HomeMy WebLinkAbout2026_05_24 SSchumacher_FDA LiedFrom:Stephen Schumacher
To:Board of Health
Cc:editor@ptleader.com; news@ptleader.com; news@peninsuladailynews.com; editor@porttownsendfreepress.com
Subject:Proof unmasked: FDA knew, FDA lied, people died
Date:Sunday, May 24, 2026 11:36:25 PM
ALERT: BE CAUTIOUS This email originated outside the organization. Do not open attachments or click on links
if you are not expecting them.
Key unsafety signals hidden by FDA: "Among the
events that emerged when masking was accounted
for were sudden cardiac death, Bell's palsy, and
pulmonary infarction ... including acute
myocardial infarction associated with the Moderna
and Pfizer vaccines, non-site-specific embolism
and thrombosis associated with the Janssen
(Johnson & Johnson) and Pfizer vaccines, dementia
associated with the Pfizer vaccine, and 'Death
and sudden death' associated with the Moderna and Pfizer vaccines."
https://kirschsubstack.com/p/new-website-unmasks-the-vaers-safety
New website unmasks the VAERS safety data exposed
by Senator Johnson. Here are all the documents
for you to see, all organized and searchable.
https://vsafetysignals.com/
Unmasked: Vaccine Safety Signals
Key Points
* The FDA's vaccine safety monitoring system has
a known flaw called "masking." When similar
products dominate the database, real warning signs can get hidden.
* This happened with the COVID-19 mRNA vaccines
(Pfizer and Moderna), where masking was roughly
eight times more likely than with other vaccines.
* A senior FDA scientist, Dr. Ana Szarfman,
applied a better method (RGPS) and found hidden
safety signals, including sudden cardiac death,
Bell's palsy, heart attacks, blood clots, and dementia.
* When she reported these findings to FDA
leadership in 2021, she was told to cease and
desist out of concern her work could fuel anti-vaccine sentiment.
*The FDA never adopted the improved method, and
the routine weekly COVID-19 vaccine data-mining
reports were discontinued in July 2022 - around
the same time outside groups were filing public records requests for them.
---
https://vsafetysignals.com/explainer/
What signal masking is, and why it matters
When a new vaccine is rolled out to tens of
millions of people, regulators need a way to
tell, quickly, whether it is causing harm at
unusual rates. The U.S. Food and Drug
Administration's main early-warning tool is a
computer program that scans VAERS (the public
adverse-event reporting database) and flags
vaccine-event combinations that show up far more
often than expected. The program does this by
comparing reports for one product against a
baseline drawn from reports for everything else.
That baseline is what makes the system work, and
it is also where it has a known blind spot. When
one product, or a small group of similar
products, dominates the database, the baseline
gets distorted, and real signals can be hidden inside it.
What "masking" actually means
Masking happens whenever the baseline a
surveillance system compares a product against is
itself made up largely of similar products with
similar adverse-event profiles. When that
happens, a real safety signal can be drowned out
by the very thing it should stand out against.
The Subcommittee's report uses a plain analogy.
Imagine you want to know whether hemlock is
dangerous. You compare hemlock's adverse-event
reports against a baseline. If that baseline is
just saline (an inert substance), hemlock's harms
stand out clearly. But if the baseline is a
mixture of arsenic and saline, hemlock's reports
look unremarkable next to a comparison group that
already contains a similarly toxic ingredient.
Hemlock has not become safer; the comparison has been corrupted.
The COVID-19 vaccines created an analogous
situation in VAERS. By 2021, reports for the
Pfizer-BioNTech and Moderna mRNA vaccines made up
such a large share of the database that they
began appearing on both sides of the comparison:
as the product being screened, and as a major
component of the baseline they were screened
against. Dr. William DuMouchel, the statistician
who originally invented the FDA's data-mining
algorithm, illustrated the effect with a concrete
number: applied to COVID-19 vaccine data, masking
was "roughly eight times more likely to occur
with COVID-19 vaccines than with other vaccines."
The two methods: MGPS and RGPS
To detect safety signals in VAERS, the FDA used a
method called the Multi-item Gamma Poisson
Shrinker, or MGPS. DuMouchel published the
algorithm in 1999, and Dr. Ana Szarfman - a
senior FDA medical officer and safety data-mining
developer - was one of the agency officials who helped adopt it.
MGPS scans large databases of spontaneous
adverse-event reports and flags vaccine-event
pairs that show up disproportionately often
compared to a baseline of all other reports.
FDA's threshold for flagging a vaccine-event pair
as a statistically significant signal was when a
key MGPS score called EB05 exceeded 2.0. That
meant, with high confidence, the pair was being
reported at more than twice the baseline rate.
MGPS has a well-known limitation: it is
vulnerable to masking. In 2012, DuMouchel and a
colleague published an updated method called the
Regression-Adjusted Gamma Poisson Shrinker, or
RGPS, designed to correct for that limitation.
RGPS still scans for disproportionality, but it
adjusts the comparison so that one large product
cannot drown out signals from a similar product.
In a March 1, 2021 briefing to senior FDA
officials, Szarfman described RGPS as "superior"
to MGPS because it "can better adjust for both,
masking (false negatives) and confounding (false positives)."
What Szarfman and DuMouchel found
On March 26, 2021, Szarfman sent senior FDA
officials a spreadsheet from DuMouchel comparing
MGPS and RGPS side by side on the same VAERS
data. The comparison identified "49 examples of
extreme masking" in the COVID-19 vaccine data.
Of those 49, more than twenty adverse events
showed a statistically significant safety signal
once RGPS adjusted for masking. These were
signals that the MGPS method was not surfacing.
Among the events that emerged when masking was
accounted for were sudden cardiac death, Bell's
palsy, and pulmonary infarction.
Over the following months, Szarfman and DuMouchel
ran further analyses and reported additional
signals to FDA colleagues, including acute
myocardial infarction associated with the Moderna
and Pfizer vaccines, non-site-specific embolism
and thrombosis associated with the Janssen
(Johnson & Johnson) and Pfizer vaccines, dementia
associated with the Pfizer vaccine, and "Death
and sudden death" associated with the Moderna and Pfizer vaccines.
In June 2021, Szarfman wrote to a colleague about
ongoing CDC-FDA discussions of myocardial events
and the absence of corresponding signals in VAERS:
In a 2022 paper in the journal Drug Safety,
Szarfman, DuMouchel, and co-authors described
their method as one that "automatically unmask[s]
signals that remain hidden by other data mining
methodologies" and concluded that masking "is
roughly eight times more likely to occur with
COVID-19 vaccines than with other vaccines."
What happened internally
Szarfman raised the masking issue with FDA
colleagues repeatedly between February 2021 and
2022. The internal correspondence shows officials
acknowledging her expertise and the limits of
their own. In a March 2021 email, one CBER
official wrote, "I know Ana [Szarfman] worked to
develop the data mining system," and later added,
"I know that she knows a lot more about data mining than I do!"
In an April 2021 email discussing Szarfman's and
DuMouchel's analysis, another CBER official
wrote, "I don't pretend to understand it, but
sounds like they are suggesting an analysis not stratified by year."
In mid-April 2021, after Szarfman circulated an
analysis of FDA's current system, a senior FDA official wrote to colleagues:
Before we potentially reach out to Ana, we should
meet internally many considerations not suited
to email... Senior FDA official, internal email, April 15, 2021
On May 7, 2021, after a draft email circulated
among Drs. David Menschik, Narayan Nair, and
Craig Zinderman of FDA's Center for Biologics
Evaluation and Research, Zinderman sent Szarfman
a directive asking her to "hold off on creating
and sending data mining reports and analyses
using COVID-19 vaccine [adverse event] data."
Szarfman replied that she would deliver analyses
only when specifically asked, and reiterated that
the RGPS method "strongly reduces confounding"
In September 2021, then-CBER Director Dr. Peter
Marks wrote to CDER Director Dr. Patrizia
Cavazzoni (to whom Szarfman reported) that
Szarfman "has been asked to cease and desist" her
vaccine data-mining work, and that her approach
"could create erroneous conflicts that feed in to anti-vaccination rhetoric."
Dr. Peter Stein, the director of CDER's Office of
New Drugs, replied that his office had "made it
clear to her that she should not be discussing or
providing internal analyses externally, and needs
to focus on her assigned work."
FDA did not adopt RGPS as its surveillance method
during the period covered by the records.
In July 2022, the final weekly COVID-19 vaccine
data-mining report was distributed inside FDA,
ending a practice that had been routine since the
vaccines were authorized. Internal CDC emails
from later that fall noted that the change in
distribution coincided with a series of public
records requests for the same data: one CDC
official wrote, "I think that because of the FOIAs
[Freedom of Information Act requests] we may have
asked FDA to stop sending these weekly data mining outputs."
What the records show
The Subcommittee published the underlying records
on which this account rests, including the
contemporaneous emails quoted above. The site
organizes them three ways: a day-by-day timeline
of internal correspondence and external events; a
quotes index grouped by speaker and topic; and a
document archive indexed by Bates number, where
each footnote on this page links to the
underlying record where one is publicly posted.
The glossary defines the pharmacovigilance terms
used here and in the source materials.
The substantive finding
A known statistical limitation of the FDA's
then-current data-mining method went unaddressed
during a period when novel vaccines were under
active monitoring. A more sensitive method,
designed by the same statistician who built the
original system, existed and was offered. The
scientists who developed both methods raised the
issue inside the agency between early 2021 and
2022, identified specific safety signals (for
sudden cardiac death, Bell's palsy, pulmonary
infarction, acute myocardial infarction,
dementia, and others) that the newer method
surfaced and the older one did not, and were
asked to stop. The records released by the
Subcommittee make it possible to follow that
sequence step by step, in the participants' own words.
Source: U.S. Senate Permanent Subcommittee on
Investigations hearing materials. This site is
not affiliated with the Subcommittee.
https://www.hsgac.senate.gov/subcommittees/investigations/hearings/unmasked-how-biden-health-officials-
purposely-turned-a-blind-eye-toward-covid-19-vaccine-safety-signals/