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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.
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
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.”
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.”
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
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
In the 1940s, the Green Revolution changed agricultural practices. The beginning of the Revolution is often attributed to Norman Borlaug who developed high-yield varieties of wheat enabling Mexico to produce more wheat than was needed by citizens in their country.1
Production of wheat and rice from high-yield varieties had dramatic success in Mexico and India, which on the surface appeared to solve food production issues. However, these new varieties were domesticated varieties bred to respond to fertilizers to increase the yield.2
The Green Revolution also reduced the number of species grown. For instance, before high-yield variety seed, there were 30,000 rice varieties grown in India.3 Now, there are 10. The homogeneity increased the susceptibility to pests and disease, which then drove the development of pesticides and insecticides.
Farmers unable to afford fertilizer and pesticide experience lower yields with new seed rather than the older strains that had adapted to local conditions, including water supply and pests.4 These changes led to many farmers planting only one crop year after year, also known as monoculture or monocropping.
This practice has led to poor soil biodiversity, unable to support healthy plant growth.5 As the soil structure and quality declines, farmers are forced to use more fertilizer, which contributes to further decline in soil quality and nutrient depletion.6 Monocropping also encourages the spread of pests and disease requiring pesticides for treatment, greatly contributing to groundwater and air pollution.
Years of monoculture farming and industrial livestock production has created rising air and water pollution problems, triggering large algae blooms,7 polluting groundwater supplies8,9 and deteriorating air quality.10
According to a report by the Office of Inspector General (OIG),11 the U.S. Environmental Protection Agency (EPA) estimates there are 18,000 large concentrated animal feeding operations (CAFOs) nationwide.12 These operations are a significant source of air pollutants. A lack of reliable methods for estimating emissions had prevented the EPA from determining statutory requirements.
In 2005, the EPA and the CAFO industry entered into an agreement in which the industry would fund an air emissions monitoring study. However, the OIG found13 that 11 years later the EPA still had not developed reliable emission estimation methods to determine if CAFO farms were complying with the Clean Air Act and other statutes.
According to the U.S. Centers for Disease Control and Prevention,14 "the most pressing public health issue associated with CAFOs stem from the amount of manure they produce." A variety of potential contaminants including pathogens, E. coli, growth hormones, antibiotics and additive chemicals are contained within the waste products.
Large CAFOs may produce more excrement waste than some U.S. cities. For instance, an 800,000-hog CAFO produces 1.6 million tons of manure each year, which is 1.5 times more waste than Philadelphia.15 According to the EPA,16 manure is a primary source of nitrogen and phosphorus runoff to surface and groundwater.
Pew Research Center17 points out an individual farm animal requires less feed and produces less manure, which may suggest a lower impact, yet industrial farming concentrates on producing the most protein in the least amount of time.
Both animals and their waste are concentrated and usually exceed the capacity of the land used, polluting the local environment and resulting in an increased health risk for those living nearby.18
Animal waste is stored in open pits, called "lagoons,"19 placing local environments in danger of pollution through leakage and overflow during storms.20 This happened after hurricane Florence to large areas of North Carolina.21
North of Tallahassee, Florida, and on the far west side of Georgia lies White Oak Pastures, owned and operated by Will Harris. He is the largest private employer in the county and is known throughout the U.S. by health conscious consumers for the non-GMO grass fed beef he produces.22
After the release of a study earlier this year by Quantis,23 Will Harris' legacy may be as the rancher who discovered how to use cows to heal the land. After collecting and evaluating data spanning two decades, the research team was so surprised they asked academics from other universities to confirm the methodology. As noted by lead author Jason Rowntree, Ph.D.:
"[B]ased on historical sampling, White Oak Pastures' holistically managed fields went from 1 percent soil organic matter to 5 percent. Soil organic matter is a key indicator for soil health and among other factors, it influences soil aggregates and nutrient cycling.
Aggregate stability indicates how well the soil holds together under rainfall, providing greater resiliency to the landscape. In the case of White Oak Pastures, aggregate stability increased 4x."
The results amazed the researchers who chose White Oak Pastures as it is one of few farms with a 25-year history of using holistically managed grazing and a long history of soil sampling. Since Harris acquired neighboring properties over the years, scientists were able to analyze different soil samples spanning 20 years.24
The study concluded conversion of annual crops to perennial pastures and holistic grazing effectively stored more carbon in the soil than the cows emitted during their lives. This result runs contrary to conventional wisdom about beef production. In fact, Harris' farm has zero waste and operates on a "save more than you spend" carbon model.
The life cycle assessment data demonstrated the farm offsets at least 100% of the grass fed beef carbon emissions. Harris commented on the ecosystem he created on his farm leading to these results:25
"Our farm is creating more in terms of organic matter in the soil and microbial biodiversity than it is depleting. This shows that it is possible for humans to positively contribute to the environment through our food production system — using holistic management and planned grazing of livestock."
The study found the net result of carbon emissions from the farm was 111% lower than conventional beef production and six times more carbon-efficient than the average production system per pound of cow.26
In addition to the contributions to groundwater and air pollution from CAFO farms, industrial monocropping increases air pollution and soil erosion. In a warning that has since come to fruition, Wendell Berry wrote, "If the present attitude continues, we may expect government policies that will encourage the destruction, by overuse, of farmland"27 and "the fertility of the soil will become a limited, unrenewable resource like coal or oil."28
Scientists from the University of Sheffield's Grantham Centre for Sustainable Futures released a report at a United Nations conference in 2015, revealing 33% of the world's land suitable for crops has been lost to erosion or pollution in the past 40 years.29
Mismanagement has reversed the natural process, turning farmland into a source of pollution as opposed to a sink. Large industrial agricultural concerns emit methane,30 nitrous oxide31 and carbon dioxide into the air, as well as nitrogen into the soil and surrounding waterways.
Reversing the process is not easy, but one farmer from New York, Ben Dobson, has been part of a worldwide "soil health revolution" focused on building organic matter in the soil.32
As a result, he enjoys healthier soil and his crops have thrived during erratic climate. Dobson commented that while the area had seen massive amounts of rainfall and more prolonged periods of drought in the recent years, his farm has not suffered more than a small drop in crop yield.33
Another farmer in New York, Klaas Martens has been using regenerative techniques for 20 years. He recalled in 2016 New York experienced one of the worst droughts in decades,34 and while neighboring farms had no crop yields, he had one of the best harvests that year.35
Dobson took a journalist from Grist36 on a tour of his farm during an interview. He explained how succession planting the ground builds up carbon momentum in the land. On other farms, the opposite occurs as the soil is plowed and it unleashes carbon into the atmosphere.
In 2017, the EPA37 found total carbon emissions from agriculture accounted for 9% of all gas released. Instead, Dobson uses plants with a robust root system to help break up clay and store carbon further in the soil where it eventually becomes humus, a stable form of organic matter.38
He plans to plant as many trees as possible as their extensive root system contains nutrients before they may escape into groundwater, thus improving water quality. A study released in Science Advances shows cover cropping, practiced by Dobson and Harris, could mitigate 103 million metric tons of carbon pollution in the air,39 equivalent to the annual emissions of around 22 million cars.40
Dobson describes regenerative farming, of which cover cropping is one strategy, as a means of managing an ecosystem to support agriculture and livestock, as opposed to producing monocrops or a single livestock species. The process is organic, as it works with a natural process that has been successful for centuries before fertilizers, pesticides and chemicals were introduced.
"The idea is that we're managing complex systems and letting some things, such as advanced biological systems, evolve by not disrupting them. As a farmer, my challenge is: How do I farm well within a cycle?"
Unfortunately, governmental policies are supporting pollution. Despite the fact many of the practices of traditional industrial farming harm the environment through the release of multiple pollutants, many agricultural policies continue to support this form of farming. For instance, although industrial farming contributes to water pollution, the operations receive exemptions under the Clean Water Act:41
"You do not generally need a permit under Section 404 if your discharges of dredged or fill material are associated with normal farming, ranching, or silviculture activities such as plowing, cultivating, minor drainage, and harvesting for the production of food, fiber, and forest products or upland soil and water conservation practices.
This exemption pertains to 'normal farming' and harvesting activities that are part of an established, ongoing farming or forestry operation."
In an interview with Grist,42 Peter Lehner, lawyer at Earthjustice,43 pointed out New York land owners are eligible to receive a tax deduction based on the size of their operation and income without meeting any environmental requirements.44
New York State Assembly member Didi Barrett has a different idea of how to protect farmers in New York and at the same time support healthy soil. Barrett supported a two-year pilot project to test different farming methods in a way designed to protect soil health and fight environmental pollution.45
Her idea is to incentivize sustainable farming practices. The current pilot program involves experimenting with different techniques on farms in Dutchess County to determine if the proposed farming practices could be feasibly scaled to the rest of the state. This follows a study in 2017 investigating financial incentives to support regenerative farming practices.46
Regenerative farming reduces soil erosion and topsoil destruction47 while improving fertility and biodiversity.48 The process helps protect water sources and diminishes water demand,49 thus reducing the need for irrigation. However, water is not the only resource being decimated by pollution.
Regenerative farming also reduces air pollution, particulate pollution and animal waste. What's more, one study50 showed organic farmers earn 22% to 35% more than their industrial counterparts51 and, as Dobson and Martens attest in their interview, during times of drought or excessive rainfall their crop yield has not fluctuated significantly.52
To be part of the pollution solution, seek out local farmers using regenerative strategies to build the health of their farm and reduce local pollution. Local cooperatives enable the purchase of eggs, meat and produce produced organically and regeneratively. In an interview I did with Harris, he noted that no farmer sets out to destroy the land or hurt animals on purpose.
He thinks most believe they are doing the right thing: They're growing the best crops and managing their livestock well. But what does animal welfare really encompass? According to Harris, this term really needs to cover more than the most obvious essentials.53
"[G]ood animal welfare used to mean you don't intentionally inflict pain and discomfort on the animal. You keep them fed. You keep them safe. You don't hurt them. And all of us believed that was good animal welfare, and most people still believe that.
To us, now, that is no longer sufficient. For me and my family and my employees, good animal welfare means it is incumbent upon us as herdsmen to create an environment in which the animals can express instinctive behavior.
Cows were born to roam and graze. Chickens were born to scratch and peck. Hogs were born to root and wallow. Those are instinctive behaviors. If they're deprived of that aptitude, that is poor animal welfare.
If you have a cow on a feedlot, a hog in a gestation crate, a chicken in a battery cage, they're safe, they're reasonably comfortable, but they can't express instinctive behavior.
It's like putting your child in a closet and saying, 'This is great. I keep the temperature at 72 degrees. I leave the light on. He'll never break his leg playing football. He'll never be abducted. He'll never be run over by a bus ... That may seem like great child rearing — except it's not."