WASHINGTON, DC - APRIL 09: White House coronavirus response coordinator Deborah Birx listens during the daily coronavirus briefing in the Brady Press Briefing Room at the White House on April 09, 2020 in Washington, DC. U.S. unemployment claims have approached 17 million over the past three weeks amid the COVID-19 pandemic. (Photo by Alex Wong/Getty Images)
Dr. Birx ‘We Don’t Need to Mandate’ Masks. Recently the good doctor has been going from network to network being critical of Tony the Fauch. Sadly when he was killing millions of people worldwide, she was silent. But now she seems to have had a change of heart.
“Four years in, we don’t need to mandate. We need to actually empower people with the information that they need for themselves and their families because every family is different. And by the way, outside is safe, and playgrounds are safe.”
We are seeing a panic across the country with some hospitals and colleges, but for the most part the vast majority of Americans are ignoring the cultists cry for masking.
But in closing Dr. Birx had something interesting to say about the vaccines.
“So, you could switch them out (vaccines) and make them quickly, and instead of doing that, we’re basing vaccines on old variants rather than the new variants, and we know today exactly who needs to be immunized,”
“There is so little data available on the safety of this latest booster, the FDA’s actions create an unnecessary risk to the public’s health.” —Dr. Pierre Kory
Let’s start there with what our doctors are saying about the safety of the new COVID shots that were recently approved by the FDA and blessed by the CDC.
It is our moral and ethical imperative to report to you the most reliable information and scientific data available of which you must be aware so that you can make the best and most informed decisions possible to preserve your health.
Dr. Kory, chief medical officer of the FLCCC and Dr. Paul Marik, the FLCCC’s chief scientific officer, want you to be fully aware of the lack of trustworthy science for the safety and efficacy of these injections before you decide whether or not you wish to receive a shot.
“Our government continues to look for shortcuts in approving vaccines under the guise of an emergency while putting the public at risk of more injuries from these boosters that have not been through the extensive review and testing that is required outside of the EUA,” said Dr. Marik.
He’s right. Pfizer and Moderna—with the full-throated assent of the FDA— have leveraged the (unnecessary) Emergency Use Authorization (EUA) that remains in effect—despite there being no emergency— in order to push these new shots to market—for a low-risk illness that produces mild symptoms for most people.
There is no emergency (except for the vaccine purveyors’ urgent desire to fill their pockets with more and more $$$.)
💉 You get exposed to ad after ad after ad trying to guilt-shame you into getting a dangerous injection for a fading strain of COVID by warning you that not doing so will place your loved ones in harm’s way. It’s simply not true, but many doctors remain afraid to talk to their patients about it for fear of reprisals by their employers, licensing bodies and medical boards. ***
“The ‘system’ does not encourage independent thinking when it comes to treatment. They want everyone to follow the same protocols — and many healthcare providers do, as they’re afraid of the repercussions,” said Dr. Joe Varon, a critical care physician and one of the co-founders of the FLCCC. “If there’s one thing that the FLCCC is proud of, it is that we never give up. If one thing doesn’t work, we go and find something else. That’s what makes us different, and what makes us a complete alternative to what’s out there in healthcare.”
100%, Joe. An alternative to the current healthcare system is critical—especially now— given that the FDA’s recommendation for this new booster was based on data submitted by the companies that have a financial interest in the approval.There was no independent or peer review of this data.
“There is the almost unfathomable rise of 6 standard deviations from the norm in disability rates coinciding with the COVID-shots rollout in late 2020 followed by their mandating on the American labor force,” said Dr. Kory, who addressed rising cases of vaccine injuries, the continuing war on ivermectin and Big Pharma on the Kevin Wall radio program this week. (Hear Dr. Kory starting at about 15:00.) “Most dispiriting of all is that the vast majority of the vaccine-injured were highly functional before these spike protein exposures or injections.”
BOTTOM LINE:Educate yourself thoroughly about the COVID shots before deciding what’s best for you and your family.
***A one-year-old California law that allowed for the punishment of physicians who provided “misinformation” to their patients—specifically regarding COVID-19 and the vaccines— will soon be voted on for repeal. Under the law, if doctors violated “scientific consensus” and official “standards of care”, they could be cited for unprofessional conduct and subject to board disciplinary action. Many physicians claimed the law violated their First Amendment rights, and prompted several lawsuits challenging its constitutionality.
Lawmakers in both Florida and South Carolina have, in official proceedings, voiced their concern over the safety, efficacy and need for the current COVID shots.
In South Carolina, attorney Aaron Siri testified in a pandemic preparedness listening session about COVID vaccine “safety” (an oxymoron?). And in Florida, Surgeon General Joseph Ladapo warned healthy adults under the age of 65 against taking a new COVID-19 booster.
“With the amount of immunity that’s in the community — with virtually every walking human being having some degree of immunity, and with the questions we have about safety and about effectiveness, especially about safety, my judgment is that it’s not a good decision for young people and for people who are not at high risk at this point in the pandemic,” said Dr. Ladapo.
Keep talking, gentlemen. Keep talking.
GREAT NEWS!
Ohio House Bill 73 advanced to the next important step in the Ohio legislature and will soon be considered by the Senate Health Committee. Testimony will be heard by the committee followed by a vote to advance the bill to the entire Ohio Senate.
The Dave and Angie Patient and Health Provider Protection Act, if passed into law, will protect the rights of doctors to prescribe repurposed drugs. This encouraging progress on bipartisan legislation will ensure access to essential treatments that were arbitrarily restricted during the pandemic.
Our own Dr. Paul Marik, who testified on HB73 before the Ohio House Health Provider Services Committee, said this about the bill’s advancement in the Senate: “The bill is not only critical to the future of the practice of medicine in Ohio, but sets an example for the nation to follow.”
“We are seeing an increase in the number of cases of COVID. That’s the bad news. The good news is that not a single patient has had to go to the hospital because of COVID.” —Dr. Joe Varon.
Dr. Joseph Varon and Dr. Katarina Lindley joined host Betsy Ashton this week for the FLCCC Weekly Webinar to discuss what they are seeing at their practices in terms of COVID, long COVID and vaccine injury/“long vax”. No need to panic, FLCCC protocols are focused on prevention, treatment and recovery!
“Fear is a liar. So—faith over fear. Do the things you always do when you get sick and find a doctor you trust.” advised Dr. Kat Lindley.
In this new episode of ‘Whole Body Health’, Dr. JP Saleeby describes how hormones, drugs and supplements can support or interfere with your thyroid. Dr. Saleeby also explains why it is important to check your thyroid hormones if you have long COVID or post-vaccine syndrome.
This is a study of COVID-19 confirmed hospitalized patients. Researchers found two groups of individuals with biomarker profiles: the first had high fibrinogen levels in relation to C-Reactive proteins (CRP) and the second had an increase in D-Dimers in relation to CRP. These molecules generally increase in relation to CRP; however, here the researchers found that the fibrinogen and D-Dimers increased while the CRP stayed low. These cohorts were associated with higher likelihood of neurological long COVID. Dr. Been takes us through both the findings and the mechanisms.
The FLCCC protocols save lives all around the world!
From the very start in March 2020, through sharing the FLCCC Alliance COVID-19 protocols, this doctor was able to share life-saving information with hundreds of his contacts, his extended family (USA, Philippines, UK, Canada, Israel), close friends, former patients, relatives and former classmates locally and overseas. The protocols prevented infection, severe infection and untimely death for ALL of his contacts. Watch his MyStory now.
After all the COVID and Vaccine lies, will Americans comply to masking up? The majority will not. And if the MSM and their medical allies are truthful, they’ll report that those getting COVID, hospitalized, and dying will be the ones who got the eight jab.
I saw Tony the Fauch out spewing his bull again. But here is one of the few times he’s being truthful. Sort of. He states they really don’t work that well, but he says mask up anyway. A placebo effect?
“Masks are really for infected people to prevent them from spreading infection to people who are not infected rather than protecting uninfected people from acquiring infection. The typical mask you buy in the drug store is not really effective in keeping out virus, which is small enough to pass through material. It might, however, provide some slight benefit in keep out gross droplets if someone coughs or sneezes on you,” Fauci wrote. “I do not recommend that you wear a mask, particularly since you are going to a very low risk location. Your instincts are correct, money is best spent on medical countermeasures such as diagnostics and vaccines.”
Who gets the jab. Not I. Just putting this out there. There’s much that I disagree with here, but there are some good points. Overall the article was trying to be fair, but only doctors from the left were included. I’ll highlight some of the good points.
by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today.
While the FDA and CDC have yet to weigh in on fall COVID boostersopens in a new tab or window, experts in infectious disease and public health are already discussing who should get them, and who may not need to.
High-risk groups get a resounding “yes” — but when it comes to younger, healthy adults, the answer is less clear.
There’s wide agreement that older adults will receive a hearty recommendation to receive the booster, which targets the XBB.1.5 strainopens in a new tab or window, said William Schaffner, MD, of Vanderbilt University Medical Center in Nashville, Tennessee and a spokesperson for the Infectious Diseases Society of America (IDSA).
The same goes for people younger than 65 who have chronic conditions, are immunocompromised, or who are pregnant, he said.
“Now for adults who are otherwise healthy and younger than 65, and young adults, adolescents, and children, that’s all going to be debated,” Schaffner noted, anticipating how discussions at CDC’s Advisory Committee on Immunization Practices (ACIP) will go when the group meets on September 12opens in a new tab or window. “Whether they receive a routine recommendation or one for shared clinical decision making … I think there will be some brisk discussion about that.”
Aaron Glatt, MD, of Mount Sinai South Nassau in Oceanside, New York, who is also a spokesperson for IDSA, said that people “who have been vaccinated, who are healthy, who are younger, are probably not the first people who should be getting in line to get another COVID booster, especially if they’ve had one.”
In addition, someone who’s recently had COVID probably doesn’t need a booster, he added.
Glatt was a strong advocate for shared decision making when it comes to COVID boosters. He gave the example of a 62-year-old who was boosted 6 months ago and is in good health. “I think for that group, there’s more leeway to say, let’s individualize the decision.”
“The good news is that you’ve had the full primary series of the vaccine and a bivalent booster, or you were vaccinated and infected, you have substantial protection against getting very sick and dying,” Benjamin told MedPage Today. “But the older you are, the greater your risk of getting very sick and dying.”
Paul Offit, MD, of Children’s Hospital of Philadelphia, said the goal of the vaccine has always been to prevent serious illness, and on that basis, the highest-risk groups who should be candidates for vaccination include the elderly, especially people over 75; people with multiple chronic conditions; pregnant people; and the immune compromised.
“These four groups will get the most benefit,” Offit said. “We’re just not going to prevent mild disease for a short-incubation-period mucosal infection for any reasonable amount of time.”
Neither Schaffner, Glatt, nor Offit thought children should be strongly recommended to get a COVID booster. Schaffner noted that in young children, Omicron has been less likely to cause severe disease. In addition, he said, doctors are seeing less multisystem inflammatory syndrome in children (MIS-C) due to COVID.
“Virtually every child has been exposed to COVID through infection or vaccination or both, so the population immunity, children included, is pretty high,” Schaffner said. “I wouldn’t be surprised if some of the recommendations for these younger healthy populations are in the shared clinical decision-making category.”
“Why does a healthy 12-year-old with three doses of vaccine need another dose?” Offit said. “There would have to be protection against severe disease and I just don’t see that evidence.”
Glatt noted that “an immunocompromised, very sick child is a different story.” But if the child is healthy, “you’d really have to show me [good data] that there’s a reason to [boost].”
Even the U.K. is focusing its booster recommendations on older and more vulnerable people. Its Joint Committee on Vaccination and Immunisation (JCVI) recommendedopens in a new tab or window offering vaccines to those at high risk of serious disease, including adults ages 65 and up, people with chronic conditions, and people who work in care homes for older adults.
Indeed, that recommendation makes sense from a population health perspective that asks who would benefit most from this intervention, said Bob Wachter, MD, of the University of California San Francisco.
But he believes even young people can get an incremental benefit from fall boosters. Wachter, whose wife has long COVID and who himself experienced a trip to the hospital because of COVID — not from respiratory distress, but from a related fallopens in a new tab or window — said he would recommend a booster to his 30-year-old children because the benefits outweigh the minimal risks.
Even though people in this age group have a low baseline risk of hospitalization from the disease, a booster would reduce that risk even further, he said. It might also help lower their risk of long COVID, he added.
“I start from the baseline that this is a very safe intervention, and there is potential benefit in almost everybody, including relatively young and healthy people,” Wachter said. “But to the question of who’s most likely to benefit, clearly those are the people at higher risk of bad outcomes.”
He added that this year’s fall booster will probably not be very popular, “because not a lot of people got it when the risk was higher and the public attention on COVID was greater.”
“It’s pretty clear that the national consciousness is over it,” he said. “If you’re a healthy 40-year-old, you’re not making a crazy choice not to get boosted.”
In total, the researchers looked at 78 studies involving more than a million people across the world. Results indicated that surgical masks reduced the risk of catching 'Covid or a flu-like illness' by just five percent - a figure so low it may not be statistically significant
Worth Posting again. Masks really don’t work that well.
Just in case you missed it, we did a similar story several months back. With the latest hysteria that’s going on out there with the fanatics about the alleged resurgence of COVID, I thought it best to remind folks on masking up. This from the Cochrane Institute.
Data collection and analysis
We used standard Cochrane methodological procedures.
Main results
We included 11 new RCTs and cluster‐RCTs (610,872 participants) in this update, bringing the total number of RCTs to 78. Six of the new trials were conducted during the COVID‐19 pandemic; two from Mexico, and one each from Denmark, Bangladesh, England, and Norway. We identified four ongoing studies, of which one is completed, but unreported, evaluating masks concurrent with the COVID‐19 pandemic.
Many studies were conducted during non‐epidemic influenza periods. Several were conducted during the 2009 H1N1 influenza pandemic, and others in epidemic influenza seasons up to 2016. Therefore, many studies were conducted in the context of lower respiratory viral circulation and transmission compared to COVID‐19. The included studies were conducted in heterogeneous settings, ranging from suburban schools to hospital wards in high‐income countries; crowded inner city settings in low‐income countries; and an immigrant neighbourhood in a high‐income country. Adherence with interventions was low in many studies.
The risk of bias for the RCTs and cluster‐RCTs was mostly high or unclear.
Medical/surgical masks compared to no masks
We included 12 trials (10 cluster‐RCTs) comparing medical/surgical masks versus no masks to prevent the spread of viral respiratory illness (two trials with healthcare workers and 10 in the community). Wearing masks in the community probably makes little or no difference to the outcome of influenza‐like illness (ILI)/COVID‐19 like illness compared to not wearing masks (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.84 to 1.09; 9 trials, 276,917 participants; moderate‐certainty evidence. Wearing masks in the community probably makes little or no difference to the outcome of laboratory‐confirmed influenza/SARS‐CoV‐2 compared to not wearing masks (RR 1.01, 95% CI 0.72 to 1.42; 6 trials, 13,919 participants; moderate‐certainty evidence). Harms were rarely measured and poorly reported (very low‐certainty evidence).
In reporting on a Montana case in which a judge ruled that the state had to include the climate effect of oil and gas permits before deciding on them, the Associated Press showed just how brain-dead the discussions of “global warming” have become.
District Court Judge Kathy Seeley ruled in favor of several young plaintiffs – ranging in age from 5 to 22 – saying they “have a fundamental constitutional right to a clean and healthful environment, which includes climate as part of the environmental-support system.”
As proof of the harm the plaintiffs are suffering, the order has a list of horribles that includes:
“Olivia expressed despair due to climate change.”
“Badge is anxious when he thinks about the future that he, and his potential children, will inherit.”
“Grace … is anxious about climate change.”
“Mica gets frustrated when he is required to stay indoors during the summer because of wildfire smoke.”
(Perhaps the judge should have ruled against the adults who are filling these poor children’s minds with climate alarmist fantasies, but that’s another story.)
The ruling was heralded by the likes of Julia Olson, executive director of the Oregon-based Our Children’s Trust, which has filed similar lawsuits in other states, who said: “Today’s ruling in Montana is a game-changer that marks a turning point in this generation’s efforts to save the planet from the devastating effects of human-caused climate chaos.”
(Apparently, after “global warming,” and “climate change,” and “climate crisis” failed to move the needle, the left is trying out “climate chaos.”)
We will admit that we find ourselves in wholehearted agreement with Emily Flower, spokesperson for Montana Attorney General Austin Knudsen, who called the ruling “absurd” and said that this “same legal theory has been thrown out of federal court and courts in more than a dozen states. It should have been here as well, but they found an ideological judge who bent over backward to allow the case to move forward and earn herself a spot in their next documentary.”
In any event, it was up to the crack reporters and editors at the once respectable Associated Press to come up with what is perhaps the most asinine sentence ever written about this issue.
“The ruling following a first-of-its-kind trial in the U.S.,” the AP reported, “adds to a small number of legal decisions around the world that have established a government duty to protect citizens from climate change.”
“A government duty to protect citizens from climate change”?
Think about that for a minute.
Do they mean any sort of climate change, such as the climate change that occurs around the world every year when temperatures can change from sub-zero to 90 degrees in a matter of months?
Or perhaps they mean that the government should protect citizens from things like El Nino, that naturally recurring – but scientifically inexplicable – climate phenomenon that we are currently experiencing, and underwater volcanic eruptions, both of which have driven this summer’s heat waves.
Or, longer term, what about ice ages? There have been five of them in the earth’s history – also for reasons nobody can fully explain. The last one ended 10,000 years ago, which is about how long these “interglacial” periods last. A few years ago, some researchers predicted the next ice age could begin in 2030. Is it the government’s duty to protect us from this climate variation?
Someone should take these AP reporters aside and explain to them a basic fact of life: The climate is always changing. Always. Sometimes for the worse. Sometimes for the better.
They might go on to explain to these reporters that the best way to deal with an ever-changing climate isn’t to wish change away, or pretend that denying a drilling permit will make one iota of difference, but to encourage human ingenuity and prosperity.
That’s how you deal with a climate that is always changing. By adapting to it. It’s why deaths from naturally occurring disasters such as earthquakes, hurricanes, and so on, have steadily fallen as mankind has become smarter and more prosperous.
It’s radical anti-growth environmentalists – aided by brain-dead reporters – not oil and gas companies, who are the biggest threats to the health, safety, and well-being of those kids in Montana.
Just putting this out there. Fauci successor at NIAID peddled dangerous Remdesivir drug as ‘silver bullet’ against Covid-19 Dr. Jeanne Marrazzo tried to use unsafe antiviral IV drug on every covid hospitalized patient at UAB.
Dr. Jeanne Marrazzo, the newly minted successor to Dr Anthony Fauci at the National Institute for Allergy and Infectious Diseases (NIAID), was recently one of America’s chief hype women for an antiviral drug that is now unanimously considered an unsafe and catastrophically failed treatment for Covid-19.
Prior to moving to her Government Health post, Marrazzo was the longtime director of the Division of Infectious Diseases at the University of Alabama at Birmingham (UAB).
In partnership with Big Pharma drugmaker Gilead, UAB played a major role in the research and development of Remdesivir. The drug was developed over a decade ago with the hopes to treat Hepatitis C and respiratory syncytial virus (RSV), but was suddenly repurposed to “treat” Covid-19 when coronavirus hysteria reached the United States.
Given the UAB-Gilead partnership, one would think that Dr. Marrazzo would refrain from commenting on issues through which she maintained a clear conflict of interest. Or at the very least, she had the duty to disclose her conflict of interest when speaking to the media about the UAB-developed “wonder drug.” She did no such thing.
Even worse, Dr. Marrazzo bashed harmless and low cost alternatives like hydroxychloroquine, while hyping the super expensive Gilead-UAB competitor drug.
“The hope was maybe, if you treat early in the disease, you don’t need a silver bullet” such as remdesivir, she told The Washington Post in a July 2020 piece. “Hospitals are on the razor’s edge,” she added, contributing to the fear and paranoia that was enveloping the nation at the time.
In interview after interview, Dr. Marrazzo had nothing but good things to say about remdesivir, despite the incredible lack of data available to support her outandish claims about the drug.
On social media, Marrazzo lavished endless praise upon Remdesivir, declaring it the best agent against coronavirus disease, and boasting that her hospital tries to use it on every covid-hospitalized patient.
“We don’t have enough remdesivir to treat everybody who’s in the hospital,” she said in a late 2020 news conference about the state of her hospital system. “It’s a really challenging situation.”
Her predecessor at the NIAID, Mr Fauci, infamously paraded Remdesivir as the “standard of care” for Covid-19 treatment, adding that it can “block the virus.”
Unsupported pseudoscientific claims about very expensive drugs (a full course of remdesivir costs the patient thousands of dollars) is nothing new for NIAID officials, who, under Fauci’s leadership, have created an agency that acts as a government marketing department for pharmaceutical companies.
Undoubtedly, Marrazzo’s Remdesivir maximalism had disastrous implications for patients hospitalized at UAB. The so-called silver bullet later took on a morbid nickname, “run, death is near,” because of the severe side effect portfolio associated with the IV drug.
The headlines speak for themselves:
Remdesivir not only failed, but actively harmed hospitalized patients, who were being injected with the antiviral agent following the recommendations of Dr. Marrazzo.
The most exhaustive studies on the Gilead-UAB drug show that there are zero clinical benefits to injecting patients with remdesivir. Many studies show that Remdesivir can severely injure vital organs such as the heart and kidneys.
Dr. Marrazzo has never publicly expressed remorse for her longtime promotion of the drug she once described as a “silver bullet” against Covid-19. She last promoted the unsafe drug in December, 2021, long after most hospital systems stopped treating patients with the Gilead-UAB disaster drug.
Last week during an Australian Senate committee hearing, Pfizer and Moderna executives were grilled under oath about covid-19 vaccine policies and vaccine safety.
Tensions were high during the public hearing, which was live-streamed via the parliamentary website.
Senators fired questions at Pfizer and Moderna executives who responded by dodging questions and refusing to take accountability for their failures.
To complicate matters, the drug company executives did not attend the hearing in-person, only via video link allowing them to plead ignorance about the studies that were presented during the inquiry.
At the commencement, the Chair warned the witnesses against giving “false or misleading evidence” and after opening statements by Pfizer and Moderna, the floor was opened to questions.
Stopping transmission
Senator Matt Canavan began question time and was laser-focused on the issue of viral transmission.
“Did Pfizer test whether your covid-19 vaccine could stop or reduce the transmission of the virus before its approval and rollout in late 2020,” asked Canavan pointedly.
Pfizer Australia’s medical director Krishan Thiru was evasive.
Left to right: Brian Hewitt, Director of Regulatory Affairs, Pfizer Australia; Krishan Thiru, Medical Director, Pfizer Australia
“To bring this vaccine to patients we were required to show that the vaccine was safe and effective…The primary purpose of vaccination was, and remains, to protect the person who received the vaccine,” said Thiru.
Canavan reminded him that Pfizer’s own CEO Anthony Bourla told a reporter on NBC news on Dec 3, 2020, that it was “not certain” if vaccinated people could catch and spread the virus, but Thiru kept repeating the mantra, “the vaccine is safe and effective.”
Canavan persisted, citing Pfizer’s official tweet on Jan 14, 2023, stating its highest priority was its “ability to vaccinate at speed to gain herd immunity and stop transmission,” and then on June 8, 2021, Bourla tweeted, “the vaccine was a critical tool to help stop transmission.”
“What evidence did Pfizer have to make that public statement to imply that vaccination could stop transmission?” asked Canavan.
Thiru pleaded ignorance saying he was not familiar with the context of the tweets and took the question on notice (to respond later in writing).
Canavan explained that federal and state governments had imposed vaccine mandates based on the evidence and advice from the manufacturers that claimed the vaccines could “stop the spread.”
Canavan also pointed to the Doherty Modelling report submitted to national cabinet in Nov 2021 that underpinned the government’s decision to impose mandates in late 2021, but again, Pfizer could not confirm whether it was consulted about the modelling.
Hewitt said, “I can’t answer that question” and took it on notice.
Moderna Executive Director of Medical Affairs for Respiratory Vaccines Rachel Dawson, said that in the phase III pivotal trials of 2020, its mRNA vaccine showed that it could reduce symptomatic infection, and that it could “make an important contribution to reducing viral transmission.”
Dawson cited real world data demonstrating that the spread of the virus was reduced in households among vaccinated individuals and that they had a “lower viral load.”
But to this day, the US regulator says the ability of Moderna’s mRNA vaccine to reduce transmission remains unproven. “While it is hoped this will be the case, the scientific community does not yet know if Spikevax will reduce such transmission,” states the FDA.
Canavan said Moderna’s evidence, “just doesn’t seem to stack up”.
“Politicians told us it will stop the spread. Clearly that hasn’t happened. Do you have a simple explanation for why very high rates of vaccination, higher than anyone expected (90%) in this country, has clearly not stopped the spread of coronavirus,” asked Canavan.
But Moderna avoided the question on transmission, presumably because it would undermine the entire argument that vaccine mandates “keep others safe,” and instead, referred to its scripted statement that “the goal of vaccination is to prevent severe infection in hospitals.”
Preventing infection
Senator Gerard Rennick then proceeded to challenge Pfizer on its claim that the vaccine was “100% effective at preventing covid-19 cases,” a statement that Bourla tweeted on April 2, 2021.
Rennick proceeded to explain why the statement was implausible.
“By September 2022, Australia had recorded 10 million cases of COVID despite having an adult population vaccinated to the tune of 95% so given those real world figures in Australia, do you still stand by that statement?” said Rennick.
But Thiru responded repeatedly, “we strongly believe, and we reiterate, that the vaccine is safe and effective for its intended use” saying that Pfizer’s vaccine remained highly effective prior to the emergence of variants.
When Rennick asked Pfizer for its definition of “highly effective” in terms of duration, Thiru responded saying, “When the wild-type virus was prevalent, efficacy of approximately or greater than 90% was maintained at six months for illness and severe disease.”
But regulatory filings clearly show Pfizer had strong evidence by April 2021 that its vaccine’s efficacy waned, and withheld the data from the public for months.
Claiming that vaccine efficacy was 90% after six months following vaccination is misleading because that figure is largely driven by the first couple months of the trial when there was still a placebo group. Had people stayed in the trial for the whole duration of the 6 months, the average overall, would have been lower.
Lack of studies
Senator Rennick proceeded to read out the TGA’s non-clinical report listing all the safety studies in animals that were not carried out prior to testing in humans.
Despite assurances that “no corners were cut,” there were no carcinogenic tests, genotoxicity tests, immunotoxicity tests, duration studies, interaction studies with other medicines, and the list went on.
Again, Thiru predictably answered, “I don’t have that report in front of me, so I’m afraid I can’t talk to that.”
When Rennick asked directly if any studies were omitted or circumvented entirely to achieve the accelerated time frame for vaccine development, Pfizer objected saying its process was “thorough and comprehensive”.
Safety problems
Senator Rennick asked if Pfizer had determined the mechanism for why its vaccine could cause myocarditis and pericarditis, but Thiru was defiant saying that Pfizer had “strong confidence in the safety profile” of its vaccine.
Rennick would not let up. “I want you to explain to me why it causes myocarditis,’ he asked several times.
Thiru conceded that Pfizer was aware of “very rare” reports of myocarditis and pericarditis temporally associated with vaccination, but could not explain the mechanism, instead opting to take the question on notice again.
Senator Alex Antic challenged Pfizer on the Fraiman re-analysis, which found one additional SAE for every 800 people vaccinated with an mRNA vaccine, but his attempts hit a brick wall.
Senator Pauline Hansen chimed in, noting the Fraiman re-analysis found a “36% increase in serious adverse events. The most common were coagulation disorders, including thrombosis, and acute cardiac injury. In every 10,000 people injected 18 will experience a life threatening or altering medical complication,” said Hansen.
Again, Thiru pleaded ignorance. “I do not have a copy of your paper. I have not examined it,” he said, “the benefit risk ratio for vaccination remains strongly positive in all indications, all age groups for which it has been approved.”
Senator Hansen became visually frustrated.
“You haven’t read up on all of this, have you?” she said angrily, “You’ve come to this inquiry and you haven’t done anything whatsoever to respond to our questions. I think it’s very poor of you to not be able to answer these questions.”
When it was Moderna’s turn to respond to the Fraiman re-analysis, they too, said they were not aware of it.
Senator Antic asked Moderna what its overall rate of SAEs was for its mRNA vaccine and how that compared to routine vaccination.
But Moderna’s director of Scientific Leadership Chris Clarke said, “I don’t have the actual rates of adverse events,” as he shuffled through the papers on his desk.
Antic was staggered by the response, “You’re before a Senate inquiry and you cannot tell me the rates of serious adverse events? I mean, it’s quite extraordinary.”
Moderna took the question on notice and said that in the clinical trials they “observed no safety concerns.”
Indemnity agreements
Senator Malcolm Roberts asked for details of the indemnity agreement between Pfizer and the Australian government.
Specifically, Roberts asked if there was any clause in the agreement that indemnified Pfizer in the situation where an employee is mandated by their employer to undergo vaccination and then experiences harm.
“Senator, any indemnity agreements between Pfizer and the Australian Government are confidential, and we’re not able to discuss that in this forum,” responded Thiru.
Roberts fired back, “What have you got to hide?”
He also asked if there was any clause in the agreement that negates Pfizer’s indemnity in the event Pfizer is found to have committed fraud in the trial, as alleged by whistle-blower Brook Jackson in 2021.
“My question is simple. What is the answer? Yes or no?” asked Roberts. But Pfizer insisted “the contents of Pfizer’s contract with the Australian Government remains confidential.”
Senator Malcolm Roberts summed up his thoughts.
“You have repeatedly refused to provide evidence and dodged questions from Senators Rennick and Antic. You have relied instead on appeals to authority, and other logical fallacies.”
Covid vaccine in pregnancy
Senator Hansen confronted Pfizer with questions about the safety of its vaccine in pregnant and breastfeeding women.
Thiru did concede that there is limited clinical trial evidence in pregnant women, but said that peak bodies such as the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) supported use of the vaccine.
“[RANZCOG] have said pregnant women in Australia are a priority group for covid-19 vaccination and should be routinely offered the Pfizer vaccine (Comirnaty) or Moderna (Spikevax) vaccines at any stage of pregnancy. They have said there is no evidence of increased risk of miscarriage or teratogenic risk with mRNA or viral vaccines.”
Forced vaccination
One of the most egregious moments of the hearing was when Pfizer’s Head of Regulatory Affairs Brian Hewitt, piped up and said no-one in Australia was ever “forced” to be vaccinated.
Senator Hansen took exception to the comment and asked if Hewitt would retract his statement.
Hewitt held his position saying, “No. I believe firmly that nobody was forced to have a vaccine.”
“A lot of Australians will disagree with you on that one,” retorted Senator Hansen.
Senator Matt O’Sullivan was incredulous. He said that in his state of Western Australia, there were mandates across the board, with “very, very few exceptions.”
“If you wanted to go to work, and earn a living and provide for your family, you had to be vaccinated. I am staggered that that was your response to questions in relation to whether or not people were forced to have vaccines,” said O’Sullivan.
Many of O’Sullivan’s constituents had to go without income because the state government was “forcing” them to be vaccinated against their will.
Hewitt looked down to read a pre-prepared answer, much to the dismay of listeners.
“Senator, mandates, and vaccine requirements are determined by governments. As a company we were not involved in any government vaccine mandates. I don’t believe the mandates actually forced individuals to get vaccinated.”
Pfizer did confirm that it enforced a vaccine mandate within its own company and that it had imported a special batch of covid-19 vaccines for its employees. Why the special batch? “So that no vaccine would be taken from government stocks,” said Hewitt.
Thiru also said there were some exemptions for medical or religious reasons and that “a small number of colleagues departed the company,” presumably because they did not comply with the mandate.
Moderna, on the other hand, distanced itself from commenting on vaccine mandates.
Clarke, Director, Scientific Leadership, Moderna.
Moderna’s Vice President of Medical Affairs Jane Leong said, “We do not have a view on decisions taken by public health agencies or governments in relation to vaccine mandates. This is purely a matter for policymakers.”
At the finish line, Pfizer and Moderna executives managed to expertly dodge questions, they couldn’t recall their own rate of SAEs, they wouldn’t admit that covid vaccines cannot stop transmission, and they refused to divulge details of their indemnity agreements with the government.
Responses to questions on notice are due Aug 17, 2023.
The sky is falling, the sky is falling, no just another climate loon ignoring Science. No my friends the world isn’t ending and glaciers will continue to break off just as they have since the beginning of time.
PBS producers ran soundbites of seven souls who claimed the fear of “climate change” had made them anxious about the future, including Mark Ikeda, who said: “Climate anxiety affects my daily life, by the decisions I make about when I want to go someplace or where I want to go or more [inaudible], how I want to travel.”
John Yang interviewed Leslie Davenport, who is a “climate psychology therapist.” She says,” We view distress, upset, sadness, grief, anger about climate change to be a really reasonable, even healthy reaction.” She referred to this field of psychology as “emerging.” One has to ask, is climate change even qualify as science?
WATCH:
Video and partial transcription courtesy of NewsBusters
This is a clown who served during the Obama administration. Thought the job was all fun and games. Much of this article is Government misinformation. But there are parts that they get right. Come 2024 all these clowns that took part in the attacks on our young and elderly will be gone or in jail.
FDA Head Robert Califf Battles Misinformation — Sometimes.
Robert Califf, MD, the head of the FDA, doesn’t seem to be having fun on the job.
“I would describe this year as hand-to-hand combat. Really, every day,” he said at an academic conference at Stanford in April. It’s a sentiment the FDA commissioner has expressed often.
What’s been getting Califf’s goat? Misinformation, which gets part of the blame for Americans’ stagnating life expectancy. To Califf, the country that invents many of the most advanced drugs and devices is terrible at using those technologies well. And one reason for that is Americans’ misinformed choices, he has suggested. Many don’t use statins, vaccines, or COVID-19 therapies. Many choose to smoke cigarettes and eat the wrong food.
Califf and the FDA are fighting misinformation head-on. “The misinformation machine is really causing a lot of death,” he said, in an apparent ad-lib, this spring in a speech at Tufts University. The pandemic, he told KFF Health News, helped “crystallize” his need to tackle misinformation. It was a “blatant case,” in which multiple studies gave evidence about very effective therapeutics against COVID. “And a lot of people chose not to do it.” There were “large-scale purveyors of misinformation,” he said, poisoning the well.
Occasionally, though, Califf and the FDA have added to the cacophony of misinformation. And sometimes their misinformation is about misinformation.
Califf hasn’t been able to consistently estimate misinformation’s public health toll. Last June, he said it was the “leading cause of meaningful life-years lost.” In the fall, he told a conferenceopens in a new tab or window: “I’ve been going around saying that misinformation is the most common cause of death in the United States.” He continued, “There is no way to prove that, but I do believe that it is.”
At other times, as in April, he has called the problem the nation’s “leading cause” of premature death. “I’ll keep working on this to try and get it right,” he said. Later, in May, he said, “Many Americans die or experience serious illness every year due to bad choices driven by false or misleading information.”
Several factors are at the root of those differences. But Americans’ choices, often informed by bad or misleading data, political jeremiads, or profit-seeking advertising, are among the causes. For instance, one 2023 paper estimated that undervaccination against COVID — caused in part by misinformation — costs as much as $300 million per dayopens in a new tab or window, accounting for both the costs of healthcare and economic costs, like missed work.
Outside experts are sympathetic. Misinformation is a “huge problem for public health,” said Joshua Sharfstein, MD, a Johns Hopkins University public health professor and former FDA principal deputy commissioner. Having a strategy to combat it is crucial. But, he cautioned, “that’s the easiest part of this.”
The agency, which regulates products that consumers spend 20 cents of each dollar on per year, is putting more muscle behind the effort. It’s begun mentioning the subject of misinformation in its procurement requests, like one discussing the needopens in a new tab or window to monitor social media for misinformation related to cannabis.
Califf has noted small victories. Ivermectin, once touted as a COVID wonder drug, “eventually” became one such win. But, then again, its use is “not completely gone,” he said. And, despite winning individual battles, his optimism is muted: “I’d say right now the trend in the war is in a negative direction.”
Some of those battles have been quite small, even marginal.
And it’s difficult to know what to take on or respond to, Califf said. “I think we’re just in the early days of being able to do that,” he told KFF Health News. “It’s very hard to be scientific,” he said.
Take the agency’s experience last fall with “NyQuil chicken” — a purportedly viral cooking trend in which users roasted their birds in the over-the-counter cold medicine on social media platforms like TikTok.
Califf said his agency’s “skeleton crew” — at least relative to Big Tech giants — had picked up on increasing chatter about the meme.
But independent analyses don’t corroborate the claim. It seems much of the interest in it came only after the FDA called attention to it. The day before the agency’s pronouncement, the TikTok app recorded only five searches on the topic, BuzzFeed Newsfound in an analysis of TikTok dataopens in a new tab or window. That tally surged to 7,000 the week after the agency’s declaration. Google Trends, which measures changes in the number of searches, shows a similar pattern: Interest peaked on the search engine in the week after the agency announcement.
Califf also claimed “injuries” occurred to participants “directly” due to the social media trend. Now, he said, “the number of injuries is down,” though he couldn’t say whether the agency’s intervention was the cause.
Again, his assertions have fuzzy underpinnings. It’s not clear what, if any, actual damage the NyQuil chicken fad caused. Poison control centers don’t keep that data, said Maggie Maloney, a spokesperson for America’s Poison Centers. And, after multiple requests, agency spokespeople declined to provide the FDA’s data reflecting increased social media traffic or injuries stemming from the meme.
In countering misinformation, FDA also risks coming off as high-handed. In September 2021, the agency tweeted about purported mythsopens in a new tab or window and misinformation on mammograms. Among the myths? That they’re painfulopens in a new tab or window. Instead, the agency explained that “everyone’s pain threshold is different” and the breast cancer-screening procedure is more often described as “temporary discomfort.”
Statements like these “erode trust,” said Lisa Fitzpatrick, MD, MPH, MPA, an infectious diseases physician and currently the CEO of Grapevine Health, a startup trying to improve health literacy in underserved communities. Fitzpatrick has previously served as an official with the District of Columbia’s Medicaid program and with the CDC.
“Who are you to judge what’s painful?” she asked, rhetorically. It’s hard to brand subjective impressions as misinformation.
Califf acknowledged the point. Speaking to 340 million Americans is difficult. With mammograms, the average patient might not have a painful experience — but many might. “Getting across that kind of nuance and public communication, I think, is in its early phases.”
Scrutiny over the agency’s role regarding food and nutrition is also mounting. After independent journalist Helena Bottemiller Evich wrote an article criticizing the agency for relying on voluntary reporting standards for baby formula, Califf tweeted to correctopens in a new tab or window a “bit of misinformation,” saying the agency did not have such authority.
An agency communications specialist made a similar intervention with New York University professor Marion Nestle, PhD, MPH, referring to a “troubling pattern of articles with erroneous information that then get amplified.” The agency was again seeking to rebut arguments that the agency had erred in not seeking mandatory reporting.
“As I see it, the ‘troubling pattern’ here is FDA’s responses to advocates like me who want to support this agency’s role in making sure food companies in general — and infant formula companies in particular — do not produce unsafe food,” Nestle retortedopens in a new tab or window. Notwithstanding the agency’s protests to Evich and Nestle, the agency had only recently asked for such authority.
Efforts to respond to or regulate misinformation are becoming a political problem.
In July, a federal judge issued a sweeping, yet temporary, injunctionopens in a new tab or window — at the instigation of Republican attorneys general, multiple right-wing political groups, and prominent anti-vaccine advocate Robert F. Kennedy Jr.’s Children’s Health Defense — barring federal health officials from contacting social media groups to correct information. A large section of the ruling detailed efforts by a CDC official to push back on suspected misinformation on social media networks.
An appeals court later issuedopens in a new tab or window its own temporary ruling — this time countering the original, sweeping order — nevertheless underscoring the extent of pushback on government pushback against misinformation. Califf has consistently played down the government’s ability to solve the problem. “One hundred percent of experts agree, government cannot solve this. We have too much distrust in fundamental institutions,” he said last June.
It’s a remarkable change from his previous tenure leading the agency during the Obama administration. “I would describe the Obama years as genteel, intellectual, and a lot of fun,” he has said. Now, however, Califf is bracing for more misinformation. “It’s just something that I think we have to come to grips with,” he told KFF Health News.
