2017, 10-24 Formal Format tviNUTPS
City of Spokane Valley
City Council Regular Meeting
Formal Meeting Format
Tuesday, October 24,2017
Mayor Higgins called the meeting to order at 6;00 p.m.
Attendance: 15rrr `
Rod Higgins, Mayor Mark Calhoun, City Manager
Arne Woodard Deputy Mayor Jolitr Hohman,Deputy City Manager
Caleb Collier, Councilmember Cary Driskell, City Attorney
Pam Haley, Councilmember Chelsie Taylor, Finance Director
Mike Munch; Councilincrri:.ber Mark Werner, Police Chief
Ed Pace, Councilmember Erik Lamb, Deputy City Attorney
Sam Wood, Councilmember Mike Stone, Parks & Recreation Director
Cilnria Mantz, Engineering Manager
Cbaz Bates, Economic Development Specialist
Carrie Koudelka,Deputy City Clerk
INVOCATION: En the absence of Pastor Larson, Councilmemher Pace gave the invocation.
PLEDGE OF ALLEGIANCE Council, staff, and members of the audience stood for the Pledge of
Allegiance.
ROLL CALL Depuw City Clerk Koudelka called the roll;all Council members were present.
APPROVAL OF AGENDA It was moved by Deputy Mayor Woodard, seconded and unanimously agreed
to approve the agenda
IN RODLlC'I'ION OF SPECiAL GUESTS AND PRESENTATIONS n/a
COMMITTEE,BOARD.LIAISON SUMMARY REPORTS
Councilmember Munch and Councilmember Haley had no report. Councilmember Wood reported that he
attended the i.T.AC (Lodging Tax Advisory Committee) meeting and they discussed the groups applying
for funds;he said the COM ittee allocations will be presented to Council for consideration, Councilmember
Collier said he celebrated the grand opening of the City Hall building on October 14th and on October i9th
he closed an event held for Safe Families. Councilmember Pace said lie attended the grand opening for City
Hall. Councilmember Woodard said he attended the City Hall grand opening and the Association of
Washington Cities regional meeting, the Library Board meeting and ABC Office Equipment's 65-year
ribbon cutting ceremony.
MAYOR'S REPORT
Mayor Higgins repotted that he attended the City Hall grand opening, the Library Board mccling, the
Spokane County Land Use steering committee meeting, a SCOPF, appreciation dinner, the Spokane Valley
skating rink opening and ribbon cutting,the Senate Law and Justice committee meeting and the ABC Office
Equipment:ribbon cutting ceremony.
PROCLAMATION n/n
Minipkcs Rcgulru Council Meeting: 10-24-2017 Page 1 o1-7
Approved by Cnunc i i! 11-14-2017
PUBLIC COMMENTS: Mayor Higgins explained the process, and then invited public comment,
Renate Fischer, Spokane Valley: said she contacted the City and left a phone message and email that were
not responded to;she said that if a City receives a concern or complaint from a citizen it is worth more than
getting a mere 'thank you' and "next"which is what she felt she received.
Scott Maclay, Spokane Valley: said he attended the .Strahan memorial at University Inigh School and he
was approached by an officer and was asked to move to the back. He said he and the officer had some
discussion and the officer walked away; later during the event, he said officers approached him and told
him he was not welcome by the family at the event, He said it was a public event at a public high school,
the school he and his kids attended. On his way out, he told the sheriff he did not appreciate the treatment
he received and he was politely shoved by an officer. He said he was grabbed by the officers, he asked the
officers if he was under arrest, he was taken to jail and arrested and denied his medication. He [hen asked
Councilmembers when it will end.
Carol Trask, Spokane Valley: gave Councihncmbcrs a document(included)from Informed Consent Action
Network(I AN)with information about vaccinations. She said she is filing notice against the Secretary of
Health and I luman Services and she believes they arc failing to perform safety tests for vaccines.
Kebbie Johnson, Spokane Valley; Paula Smith, Greenaci•es;Jaclyn Oailion,Spokane Valley; all continued
reading the ICAN documents handed out by Carol 'Trask regarding the notice being tiled against the
Secretary of Health and Human Services.
Kim Standlcr, Spokane Valley: spoke in support of the parental rights notice and shared the story of her
daughter's experience after receiving vaccinations.
Reverend Gen Haywood, Spokane Valley: gave a draft mission statement (included) to the City Council
and read some of the listed items to include in the mission statement of the Council.
Lynn Pleggmeier, Spokane Valley: said it appears the City does not have a noise ordinance and Council
should direct staff to dig out everything on noise ordinances because the noise iii the city needs to be
addressed. lie also said Council should relook at going back to an eight-hour work day for staff Eike all the
taxpayers work and they should rescind the nine-hour, every-other-Monday or Friday off for employees.
Phyllis Iles, Spokane Valley: said that growing up, she and her family members all got chicken pox,
measles and mumps and they all got life-long immunities, She said her kids were immunized and they all
had frequent illnesses. She then researched vaccines and did not vaccinate her younger children and they
were rarely ill, and she asked than Council support the parent's right to choose.
Neil Davis,Newman Lakesaid that he does business in Spokane Valley and did no[ see the flyers for the
two I3NSf crossing improvements and he did not attend the meetings,but he said he is opposed to closing
Vista,University and other crossings because many vehicles use those crossings. He said he questions the
data with regard to accidents at the crossings and he said he is in favor of the crossing improvements but in
opposition to closing the others. He said he thinks a roundabout at Trent and Barker is a silly idea and he
would like that eliminated from consideration, and he recommends an overpass leading into the
neighborhood_
Laura Rentz: thanked Council for listening to the concerns of her organization for service animals and she
said they are making headway in the community.
1. PUBLIC FIFA-RING! Proposed 2017 Budget Amendment—CiJelsie Taylor
Mayor I liggins opened the public hearing at 6:48 p.m. Finance Director Taylor said this public hearing
follows an administrative report given at the October 3, 2017, Council meeting and there have been no
changes to this amendment since then. She pointed out that the Request for Council Action (RCA) form
details the budget line items to be amended. Mayor Higgins invited public comment.
Reverend Lien Hayward, Spokane Valley: said she has concerns about Council's vision for the city, She
said they should reflect the values and hopes of the community; she said she does. not think they currently
provide a quality of life for young people to work, live and raise families and she encouraged Council to
read her draft mission statement.
Jaclyn Gallian, Spokane Valley: said it is difficult for families to manage a budget and thanked Council for
being conservative and diligent in managing the taxpayer's money.
Minutcs Regular Council Meeting: 10-21-2017 Page 2 of 7
Approved kw Council: 11-14-2017
Mayor Higgins closed the public hearing at 6:59 p.m.
2. First Reading Proposed Ordinance 17-013 Amending 2017 Budget—Chelsie Taylor
After Deputy City Clerk Koatdelka read the ordinance title, it was moved by Deputy Mayor Woodard and
seconded to advance Ordinance 17-013 amending the 2017 Budget to a second reading. Finance Director
Taylor said this is the first reading of the ordinance for the 2017 budget amendment Council just held the
public hearing for and she said it affects twelve funds, Vote by Acclamation_ In .favor: Unanimous.
Opposed.-None. Motion c'crr red
3. PUBLIC HEARING; Community Developincnt.Block Grants (CDBG)—Chaz Bates
Mayor Higgins opened the public hearing at 7:01 p.m. Economic Development Specialist.Bates said he is
here to discuss the CDBG funding and led Council through his slide presentation, stating that Spokane
Valley is a subreeeipient of funding through the Spokane County Urban Consortium. He said staff has been
looking at sidewalk projects for consideration and have identified two projects, Wilbur from Boone to
Broadway and Knox from Sargent to Hutchinon. Mayor I 1 iggins invited public comment and seeing none,
closed the public hearing at 7:05 p.m.
4. Motion Consideration: CDBT Grant Projects—Chaz Bates
It was moved by Deputy Mayor Woodard and seconded to authorize 81afi to prepare and.submit CDBG
applications for the proposed sadewa//k projects Wilbur{ load from Boone to Broadway Avenue (west side),
and Knox Avenue from Sargent to Hutchinson Avenue and to designate the Wilbur Road from Boone to
Broadway Avenue (west side)project as the top priority of the two,Economic Development Specialist Bates
said Council just held the public,hearing fbr CDBG funding and the motion designates the Wilbur project
as the priority and the Knox project as secondary. Councilmember Collier asked if there were additional
responses to the postcard mailing and Mr, Bates responded that we received no additional responses.
Couneilrncmber Munch asked why Knox would be put secondary considering it has higher traffic volume
and Councilme]nher Haley responded 'hal Wilbur is designated a"safe route to school"so it should be the
primary project.Deputy Mayor Woodard said sidewalks are an exception to the rule by HUD(Housing and
Urban Development) in Spokane Valley and while he likes both projects, he put priority on the"safe route
to school"project. Counciltnember Pace said he lives in a neighborhood without sidewalks and he hopes it
never gets them and he said he would also like HUD to go away and he would like us to stop taking money
from ITU D so he will vote no. Vote by Acclamation,- In favor: Mayor Higgins, Deputy Mayor Woodard,
Councilren ers Wood. C;olfier, Haley and Munch_ Opposed: Councihnerber Pace. Motion car'r'ied
5. CONSENT AGENDA: Consists of items considered routine which are approved as a group, Any
member of Council may ask that an item be removed from the Consent Agenda to be considered separately_
Proposed Motion:I move to approve the ConsentA„eenda,
a.Approval of claim vouchers on Oct 24, 2017 Request for Council Action Form,Total: $857,864.22
h. Approval of Payroll for Pay Period Ending October 15,2017: $349,469.14
c. Approval of October 3,2017 Council Meeting Minutes, Study Session
d.Approval of October 10, 2017 Council Meeting Minutes,Formal Format
It was moved by Deputy Mayor Woodard, seconded and unanimously agreed to approve the Consent
Agenda.
OTHER NEW BUSINESS:
6.. Second Reading Ordinance 17-012 Amending Procurement Code—rrik Lamb
After Deputy City Clerk Koudelka read the ordinance title, it was moved by Deputy Mayor Woodard and
seconded to approve proposed Ordinance 17-012 amending chapters 3.35. 3.40, 3.41, ,3.42, and 3,46
SVMG, Deputy City Attorney Lamb said this is the second reading of the ordinance and he said the City
adopted purchasing revisions in 2015 that became effective in 2016. Mayor Higgins invited public
comments_ I.y{nn Pleggemeier, Spokane Valley; said three months ago he mentioned to Council that the
Minutes Regular Council Mading; 10-24-2017 Page 3 of 7
Approved by C:nuicil_ 11-14-2017
City does business in so many parts of the community that they need a central procurement office. He said
it would benefit taxpayers to he able to go to the procurement office to see what we are buying and what
we are doing with contracts and he would like Council Ia establish a central procurement office.
Vote by Acclamation: In favor: Unanimous. Opposed. None_ Motion carried.
7. First Reading Ordinance 17-014 Adopting 2018 Budget—Chelsie Taylor
After Deputy City Clerk Koudelka read the ordinance title, it was moved by Deputy Mayor Woodard and
seconded to advance Ordinance 17-014 advancing the 2018 Budget to r seeot d reading, Finance Director
Taylor said Council has heard presentations five times prior to this evening and in this sixth presentation,
Council is asked to consider moving this ordinance forward to a second reading. Ms. Taylor outlined one
change not included in the packet materials, which is an increased tax estimate on new construction from
$125,000 to $150,000 because the County's values do not include administrative adjustments,refunds and
other such items. She said this change increases the budgcled tax revenue in the current materials by
$25,000 and she said that change will be included in the materials for the second reading of the ordinance.
Ms. Taylor then led Council through the information provided on the RCA.
Councilmember Pace asked what do we assume the inflation rate will be and Ms. Taylor said she used an
estimate of two percent. City Manager Calhoun said we will provide the CPI from the Bureau of tabor
Statistics when the ordinance comes back for a second reading_ Mayor I liggins invited public comment:
Peggy Doering, Spokane Valley: asked how many readings the City does for the budget and City Manager
Calhoun answered that Council sees the budget on eight different occasions beginning at the June budget
workshop and ending at the November adoption. 1 le said during that time there are three public hearings.
Ms, Doering then asked if the roof was repaired at CCenterPlace and Mr. Calhoun responded that it was.
Councilmember Pace thanked Ms. Taylor and stafffor holding the spending growth lower than the inflation
rate. Vote by Acclamation In favor: Unanimous_ Opposed: None.. Motion carried.
8. Motion Consideration: Allocation of Funds to Outside Agencies-Chelsie Taylor
Based on a written recommendation received from each Councilmember, it was moved by Deputy Mayor
Woodard and seconded to award 2018 Outside Agency funding as follows: Greater Spokane Valley
Chamber of Commerce - $17,694; Spokane Valley Arts Council - $30,708; Spokane Valley Heritage
Museum - $3,500• Spokane Valley Summer Theatre - $2,357 Valleyfest - $28..122; Family Promise of
Spokane-$4,607,-Greater;Spokane County Meals on Wheels-$15,266;Hearth Homes(Naomi) 820,000;
Spokane Valley Partners - $17,623; and Widows Might - $10,123, Finance Director Taylor said the City
has historically provided funding for local social service and economic development agencies and we
provide the funds to agencies upon proof of their expenditures. She said the allocations are summarized in
the agenda packet and pointed Council to item 8 of the RCA which describes a new step in the distribution
process. She said Council is asked to give a collective funding allocation in determining what agencies
receive in funding. Mayor Higgins invited public comment; no comments were offered_ Vote by
cclaraaatiora;Irr favor: Unanimous. Opposed: None_ Motion carried.
PUBLIC COMMENTS: Mayor Higgins invited public comment:
Nina Fluegal, Spokane Valley: addressed the City Manager and Deputy City Manager for connecting her
with Shane Arlt in managing the fixing of the road adjacent to the apartment complex and said she is
extremely pleased and grateful. She said this was in the making for three years and it is finally done. She
then said there are fire trucks going down 4th at high speed and they should use the arterial on 8th, she said
she would like to know who to contact about this, She said the traffic count on her road was 12,000, the
speed limits arc broken and it is.difficult to walk down her street. She said the intersection at 4th and Blake
could be a four-way stop or some other measure could be taken to hells the intersection.
Mayor Higgins called for a break at 7.°35 pan. The meeting reconvened at 7:45 p,m.
Minoles B.egular Council Meeting: 10-24-2017 Page 4 of7
Approved by Council: 11-H-2017 1-2017
ADMINISTRATIVE REPORTS:
_ Pines Grade Separation--John Hallman
Deputy City Manager Hallman introduced two representatives from the project design team, Kurt Reichelt
and Scott Marshall, here to discuss the Phase 1 development of the Pines Grade Separation project. Mr.
Reichelt said he is the project manager from l-1DR and he went through the slide presentation and the four
alternatives.
Alternative 1 — Signalized Intersection: Mayor l liggins asked how long this alternative would take to
construct and was told they estimated twenty-four months for construction. Councilmember Collier asked
why it is necessary to close the crossing at University. Council was told it is not required to close the other
crossings,but it is a request as we negotiate the contracts that some crossings are closed when improvements
are made to others, Councilmember Munch said his concern with lowering Trent is that they may hit
bedrock and when he asked if they tested for any of that he was [old it was considered and included in the
cost estimate. In response to Councilmember Haley's question, it was confirmed that sewer and water line
would also need to be lowered and that was also included in the cost. Councilmember Munch said we have
to have permission to build bridges over the railroad and BNSF could deny a new bridge if we do not meet
their requests. Mr. Reichelt said typically a grade separation project provides the railroad with an
opportunity to close other crossings but it is more of a negotiating point than a requirement_ Deputy Mayor
Woodard asked if other closures could be tied together to help make a quiet zone through the area. Mr.
Hohman said as we move forward that is a concern and in holding the public meetings, they are hoping to
receive input on those areas. He said another player in this process is Washington Department of
Transportation (WSL YI) to make sure traffic flow is appropriate on Trent and part of that is to reduce the
crossings to reduce impact at those intersections.
Alternative 1- Roundabout: Mr, Reichelt said we would maintain access to businesses but construction
would take twenty-four months. Councilmember Munch asked how much we would have to reduce traffic
speed through the roundabout; Mr. Reichelt said speeds would be reduced to 35 mph through the
roundabout. Councilmemher Collier asked if there are concerns with semi-trucks or plows going through
the roundabouts and Mr. Reichelt responded that he thinks this was taken into consideration in the design.
Mr. Hohman, in response to Councilmember Pace's questions regarding fog and visibility, said the
roundabout will have signage and illumination and the approach will he channeled for navigation. He said
these will be large roundabouts and should accommodate snowplows. Mr. Marshall confirmed the
roundabout will have wide lanes for large semi-trucks. Counciltnember Collier said he thinks it looks like
it would have potential for El ecideni s. Mr, Marshall responded that citizens could likely use some education
in navigating the lanes because there are not many roundabouts on the cast side of the state; however, he
said there are several on the west side and drivers just need to familiarize themselves and get in the
appropriate lane to get to where they are going, Engineering Manager Mantz said there is a similar
roundabout being constructed in Airway Heights.
Alternative 2 Signalized Intersection: Councilmember Munch asked about the duration ot'the impact to
Trent and Mr. Reichelt and Mr.Marshall said that because there is no elevation difference it greatly reduces
the construction time and impact to Trent. Councilmember Wood asked if arrangements would be made
regarding the property abandoned due to the realignment of Pines, Mr. Hohman said much of the land that
would he impacted is already owned by the railroad, but some is owned by the school district and the City
pre-purchased some of the land from Pinecroft LLC.
Alternative 2 Roundabout: During discussion of this alternative and the Vista and University closures,
Ms, Martz said staff received mixed reactions from citizens at the open house meeting. She said those that
were opposed to closing railroad crossings were st+{ongfy opposed. Mr. Marshall said those who wanted the
closure of the University crossing were strongly for the closures, so both sides were strongly held opinions
by the community. Councilmember Collier said during his research, he only found three fatalities at the
Minutes Regular Council M.eeti rig: 10-24-2017 Nge 5 of 7
Approved by Council: 11.14-2017
crossings going back ten years so he said he does not think they are unsafe. Councilmember Munch asked
if crossings could be reopened once they have been closed. Mr. Reichelt said he has never seen them
reopened, He said grade separations are guaranteed.sate crossings of the tracks and they are done to move
more trains. Deputy Mayor Woodard said safety is also impacted by derailments of trains coming from
aceiden[s and those could contaminate the aquifer, which would ereale a cleanup nightmare. Mr. Holman
said he can look into traffic accident counts, but it is not just car vs. train accidents, but also car vs. car
accidents due [0 ears [rying to beat the gate or stopping suddenly; he said there arc other accidents to
consider at.these crossings. Comic ilmerubor Wood said with the elimination of the crossings the noise from
the horns and the trains would also be eliminated. He said he gets several complaints about the train horns
so he said he thinks l here is an advantage to closing those crossings. Couneilmetnbcr Haley said her concern
is that the citizens still have easy access out of their neighborhoods if those roads are closed.
Councilmember Pace said [here are other alternatives to [rain horns. Mr. Hohman said the University
crossing is a current quiet zone but that does not mean trains always retrain from blowing their horns. Iie
said closing the crossing eliminates the horn noise. Councilmember Munch said he would like staff to
research the impacts of not closing the other crossings anti, he said, as the city is growing he would Iike
staff to research having them open to accommodate that future growth.
Mr, Hohman said WSDOT prefers roundabouts and the results of the open house showed that the preferred
alternative was the Alternative 2 Roundabout due to the lower cost and the lower impacts to Trent.
Councilmember Collier asked how much money the City might save if we selected this alternative now
without I IDR finishing its analysis of Alternative 1. Mr. I Lohman said there would not he much cost savings
because most of the funds have already been expended. He said we could possibly save around twenty
percent and that he will try to find out and bring the i nthrrnaation hack to Council, Deputy Mayor Woodard
said he thinks it is worth.doing the studies because that step could increase some of the grant funding from
WSDOT awarded to do the project rather than the City footing the whole bill. He said that WSDOT likes
roundabouts and we need to work with them on these protects. Mr. I Lohman said that is a good point and
Pines is also owned by WSDOT and with regard to funding he said we have worked diligently with WSDOT
to develop a strong relationship and he suspects they would want the analysis to be completed.
10. Barker Grade Separation—John Hohman
Deputy City Manager l lobman introduced Greg 1 lolder from DEA who walked Council through the slide
presentation for the five alignment alternatives for the Barker Grade Separation project. Ceuncilmember
Munch asked if the railroad will pay more money if we close two crossings as opposed to closing one_ Mr.
holder said that calculation is based on the portion of the right-of-waay. Ms. Man[z said they calculate five
percent so they would pay five percent of the two closures rather than five percent of just one elosurc.
Alternative l; Councilmember Collier asked if Barker Road would continue to the Bayou Tavern and it was
confirmed that it would. Couneilmember Collier said [his al[emative will mean the City has Iwo Barker
roads to maintain.
I1 =yrs inovr l by Deputy Miwur Ff ooc rvt'd, set:Funded and lr ianarnoarsfy agreed to extend the meeting/0.9:30
prm.
Albcrnativc 2: Deputy Mayor Woodard asked if by going further east with this alignment alternative whether
that starts to put more stress on Flora to remain open. Mr. Holder said possibly a little but not a lot. He said
the "Out of Direction" impacts will be looked at as they continue their analysis as well as the impact on
Flora and the other crossings.Alternative 3: Mr. Holder said construction of an underpass has a higher price
tag than the overpass.Alternative 4: Mr.Hohmata said while the price is attractive,this alternative does not
solve the problem. I Ie said it.just moves it down to Flora so we would likely be back in five years looking
for money to fix the problem we just created at Flora. Alternative 5: Couneilmember Collier said he likes
this option and Deputy Mayor Woodard said it would be similar in elevation to I lavana_ Councilmember
Munch asked what the lifespans are on the Wellesley bridges. Mr. Marshall said the bridges still have
Minutes Regular Council Meeting: 10-21-20 l7 Page of 7
Approved by Council] 11-14-2017
•
sip-ill-leant life an them and they have nice shoulders, Counei.imembcr Munch said it is a confusing
intersection but it has good structures. Mayor I liggins said it looks like the intersection gets more confusing
with this option.Mr.Holder said emergency responders like[he intersection and it improves response times.
Ile said we can improve the signage in the area to decrease driver confusion. Mayor I I iggins said it appears
Alternative 5 is prefeneed and Mr. Holder responded that WSDOI also likes Alternative 5. Deputy Mayor
Woodard said this alternative came from WSDOT and with the cost factor and property alignments it
appears to be the best. Councilmember Pace asked what the next most favorable option was and Ms. Mantz
said that based on the feedback a[ the public meeting, people liked al[erna[ives 1 and S. However, she
pointed out that half of the people at the meeting were from the Highland neighborhood and that Alternative
1 would improve access on Del Ray into the neighborhood.
it was moved by Deputy Mayor Woodard, seconded and u€nantniously agreed to extend the meeting to 9:45
p.m.
11,Police Dept. Monthly Report—Mark Werner
Chief Warner said that, in being brief with his report, SCOPE contributed 184 on-scare hours and be said
next month's report will have the baseline set for UCR (Uniform Crime Reporting) data, so they will he
comparing UCR data to UCR data. He then asked if Council had any que.s[ions that he might answer;
Council had no question&
12, Advance Agenda—Mayor Higgins
Councilmember Pace said that with regard to the concerns brought up during public comments relating to
the speed and traffic on 4th, he would like a [hree-part report from the fire depar[ment, police department
and traffic engineers providing data analysis. It was the consensus of Council to add this to the Advance
Agenda. Councilmember face said he would also like information on the city's streetlights (illumination):
who owns thein,how much they cost to operate,and who detcrm ines where they go. City Manager Calhoun
said we will follow up on that.
13. INFORMATION ONLY: The Department Reports were not reported or discussed.
CITY MANAGER COMMENTS
Mr_ Calhoun said that tomorrow at 2:110 p.m., the Spokane Valley Arts Council will hold a ceremony for
the art sculptures oulsidc City Hall. He also pointed out the letter crafted by Mayor Higgins ho Governor
Insley in support of renaming a portion of Pines to the Sam Strahan Memorial Highway and Council
concurred to sign and send the letter as drafted.
It was moved airy Deputy Mayor Woodard, seconded and unanimously agreed to adjourn. The meeting
adjourned at 9:32 p.m.
je f _
ATT S '. L.R. Higgi _
. . 116--al. stirjALAI c
. ristine Bainbridge,City Clerk
Minutes Regular Council Meeting: 10-24-2017 Page 7 of 7
Approved by Council: 11-14-2017
SPOKANE VALLEY CITY COUNCIL MEETING
Tuesday, October 24, 2017
6:00 pan. Regular Meeting
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6:00 .nm. Regular Meeting
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Spokane Valley Draft Mission Statement
offered October 1Q, 2017 and again on October 24, 2017
Our City Council shall provide visionary leadership in policy making that
supports: Our Mission, Our Vision, and Our Values
OUR MISSION
The City of Spokane Valley
Promotes social, economic, environmental and cultural well-being of the
community,
Ensures that resources are used efficiently and effectively as well with
transparency and accountability in decision-making,
Provides the prudent use and stewardship of local community resources,
so that the citizens of Spokane Valley may realize the best quality of life possible
through cost-effective governance.
OUR VISION
To accomplish this mission, city government is committed to provide citizens
with:
• A safe and clean community
• Efficient, effective, transparent, and quality city services.
• Infrastructure of adequatecapacity to accommodate present and future needs.
• Diverse opportunities for recreational, cultural, and economic development,
• A well-managed and fiscally sound community.
OUR VALUES
In all respects, city government is dedicated to accomplishing its mission
through:
▪ Professionalism
• Pride
• Service
• Fairness
•
Accountability
This draft mission statement was written using the statements from Marion,
Iowa; Pullman, Washington; and the Spokane Valley Governance Manual.
Submitted by
Rev. Genavieve Heywood
Pastor
Veradale United Church of Christ
611 N Progress Road
Spokane Valley, WA 99037
Vision for the City of Spokane Valley
Reading through your budget, I continue to have concern about this Council's
vision for our city. A budget needs to reflect our values and our hopes for the
citizens of this community that are here now and yet to come. I see a budget
that keeps the states quo or meets immediate needs. I do not see a budget that
envisions a quality of life that will encourage young people to stay as well as
attract ethers to make our city the place to Five, work, raise a family, and retire.
The Spokane has a vision to become a medical services city. They have been
working toward that vision. People who are science minded will need housing
and a variety of day to day services. Spokane Valley could provide the quality of
life where these science minded new arrivals can find exceptional schools,
quality roads, amazing power and wager services, attentive snow removal, and
safe neighborhoods where there is civility, respect, and accountability. We
currently are below our potential for creating that quality of life.
Consider, your mission. Take the draft mission statement and work with it. Read
it before every meeting to remind yourselves that you are temporary guardians
of the future.
Submitted by
Rev. Genavieve Heywood
Pastor
VeradaFe United Church of Christ
611N Progress Road
Spokane Valley, WA 99037
My name is Jaclyn Gallion.
There has been a lot of inaccurate talk about how exempt students
could somehow be a danger to immune compromised students.
First off, what pediatric oncologist or immunologist is telling parents
that school is a safe place for their immune compromised child?
Here is a Johns Hopkins immune compromised patient guide. Note that
it says IC patients should not touch communal surfaces- handrails,
elevator buttons, etc. How safe could a school drinking fountain be?
it recommends that IC patients wear an N-95 mask when in any public
place. To avoid a crowd- which it defines as people within arm's length.
it directly warns against being around recently vaccinated people. Do
the schools currently notify immune compromised patients when their
classmates are recently vaccinated?
Next is a medication guide for the immune suppressing medication
Stellara. This guide warns against being exposed to the recently
vaccinated.
Last is a copy of the WA DOH list of over 60 notifiable health conditions,
most are contagious and very few are even theoretically vaccine
preventable.
On the list of notifiable conditions is `vaccinia transmission" which is a
person becoming infected by contact to someone who has had a recent
smallpox vaccination, normally being military personnel. The WA DOH
recognizes vaccination provoked infection to be a real event.
Considering the widespread risk that an immune compromised student
would be exposed to in the uncontrolled environment of a school it is
responsible to have them enrolled until they are healthy?
Do non-vaccinated children place other children at risk?
1) Given all vaccine inserts list side effects directly or indirectly associated with death, it's safe to state
that vaccinated children are the ones placed at some level of risk.
2}Vaccines, made from live or attenuated viruses, have been shown to facilitate the targeted disease
after vaccination. Meaning, all vaccines are capable of causing the disease it targets.
3) How can anyone be afraid of disease, using that fear as a battle cry to vaccinate themselves and
others, but not he afraid of the same diseases caused by the vaccine? illogical ideas are what place
children at risk.
4} How can anyone he afraid of death from disease but not be afraid of death from a vaccine, when
each vaccine lists death as a direct or indirect side effect?
5) There Is no guarantee that all viruses are dead, inside non live virus vaccines. This is a guess at best
and this is also why any and all vaccines hold the potential to trigger the targeted disease.
6} Many vaccines warn of virus shedding, which means the virus can be given life Inside a live host(the
human), making the person sick and then spreading that virus to others.
7} it obviously doesn't make any sense that someone believes in vaccines yet believes a non
vaccinated person can infect the vaccinated with disease. If someone believes in vaccines, it means
they believe they're immune to the disease after vaccination, so by being afraid of non vaccinated
children they're actually declaring they don't believe in what they say they do. Non logical debate and
irrational ideas place children at risk,
8}The majority of disease outbreaks recorded since vaccination began, have clearly documented that
most people getting sick and dying of the targeted disease are the ones who have already been fully or
partially vaccinated against that disease.
9) Independent studies have confirmed that non vaccinated children are dramatically healthier in all
measurable areas of vitality,
10}With no vaccine ever being proven to increase immunity in real world populations and many
disease outbreaks occurring among the vaccinated It Is likely that those vaccinated put others at risk
more than those that are not.vaccinated.
There are many non-vaccinated children in my town and every town, in America. Those non-vaccinated
children are registered as "non-vaccinated"with the government. So why doesn't the government
study the non-vaccinated children to prove to EVERYONE that we made the wrong choice? You already
know the answer...
Johns Hopkins warns that the vaccinated
are a threat to the immunocompromised Pace 1 of 4
The Johns Hopkins Hospital Patient patient gucdc
Information ' 'x''
WO 774.;
Care at Home for the it 1
Immunocompromised Patient .
What can I do • Hand washing is the best way to prevent ,, 1
to prevent infection. '
Carry hand sanitizer with you at all times.
Infection?
• Wash with soap and water or hand sanitizes -,, ' ,,
-before and after you use the bathroom -
Should an IC child really -before and after preparing or eating food
be in the uncontrolled -after touching pets or animals
environment of a -after contact with someone who has an infection such
public school or other as a cold or the flu
public spaces? -after touching surfaces in public areas (such as
elevator buttons, handrails and gas pumps)
Wear an N95 respirator mask when you travel to and frons
Dolneedto p
CI---"Do
a mask? the hospital, when you are in the hospital, within two football
fields of construction or digging, and in any public place.
• Close all car windows and turn on the re-circulate button of
your ventilation system.
• Avoid crowds if possible. An area is crowded if you are
within an arm's length of other people.
▪ Avoid closed spaces if possible.
Can I have • Tell friends and family who are sick, or have recently had a
visitors? > live vaccine (such as chicken pox, measles, rubella,
intranasal influenza, polio or smallpox) not to visit.
• it may be a good idea to have visitors call first.
• Avoid contact with children who were recently vaccinated.
Are there any • Do not take aspirin or aspirin-like products (such as AdviF"" ,
precautions I MotrinTM or Excedrintm1) unless told by your doctor.
ou should wear a medical alert bracelet that identifies you
Are schools currently a cancer patient or bone marrow transplant patient at risk
notifying IC families when r bleeding or infection.
fellow students have been eep a current medication list with you at all times.
recently vaccinated o not take any herbal products.
with live viruses? void grapefruit juice, which interacts with many
medications.
0965 02008 The Johns Hopkins Hospital
e
Immunizations http://www.rxlist.com/steIara-drug 'warning -prectiutlons.htrn
Prior to initiating therapy with STELARAG . patients should receive all
immunizations appropriate for age as recommended by current
immunization guidelines. Patients being treated with STELARAG should not
receive live vaccines_ BOG vaccines should not be given during treatment
with STELARAS or for one year prior to initiating treatment or one year
following discontinuation of treatment. Caution is advised when administering
live vaccines to household contacts of patients receiving STELARAS
because of the potential risk for shedding from the household contact and
transmission to patient_
Non-live vaccinations received during a course of STELARND may not elicit
an immune response sufficient to prevent disease_
What should I tell my doctor before receiving STELARA®?
hBefore you receive STELARA', tell your doctor if you:
il
■ have any of the conditions or symptoms listed in the section "What is the most
1 important information I should know about STELARA®'?"
• ever had an allergic reaction to STELARA'. Ask your doctor if you are not sure.
• are allergic to latex. The needle cover on the prefilled syringe contains latex_
• have recently received or are scheduled to receive an immunization (vaccine).
People who take STELARA' should not receive live vaccines, Tell your doctor if
anyone in your house needs a vaccine. Theme es used in some types of
vaccines can spread to people with a weakened immune system, and can cause
D: 3464280
http://www.fda.govidownloadsidrugsidrugsafety/ucm187066.pdf
serious problems, You should not receive the BCG vaccine during the one
year before taking STELARA® or one year after you stop taking
STE LARA► .
wrash pillar"
frTI
Reporting Notifiable
Conditions H E 4 L 'H CARE PROVIDERS
Notifiable to the local health jurisdiction (LHJ) of the patient's residence
Phone numbers by LI-LI are listed on the ether side orchis power.If unable to reach tha LHJ orahe patent's residonoo,pk:ae call: 1-877-539-4344
LI!IMMEDIATELY NOTIFIABLE:#2equires a phone call to reach M Notifiable within 2. Requires a phone call if
a live person at the local health jurisdiction,2417 reporting after normal public health business hours
Must be repuried is sof n,:i;CUR lcallyausproted Eru Il]5i5
Animal bites,when human exposure to rabies Is suspected Hantavirus pulmonary syndrome
Anthrax Flepatllls A, acute _
Bolaillsin.(foodberne,wound and infant) 1411114fitille.mut. This list of infections demonstrates that
Srrrkitoldorfe naeiierl(,glanders)and psetadomaiief(ttme511oldpsis} HePatiltis E.acute an immune compromised'student has a
Cholera Legionellosis myriad of concerns.beyond the
DiphtheriaLeplcupirosis school vacclnffatriawentabie diseases.endance lly
LlSfierilerivsis r preventable
Dlseese of suspected faloIarrorlem origin Mumps acute
Dui-nolo acid poisoning lam nes fc shellfish poisoning) . Peduuraa
E.coli-refer to"Shiga lox in-producIng E, coil infections'. i Psittacosis
Emerging condition with outbreak potential ' Cr fever
iNeerniephiius infivaitzare(Inv AS IVO disease, children<5 years Relapsing fever{tzerrelinsls}
Salmonellosis
:Influenza, novel or unsublypable strain
Shigellosis
ifaleaatles(rubaois ,acute Vancomycin-resistant SIaphyk3rvccus aureus(not to include
Meningocci o&disease{invasive} Vancomycin-intermadiate)
Monkeypox Vibriosis
Outbreaks of suspected foctlborne origin Y@rsirtlosls
Outbreaks of suspected waterborne origin Other rare diseases or public health significance,including but
not limited lo:
Paralytic shellfish poisoning Amoebic ingilis
Anaposie
Pesticide poisoning—hospitalized,fatal,or cluster: Babesiosis
1-000-222-1222 Carbepenernese.prptrudl Carbepene -iesistent
Enlerohaderieeeae Orn
CRE}
Plague Chagas disease
'Poliomyelitis Cnccidioidornycasls
Cryprococetts OW
RAN'es,confirmed human or animal Etiehlvsis
Histoplasmosis
Rabies,sue pecked human exposure shellfish poisoning(diarrhetie)
T¢kbome rickeusloses(ir ludinrg Rocky Mountain spatted fever)
Rubella(Include congenital rubella ayndromel,acute Tick paralysis
SARS(Severe Acute FlospIratory Syndrome) Typhus
Shiga toxin-producing E.coif infections{STEC,including but Unexplained txiUCal Illness and rleaaih
riot limited io E coif 0157:H7;also includes post-dlarrhealCI Notifiable within 3 business days
hemolytic 1rremic syndrome)
Smallpox Acquired immunudeFcienccyy syndrome(AIDS),Including in persons
previously reported with HIV infection
Tubercutosis Arbre,rirel disease(ecule disease only, Including;West Nile virus,
Tularemia - (Angue,eastern a western equine encephalitis,Zile,etc.)
Vaccinia transmission This is a vaccinated person Campylobacterlosis
Shadding virus, Chane rata
Viral hemorrhagic fever Infecting a contact.
Crlarrryaie frachcsrtraafds Infection
Yellow fever
Cryplosperiidissis
Cyclosporiasis
ihtlfiuble on a monthly basis Glareliasls
Asthma,occupational(suspected or confirmed);1-9B8-8-SHARP Gonorrhea
Birth clefects:3BD.236.3573 Granuloma inguinale
{o u tlsrn speoirurn disorders.cerebral palsy,alort al•related nth • Hepatitis B,surface antigen positive pregnant woollen
darecte) Hepatitis C,acute
Hepetilie F,chronic(initial rllagnesislprevieusly unreported cases} Hepatitis D,acute and rhrrrriG
Herpes simpreat,neonatal nand genital{initial infoGfon only)
Hetipalitts C.,chronic Fitt/infection
limmunizalien reactions(severe,adverse)
The co+ditiorrs listed above are noliIieble to public health mt1YtbPIlitt in t Infltaen za•ass4t�a[lei death.laborato firmed
accordancewvilh Wr4C 245.10,1, r i
Lyrna disease i.
• ReVoilIDtheIDcnlhearth lurledictiorrarmy perarrramilldams within(hi 0 fa
iiiinrigung Nucoted{a spa her t nnedipne reallpteed by a wafting pttrrie YriM1 pl1 nutoma venereum
nurntaer), Malaria
• 'OIherrano 5ofpublic health slgnnica,tpe'rrreensedlaesseerOM- Pesticide poisoning- nomhospiterized,non-fatal,nen-cluster:
akin.of geeerel or IntmrHonal public hearh i rt,which ht occarr nail. 14Oe.222.1222
ly of net eidie0tIlliela Irl the Meth or wnkr;n U i.aar.u.but„ot ttnitt*1 Arian disease,including Creutzfeldt-Jakob disease(CJD(
tzs.•spoiled short rkrti.ttalo la,balruiauet,illi earehmai,eruPlaemrde,wt Syphilis{inctuding congenital)
other tacit barna.dseuses.nil else Irek.s s vubdic i eetai*ewes of Werra- Tatsnuei
Itunel emcee"rrrwl urmrnietic.ble rterarm 00 would ha or prow mime
Trichinosis
concern Ii delecied In Waehlegiee.
ar■tfcelit>E-es•ci sieddeath
fix'wire information,see yeas 246-.101 or hlrolaysstu duh wa.aphTutilir.Hrel-hanC11,altrli F.-r.='ni4iricrs&crlifiebleCcit taon$,;espar DOH 210-001(Ree,1111$}
}
I N
Ifr rmE+I C n nt A.c?ion Notom(c.
VIA FEDEX
October 12, 2017
U.S. l7epariment of Health & Human Services
HHS Office of the Secretary
Eric D.IIargan
Acting Secretary of Health& Human Services
2(]0 Independence Avenue,S.W.
Washington,D.C. 20201
Re: HHS Vaccine Safety Rrsponsibilitirs rmd Notice Pursuant to 42 U.S.C, §300aa-3i
Dear Secretary Hargan:
Informed Consent Action Network hereby provides notice per 42 U.S.C. § 300aa-31(b).
Americans, including the over 55 organizations listed below, whose members exceed 5
million Americans, are concerned about vaccine safety, The National Childhood Vaccine Injury
Act of 1986(the 1986 Act) made nearly every aspect of vaccine safety the exclusive responsibility
of the Department of Health&Human Services(111-IS). As the Secretary of 1-11-IS(the Secretary),
this means you shoulder virtually all responsibility for assuring the safety of vaccines
administered to America's 78 million children.
This notice respectfully requests confirmation that certain obligations regarding vaccine
safety required under the 1986 Act have been fulfilled or will forthwith be fulfilled. These specific
requests are numbered sequentially in this notice. We would welcome the opportunity to meet
and discuss reasonable means for complying with these requests. If that is not possible,the 1986
Act authorizes "a civil action ... against the Secretary where there is alleged a failure of the
Secretary to perform any act or duty" under the 1986 Act.
I, Backg!pund.
The 1986 Act granted economic immunity to pharmaceutical companies for injuries
caused by their vaccines. (42 U.S)C. § 300aa-11.) The 1986 Act thereby eliminated the market
force which drives safety for all other products — actual and potential product liability,
Recognizing the unprecedented elimination of this market force,the 1986 Act makes I lI-I.S directly
responsible for virtually every aspect of vaccine safety. (42 U.S.C. §§300aa-2, 300aa-27-)
1
When the CDC recommends a pediatric vaccine for universal use, i.t creates for that
vaccine's maker a liability free market of 78 million children typically required by law to receive
the vaccine. The number of required vaccines has grown rapidly since 1986. In 1983, the CDC
recommended that babies under one receive two vaccines:DTP and Polio.' As of 2017, the CDC
recommends that babies under one receive multiple doses of ten vaccines: DTaP, Polio, Hep B,
Rotavirus,Hib,Pneumococcal,Influenza, MMR, Varicella, and Hep A.2 In total, the current CDC
childhood vaccine schedule includes 56 injections of 73 doses of 30 different vaccines.
II. Deficiencies in the Pre-Licealsu re Safety Review of Pediatric Vaccines
All drugs licensed by the FDA undergo long-term double-blind pre-licensure clinical
trials during which the rate of adverse reactions in the group receiving the drug under review is
compared to the rate of adverse reactions in a group receiving an inert placebo, such as a sugar
pili or saline injection. For example: Enbrel's pre-licensure trials followed subjects up to 80
months and controls received a saline injection.? Lipitor's pre-licensure trials lasted a median of
4.8 years and controls received a sugar piI1,1 Botox's pre-licensure trials lasted a median of 51
weeks and c n trols received a saline injections And even with these iong-term studies,drugs are
still often recalled.
in contrast, vaccines are not required to undergo long-term double-blind inert-placebo
controlled trials to assess safety. In fact,not a single one of the clinical trials for vaccines given to
babies and toddlers had a control group receiving an inert placebo. Further, most pediatric
vaccines currently on the market have been approved based on studies with inadequate follow-
up periods of only a few days or weeks,
For example, of the two IIepatitis S vaccines licensed by the FDA for injection into one-
day-old babies, Merck's was licensed after trials that solicited adverse reactions for only five days
after vaccination and Glaxomithllines was Iicensed after trials that solicited adverse reactions
for only four days after vaccination.6 Similarly, the l zti vaccines sold by these same companies
were licensed based on trials which solicited adverse reactions for three and four days,
respectively, after vaccina tion.' 't'he only stand-alone polio vaccine was licensed after a mere 48-
hour follow-up period.8
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7 httpa;_J1www.cdc.gov voce• auslschedalmt.hcplinWellild-a[tD.tfi.9centJhnil
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2
Moreover, these trials either had no control group or a control group which received other
vaccines as a "placebo."9 This means each new vaccine need only be roughly as safe as one (or in
some rases numerous)previously licensed vaccines, Such flawed and unscientific study designs
cannot establish the actual safety profile of any vaccine. The real adverse event rate for a vaccine
can only be determined by comparing subjects receiving the vaccine with those receiving an inert
placebo. Yet, this basic study design, required for every drug, is not required before or after
licensing a vaccine.
"1iie 1986 Act expressiy requires [hatyou, as the Secretary, "shall make or assure
improvements in ,.. the licensing ... and research on vaccines, in order to reduce the risks of
adverse reactions to vaccines." (42 U.S.C. § 300aa-27(a)(2).) Given this statutory obligation:
(1) Please explain how HHS justifies licensing any pediatric
vaccine without first conducting a long-term clinical trial in
which the rate of adverse reactions is compared between the
subject group and a control group receiving an inert placebo?
(2) Please list and provide the safety data relied upon when
recommending babies receive the Hepatitis B vaccine on the
first day of life?
III. Post-Licensure Surveillance of Vaccine Adverse Events
The Tack of pre-licensure safety data leaves the assessment of vaccine safety to the post-
licensing period when they are being administered to children in the "real world." To capture
vaccine adverse events in the real world, the 1986 Act established the Vaccine Adverse Events
Reporting System (VAERS) operated by HHS, (42 L[.5. .. §300aa-25.)
In 2016, VAERS received 59,117 reports of adversevaccine events, including 432 deaths,
1,091 permanent disabilities,4,132 hospitalizations., and 10,284 emergency room visits.la
However, only a tiny fraction of adverse vaccine events are reported to VAERS. An III-IS-
funded
II IS-
funded study by Harvard Medical School tracked reporting to VAERS over a three-year period
at Ilarvard Pilgrim Health Care involving 715,000 patients and found that "fewer than 1% of
vaccine adverse events are reported." A U.S, House Report similarly stated: "Former FDA
Commissioner David A. Kessler has estimated that NAFFS reports currently represent only a
fraction of the serious adverse events."12
9 Mid.
IIhays iwnndNr.clic-rcvlv.]er .titrrkt
1whttns!llhoald,itmhr#1!-gcavfsitesldefaultifilos{AirsipuU[3mlirnnirl2}3i:kliv14.x-la7rru;-tituall' }>ar17:70,1,?dI
1/hiciwliwww,con€ross.govil061crptihro977f[_I 7-7U611rpi977,pdt
3
Assuming VAERS captures a full 1 percent of adverse events — which is more than is
estimated — the VAERS data above from 2016 may reflect that in that year alone there were
5,9.11,700 adverse vaccine events,including 43,200 deaths, 109,100 permanent disa[Al ilies,41.3,2{00
hospitalizations, and L028,400 emergency room visits.
Of course, these figures are merely estimates. It would be far better if adverse events
reports were automatically created and submitted to VAERS to avoid the issue of underreporting.
Automated reporting would provide invaluable information that could clarify which vaccines
might cause which harms and to whom, potentially avoiding these injuries and deaths.
The idea of automating adverse reaction reporting to VAERS is not new or even difficult
tv achieve) An agency within HHS, the Agency for Healthcare Research and Quality, sought La
do exactly that in 2007 when it provided an approximately $1 million grant La antomiate ERS
reporting at IIarvard Pilgrim Health Care,'¢ The result was the successful automation of adverse
event reports at Harvard Pilgrim:
•
Preliminary data were collected from lune 2006 through October 2009 on
715,000 patients, and 1-4 million doses (of 45 different vaccines) were
given to 376,452 individuals. Of these doses, 35,570 possible reactions ---
weree-ntaj ed.'5
These results should have been concerning to IIHS since they show that over only a three-year
period, there were 35,570 reportable reactions in just 376,452 vaccine recipients.
After automating adverse events reports atHarvard Pilgrim,the developers of this system
asked the CLIC to take the final step of linking VAERS with the Harvard Pilgrim system so that
these reports could be automatically transmitted into VAERS. Instead, the CDC refused to
cooperate. As the Harvard grant recipients explained:
Unfortunately, there was never an opportunity to perform system
performance assessments because the necessary CDC contacts were no
longer available and the CDC consultants responsible for receiving data
were no longer responsive to our multiple requests to proceed with testing
and evaluation.16
After three years and spending $1 million of taxpayers' money, the CDC refused to even
communicate with the IIIIS' IItarvard. Medical School grant recipients. Given HHS`s statutory
mandate to assure safer vaccines, it should have rushed forward with automating VAERS
reporting--not ignored the requests by the I-MIS's I Iaryard grant recipients-
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15 Md.
16 lbid
4
While ISIS strongly supports automating public health surveillance systems, when it
comes to vaccine safety,the CDC has only suppor[erlprojects that would limit VAERS to passive
surveillance." Automa tion would improve safety and address many of the long-standing issues
and limitations raised by CDC regarding VAERS.18 Capturing"fewer than 1%of vaccine adverse
events" thirty years after the passage of the 1986 Act is unacceptable -- and potentially deadly.
The 1986 Act expressly provides that you, as the Secretary, "shall make or assure
improvements in ... adverse reaction reporting ..-in order to reduce the risks of adverse reactions
to vaccines." (42 U,S.C. 300aa-27(a)(2).) Given this statutory obligation:
(3) Please explain why IIIIS failed to cooperate with Tlarvard to
automate VAERS reporting? And detail any steps that HHS
has taken since toward automating VAERS reporting?
(4) Please explain any specific steps taken by 1-1-HS to improve
adverse reaction reporting to VAERS?
IV. Identifying What injuries Are Caused by Vaccines
The first step in assuring safer vaccines is to identify what harms they cruse. `this would
normally be accomplished Are-licensure by long-term, inert-placebo controlled trials -but these
are never performed for vaccines. As for post-licensure monitoring,I H IS has refused to improve
VAERS as discussed above. IIence, assessing which vaccines cause which injuries is mainly left
to post-licensure studies. 1-5I-IS, unfortunately,has neglected to perform these studies.
In 1991, the Institute of Medicine(IOM)examined 22 commonly reported serious injuries
following the 1?`I1' vaccine.''' The Dm concluded the scientific literature supported a causal
relationship between the DTP vaccine and 6 of these injuries: acute encephalopathy, chronic
arthritis, acute arthritis, shock and unusual shock-like state, anaphylaxis, and protracted
inconsolable crying,2° The JOM, however, found the scientific literature was insufficient to
conclude whether or not the DTP vaccine can cause 12 other serious injuries:
Aseptic meningitis; Chronic neurologic damage; Learning disabilities and
attention-deficit disorder; Hemolytic iytic anemia;Juvenile diabetes; Guillain-
Barre syndrome; Erythema rnuifjforane; Autism; Peripheral
frrortaaieuropathy; Radiculoneur•it s and other neuropathies;
Thrombocyytopenia; Thrombocytopenicpurpura"
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is Ibid.
19It t}as,Jlwu,rE,111 . ,eco hir ;ti fl$I;+Jc4)klpterf247
Ibid.
3]Ibid-
5
The IONT Iamented. that it"encountered many gaps and limitations in knowledge bearing directly
and indirectly on the safety of vaccines" and on the poor design of the few existing studies.2z It
therefore cautioned,that:'If research capacity and accomplishment in this field are not improved,
future reviews of vaccine safety will be similarly handicapped."23
In 1994, the TOM issued another report which examined the scientific literature for
evidence that could either prove or disprove a causal link between 54 commonly reported serious
injuries and vaccination for diphtheria, tetanus, measles, mumps, polio, hepatitis B, and Hib.21
The IOM located sufficient science to support a causal connection between these vaccines and 12
injuries, including death, anaphylaxis, thrombocytopenia, and Guillain-Barre syndrome.25 The
IOM, however, found the scientific literature was insiaficient to conclude whether or not these
vaccines caused 38 other commonly reported serious injuries, including:
Demyelinatimg diseases of the central nervous system, Sterility,Arthritis,
Neuropathy„ Residual seizure disorder, Transverse r�� efftis,
Sensorineural deafness, Optic neuritis, Aseptic meningitis, InsuIi .-
cliTend nt diabetes mellitus, SIDSzs
As in 1991, this IOM Report again stated, "The lack of adequate data regarding many of the
adverse events under study was of major concern to the committee, Presentations at public
meetings indicated that many parents and physicians share this concern."27
In 2011, more than fifteen years after the IOM Reports in 1991 and 1994, HHS paid the
IOM to conduct another assessment regarding vaccine safe ty,26 This third IOM Report reviewed
the available science with regard to the 158 most common vaccine injuries claimed to have
occurred from vaccination for varicella, hepatitis 33, tetanus, measles, mumps, and rubellaY) The
I0M located science which "convincingly supports a causal relationship" with 14 of these
injuries, including pneumonia, meningitis, hepatitis, MTBE, febrile seizures, and anaphylaxis.3
The review found sufficient evidence to support "acceptance of a causal relationship" with 4
additional serious injuries_31
The TOM,however,found the scientific literature was insufficient to conclude whether or
not those vaccines caused 13.5 other serious injuries commonly reported after their
administration, including:
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27 https://www_I1 p_eduire-ad12138{CliapterIt2
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6
•ncephalitfs, Encephalopathy, Infantile Spasms, Afebrile Seizures,
Seizures, Cerebellar Ataxia, Acute Disseminated Eaac halomyelitxs,
Transverse Myelitis, Optic Neuritis, Neuromyelitis Optica, Multiple
Sclerosis, Guillain-Barre Syndrome., Chronic Inflammatory
LJemyelinatin, Polyneuropathy, Brachial Neuritis, Amyotrophias Lateral
Sclerosis, Snwll Fiber Neuropathy, Chronic Urticaria, Erythema
Nodosum, Systemic Lupus Erythematosus, Polyarteritis Nodosa,
Psoriatic Arthritis, Reactive Arthritis, Rheumatoid Arthritis, Juvenile
Idiopathic Arthritis, Arthral ia,Autoimmurne Hepatitis, Stroke, Chronic
Headache, Fibroinyalgia, Sudden Infant Death Syndrome, Hearing Loss,
T:romhocytopenia, Immune 7hrornbocytopenicP .rpura&2
Thus, out of the 158 most common serious injuries reported to have been caused by the vaccines
under review, the evidence supported a causal relationship for 18 of them, rejected a causal
relationship for 5 of them,but for the remaining 135 vaccine-injury pairs, over 86 percent of those
reviewed,the IGM found that the science simply had not been perfcrmed.38
The 1986 Act expressly provides that you, as the Secretary, "shall promote the
development of childhood vaccines that result in fewer and less adverse reactions" and "shall
make or assure improvements in ... the ... labeling, warning, ... and research on vaccines, in
order to reduce the risks of adverse reactions to vaccines." (42 I_F. .C:. §3OOaa-27(a)(2).) The first
step in reducing adverse reactions is identifying what adverse reactions are caused by vaccine.
Given this statutory obligation:
(S) For each of the 38 vaccine-injury pairs reviewed in the 1994
IOM Report which the IOM found lacked studies to
determine causation, please identify the studies undertaken
by the FJHS to determine whether each injury iscaused by
vaccination?
(6) For each of the 135 vaccine-injury pairs, reviewed in the 2011
IOM Report which the IOM found lacked studies to
determine causation, please identify the studies undertaken
by the HHS to determine whether each injury is caused by
vaccination?
Further to your duties to identify what injuries are caused by vaccines, the 1986 Act also
expressly requires you to"make or assure improvements in .,. the ,.. recall of reactogenie lots or
batches,of vaccines ,.. in order to reduce the risks of adverse reactions to vaccines" and thus each
"health care provider who administers a vaccine .,, shall record .,, in such person's permanent
32 Ibid.
33Ibid.
7
medical record ... the vaccine manufacturer and lot number." (42 U.S.C. §5 300aa-25(a), 300aa-
27(a)(2).) Since health care providers often fail to record this information:
(7) Please explain what HHS has done to assure that health care
providers record the manufacturer and lot number for each
vaccine they admin istet?
V. Identifying Which Children are Susceptible to Vaccine Injury
The JONI has consistently acknowledged there is individual susceptibility to serious
vaccine injuries. The IOM has also acknowledged that research on such susceptibility must be
done on an individual basis, considering a child's personal genome, behaviors, microbiome,
intercurrent illness, and present and past environmental exposure. HI IS, unfortunately,has not
conducted this research.
In 1994, the IOM, building on concerns raised in its 1991 report, stated: "The committee
was able to identify little information pertaining to why some individuals react adversely to
vaccines when most do not,"m The TOM urged that "research should be encouraged to elucidate
the factors that put certain people at risk."35
Yet, seventeen years later, in 2011, the 1010 acknowledged this research had still not been
done:
Both epidemiologic and mechanistic research suggest that most
individuals who experience an adverse reaction to vaccines have a
preexisting susceptibility, These predispositions can exist for a number of
reasons—genetic variants (in human or microbiome DNA),
environmental exposures,behaviors,intervening illness, or developmental
stage, to manic just a few—ail of which can interact.,.
Some of these adverse reactions are specific to the particular vaccine, while
others may not be. Some of these predispositions may be detectable prior
to the administration orf vaccinee._ much work remains to be done to
elucidate and to develop strategies to document the immunologic
mechanisms that lead to adverse effects in individual patients, 35
In 2013, H HS commissioned the I0M to review the safety of the entire vaccine schedule.37 The
TOM again explained that while "most children who experience an adverse reaction to
immunization have preexisting susceptibility," the 1 M:
34 htFpHjA WW.It o ps2duhvailf2138fchapteri12g347. Ser lain, }asa?'3 lvp,lop._duireadill#15icha1}hxi`
35 Ibid.
34 litips://www.iop.,edu/rialiii131.64,6thaptcr/5:1B2.
37 htiph://www.nap.2duiruadt13563)chapte r{1
8
found that evidence assessing outcomes in sub populations of children who
may be potentially susceptible to adverse reactions to vaccines (such as
children with a family history of autoimmune disease or allergies or
children born prematurely) wrrs limited and is characterized by
uncertainty about the definition of populations of interest and definitions
of exposures and outannes,311
HHS had failed to even define the terminology for the study of susceptible subpopulations and
hence IOM admonished I-fhIS to"develop a fra-mework (hal clarifies and standardizes definitions
of ,,. populations that are potentially susceptible to adverse events."
The IOM correctly points out in 2(17.1 that given the "widespread use of vaccines" and
"state mandates requiring vaccination of children ... it is essential that safety concerns receive
assiduous attention,"40 This is the same call for diligent attention that the IOM made in 1991 and
1994. Unfortunately, all of these calls for action have gone unheeded. The critical scientific
inquiry to identify individuals susceptible to serious vaccine injury has never been conducted.
The 1986 Act expressly provides that: you, as the Secretary, "shall promote the
development of childhood vaccines that result in fewer and less adverse reactions" and "shall
make or assure improvements in _.. the ... labeling, warning, .,. and research on vaccines, in
order to reduce the risks of adverse reactions to vaccines." (42 U.S.C. § 300aa.-27(a)(2),) Given
Ibis statutory obligation:
(8) Please advise when HHS intends to begin conducting
research to identifywhich children arae susceptible to serious
vaccine injury? If HHS believes it has commenced this
research,please detail its activities regarding same?
VI. Removing Claire "Vaccines Do Nat Cause Autism" from the CDC Website
TIIIS, unfortunately, has treated vaccine safety as a public relations issue rather than a
public health imperative, For example, the CDC claims on its website that "Vaccines Do Not
Cause Autism" even though this broad claim is plainly not supported by the scienti ft litera re.41
Indeed, as part of the iOM`s 2011 review of vaccine safety, it was asked by HIS whether
there is a causal relationship between autism and the 1_71`al' vaccine administered to children at
two, four, six, and fifteen months of age.° The IOM could not locate a single study supporting
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9
that i 'I'aI' does not cause autism-4' The iONT therefore concluded: "The evidence is inadequate
to accept or refect a causal relationship between diphtheria toxoid—, tetanus toxoid--, car acellular
pertussis—containing vaccine and autism."' The IOM's full explanation in its 2011 Report for this
finding is attached as Appendix B, In.fact, the only study the I0.M could locate regarding whether
DTaP causes autism, (Geier and Geier, 2004), concluded there was an association between DTaP
and autism:15 No research has been published since 2011 that could change the IOM's conclusion.
Based on the foregoing, the CDC cannot validly make the blanket assertion that there is no causal
relationship between vaccines and autism. The CDC nonetheless rlairrts on its website that
"Vaccines Do Not Cause Autism."
As with DTaP, there are also no published studies showing that autism is not caused by
Hepatitis 3, Rotavirus, IIib, Pneumococcal, Inactivated Poliovirus, Influenza, Varicella, or
Hepa ti tis A vaccines—ail of which NHS recommends babies receive, typically multiple times,by
one year of age 4s
Instead, HH 's claim that "Vaccines Do Not Cause Autism" relies almost entirely upon
studies exclusively studying only one vaccine, MMIR (which is administered no earlier than one
year of age), or only one vaccine ingredient, thimerosal;, with regard to autisr.47 Putting aside
the controversy surrounding. these studies, studies which focus on only one vaccine and one
ingredient while ignoring the entire balance of the CDC's pediatric vaccine schedule cannot
support the CDC's overarching declaration that "Vaccines Do Not Cause Autism."
As for the MMR vaccine, the CDC's own Senior Scientist, Dr. William Thompson",
recently provided a statement through his attorney that the CDC"omitted statistically significant
information" showing an association between the MIR vaccine and autism in the first and only
MMR-autism study ever conducted by the CDC with American children 49 Dr. Thompson, in a
recorded. phone call, staled the following regarding concealing this association; "Oh my God, i
can't believe we did what we did. But we did. It's all there. It's all there. I have handwritten
notes."5t1 Dr. Thompson further stated on that call
1 have great shame now when 1 meet families with kids with autism because I
have been part of the problem ... the CDC is so paralyzed right now by
anything related to autism. They're not doing what they should be doing
because they're,a afraid to look for things that might be associated- So anyway
1'https:fPwwwmap.aitt/a idf13ii4/ tapler/12
°'1 Ibi d,
as Ibid. Ironically,this study was disregarded"because it provided data from a passive surveillance systema, [VAERSI and lacked an
unvaccinated comparison population,"which would be true of any study using VAERS data,
l 1p5:1tiv+rw,cdc.payivaccinesf-s+;ltedeitealicptimzichild-a cicsceni.htnil
ar hit p*:{/tivv.w .i dc.govivflccinsatcty/conceEnsJ q�trsr7ti,-Ft��ati
u Dr.Thompson has been a scientist at CDC for nearly two generations and a senior scientist on over a dozer CDC publications at
the core of many of CDCs vaccine safety claims. htai l/www.1Icbi.1ilin.Jiilt.govipu4ined
http;ldwww,rescue}C!at,eomfiiles wiiliam-ihomps u.statement-27-august-2414.3,E
hltps soundcterud. ntilontotioofcdc-whi tic blorterlul1-auctiu
10
there's still a lot of shame with that. ... I am completely ashamed of what I
did.51
Hence, as for the only vaccine, WAR, actually , [udi.d by the CDC with regard to autism, it
appears the CDC may have concealed an association between that vaccine and autism.
When the former Director of the National Institute of Health, I7r. Bernadine Healy, was
.asked about whether public health authorities arc correct to claim that vaccines do not cause
autism,she answered: "You can't say that."50 When asked again,Dr.Healy explained: "The more
you delve into it—if you look at the basic science—if you look at the research that's been done, in
animals—if you also Iook at some of these individual cases—and,if you look at the evidence that
there is no link-what I come away with is: The question has not been answered."54
Former NIH Director Dr. Healy goes on to explain:
This is the time when we do have the opportunity to understand whether
or not there are susceptible children, perhaps genetically, perhaps they
have a metabolic issue, mitochondrial disorder, immunological issue, that
makes there more susceptible to vaccines plural, or to one particular
vaccine, or to a component of vaccine... I haven't seen major studies that
focus on - three hundred kids, who got autistic symptoms within a period
of a few weeks of a vaccine. l think that the public health officials have been
too quick to dismiss the hypothesis as irrational, without sufficient studies
of causation.
The reason why they didn't want to look for those susceptibility groups
was because they're afraid if they found them—however big or small they
were—that that would scare the public away. First of all, I think the
public's smarter than that; the public values vaccines. But, more
importantly,I don't think you should ever turn your back on any scientific
hypothesis because you're afraid of what it might shnw?.5
The CDC has also failed to address the science supporting a link between vaccines and
au tism.56 For example, the CDC has not addressed a study which Found a 300%increased rate of
autism among newborns receiving the hepatitis B vaccine at birth compared to those that did
not,57 Nor a recent and first ever vaccinated vs.unvaccinated pilot study which found vaccina Led
53 Ibld-
• 5tudiesof tyliVIR and autism are also erroneous because of healthy user bias,which has been emphasized as acetous sourccof error
in epidemiological vaodne safety studies by CDC scieauisls, lit tpsdJc]ui.nrgor14.109.3{nxiordiou rlia!_:.ajc.a.116.179
htlp:llwW MCbSxtews,COaticrew:{tlie,,Opc1t1uestuui-on-vaccineS,a:ud•ari link
51 lbld.
• Ibid.
56111.1p05%,WW,CC411:.povlvaccilu afetyforn rrtslaclt ,htenl
• htip:f/i]sreitirn.erg,lh1trag Iducun►estIslscielttife literature/Gi,9ia04er Goodman 1-lep13. 201111- Jf
11
children had a 420% increased rate of autism and that vaccinated preterm babies had an even
higher rate of autism.)" There is also a persuasive body of science supporting a clear connection
between aluminum adjuvants in vaccines and au tisni which the CDC,despite numerous requests,
has failed to directly or substantively address.59 Letters from three aluminum adjuvant experts
on this point are attached as Appendix C.
The critical need for HHS to properly engage in vaccine safety science regarding autism
is made even more vital by the fact that vaccine makers are immune from liability for vaccine
injury and vaccines are not st fety-tested prior to licensure to assess whether they cause autism.
Without proper long-term trials comparing those receiving the vaccine to an inert-placebo group,
it is impossible to know prior to licensure whether these products cause autism. There are also
no follow-up studies which compare vaccinated with unvaccinated individuals and hence no
supportable basis to claim that vaccines do not cause any cases of autism. Igor the CDC to make
this claim, it must dernrmstrate that a child receiving the entire vaccine schedule is at no greater
risk of becoming autistic than a child that is unvaccina ted. No such study has ever been done_
The TOM Report referenced above has confirmed that the CDC cannot make this claim even for
children receiving only the DTaP vaccine, let alone the entire vaccine schedule.
The 1986 Act expressly provides that you, as the Secretary, are to "develop and
disseminate vaccine information materials for distribution by health care providers to the legal
representatives of any child or to any other individual receiving a vaccine set forth in the Vaccine
Injury Table." (42 U.S.C. 300aa- 6(a).) This section further provides that:
The,information in such materials shall be based on available data
and information ... and shall include ... (1) a concise description of
the benefits of the vaccine, (2) a concise description of the risks
associated with the vaccine, (3) a statement of the availability of the
National Vaccine Injury Compensation Program,and (4)such other
relevant information as may be determined by the Secretary.
(42 U.S.C. §3O0aa- 6(c).) The VIS produced for every vaccine, including for DTaP,provides that
other relevant information regarding the vaccine is available at the CDC website, ww.cdc.gov.60
The CDC website in turn claims that "Vaccines Do Not Cause Autism."st Since HHS has chosen
to incorporate the CDC's website into the VIS as a resource, the information on that website
regarding the relevant vaccine must be"based on available data and information." Id. But, based
on available data and information, as highlighted by the IOM, IHIS cannot validly claim that
"Vaccines Do Not Cause Autism!' Hence:
htip:flwu.w.oatext.cornipdfi 3-1M.pdf; itttp;f+v.snu,oa4cxL nilpd ITS-3-1t7prlf
'F ji ip://vaccntie-saf,stv_Aamazonaw u-ortinVhitclici per-AlamAdjuvanEAui srr pdf
lastps:itai vw_cdcT:oviarrirt 411cpivl_skurreit!-v�a,l}Lml
iiVIKffw3vw,Cdcv- rivarrinvsa fety..icuncentslato tiarrEhLini.
12
(9) Please confirm that HI-IS shall forthwith remove the claim
that"Vaccines Do Not Cause Autism"from the CDC website,
or alternatively, please identify the specific studies on which
HHS bases its blanket claim that no vaccines cause autism?
VII.. Refusal to Conduct Vaccinated Versus Unvaccinated Study
The only scientifically valid way to answer a large portion of the questions raised
regarding vaccine safety would be a lo-ng-term, properly powered and controlled study
comparing the rate of all adverse events between vaccinated children and completely
unvaccinated children. This is the same type of study required by HITS for every drug pre-
licensure. THIS has nonetheless refused to conduct any such study, even retrospectively.
The need for this study is highlighted by the results of a few recent limited vaccinated vs.
unvaccinated studies.
Dr. Peter Aaby is renowned for studying and promoting vaccines in Africa with over 300
published studies. In 2017,he published a study finding children vaccinated with DTP were:1.o
times more likely to die in the first 6 months of life than the unvaccinated,'3 far, Aaby's study
therefore concluded that: "Ail currently available evidence suggests that DTP vaccine may kill
more children from other causes than it saves from diphtheria, tetanus or pertussis."6' More
disturbing is that children vaccinated with DTP were dying from causes never associated with
this vaccine, such as respiratory infections, diarrhea, and m al aria.65 This indicated that while DTP
reduced the incidence of diphtheria, tetanus, and pertussis, it increased susceptibility to other
infections,65
It is equally troubling that Dr. Abby's study was based on data that had been collecting
dust for over 30 years' This begs the question: what other serious vaccine injuries are we missing
because of neglect to conduct proper vaccine safetyscience.
A pilot study comparing 650 vaccinated and unvaccinated homeschooled children in the
United States provides a glimpse of the potential scope of vaccine harm.68 The study found that,
compared to cotriplelely-unvaccinated children, fully-vaccinated children had an increased risk
asliiip.,e{/wwiN.melt!.ram.silt.goviplitardnt mPF.TFTZ-rAATPLN.*:Ambos+-+Pu11V3
https://www.achi.nlra.niksovipincLarticlesfPMC.57160569/ Dr. Aahy's study was more reliable than other vaccine safety studies
because the subjects were accurately matched. An increasingly recogni7d problem in vaccine safety studies is that subjects are
typically not well-matched. People with pre-existing health problems are reluctant to receives a vaccine,.and are therefore unwittingly
used as controls. When this happens,the control group is sicker than the vacdne-expaied group at the outset of the study, Studies
with this problem give wrong results,and.make the vaccine look much safer than it really is. Dr.itaby's study was one of the few
specifically designed to avoid this error,
"Ibid.
Ibid.
66 1bid,
Ibid.
http-Jfwww.oatext.coia/p TC-3-I.ttta-} iC
1.3
of 390% for allergies, 420% for ADI ID, 420% for autism, 290% for eczema, 520% for learning
disabilities, and 370% for any neuro-developmental dela r. Fully-vaccinated pre-term infants
had an increased risk of 1,450% for a neurodevelopmental disorder, which includes a learning
disability, ADHD or autism, compared to completely unvaccinated preterm infants."
Another recent study compared children receiving the flu shot with those receiving a
saline injection in a prospective randomized double-blind study.7' Both groups had the same rate
of influenza but the group receiving the Flu shot had a 440% increased rate of non-influenza
infection:72 Like the DTP study, the flu vaccine increased susceptibility to other infections.
A properly sized vaccinated versus unvaccinated study is necessary and possible. As
stated by the IOM in 2013: "It is possible to make this comparison through analyses of patient
information contained in large databases such as VSD."71 Senior CDC Scientist, Dr. Thompson
similarly stated this type of study can and "needs to be done" but that the CDC is "not doing
what they should be doing because they're afraid to look for things that might be associated."74
When vaccine makers are generating over $33 billion in vaccine revenue annually and the CDC
is spending over $5 billion annually to promote and purchase vaccines, there is no justification
for not performing this study.'
The 1986 Act expressly provides that you, as the Secretary, "shall promote the
development of childhood vaccines that result in fewer and less adverse reactions" and "shall
make or assure improvements in .,. the ... labeling, warning, ,.. and research on vaccines, in
order to reduce the risks of adverse reactions to vaccines." (42 U.S.C . § 300aa-27(a)(2).) Since
comparing children receiving the vaccines recommended by the CDC with those that have not
received any vaccines is the only scientifically valid way to assess the safety of the CDC's vaccine
schedule:
U0) Please advise whether HHS intends to forthwith conduct
adequately powered and controlled prospective as well as
retrospective studies comparing total health outcomes of
4.9 Ibid.
a 1 LI tp:f/ww w,oatex,icart!pdfll"1X3-1 7- d f
711tItps:l/www.xtir i.nhi nih.gov/pn drniirlpsPMC:14d4712/
72 Ibid.See nisi"h1 trdfy .rrim:safetv,s.',amazonuws.com/CDC FOIA Response Ultpublished5IurCy, rif(The CDC in 21101 apparently
conducted a narrow vaccinated versus unvaccinated study comparing cliildYe1l receiving the Hepatitis B vaccine during the first
month of life versus those who did not. The results of this study were never released by the CDC,and an abstract of the Study was
only recently obtained under a FOIA request, Children vaccinated with Hepatitis B vaccine in the first month of life, compared to
children receiving no vaccines in the First month of life,had an increased risk of 829%for ADH I),762% for autism,(05%for ADD,
5E5%for tics,498%for sleep disorders, arid 2DtS% for speech delays. Note!hat while the abstract cliscusse.s comparing thimcrosal
ex posture,since the only vaccine recommended by cane month of age was IieFraulls B,and since only thimerosal containing Hepatitis
B vaccine was available at the time of this study,this study appears to have prhnarily compared children receiving Hepatitis B with
children that did not receive This vaccine.)
73 htti_woriwideve.tiap.edu/vad/13563/chaptenr2g13
7a htt}a.ti:flsoundclottrtl,camffomotion/c1c-whisttt?-blower-full-autiu
73.haps.//wtwty.bets.goyl.:.rte.sidelaultinlesdiv 117-budget-in-briefpdf;hitp /wwwberesuch,cd,n#anarkei-re earchlpharmat-eutical-
accine-tt hnolr ies•ularkcl, report-ptdn011fhtmt
14
fully/partially vaccinated children with completely
unvaccinated children?
VIII. Reducing Conflicts of Interest at HHS
The 7.986 Act created a system in which vaccines arc licensed,recommended,encouraged.,
subsidized, and defended by II-IS. The 1986 Act's scheme thus places HHS in charge of two
competing duties. On one band,HHS is responsible for vaccine safety. On the other hand,I H IS
is required to promote vaccine uptake and defend against any claim they cause any harm,
Regrettably, it appears that I-iHS has chosen to focus almost entirely on its vaccine
promotion and defense function to such a degree that it has essentially abandoned its vaccine
safety function. To restore balance, I-IIS must take serious steps to create an "ethics Firewall"
between these competing functions. :HHS also must take action with regard to its vaccine
committee members and employees that have conflicts with vaccine makers.
HHS Licenses&Recommends Vaccines. With regard to the ltDA's Vaccines and Related
Biological Products Advisory Committee (VR8I'AC), which effectively decides whether to
license a vaccine, in 2000 the U.S. House Committee on Government Reform (the Committee)
"determined that conflict of interest rules employed by the FDA and the CDC have been weak,
enforceniertt has been lax, and committee members with substantial ties to pharmaceutical
companies have been given waivers to participate in committee proceedings."'h The Committee
concluded of the VRBPAC: "The overwhelming majority of members,both voting members and
consultants,have substantial ties to the pharmaceutical rndushy."5
With regard to the CDCs Advisory Comimittee on Immunization.Practices(ACIP),which
effectively decides whether to universally recommend a pediatric vaccine, the Committee found
that ACIP members routinely fail to disclose conflicts with vaccine makers and when conflicts are
disclosed "[tlhe CDC grants blanket waivers to the ACIP members each year that allow them to
deliberate on any subject, regardless of their conflicts.„” The Committee drew focus on the
vaccine most recently approved by the ACIP and found extensive and troubling conflicts of
interest for most the ACIP members voting to recommend its universal use for children." The
Committee was further concerned that "ACIP liaison representatives have numerous ties to
re 1itt 'li i kycormia5Jon.olgfpdf pnFicts-4;avt-Reform_pdf(Forinitance,"3 nut of 5 FDA advisory coinii iiteo[VEiWAC]
members who voted to approve the rotavirus varrine it'December 199:i[than the most recently approved vaccine by tlxc VRBYAC.J
had significant financial ties to pharmaceutical companies that were developing different versions of the vaccine.')
ar ibid.
Ibid.
"!hid,(The Committees findings were that(I)The chairman served onMerck's Immunization Advisory Board;(2)another member,
who shared the patent on a rotavirus vaccine, had a$35000 grant from Merck to develop the vaccine,and was a consultant for
Merck:(3)another member was under contract with the Merck vaccine Division,a principal investigator tor SmithKline and received
funds from various vaccine makers; (4) another member received a salary and other payments from Merck;(5) another member
participated in vaccine studies with Merck. Wyeth, and SmithKline; and {6) another rneualter rocceivcd grants from Merck and
Smi thKLine.)
15
vaccine manufacturers" but act like voting members of ACIP,80 The Committee further took issue
with the extensive conflicts of interests of members of ACII'"s working groups which convene
behind closed doors and whose recommendations are typically rubber stamped by the ACII3,81
The Committee concluded that ACIP reflected "a system where government officials make
crucial decisions affecting American children without the advice and consent of the governed."$2
Despite the concerns the Committee expressed in its 20010 report, not much changed, A
December 2009 report by the FIIIS Office of Inspector General found that the "CDC had a
systemic lack of oversight of the ethics program for SCEs [aka, committee members]".83 For
example, "Most of the experts who served on advisory panels in 2007 to evaluate vaccines for flu
and cervical cancer had potential conflicts that were never resolved."84
In fact, the Inspector General found that the "CDC certified conflict disclosure forrnsl
with at least one omission in 2007 for 97 percent .-, of SCEs," "58 percent ,.. of SIGs had at least
one potential conflict of interest that CDC did not identify," and when the CDC identified a
conflict, it improperly granted broad waivers despite being castigated for this improper practice
in 2000.85 Even worse, "32 percent ,.. of SCEs ,..had at least one potential conflict of interest that
CDC identified but did not resolve" and. 13 percent of SCEs were allowed to participate in
committee meetings without even having a conflict disclosure form on file.86
As the system is set up, an ACIP vote to recommend a vaccine, grants a vaccine
manufacturer a liability-free market of 78 million American children, who are legally compelled
to receive the vaccine, and billions of taxpayer dollars guaranteeing payment. In such a system,
an ACIF vote must be completely insulated from any influence by the vaccine manufacturer,
instead,the opposite appears to be the norm.
HHS Promotes Vaccines. Moreover, while the CDC states on its website -- not less than
130 times -- that "CDC does not accept commercial support," this is simply not true,"7 For
example, the 13ri fish Medical Journal reported in 20-15 that: "Despite the agency's disclaimer, the
CIBC does receive millions of dollars in industry gifts and funding,both directly and indirectly,
and several recent CDC actions and recommendations have raised questions about the science it
cites, the clinical guidelines it promotes, and the money it is taking,"88 As another example,
pharmaceutical companies and other private entities, through the "CDC Foundation," can create
and fund programs at the CDC(over half a billion dollars' worth to-date), endow positions at the
Ibid.
51 laid.
52 laid.
5:1 Iiit as,llekig,hhs. civfne.ifreporkfi o I-04.07.0020, tlf
tap:/twww.ovum+skrcaml2009/17,a8/hcalthip g/15cik-html
bLlps.dfni .lyh m•I+ iJrcapctirlt lta�i-04.47 0260,Of (Splicing down this SR%crf un,d ittifind conflicts,UM involved employnseiit or
grants,13%involved equity ownership,and 5%involved consulting,)
"G laid.
Ntips' tsearcli_crimes*,cfvfwarrh?query=%22:CIcadC 5Fnu1+accept+commenrial+support%22 uttt3,`Yat `16Sk 9�,'38cafrili3tt rdc-main
latp://www.brrij,cornicon timi/350.1ben1-h2362
16
CDC, and even place individuals to work at the CDC, paid through "private funding!' (42
U.S.C.A. §28412-11(h)(1), (2).)
Worse, the promotion track for CDC management extends into vaccine makers. The most
prominent example is former CDC Director Dr, Julie Gerberding, who headed the agency from
2002 through 2009. Dr. Gerberding oversaw several controversial studies regarding vaccines
produced by Merck, which sought to silence those calling for an increase in the safety profile of
those vaccines. When she left the CDC she was rewarded with the position of President of Merck
Vaccines in 2010 with a reported $2.5 million annual salary and lucrative stock options,r'9
HHS Defends Vaccines. After Iit-IS licenses, effectively mandates, and promotes a
vaccine to 78 million American children with very limited sa fe[y data, [his very same government
agency is mandated to defend against any claim that the vaccine caused harm.
There is no other for-profit product where the very department responsible for regulating
that product is statutorily required to promote its uptake and simultaneously defend against any
claim it causes harm,
The Vaccine Injury Compensation Program (VICP) is effectively the only legal recourse
in America to obtain cornpensa tion for a pediatric vaccine injury, (42 U.S.C. 800aa-10 et seq.)"°
The injured must litigate against III IS and the .DOT in a quasi-judicial process Filed under seal
where the injured child effectively cannot obtain documents from or depose vaccine makers to
prove how the vaccine caused injury. (§ 3002.a.-12.) DCII and HHS have the government's vast
resources, while the injured child must secure a private attorney- (§ 300aa-1.5) Moreover, the
injured child's damages are limited to$250,000 for death and pain and suffering. (Id.)
Worst of all, the injured child must almost always prove "causation" — the biological
mechanism by which the vaccine injured the child.9' Requiring an injured child to prove
causation adds insult to injury because had H KS conducted the vaccine safety science it demands
as proof in the VICP before licensing a vaccine, the child"s injuryF may have been avoided
altogether.
This truly is the epitome of injustice: requiring a child receiving a compulsory
pharmaceutical product to medically prove to 11115 how the vaccine caused his or her irrjury,
where the science to understand vaccine injuries is not being done by the government
department, I ITIS,.tasked with this job.92 As confirmed by the ICBM, HI-iS has not conducted the
basic science needed to even determine whether commonly claimed vaccine injuries are caused
by vaccines.93 It has failed to conduct even one properly sized study comparing vaccinated to
°�1ttiNs:fl+v4vw.s��c-�tav�t�-lee[�Jcativn-eC9s;p?�cti[m=��#oti,r»erSeClK�10t7]G2FiH?y�3
9°See all Sr[[iNewiIz v.Wyeth LLC 562.U.S-223 120111
91 lalyJl vv w.gao.E., wlnszr'Isl(74J667136. [[if
92 Set Sections II,IIs,IV,V,VI,and VII above.
93 See Section IV above.
17
unvaccinated children, despite all the resources at its disposal.9 It is no wonder a single injured
child's claim faces a high likelihood of failure in the Via'.
Many parents, doctors and scientists, as well as politicians.. are legitimately concerned
• about the process whereby vaccines are licensed, recommended,promoted and defended by [he
same department. This is not because of any conspiracy, or belief an insidious in[en t, Rather,
this system eliminates the incentive, and in fact creates a disincentive for HHS and vaccine
makers, to conduct research to uncover long term chronic conditions, including the immune and
neurological system disorders, which can result from the current vaccine schedule.
`11ie 1986 Act expressly provides that you, as the Secretary, have at least equal and
arguably greater responsibility for vaccine safety than for vaccine promotion, 02 U,S, _ 300aa-
,300aa-27.) In accordance with this statutory responsibility:
(11) Please advise if you wilt
a, prohibit conflict waivers for Members of HHS's vaccine
committees (ACIP,VRBPAC, N VAC SE ACCV)7
b. prohibit HHS vaccine committee members or HHS
employees with duties involving vaccines from accepting any
compensation from a vaccine maker for five years?
c, require that vaccine safety advocates comprise half of HHS's
vaccine committees?
d. allocate toward vacci ne safety an amount at least equal to 50%
of HHS's budget for promoting/purchasing vaccines?
e. support the creation of a vaccine safety department
independent of HHS?
f. support the repeal of the 1986 Act to the extent it grants
immunity to pharmaceutical companies for injuries caused by
their vaccine products?
I , Conclusion
HHS can do better. With hundreds of vaccines in the pipeline i t must do better. Children
susceptible to vaccine injury are as deserving of protection as any other child. Avoiding injury
to these children is not only a moral and ethical duty, but will in fact strengthen the vaccine
program, Every parent that does not witness their child suffer a serious reaction after vaccination,
such as a seizure or paralysis,is another parent that will not add their voice to the growing chorus
of parents opposed to Idt-ES`s vaccine program due to safety concerns.
91 See SeCli011 VU above.
18
Unless HHS performs Us vita] statutory obligations regarding vaccine safety, and until a
frank conversation is possible regarding vaccine safety, children susceptible to vaccine injury will
not be protected from such injuries, Nor will children injured by vaccines be able to access the
services they need. We can do far better in protecting and serving children who are susceptible
or succumb to serious injuries from vaccination. The first step in avoiding these harms and
helping children already harmed is admitting there are deficiencies and working diligently to
improve vaccine safety.
We respectfully request your attention to the important conceLi Ls outlined above and hope
you agree that addressing these concerns is in everyone's best interest. These, in fact, reflect
nothing more than what Congress already explicitly recognized when passing the 19€36 Act:
vaccines can and do cause serious injury and III IS needs to work diligently to identify and reduce
these banns. If you would like to meet and discuss the foregoing, we would welcome that
opportunity and hope to work cooperatively to address these issues.
If that is not possible, Congress, as a final resort to assure vaccine safety, authorized a
"civil action ... against the Secretary where there is alleged a failure of the Secretary to perform
any act or duty under"the 1986 Act. (42 U.S.C, g 300aa-31(a).) We are prepared to authorize such
an action and this letter constitutes the notice required by 42 U.S.C. §300aa-31(b). It is, however,
our hope that the vaccine safety issues identified herein can be resolved cooperatively, with all
interested parties working together toward the common goal of vaccine safety entrusted to FIE IS
under the 1986 Act.
Very truly yours,
‘11/1 /
Del Bi,tree
cc: See Appendix A.
Enclosures:Appendices A to C.
19
Appendix A
A Voice For Choice Colorado Coalition [Or Vaccine Choice
A Voice For Choice Advocacy Fran Sincere, President
Christina Hildebrand, President 125 S. Zephyr
530 Showers Drive, Suite 7404 Lakewood, CO 80226
Mountain View, CA 94040
DA1R Foundation
Alliance For Natural Health Dawn Loughborough, President
Gretchen DuBeau, President 10200 US HWY 290 West
3525 Piedmont Road NL? B6-310 Austin, TX 78736
Atlanta, GA 30305
P;lirabeth Birt Center for Autism Law and
Arizona Coalition Against Mandated Advocacy
Vaccines Kim Mack Rosenberg, President
Kelsey Davis, President 200 Cabrini Boulevard, Suite 66
Gilbert, AZ 85212 New York,NY 10033
Autism Action Network Enriched -Parenting
John Gilmore, President Rebecca Fleischman, President
550 East Chester Street 1208Avenue M, Suite 2323
Long Beach,NY 11561 Brooklyn,NY 11230
Autism Giving Tree Focus for Health Foundation
Christina Stafford, M.Ed., BCBA, LBS, Shannon Mulvihill, R.N., Executive Director
President 776 Mountain Boulevard, Suite 202
660 'W' Street Watchung,NJ 07069
King of Prussia, PA 19406
Georgia Coalition for Vaccine Choice
AutismOnc Sandi Marcus, Founder/CEO
Ed Arranga, President P.O. Box 45
1816 West Houston Avenue Silver Creek, GA 30173
Fullerton, CA 92833
IIealth Choice
The Canary Party Mark Blaxil, President
.Tenni ler Iarson, President 6533 Flying Cloud Drive, Suite 1200
6533 Flying Cloud Drive, Suite 1200 Eden Prairie, MN 55344
Eden Prairie, MN 55344
Health Choice Massachusetts Indiaina for Medical Freedom.
Candice Edwards, President Melissa Sura, President
P.O. Box 175 5424 Grapevine Drive
Manchaug, MA 01526 Indianapolis, IN 46235
Health Choice Maryland Inlorined Choice Washington
Emily Tarsell, President Jena Dalpez, President
1501 Sulgrave Avenue, Suite 208 14106 93rd Avenue NE
Baltimore, MD 21209 Kirldand, WA 98034
Health Choice Connecticut Kentucky Vaccine Rights Coalition
Dr. Elissa Diamond Fields, President Jennifer lenge & Ashley Kennedy, Co-
P.O. Box 29 Presidents
Roxbury, CT 06783 899 Corinth Road
Corbin, KY 40701
Health Freedom Florida
Dr. Ryan Fenn & MacKenzie Fraser, Co Know The Vax
Presidents Angela Gallagher, President
153 Ivearnia Loop 4553 Aldrich Avenue North
Tallahassee, FL 32312 Minneapolis, MN 55412
health Freedom Idaho Learn the Risk
Miste Gardner K.a•lleldt, President Brandy Vaughan, President
1045 S Ancona Ave Ste 140 3463 State Street, Suite 182
Eagle,ID 83616 Santa Barbara, CA 93105
Healthcare Freedom Hawaii Louisiana Parents for Vaccine Rights
Jessica McCormick & Melisha Dooley
Natasha Sky, Co-Directors Sunny Dixon, Co-Directors
Mili]ani, HI 967119 413 Thy Lane
Metairie, LA 70003
Illinois Coalition for Informed Consent
.Ten Suter & Maine Coalition for Vaccine Choice.
Danielle Olson, Co-Directors Ginger Taylor, Director
Jacksonville, IL 62650 11 High Street
Brunswick, ME 04011
March Against Monsanto Moms Across America
Tami Canal, President Zen Honeycutt, President
7878 South 1960 East 24000 Alicia Parkway, Suite 17-236
South Weber, UT 84405 Mission Viejo, CA 92691
Michigan. for Vaccine Choice MontananS For Medical Freedom
Suzanne M. Waltman, President Edna Ment, Director
22615 Francis Street PO Box 1443
St. Clair Shores, Mf 48082 Florence, MT 59833
Minnesota Natural Health Coalition My Kids,My Choice
Lee Beaty, President Rita Palma, President
1043 Grand Ave, Suite 317 2 Purdy Avenue
St, Paul MN 5510 Baypoint,NY 11705
Minnesota Natural Health Legal Reform National Health Freedom Action
Project Jeri Johnson, President
Leo Cashman, President PMB 218, 2136 Ford Parkway
1043 Grand Ave, Suite 317 St, Paul, MN 55116
St. Paul, MN 55105
National Health Freedom Coalition
Minnesota Vaccine Freedom Coalition Roseanne Lindsay, President
Angela Gallagher,President PMB 218, 2136 Ford Parkway
4553 Aldrich Avenue North St. Paul, MN 55116
Minneapolis, MN 55412
New York Affiance for Vaccine Rights
Mississippi Parents for Vaccine Rights Aimee Villella McBride & Maria Ciavriel,
MaryJo Perry, President Co-Presidents
P.C . Box 14l 550 East Chester Street
Pelahatchie, MS 39145 Long Beach,NY 11561
Missouri Parents Against Vaccines Ohio Advocates for Medical Freedom
Janessa Ranke & Kendal Bourne, Co- Robert M. Wise, President
Presidents P.O. Box 1236
323 N. Fox Ridge Drive, Suite 204 Hartville, OH 44632
Raymore, MO 64083
Oklahomans b r Vaccine and Health Choice Spectrum Revolution
Liza Oreve, President Catharine Layton, President
P.O. Box 721356 357 S. Earlharn Street
Norman, OK 73070 Orange, CA 92869
Organic Consumers Associ°cEtion Tennessee Coalition for Vaccine Choice
Ronnie Cummins, CEO Kristen Odom-Holland, President
6771 South Silver Hill Dr. P.O. Box 4508
Finland, MN 55603 Chattanooga, TN 37405
Parents United 4 Kids Vaccine Injury Awareness League
Stefanie Fetzer & Shawna Lambert, Co- Michelle Ford, President
Presidents 10866 Washington Blvd, Suite 65
2925 Bonanza Culver City, CA 90232
San Clemente, CA 92673
Vaccine Safety Council Minnesota
People Advocating Vaccine Education, Inc. Patti Carroll, President
Lisa Jillani, CEO 6533 Flying Cloud Drive, Suite 1200
P.O. Box 690712 Eden Prairie, MN 55344
Charlotte, NC 28227
Vermont Coalition for Vaccine Choice
Physicians for Informed Consent Jennifer Stella, President
Dr. Shiro Miller, Executive Director P.O. Box 74
13749 Riverside Drive Waitsfeld, VT 05673
Sherman. Oaks, CA 91423
Rogue Recovery Virginians for Health Freedom
Tyler Dahm, President Deborah Hummer, President
3221 West 96th Avenue P.O. Box 2015
Westminster, CO 80031 Spotsylvania, VA 22553
South Carolina Health Coalition West Virginians for Health Freedom
Jennifer Black & Rebekah Watson, Co- Dr. Chanda Adkins, Director
Presidents 108 Yorktown Court
1754 Woodruff Road, Suite 112 Beckley, WV 25801
Greenville, SC 29607
Weston A. Price Foundation
Sally Fallon Morcil, President
PMJ3 106-380, 4200 Wisconsin Avenue NW
Washington,D,C., 200I 6
World Mercury Project
Robert F. Kennedy, Jr., Chairman
1227 North Peachtree Parkway, Suite 202
Peachtree City, GA 3026
Appendix B
Adverse Ffft of V : Eviderico and causality
Adverse
Effects
•
Vaccines
ivid nce and causality
Conimittee to Review Adverse Effects of Vaccines
Board on Population Health and Public Health Practice
Kathleen Straiton, Andrew Ford, El-in Rusch, and Ellen Wright Clayton,
Editors
INSTITUTE OF MEDICINE
OF THE NATtONI'L AcAr)EMW9
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
Copyright National Academy of Sconces All rignts reserved.
Adverse Effects of Vaccines:Evidence and Causality
DT- TT-, AND AP-CONTAINING VACCINES 545
Weight of Epidemiologic Evidence
The epidemiologic evidence is insufficient or absent to assess an as-
sociation between diphtheria toxoid—, tetanus toxoid—, or acellular
pertussis-containing vaccine and ataxia.
Mechanistic Evidence
The committee identified one publication reporting the development
of ataxia after the administration of DTaP vaccine, Kubota and 'Takahashi
(2008) did not provide evidence of causality beyond a temporal relationship
of. :2 days between vaccine administration and development of cerebellar
symptoms leading to a diagntxsis of acute cerebellar ataxia, The publication
did not contribute to the weight of mechanistic evidence.
Weight of Mechanistic Evidence
The committee assesses the mechanistic evidence regarding an as-
sociation between diphtheria toxoid-, tetanus toxoid-, or acellular
pertussis—containing vaccine and ataxia as lacking.
Causality Conclusion
Conclusion 10.5; The evidence is inadequate to accept or reject a
causal relationship between diphtheria toxoid—,tetanus toxoid—,ur
acellular pertussis—containing vaccine and .ataxia.
AUTISM.
Epidemiologic Evidence
The committer reviewed one study to evaluate the risk of autism after
the administration of DTaP vaccine. This one study{Geier and Geier,2004}
was not considered in the weight of epidemiologic evidence hccausc it pro-
vided data from a passive surveillance system and lacked an unvaccinated
comparison population.
Weight of Epidemiologic Evidence
The epidemiologic evidence is insufficient or absent to assess an as-
sociation between diphtheria toxoid-, tetanus toxoid—, or acellular
pertussis-containing vaccine and autism.
Copyright National Academy of Scences. All rights reserved.
Advorse Effoos of Vaccines: Evidence and Causality
546 ADVERSE EFFECTS OF VACCINES.:EVIDENCE AND CAUSALITY
Mechanistic Evidence
The committee did not identify literature reporting clinical, diagnostic,
nr experimental evidence of autism after the administration of vaccines con-
taining diphtheria toxoid, tetanus toxoid, and acellular pertussis antigens
alone or in combination.
Weight of Mechanistic Evidence
The committee assesses the mechanistic evidence regarding an as-
sociation between diphtheria toxoid—, tetanus toxoid—, or acellular
pertussis—csiniair ing-vaccine and autism as lacking,
Causality Conclusion
Conclusion 10.6: The evidence is inadequate to accept or reject a
causal relationship between diphtheria toxoid—, tetanus toxoid—, or
acellular pertussis—containing vaccine and autism.
ACUTE DISSEMINATED ENCEPHALOMYELrfiS
Epidemiologic Evidence
No studies were identified in the literature for the committee to evalu-
ate the risk of acute disseminated encephalomyelitis (Al)FM), after the
administration of vaccines containing diphtheria toxoid, tetanus toxoid,or
acellular pertussis antigens alone or in combination.
Weight of Epiderna'ologic Evidence
The epidemiologic evidence is imufficient or absent to assess an as-
sociation between diphtheria toxoid—, tetanus toxoid—, or acellular
pertussis—containing vaccines and ADEM.
Mechanistic Evidence
The committee identified five publications of ADEM developing after
the administration of vaccines containing diphtheria toxoid and tetanus
toxoid antigens alone or in combination. Four publications did not pro-
vide evidence beyond temporality, one of which was deemed too short
based on the possible mechanisms involved (Abdul-Ghaffar and Achar,
1994; Bolukbasi and Oerrienoglu, 1999; Iiamidon and Raymond, 2003;
Rogalewski et al.,2007).In addition, Rogalewski et al. (2007)reported the
administration of vaccines against hepatitis B,hepatitis A,and poliovirus in
Copyright National Academy of Sciences. All rights reserved.
Appendix C
UBC: a place o f mind Faculty of Medicine
TIlE UNIVERSITY Or BRITISH COLUMO(A Department ofOphihalmology
&VISUal Sciences
Shaw L.abor:,lory
June 2.'1, r'�}] 8286 Y�fest 10th Avenue,Room 3]I
Vancouver,BC Canada vsz 1L8
United States Department of Health & Hurnan Services Phone 604 8754111 tiocai 6x375
National Institutes of Health Fax 001 875 Isis
Food & Drug Administration www-nauaaidyRamiesulx,ca
Centers for Disease Control &Prevention
200 Independence Avenue, S,W-
Washington, D.C.20201
Re: Aluminum Ar uigants
Dear Directors_
•
] am writing to you in regard to aluminum adjuvant% in vaccines. This subject is one my laboratory works
on intensively and therefore one where I Ebel that I have some expertise. In particular,we have studied the impact of
aluminum adjuvants in animal models of neurological disease, including autism spectrum disorder (ASD). Our
relevant studies on the general topic of aluminum neurotoxicity in general and specifically in regard to adjuvants are
cited below,
°these studies and the broader existing literature regarding aluminum toxicity, lead almost invariably to the
conclusion that aluminum in any chemical form is always neurotoxic when administered to humans- Further, I am
convinced that aluminum adjuvants in vaccines may contribute to neurological disorders across the lifespan, h
adults, such adjuvant may induce macrophagic mnyofasciitis, a disease with neuropathological aspects. in children,
there is growing evidence that aluminum adjuvants may disrupt developmental processes in the central nervous
system and [herefore contribute to ASD in susceptible children.
Despite the Foregoing, the safety of aluminum adjuvants in vaccines has not been properly studied in
humans even though, pwsuant to the recommended vaccine schedule published by the Centers for Disease Control
(CDC),a baby may he injected with up to 3,6575 micrograms of aluminum adjuvant by six months of age
In regard to die above, it is my belief that the CDC's claim on its website that "Vaccines L)o Not Cause
Autism" is wholly unsupported. Given this, I remain convinced that much more research on the role of aluminum
adjuvant in vaccines and neurological disorders, including ASD, is warranted and should be a research priority for
the NIII and other funding bodies.
Fours sincerely, •
(e---'----''
r
Christopher A. Shaw, PhD
Professor
Dept. of Ophthalmology and Visual Sciences
University of British Columbia
828 W. 10th Ave.
Vancouver,British Columbia •
Canada,V5ZI M9
Tel: 604-875-4111 (ext. 68373)
Email: cashawlab@ginail.com
cillC
1
Reicv int Pub Li cations(Shaw Laboratory)
1. C'rcpcaux C, Fidi H, David MO,Baba-Amer Y,Tzavara F,giros B, aulbier Pi, Exley C, Shaw CA,
Cadusseau J,Gheiar-di RK.Non-linear dosc-response ofaluminium hydroxide adjuvant particles: Selective
dose neurotoxicity. Toxicology. 375:48-57. (2016)_
2. Crcpeaux C;, Eidi H,David M-O,'1'zavara E,Giros B, Exley C. Curmi PA, Shaw CA, Ciherardi RK,
Cadusseau I.Highly delayed systemic translocation ofalurninium-based adjuvant in CD] mice fallowing
intramuscular-injections.J. Into g. Biccherne 152:199-205, (2015),
3. Shaw CA, Li I),Tomljenovic L. Are there negative CNS impacts of aluminum adjuvants in vaccines and
immunotherapy?/a'rr wtotherripy.6 (10):l 055-1071, (2014).
4. Shaw CA,Seneff S, Kerte SD, Tornljenovic L, Aller Jr JW,Davidson RM.Aluminum--induced entropy in
biological systems: Implications. for neurological disease.J Toxicology. Volume 2014,Article ID 491316.
(2014).
5. Shaw CA,Kerte SD,Davidson RM, Seneff S. Aluminum's role in CNS-immune system interactions leading
to neurological disorders_ lrr:M:srn,?ane Res, 9:I.
6. Shaw CA,Marler TE. Aluminum and the human diet revisited. in:Communicative &Integrative Biology;
Landes Bioscience. 6:e26369. (2013).
7. Shaw CA, Tornljenovic L. Aluminum in the central nervous system(CNS):toxicity in humans and animals.
vaccine adjuvants, and autoimmunity_ humnoI Res, (20[3).
8. Shaw CA, Li Y,Tonmljenovic L Administration of aluminum to neonatal mice in vaccine in vaccine-relevant
amounts is associated with adverse tong term neurological outcomes.JInorgChem(2013).
9. Tomtjenovic L,Shaw CA. Mechanisms ofaluminum adjuvant toxicity and autoimmunity in pediatric
populations, Lupus. 21:223-230. (2012).
10, Tornljenovic L and Shaw CA. Editorial; Special Issue: The I3iochemistry/Toxicity ot'Aluminum. Current
Inorgonic Chemistry.20): 1-2.(2012),
11. Tomljenovic L and Shaw CA. Do aluminum vaccine adjuvants contribute to the rising prevalence of autism`?
,I{norg,Biochem. 105(11):1489-99. (20] ]).
12. Tornljenovic L and Shaw CA.Aluminum vaccine adjuvants: Are they safe? Current Medicinal Chemistry.
18:2630—2637. (2011).
l3. Shaw CA and Petrik MS. Aluminum hydroxide injections lead to motor deficits and motor neuron
degeneration.JInorganfc Biochem_ 103 ([1): 1555-62.(2009),
14. Petrik MS,Wong MC,Tabata RC, Garry RF, and Shaw CA.Aluminum adjuvant linked to Gulf War illness
induces motor neuron death in mice.J Neuro molecular Medicine. 9: 83-100. (2007).
2
UNIVEF S]TE .
-
a uk — PAPAAS - EST
redierch l inrrredi ale
June 15, 2017
United States Department of Health & Human Services
National Institutes of Health
Food & Drug Administration
Centers for Disease Control & Prevention
200 Independence Avenue, S.W.
Washington, D.C. 20201
Re: Aluminum Adjuvants
Dear Directors:
I am an expert in the field of aluminum adjuvants toxicity
----- MIR U955 INs5Rro I UFC in humans and animal models. I have been working in this field
since the initial description of the Al vaccine-induced
macrophagic rnyofasciitis in 1998. Since that time 1 have written
40 peer-reviewed scientific publications and one book on this
Trani 10 subject
Biology of the neuromuscular
systeim I strongly support the contention that aluminum
adjuvants in vaccines may have a role in the etiology of autism
spectrum disorder (ASD)- My view is founded on a significant
and burgeoning body of peer-reviewed scientific evidence
which makes the link between ASD and exposure to aluminum
through vaccinations and other sources. Examples of this
literature from my own group are detailed below and I urge the
Fred Reraix,director HHS to take them into consideration in forming any future
FrarrgoisJeromeAuthier,co-director opinion on the safety of aluminum adjuvants in vaccines.
Rain ain&karardi, former director The Center for Disease Control's claim on its website
Tel, +33(0)1 at 27 42 that "Vaccines Do Not Cause Autism" is unsupported with
Fag.+33(0)1 49 ai 27 33 respect to aluminum adjuvants and this claim stifles the
romain .gherardii irtserm.fr important research to determine the safety of aluminum
adjuvants used in vaccines- As an expert in the field of
aluminum adjuvants and aluminum toxicity ] solemnly declare
that more research on the role of aluminum adjuvant in
vaccines and neurological disorders, including ASD, is essential
and urgently required.
Yours very sincerely
4141rj/
Romain l(- Gherardl
Professor, Neuromuscular Pathology Expert Centre
University Paris-Est, INSERM U9SS-E10,
Henri Mondor hospital, Creteil France
ConLact at We hospital
Tel 00(33) 149812746
remain gherardi@limn.apl' .fr
nsilhan ISIri dr.
`r M UPpx HYS it 4Efl1 Te Inscrm 11955 I azul#e de Mrleinp
li
�hdm`ilp�..sl
■ R.rue fi i G6neral Sarrail 94010 Ccet it C rirx
institutmondor
de recherche biomei1 cafe
Selection of sioniflccrrrt publications from our group in the field
Gherardl H, Toxic Story_deux ou trois veriLes umbarrassaotos sur les adjuvants des vaccins-
Actes Sud(publisher),Paris,201F,, 250 pages
Crepeaux 6,Eidi H,David MO,Baba-Amor Y,Txavara f,Giros ll,Authier FJ,Exley C,Shaw CA,
Cadusseau J,Gherardi RIC Non-linear dose-response of aluminium hydroxide adjuvant particles:
selective low dose neurotoxicity-Toxicology.2017 Jan 151375:48 5f.
Masson JO,Crepeaux 6,Authier FJ,Exley C,Gherard)RIC,[Critical o;ialwsis of
reference studies on aluminiunrbased adjuvants todlcokinetics]-Ann pharrn Fr.
2017 May 30.p11:50003-4509(1.7130433-o
Van Der Cucht A,Aou n Sebaili M,GuodJ E,Aoul etate 1,Vara S,Cherardi RK,
Evangelista E,Ckialaye J,Cottereaoo A5,Verger A,Bachoud-Levi AC,Abuiizl M,
1111 E,Authier FJ,Brain(1BjF-FDG PET Metabolic Abnormalities In Patients with
Long-Lasting Macrophagic Myofascitis,J Nuel Med-2017 Mar:58[3)_192-49B.
Crepeavx G,Eidi H,David MO,Tzavara E,Gkros B,Exley C,Cu rm i PA,Shaw CA,
Gherardi RIC,Cadusseau J.Highly delayed systemic translocation of aluminum-based
adjuvant in CO1 mice following intramuscular Injections.J Inorg Blocliem,2015 htov;152:199-
205.
Eidi H,David MO,Crepeaux G,Henry L,Josh!V,Berger Mii,Sennour M,
Cadusseau J,Gherardi HH,Cu rmi PA-fluorescent nanodiamonds as a relevant tag
for the assessment nt alum adjuvant particle biodispisiLion.BMC Med.2015 Jun
17;13;144-
Van Der GuchtJlyAounSebaiLi F1,REI E,Aoui2erate1,Evangelista E,Chalaye
1,Gherardi RK+Ragunathan-Thangarajah N,Bachoud-Levi AC,Authier FJ.
Neumpsycheiagiral Correlates of Brain Perfusion SPECT in Patients with
Macrophagie Myofasclitls.PLoS One,2015 Jun 1;10(5[:e0123353-
(Chan Z,Combediere C,Authler Fl,11ier V, Lux F,Exley C,Mahrouf-Yorgov M,
D ecrouyX,Moreno P,Tillemcnr 0,Gherardi RK,Cadusseau J.Slow CCL2-dependent
translocation of biop rsisten L particles from muscle to brain.BMC Med.2013 Apr
4;11:95.
Couette M,Bolsse PAF,Ma icon P,Brugieres P,Cesaro P,Chevalier X,Gherardi
RK,tlachoud-Levi AC,Authier FJ-Long-term persistence of vaccine derived
�.luminunt hydroxide Is associated with chronic cognitive dysfunction.J Inorg
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Authier FJ,Sauvat S,Christov C,Chariot P,Raisbeck G,Poro.n MF,You F,
G llerardi R.AFOF13-adjuvanted vaccine-induced macrophagic rnyorascillls In rats Is
influenced by the genetic background.Neuromuscul Dlsord-200E May;15(5)_347-52.
Authier FJ,Sauvat 5,ChampeyJ,Dro ou I,Coquet M.Gherardl BK.Chronic fatigue syndrome in
patients with rnacrop Yogic myofasciitis-Arthritis Rheum.2003 Feh;48(4_5.0-70.
Ghere rdi RK.[Lessons from nracrophagic myofasckitis:towards definition of a
vaccine adjuvant-related syndrome].Rev Neurol(Paris},DMA.Feb;159(2);162-4,
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Ghera7rdi RH.Central nervous system disease in patients with macrophagic
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2
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0 THE B I F C H A L L CENTRE
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Innovations in Inorganic and Materials Chemistry
Tel: 01182 734080
Fax: 01782 712378
e-mail: e.exlev( 1ceele,ae,uk
h fin Wwww.keelc.ac.ulna In miniu in
June 15, 2017
United States Department of Health & Human Services
National Institutes of Heal,th
Food &Drug Administration
Centers for Disease Control& Prevention
200 Independence Avenue, S.W.
Washington, D.C. 20201
.e: Aluminum Adjuvants
Dear Directors:
I am an expert in the field of aluminum adjuvants and aluminum toxicity. 1 have been
working in this field for more than 30 years during which time T have written in excess of 150
peer-reviewed scientific publications on this subject.
I strongly support the contention that aluminum adjuvants in vaccines may have a role
in the etiology of autism spectrum disorder (ASD). My view is founded on a significant and
burgeoning body of peer-reviewed scientific evidence which makes the ]mals between ASD
and exposure to aluminum through vaccinations and other sources. Examples of this literature
from my own group are detailed below and I urge the HHS to take them into consideration in
forming any future opinion on the safety of aluminum adjuvants in vaccines.
The Center for Disease Control's claim on its website that `{Vaccines Do Not Cause
Autism" is unsupported with respect to aluminum adjuvants and this claim stifles the
important research to determine the safety of aluminum adjuvants used in vaccines. As an
expert in the field of aluminum adjuvants and aluminum toxicity 1 solemnly declare that more
research on the role of aluminum adjuvant in vaccines and neurological disorders, including
ASD, is essential and urgently required,
Telephone nurrmher+44(f 1762)5$421]
Fax 144(01782)712378
KccIt Uniyersiiy,Siaffordshirc.S15 1H 1Jniled Kingdum
Telephone number+44(41782)6211 I 1 httpf/www.keele.ac_uk
Your,: Iaitlilu]]y
Christopher Exley PhD
Professor in Bioinorganie Chem istry
Honorary Professor, University of the Highlands and Islands
List of Recent. Relevant and Sienifican I Publieation From Our Group
Exley C, Sic* P c Eriksson H (201{))The immunohiofogy of aluminium adjuvants:how do they really work?
Trends in Immunology 31, 103-109,
Exley C and House E(201 1)Aluminium in the human brain_ Monatsfrefte filr Chemie -Chemical Monthly 142,
357-363.
House E,Esiri M,Forster G,Ince PG and Exley C(2012)Aluminium, iron and copper in human brain tissues
donated to the medical research council's cogiitive function and ageing study. Metalfoniics 4, 56-65.
Exley C (2011)Aluminium-based adjuvants should not he used as placebos hi clinical trials. Vaccine 29, 9289.
Exley C (2012)When an aluminium adjuvant is not an alurniniurr1 adjuvant used hi human vaccination
programmes. Vaccine 30,2042.
Exley C(2012)The coordination chemistry of aluminium in neurodegenerative disease.Coordination Chemistry
Reviews 256,2142.2146.
Exley C,Ilouse E,Polwart A and Fain MM (2012)Brain burdens of aluminium, iron and copper and their
relationships with amyloid beta pathology in 60 human brains_Journal of Alzheimer's Disease 31, 725-730.
Davenward 8,Rentharn P, Wright 3,Crome P,Job, D, Pofwart A and Exley C(2013)Silicon-rich mineral water
as a non-invasive teat of-the `aluminium hypothesis' in Alzheimer's disease.Journal of Alzheimer's Disease 33,
423-430.
Khan Z,Coinbadiere C,Authier FJ,].tier V,l.ux F, Exley C, Mahrouf-Yorgov M,.Vecrouy X, Moreno P,
Tillement 0,Gherardi RK, and Cadusseau J (2013) slow CCI.2-dependent translocation of biopersistent
particles from muscle to brain. RMC Medicine 11:99.
Exley C (201.3)Human exposure to aluminium. Environmental Science=Processes and impacts 15, 1807-1516,
Ohlsson L,Exley C,Darabi A,Sanders F.,Siesj i P and Eriksson H (21)13)Aluminium based adjuvants and their
effects on mitochondria and lysosomes of phagocytosing cells_Journal of]norganic Biochemistry 128,229-236,
Exley C (2014)Aluminium a€ijuvants and adverse events in sub-cutancous allergy immunotherapy, Allergy,
Asthma and Clinical Immunology 10,4.
Exley C and Vickers T(2014)Elevated brain aluminium and early onset Alzheimer's disease in an individual
occupationally exposed to aluminium; a case report. Journal of Medical Case Reports 8,41.
Exley C (2014)What is the risk of aluminium as a neurotoxin? Expert Review of Neurotherapeutics 14, 589-
591.
Mold M,Eriksson II, Siesjd P,Darabi A, Shard low F and Exley C(2(114) Unequivocal identification of
intracellular aluminium adjuvant in a monocytic THP-1 cell line_ Scientific Reports 4, 6287,
Telephone number+44(01762)58421 t
Fax 144(01782)71237E
Koelc University,Si IFnrd5hire,ST5 SkCi united Kingdom
Telephrme number+44(017E2.021111 htirilwww_keele.ac_uk
Exley C(2014)Why industry propaganda and political interference cannot disguise the inevitable r oic played by
human exposure to aluminium in neurodegenerative diseases,including Alzheimer's disease. Frontiers in
Neurology 5:212. dof: 10.33 89/fneur.201'1.0021 .
Crepeaux G,Eidi II, David M-0, Tzavara E, C iron 13, Exley C, Currni PA,Shaw CA, (iherardi RK and
Cadtrssean J(2015)Highly delayed systemic translocation of aluminium-based adjuvant in CD 1 miue following
intramuscular injections. Journal of inorganic Biochemistry 152, 199-205.
Exley C(2016)The toxicity of aluminium in humans. Morphologic 100,51-55.
Mirza A,King A,Troupes C and Exley C(2016)The identification of aluminium in human brain tissue using
hirnogallion and fluorescence microscopy. Journal of Alzheimer's Disease 54, 1333-]33g.
Mold M, Shardlow E and Exley C(2016) Insight into the cellular fate and toxicity of aluminium adjuvants used
in clinically-approved human vaccinations_ Scientific Reports 6=31578_
Mirza A,King A,Troakcs C and 1• xlcy C(21 17) Aluminium in brain tissue in familial Alzheimer's disease,
Journal of'l race L]emcn[.s in Medicine and Biology 40,30-365,
Shardlow E, Mold M and Exley C(2{]17) From stock'bottle it) vaccine: Elucidating thepartic]e size distributions
of aluminium adjuvants using dynamic light scattering_ Frontiers in Chemistry 4,48.
Exley C(2017)Aluminium should now be considered a pdmary aetiological factor in Alzheimer's disease,
Journal of Alzheimer's Disease Reports ],23-25,
Telephone number+44{01782).51f471]
Fax+q4{017$2)712:78
Keele University,Snnffords]iire,ST5 513G United Kingdom
Telephone number X14(01782)fi2I]i] htip:ffwww.kcele_ac.uk