The U.S. Food and Drug Administration granted fast track designation to UB-311, a vaccine for Alzheimer’s disease made by biotechnology company Vaxxinity.1 The shot is an anti-amyloid beta immunotherapeutic vaccine that reportedly treats Alzheimer’s disease by targeting aggregated amyloid beta in the brain.2
Aside from the potential problems that can arise when a vaccine is rushed to market, the vaccine may be problematic from the get-go because amyloid beta may be a symptom of Alzheimer’s — not the cause — and could even have a protective role in the disease process.3
Fast-tracking a vaccine that’s targeting an isolated element of Alzheimer’s disease that is not the underlying cause is destined to be a massive disaster.
Alzheimer’s Vaccine Being Fast-Tracked to Market
UB-311 is being touted for eliciting a “robust and durable anti-amyloid beta antibody responses in patients,” according to Vaxxinity.4 Phase 1, Phase 2a and Phase 2a long-term extension trials have already been completed, with the company stating that the vaccine was “well tolerated in mild-to-moderate AD patients over three years of repeat dosing, with a safety profile comparable to placebo and no cases of amyloid-related imaging abnormalities-edema (“ARIA-E”) in the main study.”5
ARIA-E, a marker of fluid retention and microhemorrhages in the brain, occurs in about one-third of people taking the Alzheimer’s drug aducanumab (brand name Aduhelm).6 Similar to UB-311, Aduhelm was brought to market under an accelerated approval pathway by the FDA, despite uncertainty about the clinical benefit.7 The action sparked protests within the FDA advisory panel, and three members subsequently resigned.8
As an amyloid beta-directed antibody drug, Aduhelm also works by targeting amyloid beta in the brains of people with Alzheimer’s disease, but the findings of ARIA-E in many taking the drugs are alarming. Adam Brickman with Columbia University, New York City, suggested that the drug could potentially make cognitive decline worse instead of better. “It’s hard to put a positive spin on the neuroimaging abnormalities,” he wrote. “… [W]e simply do not know the long-term consequences.”9
While Vaxxinity is touting no cases of ARIA-E among its subjects as a success, the same holds true about the vaccine in that no one knows the long-term consequences. Vaxxinity has planned a Phase 2b trial for late 2022.10 It’s worth noting that drug development for Alzheimer’s has so far been a dismal failure, with at least 300 failed trials to date.11
One study, which was a collaboration between Washington University in St. Louis, drug companies Eli Lilly and Roche, the National Institutes of Health and others, involved 194 participants, of which 52 took Roche’s drug gantenerumab and 52 took Eli Lilly’s solanezumab.12
The drugs were intended to remove amyloid beta (Aβ) from the brain, but they failed to achieve the primary outcome of the study, which was slowed cognitive decline, as measured by tests on thinking and memory.
In fact, while the drugs did target amyloid beta, they had no effect on cognitive measures, with the researchers writing, “Both drugs engaged their Aβ targets but neither demonstrated a beneficial effect on cognitive measures compared to controls.”13
Is Amyloid Beta the Problem?
Even if drugs reduce amyloid beta plaques in Alzheimer’s patients, how this translates to affecting cognitive decline remains to be seen. While Alzheimer’s is characterized by an accumulation of beta-amyloid plaques and neurofibrillary tangles in the brain, there is controversy over their role in the development of the disease.
As researchers from the Tokyo Metropolitan Institute of Medical Science, department of dementia and higher brain function, wrote in Frontiers in Neuroscience :14
“The so-called amyloid hypothesis, that the accumulation and deposition of oligomeric or fibrillar amyloid β (Aβ) peptide is the primary cause of Alzheimer’s disease (AD), has been the mainstream concept underlying AD research for over 20 years. However, all attempts to develop Aβ-targeting drugs to treat AD have ended in failure.”
In 2009, researchers brought attention to the misguided premise of oversimplifying Alzheimer’s disease down to the amyloid-β protein precursor (AβPP) molecule, “implying that this molecule encapsulates AD so completely that the disease itself is almost of secondary importance.” This, they noted, ignores “the complexity of chronic diseases in general” and added:15
“A great deal of attention has focused on amyloid-β as the major pathogenic mechanisms with the ultimate goal of using amyloid-β lowering therapies as an avenue of treatment. Unfortunately, nearly a quarter century later, no tangible progress has been offered, whereas spectacular failure tends to be the most compelling.
We have long contended, as has substantial literature, that proteinaceous accumulations are simply downstream and, often, endstage manifestations of disease.
Their overall poor correlation with the level of dementia, and their presence in the cognitively intact is evidence that is often ignored as an inconvenient truth. Current research examining amyloid oligomers, therefore, will add copious details to what is, in essence, a reductionist distraction from upstream pleiotrophic processes such as oxidative stress, cell cycle dysfunction, and inflammation.
It is now long overdue that the neuroscientists avoid the pitfall of perseverating on ‘proteinopathies’ and recognize that the continued targeting of end stage lesions in the face of repeated failure, or worse, is a losing proposition.”
Amyloid Beta May Be Protective
There is even research to suggest that advanced protein aggregation, such as that seen in Alzheimer’s disease, could offer protective functions, perhaps protecting cells from toxic intermediates.16 Writing in the Annals of the New York Academy of Sciences, researchers suggested that amyloid beta is a response to neuronal stress, one that functions as a protective adaptation to the disease.17
Amyloid beta, they argued, accumulates relatively late in the development of Alzheimer’s disease, and while it has been found to be toxic in cell culture models, this may not hold true in humans. Instead of the prevailing notion that a mutation leads to increased amyloid beta and that leads to Alzheimer’s, the team suggested that a mutation leads to Alzheimer’s, which in turn triggers increased amyloid beta:18
“Mutations lead to cellular stress, which, in turn, leads to increased amyloid-β … in AD, cellular stress precedes increases in amyloid-β … Proteins, such as amyloid-β, that are induced under oxidative conditions and act to lessen oxidative damage are typically thought of as antioxidants and, in this regard, we recently demonstrated that amyloid-β is a bona fide antioxidant that can act as a potent superoxide dismutase.”
This would explain, they suggest, why the brains of most elderly people contain amyloid-β, often in amounts similar to those found in patients with Alzheimer’s disease (AD). They noted:19
“While such production and deposition of amyloid-β appears to successfully stave off age-related redox imbalances in normal aging, in AD, where there is a profound and chronic redox imbalance, the presence of amyloid-β, even at high levels, proves insufficient.”
The Link Between Alzheimer’s and Your Gut
If Alzheimer’s pathogenesis cannot be blamed entirely on amyloid beta, what, then, is the cause? It’s likely that many factors are to blame, with imbalances in gut microbiota among them. Research suggests, for example, that the bacteria in your intestines may influence brain functioning and can even promote neurodegeneration.20
In a study of 89 people, high blood levels of lipopolysaccharides (LPSs) and the short-chain fatty acids (SCFAs) acetate and valerate were associated with large amyloid deposits in the brain.21 LPSs and SCFAs are markers of inflammation and proteins produced by intestinal bacteria.
High levels of butyrate — an SCFA produced when gut bacteria ferment fiber —were associated with less amyloid. The study represents a continuation of prior research by the team, which found that the gut microbiota in people with Alzheimer’s disease differs from those without the condition; in those with Alzheimer’s, microbial diversity is reduced, with certain bacteria being overrepresented and other microbes decreased.22
“Our results are indisputable: certain bacterial products of the intestinal microbiota are correlated with the quantity of amyloid plaques in the brain,” explains Moira Marizzoni, a study author with the Fatebenefratelli Center in Brescia, Italy.23
Still other research suggests gut microbiota may contribute to Alzheimer’s risk via multiple avenues, including by influencing aging, diabetes, sleep and circadian rhythm.24
It’s also possible, researchers hypothesize, that decades of factors such as diet, stress, aging and genetics, combine to disrupt gut permeability and the integrity of the blood-brain barrier, allowing the entry of inflammatory agents and pathogens and inducing an inflammatory response that triggers a neuroinflammatory response in the brain.25
There’s More to Alzheimer’s Than Amyloid Beta
UB-311 — the fast-tracked Alzheimer’s vaccine — is not going to touch the many complex factors leading to the development of Alzheimer’s disease and is likely to have unintended adverse consequences. Dietary factors, for instance, are being completely overlooked by focusing on a vaccine to target amyloid beta.
Not only does what you eat affect your gut health but it also impacts cholesterol, and cholesterol also plays an important role in the formation of memories and is vital for healthy neurological function. As noted by senior research scientist Stephanie Seneff, Ph.D., insufficient fat and cholesterol in your brain play a crucial role in the Alzheimer’s disease process, detailed in her 2009 paper “APOE-4: The Clue to Why Low Fat Diet and Statins May Cause Alzheimer’s.”26
Time-restricted eating is another important strategy, as is reducing your intake of polyunsaturated fatty acids, also called PUFAs, found in vegetable oils, edible oils, seed oils, trans fat and plant oils. For a more targeted approach, natural options are available.
Animal and laboratory studies demonstrate that the spice saffron is neuroprotective, for instance. Data also show it is as effective as the drug memantine to treat moderate to severe Alzheimer’s disease.27 One of the most comprehensive assessments of Alzheimer’s risk is Dr. Dale Bredesen’s ReCODE protocol, which evaluates 150 factors, including biochemistry, genetics and historical imaging, known to contribute to Alzheimer’s disease.
In his book, “The End of Alzheimer’s: The First Program to Prevent and Reverse Cognitive Decline,”28 which describes the complete protocol, you will also find a list of suggested screening tests and the recommended ranges for each test, along with some of Bredesen’s treatment suggestions.
Overall, nourishing your brain health is best done with a comprehensively healthy lifestyle. By leveraging 36 healthy lifestyle parameters, Bredesen was able to reverse Alzheimer’s in 9 out of 10 patients.
This included the use of exercise, ketogenic diet, optimized vitamin D and other hormones, increased sleep, meditation, detoxification and the elimination of gluten and processed food. For more details, you can download Bredesen’s full-text case paper online, which details the full program.29
The number of Swedish adults diagnosed with mild forms of intellectual disability has increased sharply.
A review of statistics from the National Board of Health and Welfare by the trade newspaper Psykologtidningen has indicated that that the number of adult patients with mild forms of retardation has more than doubled, increasing by 143 percent, between the years 2008 and 2020.
In concrete figures, the number of adults diagnosed during this period increased from 1,133 to 3,114 people.
In some extreme cases, like the city of Örebro, the increase has been measured at an incredible 617 percent.
The National Board of Health and Welfare has no explanation for the spike.
“Obviously there has been an increase. It is therefore important to have a closer look at this,” Peter Salmi, a psychiatric investigator at the National Board of Health and Welfare, said in a statement.
According to Salmi, one possible explanation for the rise could be the fact that the diagnosis manual was updated in 2013. Before that, people with an IQ below 70 were automatically classified as mildly retarded. However, since then more importance is placed on how they function in everyday life and between 2013 and 2020, the number of diagnoses “only” increased by 37 percent.
Salmi further explained that investigations for ADHD and autism have increased in recent years, and those surveys include an aptitude test, which may have increased the number of diagnoses.
Mild intellectual disability (also referred to as mild developmental disorder) occurs in between 0.5 and 1.5 percent of the population. It implies shortcomings in theoretical thinking and learning. The affected individual perceives the outside world in a more concrete way and has difficulties understanding abstract words, symbols and descriptions.
My previous post on Tuesday contained some highlights from the May 3 public hearing of New York’s Climate Action Council. The CAC is the body that is charged with devising a “Scoping Plan” to inform all us New Yorkers how we will achieve “zero carbon” electricity by 2030 and a “zero carbon” economy by 2050. I attended the hearing for about two and a half hours, during which about 60 people spoke.
Reflecting on the hearing a few days later, I think there are a few more highlights that would interest the readers, and will give some more insights into the nature of progressive thinking.
As stated in my prior post, of the 60 or so speakers, all but myself and four others were vigorous supporters of the critical necessity of achieving the stated zero carbon goals by the given dates as an urgent matter of saving our planet and our children. This was so despite what appeared to me to be manifestly huge issues of physical feasibility and cost that are almost certain to cause these grand “net zero” energy schemes to fail. The CAC’s draft “Scoping Plan,” as it currently exists for public comment, does not consider these feasibility or cost issues in any remotely adequate fashion, if at all. That fact did not appear to bother the overwhelming majority of the speakers.
So what are the things that do drive the thinking of these other 55 or so speakers, who apparently represent the large majority of New York City’s citizenry? The previous post mentioned fear as a common theme — fear that use of fossil fuels by us New Yorkers will bring on storms, floods and other disasters to threaten our lives and livelihoods. But what I failed to mention was another emotion that was even more prevalent in the comments — anger.
Anger at what, you might ask? Good question. I admit that this doesn’t make any sense, but here it is. The anger is directed at the fossil fuel producers and distributors who the commenters, with near unanimity, seemed to believe were hell-bent on destroying the planet. A substantial majority of the 60 or so comments that I listened to expressed this anger in one form or another, and it was an implicit undercurrent in most of the rest.
But, you might say, all of these people are in fact the users of the fossil fuels. Essentially all of them use electricity, which in New York currently comes about 60% from fossil fuels. The large majority of them drive cars, of which some 99% in New York use gasoline. Most of them heat their homes with natural gas, and cook with natural gas. Aren’t they themselves the ones who are responsible for the problem, if there is a problem? They use fossil-fuel-burning cars and furnaces and stoves because those vehicles and appliances are cheaper and/or work better than the alternatives. And yet, somehow these people have convinced themselves that they have no responsibility at all, and the use of gasoline and natural gas by them and others is a fault of evil producers and utilities.
On this theme, two commenters in particular stand out in my mind. First was a youngish (probably in her 30s) woman from Brooklyn who described herself as having a toddler in the apartment. After relating her fears for the toddler’s future in a world of changing climate, she got to the crux of her personal testimony, which was much more about anger than fear. The gas company was putting a dangerous substance into her stove, which when burned to cook gave off toxic substances and fumes that were putting the toddler’s health at risk. Her intense rage was palpable. She urged the CAC in the strongest terms to impose legal prohibitions that would prevent this kind of conduct going forward.
Put aside for the moment that this woman apparently had no idea that there is nothing toxic about the combustion products of natural gas, which are CO2 and water. But even more bizarre was that she apparently hadn’t figured out that if she is concerned about this subject, however irrationally, she can just go out and buy an electric stove tomorrow. And why hadn’t she done that? She didn’t say. The only reasons I can think of are that natural gas stoves work better than electric ones and are cheaper. Those are perfectly good reasons. But I wouldn’t recommend that you try to argue with this woman about why she has a gas stove. She is completely convinced that it has been foisted upon her by the evil gas companies who are intent on destroying the health of her toddler, let alone the planet. I doubt that any amount of logic or reason could talk her out of that belief.
And then there was the case of an equally irrational 60-something man, who said he was from Cedarhurst, Long Island. For those unfamiliar, Cedarhurst is a very wealthy suburb of large homes just outside the New York City limits. You may have seen Cedarhurst out the window of an airplane approaching JFK airport on a flight back from Europe. The guy in question styled his testimony as a confessional. He candidly admitted to his extreme climate guilt. But he claimed that he was unable to do anything about his large carbon footprint right now because the state had failed to compel the suppliers to provide him with zero emissions alternatives. He didn’t give us any details of what fuel he currently uses to heat his home, or to cook, but chose to focus on his driving. He stated that he wanted to buy an electric car, and was ready to do it, but was prevented from doing it. How was he prevented? Because there were no electric vehicle charging stations in his town! Needless to say, he was angry about that, and demanded that the state step up to order somebody to provide the charging stations, and provide funding to be sure that the charging stations got built.
Huh? Why didn’t this guy just get his own charging station at his own house? He didn’t mention that, so we are left to speculate. Again, the only thing I can think of is that he doesn’t want to spend his own money on this. Better to gin up some anger and demand that somebody else pay for it.
The thinking is that not only perfect fairness and justice, but also perfect climate, are easily within our reach if only our leaders summon the political will to order the evil people and companies to do the right thing, and perhaps provide some funding from the infinite free pile of government money. I guess, if you believe that, you are right to be angry that the leaders haven’t yet issued the necessary orders to get the job done. What’s wrong with them?
Climate activists’ ill-founded opposition to fossil fuels threatens to stop a major pipeline project in East Africa and stymie economic growth in Uganda and Tanzania — home to some of the world’s poorest people.
Uganda is betting big on its fossil fuel reserves. In February, China National Offshore Oil Corporation (CNOOC) and France’s TotalEnergies agreed to invest $10 billion to develop two Ugandan oil reserves. But the landlocked country needs the East African Crude Oil Pipeline project (EACOP) to transport its product to a port in Tanzania.
The 895-mile-long pipeline from Uganda’s Lake Alberta region to the seaport of Tanga will be the longest electrically heated crude oil pipeline in the world and will carry 216,000 barrels per day. The project received a green light for construction after the completion of an Environment and Social Impact Assessment.
The Africa Reportsays that the investment will be huge: “(A)bout $10 billion will be invested in the sector (oil and gas) before first oil is produced in 2025, mainly on the pipeline, refinery, and infrastructure. The government has been commissioning road construction in the region where oil will be produced, in Buliisa and Hoima districts, and an airport is also being constructed in the region.” The project is expected to generate around 10,000 jobs even after the construction phase.
The Government of Uganda expects massive employment of its citizens during construction: “This will be through direct employment of about 14,000 people by the companies, indirect employment of about 45,000 people by the contractors, and induced employment of about 105,000 people as a result of utilization of other services by the oil and gas sector. Of the direct employment, 57 percent are expected to be Ugandans, which is expected to result in an estimated $48.5 million annual payment to Ugandan employees.”
However, the global war against fossil fuel has now reached Ugandan soil and extremists are determined to stop this lifesaving, economically critical project.
Vanessa Nakate of StopEACOP rants against the pipeline in a recent column in the New York Times, saying the project would bring poverty and destruction to the people of Africa. She also references extreme weather in implying the pipeline will worsen the climate.
During a visit to the ultra-rich Vatican, Vanessa says: “It is evident that there is no future in the fossil fuel industry…. we know the impacts on our food. We know the impacts on our water. We know the impacts on our livelihood…… the climate crisis is already affecting so many people not only in Uganda, but the African continent.”
But her reasons for opposing the pipeline are scientifically inaccurate and logically senseless.
She points to a forecast by the Intergovernmental Panel on Climate Change (IPCC) that predicts African droughts. But IPCC, by its own admission, has indicated that extreme weather events have no significant correlation with rising global average temperatures. Neither has there been any significant increase in the frequency of extreme cyclones, droughts, rainfall, and fires. Even if droughts and cyclones were to increase, a better socio-economic condition would enable people to adapt more effectively.
Contrary to Vanessa’s hyperbole, the world is experiencing near optimum temperatures for global food production and the advancement of human society, much as it did 1,000 years ago during the Medieval Warm Period and 2,000 years ago during the Roman Warm Period. Globally, we now have better access to clean water, better access to nutritious food, people with higher income, and a very rapid increase in life expectancy rates. How are we in a crisis if climate is aiding the improvement of every metric used to measure the quality of people’s lives?
It is shocking how Vanessa ignores the plight of millions of her own people dwelling in persistent poverty and in need of affordable, dependable energy sources like coal, oil, and gas. It is less shocking if we understand the DNA of climate extremists, which has them deny the reality of energy needs and promote unreliable, primitive, and expensive wind turbines that even economic giants like Germany and the U.S. hesitate to adopt completely.
Climate extremists like Vanessa are fostering the continuation of abject poverty in Africa — a continent with the lowest level of electrification and highest rates of poverty in the world. Vanessa claims that the pipeline is another colonial project subjecting Africans to slavery. But, it is Vanessa and her ilk who are the colonialists and would-be slave masters.
Vijay Jayaraj is a Research Associate at the CO2 Coalition, Arlington, Va., and holds a Master’s degree in environmental sciences from the University of East Anglia, England. He resides in Bengaluru, India.
“World will ‘run out of food’ in 27 years, according to chilling doomsday prediction,” reads the headline in the Daily Star (UK). The article’s subtitle:
EXCLUSIVE: Scientists have issued a terrifying warning and have said the world could be left starving without any food in just over two decades, according to a chilling doomsday countdown
If the world doesn’t run out of food next year, as Sara Menker with Gro Intelligencewarned back in 2017, scientists predict that we’ll run out in “exactly 27 years and 251 days left as of Sunday.”
In 2050? The author of the Daily Star article, Sian Hewitt, quotes sociobiologist Edward Wilson:
By then, there will be almost 10 billion people on the planet and the food demand will have increased by 70% compared to what we needed in 2017. The limit to how many people Earth can feed is set at 10 billion at the absolute maximum. The constraints of the biosphere are fixed, there’s no wiggle room here.
The amazing specificity of Wilson’s prediction is testimony to the advances that science and scientific predictions have made in just the last few years…. And, as if further evidence were necessary, Wilson is not alone:
Professor Julian Cribb, who has written books on the catastrophic prophecy, said: “This is a global food crisis and I don’t think I can see a way out of it.
It is arriving even faster than climate change.
Shortages of water, land, and energy combined with the increased demand from population and economic growth, will create a global food shortage around 2050.
World wars could become about food and water in years to come.
To meet the increasing demand from a growing population, we will need to produce more food in the next 40 years than has been produced in the previous 8,000 years.
The battle to feed all of humanity is over. In the 1970s hundreds of millions of people will starve to death in spite of any crash programs embarked upon now. At this late date nothing can prevent a substantial increase in the world death rate.
Demographers agree almost unanimously on the following grim timetable: by 1975 widespread famines will begin in India; these will spread by 1990 to include all of India, Pakistan, China and the Near East, Africa. By the year 2000, or conceivably sooner, South and Central America will exist under famine conditions…. By the year 2000, thirty years from now, the entire world, with the exception of Western Europe, North America, and Australia, will be in famine.
The power of population is so superior to the power of the earth to produce subsistence for man, that premature death must in some shape or other visit the human race.
So, there you have it. The science is settled. We have nothing to fear from climate change.
On May 5th, the World Health Organisation (WHO) issued a new report estimating global excess deaths at 14.9m for two years of the pandemic 2020-21 as the true COVID-19 mortality toll, nearly triple the official toll of 5.44m. “Excess mortality” is the difference between the number of deaths that would be expected in any time period based on data from earlier years and the number of deaths that have occurred. For countries with robust data surveillance, reporting and recording systems, this poses no real difficulty. Unfortunately, these conditions are not met in many countries. Therefore their excess mortality can only be estimated and the accuracy is a function of the reliability of the methodology and modelling used in the exercise. Given the overwhelming evidence about the flaws and deficiencies of Covid-related modelling over the last two years, and the damage caused by governments trusting modelling projections over real-world data, this should immediately throw up a forest of red flags about the WHO report.
A second reason to be sceptical is the less than stellar role of the WHO in its well-known Covid-related deference to China, the abandonment of its own summary of the state of the art science on managing pandemics from October 2019, its willingness to manipulate definitions of ‘herd immunity’ in relation to vaccines and natural immunity in order to fit with the experimental pharmaceutical and non-pharmaceutical interventions (NPIs) that came to dominate Covid policy around the world, and its self-interest in expanding its budget, authority and role in steering global health policies and management by means of a new international treaty.
A third ground for scepticism is they ascribe the total death count to the direct effects of Covid “due to the disease” and indirect effects “due to the pandemic’s impact on health systems and society”. The first part is questionable because it fails to distinguish between deaths with and from Covid. The second is disingenuous because the indirect toll of the NPIs (lockdowns, masks, induced fear, lost schooling, lost jobs, cancelled screenings and operations, aborted immunisation programs, disruptions to global food production and distribution, etc.) and vaccine-related adverse events will prove to be significantly higher than the indirect effects of the disease per se. Any study that fails to disaggregate deaths caused by the disease and by policy interventions to mitigate it lacks credibility.
Figure 1: India’s COVID-19 Deaths, Jan. 1st 2020-Mar. 27th 2022. Source: World Life Expectancy, May 8th 2022
Like many others including Will Jones on this site, I was especially struck by the new figures for India. The report pushes India up to the very top of the Covid mortality toll with 4.74m deaths, nearly 10 times more than the count of 481,486 (as of December 31st 2021), almost one-third of the world total. Sorry, but that is simply not credible.
India’s geographic diversity, population size and economic conditions make data collection especially challenging. In public lectures in Australia and Canada, to drive home the point about the scale, I usually comment that the entire Australian population is a rounding error in 1.3bn-strong India. It suffers from persistent and widespread mass poverty – India is a country of a few mega-billionaires amidst the world’s biggest pool of poor, illiterate and sick people bar none. It might be nuclear-armed, but state capacity when it comes to administration and public and social services is easily the worst of all major economies. The public sector scores high on petty corruption but low on efficiency. The public health service is risible and high quality healthcare is neither accessible nor affordable for ordinary Indians. The best doctors work in the public sector, in medium to large clinics and hospitals in metropolitan centres and as individual practitioners in most towns and villages. Consequently, health statistics are not all that reliable. But this is a general pathology, not one unique to COVID-19.
From everything I know about India, the WHO estimate does not align with overall death data, historical trends and Covid death compensation claims on the Indian Government from states. Indian experts believe that official statistics capture over 90% of all deaths. But this also means that about 10% of deaths would have been missed in previous years, yet the WHO’s ‘excess deaths’ count uses the official numbers as the baseline against which to estimate the impact of Covid. In a related vein, why would under-reporting be limited to Covid-related deaths and not, say, to suicides with its heavy social stigma and traffic accidents where the operators of overloaded buses and vans would try to drastically reduce actual numbers in order to hide the illegal loads (Figure 2)? The WHO estimates are flawed also in relying on 2019 deaths instead of using a five year average 2015-19 to wrinkle out anomalies in any given year.
Figure 2: India’s Top Dozen Killer Diseases (March 1st 2020-May 7th 2022). Top six cancers in order: oral, lung, breast, cervical, stomach, colon. Source: Chart constructed by author drawing on data from World Life Expectancy, May 8th 2022
Estimates of India’s total annual death rate range from 738 per 100,000 people by the World Bank to 1,030 per 100,000 people by World Life Expectancy. The total annual death toll therefore would be somewhere in the 10-13 million range: a very wide range. The WHO estimate of the death rate for 2021 is within the higher range from World Life Expectancy. Simply put, the WHO estimate of all-cause deaths is within any realistic estimate of the margin of error in India’s unique circumstances of scale and state capacity.
The caveats to official data notwithstanding, the WHO estimate would mean almost one-quarter additional deaths than normal. In fact it’s worse. Looking at the detailed tables, the 4.74m excess deaths is calculated from a combined excess death rate for 2020–21 of 171 per 100,00 people. This is disaggregated into 60 and 280 per 100,000 people for 2020 and 2021, respectively. That would imply a 38% jump in all cause deaths in 2021. Despite all the horror scenes we saw on TV of corpses lying in the streets and washed ashore on riverbanks, that’s just not possible. Perhaps the clue to the error lies in the title of the actual document: “Global excess deaths associated with COVID-19 (modelled estimates)” (emphasis added).
Some Daily Sceptic readers had fun with this aspect of the WHO announcement. My favourite exchange was this:
India’s own estimates of excess deaths for 2020 compared to 2019 is 480,000, of which Covid-related deaths were just under 150,000. So over 300,000 excess deaths were due to non-Covid causes, which in itself is far more believable because of the impact of the lockdown measures on exacerbating most of the conditions underlying India’s leading causes of deaths. By contrast, in 2021 the Covid-related death toll was much higher at 332,492.
Much as I have been critical in the past of official dismissals of international reports on India including weakening democratic practices, in this instance the Government is right to reject the WHO methodology of mathematical modelling based on data on 17 Indian states collected from websites and media reports: “This reflects a statistically unsound and scientifically questionable methodology of data collection for making excess mortality projections in the case of India.” As well as defective data collection methodology, the report is marred also by three critically flawed assumptions: that uncounted excess deaths occurred only in 2020-21 and not before; they occurred only for COVID-19 and not other diseases; and Covid-related deaths were due solely to the disease and not caused by policy interventions to control and eradicate it.
Ramesh Thakur is Emeritus Professor at the Australian National University’s Crawford School of Public Policy and a former UN Assistant Secretary-General.
The U.S. Food and Drug Administration (FDA) on Thursday put strict limits on the use of the Johnson & Johnson (J&J) COVID-19 vaccine, citing the risk of a blood-clotting condition the agency described as “rare and potentially life-threatening.”
In a statement Thursday, the FDA said the risk of vaccine recipients developing thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine “warrants limiting the authorized use of the vaccine.”
The FDA said it has identified 60 cases of vaccine-induced thrombosis with thrombocytopenia syndrome, including nine deaths, out of about 18 million doses administered — although the condition is likely underreported.
Women 30 to 49 years old are at the highest risk of TTS from the J&J vaccine, with about eight cases per 1 million doses of vaccine administered, according to the FDA.
According to the latest data from the Vaccine Adverse Event Reporting System (VAERS), between Dec. 14, 2020, and April 29, 2022, there were 13,873 reports of blood-clotting disorders following COVID-19 vaccines in the U.S.
In the U.S., 575 million COVID-19 vaccine doses had been administered as of April 29, including 339 million doses of Pfizer, 217 million doses of Moderna and 19 million doses of J&J.
The agency said the “known and potential benefits” of the J&J vaccine for preventing COVID-19 outweigh the known and potential risks for individuals 18 and older “for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate,” or “who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.”
The agency described TTS as “a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen [J&J] COVID-19 vaccine.”
The updated restrictions to the Emergency Use Authorization (EUA) of the vaccine, marketed under the Janssen brand, also apply to booster doses, CNN reported.
People who can still get the Janssen vaccine include:
Those who had a severe allergic reaction to the Pfizer/BioNTech or Moderna mRNA vaccine.
Those with personal concerns about the mRNA vaccines who would remain unvaccinated unless they can choose the Janssen vaccine.
Those with limited access to mRNA COVID-19 vaccines.
Symptoms of TTS include shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms (like headaches or blurred vision) or red spots just under the skin called “petechiae” found beyond the site of injection.
Experts question timing, and why just J&J?
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said limiting the authorized use of the Janssen vaccine “demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions.”
Marks said:
“We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA.
“The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”
However, Brian Hooker, Ph.D., P.E., Children’s Health Defense chief scientific officer and professor of biology at Simpson University, had a different take on the news.
“It seems like the FDA pays lip service to the fact that the spike protein can cause clotting, and to the widespread reports of clotting, by punishing Janssen, who has become the ‘whipping boy’ of the COVID-19 vaccine manufacturers through the pandemic,” Hooker said.
“I believe this is partially because of the limited use of the Janssen vaccine in the U.S. as compared to Pfizer and Moderna,” he added.
Hooker said the FDA can limit the use of the J&J vaccine without significantly impacting vaccine distribution overall, “while having the appearance of addressing the myriad vaccine adverse events caused by all the types of COVID-19 vaccines.”
As of Thursday, CNN reported only 7.7% of those considered fully vaccinated received the J&J vaccine.
Dr. Pierre Kory, founder and president of Front Line COVID-19 Critical Care Alliance, told The Defender :
“My only hypothesis is this action is some attempt for the FDA to be able to claim that they took at least some action to protect the safety of the public, akin to ‘virtue signaling.’
“Having been a keen observer of their actions throughout the pandemic, I find this action to be completely insufficient and demonstrates a calculated attempt to ensure vaccinations with similarly dangerous vaccines continue.”
Dr. Meryl Nass questioned the timing of the FDA’s restriction of the EUA.
“Why did the FDA just throw the kill switch on the Janssen vaccine, when it knew of the thrombosis problems since the rollout?” Nass asked.
Nass told The Defender the FDA may have known about the thrombosis problem even before the Janssen vaccine rollout, “since the adenovirus vector platform is known to be associated with thrombosis” for “more than 15 years.”
Kory, who noted that all COVID-19 vaccines have had a high rate of adverse events, also questioned the timing of the new restrictions.
“I find the timing of this action to be both irrational and alarming given there is extensive data from around the world, much of it being censored from media and medical journals, that all the COVID-19 vaccines, not just Janssen, have long had unacceptable and diverse toxicity signals — beyond just clotting disorders from numerous pharmacovigilance databases and epidemiological and public health data reports,” Kory said.
As far back as April 2021, U.S. and European health officials were investigating whether the J&J COVID-19 vaccines were causing blood clots.
However, there was already mounting evidence the Pfizer and Moderna vaccines could cause similar adverse reactions. U.S. regulatory officials were alerted to this risk as far back as December 2020.
The Centers for Disease Control and Prevention (CDC) in December 2021 recommended the Pfizer and Moderna mRNA COVID vaccines over the J&J vaccine due to the risk of blood clots, despite data showing the Pfizer and Moderna shots also cause blood-clotting disorders.
In January 2021, shortly after the rollout of Pfizer’s vaccine in the U.S., The Defender reported on the death of a 56-year-old Florida doctor who developed a blood-clotting disorder after the Pfizer vaccine and died 12 days later.
The Defender also reported on numerous other deaths related to blood-clotting disorders that developed after the Moderna and J&J vaccines.
On April 13, 2021, the FDA and CDC paused use of the vaccine to investigate six reported cases of TTS.
The agencies lifted the pause only 10 days later, after confirming a total of 15 cases of TTS had been reported to VAERS, including the original six reported cases, out of approximately 8 million doses administered.
Acclaimed vaccinologist, Geert Vanden Bossche, sits down for his second groundbreaking interview with Del to explain why the intense pressure mass vaccination is putting on the Covid-19 virus will likely drive it to become catastrophically deadly.
This story is about the proposed new World Health Organization pandemic treaty that can potentially eradicate the national sovereignty as we know it. It is also about the banality of evil and the impact of our individual daily choices on the future generations and the history of the world.
What’s the Deal With the World Health Organization Pandemic Treaty?
In December 2021, the World Health Organization announced their plan to develop a new pandemic treaty “strengthening” international cooperation during future pandemics. What does it mean in practical terms? The language of the announcement was vague, so we need to interpret it in context. Here’s from the horse’s mouth: (December 2021):
“In a consensus decision aimed at protecting the world from future infectious diseases crises, the World Health Assembly today agreed to kickstart a global process to draft and negotiate a convention, agreement or other international instrument under the Constitution of the World Health Organization to strengthen pandemic prevention, preparedness and response.
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, said the decision by the World Health Assembly was historic in nature, vital in its mission, and represented a once-in-a-generation opportunity to strengthen the global health architecture to protect and promote the well-being of all people.”
“In a consensus decision aimed at protecting the world from future infectious diseases crises, in December 2021 the World Health Assembly agreed to kickstart a global process by establishing an intergovernmental negotiating body (INB) to draft and negotiate a convention, agreement or other international instrument under the Constitution of the World Health Organization to strengthen pandemic prevention, preparedness and response …
As part of this historic decision, the World Health Assembly requested the Director-General to hold public hearings, in line with standard WHO practice, to support the work of the INB. Per the INB’s timeline, the first round of those hearings has been set for 12-13 April 2022, with a second round set for 16-17 June. This information on the modalities for the first round of hearings is also expected to apply to the second round as well.”
Lies, Lies, Lies
Let’s start with the issue of distorted language. In an honest world with no dark agendas, no Fourth Industrial Revolution, and no upside-down language, their treaty could sound like a beautiful idea. Like, what can possibly be wrong with benevolently guided, meaningful international cooperation during a time of crisis? A beautiful fairy tale, no?
Sadly, not a fairy tale at all but more like a horror movie because we are living in a world of shameless lying and upside-down language — and the words no longer mean what they are supposed to mean.
To deceive us, the bureaucrats are trying to create a feeling in our minds that they getting together to protect us, like a benevolent council of wise indigenous grandmothers — while in reality, it’s more like they are aiming to trap us, being a gang of greedy and ruthless wolves in sheep’s clothes that they are.
“Health” doesn’t mean actual health but rather the promotion of any product or interference that is desirable to the shareholders and the CEOs of pharmaceutical and technology companies.
Just like Fauci recently equated himself with science, the corporate mouthpieces equate whatever they want to sell or impose on us with “health,” and then say they are protecting our “health” while in fact, they are merely protecting their pockets.
We are living in a world where our leaders (translation: our fellow human being who have no intrinsic upper hand on us but who have gotten ahead on the basis of being extremely power-hungry) are taking full advantage of the fact that in order to do destructive things with the least resistance, then can call them “useful things that are good for the people,” and get away with it for some time. That’s the trick!
And besides, if the past two years are any indication, “international cooperation” means in practice that all WEF-affiliated leaders go ahead and throw their people under the bus in unison, to the sound of uniform messaging in the media.
“International cooperation” means that all countries do the same destructive thing, resulting in unnecessary human death and suffering, a disruption of social structures and the world economy, all to clear the way for their favorite “new normal.” That’s some international cooperation!
Public Hearings
Given the self-proclaimed historical nature of this treaty, the World Health Organization dedicated the whole two days to the first round of the public hearings (and they didn’t advertise it much). The first round took place in April 2022. The second round will be held in June of this year.
Dr. Tess Lawrie wrote a very moving article about the WHO pandemic treaty and the video comment submission by the World Council for Health.
Here are Dr. Lawrie’s comments on the proposed treaty, after she had a chance to participate in a call with the WHO (as well as UNAIDS, the Coalition for Epidemic Preparedness Innovations, the UN Environment Programme, and the Association of Southeast Asian Nations) as a part of the submission process.
• Calls for ‘human security centric’ not just ‘health security centric’. Apparently, they don’t just want to control your body but every aspect of your life.
• Fast approval of emergency diagnostics – and unified regulatory registration for diagnostics. In other words, more control.
• Equitable access to vaccines and ‘a mechanism to hold violators accountable’. So if a nation concludes a vaccine is not safe – as has happened in this last pandemic – the WHO would have the power to override that and jab their population anyway.
• Vaccines should be developed within 100 days. This is absurd. Safe drugs take ten years to be adequately tested and declared safe. There are more than 3.5 million people on the WHO database who have been harmed by Covid vaccines and this may be the tip of the iceberg.
I agree that these bullet points sound like it’s about control, so no surprise that it comes with more censorship!
More Censorship
While the public comments were open, the #StopTheTreaty campaign by the World Council for Health, where Dr. Tess Lawrie is on the Steering Committee, was the talk of the town in the “freedom community.” But if you searched for it on Google, you wouldn’t know anything about it! Here’s what I wrote just a few hours after the comment period ended:
“If you search for the phrase “WHO pandemic treaty” on DuckDuckGo, #StopTheTreaty comes up among the top results. On Google though no such thing exists. If you actually search for the phrase “stop the treaty,” on DuckDuckGo #StoopTheTreaty is the number one result. Google, on the other hand, tells you everything you ever wanted to know about the 1919 Treaty of Versailles!)”
For the World Health Organization, It’s Not the First Rodeo
It is curious that it’s not the first time that the WHO is trying serve the pharmaceutical industry and various industry shareholders using “pandemic preparedness” as a legal tool.
For example, in 2009, they announced an influenza pandemic (H1N1) that activated vaccine purchasing agreements and forced participating countries to large batches of doses that they didn’t need. The rushed release of a subpar medical product led to a “narcolepsy fiasco,” among other things.
According to the report by the Council of Europe’s Parliamentary Assembly:
“The Parliamentary Assembly is alarmed about the way in which the H1N1 influenza pandemic has been handled, not only by the World Health Organization (WHO), but also by the competent health authorities at the level of the European Union and at national level.
It is particularly troubled by some of the consequences of decisions taken and advice given leading to distortion of priorities of public health services across Europe, waste of large sums of public money, and also unjustified scares and fears about health risks faced by the European public at large.
The Assembly notes that grave shortcomings have been identified regarding the transparency of decision-making processes relating to the pandemic which have generated concerns about the possible influence of the pharmaceutical industry on some of the major decisions relating to the pandemic.
The Assembly fears that this lack of transparency and accountability will result in a plummet in confidence in the advice given by major public health institutions. This may prove disastrous in the case of the next disease of pandemic scope – which may turn out to be much more severe than the H1N1 pandemic …
The rapporteur considers that some of the outcomes of the pandemic, as illustrated in this report, have been dramatic: distortion of priorities of public health services all over Europe, waste of huge sums of public money, provocation of unjustified fear amongst Europeans, creation of health risks through vaccines and medications which might not have been sufficiently tested before being authorised in fast-track procedures, are all examples of these outcomes.”
Even Forbeswrote in 2010 that “from the beginning the World Health Organization’s actions have ranged from the dubious to the flagrantly incompetent.” A poignant quote:
“The WHO’s dubious decisions demonstrate that its officials are too rigid or too incompetent (or both) to make needed adjustments in the pandemic warning system — deficiencies we have come to expect from an organization that is scientifically challenged, self-important and unaccountable.
The WHO may be able to perform and report worldwide surveillance — i.e., count numbers of cases and fatalities — but its policy role should be drastically limited.
U.N. bureaucrats pose as authorities on all manner of products, public policy and human activities, from desertification and biodiversity to the regulation of chemicals, uses of the ocean and the testing of genetically engineered plants.
However, the U.N.’s regulatory policies, requirements and standards often defy scientific consensus and common sense. Its officials are no friends of commerce, public health or environmental protection. The result is a more precarious, more dangerous and less resilient world. When it comes to pestilence, the U.N. may be the greatest plague of all.”
What’s a Pandemic, Anyway?
It’s noteworthy that just before the WHO declared a pandemic, they changed the definition of the word. From the British Medical Journal:
“WHO for years had defined pandemics as outbreaks causing “enormous numbers of deaths and illness” but in early May 2009 it removed this phrase — describing a measure of severity — from the definition.
Key scientists advising the World Health Organization on planning for an influenza pandemic had done paid work for pharmaceutical firms that stood to gain from the guidance they were preparing. These conflicts of interest have never been publicly disclosed by WHO, and WHO has dismissed inquiries into its handling of the A/H1N1 pandemic as ‘conspiracy theories.’
A joint investigation by the BMJ and the Bureau of Investigative Journalism has uncovered evidence that raises troubling questions about how WHO managed conflicts of interest among the scientists who advised its pandemic planning, and about the transparency of the science underlying its advice to governments.
Was it appropriate for WHO to take advice from experts who had declarable financial and research ties with pharmaceutical companies producing antivirals and influenza vaccines?”
Boasting About the Tricks
In 2019, Marc Van Ranst, Belgian Flu Commissioner, gave a talk at the ESWI/Chatham House Influenza Pandemic Preparedness Stakeholders Conference. At around 13 minutes in, he boasted about how he “misused the fact that that the top, top football … soccer clubs in Belgium inappropriately and against all agreements vaccinated … they made their soccer players priority people.” The audience responded with laughter.
In order to understand the corruption inside the WHO, one may want to watch a pre-pandemic documentary called “Trust WHO,” produced by Lilian Franck. Among other things, it looks into various conflicts of interest as well as the examples of how the organization has been influenced by the tobacco industry and the nuclear industry.
The United Nations Has Been Hijacked
Last year, I interviewed Mary Otto-Chang, a former United Nations employee, who talked about the hijacking of the UN and the 2019 agreement between the UN and the World Economic Forum that the Fourth Industrial Revolution as a cooperation goal.
So what we are looking at is using the authority of the UN as supposedly a just and wonderful international organization that protects the people for the commercial and philosophical goals of the richest people of the world. What an intricate lie!
Banality of Evil
Most horrible things that people do to each other don’t come out of nowhere. There is usually a “warm-up” period during which evil actions are trivialized, and people’s senses are “re-trained.”
Sometimes, using upside-down language, people’s senses are re-trained to the extent of swapping out the meanings completely, where war becomes peace, and murder becomes compassion. It takes time to dehumanize entire demographics — based on a particular ethnicity, or religion, or health status, or any other arbitrary affiliation.
For example, in early Nazi Germany, there was a campaign to kill mentally disabled children, (and also do inhumane experiments on them), and the parents were often told that their children were being taken away for better care. The parents didn’t know that their children were being murdered — but the nurses who killed the disabled knew exactly what they were doing, but perhaps some of them believed that they were performing acts of mercy!
There is a powerful, must-see documentary about it, called, “The Killing Nurses of the Third Reich.” I wrote about it last year:
“The only thing that was needed for the nurses to make the transition to the horror zone was to decide that the poor suffering imbeciles had no agency. As soon as in their minds, the nurses stripped the disabled children and the mentally ill adults of their human agency and turned them into creatures akin to suffering pets, killing them became virtuous. The nurses held the disabled babies lovingly, and then killed them.”
Our Choices Matter
Something that I have been thinking about a lot over the course of my life is how our choices have long-term consequences: for ourselves, for the people around us, and even for the history of the world!
For example, to come back to the topic of pandemic preparedness, much of what happened in the U.S. in 2020 was made possible thanks to Bush’s 2005 decision to redo the pandemic preparedness plan. Who paid any attention to it back in 2005? Who could imagine that it would have such a profound impact on our lives? Nobody, probably, except for the people who planned it. And yet here we are …
Or another example. When people accept censorship against the groups that they don’t relate to, they often don’t think that the censors are coming for them next — and yet more often than not, that is exactly what happens.
Or sometimes, a choice that we make at a very young age comes back to us years later, and whatever we tried to escape stares us straight in the face, and we have to deal with it anyway.
Which is to say, courage and trying to do the right thing are not only praise-worthy, they are also very practical, especially during challenging times.
There is most certainly no formula, and no universal prescription for a time like this but it’s important to see the scammers in high chairs for who they are (including when they talk about pandemic preparedness treaties “for our own good”), and to see through them without being afraid. When we stand together, with love in our hearts, we are strong.
About the Author
To find more of Tessa Lena’s work, be sure to check out her bio, Tessa Fights Robots.
This paper, published in the “peer-reviewed” Canadian Medical Association Journal, quite simply represents an amoral, unethical and utterly transparent attempt to use pseudoscientific modelling to fabricate a false narrative. The apparent objective seems to be sowing divisions in society by marginalising and vilifying the unvaccinated.
The paper describes a “study” which is nothing of the sort. It actually describes a model which the authors have constructed. This is an unnecessarily complex model — and suspiciously so. The model itself has been very expertly taken apart by Jessica Rose here and Drs Rancourt and Hickey for the Ontario Civil Liberties Association here.
The authors appear to have tested their model to death to find the optimal combination of inputs which results in the “narrative” they wish to promote.
The logical flaws in this approach have been brilliantly analysed by Dr Byram Bridle, including a critique of the assumptions made for the various input parameters. Among the more egregious examples are:
(1) the model assumes 80% effectiveness against infection for the Covid injections vs omicron, whereas real-world data suggests zero — at best.
(2) the model assumes very little pre-pandemic immunity present within the community (they assume just 20% when for some time the evidence has suggested much higher levels, especially against severe illness).
(3) the model assumes no waning of efficacy at all over time, a claim not even made by the most ardent promoters of the covid vaccines.
Many news outlets — including Forbes— appear to have been taken in by this sham science and are reporting it as a bone fide “study” with no critical analysis whatsoever, this being their key message:
“The findings counter the common argument that the decision to get vaccinated is a personal one, the researchers said, as the unvaccinated are ”likely to affect the health and safety of vaccinated people in a manner disproportionate to the fraction of unvaccinated people in the population.”
One commentator on Twitter acerbically — though rather accurately — summed up the Forbes article thus:
It is quite clear that the model and the entire article has been constructed to push a political agenda, namely to neutralise the growing realisation by the population that the story they were told in relation to the Covid 19 injections is entirely false. Contrary to the authorities’ official narrative, in the context of Omicron the injections don’t reduce infections or transmission, and actually probably even increase them. Far from being a selfish act, it was in fact entirely rational — and beneficial to one’s fellow man — to decline the injection.
To use Dr Bridle’s words, the paper is actually “Fiction Disguised as Science to Promote Hatred”.
We support and join the many voices calling for this paper to be retracted.
Postscript: When Denis Rancourt, one of the authors of the Ontario Civil Liberties Association’s statement, tweeted the essence of their complaint with it, the paper’s author — David Fisman — didn’t respond by way of any form of scientific justification — he threatened legal action.
Virologists pushed back on the possibility of tighter regulation of viruses tweaked in the lab to be more lethal at a public meeting Wednesday.
An enhanced pandemic potential pathogen is a virus or microbe that has gained increased transmissibility — capacity to spread from person to person and reverberate throughout a population — or virulence — capacity to cause serious disease.
Experiments that are reasonably anticipated to generate deadlier pathogens are supposed to receive heightened oversight from the Department of Health and Human Services under what is nicknamed the HHS “P3CO,” short for the pandemic potential pathogen committee.
Though established just a few years ago, critics say the committee’s work is hidden from public view, suffers from glaring loopholes and needs a reboot. Work that contributes to vaccine development or results from viral surveillance efforts in nature is exempted from this extra layer of review, for example.
Speculation by some in the U.S. intelligence community that SARS-CoV-2 may have seeped out of a lab at the pandemic’s epicenter may have prompted a public meeting to consider whether current policies are adequate. Reporting irregularities by a nonprofit partner of the lab involved in gain-of-function research on coronaviruses and funded by the National Institutes of Health called EcoHealth Alliance has also led many to conclude the P3CO needs to apply to more research projects and be more accountable to the public.
One million Americans have died of COVID-19. A review by the U.S. intelligence community last summer about whether the novel coronavirus spilled over from an animal or spilled out of a lab was inconclusive.
The Office of Science and Technology Policy and NIH cohosted the meeting Wednesday.
White House COVID-19 testing czar Tom Inglesby was harshly critical of the existing framework. His top recommendation: Scientists should be required to explain in detail the goals of undertaking such research in the first place, and why less perilous methods could not reach the same goal.
“There must be an extraordinary and public justification,” he said. “I do think there are experiments we shouldn’t do.”
But lobbying groups representing virologists and other life scientists pushed back.
“The systems of review should not be a solution looking for a problem,” said Felicia Goodrum, president of the American Society for Virology.
Goodrum said regulation risks “tying two hands behind our backs” when it comes to modeling pandemic risks.
Goodrum added that the inherently unpredictable nature of manipulating viruses means that it’s unwieldy to determine whether or not an experiment will make a virus more dangerous, so the regulations should be lax.
“We must be careful about dichotomizing research as simply either ‘risky’ or not because it is not possible to absolutely predict the biology of a virus with the committee,” she said.
But Gregory Koblentz, director of the biodefense graduate program at George Mason University, said that an EcoHealth Alliance grant that funded research that made coronaviruses more deadly by swapping their spike proteins is emblematic of lapses in oversight at NIH.
The research was not regulated as gain-of-function work, but NIH did add language to the grant requiring extra reporting if the viral engineering led to viruses that were 10 times more pathogenic. (The chimeric viruses proved to be much more pathogenic than even that threshold, but EcoHealth Alliance did not report it.) That language amounts to a “tacit admission” that NIH reasonably anticipated the work was gain of function, Koblentz said.
Stefano Bertuzzi, CEO of the American Society for Microbiology, conceded that labs should report more often to Congress and that scientists could do a better job allaying public concerns, but stated that the framework is otherwise sufficient.
Bertuzzi signaled he is concerned that Congress could step in.
Labs taking steps toward greater transparency “helps guard against well intended but sometimes overly prescriptive legislative approaches that could undermine the important work that needs to take place.”
Gigi Gronvall, senior scholar at the Johns Hopkins Center for Health Security, said that the “breathless hyping of risks” overshadows strong existing biosafety measures, such as U.S. efforts to train maximum containment labs abroad.
Asked which risks have been misunderstood, Gronvall said that “there is a lot of gray” and that the proper expertise is needed to interpret gain-of-function experiments, but did not go into further detail.
Indeed, some experts called for decreased transparency for controversial research. Colorado State University Biosafety Rebecca Moritz called for limiting the scope of public records requests. U.S. Right to Know has submitted a public information request for records about the university’s research on bat coronaviruses in collaboration with EcoHealth Alliance, the U.S. Department of Defense (DoD) and the Defense Advanced Research Projects Agency.
The documents raise questions about the contagion risks, for example, of shipping of bats and rats infected with dangerous pathogens.
Kanta Subbarao, director of the World Health Organization’s Collaborating Centre for Reference and Research on Influenza, disputed the idea that research that contributes to vaccine development or results from surveillance should be included in the framework.
Many representatives of the life science and biodefense fields emphasized weighing any regulation against lost opportunities for science. But members of the public who participated in the meeting were much more skeptical of the value of certain gain-of-function work.
Alina Chan, a molecular biologist at the Broad Institute, said that the public should not be surprised by controversial gain-of-function experiments for the first time in scientific papers, long after the research has been approved and completed.
Chan called for controversial experiments to be published on preprint servers and the genomes of novel viruses to be deposited into publicly available databases within a year of discovery.
She also called for greater transparency from private “virus hunting” organizations and middlemen between the NIH and labs, an apparent allusion to the EcoHealth Alliance and the Global Virome Project.
Kevin Esvelt, a biologist at the Massachusetts Institute of Technology, said creating novel viruses in the lab, combined with the ease of synthesizing viruses from a genome sequence, poses a national security threat.
“More Americans have died of COVID than would perish if a Russian Topol SS-25 thermonuclear warhead were to be detonated in the center of Washington, DC,” said Esvelt. “Pandemic viruses can be more lethal than thermonuclear weapons. That makes them a proliferation concern.”
Suddenly Pfizer’s website and the FDA want to emphasize all the problems with Paxlovid. So in the case of this drug, these two co-conspirators apparently think that disclosures will save them from something.
Just look at this language! Compare to the lack of disclosure of adverse effects long known to be due to the COVID vaccines. Have you EVER heard FDA refer to the vaccines for children as unapproved?
PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death.
The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
AUTHORIZED USE
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
LIMITATIONS OF AUTHORIZED USE
• PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19
• PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19
• PAXLOVID is not authorized for use for longer than 5 consecutive days
PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which PAXLOVID belongs (i.e., anti-infectives).
PAXLOVID is not approved for any use, including for use for the treatment of COVID-19.
PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.
The US Democratic Party has embraced a transgender agenda that amounts to “the normalization of sadism,” author A.J. Rice has said, warning that radical trans policies would return if the party is allowed to regain power.
Speaking to RT’s America First host Scotty Nell Hughes about his new book, ‘The Curse of the Bearded Lady: How the Trans Mafia Whacked American Sanity’, Rice argued that activists have gained significant influence in schools, medicine, and corporate America while people who questioned the agenda have faced pressure to stay silent.
The author described the “trans mafia” as the sprawling network of people and institutions that have helped the movement gain influence. He singled out parts of academia, wealthy backers, and corporations, and stated that providers of transition-related treatment also have a financial incentive to keep young people in their care indefinitely.
Rice argued that the consequences of these policies ultimately fall on children who are being drawn toward gender-affirming medical treatments and on girls who are expected to share locker rooms or compete in sports with biological males.
He noted that while voters rejected the Democrats’ approach to gender in 2024, the party, which has been “captured by madness,” has since only doubled down and is seeking what is effectively “the normalization of sadism.” … Full report
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