Pfizer et les vaccins Moderna « augmentent considérablement

par Jeromec, vendredi 26 novembre 2021, 18:52 (il y a 1618 jours) @ Jeromec

https://childrenshealthdefense.org/defender/sharyl-attkisson-steven-gundry-pfizer-moder...

Pfizer, Moderna Vaccines ‘Dramatically Increase’ Heart Attack Risk, Renowned Cardiologist Warns

Pfizer et les vaccins Moderna « augmentent considérablement » le risque de crise cardiaque, prévient un cardiologue renommé

Dans une analyse présentée lors d'une réunion de l'American Heart Association, le Dr Steven Gundry, un pionnier de la chirurgie de transplantation cardiaque chez le nourrisson, a déclaré que les vaccins à ARNm contre le COVID exposent de nombreux patients à un risque plus élevé de nouveau syndrome coronarien aigu, tel qu'une crise cardiaque.

Par
Sharyl Attkisson

42

https://childrenshealthdefense.org/defender/sharyl-attkisson-steven-gundry-pfizer-moder...

Lien copié

Les vaccins à ARNm COVID-19 Pfizer et Moderna "augmentent considérablement" une mesure courante du risque cardiaque chez les humains.
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Les vaccins à ARNm COVID-19 Pfizer et Moderna «augmentent considérablement» une mesure courante du risque cardiaque chez les humains.

C'est ce qu'indique un « avertissement » récemment publié dans la revue Circulation par le cardiologue Dr Steven Gundry, qui est considéré comme un pionnier de la chirurgie de transplantation cardiaque chez le nourrisson.

L'analyse a été présentée lors de la récente réunion de l'American Heart Association.

Les «changements spectaculaires chez la plupart des patients» signifient qu'ils sont plus à risque de développer un nouveau syndrome coronarien aigu, comme une crise cardiaque, selon Gundry.

En partie, l'analyse indique :

"Nous concluons que les aspirateurs d'ARNm augmentent considérablement l'inflammation de l'endothélium et l'infiltration des cellules T du muscle cardiaque et peuvent expliquer les observations d'une augmentation de la thrombose, de la cardiomyopathie et d'autres événements vasculaires après la vaccination."

Gundry a expliqué :

"Récemment, avec l'avènement des vaccins à ARNm COVID-19 (vac) par Moderna et Pfizer, des changements spectaculaires dans le score PULS sont devenus apparents chez la plupart des patients."

Des milliers de blessures cardiaques ont été signalées à la suite de vaccins à ARNm COVID. Ces blessures conduisent à la formation et à la progression de lésions cardiaques qui peuvent devenir instables et se rompre, entraînant des événements cardiaques.

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Le test PULS (Protein Unstable Lesion Signature) mesure les biomarqueurs protéiques les plus cliniquement significatifs qui fuient des lésions cardiaques dans les parois des vaisseaux sanguins, fournissant une mesure de la réponse du système immunitaire du corps aux lésions artérielles.

Les scientifiques ont déjà établi une myriade d'effets cardiaques et sanguins des vaccins COVID-19 chez certains patients, y compris les jeunes. Parmi les événements indésirables liés aux vaccins figurent la thrombose des caillots sanguins et l'inflammation cardiaque connue sous le nom de myocardite et péricardite.

Les Centers for Disease Control and Prevention et la Food and Drug Administration des États-Unis affirment que les vaccins sont sûrs et efficaces pour toutes les personnes pour lesquelles ils sont recommandés, et que les avantages l'emportent sur les risques connus, qui apparaîtront pendant quelques années à mesure que de plus en plus de personnes se feront vacciner.''

L'original :

In an analysis presented during a meeting of the American Heart Association, Dr. Steven Gundry, a pioneer in infant heart transplant surgery, said mRNA COVID vaccines put many patients at higher risk of a new acute coronary syndrome, such as a heart attack.

By
Sharyl Attkisson

42

https://childrenshealthdefense.org/defender/sharyl-attkisson-steven-gundry-pfizer-moder...

The COVID-19 Pfizer and Moderna mRNA vaccines "dramatically increase" a common measure of heart risk in people.
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The COVID-19 Pfizer and Moderna mRNA vaccines “dramatically increase” a common measure of heart risk in people.

That’s according to a recently published “warning” in the journal Circulation by cardiologist Dr. Steven Gundry, who is called a pioneer in infant heart transplant surgery.

The analysis was presented at the recent meeting of the American Heart Association.

The “dramatic changes in most patients” mean they are at higher risk of a new acute coronary syndrome, such as a heart attack, according to Gundry.

In part, the analysis states:

“We conclude that the mRNA vacs dramatically increase inflammation on the endothelium and T cell infiltration of cardiac muscle and may account for the observations of increased thrombosis, cardiomyopathy, and other vascular events following vaccination.”

Gundry explained:

“Recently, with the advent of the mRNA COVID-19 vaccines (vac) by Moderna and Pfizer, dramatic changes in the PULS score became apparent in most patients.”

Thousands of heart-related injuries have been reported following COVID mRNA vaccines. These injuries lead to the formation and progression of cardiac lesions which may become unstable and rupture, leading to cardiac events.

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The PULS (Protein Unstable Lesion Signature) test measures the most clinically significant protein biomarkers that leak from cardiac lesions in the blood vessel walls, providing a measure of the body’s immune system response to arterial injury.

Scientists have already established a myriad of heart- and blood-related effects of COVID-19 vaccines in some patients, including young people. Among the adverse events linked to the vaccines are thrombosis blood clots and heart inflammation known as myocarditis and pericarditis.

The Centers for Disease Control and Prevention and the U.S. Food and Drug Administration say the vaccines are safe and effective for everyone they are recommended for, and that the benefits outweigh the known risks, which will be emerging for some years as more people get vaccinated.''

Un article de l'UNIVERSITÉ DE HAVARD

Médicaments à risque : pourquoi on ne peut pas faire confiance à la FDA

https://ethics.harvard.edu/blog/risky-drugs-why-fda-cannot-be-trusted

Risky Drugs: Why The FDA Cannot Be Trusted
July 17, 2013

by Donald W. Light

A forthcoming article for the special issue of the Journal of Law, Medicine and Ethics (JLME), edited by Marc Rodwin and supported by the Edmond J. Safra Center for Ethics, presents evidence that about 90 percent of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs.

All of them may be better than indirect measures or placebos, but most are no better for patients than previous drugs approved as better against these measures. The few superior drugs make important contributions to the growing medicine chest of effective drugs.

The bar for “safe” is equally low, and over the past 30 years, approved drugs have caused an epidemic of harmful side effects, even when properly prescribed. Every week, about 53,000 excess hospitalizations and about 2400 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier. One in every five drugs approved ends up causing serious harm,1 while one in ten provide substantial benefit compared to existing, established drugs. This is the opposite of what people want or expect from the FDA.

La barre pour « sûr » est tout aussi basse, et au cours des 30 dernières années, les médicaments approuvés ont provoqué une épidémie d'effets secondaires nocifs, même lorsqu'ils sont correctement prescrits. Chaque semaine, environ 53 000 hospitalisations en excès et environ 2 400 décès en excès se produisent aux États-Unis parmi les personnes prenant des médicaments correctement prescrits pour être en meilleure santé. Un médicament approuvé sur cinq finit par causer de graves dommages,1 tandis qu'un médicament sur dix procure des avantages substantiels par rapport aux médicaments existants et établis. C'est le contraire de ce que les gens veulent ou attendent de la FDA.

Prescription drugs are the 4th leading cause of death. Deaths and hospitalizations from over-dosing, errors, or recreational drug use would increase this total. American patients also suffer from about 80 million mild side effects a year, such as aches and pains, digestive discomforts, sleepiness or mild dizziness.

''Les médicaments sur ordonnance sont la 4e cause de décès. Les décès et les hospitalisations dus à un surdosage, à des erreurs ou à la consommation de drogues à des fins récréatives augmenteraient ce total. Les patients américains souffrent également d'environ 80 millions d'effets secondaires bénins par an, tels que des courbatures, des malaises digestifs, de la somnolence ou de légers vertiges.''

The forthcoming article in JLME also presents systematic, quantitative evidence that since the industry started making large contributions to the FDA for reviewing its drugs, as it makes large contributions to Congressmen who have promoted this substitution for publicly funded regulation, the FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths. New FDA policies are likely to increase the epidemic of harms. This will increase costs for insurers but increase revenues for providers.

This evidence indicates why we can no longer trust the FDA to carry out its historic mission to protect the public from harmful and ineffective drugs. Strong public demand that government “do something” about periodic drug disasters has played a central role in developing the FDA.2 Yet close, constant contact by companies with FDA staff and officials has contributed to vague, minimal criteria of what “safe” and “effective” mean. The FDA routinely approves scores of new minor variations each year, with minimal evidence about risks of harm. Then very effective mass marketing takes over, and the FDA devotes only a small percent of its budget to protect physicians or patients from receiving biased or untruthful information.34 The further corruption of medical knowledge through company-funded teams that craft the published literature to overstate benefits and understate harms, unmonitored by the FDA, leaves good physicians with corrupted knowledge.5 6 Patients are the innocent victims.

Although it now embraces the industry rhetoric about “breakthrough” and “life-saving” innovation, the FDA in effect serves as the re-generator of patent-protected high prices for minor drugs in each disease group, as their therapeutic equivalents lose patent protection. The billions spent on promoting them results in the Inverse Benefit Law: the more widely most drugs are marketed, the more diluted become their benefits but more widespread become their risks of harm.

The FDA also legitimates industry efforts to lower and widen criteria prescribing drugs, known by critics as “the selling of sickness.” Regulations conveniently prohibit the FDA from comparing the effectiveness of new drugs or from assessing their cost-effectiveness. Only the United States allows companies to charge what they like and raise prices annually on last year’s drugs, without regard to their added value.7

A New Era?

Now the FDA is going even further. The New England Journal of Medicine has published, without comment, proposals by two senior figures from the FDA to loosen criteria drugs that allege to prevent Alzheimer’s disease by treating it at an early stage.8 The authors seem unaware of how their views about Alzheimer’s and the role of the FDA incorporate the language and rationale of marketing executives for the industry. First, they use the word “disease” to refer to a hypothetical “early-stage Alzheimer’s disease” that supposedly exists “before the earliest symptoms of Alzheimer’s disease are apparent.” Notice that phrasing assumes that the earliest symptoms will become apparent, when in fact it’s only a hypothetical model for claiming that cognitive lapses like not remembering where you put something or what you were going to say are signs of incipient Altzheimer’s disease. The proposed looser criteria would legitimate drugs as “safe and effective” that have little or no evidence of being effective and expose millions to risks of harmful side effects.

No proven biomarkers or clinical symptoms exist, the FDA officials note, but nevertheless they advocate accelerated approval to allow “drugs that address an unmet medical need.” What “unmet need"? None exists. This market-making language by officials who are charged with protecting the public from unsafe drugs moves us towards the 19-century hucksterism of peddling cures of questionable benefits and hidden risks of harm, only now fully certified by the modern FDA.9

The main reason for advocating approvals of drugs for an unproven need with unproven benefits, these FDA officials explain, is that companies cannot find effective drugs for overt Alzheimer’s. Their drug-candidates have failed again and again in trials. The core rationale of the proposed loosening of criteria is that “the focus of drug development has sifted to earlier stages of Alzheimer’s disease…and the regulatory framework under which such therapies are evaluated should evolve accordingly.” Yet they admit there are no “therapies” in this much larger market where (with the help of the industry-funded FDA) companies will not have to prove their drugs are effective. In fact, these FDA officers propose to approve the drugs without ever knowing if they are therapeutic or not. Their commercialized language presumes the outcome before starting. The job of the FDA, it seems, is to help drug companies open up new markets to increase profits for the FDA’s corporate paymasters.

These two FDA officials maintain that “the range of focus must extend to healthy people who are merely at risk for the disease but could benefit from preventive therapies.” Yet they admit we do not know who is “at risk,” nor whether there is a “disease,” nor whether anyone “could benefit,” nor whether the drugs constitute “preventive therapies.” Similar FDA-encouraged shifts have been made for drugs treating pre-diabetes, pre-psychosis, and pre-bone density loss, with few or no benefits to offset risks of harm. This week, based on policy research at the Edmond J. Safra Center for Ethics, a letter of concern was published in the New England Journal of Medicine. The authors write that approval for drugs to treat “early stage Altzheimer’s disease” must meet “a much higher bar – evidence of slowed disease progression.” But without clinical manifestations or biomarkers for an alleged disease, how will such progression be measured?

Advice to readers: Experienced, independent physicians recommend not to take a new drug approved by the FDA until it is out for 7 years, unless you have to, so that evidence can accumulate about its real harms and benefits.10

----

Disclaimer: The assessment and views expressed here are solely the author’s and do not necessarily reflect those of persons or institutions to which he is associated. The comments and suggestions of Gordon Schiff, an expert in prescribing at Brigham and Women’s Hospital, and Robert Whitaker are gratefully acknowledged.

References

1. Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Archives of Internal Medicine 2012 (Nov 26);172:1680-81.

2. Hilts PJ. Protecting America's Health: The FDA, Business and One Hundred Years of Regulation. New York: Alfred A. Knopf; 2003.

3. Rodwin M. Conflicts of interest, institutional corruption, and Pharma: an agenda for reform. Journal of Law, Medicine & Ethics 2012;40:511-22.

4. Rodwin M. Reforming pharmaceutical industry-physician financial relationships: lessons from the United States, France, and Japan. Journal of Law, Medicine & Ethics 2011(Winter):2-10.

5. Sismondo S. Ghost management. PLoS Medicine 2007;4:1429-33.

6. Sismondo S, Doucet M. Publication ethics and the ghost management of medical publication. Bioethics 2010;24:273-83.

7. Schondelmeyer S, Purvis L. Rx Price Watch Report. Washington DC: American Association of Retired Persons 2012.

8. Kozauer N, Katz R. Regulatory innovation and drug development for early-stage Alzheimer's disease. New England Journal of Medicine 2013 (Mar 13);DOI: 10.1056/NEJMp1302513

9. Young JH. The Toadstool Millionaires: a social history of patent medicines in America before federal regulation. Princeton, NJ: Princeton University Press; 1961.

10. Schiff G, Galanter W, Duhig J, et al. Principles of conservative prescribing. Archives of Internal Medicine 2011;171:1433-30.