Comments to VAC 4.19.2018

Comments to VAC 4.19.2018

Below are the public comments presented to the WA DOH Vaccine Advisory Committee on April 19, 2018 by InformedChoiceWA Board and group members.

Comment by Bernadette Pajer

Q: Should WA State spend taxpayer money promoting MenB vaccines?

From the New York TimesFor Meningitis B Vaccines, Climbing Revenue, and Plenty of Skepticism

By SHEFALI LUTHRA      SEPT. 7, 2017

Link: https://www.nytimes.com/2017/09/07/business/meningitis-b-vaccines.html

Excerpts:

“There is perhaps, with all the marketing and advertising, some bending of the truth, and perhaps a little bit of creating fear — again recognizing that meningitis disease is a very severe disease,” said William Moss, a professor at Johns Hopkins Bloomberg School of Public Health who specializes in vaccines and global children’s health. The risk, he said, “is not a large enough problem to warrant routine vaccination.” 

In recent years, drugmakers’ interests have begun to expand beyond the relatively cheap, broadly used immunizations, such as a tetanus shot or the children’s hepatitis A vaccine, to new and pricier ones for less common infections.

These newer treatments have the potential to transform the business of vaccine-making, long a less lucrative side of drug production, into a cash cow. Bexsero and its competitor, Trumenba, offer clues into how this scenario plays out.

Now the drugmakers are urging all parents to be proactive. Last year, Pfizer put more than $21 million into paid advertisements for the vaccine, according to figures kept by Kantar Media, a firm that tracks multimedia advertising. GlaxoSmithKline put in just about $79,000.

Those figures don’t account for other efforts such as meningitis awareness and social media campaigns done by GlaxoSmithKline, a “substantial effort” that “wasn’t cheap,” said Mr. Jambunathan of GlaxoSmithKline. They also don’t include Pfizer’s investments in similar activities.

Already, industry analysts forecast Bexsero could bring in global revenue north of $1 billion per year by 2022, compared with about $528 million last year. Trumenba is expected to earn Pfizer $820 million by that time. It was estimated to have brought in about $88 million globally in 2016.

A: WA DOH should be a source of accurate data regarding MenB vaccines and their experimental status targeting an extremely rare infection, not in the business of promoting or marketing them. Pfizer and GSK profit highly and should shoulder all marketing costs. Taxpayers are already shouldering the cost of any injury or death sustained by the use of these vaccines as they are covered by The National Vaccine Injury Compensation Program.

https://www.hrsa.gov/vaccine-compensation/covered-vaccines/index.html

Comment by Bernadette Pajer

Q: What is the impact of a 3rd dose of MMR?

From: Recommendation of the Advisory Committee on Immunization Practices for Use of a Third Dose of Mumps Virus–Containing Vaccine in Persons at Increased Risk for Mumps During an Outbreak, January 12, 2018 / 67(1);33–38

“Two studies evaluated the geometric mean titers of mumps virus–specific antibodies after the third dose of MMR vaccine and demonstrated a significant increase (p<0.0001) 1 month after vaccination; however, antibody titers declined to near baseline by 1 year after vaccination. In the absence of a correlate of protection that would define the level of antibodies needed to protect a person from mumps disease, the clinical significance of these laboratory findings is unclear.” https://www.cdc.gov/mmwr/volumes/67/wr/mm6701a7.htm

This finding of rapid waning matches those for other viral vaccine-targeted infections, such as measles, where correlate of protection is known.

So while a 3rd dose may protect some college students during an outbreak, that dose does not confer long-term protection but sets up individuals to be susceptible again a year later and beyond. The older the individual is at the time of exposure, the more increased risk of complications.

A third dose is, at best, a temporary measure against the manmade problem caused by vaccination* programs destroying natural herd immunity in the adult population and shifting mumps out of childhood.

Rather than pushing vulnerability into the next year and later life with a third MMR dose, how else can the susceptibility-shift be addressed? The healthcare community and general public can learn about the benefits of daily adequate and therapeutic doses of Vitamins A, C, D, as well as antipyretic avoidance, to improve mumps outcomes in high school and college students while allowing them to experience wild mumps exposure and thus develop lifetime immunity. Reconsidering targeting mumps with vaccination is warranted.

*see https://kellergrover.com/cases/whistleblower-actions/active-cases-whistleblower-actions/united-states-ex-rel-krahling-and-wlochowski-v-merck-co/

Q: Is the newly formulated FluMist effective?

AstraZeneca told the ACIP: VE [Vaccine effectiveness] for current LAIC4 formulation against H1N1pdm09 is unknown

Q: Did ACIP vote to recommend FluMist for the 2018-2019 flu season?

Yes, and no. Although they voted to put FluMist on their list of recommended influenza vaccines, they spoke at length about how to “wordsmith” their statement so as not to actually endorse it. In short—their goal was to reestablish market presence for AstraZeneca, serving up the American public, mostly children, as unwitting test subjects for the newly formulated LAIV.

The meeting and vote can be viewed here: https://youtu.be/Dy9OL5ug940

Q: Will the general public be told this at the time of FluMist administration?

At the meeting, it was explained that the following “Additional Background” will be added to the Influenza Statement:

“Although the effectiveness of the new formulation of LAIV4 againt H1N1pdm09 viruses is not yet known, available data suggests that the new LAIV4 containing A/Slovenia may provide protection more comparable to that observed with pre-2009 influenza vaccines.

If by Influenza Statement they refer to the VIS, then there is a chance consumers will see it, but this statement is incomprehensible to the average person and does not constitute informed consent.

Q: Is FluMist safe:

Besides the warnings and contraindications provided by the manufacturer, questions of LAIV safety include:

  • increased upper respiratory tract bacterial carriage density of human commensal pathogens like Streptococcus pneumoniaeand Staphylococcus aureu
  • increased pneumococcal density in the upper respiratory tract of vaccine recipients, especially children, which may increase pneumococcal transmission and prevalence, leading to excess pneumococcal invasive disease in the population, especially among the elderly and others most susceptible to pneumococcal disease

PMID: 28646948 Generalized herd effects and vaccine evaluation: impact of live influenza vaccine on off-target bacterial colonization

  • may also transiently increase rates of nasal colonization with Haemophilus influenzae
  • may also transiently increase the density of Moraxella catarrhalis among carriers

PMID: 26742001The Effects of Live Attenuated Influenza Vaccine on Nasopharyngeal Bacteria in Healthy 2 to 4 Year Olds. A Randomized Controlled Trial

  • significant changes in microbial community structure, diversity, and core taxonomic membership as well as increases in the relative abundances of Staphylococcusand Bacteroides genera

PMID: 26667497 The administration of intranasal live attenuated influenza vaccine induces changes in the nasal microbiota and nasal epithelium gene expression profiles

Q: Is influenza dangerous? Or are advantageous secondary infections by human commensal pathogens—which are increased by FluMist—the real danger?

“In fact, influenza may well be thought of not as a killing disease except by the intervention of pneumonia or the presence of chronic disease in a patient . . . the 1918 H1N1 pandemic strain caused 40–50 million deaths worldwide, and disproportionately affected healthy young adults compared with other pandemic viruses. It has been estimated that more than 95% of all fatal cases were complicated by bacterial pneumonia, caused predominantly by Streptococcus pneumoniae, Staphylococcus aureus, and Streptococcus pyogenes.”

PMID: 22252001 Correlates of vaccine protection from influenza and its complications.

NOTE: It is theorized that in the 1918 epidemic “a significant proportion of the deaths may be attributable to aspirin.” PMID: 19788357  Today, it is known that use of antipyretics such as acetaminophen increases influenza mortality. To improve influenza outcomes and decrease risk of secondary infections, the general public should be alerted to the danger of antipyretics:

Eyers S, Weatherall M, Shirtcliffe P, Perrin K, Beasley R. The effect on mortality of antipyretics in the treatment of influenza infection: systematic review and meta-analyis. Journal of the Royal Society of Medicine. 2010;103(10):403-411. doi:10.1258/jrsm.2010.090441.

The Case for Letting Fevers Run Their Course: Numerous studies over the past few years have shown that taking fever reducers hurts your body’s ability to recover from an illness by Paul Offit https://www.thedailybeast.com/author/paul-a-offit

Consider the synergistic effects of FluMist—which increases strep carriage—with other pediatric vaccines, especially PCVs:

Current preventive strategies, including the polysaccharide conjugate vaccines, aim to eliminate asymptomatic carriage with vaccine-type pneumococci. However, this has resulted in serotype replacement with, so far, less fit pneumococcal strains, which has changed the nasopharyngeal flora, opening the niche for entry of other virulent pathogens (e.g., Streptococcus pyogenesStaphylococcus aureus, and potentially Haemophilus influenzae). The long-term effects of these changes are unknown . . . the large number of pneumococcal serotypes (currently 96) and the poor immunological responses against most nonvaccine serotypes inherently limit the utility of these vaccines in broadly protecting against disease.”

Greene CJ, Marks LR, Hu JC, et al. Novel Strategy To Protect against Influenza Virus-Induced Pneumococcal Disease without Interfering with Commensal Colonization. Camilli A, ed. Infection and Immunity. 2016;84(6):1693-1703. doi:10.1128/IAI.01478-15.

Comment by Jaclyn Gallion

I represent a group of parents whose children were excluded from school during the Marshallese mumps outbreak last year.  Some of our children were out of school for over 3 months.

Today marks an awful anniversary. That has forever impacted our community. 1 year ago today an excluded classmate of my son’s died by suicide. He left a note describing part of the reason to be what He considered an irrecoverable setback in his academics.

After this tragedy occurred the Spokane parents petitioned the WA Board of Health to provide us with the science backing the safety of exclusions, and the assessment of the relative risk of an exclusion versus the potential exposure to a mumps infection.  To this day we have not received a single page.  This absence of data forced us to do our own research.

We found Three major findings.

One- There has been no study into the safety of exclusions.  But there has been research demonstrating that it is an objective fact that some students will respond with a self-harm attempt if they are suspended or expelled for disciplinary purposes, which is functionally the same as exclusion.  This research resulted in a dramatic reform of disciplinary policy and procedures and who can suspend or expel a student, and the way they are treated during the process.

Compare the highly defined discipline practices to the policy free vaccine exemption exclusions.  Many of the Spokane students experienced humiliating notifications in front of peers, no structured support during exclusion, no set return date, and no re-entry plan.  Isn’t this a recipe for creating stress and potential hopelessness and despair in an academically focused student?

Two- suicide is a magnitudes greater risk than mumps has ever been in Washington state, all the way back to 1920 when records were first started to be kept.  In 62 years from 1920 to 1982 there were only 50 mumps mortalities, compared to 100 suicides annually, making it the number 2 cause of death in the 10-24 age bracket.  Mumps was never in the top anything.  There is no comparison. When WA DOH Suicide resources are accessed it is clear that excluding a student causes several know suicide risk factors and removes several suicide reduction support structures.  Where is the research demonstrating that these issues have ever been considered?

Because exclusion is known to increase the risk of a self-harm attempt, doesn’t the DOH have a duty to notify parents of this possibility, along with a list of warning behaviors to be vigilant for, and an action plan and resources if they observe their child potentially suffering?

Three- There is an equal absence of studies demonstrating that an exclusion can interrupt an outbreak.  In this specific outbreak, a year of prior experience in Arkansas demonstrated that no intervention was successful in stopping the Marshallese from infecting each other off campus.  A 3rd MMR didn’t work, and in fact some individuals had recurring Mumps infections.  The choice to not exclude Marshallese students guaranteed that there would be Mumps in Spokane schools. It was shocking to hear the school exclusions are still happening in Washington state due to the Marshallese mumps.

The small bright spot to date is that CVSD has put together procedures to try to minimize the damage of exclusion.  These procedures should be implemented statewide, along with the self-harm risk warning.

Comment by Michele Bogue

To the Washington Department of Health,

Who can identify the source of the following quote, “The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue”?  Was it a “mommy blogger”?  A quack?  No, it was the editor-in-chief of The Lancet, Dr. Richard Horton in 2015.

Former editor-in-chief of The New England Journal of Medicine, Dr. Marcia Angell stated, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor”

Dr. Relman, another former editor-in-chief of the NEJM, said, “The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful.”

The New England Journal of Medicine and The Lancet are two well respected and prestigious medical journals.  If you collectively accept them as authoritative sources, their editor’s warnings should be heeded.  

Are pharmaceutical researchers and their vaccine products operating in isolation?  In a separate enclave of scientific purity?  Recent evidence indicates they are not.  Currently, there is an active court case in the discovery phase against Merck, the sole manufacturer of the MMR in the United States, brought by two of its own virologists with allegations of being pressured and threatened into falsifying the efficacy of the Mumps vaccine.  Increasing numbers of individuals who are up-to-date on their MMR vaccines are being diagnosed with Mumps, lending support to the arguments against its efficacy claims.

In regards to the Gardasil vaccine, multiple research subjects from this vaccine’s safety study are reporting health problems developing after receipt of the Gardasil vaccination. These adverse reactions were dismissed as coincidence by the trial investigator and not accounted for in the safety data.  Trudo Lemmens, a bioethicist and professor of health law and policy at the University of Toronto, is quoted as saying,

“If I were a research subject, I would feel betrayed.  If the purpose of a clinical trial is to establish the safety and efficacy of a new product, whether it’s a vaccine or something else, I would expect that they gathered all relevant data, including whether it had side effects or not.”  These are just two examples of vaccines with red flags being raised.  There are others.

Is the Washington Department of Health hearing these serious concerns from within the scientific community?  If these warnings regarding integrity in science become widely known and extend to the vaccine industry, the public will want answers.  People in this room will be among those they ask tough questions such as, “Did you look at the science before you made your decisions?  With alarms being raised by reputable sources, did you take the time to know the science you relied on in making your decisions?  Their placebos?  The length of time outcomes were studied? Did the data support conclusions being made?”

The people of Washington state depend on their Department of Health to know the science, including the biases, the funding, and its overall integrity.  The Department of Health cannot abdicate this responsibility.  Instead the Washington Department of Health should conduct due diligence, not only for the people of the state of Washington but also for yourselves.  Don’t place your reputation in the hands of sources increasing recognized as biased and untrustworthy.