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Thoughts from the Vaccine Frontier - CDC’s Novel H1N1 Stakeholder Engagement

Safety first sign By Theresa Wrangham

As I sit in the Reagan Airport in D.C., I am compelled to share with our community my thoughts regarding the CDC’s H1N1 stakeholder’s meeting held September 10th and 11th that I was invited to attend on behalf of SafeMinds. This meeting was the last in a series of public engagement meetings to discuss novel H1N1 (swine) flu vaccine concerns and vaccination program implementation. There were a number of familiar faces in the room from the Immunization Action Coalition, Every Child by Two, Department of Defense, American Academy of Family Physicians, National Vaccine Advisory Committee (NVAC), U.S. Health & Human Services and of course the sponsor, the Centers for Disease Control (CDC).  Many representatives from state health departments and a few migrant and minority organizations representing the need for equal access to vaccines rounded out the group.

I can honestly admit,  I was unsettled by what I suspected would be a meeting with few representatives from the vaccine safety concerned community – which was the case. The meeting was by invitation only and SafeMinds and Barbara Loe Fisher from the National Vaccine Information Center were the sole representatives for the vaccine concerned community in a room of 43 other stakeholders. Chief among my concerns was how, with little representation, would our voices be heard? Everyone was respectful and had an opportunity to comment and ask questions.

This was in part a replication of the citizen public engagement meetings held in August. Stakeholders were given the same set of assumptions and information as the previous citizen groups and worked in small facilitated breakout sessions  to discuss scenarios for levels of effort regarding rollout of the vaccine program.  Implementation scenarios were “Go Easy” - designed to meet an expected low public demand for vaccine, “Moderate” would aim to raise the expected low demand for vaccine and “Full Throttle” to respond to significant vaccine demand with extensive communication activities in an effort to feel safe and not sorry.

Prior to polling stakeholders, we were also given information on the results of citizen polling outcomes from previous public engagement meetings.  All scenarios were based on the following; severity not changing from the Spring (stable and mild); a voluntary program; vaccination beginning in October with enough supply for all by February; and safety profile based on seasonal flu vaccine with a possible 1-10 in a million experiencing severe reactions such as Guillain-Barre Syndrome (GBS).

Out of the 1,056 citizen participants from the 12 public meetings 23% voted for Go Easy, 52% Moderate and 25% Full Throttle.  By contrast, the stakeholder group voted 3% - Go Easy, 40% - Moderate and 57% - Full Throttle.  Upon discussion, it quickly became apparent that preparedness was the focus due to the many public health officials present.  All felt safety was important, but Barbara and I were likely the only ones, outside federal representation, that had an appreciation for the gaps in vaccine safety research that exist, as defined by the National Vaccine Advisory Committee.  Thus, there were conclusions  on the part of many public health officials that safety was indeed assured.  So much so, that many in the meeting thought the disparity in polling between citizen groups and the stakeholder group was the result of misinformation from “fringe groups” hampering  communication efforts.  These sentiments were quickly followed by requests for CDC to do more consistent messaging, with some wanting to find a way to “work around” those expressing opposing views. 

It was at this point that I expressed that this was an opportunity to understand that “our” safety concerns were legitimate and that we didn’t want to be “worked around”.  I added that the number of individuals with vaccine concerns continues to grow and that what we want embraced is long-term improvements to vaccine safety research currently recognized as seriously deficient instead of being dismissed in favor of the “greater good” - there is room and an obligation to both safety and serving the greater good and that should these concerns remain unaddressed, distrust in vaccines would increase.

Barbara Loe Fisher of NVIC made the very salient point early on that public health officials should treat  vaccine injuries with the same respect and seriousness as injuries resulting from vaccine preventable disease and that CDC’s response to H1N1 flu should reflect the reality of the situation and the need for truthful communications to the public.   She also questioned Lance Gordon, former NVAC member, on the availability of information regarding if NIH and vaccine manufacturers will be studying the effects of H1N1 vaccine in pregnant women and children whose health is compromised, given their identification as a target group for this vaccine.  Dr. Gordon stated that studies on pregnant women were underway, however, that no studies on sick children were being conducted and added that "we can't know what the risks are for those populations until it is used on a widespread basis."  Clement Lewin, a Novartis representative, stated that testing with asthmatics was underway. Barbara underscored the need for this information, as well as any information, on what is known and not known to be given to the public, a recommendation also echoed by the NVAC’s H1N1 Vaccine Safety Subgroup. 

Given the data coming out of Australia demonstrating that the H1N1 virus has not mutated and is causing fewer deaths and complications than other flu strains, Barbara followed up with Dr. Anne Schuchat of the CDC, by asking if the CDC would consider removing the health emergency declaration enacted this past April.  Dr. Schuchat responded that the H1N1 swine flu was causing death and complications just like  regular influenza and that is very concerning and terrible and that people need to know how bad it is and the need to get vaccinated and that the CDC would not be rescinding the declaration. 
Other information from the meeting…

• with the possible exception of children 9 years old and younger, one dose of vaccine should be sufficient and  this news in effect, doubles vaccine available and should take unlicensed adjuvant off the table (hopefully);

• Thimerosal free vaccine will be widely available, however, no preference statement will be forthcoming.  In following up with Dr. Anne Schuchat, privately, after she ducked answering my questions of how using a vaccine exceeding EPA safe exposure guidelines for mercury could be justified, Dr. Schuchat indicated that the science on thimerosal is done. She added that in acknowledgement of public’s concern, thimerosal free would be available. It was also made clear that the promise made ten years ago to remove thimerosal “as soon as possible” would not be kept if Dr. Schuchat has any say in the matter; 

• Studies are being conducted on giving the H1N1 with seasonal flu vaccine and separately, but their completion date is unknown, as is the length of look back on adverse events and if adverse events will focus on more than immune response;

• Live virus vaccine (FluMist and H1N1 nasal mist vaccine) will be given separately, as they may not work when given together;

• VAERS and VSD are being beefed up (no specifics) and admission of deficient infrastructure acknowledged;

After a very long two days, I participated in focus group afterward and posed the question - how many had read the NVAC’s review of the CDC’s Immunization Safety Office Draft Research Agenda or the NVAC’s H1N1 Subgroup recommendations - and was not surprised that none had.  However, I stated that I had read it and suggested that the vaccine concerned were actually a very knowledgeable bunch in many instances and worthy of engaging in discussion.  A representative from New York summed it up best during the focus group interview, that for some reason we are often talking past each other. I reiterated that our goal was the same as theirs - the safest vaccines possible and that the NVAC report and the H1N1 subgroup recommendations might provide a starting point for dialogue.  It was apparent that safety was the common ground that we shared, although its status in relation to vaccine safety appeared to be largely unknown by our local health officials, due to their reliance on CDC as the one and only authority on safety and the perception that they are beyond error or conflict of interest.

This is just the tip of the iceberg in my opinion of the trust that CDC enjoys and the lack of  awareness among our public health officials as to what is known and not known with regard to the status of vaccine safety research and their unfamiliarity with the foundation of our resistance and distrust. I also suspect that many are very unaware of the conflicts of interest in vaccine promotion and the conducting of safety research on which CDC hangs its hat, particularly true where thimerosal is concerned. Very noticeably, stakeholders throughout the meeting nodded their heads in agreement, as did Barbara and I, on the need for safety and clear communication. The departure in what “safety” and “clear communication” meant stemmed from how educated the individual was and whether they had dug deeper than the CDC’s press releases and press conferences held on any vaccine effort or publication of any research, or similar pronouncements from professional organizations, etc. 

Of encouragement is that those of us participating in the focus group felt that more citizen representation was necessary in future stakeholder meetings; a sentiment that also had support from other stakeholders in the course of the larger discussions.  I suggested more organizations with vaccine concerns be present, as well as the vaccine injured and attorneys representing them and was met with what appeared to be agreement.

What I have come away with is a better understanding of logistics that face our local public health officials in assuring public safety and that many want to use this vaccination effort as an opportunity to put infrastructure in place from the standpoint of preparedness, whether for a pandemic or hurricane.  It is also imperative that constructive dialogue with local officials transpire to bring an awareness of the legitimate safety concerns that exist with regard to vaccines and the critical gaps in safety research that must be remedied.  These were human beings that I shared two days with who felt that we were in this together, even though there were varied degrees of understanding what “this” was.  Though they voted from a preparedness standpoint, many also listened to Barbara and me and only a few rolled their eyes.

I have no illusions of how steep the grade is on this journey or how it will continue to be fraught with putting down paternal messaging from CDC – paternal messaging were words from public health officials by the way, not me.  It will require that untruths be put down as well, and as I look into the faces of my daughters, Deanna and Rachel, who’s first words on my return weren’t “We’re so glad you’re home”, but  “How did it go?” my response was “We’ll wait and see.”  It was the same response I gave to the focus group’s last questions -  Did I think CDC would use the information from the public engagement?  I clarified my meaning by adding that for the community I represent, we have regularly engaged with public health officials and are waiting to see how safety will be improved and not just for this vaccine effort, but in light of the NVAC report and others, in the use of vaccines in general and that we had been waiting ten years or more for improvements.  “Talk is cheap, actions speak louder than words.”

Many thanks to Barbara Loe Fisher for her continued and longstanding efforts via NVIC.  Barbara was positively recognized at the outset of the meeting by CDC’s Dr. Roger Bernier for her continued public engagement efforts and it was very good to have her company on the vaccine safety frontier. 

Theresa Wrangham is the mother of Rachel, a teenager who is diagnosed with PDD/NOS, and Deanna. She lives in Colorado with her husband, Scott.  She brings to the fore an experienced parent's perspective on raising a healthy child affected by ASD and the benefits of advocacy outside family needs. Theresa was appointed to the Board of SafeMinds in 2007 and currently serves as president. She served as a past Board Member with the Autism Society of Colorado and co-founded the Autism Society of Boulder County (ASBC), serving five terms as president. She is currently the immediate past president. Theresa is also the Director of Educational Development and Conference Liaison for the US Autism & Asperger Association.

Comments

Kathy Blanco

I think all of us should inoculate ourselves from the magic and mythical mainstream media, and call the vaccine SHEEPLE...to prevent people from being trusting folk, and to stop the impairment or the use of brain and thought processes that WE ONCE HAD. Oops, maybe that already happened? AFter all mercury does mess with impulse control in the brain?

Sunny

Let me restate that last part...the approval of the FDA and recommendation of the CDC do not just IMPLY safety and effectiveness to the public---the public has been told directly by Dr. Margaret Fisher (AAP) on at least two separate occasions that vaccines are NOT approved/recommended unless their safety and effectiveness have been established:

When the vaccine/autism issue was debated on Larry King back in April, Dr. Fisher, said this about shots added to the vaccine schedule:

“Only if it's been determined to be safe and effective is it recommended for use. It's not a rubber stamp.”

(That sentence is proven to be absolutely untrue when you look at the admissions about safety/effectiveness on the package insert of the flu shot and consider that it's still currently recommended for use)

Also, the same Dr. Fisher was quoted back in December 2008 (in response to questions re: safety of flu shots for their targeted populations):

“Dr. Meg Fisher, vice president-elect of the New Jersey chapter of the American Academy of Pediatrics, said the flu vaccine has undergone extensive testing for the groups for whom it's licensed.”

(OK, so technically maybe the flu vaccine has *undergone* the testing, but it failed them all??? WTH???)

This stuff makes me CRAZY. I don't know how these people sleep at night. They KNOW how carefully they're having to choose their words---they KNOW exactly what they're NOT saying... They can't be ignorant of the cover-up they're perpetrating... How do they justify it to themselves??? I just don't get it...

OK. I'm done. I'm so glad AoA exists to help me stay sane!!! *SIGH*

Sunny

So much gratitude to you, Theresa, and to Barbara Lo Fisher for representing our community and calling them out on their plans to merely "work around" us and our pesky concerns with safety.

Lance Gordon's remark says it all as far as I'm concerned: "we can't know what the risks are for those populations until it is used on a widespread basis." He just said that the risks are UNKNOWN, and the NIH/CDC are clearly OK with that (and based on the FDA's approval of this vaccine within days of Gordon acknowledging safety studies had not been completed, the FDA is clearly OK with the unknown risks as well). This position is obviously the same one they have comfortably taken every time they've added an additional vaccine to the schedule (and/or lowered the age at which the babies would be getting them)...they say, We can't know for sure until it's out there...then, once it's out there "on a widespread basis" and horrific, chronic ailments hit our children at epidemic levels as a result, they just look the other way and move on to their next vaccine...
It's really no different than the current flu shots (recommended for pregnant women and children), whose package insert clearly says: "SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOR PREGNANT WOMEN, LACTATING WOMEN, PEDIATRIC OR GERIATRIC POPULATIONS" I guess as long as they put that little sentence there on the 4 pt. font of the package insert, that was informed consent?
Bottom-line: to the general public, FDA-approval and CDC-recommendation imply that safety and effectiveness have been established. It's extremely deceiving.

Jeanna

Of encouragement is that those of us participating in the focus group felt that more citizen representation was necessary in future stakeholder meetings; a sentiment that also had support from other stakeholders in the course of the larger discussions. I suggested more organizations with vaccine concerns be present, as well as the vaccine injured and attorneys representing them and was met with what appeared to be agreement.


Theresa- I am one of those you speak of above. I would love to be at one of those meetings as well as tell our story. We currently sit in Vaccine Court awaiting the day we are contacted....not holding my breath.
We will be at the NVIC conf in October- How can we help you? letters? face to face meetings? let me know, I'm on a mission!

Jeanna Reed
autismismedical.com

Autism Grandma

PLEASE VOTE NO ON MANDATORY VACCINES

JOIN THE 2 MILLION PEOPLE WHO HAVE ALREADY VOTED NO

Editing the following form letter [below] to add your own personal comments is optional, and here is mine:

I am on disability due to a toxic chemical injury which has caused me to develop severe reactions to virtually every chemical in our environment, including all pharmaceutical medications, in addition to food additives and preservatives. There is NO WAY that I can survive a vaccine of any kind, and there is NO WAY that my grandson can survive a vaccine of any kind due to the fact that his reactions to his last vaccines almost killed him, and immediately resulted in Autism. There are millions of chemically sensitive people including over 200,000 disabled Gulf War Veterans who cannot survive any additional vaccines without further health damages due to their exposure to multiple vaccines including Mercury, Aluminum and Squalene. There are now over a million children with autism, whom the majority have developed in direct reaction to vaccines. The concept of Mandatory Vaccines would not only further harm those like myself and grandson, but will also create many new victims who will sustain permanent health damages including DEATH. It is time to finally say NO to vaccine industry profits and YES to protect the safety of the American People.

Here is my daughter's comments:

My child developed severe life threatening reactions to his last vaccines and subsequently can no longer be exposed to any further vaccines of any kind due to the dangerous risk to his health and LIFE. He also immediately developed Autism as a direct result of the vaccine injuries. Mandatory Vaccines would actually be risking the life of my son and many more innocent children who are at high risk for vaccine reactions and permanent damages. It is time to finally protect our nation's children and so many others who cannot tolerate vaccines, including those who have chosen to avoid vaccines for the sake of protecting their children and themselves from risk of permanent harm including DEATH.

Here are my comments written in behalf of my grandson:

My name is Landin and I have autism. I was walking and talking normally until my last vaccines. Right away I was unable to walk any more, could not keep my balance, and continually fell down. I could no longer speak but could only scream or stare off into space. I could no longer respond to my family or understand anything. I lost weight because this caused me to have chronic acidic diarrhea that ate my skin away, and constant pain that also prevented me from sleeping. I had rashes all over my body and became allergic to all kinds of foods. I banged my head on the floor and walls and was hitting and biting my family instead of hugging and kissing them like I did before these vaccines damaged me so terribly. I now have aluminum levels that are off the charts which has caused heavy metal brain damage because of these vaccines. My family has done everything they can to provide me with therapies for my recovery, but I still have a long way to go. If I am forced into having even one more vaccine it could actually kill me. If I live through it, I will become even more damaged than I already am. I am asking you as an innocent child to protect me from Mandatory Vaccines.
[My grandmother is writing this in my behalf because I cannot Speak for Myself]

GO HERE TO VOTE NO ON MANDATORY VACCINES:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27275

[You may vote once for each person in your family with each different email address]

Form Letter:

I am writing to you on a matter of grave personal concern at the suggestion of the Natural Solutions Foundation, a not for profit humanitarian NGO devoted to health and health freedom, to educate decision makers and to petition for respect for our basic human rights. This letter is regarding the proposed Protecting Americans' Self-Shielding bill.

When the people of this district elected you, we anticipated that, true to your election words, you would protect our well-being and our rights. The proposed enforcement of mandatory treatment, including mandatory vaccines, for any alleged "pandemic" condition is both a violation of that commitment and a violation of my rights to control my own body and make my own health choices.

Both State and Federal legislation now provides for the mandatory vaccination, drugging or incarceration for those who refuse such "treatment."

The hype and hysteria of the media and the distortion of the science of infection and contagion by governmental and international bodies, coupled with the pharmaceutical industry's headlong rush to force yet more profits from vaccines which are untested, uninsurable and dangerous, and from drugs which are known to be both ineffective and unsafe, leads me to write to you to urge you to push back this potentially deadly tide of political pandemic response.

Independent physicians such as Dr. Ron Paul MD, Dr. Rima E. Laibow MD, Dr. Julian Whittaker MD, Dr. Joseph Mercola DO, Dr. John Wilson MD, Dr. William Rea MD and Dr. William Sears MD, among others, have all warned about the dangers of forced vaccination and the ineffectiveness of such measures to stop infectious disease. Their independent medical opinions must be given great weight while the self-serving opinions of government "experts" who demand forced vaccinations must be discounted as biased.

It is a clear violation of the Constitutional provisions against both slavery and indentured servitude since a free, unindentured or enslaved person may make his/her own health choices while an indentured servant or slave's body is owned by a master who may make health decisions about the body of the slave which may be enforced on a compulsory basis.

In addition to the moral and cultural repugnance which mandatory treatment invokes, it violates the rights of citizens and introduces the possibility of harm to them which cannot, under the current legal structure, be recompensed. Vaccination is an uninsurable risk and vaccine manufacturers are immune from liability for dangerous or even deadly products, while vaccines have never been proven to be either safe or effective. On the other hand, even the CDC admits that there are risks of significant proportion with vaccines.

Any "pandemic vaccine" would be untested upon its use as predicted by the CDC and WHO in the fall of 2009. The possibilities for disaster are enormous. Those of us who do not desire these "treatments" should be free to make such a choice with the endorsement and support of the State.

As a person who is neither an indentured servant nor a slave, but a member of your constituency, I urge you in the strongest terms to:

1. Commit to holding fact finding hearings in the immediate future to evaluate the true status of the pandemic threat and pandemic treatment safety; the Baxter Pharmaceutical incident earlier this year where annual flu vaccines intended for 18 countries were "accidentally" contaminated by live Avian Flu viruses, must be fully investigated.

2. Commit to putting your efforts toward reversing dangerous legislation and policies which can endanger the lives and health of the members of your constituency

3. Provide for sanction-free personal exemptions from proposed mandatory drug or vaccination treatment, instead offering people who do not wish to be so treated the opportunity and support necessary for self-quarantine and self-shield at home, if needed for public safety reasons. Such support would include food, water and communication support, provision of medications or supplies of their choice and other means which support their choice and safety. This alternative would be far less expensive and socially disruptive than the forced relocation of "vaccine refusers" in violation of the Geneva Conventions.

We demand full recognition of our right to protect ourselves in our own homes.

Thank you for your support of liberty and of your sworn duty to protect both the US Constitution and the well-being of your constituents.
________________________

Here is a link to the text of the bill for which we are seeking congressional sponsorship, the Protecting Americans' Self-Shielding Act - http://www.healthfreedomusa.org/?p=2888

GO HERE TO VOTE NO ON MANDATORY VACCINES:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27275

[You may vote once for each person in your family with each different email address]

Andrea

Dr. Oz is devoting a good portion of his show to swine flu today. He is really ramping up the fear. Ohhh...stupid f*cker just got a flu shot live on the air..He teamed up with Wal-greens. Everyone in the audience is getting a flu shot And they all clapped (eye roll)...He's been getting shot for 10 years. Now a commercial for Wal-Greens and their seasonal flu shots.

Maggie

Just read on Fox news that the H1N1 vaccine has been approved by the FDA. Based on what? No studes are complete yet. What does this tell us about the FDA?

nhokkanen

Theresa, thank you for devoting so much time, energy, study and patience as a representative to that public engagement process.

It must have been an interesting mix -- so many well-intentioned, earnest foot soldiers willing to be led by so many ethically conflicted bureaucrats and reps. And all trying to ignore the vaccine injury elephant in the room.

Kathy B, I tried your link but two anthromorphized musketeer chinchillas popped up. Seriously.

To Kathy Blanco

The youtube url you posted went to a site with more nonsense about Kanye West and Taylor Swift (never heard of either of them before yesterday).
Can you post the correct url ...or at least give us a title to search for?

Schoolteacher in NYC

Excellent report, much appreciated. How interesting that you were the only one that had done the reading. It reflects what I seem to see in my community of parents, namely that the more a parent has educated him/herself about vaccines, the more likely he/she is to spread out the shots or seek an exemption.

Theresa Wrangham

Benedetta,

While I didn't know that the strategy of breaking us into small groups had a name, rest assured that Barbara and I made our comments to the larger group, as we are well aware of how division into smaller groups minimized any opportunity for the larger group to hear our concerns. My only regret is that I didn't think to ask the larger group if they had read the NVAC document and subgroup recommendations - I sincerely doubt that the response would have been different except from Novartis, some feds present and Dr. Gordon. Thanks for your comment.

Theresa

Kathy Blanco

www.youtube.com/watch?v=2wXPzYFMzsE That's all I have to say...listen to the whole shebang and tell me if your not a useless pile of garbage to these people...

Benedetta Stilwell

I am glad many did not roll their eyes! I look forward to the day that none roll their eyes!

Erik Nanstiel

"Small facilitated breakout sessions" are a hallmark of consensus and crowd control called "The Delphi Technique," developed by the Rand Corporation in the 60's.

The big audience is broken up into smaller, moderated groups... it's a divide-and-conquer method to quiet dissidents and prevent the spread of dissident questions, behaviors, uproars, etc.

I urge you to look it up. There are some counter-techniques to resist being "delphi'd" and make sure the larger crowd hears everything and can participate as a cohesive whole. This Delphi technique is so effective it can even squelch a simple majority...

Tanners Dad

Just the thought of spending two days with that group turns my stomach. I am thankful that you and Barbara are such valiant knights. The sad part in this fantasy world is we are dealing with very real injury.

The only solace I take is that the ongoing Pandemic propaganda for a magical mythical creature will bore the public soon. How many vaccines can the public be subjected too? I really think the word on the street & Balance shifted when you start trying to give boys Gardasil. Praying & Posting every minute of every day. TannersDad Tim

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