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Merck — IVERMECTIN
DISCOVERY OF IVERMECTIN
A National Historic Chemical Landmark
Dedicated at Merck & Co., Inc., on December 2, 2016
<https://www.acs.org/content/acs/en/education/whatischemistry/landmarks/ivermectin-mectizan.html>
MERCK SEES THE LIGHT - PROVIDES IVERMECTIN FOR HUMANITY
By Justus R. Hope, MD The Desert Review, June 24, 2021
<https://www.thedesertreview.com/opinion/letters_to_editor/merck-sees-the-light---provides-ivermectin-for-humanity/article_df5674ee-d530-11eb-98a1-3fc9e8ddc005.html>
COVID-19 PFIZER
[T]he U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine
has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as
Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years
of age and older. The vaccine also continues to be available under emergency use
authorization (EUA), including for individuals 12 through 15 years of age and for the
administration of a third dose in certain immunocompromised individuals.
FDA Approves First COVID-19 Vaccine - Approval Signifies Key Achievement for Public Health
Food and Drug Administration (FDA) August 23, 2021
<https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine>
PFIZER, MERCK LAUNCH NEW CLINICAL TRIALS
By Kristin Jensen, BIOPHARMA DIV
BIOPHARMA DIVE, Sept 1, 2021
<https://www.biopharmadive.com/news/pfizer-merck-launch-large-new-trials-of-oral-covid-19-drugs/605939/>
Pfizer and Merck & Co. each launched pivotal clinical studies of new experimental oral
COVID-19 drugs, building on previous work to provide outpatient alternatives for patients.
Merck is studying whether its medicine, molnupiravir, can prevent COVID-19 in adults who
live with a symptomatic patient with a confirmed coronavirus infection. The trial will include
about 1,300 patients who will take molnupiravir or a placebo every 12 hours for five days.
Pfizer said the first of about 1,140 patients has received a dose of its therapy in a trial to treat
symptomatic patients who have not been hospitalized and aren’t at high risk of severe illness.
The dosing of the Pfizer treatment – a combination of an older medicine and an experimental
drug called PF-07321332 – is also every 12 hours for five days and measured against a
placebo.
Doctors dismayed by patients who fear coronavirus
vaccines but clamor for unproven ivermectin
By Hannah Knowles, Annie Gowen and Julian Mark, The Washington Post, September 1, 2021
<https://www.washingtonpost.com/health/2021/09/01/ivermectin-covid-treatment/>
“When people get fixated on inappropriate recommendations, then they unfortunately don't get
vaccinated,” said Hawaii Lt. Gov. Josh Green (D), an emergency room doctor who blames
conservative media for fanning unfounded hopes about ivermectin. “They don't do the things
that will actually help.”
____________________________________
COVID-19 vaccine booster shots
are more complicated than they appear.
Here's why.
By Jaimy Lee, MarketWatch
First Published: September 1, 2021, Last Updated: September 3, 2021
<https://www.marketwatch.com/story/the-debate-over-covid-19-booster-shots-picks-up-steam-will-they-be-limited-to-certain-high-risk-americans-11630503813>
Dr. Sara Oliver, a Centers for Disease Control and Prevention official who leads the COVID-
19 vaccines work group, on Monday said the “priority for booster dose policy should be the
prevention of severe disease in at-risk populations,” citing nursing-home residents and
frontline healthcare workers as examples. All [COVID-19] vaccines remain effective in
preventing hospitalization and severe disease, but they may be less effective in preventing
infection or mild illness recently. These reasons for lower effectiveness likely include both
waning over time and the delta variant.”
U.S. regulators have yet to OK a booster dose for the general public, and that has become a
point of contention for some public health experts.
Federal health officials have said they are concerned that the vaccines will soon be less
effective at protecting people against severe disease, hospitalization and death, and that is their
rationale for booster shots.
“The data to date doesn't show a remarkable reduction in the effectiveness of vaccines in
terms of preventing hospitalizations and deaths,” Dr. Beth Bell, a clinical professor at the
University of Washington's School of Public Health and an ACIP member, said Monday. “The
most important thing that we can do with respect to vaccines is to continue to work as hard as
we possibly can to encourage more people to get the primary series.”
____________________________________
Ivermectin and COVID-19
ERs reportedly fillingwith people
overdosing on unproven drug
By Oscar Gonzalez, CNET September 3, 2021
<https://www.cnet.com/news/ivermectin-and-covid-19-ers-reportedly-filling-with-people-overdosing-on-unproven-drug/>
In the US, the NIH is evaluating therapeutics for COVID-19 with its Accelerating COVID-19
Therapeutic Interventions and Vaccines (ACTIV) master protocol. IVERMECTIN was added
in phase three of ACTIV-6*, which will test the effectiveness of repurposed drugs.
* The ACTIV-6 master protocol(link is external) is designed to test the effectiveness of
repurposed drugs (drugs that are FDA-approved for non-COVID-19 indications and
have known safety profiles) in reducing the duration and severity of symptoms
associated with mild-to-moderate COVID-19. The large, randomized, placebo-
controlled Phase 3 trial will enroll participants who are at least 30 years old, have tested
positive for SARS-CoV-2 infection and show two or more mild-to-moderate symptoms
of COVID-19 for no more than seven days. Drugs that demonstrate efficacy in reducing
symptoms of mild-to-moderate COVID-19 will be further evaluated for effects on
clinical outcomes (hospitalization, mortality) and long-term COVID-19 symptoms.
NIH <https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials>
“The ACTIV prioritization group, trial team and trial oversight groups continuously track new
data on any agent we are studying in our trials and evaluate that data for how it might
influence our testing of that agent and the safety/well being of the participants in the trial,”
said Dr. Sarah Dunsmore, a program director at the National Center for Advancing
Translational Sciences that is part of the NIH.
What's unclear is how long the whole process will take. The studies need time to be
completed, and then the agencies will require additional time to come up with decisions based
on the data.
____________________________________
MAUI DISTRICT HEALTH OFFICE
COVID-19 CASES IN MAUI COUNTY
<https://health.hawaii.gov/maui/>
Total Cases – Cumulative
Countywide
Confirmed: 6456
(115 new)
Probable: 1392 (13
new)
Deaths –
Countywide: 73
Maui
Confirmed: 6201
(115 new)
Probable: 1353 (13
new)
Molokai Confirmed: 126 Probable: 36
Lanai Confirmed: 129 Probable: 3
Cummulative Totals as of September 2, 2021
STATE OF HAWAII COVID 19 DASHBOARD
Cummulative Totals as of September 3, 2021
THE AGE OF THE DIGITAL DOCTOR
One of the great challenges in healthcare technology is that medicine is at once an
enormous business and an exquisitely human endeavor; it requires the ruthless efciency of
the modern manufacturing plant and the gentle hand-holding of the parish priest; it is
about science, but also about art; it is eminently quantifable and yet stubbornly not.
Robert Wachter, MD
The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine's Computer Age

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Hawaii - Merck and Pfizer - Providing for Humanity - Research and Clinical Trials - The Digital Doctor

  • 1. Merck — IVERMECTIN DISCOVERY OF IVERMECTIN A National Historic Chemical Landmark Dedicated at Merck & Co., Inc., on December 2, 2016 <https://www.acs.org/content/acs/en/education/whatischemistry/landmarks/ivermectin-mectizan.html> MERCK SEES THE LIGHT - PROVIDES IVERMECTIN FOR HUMANITY By Justus R. Hope, MD The Desert Review, June 24, 2021 <https://www.thedesertreview.com/opinion/letters_to_editor/merck-sees-the-light---provides-ivermectin-for-humanity/article_df5674ee-d530-11eb-98a1-3fc9e8ddc005.html> COVID-19 PFIZER [T]he U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. FDA Approves First COVID-19 Vaccine - Approval Signifies Key Achievement for Public Health Food and Drug Administration (FDA) August 23, 2021 <https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine> PFIZER, MERCK LAUNCH NEW CLINICAL TRIALS By Kristin Jensen, BIOPHARMA DIV BIOPHARMA DIVE, Sept 1, 2021 <https://www.biopharmadive.com/news/pfizer-merck-launch-large-new-trials-of-oral-covid-19-drugs/605939/> Pfizer and Merck & Co. each launched pivotal clinical studies of new experimental oral COVID-19 drugs, building on previous work to provide outpatient alternatives for patients. Merck is studying whether its medicine, molnupiravir, can prevent COVID-19 in adults who live with a symptomatic patient with a confirmed coronavirus infection. The trial will include about 1,300 patients who will take molnupiravir or a placebo every 12 hours for five days. Pfizer said the first of about 1,140 patients has received a dose of its therapy in a trial to treat symptomatic patients who have not been hospitalized and aren’t at high risk of severe illness. The dosing of the Pfizer treatment – a combination of an older medicine and an experimental drug called PF-07321332 – is also every 12 hours for five days and measured against a placebo.
  • 2. Doctors dismayed by patients who fear coronavirus vaccines but clamor for unproven ivermectin By Hannah Knowles, Annie Gowen and Julian Mark, The Washington Post, September 1, 2021 <https://www.washingtonpost.com/health/2021/09/01/ivermectin-covid-treatment/> “When people get fixated on inappropriate recommendations, then they unfortunately don't get vaccinated,” said Hawaii Lt. Gov. Josh Green (D), an emergency room doctor who blames conservative media for fanning unfounded hopes about ivermectin. “They don't do the things that will actually help.” ____________________________________ COVID-19 vaccine booster shots are more complicated than they appear. Here's why. By Jaimy Lee, MarketWatch First Published: September 1, 2021, Last Updated: September 3, 2021 <https://www.marketwatch.com/story/the-debate-over-covid-19-booster-shots-picks-up-steam-will-they-be-limited-to-certain-high-risk-americans-11630503813> Dr. Sara Oliver, a Centers for Disease Control and Prevention official who leads the COVID- 19 vaccines work group, on Monday said the “priority for booster dose policy should be the prevention of severe disease in at-risk populations,” citing nursing-home residents and frontline healthcare workers as examples. All [COVID-19] vaccines remain effective in preventing hospitalization and severe disease, but they may be less effective in preventing infection or mild illness recently. These reasons for lower effectiveness likely include both waning over time and the delta variant.” U.S. regulators have yet to OK a booster dose for the general public, and that has become a point of contention for some public health experts. Federal health officials have said they are concerned that the vaccines will soon be less effective at protecting people against severe disease, hospitalization and death, and that is their rationale for booster shots. “The data to date doesn't show a remarkable reduction in the effectiveness of vaccines in terms of preventing hospitalizations and deaths,” Dr. Beth Bell, a clinical professor at the University of Washington's School of Public Health and an ACIP member, said Monday. “The most important thing that we can do with respect to vaccines is to continue to work as hard as we possibly can to encourage more people to get the primary series.” ____________________________________ Ivermectin and COVID-19 ERs reportedly fillingwith people overdosing on unproven drug By Oscar Gonzalez, CNET September 3, 2021 <https://www.cnet.com/news/ivermectin-and-covid-19-ers-reportedly-filling-with-people-overdosing-on-unproven-drug/> In the US, the NIH is evaluating therapeutics for COVID-19 with its Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) master protocol. IVERMECTIN was added in phase three of ACTIV-6*, which will test the effectiveness of repurposed drugs.
  • 3. * The ACTIV-6 master protocol(link is external) is designed to test the effectiveness of repurposed drugs (drugs that are FDA-approved for non-COVID-19 indications and have known safety profiles) in reducing the duration and severity of symptoms associated with mild-to-moderate COVID-19. The large, randomized, placebo- controlled Phase 3 trial will enroll participants who are at least 30 years old, have tested positive for SARS-CoV-2 infection and show two or more mild-to-moderate symptoms of COVID-19 for no more than seven days. Drugs that demonstrate efficacy in reducing symptoms of mild-to-moderate COVID-19 will be further evaluated for effects on clinical outcomes (hospitalization, mortality) and long-term COVID-19 symptoms. NIH <https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials> “The ACTIV prioritization group, trial team and trial oversight groups continuously track new data on any agent we are studying in our trials and evaluate that data for how it might influence our testing of that agent and the safety/well being of the participants in the trial,” said Dr. Sarah Dunsmore, a program director at the National Center for Advancing Translational Sciences that is part of the NIH. What's unclear is how long the whole process will take. The studies need time to be completed, and then the agencies will require additional time to come up with decisions based on the data. ____________________________________ MAUI DISTRICT HEALTH OFFICE COVID-19 CASES IN MAUI COUNTY <https://health.hawaii.gov/maui/> Total Cases – Cumulative Countywide Confirmed: 6456 (115 new) Probable: 1392 (13 new) Deaths – Countywide: 73 Maui Confirmed: 6201 (115 new) Probable: 1353 (13 new) Molokai Confirmed: 126 Probable: 36 Lanai Confirmed: 129 Probable: 3 Cummulative Totals as of September 2, 2021
  • 4. STATE OF HAWAII COVID 19 DASHBOARD Cummulative Totals as of September 3, 2021 THE AGE OF THE DIGITAL DOCTOR One of the great challenges in healthcare technology is that medicine is at once an enormous business and an exquisitely human endeavor; it requires the ruthless efciency of the modern manufacturing plant and the gentle hand-holding of the parish priest; it is about science, but also about art; it is eminently quantifable and yet stubbornly not. Robert Wachter, MD The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine's Computer Age