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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?

Before you begin...

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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.

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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)

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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.

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Awareness

Study: Organic Diet “Significantly Reduces” Urinary Pesticide Levels In Children & Adults

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CE Staff Writer 4 minute read

In Brief

  • The Facts:

    A 2019 study published in the journal Environmental Research found that an organic diet significantly reduced the pesticide levels in children and adults. Their urine was used to measure pesticide levels.

  • Reflect On:

    Are the justifications used to to spray our crops actually justified? Are they really necessary or can we figure out a better way of doing things?

Before you begin...

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Take a moment and breathe. Place your hand over your chest area, near your heart. Breathe slowly into the area for about a minute, focusing on a sense of ease entering your mind and body. Click here to learn why we suggest this.

What Happened:  A 2019 study published in the journal Environmental Research titled, Organic diet intervention significantly reduces urinary pesticide levels in U.S. children and adults” highlighted that diet is the primary source of pesticide exposure in both children and adults in the United States. It found that an organic diet significantly reduced neonicotinoid, OP pyrethroid, 2,4-D exposure, with the greatest reduction observed in malathion, clothianidin, and chlorpyrifos.

The researchers noted that all of us are exposed “to a cocktail of toxic synthetic pesticides linked to a range of health problems from our daily diets.” They explain how “certified organic food is produced without these pesticides,” and ask the question, “Can eating organic really reduce levels of pesticides in our bodies?” They tested four American families that don’t typically eat organic food to find out.  All pesticides detected in the body dropped an average of 60.5% after just six days on an organic diet.

First, we tested the levels of pesticides in their bodies on a non-organic diet for six days. We found 14 chemicals representing potential exposure to 40 different pesticides in every study participant. These included organophosphates, pyrethroids, neonicotinoids and the phenoxy herbicide 2,4-D. Some of the pesticides we found are linked to increased risk of cancer, infertility, learning disabilities, Parkinson’s, Alzheimer’s and more. (source)

The most significant drops occurred in a class of nerve agent pesticides called organophosphates. This class includes chlorpyrifos, a highly toxic pesticide linked to increased rates of autism, learning disabilities and reduced IQ in children. Organophosphates are so harmful to children’s developing brains that scientists have called for a full ban. (source)

A lot of the food we now spray on our food were  initially developed as nerve gases for chemical warfare:

To understand this controversial issue it is helpful to look at the history of pesticide use. Prior to World War II, the pesticides that we use now did not yet exist. Some pesticides currently in use were in fact developed during World War II for use in warfare. The organophosphate insecticides were developed as nerve gases, and the phenoxy herbicides, including 2,4-D (the most commonly used herbicide in Canada), were created to eradicate the Japanese rice crop, and later used as a component of Agent Orange to defoliate large areas in jungle warfare. After World War II, these chemicals began to be used as pesticides in agricultural production, for environmental spraying of neighbourhoods, for mosquito eradication, and for individual home and garden use. –  Ontario College of Family Physicians

It’s also noteworthy to mention that A study published in the British Journal of Nutrition carried out a meta-analysis based on 343 peer-reviewed publications that indicate “statistically significant and meaningful differences in composition between organic and non-organic crops/crop based foods.” The study found that

The study found that Phenolic acids are 19% higher in organic foods,  Flavanones are 69% higher in organic foods (linked to reduced risk of several age-related chronic diseases),  Stilbenes are 28% higher in organic foods, Flavones are 26% higher in organic foods, Flavonol is 50% higher in organic foods and Anthocyanins are 51% higher in organic foods.

Apart from nutritional content, the study also measured for concentrations of the toxic metal Cadmium (Cd), finding that in conventional foods, “significantly higher concentrations” were found. Conventional foods appear to have nearly 50 percent more of this heavy metal than organic foods. Furthermore, significant differences were also detected for other minerals and vitamins.

When it comes to pesticide residues on non-organic foods, the authors found that the volume of pesticide residues was four times higher in conventional crops.

Another study conducted by researchers from RMIT university nearly 5 years ago published in the journal Environmental Research found that eating an organic diet for just one week significantly reduced pesticide exposure in adults by up to 90 percent.

The Takeaway: At the end of the day, people are and have been voting with their dollar. More grocery stores and brands are offering organic options, and the industry is starting to recognize that it’s in demand. Furthermore, more people are growing whatever food they can. At the end of the day, sprayed food not only has implications for human health, but it’s detrimental to the environment as well. This is a big problem on plane Earth, we are constantly told that GMO food and the spraying of crops is the only way to combat world hunger and changes in climate, but this sentiment goes against a plethora of information showing that local organic farming/agriculture is the most sustainable.

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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Alternative News

Fact-Checker Claims No Causal Relationship Between 929 Deaths Reported After COVID Vaccine

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CE Staff Writer 13 minute read

In Brief

  • The Facts:

    Data from the CDC's Vaccine Adverse Events Reporting System (VAERS) shows, as of today, 929 deaths, 316 permanent disabilities and more than 15,000 adverse reactions reported after of the COVID-19 vaccine.

  • Reflect On:

    Should private institutions/companies have the right to mandate this vaccine for people and employees? When it comes to vaccines, should freedom of choice remain? Why is only one perspective presented by mainstream media?

Before you begin...

Coherent icon

Take a moment and breathe. Place your hand over your chest area, near your heart. Breathe slowly into the area for about a minute, focusing on a sense of ease entering your mind and body. Click here to learn why we suggest this.

What Happened: According to the CDC Vaccine Adverse Events Reporting System (VAERS), as of today (February 20th, 2021) 929 deaths, 316 permanent disabilities and more than 15,000 adverse events have been reported from people after taking the COVID-19 vaccine. This mainly represents reports that are coming in from the United States. The data shows that 799 of the deaths were reported in the U.S., and that about one-third of those deaths occurred within 48 hours of the individual receiving the vaccination. You can look it up for yourself and/or see the screenshot below. I have not looked up, or attempted to look up reports from countries outside of the U.S.

Many articles have been using VAERS to claim that the COVID-19 vaccine is causing deaths & injuries, but according to Facebook Fact Checker Health Feedback, the adverse events attributed to the COVID-19 don’t demonstrate a causal relationship between the vaccine and the adverse events. They do acknowledge, however, that VAERS records adverse events occurring after vaccination.

Health Feedback highlights the following point:

Both COVID-19 vaccines approved for emergency use by the U.S. Food and Drug Administration were thoroughly reviewed for safety and efficacy before approval. The U.S. Vaccine Adverse Events Reporting System (VAERS) enables the public and healthcare providers to report adverse events that occur after they received a vaccine. While VAERS serves as an early warning system for potential problems with vaccines, determining whether there is a causal link requires further investigation into these reports. VAERS data only tells us that an adverse event might have occurred after vaccination; on its own it cannot prove that vaccines caused the adverse event.

VAERS themselves makes this point clear by stating:

A report to VAERS generally does not prove that the identified vaccine(s) cause the adverse event described. It only confirms that the reported event occurred sometime after (the) vaccine was given. No proof that the event was caused by the vaccine is required in order for VAERS to accept the report VAERS accepts all reports without judging whether the event was caused by the vaccine.

Keep in mind that approximately 40 million Americans have had at least one COVID shot thus far.

The VAERS data can also be perceived from another perspective. There is no proof showing that the vaccine did not cause the adverse events. The reports coming into VAERS are from people who believe the vaccine is indeed responsible for the adverse event. There are, as I’ve written about many times before, other important factors that have been noted about VAERS. For example, according to some, like this U.S. Department of Health and Human Services report, VAERS is estimated to capture an estimated one percent of vaccine injuries, or at least reports by those who believe to be injured by a vaccine, because the majority of them are believed to be unreported. It’s not clear how many health professionals let alone people are even aware of VAERS.

VAERS has come under fire multiple times, a critic familiar with VAERS’  bluntly condemned VAERS in The BMJ as “nothing more than window dressing, and a part of U.S. authorities’ systematic effort to reassure/deceive us about vaccine safety.”

It’s also noteworthy to mention that, when it comes to vaccine injury In the United States, the Vaccine Injury Compensation Program (VICP)  has paid out more than $4 billion dollars due to vaccine injuries. Since 2015, the program has paid out an average total of $216 million to an average of 615 claimants each year. Furthermore, those injured by the COVID-19 vaccine won’t be eligible for compensation from the Vaccine Injury Compensation Program (VICP) while COVID is still an “emergency.”

lyson Kelvin, a virologist and assistant professor at Dalhousie University, who is currently working on COVID-19 vaccines with VIDO-InterVac, told Global News that “there’s a difference between “adverse events following immunization” and adverse events “directly related to a vaccine…Just because it’s an adverse event, doesn’t mean it’s directly related to the vaccine. It just means that it happened after someone got a vaccination… In Norway’s case, we’re talking about adverse events following immunization.”

Below is a screen shot from of the DATA:

When it comes to science and determining whether or not a vaccine is the direct cause of an injury, there doesn’t seem to be, in my opinion appropriate systems in place to investigate this. Furthermore, the VICP protects pharmaceutical companies from any liability with regards to vaccine injuries. Vaccines are a liability free product.

The scientific method in general is quick to point out that correlation does not mean causation, but again, in some cases correlation may actually mean causation. The Bradford Hill Criteria is one of the most cited concepts in health research and are still upheld as valid tools for aiding causal inference. You can look more into that too see how it all works if interested.

Another factor one must consider, also, is the politicization of science. Kamran Abbas is a doctor, recent former executive editor of the British Medical Journal, and the editor of the Bulletin of the World Health Organization. He has published an article about COVID-19, the suppression of science and the politicization of medicine, and the medical industrial complex.

Science is being suppressed for political and financial gain. Covid-19 has unleashed state corruption on a grand scale, and it is harmful to public health. Politicians and industry are responsible for this opportunistic embezzlement. So too are scientists and health experts. The pandemic has revealed how the medical-political complex can be manipulated in an emergency—a time when it is even more important to safeguard science…The UK’s pandemic response relies too heavily on scientists and other government appointees with worrying competing interests, including shareholdings in companies that manufacture covid-19 diagnostic tests, treatments, and vaccines.

According to Arnold Seymour Relman (1923-2014), Harvard professor of medicine and former Editor-in-Chief of The New England Medical Journal. 

“The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful.”

It’s no secret that vaccine hesitancy is quite high in some places when it comes to the COVID-19 vaccine, and with vaccines in general.  The Washington Post reported this week that nearly a third of military personnel are opting out of the vaccines, and ESPN reported that top NBA players are reluctant to promote the vaccine.

A survey conducted at Chicago’s Loretto Hospital shows that only 40 percent of healthcare workers will not take the COVID-19 vaccine once it’s available to them. Riverside County, California 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.

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.

Drene Keyes, described as a “gifted singer and grandmother of six,” found herself unable to breathe and began vomiting within a couple hours of being vaccinated, according to media reports. She was rushed to Riverside Tappahannock Hospital, where doctors administered an EpiPen, CPR and oxygen. Keyes’ daughter, Lisa Jones, told WKTR:  “They tried to remove fluid from her lungs. They called it ‘flash pulmonary edema,’ and doctors told me that it can be caused by anaphylaxis. The doctor told me that often during anaphylaxis, chemicals are released inside of a person’s body and can cause this to happen.”

Heidi Neckelmann, the wife of Dr. Gregory Michael from California, said that in her mind, her 56-year-old husband’s death was “100% linked” to the vaccine.  Now, at least one doctor has come forward publicly to say he also believes the vaccine caused Michael to develop acute idiopathic thrombocytopenic purpura (ITP), the disorder that killed him. According to the New York Times: “Dr. Jerry L. Spivak, an expert on blood disorders at Johns Hopkins University, who was not involved in Dr. Michael’s care, said that based on Ms. Neckelmann’s description, ‘I think it is a medical certainty that the vaccine was related.’“‘This is going to be very rare,’ said Dr. Spivak, an emeritus professor of medicine. But he added, ‘It happened and it could happen again.’

Heidi made a Facebook post about the incident:

The love of my life, my husband Gregory Michael MD an obstetrician that had his office in Mount Sinai Medical Center in Miami Beach Died the day before yesterday due to a strong reaction to the COVID vaccine. He was a very healthy 56 year old, loved by everyone in the community, delivered hundreds of healthy babies and worked tireless through the pandemic . He was vaccinated with the Pfizer vaccine at MSMC on December 18, 3 days later he saw a strong set of petechiae on his feet and hands which made him seek attention at the emergency room at MSMC…read the full post HERE.

Approximately one month ago, Norway registered a total of 29 deaths among people over the age of 75 who had their first COVID-19 vaccine. As a result, the country changed which groups to target in national inoculation programs.  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.”  Bloomberg Reported that the “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.” So, there seemed to be some conflicting information there as well, one piece of information stating that the vaccine was linked, and the other stating that it wasn’t, both from the same source.

Dr. Martin Kulldorff, professor of medicine at Harvard University, a biostatistician, and epidemiologist, Dr. Sunetra Gupta, professor at Oxford University, an epidemiologist with expertise in immunology, and Dr. Jay Bhattacharya, professor at Stanford University Medical School, a physician and epidemiologist were all the initiators of The Great Barrington Declaration. They recently announced that they are strongly in favour of voluntary COVID-19 vaccination.

It doesn’t seem like governments are going to mandate the vaccine. What instead seems to be the case is that private businesses and institutions may do so. For example, certain airlines may not allow people to travel unless they’ve had the shot. Some restaurant, entertainment facilities and other places of businesses might follow suit. Certain employers may require their employees to take the shot. All of this of course raises a number of legal and ethical concerns. We will just have to wait and see what happens. In all circumstances, I do believe the COVID vaccine should always remain voluntary, especially when it’s quite unclear if they can even reduce the risk of transmission and infection, and there does seem to be a number of concerns being raised with the vaccine.

Dr. Peter Doshi, an associate editor at the British Medical Journal published a piece in the Journal issuing a word of caution about the supposed “95% Effective” COVID vaccines from Pfizer and Moderna. You can access that here.

A few other papers have raised concerns as well, for example. A study published in October of 2020 in the International Journal of Clinical Practice states:

 COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.

In a new research article published in Microbiology & Infectious Diseases, veteran immunologist J. Bart Classen expresses similar concerns and writes that “RNA-based COVID vaccines have the potential to cause more disease than the epidemic of COVID-19.”

For decades, Classen has published papers exploring how vaccination can give rise to chronic conditions such as Type 1 and Type 2 diabetes — not right away, but three or four years down the road. In this latest paper, Classen warns that the RNA-based vaccine technology could create “new potential mechanisms” of vaccine adverse events that may take years to come to light.

Again, these are a few of multiple examples, I just wanted to provide some context. All of this warrants freedom of choice, does it not?

The Takeaway:  One thing that seems to be quite evident, in my opinion, is the fact that mainstream media and the “mainstream” in general is failing at having proper conversations around controversial topics, like vaccines, for example. Instead of using terms like “Anti-Vax conspiracy theorist, as well as ridicule, it would be great if mainstream media advocates actually addressed the concerns being raised by those who are concerned about vaccine safety and effectiveness. Should private institutions/companies have the right to mandate this vaccine for people and employees? When it comes to vaccines, should freedom of choice remain? Why is only one perspective presented by mainstream media?

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

Health

How Effective is The Covid-19 Vaccine?

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13 minute read

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?

Before you begin...

Coherent icon

Take a moment and breathe. Place your hand over your chest area, near your heart. Breathe slowly into the area for about a minute, focusing on a sense of ease entering your mind and body. Click here to learn why we suggest this.

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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