Questionable Data Used for New Covid Vaccine Approvals - Interview with David Wiseman, PhD
Ordinarily, the Food and Drug Administration’s (FDA) approval of a drug is generally followed by the Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommending that the public take it. In the case of the latest COVID-19 vaccine, this took only one day. In a September 11 press release, FDA reported on that day’s approvals for updated mRNA vaccines. Importantly the agency used an “Accelerated Approvals Program.” More specifically the agency issued an emergency use authorization for the under 12-year-old cohort, while granting formal approvals for all else under the Accelerated Approvals Program, based on a surrogate endpoint. This means they used an exception they have to rush when there are serious unmet needs—and they don’t have to have comprehensive clinical evidence.
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UK court rules 19 Year Old Woman cannot seek treatment. Doctors seek to put her on end-of-life care
UK Government denies lifesaving treatment for a 19-year-old woman. The Courts ruled in favor of a hospital who claims that the woman is incapable of making decisions about her future medical care because she is under the “delusion” that her death is not imminent.
The unidentified woman has pleaded to be given a chance to live saying “This is my wish. I want to die trying to live. We have to try everything,”
What in the world is happening in the UK??
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WHO Paper: COVID-19 Vaccines Can Induce Multiple Sclerosis
The World Health Organization (WHO) quietly published a paper, not publicizing the work, connecting COVID-19 vaccination to the inducement of multiple sclerosis. These incidents are deemed rare, in fact in the study they discuss just two incidents of this happening.
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Biden Admin Opens Up Office of Long COVID, But Ignores Plight of Vax Injured
With anywhere from an estimated 7.7 to 23 million people living in America struggling with long COVID, the U.S. Department of Health and Human Services (HHS) launched the Office of Long COVID Research and Practice to lead a Long COVID response and coordination across the federal government. In parallel the National Institutes of Health (NIH) launched a program of Long COVID trials via the RECOVER Initiative.
The news came via announcement by HHS Secretary Xavier Becerra who has been under mounting pressure to mobilize American resources to deal with the crisis. With a paucity of research findings and little direction in the front line, the COVID-19 pandemic emergency triggered a top down, federalized approach to medicine, which isn’t the way health care really works in America.
Typically, the system is far more decentralized, with physician groups afforded considerable flexibility to determine clinical solutions with of course federal processes such as drug approvals, research funding via the NIH and national public health guidance via the Centers for Disease Control and Prevention.
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Free Speech on Adverse Effects Awaken India vs Serum Institute
The right to free speech in the public interest is contentious. During Covid-19, this right is under intense scrutiny with proponents for and against making robust arguments, depending on which side of the medical industrial complex fence they stand, and what value is attributed to free speech in difficult times.
A case in point is the TNI case, which includes including Trialsite News and others as applicants. Another groundbreaking case is Missouri vs Biden, where the judge compelled government to stop colluding with social media companies that suppress the flow of information related to Covid-19.
Another critical case of extreme importance takes us to India. It is a battle between the Awaken India Movement (AIM) and the Serum Institute of India (SII) - where a recent court judgement raises questions about free speech, public interest and health. Our guest is health advocate and researcher Yoga
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US and UK Govt Pays The Price For Failure to Compensate the Vaccine Injured
"Don’t question me, I am science." That’s generally the gist of the government’s response to any criticism during the COVID-19 pandemic. Led by top bureaucrat Dr. Anthony Fauci, the government’s overconfidence was surpassed only by its hubris during the emergency where hundreds of independent reporters, fact-checkers and investigators, including media such as TrialSite News, tracked the real unfolding science, as opposed to the promulgation of one formal emergency response narrative.
How bad will the headlines have to get before the elected officials act to mitigate the damages of a failed vaccine compensation system? What will it take to ensure appropriate reform in vaccine compensation schemes such as those issued under the UK’s Vaccine Damage Payment Act or for that matter, even a more broken, dysfunctional system: the U.S. National Vaccine Injury Compensation Program (VICP)?
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47-year-old Vaccine Injured Mother files $10.5 Million Lawsuit against the Canadians Government
47-year-old Vaccine Injured Mother files $10.5 Million Lawsuit against the Canadian Government and the CBC.
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TrialSite News Founder Speaks to Vaccination as a Significant Tool Utilized in Public Health
TrialSite News Founder Daniel O’Connor discusses the false dichotomy of the pro-vaccination, vs anti-vaccination stances. Why vaccines are an important tool, just as honesty of potential vaccination issues are necessary for the public discourse.
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Pioneer Dr Paul Marik: Repurposed Medicines
In a riveting interview with Shabnam Palesa Mohamed, Dr Paul Marik talks about:
How living in South Africa trained him for excellence, resilience and innovation
Why Big Pharma is in a full spectrum war with repurposed medicines that would benefit health in low to middle income countries the most.
Losing trust in the WHO, referencing a documentary called Trust WHO: "We couldn't trust the WHO 15 years ago, we can't trust the WHO now, and we can never trust the WHO. "Their name is World Health Organisation, but they have nothing to do with health. The WHO preserves the economic, interests of the people that support them." - like Big Pharma, who he critiques for "obscene" price gouging on essential drugs. He says "this cartel must be broken."
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Australian Senator Claim: 30K Excess Deaths Caused by mRNA Vax. Calls For Investigation
Should there be a Royal Commission conducted as part of the Australian government’s COVID-19 emergency response? That’s the opening question media personality professor David Flint David asks Malcolm Roberts, an Australian politician on the “Save the Nation” show. Roberts, a member of right-leaning populist One Nation and a Queensland senator since 2019, replied “Absolutely.”
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The Challenge Of Rare Adverse Effects In Low Income Patients
In a human interest episode of Medical Files, Shabnam Palesa Mohamed talks to two South African doctors treating people with post-C19 injection adverse effects. The patients interviewed, Mrs Mulder and Mrs Wagner, bravely describe their painful experiences, how their lives were changed, that previous doctors failed to help them, and their financial struggles since. The doctors, both members of the Stop The Shots court case, share low cost treatments they are trying to alleviate symptoms, and issue an appeal to other doctors to not ignore people who need help. Both women want the world to know that their lives matter. South African are reporting adverse effects to independent platform SAVAERS.co.za
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Canadian Govt Memo Directs How to Obfuscate, Hide COVID-19 Vax Injuries
Regional media in Canada continues to dig up more dirt on potential government action, or inaction depending on one’s point of view. It has been revealed that a secret Privy Council Office memorandum leaked that revealed that injuries and deaths associated with COVID-19 vaccines could “have the potential to shake public confidence.” What appears to be an absolutely unacceptable strategy to distort and obfuscate the risks, albeit relatively rare, with COVID-19 vaccines, represents a true scandal in the making.
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Indonesian Government Being Sued Over Mandatory COVID-19 Vaccine
An Indonesian group, headed by Ted Hilbert & Fatoni Rahman, is suing the government for their vaccine mandate involving the mass immunization of all residents of Indonesia by executive order. According to Hilbert & Rahman, the mandate goes against numerous articles of the constitution of the Republic of Indonesia.
The executive order, issued on Feb. 9, 2021, required every Indonesian citizen to be vaccinated if they were eligible (Article 13A). Health workers, other frontline workers and individuals belonging to the high-risk populations including those with comorbidities as well as those aged 60 years old and above had already been prioritized since 2020.
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Israeli Study Links Nitric Oxide to Autism
Israel has done a lot of research and work on autism and how it effects children and their families. The country continually attempts to help those with the developmental disorder deal with everyday life. Israel has a national autism data base as a resource to study autism risk factors, biomarkers, outcome measures and treatment efficacy. The Middle Eastern country is continually studying the disorder and they just released another study on a potential future method of reducing the symptoms of autism.
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COVID-19 Vaccine Injured Sue President Biden, White House Staff & Others for Illicit Censorship
A group of individuals injured by the COVID-19 vaccines have filed a major lawsuit against the federal government, including President Joseph Biden, Xavier Becerra and several other prominent federal government figures, citing among other things alleged massive government censorship as part of an orchestrated illicit scheme to cover up discussion of any material problems associated with the COVID-19 vaccines.
The plaintiffs include React19 co-founder Brianne Dressen, Shaun Barcavage, Kristi Dobbs, Nikki Holland, Suzanna Newell, and Ernest Ramirez—all use social media and have or had accounts on several platforms, including Facebook, Instagram, YouTube, Twitter, TikTok, and GoFundMe.
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Atrial Fibrillation Cases Skyrocket in the UK—1 in 45 Now Live with Condition
Why is the number of persons in the UK diagnosed with atrial fibrillation surging 50% in just a decade, totaling 1.5 million today? This means that 1 in 45 people in the UK are now living with this condition. This diagnosed heart condition raises the risk of stroke, reports the British Heart Foundation. The surge is based on a 50% rise from 2013 (1 million) to today. The report doesn’t identify any year-to-year trends. What’s the culprit behind this surge? Is it lifestyle and growing health challenges in the population? What about the impact of the SARS-CoV-2 -caused pandemic? What about mass vaccination? Not surprisingly, these topics were left alone.
People with this diagnosis are five times more likely to succumb to a fatal or life-changing stroke. Atrial fibrillation is the most common form of abnormal heart rhythm and is believed to contribute to one in five strokes.
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Incompetent US COVID-19 Vax Injury Compensation Program Has No Computer Systems!
With almost 12,000 people having filed claims with the Countermeasures Injury Compensation Program (CICP), the vaccine injury compensation scheme established with the national public health emergency, just a few of these injured persons have secured any payment, and those compensated are done so on average at $1,500 per claimant. Mainstream media inches its way into coverage, discussion and commentary. It is a tragic situation for those injured by vaccines that were often mandated to take. The government, while overreaching in many respects during the pandemic, did little to nothing to anticipate the tens of thousands that would claim injuries. The program is understaffed, and now, a director from the Countermeasure Injury Compensation Program (CICP) told a Georgia-based Congressperson that they had no technology to support the scale up of the program. Also, the CICP program is severely understaffed. Who in the federal government is responsible for this reality?
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Internet Rumors Claimed Livestock Getting mRNA Vaccine. It May Be True
There have been reports of mRNA vaccines being used in livestock in the United States. According to the mainstream media, there no basis to these claims. The reports say the U.S. Department of Agriculture is requiring farmers to vaccinate their livestock with mRNA vaccines. Supposedly, this is a rumor started by a meme on social media. However, the meme has caused national reverberations.
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14-Year-Old Japanese Girl Dies From Fatal Multi-organ Inflammation After Third Dose of Pfizer Shot
In Japan a 14-year-old girl died from multiple organ inflammation just 45 hours after getting her third dose of the Pfizer vaccine. A report conducted by researchers from Tokushima University Graduate School in Japan says the girl took the shot on August 10, 2022 and died shortly afterward. The study found the girl was “healthy by nature” and was active on her middle school athletic team.
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Surge in Rare Severe Myocarditis in Newborns/Babies in the UK Causing One Death
The World Health Organization (WHO) recently reported that incidence of myocarditis led to the death of a baby, and hospitalization of an additional nine newborns and infants across south Wales and southwest England from June 2022, to March 2023. Incidence of myocarditis in babies peaked in November 2022.
In total, WHO reports 15 babies including 10 in Wales and 5 in England were diagnosed with the inflammation of heart muscle often associated with both SARS-CoV-2 infection as well as the COVID-19 vaccines. But the condition can arise from other viruses, and in fact, nine of the babies were diagnosed with enterovirus, the virus behind respiratory illness, hand, foot and mouth disease as well as viral meningitis. Reported across multiple British media, the diagnosis of myocarditis associated with any of these potential triggers is indeed very rare in babies.
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Patrick Girondi Sues Biotech and Venture Capitalist Firm over charges of violating RICO Act
A civil action has been filed, charging violations of the Federal Racketeering and Corrupt Organizations Act (RICO), fraudulent inducement and unfair business practices in the United States District Court in Massachusetts. The defendants are Nick Leschly, Mitchell Finer, Phillip Reilly, Third Rock Ventures, bluebird bio Inc., and 2seventy Bio Inc. This lawsuit is linked to the TrialSite’s ongoing tracking of the San Rocco Therapeutics (SRT), formerly Errant Gene Therapeutics, and bluebird legal conflict. See “A FamilyMan’s battle against the forefront of capitalist medicine: the case of Errant Gene Therapeutics.”
Nick Leschly, the former CEO of bluebird bio, profited $24,000,000, alone in 2018, making him the highest compensated pharma CEO in the world. The complaint alleges that his earnings were a direct result of fraudulent and corrupt RICO violations at the expense of the health of patients. Bluebird bio’s gene therapy was approved in August 2022 to treat Thalassemia for $2.8 million per patient. SRT has a safer gene therapy product that will cost over $2,000,000 less at $700,000.
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Texas AG Demands COVID-19 Vax Makers Produce Evidence on Safety & Efficacy
State Attorney Generals have led the way on many COVID-19-related freedom issues, including a response to President Joe Biden’s COVID-19 vaccine mandate for companies with 100 or more employees. A group of state AGs challenged and took the mandate to the Supreme Court. The High Court’s decision that the OSHA large-employer vaccine mandate was unlawful was the work of these AGs, as well as other parties opposing COVID-19 vaccine mandates. As noted by Tennessee’s AG, many states came forward to challenge the OSHA mandate.
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FDA Approves GSK RSV Vaccine for People Aged 60+--While still requiring ongoing Safety Monitoring
The U.S. Food and Drug Administration approved GlaxoSmithKline’s Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
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China Sought to Control the Covid Narrative with Censorship, Suppression and Lies
The world’s focus on China because of the Covid pandemic has not been a welcome event for the Asian nation, striving to become the number one economy and world power. Reports out of China claimed the country was overwhelmed with the epidemic, news the Chinese sought to suppress. Now, a press freedom group is reporting China is the biggest global jailer of journalists, with over 100 reporters currently behind bars. The group, Reporters Without Borders, claims China’s leader, Xi Jingping is conducting a “crusade against journalism”. It appears, the Chinese government is moving to “control the narrative”.
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Australia Drug Regulator (TGA) Cancels COVID-19 Era Ivermectin Ban
The Therapeutic Goods Administration (TGA), Australia’s regulatory agency over drugs and related medicinal products, announced the lifting of its COVID-19 emergency-era ivermectin-restricted access by June 2023.
TrialSite News chronicled early in the pandemic the build-up to the point in Australia when the TGA issued severe constraints on ivermectin. The publicly disclosed concern related to safety concerns for consumers using the drug without advice from licensed doctors as well as shortages. By September 2021, TGA banned general practitioner use of ivermectin.
However, starting June 1, 2023, GPs prescribing oral ivermectin for ‘off-label’ uses will no longer be limited to specialists such as dermatologists, gastroenterologists and infectious diseases specialists.
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