Have I Lost It? Promoting Medical Exemptions is not “Pro-Mandate”: No Litmus Test for Vaccine Risk Awareness
I thank Leslie Manookian for sharing her ideas on her interpretation of my article “As States Push for Reason and Rationality, New York Times Goes Over the Edge, Calls for Mandatory Death for a Genetic Minority”. I thank AoA for inviting me to set the record straight on my position on vaccine mandates.
In her article, entitled “Has James Lyons-Weiler Lost It?” she interprets my position of empowering parents and doctors with the knowledge of biomarkers to identify individuals who are most susceptible as somehow being pro-mandate.
My first defense is point to articles where Manookian herself could be seen as defending mandates with exemptions in which her line of reasoning could be equally misconstrued, such as one entitled “Suggestions on How to Claim a Medical Exemption in CA” by Leslie Manookian, hosted at the very informed and useful Weston A. Price Foundation website; an article on Revolution for Vaccine Choice in 2016 in which Manookian informs readers to:
“Conduct genetic testing prior to vaccinating to better understand your child’s risk…. Test for various disabilities, conditions, and genetic variance such as variation in MTHFR, CBS, COMT, all BHMTs, MAO-A, SOD, cytochrome p450 enzymes, and HLA type which can determine your child’s susceptibility to vaccine injury.”
Her post unfortunately misinforms the readers to use 23andMe, which does not qualify under FDA rules as a clinical genetic test, and while the FDA may be turning a blind eye to consumers who attempt to use 23andMe as clinical data, the assay has proven to be inadmissible in court. The correct test to use would be either clinical single-gene assay or clinical exome sequencing, which are FDA approved, but which also have their own limitations because interpretation is based on available knowledge to date of association of specific genes to outcomes, and studies have not been conducted to determine which variants in our population are associated with vaccine adverse events. Her FB post also misinforms readers by insinuating that these specific genes can be used to determine a child’s “susceptibility to vaccine injury”. The studies that I am advocating to determine their generalized accuracy, sensitivity, and specificity have not yet been conducted. For example, MTHFR mutations may be very common in families with ASD from vaccines, but they are also fairly common in the general population, so their clinical utility may be limited. Only studies aimed to characterize a biomarker’s performance can tell us. Those who proceed in legal settings with biomarkers not backed by translational science will waste precious time and resources in their legal fights.
Perhaps her views have changed, and she is now against biomarkers to procure medical exemptions because in her view, that would make her an apologist for exemptions? As many people know, my position has shifted significantly since 2015 - because my journey at the time on the hidden, pathetically sad state of vaccine safety science was only beginning. While writing "Ebola", I only scratched the surface on vaccine civil rights issues, and, to the chagrin of my future self, stated the oft-repeated trope about "anti-vaxxers" putting others at risk. To those persons who those words hurt, I have since apologized with an article "My Journey from Ignorance".
My goal in my second book, "Cures vs. Profits", was to highlight the best and most promising current and historical advances made by biomedicine. I made a commitment at the onset of writing "Cures" to include any negative information I uncovered during my research. I had a book with 15 chapters and decided to add what I naively believed would be an easy chapter to write. What a journey I unknowingly set out upon.
After writing my chapter on vaccines in which, by the way, I defend Brian Hooker's retracted article, I reproduced the Verstraeten "It Just Won't Go Away" email (courtesy SafeMinds), and I brought forward four major vaccine controversies - even adding an Appendix to the book highlighting those controversies. Writing that chapter changed my views permanently, and I have worked non-stop ever since to fully characterize the abuses of science that have taken place. After reading what must now be over five thousand studies and articles on vaccines, and devouring laws and regulations on informed choice, it is my personal and informed professional view is that:
(1) Mandates are scientifically unfounded;
(2) Mandates are unethical;
(3) Mandates violate Federal Regulations on informed consent.
I’ve even been censored (temporarily) by the CDC for saying so.
For me, the urgency for real vaccine risk screening to provide evidence for medical exemptions is that pediatricians believe - incorrectly - that they have no alternative but to vaccinate everyone. However, to equate providing solid evidence for medical exemptions as supporting mandates is a red herring using a drawn conclusion. Given Manookian’s own advocacy for biomarkers for screening to obtain medical exemptions, I’m left puzzled. Those who are willing and able to provide scientifically founded medical exemptions can still be against mandates in the first place.
False dichotomies disempower and divide. "Pro-vax" vs. "Anti-vax" is the largest and most limiting pair of false alternatives that has used quite successfully by those historically in control of the CDC and its official and unofficial organs to stifle critical and creative thought, and to shut down meaningful conversations.
Paul Thomas' book is a good example of an approach for those seeking a middle-of-the-road plan to reduce risk. Other individuals, such as pediatrician Dr. John Hirschfield, spend time every day imploring their colleagues to look at the fact that there is no credible safety science on HPV vaccines. He also stresses the importance of avoiding giving more than one vaccine per day- noting especially the risk inherent to giving the Tdap or DTaP vaccine with any other aluminum-containing vaccine. These two MDs sit on a spot on the vaccine risk aware spectrum that may not be abolitionist enough for some. Other MDs, such as Dr. Tenpenny, occupy a more abolitionist view. Each approach the issue on how they handle their own vaccine risk awareness both in how they approach their patients, their peers, and the public in their own way.
All are doing good, and all are against mandates. There are individuals who are staunchly and forever against vaccination of any kind for themselves and for their families. While that is a position I do not necessarily share, that is a position I deeply respect. Personal choice means personal choice.
However, I cannot imagine why anyone who is considering vaccinating would not want to know their specific risk. The situation for informed choice in the US is deplorable. Even people with medical reasons seen as valid by CDC and vaccine manufacturers with contraindications are being coerced to vaccinate. Pediatricians don’t read VISs, and vaccine inserts, and many do not know what’s in the vaccines they are injecting into infants, pregnant mothers, and children. Biomarkers could alert them to patients at highest risk. The missing pieces of the inherited risk of autism, not yet directly addressed by any of the genetic studies, is the gene x environment interactions. I found among the 850 or so genes "associated" with autism, none of the genes could easily explain the full list of symptoms that lead to a diagnosis of ASD under DSM-V. No gene explains more than 1% of ASD liability in the population, and thus in any individual, genetics alone does not explain autism.
There are those who misconstrue (purposely) that autism "is genetic" (which is a complete non-sequitur given the evidence), and I am not among them. I cannot be successful tied to such nonsensical interpretation of a clear literature that says otherwise. Published estimates of how much "genetics" explains autism range between 38% to 50% (which I have seen exaggerated as high as 80%) - and, in "Causes", I make clear that studies support that much of the "genetic" risk is actually "genetic x environment interaction" risk, due to variation that makes certain individuals more susceptible to toxins in vaccines than others. These I call "environmental susceptibility genes", and I also state that every human being has the right to express their own genetic variation without fear of being harmed by mandated vaccines for some "greater good". I’ve even called for the resignation of NIH Director Francis Collins for misinterpreting studies of early signs of ASD in the brain as proof that ASD is “genetic”.
The fact that some people have higher genetic risk of adverse events from vaccines is not widely recognized nor addressed by autism "genetic" studies, which nevertheless consistently report that as much as 50% of autism "is environmental"; i.e., cannot be explained by genetics, and these studies did not even measure a single environmental factor. The 1986 Act mandated finding those who are most susceptible, and nothing was done. Thus, biomarkers.
Due to the CDC and the IOM stifling of science on the causes of ASD, individuals with increased risk remain unidentifiable. When they do become identifiable, via biomarker screens, they are then entitled, as an identifiable genetic minority, to equal protection from harm under the Fourteenth Amendment. Pediatricians would be shielded from financial penalties for unvaccinated patients if the accountants could properly calculate the proportion of potentially vaccinated in a practice discounting completely those who should not be vaccinated due to medical and religious exemptions. Does that mean I condone the practice of kickbacks? No. They should not exist. A loophole exists by which practices, but not doctors, can accept kickbacks for prescribing drugs. The kickback on vaccines come from Blue Cross/Blue Shield incentive. If biomarkers say a patient should not be vaccinated, BC/BS should not count them at all. If a patient has a religious exemption, BC/BS should not count them at all.
In the article the Manookian criticizes, I reported that vaccine mandates condemn millions to mandatory death, GBS, paralysis, autoimmunity, allergies, encephalopathy-induced autism, tics, and job loss. It is difficult to understand how the total sum of these populations can be misconstrued to mean a "few susceptible", as Manookian represented. Exemptions are a necessary steam-valve on mandates, and her article misrepresents mine.
There are many possible futures with Vaccine Risk Biomarkers. In one of those futures, the adoption of risk biomarkers is used as a red herring argument for mandates "for the rest of us". I personally and professionally strongly reject the notion of add-ons to biomarkers beyond their intended use. I will certainly never contribute to that possible future: that position would be inconsistent with my view that mandates are scientifically unfounded, are unethical, and violate Federal Regulations that guarantee patients with informed consent. The right to refuse each and every medical procedure available - including vaccines – is necessary for a non-totalitarian pharmatopian police state (please see The Pharma Bulls are Loose, and the It’s the End of Democracy in America), and I will continue to fight for freedom of choice and bodily autonomy every chance I get. Biomarkers will empower patients in a world full of mandates.
Regulations also exist that guarantee every patients' rights to informed choice to be included- or excluded- from clinical trials, and this in my view includes weak and pliable post-licensure vaccine pharmacosurveillance ecological/correlational retrospective "safety" studies, which fall far short of a critical test of the hypotheses of causality anyway. The fact that the data from such studies have to be abused and the data completely tortured and cooked and key results removed to make associations go away is telling us that vaccine are not as safe as Pharma would have us believe.
In my view, it would be foolhardy for any state to follow California's ludicrous lead in removing exemptions. Still, I can, and most likely will be conducting new science that shows the value of family risk, genetic and immunologic indicators that are robust (high accuracy, sensitivity and specificity) and useful for medical exemptions. Does that make me for mandates? No. Not even close. Does it make mandates more likely? I don't think so, because, as happened to me, many more biomedical research professionals will find themselves near and in the rabbit hole, and as the vaccine risk screening research is conducted, many more independent estimates of vaccine adverse event rates will result. The consequences and likely future that I see will be widespread calls to reformulate approaches to artificial immunization when biomarkers demonstrate the full extent of measurable harm, and an opening of the markets to novel and creative approaches to artificial immunization.
In the best possible future, my view is it means firing ACIP and the CDC, and allowing innovation to occur by which new approaches to immunization can emerge and compete on the platform of safety. Risk biomarkers can even the playing field and allow real science to do its job.
There are many benefits to vaccine risk biomarkers, the most obvious being a reduction in the incidence of vaccine injuries. In addition to reducing the extent of neurological, developmental and immunological harm due to indiscriminate vaccination, finally, after decades of vaccine risk denialism and a lack of real science on how vaccines cause myriad injuries, independent research will bring forward a full and accurate account of the rates of vaccine adverse events and injuries. Biomarkers also require an understanding of the functional relationship between the biomarker and the disease, disease state or health outcome, and therefore a full comprehension of the molecular, genetic and environmental causes of autism and other conditions will result.
To the extent that biomarkers might perpetuate the widespread negative effects of vaccines that are not yet recognized, mistrust of science from families of loved one injured and killed by vaccines is all those involved in faux vaccine "safety" science can expect. They had the hubris to proclaim that no further science was necessary - and the incredible hubris to proclaim a short lists of vaccine injuries to be recognized by the National Vaccine Compensation Program. Manookian does not report the multiple times I’ve called for the repeal of The National Childhood Vaccine Injury Act.
I must, as an objective scientist, also warn against the same type of hubris that proclaims that safer means of artificial immunization cannot ever be made. Such generalization requires full knowledge of all possibly conceivable approaches to artificial immunization. If the assessment is based on the past performance of evil-doers, I cannot place blame on those who mistrust scientists – but those who mistrust those scientists must avoid mistrusting all scientists. I must state that a gross generalization has being made by insinuating that I am some type of wolf in sheep’s clothing. I am a scientist who was never involved in the past evils of faked vaccine studies designed to mislead and defraud the public, and lead to the denial of their rights to informed choice. All my professional career I have advocated for objectivity in science, staring down people with a larger number of degrees than I hold. It’s easy for me.
It is a pleasure to have the chance to say that I am, and I will remain, staunchly and forevermore supportive of anyone who wishes to refuse artificial immunization of any kind, for themselves and for their families for any reason - and that I am unabashedly 100% against vaccine mandates. I commit that I will continue to hold and state this position at every opportunity. My record speaks for itself. While pointing out that newer approaches to artificial immunization might be possible, I have also made the point that if I were involved in the invention and patenting of new technologies for artificial immunization, I would ask the FDA to not classify them as a biologics or vaccines, but rather as a new device, so that my (completely hypothetical) company would be held liable under the law for any adverse consequences, so the product could be recalled, and that knowledge use to improve the product. I would conduct randomized prospective clinical trials with long-term total health outcomes awareness for the participants of the studies and insure that the studies were large enough to guarantee that adverse events with rates as low as 1-2% could be detected. Expensive? Yes. Time-consuming? Yes. Will this be easy to conduct? No, it will be fought by those who seek to maintain the status quo at every turn. But it will be easier and not nearly as expensive and time consuming as the widespread ill health effects resulting from the indiscriminate use of current vaccines on population denied informed choice and kept in the dark by the CDC and the media. Our community currently has the best opportunity we may ever have to change immunization science permanently by working together to repeal the 1986 National Childhood Vaccine Injury Act and if the vaccine makers rage quit and pack up their vaccines and go home, so much the better.
Let me state this as clearly as possible: as currently formulated, vaccines are filthy, nasty vials of toxic sludge that every American citizen and parent should be able to refuse for any reason. Doctors are not qualified to and should not be put in the position to "vet" whether any individuals’ claim to a religious exemption is "valid"; they certainly are not trained on comparative theology in medical school, and they cannot know the hearts and minds of individuals who do not want to collaborate with the past evils of abortion by injecting products made with and containing proteins and DNA from aborted fetal cells and tumor cell lines. I defend religious exemptions, and I am an evolutionary biologist!
Fifty out of fifty states currently have mandates. Due to losses of local political fights, fewer now allow full both philosophical and religious exemptions – and this is more reason for rapid action on biomarkers. I believe individuals should be entitled to invoke without encumbrance. In my view, a simple "no thank you" should suffice. But exemptions to mandates are under serious legislative threat around the country. Rights to informed choice are under threat due to medical kidnap cases used as a pretext for precedent for state-enforced vaccination. Again, so I am not misconstrued: I would prefer no mandates at all. In providing evidence that can be used by patients and doctors to warrant medical exemptions, I am not, intentionally nor unintentionally, condoning mandates.
I can also not enjoin in “belief” (for me) as a guide for knowledge, because, as a scientist, my understanding is not based on belief, but is instead based on empirical results from properly designed and conducted studies (which are wanting for most current vaccines) and based on cumulative evidence. Do I doubt, as insinuated by Manookian that any parent who says their child regressed into autism after vaccination? No. When I cited in the article being critiqued that not all vaccines have been tested for association with autism, I was criticizing the generalization made by CDC, the media and Pharma when they claim Vaccines (plural) do not cause autism. I was not claiming that parents' observations were invalid - in fact, all science begins with observation. Our society is filled with millions of "observations" - children with autism, ADHD, food allergies, etc. many of whom are now becoming adults – and I do not doubt a single reported observation.
If I am not for mandates, even with vaccine risk biomarkers, what am I. I am for science, for informed choice, for titers checking, against re-vaccination when titers fail to show immunization, for considering familial risk, and for formalizing methods to measure risk of injury from vaccination. A thorough review of the literature indicating the plausibility of vaccine risk biomarkers is underway, and it includes Th1/Th2 skew as worthy of testing for its ability, along with many other measures, to accurately predict adverse outcomes from vaccination. I am against fraud, against pseudoscience, against contaminants in vaccines, against mercury, against aluminum, against vaccination in the NICU, against vaccine risk denialism and against vaccine injury denialism. I am pro-buffering against vaccine injury with alternative schedules. I would love to see studies that demonstrate that supplement can protect the human brain against vaccine injury. Do I recommend or not recommend vaccines? I cannot answer that question, because I do not practice medicine. The best that I can do is to try to reform medicine from within, and inform legislators considering specific bills. While I cannot endorse or rally against any bill or support any political candidate running for office while wearing my NFP scientist hat, I earnestly wish all great success in their efforts to end mandates completely. Should that fail, we need to protect those at highest risk. Addressing the realities of the evils of mandates by providing biomarker evidence for use for medical exemptions may not go far enough for those who would ban mandates, and not go far enough for those who would ban vaccines, and I get that. I am aiming for rationality in a world in which unwise mandates that already exist for attendance to public school are wisely tempered by philosophical and medical exemptions - for those who choose to opt out based on religious/ philosophical exemptions, and/or based on medical exemptions. Biomarkers would go a long way to inform the latter and bring reason and rationality back to the practice of medicine.
For those who express concern that I may be representing vaccine industry "propaganda", I am happy to report that I have no financial conflicts of interest to report, no relationships of any kind with any company involved in the sale, manufacture, or distribution of vaccines - or biomarkers. To the contrary, the only COIs I must report is compensation I have received for the time I have spent bringing science into cases of vaccine injury filed in the National Vaccine Compensation Program. The COIs in my book sales are obvious, but I’ve spent far more promoting the last two books than I will likely ever see from their sales. I've spent time, energy and my own resources specifically helping moms in my area defeat proposed mandates for HPV vaccine in Allegheny County, informing the public on the realities of vaccine risk, fighting alongside parents in court to maintain their rights to philosophical and medical exemptions, and standing up for their character. Biomarkers will make procuring safety for those most at risk much simpler than prolonged court battles and end the nonsense of our community being on the defensive.
I do not wish to control anyone’s narrative. I’m no wolf in sheep’s clothing. I don't follow any play book other than science, and I employ rational skepticism. And I don’t pretend to have all the answers, nor own any of the initiatives. Everyone in our community needs to push in the same general direction to increase vaccine risk awareness.
Manookian brought up Hannah Poling; I should point out that had loss-of-function mitochondrial mutations been in play as vaccine screening biomarkers, Hannah Poling’s doctors and her parents could have been alerted and her vaccine injury avoided.