Coronavirus: Thread

grarpamp grarpamp at gmail.com
Mon Jul 11 00:26:36 PDT 2022


Biden Admin Wasting $10.6 Billion On Pfizer's COVID-19 Paxlovid Flop

https://thebluestateconservative.com/2022/06/27/more-covid-waste-biden-white-house-paying-10-6-billion-for-pfizers-covid-19-paxlovid-flop/

https://www.statnews.com/2021/06/29/biogen-fda-alzheimers-drug-approval-aduhelm-project-onyx/
https://news.yahoo.com/focus-biogens-secret-campaign-bring-100000122.html
https://web.archive.org/web/20220412063619/https:/www.accessdata.fda.gov/drugsatfda_docs/nda/2021/Aducanumab_BLA761178_Cavazzoni_2021_06_07.pdf
https://www.washingtonpost.com/outlook/2021/06/10/alzheimers-drug-patients-price/
https://www.statnews.com/2021/06/08/aducanumab-lackluster-drug-high-price/
https://arstechnica.com/science/2021/06/a-disgraceful-decision-researchers-blast-fda-for-approving-alzheimers-drug/
https://www.msn.com/en-us/news/us/inside-e2-80-98project-onyx-e2-80-99-how-biogen-used-an-fda-back-channel-to-win-approval-of-its-polarizing-alzheimer-e2-80-99s-drug/
https://www.nytimes.com/2021/06/15/opinion/alzheimers-drug-aducanumab-fda.html
https://www.forbes.com/sites/davidgortler/2021/08/24/how-the-fdas-lack-of-transparency-undermines-public-trust/
https://www.forbes.com/sites/davidgortler/2021/06/11/fdas-new-cder-director-allows-approval-of-yet-another-expensive-scientifically-worthless-drug--expect-many-more/
https://pjmedia.com/columns/davidgortler/2022/02/10/fda-rushes-to-grant-euas-to-two-more-covid-drugs-with-no-long-term-safety-or-efficacy-data-while-ignoring-a-mountain-of-evidence-supporting-hcq-ivermectin-n1558200

https://www.christianpost.com/voices/sin-original-sin-original-antigenic-sin-and-covid-19-immunity.html
https://www.britannica.com/topic/biblical-literature/The-Story-of-Ahikar


Authored by Dr. David Gortler

Back in November 2021, the White House paid drugmaker Pfizer nearly
$5.3 billion ($5,290,000,000) for 10 million treatment courses of its
experimental COVID-19 treatment.  Paxlovid is an antiviral combination
of nirmatrelvir and ritonavir.

Ritonavir was developed in 1989 and nirmatrelvir was developed in
2020.  In other words, Paxlovid wasn’t developed from scratch to treat
COVID-19; the compounds already existed.

In December 2021 Pfizer claimed initial study findings showed that
Paxlovid cut the risk of hospitalization and death by nearly 90% in
people with mild to moderate coronavirus infections.  Without context
this statement is grossly misleading.  Just about everyone who gets
the existing COVID-19 mutation will have mild or moderate disease yet,
the drugmaker limited its study to people who were unvaccinated and
who faced the greatest risk from the virus due to age or health
problems, such as obesity.  An updated more recent analysis from 1,153
patients (out of a possible 2,246 patients) showed a lackluster,
non-significant 51% relative risk reduction.  A sub-group analysis of
721 vaccinated adults with at least one risk factor for progression to
severe COVID-19 showed a non-significant relative risk reduction in
hospitalization or death (treatment arm: 3/361; placebo: 7/360)

According to Pfizer’s official June 14th 2022 press release, results
from the Phase 2/3 of the amended Paxlovid EPIC-SR (Evaluation of
Protease Inhibition for COVID-19 in Standard-Risk Patients) study
showed:

    Paxlovid, the novel primary endpoint of self-reported, sustained
alleviation of all symptoms for four consecutive days was not met.
    Pfizer will cease enrollment into the EPIC-SR trial due to low
rate of hospitalization or death in the standard-risk population.

Tucked within Pfizer’s press release was the following financial
nugget for investors:  “The results from these additional analyses are
not expected to impact Pfizer’s full-year 2022 revenue guidance.”  The
reason for that is: Pfizer already has $5.3 billion in hand from
taxpayers, and has locked in “blockbuster status” (defined as one
billion dollars in sales of a single drug).

In addition to the $5.3 billion already committed, in January the U.S.
announced a confidential additional “commitment” to order an
additional 10 million doses (at the price of 5.3 billion dollars more,
for a total of $10.6 billion) giving Pfizer highly sought after “super
blockbuster status” (defined as having 10 billion dollars in sales of
a single drug).  “The administration is firmly committed to proceeding
with the (additional) purchase” a White House official stated in April
2022.

According to Bloomberg, The White House initially sought $22.5 billion
in new pandemic funding. Democrats were prepared to include just over
$15 billion in a broad government spending bill earlier this year, but
it was removed amid disputes with Republicans about whether it should
be offset by spending cuts elsewhere in the government.

The $10 billion Senate bill includes a requirement that at least half
the money must be spent on therapeutics, but why did Biden gamble
every dollar on one, single drug from one single drugmaker? Why was
Pfizer chosen to satisfy the therapeutics clause by itself?

Pfizer Altered its Paxlovid Protocol. . . After Receiving its first
$5.3 billion:

As we can see, FDA Emergency Use Authorizations (EUAs) don’t always
work out as they should, but in this case, it was because of some
manipulative action by Pfizer and an outrageous and risky bet by the
Biden White House.

That’s because with no public mention, Pfizer had secretly lowered its
own bar following its EUA after the White House had committed to
purchasing $5.3 billion dollars of product.  Pfizer stated:


“Following the Emergency Use Authorization of Paxlovid for individuals
at high risk of progression to severe COVID-19, the protocol was
amended to exclude high-risk individuals and allow enrollment of
patients without risk factors for progression to severe COVID-19 who
were either unvaccinated, or whose last COVID-19 vaccination occurred
more than 12 months from enrollment.”  (emphasis added)

This way, Pfizer was able to administer its drug to a less severely
ill, and healthier population in hopes of having a superior efficacy
signal and a decreased safety signal, but it still failed to show an
adequate clinical effect on any of its prospective
protocol-established endpoints.

Secret FDA Meetings Sound Familiar?  That’s Because it’s Happened Before:

In order to amend the protocol following FDA submission, Pfizer would
have had to have communicate about it with the FDA formally and in
writing.  A former Pfizer non-scientist executive, Patrizia Cavazzoni
is now the head of the FDA’s Center for Drug Evaluation and Research,
would have had to approve the change.  Interestingly, Pfizer’s
protocol amendment was kept under such tight wraps, that it was not
known about until the Pfizer June 2022 press release.  About a week
prior, Yale University’s YaleMedicine publication had even published a
lengthy article on the benefits of Paxlovid as quoting the outdated
original protocol endpoints.  On June 7th 2022, Pfizer CEO Albert
Bourla had announced plans to spend over $100 million to increase
Paxlovid production and committing to hire hundreds of new employees
as its way to maintain appearances with the White House and Pfizer
investors.

Paxlovid is not the first example of “secret” and scientifically
questionable decisions have been made outside of standard channels at
the FDA under Patrizia Cavazzoni’s watch.  About a year ago, secret
meetings surrounded Biogen’s multi-billion-dollar monoclonal antibody
drug aducanumab (Aduhelm) for Alzheimer’s Disease, which had failed
both safety and efficacy on every study it had attempted.  However
following contentious and potentially illegal and unethical
back-channel meeting with Biogen executives.  Biogen’s drug was
approved by Cavazzoni against advice from FDA advisory committee
members and FDA employees.  Cavazzoni affirmed her decision by writing
a comically inadequate 1.5 page justification — which mostly quoted
others’ opinions and did zero to address their debatable hypotheses.
Nearly every medical commentator  scolded Cavazzoni’s approval of
aducanumab, calling it things like “false hope,” “bad medicine,”
“disgraceful,” “dangerous” “a disaster” or “a new low.”  The
circumstances surrounding Pfizer’s Paxlovid and clinical outcomes are
similarly awful.

But unlike Biogen, I couldn’t even find any online record of a
meeting, justifying the protocol amendment for Paxlovid by Cavazzoni,
— let alone an inadequate one.  Pfizer would have had to provide
detailed reasoning in its protocol amendment and the FDA kept those
requests and those changes a secret.  Its just another example of the
total lack of FDA transparency.

I had opined in an op-ed article a year ago that Cavazzoni would
continue to make questionable decisions due to her close ties and
extended history of employment in big pharma.  Most of Cavazzoni’s
career shows her working as a non-scientist big pharma executive.
She also has a conspicuous lack basic scientific or research
experience for holding such a critical public health position.
Unfortunately, I was correct, but it’s the taxpayer that will bear the
failed Paxlovid gamble.

The White House Wasted Many Billions and Looks Stupid(er)

One question is:  why did the White House commit to and cut a blank
check of taxpayer dollars before obtaining conclusive findings?

It’s not as if Pfizer is hurting for money or that Americans don’t
already have multiple alternative inexpensive generic alternatives
with an voluminous amount of peer-reviewed evidence behind them,
covering decades and hundreds of thousands of patients.  Still the
Biden White House made the choice to purchase Paxlovid and ignore the
historic 6th century BCE wisdom from the Proverbs of Ahiqar and “throw
away two in the hand (ie, hydroxychloroquine and ivermectin) for one
in the bush (Paxlovid).”

Americans Never Needed Paxlovid; Omicron/Delta COVID-19 Symptoms Are Mild.

What we all have known for some time is that the dominant mutated
variants of Delta and Omicron (which comprise >99%, of current cases
per the CDC) infections are mild, and deaths and hospitalizations are
down because most people only get minimal to moderate cold-like
symptoms these days.  Even Johns Hopkins shows all-time record lows in
COVID-19-related hospital ICU admissions.

Pfizer may have exaggerated its experimental product and been
deceptive about changing its protocol without informing the public.
By trusting Pfizer and making a considerable gamble with taxpayer
funds, the White House flushed $5.3 billion taxpayer dollars largely
down the drain.  The White House is now on the hook for an additional
$5.3 billion for a total of $10.6 billion for an ineffective COVID-19
treatment that Pfizer had already developed, when they could have
spent almost nothing and promoted the established safety and efficacy
of hydroxychloroquine and ivermectin with an established, superior
outcome.  More practically, since Delta and Omicron are mild, we could
have just let COVID-19 mutations run their course and treat infections
symptomatically with available generic pharmacology so that
individuals can obtain natural immunity.

What a preposterous and outrageous waste of taxpayer money.  Will
President Biden or anyone else be held responsible?  I think we all
know the answer to that.

By Dr. David Gortler

Dr. David Gortler is a pharmacologist, pharmacist, and FDA and health
care policy oversight fellow and FDA reform advocate at the Ethics and
Public Policy Center think tank in Washington, DC. He was a professor
of pharmacology and biotechnology at the Yale University School of
Medicine, where he also served as a faculty appointee to the Yale
University Bioethics Center.  While at Yale, he was recruited by the
FDA and become a medical officer who was later appointed as senior
advisor to the FDA commissioner for drug safety, FDA science policy,
and FDA regulatory affairs.  He is an exiled columnist from Forbes,
where he used to write on drug safety, healthcare politics, and FDA
policy.


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