Conflicts of Interest

Conflicts of Interest
Undermine
Children’s Health
May 2019
Contents
List of Acronyms............................................................................................. iii
Executive Summary......................................................................................... iv
I. Introduction.................................................................................................. 1
Vaccination as Orthodoxy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
The Medical Marketplace Comes First. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Waning Public Confidence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
II. Co-opted Legislators and the Legal Landscape......................................... 4

The Legislation that Changed Everything . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Compensation…for a Few . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Regulatory Vacuum. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
The Beneficiaries of Liability Protection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
III. Role of Our Federal Agencies..................................................................... 9

FDA Rubber Stamping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
HPV Vaccines as a Case Study. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
CDC-Guaranteed Market . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Subpar Postlicensure Safety Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Captured Agencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Exaggerated Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
IV. Tainted Science.......................................................................................... 19

Manipulating Thimerosal Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Outsourcing the Vaccine Safety Datalink. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Throwing Autism-MMR Data in the Trash. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Turning a Blind Eye. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Generating Favorable IOM Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Ensuring Medical Journal Complicity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Funding Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Debasing and Censoring Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Using Front Groups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Coopting Physicians . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
V. What’s Needed............................................................................................. 31
Repeal the NCVIA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Eliminate Vaccine Mandates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Address Conflicts of Interest. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
List of Acronyms
AAFP . . . . . American Academy of Family Physicians
AAP . . . . . . American Academy of Pediatrics
ACIP. . . . . . Advisory Committee on Immunization Practices
ACOG. . . . . American College of Obstetricians and Gynecologists
ACP. . . . . . American College of Physicians
AHIP. . . . . . America’s Health Insurance Plans
CBER . . . . . Center for Biologics Evaluation and Research
CDC . . . . . . Centers for Disease Control and Prevention
CDER . . . . . Center for Drug Evaluation and Research
CEPI. . . . . . Coalition for Epidemic Preparedness Innovations
CHC . . . . . . Community Health Center
DOD . . . . . . U.S. Department of Defense
DOJ. . . . . . . U.S. Department of Justice
DPT. . . . . . . Diphtheria-pertussis-tetanus
DTaP . . . . . Diphtheria-tetanus-acellular pertussis
ECBT. . . . . . Every Child by Two
EIS . . . . . . . CDC Epidemic Intelligence Service
FACA . . . . . Federal Advisory Committee Act
FDA . . . . . . U.S. Food and Drug Administration
GSK . . . . . . GlaxoSmithKline
HepA . . . . . Hepatitis A
HepB . . . . . Hepatitis B
HHS . . . . . . U.S. Department of Health and Human Services
Hib. . . . . . . Haemophilus influenzae type b
HMO. . . . . . Health maintenance organization
HPV . . . . . . Human papillomavirus
IAC. . . . . . . Immunization Action Coalition
ICAN. . . . . . Informed Consent Action Network
IOM . . . . . . Institute of Medicine
IPV. . . . . . . Inactivated poliovirus
JAMA. . . . . Journal of the American Medical Association
MMR . . . . . Measles-mumps-rubella
MMRV . . . . Measles-mumps-rubella-varicella
NCVIA . . . . National Childhood Vaccine Injury Act
NEJM. . . . . New England Journal of Medicine
NIH. . . . . . . National Institutes of Health
NVICP . . . . National Vaccine Injury Compensation Program
OAP . . . . . . Omnibus Autism Proceeding
OGR . . . . . . U.S. House Committee on Oversight and Government Reform
OIG. . . . . . . Office of the Inspector General
PR. . . . . . . . Public relations
Td. . . . . . . . Tetanus-diphtheria
Tdap. . . . . . Tetanus-diphtheria-acellular pertussis
VAERS . . . . Vaccine Adverse Event Reporting System
VFC. . . . . . . Vaccines for Children Program
VSD . . . . . . Vaccine Safety Datalink
CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | iii
Executive Summary
➧➧ Confidence in vaccine programs is declining worldwide. Nearly nine in ten U.S. pedia-
tricians have encountered parents who question the Centers for Disease Control and
Prevention (CDC) vaccine schedule.
➧➧ Factors contributing to the erosion of public trust include growing awareness of
outsized vaccine industry profits, lack of scientific integrity and transparency, politi-
cization of vaccine recommendations and misleading safety claims that exaggerate
benefits and conceal risks.
➧➧ Conflicts of interest and unethical behavior encumber the key public and private
players involved in U.S. and global vaccination programs to such an extent that pub-
lic skepticism is not only understandable, but justified.
➧➧ In 1986, Congress passed the National Childhood Vaccine Injury Act (NCVIA), giving
pharmaceutical companies blanket immunity from liability for injuries resulting from
childhood vaccines. The liability protections converted vaccines from a “neglected corner
of the drugs business” into a major economic driver of the pharmaceutical industry.
➧➧ Four pharmaceutical giants—GlaxoSmithKline, Merck, Pfizer and Sanofi Pasteur—man-
ufacture and profit from every vaccine on the U.S. childhood vaccine schedule.
➧➧ The NCVIA also created the National Vaccine Injury Compensation Program (NVICP),
a burdensome administrative mechanism that allows vaccine-injured individuals to
seek financial compensation. In three decades, the program has paid out $4 billion to
a subset—barely a third—of petitioners, dismissing well over half of filed claims.
➧➧ NVICP claims represent the tip of a vast vaccine injury iceberg. As per the U.S. Depart-
ment of Health and Human Services, fewer than 1% of vaccine adverse events ever get
reported.
➧➧ Government officials have found many ways to limit the number of NVICP petition-
ers awarded compensation, for example, exhibiting “highly unethical and appallingly
consequential official misconduct” in a 2007-2008 Omnibus Autism Proceeding for
thousands of families filing claims for vaccine-induced autism.
➧➧ The Food and Drug Administration (FDA) and the CDC have played a pivotal role in
the U.S. vaccine “renaissance.” Because the two regulatory agencies work hand in
glove with vaccine companies to protect and grow the liability-free childhood vac-
cine market, neither has the impartiality required to oversee vaccine safety. The CDC
owns over 50 vaccine-related patents; the CDC also purchases half of all U.S. child-
hood vaccines—a 15-fold increase from three decades ago.
➧➧ Vaccine makers, the CDC and other government and private partners have fudged
vaccine science for decades, attending secret meetings; hiding, destroying or fraudu-
lently manipulating publicly funded data; and engaging in other unethical actions.
➧➧ In exchange for guaranteed advertising revenues from pharmaceutical companies,
medical journals play a key role in suppressing studies that question vaccine safety,
while publishing skewed write-ups that are more marketing than science.
➧➧ Most medical trade groups and physicians have been willing participants in the U.S.
vaccine program due to the financial incentives that can result in thousands of dollars
of kickbacks for enforcing the CDC-recommended schedule, despite acknowledgement
by Congress and the Supreme Court that vaccines are “unavoidably unsafe.”
➧➧ The status quo is untenable. Three urgently needed steps include repealing the
NCVIA, eliminating vaccine mandates and establishing a fully transparent and
independent vaccine safety commission. It is essential that conflicts of interest be
addressed so that sound science—rather than deep pockets—can form the basis of
vaccine policy-making.
CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | iv

I. Introduction
Vaccination as Orthodoxy and rogue interests”3 that all benefit The powerful
from their endorsement of a highly
vaccine “gospel”
V accination has been a corner-
stone of U.S. government public
health policy for decades. Although
profitable vaccine orthodoxy. The
powerful vaccine “gospel” has swept
up regulators, medical trade associa-
has swept up
regulators,
the Centers for Disease Control and tions, physicians, science journals, the medical trade
Prevention (CDC)—initially called the popular press and others “in a kind of
Communicable Disease Center— consensus dogma” that has become
associations,
opened its doors in the early 1940s “more important than the children physicians,
with a mandate primarily focused on [these institutions were] supposed science journals,
malaria eradication, it rapidly pushed to protect.”4
the popular
to “extend its responsibilities to other
communicable diseases,” including The Medical Marketplace press and others
many of the illnesses subsequently Comes First “in a kind of
targeted by vaccination.1 consensus
Economic and political interests have
The CDC has operated as the stan- steered U.S. vaccination programs
dogma” that
dard-bearer for the nation’s vaccina- since at least the 19th century, when has become
tion efforts ever since. However, a close the medical establishment and its gov- “more important
look at the agency’s behavior—and the ernment and industry allies recog-
than the
statements of internal whistleblow- nized that vaccination provided a new
ers—reveals that, for all intents and income stream and a compelling children [these
purposes, the CDC functions as a opportunity “to augment their author- institutions were]
subsidiary of a “rapacious” pharma- ity in a competitive medical market- supposed to
ceutical industry2 in partnership with place.”5 Historical documents show
the U.S. Food and Drug Administration that, from the earliest days, vaccine
protect.”
(FDA) and numerous “outside parties proponents have promoted a one-sided
CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 1

agenda, sidelining deeper inquiry into reported receiving frequent requests to Silencing Debate
safety and efficacy and castigating follow an alternative vaccine schedule
“Debate on vaccine safety is a
individuals who dare to raise questions (almost one in five parents) and, over
Kafkaesque taboo on network
(see “Silencing Debate”). In a blatant the seven-year period, a doubling of the
news channels, which accept
example of the pot calling the kettle percentage of parents refusing at least
upwards of $5.4 billion annu-
black, Dr. William Bailey belligerently one vaccine.
ally from pharma, or on the
declared in an 1899 issue of Public
editorial pages of America’s
Health Papers and Reports (a precursor to Even the most ardent vaccine
newspaper conglomerates,
the American Journal of Public Health) proponents recognize that this erosion
many of which have financial
that vaccination’s “enemies are orga- of public trust is at least partially their
ties to drug companies. …
nized and aggressive in their warfare own fault—the result of factors such
Instead of fact-based discourse,
against it.”6 as “heightened [public] awareness
the debate… has devolved
of the profit motives of the vaccine
into ‘argument by credential’
Over a century later, it is clear that industry,” lack of transparency on
and its corollary, ‘argument by
vaccine policy-makers are the ones the part of industry and conflicts of
insult.’ By reducing the issue to
whose “organized and aggressive” interest among policy-makers.12 These
a binary choice—you’re either
public relations (PR) apparatus observers even admit that “financial
pro-vaccine or anti-vaccine—
is relentlessly waging war on and bureaucratic reasons” prompt
journalists marginalize safety
questioners, effectively branding “vaccine manufacturers, health
advocates…, vilify the parents
them as heretics.7 Independent officials, and medical journals…
of vaccine-injured children and
scientists who cast doubt on vaccine not…to acknowledge the risks
silence debate on a complex issue.
orthodoxy find themselves facing of vaccines.”13 When companies
…The American public is entitled
personal attacks rather than impartial perpetuate misleading vaccine safety
to an honest, probing and robust
scrutiny of their research.8 Meanwhile, claims—exaggerating the benefits and
discussion about this critical pub-
the CDC demands that parents concealing the risks—and regulators
lic health issue—a debate based
unhesitatingly allow their children to obligingly politicize their vaccine
on facts, not rooted in fear, nor
receive endless vaccine doses during recommendations and decisions,14
on blind faith in regulators and
pregnancy, infancy, childhood and trust is damaged still further.15
the pharmaceutical industry.”
adolescence. If someone (even an
experienced doctor) dares to propose In 1967, when childhood vaccines were —Robert F. Kennedy, Jr.
a less immunologically burdensome much fewer and farther between, Dr.
SOURCE: https://childrenshealthdefense.
approach, the PR machine instantly Graham Wilson (one-time Director
org/news/why-im-not-anti-vaccine-
jumps into overdrive to discredit him of the Public Health and Laboratory and-why-we-should-all-want-to-study-
or her, despite the fact that respected, Service for England and Wales) warned vaccine-safety/
peer-reviewed science—including of the need to pay ongoing attention
from the Institute of Medicine (IOM)— to vaccine safety,16 stating, “It is for us,
supports these concerns.9 and for those who come after us, to
see that the sword which vaccines and
Waning Public Confidence antisera have put into our hands is
never allowed to tarnish through over-
Although a barrage of assurances, both confidence, negligence, carelessness,
nationally and globally, tells consumers or want of foresight on our part.”
that vaccines are safe, confidence Forty years later, Congressional
in vaccine programs is declining Representative Dave Weldon, himself
worldwide.10 The medical journal a physician, harshly criticized the
Pediatrics reported in 2013 that nearly federal agencies charged with ensuring
nine in ten U.S. pediatricians (87%) had vaccine safety for failing to heed
encountered parents who questioned Wilson’s cautions.
the CDC childhood vaccine schedule,
up from 75% of children’s doctors in The U.S. government’s Healthy People
2006.11 The surveyed pediatricians also 2020 initiative states that “childhood
immunization programs provide a unprecedented levels. There is
very high return on investment,”17 abundant evidence that vaccines are
but Americans should be asking making children sicker, not healthier—
just who is garnering the positive representing an unquestionably
returns. Globally, the vaccine industry negative return on investment for
There is
is on track to more than double its children, families and society.
worldwide revenues by 2024—from abundant
$32.5 billion in 2015 to a projected This eBook takes the position that evidence that
$77 billion18—but highly vaccinated conflicts of interest and unethical vaccines are
children in the U.S. and elsewhere are behavior encumber the key public and
suffering. As described by Children’s private players involved in U.S. and
making children
Health Defense in the eBook, The global vaccination programs to such sicker, not
Sickest Generation: The Facts Behind an extent that public skepticism is not healthier—
the Children’s Health Crisis and Why It only understandable, but justified. (For
representing an
Needs to End,19 children’s health has the reader’s convenience, the names
worsened dramatically since the of key players are bolded and italicized unquestionably
late 1980s—“precisely the same time upon first mention.) The loss of negative return
that the U.S. started expanding the confidence in vaccine safety must be on investment for
types and total number of vaccines addressed with independent, unbiased
required for school attendance.” science. The following sections
children, families
Over half of American children have illustrate how lack of integrity and and society.
at least one chronic illness,20 and ethical betrayals are impeding sound
neurodevelopmental disorders21 and public health policy and vaccine safety
pediatric autoimmune conditions22 science, while gravely undermining
have climbed to historically children’s health.
ICKest Generation:
The S
ehind the
The Facts B IS
HEALTH CRIS
CHILDREN’S
Needs
and Why It
to End
Children’s Health Defense eBook,

The Sickest Generation: The Facts
Behind the Children’s Health Crisis
and Why It Needs to End
2018
September

II. Co-opted Legislators and
the Legal Landscape
The Legislation that Changed Vaccine Injury Compensation Program
Everything (NVICP), funded by taxpayers through
an excise tax on childhood vaccines.
I n 1986, President Ronald Reagan, with

reportedly “mixed feelings,” signed
into law a piece of legislation crafted
With the stroke of a pen, Congress
essentially abolished vaccine injury
lawsuits against vaccine manufactur-
Reagan’s “Mixed
Feelings”
by then-Representative Henry Waxman ers (or health providers), while cre-
(now a health industry lobbyist); the ating an administrative mechanism According to a New York Times
legislation radically altered the vaccine (subsequently nicknamed “vaccine report, at the time of the signing
policy landscape in the United States court”)26 from which individuals could of the National Childhood
(see “Reagan’s ‘Mixed Feelings’”).23 seek—but not necessarily obtain— Vaccine Injury Act, President
Called the National Childhood Vaccine redress for vaccine injuries through Ronald Reagan “said he had
Injury Act (NCVIA), the legislation was “Special Masters” designated to serve approved the bill ‘with mixed
Congress’s response to intense pressure as arbiters. feelings’ because he had ‘serious
from vaccine industry lobbyists seek- reservations’ about the vac-
ing protection from lawsuits related to The NCVIA gave pharmaceutical cine compensation program.”
the infamously brain-damaging diph- companies what amounted to blanket Reagan’s Justice Department had
theria, whole-cell pertussis and teta- immunity27 from liability for injuries urged him to veto the Act.
nus (DPT) vaccine.24 resulting from childhood vaccines— SOURCE: Reagan signs bill on drug ex-
“no matter how toxic the ingredients, ports and payment for vaccine injuries.
The industry’s lobbying efforts paid how negligent the manufacturer or The New York Times, Nov. 15, 1986.
off in spades. Replacing judicial action how grievous the harm”28—while
with a more circumscribed “alternative also exempting companies from the
remedy…for specified vaccine-related transparency and document discovery
injuries,”25 the Act created the National normally associated with litigation.
Summarizing the legislation’s far- and members of the general public
reaching implications, Robert F. are unaware of the NVICP’s existence33
Kennedy, Jr. has stated:29 and, according to HHS, fewer than
1% of vaccine adverse events are
“That extraordinary law elimi- ever reported.34 Thus, NVICP claims
nated a principal cost associated represent only the tip of a vast vaccine
with making…drugs and left injury iceberg.
the industry with little economic
incentive to make vaccines safe. It Despite Congress’s professed intent to
also removed lawyers, judges and create a non-adversarial, “accessible
courts from their traditional roles and efficient forum for individuals Letter to DOJ Inspector
as guardians of vaccine safety. found to be injured by certain
General and Congress
Since the law’s passage, industry vaccines,”35 in practice, the NVICP pits
revenues have skyrocketed from HHS and its subsidiary agencies “During the Omnibus Autism
$1 billion to $44 billion.” (including the CDC) as adversaries Proceeding, Department of
against injured petitioners. HHS Justice attorneys…acted in
The NCVIA requires that the employees are free to decide on or concert with their client, the
Department of Health and Human reject compensation claims,36 and Department of Health and
Services (HHS) review childhood Department of Justice (DOJ) lawyers Human Services, to intentional-
vaccine safety on a biannual basis represent and defend the interests of ly misrepresent the opinion of
and report to Congress on measures HHS.37 Petitioners also face a three- their own expert witness, and
taken to improve safety. However, year statute of limitations from the to willfully conceal from the
that stipulation appears to have been time of the vaccine injury and must vaccine court and petitioners
intended largely as window dressing, meet a strenuous burden of proof if— critical material evidence show-
because—as revealed in a recent as is almost always the case—their ing how vaccines may cause
lawsuit filed by the Informed Consent illness, disability, injury or condition autism. The same DOJ attorneys
Action Network (ICAN) and Robert F. does not fall within the narrow subsequently intentionally mis-
Kennedy, Jr.—HHS officials have never parameters of the NVICP’s Vaccine led the United States Court of
complied with the statutory safety Injury Table.38 Appeals for the Federal Circuit.
review and reporting requirements As a result, fraud was ultimately
even once in over thirty years.30 As set out by the NCVIA, the Vac- perpetrated upon the Supreme
cine Injury Table was supposed to Court of the United States.”
Compensation…for a Few establish “statutory presumptions of
—Robert F. Kennedy, Jr.,
causation” for selected injuries and
and Rolf Hazlehurst
In the three decades since the NVICP’s adverse events occurring within pre-
creation, American households have scribed time periods after vaccination, SOURCE: “Request for Office of
filed roughly 20,000 petitions for making the path to compensation Inspector General to investigate
vaccine injury compensation. The less burdensome (at least for those fraud and obstruction of justice.”
https://childrenshealthdefense.org/
program has paid out $4 billion to injuries); however, because HHS can—
child-health-topics/righting-wrongs/
a subset—barely a third (31%)—of almost at will—“add or delete injuries request-for-office-of-inspector-gener-
petitioners, while dismissing well and conditions for which compensa- al-to-investigate-fraud-and-obstruc-
over half (56%) of filed claims as tion would be available and…change tion-of-justice/
undeserving of any compensation.31 the applicable time periods by which
Another 12% of petitions remains the onset of symptoms must occur,”
unadjudicated. Injured parties filed the agency has not hesitated to take
an average of 1,200 claims per year advantage of this provision to “elimi-
over the last three years, triple the nate avenues to compensation.”39 Very
average number of claims filed few new injuries have been added to
annually just a few years previously.32 the Table, despite the large number
For the most part, however, parents, of vaccines piled onto the childhood
attorneys, health care professionals schedule since 1986.
HHS and the DOJ have found many commented that vaccine
ways to limit the number of petitioners manufacturers, “given the lack of
awarded compensation. Robert F. robust competition in the vaccine
Kennedy, Jr. has called attention to market, will often have little or no
“highly unethical and appallingly incentive to improve the designs of
consequential official misconduct”40 vaccines that are already generating
exhibited by DOJ lawyers in a 2007- significant profit margins” [emphasis
2008 Omnibus Autism Proceeding added].45 The two Justices predicted—
(OAP) orchestrated on behalf of quite accurately—that the Court’s
5,400 families who had filed claims unfortunate decision would leave a
for vaccine-induced autism.41 The “regulatory vacuum” and would make
claims’ potential value exceeded it even harder to strike a balance
$100 billion—an amount that “would between “compensating vaccine- Two Supreme
have bankrupted the [compensation] injured children and stabilizing the
program many times over.”42 The DOJ childhood vaccine market.”
Court justices,
lawyers, under pressure to deprive in the Bruesewitz
petitioners of their rightful relief, In 2016, the Bill & Melinda Gates v. Wyeth case,
achieved that aim through allegedly Foundation and the Wellcome Trust—
predicted quite
fraudulent means. In September, 2018, the world’s two wealthiest charitable
Kennedy, Jr. and Rolf Hazlehurst (one foundations and two of the biggest accurately that
of the OAP parents) requested that the global funders of vaccine development46 the Court’s
DOJ Inspector General and Congress and vaccine programs47—teamed decision
investigate this fraud and obstruction up with vaccine manufacturers and
of justice (see “Letter to DOJ Inspector government partners from a variety
would leave
General and Congress”). of countries to launch the Coalition a “regulatory
for Epidemic Preparedness Innovations vacuum” and
Regulatory Vacuum (CEPI).48 According to a recent analysis
would make
in the Emory Law Journal, the blanket
The DOJ actions initiated during the immunity ushered in by the NCVIA it even harder
OAP had a number of legal spillover has been so successful for vaccine to strike a
effects, culminating in a disastrous manufacturers that CEPI is looking to balance between
(for the vaccine-injured) decision export it, creating “liability protection
(Bruesewitz v. Wyeth) by the U.S. Supreme and compensation mechanisms based
“compensating
Court in 2011 that reiterated and even on the U.S. model for vaccine liability” vaccine-injured
broadened the NCVIA’s basic no-lia- around the world.49 The law journal children and
bility premise. In their 2011 majority author, Professor Mary Holland, cautions
stabilizing
ruling, Justices asserted that the Act that this would be unfortunate for the
“preempts all design-defect claims developing world because vaccines are the childhood
against vaccine manufacturers brought likely to end up being “less safe than vaccine market.”
by plaintiffs who seek compensation they could be,” with an inevitable loss of
for injury or death caused by vaccine public confidence “both in vaccines and
side effects.”43 At the time, none of the in those recommending them.”
Justices “had reason to know that HHS
was not acting in good faith” nor that The Beneficiaries of
DOJ attorneys, in earlier cases, had Liability Protection
“conceal[ed] critical material evidence
and mis[led] the special masters and The liability protections offered by
the U.S. Court of Appeals.”44 the NVICP have sparked a gold rush50
of vaccine development since the
In a dissent to the 2011 decision, NCVIA’s passage in 1986, converting
Justices Sotomayor and Ginsburg vaccines from a “neglected corner
of the drugs business”51 into a major Merck was number-one-ranked in
economic driver of the medical and terms of annual revenue growth.52 The
pharmaceutical industries. companies’ strong vaccine sales have
helped ensure record profits (see “A
In the U.S., four companies have Lucrative Business”).53 Pfizer’s
been the principal beneficiaries. $136-a-shot Prevnar-13 vaccine (with
The four pharmaceutical giants— four doses advised before preschool
GlaxoSmithKline (GSK), Merck, Pfizer age) earned the company nearly $4
and Sanofi Pasteur—manufacture every billion in a single year, “about double
vaccine on the U.S. childhood vaccine what it made from high-profile drugs
schedule (see Table 1). For several of like Lipitor and Viagra.”54
the childhood and adolescent vaccines,
Merck enjoys a unique monopoly None of the leading vaccine
position in the U.S. Other companies manufacturers are strangers to
such as Seqirus and MedImmune are lawsuits or large financial settlements
The liability
crowding into the increasingly lucrative for other drugs in their product line protections
adult vaccine market. that, unlike vaccines, are subject to offered by the
courtroom liability. Over the past
NVICP have
In the context of the highly decade, in fact, GSK, Pfizer, Merck
consolidated global pharmaceutical and others have all paid out billions sparked a gold
market valued at $1.1 trillion (U.S. in punitive settlements for products rush of vaccine
dollars), Pfizer and Merck were the first deemed to be deceptive or harmful.55 development
and second top-ranking companies in In the case of Merck, the company’s
2016 in terms of total revenues, and payouts included $950 million56 in
since the NCVIA’s
passage in 1986,
Table 1. Manufacturers of Vaccines for Children and Adolescents in the United States converting
Manufacturers and Brand Names
Childhood vaccines from a
Vaccines GSK Merck Pfizer Sanofi
“neglected corner
DTaP Infanrix — — Daptacel
DTaP+IPV Kinrix — — Quadracel of the drugs
DTaP+IPV+HepB Pediarix — — — business” into a
DTaP+IPV+Hib — — — Pentacel major economic
HepA Havrix Vaqta — — driver of the
HepB Engerix-B Recombivax — —
medical and
Hib Hiberix PedvaxHIB — ActHIB
pharmaceutical
HPV — Gardasil-9 — —
IPV — — — Ipol
industries.
Influenza Fluarix, FluLaval — — Fluzone
MMR — MMR II — —
MMR+varicella — ProQuad — —
Meningococcal Bexero, Menveo — Trumenba Menactra
Pneumococcal — Pneumovax-23 Prevnar-13 —
Rotavirus Rotarix RotaTeq — —
Td — — — Tenivac
Tdap Boostrix — — Adacel
Varicella — Varivax — —
Key: DTaP: Diphtheria-tetanus-acellular pertussis; HepA: Hepatitis A; HepB: Hepatitis B; Hib: Haemophilus influenzae type b; HPV:
Human papillomavirus; IPV: Inactivated poliovirus; MMR: Measles-mumps-rubella; Tdap: Tetanus-diphtheria-acellular pertussis.
SOURCE: “U.S. vaccine names.” https://www.cdc.gov/vaccines/terms/usvaccines.html.

federal fines following evidence of a global vaccine sales, including in
“deliberate corporate conspiracy”57 China, helped Merck continue to “beat
related to its bestselling painkiller Wall Street expectations” in 2018.61
Vioxx. The FDA approved the drug in
1999 but Merck reluctantly withdrew it From a consumer standpoint, Merck’s
from the market in 2004 after studies track record with Vioxx raises the
showed that it doubled serious health question of whether the American
risks and had resulted in at least public can believe Merck’s claims
60,000 deaths.58 Merck pleaded guilty about the safety of its vaccines. Can
to criminal charges over its illegal a company that confessed to illegal
marketing of Vioxx and settled 27,000 activity and paid out almost $5 bil-
lawsuits for $4.85 billion.59 lion to settle lawsuits for a drug it
knew to be harmful be considered
Merck brought its human papillomavi- trustworthy when it markets expen-
rus (HPV) vaccine, Gardasil, to market sive and profitable vaccines such as
in the aftermath of the Vioxx scandal. Gardasil? In 2008, an investigation
Can a company
Dubbed by some as the “Help Pay for by the Philadelphia Inquirer described
Vioxx” vaccine, Gardasil has been a an unpublished FDA review of one of that confessed
major revenue booster. In a single Merck’s largest U.S. vaccine plants, to illegal activity
quarter of 2016, for example, in which which identified contaminated chil- and paid out
Merck posted a profit of $2.2 billion,60 dren’s vaccines and a failure to follow
the company saw a 38% jump in sales good manufacturing practices—not-
almost $5
of HPV vaccines (due to “increased ing 49 areas of concern in all.62 The billion to settle
pricing and demand”). Similar trends plant leadership’s response to the lawsuits for a
have been evident for Merck’s other FDA’s troubling findings was that
drug it knew
vaccines, with a 27% increase in mea- “Nobody’s perfect.” Previously, in
sles-mumps-rubella-varicella (MMRV) 2007, Merck had to recall over a mil- to be harmful
vaccine sales in the same quarter of lion doses of two childhood vaccines be considered
2016 after the CDC added the vaccine because it “could not guarantee the trustworthy
to its pediatric stockpile. Growing products’ sterility.”63
when it markets
expensive
A Lucrative Business
and profitable
According to a New York Times report on “soaring” vaccine prices, many factors work in favor of
record-breaking vaccine profits:
vaccines such as
Gardasil?
➧➧ Reformulation of old vaccines with a higher price tag
➧➧ Market entry of new vaccines at “once-unthinkable” prices
➧➧ Requirements for multiple doses and boosters
➧➧ Monopoly market positions for some vaccines
➧➧ Patents on manufacturing processes (vaccine patent applications rose “tenfold in the 1990s to more
than 10,000”)
➧➧ Guaranteed purchases by the federal government (Vaccines for Children Program)
➧➧ Guaranteed coverage by private insurance and the Affordable Care Act, meaning that “patients often
do not notice the prices”
SOURCE: Rosenthal E. The price of prevention: vaccine costs are soaring.” The New York Times, July 2, 2014.

III. Role of Our Federal Agencies
B oth the FDA and CDC have played
a pivotal role in the U.S. vaccine
“renaissance”64 that has burgeoned
judgments about vaccine safety, the
two agencies have continued with
business-as-usual. With vaccine pro-
With vaccine
promotion
since the late 1980s. Working hand motion superseding vaccine safety superseding
in glove with the vaccine companies monitoring as organizational goals, vaccine safety
to protect and grow the liability-free conflicts of interest are baked into the monitoring as
childhood vaccine market, they have agencies’ DNA.
helped ensure billions of dollars in
organizational
corporate revenues with little need for FDA Rubber Stamping goals at FDA and
vaccine makers to advertise or mar- CDC, conflicts of
ket their products. Although credible At the FDA, regulatory oversight of
interest are
accusations have surfaced for years— vaccines—classified as “biological
aired by legislators,65 researchers,66 products” rather than drugs—falls baked into the
watchdog groups67 and many others— under the jurisdiction of the Center agencies’ DNA.
that both the FDA and CDC lack the for Biologics Evaluation and Research
impartiality required to make accurate (CBER). The Center for Drug Evaluation

and Research (CDER) handles other HPV Vaccines as a Case Study “During Gardasil’s clinical trials, an
drugs and certain over-the-counter extraordinary 49.5% of the sub-
products. For both CDER68 and CBER,69 CBER claims that its approval process jects receiving Gardasil reported
“it is the responsibility of the company reflects a commitment to maximiz- serious medical conditions within
seeking to market a drug [or biologic] ing benefits and minimizing risks.73 seven months of the start of the
to test it and submit evidence that it is However, the history of FDA/CBER clinical trials. Because Merck
safe and effective.” approval of HPV vaccines illustrates did not use a true placebo in its
the insincerity of that assertion. The clinical trials, its researchers were
Both drug and vaccine manufacturers HPV vaccines Gardasil and Gardasil-9 able to dismiss these injuries as
have an obvious interest in painting represent a case study of risk-laden sad coincidences.”
a rosy picture of their products, vaccines that should have attracted
but the classification of vaccines as far stronger up-front regulatory —Letter from Children’s Health
“biologics” allows vaccine makers to scrutiny.74 Instead, the FDA not only Defense Chairman Robert F.
speed their products to market with gave Gardasil an initial free pass but Kennedy, Jr. to the Chair of the
far less onerous safety testing than is has repeatedly reapproved it and CDC’s Advisory Committee on
required of other new drugs. In fact, Gardasil-9 for wider use. (Gardasil-9 Immunization Practices (ACIP),
the conduct and design of vaccine is a newer nine-type formulation con- February 25, 2019
prelicensing studies often have fatal taining more than twice the amount
SOURCE: https://childrenshealthdefense.
flaws that make it nearly impossible to of neurotoxic aluminum adjuvant as org/wp-content/uploads/02-26-19-Fi-
identify possible safety risks. Gardasil.) Since 2006, the FDA’s deci- nal-3-Gardasil-9-ACIP-2-25-19.pdf.
sions have included:
For example, prelicensing clinical trials
➧➧ 2006: Granting fast-tracked
often have an absurdly brief period of approval for the original quad-
observation (sometimes as short as rivalent Gardasil vaccine75 (girls
a few days or weeks), which makes and women aged 9 to 26 years)
it impossible to evaluate longer-term
outcomes such as autoimmune ill- ➧➧ 2009: Approving Gardasil’s use
ness or cancer. The clinical trials for in boys and men (ages 9-26)
Merck’s Recombivax hepatitis B vaccine
➧➧ 2014: Approving Gardasil-976
(approved for administration on the
(girls ages 9-26, boys ages 9-15)
first day of life) monitored fewer than
150 infants and children for five days ➧➧ 2015: Approving Gardasil-9
after each dose.70 Buried in the vac- for boys ages 16-26
cine’s package insert is the information
that autoimmune diseases and “an ➧➧ 2018: Approving Gardasil-9
apparent hypersensitivity syndrome… for older women and men
(ages 27-45)77
of delayed onset [have] been reported
days to weeks after vaccination.”
Placebo-controlled trials are widely

recognized as the gold standard for
evaluating vaccine safety and efficacy,
but prelicensing studies typically test
new vaccines against existing vac-
cines instead of using true placebos
(defined as “an inert substance, such
as a saline injection”).71 This type of
vaccine-to-vaccine comparison makes
it possible to mask adverse reactions
by claiming that there are no differ-
ences between groups.72
In 2009, the FDA also okayed GSK’s cervical cancer mortality rates.87 A
HPV vaccine, Cervarix, but Merck’s current civil case brought on behalf of
FDA-facilitated stranglehold on the a 24-year-old who has suffered from
market prompted the company to systemic autoimmune dysregulation
withdraw Cervarix from the U.S. in since receiving her third Gardasil vac-
2016.78 Merck is now aggressively cine at age 16 alleges that Merck “com-
expanding its Gardasil “franchise” into mitted fraud during its clinical trials
other countries,79 generating unprece- and then failed to warn [vaccine recip-
dented worldwide demand, while con- ients] about the high risks and meager
tinuing to “rev up” U.S. sales.80 benefits of the vaccine.”88 The trial’s
legal team is benefiting from the sup-
An eight-month investigation by Slate port of an “A-team” of plaintiffs’ law
identified numerous troubling aspects firms and attorneys, including Robert
of the clinical trials that formed the F. Kennedy, Jr.
basis of U.S. and European regulators’ Baffling Procedures
decision to approve Gardasil.81 The Recent data suggest that HPV vaccines The author of an eight-month
Slate reporter minced no words when may actually be increasing cervical Slate investigation on Gardasil’s
criticizing regulators for allowing cancer risks. A 2017 study out of shoddy prelicensing clinical trials
“unreliable methods to be used to test Australia—a country that has heavily reported:
the vaccine’s safety” (see “Baffling Pro- promoted routine HPV vaccination
cedures”). These included Merck’s use since 2007—reported an increased “Experts I talked to were baffled
of “a convoluted method” that made it risk of difficult-to-detect malignant by the way Merck handled safety
difficult to objectively evaluate and cervical lesions among the HPV- data in its trials. According to…a
report side effects; its failure to docu- vaccinated.89 In all countries where professor…who studies side effects,
ment “symptom severity, duration, out- HPV vaccination coverage is high, letting investigators judge whether
come, or overall seriousness”; restric- including Australia, official cancer adverse events should be reported
tion of adverse event reporting to just registries show “an increase in the is ‘not a very safe method of doing
14 days following each injection; and incidence of invasive cervical cancer” things, because it allows bias to creep
reliance on the subjective opinion of in the vaccinated age groups.90 In in.’ …Of the short follow-up, …’It’s
clinical trial investigators regarding England, for example, “2016 national not going to pick up serious long-term
“whether or not to report any medical statistics showed a worrying and issues, which is a pity. Presumably, the
problem as an adverse event.” Not substantial increase in the rate of regulators believe that the vaccine is
infrequently, clinical trial participants cervical cancer…at ages 20-24”—the so safe that they don’t need to worry
who shared complaints of debilitating first HPV-vaccinated cohort.91 beyond 14 days.’”
symptoms with trial investigators were
SOURCE: Joelving F. What the Gardasil
dismissed with the response, “This is Despite clear indications that the proper testing may have missed. Slate, Dec.
not the kind of side effects we see with decision would be to take HPV vaccines 17, 2017.
this vaccine.” off the market, the FDA and CDC have
continued to look the other way (see
In fact, numerous post-licensure stud- “Patents and Profits”). Both agencies’
ies show that all three HPV vaccines unwavering support for Gardasil has
have grave risks, including impaired clearly helped Merck’s commercial
fertility,82 demyelinating disease,83 bottom line, so much so that the
chronic limb pain,84 circulatory abnor- CDC director at the time of Gardasil’s
malities85 and autoimmune illness,86 approval (Julie Gerberding) went on to be
to name just some of the disabilities appointed president of Merck’s profitable
reported in the aftermath of the vac- vaccine division (worth $5 billion
cines’ introduction. Overall, the “rate globally) in 2009.92 The two agencies’
of reported serious adverse reactions willingness to aggressively promote
(including deaths) from HPV vacci- HPV vaccination despite its readily
nation” is many times higher than apparent dangers illustrates a “public
health flimflam” of the first order.93
Patents and Profits
Before the U.S. introduction of HPV
vaccination, a decades-long pattern U.S. government health agencies profit handsomely from their ownership or co-owner-
of declining cervical cancer rates ship (with private sector partners) of patents, and, in the case of the CDC and the National
was already well underway,94 thanks Institutes of Health (NIH), many of the patents are vaccine-related. For example, an early
to routine cervical cancer screening. 2017 analysis of Google Patents results showed that the CDC held 56 patents pertaining to
HPV vaccines have never even been various aspects of vaccine development, manufacturing, delivery and adjuvants. By April
proven to prevent cervical cancer.95 In 2019, the search terms “vaccine Centers for Disease Control” retrieved 155 results in the
2016, researchers admitted that they Google Patents search engine, and a separate legal website displayed 10 screens worth
would be unable to ascertain HPV of CDC patents, both vaccine- and non-vaccine-related. The author of the 2017 analysis
vaccines’ long-term efficacy for “at suggests that the large number of patents held by the CDC “deserves an in-depth review to
least another 15-20 years.”96 determine exactly what current financial relationships with vaccine makers now exist and
what…current impact those revenue streams are likely having on vaccine safety positions.”
CDC-Guaranteed Market The influence of profit-generating patents on NIH policy also warrants scrutiny. According
to an in-depth report by Mark Blaxill, because “NIH frequently funds research with commer-
The CDC’s Advisory Committee on
cially valuable outcomes,” when NIH patents its inventions, the patents become “valuable
Immunization Practices (ACIP) has
commercial property” for HHS, the patents’ owner. Some of the key technologies under-
issued annual vaccine recommenda-
lying the development of the HPV vaccines Gardasil and Cervarix emerged from research
tions for the U.S. civilian population
patented by the NIH’s National Cancer Institute (NCI), which then licensed the technology
since 1995,97 working with leading
to Merck, MedImmune and GSK. By 2009, HPV licensing had become NIH’s top generator of
medical trade organizations such as
royalty revenues. Blaxill describes Gardasil as “perhaps the leading example of a new form
the American Academy of Pediatrics
of unconstrained government self-dealing, in arrangements whereby [HHS] can transfer
(AAP), the American Academy of Fam-
technology to pharmaceutical partners, [and] simultaneously both approve and protect
ily Physicians (AAFP), the American
their partners’ technology licenses while also taking a cut of the profits.”
College of Physicians (ACP) and the
American College of Obstetricians and SOURCES: Blaxill M. A license to kill? Part 1: how a public-private partnership made the government
Merck’s Gardasil partner. Age of Autism, May 12, 2010. https://www.ageofautism.com/2010/05/a-license-
Gynecologists (ACOG).98 ACIP’s indus-
to-kill-part-1-how-a-publicprivate-partnership-made-the-government-mercks-gardasil-partner.html.
try-beholden membership roster reads Padmanabhan S et al. Intellectual property, technology transfer and developing country manufacture of
like a “who’s who” of the individuals low-cost HPV vaccines—a case study of India. Nat Biotechnol 2010;28(7):671-678.
and organizations who spearhead “Patents assigned to Centers for Disease Control and Prevention.” https://patents.justia.com/assignee/
the nation’s vaccine business: fifteen centers-for-disease-control-and-prevention.
voting members from leading medi- Taylor G. Examining RFK Jr.’s claim that the CDC “owns over 20 vaccine patents.” GreenMedInfo, Jan. 17,
2017. http://www.greenmedinfo.com/blog/examining-rfk-jrs-claim-cdc-owns-over-20-vaccine-patents.
cal schools, children’s hospitals and
Vaccine patents assigned to Centers for Disease Control. https://patents.google.com/?q=vaccine&assign-
universities; eight ex officio members ee=centers+for+disease+control&oq=vaccine+centers+for+disease+control.
from federal agencies such as the FDA
and the Department of Defense (DOD);
and thirty non-voting representatives
serving as liaisons with entities rang-
ing from Sanofi to Cigna and Planned The conflicts of interest that hold ACIP
Parenthood (with the latter being a members captive to pharmaceutical
leading provider of HPV vaccines).99 industry interests are well known and well
The conflicts of interest that hold ACIP
documented. In the early 2000s, a four-month
members captive to pharmaceutical investigation by United Press International
industry interests are well known and (UPI) identified “a web of close ties” and
well documented. In the early 2000s,
financial entanglements between ACIP
a four-month investigation by United
Press International (UPI) identified members and vaccine companies.
“a web of close ties”100 and financial
entanglements between ACIP members
and vaccine companies, including:
➧➧ Sharing vaccine patents “serve a key scientific role in support
of vaccine policy development.”103
➧➧ Owning vaccine company stock
After ACIP makes its vaccine
➧➧ Getting research funding or recommendations, the CDC publishes
money to monitor vaccine testing
them in the Morbidity and Mortality
➧➧ Receiving funding for academic Weekly Report. The recommendations
departments or appointments (in CDC officials’ own words) “have
[a] major impact on immunization
policies and practice in the United
In 2003, Congressman Dan Burton States and in other countries.”104 Stated
described the “paradox” of the CDC another way, ACIP’s “imprimatur”
“routinely allow[ing] scientists with is a “golden ticket”105 for vaccine
blatant conflicts of interest to serve manufacturers. Vaccines on the CDC’s
on influential advisory committees schedule become virtually mandatory The CDC has
that make recommendations on new for American children attending a
shown itself only
vaccines, as well as policy matters,” “public or private elementary, middle
even though “these same scientists or secondary school, child care center, too willing to
have financial ties, academic affil- nursery school, family day care home issue conflict of
iations, and other vested interests or developmental center,”106 with interest waivers
in the products and companies for the only exceptions being the small
which they are supposed to be provid- proportion of children who have
if it ascertains
ing unbiased oversight.” a vaccine exemption for medical, (as it routinely
religious or philosophical reasons. does) that “the
As per the Federal Advisory Commit-
need for the
tee Act (FACA), individuals appointed Vaccine exemptions are currently avail-
to ACIP must file an Office of Gov- able to varying degrees in 47 states.107 individual’s
ernment Ethics form and annually Reflecting the public’s growing con- services
update a financial disclosure report. cerns about vaccine safety, the use of outweighs the
Voting members also are expected to non-medical exemptions increased by
publicly disclose “all vaccine-related 19% from 2009 to 2013.108 However, all
potential for
interests and work” at the beginning three types of exemptions are under conflicts of
of each ACIP meeting. However, the aggressive attack. Supported by phar- interest created
CDC has shown itself only too willing maceutical industry lobbying, 12 of 13
by the financial
to issue conflict of interest waivers if exemption-related bills signed into law
it ascertains (as it routinely does) that between 2011 and 2017 “limited the interests
“the need for the individual’s services ability to exempt,” erecting more legal involved.”
outweighs the potential for conflicts barriers for concerned parents.109
of interest created by the financial
interests involved.”101 According to an Within the no-liability context of the
investigation by the Committee on Gov- 1986 Act, the CDC and ACIP opened
ernment Reform in 2000, the CDC not the floodgates for a dramatic expan-
only frequently grants waivers but also sion of the childhood vaccine schedule.
looks the other way when ACIP mem- In the early 1980s, children received
bers provide incomplete financial dis- three vaccines for seven illnesses110—
closure.102 Moreover, a loophole allows two combination vaccines (diphtheria-
a considerable amount of ACIP’s work tetanus-pertussis and measles-mumps-
to get done in Work Groups whose rubella) and a polio vaccine—totaling
members are exempt from the FACA two dozen doses by age 18.111 In the
procedural conflict-of-interest require- decade following 1989 (beginning soon
ments, even though the Work Groups after the NCVIA’s implementation), the
CDC Recommended
Childhood Vaccine Schedule: 1986 vs 2019
12 shots 54 shots
1986 ⇒ 25 antigens 2019 ⇒ 70 antigens
8 diseases 16 diseases
DTP (2 Months) MMR (15 Months) DTP (4 Years) Hep B (1 day) Influenza (7 Months) Influenza (5 years)
Polio (2 Months) DTP (18 Months) Polio (4 Years) Hep B (1 Month) MMR (12 Months) Influenza (6 Years)
DTP (4 Months) Polio (18 Months) Td (14 Years) DTaP (2 Months) Varicella (12 Months) Influenza (7 Years)
Polio (4 Months) Hib (2 Years) Polio (2 Months) Hib (12 Months) Influenza (8 Years)
DTP (6 Months) Hib (2 Months) Hep A (12 Months) Influenza (9 Years)
PCV 13 (2 Months) PCV 13 (12 Months) Influenza (10 Years)
Rotavirus (2 Months) DTaP (15 Months) HPV (11 Years)
DTaP (4 Months) Hep A (18 Months) Meningococcal ACWY
(11 Years)
Polio (4 Months) Influenza (18 Months)
Tdap (11 Years)
Hib (4 Months) Influenza (2 Years)
Influenza (11 Years)
PCV 13 (4 Months) Influenza (3 Years)
HPV (11.5 Years)
Rotavirus (4 Months) Influenza (4 years)
Influenza (12 years)
DTaP (6 Months) DTaP (4 Years) Influenza (13 Years)
Polio (6 Months) MMR (4 Years) Influenza (14 Years)
Hep B (6 months) Polio (4 Years) Influenza (15 Years)
Hib (6 Months) Varicella (4 Years) Meningococcal ACWY
(16 Years)
PCV 13 (6 Months)
Influenza (16 years)
Rotavirus (6 Months)
Influenza (17 Years)
Influenza (6 Months) Influenza (18 years)
Note: DTP, DTaP, Tdap and MMR vaccines contain three antigens each. SOURCE: CDC Recommended Childhood Vaccine Schedule, Birth to 18
CDC packed multiple doses of several recommendations for all ages.113 At

more vaccines into the childhood present, the childhood vaccine sched-
schedule, including those for Haemoph- ule requires almost six dozen doses
ilus influenzae type b (Hib), hepatitis B through age 18 for sixteen diseases.114
(on the day of birth) and varicella
(chickenpox), as well as a rotavirus
vaccine (withdrawn a year after its Unheeded Warnings
introduction).112 Next, in the first ➧➧ 1961: A leading polio researcher states in Science that “even after licensing, a new vaccine
decade of the 2000s, the CDC recom- product must be considered to be on trial” because of the many “new variables” that accompa-
mended an even larger batch of new ny large-scale vaccine production and rollout.
vaccines, going after not just children
but also adolescents and adults: hepa- ➧➧ 1999: The head of CBER’s Viral Products Division contends that advances in vaccine technolo-
titis A, HPV, meningococcal conjugate, gy are “outpacing researchers’ ability to predict potential vaccine-related adverse events.”
pneumococcal conjugate, rotavirus
SOURCES: Bodian D. Poliomyelitis immunization: mass use of oral vaccine in the United States might
(again) and zoster (shingles), along prevent definitive evaluation of either vaccine. Science 1961;134:819-822.
with an adult tetanus-diphtheria-per-
tussis booster (Tdap) and a massive “Vaccine technology outpacing ability to predict adverse events, FDAer says.” https://childrenshealthde-
expansion of influenza vaccine fense.org/wp-content/uploads/FDA-Pink-Sheets-99.pdf.

The CDC is a major player in the vac-
Vaccine Adverse Reactions
cine marketplace, buying half of all
childhood vaccines in the U.S.115 and Package inserts catalog a range of adverse reactions that sometimes affect over half of
then selling them to contracted public vaccine trial participants. These include:
health agencies through the Vaccines
➧➧ Injection-site reactions (e.g., pain, redness, “increase in arm circumference”)
for Children (VFC) Program,116 which
pushes free and low-cost vaccines on ➧➧ Immune system responses such as fever and swollen lymph nodes
indigent children. Over the past three ➧➧ Allergic reactions such as hives, rash, rhinitis and runny nose
decades, the CDC’s vaccine purchases
➧➧ Diarrhea, vomiting, upper respiratory infection
have increased 15-fold as the average
cost of fully vaccinating a child to age ➧➧ Fatigue, drowsiness, lethargy, malaise, loss of appetite
18 rose from $100 to $2,192—while ➧➧ Muscle aches and pain
vaccine companies have raked in the
➧➧ Headaches, febrile seizures
profits.117 In addition to the CDC’s own-
ership of dozens of vaccine-related ➧➧ Behavioral indictors of distress such as irritability, restlessness or inconsolable or
patents, the agency’s involvement with prolonged crying
vaccine manufacturers also extends to VAERS reports include adverse events of even greater severity. To date, VAERS has
licensing agreements and collaboration received thousands of reports for each of the following symptoms:
on projects to develop new vaccines.118
➧➧ Arthralgia (joint pain signaling an ➧➧ Loss of consciousness
Subpar Postlicensure allergic reaction to medication) ➧➧ Musculoskeletal pain, extremity pain
Safety Monitoring ➧➧ Breathing difficulties ➧➧ Otitis media (ear infection)
➧➧ Chest discomfort and pain ➧➧ Pneumonia
In former times, researchers and regu-
lators knew that approval of a vaccine
➧➧ Convulsions ➧➧ Screaming
did not preempt the need for ongoing ➧➧ Death ➧➧ Skin disorders
safety monitoring (see “Unheeded ➧➧ Decreased mobility
Warnings”). Nowadays, however, the
➧➧ Sleep disorders
CDC, FDA and other government agen-
➧➧ “Feeling abnormal” ➧➧ Stupor
cies play more of a cheerleader role, ➧➧ Gait disturbances ➧➧ Tremors
assuring residents that the U.S. has “the ➧➧ Increased heart rate, palpitations ➧➧ Viral infections
safest, most effective vaccine supply in
history.” The vaccine industry, too, brags
about the “exhaustive and continuous” (VAERS)—has received nearly 700,000
safety assessment of vaccines, includ- reports of post-vaccination adverse
ing post-approval.119 All of these state- events since 1990 (see “Vaccine
ments blithely continue to skirt around Adverse Reactions”).124 Recalling NVICP has paid
the fact—attested to by the $4 billion in HHS’s estimate that only 1% of vac-
NVICP payouts120—that vaccines cause cine injuries get reported,125 it is likely
out over $4
permanent disability121 and death122 that millions of adverse reactions to billion proving
with some regularity. vaccines are occurring in the U.S. that vaccines
every year—yet, precisely because
cause permanent
As part of the NCVIA, legislators gave these injuries nearly always go unre-
a nod to the potential for vaccine ported, official discussions of vaccine disability and
damage by mandating that the CDC safety remain hugely misleading. death with
and FDA jointly establish a safety regularity.
monitoring system to collect and ana- When discussing VAERS, CDC and
lyze “spontaneous reports of adverse FDA researchers like to have it both
events that occur in persons following ways.126 On the one hand, they praise
vaccination.”123 That system—the Vac- the system for guiding further safety
cine Adverse Event Reporting System evaluations, but on the other hand,
the agencies warn that “VAERS data Captured Agencies Coincidence?
interpreted alone or out of context
CDC authors have admitted to
can lead to erroneous conclusions Captured agencies operate “essentially
“rare cases where a known or
about cause and effect as well as as…advocate[s] for the industries they
plausible theoretical risk of
the risk of adverse events occurring regulate,” abrogating their duty to
death following vaccination
following vaccination.” act in the public’s interest.130 Vaccine
exists,” citing:
and drug fast-tracking provide a clear
They also take pains to point out that example of regulatory capture. In 1992, ➧➧ Anaphylaxis
“an adverse health event or health Congress passed the Prescription Drug
problem that occurs following or User Fee Act, allowing pharmaceutical ➧➧ Vaccine-strain systemic infec-
during administration of a vaccine… companies to make payments to the tion after giving live vaccines
might be caused by a vaccine or might FDA (called “user fees”) in exchange for to persons with compromised
be coincidental and not related to vac- expedited approval of drugs and bio- immune systems
cination” [emphasis added]. In fact, logics, including vaccines.131 Additional ➧➧ Intussusception after rotavirus
CDC authors who churn out boiler- legislation in 2012 further facilitated vaccine
plate articles about vaccine safety “accelerated approval” by allowing the
exhibit a fondness for the notion that FDA to use “surrogate endpoints” to ➧➧ Guillain-Barré syndrome after
post-vaccination mishaps are simply a evaluate a drug or vaccine rather than inactivated influenza vaccine
fluke (see “Coincidence?”). Industry, waiting to assess longer-term clinical
too, likes to tell the public that it has benefits.132 According to a 2015 report
➧➧ Fall-related injuries associated
“guidelines and algorithms” to differ- in Fortune magazine, pharmaceutical
with post-vaccination fainting
entiate between a post-vaccination companies are more than willing to pay ➧➧ Systemic or neurologic
adverse event that “may” be causally “big bucks” to speed up the approval disease following yellow fever
related to a vaccine and an event that process133 and, in the process, they gain vaccination
is coincidental to vaccination.127 extraordinary leverage over regulatory
decision-making.134 Whereas the FDA ➧➧ Serious complications from
Physicians are critical intermediaries was publicly funded prior to 1992, by smallpox vaccination, includ-
between patients and vaccine fiscal year 2017, three-fourths (75%) of ing brain inflammation and
manufacturers, but many factors work the FDA’s annual budget increase came heart problems
to prevent them from recognizing and from user fees,135 with the pharmaceu-
➧➧ Vaccine-associated paralytic
reporting adverse events, including tical industry in essence paying FDA
polio from oral polio vaccine
the lack of medical school training regulators’ salaries.
on vaccine adverse reactions and Nonetheless, CDC researchers as-
low awareness of VAERS. A large Some of the vaccines most readily sert that “adverse events includ-
and nationally representative study approved by the FDA and heavily pro- ing deaths that are temporally
of health care providers (including moted by the CDC in recent years are associated with vaccination” are
physicians, mid-level providers and for conditions for which there was usually “coincidental”—even
nurses) found that whereas slightly not only little rationale for vaccina- though “loved ones and others
more than a third (37%) had ever tion to begin with but which have might naturally question wheth-
identified a post-vaccination adverse created new dangers. Gardasil, which er it was related to vaccination”!
event, only 17% of that subgroup had Judicial Watch has called a “large-scale
ever made a report to VAERS.128 A public health experiment,” is a case SOURCE: Miller ER, Moro PL, Cano M,
Shimabukuro TT. Deaths following
qualitative study of health providers in point.136 The FDA gave Gardasil a
vaccination: what does the evidence
in Australia (where vaccine policies speedy six-month review despite evi- show? Vaccine 2015;33(29):3288-3292.
are, in key ways, similar to those in dent concerns about long-term safety.
the U.S.) found that many providers
experienced “confusion” about the Other difficult-to-justify but mon-
types of events that would constitute ey-spinning vaccines continue to be
“reportable” adverse events and touted as beneficial in the face of sub-
also were unclear on how to define stantial evidence to the contrary. The
“serious” adverse events.129 rationale for the varicella (chickenpox)
and rotavirus vaccines is particularly
dubious. Varicella137 and rotavirus138
were nearly universal and mostly
benign childhood infections before
the introduction of the vaccines; in
the U.S. and other wealthy countries,
their impact was largely measured
in terms of “healthcare costs, missed
daycare, and loss of time from work
for parents/guardians” rather than in
terms of serious illness or mortality.139
Moreover, childhood chickenpox infec-
tions served an important purpose
for all, conferring lifelong immunity
to infected children while boosting
adults’ immunity to the related shin-
gles (herpes zoster) virus.140 With mass
varicella vaccination, shingles started
cropping up to an unprecedented “misrepresentations of past science,”
extent in both children and adults,141 the agency allows problematically
presenting what some researchers high amounts of aluminum adjuvant
The FDA’s cavalier
have described (understatedly) as “per- in vaccines to be injected into infants
verse public health implications.”142 and children,147 even though it views vaccine safety
aluminum as a toxic contaminant stance is also
The introduction of rotavirus in parenteral (intravenous) nutrition apparent in its
vaccines resulted in a substantially products given to neonates.148 A 2018
increased risk in infants of an study reveals how CBER wrongly
mixed messages
otherwise rare bowel complication calculates aluminum adjuvant about aluminum.
called intussusception—a problem toxicity, allowing amounts of The agency allows
that the FDA knew about but chose aluminum “derived from data that
problematically
to ignore during the prelicensing demonstrated that this amount of
regulatory review process.143 Although aluminum per dose enhanced the high amounts
the FDA subsequently withdrew its antigenicity and effectiveness of the of aluminum
approval for one of the problematic vaccine”—but which did “not include adjuvant in
rotavirus vaccines, the two still safety considerations.”149 When the
on the market display the same researchers properly accounted for
vaccines to be
intussusception risks144 as well as variables such as body weight and injected into
both being contaminated with foreign the simultaneous administration infants and
DNA from porcine viruses capable of multiple aluminum-containing
children, even
of causing severe immunodeficiency vaccines during a single doctor’s
in pigs.145 Had the presence of these visit, they concluded that modern though it views
“adventitious agents” been discovered vaccine schedules “place infants at aluminum as a
prior to vaccine licensure, the FDA risk of acute, repeated, and possibly toxic contaminant
probably would have been forced to chronic exposures of toxic levels of
shelve the vaccines, yet they remain aluminum.”150
in parenteral
on the vaccine schedule to this day.146 (intravenous)
Exaggerated Effectiveness nutrition products
The FDA’s cavalier vaccine safety
given to neonates.
stance is also apparent in its mixed Alongside their many misplaced claims
messages about aluminum. Guided about vaccine safety, the FDA and
by “unfounded assumptions” and CDC—as echo chambers for the vaccine
industry—also have misinformed the In fact, not only is pertussis at its high-
Learning from History?
public about vaccine effectiveness. est level since the mid-1950s, but,
Back in 1899, doctor William Bailey according to CDC researchers, it is During a smallpox outbreak in
(vaccination enthusiast and member of showing signs of being vaccine-resis- the early 1870s, a doctor ob-
the State Board of Health in Louisville, tant.158 The CDC researchers also note served that smallpox mortality
Kentucky) was honest enough to cau- “substantial heterogeneity among vac- doubled (from roughly 7% to
tion that “nothing is gained by claim- cine recipients in terms of the durabil- 15%) after adoption of smallpox
ing too much” about vaccine-induced ity of the protection they receive.” vaccination. The doctor also
immunity and stated that “the degree noted that the vaccinated often
of immunity may vary with time and West Africa has used the DTP vaccine contracted severe smallpox more
circumstance”151 (presaging the trouble- since the 1980s—formulated with readily than the unvaccinated:
some modern phenomena of vaccine a whole-cell pertussis component
“Never, however, did the faith in
failure152 and waning immunity153). instead of acellular pertussis—and it
vaccination receive so rude a shock
has an even more horrifying safety
as in the Great Small-Pox Epidemic
In the present day, officials are only and effectiveness track record than its
of 1871 and 1872. Every country
too willing to “claim too much,” con- acellular counterparts. Research pub-
in Europe was invaded with a
veniently ignoring historical evidence lished in 2017 by a prestigious team of
severity greater than had ever been
that reductions in infectious disease international scientists and led by vac-
witnessed during the three preceding
had little to do with vaccines and far cinology expert Dr. Peter Aaby found
centuries. …What was even more
more to do with improvements in san- that DTP vaccination had a negative
significant, many vaccinated persons
itation and nutrition.154 Officials also effect on child survival, with five-
in almost every place were attacked
seem to have little interest in modern fold higher mortality in young DTP-
by small-pox before any unvaccinat-
evidence documenting many vaccines’ vaccinated infants (ages three to five
ed persons took the disease. These
inability to provide the promised pro- months) compared to as-yet-unvacci-
facts are sufficient to overthrow
tection, even when vaccine coverage is nated infants.159 When the researchers
the entire theory of the protective
widespread.155 published results in 2018 for slightly
efficacy of vaccination.”
older DTP-vaccinated children (ages
The acellular version of pertussis six months to three years), they con- SOURCE: Wilder A. The Fallacy of
(whooping cough)—a component of U.S. tinued to observe more than double Vaccination. New York, NY: The Meta-
physical Publishing Company; 1899.
vaccines such as DTaP and Tdap—is the risk of death as similarly situated
https://collections.nlm.nih.gov/ext/
one of the vaccines noted for its abys- unvaccinated children.160 Explaining dw/101229606/PDF/101229606.pdf.
mal effectiveness.156 The vaccine is sup- that vaccines can increase susceptibil-
posed to protect against the respiratory ity to other infections, the researchers
infection caused by Bordetella pertussis. concluded in 2017 that “all currently
Instead, according to recent studies, available evidence suggests that DTP
pertussis is making a “surprising” come- vaccine may kill more children from
back; between 1990 and 2005, pertussis other causes than it saves from diph-
epidemics increased in the U.S. “in both theria, tetanus or pertussis” and added
size and frequency,” and over half of all in 2018 that “all studies of the intro-
cases occurred in highly vaccinated duction of DTP have found increased
adolescents aged 10 to 20 years old.157 overall mortality.”

IV. Tainted Science Notorious
episodes involve
secret meetings,
T he CDC and its governmental

and private partners have fudged
vaccine science for decades, leaving—
about the risks of thimerosal-contain-
ing vaccines.
attempts to
keep publicly
by now—a well-documented trail of The lead Simpsonwood speaker, funded data out
cover-ups and skullduggery.161 Some of Thomas (“Tom”) Verstraeten, MD, was a of the reach of
the more notorious episodes involve junior physician-biostatistician work-
independent
secret meetings, attempts to keep ing in the CDC’s Epidemic Intelligence
publicly funded data out of the reach Service (EIS). Verstraeten had been scientists,
of independent scientists, destruc- conducting analyses designed to destruction of
tion of data, fraudulent manipulation assess the impact of thimerosal-con- data, fraudulent
of data and other crimes, including taining vaccines on neurodevelop-
embezzlement. Far from being excep- mental disorders in children. His
manipulation of
tions, these incidents illustrate a earliest tables—never reported on data and other
longstanding culture of dishonesty or published but obtained through a crimes, including
and ethical violations at the heart of Freedom of Information Act request
embezzlement.
the U.S. vaccine enterprise. by the autism advocacy organization
SafeMinds—demonstrated “striking” These incidents
Manipulating Thimerosal Data and statistically significant effects illustrate a
“supportive of a causal relationship longstanding
In June, 2000, the CDC convened a between vaccine mercury exposure
scientific review panel at the Simpson- and childhood developmental dis-
culture of
wood Retreat Center near Atlanta.162 At orders (especially autism).”163 These dishonesty and
the gathering (intended to be secret), initial analyses, dubbed “Generation ethical violations
over 50 experts—representing the Zero” by SafeMinds, found consis-
at the heart of
CDC and FDA, state and international tently elevated risks (2-11 times
public health agencies and vaccine higher) in the high-exposure groups the U.S. vaccine
companies—met to discuss what they compared to the zero-exposure group, enterprise.
described as “theoretical concerns” with the strongest effects “for the
highest levels of mercury exposure at our desire to disprove an unpleasant Undeniable Safety
the earliest time of exposure.” theory.” Signal
Between February 2000 and November Despite Verstraeten’s scruples, others
“The bottom line to me is you can
2003, Verstraeten and his CDC supervi- at the CDC—with Julie Gerberding
look at this data and turn it around
sors produced four further rounds of at the helm—proceeded to hastily
and look at this, and add this
analyses that—with each round or publish a handful of poorly designed
stratum, I can come up with risks
“generation”—reduced or eliminated epidemiological studies intended to
very high. I can come up with very
the elevated and statistically signifi- shore up the Simpsonwood consen-
low risks, depending on how you
cant risks apparent in the Generation sus. Authored by industry-funded
turn everything around. You can
Zero data. This reflected, according to scientists, the studies examined a
make it go away for some and then
SafeMinds, “deliberate” methodological single neurodevelopmental outcome
it comes back for others. To me the
choices that took the findings in a (autism) and seemingly absolved
bottom [line] is, well, there is some
direction “towards insignificance.” thimerosal of any responsibility
things that just will never go away. If
When going over the “Generation One” for causing it. A study of the data
you make it go away here, it will pop
analysis at Simpsonwood, Verstraeten presented at Simpsonwood was
up again there. So the bottom line is,
made it clear that he was caught in published in Pediatrics in 2003,164
okay, our signal will simply not just
the middle. On the one hand, he with Verstraeten (now working at
go away.”
described a safety signal that would GlaxoSmithKline) as lead author. —Thomas Verstraeten,
“never go away”—showing that thimer- Although the publication used the Simpsonwood
osal exposure in infancy displayed a later generations of analyses—featur-
statistically significant dose-related ing reworked exclusion criteria, expo- SOURCE: Simpsonwood transcript,
p. 153 https://childrenshealthdefense.
association with subsequent neurolog- sure measures and statistical mod-
org/government/federal-agency-docu-
ical damage—but he also hinted at the els—Verstraeten contested the notion ments/simpsonwood-documents/
pressure that he was under to “turn that he or the CDC had “watered
everything around” and “make it go down” the original results. In a letter
away” (see “Undeniable Safety Signal”). to the editor of Pediatrics in 2004,165
Meanwhile, other Simpsonwood he described the study’s results as
attendees cautioned that “we have to “neutral,” stating, “The bottom line
be very, very careful that we got it right is and has always been the same: an
when we decide to make a policy call association between thimerosal and
on this.” By the close of the meeting, all neurological outcomes could neither
but one Simpsonwood attendee had be confirmed nor refuted, and there-
agreed to rate the association between fore, more study is required.”
thimerosal and neurodevelopmental
disorders as “weak.” Around the same time, a handful
of other CDC-sponsored epidemio-
In a post-Simpsonwood email in July, logical studies were published that
2000 to Harvard researcher Philippe intentionally used data from non-U.S.
Grandjean—a leading mercury and
neurotoxicology expert—Verstraeten
apologized for dragging Grandjean
into a “nitty-gritty discussion” about
thimerosal and neurodevelopment.
Verstraeten stated, “I do not wish to
be the advocate of the anti-vaccine
lobby and sound like being convinced
that thimerosal is or was harmful,
but at least I feel we should use
sound scientific argumentation and
not let our standards be dictated by
populations with far lower exposure to researchers. In 2005, the IOM released
thimerosal (including Sweden,166 the a consensus report, titled Vaccine
Danish general population,167 Danish Safety Research, Data Access, and Public
psychiatric departments168 and the Trust,176 which admitted to “the lim-
United Kingdom169). This made it eas- ited ability of independent external
ier to disguise potential associations researchers to conduct high-quality
between thimerosal and neurodevelop- corroboration studies or studies of
mental disorders. Despite many solid new hypotheses…after January 1, 2001”
critiques of these and other gerryman- [emphasis added], including studies
dered studies,170 the CDC continues to that “members of the public consider
Researchers at
trot them out as evidence of thimero- to have high priority” (Chapter 5).177
sal’s putative safety to this day.171 the CDC and the
In 2002, two external researchers participating
Outsourcing the Vaccine sought to gain access to VSD data. HMOs regularly
Safety Datalink They persisted until successful—but
only at the price of dealing with
publish vaccine-
Verstraeten’s dataset, which included numerous hurdles that are hard to favorable
over 100,000 children born over the construe as anything but intentional studies using
five-year period from 1992 to 1997, obstruction on the CDC’s part.178
Vaccine Safety
came from the Vaccine Safety Datalink These included:
(VSD). The VSD is a taxpayer-funded Datalink data,
➧➧ Having to submit a 200-page pro-
collection of millions of medical and posal and undergoing a months-
often drawing
vaccine records from large health long initial approval process at on the same
maintenance organizations (HMOs), the CDC
established by the CDC in 1990 to
prelicensing tactic
facilitate safety studies of vaccines ➧➧ Having to submit separate of comparing
proposals and undergo lengthy
already on the market.172 Researchers
approvals at each of the HMOs,
one vaccine
at the CDC and the participating HMOs
sometimes at considerable with another to
regularly publish vaccine-favorable expense (and sometimes with
studies using VSD data, often drawing approval granted and then
ensure a result of
on the same prelicensing tactic of retracted) “no significantly
comparing one vaccine with another elevated risk”
to ensure a result of “no significantly ➧➧ Encountering CDC refusal to
elevated risk” in the group of allow reanalysis of data from in the group of
interest.173
published CDC VSD-based stud- interest.
ies (with the CDC responding in
multiple instances that the raw
In 2001, one year after Verstraeten data no longer existed or that the
shared his VSD-based thimerosal dataset had been “damaged”)
findings at Simpsonwood, the CDC
outsourced VSD management and ➧➧ Getting charged thousands of
coordination to a private company— dollars in user fees to access the
data in a windowless room
America’s Health Insurance Plans
secured by armed guards
(AHIP)—giving AHIP responsibility for
maintaining the “strategic direction”
of VSD projects.174 Although the CDC
“The treatment that these well-published researchers have received
claims that it “tries to accommodate”
from the CDC…has been abysmal and embarrassing. I would be curious
requests from independent investi-
gators to use VSD data,175 in practice, to know whether Dr. Verstraeten [by then at GSK] …was required to
AHIP’s private control has made the go through the same process…to continue accessing the VSD.”
data virtually impenetrable to anyone
—Congressman Dave Weldon, writing to CDC Director Julie Gerberding
other than CDC- and HMO-approved
Throwing Autism-MMR
Data in the Trash
Around the same time period (the

early 2000s), Dr. William Thompson,
long-time CDC vaccine safety scientist,
was assigned to a CDC study intended
to extricate the MMR vaccine from its
controversial association with autism.
Unexpectedly, the data refused to
cooperate, showing a 250% increase in
autism in African-American boys who
received the MMR vaccine before their
third birthday (compared to African-
American boys who received the
vaccine after age three).179 When the (OGR). However, the OGR Committee
MMR study was published in 2004,180 Chairman at the time, former Repre-
the publication failed to report these sentative Jason Chaffetz, stonewalled
critical findings, despite the fact that until he left office in 2017. (According
“a greater risk specifically for African- to a report in The Guardian, drug com-
Americans deserves additional, panies had been the single largest
immediate investigation.”181 The data donor184 to his political campaigns.) Thompson...acted
analysis also showed an increased risk at the direction
of autism in MMR-vaccinated children Turning a Blind Eye of senior CDC
who had been developing normally
and had no other medical problems, Reflecting the almost Keystone-Cops-
officials, including
but the published article “mentioned like atmosphere at the CDC, another Branch Chief
the effect…only in passing.”182 infamous mid-2000s episode remains Frank DeStefano...
unresolved to this day. The “most
who ordered
A decade later, in 2014, Thompson wanted fugitives” webpage on HHS’s
sought federal whistleblower protec- Office of Inspector General (OIG) Thompson and
tion and testified to Congressman website shows that a visiting Danish his co-authors to
William Posey about the fraudulent scientist at CDC named Dr. Poul dump the datasets
omission of key autism results in the Thorsen “executed a scheme to steal
2004 MMR paper. Thompson alleged [CDC-awarded] grant money” over a
into a giant
that he had acted at the direction of six-year period from 2004 to 2010.185 garbage can to
senior CDC officials, including Branch The indictment describes how Thorsen get rid of
Chief Frank DeStefano (lead author diverted over $1 million of CDC
the evidence
on the published paper), who ordered funds to his personal bank account
Thompson and his co-authors to through fraudulent invoicing (as well establishing
dump the datasets into a giant gar- as misallocating additional monies), a causal
bage can to get rid of the evidence eventually taking refuge in Denmark vaccine-autism
establishing a causal vaccine-autism to escape prosecution for 22 counts of
connection.183 Thompson handed wire fraud and money laundering.186
connection.
over thousands of pages of docu- Thorsen has been on the OIG’s “most
ments to Congressman Posey reveal- wanted” list since 2012. Although his
ing widespread fraud in the CDC’s whereabouts in Denmark are well-
vaccine division. He also expressed known, HHS and DOJ have made no
willingness to appear, under sub- effort to push for extradition, despite
poena, before the House Committee urging from Congressman Posey to
on Oversight and Government Reform pursue the matter as a high priority.187
The CDC embraced Thorsen as one the ranks of the very same govern- The IOM
of its own before, during and after ment agencies, schools of medicine, produces reports
the embezzlement. Thorsen was an schools of public health, hospitals and specifically
insider to such an extent that he (a private foundations that have uncrit-
foreign scientist) had a CDC govern- ically supported existing vaccine poli-
requested and
ment email address and CDC credit cies for decades. paid for by
union account.188 From the time of federal agencies—
his arrival at the CDC, the agency The IOM produces reports specifically
including
seized on the allegedly unscrupulous requested and paid for by federal
Thorsen as an ideal partner to cook agencies—including the CDC—as the CDC—as
up and publish slanted epidemio- well as other organizations. The IOM well as other
logical studies out of Denmark that develops its scope of work “in col- organizations.
masked the MMR-autism and thimer- laboration with the study’s sponsor”
osal-autism associations, including and then carries out its deliberations
studies that appeared in the New behind closed doors.197 In September,
England Journal of Medicine189 and 2000, the CDC and the National
Pediatrics190 in 2002 and 2003, respec- Institutes of Health (NIH) commis-
tively. Senior CDC officials “continued sioned an IOM committee to research
to include him in discussions well and write a series of eight specific
after it was obvious he had forged immunization safety reviews, with
documents and stolen money,” also the scope closely dictated by the CDC The IOM Reviews
arranging in-person meetings and (see “The IOM Reviews”). From 2001-2004, the Institute
continuing to collaborate and publish of Medicine (IOM) produced a se-
with Thorsen after his indictment.191 The first two IOM reports, published ries of eight immunization safety
Nor was the CDC troubled by the in 2001, focused on thimerosal-con- reviews:
fact (uncovered by Children’s Health taining vaccines and neurodevelop-
Defense in 2017 but known by the mental disorders198 and the MMR vac- ➧➧ Thimerosal-containing
CDC since 2009) that Thorsen and cine and autism,199 respectively. In the vaccines and neurodevelop-
his collaborators failed to request or former, the IOM authors endorsed the mental disorders (2001)
obtain required ethical clearances biological plausibility of the hypothe-
➧➧ Measles-mumps-rubella
for the 2002 MMR study as well as a sis that “exposure to thimerosal-con-
vaccine and autism (2001)
later study.192 Instead of retracting taining vaccines could be associated
the unapproved studies, CDC super- with neurodevelopmental disorders,” ➧➧ SV40 contamination of polio
visors simply covered up the illicit concluding (like Verstraeten) that vaccine and cancer (2002)
activity.193 they could neither accept nor reject a
causal relationship. They called for ➧➧ Multiple immunizations and
Generating Favorable removal of thimerosal from all vac- immune dysfunction (2002)
IOM Findings cines given to infants, children and
➧➧ Hepatitis B vaccine and
pregnant women as a precautionary
demyelinating neurological
The IOM (now the Health and Medicine step and recommended more basic
disorders (2003)
Division of the National Academies of science, clinical and epidemiological
Sciences, Engineering, and Medicine) research—recommendations that ➧➧ Vaccinations and sudden
is a private, nonprofit entity that has remain largely unheeded to this day. unexpected death in infancy
had a mandate since 1970 to provide The second IOM report came out (2003)
the U.S. government with “indepen- against a population-level causal
dent, objective analysis” on matters of relationship between the MMR vac- ➧➧ Influenza vaccines and neuro-
health.194 The IOM has authored doz- cine and autism, yet it, too, stated logical complications (2004)
ens of reports on vaccines.195 However, that it could not disprove “the pro-
➧➧ Vaccines and autism (2004)
the organization’s independence on posed biological models” in individual
this topic is open to question, given children and reiterated the need for SOURCE: https://www.ncbi.nlm.nih.
that its members196 are drawn from further research. gov/books/NBK206941/

Although the IOM meetings took place about-face. The OAP presented the
behind closed doors, an insider leaked NVICP’s Special Masters with the
transcripts of the 2001 meetings. Well politically thorny task of evaluating
before any evidence had been reviewed, 5,400 petitions asserting that vaccines
the Committee Chairman, Dr. Marie had caused autism, either as a result
McCormick, stated, “CDC…wants us to of thimerosal, the MMR vaccine or a
declare…these things are pretty safe combination of the two.206 The Special
on a population basis” (p. 33); she later Masters eventually dismissed all of
added, “we are not ever going to come the OAP petitions, ruling that “none
down that [autism] is a true side effect of the theories of autism causation…
[of a vaccine]” (p. 97).200 The Committee were proven.” To support this ruling,
Study Director, Dr. Kathleen Stratton, they not only drew on the flawed
likewise clarified, “…The line we will epidemiological studies published by
not cross in public policy is pull the Thompson, DeStefano, Thorsen and
vaccine, change the schedule. …We others but also had the IOM’s damning
In one of its only
wouldn’t say compensate, we wouldn’t 2004 report close at hand. concessions
say pull the vaccine, we wouldn’t to biological
say stop the program” (p. 74). The In one of its only concessions to bio-
plausibility, a
transcripts suggest that, at its core, logical plausibility, a brief section of
the committee was little better than the 2004 IOM report discussed the brief section of
a “kangaroo court”; in the words of a “hypothesis” of genetic susceptibil- the 2004 IOM
parent organization, “the fix was in” ity to vaccine injury, citing the field report discussed
from the start.201 known as pharmacogenetics—“ge-
netic variants in humans that…
the “hypothesis”
By the time the IOM committee wrote change the way individuals react of genetic
its 2004 report,202 the group “man- to certain medications.”207 The IOM susceptibility to
aged to produce the outcome CDC authors suggested that “something
vaccine injury, citing
was looking for.”203 Written in what similar might be operating in infants
Congressman Dave Weldon charac- and young children exposed to cer- the field known as
terized as an “atmosphere of intimi- tain vaccines or vaccine components.” pharmacogenetics—
dation” driven by “a desire to sweep In addition, they noted that “this “genetic variants
these issues under the rug,”204 the hypothesis cannot be excluded by
2004 report reexamined the hypoth- epidemiological data from large pop-
in humans that…
esis that vaccines—specifically the ulation groups that do not show an change the way
MMR vaccine and thimerosal-con- association between a vaccine and individuals
taining vaccines—might be associated an adverse outcome” because “a rare
react to certain
with autism. This time, however— event caused by genetic susceptibility
using tactics such as “changing their could be missed even in large study sam- medications.”
charter, avoiding case reports, and ples” [emphasis added]. A few years
disregarding biological evidence”205— later, the NVICP reluctantly conceded
the IOM categorically rejected both just such a possibility, awarding over
hypothesized relationships. Leaving $1.5 million in immediate compen-
behind the 2001 position of “biological sation and an estimated $20 million
plausibility,” the 2004 report dismissed over her lifetime to a vaccine-injured
“potential biological mechanisms child, Hannah Poling, after admit-
for vaccine-induced autism” as “only ting that administration (in a single
theoretical.” day) of five vaccines for nine diseases
had worsened her underlying mito-
The initiation of the Omnibus Autism chondrial disorder and resulted in
Proceeding (OAP) in 2002 undoubtedly autism.208 TIME magazine reported,
fed into the IOM committee’s “…There’s no denying that the court’s
decision to award damages…puts a
chink—a question mark—in what
had been an unqualified defense of
vaccine safety with regard to autism.
If Hannah Poling had an underlying
condition that made her vulnerable to
being harmed by vaccines, it stands to
reason that other children might also
have such vulnerabilities.”209
Unfortunately, the 2004 IOM report

also declared that “from a public
health perspective the committee
does not consider a significant invest-
ment in studies of the theoretical vac-
cine-autism connection to be useful
at this time.” Thus, the report’s net
effect was not only to buttress the gov-
ernment’s assertion that vaccines do advertising its products in print jour- Vaccine Advertising
not cause autism (facilitating its dis- nals” because journals reach doctors—
missal of OAP claims) but also to halt the “gatekeeper between drug compa-
Pays Off
financial support for much-needed nies and patients.”212 In fact, studies Heavy-duty vaccine advertising
studies, including studies of genetic show that journal advertising gener- directed at consumers pays off
susceptibility. ates “the highest return on investment in doctor-patient encounters.
of all promotional strategies employed In 2015, Pfizer’s Prevnar-13
Ensuring Medical by pharmaceutical companies.”213 vaccine was the nation’s eighth
Journal Complicity Almost nine in ten drug advertising most heavily advertised drug;
dollars are directed at physicians. In after the launch of the intensive
The vaccine industry and its gov- the U.S. in 2012, drug companies spent advertising campaign, Prevnar
ernment accomplices could not rou- $24 billion marketing to physicians, “awareness” increased by over
tinely block meaningful science and with only $3 billion spent on direct- 1,500% in eight months, and
fabricate misleading studies without to-consumer advertising.214 (By 2015, “44% of targeted consumers
having enticed medical journals into however, consumer-targeted advertis- were talking to their physi-
a Faustian bargain. Pharmaceutical ing had jumped to $5.2 billion,215 a 60% cians about getting vaccinated
companies supply journals with increase that has reaped rewards—see specifically with Prevnar.” Slick
needed income, and in return, the “Vaccine Advertising Pays Off.”) ad campaigns have also helped
journals play a key role in suppressing boost uptake of “unpopular”
studies that raise critical questions Advertising is such an established part vaccines like Gardasil.
about vaccine risks—which would of journals’ modus operandi that high- SOURCES: Helfand C. Pfizer’s Prevnar
endanger profits. end journals such as The New England conundrum: how to convince “invinci-
Journal of Medicine (NEJM) boldly invite ble” baby boomers they need a shot?
Advertising is one of the most obvi- medical marketers to “make NEJM the FiercePharma, Apr. 10, 2017.
ously beneficial ways that medical cornerstone of their advertising pro-
Ramsey L. A shocking new ad is sham-
journals’ “exclusive and dependent grams,” promising “no greater assurance ing parents for not giving their children
relationship” with the pharmaceutical that your ad will be seen, read, and this unpopular vaccine. Business Insider,
industry plays out.210 According to a acted upon.”216 In addition, medical jour- Jul. 15, 2016.
2006 analysis in PLOS Medicine, drugs nals benefit from pharmaceutical com-
and medical devices are the only prod- panies’ bulk purchases of thousands of
ucts for which medical journals accept journal reprints (see “Cash Cows”) and
advertisements.211 The pharmaceu- industry’s sponsorship of journal sub-
tical industry “puts a high value on scriptions and journal supplements.
Fifteen years ago, an editor at The
BMJ wrote about other ways in which
drug company funding can bias
medical journals (and the practice of
medicine).217 For example:
➧➧ Advertising monies enable pres-

tigious journals to get thousands
of copies into doctors’ hands for
free, which “almost certainly”
goes on to affect prescribing.
➧➧ Journals are willing to accept

even the most highly misleading
advertisements. From 1997 to
2002, the FDA flagged dozens of
instances of advertising viola-
tions, including ads that over-
stated a drug’s effectiveness or
minimized its risks.
although vaccine-favorable studies
➧➧ Journals will guarantee favorable Cash Cows
were “of significantly lower method-
editorial mentions of a product
ological quality,” even these poor-qual- “Major [clinical] trials are very
in order to earn a company’s
advertising dollars. ity studies—when funded by the pharma- good for journals in that doctors
ceutical industry—got far more attention around the world want to see
➧➧ Journals can earn substantial than equivalent studies not funded by them and so are more likely to
fees for publishing supplements industry. The authors commented: subscribe to journals that publish
even when they are written by them. Such trials also create lots
“paid industry hacks”—and the of publicity, and journals like
“[Studies] sponsored by industry
more favorable the supplement
had greater visibility as they were publicity. Finally, companies pur-
content is to the company that
is funding it, the bigger the profit more likely to be published by high chase large numbers of reprints
for the journal. impact factor journals and were of these trials…and the profit
likely to be given higher promi- margin to the publisher is huge.
nence by the international scien- These reprints are then used to
Funding Research tific and lay media, despite their market the drugs to doctors, and
apparent equivalent methodologi- the journal’s name on the reprint
According to the Journal of the American cal quality and size compared with is a vital part of that sell.”
Medical Association (JAMA), as of 2003, studies with other funders.” SOURCE: Smith R. Medical journals and
nearly three-fourths of all funding for pharmaceutical companies: uneasy
clinical trials in the U.S.—presumably In their discussion, the authors also bedfellows. BMJ 2003;326(7400):12-
including vaccine trials—came from cor- described how the industry’s vast 2-1205.
porate sponsors.218 The pharmaceutical resources enable lavish and strategic
industry’s funding of studies (and inves- dissemination of favorable results. For
tigators) is a factor that helps determine example, companies often distribute
which studies get published, and where. “expensively bound” abstracts and
reprints (translated into various
In 2009, researchers published a sys- languages) to “decision makers, their
tematic review of several hundred advisors, and local researchers,” while
influenza vaccine trials.219 Noting also systematically plugging their
“growing doubts about the validity of studies at symposia and conferences.
the scientific evidence underpinning
[influenza vaccine] policy recommen- At the same time, and in defiance of
dations,” the authors showed that World Health Organization standards
that describe reporting of clinical trial actually is.” However, the absolute risk
results as a “scientific, ethical, and difference between the vaccine and the
Untrustworthy Research
moral responsibility,” it appears that as placebo group was 2.27%, meaning that “It is simply no longer possible
many as half of all clinical trial results the vaccine “was nearly 98% ineffective to believe much of the clinical
go unreported—particularly when in preventing the flu.” research that is published, or to
their results are negative; experts rely on the judgment of trusted
warn that “unreported studies leave an The Cochrane Collaboration (which physicians or authoritative
incomplete and potentially misleading bills its systematic reviews, ironically, medical guidelines. I take no
picture of the risks and benefits of as the international gold standard pleasure in this conclusion,
treatments.”220 for high-quality, “trusted” evidence) which I reached slowly and
recently furnished another example reluctantly over my two decades
Debasing and Censoring Results of industry-biased conclusions. In as [editor-in-chief of the New
May, 2018, Cochrane published a England Journal of Medicine].”
Researchers have reported “a signif- systematic review highly favorable SOURCE: Marcia Angell. Drug compa-
icant association between funding to HPV vaccination,227 declaring no nies & doctors: a story of corruption.
sources and pro-industry conclu- increased risk of serious adverse The New York Review of Books, Jan. 15,
sions,”221 documenting the potential for effects and—barely refraining from 2009.
drug company funding to encourage using the word “coincidence”—stating
methodological bias222 and debase- that deaths observed in HPV studies
ment223 of study designs and analytic “have been judged not to be related
strategies. Bias may be present in to the vaccine.” Cochrane claims to
the form of inadequate sample sizes, be free of conflicts of interest, but its
short follow-up periods, inappropri- roster of funders includes national
ate placebos or comparisons, use of governmental bodies and international
improper surrogate endpoints, unsuit- organizations pushing for HPV vaccine
able statistical analyses or “misleading mandates as well as the Bill & Melinda
presentation of data.”224 Many vaccine Gates Foundation and the Robert Wood
studies flagrantly illustrate these and Johnson Foundation—both of which
other types of biases and selective are staunch funders and supporters of
reporting,225 resulting in skewed write- HPV vaccination.228 The Robert Wood
ups that are more marketing than sci- Johnson Foundation’s president is a
ence—as journal insiders have admit- former top CDC official who served as
ted (see “Untrustworthy Research”). In acting CDC director during the H1N1
formulaic articles that medical jour- “false pandemic” in 2009 that ensured
nals are only too happy to publish, the millions in windfall profits for vaccine
conclusion is almost always the same, manufacturers.229
no matter the vaccine: “We did not
identify any new or unexpected safety Two months after publication of
concerns.” Cochrane’s HPV review, researchers
affiliated with the Nordic Cochrane
As an example of the use of inappropri- Centre (one of Cochrane’s member cen-
ate statistical techniques to exaggerate ters) published an exhaustive critique,
vaccine benefits, an influenza vaccine declaring that the reviewers had done
study reported a “69% efficacy rate” an incomplete job and had “ignored
even though the vaccine failed “nearly important evidence of bias.”230 The crit-
all who [took] it.”226 As explained by Dr. ics itemized numerous methodological
David Brownstein, the study’s authors
used a technique called relative risk According to the Journal of the American Medical Association (JAMA), as
analysis to derive their 69% statistic of 2003, nearly three-fourths of all funding for clinical trials in the U.S.—
because it can make “a poorly perform-
presumably including vaccine trials—came from corporate sponsors.218
ing drug or therapy look better than it
and ethical missteps on the part of the
Cochrane reviewers,231 including failure
to count nearly half of the eligible HPV
vaccine trials, incomplete assessment
of serious and systemic adverse events
and failure to note the industry funding
behind many of the reviewed studies.
They also upbraided the Cochrane
reviewers for not paying attention to
key design flaws in the original clinical
trials, including the failure to use true
placebos and the use of surrogate out-
comes for cervical cancer.
In response to the criticisms, the editor-

in-chief of the Cochrane Library ini-
tially stated that a team of editors
would investigate the claims “as a mat-
ter of urgency.”232 Instead, however,
Cochrane’s Governing Board quickly
expelled one of the authors of the cri-
tique, Danish physician-researcher
Peter Gøtzsche, who helped found
Cochrane and was the head of the Nor-
dic Cochrane Centre. Gøtzsche has
been a vocal critic of Cochrane’s discuss the need for transparency in
“increasingly commercial business autism research.236
model,” which he suggests is resulting
in “stronger and stronger resistance to Using Front Groups
say anything that could bother phar-
maceutical industry interests.”233 Add- Physician organizations such as the Scientific Censorship
ing “insult to injury,” Gøtzsche’s direct American Academy of Pediatrics (AAP)
in Action
employer, the Rigshospitalet hospital in benefit substantially from pharmaceu-
Denmark, is now trying to fire Gøtzsche tical industry advertisements in their “Firing me sends the unfortu-
(see “Scientific Censorship in Action”). affiliated medical journals, with adver- nate signal that if your research
In response, Gøtzsche plans to launch tising representing anywhere from a results are inconvenient and
an Institute for Scientific Freedom.234 tenth to a third of the organization’s cause public turmoil, or threaten
total revenues.237 Advertising income the pharmaceutical industry’s
Another favored tactic used to keep not infrequently outpaces revenues earnings, …you will be sacked.”
vaccine-critical studies out of medical earned from subscriptions. SOURCE: Peter Gøtzsche. Why we’re
journals is to either censor them on the establishing an Institute for Scientific
front end by refusing to publish them The AAP is particularly notorious Freedom. Mad in America, Dec. 30,
(even if peer reviewers recommend as a vaccine industry front group,238 2018.
their publication) or concoct excuses receiving funding from Merck, Pfizer,
to retract articles after publication. In Sanofi, GSK and others. The AAP also
recent years, journals have retracted gets substantial funding from the
articles written by top international CDC—over $20 million since 2009—
scientists, accusing them of making over a third of which is explicitly
“unjustified claims” because they dared vaccine-related.239 The AAP’s journal
to question the safety of the aluminum Pediatrics published several of the
adjuvant in Gardasil235 or wanted to studies ginned up by the CDC to hide
any relationship between thimerosal-
containing vaccines and autism,
including the Verstraeten study (which
was rejected by two other journals
first). In more recent years, Pediatrics
has led the way in browbeating vaccine
questioners by drumming up faked
concerns about “vaccine hesitancy”240
2016 Blue Cross
and parental noncompliance.241
Blue Shield
Blue Care Network
Other leading front groups that
Incentive Program
routinely propagate misleading
Booklet
information about vaccine safety
include the Immunization Action
Coalition (IAC) and Every Child by
Two (ECBT). A 2017 analysis242 in The
BMJ showed that—far from being
credible and independent sources
of information—these outfits, like
AAP, receive significant funding from
vaccine manufacturers and the CDC,
with a third of ECBT’s annual funding with 11 visits recommended by the Providers receive
coming from the latter. With industry AAP over a child’s first 30 months (and $400 for each
and CDC funding in hand, these front annually thereafter).245 In addition,
groups guarantee vaccine makers’ various financial incentive programs
eligible two-
ability “to influence policy without encourage pediatricians and family year-old who has
having to stand on the front lines.”243 doctors to follow the CDC vaccine received all 24-25
schedule, including insurers who give
vaccines by that
Coopting Physicians bonus payments to practice groups
who achieve specified vaccination age—but only
Encouraged by trade groups such as targets; practices publish and share if the provider
the AAP, physicians have, by and large, these medical and clinical data to administers
been willing participants in the U.S. show “how the care…each [physician]
vaccine program. For multiple reasons, give[s] to kids compares with the care
each and every
few doctors are willing to rock the given by their peers,” thereby exerting shot to at least
boat, no matter how many vaccines pressure on doctors to toe the line 63% of his or
are added to the schedule. Physicians’ rather than object to the targets.246
her patients.
complacency about vaccines begins
in medical school, where doctors are An example of a pay-for-performance Pediatricians
taught that vaccines are “wonderful” model is the Michigan Blue Cross who achieve the
but learn nothing about vaccine Blue Shield “Performance Recognition 63% threshold
ingredients, risks, effects on brain Program,” which uses “meaningful”
and immune system function or any payments to reward Blue Care Network
stand to make
other aspects critical to understanding HMO providers “who encourage their an additional
vaccine safety and effectiveness.244 patients to get preventive screenings $40,000 in bonus
and procedures.”247 For vaccination,
payments for
Pediatric well-child visits ensure a providers receive $400 for each eligible
steady stream of repeat customers and two-year-old who has received all 24-25 every 100 fully
revenue. The CDC advises practices to vaccines by that age (including flu vaccinated
administer vaccines at about half of shots)—but only if the provider man- two-year-olds.
the visits through the adolescent years, ages to administer each and every shot
to at least 63% of his or her patients.
Pediatricians who achieve the 63%
threshold therefore stand to make an
additional $40,000 in bonus payments
for every 100 fully vaccinated two-year-
olds,248 creating a formidable incentive
not to let any patients slip through
the cracks, and a disincentive to con-
tinue serving families who decline one
or more vaccines. In fact, a survey of
pediatricians found that twice as many
pediatricians (12%) reported “always”
booting uncooperative families out of
their practices in 2013 as in 2006,249 and
the AAP has pronounced it “ethical and
legal” to do so.250
A 2010 study251 of publicly funded

community health centers (CHCs)
serving low-income patients in
Houston furnished another evocative
example of how pay-for-performance
models work. Even in the less-than-
posh CHC setting, physicians could
receive up to $12,000 annually in
incentive payments for meeting
vaccination and other targets. As the
researchers explained:
➧➧ CHC physicians received finan-

for patients. In fact, the researchers
cial incentives “if the clinic as
a whole met or exceeded the concluded that there is little proof
thresholds for 2 of 3 indicators” that any pay-for-performance initia-
(Pap smears, mammography and tive—whether sponsored by health Author Upton
childhood vaccinations). plans, employers, or the government—
is improving health care. Moreover,
Sinclair famously
➧➧ If the clinics achieved two out of
as reported by Modern Healthcare stated decades
the three targets at the 80% to
90% level, all physicians received magazine: ago, “It is difficult
bonuses—“to encourage team- to get a man
work.” Publications by medical “The tendency of pay-for-perfor-
trade groups confirm the trend mance to ‘dangle money’ before to understand
toward payment systems that doctors has side effects. It turns something
“reward teamwork.”252
the intrinsic professional and when his
moral obligation of doing the best
➧➧ Physician awareness of the
thing for the patient into a market
salary depends
incentive program was high
“because results were reviewed transaction governed by price.”253 upon his not
regularly during monthly staff understanding it.”
meetings.” Or, as Upton Sinclair famously stated
decades ago, “It is difficult to get a
Ironically, the study found no evidence man to understand something when
whatsoever that the financial incen- his salary depends upon his not
tives improved clinical quality of care understanding it.”
V. What’s Needed
T he passage of the NCVIA in 1986
emboldened vaccine manufacturers
and their public- and private-sector
(targeting 22 diseases and “every stage
of life”) and sells almost 800 million
vaccine doses worldwide each year,
accomplices—notably the CDC—to with 70% of sales in emerging market
systematically hide the serious dam- countries.254 The company’s website
age caused by their products. In indicates that it is eager to expand
addition to making a mockery of pre- still further, calling attention to the From multiple
licensing safety testing and post-mar- “more than 25 million children… standpoints—not
keting surveillance, these entities have born every year in India alone” and
least of which is
regularly manipulated (or destroyed) the “more than a billion” adults
data to fraudulently exaggerate the worldwide over age 60.255 The other children’s dismal
benefits and effectiveness of vaccina- three companies that are dominant state of health—
tion. Manufacturers have also used in the U.S. market (Merck, Pfizer and the status quo is
their money and power to subordinate Sanofi) are equally keen to broaden
the mainstream media, medical jour- their worldwide reach.256
untenable.
nals and medical front groups, making
it possible to publish and broadcast From multiple standpoints—not least
deceptive studies that whitewash of which is children’s dismal state of
questions inconvenient to the financial health—the status quo is untenable.
bottom line. Three of the most urgent steps to be
taken include repealing the NCVIA,
Clearly, pharmaceutical companies eliminating vaccine mandates (making
have a strong interest in continuing both childhood and adult vaccination
to expand the lucrative vaccine voluntary) and addressing conflicts
market, both in the U.S. and globally. of interest by establishing a fully
GlaxoSmithKline, for example, has a transparent and independent vaccine
current portfolio of over 40 vaccines safety commission.
Repeal the NCVIA that vaccines licensed after NCVIA’s
passage were associated with “a sig-
The NCVIA has been an unmitigated nificantly higher incidence of adverse
disaster. As New York University events” compared to vaccines licensed
law professor Mary Holland has prior to the law’s passage. The
written, the Act’s passage has researcher concluded that “product
allowed the government and vaccine safety deteriorates when consumers
manufacturers to ride roughshod over are no longer able to sue manufactur-
Barriers to Vaccine Injury
three important legal protections: free ers.”260 Repealing the NCVIA and rein-
and informed consent to an invasive stating product liability would not
Compensation
medical procedure; accurate and solve all of the ethical problems that Numerous factors contribute to
complete information about vaccine permeate the pharmaceutical indus- the low levels of vaccine injury
ingredients and possible side effects; try’s business culture, but it could cur- compensation:
and the right to sue manufacturers tail the vaccine “free-for-all” environ-
➧➧ Public and medical ignorance
and medical practitioners directly ment that has prevailed since 1986
about vaccine injury
in the event of injury.257 According and might incentivize manufacturers
to Professor Holland, the absence of to treat vaccines in the same way as ➧➧ Ignorance about the NVICP
these legal protections for vaccination drugs and put safety on a more even
is “striking” compared to “almost all footing with profits. ➧➧ The NVICP’s three-year statute
other medical interventions.” of limitations
NCVIA repeal would also draw greater
➧➧ Adversarial litigation context
The legal protections listed by Holland attention to the exorbitant financial
are interrelated. For example, an stress experienced by vaccine-in- ➧➧ Inconsistent judgments by
individual cannot exercise truly jured individuals and families.261 The the vaccine court
informed consent unless he or she NVICP not only has “failed to com-
has access to full and unbiased pensate generously” but, far more ➧➧ Delayed and below-market
information.258 Recognizing this, one often than not, does not compensate compensation for attorneys
provision of the NCVIA was a mandate at all (see “Barriers to Vaccine Injury and medical experts
for the CDC to develop (and health Compensation”).262 Moreover, despite
➧➧ Medical expert fear of
care providers to distribute) patient the NCVIA legislation’s focus on child-
“anti-vaccine” stigma
education materials about vaccine hood vaccines, 71% of compensated
risks and benefits. However, not only claims have been for vaccine injuries ➧➧ Unavailability of medical
has the CDC repeatedly dumbed down in adults,263 leaving many vaccine-in- documentation
the materials in a variety of ways, jured children and their families out
but research suggests that many in the financial cold. In the only study ➧➧ Impossibly high burden of
doctors do not comply with the legal ever conducted to explore petitioners’ proof for “off-table” injuries
requirement to hand out (much less experiences with the NVICP, petition- SOURCES: Holland M. Reconsidering
discuss) them.259 Instead, the public ers described the vaccine injury claims compulsory childhood vaccination.
continues to be blandly assured that process as “confusing, time-consum- Public Law & Legal Theory Research
vaccine injuries are a “one in a million” ing, too lengthy, and traumatic,” and Paper Series, Working Paper No. 10-64,
New York University School of Law.
event and is never told that 99% of about half rated the award amount as
vaccine injuries go unreported. Under “inadequate to cover past and future Boehm J. Critics say vaccine injury fund
the circumstances, no meaningful medical care.”264 In short, whereas has strayed from original purpose.
assessment of vaccine risks is possible. Congress marketed the NVICP as a Cronkite News, May 8, 2015.
speedy, non-adversarial, no-fault com-
Research shows that by eliminating pensation mechanism that would free
consumers’ ability to sue, the NCVIA the injured of the need to prove vac-
has had a tangibly negative effect on cine-related causation, it has turned
vaccine safety. After an extensive anal- out to be slow and litigious, requir-
ysis of nationwide and state-level U.S. ing proof of causation for more than
data, a researcher reported in 2017 90% of claims filed. As one individual
familiar with the system has stated,
“even when cases are fairly simple,
‘the government will fight.’”265
Eliminate Vaccine Mandates
Medical informed consent—“the pri-

mary paradigm for protecting the
legal rights of patients and guiding
the ethical practice of medicine”—is
meaningless if an individual does
not have the option of “determin[ing]
what shall be done with his body” and
declining a given medical interven-
tion.266 Vaccination in the U.S. makes
a mockery of this ethical principle
because vaccines are increasingly
compulsory—for school attendance,267
health care employment,268 participa-
tion in the military,269 immigration270
➧➧ Conflicts of interest in national Research also
vaccine policy
and more. Vaccine proponents271 and shows that there
medical ethicists272 also have proven ➧➧ Insufficient compensation for the is no relationship
themselves willing to blur the lines vaccine-injured
“between manda-
of informed consent in other ways,
arguing, for example, that “adolescent ➧➧ An alarming decline in children’s tory vaccination
health and well-being
autonomy” and improved vaccine and rates of child-
uptake justify eliminating parental hood immuniza-
consent requirements for HPV vacci- Research also shows that there is no
nation in preteens and adolescents. relationship “between mandatory tion.”275 Rather than
(This argument prevailed in Cali- vaccination and rates of childhood trying to corral the
immunization.”275 Rather than try-
fornia in 2011 when then-Governor small percentage
Jerry Brown signed a bill allowing ing to corral the small percentage of
individuals who are currently eligi- of individuals who
minors as young as 12 to consent on
their own to the HPV and hepatitis B ble for medical, religious and philo- are currently eli-
vaccines.273) sophical vaccine exemptions into a gible for medical,
“vaccinate-at-all-costs” police-state
dragnet, the U.S. should recommit to
religious and phil-
As summarized by law professor Mary
international principles of informed osophical vaccine
Holland, compulsory vaccination pol-
icies in the U.S. have not had positive consent and make all vaccines vol- exemptions into a
untary. Unfortunately, there is an
results. Instead, they have given rise “vaccinate-at-all-
accelerating trend toward greater
to a wide variety of unintended and costs” police-state
use of mandates and “other legal
undesirable consequences, including:
instruments” not only in the U.S. but dragnet, the U.S.
➧➧ Unnecessary vaccinations that in Europe. There, some experts have should recommit
have wreaked havoc with chil- cautioned that legal sanctions are
dren’s normal immune system
being applied by “those who want to
to international
development274 principles of
punish a country—or, in the case of
➧➧ Unsafe vaccines vaccinations, a citizen—that deviates informed consent
from the norm.”276 These experts warn
and make all vac-
➧➧ Inadequate warnings about vac- that mandates often have a high cost
cine risks in the court of public opinion. cines voluntary.
Address Conflicts of Interest
As this eBook has sought to illustrate,

conflicts of interest—far from being
occasional aberrations—are part
and parcel of the U.S. vaccination
program, and they have had a decisive
and negative impact on children’s
health. Over the years since the
passage of the NCVIA, a handful of
courageous legislators who have
been troubled by the “cozy corporate
alliances” that exist between industry
and captured federal regulators277
have put forth pleas for an objective
and non-conflicted vaccine safety
commission to investigate and
resolve safety problems.278 Some
researchers, likewise, have called for both the government and the public in
an independent National Vaccine matters of health protection.”280
Safety Board—separate from the CDC
or any branch of government—to In early 2017, Children’s Health Defense Hopefully,
“ensure optimal vaccine safety.”279 A Chairman Robert F. Kennedy, Jr. dis- concerned
2006 editorial in Nature concurred that cussed the creation of a vaccine safety
in light of waning public confidence commission with president-elect
parents, health
in vaccine safety, a strong case could Trump and also met with high-level care professionals,
be made for establishing a “well- NIH and FDA officials.281 Thus far, the legislators and
resourced independent national Administration has not pursued the
others will lend
agency that commands the trust of idea, despite the glaring need to intro-
duce transparency to the U.S. vaccina- their voices to
tion program. In March, 2018, Children’s these reasonable
Health Defense took to the halls of requests so
Congress and shared its multipronged
Vaccine Safety Project with every mem-
that conflicts of
ber, arguing (among other actions) for interest can be
the need to subject vaccines to a sci- abolished once
entifically rigorous approval process,
and for all, and
require reporting of vaccine adverse
events, ensure that all parties involved sound science—
with federal vaccine approvals and rec- rather than
ommendations are free from conflicts deep pockets—
of interest and support fully informed
consent and individual rights to refuse
can form the
vaccination.282 Hopefully, concerned basis of vaccine
parents, health care professionals, legis- policy-making.
lators and others will lend their voices to
these reasonable requests so that con-
flicts of interest can be abolished once
and for all, and sound science—rather
than deep pockets—can form the basis
of vaccine policy-making.
Endnotes
1 “Our history—our story.” https://www.cdc.gov/about/history/index.html. 35 “About the National Vaccine Injury Compensation Program.” https://www.hrsa.gov/vaccine-compen-
2 Interview with Robert F. Kennedy, Jr. “Mercury, vaccines and the CDC’s worst nightmare.” https:// sation/about/index.html.
childrenshealthdefense.org/about-us/mercury-vaccines-cdcs-worst-nightmare/. 36 Children’s Health Defense. “Vaccine injury payouts: consumers on the hook for over $3.8 billion as
3 Letter from CDC SPIDER to Carmen S. Villar, Office of the Director, Centers for Disease Control and vaccine makers rake in profits.” March 22, 2018. https://childrenshealthdefense.org/news/vaccine-
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49 Holland, “Liability for vaccine injury.”
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158 Schnirring L. “Researchers find first US evidence of vaccine-resistant pertussis.” CIDRAP, Feb. 7, 2013. 188 Grundvig JO. Master Manipulator: The Explosive True Story of Fraud, Embezzlement, and Government
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nus-pertussis and oral polio vaccine among young infants in an urban African community: a natural 189 Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, et al. “A population-based
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161 Heckenlively K. Inoculated: How Science Lost its Soul in Autism. Waterfront Press; 2016. 606.
162 “Scientific review of Vaccine Safety Datalink information.” Simpsonwood Retreat 191 Clay B. “Poul Thorsen, fugitive researcher: Update August 2017.” https://childrenshealthdefense.org/
Center, Norcross, GA; June 7-8, 2000. Available at: https://childrenshealthde- wp-content/uploads/world-mercury-project-report-on-poul-thorsen-9-7-17.pdf.
fense.org/wp-content/uploads/2016/10/The-Simpsonwood-Documents.pdf. 192 Children’s Health Defense. “Criminal conduct—Poul Thorsen. Robert F. Kennedy, Jr. and Children’s
163 “Generation Zero: Thomas Verstraeten’s first analyses of the link between vaccine mercury exposure Health Defense issue report regarding new evidence of ongoing corruption and scientific misconduct
and the risk of diagnosis of selected neuro-developmental disorders based on data from the Vaccine at CDC.” https://childrenshealthdefense.org/advocacy-policy/criminal-conduct-poul-thorsen/.
Safety Datalink: November-December 1999.” SafeMinds, November 2004. https://childrenshealthde- 193 Hooker BS. “A matter of right and wrong: the CDC’s troubling lack of research ethics.” Children’s Health
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164 Verstraeten T, Davis RL, DeStefano F, et al. “Safety of thimerosal-containing vaccines: a two-phased the-cdcs-troubling-lack-of-research-ethics/.
study of computerized health maintenance organization databases.” Pediatrics 2003;112(5):1039- 194 “About us.” http://nationalacademies.org/hmd/About-HMD.aspx.
1048. 195 “Institute of Medicine publications on vaccines.” https://www.ncbi.nlm.nih.gov/books/NBK206941/.
165 Verstraeten T. “Thimerosal, the Centers for Disease Control and Prevention, and GlaxoSmithKline.” 196 National Academy of Medicine. “National Academy of Medicine elects 85 new members.” Oct. 15,
[Letter] Pediatrics 2004;113:932. 2018. https://nam.edu/national-academy-of-medicine-elects-85-new-members/.
166 Stehr-Green P, Tull P, Stellfeld M, Mortenson PB, Simpson D. “Autism and thimerosal-containing 197 “Our study process.” http://nationalacademies.org/hmd/About-HMD/Study-Process.aspx.
vaccines: lack of consistent evidence for an association.” Am J Prev Med 2003;25(2):101-106. 198 Institute of Medicine Immunization Safety Review Committee; Stratton K, Gable A, McCormick
167 Hviid A, Stellfeld M, Wohlfahrt J, Melbye M. “Association between thimerosal-containing vaccine and MC, editors. Immunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental
autism.” JAMA 2003;290(13):1763-1766. Disorders. Washington, DC: The National Academies Press; 2001.
168 Madsen KM, Lauritsen MB, Pedersen CB, Thorsen P, et al. “Thimerosal and the occurrence of autism: 199 Institute of Medicine Immunization Safety Review Committee; Stratton K, Gable A, Shetty P,
negative ecological evidence from Danish population-based data.” Pediatrics 2003;112(3 Pt 1):604- McCormick MC, editors. Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism.
606. Washington, DC: The National Academies Press; 2001.
169 Andrews N, Miller E, Grant A, Stowe J, Osborne V, Taylor B. “Thimerosal exposure in infants and 200 “Organizational meeting of Immunization Safety Review Committee Closed Session,” Jan. 12, 2001.
developmental disorders: a retrospective cohort study in the United Kingdom does not support a Available at: https://childrenshealthdefense.org/wp-content/uploads/IOM.pdf.
causal association.” Pediatrics 2004;114(3):584-591. 201 “Chapter VI: 2004. IOM slams the door (quickly).” http://putchildrenfirst.org/chapter6.html.
170 Children’s Health Defense. “Studies that the CDC claims exonerate thimerosal…and why they don’t.” 202 Institute of Medicine. Immunization Safety Review: Vaccines and Autism. Washington, DC: The
Feb. 19, 2017. https://childrenshealthdefense.org/news/studies-that-the-cdc-claims-exonerate-thi- National Academies Press; 2004.
merosal-and-why-they-dont/.
203 “IOM slams the door.”
171 Children’s Health Defense. “Don’t fall for the CDC’s outlandish lies about thimerosal.” Nov. 1, 2018.
204 “Rep. Dave Weldon, MD before the Institute of Medicine, February 9, 2004.” http://putchildrenfirst.
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org/media/6.2.pdf.
172 “Vaccine Safety Datalink.” https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/
205 “IOM slams the door.”
index.html.
206 Conte, “Misconduct, mitochondria and the Omnibus Autism Proceedings.”
173 Jackson ML, Yu O, Nelson JC, et al. “Safety of repeated doses of tetanus toxoid, reduced diphtheria
toxoid, and acellular pertussis vaccine in adults and adolescents.” Pharmacoepidemiol Drug Saf 207 Institute of Medicine, 2004.
2018;27(8):921-925. 208 Atkisson S. Family to receive $1.5M+ in first-ever vaccine-autism court award. CBS News, Sept. 10,
174 America’s Health Insurance Plans (AHIP). “The Vaccine Safety Datalink (VSD) Project: Annual Report 2010.
for 2003.” Washington, DC: AHIP; 2004. http://www.putchildrenfirst.org/media/4.15.pdf. 209 Wallis C. Case study. Autism and vaccines. TIME, Mar. 10, 2008.

210 Fugh-Berman A, Alladin K, Chow J. “Advertising in medical journals: should current practices 247 Blue Cross Blue Shield Blue Care Network of Michigan. “2016 Performance Recognition Program.”
change?” PLoS Med 2006;3(6):e130. Available at: http://whale.to/c/2016-BCN-BCBSM-Incentive-Program-Booklet.pdf.
211 Ibid. 248 “How much money do pediatricians really make from vaccines?” Wellness and Equality, June 20,
212 Ibid. 2016. https://wellnessandequality.com/2016/06/20/how-much-money-do-pediatricians-real-
213 Pew Prescription Project. “Persuading the prescribers: pharmaceutical industry marketing and its ly-make-from-vaccines/.
influence on physicians and patients.” Nov. 11, 2013. 249 Hough-Telford et al., “Vaccine delays, refusals, and patient dismissals.”
214 Ibid. 250 Walker EP. “AAP: dismissing patients over refusal to vaccinate okay, doc says.” Medpage Today, Oct. 21,
215 Robbins R. “Drug makers now spend $5 billion a year on advertising. Here’s what that buys.” STAT, 2009.
Mar. 9, 2016. 251 Gavagan TF, Du H, Saver BG, et al. “Effect of financial incentives on improvement in medical quality
216 “How to advertise.” https://www.nejm.org/about-nejm/how-to-advertise?query=footer. indicators for primary care.” J Am Board Fam Med 2010;23(5):622-631.
217 Smith R. “Medical journals and pharmaceutical companies: uneasy bedfellows.” BMJ 252 Laff M. “Family physician salaries continue to rise at rapid clip.” AAFP, June 17, 2016.
2003;326(7400):1202-1205. 253 Rice S. “Physician quality pay not paying off.” Modern Healthcare, May 30, 2015.
218 Chopra SS. “Industry funding of clinical trials: benefit or bias?” JAMA 2003;290(1):113-114. 254 https://www.gsk.com/en-gb/about-us/vaccines/.
219 Jefferson T, Di Pietrantonj C, Debalini MG, Rivetti A, Demicheli V. “Relation of study quality, concor- 255 Ibid.
dance, take home message, funding, and impact in studies of influenza vaccines: systematic review.”
256 Guzman TA. “Big pharma and big profits: the multibillion dollar vaccine market.” Global Research,
BMJ 2009;338:b354.
Jan. 26, 2016. https://www.globalresearch.ca/big-pharma-and-big-profits-the-multibillion-dollar-
220 Gulland A. Patients at risk as UK universities fail to disclose results of clinical trials. The Telegraph vaccine-market/5503945.
News, Jan. 24, 2019.
257 Holland M. “Reconsidering compulsory childhood vaccination.” Public Law & Legal Theory Research
221 Gluud LL. “Bias in clinical intervention research.” Am J Epidemiol 2006;163(6):493-501. Paper Series, Working Paper No. 10-64, New York University School of Law.
222 Chopra, “Industry funding of clinical trials.” 258 Parpia R. “Biologics r vaccines: beware of ‘informed consent.’” The Vaccine Reaction, Jan. 31, 2018.
223 Smith, “Medical journals and pharmaceutical companies.” 259 Children’s Health Defense. “Are doctors giving patients up-to-date vaccine safety information (or any
224 Chopra, “Industry funding of clinical trials.” safety information at all)?” Dec. 18, 2018. https://childrenshealthdefense.org/news/vaccine-safety/
225 Tomljenovic et al., “Human papillomavirus (HPV) vaccines as an option for preventing cervical are-doctors-giving-patients-up-to-date-vaccine-safety-information-or-any-safety-information-at-
malignancies.” all/.
226 “Time for a flu vaccine? Fugetaboutit!” https://www.drbrownstein.com/time-for-a-flu-vaccine-fuge- 260 DeLong G. “Is ‘delitigation’ associated with a change in product safety? The case of vaccines.” Review
taboutit/. of Industrial Organization. Issue 1/2018.
227 Arbyn M, Xu L, Simoens C, Martin-Hirsch PP. “Prophylactic vaccination against human papillo- 261 Boehm J. “Vaccine injury fund tops $3.5 billion, as patients fight for payment.” Cronkite News, May 8,
maviruses to prevent cervical cancer and its precursors.” Cochrane Database Syst Rev 2018 May 2015.
9;5:CD009069.
262 Holland, “Reconsidering compulsory childhood vaccination.”
228 Children’s Health Defense. “Are Cochrane reviews truly ‘independent and transparent’?” June 5, 2018.
263 Boehm J. “Critics say vaccine injury fund has strayed from original purpose.” Cronkite News, May 8,
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2015.
ent/.
264 U.S. Government Accountability Office. “Vaccine injury compensation.”
229 Macrae F. “The ‘false’ pandemic: drug firms cashed in on scare over swine flu, claims Euro health
chief.” Daily Mail, Jan. 17, 2010. 265 Boehm, “Vaccine injury fund tops $3.5 billion.”
230 Jorgensen L, Gotzsche PC, Jefferson T. “The Cochrane HPV vaccine review was incomplete and ignored 266 Hall DE, Prochazka AV, Fink AS. “Informed consent for clinical treatment.” CMAJ 2012;184(5):533-540.
important evidence of bias.” BMJ Evid Based Med 2018;23(5):165-168. 267 “State-by-state: vaccinations required for public school kindergarten.” https://vaccines.procon.org/
231 Children’s Health Defense. “Garbage in, garbage out: researchers dress down Cochrane for its flawed view.resource.php?resourceID=005979.
and biased review of HPV vaccines.” Aug. 2, 2018. https://childrenshealthdefense.org/news/garbage- 268 “Vaccination laws.” https://www.cdc.gov/phlp/publications/topic/vaccinationlaws.html.
in-garbage-out-researchers-dress-down-cochrane-for-its-flawed-and-biased-review-of-hpv-vac-
269 https://www.health.mil/Military-Health-Topics/Health-Readiness/Immunization-Healthcare/Vac-
cines/.
cine-Recommendations/Vaccine-Recommendations-by-AOR.
232 Hawkes N. “HPV vaccine safety: Cochrane launches urgent investigation into review after criticisms.”
BMJ 2018;362:k3472. 270 “Vaccination requirements.” https://www.uscis.gov/news/questions-and-answers/vaccination-re-
quirements.
233 Children’s Health Defense. “The house of cards is falling: the shake-up at Cochrane.” Sept. 18, 2018.
https://childrenshealthdefense.org/news/the-house-of-cards-is-falling-the-shake-up-at-cochrane/. 271 Haddad N, Allen RH, Szkwarko D, Forcier M, Paquette C. “Eliminating parental consent for adolescents
receiving human papillomavirus vaccination.” R I Med J (2013) 2018;101(7):12-14.
234 Gøtzsche P. “Why we’re establishing an Institute for Scientific Freedom.” Mad in America, Dec. 30,
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235 Inbar R, Weiss R, Tomljenovic L, et al. “Behavioral abnormalities in young female mice following ad-
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238 Children’s Health Defense. “How to suppress vaccine safety concerns and protect financial inter- ceinsociety.eu/reports/page1.html.
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279 Salmon DA, Moulton LH, Halsey NA. “Enhancing public confidence in vaccines through independent
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242 Doshi, “The unofficial vaccine educators.” 280 Editorial. “Developing resistance.” Nature 2006;439:1-2.
243 Handley JB. “‘Every Child by Two’ bites the hand that feeds them.” Children’s Health Defense, Mar. 281 Children’s Health Defense. “STAT News: An interview with Robert F. Kennedy, Jr. on vaccines, August
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II. Co-opted Legislators and the Legal Landscape......................................... 4

III. Role of Our Federal Agencies..................................................................... 9

IV. Tainted Science.......................................................................................... 19

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | iv

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 1

Children’s Health Defense eBook,

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 3

I n 1986, President Ronald Reagan, with

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 7

➧➧ Market entry of new vaccines at “once-unthinkable” prices

➧➧ Requirements for multiple doses and boosters

➧➧ Monopoly market positions for some vaccines

➧➧ Guaranteed purchases by the federal government (Vaccines for Children Program)

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 8

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 9

Placebo-controlled trials are widely

CDC packed multiple doses of several recommendations for all ages.113 At

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 14

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 18

T he CDC and its governmental

Around the same time period (the

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 23

Unfortunately, the 2004 IOM report

➧➧ Advertising monies enable pres-

➧➧ Journals are willing to accept

In response to the criticisms, the editor-

A 2010 study251 of publicly funded

➧➧ CHC physicians received finan-

Eliminate Vaccine Mandates

Medical informed consent—“the pri-

As this eBook has sought to illustrate,

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 35

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 36

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 37

CONFLICTS OF INTEREST UNDERMINE CHILDREN’S HEALTH | 38

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