Nobody likes rejections. But it does help to have a heads-up.
Such is the case at Tricida, which was slapped with a complete response letter as regulators turned down its lead and only drug for metabolic acidosis in patients with chronic kidney disease.
“The CRL was not surprising as it was foreshadowed by an announcement in mid-July that the FDA has identified deficiencies in veverimer’s application,” Cowen’s Phil Nadeau wrote.
That, though, doesn’t guarantee Tricida won’t run into the worst-case scenario in which the delay can stretch into years. It also didn’t stop the stock from dropping another 23.64% to $10.11, following a precipitous fall from $26.20 back in July.
CEO Gerrit Klaerner offered more candid comments in an investor call earlier this month, noting that “it is unlikely we will receive approval to market veverimer in the United States on our PDUFA goal date” since the FDA would presumably clarify its concerns in a CRL.
Having that expectation set lended Klaerner some credibility when he said he’s pleased that the FDA has provided helpful, specific comments and appears willing to work with the Tricida team.
Nadeau, who sees blockbuster potential for the drug, is still a fan. The Phase III results were “convincingly positive,” with veverimer hitting all the endpoints on durable blood bicarbonate levels and safety. A few other things are to blame, according to the analyst:
- the novelty of veverimer’s surrogate endpoint
- the lack of precedent for cardio-renal drugs being granted accelerated approval, and
- the FDA’s diminished communication with sponsors in recent months in light of the lack of in-person meetings due to Covid-19.
Regulators have laid out multiple options to address the problems they see, Tricida wrote in a release. The differences can be huge — and they won’t find out until a Type A meeting later in the year.
For instance, the FDA wants additional data beyond TRCA-301 and its extension trial to assess “the magnitude and durability of the treatment effect of veverimer on the surrogate marker of serum bicarbonate” and how applicable it is to the US population, given only 9% in the drug arm was enrolled in the country.
If regulators end up deciding they need results from the ongoing VALOR-CKD study, Tricida will have to wait until 2022-2023 for interim data and 2024-2025 for final data.
With cash, cash equivalents and investments worth $437 million at the end of the second quarter, Tricida reported that it has a runway up to early 2022.
Plan will put everyone in England within 15 minutes of green space – but what matters is justice not distance
The UK government wants every household in England to be within 15 minutes walk of a park, woodland or water.
How long does it take you to walk to your nearest park, woodland, lake or river? If it takes more than 15 minutes, according to the UK government’s new environmental improvement plan for England, something needs to be done about it. It says 38% people in England don’t have a green or blue space within a 15-minute walk of their home.
The plan promises a “new and ambitious commitment to work across government and beyond” to provide access to local green and blue spaces. It recognises the importance of connecting with nature, and that time spent outdoors is good for physical and mental health.
That’s a message researchers have been underlining for years, as a recent evidence review shows, and it has been amplified by COVID-19, which showed the importance of local green and blue spaces for wellbeing.
But the plan’s laudable ambitions overlook the ways our experiences of the outdoors are shaped by privileges of wealth and health.
If you live in a disadvantaged area, your local green space may be further away from your home, or you might have to share it with more people. As the campaign group Fields in Trust pointed out in a 2022 report, this is a question of justice.
However, there’s more to justice than the amount of space you have to share with others, or how long it takes you to get there. It’s also about how you feel and what you can do when you get there.
My own research highlights some key questions we need to ask if we’re to protect and improve our green spaces for future generations. Questions such as “Do I feel welcome here?” “Does this space meet my needs?” or “Do I get a say in how it is looked after?” highlight the fact that access is a matter of equality and democracy.
Some green spaces are greener than others
There are three key aspects of green and blue spaces that should be considered, and invested in, if the environmental improvement plan is to be more than wishful thinking.
First, not all green and blue spaces are the same or provide the same benefits. The qualities of a football pitch are very different from those provided by a woodland walk along a stream.
Lumping them all together as “green and blue spaces” overlooks the need for a variety of spaces within easy reach to meet local people’s needs for physical and mental wellbeing.
Second, not all spaces are equally well looked after. Spaces that are fly-tipped or associated with antisocial activities can feel intimidating, especially after dark.
Green and blue spaces in disadvantaged areas need more care, and that requires time and money. As Public Health England noted, access to good quality green spaces is worse in more disadvantaged areas.
Third, simply being in a space won’t necessarily bring you all the benefits a space can offer. For people suffering from anxiety or depression, for example, more structured activities might be more helpful.
Be like Birmingham
In Birmingham, the local authority isn’t content with trumpeting the merits of its 600 parks. Instead, the city has developed a city of nature plan (I was part of a team that evaluated it).
At the heart of its approach is the idea of environmental justice, which it defines as “the fair treatment and meaningful involvement of all people regardless of race, colour, national origin, or income, with respect to the development, implementation and enforcement of environmental laws, regulations, and policies”.
To apply environmental justice to the city’s green spaces, Birmingham Council has assessed each of its 69 electoral ward in terms of access to green space of two hectares (about three football pitches) or more within 1,000 metres, as well as flood risk, urban heat island effects, health inequalities and deprivation.
Through this work, it has identified 13 of its 69 wards which are most in need of investment to reach a new “fair parks standard”. These mainly central areas have less accessible green space, are more at risk of flooding and urban heating, and are more deprived.
Starting with a pilot programme in Bordesley & Highgate Ward (setting for the BBC series Peaky Blinders), the plan is then to invest in a further five priority areas in central and east Birmingham: Balsall Heath West, Nechells, Gravelly Hill, Pype Hayes and Castle Vale.
This is the kind of approach that could guide investment in many other cities. It links funding with equalities and brings together climate change, public health and community issues. It shows that quality and equity can’t just be boiled down to the distance between your home and the nearest park.
The challenge now is to learn from Birmingham’s pioneering approach and apply similar principles elsewhere. At its best, this work can be used to highlight the challenges not only of applying resources equitably, but of ensuring the resources are there in the first place, an issue the environmental impact plan rather predictably glosses over.
Julian Dobson and colleagues were funded by the National Trust and National Lottery Heritage Fund to evaluate the Future Parks Accelerator programme. The views expressed here are the author's own.depression covid-19 treatment uk
UN Initiative Targets And Doxxes Doctors And Nurses Who Don’t Follow COVID-19 Narrative
UN Initiative Targets And Doxxes Doctors And Nurses Who Don’t Follow COVID-19 Narrative
Authored by Katie Spence via The Epoch Times (emphasis…
Authored by Katie Spence via The Epoch Times (emphasis ours),
Nicole Sirotek is a registered nurse in Nevada with over a decade of experience working in some of the harshest conditions. When a hurricane devastated Puerto Rico, Sirotek and the organization she founded, American Frontline Nurses (AFLN), were there and gave out over 500 pounds of medical equipment and supplies.
She hasn’t hesitated to be the first in when an emergency hits and medical professionals are needed. She’s lost count of the number of times she’s woken up on a cot in the middle of nowhere, boots still strapped to her feet, and ready to go.
But in tears during an interview with The Epoch Times, she detailed her ordeal with harassment and doxing over the past year and how she’s contemplated suicide due to crippling anxiety and depression.
“It took such a toll on my mental health. I wasn’t sleeping and wasn’t eating,” Sirotek said.
To regain her mental health, she decided to step back from the group she started. But even that decision brought pain.
“I said after I left New York, I’d do everything that I can to make sure it didn’t happen again,” Sirotek said, recalling the death she witnessed when she volunteered in New York as a nurse at the start of the COVID-19 pandemic. “I mean, for me to step back and take a break just makes me feel like I failed!”
Sirotek is the victim of ongoing harassment. She’s received pictures of her children posed in slaughterhouses and hanging from a noose, drive-by photos of her house, and letters with white powder that exploded upon opening.
The Nevada State Board of Nursing was inundated with calls for Sirotek’s professional demise and flooded with anonymous complaints.
In response, Sirotek filed a police report. Her lawyer sent a cease-and-desist letter. The Epoch Times reviewed the documents.
The reply from the cease-and-desist letter? The client was acting within his First Amendment rights.
The Harassment Begins
In February 2022, Sirotek, as the face of AFLN, a patient advocacy network that boasts 22,000 nurses, appeared before Sen. Ron Johnson (R-Wis.) and testified about the harm patients were experiencing when they sought treatment for COVID-19.
She said she didn’t witness patients dying from the novel virus when she volunteered to work the front lines in New York at the start of the pandemic.
Instead, in her opinion, as a medical professional with multiple master’s degrees, patients were dying from “negligence” and “medical malfeasance.”
Sirotek detailed the withholding by higher-ups of steroids and Ibuprofen and the prescribing of remdesivir. Additionally, there was zero willingness to consider possible early intervention treatments like ivermectin.
As the pandemic continued, such practices only escalated, Sirotek said.
Sirotek’s testimony resulted in cheers, widespread attention, and a target on her back.
“[The harassment] all started the day we got back from DC,” Sirotek said.
At first, the attacks started with the typical “you’re transphobic, you’re anti-LGBTQ. I mean, they even called me racist,” Sirotek, who is Hispanic, recalled.
And as more patients sought AFLN’s help, the attacks increased in frequency and force.
At first, Sirotek said the attacks appeared to come from random people. But as the attacks continued, the terms “Project Halo,” “Team Halo,” and “#TeamHalo” continually cropped up. Especially on TikTok and from two accounts, “@jesss2019” and “@thatsassynp.”
“[@thatsassynp] just kept on saying how I was spreading misinformation, [that] ivermectin doesn’t work,” Sirotek said. “He kept targeting the Nevada State Board of Nursing because I was on the Practice Act Committee, and he did not feel like that was acceptable.”
Craig Perry, a lawyer representing nurses, including Sirotek, before the Nevada State Board of Nursing, confirmed Sirotek’s account. The executive director of the Nevada State Board of Nursing, Cathy Dinauer, declined to provide details on complaints or investigations, stating to The Epoch Times via email that they are “confidential.”
Sirotek said the complaints overwhelmed her ability to defend her nursing license.
“Untimely, they were filing so many complaints against me that [the Nevada State Board of Nursing] had to start filtering them as to what was applicable and not applicable. And [the complaints] just buried my nursing license to the point that we couldn’t even defend it,” Sirotek said.
Attacks Transition to Threats
Whenever Sirotek, or AFLN, tried to set up a community outreach webinar, hateful comments flooded their videos.
Julia McCabe, a registered nurse and the director of advocacy services for AFLN, told The Epoch Times that initially, they tried kicking the trolls out of the outreach videos. But they couldn’t keep up with the overwhelming numbers and had to shut the videos down, usually after only 10 minutes, she said.
To address the swarms, as McCabe labeled them, AFLN started charging an entrance fee for their webinars. But, McCabe said, they’d send out an email with a free access code to all of their subscribers before the webinar started. It helped, but not enough. The swarms kept coming. And the attacks escalated.
On June 5, 2022, @thatsassynp posted a video on TikTok calling for a “serious public uprising,” because the Nevada State Board of Nursing and other regulatory agencies weren’t disciplining nurses for spreading “disinformation.”
It became one of many such videos in the ensuing days. In the comments of one, he stated, “Also, stay tuned as [@jesss2019] will be addressing this as well. We are teaming up (as per usual) to raise awareness and demand action on this issue.” @jesss2019 responded, “Yes!!!! We will get this taken care of.”
Jess and Tyler Kuhk of @thatsassynp have “teamed up” on several occasions, targeting healthcare workers who question the COVID-19 narrative. Team Halo doesn’t officially list Kuhk on its site, but Kuhk posts with the #teamhalo.
In another video, he states, “If you’re new to this series, PLEASE watch the videos in my playlist ‘Nevada board of nursing.’ This started in Feb of this year.” His video has almost 35,000 “loves.”
On June 7, 2022, @jesss2019 posted a video on TikTok accusing Sirotek of spreading misinformation. It included a link to @thatsassynp, and his complaints about Sirotek to the Nevada State Board of Nursing and calls to remove her from the Practice Act Committee. She implored TikTok to boost the message. It, too, became one of many videos attacking Sirotek.
Specifically, @jesss2019 and @thatsassynp took issue with videos and posts from Sirotek, and AFLN, advocating for ivermectin and highlighting possible issues with remdesivir and the COVID-19 vaccines.
@jess2019 removed all of the above videos after The Epoch Times sought comment. The Epoch Times retains copies.
Sirotek says she received the first death threat against herself and her children around the same time, in June 2022.
“They cut off the pictures of my children’s faces from our family photos, where we take them every year on our front porch—we’ve got 11 years of those photos—and they cut them out and put them on the bodies of those little boys that have been sexually abused. And that’s what would get sent to my house. And I gave the police that,” Sirotek said.
In response to a request for comment from The Epoch Times, Sen. Johnson defended Sirotek.
“The COVID Cartel continues to frighten and silence those who tell the truth and challenge their failed response to COVID,” Johnson said. “It is simply wrong for Ms. Sirotek to be smeared and attacked like so many others who have had the courage and compassion to successfully treat COVID patients.”
As the threats continued and escalated, Sirotek also asked Perry to send a cease-and-desist letter to Tyler Kuhk on Aug. 1, 2022.
Kuhk, a nurse practitioner, is the person posting on TikTok under the pseudonym @thatsassynp.
The letter sent to Kuhk alleges that on at least 10 different occasions, @thatsassynp encouraged a “public uprising” against Sirotek. It also details that his videos attacking Sirotek garnered over 400,000 views.
In response, McLetchie Law, a “boutique law firm serving prominent and emerging … media entities” responded to Perry by stating in a letter dated Aug. 16, 2022, “Both Nevada law and the First Amendment provide robust protections for our client’s (and others’) rights to criticize Ms. Sirotek’s dangerous views and practices—and to advocate for her removal from the Nursing Practice Advisory Committee of the Nevada State Board of Nursing.”
It also warned that any attempt to deter Kuhk from his chosen path would “backfire” and could result in a “negative financial impact.” Neither Kuhk nor McLetchie Law responded to The Epoch Times’ request for comment.
Unable to confirm the real name behind the TikTok account @jesss2019, and thus, unable to send her a legal letter, Sirotek posted some of the threats she’d received on Facebook, pleading for @jesss2019 to cease targeting her, and recognize the possible real-world harm.
In desperation, Sirotek asked Perry to file a legal name change, which he did on Sep. 15, 2022, hoping that would thwart people’s ability to look up Sirotek’s information. Perry told The Epoch Times, “Usually, when you do a name change, it’s a public record. But under extenuating circumstances, you can have that sealed.”
In Sirotek’s case, the court recognized the threat to her and her family’s safety, waived the publication requirement, granted the change, and sealed her record on Oct. 4, 2022.
Sirotek, at the behest of Perry, filed a police report detailing the harassment on Oct. 17, 2022.
In December 2022, @jesss2019 posted a video to TikTok doxing Sirotek by revealing her name change. The Epoch Times sought comment from @jesss2019 but has not received a response. After the request for comment, the user removed the video.
Team Halo and Social Media
On Dec. 17, 2020, Theo Bertram, a director at TikTok; Iain Bundred, the head of public policy at YouTube; and Rebecca Stimson, the UK head of public policy for Facebook, appeared before the UK’s House of Commons to explain what their social media sites were doing to combat “anti-vaccination disinformation.”
All three stated their companies employed a “two-pronged approach.” Specifically, “tackle disinformation and promote trusted content.”
Bundred stated that from the beginning of the year to November 2020, YouTube had removed 750,000 videos that promoted “Covid disinformation.”
Stimson stated that between March and October 2020, “12 million pieces of content were removed from [Facebook],” and it had labeled 167 million pieces with a warning.
Bertram stated that for the first six months of 2020, TikTok removed 1,500 accounts for “Covid violation” and had recently increased that activity. “In the last two months, we took action against 1,380 accounts, so you can see the level of action is increasing,” Bertram said.
“In October, we began work with Team Halo,” Bertram added. “I do not know if you are familiar with Team Halo. It is run by the Vaccine Confidence Project at the London School of Hygiene and Tropical Medicine and is about getting reliable, trusted scientists and doctors on to social media to spread trusted information.”
Team Halo’s Origins
On Sep. 20, 2022, Melissa Fleming, the under-secretary-general for global communications at the United Nations, appeared at the World Economic Forum to discuss how the United Nations was “Tackling Disinformation” regarding “health guidance” as well as the “safety and efficacy of the vaccine” for COVID-19.
“A key strategy that we had was to deploy influencers,” Fleming stated. “Influencers who were really keen, who had huge followings, but really keen to help carry messages that were going to serve their communities.”
Fleming also explained that the United Nations knew its messaging wouldn’t resonate as well as influencers, so they developed Team Halo.
“We had another trusted messenger project, which was called Team Halo, where we trained scientists around the world, and some doctors, on TikTok. We had TikTok working with us,” Fleming said. “It was a layered deployment of ideas and tactics.”
Read more here...
Why Is There A COVID Vaccine Mandate For Students?
Why Is There A COVID Vaccine Mandate For Students?
Authored by Margaret Anna Alice via ‘Through The Looking Glass’ Substack,
Letter to the…
Letter to the Stanford Daily: Why Is There a COVID Vaccine Mandate for Students?
“Not to know is bad. Not to wish to know is worse.”
I can’t figure out why Stanford is mandating the COVID vaccine for students.
Is it to protect students from the virus, hospitalization, or death?
Is it to protect them from other students?
Is it to protect the Stanford community members from the students?
If it’s to protect the students from catching COVID, that doesn’t make sense because the CDC says it “no longer differentiate[s] based on a person’s vaccination status because breakthrough infections occur.”
The CDC also acknowledges natural immunity, noting that “persons who have had COVID-19 but are not vaccinated have some degree of protection against severe illness from their previous infection.”
It appears Stanford didn’t get the memo because Maxwell Meyer—a double-jabbed, COVID-recovered alum who was nearly prohibited from graduating for choosing not to get boosted—was informed by an administrator that the booster mandate is “not predicated on history of infection or physical location.”
Despite living 2,000 miles away from campus and not being enrolled in coursework for his final term, Maxwell was told Stanford was “uniformly enforc[ing]” the mandate “regardless of student location.” Does that sound like a rational policy?
Fortunately, a different administrator intervened and granted Maxwell an exemption, but few Stanford students are so lucky. Almost everyone else simply follows the rules without realizing they’ve volunteered for vaccine roulette.
A Cleveland Clinic study of the bivalent vaccines involving 51,011 participants found the risk of getting COVID-19 increased “with the number of vaccine doses previously received”—much to the authors’ surprise.
They were stumped as to why “those who chose not to follow the CDC’s recommendations on remaining updated with COVID-19 vaccination” had a lower risk of catching COVID than “those who received a larger number of prior vaccine doses.”
So if the vaccines don’t keep you from getting COVID, maybe they at least protect you from hospitalization?
That doesn’t wash, either, because according to data from the Coronavirus Disease 2019 (COVID-19)-Associated Hospitalization Surveillance Network (COVID-NET), hospitalization rates for 18–64-year-olds have increased 11 percent since the vaccine rollout. Worse, kids under 18 have suffered a shocking 74 percent spike in hospitalizations.
An observational study conducted at Germany’s University Hospital Wuerzburg found:
“The rate of adverse reactions for the second booster dose was significantly higher among participants receiving the bivalent 84.6% (95% CI 70.3%–92.8%; 33/39) compared to the monovalent 51.4% (95% CI 35.9–66.6%; 19/37) vaccine (p=0.0028). Also, there was a trend towards an increased rate of inability to work and intake of PRN medication following bivalent vaccination.”
A new paper published in Science titled Class Switch Towards Non-Inflammatory, Spike-Specific IgG4 Antibodies after Repeated SARS-CoV-2 mRNA Vaccination even has Eric Topol concerned:
Late after mRNA Covid vaccines, or with booster or breakthrough infections, there is a shift to IgG4 antibodies, not seen with adenovirus vector vaccines. The clinical significance is not knownhttps://t.co/5thLxRwemm @SciImmunology @UniFAU pic.twitter.com/YozSLVjVLd— Eric Topol (@EricTopol) December 22, 2022
If you don’t know what that means, Dr. Syed Haider spells it out in this tweet. He explains that the shots “train your immune system to ignore the allergen by repeated exposure,” the end result being that “Your immune system is shifted to see the virus as a harmless allergen” and the “virus runs amok.”
Latest IgG4 COVID vax study— Dr. Syed Haider (@DrSyedHaider) December 28, 2022
Think allergy shots. They train your immune system to ignore the allergen by repeated exposure.
That’s what repeated shots with the vax are doing.
Your immune system is shifted to see the virus as a harmless allergen.
Which means: virus runs amok.
Well, then does the vaccine at least prevent people from dying of COVID?
Nope. According to the Washington Post, “Vaccinated people now make up a majority of COVID deaths.”
At Senator Ron Johnson’s December 7, 2022, roundtable discussion on COVID-19 Vaccines, former number-one–ranked Wall Street insurance analyst Josh Stirling reported that, according to UK government data:
“The people in the UK who took the vaccine have a 26% higher mortality rate. The people who are under the age of 50 who took the vaccine now have a 49% higher mortality rate.”
Obtained by a Freedom of Information Act (FOIA) request to KBV (the association representing physicians who receive insurance in Germany), “the most important dataset of the pandemic” shows fatalities starting to spike in 2021.
Data analyst Tom Lausen assessed the ICD-10 disease codes in this dataset, and the findings are startling. His presentation includes the following chart documenting fatalities per quarter from 2016 to 2022:
This parallels the skyrocketing fatality rates seen in VAERS:
The vaccinated are more likely to contract, become hospitalized from, and die of COVID. If the vaccine fails on all of those counts, does it at least prevent its transmission to other students and community members?
The obvious answer is no since we already know it doesn’t prevent you from getting COVID, but this CDC study drives the point home, showing that during a COVID outbreak in Barnstable County, Massachusetts, “three quarters (346; 74%) of cases occurred in fully vaccinated persons.”
Maybe Stanford can tell us why they feel the mandate is necessary. Their booster requirement reads:
“Why does Stanford have a student booster shot requirement? Our booster requirement is intended to support sustained immunity against COVID-19 and is consistent with the advice of county and federal public health leaders. Booster shots enhance immunity, providing additional protection to individuals and reducing the possibility of being hospitalized for COVID. In addition, booster shots prevent infection in many individuals, thereby slowing the spread of the virus. A heavily boosted campus community reduces the possibility of widespread disruptions that could impact the student experience, especially in terms of in-person classes and activities and congregate housing.”
The claim that “booster shots enhance immunity” links to a January 2022 New York Times article. It seems Stanford has failed to keep up with the science because the very source they cite as authoritative is now reporting, “The newer variants, called BQ.1 and BQ.1.1, are spreading quickly, and boosters seem to do little to prevent infections with these viruses.”
Speaking of not keeping up, that same article says the new bivalent boosters target “the original version of the coronavirus and the Omicron variants circulating earlier this year, BA.4 and BA.5.”
It then goes on to quote Head of Beth Israel Deaconess’s Center for Virology & Vaccine Research Dan Barouch, who says, “It’s not likely that any of the vaccines or boosters, no matter how many you get, will provide substantial and sustained protection against acquisition of infection.”
In other words, Stanford’s rationale for requiring the boosters is obsolete according to the authority they cite in their justification.
If Stanford is genuinely concerned about “reduc[ing] the possibility of widespread disruptions that could impact the student experience,” then it should not only stop mandating the vaccine but advise against it.
Some nations have suspended or recommended against COVID shots for younger populations due to the considerable risks of adverse events such as pulmonary embolism and myocarditis—from Denmark (under 50) to Norway (under 45) to Australia (under 50) to the United Kingdom (seasonal boosters for under 50).
The Danish Health Authority explains why people under 50 are “not to be re-vaccinated”:
“People aged under 50 are generally not at particularly higher risk of becoming severely ill from covid-19. In addition, younger people aged under 50 are well protected against becoming severely ill from covid-19, as a very large number of them have already been vaccinated and have previously been infected with covid-19, and there is consequently good immunity among this part of the population.”
Here’s what a Norwegian physician and health official had to say:
“Especially the youngest should consider potential side effects against the benefits of taking this dose.”
—Ingrid Bjerring, Chief Doctor at Lier Municipality
“We did not find sufficient evidence to recommend that this part of the population [younger age bracket] should take a new dose now.… Each vaccine comes with the risk for side effects. Is it then responsible to offer this, when we know that the individual health benefit of a booster likely is low?”
—Are Stuwitz Berg, Department Director at the Norwegian Institute of Public Health
A new Nordic cohort study of 8.9 million participants supports these concerns, finding a nearly nine-fold increase in myocarditis among males aged 12–39 within 28 days of receiving the Moderna COVID-19 booster over those who stopped after two doses.
This mirrors my own findings that myocarditis rates are up 10 times among the vaccinated according to a public healthcare worker survey.
Coauthored by MIT professor and risk management expert Retsef Levi, the Nature article Increased Emergency Cardiovascular Events Among Under-40 Population in Israel During Vaccine Rollout and Third COVID-19 Wave reveals a 25 percent increase in cardiac emergency calls for 16–39-year-olds from January to May 2021 as compared with the previous two years.
The paper cites a study by Israel’s Ministry of Health that “assesses the risk of myocarditis after receiving the 2nd vaccine dose to be between 1 in 3000 to 1 in 6000 in men of age 16–24 and 1 in 120,000 in men under 30.”
A Thai study published in Tropical Medicine and Infectious Disease found cardiovascular manifestations in 29.24 percent of the adolescent cohort—including myopericarditis and tachycardia.
“[W]e need to be upfront that nearly every intervention has some risk, and the coronavirus vaccine is no different. The most significant risk is myocarditis, an inflammation of the heart muscle, which is most common in young men. The CDC cites a rate of 39 myocarditis cases per 1 million second doses given in males 18 to 24. Some studies found a much higher rate; a large Canadian database reported that among men ages 18 to 29 who received the second dose of the Moderna vaccine, the rate of myocarditis was 22 for every 100,000 doses.”
All over the world, prominent physicians, scientists, politicians, and professors are asking pointed questions about illogical mandates; the safety and efficacy of the vaccines; and the dangers posed by the mRNA technology, spike protein, and lipid nanoparticles—including in the UK, Japan, Australia, Europe, and the US.
Formerly pro-vaxx cardiologists such as Dr. Aseem Malhotra, Dr. Dean Patterson, and Dr. Ross Walker are all saying the COVID vaccines should be immediately stopped due to the significant increase in cardiac diseases, adverse events, and excess mortality observed since their rollout, noting that, “until proven otherwise, these vaccines are not safe.”
Dear Prime Minister @RishiSunak,— Dr Aseem Malhotra (@DrAseemMalhotra) December 18, 2022
YOU have the power to stop the ongoing unnecessary harm that is devastating individuals and families. @Keir_Starmer the Labour Party also lost one of its most decorated doctors @KailashChandOBE to this mRNA product. Please stop this roll out NOW https://t.co/SECbfK9joz
BREAKING:— Dr Aseem Malhotra (@DrAseemMalhotra) December 16, 2022
President of the international vascular society raises concerns about covid vaccines in relation to cardiovascular problems.
‘It would be great if someone can show us the light of where to go from here’
We must pause the mRNA jab now to stop more unnecessary harm pic.twitter.com/gIZr19SVl8
And now, perhaps most notably, Dr. John Campbell has performed a 180-degree turn on his previous position and is saying it is time to pause the mass vaccination program “due to the risks associated with the vaccines”:
A Rasmussen poll published on December 7, 2022, found 7 percent of vaccinated respondents have suffered major side effects—a percentage that echoes the 7.7 percent of V-Safe users who sought medical care as well as my own polling data.
Add the 34 percent who reported experiencing minor side effects, and you have nearly 72 million adults who’ve been hit with side effects from the vaccine.
Rasmussen Head Pollster Mark Mitchell explains:
“With 7% having a major side effect, that means over 12 million adults in the US have experienced a self-described major side effect that they attribute to the COVID-19 vaccine. That’s over 11 times the reported COVID death numbers. And also note that anyone who may have died from the vaccine obviously can’t tell us that in the poll.”
“The Pfizer and Moderna trials are both showing a clear signal of increased risk of serious adverse events among the vaccinated.…
“The trial data are indicating that we’re seeing about an elevated risk of these serious adverse events of around 1 in 800 people vaccinated.… That is much, much more common than what you see for other vaccines, where the reported rates are in the range of 1 or 2 per million vaccinees. In these trials, we’re seeing 1 in every 800. And this is a rate that in past years has had vaccines taken off the market.…
“We’re talking about randomized trials … which are widely considered the highest-quality evidence, and we’re talking about the trials that were submitted by Pfizer and Moderna that supported the regulators’ authorization.”
Dr Peter Doshi senior editor of the BMJ wants to know why we haven't already #StoptheShots when 1 in 800 are seriously harmed, yet previous vaccines were suspended for harming 'only' 1 in 100'000.— Porridge2022 (@porridge2022) December 16, 2022
Beats me too! pic.twitter.com/llT4JwL5WQ
And this is the same Pfizer data the FDA tried to keep hidden from the public for 75 years.
Nothing to see here … except 1,223 deaths, 158,000 adverse events, and 1,291 side effects reported in the first 90 days according to the 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports—and those numbers are likely underreported by a factor of at least 10 (my conservative calculations show an underreporting factor (URF) of 41 for VAERS).
Stanford is asking students to risk a 1 in 800 chance of serious adverse events—meaning the kind of events that can land you in the hospital, disable you, and kill you. And for what?
Anyone who knows how to perform a cost-benefit analysis can see this is all cost and zero benefit.
Stanford’s own Dr. John Ioannidis—professor of medicine, epidemiology & population health, statistics, and biomedical data science—demonstrated that college students are at a near-zero risk of dying from COVID-19 in his “Age-Stratified Infection Fatality Rate of COVID-19 in the Non-Elderly Population.”
One of the six most-cited scientists in the world, Ioannidis found the median IFR was 0.0003 percent for those under 20 and 0.002 percent for twenty-somethings, concluding the fatalities “are lower than pre-pandemic years when only the younger age strata are considered” and that “the IFR in non-elderly individuals was much lower than previously thought.”
And yet Ioannidis’s employer is mandating an experimental product with extensively documented risks of severe harm.
What if a Stanford student dies and the coroner determines it was caused by the vaccine? That happened with George Watts Jr., a 24-year-old college student whose cause of death Chief Deputy Coroner Timothy Cahill Jr. attributed to “COVID-19 vaccine-related myocarditis.” Cahill says, “The vaccine caused the heart to go into failure.”
“We are revoking our vaccination policy and will no longer require students, employees, and visitors to be vaccinated to come to campus.”
The timing is interesting, don’t you think? I’m sure it’s just a coincidence—even though this Clinical Research in Cardiology paper determined vaccine-induced myocardial inflammation was the cause of death in “five persons who have died unexpectedly within seven days following anti-SARS-CoV-2-vaccination.” In that analysis, the authors “establish the histological phenotype of lethal vaccination-associated myocarditis.”
Coincidences notwithstanding, Stanford may want to revoke the mandate before anything like that happens to one of its students … if it hasn’t already.
“Mandating COVID-19 vaccines under an EUA is legally and ethically problematic. The act authorizing the FDA to issue EUAs requires the secretary of the Department of Health and Human Services (HHS) to specify whether individuals may refuse the vaccine and the consequences for refusal. Vaccine mandates are unjustified because an EUA requires less safety and efficacy data than full Biologics License Application (BLA) approval.”
Dr. Naomi Wolf delivered an impassioned speech to her alma mater, Yale, in which she called their booster mandate “a serious crime. It is deeply illegal. Certainly, it violates Title IX.” She explains:
“Title IX commits the university to not discriminate on the basis of sex or gender in getting an equal education.… I oversee a project in which 3,500 experts review the Pfizer documents released under court order by a lawsuit. In that document, there is catastrophic harm to women! And especially to young women! And especially to their reproductive health.… 72% of those with adverse events in the Pfizer documents are women!”
Other universities are currently facing lawsuits for mandating the COVID vaccine in violation of state laws, including one against Ohio University, University of Cincinnati, Bowling Green State University, and Miami University of Ohio.
Abundant evidence proves the vaccines FAIL to:
prevent contraction of COVID
lower hospitalization rates
By the same token, this evidence shows the vaccines are ASSOCIATED with:
heightened transmission levels
greater chances of catching COVID
increased hospitalization rates
higher excess mortality
disproportionate injuries to women
Why is Stanford mandating these unsafe and ineffective products, again?
If logic, peer-reviewed studies, and legal concerns such as the violation of Title IX don’t convince Stanford to rescind the mandate, then what about its stated ethical commitment to upholding its Code of Conduct?
BMJ’s Journal of Medical Ethics recently published COVID-19 Vaccine Boosters for Young Adults: A Risk Benefit Assessment and Ethical Analysis of Mandate Policies at Universities. In this paper, eminent researchers from Harvard, Oxford, Johns Hopkins, and UC San Francisco (among other institutions) present five reasons university mandates are unethical.
They argue that the vaccines:
“(1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group; (2) may result in a net harm to healthy young adults; (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission; (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and (5) may result in wider social harms.” (emphases mine here and below)
They calculate that:
“To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31,207–42,836 young adults aged 18–29 years must receive a third mRNA vaccine.”
The authors conclude that:
“university COVID-19 vaccine mandates are likely to cause net expected harms to young healthy adults—for each hospitalisation averted we estimate approximately 18.5 SAEs and 1,430–4,626 disruptions of daily activities.… these severe infringements of individual liberty and human rights are ethically unjustifiable.”
This builds on a previously published BMJ Global Health article by some of the same authors titled, “The Unintended Consequences of COVID-19 Vaccine Policy: Why Mandates, Passports, and Restrictions May Cause More Harm Than Good.”
In this paper, the authors contend that COVID-19 vaccine mandates “have unintended harmful consequences and may not be ethical, scientifically justified, and effective” and “may prove to be both counterproductive and damaging to public health.”
Over the course of history, countless products once thought to be safe—from DDT to cigarettes to thalidomide for pregnant women to Vioxx—were eventually discovered to be dangerous and even lethal. Responsible governments, agencies, and companies pull those products from the market when the scientific data proves harm—and institutions that care about their community members certainly don’t mandate those products when evidence of risk becomes obvious, as is the case now for the experimental COVID vaccines.
Mahatma Gandhi once stated:
“An error does not become truth by reason of multiplied propagation, nor does truth become error because nobody sees it. Truth stands, even if there be no public support. It is self-sustained.”
The truth is clear to anyone who’s willing to look.
Will it stand up for the lives and health of its students—or will it wait until tragedy strikes another George Watts Jr. or Megha Thakur?
This is a historic opportunity for Stanford to prove its allegiance to people, scientific data, and critical thought over pharmaceutical donors, political pressures, and conformist thinking.
The stakes could not be higher.
* * *
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