Pfizer Docs Part 9: CYA FDA

Some of the documents exist merely to show the FDA is doing their job - and sometimes have no other value.

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Understanding the Postmarketing Experience report

This one document has generated a lot of noise on social media, with many people misinterpreting numbers, misconstruing lists, and generally misunderstanding the point of the report.

First, there are no smoking guns in this document and none should be expected. Pfizer has unlimited funds, a huge legal and regulatory affairs staff, and they essentially wrote the regulations - there’s no way they accidentally let something damaging to themselves get into this report.

But the real issue to discuss is what this document can actually be used for.

What’s the real purpose?

This document is what we (at least in engineering) like to call a CYA document (as in “Cover Your A**”). But it’s mostly not for Pfizer - it’s mostly a CYA document for the FDA. Anyone with experience in regulatory affairs could have summarized the contents of the document before even reading it.

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Essentially, the FDA told Pfizer (obviously not a direct quote):

Go look at these different sources of adverse event data, and tell us if anything in this data indicates your vaccine is dangerous.

And Pfizer sent back a report saying:

We looked in the places you told us, being as thorough as time allowed, and in our opinion there is no evidence of safety issues.

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The FDA did not ask Pfizer to send all the adverse event reports, and the FDA probably doesn’t want them either.

Keep in mind that FOIA only applies to the FDA - not to Pfizer. We only have access to whatever the FDA requested from Pfizer, and anything they didn’t request isn’t available. The FDA didn’t ask for the raw data (the actual reports). And this document only discusses reports that Pfizer has processed.

Among adverse event reports received into the Pfizer safety database during the cumulative period, only those having a complete workflow cycle in the safety database (meaning they progressed to Distribution or Closed workflow status) are included in the monthly SMSR. This approach prevents the inclusion of cases that are not fully processed hence not accurately reflecting final information.

They only included reports with “a complete workflow cycle in the safety database” because this “… prevents the inclusion of cases that are not fully processed hence not accurately reflecting final information.” Does this mean there are thousands of cases we aren’t hearing about?

[We don’t know what the monthly SMSR is because this acronym isn’t included in the List of Abbreviations. But for now we’re going to assume this report is some kind of summary of those.]

There are two possibilities here:

1. They have received 42,086 case reports total, and this document summarizes however many of those they’ve had time to analyze.

2. They have received an unknown number of total reports, and this document summarizes the 42,086 they have analyzed.

This statement:

Cumulatively, through 28 February 2021, there was a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events.

Makes it sound like the 42,086 are the confirmed cases (so maybe a subset of the total), but either way we have the same issue of not knowing one number in any calculation that we try to make of rates of adverse events.

To clarify, we don’t know if, to get the totals in this report:

1. They received 42,086 case reports and have processed an unknown number of these.

2. They received an unknown number of case reports and have processed 42,086.

But either way, in this system Pfizer could “hide” adverse events just by working slowly - and they would have broken no laws.

These are just the reported and/or processed cases. Are the processed cases from the first million doses, or 126 million? Are cases normally reported in the first few weeks, or does it take months to get all the data? We have no idea, we only know that as of the production of this report they still had an unstated number of unprocessed case reports.

In addition, the only data are totals of different events - but without seeing the details of Pfizer’s analysis we have no idea how they arrived at their conclusions.

It’s like a “get out of jail free” card for the FDA.

Imagine a scenario in which, some time in the future, we discover the Pfizer vaccine is extremely dangerous. Lots of angry people will be looking at the FDA for answers.

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The FDA is going to pull out this report, and say:

We don’t have the 1,800 extra staff needed to review all the adverse event reports. And we’re responsible for reviewing everyone’s submissions, not just Pfizer’s. Pfizer does have this staff.

We told them to analyze the data, and they sent us this report saying they did just that, and found nothing. If they were lying or hiding information then it’s they who have done something wrong, not us.

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This document is just evidence the FDA forced Pfizer to conduct due diligence in monitoring the safety of their vaccine. In other words, the document is evidence the FDA did their job, not necessarily that Pfizer did.

Recall this document also tells us how many staff Pfizer was adding to handle the reports. The number of staff isn’t relevant information regarding the vaccine’s safety, but it might be a convenient excuse for not having reviewed reports more quickly - should the FDA choose to use this document as evidence they (the FDA) weren’t aware of safety issues.

At that point Pfizer’s lawyers will remind us this was a “global emergency” and they were doing as much as possible - as evidenced by their increase in staff, and by addressing all areas of concern identified by the FDA.

If we later learn, via other means, that Pfizer excluded a significant number of cases, or very severe cases, from this report then the report might be scandalous. But if that data exists it’s in Pfizer’s files, and unless there’s a major lawsuit and it comes out in discovery we’re never going to see it.

Absent that kind of information this report is just evidence the FDA was “doing their job,” and so was Pfizer. Whether we believe that or not is another matter.