COVID Transmissions for 8-24-2020

Convalescent Plasma--should it have been approved?

Aug 24, 2020

Greetings from an undisclosed location in my apartment.

It has been 281 days since the first documented human case of COVID-19.

Housekeeping note:

While today is headlines-only, it goes in rather extensive depth about a particular headline from this weekend that I think demands our attention and discussion.

Glossary terms are bolded words with links to the running newsletter glossary.

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Now, let’s talk COVID.

Trump pressures FDA to approve convalescent plasma for COVID-19 treatment

We’ve talked about convalescent plasma before, and about how there is a desperate need for randomized clinical trial data to support its efficacy in the treatment of COVID-19.

Instead of waiting for that data, the Trump Administration has forced the FDA to approve convalescent plasma, according to this story in STAT news: https://www.statnews.com/2020/08/23/fda-under-pressure-from-trump-expected-to-authorize-blood-plasma-as-covid-19-treatment

This comes after comments earlier this week in which Trump complained that he felt the FDA was trying to slow down approval of COVID-19 treatments and vaccines so that they would come after the election. Considering that FDA action on the pandemic has moved at unprecedented speed, I have no idea on what basis the President made this statement.

I’ll leave the political commentary to those who are experts in it, but as an expert in pharma, I will say this is highly irregular and potentially dangerous. The FDA is an organization that is often ponderously slow, but that has led to past decisions that, for example, prevented thalidomide from harming the development of thousands of American babies when it was up for approval in pregnant women. The FDA, like most medical organizations, operates on a principle of harm-minimization. Every procedure, device, or medicine that comes to them for evaluation is a potential mechanism for the assassination of patients. Safety is a vital analysis, and must always be balanced with efficacy. While COVID-19 is a dangerous disease that kills and maims some patients who get it, it is also not something that is intentionally given to these patients. A medication for that disease would be, and we need to know how any benefits from this drug are balanced by its potential negative impacts. If 1% of patients who get convalescent plasma die of immune reactions to treatment, but it saves 1% of patients too, that’s not a drug that sounds approvable.

The problem is, we don’t have the data right now to make this type of assessment. In previous issues, I noted that our data regarding convalescent plasma do not come from a randomized, controlled trial. The Trump administration has made a claim that convalescent plasma reduced death rates from COVID-19 by 35%, but they have provided no support for this statement and I cannot find any published, proposed, or press-released evidence that agrees with this claim, offering no way to evaluate its veracity.

What we do know is that a trial at the Mayo Clinic compared more than 35,000 patients who received convalescent plasma earlier in their course of disease vs those who received it later; this trial found that 11.9% of the patients in the late-treatment group died, while 8.7% in the early-treatment group died—please note that this difference is not a 35% reduction. The Mayo Clinic study has not been peer reviewed, which is why I did not link it directly in this newsletter when I first shared it.

I will say that convalescent plasma is a treatment that has been used in other diseases and is not typically seen as being high risk for use in patients who are at serious risk of death. However, in the absence of robust clinical trial data it is very hard to make any sort of confident claims regarding the safety of the treatment. I want to say more, but I think it is important to be measured and conservative in what is potentially a politically sensitive discussion.

I believe that this is the first time in my lifetime that the FDA has issued an approval for a treatment that has no peer-reviewed, published randomized controlled trial data whatsoever, but it’s possible that I’m mistaken. Still, this type of thing is quite unusual and I don’t know how it will unfold. I hope this decision doesn’t kill anyone.

What am I doing to cope with the pandemic? This:

Cooking

I made a version of a ratatouille on Friday, but this one has sausages and pasta in it, so it’s not really traditional. Here’s how it came out:

Image is a round piece of crockery containing rounds of summer squash, tomato, sausages, and eggplant that have been arranged in concentric circles and roasted.

If there’s interest, I could provide a recipe for this, but it’s sort of involved.

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