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Condensed Comparison of Major COVID-19 Early
Treatment Pharmaceuticals |
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Late Treatment Pharmaceutical |
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Considerations |
Paxlovid |
Molnupiravir |
Nigella Sativa |
Vitamin D |
Zinc |
HCQ |
Ivermectin |
Considerations |
Bamlanivimab + |
Casirivimab + |
Sotrovimab |
Considerations |
Remdesivir |
Notes |
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FDA Endorsed
(EUA) as a COVID-19 Early Treatment Therapy |
EUA (12-22-21) |
EUA (12-23-21) |
No |
No |
No |
No |
No |
FDA
Endorsed (EUA) as a COVID-19 Early Treatment Therapy |
EUA (2-9-21) [See Notes Below] |
EUA (11-21-20) [See Notes Below] |
EUA (5-26-21)^ [See Notes Below] |
FDA
Endorsed (EUA) as a COVID-19 Late Treatment Therapy |
EUA (5-1-20) § |
Hydroxychloroquine (HCQ) and
Ivermectin (IVM) are FDA approved for other human uses. Doctors quite often
prescribe off-label use.** |
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Is the Drug
Currently Patented |
Yes |
Yes |
No |
No |
No |
No |
No |
Is the Drug
Currently Patented |
Yes |
Yes |
Yes |
Is the Drug
Currently Patented |
Yes |
Paxlovid is a combination of Ritonavir
+ Nirmatrelvir. |
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Sponsor for FDA
COVID-19 EUA |
Pfizer |
Merck |
No One |
No One |
No One |
No One |
No One |
Sponsor for FDA
COVID-19 EUA |
Eli Lilly |
Regeneron Pharmaceuticals |
GlaxoSmithKline |
Sponsor for FDA
COVID-19 EUA |
Gilead
Sciences |
There appears to
be no Consumer Advocate in the FDA EUA process. |
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Primary Data Source |
FDA.gov |
C19early.com/PL |
FDA.gov |
C19MP.com |
c19early.org/ns |
VDmeta.com |
C19Zinc.com |
HCQmeta.com |
IVMmeta.com |
Primary Data Source |
FDA.gov (2020) |
FDA.gov (2021) |
C19ly.com/meta.html |
FDA.gov |
C19regn.com/meta.html |
FDA.gov |
c19early.org/v |
Primary Data Source |
FDA.gov |
C19rmd.com |
The Non-FDA webpages
are professionally maintained by independent experts. |
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Total Number of all COVID-19 Studies |
1 |
69 |
1 |
44 |
14 |
122 |
45 |
413 |
105 |
Total Number of all COVID-19 Studies |
1 |
1 |
21 |
1 |
29 |
1 |
24 |
Total Number of all COVID-19 Studies |
5 |
76 |
Most of the patented drug studies were done by
the manufacturers.*** |
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Total Number of all Study Participants |
2,085 |
158,683 |
1,408 |
151,248 |
3,333 |
195,710 |
55,380 |
532,173 |
220,423 |
Total Number of all Study Participants |
452 |
1,035 |
35,320 |
799 |
59,056 |
583 |
54,452 |
Total Number of all Study Participants |
32,333 |
202,278 |
The more subjects tested, the better:
1000+ would be desirable. |
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Number of Early Treatment Studies
(ET) |
1 |
50 |
1 |
34 |
7 |
11 |
6 |
39 |
40 |
Number of Early Treatment Studies
(ET) |
1 |
1 |
15 |
1 |
21 |
1 |
22 |
Number of Late Treatment Studies (LT) |
5 |
67 |
ET = all COVID-19 Early Treatment studies. More
studies indicate more scientists involved, and different perspectives. More
participants means more statistical soundness. |
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Number of ET Study Participants |
2,085 |
108,512 |
1,408 |
94,532 |
1816 |
43,587 |
4,218 |
57,678 |
136,434 |
Number of ET Study Participants |
452 |
1,035 |
28,877 |
799 |
42,887 |
583 |
53,672 |
Number of LT Study Participants |
32,333 |
186,541 |
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Overall ET Effectiveness —> |
88% |
20% |
30% |
14% |
46% |
60% |
41% |
66% |
61% |
Overall ET Effectiveness —> |
74% |
70% |
52% |
67% |
47% |
85% |
29% |
Overall LT Effectiveness —> |
~10% |
0% |
It VERY important to understand that
this is the Relative benefit,
not Absolute.**** |
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Number of Human Doses |
10± million |
1± million |
Many Millions |
Many Billions |
Many Billions |
Billions |
4± Billion |
Number of Human Doses |
10± thousand |
90± thousand |
100± thousand |
100± thousand |
Number of Human
Doses |
1± million |
Estimates. The more the better, as this provides real-world safety and effectiveness data. |
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Any Long Term Safety
Data |
No* |
No* |
Yes |
Yes |
Yes |
Yes |
Yes |
Any Long Term Safety Data |
No |
No |
No |
Any Long Term Safety
Data |
No |
Where Yes, the data are based on billions of human doses. |
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Safe for Persons
with Common Diseases |
Unknown* |
Unknown* |
Yes |
Yes |
Yes |
Yes |
Yes |
Safe for Persons with Common Diseases |
Unknown |
Unknown |
Unknown |
Safe for Persons
with Common Diseases |
Unknown |
Examples of Common Diseases are:
Cancer, Diabetes, Parkinson's, etc. |
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Potential Side
Effects |
Serious* |
Serious* |
Trivial |
Trivial |
Trivial |
Moderate |
Mild |
Potential Side Effects |
Serious |
Moderate to
Serious |
Moderate to Serious |
Moderate to Serious |
Potential Side
Effects |
Serious |
An approximation based on what
appears on FDA documents and on <Drugs.com>. |
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Details about
Potential Side Effects |
FDA's Warnings |
FDA's
Warnings |
Side Effects |
Side Effects |
Side effects |
Side Effects |
Side Effects |
Details about Potential Side Effects |
Withdrawn |
FDA's Warnings |
FDA's Warnings |
FDA's Warnings |
Details about
Potential Side Effects |
Original FDA Warnings §§ |
Links to FDA documents and
<Drugs.com> webpages. |
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Restrictions |
12+ Years Old |
18+ Years Old |
No |
No |
No |
No |
No |
Restrictions |
Only for High
Risk and Non-vaccinated |
12+ Years; High Risk; Non-vaccinated |
12+ Years; High Risk; Non-vaccinated |
Restrictions |
Yes: See FDA
Warnings |
An approximation based on what
appears on FDA documents and on <Drugs.com>. |
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How is it
administered |
Pill |
Pill |
Pill |
Pill |
Pill |
Pill |
Pill |
How is it administered |
Injection or
infusion |
Injection or Infusion |
Infusion |
How is it
administered |
Infusion |
A patient-taken pill is preferable to
an injection/infusion that may require a hospital setting. |
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Total Treatment Pharaceutical Cost |
$1400± |
$700± |
$5± |
$5± |
$5± |
$50± |
$50± |
Total Treatment Drug Cost |
$2,500± |
$2100± |
$2100± |
Total Treatment Drug
Cost |
$3100± |
Approximate cost for five (5) days of COVID-19 treatment,
excluding cost of doctor visit. |
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How Phnarmaceutical
is Purchased |
Prescription |
Prescription |
OTC |
OTC |
OTC |
Prescription |
Prescription |
How Drug is
Purchased |
Prescription |
Prescription |
Prescription |
How Drug is
Purchased |
Prescription |
Prescription is negative as valuable time is lost in that process. |
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Color Code: |
Green = Positive |
Black = Neutral |
Red = Negative |
For Color Code ranges, see |
here |
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^Revised EUA: 3-25-22 |
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§ Revised EUAs: 8-28-20; 10-1-20; 10-16-20 |
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What is an Emergency Use Authorization (EUA)? |
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Understanding the Regulatory Terminology of
Potential Preventions and Treatments for COVID-19 |
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Despite the
claimed high effectiveness of sotrovimab (see above), the FDA took the
relatively unusual step of issuing a revised EUA for it. The new EUA states
that it is not effective for the latest COVID-19 variant. |
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§§ Updated FDA Warnings |
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* Some Additional Safety Data — |
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There are
multiple FDA EUA documents and modifications of the remdesivir (veklury)
case. For example, on the NIH website they list five studies that they say
were the basis for the FDA granting an EUA. On another FDA document
(<tinyurl.com/y2dj5fj6>) they say the number of studies is three. On
another, they say one! To give them the maximum benfit, we listed five (see
above). |
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Some Molnupiravir Safety Concerns |
Note:
Paxlovid includes Ritonavir and Nirmatrelvir —> |
Ritonavir Side Effects |
Unable to find side-effects, etc. listed for
Nirmatrelvir. —> |
Three disconcerting new study results about
Paxlovid: |
here |
here |
& here. |
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Note 1: One of the serious side effects that the
FDA EUA pharmaceuticals may have (that the non-EUA options have less of, or
none), is a potential conflict with pregnancy. |
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Note 2: This fascinating study revealed that
eighteen common medical conditions were not tested prior to the COVID-19
vaccine EUAs. |
A similar
situation exists with all of the FDA EUA pharmaceuticals above. |
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** Physicians prescribe
"off-label" pharmaceuticals quite frequently. Two good discussions
are |
here (NIH) |
and here (FDA). |
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*** Major pharmaceutical companies have the funds
(and experience) to run large, well-controlled studies on drugs where they
would like to get FDA EUAs. Non-patented drugs have no such financial backer. |
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ALL
scietific studies have a chance of confirmation bias, especially when there is a significant economic incentive at stake. |
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**** A good, layperson explanation of Relative vs Absolute
improvement is |
here. |
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A brief write-up about some of the takeaways from
this data is |
here. |
For recommended dosages, consult with your
physician and see |
here. |
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Using Monoclonal Antibodies (MAs) against COVID-19. |
Study: Vaccines and Most Monoclonal Antibodies are
Not Effective against Omicron |
Study:
Benefits And Risks Of Administering Monoclonal Antibody Therapy For COVID-19. |
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FDA gives remdesivir full Approval 10-22-20. |
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Bamlanivimab was granted an FDA EUA: 11/9/20. It was then withdrawn
(4-16-21) due to adverse results. |
Initial Bam authorization |
Bam Revocation |
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FDA Updates remdesivir Approval 1-21-22. |
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The FDA subsequently granted Bamlanivimab a second EUA, only if it was
used with Etesevimab. The info in the 2nd & 3rd columns in the Bam
section is for that combination. |
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"Casirivimab +" means that it is combined with Imdevimab.
The combination is called REGEN-COV. |
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See our detailed report on remdesivir: |
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For
all three MAs, the FDA does not
have a link to the clinical trial cited as their justification for the EUAs.
(They do for the Pfizer and Merck pills...) |
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here. |
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The FDA documents for each of the
three Monoclonal Antibodies (MA) has a statement similar to: There are limited clinical data available for MA. Serious and
unexpected adverse events may occur that have not been previously reported
with MA use. |
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CURRENTLY, THE COVID-19 TREATMENT GUIDELINES PANEL RECOMMENDS AGAINST
THE USE OF ALL MONOCLONAL ANTIBODIES FOR THE TREATMENT OF COVID-19: |
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SEE HERE |
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SOME CONCLUSIONS — |
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It's startling that the FDA would
give an EUA to a drug with only a 10%± relative benefit! |
See this commentary. |
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Likewise incomprehensible is that the
FDA would give an EUA to a drug with only a 30% relative benefit (3%
absolute)! |
See this commentary. |
(Merck News Release) |
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This is particularly puzzling considering that the FDA has publicly
stated that they would not give an EUA to a COVID-19 vaccine unless it had an
effectiveness of over 50%. |
See FDA Statement. |
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The referenced studies appear to
indicate that the chances of Early Treatment success against COVID-19 are
likely superior to Paxlovid by combining HCQ with all of the three OTCs
listed here. |
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The referenced studies also appear
to indicate that the chances of Early Treatment success against COVID-19 with
IVM, or HCQ, or all of the three OTCs listed here, are superior to
Molnupiravir. |
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The referenced studies appear to
indicate that the chances of Early Treatment success against COVID-19 are
likely better than any of the MAs by
combining HCQ with all of the three OTCs listed here. |
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Compared to the patented drugs, the
non-patented alternatives: have lower likelihood of adverse health
complications, plus the pharmaceutical cost is considerably less. |
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Based on the above information —
especially the Molnupiravir data — there is no reason why the FDA should not
have given HCQ and IVM their EUA blessing. |
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It's
also quite revealing that the FDA gave an EUA to three MAs only after single,
small (<800 people) clinical trials. Why isn’t this standard applied to
the non-patented options? |
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It is a major disservice to the
public that the FDA does not have a Consumer Advocate to sponsor non-patented
pharmaceuticals for FDA EUAs and approvals. |
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Likewise, the FDA should have adequate funding to run clinical trials
on pharmaceuticals recommended by their Consumer Advocate. |
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Always consult with a
qualified physician before taking any medications, OTC (Over-The-Counter) or
otherwise. |
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For questions, comments or possible errors (please
provide the evidence), email physicist |
John Droz, jr. |
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Revision: 9-1-24 |
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