abcnews | Washington County's sheriff confirmed Tuesday night that jail inmates
had been prescribed ivermectin, but did not say how many. It wasn't
clear if all the inmates who were prescribed the medication had tested
positive for COVID-19.
“There is an open investigation and we can’t comment on it right now," Embry told The Associated Press.
Dr. Rob Karas, the jail's physician, has said no inmates were forced to take the drug.
The
U.S. Food and Drug Administration has approved ivermectin for
use by people and animals for some parasitic worms, head lice and skin
conditions. The FDA has not approved its use in treating or preventing
COVID-19 in humans. According to the FDA, side effects for the drug
include skin rash, nausea and vomiting.
“Using any treatment for
COVID-19 that’s not approved or authorized by the FDA, unless part of a
clinical trial, can cause serious harm,” the FDA said in a
warning about the drug.
Embry declined to say who was the target
of the board's investigation. The board has authority over physicians,
but not jail facilities.
Sheriff
Tim Helder did not return a message Thursday, and a spokesperson for
the sheriff's office did not immediately respond to questions about the
drug's use.
In a lengthy statement released to the AP Thursday,
Karas defended the use of ivermectin to treat COVID-19. Karas said he
has prescribed it to inmates and patients at his clinics who are
significantly sick with COVID-19 since late 2020. He did not respond to
questions about the investigation and the number of inmates who have
have been prescribed the drug.
“I do not have the luxury of
conducting my own clinical trial or study and am not attempting to do
so," Karas wrote. “I am on the front line of trying to prevent death and
serious illness."
The Northwest Arkansas Democrat-Gazette
reported that the sheriff's office said Helder had learned of the drug's
use at the jail on Tuesday. In a July 20 email to Helder, Karas
recommended the sheriff's staff take it as a preventive measure against
COVID-19 but did not mention its use on inmates. Karas has said he's
taken the drug, as have members of his family.
dailymail | A jail doctor in Washington County, Arkansas, has been using an animal deworming drug to treat inmates with Covid-19 even though the US Food and Drug Administration (FDA) has specifically warned against it.
Ivermectin
is often used as a dewormer in animals including cows and horses, and
is not recommended for treating the virus. The FDA said it 'can cause
serious harm'.
During a finance and
budget committee meeting for Washington County on Tuesday night the
jail's physician Dr Rob Karas asked for a 10 per cent increase in the
medical services contract, even after the county sheriff confirmed that
the jail health provider had been prescribing the drug.
Dr Karas has faced calls to resign over the revelation.
County-elected Justice of the Peace Eva Madison brought the issue back
up towards the end of the meeting after jail officials presented their
2022 budget. 'I learned today that Dr Karas is giving ivermectin - cow
dewormer - to the inmates at the jail,' she said.
Madison told members of the Washington
County quorum court - the county's governing body - that a jail official
and county employee, who asked to stay anonymous, told her they had
been sent to the jail's clinic to get tested for Covid-19.
When
the unidentified person tested negative they told Madison they were
given a $76 prescription for ivermectin, as reported by CBS News.
'They
were concerned about the prescription, asked their primary care
physician about it and the doctor told him to 'throw that in the trash,'
she said.
'(The person) tested
negative, was given a prescription for ivermectin, was told to go to Dr
Karas's pharmacy just off campus to have it filled,' Madison told the
committee.
She added: 'He's out $76
because of Dr Karas prescribing dewormer to a county employee for
treatment of a condition that he didn't have.
'The
employee had the good fortune to have a physician that he could go to
and ask for a second opinion. Our inmates do not have that choice.'
Washington
County Sheriff Tim Helder did not say how many inmates at the 710-bed
facility had been given ivermectin and defended Dr Karas, who has been
prescribing the medication.
medrxiv | CONCLUSIONS: “This study demonstrated that natural immunity confers longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared
to the BNT162b2 two-dose vaccine-induced immunity.
Background:
Reports of waning vaccine-induced immunity against COVID-19 have begun
to surface. With that, the comparable long-term protection conferred by
previous infection with SARS-CoV-2 remains unclear.
Methods:
We conducted a retrospective observational study comparing three groups:
(1)SARS-CoV-2-naive individuals who received a two-dose regimen of the
BioNTech/Pfizer mRNA BNT162b2 vaccine, (2)previously infected
individuals who have not been vaccinated, and (3)previously infected and
single dose vaccinated individuals. Three multivariate logistic
regression models were applied.
In all models we evaluated four
outcomes: SARS-CoV-2 infection, symptomatic disease, COVID-19-related
hospitalization and death. The follow-up period of June 1 to August 14,
2021, when the Delta variant was dominant in Israel.
Results:
SARS-CoV-2-naive vaccinees had a 13.06-fold (95% CI, 8.08 to 21.11)
increased risk for breakthrough infection with the Delta variant
compared to those previously infected, when the first event (infection
or vaccination) occurred during January and February of 2021. The
increased risk was significant (P<0.001) for symptomatic disease as
well.
When allowing the infection to occur at any time before
vaccination (from March 2020 to February 2021), evidence of waning
natural immunity was demonstrated, though SARS-CoV-2 naive vaccinees had
a 5.96-fold (95% CI, 4.85 to 7.33) increased risk for breakthrough
infection and a 7.13-fold (95% CI, 5.51 to 9.21) increased risk for
symptomatic disease.
SARS-CoV-2-naive vaccinees were also at a greater
risk for COVID-19-related-hospitalizations compared to those that were
previously infected.
Conclusions:
This study demonstrated that natural immunity confers longer lasting and
stronger protection against infection, symptomatic disease and
hospitalization caused by the Delta variant of SARS-CoV-2, compared to
the BNT162b2 two-dose vaccine-induced immunity. Individuals who were
both previously infected with SARS-CoV-2 and given a single dose of the
vaccine gained additional protection against the Delta variant.
thedailybeast | The massive surge of COVID-19 infections in Israel, one of the most vaccinated countries on earth, is pointing to a complicated path ahead for America.
In
June, there were several days with zero new COVID infections in Israel.
The country launched its national vaccination campaign in December last
year and has one of the highest vaccination rates in the world, with 80
percent of citizens above the age of 12 fully inoculated. COVID, most
Israelis thought, had been defeated. All restrictions were lifted and Israelis went back to crowded partying and praying in mask-free venues.
Fast forward two months later: Israel reported 9,831 new diagnosed
cases on Tuesday, a hairbreadth away from the worst daily figure ever
recorded in the country—10,000—at the peak of the third wave. More than
350 people have died of the disease
in the first three weeks of August. In a Sunday press conference, the
directors of seven public hospitals announced that they could no longer
admit any coronavirus patients. With 670 COVID-19 patients requiring
critical care, their wards are overflowing and staff are at breaking
point.
“I don’t want to frighten you,” coronavirus czar Dr. Salman
Zarka told the Israeli parliament this week. “But this is the data.
Unfortunately, the numbers don’t lie.”
Israel vaccinated its population almost exclusively with the Pfizer/BioNTech vaccine,
which received full FDA approval on Monday and remains the gold
standard for the prevention of severe illness due to the coronavirus.
But in early July, with citizens over the age of 60 almost completely
vaccinated, Israeli scientists began observing a worrisome rise in
infections—if not in severe illness and death—among the
double-vaccinated.
Fully vaccinated people with weakened immune systems appeared particularly vulnerable to the aggressive Delta variant.
By
mid-July, Sheba Hospital Professor Galia Rahav began to experiment with
booster shots for oncology patients, transplant patients, and the
hospital’s own staff. A group of 70 elderly vaccinated Israelis with
transplanted kidneys were the first to receive a third dose.
The success of Rahav’s trials
in boosting immunity at about the sixth-month mark contributed to the
Centers for Disease Control decision, announced last week, to begin
offering booster shots to Americans in September.
In order to keep
severe illness and the number of COVID deaths down, and avoiding a
fourth national lockdown, Israel has embarked on an aggressive effort to
provide all adults with boosters in a matter of weeks.
MedPageToday | Over the last week, the topic of COVID-19 booster shots -- a third
dose of mRNA vaccine for healthy Americans -- has been thrust into the
spotlight. The surgeon general, CDC director, Anthony Fauci, MD, and
President Biden have announced that they wish for boosters to be
available by late September for healthy adults who are 8 months out from
their original two-dose series. While this will be contingent on an FDA
evaluation to determine the "safety and effectiveness of the third dose,"
a clear path forward has already been set. And just like everything
else throughout the course of the pandemic, the choice has been made
with a dearth of data and an abundance of political pressure.
Diminishing vaccine effectiveness supposedly makes the case for
boosters. But there are two big questions here: First, what is current
vaccine effectiveness? And second, what justifies boosters? Let's
consider these in turn.
What Is Vaccine Effectiveness Now?
We have to be honest, many vaccine effectiveness studies are poorly
done. All studies compare the rate of getting a breakthrough infection
among vaccinated people against the rate of infection in unvaccinated
people. But there are some issues with this approach. First, as time
goes on, more unvaccinated people have had and recovered from COVID-19
(and these individuals may be less likely to go on to get a shot). This
means that their risk of getting COVID-19 a second time is far less than
the typical unvaccinated person who has never been sick. Even if
vaccines "work" as well as before, this factor alone will result in the
appearance of diminishing vaccine effectiveness.
Decisions about boosters have to be based in science and made by
vaccine regulators. They should not be subject to the pressure of
manufacturers, politicians, or political appointees. They should not be
rushed. On Sunday television, Surgeon General Vivek Murthy, MD, was
specifically asked if the third shot was safe. His response: "the plan is contingent on that..."
Excuse me? We don't know that to be true, and yet, our top medical and public health experts are pushing for boosters? Drug safety expert Walid Gellad, MD, MPH, tweeted: "It was irresponsible to push for boosters in healthy people before safety review."
Two days after the White House's announcement, two people with knowledge of the FDA's deliberation told The Washington Post that the agency was investigating myocarditis signal with the Moderna vaccination.
Canadian data suggest the risk may be 2.5 times that of Pfizer's
vaccine. The timing of this internal information leaking to reporters
naturally leads me to wonder if reviewers in the agency are attempting
to counteract political pressure, and create space to conduct a thorough
review of booster data.
politico | The Centers for Disease Control and Prevention is using outdated and unreliable data oncoronavirus
breakthrough infections to help make major decisions, such as who gets
booster shots, according to three officials with direct knowledge of the
situation.
The agency originally tried to track
all infections in vaccinated people, from mild to severe. But in May it
decided to focus on the most severe cases, saying that would allow it to
better monitor overall conditions and make more informed, targeted
policy decisions.
Forty-nine states are now regularly
sending CDC information on hospitalized breakthrough patients. But more
than a dozen told POLITICO that they do not have the capacity to match
patients’ hospital admission data with their immunization records.Instead,
those states rely on hospital administrators to report breakthrough
infections. The resulting data is often aggregated, inaccurate and omits
critical details for teasing out trends, such as which vaccine a person
received and whether they have been fully vaccinated, a dozen state
officials said.
The
gaps in this crucial data stream raise questions about the Biden
administration’s ability to spot and respond to changes in the virus’s
behavior — such as the rapid spread of the Delta variant, which crowded
out other strains — or vaccines’ performance. It also underscores the
extent to which the CDC and public health departments across the country
are still struggling to collect and study critical Covid-19 information
18 months after the pandemic began.
“I
think it would be really challenging [for the CDC] to interpret the
results or to interpret the data when you have only some jurisdictions
reporting [breakthrough infections],” said Theresa Sokol, lead
epidemiologist for Louisiana’s state public health department, which is
working closely with the CDC on studies of breakthrough infections. “I
know that there are some jurisdictions that don't even have access to
their vaccination data. They don't have the authority or their
permission.”
Many
of the hurdles facing CDC and state officials trying to gather data
during the age of the Delta variant are the result of the patchwork of
public-health agency data systems, many of which cannot communicate with
each other. For more than a decade, states have pleaded with the
federal government for money to make it easier to gather and study
disease trends electronically. The pandemic has overloaded those arcane systems, revealing the disorganized nature of public health reporting and case investigation.
yomiuri shimbun |During the Tokyo Olympics, Delta strains originating in India raged and the number of infected people continues to increase. Why
is Japan not trying to use ivermectin, which has few reports of side
effects and has been reported to be effective in clinical trials in
other countries? On August
5, we had an urgent interview with Mr. Ozaki, chairman of the Tokyo
Metropolitan Medical Association, who had been proposing effective uses
of ivermectin from early on.
The peak of infection spread that is not yet visible
――It seems that the explosive spread of infection, which is also called the 5th wave, is still rising. The
number of people waiting at home and receiving medical treatment is
increasing rapidly. How is the Tokyo Metropolitan Medical Association
responding?
"When
the number of people waiting at home and receiving medical treatment
increased sharply in the third wave of January, this was no good, and
the Tokyo Metropolitan Medical Association and the Tokyo Metropolitan
Medical Association worked together to build a system with the goal of
24-hour support. We have been able to handle up to 37 of the 47 district
medical associations. However, the current situation where more than
1000 home caregivers are piled up every day is beyond the limit. ,
Vaccination, medical examination, home visit, etc. are not available.
Now, the health center is coordinating hospitalization. There is also a
hospitalization coordinating center in Tokyo, but there is a system that
can quickly accept and treat suddenly changed corona patients. I
haven't gotten to the point of being established. "
Many clinical trial results are "effective for prevention and treatment"
--If
you read the papers on clinical trials of ivermectin that have been
published around the world, there are many examples that are effective
for both prevention and treatment.
"I
am aware that there are many papers that ivermectin is effective in the
prevention and treatment of corona, mainly in Central and South America
and Asia. There is no effective therapeutic drug, although it is
necessary to deal with patients who develop it one after another. The
vaccine is not in time. At such an imminent time, there is a paper that
ivermectin is effective for corona, so it is a natural response for
clinicians to try using it. Doctor-led clinical practice That's why many
test papers came out. "
--Usually,
pharmaceutical companies conduct large-scale clinical trials to see the
effects, but ivermectin has been selected by the World Health
Organization (WHO) as a silver bullet for tropical diseases such as
onchocerciasis (river blindness) and lymphatic filariasis. It is a drug
approved by countries around the world more than 20 years ago. If it is effective for the new corona, it is not applicable, but it is unavoidable that we decided to use it in a pandemic.
"That's
right. The medical field of a pandemic is a battlefield. It's the same
as a field hospital. Patients are brought in and their condition
deteriorates one after another and they die. So I can understand the
feelings of the doctor who clings to this and administers it. "
"The
other day, a research group at the All India Institute of Medical
Sciences / AIIMS, which sets guidelines for the treatment of corona
infections in India, has published a paper investigating the preventive
effects of ivermectin. According to the report, about 3,900 medical
workers (staff and students) were given 0.3 mg / kg of ivermectin twice
at 3-day intervals, only once, and then. As a result of conducting
clinical trials divided into three groups of those who did not, it is
said that those who received ivermectin twice reduced the new corona
infection by 83%. It was the first time in the world to publish a paper.
It's a class research group, so it's very reliable. "
Why is no one interested in India anymore with respect to the Coronapocalypse? Can a couple of weeks really make such an incredible difference? The contrast from July to August is really stark. When the news was bad you couldn't turn to a news outlet that wasn’t reporting about the continuous megadeath in India. Now, not nary a peep...,
Speaks volumes how reporting is being used to gin up fear beyond what is suggested by the "science". Since the Indian coronapocalypse has fallen off the official narrative radar, I went over to the Times of India to have a look. They have a “Covid Tracker” that says that there were 382 deaths on Aug 22 related to Covid-21. New Cases are down 30%, to 25,320.
Now if you do the math, India has ~1.4 billion people. These Covid-21 figures don't even amount to rounding errors. Given that Ivermectin is in the Indian Covid-21 treatment protocol - AS ACROSS PARTS OF THE AFRICAN CONTINENT - maybe the 1.4 billion horse-paste eating Indian animals are getting some type of prophylactic and curative benefit from their veterinary medicine?
This site is another good place to watch and keep track of the numbers. I follow Uttar Pradesh. Their deaths from Covid today (with a population above 500 million) were …. zero, niente, rien, zed. aka none.
Of course there were likely a few, but I challenge anyone to prove that India’s numbers are as through the roof as the U.S. There are no funeral pyres burning, floating bodies in the Ganges, hospitals overflowing, shortages of O2 canisters, etc.
Ivermectin use? High.
Vaccination rate? Still in the single digits.
Florida? Under reporting did you say?
Texas? Pediatric wards packed.
Oregon? Sending children to hospital in Seattle due to lack of beds?
onafhanklik | The low frequency of cases and deaths from the SARS-CoV-2 COVID-19 virus
in some countries of Africa has called our attention to the unusual
behavior of this disease. Data from 19 countries that participated in
the WHO sponsored African Programme for Onchocerciasis Control (APOC),
from 1995 until 2015, intended to treat over 90 million people annually
and protect an at-risk population of 115 million, were compared with
thirty-five (Non-APOC), countries that were not included. The
statistics show a significant 28% lower mortality (0.72 IC 95%
0,67-0,78) and 8% lower rate of infection (0.92 IC95% 0,91-0,93) due to
COVID-19. It was concluded that the incidence in mortality rates and
number of cases is significantly lower among the APOC countries compared
to non-APOC countries. Additional studies are needed to confirm it.
Ivermectin has been banned in South Africa to used for Covid19
– there is no vaccine and those “promised vaccines” all over, are also
not of any guarantee to anybody. For how long is those vaccines, for a
year perhaps? And people still need to wear masks and closed down
businesses to harm all economies. No income, no food and no employment.
Mass control and manipulation.
What are the benefits of Ivermectin? There were already various trials in different countries.
Regarding the Covid-19 virus, it was earlier stated on 2 November 2020,
that when Covid-19 arrived in Tanzania, their President Magufuli didn’t
believe in his people to stay at home. He wanted his people to get into
the churches and mosques to pray.
Speaking
during a political rally in Chato Geita, Magufuli said his government
did not bow to pressure to lockdowns. He stated that many threatened
us with dire consequences, they wanted us to shut down the economy so
that we run away from the problem but in reality, leadership is about
carrying the problems on those you lead on your shoulders that is why
today we are here. He is not the only country that decided not to
close down the businesses and economy.
Tanzania’s
economy must go ahead as it is more important than coronavirus, which
has killed 21 people in the East African country, according to the
president.
nature | Considering
the urgency of the ongoing COVID-19 pandemic, detection of various new
mutant strains and future potential re-emergence of novel coronaviruses,
repurposing of approved drugs such as Ivermectin could be worthy of
attention. This evidence-based review article aims to discuss the
mechanism of action of ivermectin against SARS-CoV-2 and summarizing the
available literature over the years. A schematic of the key cellular
and biomolecular interactions between Ivermectin, host cell, and
SARS-CoV-2 in COVID-19 pathogenesis and prevention of complications have
been proposed.
Introduction
A
relatively recent surge in zoonotic diseases has been noted over the
past few decades. Several reasons could be responsible for this
“spill-over” of disease-causing agents from animals to humans. These
include an exponential rise in the global population causing man to
encroach new ecological habitats in search of space, food, and resources
as well as improved opportunities for rampant wildlife trade causing
inter-species pathogen jumps. The 1980s was known for HIV/AIDS crisis
that originated from the great apes, while the Avian flu pandemic in
2004-07 came from the birds. The pigs lead to the Swine flu pandemic in
2009 and bats were the original hosts of Ebola, Severe Acute Respiratory
Syndrome (SARS), Middle Eastern respiratory syndrome (MERS), and
probably Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2)
outbreak as well.
COVID-19 has already caused millions of deaths
worldwide and has paralyzed not only the world’s healthcare system but
also the political and economic relations between countries [1].
The fact that the SARS-CoV-2 virus has been thought to have originated
from wildlife and may have “jumped” into humans, not only highlights
future risks from animal-borne diseases but also provides an important
clue to its resolution.
In such a scenario, where this “jump” has been
made from animal to human, it seems only logical to review a drug that
has worked efficiently against a disease-causing agent and is available
in a form that is safe for human consumption since the early 1980 s.
Ivermectin
belongs to a group of avermectins (AVM), which is a group of 16
membered macrocyclic lactone compounds discovered at the Japanese
Kitasato institute in 1967 during actinomycetes cultures with the fungus
Streptomyces avermitilis [2].
This drug radically lowered the incidence of river blindness and
lymphatic filariasis and was discovered and developed by William C.
Campbell and Satoshi Ōmura for which they received the Nobel Prize in
Physiology or Medicine in 2015 [3, 4]. Ivermectin is enlisted in the World Health Organization’s Model List of Essential Medicines [5].
Drug
repurposing, drug redirecting, or drug reprofiling is defined as the
identification of novel usages for existing drugs. The development
risks, costs as well as safety-related failure, are reduced with this
approach since these drugs have a well-established formulation
development, in vitro and in vivo screening, as well as pharmacokinetic
and pharmacodynamic profiles. Moreover, the first clinical trial phases
of many such drugs have been completed and can be bypassed to reduce
several years of development. Therefore, drug repurposing has the
potential to reduce the time frame for the whole process by up to 3–12
years and carries great potential [6].
Although
several drugs received Emergency Use Authorization for COVID-19
treatment with unsatisfactory supportive data, Ivermectin, on the other
hand, has been sidelined irrespective of sufficient convincing data
supporting its use. Nevertheless, many countries adopted ivermectin as
one of the first-line treatment options for COVID-19.
With the
ongoing vaccine roll-out programs in full swing across the globe, the
longevity of the immunity offered by these vaccines or their role in
offering protection against new mutant strains is still a matter of
debate. The adoption of Ivermectin as a “safety bridge” by some sections
of the population that are still waiting for their turn for vaccination
could be considered as a “logical” option.
Several
doctor-initiated clinical trial protocols that aimed to evaluate
outcomes, such as reduction in mortality figures, shortened length of
intensive care unit stay and/or hospital stay and elimination of the
virus with ivermectin use have been registered at the US
ClinicalTrials.gov [7].
Real-time data is also available with a meta-analysis of 55 studies to
date. As per data available on 16 May 2021, 100% of 36 early treatment
and prophylaxis studies report positive effects (96% of all 55 studies).
Of these, 26 studies show statistically significant improvements in
isolation. Random effects meta-analysis with pooled effects using the
most serious outcome reported 79% and 85% improvement for early
treatment and prophylaxis respectively (RR 0.21 [0.11–0.37] and 0.15
[0.09–0.25]). The results were similar after exclusion based sensitivity
analysis: 81% and 87% (RR 0.19 [0.14–0.26] and 0.13 [0.07–0.25]), and
after restriction to 29 peer-reviewed studies: 82% and 88% (RR 0.18
[0.11–0.31] and 0.12 [0.05–0.30]). Statistically significant
improvements were seen for mortality, ventilation, hospitalization,
cases, and viral clearance. 100% of the 17 Randomized Controlled Trials
(RCTs) for early treatment and prophylaxis report positive effects, with
an estimated improvement of 73% and 83% respectively (RR 0.27
[0.18–0.41] and 0.17 [0.05–0.61]), and 93% of all 28 RCTs. These studies
are tabulated in Table 1.
The probability that an ineffective treatment generated results as
positive for the 55 studies to date is estimated to be 1 in 23 trillion (p = 0.000000000000043).
The consistency of positive results across a wide variety of cases has
been remarkable. It is extremely unlikely that the observed results
could have occurred by chance [8].
nih.gov | Ivermectin has continually proved to be
astonishingly safe for human use. Indeed, it is such a safe drug, with
minimal side effects, that it can be administered by non-medical staff
and even illiterate individuals in remote rural communities, provided
that they have had some very basic, appropriate training. This fact has
helped contribute to the unsurpassed beneficial impact that the drug has
had on human health and welfare around the globe, especially with
regard to the campaign to fight Onchocerciasis.57)
Today,
ivermectin is being increasingly used worldwide to combat other
diseases in humans, such as Strongyloidiasis (which infects some 35
million each year), scabies (which causes 300 million cases annually),
Pediculosis, Gnathostomiasis and Myiasis—and new and promising
properties and uses for ivermectin and other avermectin derivatives are
continuing to be found.58) These include activity against another neglected tropical disease, Leishmaniasis.59,60)
Of perhaps even greater significance is the evidence that the use of
ivermectin has both direct and indirect beneficial impact on improving
community health. Studies of long-term treatment with ivermectin to
control Onchocerciasis have shown that use of the drug is additionally
associated with significant reduction in the prevalence of infection
with any soil-transmitted helminth parasites (including Ascaris,
Trichuris and hookworm), most or all of which are deemed to be major
causes of the morbidity arising from poor childhood nutrition and
growth.61) It is also known that the prevalence of head lice is markedly reduced in children taking ivermectin tablets62) and that scabies is markedly reduced in populations taking the drug regularly.63)
Above all, ivermectin has proved to be a medicine of choice for the
world’s rural poor. In many underprivileged communities throughout the
tropics, intestinal worms and parasitic skin diseases are extremely
common and associated with significant morbidity. They usually co-exist,
with many individuals infected with both ecto- and endoparasites.64,65)
Mass treatment of poly-parasitized populations is deemed to be the best
means of control and ivermectin is the ideal drug for such
interventions. A recent study in Brazil, using locally produced
ivermectin, looked at the impact on internal helminthes and parasitic
skin diseases. The researchers concluded that “mass treatment with
ivermectin was an effective and safe means of reducing the prevalence of
most of the parasitic diseases prevalent in a poor community in
North-East Brazil. The effects of treatment lasted for a prolonged
period of time”. This study also represented the first published report
of human medical intervention using ivermectin that had not been
produced by the hitherto traditional manufacturer, Merck & Co. Inc.,
the patent on the drug expiring in 1997.66)
In
reality, the renewed interest in fighting tropical diseases, including
the involvement of the pharmaceutical industry, which has become
increasingly evident over the past three decades, and which has saved
lives and improved the welfare of billions of people, notably the poor
and disadvantaged in the topics, can be traced back to the 1987
introduction of ivermectin for use in humans. According to a recent
report, International Federation of Pharmaceutical Manufacturers &
Associations (IFPMA) data show that the global pharmaceutical industry
provided over $9.2 billion in health interventions (medicines and
equipment) between 2000–2007 alone, benefitting 1.75 billion people
worldwide.67)
The hitherto unprecedented donation of ivermectin in 1987 can rightly
be seen to be the origin of this philanthropic outpouring.
Since the inception of the Mectizan Donation Programme, Merck has donated well over 2.5 billion Mectizan®
tablets for Onchocerciasis treatment, with in excess of 700 million
treatments authorised. Currently, some 80–90 million people are taking
the drug annually through MDA in Africa, Latin America and Yemen. A
further 300 million total treatments have been approved for lymphatic
filariasis, with around 90 million treatments being administered
annually (Fig. (Fig.8
).8
). At present 33 countries are receiving ivermectin for Onchocerciasis
and 15 for Lymphatic filariasis. Consequently, around US$4 billion worth
of ivermectin tablets have been donated to date. In 2010, Ecuador
became the second country in the Americas to halt River Blindness
transmission. It is hoped that transmission of the disease in the
Western hemisphere will be stopped by 2012—a goal that will have been
achieved thanks to twice-yearly MDA with ivermectin. Lymphatic
filariasis is targeted for global elimination by 2020, and, if all goes
well, Onchocerciasis may well be eliminated from Africa soon thereafter.
They have at least two other things in common: all three were found in nature and all three led to a Nobel prize.
Aspirin is derived from salicin, a compound found in a variety of
plants such as willow trees. Its use was first mentioned by Hippocrates
in 400 BC, but was isolated only in 1829 as salicylic acid and
synthesised some years later as acetylsalicylic acid. The discovery of
the mechanisms underlying aspirin’s effects gave Sir John Vane the Nobel
prize in 1982. Penicillin was isolated from mold that grew by accident
on a Petri dish in Alexander Fleming’s laboratory. Its discovery changed
the course of medicine, and earned Fleming the Nobel prize in 1945,
which he shared with Howard Florey and Ernst Chain.
And this
brings us to ivermectin- not likely a drug you will have in your
first-aid kit, like aspirin or penicillin, but definitely a drug that has improved the lives of millions of people since its discovery in 1975.
The story of how ivermectin was discovered is quite incredible. In the
late 1960s, Satoshi Ōmura, a microbiologist at Tokyo’s Kitasako
Institute, was hunting for new antibacterial compounds and started to
collect thousands of soil samples from around Japan. He cultured
bacteria from the samples, screened the cultures for medicinal
potential, and sent them 10,000 km away to Merck Research Labs in New
Jersey, where his collaborator, William Campbell, tested their effect
against parasitic worms affecting livestock and other animals. One
culture, derived from a soil sample collected near a golf course
southwest of Tokyo, was remarkably effective against worms. The
bacterium in the culture was a new species, and was baptised Streptomyces avermictilis.
The active component, named avermectin, was chemically modified to
increase its activity and its safety. The new compound, called
ivermectin, was commercialised as a product for animal health in 1981
and soon became a top-selling veterinary drug in the world. Remarkably, despite decades of searching, S. avermictilis remains the only source of avermectin ever found.
BritishMedicalJournal |With the US awash in news about rising
cases of the Delta variant, including among the “fully vaccinated,” the
vaccine’s efficacy profile is in question. But some medical
commentators are delivering an upbeat message. Former FDA commissioner
Scott Gottlieb, who is on Pfizer’s board, said:
“Remember, the original premise behind these vaccines were [sic] that
they would substantially reduce the risk of death and severe disease and
hospitalization. And that was the data that came out of the initial
clinical trials.”
In the preprint, high efficacy against
“severe covid-19” is reported based on all follow-up time (one event in
the vaccinated group vs 30 in placebo), but the number of hospital
admissions is not reported so we don’t know which, if any, of these
patients were ill enough to require hospital treatment. (In Moderna’s
trial, data last year showed that 21 of 30 “severe covid-19” cases were
not admitted to hospital; Table S14).
And on preventing death from covid-19, there are too few data to draw conclusions—a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo).
The crucial question, however, is
whether the waning efficacy seen in the primary endpoint data also
applies to the vaccine’s efficacy against severe disease. Unfortunately,
Pfizer’s new preprint does not report the results in a way that allows
for evaluating this question.
Approval imminent without data transparency, or even an advisory committee meeting?
Last December, with limited data, the
FDA granted Pfizer’s vaccine an EUA, enabling access to all Americans
who wanted one. It sent a clear message that the FDA could both address
the enormous demand for vaccines without compromising on the science. A
“full approval” could remain a high bar.
But here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial,
with no reported data past 13 March 2021, unclear efficacy after six
months due to unblinding, evidence of waning protection irrespective of
the Delta variant, and limited reporting of safety data. (The preprint
reports “decreased appetite, lethargy, asthenia, malaise, night sweats,
and hyperhidrosis were new adverse events attributable to BNT162b2 not
previously identified in earlier reports,” but provides no data tables
showing the frequency of these, or other, adverse events.)
Prior to the preprint, my view, along
with a group of around 30 clinicians, scientists, and patient advocates,
was that there were simply too many open questions
about all covid-19 vaccines to support approving any this year. The
preprint has, unfortunately, addressed very few of those open questions,
and has raised some new ones.
I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”
FDA should be demanding that the
companies complete the two year follow-up, as originally planned (even
without a placebo group, much can still be learned about safety). They
should demand adequate, controlled studies using patient outcomes in the
now substantial population of people who have recovered from covid. And
regulators should bolster public trust by helping ensure that everyone
can access the underlying data.
Peter Doshi, senior editor, The BMJ.
Competing interests: I helped organize the Coalition Advocating for Adequately Licensed Medicines (CAALM), which has formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). A full list of competing interests is available here.
FDA |From Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum - Page 44
5.2. Pharmacovigilance Activities
Pfizer submitted a Pharmacovigilance Plan (PVP) to monitor safety concerns that could be associated with Pfizer-BioNTech COVID-19 Vaccine. The Sponsor identified vaccine-associated enhanced disease including vaccine-associated enhanced respiratory disease as an important potential risk.
divergemedia | Jim Smith, the Former President and CEO of Thomson Reuters and now the current Chairman
of the Thomson Reuters Foundation, the corporate arm of the company,
also sits as a board member at Pfizer – except under the name James Smith.
Robert Malone, the self proclaimed creator of mRNA vaccines was the
first to post Mr. Smith’s LinkedIn profile that showed the connections.
The LinkedIn profile that Mr. Malone posted reads that “Jim is a
non-executive director of Pfizer Inc.”
regarding the "Trusted News Initiative" and censorship of information regarding COVID vaccine safety, please be aware of the link between Pfizer and Reuters. I would call that a journalistic conflict of interest. What do you think? pic.twitter.com/qQCysxnPX6
Since that tweet, it appears that Mr. Smith has removed his picture off
of his LinkedIn profile in an attempt to make the connection harder to
make. However, the pictures are the same person and the “James Smith”
that sits on the board at Pfizer admits to being the Chairman of Thomson
Reuters foundation and the former president – verifying it is in fact
the same Mr. Smith. Mr. Smith is also a “member of the International
Business Council of the World Economic Forum.”
People all over the world are hungry for unbiased information that
they can trust. When the chairman of a media company like Reuters also
sits on the board at Pfizer how can we believe that there isn’t any form
of bias occurring in their coverage of the vaccine rollout? Are we to
really believe that there is no conflict here? Do people really believe
someone can sit on the board of a major vaccine manufacturer and still
provide unbiased coverage of that same vaccine? I don’t think you can
remain unbiased – but that’s just my take.
*We have reached out to the Thomson Reuters Foundation about the
connection but did not receive a message back before the release of this
article.*
thesun | The event was hosted in Napa Valley over the weekend and the clip of
the dozens of guests sitting side-by-side was shared online by Dem donor
and winemaker Kathryn Walt Hall.
Critics were quick to slam Pelosi for attending the event in an area where Covid-19 cases are once again spiking.
"Speaker Pelosi wants to lock you down again while she wines and
dines with her political donors," House Minority Leader Kevin McCarthy
said.
"It's utter hypocrisy."
Controversial QAnon Congresswomen Marjorie Taylor Greene also took shots at Pelosi's fundraiser, alleging that Democrats only care about "controlling you."
"[Speaker Pelosi] does not care about Covid," she wrote on Twitter.
"Democrats don’t care about covid. They only care about controlling you.
"Magical covid science: The virus stops spreading the minute you sit
down to eat or when you speak in a microphone or if you are one of the
elites. Liars."
This is not the first time Speaker Pelosi has been slammed for
flouting Covid-19 restrictions while California was dealing with
outbreaks.
Last year, she was caught on video inside a hair salon with no mask
on while such establishments were supposed to be closed due to the
virus.
Pelosi was widely slammed online for ignoring rules that she adamantly supported when speaking publicly.
She later alleged that the owner of the hair salon set her up.
NYTimes | President
Biden used his daily national security briefing on the morning of April
6 to deliver the news that his senior military leaders suspected was
coming. He wanted all American troops out of Afghanistan by Sept. 11,
the 20th anniversary of the attacks on New York and the Pentagon.
In
the Oval Office, Defense Secretary Lloyd J. Austin III and Gen. Mark A.
Milley, the chairman of the Joint Chiefs of Staff, wanted to make
certain. “I take what you said as a decision, sir,” General Milley said,
according to officials with knowledge of the meeting. “Is that correct,
Mr. President?”
It was.
I’ve never seen such a coordinated media-military attack on a President for asserting civilian control of the military. https://t.co/BVPXHUTxed
Over
two decades of war that spanned four presidents, the Pentagon had
always managed to fend off the political instincts of elected leaders
frustrated with the grind of Afghanistan, as commanders repeatedly
requested more time and more troops. Even as the number of American
forces in Afghanistan steadily decreased to the 2,500 who still remained,
Defense Department leaders still cobbled together a military effort
that managed to protect the United States from terrorist attacks even as
it failed, spectacularly, to defeat the Taliban in a place that has
crushed foreign occupiers for 2,000 years.
The
current military leadership hoped it, too, could convince a new
president to maintain at least a modest troop presence, trying to talk
Mr. Biden into keeping a residual force and setting conditions on any
withdrawal. But Mr. Biden refused to be persuaded.
The
two Pentagon leaders stood before Mr. Biden near the same Resolute Desk
where President George W. Bush reviewed plans in 2001 to send in elite
Special Operations troops to hunt for Osama bin Laden only to see him
melt over the border into Pakistan. It was the same desk where President
Barack Obama decided on a surge of forces in 2009, followed by a rapid
drawdown, only to discover that the Afghan military was not able to
defend itself despite billions of dollars in training. It was there that
President Donald J. Trump declared that all American troops were coming home — but never carried through a plan to do so.
diplomaticourier | With twenty years to prepare for it, there should be plenty of clarity in the post-mortem on “what went wrong in Afghanistan” for American policy. History warned us with everything but flashing red lights that all was not well as the twenty years progressed. History should also tell us that there will be as little clarity as to how America and allies failed in Afghanistan as the lack of clarity that doomed the enterprise.
The comparisons to Vietnam were already numerous. These will only proliferate as photojournalists -- instinctually sensing a fall of Saigon moment -- capture images of the chaotic and poorly planned evacuation of Kabul. Like America’s involvement in Vietnam, this failure did not happen in a vacuum; it happened in a sequence. Policy failures, lacking political will, military issues, and cultural upheaval all contributed to the images of the helicopter leaving the American embassies in both Saigon, with a long line queued up for an escape that was never to come.
That sequence continued after the Vietnam War. In the decades since, that failure has been studied and debated militarily, politically, and policy-wise. The United States military took the lessons of failure and revolutionized itself, moving to an all-volunteer force, integrating National Guard and Reserve components, and focusing on technological superiority and precision. The result was a much smaller overall force that is more capable, lethal, and diverse, while constituting only 1% of the American population.
The government which that military serves, however, failed to carry out a similar soul searching and rebuilding process. Lip service was given, policy papers were written, debates were had, but the power structure largely remained unchanged. The decades of distance meant the personal lessons of Vietnam were operationally lost to the very impersonal machine of American governance. Accountability for decision-making is lacking. The politics of the day has become more about overseeing the system for what could be gained individually and for one’s party than about operating it effectively for the gain of all. The watchdogs of the free press became increasingly reliant on access journalism to the superstars of the political world, and by omission or commission had their investigatory mandate dulled. A vast majority of the American citizenry, most of them lulled into complacency by a level of prosperity unheard of in all of recorded human history, had little interest in changing the systems that weren’t bothering them, even as the number of individuals suffering from it steadily grew.
The answers to "what went wrong in Afghanistan" begin in that grey area of unlearned history lessons from the last failure of American foreign policy leading to desperate evacuations of an embassy in Saigon to the embassy in Kabul. Afghanistan is a political failure, it is a policy failure, it is a military failure, and it is a human failure. Most of all, it is, was, and will forever be known as an avoidable failure as too many of us watched idly while it slowly metastasized into today’s crisis -- a crisis which history and common sense were warning us about.
Any post-mortem on "what went wrong in Afghanistan" that does not include a root cause of dysfunction within the United States government to operate as a competent and accountable governing mechanism is missing the root domestic cause of the foreign policy disaster that the Global War on Terror has become. The failures of the United States government to learn from past mistakes incubated the current dysfunction that inevitably bled through to foreign policy failures like America’s 20 years in Afghanistan. A United States that cannot conduct conflict resolution within its own government can neither project nor maintain a coherent foreign policy to the rest of the world.
WaPo | The
Pentagon’s effort to mandate coronavirus vaccination for all 1.3
million active-duty service members will continue to face resistance
from a segment of the force, troops and observers say, until military
leaders devise an effective strategy for countering pervasive doubt
about the pandemic’s seriousness and widespread misinformation about the
shots designed to bring it under control.
When Defense Secretary Lloyd Austin announced earlier this month that he would seek to require inoculation no later than mid-September, Pentagon data showed that thousands of personnel — about one-third of the force — remained unvaccinated. President Biden quickly endorsed the move.
The
looming mandate comes as the virus’s highly transmissible delta variant
fuels a new wave of infections globally, and after Biden, in what was
widely seen as a signal to state and local governments and the private
sector that they should follow suit, directed agencies throughout the
federal government to implement proof-of-vaccination requirements or
impose restrictions on employees who refuse. For military personnel,
administration officials have said, the need is particularly urgent.
“Right
now it’s being framed as a readiness issue,” said Katherine Kuzminski, a
senior fellow at the Center for a New American Security, pointing to
the current security crisis that has unfolded in Afghanistan’s capital,
where thousands of U.S. troops were sent with little notice to help
evacuate American citizens and U.S. allies following the Taliban’s
takeover of the country. “As we see in Afghanistan, there is certainly a
need to rapidly deploy people, and they may or may not be going to
places that have relatively high rates of vaccinations.”
But, Kuzminski added, “I don’t think we’ve seen a vaccine that was [so] politicized.”
The Defense Department did not respond to a request for comment about its efforts to address vaccine hesitancy within the ranks.
aeromagazine | The First Amendment of the US Constitution specifies that Congress
“shall make no law … abridging the freedom of speech.” In fairness,
Congress has made no such law. The executive branch is simply stating
that it will invoke its power to censor by fiat in collaboration with
social media companies, on the pretext of a national emergency.
Given that the federal government enjoys the cooperation of the vast
majority of media outlets, the fact that competing social media
narratives are sufficient to prevent them from being able to convince
the nation that their message is correct represents a significant
problem with the message itself, the effectiveness of its communication
or the credibility of their sources.
Of these three factors, credibility seems especially weak. Since the
start of the pandemic, health leaders have made definitive statements
that have subsequently needed to be reversed. First, early in 2020, they
insisted
the wearing of masks by the public was unnecessary, as it was not
believed that the virus spread via airborne transmission. That was
incorrect. The hypothesis that the origin of the virus was a lab leak
from the Wuhan Institute of Virology was labelled a conspiracy theory,
but has now been deemed as likely as a natural origin. In late March, the current CDC cirector, Rochelle Walensky, announced that vaccinated individuals were unable to carry the virus, even though existing studies confirmed that they could both carry and spread it. The CDC later awkwardly walked these comments back. In May it was announced that vaccinated individuals were free to roam unmasked
in most settings because they would not spread or contract the virus
except in the rarest of circumstances. This directive has now been
reversed again due to the rise of the Delta variant, as data have shown
that vaccinated individuals may have the same viral load as the unvaccinated, and may indeed be able to spread it to others. The CDC says that vaccinated individuals should return to masking indoors.
Even though some of these reversals were due to changing circumstances,
the ongoing back-and-forth leads many to question the credibility of
the messengers.
It has also become clear that leaders are disseminating
misinformation—or, in some cases, disinformation—on behalf of those who
know the truth but are making statements to the contrary.
In a 21 July 2021 CNN Town Hall, President Biden insisted: “You’re not gonna get Covid if you have these vaccinations.”
This was a completely inaccurate statement. Vaccinated people have
contracted Covid since the vaccinations began, and this trend is
increasing now that the Delta variant is the dominant viral strain. Data from the Israeli Ministry of Health
reveal that, at five months and six months after the second vaccine
dose, individuals are only protected from symptomatic Covid at levels of
44% and 16% respectively. Meanwhile, a new study from Israel indicates that protection from serious disease has fallen to 80%.
It may be that this misinformation was conveyed accidentally as a
result of inelegant delivery by the president. But this was a very
dangerous statement, as it promoted a false impression that the vaccines
are completely protective, and was likely to make many question and
potentially resist the new announcement from the CDC that vaccinated
people should wear masks indoors.
The CDC director declared that this was a pandemic of the
unvaccinated—and was soon echoed by President Biden. A large number of
health leaders and media contributors have continued to parrot this
phrase. But case data from Israel, the UK and many other countries prove
that vaccinated individuals are being significantly impacted. Israel
recently announced that 60% of its hospitalised Covid patients were fully vaccinated. The newest Public Health England technical report
reveals that 25% of Delta hospitalisations and 54% of Delta deaths have
occurred in the fully vaccinated. Iceland has achieved a vaccination
rate of almost 90% among adults, but still needed to reinstate public health measures
due to a surge in Delta infections. Now that the Delta variant has
taken hold in the US, there have been numerous instances of vaccinated
individuals being infected, including the notable breakthrough infections
in Provincetown, Massachusetts that were a central factor prompting new
CDC guidance on indoor masking. It is clear that the Delta variant has
produced a much more complicated landscape, in which merely the amount
of vaccine that has been administered is a less significant data point.
In short, it is false to claim that the pandemic affects only the
unvaccinated.
In addition to being inaccurate, the narrative that the pandemic now
only affects the unvaccinated has created division and hostility between
different groups, which is extremely unhelpful given the many cases of
shootings in the US, as well as violent outbursts in public spaces
including airlines. I have seen vitriolic statements on social media by
vaccinated individuals who are blaming the unvaccinated for the Delta
variant, even though it was discovered in autumn of last year, before
vaccinations were available to the general public. Even some in the
media have engaged in blaming the unvaccinated. CNN host John Berman insisted:
“If the unvaccinated aren’t to blame, who is?” We urgently need to
promote a climate in which people work together rather than being turned
against one another.
Some leaders have suggested that increased vaccination levels will
arrest the surge in the Delta variant. After the second dose, it takes
35 days with Pfizer or 42 days with Moderna to achieve fully vaccinated
status. It is obvious that new vaccinations, which take more than a
month to provide full protection, cannot prevent a viral surge that is
presently underway. Additional vaccines may indeed help more people to
have better health outcomes if they were to become infected—but that is
an entirely different claim.
Claude's constitution and other matters AI
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Ross Douthat, Is Claude Coding Us Into Irrelevance? *NYTimes*, 2.12.26.
Are the lords of artificial intelligence on the side of the human race?
That’s t...
Celebrating 113 years of Mama Rosa McCauley Parks
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*February 4, 1913 -- February 4, 2026*
*Some notes: The life of the courageous activist Mama Rosa McCauley Parks*
Mama Rosa's grandfather Sylvester Ed...
Monsters are people too
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Comet 3I/Atlas is on its way out on a hyberbolic course to, I don't know
where. I do know that 1I/Oumuamua is heading for the constellation Pegasus,
and ...
Remembering the Spanish Civil War
-
This year marks the 90th anniversary of the launch of the Spanish Civil
War, an epoch-defining event for the international working class, whose
close study...
Return of the Magi
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Lately, the Holy Spirit is in the air. Emotional energy is swirling out of
the earth.I can feel it bubbling up, effervescing and evaporating around
us, s...
Covid-19 Preys Upon The Elderly And The Obese
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sciencemag | This spring, after days of flulike symptoms and fever, a man
arrived at the emergency room at the University of Vermont Medical Center.
He ...
-
(Damn, has it been THAT long? I don't even know which prompts to use to
post this)
SeeNew
Can't get on your site because you've gone 'invite only'?
Man, ...
First Member of Chumph Cartel Goes to Jail
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With the profligate racism of the Chumph Cartel, I don’t imagine any of
them convicted and jailed is going to do too much better than your run of
the mill ...
