An Attack on Free Speech We Cannot Ignore

Lovers of Liberty got black roses yesterday from Rep. Adam Schiff via a letter he sent to the CEO of Facebook, Mark Zuckerberg and Sundar Pichai of Google. The letter makes it clear that the California Democrat seeks to limit the free speech online of American parents and groups who use their inalienable right to free speech and open expression granted to us by our Creator and spelled out in our nation’s founding documents when it comes to discussing vaccinations.

The Bloomberg News story reported that ” Google’s YouTube unfurled a change in the way it recommends videos — an automated system that has been criticized for promoting misinformation. YouTube said it would start cutting videos with “borderline content” that “misinform users in harmful ways” from its recommendation system. “

Mr. Zuckerberg, whose wife, Dr. Priscilla Chan is a pediatrician famously posted a picture in 2016 of him taking his daughter to the pediatrician and talking about vaccines on his page. In a 2016 Time article, it was suggested that he would do well to ‘shut down’ pages.

It does not matter if you have safety concerns about vaccines or if you are pro-vaccine, or have no opinion, your liberty is being attacked all the same. Today it is a suggestion to block free speech of people who talk about vaccines, tomorrow it might be people who talk about climate change, or abortion, or immigration, or domestic violence. The real issue at hand here is that a legislator is promoting the idea to very powerful businesses that speech should be limited.

Remember, vaccine injury, rare or not rare is a reality. It became such a problem to the vaccine industry due to the lawsuits they were loosing in the early 1980’s that they joined with the medical establishment and got Congress to pass the National Vaccine Injury Protection Act of 1986 which abridged your freedom to seek legal recourse and provided liability protection for the manufacturers and the health professionals who administer vaccines. About $4 billion dollars has been paid out to the vaccine injured in this program. Sadly, the program has many problems and many of the vaccine injured – the collateral damage of the vaccine mandates are not compensated. That is a conversation for another day.

What do I mean by mandates? I mean that the US government provides recommendations and the states create mandates that force parents to get their kids vaccinated if they want them to be able to go to daycare or school. In three states, religious liberty has been taken away. In California, where all but medical exemptions have been removed, there is now a discussion led by Senator Pan to remove even the medical exemption. So if state Senator Pan (who is a physician himself) gets his way, the child with a compromised immune system, who has a mitochondrial disorder, or who is allergic to an ingredient may be forced to be vaccinated in order to attend a public school their parents pay very high taxes to support! 

You may be asking yourself why would someone have a religious objection?. There are religions that oppose the use of all medicines. I will not judge them, as religious liberty is a tenant of our nation’s foundation. There are others who object on religious grounds to some of the ingredients – after all, there are cow, pig and human DNA included in various vaccines. In the Measles vaccines (MMR and MMRV) there are two aborted fetal tissue cell lines. It is vile to suggest that a family who has strong feelings about the right to life and opposes abortion should be forced to inject their babies with vaccines that contain aborted fetal tissue cell lines. Likewise for anymore who opposes the consumption of pork on religious grounds or beef to be forced to inject their child with a vaccine that contains these animals’ DNA.

Social Media is a modern form of free expression that many of us enjoy. It has helped us build bonds with friends and families who live near and far. It has helped us developed groups in which we can share like ideas and discuss topics with friends and online acquaintances. It is a place in which businesses promote products and politicians are able to promote their agendas. Its frustrating enough to learn over the last couple of years about the political bias within some of the social media companies and the manipulation of information based on political ideology; but to suggest that people and groups who have an honest discussion about medical injury aka vaccine injury should be shut out because some do not believe the risks are real, is absurd. Think about issues that many presumed not to be true, but turned out to be real: The cancer link to – glyphosate in Monsanto’s Roundup comes to mind immediately. The issue of lead in drinking water and paint; child abuse by Catholic priests; and mercury in fish. Think about the issue of PTSD and TBI in our returning military and the high rate of suicide. What if someone in government convinced Facebook and other social media sites cut off those who talked about these issues? is it far fetched, no.

What now? Well, I hope that the thousands of families in Rep. Schiff’s district who have concerns about vaccine safety especially those with vaccine injured families members demand a meeting immediately.

When Government and Media Join Forces Look Out! As a nation, we should by now recognize the warning signs. When the government – in this case, the public health officials begin a fear mongering campaign, our antenna should go up. When you see wall to wall coverage about a topic -be it flu shots or the measles outbreak, listen carefully to the word crafting and do your own research. A story about 1 in 4 kindergarteners – tied to the measles outbreak was a misdirect. The study was about kids not being fully immunized before starting school. It was not specific to measles. Are 200 cases of measles in a nation of 330 million really a crisis?

There is no honest discussion taking place about how many of those who contracted measles were vaccinated and got the disease anyway, too little focus on what it means when an international traveler brings an infectious disease into the US; and no discussion about the failure of the vaccine to provide lifelong immunity.

What is really happening is that government officials and the media have colluded to force members of the public to take a specific action, in this case, get a vaccine. They don’t remind you that the measles vaccines are live virus vaccines and a child will shed the viruses for months afterward – potentially spreading the diseases. So the mom who goes online hysterical that her 7 months old might get measles because some other mom didn’t get her child the measles vaccine totally gets it wrong – its the kid who just got vaccinated who is more likely to shed the virus and give your child vaccine strain measles. Could it be that the government creates the measles outbreak by pushing the vaccination programs so aggressively? It’s also very convenient that these all seem to happen when state legislators have before them bills to curtail personal liberty of their citizens.

We cannot ignore attacks on free speech. I may not like what you say, but I will defend your right to say it – that has to be our mantra as people if we are to preserve liberty. I have twice taken an oath to protect the Constitution. Taking that oath means something that I do not take lightly. I have been in countries in which free speech is not acknowledged, I never want to see that happen in the United States of America. #Liberty #FreeSpeech.

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Drug and Medical Industry Influence in Politics – The Facts.

6 January 2019

In the 25+ years that I have worked in and around government in the Washington, DC metro area I have had a ringside seat to the power of industry money on two of three branches of government as well as the ‘fourth estate’ the media. This blog will provide a summary of evidence on one of these three areas – industry money and power brokers and the legislative branch. There are two segments of the health industry who wield serious influence on Capitol Hill – the pharmaceutical industry through their powerful trade association (PhRMA) as well as through each of the individual companies; and medical doctors and their professional trade associations. PhRMA ranks third in lobbying expenditures in 2018 behind the US Chamber of Commerce and the National Association of Realtors. In February 2017, Senator Bernie Sanders said that Big Pharma , “What’s going on is that the pharmaceutical industry owns the United States Congress. I would admit it’s not just Republicans. They have a huge influence over the Democratic party as well.” (http://www.thefiscaltimes.com/2017/02/08/Sanders-Charges-Big-PhRMA-Owns-United-States-Congress)

Lobbying in and of itself is not wrong or bad.  (After all, I am a registered lobbyist.) In fact it is an important process for legislators and legislative staff to hear from experts about the issues of the day – a way to gather evidence on all sides of issues. The great challenge for legislators is to balance the needs of the people they represent against the desires of the industries whose representatives walk through their doors, who they rub shoulders with each week in Washington and at fund raisers across the country.

What has happened over the last two decades in the pharmaceutical industry however is much more than just straight out lobbying. Currently, there are more than 1,400 individuals registered to lobby on behalf of the pharmaceutical industry. That is almost a three to one ratio to elected officials on Capitol Hill. The industry has the power to alert this army of lobbyists each morning of their talking points of the day, and those individuals call on their former bosses, good friends, and key offices.

According to OpenSecrets.org – the amount of money the Pharmaceutical industry spent on lobbying grew from just over $60 million in 1998, to over $216 million in 2018. In 2018, the PhRMA the trade association spent more than $21 million lobbying, while top vaccine manufacturers spent the following:

  • Pfizer (formerly Wyeth, and formerly American Home Products)- $9.3 million
  • Merck – $5.9 million
  • Novartis AG – $5.33 million
  • Abbvie Inc. – $4.28 million
  • GlaxoSmithKline – $3.64 million
  • MedImmune LLC (AstraZeneca) – $1.57 million
  • Sanofi – $3. 89 million
  • Barr Labs, Inc. – $1.32 million
  • CSL Limited – $990,000
  • Seqirus Pty Ltd
  • Protein Sciences Corporation

It was always interesting to see who would attend our hearings when vaccines or thimerosal (mercury) was going to be discussed. Whenever mercury was a subject, I could count on seeing the lobbyist for the American Dental Association in the back of the hearing room and would seem him chatting with members of both sides of the aisle before and after hearing. Anytime vaccines were the topic, there was three long-standing vaccine industry lobbyist in attendance. I witnessed an event in the Senate in which these lobbyists managed to shut down a Senate hearing related to vaccine injury legislation before it even began. Their power shut down a year’s worth of bipartisan/bicamaral negotiations.

Back in 2003, Congress passed legislation that included a $2 billion a year boost to the pharmaceutical industry in Medicare. This legislation went through the powerful House Energy and Commerce Committee. Early the next year, Committee Chairman, Louisiana Congressman Bill Tauzin announced he would be retiring at the end of the session. The day after retiring from Congress, he took over the top job at PhRMA for a reported $2 million dollar a year salary. (http://www.nbcnews.com/id/11714763/t/tauzin-aided-drug-firms-then-they-hired-him/#.XDJX81xKi70) and (https://sunlightfoundation.com/2010/02/12/the-legacy-of-billy-tauzin-the-white-house-phrma-deal/)

Donations: A second way that industries and often more powerful way that industries wield their influence is through political donations. The donations of a company’s employees and Political Action Committees (PAC) are easily tracked through legally required reporting. Some politically focused donations are more challenging to track, including event sponsorship, soft money support, and monies to local, state, and national political parties.

In 2018, $16,502,354 was donated by the Pharmaceutical industry to federal level  election candidates, PACs and outside groups. Just focusing on what can easily be tracked, the following are the political contributions by the same companies, their employees and PACs also provided by OpenSecrets.org:

Company201820162014
Pfizer$1,846, 612 $2,236,666 $1,566,961
Merck 933,303 896,232 972,009
Novartis 497,694 542,547 495,690
Abbvie 922,851 944,861 687,700
GlaxoSmithKline 479,480 734,619 622,226
MedImmune (AstraZeneca) 568,097 790,342 810,283
Sanofi 685,431 1,012,092 927,580
CSL Limited 87.006 86,663 54,540
Pharmaceutical Research &
Manufacturers Of America
418,694 381,552 247,550

There are most than 1.1 million physicians in the United States. When a medical doctor or dentist reaches out to their member of Congress on a health issue, their opinion likely carries more weight than that of a single non-medical professional. In 2018, health professions spent $68 million on lobbying. The American Medical Association ranked 9th in lobbying expenditures for 2018, spending more than $15.5 million. (Exceeded by Alphabet, Inc., Blue Cross/Bue Shield, American Hospital Association, and the Open Society Policy Center.

When doctors and dentists donate to a campaign and garner donations from one or more of the dozens of professional medical associations, they are even more powerful. In 2018, health professions PAC donations to federal candidates exceeded $23 million.

The top health professions PAC was the American Society of Anesthesiologists with more than $2.85 donated in the 2018 election cycle to federal candidates, leadership PACs, political parties, and outside groups.  They also spent more than a half a million on lobbying.

There are several groups who gather the data from official sources and make them available for search and analysis. They include OpenSecrets.org and FollowtheMoney.org. ProPublica has also done an incredible job of researching these issues. Take the time to look at these sites for yourself and be informed.

During big issues like health insurance reform, the Medicare reform back in 2003 and throughout the vaccine injury and vaccine-autism discussions over the last 18 years, manufacturers, their lobbyists, the trade associations of both the manufacturers and medical doctors joined together to pool their power and influence – they developed talking points and organized their members to reach out to their legislators.

During the health insurance reform (ObamaCare) process associations even funded lengthy fellowships for doctors, nurses and others to work in legislative offices to shepherd the legislation. I know this because I met with many doctors and nurses who took time off from their ‘day job’ to spend 6-12 months in Washington working in Senate offices.

Political donations and lobbying are not always bad. Legislators rely on donors to fund their election and re-election campaigns. I am not one that endorses the idea of government-funded political campaigns. Political parties rely on donors to support their activities. There is a point, however, when that financial support moves from the support of past activities and foundational values to swaying the current or future actions. Finding and maintaining a healthy balance remains a top need for the legislative branch.

Always,

Beth

What does the Peer-Reviewed Literature of 2018 Tell Us About Thimerosal?

26 December 2018

Congressman Burton Called for Recall of Thimerosal Vaccines:  Eighteen years ago, after significant review of published and unpublished scientific literature, and hearing from experts, Congressman Dan Burton, then Chairman of the U.S. House of Representatives’ Oversight and Government Reform Committee during the July 2000 hearing called for an immediate recall of thimerosal containing vaccines. Several months later, he sent a letter to then Secretary of Health Donna Shalala.  In this letter, Chairman Burton wrote, “At the time of the hearing, I requested that the Food and Drug Administration (FDA) recall all thimerosal-containing vaccines from the market. This request was ignored. A petition to the FDA from the parents of vaccine-injured children was ignored. Additional scientific data that has been provided to the FDA regarding the dangers of thimerosal in vaccines has been ignored. I am asking that you personally respond to this request regarding an FDA recall of thimerosal containing vaccines. During a review required by the Food and Drug Modernization Act, it was learned that infants receive more mercury in the first six months of life than is considered safe according to federal guidelines… While the FDA proposes to “phase out” thimerosal-containing vaccines over time, I implore you to conduct a full recall of these products. If the only action that HHS takes is a gradual phase out, children will continue to be put at risk every day. HHS is leaving supplies of this toxic substance in doctors’ offices, at Public Health Clinics, and in managed care facilities. These vaccines will continue to be injected in children for years to come – putting our nation’s most vulnerable population – our babies – at risk for mercury poisoning. We all know and accept that mercury is a neurotoxin, and yet the FDA has failed to recall the 50 vaccines that contain thimerosal…Our children are the future of this country. As a Government we have a responsibility to do everything within our power to protect them from harm, including insuring that vaccines are safe and effective. Every day that these mercury-containing vaccines remain on the market is another day HHS is putting 8,000 children at risk. Given that thimerosal-free vaccines are available, and the known risk of mercury toxicity, to leave thimerosal-containing vaccines on the market is unconscionable…”(1) 

Secretary Shala Refuses:  Secretary Shalala ignored the request, and the FDA moved slowly to phase out thimerosal in infant vaccines.  Infant vaccines containing thimerosal remained in used in the United States until at least 2003.  Thimerosal continues to be used in many flu vaccines, other adult vaccines; and thimerosal continues to be used in vaccines globally.  About the time thimerosal was phased out of infant vaccines, a recommendation to give flu shots to all pregnant women was initiated.  Millions of women have been and continued to be administered flu shots that contained thimerosal. Thimerosal is also in other medical products still used in the US as well as in cosmetics globally.

2018 – Evidence Shows He Was Correct:  Congressman Burton has now retired from Congress; in January 2019, Donna Shalala will be sworn in as a new member of Congress; and thimerosal continues to be used in vaccines.  The more I have looked at this issue and the more I read from internal documents obtained through the Freedom of Information Act (FOIA) process, the more I believe that Chairman Burton was right in 2000; there was a need to recall thimerosal containing vaccines, to immediate cease its use, and to protect our nation’s children from needless exposure to a known neurotoxin.

Protecting Public Health or Industry?  As those who have followed this issue know all too well, the federal agencies involved in this issue, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), both part of the US Public Health Service initially joined forced with the American Academy of Pediatrics (AAP) in issuing a public statement calling for the removal of thimerosal. (2)  As Congress and parents began to pay attention, the FDA, CDC and the AAP shifted their position to be together in lockstep to protect thimerosal’s use in vaccines.  Their allegiance to protecting thimerosal rather than children was confirmed in the stances taken during the negotiations of the   Minamata Convention on Mercury in which the AAP joined with vaccine makers to promote an exemption for thimerosal from the treaty. I was at the State Department for a very heated discussion on the topic.  Those who profess to protect the public health fought in favor of keeping it in vaccines and other medicines in 2013.  Lewis Carol could have had a field day crafting this alternate reality for a those who protect a known neurotoxin rather than babies and the planet.  

Did She Perjure Herself?  In the 2012 Autism hearing before the House Oversight Committee then chaired by Congressman Darrell Issa, (https://www.youtube.com/watch?v=mrEKD8zNFXI) CDC’s Congressman Dan Burton reiterated his request to get mercury out of vaccines. During this hearing, CDC’s Dr. Coleen Boyle testified, “The IOM has evaluated this issue back in 2004 and again most recently in 2011.  And you know, their conclusion, again, it is not just looking at the work that was done at the CDC but with a total body of evidence was suggesting that vaccines and their components did not increase the risk of autism.“  This statement under oath contradicts the statement provided by the CDC Whistleblower in regard both to the Atlanta MMR study as well as to thimerosal as well as from the actual evidence available in research studies.

Thimerosal Use Continues Globally in 2018:  That hearing was six years ago, thimerosal is still in marketplace and used in some vaccines.  Neither the FDA or the CDC seem to be doing any research on thimerosal as their websites have no recent updates.  I checked the National Library of Medicines, PubMed to see what had been published in the peer-reviewed literature in 2018 on the topic of thimerosal.

I found 27 articles.

 What did I learn?   The Total Body of Evidence on Thimerosal is Concerning.  Thimerosal use may actually be increasing globally in part because of the exemption of Thimerosal in the Minamata Convention on Mercury.  Some perfumes, face creams and cosmetics in India contain thimerosal.  The use of cosmetics is increasing in India and as shown in the literature, globally, thimerosal is linked to allergic contact dermatitis (ACD) in between 1 and 15.5 percent of those tested.  Thimerosal continues to be used in both eye and ear medications even in the United States. 

 I learned:

·     Thimerosal allergic reactions may be delayed even as much as a week in one study; and that long exposure in an allergic dental patient took nine months for the lesions in her mouth to clear;  

·         ACD was reported in the US in a senior citizen using ear drops that contained thimerosal;

·         A number of clinicians reporting thimerosal-linked ACD raised concerns about their colleagues not considering thimerosal during evaluations;   

·         Thimerosal and aluminum are present in human breast milk; 

·         Thimerosal free oral cholera vaccine has been developed and shows promise in helping increase the amount of cholera vaccines available globally;

·         Ethylmercury (a component of thimerosal) caused abnormal neurogenic inflammatory reactions and alterations in the neuroimmune cells that remained for a longer period in the brain than in the blood;

·         Exposure to thimerosal caused dysfunction that leads to impaired dopamine function and behavioral abnormalities, ultimately causing oxidative stress-related neurotoxicity;

·         A neonatal dose-dependent exposure in rats to Thimerosal mimicking the childhood vaccine schedule can induce abnormal social interactions and stereotyped behaviors similar to those observed in neurodevelopmental disorders such as autism, and, for the first time, revealed that these abnormalities may be ameliorated by ALA. This indicates that ALA may protect against mercurial-induced abnormal behaviors;

·         A 79-year-old woman with normal hearing developed acute bilateral sensorineural hearing loss two days after a seasonal influenza vaccination, other obvious reasons for acute hearing loss were excluded;

·         A review of data from the Vaccine Safety Datalink concluded, “a dose-dependent association between increasing organic Hg exposure from Thimerosal-containing hepatitis B vaccines administered within the first six months of life and the long-term risk of the child being diagnosed with premature puberty”;

·         A review of the Vaccine Adverse Events Reporting System provided, “suggestive evidence of an association between Thimerosal and neurodevelopmental outcomes and provides support for carrying out additional well-designed studies examining the association between Thimerosal-containing vaccines and a wide range of neurodevelopmental outcomes”;

·         Two analyses of National Health and Nutritional Examination Survey (NHANES) data raise concerns dose dependent outcomes related to mercury, Attention Disorders, and Special Education Services Requirements;

·         Several studies evaluating the effects of thimerosal exposure to both human and animal cell lines showed the toxic effect – causing cell-death for instance;

·         “The comparable neurotoxicity of MeHg and EtHg has been established in vitro and in experimental animals. Studies dating back to 1985 unequivocally demonstrated that at a comparable dose, depending on the system tested, EtHg was either equal to or more neurotoxic than MeHg.”

·         “Hg in combination with other neurotoxic mixtures may elevate risks of neurotoxicity, but these risks arise in circumstances that are not yet predictable. Therefore, to achieve the goals of the Minamata treaty and to safeguard the health of children, low levels of mercury exposure (in any chemical form) needs to be further reduced whether the source is environmental (air- and food-borne) or iatrogenic (pediatric TCVs):

·         The NIH has funded research that is looking at numerous existing drugs including thimerosal for alternative uses; and

·         In at last one California University, pharmacy students now have mandated training to develop their communication and persuasion skills to change the minds of “vaccine-hesitant” individuals. Thimerosal’s use as a preservative is among the issues included in this training. 

 

I have made no attempt to evaluate the quality of each of these studies or pass judgement on any of the authors. To my knowledge, given the inclusion in PubMed, these are all peer-reviewed papers or review/case reports that the editors of the respective journals cleared for publication.   Brazil scientists seem to be leading the way on raising concerns about the safety of thimerosal and calling for its elimination.  Iranian scientists have published two papers in 2018 addressing the topic.  It is important to note that on at least 3 occasions mercury treated agriculture resulted in serious injury and death among Iranians.   

 Dr. Boyle was incorrect in her testimony at the time.  I know this because I had reviewed the ‘total body of evidence’ available at the time of her testimony and being present in the room when she gave that testimony, I have concern that she intentionally attempted to misinform the members of the Committee of the facts.  Most members of the public including doctors believe ‘we got the thimerosal out of vaccines’ in 2000.  Few people who are not actively engaged in this know about the Minimata Treaty, about the ongoing research worldwide that validates the risks already known in 2000, or that thimerosal is used in other medicines other than vaccines; in fragrances, face creams, and cosmetics globally. 

 

The truth is and has always been that all forms of mercury have risks, including thimerosal.  That was true in 2000 when Congressman Burton asked for a recall and its elimination; it was true in 2012, and it is true in 2018. It is past time that the FDA and the global regulatory community banned its use in any product humans are exposed to – medicines including vaccines; cosmetics, perfumes, skin creams, fungicides.  

Any public health professional who touts its safety has obviously not read the literature.  Those who point to the outcomes of the Institute of Medicine study is either ignorant about or has chosen to ignore the controversies and irregularities created by their contractual relationship with the CDC and the internal ‘pre-determination’ that has not been made public. Any doctor, nurse, pharmacist or other health professional who suggests that it is okay to inject pregnant women with thimerosal; to inject babies with thimerosal is violating their very ethical codes of ‘first do no harm’.

 Congressman Burton evidence-based decision making in 2000 was correct.  The evidence in 2018 continues to support him. 

 

As always, the opinions expressed in this Blog are purely my own. 

 Beth Clay

 

Summary of the 27 Thimerosal Papers of 2018:

 There is an entire body of articles that describe what comprises the evidence-base of science and the research hierarchy.  At the top of the hierarchy are randomized controlled, double blinded placebo controlled trials.  That is followed by human studies, animal studies, all the way to surveys, case reports, and epidemiology.

 Human Studies

 Breast Milk Study:  A study conducted in Brazil was conducted to measure the total concentration of six neurotoxic elements in banked human milk.  Breast feeding is universally recommended, especially in the first six months of life. Human milk is prescribed in Brazil and many parts of the world for premature and critically ill infants in neonatal units when the mother’s own milk is insufficient or not available. The study measured Hg-Mercury; Al – Aluminum, Cd – Cadmium, Pb – Lead, As-Silver, and Mn- Manganese in samples form 106 donors were obtained through the hospital-based milk bank. Thimersol containing vaccine exposure for their infants was obtained from the child’s vaccination card.  The study confirmed that the “metal concentration was mostly below the limit of detection (LOD) for Cd (99%), Pb (84%), and Hg (72%), and it was above the LOD for As (53%), Mn (60%), and Al (82%), respectively. Median concentrations (dry weight) of Al, As, Hg, Mn, and Pb were 1.81 μg/g, 13.8 ng/g, 7.1 ng/g, 51.1 ng/g, and 0.43 μg/g, respectively.

 Aluminum was “singly the most frequent element to which infants are exposed. Occurring binary combination (> LOD) was 56% for Al-Mn, 41% for Al-As, 22% for Al-Hg, and 13% for Al-Pb. In 100% of neonates, exposure to Al-ethylmercury (EtHg) occurred through immunization with thimerosal-containing vaccines (TCV). Association rules analysis revealed that Al was present in all of the multilevel combinations and hierarchical levels and that it showed a strong link with other neurotoxic elements (especially with Mn, As, and Hg).

(a) Nursing infants are exposed to combinations of neurotoxicants by different routes, dosages, and at different stages of development;

(b) In breastfed infants, the binary exposures to Al and total Hg can occur through breast milk and additionally through TCV (EtHg and Al);

(c) The authors concluded, “The measured neurotoxic elements were found at low frequencies in breast milk and at concentrations that pose no public health concerns for milk banking.”    This study begins to scratch the surface of an issue that has raised significant concern among safety experts, that is the combined effects on exposure to aluminum and ethylmercury in utero and as newborns.(3)

 Oral Cholera Vaccine Study: A randomized, observer-blinded, equivalence trial comparing the thimerosal preserved verses the thimerosal free whole cell oral cholera vaccine (Euvichol) in both adults and children in the Philippines. The objectives of this study were to assess safety and immunogenicity and to demonstrate the equivalence of the already WHO PQ formulation (100L fermenter, with thimerosal) to the scaledup formulation (600L fermenter, thimerosal-free).The study was conducted by scientists employed the manufacturer and funded by the Gates Foundation.  The authors reported on 2 serious adverse events in the pediatric patients, had a vibrant discussion of active adverse event monitoring over the two month study, and discussed a lack of stratification across age groups of the GMT – “Overall, Test vaccine was immunogenic in both adults and children. The equivalence of the two Euvichol variations was confirmed on the overall analysis of combined age cohorts with a statistical power >90%. However, due to an observed geometric mean titers (GMT) Coefficient of Variation higher than expected (CV range: 1.2–6.7), the immunogenicity analysis by age cohort did not reach 90% power to demonstrate the equivalence of study agents by age strata.”  The conclusion smoothed the GMT issue over, “The results of this study demonstrate the equivalence of thimerosal-free 600L Euvicho with the originally licensed Euvichol formulation (100L with thimerosal) in healthy Filipino children and adults. Based on the GMTs in the overall population, the immunogenicity of the two vaccines is equivalent for O1 Inaba and Ogawa and O139. In addition, the safety profile of the two vaccines is similar. This manufacturing of Euvichol to 600L scale may significantly contribute to the GAVI objective of expanding the current global OCV stockpile to at least 20 million doses by 2018 and also to increase the public market supply.”(4) 

 Allergic Contact Dermatitis Studies

Allergic contact dermatitis (ACD) is a delayed type of hypersensitivity from contact with a specific allergen to which the patients has developed a specific sensitivity.

 ·         In the United States, a discussion article was published in Dermatitis in January reporting on the case of a female patient who presented with pruiritis and scaling of her ear canal (for several months).  A series of patch tests were conducted to determine which of the agents she had been exposed to (in her medications, etc.) might be the cause. Clinically relevant positive reactions were noted for thimerosal.  The article also notes that thimerosal can be found in “otic suspensions, ophthalmic solutions, nasal preparations, vaccinations, hormone injections, cosmetics, and tattoo ink.” It notes that the FDA has limited thimerosal in “dermatologic medications and cosmetics because of concerns of adverse events from mercury absorption or sensitization.”  They note a positive reaction rate of 10.2% in patch testing and warn clinicians not to become complacent about thimerosal when looking for relevant exposures.(5)

·         A single-center observational study conducted in Spain reports on the allergenic response to a topical use of thimerosal known in Spain as merbromin (mercurochrome in the US). “Of the 105 patients studied, 1.9% had a positive patch test to merbromin.”(6)

·         In a retrospective records-based study of 58 patients in India who has potential allergic contact dermatitis (ACD) were evaluated via patch testing.  A positive skin patch test for thimerosal was the second most common outcome found (15.5 % of patients). In India, thimerosal is found in face creams, eye cosmetics, and perfumes. The study noted the dramatic upsurge in the use of cosmetics. The authors called for inclusion of these comman allergens such as thimerosal to be included in the common patch testing.   There was no discussion in the paper about the other known dangers of thimerosal.(7)

·         The aim of this descriptive case study conducted at the University of Sarjevo in Bosnia and Herzegovina was to evaluate the results of epicutaneous patch testing with standard series of contact allergen in patients suspected to have ACD.  A patch test study on 355 patients found thimerosal was the third most prevalent positive reaction found in 8.7% of patients.(8) 

·         A retrospective, noninterventional cohort study of 100 adolescents (aged 13-18; 74 girls, 26 boys) who were consecutively patch tested in Hungary. Contact hypersensitivity in 51 of the 100 patch-tested patients “(51%): 52.7% of the girls and 46.2% of the boys were sensitized.”  The second most common allergen was thimerosal (12%).   Additional findings include that reactions did not appear until the seventh day in 13% of the patients.(9) 

 

Animal Studies

·         A research study conducted in Iran: “Evidence suggests that the effect of heavy metals on neuroimmune cells lead to neurogenic inflammatory responses. In this study, immune cells [mast cells (MCs) and microglia] and pro-neuroinflammation cytokines (interleukin-1b and tumor necrosis factor-alpha) were assessed in the prefrontal lobe of rat brains exposed to thimerosal in different timeframes. A total of 108 neonatal Wistar rats were divided into three groups having three subgroups. The experimental groups received a single dose of thimerosal (300 mug/kg) postnatally at 7, 9, 11, and 15 days. The vehicle groups received similar injections of phosphate-buffered saline in a similar manner. The control groups received nothing. Samples of the prefrontal cortex were collected and prepared for stereological, immunohistochemical, and molecular studies at timeframes of 12 or 48 h (acute phase) and 8 days (subchronic phase) after the last injection. The average density of the microglia and MCs increased significantly in the experimental groups. This increase was more evident in the 48 h group. At 8 days after the last injection, there was a significant decrease in the density of the MCs compared to the 12 and 48 h groups. Alterations in pro-inflammatory cytokines were significant for all timeframes. This increase was more evident in the 48 h group after the last injection. There was a significant decrease in both neuroinflammatory cytokines at 8 days after the last injection. It was found that ethylmercury caused abnormal neurogenic inflammatory reactions and alterations in the neuroimmune cells that remained for a longer period in the brain than in the blood.”(10)

 ·         A Team of scientists out of Brazil have just published a study in the Royal Society of Chemistry’s journal Metallomics. Noting that recent studies identified the neurotoxic effects of thimerosal (THIM), including malfunction of the monoaminergic system, the research team used the fruit fly Drosophila melanogaster to further understand the underlying cytotoxic mechanisms.  “We focused on the dopaminergic system, and the rate-limiting enzyme tyrosine hydroxylase (DmTyrH), to test the hypothesis that THIM can impair dopamine (DA) homeostasis and subsequently cause dysfunction. We studied the effect of THIM by feeding 1–2-day old flies (both sexes) food supplemented with 25 μM THIM for 4 days and determined THIM-induced effects on survival, oxidative stress, and metabolic activity based on MTT assay and acetylcholinesterase (AChE) activity. Our results demonstrate that D. melanogaster exposed to THIM present changes in DmTyrH expression and activity, together with altered DA levels that led to impaired motor behavior. These phenotypes were accompanied by an increase in oxidative stress, with a decrease in MTT reduction, in AChE activity, and also in survival rate. These findings suggest an initiating and primary role for THIM-mediated DmTyrH dysfunction that leads to impaired DA function and behavioral abnormalities, ultimately causing oxidative stress-related neurotoxicity.”(11)

 ·         Researchers investigate the impact of thimerosal containing vaccines on gut microbial succession in rhesus macaques (Primates).  They note “Molecular mechanisms of thimerosal and EtHg transport within the body are not well understood. Human infants injected with thimerosal-containing vaccines (TCVs) showed detectable mercury in stool samples, which suggests that mercury potentially interacts with the gut microbiome. The authors noted, “it is not clear whether pediatric vaccines would alter the gut microbiota structure and/or function measured through the fecal metabolome.” Seeking to answer this question, the researchers investigate evaluated samples of fecal material gathered in a previous study to look at differences in microbial functionality as a consequence of vaccination were assessed.  By comparing the results from macaques receiving vaccines according to the recommended 1990s and 2008 schedules with a control group (receiving only saline injections), it is possible to observe how thimerosal exposure through either pre-natal or post-natal routes could impact the gut microbiota in infant and juvenile macaques.  The authors provide that “Once a TCV is administered, it is immediately dispersed in the blood stream. Thimerosal likely goes to the liver where it is broken down into EtHg and thiosalicylic acid, and possibly from EtHg to inorganic Hg through enzymatic activity.   The researchers found that neither the structure nor metabolic function of the gut microbiota was significantly different between animals in the 1990s and control groups at the Infant time point. These results suggest that the single dose of thimerosal at birth from vaccination with the HepB vaccine did not have a significant impact on the gut microbiota.  There is limited understanding of whether injected thimerosal or its metabolic products can be transferred through the placenta to enter the uterus. Although the placenta is impermeable to inorganic Hg, organic mercury such as methylmercury (MeHg) crosses the placenta and can accumulate within the fetus possibly disturbing fetal brain development. It is therefore conceivable that thimerosal itself, or its metabolite EtHg, could pass through the placenta, impact the fetal gastrointestinal tract, and thus impact the establishment of gut microbiota in the neonate before EtHg is further broken down into inorganic Hg within the maternal organs. However, both microbiota and metabolome analyses did not show significant differences between the group receiving the 2008 vaccine schedule (which included a prenatal influenza vaccine) and the control group at the Infant time point, suggesting that thimerosal injected via a TCV during the last month of pregnancy in rhesus macaques, does not significantly affect the neonatal gut microbiota.  There were other differences noted among the animals, but not specific to the thimerosal. The author notes numerous limitations to the study ranging from the small sample size.  “This is the first study to our knowledge that has measured the impact of vaccination, especially TCVs, on macaque infant gut microbial succession through metabolomic and microbiota analysis of infants soon after birth and of juveniles at 18 months of age. In this controlled animal study, the primary impact on the gut microbiome was age. We noted a few statistically significant differences on the gut microbiome structure between vaccinated and non-vaccinated groups when only animals without any medication were analyzed, but these differences were small, and appeared to be positive changes.”(12)

 ·         A rat study conducted in Iran looked at the protective protective effects of Alpha Lipoic Acid (ALA) against thimerosal.  “Thimerosal, a mercury-containing preservative has been widely used in a number of biological and drug products, including many vaccines, and has been studied as a possible etiological factor for some neurodevelopmental disabilities. Here, the protective effects of Alpha Lipoic Acid (ALA), an organosulfur compound derived from Octanoic Acid, on Thimerosal-induced behavioral abnormalities in rat were examined.  108 Wistar Rats were divided into 3 groups. “Thimerosal at different doses (30, 300, or 3000 μg Hg/kg) in four i.m. injections on 7, 9, 11, 15postnatal days. 2) ALA (at doses of 5, 10 and 20 mg/kg), following the same order; 3) single dose of Thimerosal (3000 μg Hg/kg) plus ALA at different doses (5, 10 or 20 mg/kg), by the previously described method. A saline treated control group and a ALA vehicle control (0.1% NaOH) were also included. At 5 and 8 weeks after birth, rats were evaluated with behavioral tests, to assess locomotor activity, social interactions and stereotyped behaviors, respectively. The data showed that Thimerosal at all doses (30, 300 and 3000μgHg/kg) significantly impacted locomotor activity. Thimerosal at doses of 300 and 3000 but not 30μgHg/kg impaired social and stereotyped behaviors. In contrast, ALA (at doses of 5, 10 and 20 mg/kg) did not alter behaviors by itself, at doses of 20 mg/kg, it reduced social interaction deficits induced by the highest dose of Thimerosal (3000 μg Hg/kg). Moreover, ALA, at all doses prevented the adverse effects of Thimerosal on stereotyped behaviors…The results of this preclinical study, consistent with previous studies on mice and rats, reveals that neonatal dose-dependent exposure to Thimerosal mimicking the childhood vaccine schedule can induce abnormal social interactions and stereotyped behaviors similar to those observed in neurodevelopmental disorders such as autism, and, for the first time, revealed that these abnormalities may be ameliorated by ALA. This indicates that ALA may protect against mercurial-induced abnormal behaviors.(13)

 Vaccine Study in Mice:  Researchers from the International Vaccine Institute in Seoul, South Korea evaluated and compared the immunogenicity of the two variations (thimerosal and thimerosal-free) of oral cholera vaccine (OCV) in mice. The mice were immunized with TM-free or TM-containing Euvichol twice at 2-week interval by intranasal or oral route. “One week after the last immunization, mice were challenged with Vibrio cholerae O1 and daily monitored to examine the protective immunity against cholera infection. In addition, serum samples were obtained from mice to measure vibriocidal activity and vaccine-specific IgG, IgM, and IgA antibodies using vibriocidal assay and enzyme-linked immunosorbent assay, respectively.”  The researchers found no difference in immunogencity between the thimerosal and thimerosal-free vaccines opening the door for adoption of the TM-free cholera vaccine.  They also found that the mice intranasally immunized elicited higher levels of serum antibodies than those immunized via oral route. Intranasal immunization completely protected mice against V. cholerae challenge but not oral immunization.” There authors concluded no significant difference in protection between two Euvichol variations.(14)

 Case Control Studies

 

Care Report and Literature Review.  Germany doctors report a case of deafness occurring in a temporal context of an influenza vaccination in a 79-year-old woman.  A 79-year-old woman with normal hearing developed acute bilateral sensorineural hearing loss two days after a seasonal influenza vaccination, other obvious reasons for acute hearing loss were excluded. CONCLUSION: This patient appears to be the first reported case of bilateral deafness following a trivalent seasonal influenza vaccination.(15)

 Dental Case Report.  A 33-year-old woman sought dental assistance and presented multiple unilateral lesions.  During the anamnesis, she reported having been submitted to periodontal therapy. The main complaint motivating her search for professional assistance was halitosis associated with spontaneous gingival bleeding. A patch test confirmed an allergy to thimerosal, which is a ‘compound of mercury metal’. As a result, all of her dental amalgams were removed in a single appointment.  Leucoplast lesions, the result of the latent allergy response to thimerosal, persisted for several months.  “The findings were compatible with Lichenoid Stomatitis. After clinical-pathological correlation, the diagnosis of idiopathic oral lichenoid lesion was finally established. Nine months after the removal of all the amalgam restorations, remission of the desquamative gingivitis and disappearance of reddish-white plaques, as well as the ulcerated surface of the oral mucosa were observed. Nevertheless, the reticular leucoplast and retro commissural region lesions persisted.  The complete healing of the desquamative  gingivitis, after this period, however, reinforced that it was related to the development of lichenoid lesions associated with dental amalgam, as a hypersensitive response to thimerosal. Although basic periodontal therapy may have contributed to the resolution of the DG, it was not sufficient, since the complete removal of dental amalgam restorations was necessary for the complete disappearance of the erythematous areas of the gingiva.(16)

 Vaccine Safety Datalink.  Studies suggest a relationship between exposure to endocrine disrupters, such as mercury (Hg), and premature puberty. Hg exposure from Thimerosal-containing hepatitis B vaccine, administered at specific intervals within the first six months of life, and the child’s long-term risk of being diagnosed with premature puberty (ICD-9 code: 259.1), was retrospectively examined, using a hypothesis-testing, longitudinal case-control design on prospectively collected data, in the Vaccine Safety Datalink (VSD). Cases diagnosed with premature puberty were significantly more likely to have received increased exposure to Hg from hepatitis B vaccines preserved with Thimerosal given in the first month after birth (odds ratio (OR) = 1.803), first two months after birth (OR = 1.768), and first six months after birth (OR = 2.0955), compared to control subjects. When the data were separated by gender, the effects remained among females but not males. Female cases, as compared to female controls, were significantly more likely in a dose-dependent manner to have received a greater exposure to Hg from hepatitis B vaccines preserved with Thimerosal, given in the first six months after birth (OR = 1.0281 per ug Hg). The results of this study show a dose-dependent association between increasing organic Hg exposure from Thimerosal-containing hepatitis B vaccines administered within the first six months of life and the long-term risk of the child being diagnosed with premature puberty.(17)

 Vaccine Adverse Event Reporting System (VAERS).  “Investigators postulated that early-life exposure to organic mercury (Hg) significantly increases the risk of childhood neurodevelopmental disorders (NDs). The Vaccine Adverse Event Reporting System database was utilized to conduct a hypothesis testing case-control study by evaluating 3486 total adverse event reports reported following Haemophilus influenza type b (Hib) vaccination. Exposed subjects received a Thimerosal-containing formulation (HIBTITER™, Wyeth-Lederle), while unexposed subjects received a Thimerosal-free formulation (PEDVAXHIB™, Merck). Subjects were included if they received either of these two Hib vaccine formulations between 1995 and 1999. “ Autism, Developmental Delay, Psychomotor Disorder and Neurodevelopmental disoders in general were all “significantly more likely than their respective controls to receive Thimerosal-containing Hib vaccine than Thimerosal-free Hib vaccine.”  Significant effects for neurodevelopmental disorder in general were observed for males (OR = 2.52, p < 0.005), but not females when separated by gender. For the outcomes that had no biologically plausible relation to Hg exposure, the cases were no more likely than their respective controls to receive Thimerosal-containing Hib vaccine than Thimerosal-free Hib vaccine. This study provides suggestive evidence of an association between Thimerosal and neurodevelopmental outcomes and provides support for carrying out additional well-designed studies examining the association between Thimerosal-containing vaccines and a wide range of neurodevelopmental outcomes.(18)

 National Health and Nutritional Examination Survey (NHANES). 

·         A cross section study of over 4300 kids between the ages of 13 and 19 years evaluated the hypothesis that infant Thimerosal-containing hepatitis B vaccine (T-HepB) exposure would increase the risk of an ADHD diagnosis. The evaluation used the combined 1999-2004 National Health and Nutritional Examination Survey (NHANES) and analyzed demographic, immunization, socioeconomic, and health-related variables using the SAS system. Three doses of T-HepB exposure in comparison to no exposure significantly increased the risk of an ADHD diagnosis using logistic regression (adjusted odds ratio=1.980), linear regression (adjusted beta-coefficient=0.04747), Spearman’s rank (Rho=0.04807), and 2×2 contingency table (rate ratio=1.8353) statistical modeling even when considering other covariates such as gender, race, and socioeconomic status. Current health status outcomes selected on an a priori basis to not be biologically plausibly linked to T-HepB exposure showed no relationship with T-HepB. The observed study results are biologically plausible and supported by numerous previous epidemiological studies, but because the NHANES data is collected on a cross-sectional basis, it is not possible to ascribe a direct cause-effect relationship between exposure to T-HepB and an ADHD diagnosis. During the decade from 1991 to 2001 that infants were routinely exposed to T-HepB in the United States (US), an estimated 1.3-2.5 million children were diagnosed with ADHD with excess lifetime costs estimated at US $350-$660 billion as a consequence of T-HepB. Although Thimerosal use in the HepB in the US has been discontinued, Thimerosal remains in the HepB in developing countries. Routine vaccination is an important public health tool to prevent infectious diseases, but every effort should be made to eliminate Thimerosal exposure.(19)

 ·         A cross-sectional study of more than 1100 boys aged 7-8 years of age born between 1994 and 2007 examined the potential relationship between infant exposure to mercury from three doses of Thimerosal-containing hepatitis B vaccine and the risk of boys being adversely affected (as measured by receipt of Special Education Services – SES). Using data from the combined 2001–2014 National Health and Nutritional Examination Survey (NHANES). A robust association between three doses of infant thimerosal containing hepatitis B vaccine (T-HepB)and receipt of SES  in comparison to an unexposed population  was found. Covariates, such as race and socioeconomic status were taken into consideration.  The authors acknowledge there are limitations, “Despite the limitation of this cross-sectional study not being able to ascribe a direct cause-and-effect relationship between exposure and outcome, it is estimated that an additional 1.2 million boys received SES with excess education costs of about United States (US) $180 billion associated with exposure to Thimerosal-containing hepatitis B vaccine. By contrast, exposure to Thimerosal-reduced hepatitis B vaccine was not associated with an increased risk of receiving SES. Therefore, routine childhood vaccination is important to reduce the morbidity and mortality of infectious diseases, but every effort should be made to eliminate Thimerosal from all vaccines.”(20)

 Review Articles

Dr. Dorea from the University of Brazil published two review articles in 2018 building upon a well-respected body of evidence. 

·         The first stated, “All chemical forms of Hg (mercury) can affect neurodevelopment; however, low levels of organic Hg (methylmercury-MeHg and ethylmercury-EtHg in Thimerosal-containing vaccines, hereafter ‘TCV’) exposures during early life (pregnancy and lactation) co-occur with other environmental neurotoxic substances. These neurotoxicants may act in parallel, synergistically, or antagonistically to Hg. Nevertheless, the risks of neurotoxicity associated with multiple neuro-toxicants depend on type, time, combinations of exposure, and environmental and/or genetic-associated factors. Neurological developmental disorders, delays in cognition and behavioral outcomes associated with multiple exposures (which include Hg) may show transient or lasting outcomes depending on constitutional and/or environmental factors that can interact to neutralize, aggravate or attenuate these effects; often these studies are challenging to interpret.”  Dr. Dorea offers, “The comparable neurotoxicity of MeHg and EtHg has been established in vitro and in experimental animals. Studies dating back to 1985 unequivocally demonstrated that at a comparable dose, depending on the system tested, EtHg was either equal to or more neurotoxic than MeHg.”  This paper provides an eloquent and detailed explanation of the routes of exposure.    The conclusion included: “Hg in combination with other neurotoxic mixtures may elevate risks of neurotoxicity, but these risks arise in circumstances that are not yet predictable. Therefore, to achieve the goals of the Minamata treaty and to safeguard the health of children, low levels of mercury exposure (in any chemical form) needs to be further reduced whether the source is environmental (air- and food-borne) or iatrogenic (pediatric TCVs).”(21)

 ·         Dr. Dorea confirms that vaccines continued to be the main cause of organic mercury exposure for newborns, neonates and infants immunized with thimerosal containing vaccines (TCV) in developing countries.  This paper reviews the early-life exposure to ethylmercury-EtHg and the risks associated to exposure.  A review of the English language literature found, “The risk from the neurotoxic effects of pre- and post-natal Hg exposures depend, in part, on aggravating or attenuating environmental and/or genetic-associated factors.” It also noted that public health authorities (such as those at the CDC) dismiss the toxicology of mercury (immunological and subtle neurological effects as insignificant) related to low-dose Thimerosal. The review addresses the evidence that brings into question the safety of Thimerosal that is still present in vaccines given to pregnant women, infants, and children in developing countries, and recognizes the ethical imperative to extend the use of Thimerosal-free vaccines to developing countries, not just developed countries.(22)

A review article conducted at the Mayo Clinic looking at allergens in consumer products and topical medications that can cause a reaction on the skin known as allergic contact dermatitis was published in August. Thimerosal was included in the review. (23)

 Use of Thimerosal for Other Purposes

A study funded by the NIH and conducted by researchers a Texas A&M “… screened 1,200 small molecules consisting of marketed drugs against C. parvum hexokinase (CpHK), from which four drugs one of which was thimerosal were identified as CpHK inhibitors with micromolar level of anti-cryptospordial activities at concentrations nontoxic to the host cells.  The anti-CpHK activity of the four existing drugs provided us new reagents for studying the enzyme properties of the parasite hexokinase.(24)

Laboratory Research of Human and Animal Cell Lines

Researchers from four US Institutions including Thomas Jefferson University and the University of Rochester studied Redox regulation of type-I inositol trisphosphate receptors in intact mammalian cells. 

Using human embryonic kidney cells (HEK293) developed in 1973 from an aborted fetus in Denmark, the researchers monitored the redox state of recombinant Ip3R1 thiols expressed in these cells when treated with thimerosal. The thimerosal treatment modified numerous cysteines.  This is a highly technical paper which states, “To our knowledge, this study is the first that has used proteomic methods to assess the redox state of individual thiols in IP3R in intact cells.”(25)

Researchers at the University of Naples using both human derived (from a four-year old female) and rat derived cell lines, were exposed to non-toxic concentrations (0.01 μM) of ethylmercury thiosalicylate (thimerosal) for 24 hours.   “The aim of this study was to validate the hypothesis that the exposure at non-toxic concentrations of Thim could induce neuronal death in an in vitro model of ALS. We found that SH-SY5Y neuroblastoma cells transfected with the G93 A mutant of SOD1 (SOD1-G93 A) are more vulnerable to the neurotoxicant thimerosal compared to cells overexpressing the wild type SOD1 gene (SOD1). In regard of the possible mechanism involved in the neurotoxic effect of Thim, it should be underlined that Thim exposure caused an increase of PDYN, a well-known DREAM target gene and that its knocking-down by siRNA reduced the toxic effect of Thim, thus suggesting that PDYN and DREAM can be involved, as confirmed also by the reduction of the expression of DREAM protein in our experimental condition. This hypothesis is reinforced by the findings showing that the knocking-down of DREAM increased the neurotoxic effect of Thim. To our knowledge, this is the first evidence demonstrating DREAM role in the neurotoxic effect of Thim and its correlation with ALS physiopathology. Specifically, our results indicate that in these experimental conditions DREAM is neuroprotective and is in accordance with a recent paper demonstrating that in motoneurons of ALS patients DREAM is involved in ALS physiopathology.”

Specifically, it was reported that thimerosal, in SOD1-G93 cells, but not in SOD1 cells, reduced cell survival. Thimerosal-induced cell death occurred in a concentration dependent-manner and was prevented by the Sirtuin 1 (SIRT1) activator Resveratrol (RSV).  They also reported that thimerosal decreased the protein expression of transcription factor Downstream Regulatory Element Antagonist Modulator (DREAM), but not DREAM gene. Interestingly, DREAM reduction was blocked by cotreatment with RSV, suggesting the participation of SIRT1 in determining this effect. Immunoprecipitation experiments in SOD1-G93 A cells exposed to thimerosal demonstrated that RSV increased DREAM deacetylation and reduced its polyubiquitination. In addition, RSV counteracted thimerosal-enhanced prodynorphin (PDYN) mRNA, a DREAM target gene. Furthermore, cortical neurons transiently transfected with SOD1-G93 A construct and exposed to thimerosal (0.5 μM/24 h) showed a reduction of DREAM and an up-regulation of the prodynorphin gene. Importantly, both the treatment with RSV or the transfection of siRNA against prodynorphin significantly reduced thimerosal-induced neurotoxicity, while DREAM knocking-down potentiated thimerosal reduced cell survival. These results demonstrate the particular vulnerability of SOD1-G93 A neuronal cells to thimerosal and that RSV via SIRT1 counteracts the neurodetrimental effect of this toxicant by preventing DREAM reduction and prodynorphin up-regulation.(26)

A study in Brazil evaluated evaluating the interaction between bovine serum albumin (BSA) and thimerosal (TM), an organomercury compound widely employed as a preservative in vaccines, was investigated simulating physiological conditions and using different spectroscopic techniques.  The authors concluded, “It was proven that both thimerosal and ethylmercury chloride accelerate the protein fibrillation kinetics in 42 and 122%, respectively, indicating the toxicity of these compounds in biological systems.”(27)

From the NIH:  Drug screening using assays are evaluated.  The National Center for Advancing Translational Sciences (NCATS) Pharmaceutical Collection (NPC) library containing 2816 drugs was evaluated using the in vitro co-culture assay. From the screen, 35 potent inhibitors (IC50 ≤1 μM) were identified, followed by 15 weaker inhibitors (IC50 1–50 μM). Moreover, many known angiogenesis inhibitors were identified, such as topotecan, docetaxel, and bortezomib. Several potential novel angiogenesis inhibitors were also identified from this study, including thimerosal and podofilox. Among the inhibitors, some compounds were proved to be involved in the hypoxia-inducible factor-1α (HIF-1α) and the nuclear factor-kappa B (NF-κB) pathways. The co-culture model developed by using hTERT immortalized cell lines described in this report provides a consistent and robust in vitro system for antiangiogenic drug screening.(28)

Vaccine Education Training:  Study reporting on the training of pharmacy students to change “a patient’s mind” in regard to vaccine hesitancy at the University of the Pacific in Stockton, California.  A two-week required practicum was described in which pharmacy students are trained in how to respond to patients and parents who express concerns about vaccines and vaccine ingredients.  Thimerosal was one of the topics.  “a two-week vaccine hesitancy learning unit was added to the required Practicum II course as a formative component that was not part of the students’ summative grade in the course. Practicum II is a course designed to provide hands-on learning activities in the area of developing subjective, objective, assessment, and plan (SOAP) notes, laboratory diagnosis, diagnostic tests, physical assessment and professional communication. The course is divided into small discussion groups that are led by trained teaching assistants. The goal of the learning unit was to build upon the material learned in the APhA certificate program and provide practice in counseling vaccine hesitant patients. The objectives of the learning unit were to enable a student to identify common myths associated with vaccine use, identify a patient/parent who is vaccine hesitant, apply counter strategies in communicating with a patient/parent who is vaccine-hesitant, and apply the art of rhetoric when communicating with a patient/parent who is vaccine-hesitant.”  Using hired actors, the students used scenario exercises to practice their communication and persuasion skills. There were 203 students who participated in both phases of the learning unit. Only 180 students (88.6% response rate) completed both the pre- and post-attitudes surveys, with nine items showing significant improvement.  The largest reported changes were in their knowledge about the use of thimerosal as a preservative.(29) 

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Observations about CDC Messaging on the Polio-Like Illness from a FOIA Response

30 November 2018

The Freedom of Information Act (FOIA) is an important law established to insure citizens may seek access to government materials.  According to FOIA.GOV, its basic function is “to ensure informed citizens, vital to the functioning of a democratic society.”   Since returning to the private sector in 2003, I have utilized the FOIA process numerous times with mixed results.  When reviewing the FOIA logs at the CDC recently I came across a request made by Judicial Watch in 2014 related to Enterovirus.  I requested a copy, knowing that the CDC would have fulfilled their request in line with the stipulated time requirements of the FOIA law because Judicial Watch has a legal team at their disposal to hold federal agencies accountable to the law itself.

The information requested and delivered covered a span of months in 2014 in which there was significant interest in whether children who entered the United States and became known as ‘Unaccompanied Alien Children’ (UAC) had brought with them new viruses which might be linked to the development of the polio-like syndrome being referred to as Acute Flaccid Myelitis (AFM).

News reports indicate that the Centers for Disease Control and Prevention (CDC) is stumped and does not know what is causing this. (1) Earlier this month the CDC announced they had formed a task force to investigate the issue. (2) So far in 2018, according to this report there are 106 confirmed cases of AFM in 29 states with all but five in children aged 18 years and under.  That number grew in a week’s time to 116 confirmed cases in 31 states with a total of 286 possible cases. (3)

Investigative journalist Sharyl Attkisson has long reported on this issue on her television show Full Measure (http://fullmeasure.news/)  . She initially reported on the issue in 2014 when the condition first was reported in the United States.  At the time we were dealing with an Ebola crisis as well as upsurge of illegal immigrants coming across the US Southern border.  Thousands of children and teens were apprehended by Border Patrol.  All were designated as “Unaccompanied Alien Children (UAC)”.  Federal data show that children designated as UAC have been released to sponsors in every state. (4)

What I learned about the CDC’s handling of Enterovirus specimen in UACs: 

CDC has a Division on Viral Diseases (DVD) within the National Center for Immunization and Respiratory Diseases (NCIRD); Within the DVD, CDC has a Polio and Picornovirus Laboratory Branch (PPLB).

On July 14, 2014, CDC personnel notified personnel in the NCIRD that specimens from 35 UACs who were sick with Acute Respiratory Illness (ARI) were sent to the CDC for TAC testing. The next day one of the NCIRD team mention that the respiratory bacteria group has their own TAC card and wondered if they were running tests or not. The response to that inquiry was that they didn’t have the money.   Nothing seems to have happened in July or August with these specimens. There was an apparent nudge to get the results in part due to media and public interest in the issue and a member of Congress making inquiries about Enterovirus.

On September 21, 2014 a microbiologist within the PPLB of the NCIRD acknowledged receipt of 23 specimens.  There is no discussion included about the missing 12 specimens included in the FOIA.  Which of course raises the question of how a third of the specimens go missing and no one seems to notice or care.

The test results show a date of September 18, 2014.  The outcome of the 23 NP swabs (acquired in California, Texas and Oklahoma) tested by the CDC Enterovirus Reference Diagnostic Laboratory showed the presence of Enterovirus C105 in 13; Enterovirus – C117 in 2; and one case each of Human Rhinovirus (HRV) 9, HRV 38, and HRV 37.

CDC was in the final stages in 2014 of developing a Quick Response test for Enterovirus (EV) D68.  Did this cause them to zero in on EV 68 at the expense of keeping all possible causes of AFM on the table in 2014?

Internal emails confirm an expert considered there to “clearly be an EV C-105 outbreak/cluster” and suggested they look at the locations and clinical/epidemiological data.

There was also an internal discussion about what might occur if a child had an entero and a rhino virus simultaneously.  All of these issues are topics the public should be fully informed about and have not been.

What I learned About what the CDC Told the Media and Public in 2014:

One of the lessons I have learned over the many years is that one should pay very close attention to whether or not the question asked of the CDC is actually answered.  What I observed when reviewing this FOIA information is that the question the media and public initially asked was not actually answered.

The question initially asked was if the the Unaccompanied Alien Children (UACs) has been responsible for importing enteroviruses into the US. The concern being that these tens of thousands of immigrants had brought with them a new virus that was at the root of the polio-like AFM.  Remember, there was a great lack of transparency of where these children were being housed before being sent to their sponsors.  The news was filled with stories of mystery buses taking kids to unknown facilities and even plane loads of kids being moved to various locations in the country.  During 2014, according to media treports, about 3,000 children were housed on military bases in California, Texas and Oklahoma.  While I do not have confirmation of this, it is likely this is where the specimens referenced above were obtained.

One CDC manager blamed Sharyl Attkisson in an email for circulating a ‘conspiracy theory’ about a link between the UACs and AFM. A highly ranked CDC employee expressed relief that the 23 specimens did not show EV-D68. One of the documents produced with examples of questions being asked by the media noted that the concern being expressed was on ‘conservative’ learning new outlets websites.

There were media questions from Brietbart, Fox News, Media Matters, and Accuracy in Media.  There was also an inquiry from a doctor who at the time worked for Congresswoman (now Senator-elect) Marsha Blackburn.  This doctor now works for Senator Grassley.  Cong. Blackburn went so far as to visit the CDC in the fall of 2014 and had a lot of questions.  I see no evidence to suggest she was informed about the EV-C105 discovery in the UACs.

Among the internal discussion was a discussion about the Accuracy in Media reporter’s request for information and a CDC staffer telling another CDC staffer via email that he would ‘just have to make a FOIA request and that by the time he got his response, the numbers would be different.’  There was no inclusion of Media inquiry from any of the networks (ABC-CBS-NBC) or print newspapers such as the New York Times.

Each of the reporters and the doctor-legislative staffer was told “no EV-D68 in the UACs”.  They were not told there was Enterovirus found in the specimens and that in fact there was a cluster/outbreak of EV-C105.

Sadly, from the information provided in the FOIA, it does not look like these individuals thought to clarify and ask about other viruses or that the CDC staff took the initiative to clarify to the media or Cong. Blackburn and her staff what was found in the 23 specimens.  Four years of silence – intentional (malicious) act or a lack of initiative (mediocrity) by those involved?  I have no evidence to determine either.

Polio and the C-Series of Enteroviruses

I did a specific search for Enterovirus C105 on the CDC’s website and found an article that specifically connects polio to the C-Series of Enteroviruses. “Acute Flaccid Paralysis Associated with Novel Enterovirus C105” The article authored by a team out of the University of Virginia reported on a case of a young girl who developed Acute Flaccid Paralysis and was confirmed to have EV C105. (5)

It has been four years since the analysis of these 23 samples.  Four years since this young girl’s became ill, and three years since her physicians published the above-mentioned paper identifying EV C105; however, the CDC has made no updates to their web pages and does not appear to have focused their efforts on looking at this specific Enterovirus.

Concluding Thoughts – More Questions than Answers

Like most of you, I am increasingly concerned about this paralytic disease that is being called ‘polio-like’, Acute Flaccid Paralysis or Acute Flaccid Myelitis.

I am curious as to what testing has been done in the last four years both in the children who developed this condition and among the Unaccompanied Alien Children related to infectious diseases including EV C105.  I believe this information needs to be published online and available to everyone in as close to real time as possible.  I learned through this FOIA response that the CDC has a ‘master database’ on their specimen outcomes.  Will the Task Force have access? Where is the public access?  Is anyone at the CDC looking beyond EV D68?  Are their quick response tests being developed for other enteroviruses?  Are the doctors treating the AFM cases testing for other enteroviruses like C105?  Has the CDC even made this suggestion?

I cannot help but worry that the migrants who are sitting in Tijuana, 60 percent of whom have respiratory illness already may be carrying EV C105 or something else that will develop into a life-threatening illness for these individuals and those in the surrounding areas. Because of the deteriorating conditions at this migrant camp site, some have now been bused to another location in Mexico about an hour away.  They will hopefully have better conditions, but whatever viruses they may carry, are going with them.  I hope the public health sector of the Mexican government along with the organizers of the caravan are working on improving the sanitation and reducing the spread of infections.

There is No Cure – Yet.

The CDC admits they have no cure to offer for this polio-like condition. They advise close attention to frequent hand washing with regular soap.  Entero and Rhino viruses can live on clothing and surfaces for many hours – up to 72 hours on hard surfaces like door knobs.  So, hygiene remains the number one best prevention.

Be smart – if you are sick, stay home and away from others.  Forgo hand shaking for the winter months. Up your intake of Vitamin D and Vitamin C. Get adequate rest.  If you have a child who tends to ‘catch everything’ avoid taking him or her to large public spaces like the mall, movie theaters, big box stores especially on high attendance days especially if there are reports of flu and respiratory illnesses in your community.  I am shocked at how often I see people cough and sneeze in public and make no attempt to cover nose and mouth.

Given what I learned in this FOIA’d information from 2014, I see a new FOIA request in my near future.

Sources Cited:

Links to the CDC’s websites of possible interest:

https://www.cdc.gov/non-polio-enterovirus/about/symptoms.html

https://www.cdc.gov/non-polio-enterovirus/about/ev-d68.html

https://www.cdc.gov/non-polio-enterovirus/hcp/ev-d68-hcp.html

https://www.cdc.gov/non-polio-enterovirus/about/ev-a71.html

https://wwwnc.cdc.gov/eid/article/21/10/15-0759_article

Always,

Beth Clay