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Kindness & Civility Matter

Democrats, Republicans, Libertarians, Socialists, are all labels we give ourselves and apply to others based on political leanings. They are just labels. They do not determine our character or morality.

I am an ardent believer in having lawful elections. Tuesday night in my state, the polls had closed only a minute or two and the election was called. I was stunned because the votes could not have been counted. Watching the election be called by the media today was tough, not because of who was called the victor; but because not all ballots have been counted. The process of lawful elections matters, even when it is inconvenient.

It was as if over night a decision was made to have all the media call the projected winner at almost exactly the same time (while the President was on the golf course) and change the news cycle, to begin the transition before a single state had certified the election.

Maybe the outcome will not change. What happens if it does?

There is a part of me that wants to rail and scream because of the media manipulations, the big tech controlling of free speech all of which played a role in this election cycle. There is a part of me that has serious concern about the forward marching of agendas that I believe undermine our democratic republic; and there is a part of me that just wants to see it all be over.

Watching all the celebrations in the streets I can’t help but wonder if there will be a spike in COVID cases and lockdowns mandated. I wonder if magically there will be no COVID spike even though thousands of people are shoulder to shoulder in the streets for hours on end.

I’m curious if the Massachusetts Governor will appoint Joe Kennedy to replace Elizabeth Warren if she gets a cabinet position. I wonder if Sen. Coons and Sen. Sanders will get a cabinet position. I worry about the price of oil skyrocketing. I wonder about the AOC and her Squad versus Speaker Pelosi battle that is sure to come. And I wonder who the Governor of California will appoint to replace Sen. Harris if she is indeed sworn in as Vice President.

In the next week or so, the newly elected will arrive in Washington and get new legislator training. The annual lottery for office space will take place and a majority of legislators’ offices will be moved between now and the start of the new Congress.

Whatever your feelings about the November 2020 elections; about what will happen in the legal challenges, please remember to be kind to one another. I feel like maybe at the start of each day everyone should watch a rerun of a Mr. Roger’s Neighborhood episode.

I do know I’m tried of people making negative comments about our President – like him or not, he is President; and has done a lot of good things. Two peace deals in the Middle East among them. I worry how the next administration will handle Iran. And now that it has been shown that GMO crops are losing their pesticide resistance (Thank you NPR for the story), I wonder how a return signing onto agreements that were pushing GMOs on the world will be affected.

But tonight, I’ll simply focus on trying to keep my own advice and be kind and civil!

In the words of the Dali Lama – “Be Kind Whenever Possible. It is Always Possible.”

In the words of Mother Theresa, “Kind words can be short and easy to speak, but their echoes are truly endless.”

And finally, in the words of Beth Clay, “Love in the most power energy on the planet, Kindness emanates from a place of love within; and Civility is always appropriate!”

My hope and prayer for the United States of America and all her people is that truth, justice and liberty will prevail; that we can remember kindness and civility along the way, even though it will be a challenge; and that whatever your belief system, you lean into it to see you through the coming weeks and months.

Always,

Beth

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The Dark Underbelly of COVID-19 – Bigotry & Racism

As I write this my heart is heavy with sorrow, not because I have lost someone to the COVID-19 virus, but because I was unaware of the dark underbelly of the COVID-19 pandemic and how it has affected one of my most precious treasures – one of my own children.

My children are all adults, but as a mom, your babies are your babies even if they are 30 years old. The umbilical cord may have been cut, but there is a spiritual, energetic, heartstring that will never sever. When I’m 100 and they are on Social Security, they will still in my soul be my babies, my most treasured jewels.

I thought I understood racism, after all, I grew up in the era of Martin Luther King, I was a part of the desegregation of schools in the south. I’ve written about the need for greater diversity in certain professions. I have seen crosses burning in the fields when the KKK had a meeting outside of the town where I grew up. I thought I got it.

What I didn’t realize is how at least one of my children is experiencing racism routinely with his work in hospitality. Understand, none of my children fall into the ‘snowflake’ category. They are Asian American, raised by their pale-skinned white mother in a single-parent household. They survived the financial roller coaster, that goes with a single-parent household where the other parent doesn’t meet his obligation regularly and so much more. There were times in their upbringing that we dealt with bigotry head-on from individuals who simply didn’t understand their racist comments were hurtful or didn’t care.

When Congresswoman Chu requested that President Trump stop calling COVID the Chinese virus because it was offensive, I brushed her opinion aside, thinking it was politics as usual. I am learning that when we have to explain why something isn’t racist; we already don’t understand. I don’t know if President Trump is racist or not. I presumed he was using the term China Virus to annoy the media and the Chinese leaders he is negotiating with. I now am respectfully asking our President to stop because it is received as a racist term by those in the Chinese American community – including one of my own children.

My son has previously shared how some whom he comes into contact with make racial slurs, but in the Spring of 2020, after being selected as one of the top 12 bartenders in the country, he went to the Big Apple, a city he loves and because he is Asian, had people moving away from him on the New York City Subway. One of the most diverse cities in the world and my son is being targeted because of the color of his skin and the slant of his eyes!

And then there is the increase in physical assaults on Asian-Americans. Did you know that ” …advocates found 300 news articles from throughout the country reporting attacks against Asian Americans during a roughly two-week period ending March 7.”
https://www.mercurynews.com/2020/03/21/coronavirus-attacks-against-asian-americans-reported-in-bay-area-and-beyond/

I have to speak out because one of my children could become the target of someone’s attack. I will be sending this to President Trump to ask that he do the Presidential thing and make a change to his rhetoric, to lead this country away from racism and bigotry. And I am asking each of you to consider your words and your deeds.

We will come through COVID-19. Let’s make sure we don’t use it as an excuse to attack someone based on their race or the color of their skin.

Always,

Beth

Falls Church, VA

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What a Recent FOIA Court Case Really Says

March 8, 2020: On March 5, a nonprofit organization made public their court filing regarding the failure of the Centers for Disease Control and Prevention (CDC) to produce information relevant to their Freedom of Information Act (FOIA) Request. I’m very familiar with the topic, with people involved, and with FOIA (having used it myself many times over the last 20 years). Because I am not directly involved, but realizing the importance of the process and the outcomes; I wanted to give a Hawk’s views – that of the 3,000 feet up and zeroed in.

The Case itself: The Informed Consent Action Network (ICAN) made requests of the CDC through the FOIA process. In the press release, ICAN notes the CDC after many months failed to respond to FOIA requests to provide “All studies relied upon by CDC to claim that the DTaP vaccine does not cause autism.” ICAN also made the same request for HepB, Hib, PCV13 and IPV vaccines. They further asked that the CDC provide studies to support the claim that “cumulative exposure to these vaccines during the first six months of life do not cause autism.”

Why would ICAN do this? After all, its been 20 years of drama around this topic and the government says its ‘settled science’ that vaccines do not cause autism. Having become involved in this issue in 1999 while working for Congress, I realize exactly why and thought I would explain from my perspective. The data the CDC posts on their website, the studies they have conducted and funded, do not truthfully provide a scientific underpinning for their claim that ‘vaccines do not cause autism.’ Just because they say it does, does not make it so. If I look up at the sky and say it is lime green, just because I say it is, does not make it so. If I write on this page that President Trumps’ hair is his natural color and it not chemically enhanced, that does not make that a factually accurate statement.

Zeroing in on ground level: The facts are that the CDC has only investigated and published studies on MMR, thimerosal, and a couple of other ancillary topics (and in my personal view, done that poorly – but that would be a digression). The CDC and their colleagues – have not shown that all vaccines given in the first six months of life individually or as a group have no connection to the epidemic increase of autism rates or the dramatic increase of chronic health conditions in children born since 1988. They have not shown this, because they have not studied this. If CDC had, the document they submitted to the court in response to the court filing by ICAN would be very different. What did the CDC provide in response to the federal court’s stipulation order? They provided the same series of 20 papers and reports they always provide or post, none of which are actually responsive to the requests. To take a page out of former Congressman Trey Gowdy’s recent news interviews, related to political activities, I’ll draw a picture – after 21 years of funding, after 9 months of waiting for the FOIA response, after going to a federal court, the non-profit organization ICAN was handed a basket of stale, moldy apples when it had asked for a basket of fresh peaches.

In the2012, publication by the National Academy of Sciences, Ellen Wright Clayton, Chair Committee to Review Adverse Effects of Vaccines wrote, ” The Institute of Medicine (IOM) was charged by Congress when it enacted the National Childhood Vaccine Injury Act in 1986 with reviewing the literature regarding the adverse events associated with vaccines covered by the program, a charge which the IOM has addressed 11 times in the past 25 years. Following in this tradition, the task of this committee was to assess dispassionately the scientific evidence about whether eight different vaccines cause adverse events (AE), a total of 158 vaccine-AE pairs, the largest study undertaken to date, and the first comprehensive review since 1994.

The committee had a herculean task, requiring long and thoughtful discussions of our approach to analyzing the studies culled from more than 12,000 peer-reviewed articles in order to reach our conclusions, which are spelled out in the chapters that follow. In the process, we learned some lessons that may be of value for future efforts to evaluate vaccine safety. One is that some issues simply cannot be resolved with currently available epidemiologic data, excellent as some of the collections and studies are. ” They go on to provide more scientific guidance, ” Some adverse events caused by vaccines are also caused by the natural infection. These effects often cannot be detected by epidemiologic methods, which typically cannot distinguish between the adverse events that are caused by the vaccine itself and the decrease in adverse events due to the decreased rate of natural infection. In addition, even very large epidemiologic studies may not detect or rule out rare events. Subgroup analysis or more focused epidemiologic studies, informed by as yet incomplete knowledge of the biologic mechanisms of vaccine-induced injury, may be required. Examining mechanistic evidence to assess causation is also challenging. Many of the case reports the committee reviewed simply cited a temporal relation between vaccine administration and an adverse event. Association, however, does not equal causation. More is required. The proof can be relatively straightforward, as when vaccine-specific virus is recovered from the cerebrospinal fluid of a patient who develops viral meningitis a few weeks after receiving the vaccine. Alleged adverse effects that appear to be immune-mediated, as many of them are, are more challenging, in part because the biology is not completely understood.

One potentially useful line of inquiry as science advances is to assess whether the vaccine recipient who suffers harm had a preexisting susceptibility to that particular adverse event as such studies may provide insight into the mechanisms by which such events occur. The committee is aware of the work funded by the Centers for Disease Control and Prevention (CDC) to study such individuals and looks forward to their findings. Most individuals, for example, who develop invasive infection from live vaccine viruses have demonstrated immunodeficiencies. Our work was also complicated by the wide variation in the case reports regarding what other tests had been done to rule out other potential causes. To improve the utility of these reports, periodically convening a group of experts to suggest guidelines, based on the best available science, for providing mechanistic evidence that a particular adverse event was caused by a vaccine may be useful. These guidelines could be made available on the Web, and perhaps more important, shared with clinicians who report cases to the Vaccine Adverse Event Reporting System so their reports can be as complete and useful as possible. ”

The Committee published these findings:

The framework allows the committee to “favor rejection” of a causal relationship only in the face of epidemiologic evidence rated as high or moderate in the direction of no effect (the null) or of decreased risk and in the absence of strong or intermediate mechanistic evidence in support of a causal relationship. The committee concluded the evidence favors rejection of five vaccine–adverse event relationships. These include MMR vaccine and type 1 diabetes, diphtheria, tetanus, and pertussis (DTaP) vaccine and type 1 diabetes, MMR vaccine and autism, inactivated influenza vaccine and asthma exacerbation or reactive airway disease episodes, and inactivated influenza vaccine and Bell’s palsy. The evidence base for these conclusions consisted of epidemiologic studies reporting no increased risk; this evidence was not countered by mechanistic evidence.

The literature supporting several of the causality conclusions discussed
in the previous section indicates that individuals with certain characteristics
are more likely to suffer adverse effects from particular immunizations.
Individuals with an acquired or genetic immunodeficiency are clearly recognized as at increased risk for specific adverse reactions to live viral vaccines such as MMR and varicella vaccine. Age is also a risk factor; seizures after immunization, for example, are more likely to occur in young children.

The report is thorough and massive. The Cliff notes section, i.e. the chart of vaccines, suspected adverse events evaluated in the data and their findings is more than 600 pages into the report. On page 684, the National Academy of Sciences’ prestigious panel reported that in looking at autism as an adverse event from DTP, DTaP, or TT, the epidemiological assessment was “insufficient”, the mechanistic assessment was “lacking’ and the causality conclusion was “inadequate”.

As an aside, in the same table, the panel finds the mechanistic assessment for MMR and autism “Lacking’ but uses the epidemiological assessment to reject causation.

If you do nothing more than read the chart TABLE D-1 Causality Conclusions Organized by Chapter and Adverse Event which begins on page 674 of the report, your eyes will be opened. When you read how many suspected events have not been studied by the CDC (or anyone else) even with all of the billions of dollars since 1989 that have been directed towards this. The list of suspected events are not isolated incidences, but adverse events reported often enough to raise the red flag and warrant the committee investigate.

Having read this finding, the tenants of evidence-based reporting that the CDC is obligated to follow; the statements on their website AND their public information campaign should have changed in 2012 (and it did not). The CDC, Dr. Sanjy Gupta, and everyone in public health should not be able to say (since 2012) with a straight face that the question of autism and vaccines is settled science (which is a ridiculous unscientific statement anyway). To do so is simply a false statement when the preeminent committee within the scientific community published a report in 2012 which concluded that on one set of vaccines (Diptheria, pertussis, and tetanus) given multiple times to infants the question of causation remains unanswerable because the scientific evidence is lacking. Who will be held accountable? If Congress does not engage in oversight, these misdeeds will continue.

According to the law, if the CDC had data on the vaccines in question they were obligated to provide it. They did not, so, in short, but not providing any relevant studies, and providing the National Academies 2012 report they have shown themselves to be misrepresenting the facts of autism and vaccines to the public. They have by default admitted their data are insufficient to answer the question.

Why does this matter? Setting aside the parent bully technics that have taken place over the last 20 years by public health agencies and officials, as well as social media; setting aside, the miscarriage of justice in the Vaccine Injury Compensation Program, let’s pull the lens back out to 3,000 feet – if the CDC has intentionally or by neglect posted scientifically invalid information on their website about this topic, what else on their site is inaccurate?

If there is any take away from the current infectious disease drama playing out daily in the media, the information posted on the CDC website is the ‘trusted source’. It is where doctors, nurses, families, and policymakers and the world go for information about coronavirus, measles, autism, HIV, and the flu. They have a duty to the public to have only fact-based, scientifically substantiated information on their website. We are not Cuba or Russia, or Venezuela – the agency has a legal obligation not to get caught up in politics or propaganda and stick with the tenants of fact-based, scientifically substantiated information on all topics on their webpages.

Thank you to ICAN and the partnering organizations for staying focused on evidence gathering and being willing to take the agency to court when they do not comply with FOIA law. The families of the vaccine-injured need a “Judicial Watch” equivalent to keeping focused on seeking the truth; and not giving up even when the social media giants suspend free speech, bully the parents of injured children, and elected officials ignore their duty to conduct oversight.

At the end of the day, what this FOIA Case Really Says that after more than 20 years, the question of a link between acquired autism and vaccine injury remains an open question. That inconvenient evidence-based truth is not present on the CDC’s website.

Always,

Beth

Disclaimer: This opinion is purely my own personal view and does not represent the opinion or view of any organization, entity, or person that I am currently working with or have worked with in the past.

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Where is the Moral Outrage? Why are Children in Africa, Asia, and the Middle East Not Given the Safer Polio Vaccine?

A funny thing happened on the way to the loss of religious liberty and parental rights in the United States this spring. The CDC and is public health colleagues kept everyone’s attention firmly focused on Measles, while they quietly published papers acknowledging that the oral polio vaccine continues to spread polio.   

In 2000, the World Health Organization Western Pacific Region declared Papua New Guinea (PNG) free of indigenous wild polio virus. PNG is one of 37 countries or regions with a wild polio-free certification.  As Bauri, et al reported in Notes from the Field (1)  in February 2019, the PNG National Department of Health confirmed an outbreak of poliomyelitis “caused by circulating vaccine-derived poliovirus type 1 (cVDPV1) following isolation of genetically linked virus form a patient with paralysis and non-household community contacts.”  A six- year old boy having received 2 doses of the Sabin oral polio vaccine (OPV), was identified as the ‘index patient’. Six months later, 26 confirmed cases of circulating vaccine-derived polio had been identified in nine of the 22 PNG provinces including 19 in children less than five years of age. 

Bauri also reports that the Acute Flaccid Paralysis (AFP) Surveillance system is being improved in PNG and the 2018 surveillance found 7.0 per 100,000 persons under the age of 15 years with non-polio AFP compared with 0.8 in 2017.  Less than 50 percent of the cases of non-polio AFP were further evaluated through stool sampling.  There is also expressed concern due to the discovery of cVDPV1 (the vaccine strain poliovirus) in seven sewage samples in major urban environments in PNG.  CDC issued a level 2 Travel Health Notice for all travelers to PNG to be fully vaccinated against polio.

In March, Mbaeyi, et al, (2) published, Update on Vaccine-Derived Poliovirus Outbreaks – the Democratic Republic of the Congo and the Horn of Africa, 2017-2018. The authors note the use of the live attenuated Sabin oral polio vaccine (OPV) has helped with the global eradication goals while also noted its use is resulting in the person to person transmission of vaccine-derived poliovirus (VDPV) disease. VDPV disease presents with paralysis. 

Two months after this report, Green, et al (3) reported a paper entitled Progress Towards Polio Eradication in which the team recounts the success of the Global Polio Eradication Initiative (GPEI).  The program which began in 1988, the authors claim that wild poliovirus (WPV) transmission had been interrupted in all countries except Afghanistan, Nigeria, and Pakistan.  Apparently, there are now 3 Wild Polio Virus types.  WPV type 2 (WPV2) was declared eradicated in 2012 and WPV type 3 (WPV3) had not been detected since 2012.  Eight countries during the study period reported 210 cases of circulating vaccine-derived poliovirus (CVDPV) from 2017 to May 2019.   The eight countries (Democratic Republic of Congo, Indonesia, Mozambique, Niger, Nigeria, Papua New Guinea, Somalia, and Syria).  Through concentrated international efforts, 1.8 billion doses of polio vaccines both oral and injected were allocated for use in 2017.

The authors note that the use of AFP Surveillance systems among children less than 15 years of age is how detection of polio cases occurs.  When a child develops AFP, a stool sample is tested.  If a child with either type of polio (wild or vaccine derived) does not present symptoms that include AFP, their case likely will not be detected or counted.  In 2017, 22 wild polio virus type 1 (WPV1) cases were reported in Afghanistan and Pakistan and in 2018 33 cases.  In the first quarter of 2019, 12 WPV1 cases were confirmed in Afghanistan and Pakistan.

All three of these papers discuss measures to curtail the spread of polio virus through increased immunizations. None discuss public health measures to decrease the risk through improvements in sewer systems and reducing the risk of transmission while the virus sheds, which all three report the discovery of circulating vaccine-derived poliovirus in sewage systems. While vaccines are considered the second most important advance in public health, the first is clean water and effective sewer systems. Sadly these public health experts are ignoring the obvious additional measure needed.

It would seem that the CDC and WHO scientists have chosen not to inform the WHO Director-General because Dr. Tedros is quoted in a WHO bulletin, “My wish for 2019 is for zero polio transmission.” (4)

A time for moral outrage. None of these stories presents any discussion on a conversion to the IPV which is not likely to transmit poliovirus.  

My question is why? Why are we as a global community not willing to promote IPV world-wide?

Why haven’t Bill and Melinda Gates through their vaccine promotions in the Gates Foundation used their influence to help stop the spread of vaccine-derived polio? 

Twenty years ago the Advisory Committee on Immunization Practices recommended all polio virus vaccines administered in the United States ““be an inactivated poliovirus vaccine (IPV) beginning January 1, 2000.”(5)  In the 1999 decision, it was reported, “Since 1979, the only indigenous cases of poliomyelitis reported in the United States (n=144) have been associated with use of the live oral poliovirus vaccine (OPV) (an additional six imported cases have been reported since 1979, the last of which occurred in 1993).”(6)  The ACIP suggest the risk for vaccine-associated paralytic polio (VAPP) would be anticipated once in every 2.4 million doses distributed.

The spread of polio through the oral polio vaccine is well documented.  Burns, et all provide a detailed description of the issues in their 2014 paper, Vaccine-Derived Poliomyelitis. (7) They also note that the OPV can result in chronic polio infection.

In looking at this, I am reminded of the discussions before the Oversight Committee, at the State Department during the Mercury Treaty discussions and at numerous scientific and advisory committee meetings.  When Congressman Burton asked HHS to ‘get the mercury out’ and to set a preference for mercury-free (i.e. thimerosal) vaccines, he was told repeatedly that the United States could not make a recommendation or policy to promote mercury free vaccines in the United States and not do the same world-wide.  And yet, that is exactly what has been going on with polio since 1999.  So, CDC and others at the same time they were saying we must shift from OPV to IPV in the US for safety reasons, were unwilling to use the same strategy to accelerate the removal of thimerosal from vaccines.  And misrepresented this policy of needing to have some recommendations globally as domestically to Congress and the public.

Polio is one of those infectious diseases that freak people out.  The goal for 30 years has been to eradicate polio.  To succeed, maybe it is time to discuss a shift from OPV to IPV vaccines globally. I do not want to see the WHO continue their focus on discussing vaccine hesitancy as a condition to be diagnosed, but rather to talk about how to improve the safety of the vaccines administered globally and to incorporate into this discussion a need to make increased efforts to improve the availability of  safe, clean water and adequate sewage systems to reduce the transmission of all types of polio and other conditions such as cholera.  

Sources Cited

1.     Bauri M, Wilkinson AL, Ropa B, Feldon K, Snider CJ, Anand A, et al. Notes from the Field: Circulating Vaccine-Derived Poliovirus Type 1 and Outbreak Response – Papua New Guinea, 2018. MMWR Morb Mortal Wkly Rep. 2019;68(5):119-20. doi: 10.15585/mmwr.mm6805a6. PubMed PMID: 30730867; PubMed Central PMCID: PMCPMC6366675 potential conflicts of interest. No potential conflicts of interest were disclosed.

2.    Mbaeyi C, Alleman MM, Ehrhardt D, Wiesen E, Burns CC, Liu H, et al. Update on Vaccine-Derived Poliovirus Outbreaks – Democratic Republic of the Congo and Horn of Africa, 2017-2018. MMWR Morb Mortal Wkly Rep. 2019;68(9):225-30. doi: 10.15585/mmwr.mm6809a2. PubMed PMID: 30845121; PubMed Central PMCID: PMCPMC6421971 potential conflicts of interest. No potential conflicts of interest were disclosed.

3.    Greene SA, Ahmed J, Datta SD, Burns CC, Quddus A, Vertefeuille JF, et al. Progress Toward Polio Eradication – Worldwide, January 2017-March 2019. MMWR Morb Mortal Wkly Rep. 2019;68(20):458-62. doi: 10.15585/mmwr.mm6820a3. PubMed PMID: 31120868; PubMed Central PMCID: PMCPMC6532951 potential conflicts of interest. No potential conflicts of interest were disclosed.

4.    Public health round-up. Bull World Health Organ. 2019;97(2):77-8. doi: 10.2471/BLT.19.010219. PubMed PMID: 30728612; PubMed Central PMCID: PMCPMC6357566.

5.     Centers for Disease C, Prevention. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding routine poliovirus vaccination. MMWR Morb Mortal Wkly Rep. 2009;58(30):829-30. PubMed PMID: 19661857.

6.    Centers for Disease C, Prevention. Recommendations of the Advisory Committee on Immunization Practices: revised recommendations for routine poliomyelitis vaccination. MMWR Morb Mortal Wkly Rep. 1999;48(27):590. PubMed PMID: 10428098.

7.     Burns CC, Diop OM, Sutter RW, Kew OM. Vaccine-derived polioviruses. J Infect Dis. 2014;210 Suppl 1:S283-93. doi: 10.1093/infdis/jiu295. PubMed PMID: 25316847.

Always,

Beth Clay, June 27, 2019

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Looking at the Suggested ‘Scarlet A’ for Unvaccinated Kids through the Lens of Ryan White

Today I saw a Facebook posting that reminded me of the 1980s and the 1640s.  The posting was one of many ill-informed, potentially fake and hate-filled railings against parents who have made a medical or religious decision not to vaccinate their child with the Measles, Mumps, Rubella (MMR) vaccine.  This particular posting suggested that unvaccinated children should wear a skull and crossbones marking to identify them as unvaccinated.  The posting suggested it be on the child’s forehead, which is why I think it may have been a propaganda posting because hopefully no American actually posted something so egregious. I worry we are quickly devolving as a society over the measles matter.  I will not call 626 cases of measles in the US over the course of four months in a population of 330 million an epidemic because it is not. 

The Scarlet Letter: As the day went on, the comment stuck in my mind.  This is not the Boston of the 1640’s depicted in Nathaniel Hawthorne’s “Scarlet Letter” a work of fiction in which a woman is forced to wear the Scarlet “A” on her clothing to announce to all in the public that she is an adulteress. Can we even imagine an America in which everyone who for instance has speeding tickets has to wear on the front of their clothing a Scarlet “S” when in public; or someone who has a sexually transmitted disease has to wear a Black X.  As I write this, I am reminded of how Hitler forced people who were Jewish to declare their religion by wearing a Star of David on their jacket, setting them up for persecution and discrimination. Do we really want to persecute unvaccinated children?

Ryan White:  It is also not 1984 when a young boy named Ryan White developed HIV/AIDS from a blood transfusion he received to manage his hemophilia.  In 1985 after his Mom prevailed in court against the Kokomo, Indiana school district that had refused to allow Ryan to attend public school, Ryan shared how he was verbally abused and harassed.  If you are too young to remember HIV/AIDS in the 1980s and early 1990s and how the public and politicians treated those who were infected, it is not one of those times we as a nation can be proud of.  Many from school officials, to politicians, to families and the general public who feared the ‘unknowns’ associated with HIV/AIDS, stood in judgement of those who contracted the disease from sexual activity especially if they were gay men.  Ryan’s case was different, he was a teenager who did nothing ‘wrong’ in the eyes of society.  He was young, middle class, white, and from the Heartland of our country.  He could have been the young boy next door to any of us.  I remember discussions about Ryan and the fear that he might infect classmates. This was about the same time there was a circulating story that the government could not rule out that if a mosquito was flying around and landed on and drew blood from an HIV/AIDS infected individual; and then flew off and landed on someone else that they would not infect that second individual.  The fear of just being in the room with someone with HIV was real. 

In the early 1990s, after having worked with Dr. Richard Krause, the former Director of the NIAID during those early HIV days; I learned a great deal about our ‘microbial’ world. He had retired from the NIH to go to Emory; which proved not to be a good fit for him, so he returned to the NIH as a Senior Scientist at the Fogarty International Center where I got to know him.  In 2005, in the tribute that Dr. Krause wrote about his friend Mac McCarty, the “last survivor of the three-man team that demonstrated that genes are made of DNA” (and not protein as many originally thought). Dr. Krause quoted Dr. McCarty’s paper, “The 1944 paper on pneumococcal transformation begins: “Biologists have long attempted by chemical means to induce in higher organisms predictable and specific changes which thereafter could be transmitted in series as hereditary characters.” All that, and then some, has come to pass: witness the human genome, recombinant DNA technology, and genetically engineered animals that produce complex proteins such as human antibodies.”(1)

In 1968 and 1971, Dr. Krause and his colleagues’ studying rabbits and immune response to immunization reported:

“A number of variables are known to influence the magnitude of the immune response including the chemical and physical nature of the antigen, the method of immunization, prior sensitization to the same or a similar antigen, and the genetic background of the animal. Furthermore, these factors may either amplify or limit the wide variability in the characteristics of the immune globulins which are produced.” (2)

“Certain rabbits immunized with streptococcal and pneumococcal vaccines produce high concentrations of antibodies to the carbohydrate antigens.  These antibodies may have a remarkable molecular uniformity, and studies on their primary structure are currently underway. Since only a small percentage of random-bred rabbits produced uniform antibodies in quantities which were sufficient for extensive structural studies selective breeding of these special rabbits was begun in order to increase the number of rabbits which respond in this way.” (3)

Scientists like Dr. Krause recognize that the different rabbits responded differently to the vaccines they were studying based on several factors including genetics and prior exposures. His 1971 report focused on increasing the stock of animals that would be useful in research; however, the two papers highlight key factors that can be translated to our understanding of the human response to vaccines – different people respond differently based on numerous factors including genetics, environmental factors, and prior exposures.

It is why we cannot have a one sized fits all vaccine program.

It’s About Preserving Rights:  One of the reasons I am vocal about the rights of parents to make medical decisions whether to or not to vaccinate is because I believe in liberty.  I also believe in religious liberty. Our nation was founded on the premise of liberty.  I have twice sworn an oath to protect and preserve the Constitution. It is not an oath that ended when I left government service. We must stand together and protect parental rights and religious liberty. I did not get involved in investigating the state of our vaccine policies in the United States, and concerns about vaccine injury because someone I loved suffered a serious reaction to a vaccine, but initially because it was my job.  I stayed engaged when it was no longer my job because it is a moral obligation to continue seeking truth and justice. 

Doesn’t the MMR Vaccine Protect the Vaccinated? Government authorities, Merck the vaccine manufacturer in the United States and doctors who appear on television promoting vaccines all say that the MMR is great. The public has been told that the vaccine is safe and effective. If the vaccine is everything that it is promoted to be, given the high immunization rates nation-wide the herd immunity public health officials promote as the goal to protect those who cannot be vaccinated has been met.

The suggestion that parents who have obtained medical or religious exemptions to measles (MMR) vaccination must be forced to vaccinate their child to protect those who can’t be vaccinated is a perverse view of public health.  Parents with children too young to be vaccinated, or with medical conditions that preclude getting the MMR have suggested that their rights to take their child out in public during an outbreak is more important than the rights of parents of unvaccinated children. They seem to ignore the reality that the MMR is a live virus vaccine and can shed measles virus (as well as Mumps and Rubella) for months after given.  We do not know if the increased number of measles cases in the US in 2019 is at all related to vaccine strain measles because so far, there are no journalists asking the tough questions, like whether or not those diagnosed with measles have been tested to confirm the strain of measles, to determine if it was brought in from Israel, Honduras, or the Philippines or if it originated in the US from wild-type measles. So far public health authorities have failed to report if they are testing and if so to make those test rules public.

I would suggest that it is the responsibility of the parents of a child who is unvaccinated because of age or medical condition to protect that child.  It is not your neighbor’s job to protect your child, nor the parent of another child, but yours.  Measles is not the bubonic plaque. It can be deadly but typically is not.  And even if Measles was a deadly disease in the US in 2019, taking away the rights of others, labeling unvaccinated children so they can be discriminated against and bullied is not the answer. Demonizing the parents, advocates, and medical professionals who speak out about vaccine injury and call for improved quality and a restoration of parental rights is not the answer.  And it is not the fault of Dr. Andrew Wakefield! (The misinformation campaign about Andy is a story for another day.)

Is our Nation Lost?  Our civilized society is devolving quickly into a nation that bullies parents, threatens $1,000 fines and jail for the failure of parents to compromise religious belief and vaccinate their child. Local and national media outlets dutifully report about the measles outbreak and shame parents who have not vaccinated.  I have seen repeatedly reporters on Fox News who promote themselves as conservatives, and anti-abortion shame parents for not giving their kids the MMR vaccine without acknowledging (or maybe oblivious to the reality) that the MMR is produced on two cell lines developed from tissue that was taken two aborted human fetuses. Can you be anti-abortion and pro-MMR?  I  have watched some of my favorite local media anchors (who happen to be African American) push the vaccine without acknowledging the CDC Whistleblower who saved the data covered up by his colleagues in the Atlanta MMR study that showed a statistically significant increased risk of autism to African American boys based on the timing of the vaccine (before 36 months).  I have yet to see a single outlet have a true discussion that is fair and balanced. Where are the interviews with parents of kids who were injured by the MMR and compensated in the National Vaccine Injury Compensation Program?  It is as if investigative journalism has been banned when it comes to the measles outbreak. The power of Merck and the pharmaceutical industry to control news stories is real.  Think about all the moneys the networks make at local and national level from drug ads.

Is the great experiment of our Constitutional Republic going to be lost because our federal government in the 1980s took away the rights of parents to sue Merck, the maker of the MMR and to sue the doctor, nurse, or pharmacist who injected the vaccine only to have that assault on civil liberty compounded by forced vaccination by the state and local authorities?

Ryan White’s legacy with HIV/AIDS turned out not to just be about getting to attend public school.  His legacy lives on every year at the NIH where it is mandated that each agency track how much money is spent on HIV/AIDS. He short life lives on every time we fight against discrimination and bullying.  And his legacy lives on when we promote the rights of every citizen.

It is my hope that we can move past the fear-mongering and hysteria, the name-calling and divisiveness of the propaganda campaigns online and in the news and in statehouses across the country.

Always,

Beth

Sources Cited

1.         Krause RM. Obituary: Maclyn McCarty (1911-2005). Nature. 2005;433(7024):372. doi: 10.1038/433372a. PubMed PMID: 15674278.

2.         Braun DG, Eichmann K, Krause RM. Rabbit antibodies to streptococcal carbohydrates. Influence of primary and secondary immunization and of possible genetic factors on the antibody response. J Exp Med. 1969;129(4):809-30. PubMed PMID: 5766948; PubMed Central PMCID: PMCPMC2138622.

3.         Eichmann K, Braun DG, Krause RM. Influence of genetic factors on the magnitude and the heterogeneity of the immune response in the rabbit. J Exp Med. 1971;134(1):48-65. PubMed PMID: 5558071; PubMed Central PMCID: PMCPMC2139032.

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Lessons on Faith From My Two Fathers

God, my Father in Heaven sent me a father on earth. I am a daughter in both their images. My father on earth- my dad gave me characteristic features such as my high forehead and distinctive Clay family nose. My Father in Heaven gave me a heart that beats to keep my body alive, while it also feels emotions to keep my soul alive. 

God, my Father in Heaven, gave me eyes to see, while my father on earth taught me to use my eyes to see a person not just as they appear, but as they are beyond the surface. God granted me discernment; Dad taught me how to discern. God granted me intelligence, and Dad taught me to always seek knowledge.

God my Father in Heaven teaches ‘And thou shalt love the Lord thy God with all thy heart, and with all thy soul, and with all thy mind, and with all thy strength…’ and he teaches, ‘Now faith is the substance of things hoped for, the evidence of things not seen.’

Just as I have always known my Father in Heaven loves me even when I am disobedient, obstinate, and willful; I have always known that my father on earth loves me as I am, imperfect, willful, and stubborn. God’s love is ever present, even though I cannot see Him. Through the years, and the miles apart, Dad, my father on earth’s love has never been in doubt.  I know he loves me, as sure as I know that just as God gave his Son to the world as our Redeemer. Love is an energy that cannot be destroyed.  Love transcends time, space, and dimensions.

As my father on earth transcended this dimension to join my Father in Heaven, the greatest lesson in faith is delivered. God teaches us to have faith in what is unseen, and my Dad has gone from seen to unseen when he passed from this world.

And yet, he is not gone, he is moving from one mountain top to the highest of mountain tops. Dad’s physical decline is no more, he is exalted to join his father and mother, his sister and brother and my brothers in Heaven. The love a daughter feels for her Father on earth and heaven can never be separated, just as it is written in Roman’s, ‘Nor height, nor depth, nor any other creature, shall be able to separate us from the love of God, which is in Christ Jesus our Lord.’

Just as God said, “Be Still and Know that I am God;” I can pause, be still and know that my Father lives.  

Beth Clay – April 2019

@ All Rights Reserved 2019

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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

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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 3000 μg Hg/kg) significantly impacted locomotor activity. Thimerosal at doses of 300 and 3000 but not 30 μg Hg/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) 

Sources Cited

1.         Dan Burton CO. Letter to HHS Secretary Donna Shalala calling for recall of Thimerosal vaccines. In: Representtaives UHo, editor. House Oversight Committee Website: US Government; 2000.

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A Memorable Memorial Day – 2020

Memorial Day, the unofficial start of the summer break, is truly a sacred day. It is a day we honor the men and women who gave their all – literally – in defense of our great nation, in defense of our liberty and freedoms. Many in our country have lost all of their rituals and ceremonies. Memorial Day began as Decoration Day – and grew up spontaneously in many communities around the United States. On this day, Americans would visit the burial sites of their loved ones who had died during the Civil War, and decorate their grave stones. Eventually there were local parades, and as time went by it became a national day to honor all who have died in service to the nation.

This year we are facing a different war – not the war of the unseen enemy – a virus, not the war between the US and our adversaries, but a new civil war. Over the last 20 years I have watched as public health authorities have sought to take away parental decision making related to health (vaccinations); and seen a continued slippery slope in publicly policies and actions related to religious and personal liberty.

Over the last couple of years we watched a member of Congress (Rep. Adam Schiff) encourage social media CEOs to curtail freedom of speech and expression on their sites when it came to vaccines. When another member of Congress (Rep. Bill Posey) pointed out to them the errors in Rep. Schiff’s claims, they were ignored – because the bigger goal was it seemed to control the flow of information and what the public would see if they typed words like vaccines, measles, MMR into a search engine on Facebook on Google, etc.

At what point did the public become so complacent that they find it okay that you are forced to a government website for information? Why is the Grey Lady – the New York Times, and the paper that’s tagline is ‘democracy dies in the dark’ the Washington Post are not objecting and informing the public. Why is Congress and the White House so silent on the matter?

Did the men and women who died on battle fields or from the wounds they received in Vietnam, Korea, Iraq, Afghanistan and so many other places around the world die in vain?

This year, without a single bullet being fired, without a single Congressional hearing, without a single town hall, government leaders after listening to public health officials, all of whom have been entrenched in government for decades, all of whom have been party to the curtailing of family liberties and often religious liberties directly or by the giving of recommendations have taken unprecedented actions and because we as a nation were afraid or felt we had no choice, we complied. Two weeks of stay at home orders turned into two months. Schools were shut down over night, with no plans in place to continue education, to provide meals that for some are the only reliable meals they get; and no plans to deliver the legally required IEP agreed upon services to those with special needs. Overnight parents, were expected to stay at home – work or be unemployed – home school, and keep themselves and their families safe and healthy.

Churches were told to close.

Nursing homes locked their doors to visitors – only immediately family allowed in if someone was actively dying. Hospitals did much the same – news articles reporting the anguish of health professionals unable to take the time to be with someone who otherwise was alone as they passed away.

These public health authorities have flip flopped back and forth depending on which way the media is driving the public opinion – don’t wear masks – they do no good if you aren’t sick – and then a few weeks later not just a recommendation to wear masks – but mandates.

Governors and local authorities making major decisions based on arbitrary information.

For 20+ years, I have heard these public health authorities extol the importance of evidence-based medicine – and the setting of public policy based in science. This is usually said to discount parents, or those in the complementary and alternative health world (as if there is no science – when in truth there is in these fields).

Since March, we have been subjected to national and state declarations of emergency (which actually is simply a mechanism to turn on the spigots of federal funding), and forced limitations on personal movements and even speech limitations on line. High regarded scientists whose comments different from the agenda have their you tube videos taken down, and any dissenter is attacked or shut down. And now there are active measures being taken to do conduct nationwide (even global) ‘contact tracing’ – which if that doesn’t send shivers up your spine its because you don’t now what it is.

How can this be where we are as a nation in 2020?

I have said before that there is always a tug of war that goes on between the public and the public health sector in regard to personal liberty. Public health always want to count everything, track everything, force everything. Their focus is not personal privacy or individual liberty. They are part of the ‘state’ and ask such want compliance, and mandates, and control. And because their is big money in these venture, government and corporate are joining forced, pulling us closer and closer to that mud pit of oppression, socialism, even communism.

We need some strong men and strong women to join forces on our side, to yank that rope back, to bring us back from the brink of total loss of liberty, to the collapse of the Constitution. Republic, libertarian, democrat, liberal – it doesn’t matter. If you are an American, and you care about liberty, don’t let all the deaths of the men in women in the military be in vain…..together we become unbeatable. Together we protect and preserve liberty and freedom.

Don’t be asleep at the switch about your liberty – take some time today to give thanks to those who fought for it, and gave their lives so that you could be free. And then come tomorrow – take stock, get engaged, and demand your freedoms be protected and restored.

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Being Like Barnabas in Social Media

This week has been both a joyous and a bit of a sad week for me. Early this week was the first occasion my father’s birthday occurred since his passing last spring. I have a firm faith that what we call death is a doorway from this life to the next; and that since his passing, after years living with Type III diabetes (aka Alzheimer’s), I feel my father’s essence more since his passing. But it was still a bit sad. Everyone who knew my Dad well and anyone who has loved someone who journies this path likely knows what I mean. Dad could transmit more with the tilt of his head and a half-smile than most of us could in an hour-long conversation. Not a perfect man, but when it mattered an encourager.

Yesterday was my mother’s 86th birthday. We spoke at great length and she is feeling so blessed to have lived such a long life; even if these last few years have been with a decline in her physical health. She lives in a skilled nursing facility now, but true to form, she is always working on learning something new. This fall she learned a complicated crochet stitch, more complex because she is left-handed. And now she is learning to paint Mandalas. As someone who lives daily with excruciating pain from the degeneration of her bones, the process of painting a mandala is meditative and helps her focus on something other than the pain. She is focused on living her life to the best of her ability on her terms, and that gives me great comfort. In the last few months as I have taken on a new big project she has been the captain of my encourager squad.

When I am able to, I listen online to my mother’s church service* so that we have something we can talk about together. (She watches it on her Kindle.) This morning the minister spoke about Acts 15 and talked about Barnabas. He talked about how Barnabas was an encouraging force – he nurtured and sought to be a positive influence rather than be a complainer or only point out the negative. This hit home to me in such a way that I felt I needed to stop what I was doing and write.

I could write about the polarization of Washington, but what hit home for me today was how this related to Social Media. On some of the pages and groups, I am on, there is so much focus on the negative; on standing in judgment, and speaking ill of something or someone. There are times my soul just hurts when I see good people going so negative. When we chip away at the underpinnings of a person’s self-esteem or an organization’s growth by focusing on a public forum on the negative, even if well-intentioned, there are lasting consequences that may not be the intent of the writer, but will result.

Can we all try to be more like Barnabas, and encourage and nurture people and organizations in a positive fashion? Will it be easy? No. Getting out of the rut of negativity is hard, but it can be done.

I challenge each of us to try to practice Barnabas-style social media postings for a week.

It is my hope and prayer by bringing this up, that myself and maybe just one other person on the planet will take up the challenge.

Always,

Beth

*Washington Baptis Church http://www.washingtonbaptist.org/