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Perspective
The
NEW ENGLAND JOURNAL
of
MEDICINE
january 13, 2011
n engl j med 364;2 nejm.org january 13, 2011 97
smallpox was hindered by a bur-
geoning antivaccination move-
ment. The result was ongoing
smallpox outbreaks and needless
deaths. In 1910, Sir William Osler
publicly expressed his frustration
with the irrationality of the anti-
vaccinationists by offering to take
10 vaccinated and 10 unvaccinat-
ed people with him into the next
severe smallpox epidemic, to care
for the latter when they inevitably
succumbed to the disease, and ul-
timately to arrange for the funer-
als of those among them who
would die (see the Medical Notes
section of the Dec. 22, 1910, issue
of the Journal). A cen-
tury later, smallpox
has been eradicated
through vaccination, but we are
still contending with antivacci-
nationists.
Since the 18th century, fear and
mistrust have arisen every time a
new vaccine has been introduced.
Antivaccine thinking receded in
importance between the 1940s
and the early 1980s because of
three trends: a boom in vaccine
science, discovery, and manufac-
ture; public awareness of wide-
spread outbreaks of infectious dis-
eases (measles, mumps, rubella,
pertussis, polio, and others) and
the desire to protect children from
these highly prevalent ills; and a
baby boom, accompanied by in-
creasing levels of education and
wealth. These events led to pub-
lic acceptance of vaccines and their
use, which resulted in significant
decreases in disease outbreaks, ill-
nesses, and deaths. This golden
age was relatively short-lived, how-
ever. With fewer highly visible out-
breaks of infectious disease threat-
ening the public, more vaccines
being developed and added to the
vaccine schedule, and the media
permitting widespread dissemina-
tion of poor science and anecdotal
claims of harm from vaccines,
antivaccine thinking began flour-
ishing once again in the 1970s.
1
Little has changed since that
time, although now the antivacci-
nationists’ media of choice are
typically television and the Inter-
net, including its social media out-
lets, which are used to sway pub-
lic opinion and distract attention
from scientific evidence. A 1982
television program on diphtheria–
pertussis–tetanus (DPT) vaccina-
tion entitled “DPT: Vaccine Rou-
lette” led to a national debate on
the use of the vaccine, focused on
a litany of unproven claims against
it. Many countries dropped their
programs of universal DPT vac-
cination in the face of public
protests after a period in which
pertussis had been well con-
trolled through vaccination
2
—
The Age-Old Struggle against the Antivaccinationists
Gregory A. Poland, M.D., and Robert M. Jacobson, M.D.
Since the introduction of the first vaccine, there
has been opposition to vaccination. In the 19th
century, despite clear evidence of benefit, routine
inoculation with cowpox to protect people against
Articles from
the NEJM Archive are
available at NEJM.org
The New England Journal of Medicine
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Copyright © 2011 Massachusetts Medical Society. All rights reserved.
PERSPECTIVE
n engl j med 364;2 nejm.org january 13, 2011
98
the public had become compla-
cent about the risks of the disease
and focused on adverse events
purportedly associated with vac-
cination. Countries that dropped
routine pertussis vaccination in
the 1970s and 1980s then suf-
fered 10 to 100 times the pertus-
sis incidence of countries that
maintained high immunization
rates; ultimately, the countries that
had eliminated their pertussis
vaccination programs reinstated
them.
2
In the United States, vac-
cine manufacturers faced an on-
slaught of lawsuits, which led the
majority of them to cease vaccine
production. These losses prompt-
ed the development of new pro-
grams, such as the Vaccine Injury
Compensation Program (VICP), in
an attempt to keep manufacturers
in the U.S. market.
The 1998 publication of an ar-
ticle, recently retracted by the
Lancet, by Wakefield et al.
3
created
a worldwide controversy over the
measles–mumps–rubella (MMR)
vaccine by claiming that it played
a causative role in autism. This
claim led to decreased use of
MMR vaccine in Britain, Ireland,
the United States, and other
countries. Ireland, in particular,
experienced measles outbreaks
in which there were more than
300 cases, 100 hospitalizations,
and 3 deaths.
4
Today, the spectrum of anti-
vaccinationists ranges from people
who are simply ignorant about sci-
ence (or “innumerate” — unable
to understand and incor porate
concepts of risk and probability
into science-grounded decision
making) to a radical fringe ele-
ment who use deliberate mis-
truths, intimidation, falsified data,
and threats of violence in efforts
to prevent the use of vaccines and
to silence critics. Antivaccination-
ists tend toward complete mistrust
of government and manufactur-
ers, conspiratorial thinking, de-
nialism, low cognitive complexity
in thinking patterns, reasoning
flaws, and a habit of substituting
emotional anecdotes for data.
5
Their efforts have had disruptive
and costly effects, including dam-
age to individual and community
well-being from outbreaks of pre-
viously controlled diseases, with-
drawal of vaccine manufacturers
from the market, compromising of
national security (in the case of
anthrax and smallpox vaccines),
and lost productivity.
2
The H1N1 influenza pandemic
of 2009 and 2010 revealed a
strong public fear of vaccination,
stoked by antivaccinationists. In
the United States, 70 million dos-
es of vaccine were wasted, al-
though there was no evidence of
harm from vaccination. Mean-
while, even though more than a
dozen studies have demonstrated
an absence of harm from MMR
vaccination, Wakefield and his
supporters continue to steer the
public away from the vaccine. As
a result, a generation of parents
and their children have grown
up afraid of vaccines, and the
resulting outbreaks of measles
and mumps have damaged and
destroyed young lives. The re-
emergence of other previously
controlled diseases has led to
hospitalizations, missed days of
school and work, medical com-
plications, societal disruptions,
and deaths. The worst pertussis
outbreaks in the past 50 years
are now occurring in California,
where 10 deaths have already
been reported among infants and
young children.
In the face of such a legacy,
what can we do to hasten the
funeral of antivaccination cam-
paigns? First, we must continue
to fund and publish high-quality
studies to investigate concerns
about vaccine safety. Second, we
must maintain, if not improve,
monitoring programs, such as
the Vaccine Adverse Events Re-
porting System (VAERS) and the
Clinical Immunization Safety
Assessment Network, to ensure
coverage of real but rare adverse
events that may be related to
vaccination, and we should ex-
pand the VAERS to make com-
pensation available to anyone,
regardless of age, who is legiti-
mately injured by a vaccine. Third,
we must teach health care pro-
fessionals, parents, and patients
The Age-Old Struggle against the Antivaccinationists
The Cow Pock — or — the Wonderful Effects of the New Inoculation.
J. Gillray, 1802. Courtesy of the National Library of Medicine.
The New England Journal of Medicine
Downloaded from nejm.org at MAYO CLINIC LIBRARY on January 20, 2011. For personal use only. No other uses without permission.
Copyright © 2011 Massachusetts Medical Society. All rights reserved.
n engl j med 364;2 nejm.org january 13, 2011
PERSPECTIVE
99
how to counter antivaccination-
ists’ false and injurious claims.
The scientific method must in-
form evidence-based decision
making and a numerate society if
good public policy decisions are
to be made and the public health
held safe. Syncretism between the
scientific method and unortho-
dox medicine can be dangerous.
Fourth, we must enhance pub-
lic education and public persua-
sion. Patients and parents are
seeking to balance risks and ben-
efits. This process must start with
increasing scientific literacy at
all levels of education. In addi-
tion, public–private partnerships
of scientists and physicians could
be developed to make accurate
vaccine information accessible to
the public in multiple languag-
es, on a range of reading levels,
and through various media. We
must counter misinformation
where it is transmitted and con-
sider using legal remedies when
appropriate.
The diseases that we now seek
to prevent with vaccination pose
far less risk to antivaccination-
ists than smallpox did through
the early 1900s. Unfortunately,
this means that they can con-
tinue to disseminate false science
without much personal risk, while
putting children, the elderly, and
the frail in harm’s way. We can
propose no Oslerian challenge to
demonstrate our point but have
instead a story of science and
contrasting worldviews: on the
one hand, a long history of stun-
ning triumphs, such as the erad-
ication of smallpox and control
of many epidemic diseases that
had previously maimed and killed
millions of people; on the other
hand, the reality that none of
the antivaccinationists’ claims of
widespread injury from vaccines
have withstood the tests of time
and science. We believe that an-
tivaccinationists have done signifi-
cant harm to the public health.
Ultimately, society must recognize
that science is not a democracy
in which the side with the most
votes or the loudest voices gets
to decide what is right.
Disclosure forms provided by the au-
thors are available with the full text of this
article at NEJM.org.
From the Mayo Clinic Vaccine Research
Group (G.A.P., R.M.J.), the Department of
Medicine (G.A.P.), and the Department of
Pediatric and Adolescent Medicine (G.A.P.,
R.M.J.), Mayo Clinic, Rochester, MN.
1. Wolfe RM, Sharp LK. Anti-vaccinationists
past and present. BMJ 2002;325:430-2.
2. Gangarosa EJ, Galazka AM, Wolfe CR, et
al. Impact of anti-vaccine movements on
pertussis control: the untold story. Lancet
1998;351:356-61.
3. Wakefield AJ, Murch SH, Anthony A, et al.
Ileal-lymphoid-nodular hyperplasia, non-
specific colitis, and pervasive developmental
disorder in children. Lancet 1998;351:637-41.
[Retraction, Lancet 2010;375:445.]
4. McBrien J, Murphy J, Gill D, Cronin M,
O’Donovan C, Cafferkey MT. Measles out-
break in Dublin, 2000. Pediatr Infect Dis J
2003;22:580-4.
5. Jacobson RM, Targonski PV, Poland GA.
A taxonomy of reasoning flaws in the anti-
vaccine movement. Vaccine 2007;25:3146-52.
Copyright © 2011 Massachusetts Medical Society.
The Age-Old Struggle against the Antivaccinationists
ACOs and the Enforcement of Fraud, Abuse, and Antitrust Laws
Robert F. Leibenluft, J.D.
H
ospitals and physicians are
eagerly awaiting regulations
for accountable care organizations
(ACOs), which many observers
view as the best hope provided
by the Patient Protection and
Affordable Care Act (ACA) for
needed delivery system reform.
Starting in 2012, health care pro-
viders in ACOs that furnish ef-
ficient, high-quality care to
Medicare patients will share in
Medicare’s savings. Providers are
concerned, however, that in cre-
ating ACOs they risk violating
fraud, abuse, and antitrust laws.
1
To address these fears, the De-
partment of Health and Human
Services (DHHS), the Federal
Trade Commission, and the De-
partment of Justice, under the
direction of the White House, are
collaborating to provide waivers,
safety zones, and guidance to
providers.
An ACO, as defined by the
ACA, is an organization of health
care providers that agrees to be
accountable for the quality, cost,
and overall care of Medicare pa-
tients for whom they provide the
bulk of primary care services.
2
ACOs must have defined pro-
cesses for promoting evidence-
based medicine, reporting data
with which to evaluate the qual-
ity and cost of care, and coordi-
nating care. ACOs that meet
specified quality standards will
receive a share of the savings if
Medicare’s cost for the care of
their assigned patients is below
a certain benchmark. ACOs, along
with bundled payments and oth-
er payment innovations, are in-
tended to transform the health
care delivery system both by re-
placing fee-for-service payments,
which tend to increase utilization,
and by boosting collaboration
among providers so as to reduce
costs and improve quality.
However, providers organizing
ACOs may fear violating fraud-
The New England Journal of Medicine
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Copyright © 2011 Massachusetts Medical Society. All rights reserved.
