$100,000 World Mercury Challenge
There’s been a lot of buzz lately about the $100,000 World Mercury Challenge for anyone who could find a scientific study that demonstrated the safety of thimerosal-containing vaccines in children and pregnant women. Well, I’m in luck because I literally just spent the entire last month reviewing the scientific literature on this very topic via PubMed and GoogleScholar searches. I started down this rabbit hole research project out of concern that even though thimerosal, a known neurotoxin, has been phased out of most vaccines, it continues to be used in 50% of flu vaccines given to pregnant women and children above EPA safety guidelines for mercury. There is, of course, a difference between methlymercury and ethylmercury (the kind that thimerosal primarily decomposes into). However, because a reference dose safety guideline has still never been set for ethylmercury, federal agencies and the World Health Organization continue to use the methylmercury guideline. https://thinklovehealthy.com/2016/07/31/mercury-in-vaccines-history-toxicity/. This discrepancy has literally kept me up at night wondering and worrying and mulling over the research available to us. Luckily, though, for us it has also given us a lot of background research to start from to win that $100,000.
Honestly, it would be really amazing to win $100,000, but coming up with all of the counterpoints to some of the data and research I’ve found actually seems incredibly daunting to do by myself. Maybe as a team effort we could dismantle each argument point by point and split the winnings? We’ll have to stay focused, though, and not get side-tracked by snarky Facebook memes that are currently in vogue proving the efficacy of vaccines. The efficacy of vaccines is not in question here. The question at hand is whether or not thimerosal use in vaccines is safe for children and pregnant women. So, let’s stay focused, people! We have money to win here! In order to prove that thimerosal use is safe in vaccines for pregnant women and children, we’ll have to 1) look at the 165 scientific peer-reviewed studies that demonstrate that thimerosal does cause harm and explain study by study why none of this data is valid 2) look at all of the critiques of the 7 epidemiological studies commissioned by the CDC during a time when they were under intense litigation pressure to prove that thimerosal doesn’t cause autism and explain why none of these critiques of methodology flaws are valid. 3) We’ll also have to be able to address claims of conflict of interest that have been leveled against the CDC including, but not limited to receiving money from pharmaceutical and vaccine companies not given to the CDC directly, but indirectly through the CDC Foundation for the past 20 years. Is anyone up for the challenge? I’ve done a lot of background research on this so we have a good foundation to start from. So here goes, our first order of business to win that $100,000:
DISPROVING 165 THIMEROSAL STUDIES SHOWING EVIDENCE OF HARM
I know it sounds crazy that there are 165 peer reviewed scientific studies that show evidence of harm resulting from thimerosal exposure, but here is a link to a comprehensive list of these studies so you can have a look at them: http://mercury-freedrugs.org/docs/20140329_Kern_JK_ExcelFile_TM_sHarm_ReferenceList_v33.xlsx. I didn’t come up with this list, but it does mirror what I found in my own PubMed/GoogleScholar search. A number of these studies, including a recent meta-analysis published by 2 CDC scientists, indicate that ethylmercury is just as toxic as methylmercury. So our first task will be to look at the 149 studies done on human tissue cultures and animals studies that have shown harm from exposure to this neurotoxin and explain why there is absolutely zero chance any of this could be extrapolated to human beings and more pertinently, to a developing fetus during critical periods of development to the brain and central nervous system. Our second task will be to look at 16 of the studies that were conducted on human infants and/or children that found harm in the form of: death; acrodynia; poisoning; allergic reaction; malformations; autoimmune reaction; Well’s syndrome; developmental delay; and neurodevelopmental disorders, including tics, speech delay, language delay, attention deficit disorder, and autism and explain case by case why each of these studies are not valid. Is anyone up for helping me review each of these 165 studies one by one? It’s honestly a bit too overwhelming for me to do on my own.
According to New York Times medical journalist David Kirby who wrote the book Evidence of Harm: Mercury in Vaccines, a Medical Controversy, the first research study ever done on thimerosal’s safety was conducted by the vaccine company Eli Lilly, which began producing and marketing thimerosal in the 1930s. It turns out that in a rush to market their product and prove its safety, they secretly sponsored a 1930 toxicity study on patients known to be dying of meningococcal meningitis. “Doctors injected 22 patients with high levels of thimerosal and then monitored them for toxic effects. Most died within days, from meningitis. Thus, no adverse thimerosal effects were observed. Lilly cited this study repeatedly for decades as proof that thimerosal was of low toxicity and harmless to humans.” I think we can all agree that this is an invalid study, so we probably shouldn’t site this one to prove thimerosal is safe.
Eli Lilly also received numerous articles and letters from doctors and medical institutions between 1940 and 1972 citing examples of harm from thimerosal injection. For the sake of brevity, here are just a handful of them:
1947- Article received by Lilly: “No eruptions or reactions have been observed or reported to Mertiolate [thimerosal] internally, but it may be dangerous to inject a serum containing it into a patient sensitive to Mertiolate.”
1948- Article received by Lilly: “Mertiolate is such a commonly used preservative for biologicals, plasma, cartilage, etc., that it would seem important to determine whether harm would result following its subcutaneous or intravenous injection in skin sensitive individuals.”
1963- Article received by Lilly: “There is another point of practical significance: does the parenteral injection of Mertiolate-containing fluids cause disturbances in Merthiolate-sensitve patients? It is known that person that are contact-sensitive to a drug may tolerate the same medications internally, but it seems advisable to use a preservative other than Mertiolate for injections in Mertiolate-sensitive people.”
1967- Lilly’s Medical/Science Department requests that the claim “non-toxic” on thimerosal labels be deleted in the next printing run.”
1972-Article received by Lilly: Merthiolate in vaccines caused six deaths–” The symptoms and clinical course of the six patients suggest subacute mercury poisoning.”
1976-Lilly responds to Rexall Drug Company’s efforts to place the following warning: “Frequent or prolonged use or application to large areas may cause mercury poisoning.”
What should our angle be here? I think our main argument to dismiss letters of concern indicating harm and toxicity of thimerosal could be that not all of these cases were specifically vaccine-related. Of the ones that were vaccine-related, we don’t know the levels of thimerosal used in vaccines back then. Or do we? Someone should research this. It could be worth $100,000. Plus many of these articles and letters of concern from medical journals and doctors are anecdotal and old data. We could argue we should only look at the more recent evidence of studies conducted.
COUNTERARGUMENTS TO CRITIQUES OF 7 EPIDEMIOLOGICAL STUDIES THE CDC HAS USED TO DEMONSTRATE NO EVIDENCE OF HARM
The CDC relies on 7 epidemiological studies to prove that thimerosal doesn’t cause harm in vaccinated children. In order to use these studies as proof to those who believe in the evidence of the 165 scientifically peer-reviewed studies that indicate thimerosal does cause harm, we’ll have to be able to address the critiques they’ve made against each of these 7 studies.
For those who need a refresher, epidemiology is the study of how often diseases occur in different groups of people and why. Some argue that a potential weakness of epidemiology studies is that when looking at data of populations of people, it’s possible to miss unknown subpopulations who have, for example, unknown genetic susceptibilities to any number of things. The possibility of thimerosal sensitivity was referenced in many of the letters and articles Elli Lily received, and at least 60 PubMed studies (by my own count) that studied the relationship between mercury and autism indicate that people with ASD carry a heavier mercury burden in their bodies than the general population, suggesting that they may have greater difficulty clearing/detoxifying mercury from their systems. If we can get through all of the scientific critiques to all seven of these epidemiology studies, though, we can at least claim that thimerosal is safe for the majority of people?? Shall we have at it? Addressing some of those critiques one by one so we can win that $100,000:
THE VERSTRAETEN STUDY 2004
Our first order of business regarding the Verstraeten Study is that we’re going to need someone with PR skills. This study is actually incredibly controversial in part because of the Simpsonwood Report, minutes from a closed-door meeting reviewing the initial results of this study between CDC scientists, vaccine companies, statistician and other consultants that a parent advocacy group obtained from the CDC through the Freedom of Information Act. We’ll have to be able to explain some of the concerning statements that were made regarding this study in which statistical re-analysis of the results to change “highly significant results down to a fairly marginal result” and litigation concerns “The medical legal findings in this study, causal or not, are horrendous,” are openly discussed. A few other quotes we’ll need to be able to explain:
“What if the lawyers get ahold of this? There’s not a scientist in the world who could refute these findings.”
“You can look at the data and turn it around and look at this and add this stratum and I can come up with very high risks. And I can come up with very low risks depending on how you turn everything around. You can make it go away for some and then it comes back for others…so the bottom line is, okay, our signal will simply not just go away.”
When asked if the thimerosal hypothesis was biologically plausible, “When I saw this and went back through the literature, I was actually stunned by what I saw. Because I thought it is plausible. So basically to me that leaves all the options open and that means I cannot exclude such a possible effect.”
“The number of dose related relationships are linear and statistically significant. The increased incidence of neurobehavioral problems in children in the past few decades is probably real.”
“The earlier you work with the central nervous system, the more likely you are to run into a sensitive period for one of these effects. It changes enormously the potential for toxicity. There’s a host of neurodevelopmental data that would suggest we’ve got a serious problem. To think there isn’t some possible problem here is unreal.”
“The rise in the frequency of neurobehavioral disorders is much too graphic. We don’t see that kind of genetic change in thirty years.”
“[This study] leads me to favor a recommendation that infants up to two years old not be immunized with thimerosal containing vaccines. My gut feeling? It worries me enough. Forgive this personal comment, but I got called out at 8 o’clock, and my daughter-in-law delivered a son. Our first male in the next generation, and I do not want that grandson to get a thimerosal containing vaccine until we know better what is going on.”
“One thing is for sure, there is certainly an under-ascertainment of all of these cases. Some children are just not old enough to be diagnosed. So the crude incidence rates are probably much lower than what you would expect, because the cohort is still very young.”
“You could readily find a junk scientist who could support the claim with a ‘reasonable degree of certainty,’ but you will not find a scientist with any integrity who would say the reverse with the data that is available.”
Dr. John Clements of the World Health Organization warned that research results would have to be “handled.”
The Verstraeten Study published by the CDC consists of an analysis of a subset of records from the medical records databases called the Vaccine Safety Datalink (VSD). This study went through at least four generations of statistical re-analysis before it was released to the public four years after the initial study. Each generation of the study found lower and lower statistically significant links between autism, neurodevelopmental disorders, speech delay (an early symptom of autism) and tics until it was finally released to the public in its final version. Some of the critiques of the different generations of statistical re-analysis that occurred in between the initial study and the final version include:
1) In the final version, the VSD team eliminated the combined umbrella of “neurological developmental disorders” by breaking that general outcome into individual categories like ADHD, speech delay and tics. By doing this they could claim that their original findings were no longer “consistently statistically significant.”
2) The researchers also decided to include only those cases that had been confirmed by a behavioral specialist. If the behavioral specialist had been outside the HMO, the diagnosis would not be included on their HMO chart. This essentially gave the authors the ability to “cherry pick” cases out of the original data set, thus watering down the initial statistically significant link. According to New York Times medical journalist David Kirby, when they made this change in the methodology in the ADHD/ADD category only 40% of the original diagnoses were confirmed. With speech and language delays, only 50% of the original diagnoses were confirmed. With autism, only 80% of the original diagnoses were confirmed. Thus, by essentially deleting a majority of the nuerodevelopmental diagnosis from the original data set, the authors were able to claim that there was no longer a significant link.
Concerning these two points, Dr. Neal Halsey, the vaccine expert and advocate from John Hopkins published a letter in Pediatrics in 2003 questioning this methodology. He wrote that in the IOM version of the study there had been a statistically significant dose-escalating association between thimerosal and neurodevelopmental delay, which he said was a reasonable form of analysis given that mercury toxicity was associated with multiple effects on neurological development. Dividing the umbrella category, he argued, substantially reduced the power to find important relationships. He claimed there was no reason to exclude diagnosis made by regular doctors (i.e. you don’t need a specialist to diagnosis ADD).
3) Compared to the population at large, the study found relatively few children with autism, which it could easily be argued would seem to be a direct result of the above “cherry-picking” of the data from the original dataset. In other words, the data that was finally presented simply did not reflect real rates of autism in the general population.
4) The authors changed the exclusion criteria halfway through the study. They added back in children “at risk” for adverse outcomes, regardless of thimerosal exposure. This had the effect of “mudding the waters” by producing more outcomes in the lower exposure categories, resulting in an overall lowering of relative risks.
5) The authors broke up data from the largest HMO into data from individual clinics, thus lowering statistical power and enabling them to eliminate any “consistent statistically significant” risk from the initial study.
6) Researchers threw back in the cohort of young children from birth to 3, even though the average age of autism diagnosis is 4.4 years, which would have the effect of watering down the relative risk found among all children. This statistical maneuver was explicitly referred to in the Simpsonwood Transcripts with the explicitly stated purpose of eliminating their original highly statistical findings:
“All those kids that Tom has excluded, I have thrown them in. I think there is a clear argument that is going too far, but that further brings things down. So you can push, I can pull. But there has been substantial movement from this very highly significant result, down to a fairly marginal result”
6) Researchers did not look for outcomes like Asperger’s Syndrome (which has been included in ASD diagnosis since 2012) and PDD-NOS, which would have yielded even higher results than the original findings.
7) And finally, the principal investigator of this study, Verstraeten, worked for a vaccine company at the time of the publication of this study but neither he nor the CDC disclosed this conflict of interest when they released the final version of this study to the public.
That’s a lot to digest, I know. But we’ll have to be able to really study the research and the know it forwards and backwards in order to find what some valid counterpoints to these critiques might be. Any ideas for this one?
SIX OTHER EPIDEMIOLOGY STUDIES
I wish we could rely on our public health agencies to do this review for us, but since the CDC derailed a scheduled 2012 review of their underlying science by the Institute of Medicine (IOM) and killed a 2006 review of thimerosal safety by the National Toxicology Program, unfortunately, we’ll have to do that review ourselves. We have six other studies we’re going to need to exonerate from criticism before we can claim that thimerosal is safe. This is already lengthy, though, so let’s hold off on reviewing those just yet. A discussion of these studies will be a bit boring for a few of them, involving allegations of flawed methodology and similar statistical maneuvers like the ones referenced in the Verstraeten study. Others will be a bit juicer, like the three that were authored and/or co-authored by a man who is literally on the Office of Inspector General of the Department of Health and Human Services Most Wanted Fugitive List. (No joke.) But let’s hold off on those for now. We have a lot of work to do first just to redeem the Verstraeten Study.
CDC CONFLICTS OF INTEREST
I know, I know — questioning the integrity of the CDC and potential conflicts of interest sounds like the stuff of conspiracy theories. A full discussion of these allegations are another piece entirely that we’ll have to put off for now. But in order to debunk these concerns we’d have to address actual real-life happenings like CDC whistleblowers on the MMR and Zika vaccine as well as a group of over a dozen internal CDC senior scientists who wrote an open letter to some of their upper leaders in management stating, “We are a group of scientists at CDC that are very concerned about the current state of ethics at our agency. It appears that our mission is being influenced and shaped by outside parties and rogue interests. It seems that our mission and Congressional intent for our agency is being circumvented by some of our leaders. What concerns us most, is that it is becoming the norm and not the rare exception…Finally, most of the scientists at CDC operate with the utmost integrity and ethics. However, this ‘climate of disregard’ puts many of us in difficult positions. We are often directed to do things we know are not right.” http://www.huffingtonpost.com/carey-gillam/spider-bites-cdc-ethics-c_b_12525012.html
SUMMARY
In summary, we have 165 studies that show evidence of harm from thimerosal that we need to read through and find ways to dismiss as irrelevant; at least 60 additional studies that show a correlative and/or causal relationship with autism and mercury that we’ll need to find holes in to prove that the mercury/autism link has no basis; and 7 studies commissioned by the CDC to exonerate from scientific critique in order to prove that thimerosal doesn’t cause harm — oh, wait, I mean that it doesn’t cause autism. This means that even if we were able to do all that, we’d only be able to prove that thimerosal doesn’t cause autism. We wouldn’t actually be able to prove that it is safe from other potential adverse effects like the ones listed in the 165 studies that indicate that thimerosal is a neurotoxin that causes harm. And let’s not forget that only one of those seven epidemiological studies actually looked at potential harm to the developing fetus via thimerosal exposure from vaccines to the pregnant mother.
Actually, now that I think about it, I think our entire case might rest on this one study that the CDC references for vaccine safety focusing on pregnant women because it is the only one that comes close to addressing the entirety of the challenge: to find a single study that proves that thimerosal in vaccines is safe for children and pregnant women. Again, though, this one study only looked at one potential adverse effect — autism, and actually has a number of allegations of methodological flaws that we’ll have to address before we can even claim it. So maybe we don’t have a case after all? And maybe the whole point of this challenge was to get us to really reflect and engage with the full breadth of scientific literature available to us and likewise to reflect on vaccine safety issues? This one study that looked at thimerosal exposure to fetuses via exposure to pregnant women wasn’t done proactively as a safety study before the recommendation that pregnant women receive thimerosal-containing flu shots in 2002 or before pregnant women started received thimerosal-containing Rho injections since the 1960s. This study was conducted retrospectively looking at epidemiological data in 2010, eight years after the original recommendation that pregnant women receive flu shots and fifty years after women began receiving thimerosal-containing Rho injections above EPA limits for safe mercury exposure. And again, this study only looked at one potential adverse outcome — autism, their main litigation concern. In other words, aside from the bogus study Eli Lilly conducted in 1930, no proactive safety studies have ever been done to determine thimerosal’s safe use on pregnant women and the developing fetus and safety tests have never been conducted to determine what a safe reference dose is for this known neurotoxin. And maybe that’s the whole point? We still don’t have this essential information. Does anyone else find this concerning? And for anyone still standing on the fence wondering if the thimerosal safety issue is really closed, maybe we should just go ahead and ask our doctors not to inject us and our children, and especially pregnant women with vaccines with a known neurotoxin that still remains above the EPA guideline for safe mercury exposure in children. Non-mercury alternatives are available. It certainly couldn’t hurt to ask for them.
