDA should have said that it is time to move to a randomized, controlled study.

Finally, that leads us to the political aspect of this, damn it all. Yesterday’s press conference was announced the night before by the White House as concerning “a major therapeutic breakthrough”. The president and his allies echoed this language, with phrases like “historic breakthrough”, “a truly historic announcement”, and so on. It wasn’t. Convalescent plasma has been used for many decades in other infectious diseases, and it was tried very early on in the first countries affected by the coronavirus. Announcing an Emergency Use Authorization this late in the game for it in the US is, as I tried to convey in the above paragraph, closer to being something that we should be vaguely ashamed about.

And... yikes!

Commissioner Hahn’s and Sec. Azar’s obsequious statements yesterday (and the mangling of the statistics to make everything look rosier) were terrible to see. And the FDA’s own web site announcement includes the phrase “Another Achievement in Administration’s Fight Against Pandemic” in the headline, which is a first, to the best of my knowledge, since the FDA is not supposed to be tied to any particular presidential administration and is not supposed to be shining anyone’s shoes. But hey, if you’re going to have someone licking them, someone else has to step in with the rag right afterwards, and they’d better snap the thing so the big guy can hear it.

Sorry for the extensive quoting.

BC