Comments Due on National Vaccine Plan 3/31 by 5:00 pm EDT

[Guest guest]

Comments Due on National Vaccine Plan 3/31 by 5:00 pm EDT

Reminder: Comments Due on the National Vaccine Plan (with sample draft letter

for personalization and filing)

 

            Public comments are due on the draft National Vaccine Plan (NVP) by

5:00 pm EDT Tuesday, March 31.  The NVP is being developed by the National

Vaccine Program Office of HHS and will guide U.S. vaccination activities for the

next 10 years. The draft Plan fails on many points. To paraphrase

McCarthy's slogan from the Green the Vaccines rally last June [ " Too many, too

soon " ], the Plan calls for " More, Sooner. " And rather than a " Safety First "

approach, the Plan reflects the same " Safety Last " perspective of the existing

global vaccine enterprise, giving far more weight to vaccine development and

promotion than to safety considerations.

 

    The call for public comment is by far the most important opportunity for

public participation in setting vaccine policy in over a decade. Electronic

comments should be submitted to NVPComments@....  The Federal Register

notice contains a snail mail address.  The notice seeking comments was published

in the Federal Register on January 14.  

 

    This opportunity for public input is part of a major federal effort to

re-examine vaccine policy caused in part by declining public confidence in

vaccines, increasing mistrust and skepticism of CDC research and oversight,

increased use of exemptions and " alternative " schedules, concerns raised by

pediatricians reflecting significantly increased parental uncertainty about both

the safety and benefits of vaccines, and recent public actions such as

McCarthy's/Jim Carey's Green the Vaccines rally at the Capitol last June, calls

by prominent scientists such as Bernadine Healy for improved safety science

especially with respect to autism, and the Government's concession in February,

2008, in the Poling case that vaccines can cause autism.

 

    The current draft introduction to the NVP  and strategic plan  are an update

of the plan first published in 1994.  The NVP is required by the 1986 Vaccine

Injury Compensation Act.

 

            A sample draft letter to submit for comment is provided below, which

you can cut and paste into your own comment and modify or personalize as

desired.  I cannot overstate the importance of broad participation.  These

comments should guide development and implementation of the Plan and make a

record for Congressional and media oversight of what the public wants and

expects for future vaccination activities.

 

    The Plan sets forth five general goals and each goal has a series of

outcomes ( " indicators " ) and objectives underpinning it:

 

Goal 1: Develop new and improved vaccines.

Goal 2: Enhance the safety of vaccines and vaccination practices.

Goal 3: Support informed vaccine decision-making by the public, providers, and

policy-makers.

Goal 4: Ensure a stable supply of recommended vaccines, and achieve better use

of existing vaccines to prevent disease, disability, and death in the United

States.

Goal 5: Increase global prevention of death and disease through safe and

effective vaccination.

 

            Public input is specifically sought in response to the following

questions, set forth in the introduction:

 

<<First, are the goals and indicators appropriate? Should the plan be fully

achievable, aspirational, or a combination of the two? In particular, we would

appreciate some recommendations for the numeric targets for the indicators - in

particular suggestions on how we ultimately set the targets. We would also

appreciate comments on the overall vaccine and immunization enterprise described

in the draft strategic Plan, recognizing that the implementation plan will

follow shortly. Finally, we would appreciate guidance regarding how to think

about the concept of 'accountability' for non-federal stakeholders that are part

of the plan, because their role is so critical.>>

 

    However, I emphasize that public comments should go beyond these particular

questions. Safety must pervade all 5 goals.  Money should not be invested in

vaccine development unless assurance is given that existing as well as new

vaccines are truly safe, individually and as part of the ever expanding vaccine

regimen.  Honest communication requires a clear statement that the safety of the

vaccine schedule has never been demonstrated; therefore the schedule must be

regarded as an unethical experiment and true informed decision-making weighing

risks and benefits is not possible.  The world will increasingly reject vaccines

not perceived as safe in developed countries.

 

            In short, the Plan must propose and implement an aggressive " safety

first " safety system that contains the following components:

 

1.  Sound science.

2.  Independence.

3.  Meaningful oversight.

4.  Transparency.

5.  Accountability.

6.  Honesty and integrity.

7.  Adequate safety net.

 

            A meeting of the National Vaccine Advisory Committee for

" stakeholder input " was held on February 6 in Washington.  Summaries from that

meeting can be viewed here.  A " stakeholder input " meeting was held by NVAC's

Vaccine Safety Working Group on March 16 to review a parallel vaccine effort by

the CDC's Immunization Safety Office.  A " consensus group " developed a very good

vaccine safety research agenda which you can review here . Sallie Bernard, Vicky

Debold, Bell, and Barbara Loe Fisher represented the " safety concerned "

advocates that also included representatives from public health, pediatricians,

federal agencies, NVAC members, parental vaccine advocacy organizations, and

members of the public.  For those living in or near Syracuse, New York, there is

a meeting to solicit local public input on April 4.  Those wishing to attend

should contact Charlotte (Chuckie) Holstein at FOCUS Syracuse,

FOCUS@...,

315-448-8732.

 

            The Institute of Medicine is conducting an " independent " review of

the Plan, which has and will include several opportunities for public input.

 Information on the IOM meetings can be found here.   The next meeting of the

IOM panel is April 14 in Washington.  IOM submitted a preliminary letter report

last June.  The comments you file here should also be sent to the IOM at

VaccinePlan@..., and can be submitted through IOM's final meeting on this

project on June 4.

 

            Sample draft comment letter:

 

[your name and address]

[date]

 

Attn: National Vaccine Plan RFI

 

National Vaccine Program Office

Dept. Of Health and Human Services

Room 443-H

200 Independence Ave. SW

Washington, DC 20201

 

A " safety first " agenda must be the cornerstone of this country's program of

mass vaccination.  Rapidly growing doubts undermine public confidence, threaten

the benefits of vaccines, and risk return and spread of preventable infectious

diseases.

 

1.  Sound science.  The heart of an effective safety system is sound science.

 The vaccine schedule has never been proven safe in animal or human trials that

compare both the acute and chronic health status of vaccinated versus

unvaccinated individuals. The schedule must therefore be regarded as an

unethical experiment.  Ethical codes from Hypocrites to Nuremberg and their

modern embodiments in law emphasize the physician's duty to the individual

patient, especially the mandate to avoid harm, and must not be replaced or

overwhelmed by one-size-fits-all industrialized medicine or a public health

preference for herd immunity. The NVP must include an extensive research program

that entails both prospective [e.g., National Child Health Study] and

retrospective studies in humans and animals.  It must be a comprehensive

program, not just a single study, and must include research on mechanisms of

immunity and adverse effects and investigations on how to

prevent and treat adverse effects.

 

Adequate safety science is decades late.  Gaps in our knowledge have and will

continue to undermine public trust, as well as over-interpretation and " spin "

put on the flawed and fraudulent studies conducted and funded by CDC.  The

continued benefits of mass immunization cannot be justified by " acceptable "

levels of collateral damage.  The burden of both acute and chronic

vaccine-caused injury must be determined and continuously monitored so that

changes can be made in vaccines (e.g., removal of heavy metals and viral

interaction), the schedule (e.g. spreading out multiple vaccines), public health

policy (e.g. greater reliance on anti-virals and other prophylactic measures),

administration, and screening of children with a genetic susceptibility to

minimize adverse effects.  This is not only an ethical obligation but a legal

duty as set forth by Congress in Section 27 of VICA.

 

2.  Independence.  As noted above, the ethically required studies on the safety

of the vaccine schedule have never been done, primarily because those charged

with safety research are also charged with vaccine development and promotion, a

certain conflict of interest.  CDC has conducted and/or funded a series of

studies purporting to disprove any connection between vaccines and autism.

 These all suffer from serious design and methodological flaws including

over-interpretation of results.  In one major study, Safety of

Thimerosal-Containing Vaccines, Verstraeten et al (2003), protocols and

inclusion/exclusion criteria were changed following initial results that showed

an association between mercury in vaccines and neurodevelopmental delays

including autism.  Documents obtained under FOIA revealed that this post hoc

data manipulation was done after review of initial findings in a secret meeting

with vaccine companies explicitly to conceal any

" signal " of adverse events. These revelations of scientific fraud have been

detailed in Evidence of Harm by Kirby and in articles by F.

Kennedy, Jr.  The lead author eventually published a retraction of any " no

causation " interpretation in Pediatrics and called for additional research.  

 

The safety system must be completely independent of CDC, the agency charged with

promoting vaccines.  Structural separation of safety from promotion has been

implemented long ago for agencies such as the National Transportation Safety

Board, the Consumer Product Safety Commission, and the Nuclear Regulatory

Commission to avoid both the appearance and reality of conflicting interests.

 Tom Insel, Chairman of the Interagency Autism Coordinating Committee and

Director of NIMH, explained at an IACC meeting January 14 that HHS has a

conflict of interest in conducting vaccine safety research because it is the

" client " in Vaccine Court in order to help CDC delete a comprehensive program of

vaccine safety research from the strategic plan for autism research.

Accordingly, a new Vaccine Safety Commission must be established which is

independent of HHS. It should have a separate budget from Congress of at least

$100 million annually.

 

3.  Meaningful oversight. Vaccine policy is presently set by three committees

composed almost exclusively of representatives from public health, academia,

industry, and stakeholders with a financial interest in increased consumption of

vaccines, with only token representation from parents and the vaccine safety

advocacy community.  The new Vaccine Safety Commission must be overseen by

parents, the only group with an unyielding commitment to the health of their

children and by representatives from the vaccine safety community.  Parents who

favor full vaccination and parents who have concerns over vaccine safety share a

common interest in the safest possible schedule.  Avoiding acute and chronic

adverse effects is absolutely crucial to maintain high coverage rates thereby

reducing the risks from infectious disease.  The Commission should have

available advice from industry, academia, doctors, and public health

professionals, but the final decisions

must be left with those most committed to healthy children and those free of

both the appearance and reality of financial conflicts.

 

4.  Transparency.  The present secrecy surrounding vaccine safety data is

anathema to public confidence.  The taxpayers have paid for the FDA/CDC VAERS

system and the CDC's Vaccine Safety Datalink (VSD) since 1991, and they are

hailed as the premier databases for assessing vaccine safety.  Yet these vital

data are kept secret from the public and researchers independent of CDC and

industry.  For example, critical VAERS data on vaccine distribution, necessary

to calculate adverse event rates, is withheld by FDA, who claims it is an

industry " trade secret " . Indeed, in part to keep VSD away from FOIA and

Congressional subpoenas, CDC moved the database to the " custody " of a trade

association of HMO's. Petitioners' counsel and their experts can't even gain

access to VSD for purposes of effective case presentation in Vaccine Court. In

2005, IOM recommended transparency of VSD but to date these data remain a

closely guarded secret.

 

VSD and all industry data submitted pre- and post-licensure to FDA must be made

public on an ongoing basis.  CDC, NIH, and Congress have noted serious flaws in

VSD.  It should be upgraded from " administrative " (billing records) to a

research quality database by, e.g., linking mothers and children, including

maternal exposures, long-term tracking of children and their health outcomes,

standardized diagnostic criteria, and inclusion of unvaccinated children and

their waiver status.  Appropriate debates over interpretation should occur in

the open scientific literature and not behind closed doors.

 

5.  Accountability. The new Vaccine Safety Commission must have the authority to

clear vaccines for inclusion on the schedule, remove them from the schedule, and

approve the Vaccine Information Statements on risks and benefits and other

information which by law must be given to parents and patients prior to

vaccination.  Moreover, vaccination must remain voluntary, not only because this

is a basic ethical requirement, but because the right of refusal is a powerful

motive toward safer vaccines.  Religious, medical, and philosophical exemptions

must be available in every state.

 

6.  Honesty and integrity. HHS has conceded (in secret settlements) and the

Vaccine Court has held (in at least 12 published decisions) that vaccines can

cause autism.  The question now shifts to how many children have been injured

and what are the appropriate biomarkers to use in determining entitlement to

compensation.  Yet, HHS dishonestly states as late as a February 20 statement:

" The government has never compensated, nor has it ever been ordered to

compensate, any case based on a determination that autism was actually caused by

vaccines. "  Such denial is unacceptable and is guaranteed to undermine public

trust. HHS must publicly admit, and include on VIS's and other materials that

vaccines can cause autism.  Such admission will help stimulate necessary safety

research and encourage parents to work with their pediatricians to take

precautions where indicated.  VIS's must also clearly state that the safety of

the schedule has not been proven by

comparison to unvaccinated animals and humans, and that the schedule must be

regarded as experimental.  They should also describe the health status of

children included in industry trials and state that safety has not been verified

in less healthy children; and list the contraindications and adverse events as

contained on the FDA-approved label. Communicating the benefits of vaccines

without accurately disclosing their risks and gaps in safety knowledge is

dishonest and further undermines public trust.

 

7.  Adequate Safety net. No vaccine or schedule can be made perfectly safe. To

preserve the benefits of full vaccination, society has a legal and ethical duty

to generously compensate those injured by vaccines, in effect " collateral

damage " in the war against infectious disease.  The tort law system under state

law is the traditional means of motivating product safety and compensation of

the injured.  Congress replaced this with the Vaccine Court and VICP in 1986 in

order to serve the twin goals of protecting industry from " excessive " litigation

and protecting public confidence in vaccines by implementing a non-adversarial

family-friendly no-fault compensation program.  The failure of VICP to largely

achieve this second goal is and will continue to undermine public acceptance of

full vaccination.  Necessary changes include: making the program optional;

increasing the statute of limitations to at least the traditional state limits;

preserving the

right to " opt out " of the program before or after decision to pursue

traditional tort remedies; faithfully implementing the Congressionally mandated

lower burden of proof by resolving scientific doubt in favor of petitioners;

providing for discovery and juries; providing timely compensation to lawyers and

expert witnesses; no limits on compensation for pain and suffering or death; and

providing that awards to children will be administered through trusts

independent of Government.

 

An effective safety system, as outlined above, is an essential part of the

National Vaccine Plan.

 

Sincerely,

 

[your name or that of an organization; anonymous comments will not be

considered]

 

Love, Gabby. :0)

http://stemcellforautism.blogspot.com/

 

" I know of nobody who is purely Autistic or purely neurotypical. Even God had

some Autistic moments, which is why the planets all spin. " ~ Jerry Newport