The Atlanta Manifesto is a richly researched and compelling report
was written 3 years ago by Mark Blaxill and Barbara Loe Fisher and
submitted to the Center for Disease Control (CDC) following their
participation in a “Blue Ribbon Panel” convened by the
CDC. The report of the panel was so far from the discussion presented
that Blaxill and Loe Fisher felt compelled to write a corrective report
on the meeting. Although it was presented to the CDC over 3 years
ago there has been no response from the CDC since it was submitted.
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org
Please take the
time to read this exceptionally important document and share it widely.
The
Atlanta Manifesto
Safety
Last to Children First
PART 1 |
Safe Minds and the National Vaccine Information
Center (NVIC) are pleased to have an opportunity to present a case
for change in our nation’s public health strategy. We are grateful
to Dr. Julie Gerberding and her staff for reaching out for a range
of views on this subject. As parents and citizens, we have joined
this discussion feeling the weight of great responsibility on our
shoulders, because we see an urgent need for change in public health
policy and practice. The health of the children of our country is
deteriorating. Yet rather than facing this reality, our public health
leadership has turned away from the challenge in order to defend entrenched
practices and controversial policies, some of which may have contributed
to these adverse trends. Accordingly, we want to make a strong and
clear statement: the public health agenda in our country requires
comprehensive reform.
The authors represented our respective organizations — National
Vaccine Information Center and Safe Minds — as invited participants
to the Blue Ribbon Panel on Vaccine Safety on June 3-4, 2004, in Atlanta.
We appreciated receiving our invitations to attend. We also respect
and acknowledge the efforts of the chair, Dr. Louis Cooper, to summarize
the discussion in his Summary Report. Given the mix of the participants,
many of whom have close ties to the past CDC leadership and/or personal
involvement in setting the recent course of U.S. public health policy
and practice, we did not expect that the Summary Report would convey
our sense of urgency and concern. Although the Summary Report represented
a good faith effort to report on the Blue Ribbon Panel’s proceedings,
it did not provide a coherent reporting of the case for comprehensive
change. Accordingly, our two organizations have joined together to
author this White Paper on Vaccine Safety, entitled, “From Safety
Last to Children First.”
We should note at the outset that our most fundamental dissent from
the larger group is the framing of the agenda itself. We are far less
concerned with focusing on vaccination than we are concerned with
focusing on better health outcomes for America’s children. Although
our organizations have frequently (and unfairly) been described as
“anti-vaccine,” we share the view that vaccine programs
to manage infectious diseases can be a valuable part of strategies
to advance the mission of childhood health. These diseases, however,
reflect only a fraction of the adverse health outcomes facing children
today and a decreasing fraction of these. So although the focus of
the agenda for the Blue Ribbon Panel reflects the misplaced emphasis
on infectious diseases, we choose not to restrict our Response to
the Summary Report to the agenda as defined. Instead we will address
the case for change based on some core principles and a hopeful vision
of the future.
We share a sense of hope that America’s public health focus
can be reformed to serve the health needs of children and families
in the 21st century. A forward-looking focus for public health practice
would embrace:
1) A mission of securing positive health outcomes for children and
families;
2) A commitment to a total health perspective, including chronic as
well as infectious disease, developmental disability as well as episodic
illness, and quality of life as well as the absence of disease;
3) A recognition of the crisis of the chronic disease epidemics among
children, including autism, learning disabilities, attention deficits
and other neuro-developmental disorders as well as asthma, allergy,
juvenile-onset diabetes and other autoimmune disorders;
4) A vaccine policy that treats all citizens, including parents, as
intelligent participants in the health choices they make for themselves,
their children and their communities and requires true informed consent
for participation in vaccine programs;
5) An operating philosophy that sets a goal of zero vaccine adverse
reactions and treats each reaction respectfully, indeed as a resource
for diagnosis and prevention of future vaccine adverse reactions,
especially those that lead to chronic adverse health outcomes;
6) A governance model for vaccine policy-making based on true public
accountability, characterized by public inclusion, openness to scientific
criticism and a willingness to accept past shortfalls as an opportunity
for learning, growth and change.
We believe that this positive focus is notably absent in public health
policy and practice today. Consequently, we share a grave concern
that the past approach of public health authorities requires comprehensive
and fundamental reform. In contrast to our vision of hope, we see
a current approach that is fixated on:
1) A mission of fighting a war on disease that disregards the secondary
and tertiary consequences of war and views innocent children as inevitable
casualties;
2) A commitment to an unprecedented expansion in the childhood vaccine
program , with inadequate, if any, consideration given to the cumulative
and interactive effects of this strategy;
3) A consistent posture of hyping the risk of infectious disease,
a communication model that relies on fear, hyperbole and incomplete
information;
4) A vaccine program concerned largely with herding “the public”
into a state of compliance, reflecting a view of citizens as a monolithic
entity in need of instruction rather than engagement;
5) An operating ethos in vaccine safety management of utilitarianism,
one that allows for “acceptable losses”, based on an approach
that places “safety last” in funding priorities;
6) A pattern of governance in which many decision-makers have direct
financial and/or career conflicts of interest that produce biases
to program expansion and the defense of past policy decisions.
The continued pursuit of the current approach has created an adversarial
environment that jeopardizes the health of America’s children
and the long-term well-being of our nation. Within the CDC, a defensive
bureaucracy finds it increasingly difficult to reconcile past ideological
and policy commitments with the emerging realities. Parent organizations,
faced by institutional complacency (with respect to epidemic childhood
illnesses like autism) and defensiveness (with respect to the examination
of plausible environmental and biological hypotheses), are forced
into confrontations they do not enjoy, consuming time they do not
have. Pediatric organizations, long resigned to becoming instruments
of state policy by allowing their members to become a toll gate for
vaccine administration in well child visits, have come adrift from
the service mission that motivates most pediatricians, securing positive
health outcomes for children, not maximizing their office visits.
Vaccine manufacturers, prisoners of their extraordinary corporate
profit rates, pursue short term profit enhancement with too little
regard for the adverse effects to which inappropriate usage of their
products may contribute. In the meantime, as a nation we have too
many sick children and no shared view about how they got that way.
This all must change.
PART
2
From Waging a War on Disease to Securing Childhood Health
For those who join high level discussions of vaccine policy for the
first time, it is quite surprising to see many CDC officials wearing
uniforms. By embracing a military identity, these officials emphasize
their unique prerogatives. That they possess the authority: to deploy
the coercive powers of the state as they see fit; to deprive citizens
of their liberty in the name of the greater good; and to enforce what
they consider to be necessary human sacrifices as they do battle with
dangerous microbes and viruses. The language of conflict — the
“war on disease,” “combating the causes of epidemic,”
“fighting emerging infections” — is closely connected
to the language of military power and, of course, “Disease Control.”
History teaches us that when government officials are determined to
fight a war, any war, truth can be the first casualty.
Nurse Although the CDC hosts multiple centers for disease prevention,
a clear organizational focus on chronic childhood disease and disability
and on overall childhood health is absent. The Center for Chronic
Disease Prevention focuses almost exclusively on adult conditions,
while the Center for Birth Defects and Developmental Disabilities
(NCBDDD) focuses its attention on a selective set of childhood conditions,
a set that excludes autoimmune conditions. The NCBDDD has meanwhile
demonstrated puzzling complacency in its approach to developmental
disorders such as autism. Effectively, the CDC’s largest institutional
commitment to childhood health lies within the National Immunization
Program, a group with an exclusive focus on preventing infectious
diseases through mandated mass vaccinations. For most American families,
the childhood immunization program represents the public face of the
CDC and its most concrete intervention in our everyday lives. We exaggerate
only a bit when we say the war on infectious disease as implemented
by the NIP is America ’s primary childhood health initiative.
In the war on infectious disease, the CDC measures progress by its
surveillance of “notifiable diseases.” There are now more
than 60 such notifiable infectious diseases and the CDC reports these
diseases on a weekly basis for each state and territory, with annual
breakdowns that itemize case counts by age group, including children.
By contrast, no such chronic disease and disability surveillance exists
for children, with the sole exception of some rudimentary asthma data.
As to clear childhood health crises such as the epidemic of autistic
spectrum disorders (ASDs), the CDC only says, “We do not know
if ASDs are becoming more common in the United States .”
Clearly, our public health officials possess asymmetric information
with respect to the total health of children and how it is changing.
This asymmetry results in part from institutional inertia, in part
from limited funding and in part from different perceived relevance
of such timely reporting for intervention purposes. Whether or not
this asymmetry was ever deliberate, it has resulted in clear ignorance
regarding chronic disease. And although one might attempt to excuse
such ignorance as an historical legacy, at some point such ignorance
becomes willful: a conscious choice to forego the acquisition of unwelcome
knowledge; an attempt to preserve plausible deniability in the face
of disturbing news. In a parent, such denials would amount to negligence.
Indeed, diligent, concerned parents have become the most vocal critics
of our public health officials’ performance in the area of childhood
health.
Yet while parents may know a great deal about their own children,
they inevitably possess a limited view of populations, enhanced perhaps,
but quite possibly distorted, by shared group experiences in advocacy
groups. Scientists typically rely on more rigorous surveillance and
research to provide reliable trend and incidence data. Yet scientists
and other “experts” will only know what basic surveillance
tells them or what they seek to know through sponsored research. When
basic surveillance and critical research is lacking, scientists become
less reliable sources than parents, absent primary information sources
of any kind.
As parents, we therefore often look to front line health professionals
such as therapists and nurses for their perspective. These professionals
have a broader perspective on childhood health than either parents
or scientists. Among such health care professionals, the message is
clear: something new and terrible is happening to America ’s
children. Consider, for example, a quote from a representative of
school nurses in Missouri, testifying before Congress in 2000.
“The elementary grades are overwhelmed with children who have
symptoms of neurological and/or immune system damage: epilepsy, seizure
disorders, various kinds of palsies, autism, mental retardation, learning
disabilities, juvenile-onset diabetes, asthma, vision /hearing loss,
and a multitude of new conduct/behavior disorders …
We (nurses, principals and teachers) have talked many times about
the possible cause(s) of the continuing increase in pervasive developmental
disorders (PDD), such as autism. From the literature we have found,
we should expect a rate for PDD of about 2-5 in 10,000. In our community
the rate in Kindergarten, 1st and 2nd grade is more like 1 in 150.
The teaching staff is overwhelmed ….
We are all now faced with a moral dilemma: will we protect the “sacred
cow of conventional vaccine philosophy” or will we stand up
and speak out for the “health and well being of innocent children”?
We choose children. We wonder, which will our government choose?
-Patti White, RN Missouri Central District School Nurse Association.
Statement to the Subcommittee on Criminal Justice, Drug Policy, and
Human. Resources of the Committee on Government Reform U.S. House
of Representatives.
In the year 2000, there were 122 cases of AIDS reported in children
under five years of age, 37 cases of measles, 57 cases of mumps, 10
cases of rubella, 43 cases of hepatitis B, less than 3,000 cases of
pertussis, and zero cases of tetanus, diphtheria and 9 other notifiable
diseases. By contrast, California — with over 10% of the U.S.
population — reported over 6,700 new cases of PDD/autistic disorder,
by extrapolation a national reporting rate of 70,000 children annually.
Over 800,000 children under five reported an episode of asthma. New
juvenile-onset diabetes cases probably numbered in the thousands (unfortunately,
no reliable surveillance exists).
We do not presume to judge the relative significance of these diseases
to childhood health, however we do submit that chronic diseases are
in no way less harmful to children. We would also note that the vast
majority of children recover from a case of childhood infectious disease
(as parents looking back on our childhood, most of us remember uneventful
recoveries from these diseases as children).
We represent a growing constituency of parents of children who developed
normally and then acquired a chronic developmental disorder early
in childhood. Our children will never fully recover. Although we recognize
the risk of childhood disease, we would gladly trade a few episodes
of vaccine-preventable, infectious disease in our children for the
disabilities they will live with for the rest of their lives. Tragically,
our ranks have swelled dramatically. Indeed, the numbers suggest that
the weight of the modern public health agenda should revolve around
families like ours. The problem we represent therefore is new. It
has, moreover, emerged and grown in parallel with the growth in the
number of required childhood vaccines. So although we recognize the
risk of jumping to premature conclusions regarding causality, we also
deplore complacency and defensiveness in any form. It is time, indeed
long past time, for our public health officials to reset their priorities
and turn their attention to the health issues of greatest consequence
for children in the 21 st century.
PART 3
From Expansion of Vaccine Interventions to a Commitment to a Total
Health Perspective
The Blue Ribbon Panel was convened to
consider a proposal to separate vaccine risk management from risk
assessment [at the CDC]. We concur with the spirit of this proposal
and believe that independence in vaccine safety assessment is overdue.
The National Immunization Program has long confused vaccine safety
with vaccine promotion. But we also see a deeper force driving the
problems with vaccine safety, a force that goes beyond simple questions
of organization and governance. The longstanding commitment of our
public health leadership to expansion of the mandatory vaccination
programs places pressure on the watchdogs of safety to make vaccine
risk assessment friendly not just for current programs, but also for
new vaccines. Dr. Robert Chen, the official most responsible for vaccine
safety over the last decade has openly confessed to this bias in print.
“Given the current increasingly “anti-vaccine” milieu,
it is hard to imagine that the full potential of new vaccines will
be harnessed. To avoid this impending tragedy, we need to critically
examine the factors influencing this change in public sentiments.”
- Dr. Robert Chen, Vaccine Safety and Development Branch, National
Immunization Program, CDC, “Vaccine Risks: real, perceived and
unknown”, Vaccine, 1999.
Dr. Chen sets forth here the central fallacy of modern vaccine policy:
if some vaccine interventions have done some good, then more interventions
will do more good. His conclusion that the failure to expand the vaccine
program would be a “tragedy” reflects this a priori assumption,
shared by so many, that we have only just begun to harness the potential
for strategies of increased intervention. Numerous careers, major
research programs and large-scale commercial investments have been
bet on the promise of public acceptance of unlimited vaccine interventions.
Much is at stake.
In just a few short years, we have seen the effects of this strategy.
Through the 1970s, the childhood immunization schedule consisted of
interventions against a short list of diseases: smallpox, polio, diphtheria,
pertussis and tetanus. Today, the CDC’s “universal use”
list for children has expanded to include vaccines against measles,
mumps, rubella, hepatitis B, haemophilus influenza B, varicella, pneumococcal
and influenza. Before they reach their second birthday, a child born
today will receive 32 separate vaccine doses when following the CDC’s
recommended schedule. With these additions, we have embarked on a
public health strategy that constitutes a radical shift in the way
our species experiences its environment and a radical shift in the
way the human immune and neurological systems develop during the first
critical months of life. In a quite literal sense, we have entered
unexplored territory.
As the childhood vaccine program has expanded, it has also changed
character. The earliest vaccines—polio, diphtheria, smallpox—protected
against highly infectious and frequently fatal diseases, diseases
to which infants were also highly vulnerable. The new additions to
the vaccine program have not targeted similar attributes or shared
the same benefits. These new targets are often less dangerous to children
(chickenpox or rubella), less infectious (haemophilus influenza B
or pneumococcal) or otherwise less prevalent among children (hepatitis
B).
Although the original vaccines had demonstrable preventive benefits,
their risks were also meaningful. Dramatic, sometimes fatal, adverse
events associated with neurological damage have been documented, most
notably with whole cell pertussis vaccine, but also with oral polio
vaccines. The re-introduction of smallpox vaccine after September
11, 2001 was curtailed due to unacceptable rates of adverse events,
including cardiac events that led to death. One distinguishing feature
of these events, however, was their clear cause-and-effect relationship
with single vaccine exposures.
As the vaccine program has expanded, we face new safety concerns.
In addition to the ongoing risk of single vaccine adverse events,
we need to recognize new exposure risks, either from the cumulative
effect of vaccine ingredients or from the unintended consequence of
interactions between vaccine and other environmental antigens and
the potential for accidents in a complex, closely-coupled system like
the developing immune system.
Vaccine mercury exposure provides a dramatic example of the cumulative
effect risk. Exposing the developing brain to mercury was never a
good idea, but the introduction of two new vaccines in the early 1990s
(not to mention the increasing practice of antenatal Rho D immunization)
tripled the earliest exposure rates. These additions effectively compounded
acknowledged mercury risks to pregnant mothers from seafood consumption
and dental amalgams. In the case of mercury, we see the dark side
of the “more is better”, expansionist bias: if some mercury
exposure is bad, then more is unquestionably worse. Yet now the CDC
has recommended new childhood mercury exposures via influenza vaccines,
when evidence continues to accumulate underscoring the danger of these
exposures.
More complex, but no less concerning, is the issue of interactive
effects. We simply do not know what the risks of these 39 doses of
12 vaccines might be for human health when combined together in developing
infants. In the face of this recent escalation in intervention, common
sense would suggest a testing discipline involving more than assessments
of each new vaccine, or even combination vaccine, on its own, but
rather involving comprehensive assessments of the old strategy vs.
the new strategy in their entirety. Such comprehensive testing has
been dismissed as too expensive, or even absurd. But it has never
been attempted.
So as parents, we are faced with a puzzling paradox. We want our children
to be healthy, but they are not, even though we have done what we
have been told to do by public health officials and pediatricians.
We see families around us in similar distress, with asthma inhalers
and epi pens as common in schools today as peanut butter and jelly
sandwiches were in our day. We are concerned about a radical strategy
of intervention that has never been tested for safety and yet we watch
as responsible government officials behave defensively and with more
regard for their beliefs and careers than for the future of our children.
We want to believe in the integrity of our public health system, yet
we cannot, because we fear that excessive specialization and bureaucratic
inertia has led us away from the only focus that matters: the overall
health and well-being of our children. We believe it is time to call
a halt to the expansionist momentum and revisit basic strategic premises.
We strongly encourage the CDC to move away from strategies focused
on the parts to a strategy focused on a total health perspective.
This may be difficult, but it is necessary if we are going to answer
the question: why are so many children chronically ill today?
PART 4
From Hyping The Risk Of Infectious Disease To Facing The Reality Of
Chronic Disease Epidemics
As
the vaccine program expands and the complex assessment of marginal
cost and benefits becomes more critical, the integrity of the analysis
surrounding these assessments matters even more. A prior commitment
to a strategy of program expansion casts suspicion on the CDC’s
internal analysis when the institutional proponents of the expansion
strategy control the interpretation and dissemination of information
and analysis. The obvious concern is that benefits may be overstated
and that risks will be suppressed.
We see pervasive evidence of bias among CDC’s analysts that
lends credence to such concerns. Hepatitis B vaccine policy serves
as useful first case in point.
CDC officials display a bias toward vaccine interventions. When the
mandatory hepatitis B vaccination was added to the childhood immunization
schedule in 1991, this new initiative was the outcome of years of
policy discussions. CDC infectious disease specialists took a public
advocacy stance in favor of “worldwide elimination of hepatitis
B transmission,” claiming “we have the way, we need the
will.” Oddly, for a disease transmitted primarily through promiscuous
sexual activity and intravenous drug use, the strategy they chose
was universal infant immunization, including a first dose immediately
at birth. Yet claims supporting the wisdom of this “way”
have been called into question by recent research showing that infant
hepatitis B immunization provides protection for five years at most.
CDC models exaggerate the incidence of infectious disease. Promoting
a short-lived intervention in populations far removed from the main
source of the infection is odd enough, but the CDC felt obliged to
defend the urgency of such an unusual choice by overstating the overall
risks of this (largely adult) disease. Until the late 1990s, annual
infections by hepatitis B virus (HBV) in the U.S. were routinely quoted
at more than 300,000 despite the fact that CDC’s own surveillance
numbers showed far fewer cases, less than 10% of the quoted cases,
and these case counts fell rapidly through the 1990s
CDC models overstate childhood disease risk to justify vaccine interventions.
Defenders of the universal hepatitis B vaccine birth dose policy estimated
that 25,000 HBV infections occurred annually in children prior to
the introduction of the vaccine. These calculations have not been
challenged but are full of holes: surveillance reports of childhood
infections have never reached even 1% of these modeled levels; the
models that produce high infection estimates require large rates of
horizontal transmission, transmissions that have never been reliably
described; and distinctions between peri-natal transmission (where
mothers could reasonably be offered a choice between vaccine exposure
and maternal HBV testing) and childhood transmission (where vaccines
provide unique benefits) have never been established. In evaluating
a policy that requires annual immunizations of millions of newborns,
rigor and accuracy in making such distinctions are critical, but such
scrutiny has been forsaken in favor of salesmanship and hype.
We have by now become familiar with the fear-mongering that makes
infectious disease a reliable news item. From the infamous swine flu
to the West Nile virus, we have grown accustomed to seeing the threat
of deadly infection on the front page and the evening news. Even with
more legitimate threats like SARS, the reality of these threats consistently
fails to meet the hype, yet spreading the fear of infection remains
a reliable tactic. By contrast, chronic diseases–perhaps because
they are judged to be less preventable, a matter for families to accept
rather than a prevention opportunity — receive nowhere near
the same attention or priority. Autism rates have increase tenfold
but the CDC has not yet declared a public health crisis. Similar to
the case of hepatitis B, autism provides a second case example of
CDC policy bias.
CDC surveillance designs fail to specify chronic disease variants.
The featured activity in CDC’s autism surveillance activities
is the Metropolitan Atlanta Developmental Disabilities Surveillance
Program (MADDSP). Although only a single publication has been produced
so far as an output of this effort, this publication revealed the
manifold weaknesses of the program. The MADDSP approach fails to distinguish
between the sub-categories of the Pervasive Developmental Disorders
(PDDs) — autistic disorder, PDD not otherwise specified and
Asperger’s syndrome — an approach that makes it impossible
to compare results of MADDSP with other studies around the world.
MADDSP researchers place children in diagnostic categories based only
on a records review and do not require standardized diagnostic interviews.
Diagnostic precision is essential to effective surveillance (can you
imagine hepatitis reports that fail to distinguish between viruses
A, B and C?) yet the MADDSP program has abandoned any effort to institute
such precision. Even so, the CDC now offers their approach as the
model for other states to follow. Lack of diagnostic precision may
provide a deliberate refuge for analysts who are not interested in
obtaining good facts, but makes for poor health policy in the long
run.
CDC studies avoid the assessment of chronic disease trends. When CDC
studies have embraced a more rigorous approach to PDD classifications,
they have still failed to report accurately on time trends. The autism
prevalence researchers in Brick Township, NJ provided accurate estimates
of autism rates in a well-defined study population. Yet they suppressed
important evidence on changes in autism rates over time, reporting
rates by only two large age groups. More disturbing, these authors
failed to publish autism rates by birth year, rates that would have
demonstrated clear and compelling evidence of an increasing time trend
in autism rates. Safe Minds has obtained these rates, and they contradict
the CDC authors’ claims that “prevalence rates for the
two [time periods] were not different.” We cannot help but wonder
how the surveillance disciplines, so well developed in infectious
diseases, break down so completely in chronic diseases like autism.
Yet they do.
When increasing trends are acknowledged they are dismissed with speculation.
When discussing the undeniable increases in reported autism rates,
CDC officials profess little concern and offer unsupported hypotheses
that attempt to play down the likelihood of any real increase. The
NCBDD web site on autism offers the following account.
“The studies that have looked at how common ASDs are often used
different ways to identify children with ASDs, and it is possible
that researchers have just gotten better at identifying these children.
It is also possible that professionals know more about ASDs now and
are therefore more likely to diagnose them correctly. Also, a wider
range of people are now being classified as having ASDs, including
people with very good language and thinking skills in some areas who
have unusual ways of interacting or behaving.”
In the face of the spectacular rise in reported autism rates, speculations
like these cry out for scientific support. Yet there is no scientific
evidence of any kind that supports a single one of these speculations.
How is such carelessness allowed?
Taken together, these tendencies form a pernicious pattern of misinformation
and deception. The favored diseases and interventions are supported,
while the inconvenient trends and anomalies are suppressed. Responsible
public health management demands a clear-eyed view of the current
health reality, one based on high-quality data, sound analysis and
rigorous logic. It is time to start facing this reality without further
delay.
PART 5
From Herding the Public to Informed Consent
The rising complexity of vaccine risks
and benefits makes the assessment of risk far more sensitive to the
assessment of such complex trade-offs. But when the guardians of vaccine
safety [at the CDC] play a dual role as advocates of program expansion,
the potential for bias, conflict of interest and bureaucratic error
in these assessments rise when there are no mechanisms in place for
self-correction. When advocates of vaccine programs can also exercise
the coercive power of the state to enforce their decisions through
vaccine mandates, the risks of catastrophic failure multiply.
In an open society, we typically rely on the free choices of informed
citizens as the corrective mechanism for dealing with complex trade-offs.
We express our freedom in two ways, through the free market (for economic
trade-offs) or free elections (for policy making). In either domain,
we know from long experience that assigning decision rights to centralized
state authorities can produce lasting inefficiencies and/or inappropriate
concentrations of power. Checks and balances on such power are essential
to prevent the abuse of power by the state and secure improved outcomes
for society.
Vaccine programs introduce special problems in an open society. Mass
vaccination programs for infectious disease prevention are based on
the premise that herd immunity is the only way to manage infectious
diseases. Achieving herd immunity requires widespread compliance,
indeed significantly greater compliance than either free markets or
free elections require for success. Vaccination coverage rates sufficient
to provide herd immunity have been estimated to be in the 80-95% range
depending on the disease. Achieving such high compliance rates in
large populations demands extraordinary efforts. Compounding this
difficulty, public health officials have increasingly defined success
as compliance rates approaching 100%, a shift from a goal of herd
immunity to a goal of local elimination, even global eradication,
of most diseases for which vaccines have been developed. With such
aggressive targets the exercise of economic choice (”I don’t
want to receive that service”) or the declaration of dissent
(”I don’t support that policy”) runs in direct opposition
to the interests of the bureaucracy in meeting its performance goals.
In order to reach these rising compliance targets, vaccine program
sponsors ask for and typically receive exemptions from normal checks
and balances on state power. These exemptions are justified because
the prevention of disease is seen as an area in which the interests
of the collective override the rights of the individual. Consequently,
manufacturers receive exemptions from product liability laws. Citizens
face powerful sanctions if they fail to comply with state recommendations
— children can be denied entry to school, parents can be declared
negligent, and pediatricians can deny service to families when they
choose not to vaccinate. Program managers are protected from accountability
to external parties in numerous ways.
These exemptions can end up producing an unhealthy relationship between
citizens and central authorities. In the eyes of the officials, a
diverse and autonomous citizenry becomes a monolithic and (ideally)
submissive “public.” The public must be convinced of the
virtues of compliance so that the herd can maintain its immunity and
remain safe from disease. The more submissive the herd, the greater
the opportunity for heroic achievements in disease elimination and
the less the need to apply coercive measures to dissenting citizens.
Yet the childhood immunization program is the only medical intervention
capable of producing injury or death that the state imposes on healthy
children. Vaccines are also the only privately manufactured product
whose universal consumption is made a prerequisite for participation
in public services. These extraordinary exemptions from our normal
democratic system of checks and balances and free markets demand extraordinary,
and constant, scrutiny. Vaccine program management must not only work
when safety is secured, it must also be robust in the face of safety
failures.
But how robust can our system of vaccine safety management ever be?
If one assumes that program managers are always diligent, competent
and correct in their assessments and that the programs themselves
unambiguously and universally safe, then these exemptions from our
standards of openness are a small price to pay for results. But when
there is a possibility of negligence, incompetence, or even well-intentioned
error, these protections run the risk of perpetuating and exacerbating
truly catastrophic failures. In their book, The Virus and the Vaccine,
Deborah Bookchin and Jim Schumacher elaborated the dangers:
“The decisions of our health policy makers, even when well intentioned
are not always well informed. And sometimes those decisions are not
even well intentioned. Sometimes they are based on bias or inadequate
scientific evidence. Sometimes they are biased by the close relationship
between the pharmaceutical industry and the government health officials
who are charged with regulating that industry. Moreover, sometimes
even the best scientists can make mistakes. The safest medical products
can have unforeseen side effects. Things do occasionally go wrong,
sometimes dreadfully wrong, during even the most noble of scientific
endeavors .”
And when things do go wrong, the inevitably defensive reactions can
creep down a slippery slope from the prevention of unnecessary panic
to the dissemination of propaganda and the suppression of dissent.
The resources available to health officials to mount defenses in the
face of failure are extensive. Prestigious journals can relax their
standards in support of questionable research; at-risk constituencies
can mobilize resources to attack discomforting facts; funding agencies
can deny resources for investigations into possible failures; and
conscientious scientists can face disincentives (even sanctions) when
they pursue unpopular investigations.
One powerful bulwark against such breakdowns is the right of informed
consent. Informed consent requires and empowers each citizen to make
choices for themselves and their families based on their independent
assessment of risks and benefits. Informed consent thereby provides
a counterbalancing force against overreaching activities of the state
and provides incentives for manufacturers to improve the safety and
effectiveness of their products:
• In the absence of an ability to choose between vaccine formulations,
combinations and producers, citizens can at least exercise choice
with respect to timing and receipt of specific vaccinations;
• In the absence of meaningful product guarantees or warranties,
citizens can request and expect the provision of scientific information
regarding attributed risks and benefits of vaccines;
• In the absence of clear scientific knowledge regarding the
immunolog
ical
mechanisms, failure modes and adverse exposure consequences, citizens
can seek, consider and act on information from multiple sources, reserving
the right to critically review official interpretations of vaccine
benefits and risks and freely act upon the information they have obtained.
Today, parents who wish to make a different choice with respect to
their children’s vaccinations face numerous obstacles. They
can claim a medical exemption if their child has suffered a “severe
vaccine reaction” that must meet restrictive CDC standards as
a contraindication to further vaccination and are able to find a doctor
willing to write a medical exemption to vaccination. They can, in
most states, claim exemption based on sincerely held religious beliefs.
In eighteen states, they can exercise their right to a philosophical
or conscientious belief exemption to vaccination. But everywhere these
rights might be exercised, they are, practically speaking, nearly
impossible to obtain (in the case of medical exemptions), under challenge
(religious exemptions) or available only to a small number of parents
who are aware of their rights.
In real life, when parents resist their pediatrician’s advice,
they risk sanctions of varying severity, up to and including loss
of medical care, health insurance and even custody. Pediatricians
or nurses can and do notify Child Welfare authorities when parents
resist vaccination and the parents can be charged with child medical
neglect. Parents can postpone the age at vaccination, but in doing
so they forego access to most child-care and educational services.
Indeed, with respect to the universal hepatitis B birth dose, they
often find that vaccination takes place in hospital nurseries without
their knowledge, preceding consent. The provision of true informed
consent, which has defined the ethical practice of modern medicine
and is so essential as a counterweight to state power, remains a distant
promise for most American parents.
PART 6
From Safety Last to a Quest for Zero Vaccine Adverse Events
Members of our organizations (SafeMinds and the National Vaccine Information
Center) recall private conversations during which National Immunization
Program officials revealed their underlying utilitarian philosophy:
parents of vaccine injured children, calling for reform of the vaccination
system, were described as “selfish”; adverse events were
described as “acceptable losses”; while adverse events
resulting in injuries and death were dismissed as either coincidences
or the inevitable by-products of the pursuit of the “greater
good.” Dr. Robert Chen, the man most responsible for setting
the tone and direction of NIP safety practices for over a decade,
described the end result of a utilitarianism mindset on safety management
at NIP in 1999:
“[W]e have been relatively slow in appreciating the importance
the public now places on vaccines safety. In fact, much of our resource
allocations still unfortunately reflect safety last rather than safety
first…Furthermore…we have not been as interested in preventing
vaccine-induced illnesses as we are with vaccine-preventable diseases.”
The fact that Chen would make this concession in print suggests strongly
that not only does this “safety last” mindset exist, but
that it is more severe and pervasive than he and others acknowledge.
Indeed, it affects all aspects of safety management in the childhood
immunization program. A partial list of “safety last”
examples would include the following.
• The CDC has long acknowledged the central problem with the
Vaccine Adverse Event Reporting Systems (VAERS): that the reporting
of vaccine adverse events will necessarily be reduced under a passive
reporting system. Estimates of the underreporting vary (a common estimate
is that only 5-10% of adverse events are reported), yet there are
only limited efforts in place to promote and encourage the reporting
of these events as mandated by Congress (under PL 99-5500).
• When observed, adverse events are routinely dismissed by pediatricians
as unrelated to vaccination, with the tacit support and encouragement
of NIP officials. Adverse event reports are frequently met with the
assertion that the timing of onset of seizure disorders, sudden infant
death syndrome, hospitalizations and other vaccine injuries are only
coincidentally related to vaccination.
• When faced with adverse event claims, families of vaccine
injured children in the Vaccine Injury Compensation Program (VICP)
often find themselves the target of active suppression of those claims,
as even straightforward events are routinely opposed in an adversarial
process. Expert witnesses for the CDC called to testify in VICP award
proceedings routinely deny the very existence of vaccine adverse events.
• More broadly, the Vaccine Injury Compensation Program, originally
conceived as a means for rapid compensation for families suffering
from vaccine injury, has approached the management of compensation
with a stubborn reluctance to grant awards. The result of this reluctance
is that only a fraction of the hundreds of millions of dollars set
aside in the vaccine injury trust fund has ever been paid out.
• In the meantime, vaccine manufacturers have received widespread
protection from product liability claims, an exemption that substantially
reduces the normal marketplace incentives on manufacturers to ensure
the safety of their products.
• This unusual liability exemption stands in stark contrast
to disturbing examples of longstanding product contamination, including
the recent discoveries of connections between contaminated polio vaccines
and highly carcinogenic simian virus (SV40) detected in many human
cancers.
• More complex safety concerns have faced even greater neglect,
as safety testing of the new expanded-program strategies, e.g., comparing
exposed populations to zero exposure populations, has never been attempted.
• When high profile safety investigations have taken place,
these investigations have been carried out by interested parties.
In the case of three thimerosal studies in Denmark, for example, the
primary authors for all of them were directly employed by a vaccine
manufacturer (or its affiliates) that held direct profit interests
in the products involved
These problems have all been compounded as the safety management agenda
has shifted from evaluating narrowly defined events, such as a seizure
response to a dose of whole cell pertussis in DPT vaccines, to assessing
adverse effects rooted in cumulative exposures to vaccine elements
( e.g., thimerosal exposure from three separate childhood vaccines
in combination with prenatal mercury exposures from maternal dental
amalgams or seafood ingestion) or the interactive effects of multiple
antigen vaccines and/or multiple vaccines given in close succession.
Co-factors, which could also play a role in vaccine adverse events
suffered by an individual, such as coinciding viral or bacterial infection
at the time of vaccination; simultaneous exposure to environmental
toxins, such as pesticides or toxic mold; or predisposing genetic
factors due to biodiversity in an ethnically diverse population, are
never factored in. Vaccine safety administrators are ill prepared
even to acknowledge the possibility of such effects, let alone evaluate
them.
One consequence of combining mandatory vaccination policies with exempting
manufacturers from product liability has been the absence of free
market competitive pressures to raise quality performance. As the
quality revolution in management swept through the business world
in the latter part of the 20th century, most competitive industries
have embraced quality disciplines that have not yet penetrated the
NIP. One of the leading quality management experts, Philip Crosby,
in his influential book, Quality is Free (1980), succinctly described
one of the core lessons of quality management.
“The first step is to examine and adopt the attitude of defect
prevention. This attitude is called symbolically, Zero Defects. Zero
Defects is…a standard that management can convey to employees
to help them decide to do the job right the first time…Most
people talk about an AQL, an acceptable quality level. An AQL really
means a commitment before the job to produce imperfect material…Consider
the AQL you would accept on the products you buy. Would you accept
in advance an automobile that you knew in advance was 15% defective?…How
about the nurses that care for newborn babies? Would an AQL of 3%
on mishandling be too rigid?…The only proper performance standard
is Zero Defects. Why settle for less? People accept the performance
standards you give them.”
The pursuit of zero defects in vaccine safety would demand a performance
standard of zero adverse reactions. Such a goal need not be immediately
attainable, but the relentless focus on continuous improvement toward
that goal would mean that no disabling injuries or deaths would be
viewed as acceptable. Instead, every adverse reaction would be managed
as an opportunity for analysis of the root causes of vaccine failures.
Instead of encouraging reclassification of adverse events as coincidental
events, severe reactions would be treated with respect, compassion
and curiosity. And instead of fighting injured families as greedy
opportunists, compensation programs would be restored to their original
role, as an occasion to provide justice and deserved financial support.
But as Philip Crosby describes it, embracing Zero Defects (Zero Adverse
Reactions in this context) requires adopting a new attitude, one that
several panel participants noted would require sweeping cultural changes
in all aspects of vaccine safety management. Culture change can only
come from the top. This brings us to the conditions and context for
leadership on vaccine programs and safety, in other words, vaccine
governance.
PART 7
From Conflicts of Interest to True Public Accountability
Public institutions have the responsibility to carry out public affairs
with governance mechanisms that keep decisions free of conflicts of
interest and resultant self-dealing by interested parties. As our
society has evolved, the influence of well-organized and well-funded
interest groups has made avoiding such conflicts of interest progressively
more difficult. In the area of vaccine safety, we see serious conflicts
between the promotion and management of the childhood immunization
program and the exercise of diligence and care in the safety monitoring
of the program.
These conflicts play out in numerous ways. Indeed, despite many years
of effort by dedicated consumer advocates, we fear that vaccine program
governance has deteriorated to a point where the most economically
interested parties have effectively collaborated to dominate decision-making
in ways that maximize their direct benefits, while marginalizing the
legitimate concerns and life-altering experiences of dissatisfied
customers of the vaccine programs. These parties—vaccine manufacturers,
health maintenance organizations (HMOs), pediatrician groups and government
public health officials–have demonstrable interests in favor
of expanding vaccine administration and mandates while constraining
vaccine safety initiatives and in some cases suppressing unwelcome
vaccine risk findings. To illustrate this governance dilemma, we review
the interlocking interests of these four parties briefly.
Vaccine manufacturers. Maintaining a successful vaccine program requires
the participation of a viable base of vaccine suppliers. These suppliers
deserve the opportunity to make competitive, market returns, consistent
with their risks and investments. Increasingly, however, the “market”
for vaccine suppliers has become a regulated state oligopoly, not
really a market at all, but rather a highly managed public-private
partnership with guaranteed returns and minimal financial risks. Large,
stable and growing markets are guaranteed by official decree. Product
liability is more limited than for any other manufactured product.
New firm entry is highly constrained and only a small set of competitors
share the market, with only a small set of competitive formulations
granted market access at any point in time. Public health officials,
in their quest to serve their suppliers, have effectively become supplier
advocates, consistently acquiescing in decisions that benefit vaccine
manufacturers and disadvantage consumers.
The extraordinary profitability of pharmaceutical manufacturing (the
2001 profits of the top 10 pharmaceutical manufacturers exceeded the
profits of the rest of the Fortune 500 combined) can make vaccines
appear unattractive as a business: indeed drug manufacturers have
long complained about the poor relative profitability of their vaccine
divisions. But as the vaccine program has expanded and most childhood
vaccines produced by manufacturers have been added to the CDC’s
“universal use” and state mandatory vaccination requirements,
this performance profile has shifted. New, patent protected products
with high prices and healthy margins have replaced older vaccine formulations
in the product mix. While decisions to endorse and promote the strategic
expansion of childhood vaccines (vaccines with increasingly small
incremental consumer benefits) have provided large financial benefits
to these companies, the management of safety concerns has consistently
placed manufacturers’ interests ahead of those of consumers.
Despite demonstrable health threats, recalls of dangerous vaccine
products are a rare event. Remarkably, polio vaccines contaminated
with highly carcinogenic viruses were never recalled and have now
been associated with widespread cancer incidence. Similarly, longstanding
calls to recall vaccines containing the highly neurotoxic element,
mercury, have gone unheeded, with unknown developmental consequences
in the millions of children exposed after the risks of mercury exposure
were first identified. Even now, new flu vaccine formulations containing
mercury have received CDC endorsement. Meanwhile, sensitive safety
investigations into vaccine failures have been entrusted, in some
cases, to vaccine manufacturers themselves and, in others, to researchers
with close financial ties to manufacturing companies. Not surprisingly,
the research results of such investigations routinely find no adverse
consequences of vaccine exposure.
Health maintenance organizations. HMOs face the unique challenge of
maintaining profitability in the face of skyrocketing health care
costs and pressure from their own customers, primarily private companies
seeking to minimize the cost of providing health care benefits. In
pursuit of their profit goals, these insurers have clear interests
in minimizing the cost of their service obligations and reducing the
variability of their patient risk profiles, while also projecting
an image of responsive service and high quality care to their patients.
Because of the known turnover in their patient bases, HMO investments
in health and prevention require relatively short payback periods;
by extension, long-term risk reduction and chronic disease prevention
is unlikely to receive HMO financial support.
By contrast, childhood vaccinations provide a strong economic benefit
to HMOs: they provide visible services to young families; the unit
of service delivery (the well child visit) is highly predictable,
routinized and therefore low cost at the delivery level; and they
prevent less structured (and potentially higher cost) care delivery
in the case of children infected with a childhood disease. Another
economic goal of HMOs lies in restricting the cumulative number of
well child visits, one reason why combination vaccines have proven
popular. The potential adverse consequences of an expanded childhood
vaccine program (and expanded vaccine combinations) are either out
of their services scope ( e.g., autism and other developmental disabilities)
or beyond their preventive planning horizon (e.g., asthma, diabetes,
cancer).
With respect to vaccine safety, HMOs can, and in some cases do, provide
important information resources for safety management. Given the value
of their patient data, HMOs have an interest in maintaining control
over their private databases. Pooled databases like the Vaccine Safety
Datalink provide information resources of extraordinary potential
societal value; yet by increasing the transparency around health outcomes
across different participating HMOs, information sharing also threatens
the autonomy of these organizations. The public interest lies clearly
in full and prompt reporting of health outcomes, especially as they
relate to vaccine safety, but HMOs have resisted the expansion of
public health claims on their data resources. They typically fall
back on claims of patient confidentiality to restrict outside access,
but these claims are rarely in the interests of their patients, instead
they are largely a mechanism to retain autonomy and control. As a
consequence, resources for vaccine safety reporting have remained
highly restricted, non-standardized, inaccessible and unreliable for
assessing health outcomes.
Pediatricians. One consequence of the cost squeeze in health insurance
has been that pediatricians, like most primary care physicians, have
become captives of a new economic model of primary care delivery:
high volume, low touch, and increasingly structured around compensation
rules for specific diagnosis codes rather than time spent with children.
Most pediatricians enter the field of pediatric medicine out of a
desire to serve children. Increasingly, they are becoming captives
of the compensation rules regarding allowable services. One of these
allowable routines is the well child visit, a repeatable and tightly
defined procedure that is little more than a tollgate for vaccine
administration. The economics of pediatric practice have become increasingly
dependent on these tolls, and the well child toll has become a critical
component of a pediatrician’s annual income.
By contrast, as the front line of vaccine adverse effect reporting,
pediatricians have incentives to avoid adverse event reporting. When
faced with a possible vaccine adverse event, each pediatrician has
discretion in associating the event with the vaccine, although the
National Childhood Vaccine Injury Act obligated the pediatrician simply
to report the event and not make a causation determination at the
provider level. Pediatricians have a personal stake in the success
of the vaccine program and, more important, an emotional stake in
the absence of causal relationship between vaccination and injured
children. No pediatrician wants to believe that their personal interventions
have caused harm to their young patients.
At the same time, the report of an adverse event takes time and effort
while also causing the pediatrician to fear litigious behavior on
the part of parents, even though the 1986 Vaccine Injury Act protected
pediatricians from most vaccine injury lawsuits. For all these reasons,
pediatricians view reporting vaccine reactions as a risk rather than
a benefit. Not surprisingly, the groups that represent pediatricians
seek to minimize the concerns over adverse events and preserve the
confidence of parents in the childhood immunization program and its
associated well child visit.
Public health officials. Public health officials in positions of vaccine
policy leadership typically have sustained long careers in the field
and have participated in the long trail of policy choices that has
produced the current expansive strategy. These career officials draw
meaning from this legacy of work and often reveal their search for
meaning by seeking other ways to expand their mission, either through
heroic efforts at disease eradication (”Worldwide elimination
of hepatitis B transmission: we have the way we need the will”)
or global collaborations to spread vaccine successes to new countries.
They certainly have little appetite for seeking evidence that might
constrain this mission or, what would be far worse, to demonstrate
that it might have inflicted more harm than good.
As the regulatory hub for the field vaccine development, these officials
interact regularly with interested parties in the vaccine program:
the vaccine manufacturers, the HMO industry representatives and pediatrician
groups. After many years of collaboration in this community (what
Eisenhower might have called the vaccine development complex), public
health officials can easily lose their objectivity as they are caught
in the web of their connections with industry professionals: they
may become friends with their industry colleagues–certainly
they often develop mutual respect as colleagues–as they also
maintain a range of professional and social contacts across the community.
Those who may question or criticize their mission are threatening
and unwelcome. Frequently, these outsiders are dismissed with epithets:
they (indeed we) are derided as “anti-vaccine”, “not
scholarly” or “junk scientists and charlatans.”
Effective dismissal, however, requires a larger scale denial of resources
for which these officials serve as gate-keeper: they deny funding
for legitimate vaccine injury hypotheses; they deny independent access
to vaccine safety data resources; they forgo deep investigations into
adverse consequences; they work to deny exemptions and informed consent
provisions in vaccine laws; and they effectively deny meaningful access
and participation in vaccine research-setting priorities and policy-making
to the interested and injured parties
Missing from this governance system are the only parties without a
real conflict of interest, the real customers of the childhood immunization
program: parents and children. As parent organizations, we represent
a part of that most vital constituency, not the whole constituency,
but a vital part nevertheless. And we are calling for a clear break
from the practice of business as usual. It is time that the public
health officials became more accountable to the parents, whose children’s
lives are on the line, than to the industry, which profits from government
mandates and protections.
PART
8
Conclusion
We conclude this white paper with a distress call, not because we
are alarmist by natures, but because we share a concern that the default
path of vaccine development and safety management will not lead us
closer to the hopeful future we described at the beginning of this
report. Instead, we fear that the more likely direction will turn
sharply toward an even more extreme approach to childhood public health
strategy.
• The mission will continue to creep, away from mere overemphasis
on infectious disease prevention and management to a pursuit of disease
eradication, a far more radical and quixotic goal;
• The strategy will continue to overreach, from a step-wise
expansion of the U.S. vaccine program expansion to a global escalation
of vaccine interventions across diseases and geographies;
• The communication approach will grow increasingly strident,
shifting from the mere hyping of infectious disease risk to promoting
an ambiance of fear, hijacking the threat of terrorism to lend legitimacy
to the creeping mission;
• The style of engagement with families will become more coercive,
moving from an emphasis on herding the public with public relations
to imposing forced vaccination with all the necessary suppression
of dissent and infringement on civil liberties that would be required
to institute such coercive measures;
• The operational oversight of vaccine safety will degenerate,
from the current utilitarian stance, which merely devalues adverse
reactions, to a more Orwellian posture in which adverse event denial
becomes the prevailing mode of management;
• The program governance standards will decline further, from
a half-hearted attempt to manage conflict of interest to a full embrace
of governance by and for the vaccine development complex, as continued
engagement with increasingly restive (and non-compliant) parent groups
becomes less and less appealing.
We believe you have an historic opportunity to signal a new day in
childhood public health management.
To do this, we suggest you take the following ten simple steps.
1. Declare autism a national emergency. It is the proverbial “canary
in a coal mine” for a host of chronic neurological and immune
system disorders.
2. Launch a full-scale investigation into all potential environmental
causes of autism and related disorders, including mercury and vaccines.
3. Extend the investigation to address the broader increases in immune
and neurological dysfunction in children, including learning disabilities,
attention deficit disorders, asthma and diabetes.
4. Design and launch a comprehensive surveillance system aimed at
quantifying the incidence rates, trends and costs to society for chronic
diseases and disabilities in American children.
5. Re-structure CDC vaccine program funding priorities to commit funds
for independent research into the biological mechanisms of vaccine
injury and death, including research into genetic and other biological
factors which put some individuals at greater risk than others for
suffering vaccine adverse events.
6. Launch a comprehensive audit of the safety of the newly expanded
vaccine program, comparing the incidence of chronic disease and disability
in high, low and zero vaccine exposure populations.
7. Maintain and expand independent researcher access to government
vaccine risk assessment data resources such as the Vaccine Safety
Datalink and the Vaccine Adverse Event Reporting System.
8. Remove vaccine risk assessment and vaccine safety oversight responsibilities
from CDC and FDA and place them in a separate federal agency, with
accountability to the general public, including parent groups.
9. Charge the new federal agency with responsibility to investigate
vaccine adverse reactions and provide necessary resources for a comprehensive
re-assessment of long-term health outcomes of alternative childhood
vaccination strategies.
10. Reconstitute the current leadership of the NIP to include outside
scientists with no previous involvement in vaccine development, regulation,
policy-making or promotion.
We appreciate the opportunity to submit this report and hope that
we will have an occasion to review it with you in person in the near
future.
(Editor’s
note: To date — more than three years later — there has
been no response from Gerberding or anyone else at the CDC.)
Mark Blaxill is Editor at Large for Age of Autism. Barbara Loe Fisher
is co-founder of the National Vaccine Information Center.