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Diabetic Shares Why He Quit ‘The Ketogenic Diet’

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In Brief

  • The Facts:

    A ketogenic diet might not be as safe and effective in the long term as a balanced whole foods diet, and fasting is a more hazard-free way of promoting fat-burning ketosis in the body.

  • Reflect On:

    Many people are adopting the ketogenic diet for various reasons, completely cutting or drastically reducing their carb intake. But is this safe in all cases?

The ketogenic diet is becoming quite popular. However, many people are promoting it without acknowledging the fact that it might not be safe for everybody. I’m specifically referring to a diet that’s high in fat and low in carbs. Don’t get me wrong, these types of diets are proving to be great interventions for people with cancer, epilepsy, and neurodegenerative disorders. While there is no doubt that this type of diet might be quite an effective health intervention for some, that’s not true for all health issues, and we still have a long way to go with regards to the research to get the full picture.

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I’ve written multiple articles about the benefits of ketones (what your blood produces when your body switches from burning glucose to burning fat). However it must be noted that promoting this fat burning state long term by only consuming fat, and no carbs, can in certain cases have negative health consequences.

-->Listened to our latest podcast episode yet? Joe speaks with journalist Derrick Broze about the need for journalistic standards, Qanon, and agorism. Click here to listen!

I’ve always been a supporter of  the body producing ketones by going into fat-burning mode. If we are constantly eating, especially carbs, we’re always going to be burning glucose and never really deplete those reserves so we can start burning our fat, much of which is the main cause of a variety of diseases.

Fasting

The difference here is that I’ve promoted fasting as a way to reap the benefits of ketones instead of a low fat, high carb diet. If one fasts a couple times a month for a few days, your body will go into ketosis and experience autophagy. You can completely regenerate your immune system, repair damaged DNA, and even kill cancer when you practice fasting. This does not mean you should eat high fats and no carbs when you break your fasts, you should simply eat a healthy diet full of whole foods with plenty of fruits and vegetables–at least that’s what I believe based on my research.

Fasting (which produces ketones) is what is showing huge promise for cancer patients, as well as people who suffer from diseases like Parkinson’s and Alzheimer’s. Combining fasting here and there, or even intermittent fasting here and there with a plant-based whole foods diet, which includes carbs, is extremely healthy. The prolonged state of ketosis might be necessary for cancer patients, but again, there are still a lot of questions unanswered.

Carbs are not the enemy, and this has been shown by multiple studies. A keto diet may cause short term weight loss, obviously (fasting would do the same thing, it’s the same as a keto diet without having to constantly eat high fats and no carbs). However, this may come at a serious price. A 2010 review found that low-carb, animal-based diets increased cardiovascular death by 14%, cancer death by 28%, & all-cause mortality by 23%- trends confirmed in other large studies.

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Animal Proteins The Problem?

This however might not be due to not eating carbs, but simply from the protein found in animal products. Dr. Colin Campbell, is the Jacob Gould Schurman Professor Emeritus of Nutritional Biochemistry at Cornell University and an American biochemist who specializes in the effect of nutrition on long term health. Through his “China study” and other work, he found that over-consumption of animal protein actually “turned on cancer.”  Protein from plants, however, had the opposite effect.

That being said, as mentioned earlier, the ketogenic diet may be used for treatment of various diseases. For example, a study titled “The Ketogenic Diet & Hyperbaric Oxygen Therapy Prolong Survival in Mice with Systemic Metastatic Cancer” explains how it’s already known that the ketogenic diet elevates blood ketones and has been shown to slow cancer progression in both animals and humans. The study also revealed that the ketogenic diet “significantly decreased blood glucose, slowed tumor growth, and increased mean survival time by 56.8 percent in mice with systemic metastatic cancer.”

Just to re-iterate, fasting has the same effect on tumor growth. So why utilize a ketogenic diet when one can utilize fasting instead which also elevates blood ketone levels and slows/kills the progression of cancer? Something to think about. Is it really that healthy to prolong a state of ketosis for so long and completely deprive your body of the nutrients found in many whole foods and plant foods?

Keto diet research is in its infancy, focusing on short-term blood results & body weight – not actual rates of disease or death. And some findings are concerning. LDL cholesterol levels tend to rise (or at best, stay the same) on keto diets. An overwhelming wealth of research shows that the higher the LDL, the higher the risk of cardiovascular disease.

 A keto diet is low in refined grains & added sugar, which is great. But it also can be low in phytonutrients, antioxidants, & fiber, all of which have profound benefits, and it forbids some of the most powerfully health-promoting foods on earth – whole grains, legumes, & many fruits. To me, that’s just not good medicine. – Michelle McMacken, internal medicine physician

The truth is, you can still be on a ‘ketogenic diet’ and eat a whole foods plant based diet. If you throw in fasting periods you are going to get the benefits of burning your fat stores and producing blood ketones anyway. There is no reason to go so strict as to deprive your body of carbohydrates unless you are using it as an intervention for a specific disease, and those interventions still have a lot of science and examination to go.

Dr. Mark Mattson,  Chief of the Laboratory of Neuroscience at the National Institute on Aging and  professor of Neuroscience at Johns Hopkins University, explains what fasting does to the brain in this great TED talk. Not once does he mention a high fat ketogenic diet, he is only referring to fasting. Here’s a great quote from that talk:

Why is it that the normal diet is three meals a day plus snacks? It isn’t that it’s the healthiest eating pattern, now that’s my opinion but I think there is a lot of evidence to support that. There are a lot of pressures to have that eating pattern, there’s a lot of money involved. The food industry — are they going to make money from skipping breakfast like I did today? No, they’re going to lose money. If people fast, the food industry loses money. What about the pharmaceutical industries? What if people do some intermittent fasting, exercise periodically and are very healthy, is the pharmaceutical industry going to make any money on healthy people?

Recent Study

If we take a look at a recent study from 2014, published in the journal Trends In Molecular Medicineit outlines and confirms what several studies before it have already done:

  • Caloric restriction (diet high in nutrients but low in calories) and its mimetics (CR) improve lifespan and reduce cancer incidence
  • CR and CR mimetics sensitize cancer cells to chemotherapy
  • CR and CR mimetics combined with chemotherapy enhance anticancer immune responses

According to the study:

Caloric restriction (CR) is currently the most robust environmental intervention known to increase healthy life and prolong lifespan in several models, from yeast to mice. Although the protective effect of CR on the incidence of cancer is well established, its impact on tumor cell responses to chemotherapeutic treatment is currently being investigated. Interestingly, the molecular mechanisms required to extend lifespan upon reduced food intake are being evaluated, and these mechanisms may offer new opportunities for therapeutic intervention. In addition, new findings suggest a beneficial effect of CR in enhancing the efficiency of tumor cell killing by chemotherapeutic drugs and inducing an anticancer immune response.

None of these studies mention adopting a ketogenic diet.

That being said, in 2010, a case report was conducted on a 65-year-old woman who had a brain tumor causing numerous neurological deficits. In addition to standard care, she was put on a ketogenic diet. After two months, she experienced a complete remission of her tumor, yet when the diet was suspended, the tumor returned. We’ve also seen similar results on cancer growth with just pure fasting.

My way is to just eat healthy, and do a little fasting if you want to experience the health benefits of ketosis. You can eat a plant-based whole foods diet and still deplete your glucose reserves with intermittent fasting if you are looking to lose weight.

Man Shares Why He Quit

I came across this post via Forks Over Knives (a great resource), and while it’s just onme perspective, I thought it was important to share because the best knowledge comes from experience.

Keep in mind I have written about fasting as a tool to manage and even reverse diabetes. You can read that here.

Exercise physiologist and diabetes educator Drew Harrisberg has been amazed at the improvements to his health within a month of going from keto to plant-based. We’ll continue to check in with Drew throughout his WFPB journey, so stay tuned here for updates.

If you’re reading this story in the hope of seeing drastic before and after photos, I’m afraid you’re going to be disappointed. However, if I could wear my body inside-out, I think you’d find my transformation pretty damn impressive (if I say so myself)! My story is about how a drastic change in my nutritional approach—going from keto to plant-based—allowed me to regain control of my insulin and blood sugar levels and, ultimately, to thrive again.

Health-Conscious History

I’ll start by introducing myself. My name is Drew Harrisberg. I’m an exercise physiologist, diabetes educator, sport scientist, and most importantly, I’m a happy and healthy guy thriving with type 1 diabetes. I’ve not only accepted living with it; I’ve learned to love it and manage it so that it doesn’t manage me.

The diagnosis came unexpectedly when I was 22 years old. It was a moment that changed my life forever. I remember making a conscious decision that I would become an expert in managing my disease and that I would share everything I discovered with the world. So the journey began. I went back to university and completed my second degree to add to my exercise physiology title, this time in diabetes education and management.

Since being diagnosed with diabetes, my life has been one big self-experiment. The cool thing is, I’ve been the subject and the lead scientist. I’ve made countless mistakes and discovered just as many solutions.

My first nutritional triumph came very soon after my diagnosis, when I transitioned from the conventional food pyramid to a mostly plant-based, low carb (50-150 grams per day), Paleo approach. About 70 percent of my diet consisted of low-carb, non-starchy vegetables; nuts; and seeds. Animal foods (meat, fish, eggs, and dairy) made up only about 30 percent of my diet, but I had some animal products with every meal. I ate very minimal fruit (just berries) and almost no grains, legumes, or nightshades. I followed this way of eating for the first seven years of my diabetes journey, and it did help me to achieve some great results: My insulin requirements dropped significantly, my blood sugar levels were tightly controlled, and some physical ailments, such as chronic sinusitis and shin splints, disappeared and never came back. My overall health improved.

Recently, my desire for personal development led me down an entirely different road. All the buzz about the ketogenic diet had me interested, so I decided to try it out in the hope that I could further reduce my insulin requirements and achieve even better blood sugar control.

One Step Forward, 10 Steps Back

Initially, that’s exactly what happened. After two months on a ketogenic diet, I was lean, fit, had great focus and concentration, could go long hours without eating, had stable blood sugar levels, and had lower insulin requirements. At this point, it seemed like keto was a magic bullet, and I was a huge proponent of this way of eating. But after two months, everything took a horrible turn for the worse. I became the most insulin resistant I have ever been. I lost all metabolic flexibility. Sure, I was a very efficient fat- and ketone-burner, but it was at the expense of the ability to tolerate any glucose whatsoever. Not only could I no longer eat the smallest amount of carbs without a massive blood sugar spike but also I was resistant to the insulin that was meant to bring my levels back into the normal range. It would have been easy to blame my high blood sugar levels on the tiny amounts of carbs I was eating, but that would have been a mistake. Here’s why: Even if I didn’t eat anything and my liver dumped glucose into my bloodstream, I couldn’t fix my high blood sugar levels, because I was resistant to the insulin that I was injecting. It felt like I was on my way to developing type 2 diabetes (type 1 is more than enough, thank you). It was a very frightening reality and a huge wake-up call.

I came to an eye-opening realization: The ketogenic diet is a short-term, Band-Aid solution. By removing carbs from the diet, you’re simply removing a trigger that leads to symptoms (hyperglycemia) without addressing the actual cause. Then when you add carbs back in, your body can’t tolerate them, which makes it seem like carbs are “bad” for you, but really they’re the victim of something else. After spending hours and hours down a rabbit hole of research, it turns out that high amounts of intramyocellular fat accumulation cause the cell to become dysfunctional, leading to insulin resistance and impaired glucose tolerance. I’ve seen numerous keto advocates demonizing carbs because they personally can’t tolerate them. Once again, it may seem like the banana caused your blood sugar to go up, but what it really did was trigger a symptom that was caused by a much deeper problem. After becoming aware that the large amounts of saturated fat I was eating (from eggs, chicken, meat, and full-fat dairy, and coconut oil) was making me insulin resistant, I knew I had to make a change.

Getting to the Root of the Problem

Having made the connection between poor health outcomes and saturated fats, I was hesitant to return to a Paleo diet. I realized that perhaps when I’d previously done well on Paleo, I was just “getting away with it” because of the healthy plant foods that I was eating. Were my positive results on Paleo due to the 30 percent of my diet that was animal products or the 70 percent that was plants? I suspected it was the latter. The only way to truly find out was to start a strictly plant-based approach and track the changes.

So, I decided to embark on a journey to see if removing those foods altogether and eating more carb-rich plant foods would reverse the metabolic damage I had caused. I immediately embarked on a strictly whole-food-plant-based journey.

I dropped my fat intake from 75 percent of daily energy to less than 20 percent. I removed all animal foods and oils. Rather, I focused on getting healthy fats from avocados, nuts, and seeds. I also added whole grains and legumes back into my diet (both of which I hadn’t eaten in nearly seven years since following a paleo approach) and an abundance of all types of fruit. Within 48 hours my insulin sensitivity started to return to normal. Within 1 week my carbohydrate intake was the highest it had been since being diagnosed with diabetes, and my insulin intake was reducing day by day.

As I write this story, I’ve been strictly plant-based for 30 days and the results have been astonishing. I’ve achieved my best ever insulin-to-carb ratio, and it feels like I’ve regained control of my health. What started as a plant-based journey toward personal development and health has turned into something so much bigger. The positive impact I’m having on myself, the people around me, the environment, and animals gives me so much fulfillment and joy. I cannot wait to see where this journey takes me over the long-term.

The Takeaway

Interesting discoveries and findings are often turned into fads. It’s important to really do the research, and listen to what your body needs. Everybody has different requirements, and at the end of the day, completely eliminating carbs from your diet doesn’t seem to be the healthiest choice. Fasting, on the other hand, if done correctly, has shown no adverse health effects and nothing but benefits for the body.

Dive Deeper

These days, it’s not just knowing information and facts that will create change, it’s changing ourselves, how we go about communicating, and re-assessing the underlying stories, ideas and beliefs that form our world. We have to practice these things if we truly want to change. At Collective Evolution and CETV, this is a big part of our mission.

Amongst 100's of hours of exclusive content, we have recently completed two short courses to help you become an effective changemaker, one called Profound Realization and the other called How To Do An Effective Media Detox.

Join CETV, engage with these courses and more here!

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Health

Study: Weekly Use of Disinfectants Greatly Increases Your Risk of Fatal Lung Disease

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In Brief

  • The Facts:

    A 30-year study conducted by Harvard researchers and the French National Institute of Health and Medical Research found that people who use disinfectants once a week have a 22-32% increased chance of developing lung disease.

  • Reflect On:

    How reliable are regulatory agencies when it comes determining how safe the products we use for cleaning are for our health and environment? Did you know that there are a number of effective alternatives and products available out there?

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What Happened: A 30-year study conducted by researchers at Harvard University alongside researchers at the French National Institute of Health and Medical Research (Inserm) found that regular use of bleach and other commonly used disinfectants can increase your chances of developing fatal lung disease. The study found that those who used these types of products just once a week had up to a 32% increased chance of developing the condition.

It’s called chronic obstructive pulmonary disease (COPD). Researchers looked at the incidence of the disease for the study in more than 55,000 nurses in the United States. Nurses were used for the study because they use disinfectants to clean surfaces on a regular basis. In this study population, 37 percent of nurses used disinfectants to clean surfaces on a weekly basis and 19 percent used them to clean medical instruments on a weekly basis.

In the UK alone, COPD is present approximately 1.2 million people. It includes various lung conditions like chronic bronchitis and emphysema. Obviously there are multiple factors that play a role, but according to this study, disinfectants are definitely one of them or at the very least, can’t be ruled out. Correlation may not mean causation but it’s safe to assume that breathing in these substances is not really safe, in my opinion, and can be detrimental to our health.

As far as deaths go, 25,000 people a year die from COPD in England. This number represents the third highest death rate from the disease. This study is thought to be the very first to identify such a link between COPD and specific cleaning products/chemicals known as “quaternary ammonium compounds (quats).”

To the best of our knowledge we are the first to report a link between disinfectants and COPD among healthcare workers, and to investigate specific chemicals that may underlie this association…Some of these disinfectants, such as bleach and quats, are frequently used in ordinary households, and the potential impact of domestic use of disinfectants on COPD development is unknown…Earlier studies have found a link between asthma and exposure to cleaning products and disinfectants at home, such as bleach and sprays, so it is important to investigate this further.- Inserm researcher Orianne Dumas (source)

The researchers analysed data from a mass study on female US nurses commenced by Harvard in 1989. In 2009, they looked at those who were still working as nurses who had no history of COPD and tracked them until May this year. During that period, 663 were diagnosed with the condition.

A follow up study published in 2019 examining more than 70,000 nurses came to the same conclusions.

We found that use of several specific disinfectants was associated with higher risk of COPD development; these included hypochlorite bleach (chlorine), hydrogen peroxide, alcohol, and quaternary ammonium compounds (commonly used for low-level disinfection of noncritical items, such as environmental surfaces) and glutaraldehyde (used for high-level disinfection). Several of these exposures often occurred concurrently, and disentangling the role of each product was challenging. When studying combinations of exposure to specific disinfectants, we found the highest risks of COPD incidence among nurses exposed to hypochlorite bleach or hydrogen peroxide and in those combining these exposures with exposure to aldehydes. Both the chemical properties of specific products and the greater number of products used could explain these elevated risks. Moreover, all of the agents that were associated with COPD incidence when evaluated separately have been described as airway irritants.

Why This Is Important: 

The everyday use of bleach currently has no specific health guidelines, and that’s very true with many other products as well. Cosmetics is a great example, that particular industry is not quite regulated as it should be, and products that do pass through federal health regulatory regulation and inspection are not always safe. Glyphosate is a great example, and there is a growing concern today among academics, journalists and everyday people regarding the close relationship between these regulatory agencies and the companies that manufacture these products. Sure they may work, but the case with many of these products is that there are alternatives that are just as effective and much more safer.

Whether it’s banking soda and vinegar, tea tree oil and lemons, or something else, the market and natural health stores are now filled with cleaning products that do not pose the same threat as mainstream conventional cleaning products. They’re not hard to find, all it takes is a simple internet search, or a trip to your local natural health food store. Many regular chains are also starting to carry more health and environmentally sound cleaning/disinfectant products as well. If you’re truly concerned and put effort into searching, you’ll have no problem finding these products.

Dive Deeper

These days, it’s not just knowing information and facts that will create change, it’s changing ourselves, how we go about communicating, and re-assessing the underlying stories, ideas and beliefs that form our world. We have to practice these things if we truly want to change. At Collective Evolution and CETV, this is a big part of our mission.

Amongst 100's of hours of exclusive content, we have recently completed two short courses to help you become an effective changemaker, one called Profound Realization and the other called How To Do An Effective Media Detox.

Join CETV, engage with these courses and more here!

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How Effective is The Covid-19 Vaccine?

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In Brief

  • The Facts:

    The 95% efficacy of the Pfizer vaccine is widely touted by the media and the medical establishment, but there are important questions to be asked about this claim.

  • Reflect On:

    Are we being given all information available from covid vaccine study to make informed decisions? Are the studies even being done in a way that represents what effects the vaccine may have on the whole population?

Are you going to decline the Covid-19 vaccine if it is offered to you? Why or why not? No matter how certain you are in your reasoning there will no doubt be someone else who feels exactly the opposite to you and will be just as certain of their position. We trust different sources of information, we have had different experiences with vaccines and we have different impressions of the threat of SARS-COV2 to us and our species.

I would suggest that those in the “vaccine cautionary” community would decline the vaccine based on their ideas around its potential risks. On the other hand, supporters of the vaccine are more likely to focus on its potential benefits. The debate has largely been centered around the disagreement people have about the risks. In this essay I will consider the uncertainty I and others have about its benefits.

Is the Medical Community biased about the Vaccine?

As a contributor to Collective Evolution I am well aware of the “cautionary” perspective on vaccinations and CDC directives. As a physician, I have a reasonable understanding of how those in the medical community regard the “best of what modern science has to offer”. I am part of a Physician group on social media where doctors can seek advice from each other around all matters Covid-19, from interesting cases to rare side effects to how to address special concerns raised by patients. It has been alarming to realize how unilateral the support of vaccination is in this community. 

I mean no disrespect to my medical colleagues. Many of those in this community have seen their patients die from this very real virus. They have had to struggle with the divergent directives coming from the CDC. They have had to work through many weeks where Personal Protective Equipment (PPE) was in short supply as their hospital wards rapidly reached capacity and overflowed. Now that the Pfizer and Moderna vaccines have met minimum requirements for efficacy under the Emergency Use Authorization (EUA), they are faced with yet another impediment to getting themselves and their patients through this pandemic: growing skepticism around the vaccine coming from the very same people they are endeavoring to help. Their frustration around the situation is understandable, but is it biasing them?

Before consenting to any intervention it is important to understand its relative risks and benefits. As I mentioned earlier, there has been much concern in the “vaccine cautionary” sphere about side-effects and deaths. Here I will take a closer look at what we know about the benefits of the vaccine based on Pfizer-Biontech’s  briefing document to the FDA’s Vaccines and Related Biological Products Advisory Committee. How confident can we be in the efficacy of the vaccine? Has the manufacturer done its due diligence in its analysis and in being transparent? These are the central questions that need to be answered.

Understanding False Positives and Negatives

There has been a lot of discussion about the rate of “false-positives” with regard to the Polymerase Chain Reaction (PCR) test for confirming infection with SARS-COV2. The PCR test can return a positive result even if only trace fragments of the virus are present. Fragments of the virus on a nasal swab is not necessarily representative of an active infection or transmissibility. Moreover the sensitivity of this test is dependent on the number of amplification cycles, or the cycle threshold (Ct), used.  The Ct is not standardized. It is not unreasonable to say that there will be a percentage of people who test positive that do not have the disease. Nevertheless, without a better test we as the public must treat all positive PCR tests as an indication of an infection. We must assume the test is right. The rate of false positives, whatever it is, is directly proportional to the overestimation of the prevalence of the disease. 

Here I would like to discuss the significance of “false-negatives”. These are people who get a negative PCR result but may still be infected. The rate of false negatives is directly proportional to the underestimation of disease prevalence. This aspect of the inaccuracy of our primary diagnostic test gets relatively little attention for practical reasons. If you are suffering symptoms consistent with Covid-19 but have a negative PCR test we assume that you have Covid-19 anyway. In other words, if someone is symptomatic we assume that the test is wrong, i.e. that it is a false-negative, and necessary measures are taken. We quarantine and isolate until we feel healthy again whether we have Covid-19 or not. 

Because we are in the midst of a pandemic we have no choice but to make these assumptions. We are responding appropriately given the limitations of the test. Because of the assumptions we are forced to make, we are exaggerating the prevalence of the disease and our response to it to some extent. It is the nature of the situation we are in.

How do we know that the Vaccine is 95% effective?

With this in mind I would like to discuss a post in the opinion blog of the British Medical Journal (BMJ) that appeared earlier this month. The author, Peter Doshi (PhD and Associate Editor at the BMJ), takes a rigorous look at the results reported by Pfizer regarding the efficacy of their mRNA vaccine. The success of their vaccine has been widely publicized to be 95%. Where exactly does this figure come from?

During the four weeks of observation (three weeks between 1st and 2nd dose followed by 7 days), 162 participants who received the placebo expressed symptoms of Covid-19 and tested positive by PCR. Compare that with only 8 in the group that received their experimental vaccine. The chance of getting Covid 19 after receiving the vaccine was about 20 times lower than if you got the placebo. This is the basis of the claim that their vaccine was 95% effective, well over the 50% threshold required for Emergency Use Authorization that allows their product to be deployed despite the fact that the two-year Phase III trial is still 20 months from completion.

How did Pfizer handle study participants in the “Suspected Covid-19” group?

It is less commonly known that of the nearly 38,000 participants in the Pfizer study, 3,410 fell into a group labeled “suspected Covid-19”. These are people who developed symptoms consistent with disease but tested negative by PCR. 1,594 of those in this group received the vaccine and 1,816 received the placebo. It should be quite clear that how we regard this much bigger group of symptomatic participants will have an enormous impact on the true efficacy of the vaccine. In other words, if we assume that the PCR test was accurate in all of these people and that they didn’t have Covid-19 and developed symptoms from another virus, the flu for example, then the vaccine would in fact be 95% effective as reported. On the other hand, if the PCR test was wrong every time and they all in fact had Covid-19, the efficacy of the vaccine would be much different: 1602 (1594 + 8) in the vaccine wing vs. 1978 (1816 + 162) in the placebo wing results in a vaccine efficacy of only 19%. 

The PCR test (like any test) can be wrong some of the time and right some of the time. No test is 100% accurate, however in this situation the accuracy of the PCR test has a very large impact on how we interpret the results of the vaccine trial. The true efficacy of the Pfizer vaccine can be known only if we know how many symptomatic people in each wing had Covid-19 despite testing negative by PCR.

It is likely that the percentage of false negatives are different in each arm. As the FDA briefing document on the Pfizer study and the BMJ piece correctly note, there should be fewer false negatives in the vaccine group. Why? It is because there is a greater chance of developing Covid-19 symptoms after receiving the vaccine compared to getting a placebo. Reactogenicity, or the acute response of the body to the vaccine, is common. Most of the acute inflammatory reaction to the vaccine occurs in the first seven days after receiving the vaccine. Looking more closely at the data, 409 patients in the vaccine group developed symptoms in the first seven days after inoculation. Compare this to 287 in the placebo group. If we assume that any participant who expressed symptoms in the first seven days must be suffering from the side effects of the vaccine or the placebo and not a new Covid-19 infection, the efficacy of the vaccine would still only be 29% if everyone else in that group was a false negative. This is admittedly a very large assumption but it is not outside the realm of possibility.

There are other more extreme possibilities. If all of the vaccinated participants who were suspected of Covid-19 truly did not have the disease and all of the unvaccinated (placebo) participants who were suspect did have the disease we would have a true miracle vaccine. Why? It would mean that only 8 people got the disease in the vaccinated group compared to 1978 in the placebo group. This would mean that the vaccine was approximately 99.6% effective. On the other hand, if all those who got vaccinated in the suspected group got Covid-19 and those who got the placebo didn’t, the vaccine would be not just ineffective, it would be dangerous.

Putting aside extreme and unlikely possibilities, the matter of the 3,412 “suspected Covid-19” participants and our assumptions about them still has very large implications. Let us say hypothetically that we as a nation decide to vaccinate our entire population with the Pfizer vaccine assuming that it has a 95% efficacy in preventing the disease. In other words, we are assuming that none of those “suspected” of having Covid-19 actually have the disease. This is in fact the assumption that the FDA is making when approving the use of the vaccine under the EUA. We can predict that within a month about 6.3% people will develop Covid-like symptoms from something other than vaccine reactogenicity or the disease itself. This is based on the number of participants who became symptomatic (from something other than reactogenicity) despite getting the vaccine and testing negative (1,185) divided by the total number who got the vaccine (18,801) = 0.063. That’s what happened in the study.

In a population of 300 million, we would expect roughly 19 million people to develop symptoms of Covid from something other than SARS-COV2 within a month. We can agree that we must be extremely confident about whether these 19 million people have the disease or not. Why would we assume they all don’t have Covid-19 when the vaccine trial itself considered them to be “suspected” of having it? We won’t. We shouldn’t, and practically speaking, we will be in the same situation we are in right now.

Pfizer either did not do or report additional testing that would have helped

The real issue here is that we shouldn’t be guessing about such important numbers. What do you suppose Pfizer did, knowing that this larger pool of symptomatic participants could have an enormous impact on the estimation of their vaccine’s efficacy? In my opinion, they should have tested everyone who developed symptoms for antibodies to help quantify the percentage of false negative PCR tests. If a participant felt like they were coming down with Covid-19 but had a negative PCR test, it seems clear that performing an antibody test would have offered additional clarity. This was either not done or not reported.

We must be careful when interpreting the power of a vaccine study. Although tens of thousands of people were enrolled, the only meaningful numbers with regard to efficacy have to do with those who contracted the disease during the period of observation. This is the only way to assess the efficacy of the vaccine. When Pfizer only considers participants that became symptomatic and tested positive we only have a group of 170 cases to cross compare.

The 3,410 people who became symptomatic but tested negative during the four weeks of observation would represent a much larger set of cohorts and would amplify the power of the study 20 fold if infection could be confirmed or ruled out through additional testing. In other words, the 3,410 symptomatic people should be the ones that Pfizer were hoping would emerge when they enrolled 37,000+ individuals in their study. I find this lapse in diligence suspicious and at the very least inexplicable, especially in light of the latitude they are granted under the EUA. The fact of the matter is that we do not know if this was done. Pfizer, per their own protocol, will not make this data available until the trial is completed 20 months from now. 

Why didn’t Pfizer look harder?

This forces us to ask some sobering questions. If Pfizer is required (or has agreed) to make all data available in two years, would they have conducted antibody tests on the “suspected Covid” group? If those results told a different story it would be quite damning, if not now, eventually. Their product would not be permitted for use under the EUA if a 50% efficacy requirement could not be met. On the other hand, if antibody tests were conducted and the results confirmed the impressive efficacy of the vaccine, why wouldn’t they have made the data available right now?

It should be clear that if Pfizer’s primary goal was to obtain approval under the EUA they would have had little incentive to do further testing to confirm their product’s efficacy. Why would they take the risk of seeking more information on 3,400 participants that could potentially overturn their results that were based on only 170 outcomes? This is where we must be very careful in our assessment of the situation. If you believe Pfizer and vaccine manufacturers are only out for profit, it would be easy to conclude that they are being manipulative. If you believe that these corporations are seeking to improve public health and safety you may grant them a lot of latitude here. To be truly objective we must ask if they have been scientific in their approach.

At the very least I feel that they have not been diligent, and their position hints at disingenuousness: Pfizer didn’t mention this group of participants in their 92 page report or in their publication in the New England Journal of Medicine. This group was only mentioned in two paragraphs of a 53 page briefing to the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA submitted December 10, 2020. The FDA, an agency of the department of Health and Human Services that ostensibly serves to protect the public by ensuring the safety of drugs, biological products and medical devices, continues to remain silent around this issue.

The Take Away

The 95% efficacy of the Pfizer vaccine is widely touted by the media and the medical establishment. Why didn’t Pfizer test or report the testing of an enormously important group of participants in their trial? We can predict that without these additional tests deploying the vaccine will not change our behavior nor our attitude to this pandemic.

Dive Deeper

These days, it’s not just knowing information and facts that will create change, it’s changing ourselves, how we go about communicating, and re-assessing the underlying stories, ideas and beliefs that form our world. We have to practice these things if we truly want to change. At Collective Evolution and CETV, this is a big part of our mission.

Amongst 100's of hours of exclusive content, we have recently completed two short courses to help you become an effective changemaker, one called Profound Realization and the other called How To Do An Effective Media Detox.

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Alternative News

Norway Investigates 29 Deaths in Elderly Patients After Pfizer Covid-19 Vaccination

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In Brief

  • The Facts:

    Norway has registered a total of 29 deaths among people over the age of 75 who’ve had their first Covid-19 vaccination shot, raising questions over which groups to target in national inoculation programs.

  • Reflect On:

    Should freedom of choice always remain here? Should governments and private institutions not be allowed to mandate this vaccine in order to have access to certain rights and freedoms?

What Happened: 29 patients who were quite old and frail have died following their first dose of the Pfizer COVID-19 vaccination. As a result, Norwegian officials have since adjusted their advice on who should get the COVID-19 vaccine.

This doesn’t come as a surprise to many given the fact that the clinical trials were conducted with people who are healthy. Older and sick people with co-morbidities were not used in the trials, and people with severe allergies and other diseases that can make one more susceptible to vaccine injury were not used either. It can be confusing given the fact that vaccination is being encouraged for the elderly in nursing homes and those who are more vulnerable to COVID-19.

Steinar Madsen, medical director of the Norwegian Medicines Agency (NOMA), told the British Medical Journal (BMJ) that “There is no certain connection between these deaths and the vaccine.”

On the 15th of January it was 23 deaths, Bloomberg is now reporting that a total of 29 deaths among people over the age of 75 who’ve had their first COVID-19 shot. They point out that “Until Friday, Pfizer/BioNTech was the only vaccine available in Norway”, stating that the Norwegian Medicines Agency told them that as a result “all deaths are thus linked to this vaccine.”

“There are 13 deaths that have been assessed, and we are aware of another 16 deaths that are currently being assessed,” the agency said. All the reported deaths related to “elderly people with serious basic disorders,” it said. “Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site, and worsening of their underlying condition.”

Madsen also told the BMJ that,

There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly. We are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease. We are not asking for doctors to continue with vaccination, but to carry out extra evaluation of very sick people whose underlying condition might be aggravated by it. This evaluation includes discussing the risks and benefits of vaccination with the patient and their families to decide whether or not vaccination is the best course.

The BMJ article goes on to point out that the Paul Ehrlich Institute in Germany is also investigating 10 deaths shortly after COVID-19 vaccination, and closes with the following information:

In a statement, Pfizer said, “Pfizer and BioNTech are aware of reported deaths following administration of BNT162b2. We are working with NOMA to gather all the relevant information.

“Norwegian authorities have prioritised the immunisation of residents in nursing homes, most of whom are very elderly with underlying medical conditions and some of whom are terminally ill. NOMA confirm the number of incidents so far is not alarming, and in line with expectations. All reported deaths will be thoroughly evaluated by NOMA to determine if these incidents are related to the vaccine. The Norwegian government will also consider adjusting their vaccination instructions to take the patients’ health into more consideration.

“Our immediate thoughts are with the bereaved families.”

Vaccine Hesitancy is Growing Among Healthcare Workers: Vaccine hesitancy is growing all over the globe, one of the latest examples comes from Riverside County, California. It has a population of approximately 2.4 million, and about 50 percent of healthcare workers in the county are refusing to take the COVID-19 vaccine despite the fact that they have top priority and access to it.  At Providence Holy Cross Medical Center in Mission Hills, one in five frontline nurses and doctors have declined the shot. Roughly 20% to 40% of L.A. County’s frontline workers who were offered the vaccine did the same, according to county public health officials. You can read more about that story here.

Vaccine hesitancy among physicians and academics is nothing new. To illustrate this I often point to a conference held at the end of 2019 put on by the World Health Organization (WHO). At the conference, Dr. Heidi Larson a Professor of Anthropology and the Risk and Decision Scientist Director at the Vaccine Confidence Project Emphasized this point, having  stated,

The other thing that’s a trend, and an issue, is not just confidence in providers but confidence of health care providers. We have a very wobbly health professional frontline that is starting to question vaccines and the safety of vaccines. That’s a huge problem, because to this day any study I’ve seen…still, the most trusted person on any study I’ve seen globally is the health care provider.

A study published in the journal EbioMedicine  as far back as 2013 outlines this point, among many others.

Pfizer’s Questionable History:  Losing faith in “big pharma” does not come without good reason. For example, in 2010 Robert G. Evans, PhD, Centre for Health Services and Policy Research Emeritus Professor, Vancouver School of Economics, UBC, published a paper that’s accessible in PubMed titled “Tough on Crime? Pfizer and the CIHR.”

In it, he outlines the fact that,

Pfizer has been a “habitual offender,” persistently engaging in illegal and corrupt marketing practices, bribing physicians and suppressing adverse trial results. Since 2002 the company and its subsidiaries have been assessed $3 billion in criminal convictions, civil penalties and jury awards. The 2.3-billion settlement…set a new record for both criminal fines and total penalties. A link with Pfizer might well advance the commercialization of Canadian research.

Suppressing clinical trial results is something I’ve come across multiple times with several different medicines. Five years ago I wrote about how big pharma did not share adverse reactions people had and harmful results from their clinical trials for commonly used antidepressant drugs.

Even scientists from within federal these health regulatory agencies have been sounding the alarm. For example, a few years ago more than a dozen scientists from within the CDC put out an anonymous public statement detailing the influence corporations have on government policies. They were referred to as the  Spider Papers.

The Takeaway: Given the fact that everything is not black and white, especially when it comes to vaccine safety, do we really want to give government health agencies and/or private institutions the right to enforce mandatory vaccination requirements when their efficacy have been called into question? Should people have the freedom of choice? It’s a subject that has many people polarized in their beliefs, but at the end of the day the sharing of information, opinion and evidence should not be shut down, discouraged, ridiculed or censored.

In a day and age where more people are starting to see our planet in a completely different light, one which has more and more questioning the human experience and why we live the way we do it seems the ‘crack down’ on free thought gets tighter and tighter. Do we really want to live in a world where we lose the right to choose what we do with our own body, or one where certain rights and freedoms are taken away if we don’t comply? The next question is, what do we do about it? Those who are in a position to enforce these measures must, it seems, have a shift in consciousness and refuse to implement them. There doesn’t seem to be a clear cut answer, but there is no doubt that we are currently going through that possible process, we are living in it.

Dive Deeper

These days, it’s not just knowing information and facts that will create change, it’s changing ourselves, how we go about communicating, and re-assessing the underlying stories, ideas and beliefs that form our world. We have to practice these things if we truly want to change. At Collective Evolution and CETV, this is a big part of our mission.

Amongst 100's of hours of exclusive content, we have recently completed two short courses to help you become an effective changemaker, one called Profound Realization and the other called How To Do An Effective Media Detox.

Join CETV, engage with these courses and more here!

Continue Reading
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