Coronavirus Origins: Anatomy of a Scientific Inference

Coronavirus Origins: Anatomy of a Scientific Inference

James Lyons-Weiler, PhD – 2/15/2020

Objective science is not about being right or wrong. It’s about positioning yourself toward maximizing your chances of learning something. Here I provide a lesson in the philosophy of Science – outlining an approach that, once abandoned, all of Science should strive to return.

THE PAST TWO WEEKS have been a fascinating exercise in Science – with many factors and forces influencing comprehension and expectation. I think it’s a fantastic opportunity for the public to have witnessed objective Science in action, and to see the definition of rigor in Science defined as operating in vacuum separated from profit motive and independent of ego.

The scientific philosopher Karl Popper urged scientists to move beyond the collection of pieces of information that confirm their favorite ideas. This type of inference-making is called positivism – and it leads to a bunch of collected facts and figures from an otherwise jumbled mess which, while appearing to be internally consistent and mutually supportive, can nevertheless be positively misleading to an incorrect inference. If we base our generalization from individual instances to the general case, a process called induction.

Since we base what we know about our world on observations, what could save us from merely agreeing with our Royal Selves with all of the confirming instances we can manage, or choose, to collect? And what do we do about the annoying contradicting observations that do not fit our induced generalized claims, since we have based our world view on all of the past confirming instances?

In other words, where does the demarcation exist between making stuff up and Science?

Enter: The Hypothesis

Popper offered a highly formalized calculus of the nature of objective scientific inference in which our goal should not be generalization via induction, but, instead, inferences more securely based on a form of deduction, specifically hypothetico-deductivism. In hypothetico-deductive science, we pose an hypothesis, or a conjecture, based on our Background Knowledge of a topic. At this time, we do not create a knowledge claim, upon which we stake our fame and glory (ego). Instead, we state the hypothesis clearly, and then imagine the most significant critical test of said hypothesis. For Popper, a Test is only truly critical if it can, in fact, potentially refute, or falsify, the stated hypothesis. If a Test does not truly place a hypothesis at the risk of being falsified, it’s not truly a critical test.

Enter: The Evidence

Once the Critical Test has been defined, and the scientific experiment or study has been executed, the information on the outcome of the Critical Test is called Evidence. We are to use, Popper says, the Evidence we have collected to re-assess the original Hypothesis, which you will recall was based on background knowledge.

If the critical test provides evidence that refutes the hypothesis, the hypothesis is considered falsified.

If the critical test provides evidence that fails to refute the hypothesis, and, importantly, the critical test was constructed and executed in such a manner that the hypothesis could actually be refuted if it were false, the hypothesis is said to be corroborated.

In either outcome, we update our background knowledge based on the evidence from the critical test, and move along secure in the hope that we have learned something.

Via H-D science, there is no role for ego; for Popper, the source of the hypothesis plays no necessary or useful role in whether the hypothesis will be falsified or not; i.e., the critical test is to be defined and constructed in a manner by which its design and execution is truly independent of whether the subjective scientist individually favors, or the current consensus favors, or dislikes, the hypothesis being tested. The only thing that matters is that the critical test is actually capable of potentially falsifying the hypothesis. That’s it.

If there was one word that should be dropped from discussions in science, it’s “prove”. Scientists don’t prove anything; as I say in discussions, proofs are for maths, logic, publications, and whiskey. Another term that I find to be extremely unscientific is “debunk”. The origin of the term has it roots in the term “bunkum”, of which the first recorded use was in 1828, when it was used to describe a “speech for Buncombe County, North Carolina” given by North Carolina representative Felix Walker during the 16th United States Congress (1819–1821). To “debunk” then means” to call someone out for bad, incorrect, or ineffectual speech, and if Science is being conducted objectively, it’s about the process, not about the speech, nor the speaker.

These terms are convenient clubs used by those who would gladly destroy the career of objective scientists whose results threaten their promise to their investors, and they play no role in the logic of Science.

Instead of these pop-culture representations of sciency-sounding things, it is importantly, that it is understood and expected that the available background knowledge, or assumptions, may not be perfect for any such enterprise in Science. In fact, the entire purpose of Evidence from a Critical Test is to determine whether the available background knowledge is to be updated, or left alone intact, unfettered by new knowledge. This is a far cry from “proving” an hypothesis. We simple either refute or fail to refute – and we only can do so if the test we use is, in fact, a critical test.

Bold vs. Weak Hypotheses

Popper did distinguish between weak hypotheses that do not go too far beyond the Background Knowledge and bold hypotheses that do go far beyond the background. These differences were important, because the further away from the background knowledge a stated hypothesis lays, the greater the degree of Corroboration – not confirmation, Corroboration – the Evidence from the Test results provide the hypothesis.

In fact, the more unexpected it is that the hypothesis survive a truly critical test, the more scientist should be impressed. Popper offered a term for this: Surprise. The higher the degree of surprise, the more improbable the outcome if the hypothesis was incorrect, and thus the higher the degree of corroboration – and the more we realize we need to update our background knowledge. Elegant.

Imagine if I come to you with a coin. I ask you: what do you think the chances are, if I flip this coin, you’d see it land on “Heads”. Most would say “50%” – a few would say “50%, if it’s ‘fair’ coin”. You watch me flip a coin, and it lands on its edge. This is so utterly improbable that you would not only be surprised: you’d be amazed. Now imagine if I give you the same coin, and you flip it – and it lands on its edge AGAIN. Clearly, you’d have found that the probability model in your head: 49.99999% chance heads, 49.99999% tails, 0.00002% edge, was wrong. You might flip it again, and again to determine how far off your 50:50:0 model was, and, for that coin, you’d say “Ok, this coin is not fair, it’s different” – if the data supported that.

Would you then generalize to all coins, and say “all coins are 10:10:80?”. No. That induction is not warranted from your observations with a single coin. That’s why independent replication is so important to Science- it determines whether an inference generalizes, and if so, how well it generalizes.

Entities that make overgeneralized claims often can get away with doing so because they carry the mantle of authority. But authority will not make a study replicate, or make a model able to predict well on new data. Biases from fraud, to hide evidence of harm from pharmaceutical and agricultural practices, are everywhere. In academia, to say so is death to one’s career. Which is why we need independent Scientists doing Objective Science in full view of the public. If it looks different, it’s because there is no agenda. I’m quite happy to be “wrong” over and over and over, as long as I am learning something about the world and the universe around us.

In the case of Coronavirus, the New Media and even some MSM picked up the idea that my statement that “at the present time, the most likely hypothesis is that novel coronavirus is lab-based” ignored the explicit caveat that Del Bigtree of The Highwire provide numerous times: it’s a ‘theory’ he said (he meant hypothesis). My infamous article actually listed multiple hypotheses, and presented the available evidenced structured as it was presented to me. I stated these hypotheses with every intent to attempt to define critical tests, old-school, in the Popperian fashion, to attempt to refute and thereby either falsify or corroborate each one. The last man standing wins.

This is only possible in a free and open society in which free and open discussions are possible. Numerous scientists from around the world have contacted me throughout the process to weigh in

It is no coincidence that Popper co-authored one of my favorite books: “The Open Society and Its Enemies” – highly recommended reading and something all who want open social media – freedom of expression – freedom of the press – freedom of Science from profit motive bias should read and give to their loved ones and friends.

Popper worked all of this out in formal calculus that, unfortunately, has all been but forgotten due to a non-sequitur “next phase” of the philosophy of science – Thomas Kuhn’s “Scientific Revolutions”, which focused on paradigm shifts, placing the power to create knowledge in the firm grasp of consensus – which of course we now know lends itself well to group think, to manipulations of perception, to propaganda, such as to claims of observational studies – weak science not capable of testing a core feature of important hypothesis of causality – as “rigorous” and sometimes even “more rigorous” than randomized prospective clinical trials with inert placebos. Under Popperian Science, the truth is reality, independent of us. It impacts us, it is something we approach asymptotically, using Science is a way of discovering knowledge. Under Kuhnian science, the loudest person in the room can define the truth; that often can mean the buyer with the largest purse.

Since entering into the domain of Coronavirus research, asking questions, posing hypotheses, defining critical tests, examining the evidence, and updating background knowledge based on the outcome of those tests, dozens of scientists from around the world have written to me in support of my efforts to address the questions we all have head-on. Some have been supportive, offering agreement; some have been supportive by challenging me. In reality, they were not challenging me, they were challenging the hypothesis. So I’m honestly grateful!

The manuscript showing the results of our study of spike protein motifs is under review, and I have asked the journal Editor to permit pre-review publication for the sake of humanity. If the publisher agrees, the results will be available to all very soon. Fingers crossed.

The conduct of independent science for the sake of knowing, in hopes it might reduce human pain and suffering, is gratifying because those who understand that it’s not about me – it’s about the 67,000 human beings with COVID-19 who may be suffering needlessly for want of a full understanding of the mechanisms of pathophysiology that SARS 2 has in it attack on humanity. It’s different from SARS – and understanding those difference draws on ecology, evolution, genetics, biochemistry, and an ability to divorce one’s ego or agenda from the outcomes of a study.

Posing incorrect hypotheses is a good, healthy and essential part of Science. Being willing to pose risky hypotheses is key to being able to make advances in knowledge.

Today, I received a card in the mail from a concerned US citizen who understands why IPAK exists, why independent Science must be made to thrive and grow in the face of a massive paradigm of science-for-the-stakeholders.

His card read:

“JLW,

If another planet offers you another position with bette(r) working conditions – free from politicized science, don’t take it!

We need you here.

MR.”

This person’s enclosed donation to IPAK will keep objective, unbiased, but imperfect hypothetico-deductive Science alive in the US.

I feel that I have a responsibility at this time in history to reverse course on the tyranny of pseudoscience and Science-like activities conducted by individuals with an agenda other than using Science as a way of knowing.

CORONAVIRUS ORIGINS HYPOTHESIS TESTING

THE HYPOTHESIS.

Step 1: Background knowledge. No one could ID the novel segment. There had been 5 coronavirus outbreaks in China in seven years; 4 from the lab, 1 from a civet (cat-like animal) as an intermediate host. Vaccines made using recombined SARS spike proteins have been made and have undergone testing since the mid-2000’s.

Step 2: Initial observations. I found it to match p-ShuttleSN, which was clearly related (somehow) to the Coronavirus Spike protein. Found a patent for a SARS vaccine that used pShuttle-SN to move a SARS spike protein into an adenovirus.

Step 3: I made the bold conjecture, given the background knowledge of a 4:1 risk of accidental vs. laboratory release of SARS coronavirus, that this was (a) likely an accidental laboratory release, and (b) most likely of laboratory origin

THE TEST: PHYLOGENETIC RELATIONSHIPS AND A SPECIAL MOTIF PATTERN.

I used phylogenetics to determine the relationship of all of the Spike protein sequences I could access, including pShuttle-SN. I sought new evidence: If pShuttle-SN turned out to be most closely related to SARS CoV 2, it may well be related causally.

It wasn’t. It clustered with SARS CoV-1, specifically, in what I call the “Cancer Center cluster”, with sequences from a Genome Center. While it was possible to replicate the alignment issue with other coronaviruses, it seemed to be related to a shorted N-terminal Domain of the S1 section of the Spike protein. Noted.

Further test: Other artificially modified spike proteins might be most closely related to SARS CoV 2.

They aren’t.

A final critical test: Since SARS CoV Spike protein is different, and different because it was from nature, but, were there any reliable sequences from a natural source from long ago that had the same type of Spike protein? If so, then we have to rule out laboratory ORIGIN – as in design, because such as finding would be highly improbable.

Result: Using motifs, I searched known B-Coronavirus Spike proteins to see if there were any older sequences from nature that also include the motif pattern that appears to be indicate (may be) indicative of a the special pathogenicity in SARS CoV 2. I found one that matched all of the known closest relatives and examples of SARS CoV 2. It was from 2005 and from a natural source: a bat. (Details to appear soon following peer-review or agreement to pre-publish).

The net result? We have updated our background knowledge, and learned something new. We have a potentially useful pathogenicity signal (shorted NTD, two missing motifs and a Gp40 motif in the C-terminal region) that anyone with a high school degree could learn to recognize with about 20 minutes training, a laptop and access to the internet. The new hypothesis – that a pathogenicity signal exists – itself is a conjecture, and needs to be tested. It falls into the realm of “Applied Science”, drawn from “Pure Science” – the act of daring to ask questions and pose hypotheses merely for the sake of knowing.

So there we have it – the Anatomy of a Scientific Inference. In my view, all of Science should return to Popperian Hypothetico-Deductivism and cast off the control of the funding masters who limit what we can study, and what we can publish. Remember that to do Objective Science means divorcing your ego from your hypothesis.

Some will complain in the comments that the Philosophy of Science has ‘moved’ on, but in reality, I’m not accepting that. Kuhn’s permission slip for induction – and that’s what it has been used for – has led biological sciences and medical sciences down a path that is making people sick. Philosophers of Science who used to enjoin Popper have abandoned all hope in the face of the juggernaut and have become Stoics – a metaphysical rising above the issues as irreconcilable. Two decades ago, I proved (using logic), using Popper’s calculus that having more scientists looking at the same problem and discussing it is more likely to yield progress in science – simple because each had their own background knowledge, meaning that the chances that someone in the room has the missing component of background knowledge to accurately and correctly interpret the evidence of a critical test of a hypothesis. The journal editor returned the manuscript with the apology that no one uses Popper’s calculus anymore. That needs to change.

Nevertheless, Vestiges of Objective Science still exist: We still use experiments with controls to test the hypothesis of interest – and the degree to which we can reject the null hypothesis is measured by a p-value. That p-value is the degree of surprise that we should express if we saw the null hypothesis rejected by chance alone. Like flipping a coin and seeing it land on its edge. We know there is a small probability, and if it were to happen again and again, we would have to surmise that our background knowledge, or expectation, needed to be updated.

But if we cannot discuss hypotheses for fear of being ‘wrong’, or cannot publish results because it may upset our funding source, or it may go against any particular political agenda, we’re going down the wrong path. We still don’t know if there is something different in China with respect to the mortality rate of the novel coronavirus. The two hypotheses that I posed

(A) the Chinese government proceeded with a large-scale coronavirus vaccination trial, or

(B) the new vaccine law (Dec 1, 2019) may be related somehow

will both soon be partly tested by the amount of of serious illness and death outside of China associated with infection. So far, there have been only four deaths outside of China, in 688 known cases, a rate of 0.005% (about what I predicted). In China, the per-case fatality rate estimate ranges from 2.1% to 2.3%, depending on whether suspected cases are included in the denominator of the total number of cases. Hopefully for the world, this hypothesis bears out.

Science is a social enterprise by which we compare our interpretations of outcomes of studies with other scientists, who can share theirs back. The age of “retraction” due to differences in interpretation, and “debunking” by shady characters with ties to Pharmaceutical companies, are over. I’ve led chants of “What do you want?” to which the crowd replies “SCIENCE!” and I have to tell you, I think we’ve reached a turning point where profitability is being given the boot out of the logical calculus of Science, and the public is learning the difference between Science, and Science-Like Activities.

I encourage every Scientist to state their bold hypotheses loudly, and clearly, and outline their reasoning. Because, as my Master’s degree mentor Paul Colinvaux shared with me, his academic advisor Dan Livingstone thought that being found to have posed an incorrect hypothesis would be “wonderful, because then we would have learned something”.

SARS CoV-2 CASES TO DATE (2/14/2020)– Update here.

Mainland China: 63,862
Thailand: 33
Japan: 29 (plus more than 200 on cruise ship off coast)
Singapore: 67
Hong Kong: 56
South Korea: 28
Taiwan: 18
Australia: 15
Malaysia: 19
Germany: 16
Vietnam: 16
Macau: 10
U.S.: 15
France: 11
United Arab Emirates: 8
Canada: 7
Italy: 3
Russia: 2
UK: 9
Philippines: 3
Cambodia: 1
India: 3
Belgium: 1
Finland: 1
Nepal: 1
Spain: 2
Sri Lanka: 1
Sweden: 1

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CLEAR EVIDENCE it is NOT a Bioweapon. So What’s All This About ACE2 and nCoV-2019 (COVID-2019)?

CLEAR EVIDENCE it is NOT a Bioweapon. So What’s All This About ACE2 and nCoV-2019 (COVID-2019)?

LIVING IN THE LAND OF ABJECT OBJECTIVITY, as a truly independent scientist, I see streams of information from a wide and diverse number of sources. It’s also a cozy little spot where arrows of bias from “both sides” of every issue are flung with remarkable ease – and with little consideration for liability over unwarranted attempts at defamation.

Of course, some would say I’ve “defamed” myself merely by admitting that vaccines can harm, and vaccines can kill – as if that’s (a) not true, and (b) a reality that is so taboo that anyone who dares breathe a word of it is fair game for the slightest expression of hate (such as name-calling) and outright accusations of being a fraud.

Peanut gallery managers who do little to actually effect change in a positive manner, enjoy the chance to bully someone with, apparently, society’s blessings. “Hit ’em harder!” “Well done!” Except everything I publish is backed by experiment, if not that, by observational studies, if not that, by summary statistics, if not that, by initial observersations leading to Science. Their habit of following objective scientists around is a mere annoyance.

COVID-2019?

World Health Organization (WHO) has renamed the virus SARS-CoV-2, and the disease it causes COVID-2019. The classification of viruses should ideally reflect their phylogenetic relationships and especially inherited genetic capacity for pathogenicity [thx reader for the update on the name]. But that would require a deep understanding of the evolutionary history of the functional elements contributing to the virulence and transmissibility of viruses – something that public health officials and run-of-the-mill MDs are too distant from to understand.

For the last week, I’ve been analyzing the motif patterns in B-CoV’s, and as a result of that, having settled the issue that pShuttle-SN is not likely to have been involved in the origin of COVID-19, and furthermore that no recombinant B-coronavirus for which we have data is likely to be ultimately found to be the ancestor of COVID-19 (in review), it’s time to look at another claim about the virus now raging: ACE2.

ACE2

A paper, “The novel coronavirus 2019 (2019-nCoV) uses the SARS-coronavirus receptor ACE2 and the cellular protease TMPRSS2 for entry into target cells”, published on bioRxiv, examined SARS 2 (new name for 2019-nCoV) cell entry using pseudoviruses made (using recombinant technology) that express the SARS 2 spike protein, which is used by SARS 2 to gain entry into cells. The pseudoviruses were made using vesicular stomatitis virus (VSV) particles. The authors of the study evaluated the abilty of these pseudoviruses to enter a variety of human and animal cell lines under different experimental conditions.

Their experiments and analysis found that SARS 2 Spike protein binds to angiotensin-converting enzyme 2 (ACE2), and that it uses a cellular protease called TMPRSS2 to activate, or “prime” viral fusion and entry into cells.

This means that TMPRSS2 might be potentially useful therapeutic target for the treatment and prevention of SARS 2 entry into cells. One such candidate is camostat mesylate, a known TMPRSS2 inhibitor. Camostat mesylate is approved for human use in Japan.

The authors also noted that serum from a convalescent SARS-CoV patient neutralized S-protein mediated entry into cells. This means that survivors of the infection may be a useful source of biologics to help others who are infected survive or avoid critical illness. The rate of critical illess of COVID-19 in China is staggering.

It’s important to note that the SARS 2 Spike protein uses a different cellular entry receptor from MERS-CoV, which uses human DPP4. Also, the seasonal coronavirus uses 229E (human APN), and that other coronaviruses, including SARS and HCoV-NL63, use ACE2 to enter cells. The finding that COVID-2 has especially strong binding capacity to ACE2 is consistent either with recent adaptation for living in humans, or for older adaptation in the wild to a mammal that has ACE2 structures that resemble humans.

ACE2 has other roles in the body has well; gene expression data tell us that it plays a role in the regulation of cardiovascular and renal function, as well as fertility (Refseq).

IS COVID-2019 DESIGNED TO SPECIFICALLY ENTER VIA ACE-2 TO “TARGET” ASIANS?

So, clearly there are important positions that people can take in the area of international intrigue. In the area of bioweapons rumors, Western countries like the US and Canada have touted the idea that COVID-19 might be a bioweapon that escaped. In China, far-right groups are touting that the virus was made by the US and is an attack on the Han people.

Polymorpisms certainly exist in the ACE locus, and earlier studies found differences among Asians, Caucasian, and people of African descent with respect to the frequencies of two alleles – the D and I alleles. Alleles combine in pairs to make genotypes (one from mom, one from dad), and the meta-analysis reported that the II, ID and DD genotypes were found at 22.5% II, 47% ID, and 30.5% DD. (As an aside, here’s a handy Hardy-Weinberg calculator to test for HW-Equilibrium to see if there’s anything ususual about this distribution that might lead to a hypothesis of ongoing selection. For those who like to do such things).

The specific D allele frequency found across ethnic groups were 39.1% in Asians, 56.2% in Caucasians, and 60.3% people of African descent. (For those who may not know, the corresponding I allele frequency) would be 100%-D for each ethnic group).

This distribution of genotype and alleles of the ACE gene would be a TERRIBLE target for a bioweapon that is alleged to target Asians for obvious reasons: it would end up targeting a huge proportion of the rest of the world, and the “home” population, whichever side targeted people based on their ACE genotype.

So, without bothering to condescend to those who thought that somehow ACE was so different in Asians that a bioweapon has been masterminded and has been recently, I am very happy to say that the likelihood of this from a purely strategic standpoint is nil. (NB: ACE is a different gene from ACE2, see article addressing this here).

Since recombination in nature is not a likely explanation of the massive morbidity and mortality of COVID-19 from SARS 2, and recombination technology was not used to create this, and it is not a US Bioweapon that backfired, nor a Chinese bioweapon that backfired, we still need to wonder: why is the mortality and critical illness from COVID-2019 in the Wuhan district so high in comparison to that seen in the rest of the world so far?

Another possibility is high ambient exposure to bat coronaviruses. People in the region, however, have been eating wild-caught animals for thousands of years. Since China has such an exceptional written history going deep into their past, it would behoove humanity to study the ancient scrolls from China for evidence of plagues traced to eating bats, pangolins and other animals we now know understand can harbor coronaviruses. It is likey that B-coronaviruses have been infecting humans for tens if not hundreds of thousands of millenia.

So what’s different in 2019? On Dec 1, a new national vaccine law went into effect. “China is to implement a state immunization program, and residents living within the territory of China are legally obligated to be vaccinated with immunization program vaccines, which are provided by the government free of charge. Local governments and parents or other guardians of children must ensure that children be vaccinated with the immunization program vaccines (art. 6).”

The first reported case of COVID19?

December 1, 2019.

In my first article on the origins of the virus, I mentioned that one way to get hundreds of thousands super sick from a coronavirus is to have sensitized the population with a vaccine containing a spike protein. Why? Because prior animal studies showed high mortality following re-challenge in vaccinated animals. See studies, below.

References

Staessen, J., Ginocchio, G., Wang, J. G., Saavedra, A. P., Soubrier, F., Vlietinck, R. & Fagard, R. (1997). Genetic variability in the renin-angiotensin system: prevalence of alleles and genotypes. Journal of Cardiovascular Risk 4, 401–422.

Te et al., 2012. Immunization with SARS coronavirus vaccines leads to pulmonary immunopathology on challenge with the SARS virus. PLoS One 7(4) https://www.ncbi.nlm.nih.gov/pubmed/22536382

Tseng et al., 2012. Double-Inactivated Severe Acute Respiratory Syndrome Coronavirus Vaccine Provides Incomplete Protection in Mice and Induces Increased Eosinophilic Proinflammatory Pulmonary Response Upon Challenge https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3209347/

Yasui et al., Prior immunization with severe acute respiratory syndrome (SARS)-associated coronavirus (SARS-CoV) nucleocapsid protein causes severe pneumonia in mice infected with SARS-CoV. J Immunol. 181:6337-48 https://www.ncbi.nlm.nih.gov/pubmed/18941225 https://www.jimmunol.org/content/181/9/6337.long

SARS-CoV-2 Vaccine Recommended Readings

Immunization with inactivated Middle East Respiratory Syndrome coronavirus vaccine leads to lung immunopathology on challenge with live virus.Lung mononuclear infiltrates occurred in all groups after virus challenge but with increased infiltrates that contained eosinophils and increases in the eosinophil promoting IL-5 and IL-13 cytokines only in the vaccine groups. Inactivated MERS-CoV vaccine appears to carry a hypersensitive-type lung pathology risk from MERS-CoV infection that is similar to that found with inactivated SARS-CoV vaccines from SARS-CoV infection.https://www.ncbi.nlm.nih.gov/pubmed/27269431

Vaccine efficacy in senescent mice challenged with recombinant SARS-CoV bearing epidemic and zoonotic spike variants.“VRP-N vaccines not only failed to protect from homologous or heterologous challenge, but resulted in enhanced immunopathology with eosinophilic infiltrates within the lungs of SARS-CoV-challenged mice. VRP-N-induced pathology presented at day 4, peaked around day 7, and persisted through day 14, and was likely mediated by cellular immune responses.” https://www.ncbi.nlm.nih.gov/pubmed/17194199

Immunization with Modified Vaccinia Virus Ankara-Based Recombinant Vaccine against Severe Acute Respiratory Syndrome Is Associated with Enhanced Hepatitis in Ferrets “Immunized ferrets developed a more rapid and vigorous neutralizing antibody response than control animals after challenge with SARS-CoV; however, they also exhibited strong inflammatory responses in liver tissue.”

https://jvi.asm.org/content/78/22/12672.abstract

Animal Models for SARS and MERS coronaviruses. “The concern that is extrapolated from the FIPV vaccine experience to human SARS-CoV vaccines is whether vaccine recipients will develop more severe disease if they are exposed to or infected with SARS-CoV after neutralizing antibody titers decline. The second concern is whether recipients of a SARSCoV vaccine would be at risk of developing pulmonary immunopathology following infection with an unrelated human coronavirus e.g. 229E, OC43, HKU1 or NL63 that usually causes mild, self limited disease. Although findings from preclinical evaluation have revealed these concerns, studies in animal models may not be able to provide data to confirm or allay these concerns.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4550498

https://science.sciencemag.org/content/303/5660/944.full

Lab-Made Coronavirus Triggers Debate  “…a study on his team’s efforts to engineer a virus with the surface protein of the SHC014 coronavirus, found in horseshoe bats in China, and the backbone of one that causes human-like severe acute respiratory syndrome (SARS) in mice. The hybrid virus could infect human airway cells and caused disease in mice…”

https://www.the-scientist.com/news-opinion/lab-made-coronavirus-triggers-debate-34502

Certainly additional advances have been made in attempts to make Spike-protein related vaccines safer.Feel free to post additional recommended reading.

RECOMMDED RELATED:

CLEAR EVIDENCE it is NOT a Bioweapon. So What’s All This About ACE2 and nCoV-2019 (COVID-2019)?

2019-nCov Vaccine Recommended Readings

Why over the next two weeks the world will learn how bad the 2019 nCoV Coronavirus Pandemic will be

Why over the next two weeks the world will learn how bad the 2019 nCoV Coronavirus Pandemic will be

I’ve made my pleas for a humanitarian response to the outbreak in China but have not underscored the reasons for serious concern. Here I outline the realities we are facing, what we know, what we don’t yet know, and why we will know much more in two weeks.

  • This virus cannot be modeled on past outbreaks of SARS. We know that compared to SARS this virus has vastly outstripped the increase in the number of cases by at least an order of magnitude if not more.
  • The symptoms of infections of this virus are atypical of other SARS-like coronaviruses.
  • There could be a 5-7 (or even up to 14, per CDC) day asymptomatic period, during which the thousands of individuals who traveled out of China would have had time to interact with and infect tens of other people, meaning tens of thousands of people would have been infected before the end of January.
  • These people are now beginning to experience
    1. Dry Cough
    2. Fever
    3. Shortness of breath
    4. Nasal congestion
  • After a few days they will experience
    1. Fatigue
  1. After a day or so more they may experience
    1. Nausea
    2. Vomiting
    3. Abdominal pain
    4. Loose stools
  1. You can hear Dr. John Campbell review some individual cases in detail in this useful video:
  1. In the critical phase, some patients begin to recover and feel better, only then to crash and become critically ill with low oxygen levels, eosinohilic and upper and lower lung pneumonia due to cellular death in the alveoli (grape-like clusters of air sacs in the lungs).
  1. Today on 2/6/2020, clearly those people would have had a chance to interact with tens of people each, potentially infected hundreds of thousand of people, who will in five more days’ time.
  2. Around the time that these individuals begin to present symptoms, some of the first cohort will be entering the critical phase of the disease. At this time, no one can predict who will progress and who will not. Originally reports from China were that the elderly and the immunocompromised were the only persons dying. Now, it’s clear that there is not any clear age-associated risk.
  3. Take, for example, the case of Dr. Wenlian Li.

Dr. Li’s report in December led the nation of China to take the SARS-like coronavirus theory seriously. He was harassed by local police and made to sign a retraction. But national government agencies took his warning serious and Li returned to work to help care for patients, and became infected. Dr. Li died today; he was 33.

Details from late January in this article reviewing clinical presentation:

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(20)30183-5.pdf

“Common symptoms at onset of illness were fever (40 [98%] of 41 patients), cough (31 [76%]), and myalgia or fatigue (18 [44%]); less common symptoms were sputum production (11 [28%] of 39), headache (three [8%] of 38), haemoptysis* (two [5%] of 39), and diarrhoea (one [3%] of 38). Dyspnoea* developed in 22 (55%) of 40 patients (median time from illness onset to dyspnoea 8·0 days [IQR 5·0–13·0]). 26 (63%) of 41 patients had lymphopenia. All 41 patients had pneumonia with abnormal findings on chest CT. Complications included acute respiratory distress syndrome (12 [29%]), RNAaemia (six [15%]), acute cardiac injury (five [12%]) and secondary infection (four [10%]). 13 (32%) patients were admitted to an ICU and six (15%) died. Compared with non-ICU patients, ICU patients had higher plasma levels of IL2, IL7, IL10, GSCF, IP10, MCP1, MIP1A, and TNFα.”

*(Dyspnoea means shortness of breath, haemoptysis means coughing up blood)

We Do Not Yet Know the Full Death Rate in China

The article above cites 15% mortality rate – but those cases are going to have been the worst cases presenting leading to suspicion of infection. The death rate outside China appears to be much lower than within China, which is at least 2% but according to some reports is in the double digits. The per-case death rate is hard to know because we do not know the accurate full number of people infected, and we also have to rely on death rate estimates from China via the WHO.

This website is going to be key to determining whether the death rate outside of China will catch up to the 2+% rate seen in China.

https://www.worldometers.info/coronavirus/

Right now the website reports 31,481 cases with 638 deaths, with 4,824 in critical condition, and 1,563 recovered. Unofficial reports of mass fatalities across Wuhei have many people convinced that the official death toll is unreliable.

Watch the Per-Case Fatality Rate Outside of China

Outside of China the apparent per-case fatality rate is still zero, with all deaths outside of China being two cases that originated in Wuhan and traveled outside of the country to Hong Kong and Phillipines. A reported death of a 22-year male in Malaysia reported to be infected with coronavirus has not been confirmed.

How will we know?

Watch the death rates in the people who have left China who are currently in quarantine.

The next two weeks will inform the world of the immediate threat of serious, deadly pandemic, or if, as I speculated, the Chinese or Asian population is somehow sensitized to 2019-nCoV or at higher risk of fatality.

Fatality rates in countries with large SARS and MERS outbreaks will tell us if the past outbreaks sensitized specific populations.

Molecular Epidemiology of Spike Protein Sequences in 2019-nCoV: Origin Still Uncertain and Transparency Needed

Here are the stats for readership of this blog for the last two weeks. Nearly 200,000 hits.

OUR INITIAL ASSESSMENT that the available 2019-nCoV sequences contained an inserted stretch of nucleotide sequences upstream from the canonical position of the Spike (or Crown) Protein Sequence in the human samples that was similar to pShuttle-SN has been under useful and productive scutiny since we first published that we, unlike other labs, were in fact able to find a match between the “middle fragment” and sequences in non-viridae databases. The match to a pShuttle-SN vector technology, which led to the assessment that perhaps the sequence was the product of an attempt to modifiy a bat coronavirus in the lab has raised controvery but please note that was not the only evidence of interest. We know of viruses within which the SARS protein gene sequence has in fact been added to study the transmission of SARS virus; it has also been added to adenovirus to create hopeful vaccine, so it is not beyond reason to consider whether the virus currently estimated to be infecting >200,000 people in China might be a product of laboratory manipulation, and the reporting of the odd out-of-place sequence in the study that proposed recombination was also important. The divergence of the nCoV Spike protein compared to the rest of nCoV and the bat coronaviruses was also compelling.

The specific mechanism by which those factors could come out is unclear. They could also been due to unwitting recombination in between a SARS virus being studied in a lab that was also studying or housing animals with bat coronaviruses. Or recombination in a human infected with both The scientific community ruled out the possibility of natural recombination in the wild, whereas I preferred to leave a 5% chance that it might have been caused by a recombination event in the wild. Importantly, I still have not ruled that out.

The official Chinese position in an article published by by Dr. Shi a “Chinese Academy of Sciences researcher in the field of bioinformatics” is that the viruses are too different in comparison to other bat coronaviruses across the genome, with random, non-patterned changes, and that there are no endonuclease sites in bat coronaviruses and thus pShuttle-SN or other endonuclease technologies could not have been used, supporting recombination in the wild. The latter statement is demonstrably incorrect, there are many endonuclease sites in bat coronavirus sequences, determined using a bat coronavirus most similar to the sequence clade in question (trees below).

Dr. Shi is correct that there are scattered differences, but evolution need not pattern anything in an orderly manner in RNA viruses, which fast evolving, and we do not yet know that a recombination event might have occurred or have been used where the recombination occurred outside the Spike protein coding sequence, within the Spike protein coding sequence, or perhaps a combination of both. Evolution does not care to “pattern” things for human consumption; evolution brings forth viruses that work to create more viruses. When recombination is suspected, artificial or real, we study evolution at the sequence level best by inheritance patterns of motifs; overall rates are, as we have seen, and will see below, frustratingly limiting.

Before we look at the evolutionary trees, I want to stress that I have published and will repeat that given the mass casualities in China and the prospect of such events around the world, keeping the possibility of one or more recombination events on the table, or even a laboratory origin of nCoV2019 is important specifically and exclusively for scientific and humanitarian purposes. As human societies often do, people will want to rush to point fingers of blame and my position is that if it’s a vaccine type gone wrong, or even a bioweapon that backfired. Let’s not by hypocritical; the US and many other countries of course have been studying the SARS spike protein for vaccines and have of course been conducting research on bioweapon. That’s no longer the point. The point is – and the only point that matters – is that we have a massive humanitarian crisis in China and therefore (1) any available data on the pathophysiology of this virus, man-made in part or in toto or not, must be brought forward, (2) China needs aid to bring R0 down below 1,0, (3) the rest of world needs to act now to stop the spread of the virus by behavioral changes including routine mass effort for santization of common surfaces and self-social isolation (don’t touch other people or your face in public). The world cares, and should care, most about putting the fire out, not who or what started it.

However, Science might help provide clues for treatments and perhaps for rapid diagnosis. As promised to many who have contacted me, we have completed a more thorough (but unfortunately not exhaustive) analysis of Spike protein seqeunces with sequences that are at hand. A note of caution: some of the sequences may be different that then ones we analyzed due to what we were informed to be “database update errors”, whatever those include. We were contacted by a person who evidently knew about a “natural” bat coronavirus isolated in July 2013 at the Institute of Virology in Wuhan, China who pointed us to a sequence available NCBI’s Nucleotide database but that had been uploaded only in January, 2020. We do not know when when the sequencing was done, whether it was a frozen sample just recently sequenced, or whether it was isolated from laboratory propagated viral lines in human cell lines. Oddly, the original gap that we found, and that was reported in the peer-reviewed study that pointed to potential recombination in snakes, and that a second, independent peer-review study also found and could not match (and called a “middle fragment” can no longer be found using the same accession numbers. I am not certain of who curates NCBI’s databases at this time, but NCBI should have a record of any evidence of un-annotated updates and I leave it to them to sort this issue out.

To help elucidate possible relationships among the available Spike proteins, based on current sequences, including the ins1378 segment, I present two phylogenetic trees, derived at https://mafft.cbrc.jp/ and rendered using phylo.io. The tree-generating algorithm was Neighbor Joining (NJ), invented by my postdoctoral mentor Dr. Masatoshi Nei, and Dr. Naruya Saitou in 1987. The tree was estimated using all variable positions, and raw differences. The Jukes-Cantor model was not used because it overweights nucleotide substitutions that might be more frequent and underweights nucleotide substitutions that might be less frequent during RNA virus evolution. N=1,000 bootstrap iterations were used to assess the confidence of the placement. Caveat: any within-sequence recombination is masked by the assumption that the process is tree-like; gappy areas were retained and not force-aligned. The full alignment is available here.

Size = 23 sequences × 1087 sites
Method = Neighbor-Joining
Distance = Raw difference
Bootstrap resampling = 1000
Alignment id = .200206212318090CHjzDGoNBMcL1glmdiZ7Plsfnormal

Tree 1 Bootstrap values.

Tree 2. Same estimated tree with branch lengths.

Clearly we see that the Spike protein from the 2019-nCoV human sequence is most similar to the sequence isolated from bat feces in the Wuhan Institute for Virology in 2013, deposited in January 2020. The next closest sequence is from the Institute of Military Medicine, Nanjing Command.

Looking a the raw distances, compared to those for the overall genome, the spike protein appears to more evolutionary labile – that is, there are more variable sites and the evolutionary distance is greater in the Spike protein-encoding sequences. The great distance between the Wuhan sequences and the other bat-like coronaviruses is distinct for the Spike protein, and contrasts with other published results. There are plenty of variable sites to have moderate confidence in this result (BSV = 82), however, compared to most bootstrap values published in coronavirus sequences and most of those in this tree, the value of 82 points to some signal other than inherited variation that covaries well with the rest of the inherited variation, just as in the original analysis with the low bootstrap value. (The higher bootstrap value here compared to the full genomic analysis placing 2019-nCoV more within the bat coronaviruses albeit with lower bootstrap values is likely due to a number of factors, include the use of a Jukes-Cantor constraint on the model of evolution in the original analysis).

The data do not support a 1:1 relationship with pShuttle-SN (as published in 2005) and the SARS-like spike protein in 2019-nCoV, and I never posited that relationship. I merely pointed out it was similar to it, when no one else could match the middle fragment to anything But the pShuttle-SN has ALSO been evolving in the lab, no doubt, and I would like to see a newly deposited sequence in NCBI’s Nucleotide database. Other vector tech has no doubt been used by other labs putting the SARS spike protein.

Parsimony (Occam’s Razor) would, with the existing sequences, tend to lead to the conclusion that the Spike protein is there simply because bat coronaviruses have Spike proteins. Does that mere fact lead to the assumption that a bat coronavirus never underwent recombination in nature or the lab (experimentally) or accidentally? No, it does not. The oddities in the behavior of the sequence data “updates” deserve further scutiny. Why would two peer-reviewed publications, one from China, mention a middle fragment that could not be aligned? These questions require transparency.

Nevertheless, the Spike protein relationships still seem to tell a different story of relationship of 2019-nCoV and related coronaviruses in Wuhan compared to published full genomic analyses that might be very important. They stand out as different, distinct. Some important limitations here are (1) all trees are estimates, not observations, and should not be used as “proof” of anything (science does not deal with “proof”;’ (2) the method assumes a tree-like relationship and cannot rule out recombination origins; (3) the method is based on limited data in terms of samples (taxon sampling). So, as always, more data may clarify.

Calls to Action for Scientists

I strongly encourage those who can to post their own analyses of the fasta file, or their own alignments, etc to the comments, especially if they are more relevant to the questions of recombination. Please understand if we cannot comment on each and every post given the flurry of activities ongoing at IPAK about this and other pressing issues.

  1. Detailed sequence-level analyses are needed to determine if there has been recombination or other editing of these sequences both inside and outside of the Spike protein region. Are there the expected number of synonymous and non-synounmous substitutions as would be expected under natural inheritance model? Is there any test that could be done to detect very important changes that might be adaptive to 2019-nCoV?
  2. Analyses capable of detecting recombination – or ruling it out – should be applied and published ASAP. Feel free to post links to any such analyses in the comment.
  3. Also, please post your own interpretation and comments, and reference other information as may be relevant.

All deposited sequences will continued to analyzed as we monitor the situation.

References

As Goes China, So Goes the World

As Goes China, So Goes the World

James Lyons-Weiler, PhD 2/5/2020

OVER THE PAST FIVE DAYS OR SO, over 150,000 people have read articles here at jameslyonsweiler.com on the 2019-nCoV.

In times of crises, the human mind want to feel that someone is in control. So it’s easier to believe that a rogue virus that may prove to have double-digit mortality in China was in fact the construct of a human being bent on world domination, or a human being bent on maximum profit from the a vaccine for the cold virus.

I’m sure both of those types of people exist. Wanting some sense of control does not influence facts.

And I’m also sure that pShuttle-SN has been used to make vaccines, including a recombined adenovirus. And I’m sure that the SARS Spike protein has been put into recombined viruses in Korea, Japan, US/Australia, Germany and likely in many other countries. I’m sure there are endonuclease sites in some bat coronaviruses close to 2019-nCoV that could be used to insert a variant Spike protein.

I’m sure that the sequences I analyzed had a large gap, I’m certain the study that published the original Wuhan sequence reported an odd sequence they could not match to any other, speculating a recombination event with snakes; I’m certain that another study also found a “middle fragment” that they also could not place. Given that I matched the INS1378 at pShuttle-SN, created in China, used in an adenovirus, the further evidence of the match between the disease progression in mice in pre-clinical trials and that which we see in the Chinese population thus far seems to me to point to prior exposure by millions to SARS spike protein somehow. A vaccine? Sure, why not, there were Phase I trials of just such a vaccine. Phase II/III? Surreptious? Maybe not, maybe so.

How about a human population sensitized to the Spike due to prior exposure, from diet, from subclinical infection, or chronic exposure to the Spike protein via infected meat, while also receiving aluminum-adjvanted vaccines?

If the areas of world that have had past outbreaks of SARS, MERS or other coronaviruses also have double-digit mortality, but areas w/out past exposure to coronaviruses have much lower mortality, I’ll be attributing that disparity to hyperimmunity.

Important message below, but NB: we forget what happened in animal safety trials at our own peril.

Must read (.pdf) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3335060/pdf/pone.0035421.pdf

There are other vaccines being studied that do not use the recombinant RSV or adenovirus with SARS spike protein added, such as mRNA vaccines that may silence the viruses’ ability to make proteins in our cells, but again their safety has not yet been fully established. They work like viruses, hijacking our cellular machinery to make more of themselves.

If these artificial viruses encode the Spike protein, they still may set us up for future high mortality due to sensitization.

My message at this time, 2/5/2020, is that no one should hedge any bets on my hypothesis that something is different in China. Give the delay in the progression of the disease, we won’t know mortality statistics for countries other than China for two weeks. We don’t really know the denominator (number of cases), nor do we know the numerators (number deaths, number of critcally ill). But we have some idea that it’s much, much worse than the official statistics.

So, my position today is: As China goes, so goes the rest of the world. Which means, as I argued for with Ebola, we all have a humanitarian calling right now to HELP CHINA, but we also have a selfish reason to want to help China, if anyone needs one.

Sure, we may “need” our supplies. But 200,000 cases is nothing compared 1.1 billion cases. China needs them more.

We all need to assume each and every person we touch, and ourselves, are contagious. Practice say “hello” by bumping elbows. Public places should designate and hourly “sanitary custodian” to wipe down all common shared surfaces with bleach-containing wipes. As in Ebola, don’t raise your hands above your shoulders – keep your hands away from your face. Don’t shake hands, hug or kiss. If you’re sick, wear a mask in public (they won’t help if you’re not infected). Work from home if you can. Every moment spent alone, or with one other with who you are intimate, is less opportunity for 2019-nCoV. Start NOW.

CDC has some recommendations but they are as of this date not aggressive enough on isolation.

We need too send a message of hope to the people of China that they are not alone.

We need to send aid – human helping hands – to help China bring R0 down to zero.

Volunteers to sanitize shared, common surfaces.

People to help comfort, feed and wash the ill and to bury the dead.

Regardless of the source of this virus, we need to help China see the world as a loving place.

And scientists around the world studying Coronaviruses with any unpublished data need to bring those data forward – including any knowledge on the disease progression of this virus.

This virus’ Spike protein appears to be most similar to that from an isolate from the Institute of Virology in Wuhan, China. Its next closes cousin appears to be from an isolate from the Institute of Military Medicine, Nanjing Command, China.

What does that tell us? Not much except these two labs have viruses that are the most similar to 2019-nCoV with respect to their Spike proteins. The Institute of Virology published a sequence in January 2020 from a fecal sample isolated from bat feces in July 2013. Are they propagating the virus in human cell lines? Mice? Rats? We cannot settle “common lab origin” vs. “common ancestor in the wild”. Both samples would have an common ancestor in the wild, would they not?

There is a lot of diversity in the Spike protein across all coronaviruses, much more than is seen in the other genes in the genome.

What does that tell us? Nothing for or against the hypothesis of genetically modified coronavirus. These areas would evolve most quickly in a setting where interpspecies transfers are common: they evolve to be able to enter cells in a new species, and evolve the ability to infect different types of tissues based on the receptors on the surfaces of those cells.

These facts do, however, point to the two most important laboratories on the face of the earth right now: Wuhan Institute of Virology and the Institute of Military Medicine Nanjing Command, China. If they have ANY animal studies on the disease progression of their specific isolates most similar to 2019-nCoV, they should bring those data forward. Any information an antiviral drugs, interference RNA treatments, or the relative efficacy of any treatment at all, they should bring them forward.

As should any laboratory in the world has experimented with recombined viruse with S-proteins related to 2019-nCoV.

If the Chinese believe their population is highly sensitized, they should say so, because the rest of the world will be more likely to send much-needed supplies. As I said, this could be due to chronic exposure to bat coronaviruses in a population with long-term peristant adjuvants in their bodies, such as aluminum. Or it could be due to past vaccine experiments. It really does not matter at this point except we need to know what we can expect as 2019-nCoV in the rest of the world.

Yes, China, there are endonuclease sites in some bat coronaviruses that could be used to insert a variant of SARS spike protein, I checked.

But here’s the rub – while everyone’s focused on “recombination in the wild” or “recombination in the lab” – what about “recombination is humans”?

A human origin scenario for 2019-nCoV would go like this:

A laboratory worker working with propagated isolated culture of a bat coronavirus accidentally becomes infected while also have, or a loved one has a SARS infection. Or two laboratory worker cross-infect each other accidentally.

The callous will say I’m accusing Chinese research of sloppy protocol. There’s not time right now for that.

Because we had better act as if as goes China, so goes the world.

And we had better remember the outcome of animal studies that used recombined viruses with SARS spike proteins – immunity, but at the cost of high mortality upon secondard infection.

Listen to my plea for action to help the Chinese and to Gary Null and I discuss how to avoid the Coronavirus on the Gary Null Show. I make the case for a recombined origin, perhap using pShuttle-SN. I don’t want to overstate that case – listen til the end.

https://www.podbean.com/eu/pb-3zzz5-d27d68

Moderately Strong Confirmation of a Laboratory Origin of 2019-nCoV

Moderately Strong Confirmation of a Laboratory Origin of 2019-nCoV

James Lyons-Weiler, PhD 2-2-2020

UPDATE – 2/9/2020 – IPAK HAS CONDUCTED FURTHER, IN-DEPTH STUDIES OF THE GENOMIC AN PROTEIN SEQUENCES OF THE 2019-nCoV CORONAVIRUSES AND THEIR RELATIVES AND HAVE COMPELLING RESULTS OF A KEY SIGNATURE USEFUL FOR IDENTIFYING A PARTICULARLY PATHOGENIC CORONAVIRUSES LINEAGE. GIVEN THAT WE HAVE FOUND THIS SIGNATURE, A FUNCTIONAL MOTIF FINGERPRINT, PRESENT IN THE HK-3 CoV FROM 2005, WE BELIEVE THIS EXONERATES RECOMBINATION IN THE LAB AS A SOURCE OF THE VIRUS. THIS DOES NOT EXONERATE ACCIDENTAL RELEASE, HOWEVER. WE ARE WORKING TO PUBLISH OUR FINDINGS.

IN THE INTEREST OF TRANSPARITY, WE ARE KEEPING THE ARTICLE BELOW AS ORIGINALLY PUBLISHED FOR POSTERITY AND PROVENANCE. – JLW

Dr. Marc Wathelet commented that he was puzzled about my report of a spike protein gene homologous to part of the pShuttle-SN vector, given that spike glycoproteins are found in bat coronavirus. He urged me to analyze the homology (sequence similarity) of the SARS-like spike protein element I reported with other spike proteins, saying that any scientist working on coronviruses would be surprised if there were not a spike protein.

I replied in comment that I, too, would expect protein sequence level homology due to shared conserved domains, but assured him that I would undertake further genome sequence-level (nucleotide) analysis as the location of the novel sequence relative to the other spike proteins is certainly of interest.

A few recent publications (sent to me by followers/readers) contained further bat coronavirus accession numbers, and SARS accession numbers, so I procured the spike protein coding sequence (CDS) of these from NCBI’s nucleotide database and aligned them using Blast, with the sequence from the first 2019-nCoV protein as the anchor. (Oddly, that Genbank entry does not label the S protein CDS as a spike glycoprotein, instead annotating it only as a “structural protein”).

The resulting massive alignment confirms a major unique inserted element in 2019-nCoV not found in other bat coronaviruses, nor in SARS in the homologous genomic position:

This is why full genome phylogenetic trees cannot tell the full story of recombinant viral evolution.

Blasting the novel sequence region against all non-viral sequences (to pick up vector technology) again results in pShuttle-SN (no surprise) but now this time is also picked up a recombinant coronavirus clone Bat-SRBD spike glycoprotein gene from UNC, USA. (Genbank entry) and other synthetic constructs.

As I published earlier, before anyone points fingers at the Chinese, note that recombinant viruses have been in play in laboratories all across the world in many nations.

The overlap occur at the 3′ end of the novel region (search restricted from 21600-22350 bp in the query 2019-nCoV sequence originally blasted against the other coronavirus CDS. It could arguably merely be that I selected too large a region; I chose the region visually to include the fully potentially inserted sequence including any homologous vector elements at the 5′ or 3′ end.

It is worth pointing out that due to the length of overlap, the sequence strength is considered moderately strong: highly significant E-value, high %identity, but short sequence length. These findings cannot be considered strong validation for obvious reasons: produced by the same analyst, using (part) of the same data. Spike proteins determine receptor binding for entry into cells, and 2019-nCoV appears to, like some bat species SARS coronavirus, target ACE2 receptors [1].

For those tracking closely, I confirmed that the novel inserted sequence in the large alignment above is the same as the novel sequence I reported a few days ago. The sequence of interest is here.

[1] Hou et al., 2010. Angiotensin-converting enzyme 2 (ACE2) proteins of different bat species confer variable susceptibility to SARS-CoV entry Arch Virol 155:1563-1569

https://www.msi.umn.edu/~lifang/otherflpapers/bat-ace2-archivesofvirology-2010.pdf

These results do show, however that the novel sequence is not likely present in other coronaviruses.

Thus, it still seems prudent that this inserted sequence in 2019-nCoV become the focus on urgent research, and that laboratory sources be included in the search for the origins of 2019-nCoV and potential targets for treatments and expected pathophysiology in patients infected with 2019-nCoV.

I am grateful to Dr. Wathelet for this inquiries and requests for additional clarification.

RECOMMDED RELATED:

CLEAR EVIDENCE it is NOT a Bioweapon. So What’s All This About ACE2 and nCoV-2019 (COVID-2019)?

2019-nCov Vaccine Recommended Readings

Why over the next two weeks the world will learn how bad the 2019 nCoV Coronavirus Pandemic will be

On the Oddities and Unusual Characteristics of the 2019-nCoV Virus Genomes and Their Analyses

On the Oddities and Unusual Characteristics of the 2019-nCoV Virus Genomes and Their Analyses

James Lyons-Weiler, PhD – 2/1/2020

UPDATE – 2/9/2020 – IPAK HAS CONDUCTED FURTHER, IN-DEPTH STUDIES OF THE GENOMIC AN PROTEIN SEQUENCES OF THE 2019-nCoV CORONAVIRUSES AND THEIR RELATIVES AND HAVE COMPELLING RESULTS OF A KEY SIGNATURE USEFUL FOR IDENTIFYING A PARTICULARLY PATHOGENIC CORONAVIRUSES LINEAGE. GIVEN THAT WE HAVE FOUND THIS SIGNATURE, A FUNCTIONAL MOTIF FINGERPRINT, PRESENT IN THE HK-3 CoV FROM 2005, WE BELIEVE THIS EXONERATES RECOMBINATION IN THE LAB AS A SOURCE OF THE VIRUS. THIS DOES NOT EXONERATE ACCIDENTAL RELEASE, HOWEVER. WE ARE WORKING TO PUBLISH OUR FINDINGS.

IN THE INTEREST OF TRANSPARITY, WE ARE KEEPING THE ARTICLE BELOW AS ORIGINALLY PUBLISHED FOR POSTERITY AND PROVENANCE. – JLW

WHEN PHYLOGENETICISTS use sequence data to derive an overall phylogenetic relationship among organisms of viruses, the resulting tree-like pattern is called a phylogenetic tree. In my review of the analysis of the Wuhan coronavirus 2019-nCoV isolated from humans, I emphasized the lack of strong phylogenetic signal from a low “bootstrap” value (100 being highest, <80 usually considered a sign of either insufficient data or something else, like recombination.

That 76 bootstrap value was paired with a de novo appearance of a sequence encoding a SARS-like protein in a virus derived from a bat coronavirus. I had attributed much significance to this finding, as should the rest of the world (i.e., do not reject that the 2019-nCoV is a product of recombination.

There are two ways on this planet for viruses to recombine: in nature, via co-infection with a common host, and in the laboratory. I evaluated the likelihood of those two outcomes two days ago, and the article went viral, helped by the coverage by the Highwire team. Some have misinterpreted the article as saying that I have ruled out a bioweapons origin; however, I have not. The level of evidence supporting an accidental laboratory release of vaccine type, or of a bioweapon, or of a vaccine experiment gone wrong, sensitizing people to serious illnesss and death upon subsequent exposure, are all about the same. What gives a vaccine program the edge is the match between the outcomes in SARS vaccine research in animals and the symptoms and mortality profile of nCoV in humans.

Researchers have been putting SARS protein-encoding genes into viruses since at least 2005. Here’s a study of the use of a SARS-protein gene put into an adenovirus. Here’s another. And they have been putting SARS protein gene sequences into viruses to try to develop vaccines.

Before anyone blame Chinese researchers, one study is from China, another from Korea. German scientists have conducted similar research, and I’m sure the US has, and researchers around the world. Here’s a group of scientists in the US putting the bat coronavirus spike protein into a mouse-adpated SARS.

The placement of 2019-nCoV in a phylogenetic tree nestled within the bat coronaviruses might be assuage some into thinking that there merely been a zoonotic event – transfer of a virus from an animal host to humans – and that therefore the risk of worldwide pandemic from a weaponize or vaccine research or vaccine-escaped coronovirus is low. But it does not.

A new study out of China gives a phylogenetic tree w/out bootstrap values and their result clusters 2019-nCoV within bat coronaviruses, and, oddly, with SARS coronaviruses. This is odd because the prior analyses had placed 2019-nCoV clearly within the bat coronaviruses to the exclusion of SARS coronaviruses. The new Chinese study points to a bat coronavirus as the virus for which we have data that is most similar to 2019-nCoV: HKU9-1.

So let’s look at the neighbors in the tree, HKU9-1, aligned to 2019-nCoV:

HKU9-1 graphical alignment to 2019-nCoV from Wuhan, China (IPAK result)

See the DOT-plot showing the gaps and the overall gaps shows a disrupted match as well.

It’s all broken up with large gaps of missing sequences. Read how the authors of the paper attribute to multiple rounds of natural recombination “blurring” the relationship:

These scientists are speculating exclusively about natural recombination events, when the sequence they are analyzing has major genomic differences partly inconsistent with the most recent common ancestory of the 2019-nCoV being HKU9-1, in a world in which laboratory recombination research into viruses to make vaccines is 100% known to be ongoing.

We can say with certainty that 2019-nCoV has at least two ancestors: the ancestry of the entire genome, and the ancestry of the SARS spike protein.

I discount the wild recombination idea because natural selection would likely remove individual animals if the recombination occurred in nature due to high mortality. So recombination in the wild is purely speculative.

This looks like an attempt to develop a vaccine to me.

“HIV Sequences” Unsurprising – Maybe

A report of four additional sequences put into the Spike protein, which at the amino acid level are short sequences, but that the nucleotide level are, combined, improbably there by chance, point more toward a bioweapon. The E-values of the match to the HIV sequences are not significant, and there are many more matches to other non-HIV sequences. The presence of all four sequences, the pathogenetic capacity of those additonal novel sequences of are unknown, are of interest to some, but most who understand sequence analysis will attribute their matching to chance.

So who, or what, put SARS spike glycoprotein sequence into 2019-nCoV remains a mystery. Al coronaviruses in all laboratories in China, and around the world for that matter, should be sequenced and in the name of transparency they should all be published so we can all determine the most likely origin. All focus on the origins of the 2019-nCoV virus should include laboratory origin as a leading hypothesis.

RECOMMDED RELATED:

CLEAR EVIDENCE it is NOT a Bioweapon. So What’s All This About ACE2 and nCoV-2019 (COVID-2019)?

2019-nCov Vaccine Recommended Readings

Why over the next two weeks the world will learn how bad the 2019 nCoV Coronavirus Pandemic will be

On the Origins of the 2019-nCoV Virus, Wuhan, China

On the Origins of the 2019-nCoV Virus, Wuhan, China

James Lyons-Weiler, PhD – 1/30/2020

UPDATE – 2/9/2020 – IPAK HAS CONDUCTED FURTHER, IN-DEPTH STUDIES OF THE GENOMIC AN PROTEIN SEQUENCES OF THE 2019-nCoV CORONAVIRUSES AND THEIR RELATIVES AND HAVE COMPELLING RESULTS OF A KEY SIGNATURE USEFUL FOR IDENTIFYING A PARTICULARLY PATHOGENIC CORONAVIRUSES LINEAGE. GIVEN THAT WE HAVE FOUND THIS SIGNATURE, A FUNCTIONAL MOTIF FINGERPRINT, PRESENT IN THE HK-3 CoV FROM 2005, WE BELIEVE THIS EXONERATES RECOMBINATION IN THE LAB AS A SOURCE OF THE VIRUS. THIS DOES NOT EXONERATE ACCIDENTAL RELEASE, HOWEVER. WE ARE WORKING TO PUBLISH OUR FINDINGS.

IN THE INTEREST OF TRANSPARITY, WE ARE KEEPING THE ARTICLE BELOW AS ORIGINALLY PUBLISHED FOR POSTERITY AND PROVENANCE. – JLW

RECOMBINATION technology has been in use in molecular virology since the 1980’s. The structure of the 2019-NCoV virus genome provides a very strong clue on the likely origin of the virus.

Unlike other related coronaviruses, the 2019-nCoV virus has a unique sequence about 1,378 bp (nucleotide base pairs) long that is not found in related coronaviruses.

Looking at the phylogenetic tree recently published derived using all the full genome sequence, we see the 2019-nCoV virus does not have clear monophyletic support given the bootstrap value of 75 (Fig 1).

Close-up on Bootstrap value of 75 for available 2019-nCoV from Lu et al., 2020 The Lancet article [Full Text]

There is no doubt that there is a novel sequence in 2019-nCoV; we confirmed this via sequence alignment. Here’s the DOT plot:

The gap in the line shows a lack of sequence homology beween the most similar bat coronavirus and 2019-nCoV. The inserted sequence, which should not be there is here:

A database search by the first team to study and publish the whole genome sequence for the origins of the inserted sequence turned up no hits (Ji et al., 2020). They conducted a codon-bias analysis which led them to speculate that perhaps there had been a recombination event between a coronavirus in snakes with a coronavirus from bats (Ji et al., 2020). [Full Text]

This led to criticism on Wired(3) with quote dismissing the snake origin hypothesis as lacking evidence. There is, however, clear evidence that the novel sequence, which I will refer to henceforth as INS1378, is from a laboratory-induced recombination event. Specifically,

(1) The sequence similarity to other coronavirus sequences is lower to its most similar sequences in any coronavirus than the rest of the genome (IPAK finding)

(2) The high sequence similarity of INS1378 to a SARS spike protein (2; IPAK Confirmed).

(3) We also found significant sequence similarity of INS1378 to a pShuttle-SN vector that was in use in the 1980’s in China to create a more immunogenic coronavirus (IPAK finding, details below, Option 4).

Here, I review four Option on the origins of the 2019-nCoV Coronavirus isolated from human patients from Wuhan, China.

Option 1. Natural coronavirus related to bat coronaviruses, Not a Recombined Virus.

Evidence for: Phylogenetic clustering with Bat coronaviruses.

Evidence against: Low bootstrap support (N=75) and presence of a INS1378.

Status: Falsified hypothesis.

Test: Survey coronviruses in animals in the wild.

Option 2. A recombined virus that naturally picked up a SARS-like spike protein in it N-terminus (3′ end) of the viral genome.

Evidence for: The INS1378 codon bias similar to snakes ($)

Evidence against: Insufficient match in database search to other known CoV spike proteins (Ji et al., 2020)

Status: Speculative hypothesis. Unlikely.

Test: Find an isolate that matches 2019-nCoV in the wild and reproducibly independently isolate the virus from a wild animal (a match will confirm).

Option 3. A recombined virus made in a laboratory for the purpose of creating a bioweapon.

Both China and the US hinted at the other side’s potential liability in playing a role in bringing about a novel coronavirus in the lab specifically for the purpose of being used as a bioweapon. To add to the intrigue, a Chinese Scientist was released from BSL-4 laboratory in Manitoba, Canada for violating protocols, allegedly sending samples of deadly viruses to mainland China.

On January 26, The Washington Times published this article citing an Israeli defense expert claiming that China has likely proceeded with a bioweapons program, but ending the article with a quote to London’s Daily Mail from a US scientist Rutgers University microbiologist Richard Ebright that “at this point there’s no reason to harbor suspicions” that the lab may be linked to the virus outbreak.

The same person was quoted in a Feb 2017 Nature article stating that SARS had escaped the Wuhan a facility in Beijing (corrected 2/2/2020) “multiple times”.

Evidence for: Presence of BSL-4 laboratory 20 miles from the Wuhan seafood market

Evidence against: Published opinion.

Status: Rumor. But see below.

Option 4. A recombined virus made in a laboratory for the purpose of creating a vaccine.

IPAK researchers found a sequence similarity between a pShuttle-SN recombination vector sequence and INS1378. Here’s a shot of the alignment and the DOT Plot.

Here’s the nucleotide sequence at NCBI’s Nucleotide database. Here’s a patent for its use in recombination virology.

The pShuttle-SN vector was among many described in a 1998 paper by Bert Vogelstein et al; here is a company where one can purchase the pShuttle-SN vector: {CORRECTION: THE P-SHUTTLE VECTOR PLASMID WAS DESCRIBED BY VOGELSTEIN ET AL; THE PSHUTTLE-SN VERSION IS WAS PUBLISHED IN 2005 AS CITED AT THE ADDGENE PAGE; THE RECOMBINED ADENOVIRUS PATENT LINK CITES P-SHUTTLE-SN AS WEL IN USE FOR INSERTING SARS SPIKE PROTEINS INTO OTHER ORGS }

It turns out that the sequence from pShuttle is most closely related to the Spike protein from SARS coronavirus.

This particular technology was used in 2008 to attempt to develop a more immunogenic vaccine against coronavirus. Here’s a Chinese patent for that technique and product intended for use in a vaccine.

The patent summary reads:

SARS vaccine of adenovirus vector and preparation method, application of coronavirus S gene
Abstract
(translated from Chinese)
The present invention belongs to the field of genetic engineering, particularly relates to adenoviral vector SARS vaccines, their preparation and coronavirus S genes in SARS (SARS) on vaccines for the prophylaxis. By means of biological engineering, the coronavirus S gene in combination with deficient recombinant adenovirus, the protective immunogen protein or polypeptide expressed therein, through expansion culture, purification, and formulation to prepare a mucosal immunogenicity can cause the gene vaccine, respiratory mucosal immune response induced by the body to produce antibodies against the virus infection. Specific conditions of the present invention, compared with conventional inactivated virus particle vaccine, safe, easy to use, without limitation intramuscular, have broad clinical applications.

In 2015, The US called for an end to research creating new viruses in the lab that have increased threat (higher transmissibility, higher pathogenicity, higher lethalithy) (3)

The very researchers conducting studies on SARS vaccines have cautioned repeatedly against human trials;

“An early concern for application of a SARS-CoV vaccine was the experience with other coronavirus infections which induced enhanced disease and immunopathology in animals when challenged with infectious virus [31], a concern reinforced by the report that animals given an alum adjuvanted SARS vaccine and subsequently challenged with SARS-CoV exhibited an immunopathologic lung reaction reminiscent of that described for respiratory syncytial virus (RSV) in infants and in animal models given RSV vaccine and challenged naturally (infants) or artificially (animals) with RSV [32], [33]. We and others described a similar immunopathologic reaction in mice vaccinated with a SARS-CoV vaccine and subsequently challenged with SARS-CoV [18], [20], [21], [28]. It has been proposed that the nucleocapsid protein of SARS-CoV is the antigen to which the immunopathologic reaction is directed [18], [21]. Thus, concern for proceeding to humans with candidate SARS-CoV vaccines emerged from these various observations.” – Tseng et al.,

The disease progression in of 2019-nCoV is consistent with those seen in animals and humans vaccinated against SARS and then challenged with re-infection. Thus, the hypothesis that 2019-nCoV is an experimental vaccine type must be seriously considered.

Evidence for: Sequence homology between INS1378 to pShuttle Coronavirus vaccine; presence of a SARS-like Spike protein in bat coronavirus, otherwise most similar to bat coronaviruses; low bootstrap value.

Evidence against: Low sequence homology (but highly signifiant). NB these viruses are RNA viruses and they can evolve quickly, even under laboratory conditions.

Status: Most likely.

Test: Determine the nucleotide sequence all laboratory types of coronavirus being studied in China (a match will confirm). Find an isolate that matches 2019-nCoV in the wild and reproducibly independently isolate the virus from a wild animal (a match will falsify).

The available evidence most strongly supports that the 2019-NCoV virus is a vaccine strain of coronavirus either accidentally released from a laboratory accident, perhaps a laboratory researcher becoming infected with the virus while conducting animal experiments, or the Chinese were performing clinical studies of a Coronavirus vaccine in humans.

Dr. Dale Brown brought to my attention the studies that have reported serious immunopathology in animals – rats, ferrets, and monkeys – in which animals vaccinated against coronoviruses tended to have extremely high rates of respiratory failure upon subsequent exposure in the study when challenged with the wild-type coronavirus.

“Caution in proceeding to application of a SARS-CoV vaccine in humans is indicated”- Te et al., 2012 [Full Text]

Yasui et al., (2012) reported severe pneumonia in mice who were vaccinated against SARS who were subsequently infected with SARS.

Another study of a double-inactived SARS vaccine found increased eosinophilic proinflammatory responses in vaccinated mice, especially older mice, writing:

“Importantly, aged animals displayed increased eosinophilic immune pathology in the lungs and were not protected against significant virus replication.”

If the Chinese government has been conducting human trials against SARS. MERS, or other coronviruses using recombined viruses, they may have made their citizens far more susceptible to acute respiratory distress syndrome upon infection with 2019-nCoV coronavirus.

The implications are clear: if China sensitized their population via a SARS vaccine, and this escaped from a lab, the rest of world has a serious humanitarian urgency to help China, but may not expect as serious an epidemic as might otherwise be expected.

In the worst-case scenario, if the vaccination strain is more highly contagious and lethal, 2019-nCoV could become the worst example of vaccine-derived contagious disease in human history. With an uncharacteristic aysmptomatic prodromal period of 5-7 days, individuals returning from China to other countries must be forthright and cooperative in their now-prescribed 2-week quarantine.

RELATED: Moderately Strong Confirmation of a Laboratory Origin of 2019-nCoV

Citations

Lu, R et al., 2020. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding The Lancet. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2820%2930251-8/fulltext

Tseng et al., 2012. Double-Inactivated Severe Acute Respiratory Syndrome Coronavirus Vaccine Provides Incomplete Protection in Mice and Induces Increased Eosinophilic Proinflammatory Pulmonary Response Upon Challenge https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3209347/

Te et al., 2012. Immunization with SARS coronavirus vaccines leads to pulmonary immunopathology on challenge with the SARS virus. PLoS One 7(4) https://www.ncbi.nlm.nih.gov/pubmed/22536382

Yasui et al., Prior immunization with severe acute respiratory syndrome (SARS)-associated coronavirus (SARS-CoV) nucleocapsid protein causes severe pneumonia in mice infected with SARS-CoV. J Immunol. 181:6337-48 https://www.ncbi.nlm.nih.gov/pubmed/18941225 https://www.jimmunol.org/content/181/9/6337.long

RECOMMDED RELATED:

CLEAR EVIDENCE it is NOT a Bioweapon. So What’s All This About ACE2 and nCoV-2019 (COVID-2019)?

2019-nCov Vaccine Recommended Readings

Why over the next two weeks the world will learn how bad the 2019 nCoV Coronavirus Pandemic will be

Scientist Demands Apology and Retraction from CBC’s Marketplace

Scientist Demands Apology and Retraction from CBC’s Marketplace

Sent: 1/27/2020

Dear Marketplace Team and CBC Leadership,
I am writing to formally request a retraction and correction and request that you issue apologies for misrepresentation of the events which occurred at the VIP Event following the VIE Event in Washington, DC late last year.


I have, and the public has, scrutinized both your online written and video versions of coverage of the conversation I had with your reporter in which I explained – at some length – how IPAK runs Science Days – events at which I educate the public on peer-reviewed and forthcoming science from IPAK, The Institute for Pure and Applied Knowledge, in Pittsburgh, PA, USA.  We have found your representation of that conversation at striking odds with reality.  While the entire coverage leaves much to be desired in terms of factual content and objectivity, I am writing only with respect to aspects that directly impact me, my reputation, and potentially my livelihood.


First, your video coverage left off my phrase “If you want to support IPAK” – which specifically and obviously means if you want to support biomedical research. IPAK conducts objective scientific research in the public interest, and we have peer-reviewed publications from 2017-2020 of which any competent investigative reporting team would be aware.
Second, your written coverage clearly misattributed a phrase about “quid pro quo” to your reporter, and then put words in my mouth: “right”. In fact, when I describe “IPAK Science Days” to individuals requesting information such as that requested by your reporter, I am always careful to use the phrase “That way it’s NOT a quid pro quo”.  The online written version is therefore incorrect.  I categorically deny saying “Right”.  This is the lowest form of yellow journalism available to you.


Unfortunately, your highly edited video also leaves the impression that I, or someone, is saying “So we have a quid pro quo” because in the video caption, the quotation is in incorrect and the attribution to a speaker is ambiguous.  That video is highly edited because, I believe, if the actual video was shown, my mouth would be seen forming an ‘O’ shape on the word “No” in the phrase “No quid pro quo”.


People not affiliated with IPAK have contacted me since your airing and reminded me of past conversations in which I say (1) I do not charge to appear at local events at which I educate committees or elected officials interested in matters relevant to my research, (2) IPAK would run a local event to also educate the public, and charge a fee (donation), and (3) That way there is NO quid pro quo.


According to the Legal Dictionary, “Quid pro quo, or the exchange of valuable consideration, is required for the formation of a valid contract between individuals who are not merchants. This requirement of mutual consideration, or the exchange of something of value, indicates the sincerity of the parties’ intent to adhere to the contract between them.”
For me to say “That way there is no quid pro” is to assert, as I should, that although I may become physically located where it is convenient for me to offer education in public comments on matters related to my research, it is not intended, nor should it be expected, that I will necessarily testify nor comment in any way favorable to or in opposition to any particular vote, ruling, or legislation being considered.  Your reporter and I never discussed any details at any time of the nature of any specific comments or positions on legislation during or after the event. In fact, your reporter and I never discussed any legislation, or hearing, or committee meeting pending on any issue. Your reporter only asked about how to get me to Western Provinces in Canada, where he claimed to be organizing vaccine-interested groups.  Given that any such groups should form their positions on Science, the IPAK educational events themselves are of sufficiently high value that registrants who donate to IPAK will have received solid, well-referenced facts and my considered opinion on those facts from scientific studies.  There is never, however, any requirement of donations, and volunteers at such events are always instructed to allow anyone in regardless of their ability to donate.


Your coverage implies that I would be supplanting the value of the public service provided by the formal IPAK events I offer with the value of my uncontrolled, uninfluenced, self-generated testimony or opinion to panels, committees or legislative bodies,  I assure you and assert that was the opposite of my intent of discussing “quid pro quo” so as to avoid any such confusion and to prevent your reporter (posing as an activist) from presuming that I could be influenced in what I say in any way based on any donations that might (or might not) be received associated with such an event.  My comments are my own, personally, and I when I do educate legislators and public health officials, I always refuse to offer any opinion on pending legislation, in keeping with my understanding that individuals who operate not-for-profit organizations should not directly advise on pending legislation.


Your characterization of IPAK offering local educational events as a form of quid pro quo transaction is your own construction, and is inaccurate with respect to intent and to legal definition, and it is clear that your manipulation is intended to provide a falsehood that might be used to impede my participation at such events in the future.  Apologies and retraction via editing are both in order.


Your reporter also hurtfully and irresponsibly claimed in the published video report that I “want to be seen as a Scientist”.  I attach my NIH Curriculum Vitae which includes my past and present employment.  I have served on US NIH grant review panels and have assisted various funding agencies in their writing of issued calls for proposals.  I brought in >$27.5 million in collaborative funding while Full Faculty under Dr. Ronald Herberman at the University of Pittsburgh Cancer Institute.  I founded and ran the University of Pittsburgh’s Bioinformatics Core with support from the Dean of the School of Medicine and the Senior Vice Chancellor of the University of Pittsburgh.  I have advised graduate students and served on PhD dissertation committees. I have over 50 peer reviewed research studies, a fact that any competent investigative reporter would have discovered with a simple search of any number of research publication databases, including the US NCBi’s Pubmed:


Search NCBI’s Pubmed for AU=”Lyons-Weiler”

To date, none of my research studies have been retracted.  I am now, and will die, a Scientist, regardless of your reporter’s insensitive and uninformed implication that I am not.


I specifically request an apology from that reporter, and the team for failing to research my background and for failing to reach out to me for information on my resume and for calling my credentials and my lifelong service to Science in question.  A deep search in the Canadian Ministry of Science records should turn up my name on a collaboration while I was full faculty at the University of Pittsburgh Cancer Institute on a consortium that worked on a grant proposal which led to successful funding of Canadian scientists for the study of metastatic breast cancer.  I suggest you might be able to request and confirm said information from Dr. Arun Seth of the University of Toronto (cc’d).  A more in-depth look at my past will reveal that I was the Founding Editor-in-Chief of the international research journal, Cancer Informatics, and that my scientific integrity caused me to lead a revolt against the publisher to secure and protect the bona fide peer review process I had established upon founding the journal when lesser scientists proposed corrupting that process.  I have been a defender of Science in the public interest for some time and am now Editor-in-Chief of Science, Public Health Policy & the Law.


We have numerous ongoing and active studies at IPAK, including an IRB-approved “Vaccinated vs. Unvaccinated” study looking at the risk of chronic health outcomes. I am also currently working with Dr. Chris Shaw (University of British Columbia) in attempts to fund his laboratory to conduct dose escalation studies of aluminum hydroxide in infant mice – specifically because neither of our government’s regulatory agencies have pursued research capable of determining a per-body weight dose limit of aluminum hydroxide, an adjuvant used in about 60% vaccines recommended by US CDC pediatric schedule.  IPAK has estimated a per-body weight informed pediatric dose limit leading to two peer-reviewed publications (attached), in one of which we have estimated the number of days infants are in aluminum toxicity under the US CDC’s recommended schedule.  That estimate is 70% of days in the first seven months of life, and 25% of days in the first two years of life.  By comparison, under an alternative plan, infants are expected to be in aluminum toxicity 5% of days in the first seven months of life.  I will continue to try to fund Dr. Shaw’s research with a new Autoimmune Research Fund initiative at IPAK until we have successfully determined the dose effect of injected forms of aluminum in infant mice, a gaping hole in vaccine science.
I would expect that Canadian legislators, committees, and the public would want to make decisions on policies about the use or non-use of competing vaccination technologies and options on Canadian children, which is why I came to New Brunswick, at my own personal expense, and offer my insights in New Brunswick on August 27 2019.


Dr. Lyons-Weiler’s Testimony in New Brunswick, Aug 27, 2019 (Video)


I had no prior agreement for payment of any kind to me personally nor to IPAK with any Canadian citizen or Citizen’s group for my trip to New Brunswick, and I restricted my comments to what I know of the state of vaccine safety science.  I offered no “IPAK Science Day” associated with that event.  There is never any quid pro quo.


I believe it is in CBC’s best interest, and in the interest of the public’s view of the Marketplace team’s journalistic integrity, and in the interest of the public, that you issue an apology, retract and re-issue your edited and updated online written coverage, that you remove, edit and update the online video, also with an announcement of a correction in the first few minutes of the video, and include in both locations a copy of the apology letter addressed to me,  “Dr. Lyons-Weiler”, signed by all reporters and editors involved in both the online and video version.


I urge your team to conduct a more complete inquiry into the backgrounds of those you are targeting to spare others of the pain and suffering caused by your thoughtless and callous handling of my reputation.  It does not serveyour national reputation for CBC to misquote, misattribute, nor to misrepresent and malign the character and integrity of a productive citizen, to misrepresent the career title of any person you feature in a “news” video.  


I strongly advise you that your treatment of me as a professional has certainly done a disservice to your character as a team, and to CBC as a serious news organization.


Sincerely,


James Lyons-Weiler, PhD

Working Scientist, Father

CEO/Director/Scientist

The Institute for Pure and Applied Knowledge

Podcast: UnbreakingScience.com

Invite Your Public Health Officials to the Emergency IPAK HPV Vaccine Science Crisis Webinar

Date of Webinar: 2/1/2020

Time: 3PM EST

James Lyons-Weiler, Pittsburgh, PA

To invite your Public Health Officials, send them the link to this blog article.

In a stunning revelation and a hopeful lean toward objectivity, a study reviewed by The Independent (See:”Cervical cancer rises among young women as progress on deadly disease ‘stalls’) brings forward results that I and others have predicted and reported: a net increase in cervical cancer rates in populations vaccinated against HPV. I first wrote about HPV type replacement in an article that was picked up by a number of news outlets (notably Epoch Times). I also then wrote further about type replacement, and penned an article on LinkedIn highlighting the increase in cervical cancer data in the UK.

In 2018, I sued the Allegheny County Board of Health for what I considered – and still consider – to be a violation of PA’s Sunshine (Open Meetings) act. I won a ruling from a judge that the stated that ACBOH’s non-binding resolution was null and void ab initio. The case cost me about US$15K. I sued neither for damages nor for monetary settlement for harm (nearly being arrested for exercising my citizen’s right to ask for a clarification on procedure was distressing; see Video).

I also did not hold out for an admission of wrong-doing. I simply wanted to correct a requirment not met by the ACBOH to call for open comments prior to voting for a motion, and for not advertising the specific motion in its minutes prior to the meeting. [NB: As of this writing, The Board of Health is still distributing their recommendation on their website with an active link, in violation of the rules governing their communications to the Public]

Why would a person spend so much time, energy and effort on an issue to repair a technical glitch?

It wasn’t that I was nearly arrested for requesting a point-of-order clarification. It’s not that I have any personal vendetta against any on the ACBOH, although I, and others, do find Dr. Lee Harrison’s repeated failure to report conflicts of interest related to HPV vaccines concerning and a likely source of bias in his decision to initiate a mandate of the HPV Vaccine in Allegheny County.

I sued because Public Health Officials serve and answer to the Public – and the public understands the reality of HPV vaccine science than they do. Board of Health members merely rely on CDC’s position on vaccines, which is one-sided, and they should be expected to understand the full body of science and form their own positions on recommendations for which they vote for, or against.

Reliance on CDC is risky. In fact, CDC’s study on type replacement failed to detect type replacement specifically due to the manner in which the study was designed and how the data analysis was conducted. I found ample evidence of type replacement (a result that Mary Holland, Kim Mack Rosenberg, and Eileen Iiorio included in their book, “HPV Vaccine on Trial“).

Many other studies have detected type replacement, and I have cited them in my articles. Since recommendations on HPV vaccine never include consideration of the details of the studies conducted that fail to detect type replacement, studies that find explanations for variation in HPV types other than the vaccine are not relevant to whole-population vaccination recommendations.

The CDC took over the Cochrane Collaboration’s review of HPV vaccines, leading to an uproar of controversy leading to resignation of Board Members – the reprehensible and wrongful excoriation of a Founder of the Cochrane Collaboration who spoke out against the violation of conduct of the Collaboration for accepting outside money. Notably, the CDC contact with Cochrane Collaboration was the same scientist who was the senior author on the CDC’s study on HPV type replacement.

The issue of type replacement was notably absent from the Cochane Collaboration’s report. I had of course contacted her when I found the error in their study, which I was tipped off to by IPAK Advisory Board member Josh Mazer. I showed CDC the results of my analysis showing unambiguous evidence of type replacement, and rather then act upon my concerns, they stopped replying to my emails.

The problem with Type Replacement is that evolution predicts that rarer, more lethal types of HPV not targeted by the vaccine will increase in prevalence as the vaccine clears the less lethal, more common HPV virus types from the population. Rarer viruses tend to be rare becausethey are more deadly – and they take their hosts out. The expected result is increased rates of more aggressive forms of cervical cancer in younger patients. I have predicted many times in many places that we will witness more aggressive cervical cancer in younger women – and that is precisely the finding of the new study reviewed by The Independent. Think “evolution of antibiotic resistance”; type replacement is “evolution of vaccine resistance” – the emergence of more persistent, aggressive and lethal forms of viruses due to the use of vaccines.

On February 1, 2020, IPAK, The Institute for Pure and Applied Knowledge will host a free webinar open to Public Health officials and concerned citizens from anywhere in the United States. We will review the evidence of not only type replacement, but also the clinical errors made in the administration of the vaccine, including MD’s informing vaccine recipients that they are now “protected from HPV”; how cancer experts have testified and the press has erroneously reported that the HPV vaccines represent a chance to “eradicate” HPV-related cervical cancer; and of course the evidence of the increase rate of frank cervical cancer attributable to over-confidence in the HPV vaccine and type replacement.

The CDC is entirely responsible for misleading the public on Type Replacement; they should have acted upon my communications. Given the obtuse nature of the analysis they conducted, it is difficult to see how they did not choose that particular means of analysis to obtain the specific, desired result. The results involved multiple hypothesis testing of shifts in individual types, not a test of overall type shifting between vaccine-targeted and non-targeted types (Figure above, CDC Data, IPAK Analysis).

Those who have represented smoking-related throat cancer as a cause for mandates or for increasing HPV vaccine uptake were working under the advisement of the cancer and public health “experts”.

These experts should have researched the research the CDC relied upon to reject type replacement and sought more information from non-CDC studies. But then, they likely do not understand evolutionary biology and ecology as well as they should to be able to predict that with about 223 other types of HPV, many of which are oncogenic, the HPV vaccine itself coupled with changes in personal behavior, medical screening and adherence to medical screening will cause type replacement.

Those conducting research on HPV efficacy relied on proxy outcomes of a reduction in HPV-Vaccine Targeted Type-Related CINs should have reported overall CIN differences and should not have cherry-picked the results that shed a favorable light on the HPV vaccines of CIN related to vaccine-targeted types only.

Perhaps everyone knows all of this, but no one is willing to hold Merck and Merck-funded researchers, including those at the CDC, accountable.

Therefore, IPAK will host a webinar at which the identities of the attendees are kept secret. This will be an informational webinar only. The evidence presented will be difficult for some to accept, especially those who we tried to warn, those who we had to sue to attempt to garner their attention on the seriousness of the issue with HPV vaccine safety science. We will review why adjusting for correlative outcomes (such as Chlamydia infection) or adjusting for lifestyle choice differences between those who seek and those who do not seek that vaccine does not rule out type replacement – and how important it is for Public Health Officials and medical doctors to communicate full details of attendant behavior-related risks to individuals who seek or accept the HPV vaccine.

To register for the webinar, go to this link or click on the “Register Now” button, below. We request a $1 donation to enable registration. Your information will be kept private by IPAK and never shared. Your affiliation information, however, would be appreciated so we can follow up with residents of your states so they know that SOMEONE in a role of Public Health Official has received and processed the evidence that the HPV vaccine program may be far worse than ineffective and that they can expect their Public Health Officials to base discussion and decisions on the balance of Science.

From Claus Nørgaard Gravesen:

Let’s look at the actual and factual data according to the Cochrane review (detailed Danish article about the review here):
Precancer for all HPV-types except 16 and 18:
Vaccinated: 249 (out of 10,000 women)
“Unvaccinated: 198 (out of 10,000 women)
We actually see a large increase in precancer in women 25 to 45 years of age of 25.76% from “unvaccinated” to vaccinated in the 223 other HPV-types apart from just HPV-16 and HPV-18.
That’s a very significant increase, caused by the vaccines, which in no way can be explained away.
The HPV-vaccines clearly cause precancer and should be stopped immediately.
Besides the Cochrane reviews additional own words:
“Pregnancy outcomes: The effects on congenital abnormalities and stillbirths are uncertain”
“Increased risk of adverse pregnancy outcomes after HPV vaccination cannot be excluded”
Which we are seeing further signs of adverse consequences of in this very recent study published as late as Monday, June 11th 2018:
A lowered probability of pregnancy in females in the USA aged 25-29 who received a human papillomavirus vaccine injection.”

CBC Marketplace’s Constructed Narrative Falls Even Further Apart

Yesterday, I penned an article with screen shots of the CBC’s Youtube video coverage of the VIP after party of the VIE event in Washington last year.

The video shown shows words in a manner in which it would seem to imply that I said “Now we have a quid pro quo” to the reporter during a cutaway where the person who is speaking about “quid pro quo” is not on camera.

I have made it clear that I never said “Now we have a quid pro quo”. The recording clearly is “SO THERE IS NO quid pro quo.” Their video editing, including their caption placement, clearly manipulate viewers leading to the impression that the reporter and I came to some arrangement. Never happened.

Their written version of the event online now represents it as if the reporter said it.

“So, what I would rather do is, I do a science day the day before,” he said. “I’d run an event where you … charge admission as per my website.”

“Sounds like a promo thing for you, a marketing thing for you,” said our journalist. “Now we’ve gotta quid pro quo.” 

“That’s right,” he said, later detailing through an assistant that for a group of 400 people, he would want about $20 US per person, netting around $10,000 Cdn.

No, I never said “That’s right”.

I can tell you that our fact-checking team, and many, many others hear ME saying “So there IS NO quid pro quo”, which is in keeping with my message about “What I’d RATHER DO” (is educate the public than be paid to travel to lobby). And while the Science days are educational, I can also tell you that we do a LOT of “marketing” at IPAK; it’s called promotion, it’s key to the success of any not-for-profit, but unlike other not-for-profits, we specifically limit the amount of revenue that we program to promotion. We don’t have to spend 90% of our revenues on promotion. Because we offer sincere, objective Science, which the public was chanting for on the Washington mall. Bring the unedited conversation forward, CBC.

Should Have Said “Donations”

I’ve explained in the first article that IPAK events do not require anyone to commit to a specific amount, that the numbers cited are suggested donations, and that we ask people in who can only donate less for any amount they can donate. We also invite people in who choose to not donate in without any transaction. I also explained that the reporter made up the number “400” so as to inflate the sum of whatever amount we quoted. We provided him with an estimate, which should have been between $15 and $20 for a suggested donation. And it’s clear that we put funds at IPAK to good use.

We all make mistakes. We at IPAK should not discuss “costs” of our donations, and we usually do not, but instead, we should discuss suggested donations. My assistant was corrected and apologized for not knowing, but I never spelled out for her the difference. She has not been involved in the planning or running of IPAK events. The program is active now; interested parties can contact us at info@ipaknowledge.org.

IPAK Events Are Not All About Autism

“Vaccines cause autism in some people” is what I said at the VIE event. A bold statement, a bit like holding a lightning rod on top of a mountain in a lightening storm to utter such words in public.

Except CBC was already informed before their yellow journalism piece came out, by me, with links to videos, that Dr. Julie Gerberding of the CDC and the late, great Dr. Bernadine Healy, former Director of the NIH said as much, on the air, in US television news many years ago (see links to videos in my scoop of CBC News here). And it’s no secret – I have published my understanding of specific mechanisms by which vaccines might cause autism in some people in writing. A good investigative reported would have known that, and they would have not treated like it’s some shocking secret. Their recording of me is from arguably the most public place in the world – my speech at theNational Mall.

What may be news is that I won’t back down. I won’t be intimidated by anyone to change my position, given what I’ve seen in the mechanism literature. Under any circumstances. Press hit pieces, personal threats, all mean nothing to the reality of the piss-poor nature of the CDC’s attempts to hide the link between vaccines and autism and the risk that some child somewhere may become permanently mentally disabled by a vaccine. #NotOneMore.

If you listen to the reporter voicing their constructed narrative, you will in fact hear her state that I say at IPAK Events that “Vaccines Cause… Autism”. She uses information she got from a VIE event (NOT an IPAK event), and, further, she leaves the incorrect impression that vaccines and autism are the only thing we discuss at IPAK events. We are planning an event on “Autoimmunity in Autism” in June 2020, filled with all sorts of science, reviews of science, new science, more science on autism and autoimmunity in autism than the Marketplace journalistic team could probably handle. Nevertheless, they are hereby invited. With or without hidden cameras. Open interviews would be decent.

One good thing is that I think I can now answer my question in my first post about CBC. No, CBC did not run an objective piece. They invited comments from their targets, and they ignored all of the comments they received. No, CBC is not a legitimate news source for health-related matters. Their journalistic integrity in my view is virtually non-existant. And that’s sad. Because I grew up watching CBC. And Beachcombers. And Superdave Obsborn on Bizarre. I used to love CBC News. It was refreshingly independent of US influences. It was Canadian. Seems now it’s mostly corporation-owned.

‘So There is No Quid Pro Quo’, or ‘So We Have a Quid Pro Quo’?

So, CBC, which is it? The video leaves the attribution ambiguous. I claim that I said “So it’s not a quid pro quo”. Your written article claims your reported said “So we have a quid pro quo”. Bring the full recording foward, CBC, unedited. Everything everyone at the event told you. Not cherry-picked and manipulated expressions taken out of context.

People can listen for themselves. The cutaway at exactly that time, and the existence of two edits of the video, as I discovered and described in yesterday’s post, is troubling. Their apparent sleight of hand plays well into their false narrative. But, for the record, “There is NO QUID PRO QUO”.

Regardless of such low-ball tactics, we have a team reviewing the video and the written article for false statements made by their reporter, and we will be setting the record straight on a future episode of Unbreaking Science. It should be eye-opening, perhaps even to the investigative reporters who did not do much investigative anything.

Perhaps CBC should look into CDC’s Walter Orenstein’s role in determining the outcome of the IOM’s look into vaccines and autism. And how Dr. Marie McCormick, who chaired the IOM’s Immunization Safety Review Committee, told her fellow committee member when they first met in January 2001 that CDC “wants us to declare, well, that these things are pretty safe” and “We are not ever going to come down that [autism] is a true side effect” of thimerosal exposure”, and how the committee’s chief staffer, Kathleen Stratton, even predicted that the IOM would conclude that the evidence was “inadequate to accept or reject a causal relation” between vaccines and autism. The committee was instructed that the outcome was what “Walt wants” — referencing Dr. Walter Orenstein, then director of the National Immunization Program for the CDC, who also played a role in putting Dr. William Thompson on leave for daring to inform Dr. Julie Gerberding of the link between on-time MMR vaccines and autism in African American boys.

Or maybe CBC should look into how Coleen Boyle changed the study design of at least one study after her team found an association between on-time MMR vaccine and delayed MMR.

At the very least CBC should investigate Poul Thorsen, on OIG’s Most Wanted List, a fugitive from justice, accused of stealing over $1Million US (and CDN) dollars that was supposed to go into autism research, who is still on projects funded by the US NIH, still publishing on papers appearing in NCBI’s Pubmed? Start with James Grunvig’s book “Master Manipulator“. He’s done all the legwork for you, CBC.

Or perhaps they might look into and report how Dr. Julie Gerberding left CDC after overseeing those fiascos for a cushy job at Merck and received millions in Merck stock. NOW you’ve got a quid pro quo to talk about!

Maybe you should interview Congressman Bill Posey, who entered into the Congressional Record how Dr. William Thompson shared with him files he was instructed to destroy on how the MMR vaccine might lead to ASD if given too early. Here, I’ll do the hard part for you.

https://www.c-span.org/video/?c4546421/user-clip-rep-bill-posey-calling-investigation-cdcs-mmr-reasearch-fraud

Then investigate the experience of Robert F. Kennedy, Jr. and Del Bigtree when they met a smiling and cooperative Anthony Fauci and Francis Collins with Whitehouse staff whose smiling faces turned to stone the minute the whitehouse staff members left the meeting. Then investigate by former CDC Director Thomas Frieden testified to a Congressional Committee that we (in the US) would not have an outbreak of Ebola unless there are mutations in the virus (in 2014/2015) and “there are none” – and whether that is related to the CDC’s PCR-based airport screening test for Ebola, based on the 1995 Zaire strain.

These are much more relevant to investigative reporting than a hypothetical event with 400 fictitious people your reporters made up.

CBC Marketplace, you are cynical, deceitful and blind. You missed the story of the last 50 years. You are misleading the Canadian public to accept a woefully dangerous import fromt the US – CDC-style vaccine risk and injury denialism – and Canadians will suffer as a result. You can redeem yourself by digging into the CDC cover-up and the crimes committed in the name of manipulating public opinion. Bring on Brian Hooker. Del Bigtree. Dr. Wakefield. I won’t appear on your show until you apologize for manipulating my words. The best you can get from me is a free copy of my book, “Cures vs. Profits: A Translational Success Story”, which contains the Chapter I wrote during which I chronicled my discovery of the facts that I wish were untrue, and in which I track down the details of the CDC fiasco and three other vaccine controversies.

CBC leadership, watch the documentaries Vaxxed and Vaxxed II. Invite Polly Tommey on, who even now spends 10-12 hours a day interviewing parents of vaccine injured children. You’re on the wrong side of history. We are building a new culture of decency, and respect, and the vaccine industry lobbyists’ heads are spinning, just as they should be. No amount of money for any politician and no new vaccine factory is worth the chronic illness, impaired autoimmune systems, and impaired neurodevelopmental disorders in your local town, city, province, or nation. As formulated, current vaccines are unsafe.

For now, here I address CBC’s misquote and/or misattribution, depending on which version of the CBC’s report you care to pick.

See the Evidence: Scientist Calls Out CBC’s “Marketplace” with Grave Allegations of Compromised Journalistic Integrity

I grew up across the St. Lawrence River from Johnstown, Canada. I spent my youth sharing many experiences with Canadians; their television stations would broadcast right into my living room. “Beachcombers” was one of my favorite shows in the 1970’s. As I informed a committee in New Brunswick, Canada last year, I’ve lived many places around the US, and no one understands why I wear socks with sandals.

Fast forward to 2020, and I find myself targeted by CBC’s “Marketplace” program for – gasp – being paid to educate the public about Science. In a hit piece on their program, they targeted me, Robert F. Kennedy Jr., Del Bigtree and Dr. Andrew Wakefield. Their “undercover expose” itself leaves something to be desired overall. There was no need for any undercover reporters; we more than welcome media coverage at all of our events. Everything I said to CBC is precisely what I would have said if I had been asked in an open interview.

But I want to focus on one specific aspect of their coverage.

In their undercover interview of me, they never asked me for nor established my credentials. They claim I want to be seen as a Scientist. Sorry, CBC, I’m a PhD Scientist. And a Master’s. And a BA.

At the VIP event following the VIE Event in Washington, DC, a man, who identified himself as Canadian, asked me “So how much would it cost to bring you to Vancouver?”

“I don’t charge”, I replied. And the video has the rest of my response. Well, some of it. In one part of the exchange, I tried to make it clear that my intention was to not establish a quid pro quo – an exchange of testimony for money – because that would make me a lobbyist. I offered instead to run an IPAK Science Day – a purely educational event – at which I would go through the recent studies being conducted at IPAK, which were partly funded by donations for such event in the past. Such research includes our study on the expected chronic aluminum toxicity in infants under the CDC’s schedule.

In that exchange, I made it clear that it was not intended to be a “quid pro quo”, but, rather, since I would be on site at the same time as doing an IPAK Science Day, no one would have to pay for my airfare or lodging, etc. and if a Committee wanted to be educated, I would be available.

The reporter contacted IPAK and expressed further interest in running an IPAK Science Day. In the middle of communications, he made up an astounding number of people that he said he was sure he could get to attend. He wanted to know what the charge would be. Gretchen and I discussed it, and we let him know that we would have a sliding scale. Our intention was that these would be recommended donations, and in the past, I’ve instructed volunteers manning the check-in tables at IPAK conferences and other events to allow anyone in, no matter the size of their donation, and to let anyone in who cannot donate.

The video then shows a cutaway to a production booth – I presume at the CBC – and the video is running on the monitors in the production booth. The cut-away segment includes a lot of background noise, but you can hear me saying something about a quid pro quo.

Except that’s NOT what I said. I informed the man that we did it this way so as to AVOID a quid pro quo. As in “So there IS NO quid pro quo”. If you listen to it yourself (and many supporters have), you can see they twisted the words “So there is NO quid pro quo” into “Now we’ve got a quid pro quo”.

That would explain the cutaway, because if they showed my face up front, you’d be able to see my mouth forming an “Oh” on the “NO quid pro quo”.

Look at the monitor in the video during the cutaway. They are playing the sound of me saying “So there would be no quid pro quo”, but the text on the screen is from a few seconds before when I’m saying “So I’d come where you are, charge admission…” See for yourself.

Similar text is also played over a earlier timing in the video in their production:

This shows that the video is clearly very heavily manipulated to make specific words appear on the screen in a specific manner. Now, CBC clearly does not want anyone to see my face when the expression “quid pro quo” is stated. They have the video. They should produce the video, unedited, so everyone can see what they’ve done.

And they should apologize. Because I NEVER, EVER would suggest that anything I do is a quid pro quo. The only time I’ve used that phrase is to communicate to be perfectly clear that no one controls what I say, how I say it, or who I say it to. Anyone who knows me know that’s not possible anyway.

Get real, CBC.

I first alerted CBC directly on the comment section of their YouTube Channel:

When I checked the video for my comment on another person’s phone, and through another browser on my laptop, it was gone.

I had left the tab open where I originally commented so I added a comment – “CBC, are you removing my comments? Love, James Lyons-Weiler, PhD”

Nevertheless, neither comment is viewable by others, evidently.

As I was checking for their removal of my comments, an IPAK supporter and mom named Missy sent this message to me:

Shortly thereafter, another message

And an email from a colleague requesting help finding my comment:

“Jack,
Share your exact handle with us. I just searched for “James” and “Lyons” in the comments and it didn’t come up. It might be way at the bottom and the search feature might only search comments that have loaded… or they may have removed it already? Please let us know exactly what to look for.”

On Youtube, one can sort comments on Most Relevant or Most Recent. My two comments are not present anywhere.

So here are my missing comments to CBC on Youtube. There’s much more to come on the CBC’s Marketplace team’s lack of journalistic and professional integrity.

James Lyons-Weiler: Their assertions are paper thin. If you want to support IPAK, I’d host an event near you. That way there is NO QUID PRO QUO. That’s my message. Their video is 100% wrong and they are being dishonest. Watch at about 9:12 – I clearly state “NO quid pro quo”, meaning, if IPAK hosts a public event near you, those in attendance would be asked for a suggested donation. Why did they cut away? My bet is you can see me form an “O” when I say “NO quid pro quo”. That up-close video will be the focus of scrutiny. Also, their’ “$10,000” was based on their random number of 400 people that we were told. They were told it was a sliding scale more people, lower suggested donation. That’s how we operate. If we suggest donations of $15-$20 per head, and 100 people show up, we’re lucky. We put the funds to good use, with peer-reviewed research. Check Pubmed. https://www.ncbi.nlm.nih.gov/pubmed/?term=lyons-weiler I state VERY CLEARLY that if I were to be paid to be flown out to Vancouver (a place I love, BTW!) to testify, I’d be a paid lobbyist. Educating the public is what I offered. Is CBC Marketplace anti-science? Read their email to me inviting comment, and my reply to them sent immediately after they contacted me. Did they cover my reply and include all of the science I cited and the realities we are facing about vaccine safety science? No. Did they interview the 1,000s of parents of vaccine injured children in attendance at the VIE event to find out why they would come out and stand in the cold to support medical freedom, informed consent, and objective Science? No. It appears to me like their own cameras have caught them constructing a false narrative, not reporting the news. I don’t WANT to be SEEN as a scientist, I AM a scientist, and have been throughout my adult life and career. My bio is available online for all – including the reporters – to see – https://jameslyonsweiler.com/author-and-research-scientist-james-lyons-weiler-phd-extended-biography/ These reporters clearly WANT to be seen as objective reporters. Now pardon me as go back to analyzing human subjects research data for our Vaccinated vs. Unvaccinated study. Yes, it’s IRB approved. Yes, it will be submitted for publication for peer review. Shame on you, CBC, you have a lot to learn about being a sensible part of solving a very complex problem facing our society.

Watch “Unbreaking Science” tonight, 1/19/20 on Youtube and Facebook. I have a special treat for CBC tonight which I will add to this article.

Vaccine Risk Denialism Has Placed Pediatricians and Other Physicians in a Precarious Social Position

Following a lecture I gave at UCLA earlier this month reviewing our research on chronic vaccine aluminum toxicity expected from the CDC pediatric vaccine schedule, I was being dropped off at the LAX via a hotel shuttle. The shuttle driver, a middle-aged woman, asked me what I did for a living.

“I am a biomedical research scientist”, I replied.

“Oh, biomedicine, cool” she said. “What area?”

“Vaccine safety research” I said, pretty well knowing what to expect next.

“Vaccine safety research? I thought that had already determined that vaccines are safe and effective”.

I’ll leave the rest of the conversation, which went very well, to your imagination.

As I assess the anticipated future reaction of the rest of the American public as they realize that the success of the vaccination program as a primary driver in the reduction of infectious diseases is overstated, and as they realize that the vaccine safety science is not settled, I can fairly well tell where the axe of accountability is going to fall.

The public’s view is that the pristine reputation and awarded authority of the CDC is to be heralded. To cite a CDC statistic or fact quoted from CDC, say, on rates of specific health conditions is to imbue those statistics and facts with a sheen of trust. CDC’s reputation is impeccable. This fact puzzles the vaccine risk aware, who are aware that former CDC Director Julie Gerberding, who oversaw the CDC during the CDC’s key years in “investigating” vaccine safety with underpowered and manipulated studies, left CDC for a high-ranking job at Merck in their vaccine division. Most do not know that Dr. Gerberding also led the ATSDR – the toxicology division at CDC that cherry-picked aluminum safety data and, contra the rest of the world’s understanding of aluminum toxicity science, misinterpreted the one study they chose – an oral dose of ingested form of aluminum in adult mice – they relied upon to convince the world that vaccine doses of aluminum are likely safe.

Most Americans deflect the real significance of the knowledge that a CDC Director left for Merck with an eye-roll of how corrupt “the system” is, as if the status quo, as wrong as it is, is to be expected because it is the status quo. Most Americans seem to fail to process or let in the fact that this person oversaw the most corrupt era in biomedical science on the most imporant question of the latter quarter century: are vaccines safe for our children, our legacy, our reason as parents for everything we do?

The preamble to the United States Constitution reads

“…to secure the blessings of liberty to ourselves and our posterity…”

Our posterity is our children, our future generations.

Nevertheless, when Pharma convinced the Senate in the 1980’s that because there were so many lawsuits for injuries from vaccines they would pull out of the vaccine market unless their products were made liability-free, the result was the 1986 National Childhood Vaccine Injury Act. Vaccine manufacturers were indemnified from liability – and since the Act became law, no American citizen can sue pharmaceutical companies for injury from their products. Part of the result has been a stagnation in technological development: vaccines would have been made safer due to recalls and losses in court. Instead, the paradigm that vaccine are “unavoidably unsafe” took hold, becoming codified, and it now represents the backbone legal paradigm upon which vaccine law and policies are based.

At the same time, the US public believes that “vaccine are safe, full stop” because that’s what the CDC says, and that’s what they are told by the media. This is not a paradox, but is, instead a direct contradiction of a statement of reality. The CDC and media are following a vaccine risk and injury denialist agenda that flies in the face of increasingly abundantly obvious facts:

(1) The National Vaccine Injury Compensation Program has doled out over $4.5Billion in awards and settlements for vaccine INJURY.

(2) The US passed a law in 1986 mandating that vaccines be made safer, and that steps be taken to identify individuals who are at highest risk of vaccine injury or death. Those parts of the NCVIA have not been fulfilled, and yet vaccine manufacturers enjoy legal protection from liability.

When it became clear that vaccine makers were to become free from liability, pediatricians became concerned over their exposure to medical malpractice and injury lawsuits, and thus they, too were indemnified. The deal with those writing the act initially included that pediatricians would explain known risks to all patients and parents of patients so they could allow for prior and voluntary informed consent – in other words, parents would decide. The physicians countered with complaints that such a process would take too long and that the public really would not be able to make the right choice in the face of such information, and so a compromise was crafted by which physicians could become “learned intermediaries” who would communicate the risks via CDC’s Vaccine Information Statements (VISs). These sheets of paper were to be given to patients prior to any vaccination decision, and the physcian was to abide by the decision of the parents or patient.

That’s the law codified following the compromise.

Since then, the CDC has worked to change the language of the VISs out of concern that they were scaring parents away from vaccination. They went so far as to try to censor American citizens’ comments, including yours truly, in an open, public comment period against weakening the language of the MMR. Some simple legal communications reverse their very bad decisions.

Since then, the American Academy of Pediatrics has issued a statement that pediatricians can kick families who choose to not vaccinate out of their practices. Since then, the US Press has amplified irresponsible and Un-American calls to prosecute American doctors and citizens for discussing vaccine risk.

Let’s remember that since then, in 2017, Rachel Cohen, of The Boston Herald called speech against vaccines a “hanging offense”. Lynching – a mob act of violence that is the epitome of an expression of hate in America, does not belong in the minds of those seeking a rational future of healthy immunity.

Since then, in 2018, the WHO called so-called “Anti-vaxxers” (itself a form of hate speech) one of the top public health threats of 2019.

It is stunning, therefore, that the WHO scientists last month on Dec 2, 2019, were videotaped calling for vaccine safety science to shore up public confidence in vaccines.

These events are best covered, I think, by the Highwire’s Del Bigtree and team’s latest episode, their first in 2020, the snippets played capture language being used that some in the US would like to have labeled ‘hate speech’.

Some selected stunning admissions from WHO are here.

You can access the full WHO video here, and the Highwire coverage on Youtube. https://www.who.int/news-room/events/detail/2019/12/02/default-calendar/global-vaccine-safety-summit

In the WHO video of the event, Dr. Heidi Larson, a US anthropologist (not a biologist, nor a geneticist, nor an immunologist), says the following:

“We’re in a unique position in human history, where we’ve shifted the human population … to dependency on vaccine-induced immunity. And that’s on the great assumption that populations would cooperate. And for many years people lined up, the six vaccines, people were there, they saw the reason. We’re in a very fragile state now. We have developed a world that is dependent on vaccinations. We don’t have a choice but to make that effort, to make that extra… Our biggest, one of our biggest challenges, I think now, is getting rid of the term ‘anti-vax’, getting rid of the hostile language, and starting to have more conversations, to be open to questions, to make people feel like they shouldn’t be judged when they’re asking questions. As crazy as those questions might seem to you, as, as stupid as they might seem, or as ignorant as they might seem. We can’t risk losing another person’s confidence in safety right now.”

This is the same Heidi Larson who had previously called for tracking of vaccine dissenters (BBC Video Link, courtesy John Stone:)

https://www.bbc.co.uk/programmes/p07p83wm

The WHO’s Vaccine Confidence project represents a major paradigm shift, and governments of the world and the press should take note: All of the points made by the participants have been being made repeatedly over the years by the so-called “Anti-Vaxxers”, the “Vaccine Hesitant”, who prefer to be called “The Vaccine Risk Aware”, or, especially if they or their loved ones represent the initial observations of vaccine injury, “Ex-Vaxxers”.

The Vaccine Risk Denialism agenda has left pediatricians in an extremely socially vulnerable position. As studies come out in 2020 showing adverse health outcomes associated with vaccination, the public will be demanding answers from their pediatricians on how they could not have known. “I did not know, we were not taught anything about vaccines in medical school” is not going to be an acceptable answer. Proof of this is below, in the videos and the transcripts for selected clips.

I know the public will demand answers, and they will demand change. As a voice of reason, I propose that we take a civilized response as possible, and, along with parents of vaccine injured children, establish a Vaccine Injury and Death Truth and Reconciliation Panel, empowered by Congress with prosecutorial powers, to bring forward complete and full disclosure from all parties to scientific fraud and medical malfeasance and misconduct. There are a large number of changes that must be made right away to ensure safe passage of our population out of vaccine dependency into a future of healthy immunity.

(1) Vaccines should no longer to legally considered “unavoidably unsafe”.   A House and Senate resolution stating this should suffice.

(2) Pediatricians should no longer be protected from liability.  Informed consent in the officemust be mandated and existing laws and Federal regulations must be enforced.

(3) Vaccine makers should no longer protected from liability. 

(4) Mandatory active tracking of vaccine injury by a non-governmental institution should be enacted.

(5) Parts of the Act that mandate making vaccines safer and finding those at highest risk would have to be prioritized and such research should be independent of vaccine profit interests.

(6) Ban thimerosal.

(7) Ban aluminum.

(8) Ban unsafe epitopes.

(9) All vaccine safety science should be done with a pool of funds from Pharma and the US Gov’t, distributed via NIH-like grant reviews to investigators not vested in vaccinations.

(10) Ban incentives for vaccine quotas.

(11) Mandate the funding of curative treatments for vaccine injuries.

(12) Immediate compensation of all who have filed in the NVICP and reform the compensation program to seek out and identify those most harmed by vaccines.

(13) Reform vaccine risk education in medical schools.

I have a hard time considering not prosecuting someone to make an example of for violating the rights to informed consent for experimentation without consent; it’s in CFR, and violations are rampant. 

We need to codify real restrictions in regulatory agency personnel rights.
Most don’t know, for example, that Dr. Julie Gerberding headed up the ATSDR at CDC when they faked aluminum safety transmogrifying a PTWI (provisional tolerable weekly intake) from 1-2 mg/week to 1 mg/kg/day (adults).

Most do know that oral doses of aluminum have nothing to do w/injected doses, but most do not know that that FDA’s  850-1150 mcg per dose fiasco seems “safe” due to ATSDR’s bullshit on aluminum oral safety doses.

Dr. Gerberding headed up the ATSDR, buried the Destefano et al. fraudulent study, and made CYA statements in the press on vaccines and autism before she jumped ship.

The audacity of the social and societal impact of these comments today, in mid-January, 2020, may appear to be beyond the pale of objectivity or even reality to some. But I will predict, given the discussion that the WHO has now opened, that by January 13, 2021, we will see either major societal upheaval as the entrenched system of corruption fights to maintain its stronghold, or a Truth and Reconciliation movement that will carry forward a civil change in society.

I would be pleased to help create the panel of individuals that I think would be most able to adjudicate the proceedings. My selections will surprise some. Of course, trust in these people is key, and they should be non-partisan. They should have done their homework on vaccines, and in an established manner, they should have wisdom of experience. Most of all, they should be pro-science. We cannot have a future in which Science is blamed for Corruption’s influences.

And they should protect pediatricians and lead the charge for reform of vaccine risk education in medical schools.

Here is the Youtube-generated transcript of the Highwire’s selected clips, slightly edited from listening to the audio (emphases mine):

Prof. Heidi Larson, PhD (Director, WHO Vaccine Safety Confidence Project). There’s a lot of safety science that’s needed and without the good science we can’t have good communication so although I’m talking about all these other contextual issues and communication issues. It absolutely needs, science [it] is the backbone. You can’t repurpose the same old science to make it sound better if you don’t have the science that’s relevant to the new problem. So we need much more investment in safety science.

Soumya Swaminathan, MD (Chief Scientist, WHO Pediatician). I think we cannot overemphasize the fact that that we really don’t have very good safety monitoring systems in many countries and this adds to the miscommunication and the misapprehensions because we’re not able to give clear-cut answers when people ask questions about the deaths that have occurred due to a particular vaccine and this always gets blown up in the media. One should be able to give a very factual account of what exactly’s happened and what the cause of that saw but in most cases there’s some obfuscation at that level and and therefore there’s less and less trust then in the system.

Dr. Martin Howell Friede (Coordinator, Initiative for Vaccine Research, WHO/HW/IVR). Every time that there is an association be a temporal or not temporal the first accusation is it is the adjuvant and yet without adjuvants we are not going to have the next generation of vaccines and many of the vaccines that we do have ranging from tetanus through to HPV require adjuvants in order for them to work so the challenge that we have in front of us is how do we build confidence in this and the confidence first of all comes from the regulatory agencies.

When we add an adjuvant it’s because it is essential we do not add adjuvants to vaccines because we want to do so but when we add them it it adds to the complexity and I give courses every year on how do you develop vaccines how do you make vaccines and the first lesson is while you’re making your vaccine if you can avoid using an adjuvant please
do so Lesson two is if you’re going to use an adjuvant use one that has a history of safety and lesson three is if you’re not going to do that think very carefully

Stephen Evans (BA MSc FRCP Hon. FRCP, Professor of Pharmacoepidemiology, London School of Hygiene and Tropical Medicine). It seems to me that adjuvants multiply the immunogenicity of the antigens that they are added to and that is their intention it seems to me they multiply the reactogenicity in many instances and therefore it seems to me that it is not too unexpected if they multiply the incidence of adverse reactions that are associated with the antigen but may not have been detected through lack of statistical power in the original studies.

Friede: You are correct as we add our events especially some of the more recent adjuvant such as the ASO and Saponin and derived adjuvant we do see increased local reactogenicity. The primary concern though usually is systemic adverse events rather than local adverse events and we tend to get in the Phase Two in the Phase Three studies quite good data on the local reactogenicity. Those of us in this room that are beyond the age of 50 who have had the pleasure of having the recent shingles vaccine will know that this does have quite significant localreactogenicity if you got the vaccine. You know that you got the vaccine.

But this is not the major health concern the major health concern which we are seeing are accusations of long term long term effects. So to come back to this once again I’m going to point to the regulators. It comes down to ensuring that we conduct the Phase Two in the Phase Three studies
with adequate size and with the ad with appropriate measurement.

Dr. David Kaslow, MD (VP Essential Medicines Drug Development Program (PATH Center for Vaccine Innovation and Access). So in our clinical trials we are actually using relatively small sample sizes and when we do that we’re at risk of tyranny of small numbers which is you just need a single case of Wegener’s granulomatosis and your vaccine has to solve Walt’s (Orenstein) “How do you prove a null hypothesis” and it takes years and years to try to figure to figure that out so it’s a real conundrum right getting the right the right size dealing with the tyranny of small numbers making sure that you can can really do it and so I think one of the things that we really need to invest in are kind of better biomarkers, better mechanistic understanding of how these things work so we can better understand adverse events as they come up.

Dr. Marion Gruber (Director, Office of Vaccine Research and Review, CBER, FDA). One of the additional issues that complicates safety evaluation is if you look at a new struggle is the length of follow-up that should be adequate in a let’s say pre-licensure or even post marketing study if that’s even possible… and again as you mentioned pre-licensure clinical trials may not be powered enough … it’s also the subject population that you administer the adjuvant to because we’ve seen data presented to us where in at event a particular achievement added to a vaccine antigen did really nothing when administered to a certain population and usually the elderly you know compared to to administering the same formulation to two younger age strata so so these are things which need to be considered as well and further complicate safety and effectiveness evaluation of achievements combined with vaccine antigens

Dr. Bassey Okposen, Program Director, National Emergency Routine Immunization Coordination Center, Nigeria). It comes back my mind to our situation in Nigeria where our six weeks 10 weeks 14 weeks a child is being given different antigens from different companies and these vaccines have different are different different preservatives and so on something crosses my mind is there a possibility of these advanced preservatives cross-reacting amongst themselves have they ever been study on the possibility of cross reactions among themselves that you can share the experience with us?

Dr. Robert Chen (Brighton Collaboration). Now the only way to tease that out is if you have a large population database like the Vaccine Safety Datalink as well as some of the other national databases that are coming to being where the actual vaccine exposure is tracked down to that level of specificity of who is the manufacturer what is the lab number etc etc And and there’s initiative to try to make the vaccine label information
bar-coded so that it includes that level of information so that in the future when we do these type of studies were able to tease that out. And and in order to be –each time you subdivide them the sample size gets becoming more and more challenging and that’s what I said earlier today about that we’re really only in the beginning of the era of large data sets where hopefully you could start to kind of harmonize the databases for multiple studies and there’s actually a initiative underway. Helen there may want to comment on it to try to get more national vaccine safety data base linked together so we could start to answer these type of questions that you just raised.

Larson: The other thing that’s a trend and in an issue is not just confidence in providers but confidence of healthcare providers. We have a very wobbly health professional front line that is starting to question vaccines and the safety of vaccines. When the front line professionals are starting to question or they don’t feel like they have enough confidence about the safety to stand up to it to the person asking them the questions I mean most medical school curriculums even nursing curriculums I mean in medical school you’re lucky if you have a half-day vaccines nevermind keeping up to date with all this.

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What the Public Should Expect from Legitimate Scientists

What the Public Should Expect from Legitimate Scientists

WHEN IPAK launched our initial inquiry into the FDA logic behind lax regulation of pediatric dosing of aluminum, we had no idea what we would find in terms of the history of how and why dosing of aluminum in vaccines is stated per dose, rather than in terms of mcg/kg/day. We had no idea that we would find, when studying the provenance of information in the science behind vaccine aluminum toxicity, the use of information from oral doses of ingested forms of aluminum fed to adult mice and rats. We expected the bulk of the consideration would be data from dose escalation studies of injected forms of aluminum in infant mice. Failing to find any such studies, we wondered what a toxic pediatric dose limit might look like, thus leading to our “Reconsideration” study.

We also found studies that were based – roughly – on the plasma clearance rates of aluminum in adults – only to find serious issues with the studies providing the initial model parameters upon which the now infamous Mitkus study were based. The Mitkus study estimated pediatric plasma clearance of aluminum from available data from creatinine, not aluminum hydroxide salts – for which there can be no explanation other than the US FDA did not find it a priority to use Science to estimate pediatric clearance. Their multicompartment model itself has issues, not the least of which is the consideration that the initial model data were based on a single dose in a handful of human adults. The CDC schedule exposes infants to repeated doses in a manner completely independent of bodyweight and not based on any empirical data even from serum or plasma clearance. And, as I have pointed out more precisely, plasma clearance is irrelevant to the mechanisms of pathophysiology of aluminum. The tissue damage is not conducted in plasma. However, it is worth pointing out that 80% of injected aluminum is bound to transferrin, preventing dietary-sourced iron from being moved from the blood into the bone marrow, where red blood cells are made. An expected effect of aluminum, therefore, is anemia. There are other effects as well that will be explored in peer-reviewed articles that are being prepared.

There is a recent article – a very good one – by AHRP that outlines how the very same characters who have attacked my character, my personality, and insulted me regarding my career path – have similarly attacked another scientist, Dr. Gayle Delong, with the intent – and effect – of having a study she conducted to examine the question of whether the HPV vaccine reduces human fertility retracted. The same set of characters also attacked a Japanese researcher for demonstrating issues with aluminum injections in mice, a researcher from Spain who found horrific outcomes in sheep vaccinated with aluminum-containing vaccines.

A small vocal minority of people should not determine the course of scientific discourse in any inquiry, especially in an area of inquiry that influences the health of billions of people. Their tactics are telling. They would appear to want to leave the impression of being professional scholars when addressing editors of journals, only to turn around and act completely sophomoric with juvenile, inappropriate, and even defamatory statements (such as calling me an “Ex-Scientist”, or even calling me “Anti-vaccine”) in blog articles. The fact that the same people are involved in the letters to editors and in the public shaming exercises is evidnece of their scarcity. Perhaps three or four people are responsible for the veritable book-burning, skewing the balance of science in favor of ignorance, damaging Science, compromising the integrity of Science, leading to a continuance of the status quo, regardless of whether anything is seriously wrong with injecting aluminum and mercury into pregnant women and infants with developing brains and immune systems. These rogue agents are no doubt learning that their charade is becoming well known, their behavior predictable, and therefore the impact of their criticism in both arenas will become increasingly decreased – especially given the large number of studies currently underway being conducted on all aspects of vaccine safety and efficacy by institutions that have no financial interest in profits from vaccines.

The public, however, should also be aware that this is not how Science is conducted. Scientific discourse is an essential part of progress in Science, but the place for such discourse is not in secret letters to editors, but instead in the form of published discourse in the pages of a journal, to which the authors of the original study would have an opportunity to reply, point for point, in the open, for all to see and consider. Rational consideration of both sets of points by the Scientific community would then lead to individual and then joint (group) consensus on ther merits or demerits of a study.

In this way, all phases of Science –

There are three main phases in the lifecyle of Scientific inquiry. In the private phase, an investigator or team of investigators conceives of a study, designs the study, conducts the measurements, plans and conducts the analysis, writes the results in a paper. In the peer review phase, (optimally) anonymous reviewers have a go at the paper, offer critical review, and weigh in on whether a study should be published. In the public phase, the study is read by the community. Community members can offer feedback in the form of viewpoints in praise of (or critical of) the details of a given study. Fundamental flaws are unlikely given the peer reviewers would have already likely considered issues with the design features of a study. If, however, such flaws make the conclusions of a study unwarranted – and this requires a careful read of the actual conclusions of the author(s) of a study – the study might be withdrawn by the author(s), retracted by a journal, or allowed to stand if the authors’ replies ‘rehabilitate’ the study with, for example, further evidence.

There are other options instead of outright retraction. A revision is possible via the publication of an “Erratum” – in which which the study author(s) acknowledge a mistake, and state whether or how the error impacted the conclusions of the study.

So what can the Public expect from a legitimate Scientist? The Public can expect a Legitimate Scientist to stand up for his, or her, reputation, and, in so doing, stand up for Science as a way of knowing. I will defend and promote anything that enhances rationality in Science and will work to minimize anything that sustains an illegitate cabal of conspirators whose online tantrums reveal their true nature. In this manner, Science is created and sustained as a human enterprise.

Others, unfortunately, are waiting for newly published Science to destroy.

Is CBC’s ‘Marketplace’ Planning a “Spy vs. Spy” Hit Piece on IPAK and James Lyons-Weiler, PhD For Educating the Public on Science?

On New Year’s Eve, I received an email from a Katie Pedersen from CBC News informing me that CBC news had sent an undercover reporter to a VIP event following the VIE event in Washington, DC. I had a conversation with a man who represented himself as being interested in how best to organize vaccine risk awareness in the Western Provinces of Canada. I offered by opinion, and then he pursued setting up an IPAK Science Day (to my knowledge unconnected to any particular piece of legislation, but nevertheless) and asked an IPAK Science Facilitator (SF) to inquire about costs. In email exchanges, he proferred that he could bring in 400 people; obviously, the more people, the lower the cost. I think the last communication I had about this with my SF was a quote of $15 if it were that many people. We never agreed on a final donation level per person for the fictional event he was planning. Nevertheless, here is the statement I shared with Ms. Pederson. See what you think?

I notice in the message that they twist my words a bit to make it seem like I want to inflict damage to the public via “death by 1,000 cuts”; clearly, that would be rather psychopathic. I’m grateful to Katie for sharing their misinterpretation, and the chance to correct it. I represent the public’s interests in objective, evidence-based medicine and biomedical research. I am looking forward to their broadcast sometime after January 7th, I’m told.

MY REPLY/STATEMENT TO CBC NEWS

Thank you for your email message.

My statement is provided below, with the proviso that the entire statement be used, and if you decide to use part of the statement, that you inform the public that you have edited by comment, and where they can
access the complete comment.

Given the misinformation campaigns that our, and other organizations have uncovered regarding the unscientific claims made by US CDC and other organizations on the universal safety of vaccines, I stand by my position that we must educate the public and the medical/regulatory community at all points (“death (of ignorance) by 1,000 cuts).

The question posed about strategy was in the context of whether one large organization would be effective. One organization would likely underrepresent the size of the population of vaccine risk aware Canadians. Clearly, one large organization would also be susceptible to capture by those who profit to the tune of $US27Billion a year from vaccines in the United States. Regulatory capture of US regulatory agencies is now 100%; FDA receives most of its funding from pharmaceutical companies’ fees for processing clinical trials submissions; CDC receives over $20 million per year from pharmaceutical interests via their “not-for-profit” CDC Foundation, which also funds activists organizations that deny that vaccine injury and death do occur. Whether such funds are also funneled into lobbying efforts is under investigation.

The US National Vaccine Injury Compensation Program has paid out over US$4.5 Billion in compensation and settlements for vaccine injuries in the US, and has become a seriously adversarial program when it was promised to US citizens that it would be set up as a non-adversarial application process for settlements following vaccine injury or death. There is so much wrong with the ethics of the regulation of vaccines that effective organizations would work on all points at oner time, thus keeping our adversaries’ (Pharma lobbyists’) heads spinning on how to counter the emerging truths. In speaking with me on how to organize vaccine risk aware organizations, your reporter asked my opinion, which I gladly gave, because I am convinced that we need vaccine risk research reform. The solution to ignorance is Science, and society has been kept in the dark on 1,000 issues on vaccine. The larger the number of orgnizations, the more effective the pursuit to educate as many as possible, and thus, my analogy is apt. Truly informed choice requires knowledge, and citizens should be entitled to free, prior, informed and voluntary consent, under international bioethics guidelines.

In my analytical and professional review of observational/correlation studies conducted and contracted by the US CDC and considered by the National Academy of Sciences’ Institutes of Medicine (IOM) on the question of vaccines and autism, the quality of the science used by CDC to propagate misinformation is extremely poor, with underpowered studies predominating, which are not capable of detecting an association between vaccines and autism given the type of study. This problem was recognized by IOM in a 2012 report in which they rejected 17/22 studies forwarded to them by CDC for consideration, including the now infamous Destefano et al. study, which excluded results showing increased risk of autism from on-time MMR vaccination in African American males and in children with isolated autism. In the end, the IOM did not find that vaccines do not cause autism. They found that insufficient evidence existed to determine whether a causal relationship exists or not. In a series of reports, that were supposed to continue into perpetuity under the 1986 National Childhood Vaccine Injury Act, the IOM found insufficient evidence, rejected 17/22 studies as flawed, and then came to a determination somehow that the issue was settled. HHS stipulated in a lawsuit to the Informed Choice Action Network, and to Robert F. Kennedy, Jr., that further bienniel safety reports by HHS/CDC to Congress never occured, in spite of the provisions in the 1986 act mandating continuing studies and reports. How the announced IOM determination came about is circumspect; it appears the chairperson unilaterally announced a determination at a press conference that was not quite what the committee had found and misrepresented the full committee’s position. In 2001, the IOM was informed by Dr. Marie McCormick that Dr. Walter Orenstein of the CDC did not want them to find evidence that supported the association between vaccines and autism. In minutes acquired by Safeminds (attached), Dr. McCormick had made it clear – the committee was not to conclude that vaccines are related to autism is any way, and that was the preferred outcome of the CDC. The IOM was supposed to be an independent research body, not one dictated to by the CDC.

Link 0:https://www.nap.edu/download/13164

I have further formally evaluated the 5 studies, along with the 46 sent to POTUS by AAP, and found methodological flaws that make the conclusion “Vaccine Do Not Cause Autism” an unlikely conclusion.

Moreover, no studies have been conducted on the presence of a genetic risk of vaccine sensitivity leading to autism. It is my published scientific view that autism is a detoxification deficiency syndrome with a genetic basis, and that vaccines are not exonerated as a causal factor. The late great Dr. Bernadine Healy, former Director of the US National Institutes of Health, and Dr. Julie Gerberding, former Director the US CDC, who left CDC for a lucrative high-ranking position at Merck, both stated on public television that individuals with certain genetic risk factors might be predisposed to develop autism following vaccination.

Link 1: https://www.youtube.com/watch?v=UZFPpHBNp2M


Link 2: https://www.youtube.com/watch?v=7IP7LM56qc8

CDC studies on vaccines and autism have only focused on two vaccines. It is stunning, therefore, that CDC relies on an unwarranted and unscientific claim that “Vaccines Do Not Cause Autism” based on studies focused on two vaccines. Consider that most vaccines on the CDC schedule have not been tested for association. Science that has found association has been ignored by CDC. CDC has relied on the wrong types of studies because correlation studies cannot test causality, and not all vaccines have been tested for association with autism. The correct type of retrospective study seeking a genetic and vaccine interaction would look at those who are highest risk of ASD with, and without any vaccination. Such studies, we are told, would be unethical, but that position begs the question of the risk:benefit ratio of vaccines, which is unknown. Harvard-Pilgrim reported that only as few of 1% of vaccine adverse events are reported to the US HHS’s VAERS system, which is touted as evidence that vaccine adverse events are studied in so-called “post-market surveillance studies”. This is odd because any user of the VAERS system must acknowledge that the system cannot be used to assess causality. When CDC learned of the ESP-VAERS project results, they stopped returning phone calls.

Link 3: https://healthit.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf

Regarding payment for coming to any location to meet and educate citizens, lawmakers, or regulatory body members, it is a fair balance of the role of truly not-for-profit organizations to educate, while others lobby on any specific legislation that might be pending. Clearly, as a lifelong educator, it is not unexpected that I would be paid for services at an educational event. In my travels, I have neither testified for, nor against any particular pending bill, and in fact when I do testify or provide comment to elected bodies, I always make a point to state clearly, and up front, that I will not be sharing my position for, or against, any particular bill or piece of legislation. I also reveal that I have a potential conflict of interest given that I am an expert witness on numerous cases of vaccine injury pending and concluded in the National Vaccine Injury Compensation Program. It is not my position to lobby for votes or campaign for, or against any particular candidate for public office, and I refrain from doing so. If your reporter had asked me my position on any particular bill, which he did not, I certainly could have shared my position to him, for he is not an elected official charged with voting for, or against, any legislation, and I am free to voice my opinion to individuals. If any reporter were to ask me my opinion on any particular candidate, I would likely refrain unless that candidate was running for office in my district, and I do not spend time scrutinizing individual candidates nor elected representatives.

The IPAK Science Day program, new to 2020, has only just begun, but your math assumes a specific “cost” and attendance combination that is not assured, and does not include consideration of costs associated with running such a conference. IPAK has, and will continue to offer other, larger conferences in the past, including a conference on Vaccine Safety Science in 2017 (see e.g., http://www.ipakfocus.com/ ) with speakers from academia and from other organizations. IPAK offers online courses as well, focused on how to read, interpret and critically evaluate scientific research studies. Your reporter insinuated that there must be a way for me to “get paid”, and I merely informed him (or intended to inform him) of our planned Science Days as an alternative, which for maximum public benefit will occur the day before large gatherings in state capitols, whether I testify or offer public comment, or not. Regardless, for the record, IPAK, not I, as an individual, receives payment for such events as suggested donations for conferences, Science Days and online courses via registration “fees” collected as donations to IPAK via our website, and such funds are used to meet the cost of the events (venue, catering, AV, etc), and to support biomedical research in the public interest. We have allowed individuals who attend such events who do not wish to donate to attend without donation.

Rather than conduct politics, I much prefer to stay in the education and research zone to fill in the gaps by conducting the scientific biomedical research and education that US regulatory agencies and Universities have neglected. For example, US FDA has never published a per body-weight informed, per-day pediatric dose limit of aluminum for childhood vaccination practices. We have filled that gap with two recent peer-reviewed publication in the Journal of Trace Elements in Medicine and Biology (attached (Study 1 Study 2)) comparing the expected aluminum exposure in three vaccine schedules. Our results suggest that under the CDC schedule, we are subjecting infants to toxic levels (whole body burden) aluminum toxicity for 70% of days in the first seven months of life, compared to Dr. Paul Thomas’ “Vaccine Friendly Plan“, (an alternative vaccine schedule) which leads to an expected 5% of days up to seven months in aluminum toxicity. No body weight consideration is given to vaccination of pre-term, low birthweight infants in the NICU with 250 mcg of aluminum injected on Day 1 in the Hepatitis B vaccine. In 2017, in our #NICUChallenge, I issued a challenge to the medical community to provide evidence, in the form of peer-reviewed research, that 250 mcg of aluminum injections into 2kg infants in the NICU is safe; none provided any such evidence. About 80% of influenza vaccines contain thimerosal, and no reliable research studies have been conducted that show that aluminum in pediatric vaccines do not interact synergistically with thimerosal to cause problems with infant brain development. While vaccines are represented by some as universally “safe and effective”, the Informed Consent Action Network has provided a fantastically thorough assesment of the randomized clinical trials that have been conducted, and have reported that nearly all vaccines were tested against an adjuvant, or another vaccine, instead of an inert (inactive) placebo (See Vaccine Science White Paper, attached [Link]). No study of the health of children under the entire US CDC-recommended pediatric vaccination schedule has been compared to the health of children who are not vaccinated, and thus no such knowledge claims of universal safety and effectiveness are warranted. In the US, citizens in an identifiable at-risk group are entitled to equal protection from harm, and the denial of vaccine injury and death is a very cruel example of institutionalized and codified bigotry against the most at-risk families.

Your reporter neglected to ask me who the “them” was to which I was referencing, in terms of my comment of “keeping their heads spinning”, so I will take a moment to clarify: by “them”, I meant, specifically, the small number of agents working on behalf of pharmaceutical companies to misinform the public and lawmakers by exaggerations of the quality of vaccine safety science; those who misinform the public, through the media, on important facts that an informed public should want to know: that vaccines contain neurotoxins, immunotoxins, some are made with aborted fetal cells, that science certainly does exist that aluminum hydroxide induces conditions such as asthma, allergic rhinitis, Lupus, rheumatoid arthritis and other autoimmune conditions in mice and rats at doses that overlap the per-body weight doses of aluminum exposure in human children on the CDC schedule, and that if a genetic basis of autoimmunity is present, the dose used in animal studies is smaller. Most of the public does not know that autoimmune conditions can be reliably and reproducibly induced in rats and mice with aluminum hydroxide. In terms of ‘weaponizing books’ against misinformation and Science-Like Activities that have been used as poor substitutes for bona fide vaccine science, I believe such books, including “HPV Vaccine on Trial“, which reveals serious flaws in Merck’s submitted research to the FDA for approval of their Gardasil vaccine, and my own book, “The Environmental and Genetic Causes of Autism” (Simon & Schuster), which cites primary, peer-reviewed source material (1,000 peer-reviewed studies cited in the latter), are excellent tools to educate as many people as possible of the balance of the evidence and Science that exists in spite of cherry-picking by CDC, AAP, and others. (For what it’s worth, I borrowed the term “weaponize books” from an online detractor who accused us of weaponizing books. I think you will agree that books are an excellent weapon against ignorance?)

For the record, I am far from anti-vaccine; I am pro-science, and the problems with vaccines that have been buried by a denialist agenda are now becoming common knowledge in the public. Continued denial of vaccine risk and injury will only increase the number of families with vaccine injured members, increase the number of vaccine risk aware citizens, and we therefore need to chart a new path toward, as US Congress mandated in 1986, to make vaccines safer, and to identify those at highest risk.

Science is for asking questions, and vaccines are in no way immune to independent scientific inquiry. Studies on toxicity, safety and efficacy are all fair game to scientists worthy of the title. US regulatory agencies including CDC, NIH, and the FDA have abdicated their roles as keepers of the public trust in Science, and that explains why IPAK, the Institute for Pure and Applied Knowledge, has such broad and growing international appeal to the public as an alternative, truly not-for-profit entity is carrying the torch of objectivity in Science into the next decade. Hopefully, others will respond by following in kind with objectivity and concern for the safety of all children and adults who choose to vaccinate.

If you need any further details on statements I have made, I will gladly provide additional reference material.

Sincerely,

James Lyons-Weiler, PhD
PS See http:/icandecide.org/ for more information from that organizations’ research and legal dealings with the captured regulatory agencies in the US.

PPS The following is a direct quote from the IOM 2012 report in which IOM soundly rejected 17/22 studies as flawed. Those studies were cited by the Taylor meta-analysis, and by AAP, as if IOM had not scrutinized them. This is an example of fact white-washing that lead to ignorance, which must die by 1,000 cuts. The quote begins at “The committee”. I provided the link as Link 0, above.


The Taylor meta-analysis’ conclusion is based in part on studies rejected by IOM in 2012 as too flawed to be considered for the report on vaccines/autism link. In fact they rejected 17/22 studies. leaving five studies:

“The committee reviewed 22 studies to evaluate the risk of autism after the administration of MMR vaccine. Twelve studies (Chen et al., 2004; Dales et al., 2001; Fombonne and Chakrabarti, 2001; Fombonne et al., 2006; Geier and Geier, 2004; Honda et al., 2005; Kaye et al., 2001; Makela et al., 2002; Mrozek-Budzyn and Kieltyka, 2008; Steffenburg et al., 2003; Takahashi et al., 2001, 2003) were not considered in the weight of epidemiologic evidence because they provided data from a passive surveillance system lacking an unvaccinated comparison population or an ecological comparison study lacking individual-level data. Five controlled studies (DeStefano et al., 2004; Richler et al., 2006; Schultz et al., 2008; Taylor et al., 2002; Uchiyama et al., 2007) had very serious methodological limitations that precluded their inclusion in this assessment. Taylor et al. (2002) inadequately described the data analysis used to compare autism compounded by serious bowel problems or regression (cases) with autism free of such problems (controls).

DeStefano et al. (2004) and Uchiyama et al. (2007) did not provide sufficient data on whether autism onset or diagnosis preceded or followed MMR vaccination.

The study by Richler et al. (2006) had the potential for recall bias since the age at autism onset was determined using parental interviews, and their data analysis appeared to ignore pair-matching of cases and controls, which could have biased their findings toward the null. Schultz et al. (2008) conducted an Internet-based case-control study and excluded many participants due to missing survey data, which increased the potential for selection and information bias. The five remaining controlled studies (Farrington et al., 2001; Madsen et al., 2002; Mrozek-Budzyn et al., 2010; Smeeth et al., 2004; Taylor et al., 1999) contributed to the weight of epidemiologic evidence and are described below.”

EMAIL FROM CBC’S KATIE PEDERSEN:

On Tue, Dec 31, 2019, 3:18 PM KATIE PEDERSEN katie.pedersen@cbc.ca wrote:


Dear James Lyons-Weiler,

I am a journalist with CBC News: Marketplace, a national consumer affairs program with Canada’s public broadcaster.

Our team is working on a story about vaccine hesitancy and recently attended the V.I.E. Event in Washington, DC as part of our research.

While at the VIP event on the evening of November 14, we documented a conversation that took place between one of our journalists and yourself about the anti-vaccination movement and your role within it.

During this conversation, our journalist asked you for advice about how to start regional anti-vax movements in Canada. You told him among other things to use a tactic of “death by 1000 cuts.” You also told him “keep their heads spinning” in reference to how to further progress the cause with the public and legislators. You also recommended “weaponizing” books by giving out publications that raise questions about HPV.

You told the journalist that you wouldn’t charge to speak at an event in Canada because that would make you an “international lobbyist,” but you proposed another way to get paid where you would hold a “science day” the day before and charge admission in return for speaking.

When we later followed up with you and your team via email, we learned from these conversations that fees would be $20 to $45 USD depending on attendance. Based on an attendance of 400, this would have totalled $8,000 USD.

We plan to report what we’ve learned from our team’s conversations with you in an upcoming broadcast on Marketplace. We also plan to report that you have spoken at other events, claiming that vaccines “can and do cause autism.”

Over the course of our research, we spoke with many leaders in the anti-vaccination movement and consulted with scientists, medical doctors, researchers and vaccinologists about the issue of vaccine hesitancy in Canada and around the world. The broadcast is not about yourself specifically, but rather, a broader documentary about vaccine hesitancy.

Now in our 47th season, Marketplace is broadcast across Canada and is one of the longest-running current affairs programs in the country. We are committed to fair and responsible journalism in all our reports.

We would like to provide you the opportunity to respond to our findings. Our report will be one of our first episodes after the holidays, so we sincerely hope you can provide us with a statement by Tuesday, January 7.

If you have any questions, you can reach me on the phone at xxx-xxx-xxxx or via email at xxxxxxxx@cbc.ca. Thank you in advance for your response

Sincerely,

Katie Pedersen

Katie Pedersen

CBC Marketplace
p: xxx-xxx-xxxx
c: xxx-xxx-xxxx
e: xxxxxxxx@cbc.ca

Pharmacist-in-Hiding AAAB Continues to Ignore the Obvious

Pharmacist-in-Hiding AAAB Continues to Ignore the Obvious

There is evidently another round of ignoring the obvious in the back-and-forth between AAAB, the Anonymous Aluminum Apologist Blogger (AAAB), who introduces themself thusly, and themselves:

“This article is by VaultDwellerSYR, a pseudonym used by a faculty member of a School of Pharmacy within a large medical school.”

Feigning fear of “attack” due to a “delicate time” in their career, this person appears to be afraid of losing a bid for career advancement in academia. For what? For engaging in open, rational discourse in the leaves of a peer-reviewed journal. Has part of academia fallen so low that bona fide publications on the question of aluminum toxicity, even in defense of its safety, have become taboo? If so, I am so very glad to be a truly independent research scientist.

AAAB pastes post-it notes of “victim” all over themself for my daring to call them out on their charades, and their mischaracterization of my criticism of them for failing to grasp at the real brass ring of honest, open dialog on issues that truly matter. But that’s all chatter, irrelevant to the points at hand.

In this latest retort, AAAB behaves less sophomorically than in his first tirade, realizing of course now that they are dealing with a true professional, a veteran of many, many academic engagements and research projects. The tone of the two articles is markedly shifted, which I take as me raising the standard of articles published at the website, Skeptical Raptor.

So let’s have a go at this latest rebuttal. First, I refute and negate that it is “my responsibility alone” to show that my null hypothesis – the curve outlined by Clark’s rule, is not “irrelevant”. It’s the only null hypothesis of a safe pediatric dose of aluminum ever published. AAAB side-stepped the challenge to come up with his own curve, pitching the challenge back to me.

I could, for the fourth time, throw down the guantlet to the FDA and ask What IS a the safe level pediatric dose curve for aluminum adjuvants in humans? I’m not the one who published so many recommendations of aluminum oxyhyroxide-containing vaccines; that was ACIP. I’m not the one who publishes a recommended schedule packed full of ACV’s; that’s CDC. I’m not the one who is eternally silent on a safe dose of aluminum for newborns, infants in the NICU, 1-year olds, 2-year olds and so on. My colleague Dr. Ricketson and I in 2018 proposed what might be – might be- a logical approach to addressing the pediatric safe dose limit, given that FDA has published limits per dose for adults, and we know roughly what adults weigh. So there’s our PDL for others to consider, to test; Science is, at its finest, a social enterprise: by all means, have it.

Does AAAB present new data on a new PDL refuting the hypothesis that Clark’s rule provided? No. Instead, AAAB carries on with the practice of obfuscation (of which FDA’s Mitkus paper is a glaring example), and thoroughly derails his own argument, again, of which I will shortly outline the shortcomings. But he does call upon me to test, with empirical data, the PDL implied by FDA’s 850 mcg per dose per adult body weight is, in fact, a correct estimate. Rest assured, AAAB, we are analyzing human subjects research data that seems likely to help us address that problem. We would expect, in a pediatric population, the rates of autoimmune conditions to be equivalent between children whose parents did not decline aluminum-containing vaccines and children whose parents did decline such vaccines. Please be patient, those data are in hand, but they are being written up right now.

We specifically undertook the studies we did because the FDA’s Mitkus study, and no other study, led to a PDL. AAAB would have his readers believe that because a multi-compartment model exists that is “complex, very complex”, Clark’s rule is irrelevant. That does not cut it for me. The mere existence of a complex multi-compartment model does not refute anything; it’s not robust empirical data, and it’s not based on rigorous empirical data for what it is.

(1) The study they cited would never lead to Clark’s rule, could never lead to Clark’s rule, and is unrelated to and thus does not falsify Clark’s rule whatsoever. Why? For one, it’s focused on plasma concentration first, which I already spelled out for AAAB is irrelevant to the known, i.e., published, mechanisms of action of aluminum toxicity.

(2) The study that AAAB thinks Weissman’s study validates (Flarend et al.) reported that 95% of aluminum hydroxide was still in the body of the rabbits after 28 days. That’s a big problem. Our concern (see point #1) is whole-body clearance, not plasma. The drop on plasma from high levels to low levels without evidence of body exit is a cause for grave concern, not a cause for reassurance. Perhaps an analog toxin would help. There are other toxins that have rapid plasma clearance, such as arsenic. Is arsenic safe due to rapid plasma clearance?

(3) [Added on 12/31, day 2 of this article] – The Weissner study deferred to the future for infant-to-2-year-old knowledge of the safety of aluminum adjuvants:

“With respect to children simple allometric dose scaling
is not adequate, in particular for infants below 2 years of
age due to complex age-related developmental changes (Lu
and Rosenbaum 2014). For that purpose, physiology-based
modeling is required as it is increasingly used in pediatric
drug development and toxicologic evaluations (Sharma and
McNeill 2009; Barrett et al. 2012).”

So AAAB’s appeal to Weissner is redundant, and his (and Orca’s) mispresentation that “all is well with aluminum dosing in infants” is disproven by his own source material. Weissner’s own model did not lead to a PDL, and she did not cite our PDL, published in 2018. [End section added on 12/31/2019].

AAAB teaches students how to use PK, using a trapezoidal model for estimating the area under the curve. Measurement alone does not ensure objectivity, even if it is quantitative. Thus, I’m not impressed: it really does not matter what tool you are measuring if you are measuring the wrong thing, or not able to interpret the significance of a 28-day retention of 95% of a toxin that is continuously, slowly being released over a long period. Thus, chronic toxicity.

The lack of fine-scale data is a bit bothersome for AAAB, and they surmise (guess) what would have been seen. They celebrate the horrific finding that plasma clearance is so fast it leads to measurements about the same as saline. So would arsenic. It’s problematic for aluminum safe dosing, evidently, because otherwise it would also clear from the body, which it does not, for quite some time. Time enough to interfere with brain development and balanced cellular development in the immune system. Aluminum kills cells via ER stress, and is released from those cells with oddly mishapen proteins: a recipe for autoimmunity if I ever heard one.

AAAB claims that I consider “my model” (i.e., the Clark’s rule-based PDL “valid”. Not quite. I don’t even consider the starting value of 850 mcg of aluminum for an adult “valid”. And I, and my co-authors, say so. I, and co-authors, also lament that the only safe level for aluminum that is body-weight based is the 4-5 mcg/kg/day limit for individuals with renal impairment. We propose that Clark’s rule might be useful for a liberal safe level, because, after all, infants have 20% glomular filtration rate at birth, and do not reach full adult capacity for two years. Aluminum is also a cause of renal impairment, so no, I don’t stand by Clark’s rule as “valid”. It would help if AAAB read our studies in detail to grasp our stance. Peer reviewers did. AAAB should not misrepresent our study nor position, for they risk setting up straw men, which we are not obligated to defend.

Nevertheless, nothing in our studies conflates IV administration with IM injection; we state clearly all of our concerns of the available studies that use IV administration. Our studies represent, and should be read as critique of the studies that came before ours, and include lamentations over the use of citrated forms, IV administration, adult instead of infant mice, oral forms instead of injected, etc, etc. AAAB would have their readers imagine that those criticisms apply to our study; they don’t, or rather, if they do, it’s because we, like Mitkus, used Priest’s flawed model. So our deconstuction is aided by these barbs aimed curiously only at our study, but those criticism are clearly already stated as limitations in our study, but they are not in Mitkus’ et al., nor sufficiently so in the Priest et al. study.

Our message is that Clark’s rule is evidently the best we can do toward an empirical regulation-based PDL that recognizes the limitations that AAAB acknowledges, which is why I am grateful for AAAB putting such a bright light on the flawed logic behind claims of safety of aluminum adjvants in doses as high as those found in the CDC’s pediatric vaccination schedule.

In the very, very complex model, I count ten compartments and twenty-seven transition parameters. Maybe twenty eight, but the missing parameter for which data are most relevant are data on the rate at which aluminum is exiting from the body. So let’s say there are thirty seven parameters, all estimated with error. I agree with AAAB that any study designed to grapple with estimation of so many parameters would have to be duly powered, and I agree with AAAB that the study AAAB cites is, likely, insufficiently powered. However, the model itself is irrelevant to the question posed by our research study unless it leads to an alternative, per-body weight, per day pedatric dose limit of aluminum hydroxide in humans – which it does not.

AAAB likes to falsely accuse me of not understanding different forms of chemicals, a canard that is irrelevant to whether studies have or have not been conducted to study the whole-body clearance of the forms of aluminum administered in the manner in which they are used in humans (that includes, once more, in infants, not adults). AAAB is clearly missing the larger picture, completely.

Neither I, nor my colleagues, ever claimed that aluminum release from the site of injection was rapid. The lengthy exposure from a granuloma may be reassuring to those who would see it as such – reassuring because it keeps plasma concentrations low. But that, too, is flawed thinking. In his own attack on our article, the primary focus by AAAB thus far has been on plasma clearance; whatever amount is there in the first few hours, and days, is reassuring to AAAB; it’s the net product of the inputs and the outputs; odd then that the clearance is a cause for concern for those who cite and acknowledge the published Science on specific, known mechanisms of pathophysiology (e.g., me) but it remains reassuring for those who do not (e.g., AAAB), even after it has been cited to them.

Long-release appears to not be a concern for AAAB, even though during that long release a patient may be exposed to other viruses and bacteria via infection, leading to increased likelihood of an adaptive immune response to such pathogens, which in a perfect world would be reassuring – a freebie vaccine, if you will. I have written extensively about the role of the oddly shaped proteins that are released due to the cellular death option of the adaptive unfolded protein response following genetic and environmental ER Stress. There is ample reason already to avoid a permanent state of being an overly adjuvanted person in a world of complex proteins. In world in which genetic variation exists among humans bringing some patient’s any-proteins one or two steps more similar in amino acid sequence or three-dimensional structure to a pathogen’s protein, the clinically unnecessary long-term duration of aluminum “in the body” (which includes, I remind AAAB, the bolus at the site of injection) logically then leads to the expectation of increased risk of autoimmunity through molecular mimicry. A second infection from a virus or bacteria could then cause cause a flare-up of an the autoimmune disorder.

For unknown reasons, AAAB cites (albeit obliquely) other’s representation of macrophage transportation of aluminum to the brain as well as descriptions of vaccine aluminum as nanoparticles. For the record, it is not questioned in mainstream aluminum toxicity whether aluminum can enter the brain, or not. An early published description (1985) of amyloid plaque cores (APCs) reports the non-proteinaceous part to be aluminum, part silica:

This reality should have been a source of dire concern for all since it was reported. There are many, many citations of findings of aluminum in the brain. The entire discussion on mechanisms of how aluminum enters the brain is obviated by its presence in the brain, and its known high brain persistance, all recorded in the scientific literature.

The issue of AAAB’s unfamiliarity of studies on the nature of aluminum brain toxicity can be rectified by further reading, such as the quote by Gherardi et al. (2015):

“…poorly biodegradable aluminum-coated particles injected into muscle are promptly phagocytosed in muscle and the draining lymph nodes, and can disseminate within phagocytic cells throughout the body and slowly accumulate in the brain” (Gherardi et al., 2015).

This citation and diverse many other references on aluminum neurotoxicity can be found here, especially Bondy (2015).

I also refer AAAB to this study that found intussesception and death due to aluminum-containing vaccines in guinea pigs:

https://www.ncbi.nlm.nih.gov/pubmed/31270308

It provides more data that shows that tissue-based toxicology is appropriate for aluminum, and that aluminum-containing vaccines are problematic. The study, “Incidental induction of secondary bowel disorders in guinea pigs during a batch safety test of veterinary vaccines”, reports:

“Histopathologically, the white nodules on the serous surface were granulomatous inflammatory foci that consisted of centrally located eosinophilic amorphous deposit, which were surrounded by macrophages, lymphocytes, and fibrin deposits. These granulomatous foci did not invade the muscular layer of intestine. The similar granulomatous inflammatory foci were detected within the sites of intussusception (Fig. 1b) and the focus of intestinal adhesion (Fig. 1c) in the symptomatic 7 guinea pigs. The eosinophilic amorphous deposits, which were found within the granulomatous foci, yielded partly positive response to aluminum staining…

The relevant aluminum toxicity levels are in tissue, not plasma.

Tissue, not plasma. Thus, whole-body toxicity is relevant, and plasma levels are irrelevant.

AAAB gallantly excused me from offering an apology (for heavens knows what imagined slight I may have conducted for daring to defend my position). However, not that I’m even slightly interested in AAAB’s identity, but I would never apologize to an anonymous, random person on the web.

AAAB also said that they did not care to have a response from me, that they didn’t require one, which, as ostentatious as that sounds, I respond, I’m sorry. We now live in a world in which independent objective not-for-profit Science, funded by the people, conducted for the people, is a reality. So you will be hearing from me and my colleagues again, and again, and again as we reduce human pain and suffering through knowledge.

To best support our research, pitch in with a small monthly donation to IPAK, the Institute for Pure and Applied Knowledge.

Orca Beaches Himself on Aluminum Toxicology, Killing Mitkus in the Process

Orca Beaches Himself on Aluminum Toxicology, Killing Mitkus in the Process

EVER SINCE I first published a reveal that pharmaceutical companies have successfully orchestrated a take-over of regulatory agencies at the expense of objectivity in the science of public health, I’ve been attacked for daring to hold the view that Science is for asking questions, and that, above all, objectivity should play a role in all of Science, including vaccine safety science. Among those assailing such an evidently revolutionary concept is an MD who has evidently assigned himself the role of gatekeeper over the safety of vaccines as a liability-free commercial product. While not trolling papers in journals requesting their retraction if they shine a bad light on vaccines, this MD’s latest assault occured a few days after independent investigative journalist and author James Grundvig revealed the irksome Orca’s identity as David Gorski, questioning whether a person employed in vocation as austere and revered as a medical doctor should conduct themselves in public like a five-year-old spewing filth and personal attacks on stewards of Objectivity in Science, allegedly in the name of Science, skewing his five followers’ perception of how one should think about vaccine safety science.

Among the most important of Orca’s (David’s) complaints about our latest objective Scientific research on the toxicity of aluminum in CDC’s pediatric schedule is his claim that our model has a flaw the he “immediately spotted”:

“I immediately spotted the sloppy, false assumption behind Lyons-Weiler’s (sic) ‘model,’ namely its use of data from intravenous, one dose administration of aluminum to base its model for IM doses of aluminum on and its failure to take into account the much lower bioavailability of aluminum from IM administration compared to IV…”

Well, good for you, David. We immediately spotted that flaw in the aluminum modeling area as well.

Here, David is referencing the Priest study. It’s too bad that Orca did not also “immediately spot” that the Priest study was used by the FDA and is the very keystone of FDA’s allowance of aluminum in vaccines is safe in their Mitkus et al . study.

Thank you, David. You have in one fell swoop made our entire points all the more clear and validated our conclusions. You’ve slayed Mitkus.

We at IPAK have bent over backwards to lament the lack of actual empirical data underlying the claims that aluminum dosing in vaccines is safe. Anyone who actually read and understood our first, or our second study will find that we have made extra effort to lay out the limitations of our study, including the weakness of the available data upon which our assumptions are based.

All of these concerns are to be foisted equally upon the FDA’s Apology-for-Not-Conducting-Science, the Mitkus study.

Every. Last. One.

Like McFarland et al. 2020, The Mitkus Aluminum Apology study uses models based on Priest’s extremely limited empirical data. That is one of the reasons why I started our research in this area in the first place: Thus, our study. Since FDA has not published nor enforced any aluminum adjuvant dose limits for pediatric vaccines or vaccine schedules, we reverse-engineered a pediatric dose limit based on an adult limit FDA has published – 850 mcg per adults – and, using a very commonly used rule to estimate pediatric doses limits when none exists, we published our FDA-based PDL. As I have published in my last response to an equally baseless attack by AAAB, the Mitkus study is dead, and these two have made what is perhaps their most significant intellectual contribution in Science by killing it.

David claims, incorrectly, that the FDA’s limit is based on Bishop et al., and therefore a new limit is not needed. Here is part of the abstract from Bishop et al.(1997) that tells us that David is not even reading his own source material and knows nothing whatsoever of the provenance of information leading to 850 mcg per dose in the limit set by the FDA:

METHODS
We randomly assigned 227 premature infants with gestational ages of less than 34 weeks and birth weights of less than 1850 g who required intravenous feeding before they could begin enteral feeding to receive either standard or specially constituted, aluminum-depleted intravenous-feeding solutions. The neurologic development of the 182 surviving infants who could be tested was assessed by using the Bayley Scales of Infant Development at 18 months of age.

RESULTS
The 90 infants who received the standard feeding solutions had a mean (±SD) Bayley Mental Development Index of 95±22, as compared with 98±20 for the 92 infants who received the aluminum-depleted solutions (P = 0.39). In a planned subgroup analysis of infants in whom the duration of intravenous feeding exceeded the median and who did not have neuromotor impairment, the mean values for the Bayley Mental Development Index for the 39 infants who received the standard solutions and the 41 infants who received the aluminum-depleted solutions were 92±20 and 102±17, respectively (P = 0.02). The former were significantly more likely (39 percent, vs. 17 percent of the latter group; P = 0.03) to have a Mental Development Index of less than 85, increasing their risk of subsequent educational problems. For all 157 infants without neuromotor impairment, increasing aluminum exposure was associated with a reduction in the Mental Development Index (P = 0.03), with an adjusted loss of one point per day of intravenous feeding for infants receiving the standard solutions.

CONCLUSIONS
In preterm infants, prolonged intravenous feeding with solutions containing aluminum is associated with impaired neurologic development.

If David were correct (which he certainly is not), he would also criticize the FDA for setting a limit based on IV-sourced aluminum, just as he criticized McFarland et al. (2020) for using IV-sourced aluminum. David, however, is known his penchant for selective criticism, inconsistently applying standards of evidence to science he does, or does not agree with. David Gorski, MD is a master subjectivist when it comes to matters of science.

IPAK Did Its Homework PRIOR to Starting Any Study of Its Own

IPAK’s first foray into aluminum safety science was to map the provenance of the claim by FDA that 850 mcg of aluminum is safe regardless of body weight. One can find a reference to an 850 mcg limit as far back as 1984

Gupta (1995) (before Bishop) wrote:

“We, therefore, recommend that for immunogenicity studies of aluminum compound-adsorbed antigens in animals, the formulation intended for human use should be injected with a minimum dilution, preferably undiluted. The usual dose of aluminum used for human vaccines is around 0.5 mg. The upper allowable limit of aluminum adjuvants for injection in humans is 1.25 mg aluminum as per World Health Organization regulations (1990) and 0.85 to 1.25 mg aluminum as per United States Food and Drug Administration guidelines (May et al., 1984).”

May et al. (1984) cites the FDA’s 850 mcg to CFR 610.15 to the year 1982:

So much for Orca’s absolutely false knowledge claim.

During the 1990-2011 expanse of the vaccine schedule following the abandonment of Ethyl mercury (for all but influenza vaccine, preferentially prescribed, btw, by ACIP/CDC for pregnant women), the WHO, The CNANIC, the ATSDR, and the FDA all relied very heavily on animal studies fed a different type of aluminum than is injected into newborns in a flurry of considerations to the question of ‘how much is too much’. Worse, the animals were adults. Still worse, FDA cherry-picked one study, ultimately leaning on Golub et al., an oral exposure study, and they misrepresented the findings of that study to make injected doses of aluminum hydroxide doses appear safe.

A rough outline is provided over this timeframe:

1981 CFR amended to include 1250 mg/dose
1996-2007 PTWI estimated at 1 mg/kg/week; 0.5 mg/kg-day US child > 2 years of age (WHO Evaluation and Certain Food Additives and Contaminants. Section 4.1 Aluminum, 1996-2007)
1996 Committee on Nutrition Aluminum Neurotoxicity in Infants and Children (J Pediatrics),
1 mg/kg-day (in error as to PTWI- “provisional tolerable intake”)
2001 0.85 mg “selected empirically from data because it enhance the antigenicity and effectiveness of the vaccine” (Baylor et al 2001)
2001-2008 ATSDR set MRL/NOAEL to 1 mg/kg-day from all sources based on Golub 26 mg/kg-day NOAEL (ATSDR references Baylor et al (2001),
2001 MRL/NOAEL 2 mg/kg-day in adult humans from dietary sources (Golub et al 2001 (62 mg/kg-day, Keith et al)
2011 MRL=1 mg/kg bw/day (ATSDR, 2008), Mitkus (2011)

During this period of time, a discord between two committees’ recommendations was discovered.

IPAK DEEP-DIVING INTO THE HISTORY OF ALUMINUM ‘SAFE’ LEVELS PRIOR TO CONDUCTING OUR PEER-REVIEWED RESEARCH STUDIES.

What we did not find were dose-escalation studies in mice matching per-bodyweight injections of aluminum forms in vaccines in infant mice. We found the Flarend et al. rabbit study, which reported that only 6% of the injected aluminum hydroxide had left the body after 28 days. In that study, btw, the authors lost one of the rabbit brains. Where is Orca’s outrage?

It goes without saying that David Gorski knows nothing about aluminum safe levels in vaccines, and would prefer that the public know nothing, as well.

2019: CFR is still 850 mcg/DOSE, no published or enforced restrictions on pediatric dosing of aluminum, no information available on body weight considerations for aluminum dosing limits, and no additional information on CDC Catch-Up schedule aluminum dosing limits.

The second fatal error that Orca makes, which is the same error made by his hero Pharmacist hiding away in a major medical school (who, Orca gushes, uses “equations and everything!“) is to claim that plasma clearance rates have any relevance whatsoever on aluminum salt toxicology. The false narrative that “low bioavailability” for metals such as Ethyl mercury and aluminum oxihydroxide equal safety has now fallen completely apart and lies in shambles at the feet of these two individuals. As explained in many places now in the peer-reviewed literature which Orca conveniently ignores, most of which is cited by our two studies, or cites our first study, the issue of aluminum toxicity is tissue-based, cellular, right down to the organelles that make our cells work. In other words, not plasma.

I don’t defend our research with a childish glee that David appears to enjoy in his ineffectual hit pieces, but I relish the opportunity to educate the public precisely why IPAK deserves monthly donations to keep asking questions, doing analyses, and posing solutions to the problem of the abject poverty of objectivity in public health science, and wherever it is missing in biomedical research as well.

Sadly, there is no credible empirical Science that shows that the amount of aluminum in the CDC’s pediatric vaccination schedule is safe in the short or long-term. There is no credible empirical Science that shows that the use of a thimerosal-containing influenza vaccine and aluminum-containing vaccines in the same office visit, or in successive office visits, does not induce serious synergistic toxicity, especially for low-birthweight babies, or infants of mothers with low income, or African American males. Sadly, none of the Science that one would expect to have been done has been conducted.

Instead, we are left with a bloated, beached whale wondering how it became stranded, high and dry, and a Pharmacist who likely by now wishes he never engaged with a bona-fide, publicly funded working Scientist.

Aluminum Pediatric Dosing in Vaccines: Anonymous Aluminum Apologist Bloggers’ Fatal Error Totally Supports Our Conclusions

Aluminum Pediatric Dosing in Vaccines: Anonymous Aluminum Apologist Bloggers’ Fatal Error Totally Supports Our Conclusions

AS A WORKING SCIENTIST, highly trained and skilled in both the art and in the importance of bona fide scientific discourse, it bothers me when I see sorry excuses for scientific engagement such as the articles published, sans peer review, at the obscure Vaccine Risk and Injury Denialist website “Skeptical Raptor”. These articles use an immature style of attacking objective Science under the pretext of defending Science, composed of a mixture of ad-hominem attacks combined with a Gish-Gallop of throwing anything and everything they think might stick at bona fide Scientific inquiry, with a swirl of argument from authority while hiding behind the pretext of fear of being attacked by anti-vaccine, I mean, vaccine risk aware advocates. Science? I don’t think so.

The over-the-top high-horsed tone of the articles published at Skeptical Raptor may be amusing to those who enjoy a good street fight. However, Scientific discourse requires that we take a different tack than Romper Room tantrums in our response. I will indulge a bit in this about the website, however, by stating that in my experience, the anonymous Ghost authors of the (non peer-reviewed) articles at Skeptical Raptor have never met a vaccine-induced injury or death they did not like.

I am only responding to this blog because my colleagues thought I should. I hate to amplify SR; it’s a hate-filled place. I would have expected more from people who call themselves Scientists. Surely the vaccine risk and injury denialista could have found someone willing to take our peer-reviewed study on old-school style, in the pages of the Journal of Trace Elements in Medicine and Biology, where our study was published following blinded peer review (3 reviewers). Frankly, I’m disappointed by the lost opportunity for bona fide rational discourse. In contrast, their online attack is not peer reviewed; the author, or author(s), hid behind the above-mentioned pretext of fear of attack. Perhaps there is a conflict of interest or two they would prefer to not reveal. In contrast, my resume and biography are on the web and I make no income from the sale, manufacture and distribution of vaccines.

Ironically, in their online attack on Science, the ghost author, or authors, whom I will refer to as the anonymous aluminum apologist bloggers (AAAB), unwittingly attacked and destroyed FDA’s “Apology Study” research on aluminum in their attempt to attack our study. I’m referring to the Mitkus study, which was FDA’s attempt to dispense with empirical research such as age-appropriate dose escalation studies of aluminum hydroxide in mice to determine the actual per body weight dose limits for humans. The AAAB’s unwitting attack on the FDA’s Apology Aluminum study (Mitkus et al.) starts with four entire paragraphs of futile and pointless ad-hominem attacks. They cite measles, however, the live virus measles, mumps and rubella (MMR) vaccine does not contain aluminum, and thus their “anti-vaxxers are going to destroy us all” trope proves equally futile.

Because such attacks are irrelevant in Objective Science, we’ll move right along to see how they slayed the FDA’s Mitkus study.

The first error in reasoning that I point out might actually save the Mitkus study, for now. The aluminum apologist blogger claim that because none of the authors of McFarland et al. are toxicologists, we did not know that we should be focused on plasma clearance rates.

Right there, we are done.

Whoever wrote this critique clearly knows or cares nothing about aluminum toxicodynamics. It’s all spelled out in the peer-reviewed literature: aluminum injected into the human body, either by intramuscular injection (IM injection) or IV, has a strong affinity for solid human tissue, explaning thus precisely why its “bioavailability” as measured by plasma clearance is very low. It is not low because it is cleared from the body in urine, feces, sweat, etc. This is why we changed, in our first study, the language from “absorption” to “metabolic availability”: all of the aluminum injected in each vaccine (100%), and all aluminum that is absorbed by the intestine (0.3%) must be dealt with by the body, and in those systems, the toxic effects also manifest. The mechanisms of aluminum toxicity described in the literature ignored by AAAB are intracellular, and include mitotoxicty, disruption of the cytoskeleton, and endoplasmic reticulum stress. A full collection of references on the cellular mechanisms of aluminum toxicity is available here. AAAB cites none of this literature.

Measuring aluminum in the the plasma (or serum, or blood) clearance does not reflect whole-body content and actual aluminum toxicdynamics: aluminum exerts its toxic effects while adhered to tissues, and inside cells. The body clearance, therefore is the concern. Whilst in cellular tissues, aluminum can be expected to act as an adjuvant on proteins from other viruses and bacteria, and oddly shaped human proteins expelled during cellular death following aluminum induced endoplasmic reticulum stress. The longer the whole-body retention, the more likely the aluminum is to induce harm during “detox-retox”, which we refer to in our study.

The long-term duration of aluminum in the human body is a cause for concern over chronic re-exposure via aluminum cellular release and recirculation. Take, for example, a recent study that focused on plasma concentrations and relative amounts to brain, bone and other tissues (Weissner et al., 2019). The authors report:

“Crude linear extrapolation from 100% on day 0 through the mean dose fraction of V1 remaining at the injection site on day 80 (77.7%) predicts that complete absorption of Al from AH-adjuvanted vaccines will take at least 350 days (1 year).

In contrast, linear extrapolation through the remaining dose fraction for V3 (14.5%) suggests that Al from AP-adjuvanted vaccines might be completed much earlier after ca. 120 days.”

Source: Weissner et al., 2019. https://link.springer.com/article/10.1007/s00204-019-02561-z

That’s a long time for the body to learn and reinforce autoimmunity – and that’s just absorption. That’s not whole body clearance.

Similarly, Flarend et al.’s rabbit study found that only 6% of aluminum hydroxide injected into rabbits had passed from the body after 28 days.

Flarend et al. Al elimination (whole body clearance)

That means that the aluminum resides in human tissue, including bone, brain, and other organs, actively impairing cellular function, inducing cell death. Aluminum in all of these tissues is not static. The aluminum apologist bloggers ignore that while the amount of aluminum that makes it into the brain is relatively small compared to bone, its retention is much longer in the brain, and aluminum salt molecules remain toxic, killing cell after cell. This would explain why 90% of aluminum measured in the brain is found in the extracellular matrix, as reported by Priest. If it was not cytotoxic, it would be found in the cells.

In attacking our lack of focus on plasma clearance, AAAB showed the soft underbelly of why the Mitkus et al. study is all but flotsum in the scientific literature on aluminum because it focused on plasma clearance. Plenty of peer-reviewed critiques are available[1] and see citations in McFarland et al. 2020.

Mitkus is, in my professional opinion, dead. That is part of the reason WHY we used Clark’s rule.

As for AAAB’s criticism of cherry picking, AAAB is/are guilty of this very offense, otherwise they would never claim (incorrectly) that we should all be concerned only about plasma concentration. Vaccine risk and injury apologists used the same tactic to try to convince the medical community and the public that Ethyl mercury was not a problem because it cleared from the serum more quickly than Methyl mercury. But hundreds of thousand of Americans are not complaining about symptoms of their plasma. “Doctor, my plasma hurts”. No. They are complaining about symptoms of whole-body toxicity. Our study made it perfectly clear that we are addressing whole-body toxicokinetics. It’s a pretty straightforward analysis, and the difference between plasma and cellular organs is readily apparent.

Unlike the AAAB, we are concerned about the effects of aluminum on the circulatory system, the digestive and excretory sytem, the endocrine system, the integumentary system, the immune sytem, the muscular system, the nervous system, the renal and urinary system, the reproductive system, the respiratory sytem and the skeletal system. Why? Because these are the systems about which the public is reporting symptoms. The previous literature seems to consider the relative amount destined for bone to be “reassuring”, and refers to it as a storage depot, ignoring the constant exposure of cells circulating through bone as source of constant flux, recirculation, and exposure. The long-term whole-body burden is relevant when such diverse conditions as neurodevelopmental and immunological disorders are attributable to aluminum.

Plasma clearance rates are irrelevant to our study, other than the transient period of time that aluminum moves from tissue to tissue as it induces apoptotic and necrotic cell death. Priest largely focused on rates determined with co-administered citrates, which enhance the absorption, or adsorption, to tissue, and would expedite the plasma-based “bioavailability”. Importantly, Mitkus assumed that 90% of aluminum in whole blood was found in plasma (not 90% of whole body), with the rest adhered to erthrocytes, where it causes eryptosis (red blood cell death), and therefore likely causes anemia, so says Science. [ https://lupusnewstoday.com/2017/01/04/red-blood-cells-suicide-cause-anemia-sle-study-finds/ ] Note that animal studies of Lupus use aluminum hydroxide to induce SLE-like symptoms.

The diseases of the blood to which aluminum may also contribute are significant sources of morbidity and mortality in the US population, and in the population around the world. Having read all of the studies that use aluminum hydroxide to induce autoimmune conditions in mice, I’ve determined that the per-body-weight doses approach those in humans if the study use an animal that is a genetic mouse or rat model that predisposes the animal to the autoimmune condition. Conditions like asthma, allergic rhinitis, lupus, Sjogren’s syndrome, and so on are routinely and reliably induced by injections of aluminum hydroxide. But that’s just Science.

Similarly, animal studies reliably and reproducibly induce asthma and other autoimmune symptoms in mice using aluminum hydroxide. These are serious diseases with serious mortality burden; about 45 people in the US die from asthma every day. Readers can search Pubmed for studies that induce autoimmunity in mice and rats here:

The doses in these studies were systematically analyzed to compare them per body weight to a single dose in a single vaccine that a two-year old human receives on the CDC schedule, resulting in the following table:

This table and the paper in which it can be found, along with all of citations, is available here. (That paper survived peer review, but the publisher found a link to it on the IPAK website and claimed that we already published it. So much for the ‘open science’ and ‘open review’ experiment!)

Mitkus, based on Priest, used data from single or a handful of clearance rates of isotope-labeled aluminum. Our study took a different approach to a pediatric dose limit that introduces the question: since plasma-based bioavailability does not inform on whole-body toxicity corrected for body, weight, if 850 mcgs are “safe” for an adult, how does that scale to infants, newborns and toddlers? We also explored the effects of successive doses on accumulation and clearance, and introduce the problem that not everyone might be able to clear aluminum at the same rate as others, including those with genetic impairment of any number of biological pathways involved in detoxification, and newborns, which only have 20% glomular filtration rate of adults. None of the available studies on aluminum toxicology have considered aluminum toxicogenetics. Yet there is a patch for testing for aluminum allergy – clearly some people could be screened for aluminum allergy, yet pediatric practice ignores this reality.

The aluminum apologist bloggers also incorrectly interpret our results: They claim that we conclude that all of the aluminum injected simply accumulates:

“As it reads, the authors are trying to claim that under no circumstances aluminum is eliminated from the body and that the aluminum injected will accumulate in the body during the first 18 months of life.” – AAAB

None of our assumptions or conclusions even remotely resembles this straw man, and, as a straw man, it deserves no further attention than to say they must not have read, or understood, the full study.

We estimated a pediatric dose limit (PDL) based on a presumed per-dose safe level used clinically by FDA regulations, and compare the Priest equation results. By considering both body weight and cumulative retention, scaling their enforced per dose limit, we come to a very different conclusion than Mitkus. Notably, the McFarland et al. study did not derive the PDL estimate, it was already published in 2018, and we merely cited that previous estimated PDL. Why the FDA has not published and certainly does not enforce a per-body weight pediatric dose limit per day for aluminum hydroxide from vaccines is a mystery. On catch-up days, children can receive 5-9 vaccines in a single day.

Given their interest, I am surprised the aluminum apologist bloggers did not critique Mitkus and Priest for basing so much of their modeling on citrate-bound aluminum, which has a much higher absorption rate, thus clearing the plasma more quickly, making even our results (McFarland et al.) overly optimistic.

A salient question is why do AAAB not present their own whole-body PDL based on their own proposed methodology and submit it for peer review? The answer, I believe, is that they are afraid of (a) finding that their estimates would be similar to ours, and (b) they would be labeled “anti-vaccine” and lose their jobs, and perhaps (c) they may suffer from a cognitive blindness due to financial conflicts of interest (see (b)). (NB: Being in a School of Pharmacy as reported induces a COI).

Instead, they prefer childish Romper-Room Taliban-wanna be tactics.

If they do accept the challenge to actually engage in Scientific Discourse, I would expect them to start with the questions that began my research into aluminum pediatric dosing:

(1) How did the FDA come to determine that 850 mcg of aluminum is ‘safe’ for a single dose? (Answer: oral doses of oral forms of aluminum in adult mice levied via assumption after assumption into a per-injected dose amount of injected forms in humans. Then they abandoned all that, cherry-picked and misrepresented the Golub et al. study, and based it on the dose needed for a significant immune reaction).

(2) Why is aluminum dosing in vaccines expressed as “per dose” and why do the limits ignore both body weight, time and multiple doses?

(3) Why is there only one only published aluminum dose limit (4-5 mcg/kg/day) from parenteral sources (btw, anonymous aluminum apologist blogger, ‘parenteral’ means ‘non-dietary’, look it up, it arguably could include vaccines and not only IV sources.

(4) What IS the pediatric dose limit of aluminum hydroxide for humans, is it enforced, do pediatricians use it, does CDC consider it for catch-up days, or are we just arbitrarily injecting infants, newborns, and toddlers with toxic doses of aluminum and not realize it?

(5) AAAB represent themselves as stewards of Science. Why not join the increasing number of Scientists who are joining me in calling upon the FDA to do the dose increment studies in infant mice for all forms of aluminum used in humans so we know precisely which ill effects are likely to be expected by citizens who provide informed consent for vaccination with aluminum-containing vaccines?

Who’s afraid of a little Science?

PS If AAAB prefers anonymous bloggers, try Vaccine Paper’s execution of Mitkus and other “aluminum in vaccines is safe” apologist Science-Like Activities.

Memo to HHS et al:Personal Exemptions are an Essential Safety Valve on Whole-Population Vaccination Programs

MEMO

Date: 10/24/2019

TO: Office of Infectious Disease and HIV/AIDS Policy (OIDP), Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services (HHS).

FROM: Dr. James Lyons-Weiler, PhD

RE: Request for Information (RFI) From Non-Federal Stakeholders: Developing the 2020 National Vaccine Plan

Non-experts in vaccine science such as policy makers and lawmakers have no frame of reference for skepticism of the claims of wholesale and universal safety of vaccines.  To non-expert who have not read vaccine safety studies, and who do not have knowledge of important principles and proper practices of clinical trial study, claims of universal vaccine safety and the robustness and reliability of vaccine safety science appear reassuring.  The thinking is that universal vaccination will lead to “herd immunity”, and thus individuals “should” vaccinate for the “greater good”.

However, a few cogent facts, such as the existence of a National Injury Compensation Program, the existence of a limited Table of Vaccine Injuries (published by HHS), the fact that the National Vaccine Injury Compensation Program has paid out over US $4Billion in settlements and awards to families who have members who have experienced on-table and off-table vaccine injury. 

A moment’s reflection on these facts, however, should cause such individuals to pause and realize the following:

  •  Any paradigm of 100% forced vaccination will reveal, by injury, maiming or death everyone in the population who is susceptible.
  • Science has not defined any way (yet) to identify, contra the 1986 National Childhood Vaccine Injury Act, the individuals in the population who are most susceptible.
  • Susceptibility to vaccine injury and death almost certainly has a genetic risk that is not universally shared across the population.
  • By placing some potentially identifiable individuals at risk, universal forced vaccination is discriminatory and therefore places some families at increased risk of carrying all of the burden of morbidity and mortality
  • Under the 14th Amendment, this potentially identifiable, albeit heterogeneous population, is entitled to Equal Protection from harm from vaccines.
  • Families learn, via direct, personal empirical observation and experience, ahead of the ability of science, that they are at increased risk compared to the general population
  • Non-medical exemptions, put in place by past generations, provide citizens who have already tried to participate in the whole-population vaccination program to opt out without carrying an undue burden of vaccine injury and harm.
  • Vaccination programs without non-medical exemptions are cruel and inhumane to an identifiable subset of individuals and families who should not vaccinate..
  • Vaccine injury and death denialism based on the absence of studies that have yet to be conducted is cruel.

The above points alone are sufficient to warrant the continuance of universal personal exemptions to vaccine mandates (aka “philosophical exemptions”).

The counterarguments to this position are falsifiable, and include

  • CLAIM: Vaccine studies have been conducted that should have detected the adverse events claimed by citizens who no longer want to vaccinate.

REALITY: Most vaccine safety studies that could have detected serious adverse events now being claimed by tens of thousands or in some cases hundreds of thousands have been too brief, too small, correct for outcome variables related to likely vaccine adverse events, or exclude individual likely at high risk of serious vaccine adverse events.  Unlike trials for drugs, clinical trials of vaccines have short outcome follow-up periods.  We rely on post-market “surveillance” studies that employ passively collected vaccine adverse events, which capture less than 1% of vaccine injuries[1].  This means that although they are required by law to do so, most doctors fail to report ill health following vaccination to the Vaccine Adverse Events Reporting System (VAERS).  The requirement to report any ill health following vaccination exists whether the physician thinks the ill health is due to the vaccination or note, but there is no penalty to physicians who refuse to submit reports to VAERS. Post-market surveillance studies of VAERS data therefore cannot find new, real vaccine adverse events that doctors think are attributable to vaccines. Further, by most short-term randomized clinical trials on vaccine safety have been conducted without a proper inert placebo. Remarkable, nearly all have been conducted comparing the safety to other vaccines or to active vaccine ingredients such as various forms of aluminum, an adjuvant designed to activate the immune system Fig 1; [2].

Figure 1. Comprehensive literature analysis and review of vaccine safety studies by ICAN (Informed Consent Action Network) published in 2018[2] reveals the absence of studies that use inert placebo in a control group to study vaccine safety.

The absence of appropriate control for potential harm to health from aluminum adjuvants puts the US vaccination program in a state at risk of being rejected by the public as poor science.  The reliance of observational studies for long-term health outcomes and the lack of studies focused on the effects of receipt of multiple vaccines at once also places the vaccination program at risk of rejection by an increasingly vaccine-risk aware public.

CLAIM: Vaccines are such a boon to public health that individuals are not entitled to a choice or to informed consent.

REALITY: Current vaccines – and post-market surveillance studies – are not exempt from Federal rules and laws protecting the individual’s right to informed consent.  Nothing in the Code of Federal Regulations, for example, distinguishing individuals’ rights to decline to participate in vaccine safety studies, including whole-population human subject post-market surveillance studies.  Vaccination programs without personal exemption violate provisions of the National Research Act [Title II, Public Law 93-348], Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research [45 CFR 46] and revisions of various regulations, rules, and laws ([21 CFR 50, [21 CFR 56], [45 CFR 46 Subpart D], [10 CFR 745]. Pregnant women and fetuses are afforded special protections by [45 CFR 46 Subpart B], and children are afforded additional protections by [45 CFR 46 Subpart D]. Currently, rights of pregnant women and fetuses are violated with each and every vaccine administered to them because not only is there a paucity of pre-licensing clinical trials, no vaccine has been licensed for use to protect fetuses, and pregnant women are not told any of this as they are pressured to get vaccinated. Of note, in the Common Federal Policy for the Protection of Human Subjects (“Common Rule”) [10 CFR 745] Sec 745.103(b)(3), none of these rights were revoked by any subsequent legislation, including [21 CFR 50.24], which allows the relaxation of requirements for informed consent during emergencies. In fact, the Common Rule re-asserted safeguards both for informed consent, and for special protections against coercion:

I cite here section §46.116, “General requirements for informed consent”:

Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

“When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.”

Any whole-population vaccination program that does not include personal exemptions subjects the entire population to coercion, thus violating the US Code of Federal Regulations.  Personal exemptions allow individuals to react to adverse events they experience while participating in post-market surveillance studies, and such decisions should be respected.  The rights of any individual to opt-out of human subjects experimentation should be preserved.

The question of the value of entire vaccination on public health has two problems at this time (10/2019) based on two points.  First, some studies show significant population health reduction from vaccination (e.g., 3-6). Current vaccines are aging, and many appear to be no longer effective at preventing transmission of the wild-type pathogens they were designed to protect against.  These include influenza vaccines (annually announced in the press as inexact), pertussis vaccines [7,8], and the MMR for mumps[9], rubella[10] and possibly measles [11].  Outbreaks of pertussis and mumps in completely vaccinated populations are now commonplace, and individuals up to date on measles vaccination now develop measles after exposure to other vaccinated or unvaccinated who are infected. For influenza and measles, vaccinated individuals tend to have milder symptoms, but can carry the pathogens into schools and other public places. For mumps, rubella and chickenpox, break-through infections in vaccinated persons can be more serious, Instead of acknowledging the role of asymptomatic transmission, now routinely reported in numerous studies and discussed openly in the vaccine science literature [7], public health policy and the whole-population vaccination agenda blames the 1-2% who are not vaccinated.  This is different from individuals “shedding” vaccine-type live organisms, it is now also known that a large percentage of individuals who were diagnosed with measles in the 2014 Disneyland outbreak had breakthrough viremia and symptoms of measles from the vaccine type. It is now impossible to blame unvaccinated individuals on outbreaks, which will continue even if the US achieves 100% vaccination coverage in all children for all vaccines on the CDC schedule.  No form of herd immunity can exist when the vaccine in question masks the infection. The vaccinated asymptomatic carriers of infectious agents can carry infections into schools and into other public places just as well, but for longer periods of time, because, unlike the unvaccinated, they have no symptoms.  It is even reasonable to assert that the unvaccinated serve an important public health service by alerting schools of the presence of an active transmission chain of viruses and bacteria that can threaten the lives of the immunocompromised.

Given these realities, the claim that vaccines are such a boon to public health that individuals are not entitled to a choice or to informed consent is clearly falsified.

Clearly, those pushing for universal vaccination with current vaccines are hoping to continue their contracts by masking symptoms of illness from circulating wild-type pathogens that their vaccines no longer effectively target.  A case in point in the case in a PA court in which two whistleblowers report that their supervisors at Merck told them to spike human samples with rabbit-derived anti-mumps virus antibodies to defraud the FDA and the US public to continue Merck’s contract for the MMR vaccine. The systematic fraud is not sustainable, and removal of personal exemptions will not prevent the obvious failure of many of the current vaccines.

In the meantime, US citizens are asserting their rights under the US CFR and will continue to do so; no parent who has witnessed serious adverse events in their child or children will continue to vaccinate no matter what laws are passed to coerce them.  Personal exemptions are a safety valve not only the vaccination program – they are the way our society enacts the ethos embodied by our own national, and international laws protecting human beings from harm from human experimentation.  Loss of personal exemption options may appear to be a trivial change to the majority of Americans, but for some, it means certain death and destruction of their lives.

For these reasons and realities, it would be both immoral and unethical to remove or deny personal exemptions to vaccination.

Respectfully,

Dr. James Lyons-Weiler, PhD

2912 Kilcairn Lane

Allison Park, PA 15101

[1] https://healthit.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf

[2]ICAN. 2018. Letter to US Department of Health & Human Services re:HHS Vaccine Safety Responsibilities and Notice Pursuant to 42 U.S.C. § 300aa-31. https://www.icandecide.org/wp-content/uploads/2019/08/ICAN-Reply-1.pdf

[3]  Aaby, Peter.  2019. “This Vaccine (DPT) is Killing Children”  Symposium on Scientific Freedom, Copenhagen 9 Mar 2019. https://www.youtube.com/watch?v=udbUKD28K28

[4] Mogensen SW, Andersen A, Rodrigues A, Benn CS, Aaby P.

The Introduction of Diphtheria-Tetanus-Pertussis and Oral Polio Vaccine Among

Young Infants in an Urban African Community: A Natural Experiment.

EBioMedicine. 2017 Mar;17:192-198. doi: 10.1016/j.ebiom.2017.01.041.

[5]Bodewes et al., 2011. Annual Vaccination against Influenza Virus Hampers Development of Virus-Specific CD8+ T Cell Immunity in Children J Virol 85:11995-12000.

[6] Cowling, BJ et al., 2012. Increased risk of noninfluenza respiratory virus infections associated with receipt of inactivated influenza vaccine. Clin Infect Dis. 54(12):1778-83. doi: 10.1093/cid/cis307.

[7] Cherry, JD. 2015. Epidemic Pertussis and Acellular Pertussis Vaccine Failure in the 21st Century Pediatrics 135(6):1130-1132. https://pediatrics.aappublications.org/content/135/6/1130

[8] Althouse, BM, SV Scapino. 2015. Asymptomatic transmission and the resurgence of Bordetella pertussis. BMC Med 13:146. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482312/

[9] Atrasheuskaya AV, Neverov AA, Rubin S, Ignatyev GM 2006.Horizontal transmission of the Leningrad-3 live attenuated mumps vaccine virus. Vaccine. 24(10):1530-6.

[10] https://www.ncbi.nlm.nih.gov/books/NBK8200/

[11] Muller, CP. 2001. Measles elimination: old and new challenges? Vaccine 19:17-19. https://www.sciencedirect.com/science/article/pii/S0264410X00004552