Beth Clay – Page 3 – Musings, Memos and News

6 January 20196 January 2019

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:

Company	2018	2016	2014
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

27 December 201827 December 2018

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)

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24. Eltahan R, Guo F, Zhang H, Zhu G. The Action of the Hexokinase Inhibitor 2-deoxy-d-glucose on Cryptosporidium parvum and the Discovery of Activities against the Parasite Hexokinase from Marketed Drugs. J Eukaryot Microbiol. 2018. doi: 10.1111/jeu.12690. PubMed PMID: 30222231.

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29. Vyas D, Galal SM, Rogan EL, Boyce EG. Training Students to Address Vaccine Hesitancy and/or Refusal. Am J Pharm Educ. 2018;82(8):6338. doi: 10.5688/ajpe6338. PubMed PMID: 30425397; PubMed Central PMCID: PMCPMC6221531.

12 December 201827 December 2018

Does Industry-Government Collaboration Erode the Integrity of the Scientific Process?

On an almost daily basis, there are news stories sharing with the public the‘latest’ research findings. Everything from whether wine, meat, or bread are good for you; where you should take a multivitamin,to the latest findings on drugs and devices being developed to diagnose and treat cancer, diabetes, and a myriad of other conditions. There are threeissues about which I have increasing concerns:

Researchers who fail to disclosefinancial conflicts of interest in scientific publications or media interviews;
Industry-government collaborationsand research outcomes; and
Treating all researchoutcomes as equal in media discussions.

A National Institutes of Health (NIH) online training module on research integrity provides, “The scientific community and the community at large rightly expect adherence to exemplary standards of intellectual honesty in the formation, conduct, reviewing, and reporting of scientific research.” (1) If the integrity of the scientific process breaks through a failure of those involved to adhere to the highest standards of intellectual honesty then our annual $30 billion-plus investment in research at the NIH is wasted because the public will not be able to trust the outcomes. The same can be said at the Centers for Disease Control and Prevention (CDC)and other federal research and regulatory organizations. In the early 1990s, I received some of the best training one can from an NIH manager responsible for training committee Management Officers. She was a stickler for the rules and with good reason. At the NIH, the Institute or Center advisory committees are responsible for a final phase of reviewing and approving research grants for funding (thefinal decision is the Institute or Center Directors). These individuals aregiven access to confidential research information which eventually might resultin patents. They are also oftenresponsible giving feedback on the direction research funding will befocused. Those who serve on advisoryboards go through an extensive financial disclosure process. If the advisor has stock holdings, researchgrants, or consulting relationships with corporations or other potentially conflictedorganizations, this is supposed to be disclosed and consideration on whether theindividual can participate in closed door sessions where grant applications arereviewed and discussed is determined. Aconflict of interest waiver process exists and public disclosure during themeeting is supposed to occur. Otherfederal agencies have the same process as it is directed in part through theFederal Advisory Committee Act (FACA). Atthe Food and Drug Administration (FDA) their advisory bodies weigh in not ongrant funding, but on product approval. The outcomes of the vote of an FDA advisory committee can mean tens ofmillions of dollars made (or lost) by a company.

The vast majority of those who work within our federal health agencies I believe are good people. I have met some who were passionate about public service, some who were mediocre at best, and others that were simply showing up each day. I have also met a few that the word scoundrel is a polite descriptor. There are many unsung heroes at the NIH who have changed our lives for the better by being dedicated public servants. One of those people, for instance, is Dr.Stephen Groft, now retired director of the Office of Rare DiseasesResearch. I first met him when he was helping bring together five federal agencies to create a Biodiversity program to be managed by the NIH’s Fogarty International Center in the early 1990s. The Biodiversity program was established to address the interdependence of biodiversity exploration for potential applications in health, with investments in research capacity that support sustainable use of these resources, the knowledge to conserve them, and equitable partnership frameworks among research organizations in the U.S. and low- and middle-income countries (LMICs), as defined by the World Bank. I was able to observe Dr. Groft at this time show great patience and professionalism in negotiating the terms of the project with agencies with competing interests and see the program launched. Today, a quarter century later, the program continues. I had no idea at the time, the integral role Dr. Groft played in the Orphan Products Drug Act. He was so adept at managing challenging situations that NIH and HHS leadership frequently called upon him to manage difficult tasks. These included being the first acting director of the Office of Alternative Medicine (the Congressionally mandated, predecessor organization to the National Center for Complementary and Integrative Health); and serving as Executive Secretary of the White House Commission of Complementary and Alternative Medicine Policy, also mandated by Congress. I had the honor and privilege of working with him for a couple years before leaving the NIH to work for Congress. All these years later, I have never met anyone with more integrity, compassion, patience, and dedication to the public good than Dr. Groft. (2,3)

It is because I know there are good people within the agencies, that I believe we each have a role in helping fix the growing problems, to work together to shoreup the foundations of scientific integrity before they crumble. Shinning thelight of day on these issues is a first step to identify issues and worktowards solutions.

The NIH Mission is: “to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledgeto enhance health, lengthen life, and reduce illness and disability.” (4)

The Food and Drug Administration’s (FDA)Mission is: “Protecting consumers and enhancing public health by maximizingcompliance of FDA regulated products and minimizing risk associated with thoseproducts. (5)

The Centers for Disease Control and Prevention(CDC)’s Mission is: “CDC works 24/7 to protect America from health, safety and security threats, both foreign and in the U.S.Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights disease and supports communities and citizens to do the same. CDC increases the health security of our nation. As the nation’s health protection agency, CDC saves lives and protects people from health threats. To accomplish our mission, CDC conducts critical science and provides health information that protects our nation against expensive and dangerous health threat and responds when these arise.”

In addition to their Mission, the CDC now has a Pledge to the American People

Be a diligent steward of the funds entrusted to our agency
Provide an environment for intellectual and personal growth and integrity
Base all public health decisions on the highest quality scientific data that is derived openly and objectively
Place the benefits to society above the benefits to our institution
Treat all persons with dignity, honesty, and respect (6)

I have included these mission statements because I want to reiterate the specific roles of each agency. It is a reminder to all what where personnel in each agency should be focused.

Concern 1a: Conflicts of Interest in Research: I am not alone in my concern about conflicts of interest in research.

A Hastings Center report included the following:

A 1999 study of the Association of University Technology Managers found that 68% of academic research institutions held equity in companies thatin turn sponsored research at the institution.
A Journal of the American Medical Association (JAMA) 2003 review reported on studies suggesting that about 1 in 4 academic investigators received industry funding for research, a third had personal financial ties with industry sponsors and 40% had accepted research-related gifts.
The 2003 JAMA paper also found “strong and consistent evidence” that industry-sponsored research tends to draw conclusions favoring industry, often uses an inactive control, and sometimes administers a higher dose of the sponsor’s drug than of the comparison drugs or uses comparison drugs that are poorly absorbed. Industry sponsorship of research, as well as involvement with start-up companies and other commercial relationships, were significantly associated with delaying publication or withholding data.
60 percent of respondents in a 2007 survey published in JAMA had personal relationships with industry.
The death of Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania in1999, conflicts of interest were among the allegations leveled at the research team and the university. The lead investigator and university held equity stakes in a company with a financial interest in the experiment, and the lead investigator and medical school dean held patents on processes used in the trial.
Rezulin, touted as a type-II diabetes wonder drug was fast-tracked for approval in 1997. The FDA dragged its feet in calling for its removal from the marketplace three years later even with 90 cases of liver failure reported. More than half of the scientists involved in testing Rezulin had received funding or other compensation from Parke-Davis/Warner-Lambert, its manufacturer.
The Los Angeles Times published a series of articles between 2004 and 2005 revealing that some NIH staff collected significant funds from companies whose products were the subject of NIH research and that the NIH failed to inform the patients involved in the studies. As a result, the NIH’sobjectivity was called into question. The paper reported that this was possible in part because of a relaxing of the rules by then Director Harold Varmus.
An FDA advisory board voted in 2005 to approve the painkiller Bextra, Celebrex, and Vioxx staying in the marketplace even after being informed of the data showing an increased risk of heart attacks. After the vote, it was made public that 10 of the 32 panel members had been recent consultants to the companies that manufacturedthese drugs. Had the conflict been known, and these individuals notparticipated in the discussion and vote, the outcome may have been different.(7)

In 2009, the National Academy of Sciences took on the topic under contracts with the NIH, the Robert Wood Johnson Foundation, the Greenwall Foundation, the ABIM Foundation of the Josiah Macy, Jr. Foundation, the Burroughs Wellcome Fund, and an endowment fund of the Institute of Medicine. The report opens with an admission that stories on conflicts of interest had become prevalent enough to be broadcast almost weekly. The NationalAcademy report stated, “Patients and the public benefit when physicians and researchers collaborate with pharmaceutical, medical device, and biotechnology companies to develop products that benefit individual and public health. At the same time, concerns are growing that wide-ranging financial ties to industry may unduly influence professional judgments involving the primary interests and goals of medicine. Such conflicts of interest threaten the integrity of scientific investigations, the objectivity of professional education, the quality of patient care, and thepublic’s trust in medicine.”(8)

During the June 15, 2000, House GovernmentReform and Oversight Committee hearing discussing our investigation on advisory committee’s conflicts of interest, after explaining the nature of our investigation (reviewing conflicts in two advisory bodies during the Rotavirus approval timeframe), Chairman Burton’s opening statement included the following:

“Families need to have confidence that the vaccines that their children take are safe, effective and very necessary. Doctors need to feel confident that when the FDA licenses a drug, that it’s really safe and that the pharmaceutical industry has not influenced the decision-making process. Doctors place trust in the FDA and assume that if the FDA has licensed a drug, it’s safe for use. Has that trust been violated? How confident in the safety and need of specific vaccines would doctors and parents be if they learned the following:

One, that members, including the chair of the FDA and CDC advisory committees who make these decisions, own stock in drug companies that make the vaccines.
Two, that individuals on both advisory committees own patents for vaccines under consideration, or affected by the decisions of the committees.
Three, that three out of the five of the members of the FDA’s advisory committee who voted for the rotavirus vaccine had conflicts of interest that were waived.
Four, that 7 individuals of the 15-member FDA advisory committee were not present at the meeting. Two others were excluded from the vote, and the remaining five were joined by five temporary voting members who all voted to license the product.
Five, that the CDC grants conflict of interest waivers to every member of their advisory committee a year at a time and allows full participation in the discussions leading up to a vote by every member, whether they have a financial stake in the decision or not. So they’rediscussing it, influencing other members possibly, whether they have a financial stake or not.
Sixth, that the CDC’s advisory committee has no public members, no parents have a vote in whether or not a vaccine belongs on the childhood immunization schedule. The FDA’s committee only has one public member. These are just a few of the problems we found.

Specific examples of this include:

Dr.John Modlin. He served for 4 years on the CDC advisory committee and became the chair in February 1998. He participated in the FDA’s committee as well. He owns stock in Merck, one of the largest manufacturers of the vaccine, valued at$26,000. He also serves on Merck’s immunization advisory board. Dr. Modlin was the chairman of the rotavirus working group. He voted yes on eight different matters pertaining to the ACIP’srotavirus statement, including recommending for routine use and for inclusion in the Vaccines for Children program. It was not until this past year that Dr.Modlin decided to divest himself of his vaccine manufacturer stock.
At our April 6th autism hearing, Dr. Paul Offit disclosed that he holds a patent on a rotavirus vaccine and receives grant money from Merck to develop this vaccine. He also disclosed that he is paid by the pharmaceutical industry to travel around the country and teach doctors that vaccines are safe. Dr. Offitis a member of the CDC’s advisory committee and voted on three rotavirus issues, including making the recommendation of adding the rotavirus vaccine to the Vaccines for Children program.
Dr. Patricia Ferrieri, during her tenure as chair of the FDA’s advisory committee, owned stock in Merck valued at about $20,000 and was granted a full waiver.
Dr.Neal Halsey, who serves as a liaison member to the CDC committee on behalf of the American Association of Pediatrics, and is a consultant to the FDA’s committee, has extensive ties to the pharmaceutical industry, including having solicited and received startup funds from industry for his Vaccine Center. As a liaison member to the CDC committee, Dr. Halsey is there to represent the opinions of the organizations he represents but was found in the transcripts to be offering his personal opinion.
Dr.Harry Greenberg, who serves as chair of the FDA committee, owns $120,000 of stock in Aviron, a vaccine manufacturer. He also is a paid member of the board of advisors of Chiron, another vaccine manufacturer, and owns $40,000 of stock. This stock ownership was deemed not to be a conflict, and a waiver was granted. To the FDA’s credit, he was excluded from the rotavirus discussion, because he holds the patent on the Rotashield vaccine.

How confident can we be in the process when we learned that most of the work of the CDC advisory committee is done in ‘‘working groups’’ that meet behind closed doors, out of the public eye? Members who can’t vote in the full committee because of conflicts of interest are allowed to work on the same issues in working groups, and there is no public scrutiny. I was appalled to learn that at least 6 of the 10 individuals who participated in the working group for the rotavirus vaccine had financial ties to pharmaceuticalcompanies developing rotavirus vaccines.

How confident can we be in the recommendations for the Food and Drug Administration when the chairman and other individuals on their advisory committee own stock in major manufacturers of vaccines? How confident can we be in a system when the agency seems to feel that the number of experts is so few around the country that everyone has a conflict and thus waivers must be granted? It almost appears that there is an “old boy’s network’’ of vaccine advisors that rotate between the CDC and FDA, at times serving simultaneously. Some of these individuals served for more than 4 years. We found one instance where an individual served for 16 years continuously on the CDC committee. With over 700,000 physicians in this country, how can one person be so indispensable that they stay on a committee for 16 years?”

18 Years Later It Has Not Gotten Better: The NewYork Times reported this month about the failure of very prominent physicians to report in research publications their industry ties. The article reports, “Dr. Howard A. “Skip” Burris III, the president-elect of the American Society of Clinical Oncology, for instance, declared that he had no conflicts of interest in more than 50journal articles in recent years, including in the prestigious New EnglandJournal of Medicine. However, drug companies have paid his employer nearly$114,000 for consulting and speaking and nearly $8 million for his research during the period for which disclosure was required. His omissions extended to the Journal of Clinical Oncology, which is published by the group he will lead.” The investigation also stated a Dr.Robert J. Alpern, dean at the Yale School of Medicine and dozens of others had also failed to report their conflicts. Dr. José Baselga, was forced to resign as chief medical officer of Memorial Sloan Kettering Cancer Center in New York, after it was reported that he failed to disclose industry ties in journal articles. (13, 14) I have done my own reviews of disclosures in research papers and found great inconsistencies in how financial disclosures and conflicts of interest are detailed in research papers. Journals have a role to play in establishing a standard industry-wide and requiring conformity. Federal grant managers also have a role to play in assuring that authors of studies from federally funded research accurately document their funding sources and competing interests or industry ties.

Concern 1b: Undisclosed Conflicts of Interest by Doctors in the Media: With the publication of medical research, or reports about a medical product, media outlets have a Rolodex of medical doctors they often turn to for tv interviews (or for quotes in print media). A few years ago, I conducted an interview with a doctor who had been quoted in the national print press with the intent of writing a paper on the issue of doctors in the media. Time constraints prevented my moving forward with that article, however, I remember vividly this doctor explaining that he gave speeches on behalf more than a dozen different pharmaceutical companies. This information had not been disclosed in the media story and would have been shown his opinion to likely be influenced against the product he discussed by his ties to the pharmaceutical industry. The doctor rather indignantly explained he did not need to disclose his activity because the slide shows he was using were “FDA Approved”. At that point in my interview, I just had to laugh (FDA to my knowledge does not pre-approve pharmaceutical company slide shows used to market their products to the doctors.).

There are a number of doctors who become regular media spokespersons. For instance, you can always count on any story dealing with vaccines to see Dr. Paul Offit interviewed. What is not included typically in his interviews is a disclosure that he was a patent holder (until it was sold); that he is a consultant to one or more drug companies, and that his academic salary is in essence is paid by an endowment provided by Merck. Dr. Stanley Plotkin confirmed during a deposition in early 2018 that he had not included in his curriculum vitae his industry consulting, and according to the CMS doctor payment tracking database from 2013 to 2017 he has accepted over $100,000 in industry funds each year. His deposition confirms he has been taking industry money most if not all his career. In reviewing his media quotes over recent years, there is no disclosure of his financial ties pharmaceutical companies which include Sanofi, Merck, and Glaxo. Another search on the CMS database found that Dr. Jacqueline Wolf, a professor from Ohio University, who is quoted in a 2018article on drugs during pregnancy received payments above the national mean in 2017 from industry.

The public should be fully informed when a doctor whose being used by the media to offer their ‘expert’ opinion for or against a product has financial ties to the drug industry so they can determine for themselves how to receive that opinion.

Concern 2: Industry-Government Collaborations and Research Outcomes

The case of Rezulin: When the Rezulin story broke, I was leading the Oversight inquiry on conflicts of interest and met with staff from the FDA. We asked why it took so long to get the drug out of the marketplace. Their excuse was that Rezulin was such a good drug- the greatest thing the diabetes community had seen in a long time – that they were reluctant to have it withdrawn. Many people died from liver failure because the FDA was slow moving. At the time, the compounding factor that came to light was that Dr. Richard C. Eastman, head of the NIH’s diabetes division was overseeing the Rezulin research and requested an outside activity clearance to become a paid consultant in late 1995 to Warner-Lambert. He claimed at the time that he had been granted outside activity clearance and received almost $80,000 over two years as a consultant and may have received another quarter million from other outside sources. I was told at the time that the NIH had rejected his request for outside activity, but that his supervisor failed to inform him of this and he went forward with an assumption that it was approved. The process requires confirmation of approval, so both the supervisor and Dr. Eastman failed to follow through correctly. This breakdown in the process cost dozens of lives.

There was a time when the NIH held itself out to be a truly independent and free from commercial influence. In fact, President Reagan’s Secretary of Health, Margaret Heckler described the NIH as “an island of objective and pristineresearch, untainted by the influences of commercialization.”

I doubt that Secretary Heckler could have imagined a time when Congress would direct federal officials to engage more intimately with corporations. That is exactly what happened with the passage of the 21^st Century Cures Act. We have been hearing about how much better the drug development process is going to improve because of this expanded collaboration. I have grave concerns because government officials are just as vulnerable to industry influence when their interactions are increased as academia are. The evidence is growing to support this concern. After all, he who holds the cash, holds the power. Or to quote a 1964 Wizard of Id comic strip – “Whoever has the gold makes the rules.”

One of the open secrets of federal health agencies is the indirect manner agencies accept funds and indirect support from industry for research and programmatic purposes. In the 1990s, Congress established both the NIH Foundation and the CDC Foundation as pathways for industry and organizations to donate to agency activities and to partner with them. They were intended to facilitate public-private partnerships and be a protection against industry influence research outcomes. The foundations appear not to have complied with transparency regulations so much so thatCrossFit, Inc. has filed a Freedom of Information Act (FOIA) lawsuit to force compliance. Crossfit has concerns about the influence of the soda industry on dietary recommendations. Their initial attempt to gather information provedunsuccessful.

The CDC Foundation raised over $43million in Fiscal Year 2016-2017. It providesa list of its donors; however, it does presently post specific informationabout the level of each donation. Thecorporate donors are vast including Bayer, Bill and Melinda Gates Foundation, BloombergPhilanthropies, Coca-Cola Company, Cargill, GAVI, Genzyme, the Guttmacher Institute,Janssen, Merck, Pepsico, Pfizer, Sabin Vaccine Institute, Vaccines andMedication in Pregnancy Surveillance System, many universities, including statesponsored schools (the question of taxpayer funded school donated to a federal agencythrough a foundation is a topic for another day), UNICEF, the state ofCalifornia, and Major League Baseball.

Examples of how this works:

The Contraceptive Use Module For States Project being conducted by the CDC. The CDC Foundation has ‘partnered with the Guttmacher Institute for a $2.8 million project to “support state use of a module on the Behavioral Risk Factor Surveillance System that assesses contraceptive use among women aged 50 and younger. This effort will allow for the development of state-level estimates of the methods of contraception used and reasons for not using contraception.” From their website, one learns that the Guttmacher Institute was founded in 1968 as the Center for Family PlanningProgram Development. The Center was originally housed within the corporate structure of the Planned Parenthood Federation of America (PPFA). Its early development was nurtured by Alan F. Guttmacher, an obstetrician-gynecologist, author and leader in reproductive rights who was PPFA’s president for more than a decade until his death in 1974. TheCenter was renamed in Dr. Guttmacher’s memory, and the Guttmacher Institute incorporated as an entirely independent nonprofit policy research institute with its own Board in 1977 but remained a special affiliate of PPFA through2007. Among the activities of the Guttmacher Institute focus are contraception and abortion. The Guttmacher Institute is a leader in promoting access to abortion services. As an aside to this matter, the most recent past Director of the Eunice Shriver National Institute of ChildHealth and Human Development (NICHHD) at the NIH was Dr. Alan Guttmacher, nephew of Alan F. Guttmacher. During the early days of his tenure at the NICHHD he continued to serve on the Board at the Guttmacher Institute and NICHHD before, during and after his tenure have provided grant funds to the Guttmacher Institute.
The Bill and Melinda Gates Foundation has poured millions into the CDC Foundation for numerous projects including the development of surveillance systems, paying for scientists from financially disadvantaged countries to attend conferences, and projects related to rotovirus, norovirus, tobacco control, and zika. In one instance, they funneled the funding through Bloomberg Philanthropies, who have also provided at least $10 million to the CDC Foundation for various projects including tobacco use surveillance.

The Foundation for the NIH (FNIH) has raised over $1 billion in its 22-year history. Its website states that, “FNIH develops collaborations with top experts from government, industry, academia and the not-for-profit sector and provides a neutral environment where we can work productively toward a common goal.” In itsMay 2018 report, the Board of Directors include former NIMH director Thomas Insel (now in the corporate world); and many pharmaceutical industry individuals such as the Chief Medical Officers of both Pfizer and GlaxoSmithKline, This report also states they have raised over $400million for various NIH Institutes and Centers and a total of more than $555million. Three of the accomplishments include:

The NIH, the FNIH and twelve leading pharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year, ~$220million public-private research collaboration as part of the Cancer Moonshot.PACT will identify and develop robust, standardized biological markers of disease to advance new immunotherapy treatments that harness the immune system to attack cancer.
The FNIH, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), has launched a new project to shorten the treatment times of tuberculosis (TB) in drug–sensitive patients through individualized therapy. The $24 million project, “Using Biomarkers to Predict TB Treatment Duration”(PredictTB), is funded in part through a $13 million donation from the Bill& Melinda Gates Foundation, with management support provided by the NIAID and the Catalysis Foundation for Health.
The NIH, the FNIH, five leading pharmaceutical companies, together with Verily(Alphabet Inc.’s research organization devoted to the study of life sciences)and the Michael J. Fox Foundation (MJFF), launched in February of 2018 the Accelerating Medicines Partnership for Parkinson’s Disease (AMP PD), a five-year, $24M million public-private research partnership to identify and validate diagnostic, prognostic, progression and predictive biomarkers for PD. Some of the goals of this partnership are to improve clinical trial design, better patient stratification, the ability to monitor disease progression, and the potential to identify new pathways for therapeutic development.

MACH Trial defunded: Sharyl Attkisson’s show, Full Measure ran a story this past week regarding the $100,000 NIH Research Study slated to test moderate alcohol consumption health effects. (9) Her report shared internal emails from NIH employees within the National Institute of Alcohol Abuse and Alcoholism (NIAAA) who were actively recruiting industry sponsorship, which violates NIH policies. While the NIH had committed to at least $10million, over $67 million had been committed to the project by Anheuser-Busch In Bev, Carlsberg Breweries A/S, Diageo plc, Heineken, and Pernod Ricard USA LLC. In the June 2018 announcement: “The National Institutes of Health plans to end funding to the Moderate Alcohol and Cardiovascular Health (MACH) trial…The decision is based on concerns about the study design that cast doubt on its ultimate credibility…significant process irregularities in the development of the funding opportunities for the MACH funding awards undermined the integrity of the research process…NIH Office ofManagement Assessment (OMA) determined that a small number of NIAAA employees violated NIH policies in soliciting gift funding and circumvented standard operating procedures designed to ensure a fair competition for NIH funding. These policy violations were committed by NIAAA employees prior to the involvement of the Foundation for the National Institutes of Health (FNIH). (10)

The FNIH website states: “Prospective epidemiological studies consistently relate moderate alcohol consumption with lower risk of cardiovascular disease, ischemic stroke, and type 2 diabetes. However, this association remains controversial due in part to the lack of gold-standard randomized evidence. This project is intended to meet the need for a clinical trial. The primary study objectives are: 1) determine the effects of one serving of alcohol daily, compared to no alcohol intake, on the time to incident cardiovascular disease among adults at above average cardiovascular risk; and 2) to determine the effects of one serving of alcohol daily on the time to incident diabetes among participants free of diabetes at baseline. The study design will be a randomized, multicenter, international,assessor-blinded, parallel group, balanced clinical trial. FNIH has been asked to secure private-sector funding and to create an arms-length relationship between funders and NIH, in order to ensure an unbiased trial.”

In a Washington Post article about the halting of the study (11), an exchange between Senator Patty Murray and NIH Director Francis Collins was included, “Sen. Patty Murray (D-Wash.) asked whether what happened at NIAAA with the alcohol study might have happened at other institutes in the sprawling NIH operation. Collins answered, “I’m very concerned this might be the tip of a larger iceberg,” adding that his investigators are looking for other examples at NIH.” The article also mentions that in April, Dr. Collins called an abrupt halt to the planned receipt of funding from dozens of pharmaceutical companies for the $400 million Opioid ResearchPartnership. In making the announcement, Dr. Collins stated, “I fully embrace [the] recommendation that NIH should vigorously address the national opioid crisis with government funds and decline cash contributions through partnerships from the private sector,” Collins said in a statement. Instead of accepting cash from drug companies interested in teaming up, Collins said the NIH would lean on industry only for help in setting up a clinical trial network, establishing common biomarkers for drug development, and sharing data.” (12) There is at least one organization calling for an Inspector General investigation.

In addition to the two Congressional formed nonprofits there are also a number of “Friends of the___” type collaborations and non-profits whose functions are to promote the agenda of the agency they support and to funnel industry funding to the agency’s projects. One example:

The Friends of NCBDDD is a coalition of government and private sector participants who work together to enhance the mission and activities of the National Center on Birth Defects andDevelopmental Disabilities (NCBDDD) (at the CDC). The member groups include numerous medical trade associations including the American Academy ofPediatrics and the American Psychological Association; non-profits such as the Tourette’s Association, Autism Speaks; state agencies; businesses; and even large law firms involved in government relations. This organization ‘shares information’ and works together to push policies and legislation.’ The organization provides no funding information, nor does it list the members of its “Executive Committee’. The industry has influence directly or indirectly through the funds it provides to the trade associations and non-profits involved.

Concern 3: Treating All Research Outcomes as Equal in Media Discussions: Not all research is equal. That is a fact. There is a reason the gold standard of research developed in the 20^th century. That gold standard is the double-blind, placebo-controlled clinical trial. In truth, there is a research hierarchy that the public should be better informed. There is a discussion among the experts about the need for a topology focus – a research matrix per se – matching the research question to the type of research needed to be conducted to answer the question with credibility. One interesting article on the topic can be found at: https://www.cebma.org/wp-content/uploads/Petticrew-Evidence-hierarchies-and-typologies.pdf

There are times in which a randomized, double-blind, placebo-controlled clinical trial is neither feasible or practical. That is a discussion for a different day. It can be summarized by explaining that when the intervention is not a single agent like a drug or a vaccine but is a multi-mode intervention or an intervention requiring person to person interaction such as acupuncture, chiropractic or massage; blinding and placebo-controlled are not practical. I would also suggest that longterm studies that function outside of a controlled environment are ripe for non-compliance. (A major Vitamin E clinical trial is an example, where a significant portion of the participants were non-compliant.) I would also issue a caution about the misuse of the term ‘evidence-based’ by some who seek to suggest that the decision to use a different approach or product is not also based in scientific evidence. That too is a conversation for another day. Too often it is sophomoric “my science is better than your science’ bullying technique.

Two of the specific types of research that I have concerns are being given a higher level of prominence in the news than they warrant are surveys and epidemiology, especially epidemiological reviews of administrative(billing) records and electronic health records. One scholarly paper “A nurses’ guide to the hierarchy of research designs and evidence” available at: http://www.ajan.com.au/Vol33/Issue3/5Broomfield.pdf provides a basic analysis and a pretty good graphic. Surveys are considered low on the hierarchy because they along with case studies have the greatest change of bias. Surveys can be manipulated easily by determining where the study will be conducted. The outcomes of asking questions for instance about stroke, alcohol consumption, even mental health likely will vary widely depending on where surveys are conducted, sometimes even within the same city. The number of individuals included in the survey and the survey questions themselves matter. The way an individual asks the questions may actually affect the response. And to quote the famous television doctor, Dr. House, “People Lie.” It is a human inclination to want to answer a question the way one thinks it should be answered on some issues.

After 18 years of following the CDC’s use of epidemiology to prove the safety of various vaccines or vaccine ingredients, I continue to be amazed at the lack of a vigorous pushback from scientists at the NIH and the academic community. One cannot answer a question of toxicology with a retrospective review of medical billing records or any other type of epidemiology. And yet, this is exactly what the CDC has put forward and been sanctioned through their contract with the National Academy of Sciences. Remember when I stated above, “He who has the cash has the power”? The CDC was the keeper of the funds to pay the National Academy for their evaluation of vaccine issues related to neurodevelopmental disorders. The CDC gave its marching orders to focus only on the epidemiology and ignore the animal studies and ther more profound research. They had the cash and thus the power. The National Academy complied.

For those who are unfamiliar with the details, the Federal National Vaccine Injury Compensation Program used 5 CDC epidemiological studies as their basis for denying over 5,000 families’ compensation for their children’s devastating vaccine injury in the Autism Omnibus proceeding. How do I know this? Because I have seen the letter one of the families received from the courts explainingthe basis for the denial. These studies have problems in design and implementationand at least two of them were managed by a researcher who has been on the OIGMost Wanted list since 2012.

It is not just the CDC’s vaccine-related epidemiology research that concerns me. One group of studies paid for by the CDC and conducted by some of the same researchers involved in their autism-vaccine research looked at alcohol consumption during pregnancy. The methodology of the study, combing through the Danish health records and then interviewing the mothers about their alcohol consumption during pregnancy, sometimes years later, and then a review of the child’s medical records resulted in the publication of ‘research’ that set decades of public health messaging about alcohol avoidance on its ear. The BBC headline in 2012 read “Moderate drinking during pregnancy branded ‘safe’”. (15) This series of research continues to get media play, “Opinion: A couple of drinks when you’re pregnant really isn’t that bad “(16) The CDC is on the record on their website in stating there are no safe exposure levels to alcohol during pregnancy. Sadly, epidemiology can be manipulated. Think Enron and accounting. Based on years of reviewing how it’s been manipulated to achieve a predetermined outcome, I have very little confidence in this type of research. At the end of the day, why take a risk with your child’s neurodevelopment? Is any glass of wine so important as to potentially set your child up for a lifetime of challenges?

Some of the most egregious promotions of scientific outcomes related to studies with negative outcomes are those related to dietary supplements. The news loves to hate vitamins and often overplays the power of a study or how it compares to other research. An informative article available at http://www.thebody.com/content/75580/are-vitamin-pills-a-waste-not-so-fast-dissenting-e.html details the yo-yo media coverage and many of the problems in nutrient research.

A final area of research focus that I have concerns about are studies known as a meta-analysis or systematic review. The Cochrane Collaboration began promoting this method of analyzing all the studies in a certain topic and judging it. This is increasingly popular and being utilized by federal policymakers to look at a number of issues including the non-pharmacologic pain management research. There are a number of challenges with this emphasis on meta-analysis. The first is asking too broad a question. For instance, a recent meta-analysis commissioned by federal officials to look at non-pharmacologic pain management research claimed to have been a comprehensive analysis of all clinical trials related to all complementary and alternative therapies. The actual analysis focused on a handful of therapies and even within that analysis, there were shortcomings. The second is the apriori determination to only accept randomized, placebo-controlled trials. If the NIH has never funded these types of studies, and if none exist in the literature, how can the analysis provide an accurate assessment? These types of analysis fail to incorporate the full body of evidence or address the reality that there are times placebo-control is impossible. The other aspect, particularly in complementary therapies, is that if the researcher has a bias against, or a lack of extensive understanding of the field, the ability to accurately review the data isskewed.

Conclusion: At the end of the day, all of the issues detailed above boil down to one thing – integrity. Researchers who lack the integrity to disclose industry relationships and payments undermine the entire foundation of public trust in science. The CMS Doctors payment dataset is only accurate if doctors are honest about the payments they receive from industry. The Congressionally created foundations established to funnel industry funds to agencies must operate with full transparency in order to ensure true independence in research. Friends oforganizations need to also be transparent in their staff/leadership andfunding.

Abraham Lincoln once said, “Nearly all men can stand adversity, but if you want to test a man’s character, give him power.” The public has entrusted government officials and academic researchers with a great deal of power. It is my hope that as Dr. Collins begins investigating the ‘tip of the iceberg’, that we can have anhonest dialogue in the public forum regarding these matters and affect real change.

One recommendation I would put forward today is a change in HHS advisory committee policies. At least one- third of the members of each research and policy related advisory committee should be public members – individuals or parents whose lives are directly affected by the decisions of that body; individuals who are not part of the government-academic-industry communities, but rather advocates and individuals from the general public. This is a first step in ensuring sunlight on government research matters. A second recommendation is that Congress needs to do annual reviews of the CDC and NIH Foundation to ensure they comply with their transparency requirements. A third is that journals and the NIH need to settle on a consistent conflict and funding reporting style and include it in the information provided in the Abstract through the PubMed system. Someone within the PubMed management needs todo regular reviews to ensure compliance and even do evaluations to confirm that authors with numerous studies consistently report their conflicts and funding.

And in closing, I’ll quote Theodore Roosevelt, “No nation can be really great unless it is great in peace, in industry, integrity, honesty. Skilled intelligence in civic affairs and industrial enterprises alike; the special ability of the artist, the man of letters, the man of science, and the man of business; the rigid determination to wrong no man, and to stand for righteousness—all these are necessary in a great nation.”

I pray we all continue to strive towards being and remaining a great nation.

Always,

Beth

Sources Cited:

https://researchethics.od.nih.gov/ScientificIntegrity9.aspx
https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm
https://globalgenes.org/raredaily/stephen-groft-champion-of-rare-diseases-research-retires/
https://www.nih.gov/sites/default/files/about-nih/strategic-plan-fy2016-2020-508.pdf
https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM291748.pdf
https://www.cdc.gov/about/organization/mission.htm
https://www.thehastingscenter.org/briefingbook/conflict-of-interest-in-biomedical-research/
Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice; Lo B, Field MJ, editors. Conflict of Interest in Medical Research, Education, and Practice. Washington (DC): National Academies Press (US); 2009. Summary. Available from: https://www.ncbi.nlm.nih.gov/books/NBK22926/
https://www.facebook.com/FullMeasureNews/photos/pb.394287324102292.-2207520000.1544565902./909147952616224/?type=3&theater
https://www.nih.gov/news-events/news-releases/nih-end-funding-moderate-alcohol-cardiovascular-health-trial
https://www.washingtonpost.com/news/to-your-health/wp/2018/05/17/nih-halts-controversial-study-of-moderate-drinking/
https://www.statnews.com/2018/04/19/nih-industry-partnership-ethics-opioids/
https://www.nytimes.com/2018/12/08/health/medical-journals-conflicts-of-interest.html?action=click&module=Top%20Stories&pgtype=Homepage
https://www.thedailybeast.com/dozens-of-top-doctors-failed-to-reveal-industry-ties-in-medical-studies-report
https://www.bbc.com/news/health-18506174

1 December 2018

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

30 November 2018

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Polio and the C-Series of Enteroviruses

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

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

Concluding Thoughts – More Questions than Answers

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

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

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

There is No Cure – Yet.

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

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

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

Sources Cited:

https://khn.org/morning-breakout/cause-of-polio-like-illness-in-children-continues-to-stump-experts-even-as-dozens-of-more-cases-emerge/
http://fortune.com/2018/11/20/cdc-afm-acute-flaccid-myelitis-polio/
https://fox2now.com/2018/11/28/cdc-identifies-31-states-with-116-confirmed-cases-of-polio-like-disease/
https://www.acf.hhs.gov/orr/resource/unaccompanied-alien-children-released-to-sponsors-by-state
Horner, L. M., Poulter, M. D., Brenton, J., & Turner, R. B. (2015). Acute Flaccid Paralysis Associated with Novel Enterovirus C105. Emerging Infectious Diseases, 21(10), 1858-1860. https://dx.doi.org/10.3201/eid2110.150759.; https://wwwnc.cdc.gov/eid/article/21/10/15-0759_article

Links to the CDC’s websites of possible interest:

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

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

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

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

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

Always,

Beth Clay

17 July 201817 July 2018

We are Getting Played on the Russia Collusion but Not in How You Might Think!

17 July 2018: The United States of America is a Democratic Republic and sometimes referred to as a Constitutional Republic. The meaning of our words can matter greatly in particular in discussing what type of a country we are at this time in our history. The point of this blog is not to expound upon these terms, rather to explore this, please start with a 2016 opinion piece by Eugen Volokh in the Washington Post which is available here: https://tinyurl.com/ybnv9tsg.

For months the American public has been subjected to daily political discourse about Russian collusion in our 2016 presidential election. In fact, the US Department of Justice (DOJ) has twice in the past year issued indictments for Russian intelligence operatives. The indictments accuse Russian spies of spying. The latest indictment is available here: https://www.justice.gov/file/1080281/download

What is important about this latest indictment is that it (1) names the spies (which may prompt other individuals to make connections not previously made); (2) confirms that cyber attacks and cyber thefts occurred, and (3) reminds us why using non-secured email accounts and private servers for official government (including classified or sensitive information) is against federal policies. There is zero chance that any of the 25 indicted Russian spies will returned to the United States to face prosecution. Even if Russian law allowed this (which I understand it does not); the United States Justice and State Departments have been unable in 7 years to convince Denmark (a nation we have an extradition treaty with) to send Dr. Poul Thorsen back to the US to face prosecution for 22 counts of wire fraud and money laundering – related to theft from the CDC grant which produced the autism and vaccines are not linked studies (discussion for another day). If they cannot get a single doctor back from a friendly nation; they a not going to get two dozen Russian intelligence operatives back on US soil. There is an entirely other line of discussion about how if by some miracle this happened, the fact that the FBI destroyed devices for Secretary Clinton, returned others, and failed to take possession of the DNC or DCCC servers that lawyers representing the defendants could get the case thrown out because the devices could not be presented. The DOJ was clear in stating that the evidence did not show that any of the acts resulted in changing a single vote in the election. Which I’m pretty sure was intended as a taunt to the Russians.

Yesterday, John Brennan tweeted that he felt that President Trumps’ performance in Helsinki was treasonous. Setting aside the crazy place we are in as a society when a Former CIA Director is tweeting; and that he has become one of the most vitriolic political tv pundits against a sitting president; he also admits that in 1976 he voted for a communist in the presidential election. One has to wonder how he made it through Senate confirmation, and why he was even selected to be CIA Director in the first place given that he voted for a communist party candidate for president. An interesting article about Brennan in the American Thinker can be found here: https://tinyurl.com/y7fktjh8 . One might wonder who is working to destabilize our country more?

I digress from my original topic on purpose – to show how easily we can be distracted from what is really important – protecting and defending the Constitution of the United States and all that we as a People hold dear. Our lives, our liberties, and our ability to pursue happiness. Even before, but currently while all of this attention has been focused on whether the Trump campaign ‘colluded’ with the Russians to win the election; the real attack on the USA has been hiding in plain sight. Communist operatives have been chipping away at our liberty by influencing our thought process. Think about this – politicians and the media now frequently use the term ‘workers’ instead of work force or the word employees. The radio personality Chris Plante repeats it in his tongue in cheek remarks.

There is always a battle to protect our democratic republic – to protect democracy against communism. And yes, to protect capitalism. Why, because communism is an evil, like a cancer on liberty -it always seeks to grow and take over. In our civilized society, we shy away from using such strong language – but it is a truth we should not ignore.

So, what exactly is communism? It is a political theory espoused by Marx and Lenin (and Putin, the Castros in Cuba, Xi and the Politburo in China, the Kim family in North Korea, and the leaders of Laos and Vietnam) in which all economic and social activity is controlled by a totalitarian state dominated by a single and self-perpetuating political party. (The Communist Party) In short, it is a way of life in which the citizens of a country have no liberty, no true control over their own destiny. The Communist party replaced a monarchy with a small group of people of their own choosing who make decisions about every aspect of the citizenry’s lives – from where you go to school, to career pathways, to what type of medical care you get, to where you live. There is no religious liberty, no freedom of speech, and neighbor is encouraged to spy on neighbor.

The US post World War II efforts to protect our nation and the planet from the evils of communism focused on ‘containment’. It is the very reason NATO exists. In recent years, the attempts to expand communist rule are present, Communist China is building new islands to expand its territory, after re-exerting its authority over Taiwan and Hong Kong; and Communist Russia grabbed Crimea. Russia exerts its power over Europe during the winter with threats to cut off their hearing oil supply. This manipulation has direct effect on activities at the United Nations and other global governing bodies.

Less obvious grabs of power have been happening for many decades. Socialism has its foothold around the planet. And why is that a problem? Because socialism is a stepping stone to communism. In fact, it is espoused in Marx’s theory as the transition phase between capitalism and communism. For decades we have heard for instance that we as a nation are wrong for not having a single payer health system, aka Medicare for all, or National Health Service (such as Canada and most or all of the Europe.). Nationalizing our health care would be a major mistake in my opinion because it will take away the freedom of Americans to select not just who delivers their care, but what type of care they will receive. For those of us who prescribe to a different philosophy of healing, or who promote the rights of those who choose a different path, these will be eliminated because only the dominate force (mainstream allopathic aka conventional drug centric) medical model. (This too is a topic for another day).

Nationalizing any sector of our society or industry is destructive to every other aspect. Government managed systems are notoriously inefficient, with bloated budgets and if they had to compete in the open market would fail. It is one of the reasons there is so great a discussion about how to provide better care for our veterans – because the VA as great as the mission is, have become inefficient because it is so big, with too many layers of management. Long waits, corruption, waste, fraud, and abuse – all symptoms of the greater problem – that government managing an entire sector of our society is not optimal.

As much as I was outraged at the manipulation of the Democratic National Committee to deny Senator Bernie Sanders a fair chance at the nomination; I was almost relieved, because Senator Sanders was never a democrat. He caucused with the democrats and was even given a chairmanship at one point. Sen. Sanders was always a socialist running as an independent to be elected to House and then Senate. He knew to have any chance at being elected President he had to join the democratic party. As soon as he lost the nomination, he quit the democratic party.

There is a lot happening in the US that we do not attribute to a promotion of communist ideals, but they are. Anytime religious liberty, journalism, freedom of speech are attacked, curtailed, or undermined, communism gains ground. When Democrats seeking public office compete against each other to be ‘the most progressive’, liberty is losing. When Nico LaHood, a democratic district attorney in Texas was defeated in the democratic primary in large part due to a million-dollar investment in the campaign by George Soros who felt Nico was not liberal enough, communism was the real winner.

In April, Franklin Bynum ran unopposed to win the Democratic nomination to become a criminal court judge in Houston. He is running as a socialist. This New York Times article lists many others running at all levels of government running for office. https://www.nytimes.com/2018/04/20/us/dsa-socialism-candidates-midterms.html

Rep. Joe Crowley, a top democrat in the House lost his primary to Alexandria Ocasio-Cortez who is a ‘democratic socialist’, who promotes socialist/communist perks – guaranteed jobs, guaranteed housing, guaranteed health care, etc. An article in the Washington Times took the gloves off a bit. https://www.washingtontimes.com/news/2018/jun/27/alexandria-ocasio-cortezs-socialism-makes-her-enem/

Democrats across the country were quick to jump on board and claim a little media time by being supportive of Alexandria including Senator Elizabeth Warren and New York City Mayoral Candidate Cynthia Nixon. The DNC sang her praises as the future of the democratic party. All of this before she had much media attention and before we learned that she misrepresented herself in the campaign. She did not grow up in the working-class neighborhood of the Bronx she will represent, but in Westchester County attending Westchester schools; going to Boston University and interning for Sen. Ted Kennedy. http://www.dailymail.co.uk/news/article-5905247/Girl-Bronx-Alexandria-Ocasio-Cortez-actually-grew-wealthy-Westchester-County.html She worked on Sen. Bernie Sanders’ campaign before moving back to the Bronx and setting her sights on Congress. She gained further notoriety in bashing Israel on Front Line: https://www.jta.org/2018/07/16/news-opinion/alexandria-ocasio-cortez-criticizes-israel-occupation-palestine . After getting tripped up in the interview, she back peddled a bit and claimed she was not an expert in geopolitics, which some call into question given her major in college was international relations.

The truth is that the Russians and other communist are laughing at us right now because we do not realize as a nation how much we have compromised our Constitution and liberty. When Congress takes away the rights of Americans to sue big companies when a child is medically injured, Communists laugh; when legislators introduce bills to nationalize health care, communists laugh; when there are protests in the streets calling for the elimination of ICE (and politicians join in) Communists laugh; when legislators across the country mandate medications as a condition of school participation, communists laugh; when government officials seek to control the free market system with price controls and crop subsidies, Communists laugh. When billionaires promote programs in which everyone gets a salary, Communists laugh.

Communists will not take over the United States of America through a frontal assault or direct invasion; rather they seep in like the dark, slowly. You may not notice at first that the sun is setting, you have to be listening to hear the changing songs of the birds and the bugs to be aware of the coming dark. The warning signs are there, but we miss them if we do not listen.

Communism is sneaking into our society and President Trump is not the one at fault. He is not the ‘bad guy’ in all of this. I think he could have handled himself better yesterday; but yesterday was nothing in the big picture of the communist proselyting in the United States to convert a freedom loving people to slaves of a communist politburo who promise free health care, free college, government jobs for all, mandatory minimum wages, and abolishment of the rule of law.

President Putin, I am sure is laughing with his communist cronies, the old KGB ‘intelligence operative’ knows President Trump knows the Russian cyber attacks and spying were sanctioned. He knows that we know they spy in the US and around the world, the same way we spy on Russia and around the world. (Didn’t President Obama have to apologize to Germany’s Chancellor Merkle for listening to her calls and the calls of her government ministers?) Putin is laughing at how fickle Democrats are about communism. In 2012 President Barrack Obama laughed at Mitt Romney about his concern about Russia during a presidential debate (as did Senator and then Vice President Joe Biden as well as Sen. John Kerry.). President Obama’s Secretary of State Hillary Clinton seeking to play off a marketing campaign for a US office supply store took a ‘reset’ button to a meeting with the Russian, he laughed at the foolish ploy (and that her translators bungled the translation so badly did not help either). Some Democrats promote ideals of communism – with government management of so many sectors of society; but when President Trump doesn’t attack President Putin publicly, they go ballistic.

Putin laughs when billionaire Michael Bloomberg, who took a page out of the communist playbook to change the law to suit his own desires –so he could be mayor of New York City for a third term; begin promoting gun control. (He further showed his allegiance only to himself by changing political parties not once, but twice.) Why does Putin laugh? Because, when you take the guns away from law-abiding citizens, he knows the government can take control.

In 1963, President John F. Kennedy stated, “There are many people in the world who really don’t understand, or say they don’t, what is the great issue between the free world and the Communist world. Let them come to Berlin. There are some who say that communism is the wave of the future. Let them come to Berlin. And there are some who say in Europe and elsewhere we can work with the Communists. Let them come to Berlin. And there are even a few who say that it is true that communism is an evil system, but it permits us to make economic progress. Lass’ sie nach Berlin kommen. Let them come to Berlin.”

I have been to Berlin and to Russia. I understand with all my soul what President Kennedy meant.

Republicans are not free of the communist influence either. Republicans have and continue to participate in promoting programs and crafting new laws that chip away at the Constitution, at our liberty.

In 1980, President Ronald Reagan stated, “Freedom is never more than one generation away from extinction.”

President Reagan also stated, “I’ve always believed that this blessed land was set apart in a special way, that some divine plan placed this great continent here between the oceans to be found by people from every corner of the Earth who have a special love for freedom and the courage to uproot themselves, leave homeland and friends, to come to a strange land. And coming here they created something new in all the history of mankind – a land where man is not beholden to government, government is beholden to man.

Our Constitution should be the ‘true north’ on our compass that directs our actions as a government and as citizens. Maybe it’s time to pause and study our founding documents and refocus our efforts as a nation to preserve and protect our ‘true north’. https://www.archives.gov/founding-docs/constitution

To paraphrase President Reagan, Communism denies the God-given liberties that are the inalienable right of each person on the planet, indeed, they deny the existence of God.

Please do not let yourself get too distracted by the bright and shiny objects (ie news stories) distracting you from what is really important.

Always,

Beth Clay