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Fazlollahi, A., Zahmatyar, M., Noori, M., Nejadghaderi, S. A., Sullman, M. J. M., Shekarriz-Foumani, R., . . . Safiri, S. (2021). Cardiac complications following mRNA COVID-19 vaccines: A systematic review of case reports and case series. Rev Med Virol, e2318. doi:10.1002/rmv.2318. https://www.ncbi.nlm.nih.gov/pubmed/34921468
Foltran, D., Delmas, C., Flumian, C., De Paoli, P., Salvo, F., Gautier, S., . . . Montastruc, F. (2021). Myocarditis and Pericarditis in Adolescents after First and Second doses of mRNA COVID-19 Vaccines. Eur Heart J Qual Care Clin Outcomes. doi:10.1093/ehjqcco/qcab090. https://www.ncbi.nlm.nih.gov/pubmed/34849667
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First, Japan's health ministry acknowledged the growing rate of heart inflammation among the vaccinated population. Then Japan's public and private sectors were alerted to the fact and forbidden to discriminate against those who refuse the COVID vaccine. Furthermore, Japan has made it clear that "informed consent" is required to receive the vaccine. Japan now insists the vaccine labels warn of dangerous potential side effects such as myocarditis.
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NHK-Japan (Japan Broadcasting Corporation) | Japan's health ministry has listed inflammation of the heart muscle and of the outer lining of the heart in younger males as possible serious side effects of the Moderna and Pfizer COVID vaccines.
It says that as of November 14, out of every one million males who had the Moderna vaccine, such side effects were reported in 81.79 males aged 10 to 19 and 48.76 males in their 20s.
The figures were 15.66 and 13.32 respectively for those who had the Pfizer vaccine.
The ministry held a panel of expert on Saturday [Dec. 4] and proposed warning of the risk by printing "serious side effects" on the documents attached to the vaccines.
It will also require hospitals to report in detail incidents involving people who developed the symptoms within 28 days after being vaccinated, according to the law.
The plan was approved by the panel, and the ministry will notify municipalities.
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RairFoundation.com | Japan announces that public and private sectors can not discriminate against those who refuse the experimental mRNA gene therapy injections.
Japan is now labeling Covid “vaccines” to warn of dangerous and potentially deadly side effects such as myocarditis. In addition, the country is reaffirming its commitment to adverse event reporting requirements to ensure all possible side effects are documented.
These efforts from Japan’s health authority are in stark contrast to the deceptive measures taken by other countries to coerce citizens into taking the injection, downplaying side effects, and discouraging proper adverse event reporting.
Additionally, Japan is emphasizing informed consent and bodily autonomy. Until the coronavirus pandemic, the concept of “informed consent” was considered sacred to healthcare professionals in the West.
Japan is particularly raising concerns about the risks of myocarditis in young men injected with Pfizer or Moderna’s gene–therapy treatment. The country is enforcing a strict legal reporting requirement of side effects that must take place within 28 days of the injections.
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BROWNSTONE INSTITUTE | Japan’s ministry of health is taking a sensible, ethical approach to Covid vaccines. They recently labeled the vaccines with a warning about myocarditis and other risks. They also reaffirmed their commitment to adverse event reporting to document potential side-effects.
Japan’s ministry of health states: “Although we encourage all citizens to receive the COVID-19 vaccination, it is not compulsory or mandatory. Vaccination will be given only with the consent of the person to be vaccinated after the information provided.”
Furthermore, they state: “Please get vaccinated of your own decision, understanding both the effectiveness in preventing infectious diseases and the risk of side effects. No vaccination will be given without consent.”
Finally, they clearly state: “Please do not force anyone in your workplace or those who around you to be vaccinated, and do not discriminate against those who have not been vaccinated.”
They also link to a “Human Rights Advice” page that includes instructions for handling any complaints if individuals face vaccine discrimination at work.
Other nations would do well to follow Japan’s lead with this balanced and ethical approach.
This policy appropriately places the responsibility for this healthcare decision with the individual or family.
We can contrast this with the vaccine mandate approach adopted in many other Western nations. The U.S. provides a case study in the anatomy of medical coercion exercised by a faceless bureaucratic network.
A bureaucracy is an institution that exercises enormous power over you but with no locus of responsibility. This leads to the familiar frustration, often encountered on a small scale at the local DMV, that you can go round in bureaucratic circles trying to troubleshoot problems or rectify unfair practices. No actual person seems to be able to help you get to the bottom of things—even if a well-meaning person sincerely wants to assist you.
Here’s how this dynamic is playing out with coercive vaccine mandates in the U.S. The CDC makes vaccine recommendations. But the ethically crucial distinction between a recommendation and mandate immediately collapses when institutions (e.g., a government agency, a business, employer, university, or school) require you to be vaccinated based on the CDC recommendation.
Try to contest the rationality of these mandates, e.g., in federal court, and the mandating institution just points back to CDC recommendation as the rational basis for the mandate. The court will typically agree, deferring to the CDC’s authority on public health. The school, business, etc., thus disclaims responsibility for the decision to mandate the vaccine: “We’re just following CDC recommendations, after all. What can we do?”
But CDC likewise disclaims responsibility: “We don’t make policy; we just make recommendations, after all.”
Meanwhile, the vaccine manufacturer is immune and indemnified from all liability or harm under federal law. No use going to them if their product—a product that you did not freely decide to take—harms you.
You are now dizzy from going round in circles trying to identify the actual decision-maker: it’s impossible to pinpoint the relevant authority. You know that enormous power is being exercised over your body and your health, but with no locus of responsibility for the decision and no liability for the outcomes.
You are thus left with the consequences of a decision that nobody claims to have made. The only certainty is that you did not make the decision and you were not given the choice.
Japan’s policy avoids most of these problems simply placing responsibility for the decision on the individual receiving the intervention, or the parent in the case of a child who is not old enough to consent.
Incidentally, this focus on choice and freedom was somewhat reflected in Japan’s policies throughout the pandemic, which were less stringent that most countries, including those in the U.S.
Japan’s government, unlike the governments in most countries in the “free” world, refuses to force and intimidate its population to get vaccinated against covid-19.
An official statement on its health ministry website reads as follows:
“Although we encourage all citizens to receive the COVID-19 vaccination, it is not compulsory or mandatory.
Vaccination will be given only with the consent of the person to be vaccinated after the information provided.
Please get vaccinated of your own decision, understanding both the effectiveness in preventing infectious diseases and the risk of side effects.
No vaccination will be given without consent.
Please do not force anyone in your workplace or those who around you to be vaccinated, and do not discriminate against those who have not been vaccinated.”
Japan’s approach to vaccinating its population appears to be in stark contrast to that practiced in the west.
Not only vaccine mandates are now being enforced in Europe and America, governments like that in Germany, by far the most totalitarian when it comes to dealing with Covid, is now openly inciting hatred against people who do not want to get vaccinated, and removes them from society and the public sphere.
The Japanese approach seems to be working seeing how almost 80% of its population is now fully vaccinated.
In the past Japan, unlike governments in Europe and America, also refused to impose a national lockdown on its population, resorting only to declaring a state of emegency and imposing only localized lockdowns in specific places and cities.
Japan’s approach to fighting the pandemic seems to have paid of, as it has one of the lowest death tolls from covid in the world per its population.
With the oldest population in the world, and with almost 125 million Japanese, Japan saw only around 18,000 deaths from covid in the last 2 years.
In comparison, France, which has half of the population that of Japan, had over 121,000 deaths from covid, and counting.
However you never see any mention of this on the corporate media, which praises countries like France and Germany and its leaders for the “good job” they did and how “well” they handled the pandemic.
The fact that Japan never had a national lockdown, or that it refuses to force its citizens to get vaccinated or demonise and penalise those who won’t, while doing much better than almost any other major developed country in the world, seems to fly in the face of the narrative that is being promoted and propogated by the corporate media and global institutions.
A new study from the University of California, Davis, Genome Center, UC San Francisco and the Chan Zuckerberg Biohub shows no significant difference in viral load between vaccinated and unvaccinated people who tested positive for the delta variant of SARS-CoV-2. It also found no significant difference between infected people with or without symptoms.
https://publichealth.jhu.edu/2021/new-data-on-covid-19-transmission-by-vaccinated-individuals
New data was released by the CDC showing that vaccinated people infected with the delta variant can carry detectable viral loads similar to those of people who are unvaccinated, though in the vaccinated, these levels rapidly diminish. There is also some question about how cultivatable—or viable—this virus retrieved from vaccinated people actually is.
(The Center Square) – The head of Indianapolis-based insurance company OneAmerica said the death rate is up a stunning 40% from pre-pandemic levels among working-age people.
“We are seeing, right now, the highest death rates we have seen in the history of this business – not just at OneAmerica,” the company’s CEO Scott Davison said during an online news conference this week. “The data is consistent across every player in that business.”
OneAmerica is a $100 billion insurance company that has had its headquarters in Indianapolis since 1877. The company has approximately 2,400 employees and sells life insurance, including group life insurance to employers in the state.
Davison said the increase in deaths represents “huge, huge numbers,” and that’s it’s not elderly people who are dying, but “primarily working-age people 18 to 64” who are the employees of companies that have group life insurance plans through OneAmerica.
“And what we saw just in third quarter, we’re seeing it continue into fourth quarter, is that death rates are up 40% over what they were pre-pandemic,” he said.
“Just to give you an idea of how bad that is, a three-sigma or a one-in-200-year catastrophe would be 10% increase over pre-pandemic,” he said. “So 40% is just unheard of.”
Davison was one of several business leaders who spoke during the virtual news conference on Dec. 30 that was organized by the Indiana Chamber of Commerce.
Most of the claims for deaths being filed are not classified as COVID-19 deaths, Davison said.
“What the data is showing to us is that the deaths that are being reported as COVID deaths greatly understate the actual death losses among working-age people from the pandemic. It may not all be COVID on their death certificate, but deaths are up just huge, huge numbers.”
He said at the same time, the company is seeing an “uptick” in disability claims, saying at first it was short-term disability claims, and now the increase is in long-term disability claims.
“For OneAmerica, we expect the costs of this are going to be well over $100 million, and this is our smallest business. So it’s having a huge impact on that,” he said.
He said the costs will be passed on to employers purchasing group life insurance policies, who will have to pay higher premiums.
The CDC weekly death counts, which reflect the information on death certificates and so have a lag of up to eight weeks or longer, show that for the week ending Nov. 6, there were far fewer deaths from COVID-19 in Indiana compared to a year ago – 195 verses 336 – but more deaths from other causes – 1,350 versus 1,319.
These deaths were for people of all ages, however, while the information referenced by Davison was for working-age people who are employees of businesses with group life insurance policies.
At the same news conference where Davison spoke, Brian Tabor, the president of the Indiana Hospital Association, said that hospitals across the state are being flooded with patients “with many different conditions,” saying “unfortunately, the average Hoosiers’ health has declined during the pandemic.”
In a follow-up call, he said he did not have a breakdown showing why so many people in the state are being hospitalized – for what conditions or ailments. But he said the extraordinarily high death rate quoted by Davison matched what hospitals in the state are seeing.
"What it confirmed for me is it bore out what we're seeing on the front end,..." he said.
The number of hospitalizations in the state is now higher than before the COVID-19 vaccine was introduced a year ago, and in fact is higher than it’s been in the past five years, Dr. Lindsay Weaver, Indiana’s chief medical officer, said at a news conference with Gov. Eric Holcomb on Wednesday.
Just 8.9% of ICU beds are available at hospitals in the state, a low for the year, and lower than at any time during the pandemic. But the majority of ICU beds are not taken up by COVID-19 patients – just 37% are, while 54% of the ICU beds are being occupied by people with other illnesses or conditions.
The state's online dashboard shows that the moving average of daily deaths from COVID-19 is less than half of what it was a year ago. At the pandemic's peak a year ago, 125 people died on one day – on Dec. 29, 2020. In the last three months, the highest number of deaths in one day was 58, on Dec. 13.
Direkt aus dem dpa-Newskanal
Stuttgart/Heidelberg (dpa/lsw) - Der Chef-Pathologe der Uni Heidelberg, Peter Schirmacher, drängt zu viel mehr Obduktionen von Geimpften. Neben Corona-Toten müssten auch die Leichname von Menschen, die im zeitlichen Zusammenhang mit einer Impfung sterben, häufiger untersucht werden, sagte Schirmacher der Deutschen Presse-Agentur in Stuttgart. Der Direktor des Pathologischen Instituts in Heidelberg warnt gar vor einer hohen Dunkelziffer an Impftoten und beklagt: Von den meisten Patienten, die nach und möglicherweise an einer Impfung sterben, bekämen die Pathologen gar nichts mit. Allerdings widersprechen ihm in dem Punkt andere Wissenschaftler ebenso wie die Ständige Impfkommission (Stiko) und das Paul-Ehrlich-Institut.
Seit einem Jahr werden an den Unikliniken im Südwesten Corona-Tote obduziert, um die Erkrankung besser zu verstehen. Das Land unterstützt die Covid-19-Obduktionsforschung der Universitätspathologien mit rund 1,8 Millionen Euro. Schirmacher leitet das Autopsie-Projekt. Die Erkenntnisse von bislang mehr als 200 Obduktionen hätten unter anderem zu einer besseren Behandlung und Beatmung von Covid-Erkrankten geführt, sagt er. "Die hier gewonnen Erkenntnisse helfen also dabei, Erkrankte nun besser und erfolgreicher behandeln zu können und Leben zu retten", sagt auch Wissenschaftsministerin Theresia Bauer (Grüne). Schirmacher, seit 2012 Mitglied der Nationalen Akademie der Wissenschaften Leopoldina, hofft, dass die Förderung nächstes Jahr fortgesetzt wird.
Der Mediziner will nun verstärkt seltenen, schweren Nebenwirkungen des Impfens - etwa Hirnvenenthrombosen oder Autoimmunerkrankungen - auf den Grund gehen. Das Problem aus seiner Sicht: Geimpfte sterben meist nicht unter klinischer Beobachtung. "Der leichenschauende Arzt stellt keinen Kontext mit der Impfung her und bescheinigt einen natürlichen Tod und der Patient wird beerdigt", berichtet Schirmacher. "Oder er bescheinigt eine unklare Todesart und die Staatsanwaltschaft sieht kein Fremdverschulden und gibt die Leiche zur Bestattung frei."
In Baden-Württemberg arbeiteten die Pathologen daher mit Staatsanwaltschaften, der Polizei und niedergelassenen Ärzten zusammen, berichtet Schirmacher. Mehr als 40 Menschen habe man bereits obduziert, die binnen zwei Wochen nach einer Impfung gestorben sind. Schirmacher geht davon aus, dass 30 bis 40 Prozent davon an der Impfung gestorben sind. Die Häufigkeit tödlicher Impffolgen wird aus seiner Sicht unterschätzt - eine politisch brisante Aussage in Zeiten, in denen die Impfkampagne an Fahrt verliert, die Delta-Variante sich rasant ausbreitet und Einschränkungen von Nicht-Geimpften diskutiert werden.
Schirmacher erhält denn auch deutlichen Widerspruch von anderen Wissenschaftlern. Die Aussagen, man wisse derzeit zu wenig über Nebenwirkungen und die Gefahren des Impfens würden unterschätzt, seien nicht nachvollziehbar, teilte das Paul-Ehrlich-Institut mit. Insbesondere für schwerwiegende Reaktionen, zu denen auch gehört, wenn ein Mensch nach einer Impfung stirbt, bestehe eine Meldepflicht nach Infektionsschutzgesetz. "Ich kenne keine Daten, die hier eine begründbare Aussage zulassen und gehe nicht von einer Dunkelziffer auf", sagte der Chef der Ständigen Impfkommission, Thomas Mertens.
Für die Annahme einer hohen Dunkelziffer von Impfkomplikationen oder gar Todesfällen bestehe kein Anlass, betonte auch der Immunologe Christian Bogdan von der Uniklinik Erlangen. "Auch kann von einer Vernachlässigung möglicher Gefahren von COVID-19-Impfstoffen nicht die Rede sein." Gerade die letzten Wochen und Monate hätten gezeigt, dass das Surveillance-System gut funktioniere. So sei in Deutschland sehr frühzeitig das seltene Auftreten von Hirnvenenthrombosen nach einer Impfung mit Astrazeneca (1-2 Fälle auf 100 000 Impfungen) als Komplikation erkannt worden, sagt Bogdan.
Schirmacher beharrt auf seiner Meinung. "Die Kollegen liegen da ganz sicher falsch, weil sie diese spezifische Frage nicht kompetent beurteilen können", reagierte er. Er wolle keine Panik verbreiten und sei keinesfalls ein Impfgegner, sagt der Professor, der sich selbst nach eigenen Angaben gegen Corona impfen ließ. Die Impfung sei ein wesentlicher Bestandteil im Kampf gegen das Virus, stellt er klar. Aber man müsse die medizinischen Gründe für eine Impfung individuell abwägen. Aus seiner Sicht wird die "individuelle Schutzüberlegung" überlagert vom Gedanken der schnellen Durchimpfung der Gesellschaft.
Auch der Bundesverband Deutscher Pathologen dringt auf mehr Obduktionen von Geimpften. Nur so könnten Zusammenhänge zwischen Todesfällen und Impfungen ausgeschlossen oder nachgewiesen werden, sagt Johannes Friemann, der Leiter der Arbeitsgruppe Obduktion in dem Verband. Allerdings wird aus seiner Sicht noch zu wenig obduziert, um von einer Dunkelziffer zu sprechen. "Man weiß noch gar nichts." Hausärzte und Gesundheitsämter müssten sensibilisiert werden. Die Länder müssten die Gesundheitsämter anweisen, vor Ort Obduktionen anzuordnen. Das hatte der Pathologen-Bundesverband bereits im März in einem Schreiben an Gesundheitsminister Jens Spahn (CDU) gefordert. Er blieb unbeantwortet, sagt Friemann.
© dpa-infocom, dpa:210801-99-647273/3
Directly from the dpa news channel
Stuttgart / Heidelberg (dpa / lsw) - The chief pathologist of the University of Heidelberg, Peter Schirmacher, is pushing for many more autopsies of vaccinated people. In addition to corona deaths, the bodies of people who die in connection with a vaccination should also be examined more frequently, said Schirmacher of the German Press Agency in Stuttgart. The director of the Pathology Institute in Heidelberg even warns of a high number of unreported vaccine deaths and complains: the pathologists would not notice anything about most patients who die after and possibly from a vaccination. However, other scientists disagree with him on this point, as do the Standing Vaccination Commission (Stiko) and the Paul Ehrlich Institute.
For a year now, corona deaths have been autopsied at the university hospitals in the southwest in order to better understand the disease. The country supports the Covid-19 autopsy research of the university pathologies with around 1.8 million euros. Schirmacher is leading the autopsy project. The findings of more than 200 autopsies so far have led, among other things, to better treatment and ventilation of Covid sufferers, he says. "The findings gained here therefore help to be able to treat patients better and more successfully and to save lives," says Science Minister Theresia Bauer (Greens). Schirmacher, who has been a member of the Leopoldina National Academy of Sciences since 2012, hopes that the funding will be continued next year.
The doctor now wants to get to the bottom of rare, serious side effects of vaccination - such as cerebral vein thrombosis or autoimmune diseases. The problem from his point of view: vaccinated people usually do not die under clinical observation. "The morgue doctor does not establish a context with the vaccination and certifies a natural death and the patient is buried," reports Schirmacher. "Or he certifies an unclear manner of death and the prosecutor's office does not see any external fault and releases the body for burial."
In Baden-Württemberg, the pathologists therefore worked together with public prosecutors, the police and local doctors, Schirmacher reports. More than 40 people have already been autopsied, who died within two weeks after vaccination. Schirmacher assumes that 30 to 40 percent of them died from the vaccination. From his point of view, the frequency of fatal vaccination episodes is underestimated - a politically explosive statement in times when the vaccination campaign is losing momentum, the Delta variant is spreading rapidly and restrictions on non-vaccinated people are being discussed.
Schirmacher also receives a clear contradiction from other scientists. The statements that we currently know too little about side effects and the dangers of vaccination are underestimated are not comprehensible, the Paul Ehrlich Institute said. In particular, for serious reactions, including when a person dies after vaccination, there is a reporting obligation under the Infection Protection Act. "I do not know of any data that allow a substantiated statement here and I am not going from an unreported number," said the head of the Standing Vaccination Commission, Thomas Mertens.
There is no reason to assume a high unreported number of vaccination complications or even deaths, said immunologist Christian Bogdan from the University Hospital Erlangen. "There can also be no question of neglecting the possible dangers of COVID-19 vaccines." The last few weeks and months in particular have shown that the surveillance system is working well. For example, the rare occurrence of cerebral vein thrombosis after vaccination with Astrazeneca (1-2 cases per 100,000 vaccinations) was recognized as a complication in Germany at a very early stage, says Bogdan.
Schirmacher insists on his opinion. "The colleagues are certainly wrong because they cannot competently assess this specific question," he responded. He does not want to spread panic and is by no means an opponent of vaccination, says the professor, who had himself vaccinated against corona according to his own statements. Vaccination is an essential component in the fight against the virus, he clarifies. But one must individually weigh the medical reasons for vaccination. From his point of view, the "individual protection consideration" is superimposed on the idea of the rapid vaccination of society.
The Federal Association of German Pathologists is also pushing for more autopsies of vaccinated people. This is the only way to exclude or prove links between deaths and vaccinations, says Johannes Friemann, the head of the autopsy working group in the association. However, from his point of view, there is still too little autopsy to speak of an unreported number. "You don't know anything yet." Family doctors and health authorities need to be sensitized. The states would have to instruct the health authorities to order on-site autopsies. The pathologists' Association had already demanded this in March in a letter to Health Minister Jens Spahn (CDU). He remained unanswered, says Friemann.
© dpa-infocom, dpa:210801-99-647273/3
Death Reports: Reports of vaccine-associated deaths and disability in children and young adults
List of injured/ dead athletes (takes you away from this page) - these have not all been independently verified
Ernesto Ramirez Jr: 16-Year-Old Boy Dies 5 Days After Receiving Pfizer COVID-19 Vaccine, Father Speaks Out
Ernesto Ramirez, Jr. - Death due to vaccination: Verified by a pathologist and a cardiology. I have personally met with Junior’s father and the cardiologist- independently verified. Although this new story made Main Stream News - those stories are now gone from the Internet searches.Fifth student dies after receiving Pfizer vaccine shot in Vietnam
New Zealand Authorities Link 26-year-old Man's Death To Pfizer COVID Vaccine
High school student dies after receiving COVID-19 vaccine shot (Vietnam)
Teen Dies Of Cardiac Arrest Weeks After Receiving Pfizer COVID-19 Vaccine
Teen dies days after getting COVID-19 vaccine, officials investigating
Disability in children and young adults - reports and references
VAERS database to December 17, 2021 The USG is not verifying VAERS deaths. The medical reports linked do give a detailed description of death and time from vaccination. Make your own judgements.
These Pediatric Deaths were all in the VAERS system. All were normal children or adolescents (persons with significant co-morbidies or deaths by suicide were removed from this list).
All reports were checked for legitimacy (appear to have been sent in by a physician or medical personnel). Parental or VAERS reports sent in by family members were removed.
16 year old girl, 9 days after Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1225942
15 year old boy, 1 day after Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1242573
15 year old boy, 23 days after Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1382906
16 year old boy, 4 days after Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1386841
17 year old girl, 15 days after Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1388042
13 year old boy, 1 day after Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1406840
17 year old girl, 6 days after Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1420762
13 year old boy, 17 days after Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1431289
(This boy was COVID positive, but had also been vaccinated 17 days prior)
16 year old boy, 6 days after Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1475434
16 year old boy, 4 days after Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1498080
13 year old girl, 26 days after Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1505250
16 year old girl, 9 days after Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1694568
16 year old boy, 23 days after Pfizer injection https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1734141
16 year old girl, 1 day after Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1757635
15 year old boy, 6 days after Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1764974
13 year old female, 15 days after Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1815096
17 year old girl, 36 days after Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1828901
16 year old girl, 9 days after Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1854668
5 year old girl, 4 days after Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1890705
34. 15 year old girl, onset on day of Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1592684
14 year old boy, 38 days after Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1690103
16 year old boy, 6 days after Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1702154
16 year old girl, days until death not noted: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1732657
17 year old boy, 9 days after Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1737907
15 year old boy, on day of Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1845034
13 year old boy, on day of Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1862946
12 year old boy, on day of Pfizer injection: https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1865979
13 year old girl, 31 days after Pfizer injection:
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1913198
17 year old boy, 7 days after Pfizer injection
https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1953860
Links can be confirmed by using the search function on this link : https://openvaers.com/openvaers
Just type in the last 7 digits of the links above to find the VAERS record
https://rwmalonemd.substack.com/p/omicron-today-january-6th
Omicron's feeble attack on the lungs could make it less dangerous. Kozlov M. Nature. 2022 Jan 5. doi: 10.1038/d41586-022-00007-8. Epub ahead of print. PMID: 34987210.
“Early indications from South Africa and the United Kingdom signal that the fast-spreading Omicron variant of the coronavirus SARS-CoV-2 is less dangerous than its predecessor Delta. Now, a series of laboratory studies offers a tantalizing explanation for the difference: Omicron does not infect cells deep in the lung as readily as it does those in the upper airways.”
Importance: I discussed this back on December 15th in my Substack article:
“Has Omicron shifted receptor binding specificity away from deep lung tissue? Could this be why it appears that Omicron is less severe than other variants?”
Now this has now been confirmed in an animal model.
The importance of this research is also that it answers the question of whether those who have neither been infected of vaccinated will have a less severe course of disease. That answer is good news. Omicron is more mild for everyone, significantly more mild.
The CDC has now approved boosters for ages 12-17 years of age. Of course we all know that this age cohort, particularly young men, has significant adverse events. So, we all have to ask why is this happening? Omicron is mild, there is no need for a vaccine or a booster, that does not stop transmission. In fact, there is even evidence that the vaccinated are catching Omicron more easily!
The truth is most of us have had some variant of COVID-19. But even if we haven’t, we will experience Omicron as a cold. But the vaccine has many adverse events - here are just a some of the peer reviewed literature on these side effects and death.
So, please parents - do your homework - make your decisions based on facts.
Omicron Variant (B.1.1.529): Infectivity, Vaccine Breakthrough, and Antibody Resistance. J Chem Inf Model. 2022 Jan 6. doi: 10.1021/acs.jcim.1c01451. Epub ahead of print. PMID: 34989238.
Abstract
“…Here, we present a comprehensive quantitative analysis of Omicron's infectivity, vaccine breakthrough, and antibody resistance. An artificial intelligence (AI) model, which has been trained with tens of thousands of experimental data and extensively validated by experimental results on SARS-CoV-2, reveals that Omicron may be over 10 times more contagious than the original virus or about 2.8 times as infectious as the Delta variant. On the basis of 185 three-dimensional (3D) structures of antibody-RBD complexes, we unveil that Omicron may have an 88% likelihood to escape current vaccines.
…However, its impacts on GlaxoSmithKline's sotrovimab appear to be mild.”
Importance:
Based on modeling, the Omicron may have an 88% likelihood to escape current vaccines.
Do I need to write more?
Age-associated SARS-CoV-2 breakthrough infection and changes in immune response in mouse model. Emerg Microbes Infect. 2022 Jan 6:1-36. doi: 10.1080/22221751.2022.2026741. Epub ahead of print. PMID: 34989330.
Highlights:
Older individuals are at higher risk of SARS-CoV-2 infection and severe outcome but the underlying mechanisms are incompletely understood. In addition, how age modulates SARS-CoV-2 re-infection and vaccine breakthrough infections remains largely unexplored. Here, we investigated age-associated SARS-CoV-2 pathogenesis, immune responses, and the occurrence of re-infection and vaccine breakthrough infection utilizing a wild type C57BL/6N mouse model.
The study demonstrates that interferon and adaptive antibody response upon SARS-CoV-2 challenge are significantly impaired in aged mice in comparison to young mice, which results in more effective virus replication and severe disease manifestations in the respiratory tract.
Aged mice also showed increased susceptibility to re-infection due to insufficient immune protection acquired during primary infection.
Importance:
“In mice, a two-dose COVID-19 mRNA vaccination conferred limited adaptive immune response among the aged mice which rendered them susceptible to SARS-CoV-2 infection.”
The significant adverse event profile of the genetic vaccines, combined with the more mild disease profile of Omicron has to raise the possibility that the boosters may not be good “medicine,” even for the elderly.
We will have more variants- natural immunity is robust and more broadly protective. Omicron is going to rip through the US population.
Maybe it is time to entirely re-evaluate our entire SARS-CoV-2 vaccination program?
https://www.canadiancovidcarealliance.org/
https://www.skirsch.io/how-to-treat-covid/
This article primarily covers treating COVID, long-haul COVID, and side-effects from COVID vaccines. We also talk about the Together trial results, why clinical trials fail, etc. We include COVID prophylaxis and early treatments that do not currently require a prescription because in many countries the prescription drugs may not be available.
Disclaimer: This info is for educational purposes only. Please consult with your doctor before taking any drugs.
If you have to get a vaccine, which one is the safest?
Pfizer, then Moderna, then J&J. See Vaccine risk benefit by age.
How to avoid vaccine side effects
- Many people will try to get Sinovac-CoronaVac or Sinopharm. The vaccine doesn't work, but there are no side effects and you get your vaccine card which is the important thing. But it may not be "usable" in other countries.
- If you are forced to get one of the US vaccines, using .2mg/kg of ivermectin the day before, the day of, and the day after will reduce your chance of side effects by 95% according to a prominent researcher in Brazil we know. Of course, the FDA and AMA are trying their best to block your access to ivermectin, a new low for medicine. The mainstream medical community are cheering them on.
Treating COVID
Got COVID? Treating it ASAP is key for best outcomes. Even if it seems mild at first, treat COVID like you'd treat a fire in your house: the sooner you put it out, the less the long term damage.
Remember: The only thing all the COVID patients in hospitals today have in common today is that they didn't treat their infection using a proven early treatment protocol (or they waited too long).
Step 1: Find a doc, get a prescription, and get the medications filled now so that they can be on hand for your immediate use. This is critical for new variants because every hour counts. In some cases, you may need to have another condition in order to get a prescription, e.g., if you have OCD, you can get fluvoxamine for that condition and the use for COVID is a nice fringe benefit. There are also some treatments that don't require a prescription.
Step 2: As soon as you think you might have COVID, start treatment. Don't wait for a positive test. If your test result ends up being negative, stop the treatment. Because the treatments are so safe, everyone, even kids, can and should be treated immediately upon suspected COVID. Early treatment reduces risk of hospitalization, death, and reduces the chance of getting long-haul COVID which can be very hard to treat. If you started treatment early, your symptoms should start reversing about 24 hours after you start treatment.
List of doctors
Your doctor is unlikely to know how to treat you correctly. Here is a list of telemedicine providers who know their stuff and will give you a prescription for you to fill now so that you will have ALL the drugs on hand if/when you get sick. This is important because you want to have all the drugs immediately available. Time is critical.
List of doctors who will write early treatment COVID prescriptions
They generally will prescribe to you one of the following early treatment protocols or some modification that they personally like. Each physician ends up using his own judgement based on what they've personally seen work the best.
- Modified Patterson protocol (shown below)
- I-MASK+ protocol from flccc.net. See this Chris Martenson video.
- Tyson-Fareed protocol: Has 99.76% risk reduction and no safety downsides.
- Zelenko early treatment protocol: Another highly effective treatment.
- Chetty protocol: Described in this paper, it has over 99% risk reduction.
- Italy protocol: This is extremely effective. Reportedly, only 4 out of 66,000 people died in Italy. This is an HCQ-based protocol because ivermectin is prohibited in Italy.
- Egyptian protocol: Very successful in Egypt
- Dr. Urso protocol (the lack of units is a bit troubling):
Modified Patterson early treatment protocol for COVID
Based on recommendation of Dr. Bruce Patterson with a few minor improvements. Patterson who treats thousands of long-haul COVID and vaccine cases so he knowns more than anyone else the drugs that in combination are the most effective in countering the inflammation caused by COVID. Take all drugs (that you can access) IMMEDIATELY after you suspect a COVID infection (except as indicated). The following are all safe and do not interact with each other.
- Fluvoxamine (luvox) 50mg twice a day for 14day. If not available, use fluoxetine (prozac) 30mg once a day x 14 days. If already on an antidepressant, consider talking to your doctor about switching. Avoid caffeine, alcohol, tylenol, and benadryl while on fluvoxamine. Fluvoxamine prevents brain fog because it passes through the blood brain barrier. In rare cases, can cause hair loss. If you can't tolerate fluvoxamine, try Prozac instead. It works just as well (proven in multiple observational studies). If you are jittery, have dilated pupils, or other side effects, you may need to reduce the dosage. For details on fluvoxamine, see My substack article on fluvoxamine.
- Ivermectin .4 mg/kg every day for a minimum of 10 days and continue until symptoms resolved. Take with a meal or right after a meal for best absorption. Ivermectin is one of the safest drugs ever invented. See the FLCCC website for more info. Some people are super sensitive and can't take that dose every day. In that case, taking it every 3 days should be fine since it is slowly eliminated from your body.
- Inhaled budesonide: 400 µg per actuation (two puffs to be taken twice per day; total dose per day 1600 µg) x 14 days (or until resolution of respiratory symptoms). You really want to throw the kitchen sink at this virus and the number one reason people got to the hospital is respiratory distress. The latest Together trial will be testing fluvoxamine and budesonide in combination. We recommend this even if you don't appear to have any respiratory symptoms because you want to play it safe and keep it that way.
- NAC: 600mg/day for 14 days. This mitigates the damage caused by the spike protein. This is a super safe drug that was available over the counter for 60 years. After 60 years of safety, and incorporation in 1,500 products, it was made prescription only so people would not have access to it and would be forced to get vaccinated.
- Vitamin D3: 15,000 IU/day for 14 days to lower inflammation.
- Pravastatin: 20mg x 14 days. Other statins can be used but this is the best.
Early-treatment "options"
Here are a few optional "add-ons" that you can safely add to any of the protocols that can make a difference (if not already in your protocol). You can even do quite well using these as your only defense. Although all are available without a prescription, always discuss with your doctor before taking these. They can be considered if you cannot adopt a proven combo protocol or you simply want an extra margin of protection.
It is not always the case that more is better. You can run into weird interactions when taking lots of drugs at the same time.
- Benadryl + lactoferrin: Take as soon as you have symptoms. Both are very safe and available without a prescription. Together they are 99% effective according to this article. Here is the paper. CAUTION: Do not combine benadryl and fluvoxamine; they interact. Benadryl can cause your eyes to dilate.
- Aspirin: Reduces chance of death by around 50%. Either size works. Take once a day for 10 days after first symptoms.
- Nigella sativa (no prescription needed)
Black seeds 40mg/kg orally once per day for 14 days. $9 gets you a 70 day supply. Reduces hospitalization risk by 75%. Death by 95% . - Vitamin D3: 15,000 IU/day for 14 days to lower inflammation. Up to 80% reduced risk. Ideally, you'll want to take with magnesium for complete absorption. Also, if you try to load up AFTER you get COVID, it will take too long unless you pre-order this and have it on hand: d.velop Vitamin D.
- Povidone-iodine (Betadine): .5% to 1% solution (no prescription needed; widely available at drug stores at low cost). Do it 3 times a day for the first 3 days. The 1% will be somewhat uncomfortable. The .5% will hurt less. So if you can't tolerate the 1%, dilute it down 1:1 with purified water.
The pro tip is to buy the 10% solution and then dilute it down to 1% or even .5%. Otherwise you'll be sorry. So a bottle of the 10% solution (which will cost you around $15 or less for an 8oz container) is going to last you a LONG LONG time.
Mouthwash/gargle and nasal drops (or rinse) 3 times a day starting on first symptoms. After 7 days you'll see a 99% drop in viral load and you'll lower your risk of death by nearly 90%. See Effect of 1% Povidone Iodine Mouthwash/Gargle, Nasal and Eye Drop in COVID-19 patients and Rapid initiation of nasal saline irrigation: hospitalizations in COVID-19 patients randomized to alkalinization or povidone-iodine compared to a national dataset which shows that early treatment can reduce your risk by 95% if you start early for just this one simple, easy, very safe intervention. You can get both solutions on Amazon or at www.immunemist.com. DO NOT USE THIS EVERYDAY as a prophylaxis. Instead, use within 12 hours of higher risk contact, or twice a day for 14 days if you get infected with COVID. It's basically a stronger solution than the hypertonic saline solution. - Colgate Total (no prescription needed)
Total contains cetyl pyridinium chloride (CPC). Within 12 hours after possible contact, swish and gargle for 30 seconds and put a saturated Qtip up your nose (watch this instructional video). You can use other mouthwashes with CPC. This is a very simple and inexpensive solution to the problem ($5 per month) that protects you against other viruses as well. - Hypertonic saline solution nasal rinse (no prescription needed)
Create a hypertonic solution by adding 1 tsp of salt (5g) to 8oz water. This will create a 2% solution. Do a nasal rinse with a squeeze bottle (I use the 8 oz NeilMed squeeze bottle) or a neti pot. If you do the rinses occasionally (because you are rarely exposed), the NeilMed bottle is fine. If you do more often, the neti pot is better since there is no pressure so less potential damage to sensitive nasal structures. Do this within 12 hours after a risky incident (e.g., before bed). For extra credit, with remaining hypertonic solution, gargle, swish and then spit after 20-30 seconds. However, most COVID infections are through the nose. A lot of doctors say you should use purified or distilled water. Others I highly respect say that's overkill and say tap water is fine. I've always used warm tap water (at same temperature as your body temperature) and never had a problem. Compliance is the most important factor. - NAC: 600mg/day for 14 days. This mitigates the damage caused by the spike protein. This is a super safe drug that was available over the counter for 60 years. After 60 years of safety, and incorporation in 1,500 products, it was made prescription only so people would not have access to it and would be forced to get vaccinated. I bought mine at Thorne. No prescription needed.
- Glutamine: 10 g l-Glutamine available in powder forms were given 3 times a day with meals. In the control group, 38 out of 230 covid patients died. In the glutamine group, 0 out of 222 patients died:The effect of glutamine supplementation on serum levels of some inflammatory factors, oxidative stress, and appetite in COVID-19 patients: a case-control study - PubMed (nih.gov) Again, no mortality and no ICU admission in the glutamine group… Effect of oral l-Glutamine supplementation on Covid-19 treatment - PubMed (nih.gov)
Prophylaxis protocols (recommended)
Lactoferrin (no prescription needed)
"“We found lactoferrin had remarkable efficacy for preventing infection, working better than anything else we observed," Sexton said. He adds that early data suggest this efficacy extends even to newer variants of SARS-CoV2, including the highly transmissible Delta variant.” This is safe.
However, it may be more convenient just to skip the prophylaxis, get COVID, and treat it early.
Prophylaxis protocols (not recommended)
FLCCC prophylaxis protocol
This is an ivermectin-based protocol. However, in consultation with other docs (gut specialists), I do not recommend it because it will destroy the good bacteria in your gut. In general, do not take prescription drugs for prophylaxis.
Nasal irrigation (no prescription needed)
Done twice a day has been remarkably effective in preventing COVID infections. See hypertonic above for details. Again, this is NOT recommended because you will upset the bacteria balance in your nose. If you do it, you only want to treat on an acute basis (i.e., when you are sick).
Other drugs that work against COVID-19
See C19 Early for a list of drugs and effect sizes.
Treating long haul COVID
Bruce Patterson’s long haul COVID treatment relies on four drugs. The dosing depends on what your bloodwork shows (based on the Cytokine 14 panel available at covidlonghaulers.com), so the dosages are averages.
- Fluvoxamine: 50mg BID
- Ivermectin: .2mg/kg every 3 days
- Pravastatin: 20mg (substitute for fractal kinase inhibitor)
- Maraviroc 300mg PO BID. This reduces CCR5 and takes about 5 days to work.
The other option is going to covidlonghaulers.com and getting tested. Then they'll prescribe drugs based on your test results.
Treating pre- and Post-Vaccine Inflammatory Syndrome (PVIS)
Ideally start this 3 days before you vaccinate. Less ideally, start this immediately after vaccination.
Continue for 14 days if using to minimize vaccine side effects.
The longer you wait, the more likelihood of permanent damage to heart, lungs, and brain. Once those tissues are scarred from inflammation, they will never heal. This is why many long-haulers never regain full function. It's exactly the same story with vaccine victims. Watch this 8 minute video featuring Dr. Charles Hoffe.
- Fluvoxamine: 50mg BID (can substitute 30mg Prozac QD)
- Ivermectin: .2mg/kg daily. You may see results in less than 24 hours. Note this is a lower dose than an active COVID infection.
- Prednisone: 5mg/day for inflammation. Note: this is a low amount because if you give more you start to affect the immune system which is problematic because you want the macrophages to clear out the spike protein
- Pravastatin: 20mg (substitute for fractal kinase inhibitor)
- Maraviroc 300mg PO BID. This reduces CCR5 and takes about 5 days to work.
For best results, go to covidlonghaulers.com and getting tested with the 14 cytokine panel and they'll prescribe the appropriate drugs based on your test results (since the Maraviroc is pretty pricey). You also will want to get the Spike Protein test at incelldx.com (but it seems it isn't available as of Sept 7, 2021).
Or check out the FLCCC I-Recover protocol; it can be used for PVIS as well (as they note in the text).
Drugs that may be available in the future
These drugs will be difficult to impossible to obtain currently in the US but may be available in other countries:
- enovid. This drug is made by SaNOtize . It probably won't be available in your area, but it appears to be effective.
- Interferon Lambda: If you can get a single injection of Interferon Lambda (made by Eiger), that is the drug with the largest effect size and best safety profile. It is currently only available in clinical trials. It should be taken ASAP after infection for best results. It drastically reduces d-dimer which is an excellent indication that has a dramatic effect in lowering blood clotting (and likely inflammation). You basically will not get hospitalized if you get this drug. If you only can take one drug, this is the drug to take. If you can get access to this drug early, everything else is optional.
- Camostat: 200mg taken orally, 4 times daily, for 7 days will absolutely reduce your chance of long haul COVID symptoms and reduce your risk of hospitalization. It isn't approved in the US, but is approved in other countries. It will not change your time to recover. It's about preventing you from developing long-haul COVID symptoms and severe disease. It's an antiviral so take ASAP.
- Proxalutamide: Appears extremely impressive, near 100% efficacy. Now in Phase 3 trials in USA.
Currently, the five most effective drugs for COVID are:
- Interferon lambda
- Fluvoxamine or Fluoxetine (Prozac)
- Ivermectin
- Inhaled budesonide (see this tweet)
- Camostat
That list was made on July 26, 2021. It will be 4 months before the rest of the world figures it out.
Note about Together trial results for fluvoxamine and ivermectin
Why did Ivermectin seem to fail and Fluvoxamine not do so well? Ivermectin was dosed for 3 days; fluvoxamine for 10 days.
We don't think the trial was gamed at all. I think this was a legit result.
We know the PI Edward Mills and believe he is totally honest and we have no reason not to believe the results he obtained. But we also believe other researchers as well.
So the question everyone has is how could these drugs do so well in other studies?
The answer: the variant was different. P1 is the variant in Brazil and makes Delta look like a walk in the park. If you do not treat P1, instantly upon symptoms, you will see big failures.
Had fluvoxamine been given on Day 0 instead of Day 4, there would have been a dramatically different result.
Had ivermectin been dosed at .6mg/day for 14 days starting on Day 0 (the first day of symptoms), there would have been a dramatically different result.
The more aggressive the variant, the earlier and harder you have to treat it.
Ivermectin likely failed for these five reasons:
- Too little a dose
- Started too late
- Not taken with meal or shortly after
- Not continued for long enough
- Many patients may have already been taking ivermectin
The healthcare systems need to encourage people to have the meds in the cabinet for immediate use. Nobody does that. That's why we have a problem.
Also, you can't treat Delta and P1 in the hospital... it is much much tougher there. It's like a fire department arriving when the entire building is in flames.
Early aggressive treatment is key. There are near ZERO hospitalizations and DEATHs for anyone treated early. But the press never talks about that. The NIH or CDC never says that either. Why not?
You can't say vaccination works: at Mt Sinai in NY, 27% of the hospitalized cases are vaccinated, and 17% of ICU patients are vaccinated.
The sooner we stop following the NIH advice that early treatments don't work, the sooner we will start saving lives.
Ways a clinical trial can fail
Clinical trials on repurposed drugs should always be tested first on outpatients by physicians who prescribe on a shared decision making basis. Once a protocol is found to be reliable, then it can be "locked" into a clinical trial for "proof" of efficacy. Sadly, we do the opposite which wastes a lot of time and money. We form a hypothesis and then invest millions to test it out in a large scale trial rather than on an outpatient basis.
Here are some ways a clinical trial can fail.
- Dose: standard dosing may need to be increased for new variants. The FLV dosing of 50mg BID was tested for alpha variant. In general, increase dose for aggressive variants or treatment that is started later after infection. In this trial they used 100mg BID. The downside is that this dose can lead to compliance problems where people have to discontinue the use of the drug.
- Timing: Ivermectin is best taken with a fatty meal or right after, not on an empty stomach. The FDA however requires the drug to be taken on an empty stomach in trials due to worries about liver toxicity, even though this hasn't been a problem in any other trial. This seems very silly.
- Treatment delay: Treatment in Together started on average 4 days after symptoms. Too long of a wait especially for fast replicating variants like Delta. The lesson is start treatment IMMEDIATELY after symptoms recognized or before, especially with aggressively replicating variants. This is the most important determinants of success; once the damage is done, it is hard to reverse. This is the most important thing to get right.
- Compliance: Patient compliance in the Together trial was estimated to be somewhere around 80%. If compliance is low, it is going to limit your effect size. How can the study prove that everyone took all their meds as directed? We can only see this by looking at the source data of the study for clues. As the pandemic continues, we've found patient compliance to drop dramatically. Early in the pandemic, you could call participants and talk to you. Today, you call and they hang up on you.
- Duration: Delta can hang around for 33 days. Treatment should be continued until 5 days after symptoms resolve. So shouldn't be a fixed duration (like it was in the trial). In the trial, the duration for ivermectin was only 3 days; was 10 days for fluvoxamine.
- Deception: Participants were supposed to be early in COVID, but many could have given inaccurate information either willfully or mistakenly. There was no way to tell because this wasn't measured. This explains how so many ended up in the hospital so fast (e.g., within 1 day after treatment started). There wasn't baseline bloodwork taken to assess disease state of the participants. They could have determined disease stage from this and better assessed outcomes.
- Lack of adaptability: Some doctors find that using D-dimer and CRP to guide the dose and duration can be very helpful. That is rarely done in a clinical trial.
- Single drug: Using a multi-drug protocol will work better especially if the drugs are synergistic. For example, many people claim HCQ without zinc is a non-starter.
- Tampering: Phase 3 trials don't have levels of controls to detect manipulation. It relies on everyone being trustable in doing their jobs. If the drugs are switched accidentally (placebo vs. real drug), no one will know. This is why it is important to look at the source data and the side effect reports. Even the best designed studies are susceptible to tampering. That tampering could be deliberate or accidental and it can be hard to detect.
- Data manipulation: One ivermectin study showing a positive result was clearly manipulated. Data manipulation does happen. It can sometimes take months before this is exposed.
- Controls may already be taking one of the study drugs: A major reason why ivermectin trials don't fare too well in S. America is that lots of controls may have taken ivermectin. For example, in the TOGETHER trial, it was NOT an exclusion criteria (and so the data should be segmented by that before coming to conclusions).
- Dropouts. People can drop out of the trial causing you to lose statistical power.
- Missing data. People can not report back what happened.
- Low event rate. You may underpower the trial because people are healthier than you presumed or the virus mutates to a less dangerous strain.
- Competitive sabotage. A competitor can pay enrollees to enroll in the trial and not take the drug.
These are issues that can come up with any trials, even well done trials. It's a shame these trials in general do not have more controls to detect these mistakes. They happen. This is a known limitation of every clinical trial; few if any have any robustness to errors.
One other very important point is that researchers are PROHIBITED by their IRB and other entities from testing ivermectin doses and durations that would be effective! One doctor in the US just told me that they wouldn't let him go higher than 200mg/kg for 3 days. That's crazy. Ivermectin is one of the safest drugs on the planet.
An idea for rapidly screening drugs against COVID
The biggest problem with COVID is the inflammation and clotting. The vaccines create the same rise in CRP and D-dimer as COVID and it's very reliable (happens post-vax in over 60% of cases).
Therefore, if we want to test a single drug against COVID, all we need is 5 volunteers who have been recently vaccinated. Treat immediately after vaccination with the drug. Measure CRP and D-dimer at 5 days. If both are normal in all 5 patients in 5 days, you have a candidate drug.
Once you have 3 candidate drugs and test the combo in a clinical trial.
For more information
- Early treatment is key to better outcomes
- Detailed advice on treatment
- Ten things to know about treating COVID infections
- Drugs and dosages
- Summary of what we know about treating early (just read the introduction)
- Short summary of the case for using fluvoxamine for COVID (slides only)
- Video presentation of the slides: 15 minutes at start of Semmelweis effect seminar
- Detailed summary of the evidence supporting the use of fluvoxamine for COVID
The tl;dr is that every piece of evidence we have ever seen (observational studies, randomized trials, doctor experiences) is positive. There are no cases where fluvoxamine made things worse. If treated early enough with fluvoxamine, patients can recover and completely avoid long-haul COVID issues. - COVID-19 Early Treatment Fund (CETF) Introduction - YouTube
- Fluvoxamine: Finding a possible early treatment for COVID-19 in a 40-year-old antidepressant - 60 Minutes - CBS News
https://americanbuddhist.net/2021/12/13/france-covid-mortality-with-vs-without-hcq/
In a recent presentation, Pr. Million from IHU Marseille has presented their first numbers of Covid mortality by age group in 2021.
He has highlighted the improved 2021 mortality where patients did not get HCQ+AZ, which he attributed to the discreet introduction of Ivermectin.
IHU has adopted Ivermectin in 2021 but has stayed silent about it.
Possibly to avoid controversy and maintain access to the drug, and more likely because French regulators insisted that off-label use was a right but any publicity would be sanctioned.
https://abcnews.go.com/Business/pfizer-fined-23-billion-illegal-marketing-off-label/story?id=8477617
— -- In the largest health care fraud settlement in history, pharmaceutical giant Pfizer must pay $2.3 billion to resolve criminal and civil allegations that the company illegally promoted uses of four of its drugs, including the painkiller Bextra, the U.S. Department of Justice announced Wednesday.
Besides Bextra, the drugs were Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug. Once the Food and Drug Administration approves drugs, doctors can prescribe them off-label for any use, but makers can't market them for anything other than approved uses.
Pfizer subsidiary Pharmacia & Upjohn pleaded guilty to a felony violation for promoting off-label uses of Bextra, such as for pain relief after knee replacement surgery. At the FDA's request, Pfizer pulled Bextra off the market in April 2005 because its risks, including a rare, sometimes fatal, skin reaction, outweighed its benefits. It had been approved only for treating rheumatoid arthritis, osteoarthritis and menstrual pain.
As part of the settlement, Pfizer PFE will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the USA for any matter, according to the Justice Department. Pharmacia & Upjohn must pay a $105 million criminal fine.
Pfizer also has agreed to pay $1 billion in civil damages and penalties to compensate federal health-care programs for false claims submitted as a result of its marketing Bextra and the other four drugs for off-label use or at unapproved dosages.
In an interview Wednesday with USA TODAY, former Pfizer sales representative John Kopchinski said he was told to distribute 20-milligram samples to rheumatologists and orthopedists, even though the FDA had approved only 10-milligram doses for arthritis. The 20-milligram doses were approved only for menstrual pain, yet Kopchinski says he never called on gynecologists or other doctors who would treat that complaint.
In 2003, Kopchinski, 45, a West Point graduate, filed the first whistle-blower lawsuit, leading to the Justice Department investigation. Kopchinski says he was inspired by David Franklin, who filed a whistle-blower lawsuit against Pfizer for promoting Neurontin — at the time approved only to control seizures — for unapproved uses such as treating bipolar disorder.
When Kopchinski began questioning Pfizer's marketing of Bextra and sued, Pfizer fired him, a violation of the anti-retaliation provision of the federal False Claims Act, says his attorney, Erika Kelton of the Washington, D.C., firm Phillips & Cohen. At the time, his son was 2 and his wife was pregnant with twins.
Kopchinski, who began working for Pfizer in 1992, says he was the last employee personally hired by former CEO Edward Pratt, with whom he began corresponding while serving in the first Gulf War.
Kopchinski says one night while on guard duty, he saw a photo of Pratt, now deceased, in Reader's Digest and decided to write him to ask if he wanted to "adopt" his platoon. At the time, Kopchinski says, Pfizer owned Coty cosmetics, and Pratt, an assistant secretary of the Army in the Kennedy administration, responded by sending over three cases of cologne.
Although Kopchinski worked three years as a financial adviser after leaving Pfizer, he says, "I pretty much depleted my 401(k)."
Of the $102 million share of the settlement that will be divided among six whistle-blowers, Kopchinski will receive $51.5 million. To celebrate, he and his wife took their three children out of school Wednesday to have a new family portrait taken and to go to Chuck E. Cheese's for pizza. Kopchinski, who now lives in San Antonio, says he and his wife plan to be stay-at-home parents.
Pfizer mentioned the $2.3 billion settlement this past January in filings with the Securities and Exchange Commission, in which it said it was taking a $2.3 billion charge against earnings related to lawsuits, but the lawsuits were sealed and the investigation ongoing at the time, so no details could be released, Justice Department spokesman Charles Miller said Wednesday. Shares of Pfizer closed at $16.28, down 10 cents.
In a statement, Pfizer senior vice president and general counsel Amy Schulman said: "We regret certain actions taken in the past, but are proud of the action we've taken to strengthen our internal controls and pioneer new procedures."
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