The nomination of Robert F. Kennedy Jr. as Secretary of the Department of Health and Human Services: a new beginning?

By MD, PhD Frederik Schaltz-Buchholzer, Assistant Professor in Vaccine Epidemiology, University of Southern Denmark

Today’s guest column is by Dr. Frederik Schaltz-Buchholzer. He is Danish expert in vaccine science, who is supportive of US reforms. How can he possibly be enthusiastic about RFK Jr? And enthusiastic despite writing, “[Mr Kennedy] focuses on topics that are potentially important/relevant, and then unfortunately often exaggerates or distorts the facts.” So what are the facts, and what are the distortions? Why is this expert in vaccine science largely in agreement with RFK Jr’s skepticism? In my opinion, this is why Sensible Medicine exists. To take you, the reader, out of your comfort zone, and towards a more refined view of evidence based medicine. If you believe in what we are doing, subscribe.

Vinay Prasad MD MPH

As a Danish vaccine scientist with many collaborations with US scientists and friends and family living there, US events and nominations are important. During COVID-19, we also had to fight hard to prevent the overflow to other countries of catastrophic US public health policies such as toddler masking, school closures, pediatric COVID-19 vaccination, vaccine mandates, vaccinating healthy youngsters and young adults, and the ruthless lockdowns.

So what happens in the US concerns us all, and the nomination of Robert F. Kennedy Jr. will be a major disruptive force for years to come.

My prediction? RFK Jr. will be a net positive for public health in the US. The mainstream media – who were the most important enablers of the destructive COVID-19 policies - are falling over themselves and screaming wolf, oblivious to the fact that current US public health is a complete failure.

Within public health, a new beginning with radical reforms are needed in the US

The US is the richest and most powerful country in the history of the world and this position has been consolidated in recent years, although the country might fall into a spiraling debt trap soon enough. The US outspends every single major country on health care, investing a much larger proportion (~18%) of a much higher GDP.

Yet there is a very high, unexplained excess mortality among Americans. Up to 70 years of age, the all-cause mortality rate is ≈4 times higher in the US versus comparable countries of the Western hemisphere. As another example of how extreme an outlier the US is, the life expectancy is markedly lower in the US vs the UK for every income distribution except perhaps the top 1% (where it is the same). These are incomprehensible and completely unacceptable differences. Yet it seems that US public health authorities has simply accepted this as the state of affairs, rather than trying to procure what can explain this absurd disparity in health outcomes.

There are probably several causes and some possible explanations are the higher use of pesticides such as glyphosate, additives in processed foods (which Americans over-consume, but the English also get a lot of), ultra processed foods, seed oils, unequal access to health care, and overconsumption of medicines and vaccines. Another possibility is that what is currently happening in the US is what is on the horizon for the rest of the world, although this seems unlikely.

IS RFK JR. RIGHT OR WHAT?

For one thing, he has teamed up with public health champions Bhattacharya to lead the NIH and Marty Makary to lead the FDA. Excellent choices.

RFK Jr. has brought attention to important problems with ultra processed foods, seed oils, pesticides and food additives. Many of these substances are either banned or used to a lower degree in Europe, which might explain why many Americans report weight loss when visiting Europe. Banning dyes, pesticides, hormones and food additives that has been banned or restricted in most other developed countries decades ago is a very low-hanging fruit.

RFK Jr. is critical of the US vaccination schedule, and so am I. I encourage everyone to have a natural skepticism towards any medication or syringe that we are offered. As an example, data has now appeared suggesting that NSAID ingested by pregnant women in the first trimester can affect the fertility of their female offspring, and that paracetamol (acetaminophen) disturbs the hormone balance in men. Despite such recent findings, even in Denmark, mRNA vaccines against COVID-19 are recommended to pregnant women, despite the complete lack of adequate RCTs documenting safety and efficacy of such an intervention.

The US childhood vaccination schedule (on the left below) is even more diverging from the Danish schedule (on the right below) than the US vs Denmark mortality figures.

It tells us everything that the many vaccines on the US schedule has made the font so small that you can hardly read it. In addition to this, several vaccines are recommended as yearly shots. COVID-19 vaccine is recommended from 6 months of age, whereas it is only recommended at 65 years of age in Denmark.

From birth to 18 years of age, I count 11 separate vaccine injections to Danish children, whereas it seems that American children would receive 72 vaccine injections up to 18 years of age if they follow the current schedule.

I consider several of the vaccines (e.g. hepatitis B, COVID-19, influenza) in the US program to be completely unnecessary and I would not subject my children to this vaccination program if I lived in the US.

Specifically for hepatitis B vaccination, it makes sense in some contexts to give the vaccine to prevent mother-child transmission of Hepatitis B. Thus, in Denmark, the vaccine is given to newborn children of mothers who are chronically infected with hepatitis B (detected via routine screening). The problem in the US is that mass vaccination is carried out even though only approx. 0.4% are infected with Hepatitis B.

This is massive overtreatment.

It is also a problem that the hepatitis B vaccine is a killed vaccine, for which the overall health effects (also called non-specific effects, see below) have not been sufficiently elucidated. It would shock most that this is the case for the majority of our vaccines; their overall health effects on all-cause morbidity and mortality has never been assessed in randomized trials.

So on this point, RFK Jr. is spot on.

He has also said that vaccines cause autism. There is no scientific evidence for this. In the case of the MMR vaccine, Danish researchers helped show that MMR is not associated with autism. On the other hand, we do not have data to say that vaccines do NOT cause autism, aside from MMR. So this is reasonable to investigate, including the importance of co-administration, age at vaccination and vaccine sequence. Some years ago, RFK Jr. also said that HPV vaccines do not prevent cervical cancer, or even that they increase the risk of cervical cancer. This is not correct – the data indicates high efficacy. The major issue I have with HPV vaccines is that almost all trials were conducted against active placebo (e.g., the placebo arm received the vaccine adjuvant, not a true placebo). So if the adjuvant has side effects or detrimental non-specific effects, it would not be detected.

In a pediatric vaccination program, it is useful to place importance of the severity of the target disease in the population in question. If the targeted disease is not severe (or very rarely severe) in pediatric populations, then the vaccine is likely to be unnecessary since the benefit is negligible, and all vaccines should be weighed for their theoretical benefit versus known and unknown (possible) side effects.

The Danish vaccination program is far better balanced in terms of adressing the severity of the target disease and the risk of side effects, which ensures acceptance and acknowledgement of importance from the families, who at the end of the day must find vaccination reasonable to bring their children for vaccination. The vaccine coverage is thus far higher in Denmark than in the US.

In addition to several of the vaccines being unnecessary, the US vaccination schedule is very densely meshed, with co-administration of many vaccines. I do not find that we in vaccinology have come to the bottom of the meaning of co-administration and the order in which the vaccines are given, which makes me quite concerned about the composition of the US vaccination programme.

Furthermore, our research into the non-specific effects of vaccines – i.e. a vaccine's overall health effects on all-cause mortality and morbidity, not just the protection against the target disease and short-term side effects, has highlighted the importance of two overarching categories of vaccines:

Live vaccines (BCG, MMR, OPV, yellow fever, rotavirus, varicella vaccine), and

killed vaccines (such as IPV, Hepatitis A/B, rabies, influenza, penta/DTaP).

The consistent pattern we have seen is that the more archaic and “simple” live vaccines have beneficial non-specific health effects because they train our innate immune system. Live vaccines are weakened (attenuated) versions of the bacteria or virus in question. They can typically replicate in our bodies, which is detected by our immune system, creating the immune reaction that leads to immunity. Due to these properties, no adjuvants are needed to alert the immune system.

In contrast, the killed vaccines we have studied unfortunately have negative non-specific effects. These negative effects are especially evident for females. In developing countries, this manifests itself as a higher mortality rate for female children, with an increased Female/male mortality rate ratio. In Denmark and Australia, a vaccine such as DTaP-IPV-Hib has been associated with a slightly increased risk of childhood eczema. My colleagues found that Danish children that had received the live MMR as the latest vaccine had a lower risk of admission for infection, when compared to children who had received the killed DTaP-IPV-Hib as the latest vaccine.

The non-specific effects of vaccines are most significant for the most recently administered vaccine, indicating that the immune system adapts to each stimulus. Thus, an Australian pediatrician has calculated that by simply rearranging the existing vaccine schedule used in developing countries, prioritizing to have had a live vaccine as the most recent vaccine for as much time as possible, we could potentially save up to 1 million children per year.

For these reasons, my 2 girls have received a modified version of the Danish schedule, with delayed and/or skipped killed vaccines (diphtheria-tetanus-whooping cough-polio-Hib 1 (pentavac) and PCV-1) and with addition of several live vaccines (BCG, measles vaccine, varicella vaccine) that are not in the program.

Although the non-specific effects of live and killed vaccines has been known for decades, as reviewed by the WHO in 2014, vaccination programs are yet to be updated with the latest knowledge.

Disruption needed

While I have not read all of RFK’s statements closely, my general impression is that he focuses on topics that are potentially important/relevant, and then unfortunately often exaggerates or distorts the facts. For example, he has referred to a vaccine study from our group, where the main conclusions were correctly presented, but things were also invented, such as that my colleagues were sent by the Danish state and Bill Gates was involved.

Overall, I think that it is healthy to disrupt a US pharma-science complex that is far too closely interwoven, for example with FDA regulators switching to top positions in Big Pharma after having been responsible for authoritative approval of their products. The control of the pharmaceutical industry's products is too thin, and it should be completely excluded, for example, that the pharmaceutical industry is responsible for testing their own products. I am tired of reading reports from randomized trials where the investigator (employed by the pharmaceutical company) assesses that a side effect in the intervention group was not associated with their product. Because it is impossible to know this the first time a vaccine or medication is given to a larger group of people.

Had independent researchers been responsible for designing, conducting and analyzing trial data for the COVID-19 vaccines, I am convinced that they would never have been used so extensively, and perhaps they would not have been approved at all.

The current system is so dysfunctional that a killed malaria vaccine, which my colleagues had shown in randomized data doubles infant mortality for females, is being rolled out across Africa. The vaccine manufacturer had first promised to publish mortality data broken down by sex, then they failed to do so until they were forced to, and even after this completely unambiguous data came to light, the vaccine is still well underway to be rolled out anyway. This despite the fact that according to the manufacturer's own data, it is not even an effective malaria vaccine, and the vaccine is expensive and logistically difficult (given in many doses outside the normal vaccination programme). We know from previous experiences that once a vaccine is established in the vaccination program, it is very difficult to get rid of it again.

In conclusion, our current system for testing, approving and regulating vaccines is inadequate, and for the majority of the vaccines currently used, the importance of aspects such as the non-specific effects of vaccines, sequence, and co-administration has not been adequately assessed. By all health outcome measures, US public health is a complete failure and someone who thinks radically different is needed.

Despite his shortcomings, RFK Jr. can be this person and it bows well that he has surrounded himself with COVID-19 era heroes and evidence-based medicine champions Bhattacharya and Makary.