What are the risks and benefits of each vaccine?
The COVID-19 vaccines have provided a once-in-a-lifetime opportunity to answer this question
A Midwestern Doctor | The Forgotten Side of Medicine | April 5, 2023
A major problem I see throughout the scientific and political sphere is that people cannot maintain a perspective that allows them to see the whole picture; rather they tend to focus or fixate on things they have some type of emotional or subconscious priming to focus on (this has been an issue throughout history). This is why you can have someone be around an individual they like and they primarily register the one good thing the individual did (while ignoring all the bad things) and conversely why they will ignore all the good things another individual they don’t like is trying so hard to do and focus on the one bad thing that individual did.
This human tendency ends up becoming a huge problem because the media will emotionally condition the public to focus on the one side on an issue which favors its corporate sponsors. This in turn leads to these people getting up in arms about that one point when individuals who dissent against the corporate narrative try to highlight the issues that greatly outweigh any purported benefit of the narrative.
This is particularly common with complex issues (which are difficult to understand to begin with) and one of my longstanding frustrations has been that despite the harms of vaccines greatly outweighing their benefits, many of you can only register the danger of the (often insignificant disease) the vaccine allegedly protects against. In my eyes, one of the upsides about COVID-19 is that this selective reframing of reality and the media lies to maintain it went to such an extreme extent, much of the public became able to realize it was absurd and started taking the time to try and fully understand the subject.
One of the common questions I get from readers relates to another complex question—which vaccines are safe for their kids, and which ones are a bad idea? This is surprisingly difficult to answer because you must weigh the likelihood of an adverse event from a vaccination vs. the likelihood of suffering a complication from the disease that the vaccine would prevent you from getting and compute a figure that takes the weighted average of each into consideration.
In order make this determination, you need to consider all of the following:
Disease Risk
How likely is it for a person to get the disease?
Some diseases we vaccinate against are incredibly rare (e.g., tetanus).
How likely is the disease to cause a negligible, minor, moderate, severe, or fatal complication?
It is very important to distinguish between these categories because, for most infections, the risk of you catching it and then it becoming a severe condition is extremely low. For example, a Neisseria meningitidis infection (which can cause septic meningitis) is really bad and can progress very quickly, but also is very rare for people to develop (one in ten people are asymptomatic carriers whereas approximately one in a million get it a year).
How likely is it that the severity of the disease can be improved with an existing medical treatment?
Most of the infections we vaccinate against are very easy to treat. Unfortunately, the focus is always on vaccinating against the disease rather than providing treatment for it (especially if the treatment is something more unorthodox than an antibiotic). In the case of COVID-19, while severe complications represent the minority of cases, they (and the more minor ones) can in most cases easily be prevented by early outpatient treatment. Unfortunately, the Federal government has refused to disclose to the public what the effective treatments are for it (presumably because it would make it impossible to continue making money off COVID-19).
How likely is it that you will have access to the necessary treatment before you get seriously ill?
Although I dislike the vaccine approach, I have to acknowledge that this is one of the strongest arguments for it. For rapidly progressing diseases, for those in isolated areas, for those unable to recognize their need to seek medical care, and for those of limited economic means, they often cannot get the necessary treatment for the disease before it is too late to prevent a severe complication.
In general, it’s very rare that a vaccine-preventable disease has both a significant likelihood that you will get it and a significant likelihood that it will develop into a severe condition. Many of those believed to fall into this category are no longer an issue in the United States (e.g., polio or smallpox), regardless of whether or not you are vaccinated, but people who look at this question are often fixated on the past presentations of the disease when it was more pathogenic or when we did not have a way to treat it.
Vaccine Efficacy
How likely is the vaccine to be effective in preventing the disease, and do the presence of vaccine antibodies correlate with a decreased risk of the disease?
Many vaccines fail to do one or both of these. COVID-19 has provided the greatest red pill in history on this topic, especially since successive COVID-19 vaccines actually increase your risk of catching the disease.
How likely is the vaccine to be effective at preventing severe complications of the disease?
The human papillomavirus vaccine (which “prevents” cervical cancer) is an excellent example of a vaccine that does not live up to its promise to do so because it’s promise was based on a series of erroneous (and wishful) assumptions.
How long does the vaccine’s protection last following immunization?
Many vaccines suffer from the problem of declining immunity, hence needing repeated boosters to be given which re-expose the recipient to the risks of the vaccine. COVID-19 again has provided the greatest red pill in history on this topic, as the immunity from it wanes approximately 3 months after the most recent injection.
How likely will it be for the vaccine to prevent you from getting the disease when you need to be protected?
The hepatitis B vaccine is routinely given at birth, and then twice more very early in life. This is nonsensical for two reasons. First, at the time of birth, infants lack an immune system that can mount a proper antibody response to the vaccine. Second, hepatitis B is spread by blood-to-blood contact (e.g., sharing heroin needles or having unprotected sex), both things very unlikely to happen in childhood. This is important because the hepatitis B vaccine typically only lasts for around 6-7 years (estimates vary). The best explanation I have seen for why the vaccine is given immediately following birth (despite being completely unjustifiable) is that it habituates parents to come in for regular well child vaccination visits starting at two months.
How long does it take for the vaccine to create a selective pressure that causes the pathogen to no longer be covered by the vaccine?
This is a huge problem for any vaccine that “works”, because it rapidly creates selective pressure for variants not covered by the vaccine’s antigen. The only vaccines that do not suffer from this issue are the ones where the vaccine does not create selective pressures against the vaccine (e.g., the non-contagious tetanus bacteria toxin) and live attenuated vaccines since they contain so many different antigens [note: except for tuberculosis, all live attenuated vaccines are viruses]. Live attenuated vaccines, unfortunately, can cause infections of the vaccine strain in the immunocompromised host, and are frequently contaminated with other viruses that were present in the medium used to cultivate the virus.
Because this is a longstanding problem, many theorized that the COVID-19 vaccine (due to it only containing a single antigen in a rapidly mutating part of the spike protein) would rapidly trigger the production of more pathogenic variants. This is, of course, what happened soon after it hit the market.
Does the vaccine have other benefits besides preventing the disease?
Some live attenuated vaccines broadly stimulate the immune system. In third world countries with a high infectious disease burden, this actually saves lives (this has been shown with the measles-mumps-rubella vaccine [MMR] and the tuberculosis vaccine [BCG]) because the immune system is better able to fight off those otherwise fatal infections modern medical care is not available for.
Note: conversely, other vaccines like DPT, when studied were found to do the opposite and broadly increase the risk of death due to the immune suppression they create.
Population Immunity
Assuming that the vaccine “works”:
Does vaccination create a selective pressure for vaccine resistant variants to produce more or less dangerous variants?
With certain vaccines, the strains created by the selective pressure of the vaccine are more dangerous than those that preceded them, and they affect different age groups. This has primarily been shown with the childhood vaccines for bacterial infections.
Does developing a population-wide vaccine immunity to a disease improve or worsen the disease’s consequences?
Two of the best examples of this were the chickenpox vaccine and the measles vaccine (two relatively benign diseases in the era preceding vaccination due to a robust herd immunity).
If you get chickenpox as a child, it is benign, but if you get it as an adult, it can often give you a horrible (and sometimes recurrent) case of shingles. The CDC eagerly expected rolling out the chickenpox vaccine would decrease shingles, but the opposite instead happened (so they, of course, suppressed the data). The researcher who conducted those studies, with a good basis for doing so, theorized that this happened because the reduction of chickenpox in the population prevented people from having their immune response to it be periodically boosted by natural exposure.
In the case of measles, if there is no pre-existing immunity and poor living conditions (e.g., widespread vitamin A deficiency), the disease can be horrible (e.g. measles killed 10% of Native Americans it infected in one outbreak). In the past, infants received antibodies from their mother’s milk (the importance of breast feeding is discussed here), which provided them sufficient protection to build up permanent natural immunity once they were exposed to the virus. The population-wide herd immunity we used to have does not exist now, and periodic measles outbreaks still occur despite the majority of the population being vaccinated. Because we lack that immunity, many are vulnerable to measles, which is always addressed by vaccinating even more people for the disease.
Is there a benefit to developing the disease naturally that is prevented by vaccination?
One of the lesser known facts about diseases is that childhood infections are often critical for helping the immune system develop. A variety of diseases that are much more severe in adults than their corresponding “vaccine preventable” childhood infections are observed to result from not catching the disease in childhood. Some examples include:
-Not having a chickenpox infection increasing your risk of glioblastoma (a horrible brain cancer) later in life.
-Not having a mumps infection increasing your risk of ovarian cancer (one of the most deadly cancers for women).
Note: research substantiating these links and more can be found here.
Vaccinating While Infected
If you are already infected at the time you receive the vaccine, does this improve or worsen your response to the infection?
This was a major problem with the human papillomavirus (HPV) vaccine, as it was shown in the study data that Merck submitted to the FDA that if you had a pre-existing HPV-16 or -18 infections, your risk of developing a cancerous lesion was increased by 44.6% following vaccination. I also have now seen many things which suggest that getting a vaccine while you are infected with COVID-19 significantly worsens the infection.
If an existing infection worsens following vaccination, how practical is it to test for the infection prior to vaccination, and vaccinate at a later time?
As far as I know, a pre-existing infection is never tested for before vaccination. I presume that this is because public health authorities never want to do anything which might encourage vaccine hesitancy. This is particularly absurd with COVID-19 because we are continually passing out free tests and encouraging people to test multiple times per week…except when they are going to be vaccinated.
Vaccine Side Effects
How likely is the vaccine to cause a minor, moderate, severe, or fatal side effect?
One of the important things to understand about toxins is that their side effects distribute on a bell curve, which means that their side effects become increasingly rarer as they increase in severity. Although the severe reactions are the most noticeable (e.g., the rapid progression to lifelong autism or sudden infant death syndrome), less severe chronic complications are much more common, and in my opinion, create the greatest burden to society (this is very well illustrated by Edward Dowd’s figures below).
An explosion of chronic illness (particularly of neurological and autoimmune nature) in our society has paralleled the mass vaccination of society. This has been most apparent at three times in history: the period of the smallpox vaccines, after 1986 when Fauci passed legislation to shield manufacturers from liability for producing dangerous vaccines (which led to a rapid increase in the number of childhood vaccinations and no motivation to ensure their safety), and following the COVID-19 vaccines. In each case, we’ve tragically become acclimated to an increase in baseline levels of chronic illness which never existed in the past, and we have simply assumed that the current disease burden is normal, when in reality it is not.
Similarly, although the sudden deaths from the COVID-19 vaccine are tragic, many less severe but debilitating or disabling reactions are much more common.
How easy is it to recognize that these effects occurred?
Given how difficult it is to get doctors to acknowledge the most extreme reactions to a childhood vaccine, it should come as no surprise that the more subtle issues go mostly unrecognized or are dismissed (to the point that members of the societal orthodoxy commonly produce memes making fun of anti-vaxxers who blame their various health issues on vaccines).
One of the struggles I have experienced throughout my career in medicine is the fact that I can notice right away that a vaccine injury has occurred while sadly, most of my peers cannot. Most of the signs that scream out to me are rarely detected by my colleagues, and the symptoms either don’t register or they give some type of innocuous explanation for them (e.g., it’s a behavioral thing that requires an SSRI to treat—something I do not support). Furthermore, if I try to point them out, all it accomplishes is undermining my credibility.
This has been particularly fascinating to watch with COVID-19, as countless patients are all developing the same symptoms after vaccination, and yet most doctors ardently insist they have nothing to do with the vaccines. Fortunately, this does appear to be beginning to change, as the medical field’s eyes are opening up to the issue (largely because many healthcare workers have also been injured).
How consistent and safe is the vaccine’s manufacturing process?
Because vaccine manufacturers are exempt from liability for unsafe products they produce, many corners often end up getting cut with the production process so more money can be made by the manufacturer (to this point America’s facilities that make our vaccines have been plagued with production concerns such as potential contamination) the FDA has done almost nothing to address. Additionally, since many vaccines are grown in cell cultures, contamination from things already present in the cells (e.g., retroviruses) is inevitable, and some believe this is a key issue with the vaccines.
With the COVID-19 vaccines, it has been demonstrated that much less due diligence was done with producing the vaccines (likely due to Operation Warp Speed enabling this malfeasance) and as a result, there is immense variation in what is present in each vaccine. Presently, this is the best explanation I have found for why people react so differently to the vaccines and why “hot lots” exist.
Does the vaccine priming your immune system to target one pathogen reduce its ability to respond to other pathogens or cancerous cells within the body?
This is a frequent but underappreciated consequence of vaccination. As far as I know, the worst offender in this regard has been the COVID-19 vaccines, which have been linked to both an explosion of cancers and unusual diseases typically only seen in immune-suppressed individuals.
Does the vaccine impair circulation and cause microstrokes in the body?
I believe that this is one of the primary mechanisms of harm done by vaccines, and frequently what must be focused on when treating these patients (e.g., we have seen miraculous results for individuals with COVID-19 vaccine injuries who we treated with simple methods for addressing their zeta potential). As this is a complex but critically important subject to understand, I put together an article explaining it here, and a series explaining how it affects the body and how to treat it here.
Does the vaccine cause the immune system to attack the body and give rise to chronic illnesses?
All vaccines work by provoking the immune system to go into overdrive to attack the vaccine antigen that is present. The downside to this is that it typically also causes the immune system to attack other proteins in the vicinity (e.g., a mice study showed that mice develop allergies to pollen that is in the air at the time of their vaccination). Autoimmunity is especially likely to happen if the vaccine shares antigen sequences with human tissue (homologies) and contains a very strong adjuvant (the vaccine component which stimulates the immune system). Before the COVID-19 vaccines (which have a remarkable number of homologies with human tissue), Gardasil (the HPV vaccine) was the greatest offender here as it had to use a very strong adjuvant and had homologies to human tissue.
If a vaccine causes negative reactions, does the risk increase if multiple vaccines are given concurrently?
Everything I have seen has shown that the more vaccines that are given (especially if they are received at the same time), the more likely people are to develop a severe reaction to the vaccine. This, for example, is why Sudden Infant Death Syndrome has been correlated to receiving multiple vaccines simultaneously, why many parents have observed their child developing autism after multiple vaccinations, and why some doctors advocate for not following the CDC schedule and spacing out the required vaccinations.
Similarly, if the same vaccine is provided multiple times (especially if it has tissue homology) each successive time it is given, it is more likely to create an autoimmune condition. Although I have seen this with other vaccines, this effect has been by far the most dramatic with the COVID-19 vaccines because their risk of a severe adverse event increases significantly with each successive vaccination.
Although increased autoimmune priming likely plays a role, the best model I have to explain the cumulative toxicity with vaccines is largely due to them successively impairing the zeta potential of the body, which creates catastrophic consequences once a critical threshold is passed. Analogously, I often see the worst responses to vaccines in individuals who already have an impaired zeta potential and cannot tolerate the additional reduction created by one more vaccine.
Unfortunately, since vaccines are considered “safe and effective” their potential harms are never considered. This is why individuals who try to propose very simple measures that could greatly mitigate the harm of the vaccination schedule (like spacing out vaccines) are relentlessly attacked under the justification that “they are not following CDC guidelines” and thus creating vaccine hesitancy.
At this point, we have never had a study performed on the cumulative effects of children receiving the entire vaccine schedule. Anyone who tries to do so is attacked for unethically experimenting on children, since the placebo group (who are not vaccinated) are placed at a “great and unjustified” risk because they are being denied life-saving vaccines (for diseases they will never get).
Since these studies have thus far never been completed, a variety of less controlled ones (e.g., comparing vaccinated and unvaccinated children in the same medical practice) are published. While these studies show a massive number of complications arise from vaccination, they are typically dismissed as not being valid since they weren’t a controlled study, and in many cases, the authors are attacked (e.g., consider what happened to Paul Thomas). Similarly, I and many colleagues can often immediately recognize children who were never vaccinated (as they are healthier in the body, mind and spirit), yet the changes vaccination create have become so normalized in our society, most doctors now lack the ability to recognize the currently accepted baseline is not normal.
If the vaccines cause negative reactions, who is the most susceptible to them?
There is a huge variation in responses to vaccines. Typically, individuals who have had a bad reaction to a vaccine are more likely to have bad reactions in the future, and there are a variety of other signs that predict the likelihood of a bad reaction to vaccines (e.g., previous adverse reactions, pre-existing autoimmune conditions, poor physiologic zeta potential, genetic metabolic defects, having previously had the infection the vaccine is for).
Unfortunately, since vaccines are considered 100% safe, virtually nothing qualifies as an exemption to them (which California has used as a justification to revoke the licenses of anyone who writes exemptions, hence leading to it now being almost impossible to get vaccine exemptions there). To highlight the absurdity of it, I had a friend who had a documented anaphylactic reaction to the Moderna vaccine they had to go to ER for, and was simply told that they needed to get a different COVID vaccine. I have also heard of a case where someone hospitalized in a California ICU for a vaccine reactions and could not find a doctor in the state who was willing to write a medical exemption for their employer.
The Public Health Perspective
One of the largest issues with public health is that it does not see people as individuals, and instead uses theoretical constructs (that are often wrong) and applies them to the entire population. I believe that this is done because it is the most practical way for a centralized bureaucracy to affect the health of a large swath of people with whom it has no direct contact with.
This approach is a huge problem because many individuals behave differently from others (e.g., some derive no benefit from the intervention and some react poorly to the interventions). Unfortunately, for the centralized public health approach to work, the public’s diversity must be ignored, and dissent must be forcefully suppressed when members of the public complain.
Many issues in life I believe ultimately come down to people being lazy and taking the easy way out when addressing a complex problem. For example, in the recent series on SSRI antidepressants (this article and this article), one way the entire debacle could be summarized is that patients with mental health issues require a therapeutic relationship with a counselor who can help them navigate their issues, but this is far too time consuming for most doctors in practice.
Psychiatric medications offer an easy way out; you can just give the drug for the symptom, feel like you solved it, and not have to deal with the patient. Unfortunately, this often doesn’t work, and the medications make the patients worse. At this point, the choice to do one’s job properly or default to a lazy approach again comes up. The doctor can actively monitor the patient for adverse reactions to their drug and intervene before those effects are catastrophic, or gaslight the patient, tell the patient the drug works and just give them more of it or another drug. Most of the catastrophic events I’ve heard about from SSRI-injured patients happened because the doctors took the lazy approach to handle their issues.
Similarly with public health, if a contagious disease is present that the system believes needs to be addressed, there are two options:
• Adopt comprehensive public health measures that contain and mitigate the spread of the disease and encourage practices that increase the natural immunity of the population.
• Add a vaccine for it to the vaccine schedule and mandate it so everyone takes it.
Since the second approach takes much less work, it’s a foregone conclusion that it will happen. Similarly, since the approach will inevitably fail to prevent many people from catching the disease, excuses will be made for why this happens that ultimately boils down to “not enough vaccines were given.”
Likewise, it’s inevitable that injuries will occur from these campaigns (which often outweigh any benefit achieved by the vaccines). When this happens, those injuries are written off by the centralized public health administrators as “necessary collateral damage” for the greater good that the vaccine creates and system-wide policies will be adopted to conceal those injuries and gaslight the injured.
Typically, once it becomes clear that the vaccine is not completely “safe and effective” the justification provided to the public is that the vaccines create “herd immunity” to the disease, and that this benefit outweighs the negative consequences of the vaccine. Unfortunately, in most cases (for many of the reasons listed above) the vaccines do not create herd immunity and instead become a product the population needs to take indefinitely while the disease continues to persist.
Note: for those interested in this subject, I discussed how vaccines consistently fail to prevent disease transmission here, and how we watched this unfold with the COVID-19 vaccines here.
Which Vaccines Should Be Avoided?
For each vaccine, as we consider the risk of its disease, the efficacy of the vaccine, the effects of developing vaccine immunity within a population, the issues with vaccinating while infected, and vaccine side effects, it should become clear that this is an immensely complex question to answer. There are so many potential risks and benefits of different magnitudes that combining them into a weighted average borders on the impossible.
This helps to illustrate some of the major issues that arise when you provide an intervention with known harms as a preventative for a potential risk that may or may not happen (note: the same can also be said for statins). My own belief is that if a therapy has known harm, the benefit for it needs to be concrete (e.g., all antibiotics are to some extent toxic, but most would agree that toxicity is outweighed if someone has a dangerous infection the antibiotic will treat). In the case of vaccination, there are a few vaccines that can be given therapeutically (BcG, rabies, and ones made from the patient’s own serum) so that a clear discussion can be made about the relative risks and benefits of each, but that is not the case for virtually every other vaccine on the market.
Typically speaking, to analyze complex questions like this, we depend on large clinical trials. The problem with such trials is that since they are industry-funded, they always omit most of the adverse events that arise (e.g., they reclassify a severe event as something nebulous, they use a toxic placebo to mask the increase in adverse events seen amongst the vaccinated, or they only monitor subjects for a brief period of time, which is not long enough for most of the vaccine side effects to appear). Generally speaking, the only way to get around this issue is to assess the total number of people who die in each group (as there is no way to reclassify death), and when this metric is looked at in the trials for the worst vaccines (e.g., Gardasil or Pfizer’s COVID-19 vaccine) the total death rate is shown to be increased by vaccination.
The other option is to look at population statistics. Sadly, while these consistently show vaccines cause significant harm, public health officials tend to ignore this data.
When I approach this question I use the following algorithm, where each item takes precedence over the ones after it.
1. Does the vaccine have an unusually high degree of toxicity?
2. Does the vaccine potentially provide an important benefit?
3. Does the vaccine have other reasons to make me concerned about its potential side effects?
4. Does the vaccine actually work?
5. Does the vaccine still work?
I will now briefly discuss some of the vaccines on the current CDC schedule that I feel are the worst offenders.
First, let’s consider the HPV vaccine and the benefits it created by “preventing cervical cancer.”
While I have seen datasets (when stratified by age) showing Gardasil (and other HPV vaccines) actually increased the cervical cancer death rate in those vaccinated, I will give it the benefit of the doubt here. As the graph shows, cervical cancer rates were already approaching 0 before Gardasil, so it is difficult to say if any of the lives saved were due to it (at this point I believe the cancer prevention attributed to Gardasil is false).
Note: many other diseases whose decline was attributed to vaccination also actually had most of their decline occur prior to a vaccine being available.
However, assuming all lives were saved by Gardisil, in England, each year it has saved 6 lives per 100,000 (0.0006%) people, and in the United States, 2 lives per 100,000 (0.0002%) people. Conversely in the clinical trials, 133 per 100,000 (0.13%) participants died (in comparison, the average death rate at the time for those the same age as the trial participants was 43.7 per 100,000). This means, in the best case scenario for the vaccine, for 100,000 people you traded killing 89.3 of vaccine recipients in return for saving 2.
Even though this is terrible, the greater issue is that in the original HPV clinical trial, between 2.3% to 49% of the individuals who received Gardasil developed a new autoimmune condition. We do not know exactly where in that range the total number of new autoimmune disorders was, as Merck classified many autoimmune disorders simply as “new medical conditions” (industry trials always reclassify something they don’t want to show up in the final trial with vague labels like this), but other investigations have concluded the 2.3% figure significantly underestimated the rate of new autoimmune conditions.
So, in return for saving 2 lives per 100,000 people while killing 89.3, you are also giving 2300 (and likely many more) a new life-altering autoimmune condition. All in all, I would not say this represents the best risk-to-benefit ratio. Unfortunately, because Gardasil is so profitable, nothing has been done about this despite numerous red flags being set off and many petitions being made to the FDA to address it.
Diphtheria, Pertussis and Tetanus (DPT)
I am not a fan of the DPT vaccine for the following reasons:
• It is the vaccine most clearly linked to infant deaths (I summarized the extensive degree of evidence substantiating the link that has accumulated over the last century here).
• The vaccine frequently causes permanent brain damage (especially the older version of it). In addition to hearing this from many parents, this happened to two members of my extended family who received the slightly older and more toxic version of it.
• I believe it is one of the primary causes of childhood ear infections (one of the most common complaints parents see their pediatricians for). Many doctors have observed this link, and the best example I heard of came from a doctor and medical missionary who decided to vaccinate an ashram (Indian temple) he was staying in. Before the vaccines, ear infections were non-existent, immediately afterward a large number of children came down with them.
Conversely, I believe the benefit is minimal because:
• The vaccine does not prevent the colonization of any of these bacteria. This is why pertussis outbreaks occur in fully vaccinated populations.
• Diphtheria is now non-existent in the United States, so there is no reason to vaccinate against it (additionally it can be treated with modern antibiotics).
• Tetanus is now very rare (there are approximately 30 cases a year) and it’s actually difficult to say how much the vaccine antibodies protect a person from tetanus (studies have shown that the vaccine produced antitoxin does not prevent tetanus).
Note: it is impossible to get a vaccine that is only for tetanus. Anyone who tells you otherwise is lying. For example, I’ve had multiple family members who went to the ER for a laceration, were told they needed to get a tetanus vaccine, agreed to on the condition it only had tetanus, but not diphtheria or pertussis, and when I reviewed their medical records, they had received the DPT vaccine.
Hepatitis B
As stated above, I do not believe childhood hepatitis B vaccines can be justified. Additionally, the vaccine does create complications and has been repeatedly associated with neuromuscular autoimmune conditions. I believe that this is most likely due to the fact that the antigen used shares a homology with myelin (the coating of nerves), but it may be for other reasons as well.
In adults who are at risk of a hepatitis B infection (e.g., healthcare workers who can accidentally get poked with infected needles), there is a stronger justification for this practice. I do not know how reliable my approach to this problem has been, but each time I have been exposed to potentially infected fluids (including from a hepatitis patient), I avoided the medications and vaccinations offered to me and instead immediately got an ozone or ultraviolet blood irradiation treatment. I am not sure if that was necessary, but I have never developed one of those infections.
In the most memorable instance, my team worked with a patient who exposed many of us to his fluids, and after a preliminary HIV test came back positive, everyone was given antiretroviral medications. I declined them (which everyone made fun of me for) since I knew they were dangerous and I thought it was extremely unlikely he had infected any of us. Later, a few of the healthcare workers told me they had experienced significant complications from the antiretrovirals, which they thought might have been the early stages of HIV, and later still we were told that the test the patient had gave a false positive and he did not, in fact, have HIV.
Measles, Mumps, Rubella (MMR)
As discussed above, it is a bit of a debate if the MMR vaccine decreases measles rates, since while regular vaccination does reduce measles rates, permanent immunity to it disappears within the population, and outbreaks will still occur within the vaccinated population. Sadder still, deaths from measles had almost completely disappeared at the time the vaccine for it was introduced (so there was essentially no justification for introducing it), and in effect by creating the vaccine we turned a non-existent problem into a permanent one by doing so. From my perspective, the greatest problem with the MMR vaccine is its frequent association with autism, something I believe is much worse than developing measles and something you are at a much higher risk for than the infection itself.
Polio
Two types of polio vaccines exist. The inactivated polio vaccine (currently used in the USA) and the live attenuated one (frequently used in poorer nations). The inactivated one does not prevent you from catching polio, but does to some extent (I don’t know how to calculate the exact figure) prevent a polio infection from causing polio-like paralysis. Since it does not prevent infection, it has no effect on transmission. The live polio vaccine does prevent you from becoming infected with polio, but has the unfortunate side effect of sometimes causing polio in the recipient and spreading the weakened polio virus into the environment.
At this point, the polio virus is mostly extinct, and from 2017 onwards, more cases of polio have resulted from the vaccine than polio itself (note: one of my friend’s relatives developed polio from the vaccine). One of the most tragic examples occurred in India where Bill Gates diverted their health budget to aggressively vaccinating against polio, which resulted in 491,000 children developing a “polio-like” illness.
Given that there is no reason to vaccinate against polio, there is no benefit to outweigh the vaccine’s risks. The risk from this vaccine is harder to quantify as I have met many people who have had bad reactions to it, but they did not have a consistent pattern to the injuries (which I often see with other vaccines).
Influenza
There is presently no evidence that the (often mandated) influenza vaccine prevents an individual from getting the flu (which, in most cases, is a relatively benign infection) or transmitting it to others. Additionally, there is evidence that the vaccine increases your likelihood of developing a severe case of influenza and developing influenza in the subsequent year. Furthermore, many individuals have developed injuries from the influenza vaccine.
Meningococcal
Initially, due to the severity of a Neisseria meningitidis infection, I initially thought the meningococcal vaccine would probably be a vaccine you could make a strong case for. Unfortunately, there are multiple dangerous strains of this bacteria, and one of those strains (strain B) is very difficult to make a vaccine for, since it has homology with tissue of the human body.
Not surprisingly, this has created a selective pressure on the bacteria and now the majority of infections are caused by strain B, which until recently, the scheduled vaccine did not cover (and at this point I am unsure how effective this newer vaccine is). Furthermore, as discussed above, many people carry this bacteria and are asymptomatic—the infection is very rare and the primary group at risk are those with pre-existing susceptibilities, not the general population.
Conversely, the vaccine has a variety of potential autoimmune complications. By far the most common one I encounter is that it causes Crohn’s disease (typically a few months after vaccination), and I think this side effect alone outweighs any potential benefits from the vaccine.
For those wishing to learn more about this subject, I would suggest reading this article on why vaccines consistently fail to create herd immunity, Miller’s Review of Critical Vaccine Studies (especially in regard to the HiB and Pneumococcal vaccines), and the textbook Vaccines and Autoimmunity. Peter Gøtzsche (one of my heroes) has also written a good review of the evidence surrounding the vaccines, Vaccines: Truth, Lies, and Controversy, which highlights many issues with them but also has the typical pro-vaccine bias and contains certain conclusions I do not agree with (but makes it an excellent book for opening the eyes of more conventional physicians). Finally, Turtles All The Way Down also does a deeper dive on many of these vaccines.
Pneumococcal and Haemophilus influenzae type B (HiB)
These two are probably the most difficult routine vaccines to have a clear-cut position on. This is because:
• These two infections, especially HiB are the vaccine-preventable illnesses that are the most likely to cause severe complications in children. For example, when the HiB vaccine came out, pediatricians around the country noticed a significant decline in the rates of infants with meningitis, which is a big deal. Similarly, in modern-day pediatrics, many of the most common concerning infections doctors encounter are pneumococcal.
• Although these vaccines have adverse effects, they are not as dangerous as those of many other vaccines.
• Because these vaccines work but target an easily mutable part of the bacteria, their adoption triggers their target bacteria to mutate, become resistant to the vaccines, and, in some cases, affect different populations. For example, the pneumococcal vaccine is continually being updated and re-released, with additional strains being covered in each successive version (and I’ve seen multiple vaccinated children with potentially life-threatening pneumococcal infections who had been vaccinated). In the case of the HiB vaccine, it selected for the A strain (HiA), which in some areas was more deadly than HiB, and also selected for strains that affected adults (typically HiB only affects children), leading to severe HiB infections becoming a disease of adults and the elderly.
Note: studies supporting the contentions in this section can be found within this excellent book.
The Risks and Benefits of the COVID Vaccines
Although many tragic things have happened with the COVID-19 vaccines, the circumstances around them have also made it possible to shed light on the actual risks and benefits of a vaccine, a topic that is typically far too obfuscated for anyone to make sense of. The clarity this time around is primarily because:
• The novel vaccines were rapidly rolled out onto the entire population at the start of 2021. This makes it possible to compare numerous existing yearly trends to before and after the deployment of the COVID vaccines.
• A lot of people strongly objected to how the vaccines were pushed onto the population, and did a lot of work to prove that the risks from these vaccines greatly outweighed their benefits in almost every aspect that was examined.
For example, many people are aware of this dataset:
Recently two things became available, which I believe help to clearly illustrate the poor risk-to-benefit ratio of the COVID-19 vaccines.
Rasmussen Reports
The first was a recent poll from Rasmussen Reports. Before discussing it, I would like to share the results from two of their prior polls on this issue:
Both of these reports serve to highlight that the damage from the COVID vaccines is on a scale that the general public is fully aware of, despite the massive amounts of propaganda telling them otherwise. Let’s now look at Rasmussen’s recent results:
There are a few important takeaways from these polls:
• Although Democrats tend to believe that the COVID virus is dangerous and that vaccines are safe relative to Republicans, they have now seen so much evidence to the contrary that the gap between them is much smaller. This is especially true for the vaccine deaths, which will likely have immense political repercussions for the party that forced them on America.[
• In the public’s perception, the same number of people have died from COVID-19 as from the vaccines. Given that many of the COVID-19 deaths occurred before the vaccines, many of those deaths were not actually due to COVID-19, and that the vaccines do not offer complete protection against COVID-19, this is a strong argument that the benefits of the vaccines do not outweigh their risks, especially when you factor in their much more common complications which disable but do not kill the recipient.
• Many respondents likely did not understand what “household” meant (and likely instead interpreted it to just mean someone they knew). This is because nowhere near 11% of US households have had a COVID-19 or vaccine death in them.
Note: Many people disparage Rasmussen and claim they have a right-wing bias. I, however, consider them to be one of the most accurate political polling firms in the country.
Edward Dowd has taken an innovative approach to red-pilling the public—showing the financial costs of the vaccine program for the country and making people feel like chumps for investing in fields that are being adversely affected by those costs. Since everyone can relate to money, this makes the concept much easier for individuals to grasp, and more importantly, since money is the most important thing to the upper class, they are likely to be motivated to act against the vaccination program in order to protect their assets.
Dowd has assembled a team of experienced analysts that has done a lot of work to calculate the costs of the vaccine program. Recently they released a report which speaks for itself:
When I reviewed Dowd’s report, I realized that there were a lot of issues that I know have human and economic costs that it was not counting, presumably since they are impossible to calculate. This means he had to underestimate the harms that have been caused by the vaccine program.
Because things like this are so difficult to estimate, you have to err on the conservative side and avoid claiming things you cannot quantify or are unsure of. Similarly, I have the same experience each time I write an article here, and do not mention a lot of things I am passionate about after I realize I can’t actually back them up.
These recent publications (and the datasets that Dowd’s estimate is based upon) show clearly and unambiguously that the risks of the COVID vaccines greatly outweigh any possible benefit they might have. Given that much of the country is beginning to see this now, it will be very interesting to see how this issue unfolds in the coming years as our institutions struggle to rebuild the trust they spent decades creating in America. My hope is that this process will allow us to also critically examine the entire vaccine program, which has by and large enjoyed complete immunity to scrutiny, due to both the difficulty in comprehensively assessing it and our institutions’s adamant protection of them.
One of the themes of my articles here has been to discuss the progressively evolving pleas for COVID amnesty, which in the space of slightly under a year have gone from “the experts were wrong, but you should still trust them rather than your gut” to “America’s COVID-19 response was based on lies.” Recently, the author of one plea (I did not completely agree with) posted something I felt made an excellent conclusion to this article.
At this point, I believe that all vaccines can cause harm frequently enough that the harm must always be considered when evaluating the vaccine. For this reason, I always feel very torn on what to do when people ask me to provide them with a way to protect themselves from the harms of a vaccine they have to get (note: the two best approaches I know of are taking a lot of vitamin C beforehand, and doing whatever you can to strengthen your zeta potential).
This is because regardless of what you do, you will still always have patients who are harmed by taking the vaccine, and I hate being complicit in what happens. To this point, I have had times where I repeatedly warned a patient against vaccinating where I felt they were at risk of an adverse reaction, and they had one anyway, and then they suffered a permanent complication and I was left having to try to help them get better.
I also believe that natural immunity is always superior to vaccine immunity. For this reason, I believe that the correct approach to handling almost all diseases you can vaccinate against is to accept the inherent risk of getting it as an unvaccinated individual and be familiar with what treatment protocol you need to implement if you got the infection so that you can clear the infection and develop natural immunity. Just imagine how different the world would be now if we had followed that approach instead of suppressing every single treatment for COVID-19 and mandating a deadly and ineffective vaccination on the population.
‘Sad Day for Babies and Mums’: FDA Panel Recommends Pfizer’s RSV Vaccine for Pregnant Women
By Michael Nevradakis, Ph.D. | The Defender | May 19, 2023
Advisers to the U.S. Food and Drug Administration (FDA) on Thursday recommended, by a vote of 10 to 4, that the agency approve Pfizer’s respiratory syncytial virus (RSV) vaccine for pregnant women, despite questions about the vaccine’s safety.
During Thursday’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, committee members and medical experts raised concerns about premature births identified during Pfizer’s clinical trials.
The FDA is expected to issue a final decision on the vaccine in August. If approved, it would become the first RSV vaccine authorized for pregnant women.
The Centers for Disease Control and Prevention (CDC) must “sign off” on Pfizer’s vaccine for pregnant women prior to it becoming available to the public.
According to Axios, the CDC’s immunization advisory committee is likely to discuss FDA-approved RSV vaccines during its June meeting.
Dr. Meryl Nass, an internist, biological warfare epidemiologist and member of the Children’s Health Defense (CHD) scientific advisory committee, told The Defender that while the FDA is not obliged to follow the recommendations of its advisory committees, “it almost always does so.”
The appeal of a maternal vaccine like Pfizer’s is “the way it would create neutralizing antibodies in pregnant women that can be transferred to infants in the womb,” Axios reported.
However, “there are health risks, including preterm births,” Axios added, noting that GlaxoSmithKline Biologicals’ (GSK) recently halted its trial of a similar RSV vaccine for infants. According to NBC News, the GSK vaccine “showed a higher preterm birth rate among some vaccine recipients.”
Commenting on the FDA’s recommendation of Pfizer’s RSV vaccine, Dr. Peter McCullough, a cardiologist, told The Defender :
“This product represents an unprecedented attempt to vaccinate mothers for no benefit to them and only theoretical efficacy in babies. In the trial, less than 2% of infants at any time point contracted RSV, which is easily treatable with nebulizers.
“Pregnancies should not be threatened with novel vaccines for uncommon and low-risk infantile illnesses.
“Widespread use of this reactogenic vaccine can be expected to cause fetal loss in some unfortunate women. A single case of pregnancy termination would not be worth the population being vaccinated.”
The positive recommendation from the VRBPAC comes two weeks after the FDA approved Arexvy, the first vaccine authorized for RSV. That vaccine, produced by GSK, is intended for adults 60 years of age and older.
It also comes as Pfizer is expecting an FDA decision later this month for its RSV vaccine for adults 60 and over, with the same formulation as the one for pregnant women. The VRBPAC recommended the vaccine for this age group in February.
Pfizer is also “evaluating how its shot performs in other age groups,” Axios reported.
‘A sad day for babies and mums’
According to CNBC, Pfizer’s RSV vaccine, marketed as Abrysvo, will be administered as a single dose to pregnant women in their second or third trimester.
NBC News reported that the shot would be given to pregnant women at 24 to 36 weeks gestation and that the “protective antibodies transfer to infants through the placenta.”
The FDA advisory panel found that data from Abrysvo’s clinical trial “supports the safety of the vaccine” for pregnant women, while the same panel voted unanimously “that available data supported the vaccine’s efficacy for giving the shot to women in their second or third trimesters of pregnancy.”
An FDA briefing document said safety data from Abrysvo clinical trials was “generally favorable.”
According to the trial data, Abrysvo “had an 81.7% efficacy at protecting newborns in the first three months of life against severe illness and a 69.4% efficacy through the first six months,” Axios reported.
The trial consisted of nearly 7,400 participants, according to NBC News, adding that Abrysvo “also lowered the risk of developing respiratory disease from RSV that required doctors’ visits by 51% within about six months.”
“After that, however, the vaccine didn’t appear to make a big difference,” according to the NBC News report, which also reported that “a slightly higher rate of preterm births — defined as before 37 weeks’ gestation — among people who received the vaccine (5.7%) versus those who got a placebo (4.7%)” was identified.
“The difference wasn’t statistically significant, however, so it’s unclear whether it was vaccine-related,” NBC News added. CNBC reported that both percentages were below the overall percentage for preterm births in the general population (10%).
According to CNBC, the clinical trial for Abrysvo “reported 18 peripartum fetal deaths.”
However, the FDA said these deaths were “unlikely” to be related to the shot. According to Axios, “The fetal deaths present in the vaccine group (0.3%) were not related to Pfizer’s vaccine … Similarly, 4 out of 5 infant deaths were considered unrelated to the shot, with one being possibly connected to the shot, although that remains unclear.”
Data reported by Pfizer to the CDC indicated that 14% of pregnant women who participated in Pfizer’s trial sustained an adverse event, with 4.2% sustaining a “serious” adverse event, 1.7% experiencing a “severe” adverse event and 0.5% suffering a “life-threatening” adverse event.
Similarly, the same data showed that 37.1% of infants whose mothers received the experimental Pfizer vaccine experienced adverse events within one month of birth — with 15.5% classified as “serious,” 4.5% as “severe” and 1% as “life-threatening,” while efficacy waned within months of vaccination.
According to the National Vaccine Information Center (NVIC), “The RSV clinical trial data also included the death of one pregnant woman, 18 stillbirths (10 in vaccinated pregnant women and eight in unvaccinated pregnant women), and 17 infant deaths (five from the vaccinated pregnancy group and 12 in unvaccinated pregnancy group).”
Attorney, journalist and podcaster Daniel Horowitz, in an article published Monday in the Conservative Review, quoted Phase 2 trial data for Abrysvo. He wrote: “Pfizer reported 3 out of 116 (2.6%) premature births in the placebo group and 6 out of 114 (5.3%) in the group that received the vaccine that was chosen as Pfizer’s final product,” adding that Pfizer “was studying preterm birth as an ‘adverse event of special interest.’”
According to NBC News, “The most common side effects of the shot reported among pregnant women were fatigue, headache, muscle pain and injection site pain.”
Nass told The Defender there were essentially three problems with the Abrysvo clinical trial data, “two of which were identified by Pfizer and the FDA.” She said:
“There were about 20% more preterm babies and low birth weight babies in the group, whose mothers had been vaccinated versus the group whose mothers had received a placebo. This was very concerning but was disregarded by most of the committee.
“It was unclear to me whether Pfizer had collected enough information on the health of the pregnant women after vaccination. It is hard to tell when you were studying, newborns and babies, whether they have had a side effect from their mothers’ vaccination. The children weren’t studied for long enough to compare their intellectual ability or other parameters.”
The third problem reflected concerns arising from the problems GSK’s candidate vaccine for pregnant women encountered, Nass said. However, “the FDA claimed the GSK clinical trial data were proprietary, and they were unable to provide them,” even though it was pointed out that these findings had been published and were in the public domain.”
“No one questioned the veracity of the data Pfizer presented, despite the fact that Pfizer repeatedly presented data on its COVID vaccine efficacy to this committee that made the vaccines appear much more efficacious than they turned out to be,” Nass said.
McCullough, writing on his Substack, also questioned the Abrysvo clinical trial data. “Pfizer has aggressively advanced RCTs [randomized controlled trials] into the pregnant population with no assurances on long term outcomes. There is no direct benefit to the mothers.”
“Furthermore, the sponsors moved the goal posts to make it easier to have a successful trial. We should demand long-term safety, high efficacy … and at least one year of durability, for such a rare and easy-to-treat condition in babies,” he added.
Calls for ‘tougher scrutiny’ of the RSV vaccine ignored
Some health experts called for “tougher scrutiny” of Abrysvo leading up to Thursday’s VRBPAC meeting, Axios reported, “after trials for GlaxoSmithKline halted trial for a similar shot over increased risks of preterm births and neonatal deaths.”
“Pfizer has not reported similar safety concerns, but some health experts told the British Medical Journal [BMJ] that they hope FDA staff will take the GlaxoSmithKline results into consideration when reviewing the vaccine,” according to Axios.
“Results have raised concerns about a possible increase in preterm births, and experts are calling for further analyses of the data and for post-approval monitoring of the vaccine, should the FDA approve it,” The BMJ analysis stated.
Horowitz said the “formulations of most of these shots are likely very similar, so red flags from one cohort of the study should inform us on the problems with the other.”
According to Nass, who live-blogged the meeting, one VRBPAC member, Dr. Henry H. Bernstein, a professor of pediatrics at Hofstra University, said during the meeting “he does not want another rotavirus vaccine repeat, in which the signal was known when licensed, but was not statistically significant.”
The rotavirus vaccine was pulled within one year because of intussusception, she said. Intussusception is a life-threatening illness that occurs when a portion of the intestine folds like a telescope, with one segment slipping inside another segment. This causes an obstruction, preventing the passage of food that is being digested through the intestine.
Dr. Paul Offit, a pediatrician at Children’s Hospital of Philadelphia and VRBPAC panelist, was quoted by CNBC as saying that the problems with GSK’s trial are “hanging over” Pfizer’s RSV shot for pregnant women and infants.
“If GSK truly abandons a program on a similar, almost identical vaccine, that is going to hang over [Pfizer’s] program. I think it needs to be addressed,” Offit added.
Offit separately told Reuters “I worry that if preterm births are in any way a consequence of this vaccine that would be tragic in many ways.”
Science magazine quoted FDA medical officer Dr. Yugenia Hong-Nguyen, who said the rate of premature births was “not statistically significant and lower than background incidence rates in the general population.”
Other VRBPAC members were less concerned. Dr. Daniel Feikin, a Johns Hopkins University epidemiologist and “temporary voting member”, said, “I’m not convinced that there’s a clear causal relationship between this vaccine and preterm birth,” Reuters reported.
Another VRBPAC panelist, Dr. Jay Portnoy, a pediatrics professor at the University of Missouri-Kansas City, said, “If the vaccine actually lives up to the data that we’ve seen today, I can guarantee that many infants and their parents will breathe easier in the coming years.”
Pfizer representatives also sought to downplay concerns with Abrysvo. According to CNBC, Dr. William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, said, “Certainly in our eyes, there is no definitive evidence to suggest that there is a risk of prematurity.”
“So, the question is, do you hold hostage the potential benefits of the vaccine for something which you have no statistical significance at this point?”
Dr. Anthony Fauci also raised concerns about vaccines for respiratory illnesses, Horowitz wrote in a May 4 article. A paper co-authored by Fauci and published in January in Cell Host & Microbe stated that the challenges for RSV and flu vaccines were “many and complex” and that RSV vaccines were not good at providing immunity.
In a November 2022 episode of “RFK Jr. The Defender” podcast, Robert F. Kennedy Jr., then-chairman and chief litigation counsel for CHD (now chairman on leave), described RSV as “a vehicle for re-implementing the COVID-19 playbook all over the country and responding with vaccines.”
Nass characterized Thursday’s VRBPAC approval of Abrysvo as “a sad day for babies and mums,” adding, “Is there a reason to trust Pfizer’s data on its RSV vaccine, when we could not trust its COVID vaccines?”
“Currently, pregnant women are advised (not by me!) to get the flu, TdaP [tetanus-diphtheria-pertussis] and COVID vaccines during pregnancy. This would be a fourth pregnancy vaccine,” Nass wrote.
Nass said Thursday’s VRBPAC meeting was held with four temporary members.
“Did FDA stuff the meeting with four new temporary members in order to get the majority yes votes it wanted?” Nass asked.
Horowitz noted in his article published Monday that Pfizer vaccines have previously been approved despite concerns about their impact on pregnant women, citing trial data from the Pfizer-BioNTech COVID-19 vaccine.
Pfizer seeks to ‘offset declining revenue from its COVID-19 products’
According to Reuters, “Pfizer is counting on new medicines and vaccines to help offset declining revenue from its COVID-19 products,” noting that the market for RSV vaccines is expected to surpass $10 billion by 2030 and that Pfizer is “ready to launch” its RSV vaccines for both pregnant women and older adults “later this year.”
Pfizer CEO Albert Bourla said he expects increased revenue for the company in the coming years from the company’s RSV and flu shots.
On her Substack, Nass noted:
“As a consequence of the 21st Century Cures Act of 2016, all vaccines recommended by CDC for pregnant women have all manufacturer liability waived, and are placed in the national vaccine injury compensation program. This improves profitability and may result in mandates.”
Several other Big Pharma drugmakers are now clamoring to enter the potentially lucrative RSV vaccine market, after decades of failed attempts to develop a vaccine.
Moderna is developing an mRNA RSV vaccine for older adults. According to Axios, it “was found to be 83.7% effective in preventing RSV with one or two more symptoms” and “The company plans to apply for FDA approval this quarter.”
According to Horowitz, Moderna’s candidate vaccine “openly shows 200 adverse events and 10 serious ones per mild case [of RSV] avoided.”
Bavarian Nordic, known for its development of a vaccine in response to last year’s monkeypox outbreak, is also developing an RSV vaccine for adults 60 and over,” expecting to release Phase 3 clinical trial data by midyear.
AstraZeneca and Sanofi also are seeking FDA approval for a monoclonal antibody treatment for RSV that would be administered to infants and toddlers up to age 2. Sanofi says the antibody, nirsevimab, was found to be 83.2% effective in reducing RSV-related hospitalizations.
However, the NVIC reported that the effectiveness of nirsevimab “is not known beyond 150 days” and it is unclear if the drug prevents ICU stays or deaths.
In all, “Eleven RSV vaccines (including GSK’s approved shot) are being actively studied in U.S. trials,” NBC News reported. “Six are for older adults, and five are designed to protect infants or children.”
Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
How Fauci, scientists with ties to Wuhan lab persuaded the intelligence community COVID had a natural origin
By Emily Kopp | U.S. Right to Know | May 16, 2023
Scientists with connections to the Wuhan Institute of Virology — including Anthony Fauci — steered the U.S. national security state away from hypotheses about the origins of COVID-19 that could implicate their research, emails obtained through the Freedom of Information Act show.
Their sphere of influence spanned the intelligence community and the White House.
On February 3, 2020, scientists tied to high risk coronavirus research in Wuhan joined a call with national security officials about how to uncover how an exceptionally infectious virus had emerged from that city.
The call included officials with the Federal Bureau of Investigation, the Office of the Director of National Intelligence and the White House’s Office of Science and Technology Policy, an email obtained by U.S. Right to Know shows.
The intelligence community’s premature assessment that COVID-19 was a natural virus has in turn been wielded by Fauci and by other virologists to minimize the lab leak theory.
The call shows the apparent power of a small clique of scientists to cloud the public’s understanding of the pandemic.
The Wuhan Institute of Virology’s two closest collaborators, EcoHealth Alliance President Peter Daszak and University of North Carolina virologist Ralph Baric, were on the call.
Daszak runs the intermediary organization that shepherded funds from the National Institutes of Health to the Wuhan lab complex.
Baric is a coronavirologist who innovated engineering techniques and applied them to viruses prospected in the wild by the Wuhan lab. Baric — despite developing undetectable genetic engineering methods nicknamed “no see ‘um” after the barely perceptible flies found in the Southeast — apparently helped persuade the intelligence community that the novel virus betrayed no signs of engineering.
Facilitated by the National Academies of Sciences, Engineering, and Medicine, the purpose of the Feb. 3 call was to respond to “misinformation.”
“Thank you for participating in today’s meeting of experts to discuss and identify what data, information and samples are needed to understand the evolutionary origins of 2019-nCoV and more effectively respond to the outbreak and resulting misinformation,” wrote Andrew Pope, director of the board on health sciences policy for the National Academies.
Fauci briefed the group on “NIAID’s perspective,” the agenda shows. Fauci’s National Institute of Allergy and Infectious Diseases, or NIAID, had underwritten Daszak and Baric’s work.
The agenda shows that the Feb. 3 call was prompted in part by a flawed and ultimately withdrawn preprint alleging similarities between the genome of SARS-CoV-2 and HIV, which had set off alarm bells in the infectious diseases community.
It’s also clear that rumors about the Wuhan Institute of Virology had already begun swirling on Chinese social media.
The discussion was co-led by Fauci, director of the White House’s Office of Science and Technology Policy Kelvin Droegemeier, and Chris Hassell, who in addition to serving as senior science advisor to the Department of Health and Human Services also serves as the chair of the secret committee that oversees gain-of-function research with pandemic potential.
Contemporaneous emails show that Fauci was discussing the apparent connections between NIAID and gain-of-function research in Wuhan with his boss, NIH Director Francis Collins. Fauci was routinely meeting with top national security officials at that time, including in the White House Situation Room, his schedule shows.
Two days prior, Fauci and Collins had discussed the matter with a small group of virologists in a confidential call. Those virologists went on to write a highly influential letter which prompted news organizations around the world to prematurely dismiss the lab leak hypothesis as a conspiracy theory.
One of those virologists, Kristian Andersen with Scripps Research Institute, also participated in the Feb. 3 call.
Emails previously reported by U.S. Right to Know show that Andersen dismissed the idea of an engineered virus to the National Academies group as “crackpot.” Yet days later he insisted in a separate email that the scientific evidence was not conclusive enough to have high confidence in either the natural or lab hypotheses.
Congress is investigating the matter.
Despite the complexity of the question at hand, the National Academies group had wrapped up its work within a few days.
The letter that resulted from the Feb. 3 call from the National Academies to the White House’s Office of Science and Technology Policy assumed a natural origin.
The possibility of the virus emanating from research — which scientific organizations and U.S. intelligence elements now believe to be possible — was subsequently dismissed, according to Daszak.
Daszak seemed to think that this National Academies letter – together with the letter coauthored by Andersen – were enough to dissuade the White House from exploring a possible lab origin.
“I don’t think this [National Academies] committee will be getting into the lab release or bioengineering hypothesis again any time soon — White House seems to be satisfied with the earlier meeting, paper in Nature and general comments within [the] scientific community,” Daszak told Baric.
State Department intelligence unit
A few weeks later, Baric may have briefed the State Department’s analysts, another email shows.
Baric’s gain-of-function research was at the center of speculation about a possible lab origin.
Baric’s research had privately alarmed Fauci and Andersen. Fauci met with Baric nine days after the Feb. 3 call, Fauci’s schedule shows. They discussed “chimeras,” or engineered viruses, according to virologists close to Baric.
Yet emails obtained from the State Department appear to show that Baric was asked to brief the State Department’s Bureau of Intelligence and Research about the pandemic’s possible origins.
The briefing coincided with the premature letter “debunking” the idea that SARS-CoV-2 was engineered coauthored by Andersen, which published on March 17.
Baric apparently received several emails inviting him to participate in an “analytic exchange” between March 23 and March 25.
The Bureau of Intelligence and Research briefing occurred on March 26.
“U.S. scientists say available genomic evidence shows that the SARS-CoV-2 virus probably emerged naturally in an animal before crossing to humans and was not engineered in a lab,” the write-up of the briefing read.
Baric’s apparent inclusion on the call is remarkable because he innovated viral engineering techniques that do not reveal any scars or signs of engineering.
David Feith, former U.S. Deputy Assistant Secretary of State for East Asian and Pacific Affairs, said in sworn testimony to Congress last month that concerns about conflicts of interest skewing the briefing were valid, but that he was precluded from naming which virologists participated.
Feith said that the experts on the call stressed the “good quality” and “robust biosafety and biosecurity programs” of China’s virology labs.
Baric would later express concerns about coronavirus gain-of-function research occurring in BSL-2 conditions at the Wuhan Institute of Virology, lower than the BSL-4 conditions required for the most dangerous pathogens.
Feith described the State Department call as “diversionary” in his Congressional testimony.
“Officials and experts who could have helped equip their colleagues (and the public) with the appropriate background to understand a novel and grave situation and weigh probabilities accordingly instead overwhelmingly deflected and denied,” Feith said.
Red Dawn
Baric prematurely assured leading infectious diseases experts that COVID could not have been engineered through more informal channels as well.
The “Red Dawn” email chain in early 2020 consisted of speculation about the unfolding pandemic and included active and former officials from across several departments and agencies, including HHS, CDC, the Department of Homeland Security, the Veterans Affairs Department and the Pentagon.
Someone on the email chain asked whether restriction sites along the viral genome suggested the pathogen was artificial.
“There is absolutely no evidence that this virus is bioengineered,” Baric responded.
IC assessment
In late April 2020, the Office of the Director of National Intelligence released an unusual statement that the intelligence community concurred with the “wide scientific consensus” that the virus was not engineered, a statement that appeared to echo the conclusions of the Feb. 3 and March 26 briefings.
“A majority of the views now is that it was natural, it was organic,” said Defense Secretary Mark Esper.
In fact, a scientific consensus on this matter did not exist then and does not exist now.
Even so, the idea that SARS-CoV-2 could not be engineered also found its way into the 90-day review that the intelligence community concluded in August 2021.
“Most agencies also assess with low confidence that SARS-CoV-2 probably was not genetically engineered; however, two agencies believe there was not sufficient evidence to make an assessment either way,” the declassified assessment reads.
U.S. Right to Know obtained documents reported in this article through Freedom of Information Act requests to the Department of Health and Human Services and the State Department. All of the documents obtained in the course of our investigation into the origins of Covid-19 can be reviewed here.
With reporting by Hana Mensendiek
The Political Agenda of the IPCC
BY ROGER PIELKE JR. | THE HONEST BROKER | MAY 15, 2023
The Intergovernmental Panel on Climate Change (IPCC) was established as a scientific assessment process more than 35 years ago. Scientific assessments are of critical importance in many areas to help policy makers and the public to identify what is known, what is uncertain, as well as where there is contestation, uncertainties and areas of fundamental ignorance. Such assessments can also help us to understand policy options and expectations for how different choices might lead to different outcomes.
Regular readers of The Honest Broker will know that I have taken issue with the recent IPCC Sixth Assessment (AR6) based on an unacceptable number of errors and omissions in my areas of expertise, as well as its over-reliance on the most extreme climate scenarios. Today I take a look at the IPCC’s self-described political agenda and argue that the institution finds itself at a fork in the road.
Before proceeding, I want to be clear about what I mean when I talk about “the IPCC.” In one sense there is really no such thing as “the IPCC.” The organization’s assessment process includes many hundreds of people who do their work across three Working Groups to produce many dozens of chapters covering a wide range of topics. The Working Groups are largely independent of each other and even chapters within the same Working Group can be written largely independently of other chapters.
In another sense there is indeed such a thing as the IPCC — Specifically, its leadership and most engaged participants. These core participants represent a kind of climate in-group with a shared sense of purpose and an overarching commitment to a shared political agenda. For some people, their entire career is centered on the IPCC. These core participants do have a shared political agenda which can be seen in varying degrees within the reports.
So what is the political agenda of the IPCC in-group? Transformational change
When the IPCC released its Synthesis Report in March, it announced:
Taking the right action now could result in the transformational change essential for a sustainable, equitable world
It would be easy to write this sentence off as containing consultant-like and empty buzzwords. But the notion of “transformational change” has been widely employed in the academic literature on climate and the IPCC clearly defines what it means by “transformational change.”
In its AR6 Working Group 3 report the IPCC explains that transformation involves more than simply transitioning from one type of technology to another (emphasis added):
While transitions involve ‘processes that shift development pathways and reorient energy, transport, urban and other subsystems’ (Loorbach et al. 2017) (Chapter 16), transformation is the resulting ‘fundamental reorganisation of large-scale socio-economic systems’ (Hölscher et al. 2018). Such a fundamental reorganisation often requires dynamic multi-stage transition processes that change everything from public policies and prevailing technologies to individual lifestyles, and social norms to governance arrangements and institutions of political economy
Transformational change means that everything changes.
What are examples of these sorts of changes? The IPCC identifies “the potential for virtuous cycles of individual level and wider social changes that ultimately benefit the climate.”
The IPCC continues (emphasis added):
The starting point for this virtuous circle are inner transitions. Inner transitions occur within individuals, organisations and even larger jurisdictions that alter beliefs and actions involving climate change (Woiwode et al. 2021). An inner transition within an individual (see e.g., Parodi and Tamm 2018) typically involves a person gaining a deepening sense of peace and a willingness to help others, as well as protecting the climate and the planet . . .”
What are examples of such “inner transitions”? The IPCC explains:
Examples have also been seen in relation to a similar set of inner transitions to individuals, organisations and societies, which involve embracing post-development, degrowth, or non-material values that challenge carbon-intensive lifestyles and development models . . .
The IPCC discusses the importance of “degrowth” to its vision of transformation in its AR6 Working Group 2 report:
Consumption reductions, both voluntary and policy-induced, can have positive and double-dividend effects on efficiency as well as reductions in energy and materials use . . . a low-carbon transition in conjunction with social sustainability is possible, even without economic growth (Kallis et al. 2012; Jackson and Victor 2016; Stuart et al. 2017; Chapman and Fraser 2019; D’Alessandro et al. 2019; Gabriel and Bond 2019; Huang et al. 2019; Victor 2019). Such degrowth pathways may be crucial in combining technical feasibility of mitigation with social development goals (Hickel et al. 2021; Keyßer and Lenzen 2021).
These views are no doubt legitimate and sincerely held. But I seriously doubt that a climate agenda focused on changing everything, grounded in inner transitions to support degrowth is going to get very far in Peoria, much less anywhere else. More broadly, why are they being used to frame a scientific assessment?
I’m far from the first to recognize that the IPCC has adopted a political agenda focused on transformational change. Writing in 2022, Lidskog and Sundqvist explain:
Transformation has become a buzzword within scientific and political discourses in which “transformative change” is stated to be the solution to many severe environmental challenges. Expert organizations such as the IPCC and IPBES have stressed that transformative change is necessary to meet environmental challenges (IPCC, 2018; IPBES, 2019). . . While transformative change is seen as the way forward and as an uncontroversial ambition—it is difficult to find anyone who is critical of it—its meaning is nevertheless unclear.
The adoption of transformational change as an overriding political objective in the IPCC AR6 (and in the IPCC 1.5 report before that) represents a departure from a more politically neutral use of the concept in the IPCC Fifth Assessment Report (AR5). In 2014, the AR5 described “transformation pathways” to refer to technological alternatives for mitigation, not to demand that everything must change across society:
Stabilizing greenhouse gas (GHG) concentrations at any level will require deep reductions in GHG emissions. Net global CO2 emissions, in particular, must eventually be brought to or below zero. Emissions reductions of this magnitude will require large-scale transformations in human societies, from the way that we produce and consume energy to how we use the land surface. The more ambitious the stabilization goal, the more rapid this transformation must occur. A natural question in this context is what will be the transformation pathway toward stabilization; that is, how do we get from here to there?
The IPCC AR5 acknowledged that there were many ways to address accumulating greenhouse gases (GHGs) in the atmosphere:
[T]here is no single pathway to stabilization of GHG concentrations at any level. Instead, the literature elucidates a wide range of transformation pathways. Choices will govern which pathway is followed . . .
This expansive view of policy possibilities is far removed from “processes that change everything” and a “deepening sense of peace.” The IPCC AR5 and AR6 have been rightly criticized for not considering a larger set of possibilities for mitigation (notably, equity), which also reflects a political orientation.
The IPCC – or to be more precise, influential elements of the IPCC – appears to have been captured by an in-group with shared political views related to climate. These views embrace concepts like degrowth and planetary boundaries and turn climate policy on its head such that ends become means.
Transformational change views climate policy as a lever through which to “change everything.” The expressed need for such momentous changes across society are grounded in a frightening, even apocalyptic, perspective on the future. As the head of the IPCC exhorted in March, the IPCC “underscores the urgency of taking more ambitious action and shows that, if we act now, we can still secure a liveable sustainable future for all.”
The political agenda of the IPCC reads as if it was developed by wealthy American and Europeans academics. The billions of people around the world who may lack energy services or enough food probably would welcome an agenda of change. Instead, the IPCC emphasizes transformational changes in the lifestyles of ordinary people in rich countries, for instance, the recent Synthesis Report explained: “Many mitigation actions would have benefits for health through lower air pollution, active mobility (e.g., walking, cycling), and shifts to sustainable healthy diets.”
I have little doubt that many who have worked on the IPCC AR6 might read this post and say, “Hmmm, I never saw any of that,” others might say, “Yup, that’s our agenda, so what?” and still others might say, “I have a different political or professional agenda that I inserted into the report.” Further, one can surely dive into the almost 10,000 pages of the AR6 reports and selectively construct a different political narrative. However, I argue that “transformational change” is what in the jargon of symbolic politics is called the “master symbol” — the dominant political framing of the AR6.
The IPCC has clearly departed from its role as a scientific assessment and is now much more deeply engaged in political advocacy. Trying to simultaneously engage in assessment and advocacy is never a good idea. I hypothesize that the IPCC’s political agenda of transformational change plays more than a small role in its stubborn reliance on implausibly extreme scenarios and its multiple errors and omissions related to the science of extreme weather and disasters — both of which help to underscore the demand for urgent and large-scale societal change.
The IPCC finds itself at a fork in the road and should be reformed. It needs to either operate as a trustworthy scientific assessment or alternatively, to fully embrace its current role as an environmental advocacy group pushing transformational change. There is no middle ground.
Dutch-Led Network Of International Experts Finds “Serious Errors” In Latest IPCC Report
By P Gosselin | No Tricks Zone | May 12, 2023
The UN Intergovernmental Panel On Climate Change (IPCC) is misleading policy makers by focusing on an implausible worst-case emissions scenarios, concludes a new analysis report published by the Clintel Foundation: “The Frozen Climate Views of the IPCC“
The IPCC is hiding the good news about disaster losses and climate-related deaths and wrongly claims the estimate of climate sensitivity is above 2.5°C. Also errors in the AR6 report are worse than those that led to the IAC Review in 2010, concludes the report by The Climate Intelligence Foundation (Clintel), which was founded in 2019 by emeritus professor of geophysics Guus Berkhout and science journalist Marcel Crok.
Opposite of IPCC claims likely true
Another result: The IPCC ignored crucial peer-reviewed literature showing that normalized disaster losses have decreased since 1990 and that human mortality due to extreme weather decreased by more than 95% since 1920.
Clintel accuses the IPCC of cherry picking from the literature to claim increases in damage and mortality due to anthropogenic climate change, when in fact the opposite is likely true.
Rewrote climate history
The Clintel report is 180 pages long and the first serious international ‘assessment of the IPCC’s Sixth Assessment Report. In 13 chapters the Clintel report shows the IPCC rewrote climate history, and emphasizes an implausible worst-case scenario, favoring bad news and ignoring good news.
“The strategy of the IPCC seems to be to hide any good news about climate change and to hype anything bad,” reported the Clintel press release.
The errors and biases that Clintel documents in the report are far worse than those that led to the investigation of the IPCC by the Interacademy Councel (IAC Review) in 2010. Clintel believes that the IPCC should reform, or be dismantled.
Clintel is a network of international scientists who analyzed several claims from the Working Group 1 (The Physical Science Basis)
and Working Group 2 (Impacts, Adaptation and Vulnerability) reports. This led to the latest report: “The Frozen Climate Views of the IPCC”.
IPCC ignores 97% of all papers
Clintel explains how the IPCC ignored 52 out of 53 peer reviewed papers dealing with “normalized disaster losses” and found no increase in harms that could be attributed to climate change. Yet, the IPCC highlighted the single paper that claimed an increase in losses.
Cherrypicking, rewriting history
The IPCC also has tried to rewrite climate history by erasing the existence of the so-called Holocene Thermal Maximum (or Holocene Climate
Optimum), a warm period between 10,000 and 6000 years ago, and has introduced a new hockey stick graph, which is the result of cherry-picked proxies. The IPCC ignores temperature reconstructions that show more variability in the past, such as the well-documented Little Ice Age.
In its recent report, the IPCC also has grossly exaggerated sea level rise and CO2’s ability to warm the earth’s atmosphere and thus appears to have remained ‘addicted’ to its highest emissions scenario, so-called RCP8.5, which in recent years has been shown by several published papers to be implausible and thus should not be used for policy purposes.
Severely biased
“We are sorry to conclude that the IPCC has done a poor job of assessing the scientific literature,” the Clintel scientists report. “In our view the IPCC should be reformed, and should include a broader range of views. Inviting scientists with different views, such as Roger Pielke Jr and Ross McKitrick, to participate more actively in the process is a necessary first step.”
If the inclusion of other views does not permitted, then the IPCC should be dismantled, the scientists say.
Reality: Future is far less bleak
“Our own conclusions about climate – based on the same underlying literature – are far less bleak. Due to increasing wealth and advancing technology, humanity is largely immune to climate change and can easily cope with it. Global warming is far less dangerous to humanity
than the IPCC tells us.”
Clintel also published the World Climate Declaration, which has now been signed by more than 1500 scientists and experts. Its central message is “there is no climate emergency”.
Clintel press release here.
Autopsy of Fatal Delta Variant in a Fully Vaccinated Man
Findings Suggest Complete Failure of Pfizer-BioNTech COVID-19 Vaccine Induced Antibodies
By Peter A. McCullough, MD, MPH | Courageous Discourse | May 18, 2023
Autopsies have played a critical role in the history of medicine. The novel coronavirus pandemic is a period of time where autopsies have been particularly helpful in advancing our understanding of COVID-19 disease. So the question on the table is: if the mRNA COVID-19 vaccines raised antibodies against the ancestral wild type Wuhan strain of SARS-CoV-2, would they cover the Delta variant? The only real way to know is to find a case who is fully vaccinated with “protective” antibodies in the bloodstream who contracts COVID-19. Recently such a patient has been reported from Catania, Italy.
Esposito, et al, published an autopsy of an 83 year old man who was admitted to the hospital with heart failure and was later diagnosed with acute COVID-19 and succumbed 18 days later. There is no mention of treatment with lifesaving medications in the McCullough protocol such as ivermectin, corticosteroids, or anticoagulants. Sadly his lungs were ravaged with SARS-CoV-2 despite having adequate antibody titers for the Spike protein generated from the Pfizer-BioNTech COVID-19 Vaccine.
Esposito, M.; Cocimano, G.; Vanaria, F.; Sessa, F.; Salerno, M. Death from COVID-19 in a Fully Vaccinated Subject: A Complete Autopsy Report. Vaccines 2023, 11, 142. https://doi.org/10.3390/vaccines11010142
The important points of this paper are: 1) the original Pfizer-BioNTech COVID-19 Vaccine failed to stop the Delta variant, 2) antibodies are an invalid surrogate of protection and should have never been used 8 times by the US FDA in EUA approvals for extended use of COVID-19 vaccines.
Biden’s New NIH Head Solidify’s America’s Breakaway Health Agency Crisis
By Jefferey Jaxen | May 18, 2023
American health agencies are in a crisis of their own making. The pandemic response has both amplified and spotlighted the classic shortcomings and limitations of agencies like the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH).
News this week reports Biden has chosen Dr. Monica Bertagnolli, formerly National Cancer Institute Director, to lead the NIH. Bertagnolli fills the absence left by Dr. Francis Collins.
In a post-Covid world, much of the public-facing legacy of agency directors is written by their actions during the failed pandemic response. History will show it as a doomed era where no leadership escaped without tarnished careers from their unified actions to viciously mandate Covid shots, mask kids, keep schools closed and lockdown society causing irreparable harm to the American economy – all without the science to back up their decisions.
Former NIH head Collins will be forever known as the man who shut down scientific debate at a time when open dialogue about the already known, published research could have saved lives, the economy, and the mental health of our current population. Purposely ignored warnings, which came in the form of the Great Barrington Declaration, that internal emails show Collins and Fauci colluded to publish a ‘devastating takedown’ of its premise using the full weight of their agencies and media power.
Dr. Bertagnolli’s deep funding by Pfizer, and to a lesser extent from Johnson & Johnson subsidiary Janssen, is chronicled by The Daily Signal :
From 2015 through 2021, Bertagnolli received more than 116 grants from Pfizer, totaling $290.8 million. This amount made up 89% of all her research grants, according to Open Payments, a national transparency program under the Center for Medicare & Medicaid Services that collects and publishes information about financial relationships between drug and medical device companies and certain health care providers.
Her extensive background in cancer research and ties to Pfizer and other pharma companies raises questions about the timing of her placement at the head of NIH, the largest single public funder of biomedical and behavioral research in the world at more than $40 billion.
The Covid vaccine gold rush has come to an end for companies like Pfizer and Moderna. A brief look at headlines tells of the next profit push on the horizon being mRNA cancer vaccine therapies.
Meanwhile, an epidemic surge of cancers of unknown causes is also grabbing headlines.
Bertagnolli appears well-positioned to streamline an injectable pharmaceutical ‘answer’ to a growing cancer question while obscuring further investigation into its root cause(s).
Meanwhile, Walensky’s abrupt departure from a badly damaged CDC has public trust in the agency racing for the doors at breakaway speeds.
The FDA has done no better. After Trump’s director, Stehpan Hahn stepped down as the administration changed hands, Biden kept the agency without a presidential nomination for commissioner for the maximum time allowed by law – nearly one year.
In that time, the FDA pushed through emergency use authorizations for J&J’s Covid shot, expanded Pfizer’s EUA to 12-15 yr-olds and 5-11 yr-old, added EUA booster doses and mishandled massive warnings about increases in myocarditis, Guillain-Barre syndrome and thrombocytopenia after Covid shots. The agency’s authoritarian booster push also saw infighting due to a lack of data to inform the decision culminating in two of the FDA’s top, longtime vaccine regulators [Kruse & Gruber] departing in disgust.
A recent BMJ article titled The decline of science at the FDA has become unmanageable states, … the corruption of the FDA’s scientific culture remains the primary culprit driving the deterioration of safety and effectiveness standards.”
By all measures, America’s health agencies are in rapid decline as a litany of historical issues like Big Pharma’s revolving door influence, an outward mission-directed posture of mandates and censorship, a continued doubling down on bad policy, and an imbalance focusing on liability-free injectable products as the answer has left American marooned.
The path forward for American health, suffering in many categories, has challenges ahead. Yet the many failures and outright censorship of the medical and research communities during the failed pandemic response have created a new space being rapidly populated by medical professionals, experts, and citizen journalists who see the value and desperate need to investigate and report on reality, expose bad science and maximize open debate surrounding key health issues. It is the best of times and it is the worst of times.
FDA not fit for purpose – the Makena® fiasco
For years, the FDA allowed a drug to be injected into pregnant women that was neither safe, nor effective. Finally, it has been withdrawn.
BY MARYANNE DEMASI, PHD | MAY 15, 2023
Previously, I wrote about Makena, a synthetic hormone given to millions of pregnant woman, to prevent premature birth. It was highly controversial because there was no robust proof that it was safe or effective, despite having FDA-approval.
Last month, after many years of use, the FDA finally decided to withdraw Makena from the market.
Adam Urato, a maternal-foetal medicine specialist at MetroWest Medical Centre, Massachusetts welcomed the decision, but said it took the FDA far too long.
“I cannot believe we’ve been injecting this hormone into pregnant women for 20 years, all the leading medical organisations recommended it, the FDA approved it – and it took this long to finally acknowledge the drug did not work,” he said.
Urato opposed the use of Makena from the start. He testified before the FDA, he wrote in the media and in medical journals, and helped petition the FDA to withdraw the drug from the market.
Adam Urato, maternal-foetal medicine specialist, MetroWest Medical Centre, Massachusetts.
Preterm birth is a major issue in obstetrics. In the US, one in 10 babies are born prematurely, and accounts for most of the neonatal morbidity and mortality.
Physicians were desperate for a solution, and Makena seemed to hold promise.
It wasn’t cheap though. Makena was 5,200% more expensive than generic versions of the same medication.
Large amounts of public money in the Medicaid program and other health insurance dollars were used to pay for the weekly shots at a total cost of $30,000 per pregnancy.
How it began
The drug maker sought fast-track approval of Makena, citing a 2003 study that was so flawed, the FDA’s own statistical reviewer commented that the drug was not worth approving.
The FDA approved it anyway on the basis that the drugmaker conduct more in-depth research into the medication’s effectiveness.
Then, in 2019 a confirmatory trial found the drug did not work. And by this stage, there were documented harms including gestational diabetes, depression, blood clots and a non-statistical doubling in stillbirths.
But instead of pulling the drug off the market, the FDA allowed Makena to be licensed for another four years.
“It should’ve been pulled immediately,” said Urato. “There were substantial profits for the drug company even after a confirmatory trial found it did not work, so it’s no wonder it was dragging its feet.”
It begs the question…
How is it even possible that a drug, which was neither safe nor effective for pregnant women, was allowed to be on the market for so long?
Urato says it’s a direct symptom of the medical-industrial complex – an entanglement of big pharma, medical organisations, and regulatory agencies – that creates an underlying motive to bolster profits, over health.
“For two decades the drug brought in billions in profits, and that money was used to fund physicians, researchers, professional medical societies, and academic institutions,” said Urato.
This makes it exceedingly difficult, if not impossible, for patients to navigate the healthcare system and know who to trust.
“We need elected officials that are going to put the interests of patients and the public first, and not be tainted, or corrupted by industry. We need to separate our politics and our regulatory bodies from industry funding,” he added.
Lesson learned?
Urato feels vindicated for his work, but says it’s no time for a victory lap. Instead, the Makena fiasco should provide us with tangible lessons to safeguard us against such scientific transgressions in the future.
“We must ‘first do no harm’ and follow the precautionary principle,” insisted Urato.
“When you’re exposing developing babies to synthetic chemical compounds, you can’t just assume it’s safe, until harm is proven. You must assume that the chemicals are having chemical effects on the foetus, because that’s what chemicals do.”
The Diethylstilbestrol (DES) disaster should have been a reminder to all obstetricians about the harms of giving synthetic hormones to pregnant women without sufficient data. But once Makena was rolled out, Urato said, “it was like everyone forgot the past.”
“I counselled my patients on my concerns about exposing them and their babies to a synthetic hormone with unknown short and long-term effects, so I guess I could have been accused of peddling ‘misinformation’,” said Urato cognisant that he was going against medical consensus.
“But what is considered misinformation today, may be scientific fact tomorrow. I helped to prevent a generation of mums and babies in my community from being exposed to a useless drug. That’s why it’s so important that doctors have freedom of speech to express their views,” said Urato.
It’s estimated that hundreds of thousands of pregnant mothers and babies were exposed to the ineffective and risky synthetic hormone over the past 2 decades.
“Time and time again, drugs and devices are pulled off the market for safety issues. If the FDA approves a drug, it does not mean that it will be proven to be safe and effective over time. The FDA has lost the public’s trust,” Urato said.
Missed Bacterial Pneumonia Cases Left Untreated Were the Majority of COVID-19 Hospital Deaths
In April 2020, I warned about that the false positive-prone non-quantitative RT-PCR was deadly. Now we know, again, I was (sadly) correct.
By James Lyons-Weiler | Popular Rationalism | May 17, 2023
Hospital protocolists sticking to the strict hand-me-down highly profitable “COVID protocol” may have doomed a majority of admitted COVID-19 patients to death due to a perfect storm of institutional failure.
I first warned FDA in early 2020 that because the commercial kits did not use internal negative controls there would be arbitrarily high COVID-19 false positive rates due to the abuse of non-quantitative PCR. The majority of “cases”, I pointed out, would be false because the test was to be used as a screening device – and when you screen with an imperfect test when prevalence is low, you end up with more false positives than negatives in the set of positives.
Knowing that people who were symptomatic for respiratory infections would be among the most tested population and that Fauci’s medical approach to COVID-19 was to tell people to go home and get as sick as possible, it was readily clear that people would be dying due to lack of treatment for treatable conditions, like bacterial pneumonia and fungal infections in the lung.
Now a study from NIH-funded researchers in Chicago, IL has found that unresolved respiratory infections – not necessarily those involved in SARS-CoV-2 – were present in people who failed to “respond” to mechanical ventilation.
The authors wrote:
“Recent data suggest that secondary pneumonia is present in up to 40% and pneumonia or diffuse alveolar damage is present in over 90% of autopsy specimens obtained from patients with acute SARS-CoV-2 infection (18). Consistent with these observations, we and others found high rates of ventilator-associated pneumonia (VAP) in patients with SARS-CoV-2 pneumonia requiring mechanical ventilation, suggesting that bacterial superinfections such as VAP may contribute to mortality in patients with COVID-19 (7, 19–22). These findings prompt an alternative hypothesis that a relatively low mortality rate directly attributable to primary SARS-CoV-2 infection is offset by a greater risk of death attributable to unresolving VAP (23).”
They concluded:
“These data suggest mortality associated with severe SARS-CoV-2 pneumonia is more often associated with respiratory failure that increases the risk of unresolving VAP and is less frequently associated with multiple-organ dysfunction.”
Unsurprisingly, the study found that people with bacterial pneumonia who were on ventilators had the highest mortality. Although their analysis restricted consideration to bacterial pneumonia cases detected 48 hours after ventilation, they did not distinguish between undiagnosed cases of bacterial pneumonia upon admission and those acquired in-hospital (nosocomial infection). The rate of co-infection is not clear either, due to insufficient testing for bacterial pneumonia in patients once diagnosed with COVID-19.
The study leads to the stunning potential that perhaps 58% of “COVID” cases were respiratory issues other than COVID (43% bacterial pneumonia, 16% non-pathogen causes of respiratory failure). Treated as “COVID”, these patients were doomed to a fate of non-treatment due to mis- or under-diagnosis.
It is unclear what percentage of deaths attributed to COVID-19 could have been prevented via a standard therapy for bacterial pneumonia, but it is potentially very high. Fauci’s prescription – sending patients home to do nothing – no corticosteroids, no antibiotics just in case it was bacterial – drove the COVID-19 death rate up far higher than it had to be.
Gao et al., 2023. Machine learning links unresolving secondary pneumonia to mortality in patients with severe pneumonia, including COVID-19, Journal of Clinical Investigation (2023). DOI: 10.1172/JCI170682
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From the Archives
Precedents for Pizzagate
Marc Dutroux, Belgian pedophile, sadist, and serial killer with friends in high places
By Aedon Cassiel | Counter – Currents | December 23, 2016
To reiterate a point that should be clear to the more astute reader, my goal in this series (part 1, part 2) has not been to defend “Pizzagate” as such. My goal has been to defend the people who want to investigate it against specific accusations levied against them by people who think Pizzagate has revealed no intriguing information at all—for a specific reason, which I will be honing in and focusing on much more directly in this closing entry.
Whereas the mainstream critics of Pizzagate would have you believe that the dividing line is between paranoid conspiracy theorist followers of “fake news” and level-headed people who follow trustworthy news sources and rely on cold, hard reason to determine the truth, my goal has been to show that—whatever is or is not happening with Pizzagate itself—this framing of the issue is arrogant, insulting, and the product of extremely narrow tunnel vision. … continue
Blog Roll
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- THE CHILDREN GAMBIT
- A note on comment posting at Alethonews
- Trump stalls over Iran strike plan, Iran holds all the aces
- Zelensky’s Ceasefire for Elections is Strategic Gambit, Not Democratic Move
- US and Dutch pilots flying F-16s for Ukraine – Western media
- West’s Claims of Non-Involvement in Ukraine Conflict ‘Epitome of Hypocrisy’ – Expert
- Putin aide urges retaliation to ‘Western piracy’
- If Americans Knew
- Israel’s Favorite American President
- Israel’s “Yellow Line” Is a Death Trap for Palestinians. We Drove Into It.
- Why Israel’s expanding occupation in Syria presents a critical legal test
- Gaza is not a natural disaster. It is the victim of genocide enabled by global inaction
- Netanyahu’s plan to “end” US aid to Israel is to give even more money under a different name
- Israel ceased firing on Gaza for just 15 days of the “ceasefire” – Not a ceasefire Day 130
- In Gaza, “rats run over our faces” – Not a ceasefire Day 129
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- Israel battles Palestinian right of return, one Palestinian at a time – Not a ceasefire Day 127
- Noor’s short life of unimaginable suffering
- No Tricks Zone
- New Study: A 4°C Warmer Beaufort Sea Had ‘No Sea Ice’ 11,700 – 8200 Years Ago
- Unfudging The Data: Dutch Meteorological Institute Reinstates Early 20th Centruy Heat Waves It Had Erased Earlier
- German Gas Crisis…Chancellor Merz Allegedly Bans Gas Debate Ahead of Elections!
- Pollen Reconstructions Show The Last Glacial’s Warming Events Were Global, 10x Greater Than Modern
- Germany’s Natural Gas Storage Level Dwindles To Just 28%… Increasingly Critical
- New Study Rebuts The Assumption That Anthropogenic CO2 Molecules Have ‘Special’ Properties
- Climate Scientist Who Predicted End Of “Heavy Frost And Snow” Now Refuses Media Inquiries
- Polar Bear Numbers Rising And Health Improving In Areas With The Most Rapid Sea Ice Decline
- One Reason Only For Germany’s Heating Gas Crisis: Its Hardcore-Dumbass Energy Policy
- 130 Years Later: The CO2 Greenhouse Effect Is Still Only An Imaginary-World Thought Experiment
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