By Peggy O’Mara
Mothering has been publishing articles on vaccination for 27 years. In 1979, our
first article on vaccines was intended for the early Mothering readership of
natural-living pioneers who questioned medical interventions in general.
Newer generations question not only the general effects of vaccinations, but
also specific vaccines and specific ingredients of vaccines. In 1982, for
example, parents whose children were injured by the whole-cell pertussis vaccine
formed the organization Dissatisfied Parents Together (DPT) and lobbied for
passage of the National Childhood Vaccine Injury Act, which went into effect
October 1, 1988. This act created the Vaccine Injury Compensation Program
(VICP), and required vaccine providers to give benefit and risk information to
parents before children are vaccinated, to keep written records of vaccine
manufacturers’ names and the lot numbers of each vaccination given, and to
report adverse events following vaccination to the federal government through
the Vaccine Adverse Events Reporting System (VAERS).
DPT became the National Vaccine Information Center in 1989, and the
organization’s continued advocacy for a safer pertussis vaccine led, in 1996, to
the licensing in the US of the acellular pertussis vaccine, which has been in
use in Japan since 1981. Fewer adverse events are associated with the acellular
than with the whole-cell vaccine.
Two other vaccines began to be questioned in the 1990s: measles-mumps-rubella
(MMR) and hepatitis B. The MMR vaccine, added to the vaccine schedule in 1979,
is a live vaccine and does not contain a preservative. Research reported in 1998
by British physician Wakefield, and since confirmed by others, showed the
presence of a persistent measles infection in the guts of some autistic children
who had never had measles. It has been theorized that combining measles and
mumps viruses in a single vaccine may cause gastrointestinal problems that could
lead to autism.
In 1991, the Centers for Disease Control (CDC) recommended that all infants
receive their first dose of the hepatitis B vaccine before being discharged from
the hospital, even though the only newborns at risk are those born to mothers
already infected with hepatitis B. Only 15 states require mandatory hepatitis B
screening for all pregnant women, yet 35 states require that children have three
full doses of hepatitis B before they can be admitted to daycare or begin
In 1998, France became the first country to stop requiring hepatitis B
vaccination for schoolchildren. This followed reports that many French children
were developing chronic arthritis and symptoms resembling multiple sclerosis
following administration of the vaccine.
On May 18 and 19, 1999, the House Subcommittee on Criminal Justice, Drug Policy,
and Human Resources held a hearing chaired by Mica (R-FL), “Hepatitis B
Vaccine: Helping or Hurting Public Policy?” According to testimony by Jane
Orient, MD, executive director of the Association of American Physicians and
Surgeons, “Children younger than 14 are three times more likely to die or suffer
adverse reactions after receiving hepatitis B vaccine than to catch the
disease.” An independent analysis confirmed that in 1996 there were 827 serious
adverse events in children under 14 associated with hepatitis B reported to the
VAERS. During that same period there were only 279 reported cases of hepatitis B
in children under 14.
Following the hearing, the American Academy of Pediatrics (AAP) and the CDC
suspended the hepatitis B vaccine for low-risk newborns. On July 9, 1999, a
joint statement by the Public Health Service (PHS) and the AAP called for a
rollback of the recommendation that all newborn infants receive the hepatitis B
vaccine at birth, and for a delay in the vaccination of premature or underweight
These concerns, however, are dwarfed by concerns about thimerosal, the
mercury-based preservative used in all vaccines and biologics since the 1930s.
The FDA Modernization Act of 1997 called for the Food and Drug Administration to
review and assess the risk of all mercury-containing foods and drugs. In
response, the FDA asked US vaccine manufacturers to provide information about
the thimerosal content of their preparations.
Later that year, the Environmental Protection Agency (EPA) released the “Mercury
Study Report to Congress,” in which the agency set a reference dose of 0.1
microgram of mercury per kilogram of weight per day as the precautionary limit
for mercury exposure. On July 17, 1999, the EPA notified vaccine experts that if
infants younger than six months receive a number of vaccines containing
thimerosal during a single visit to the doctor, their mercury levels might
exceed the EPA’s precautionary limit for mercury exposure. The FDA requested
that vaccine manufacturers voluntarily phase in a replacement for thimerosal.
That same year, the AAP and the PHS also called for the removal of thimerosal
from childhood vaccines, something that had been done in Denmark seven years
earlier. However, no recall was ever issued in the US, and no deadline was set
for the removal of thimerosal.
While most childhood vaccines today are available with “only” trace amounts of
thimerosal, the AAP no longer cautions about the use of thimerosal in vaccines,
and does not suggest thimerosal-free vaccines for infants and pregnant women
when recommending the flu vaccine. The media downplay and often dismiss concerns
about vaccines, particularly about vaccines containing thimerosal. The
prestigious Columbia Journalism Review acknowledged this in October 2005, and
concluded that it “seems too soon for the press to shut the door on the debate.”
Choosing whether or not to have a child vaccinated, especially in light of the
politics of vaccines, must be an independent decision. It should not be coerced,
but be the product of true informed consent. Few people even know that they have
a choice regarding vaccinations, much less know what informed consent really is.
In fact, all 50 states grant medical exemptions to vaccination. All states
except Mississippi and West Virginia have religious exemptions, many of which
are written broadly. An increasing number of states also have philosophical
exemptions: Arizona, California, Colorado, Idaho, Louisiana, Maine, Michigan,
Minnesota, New Mexico, Ohio, Oklahoma, Texas, Utah, Vermont, Washington, and
Wisconsin. More recently, California, Delaware, Illinois, Iowa, Missouri, and
New York have banned the use of thimerosal in vaccines, and bans in many more
states are in process. Representatives Weldon (R-FL) and Carolyn Maloney
(D-NY) have introduced a national bill to ban thimerosal in all US vaccines.
Some parents want to comply with the entire vaccination schedule; others want no
vaccinations at all. Some parents want certain vaccines but not others. And some
want to delay the vaccines until their baby is older. These parents will all
need written exemptions from their state health departments, even though
exemptions are technically designed for those who choose to forgo vaccines
While vaccine advocates debate the wisdom of conscientious choice regarding
vaccines, ethicists insist that it is integral to the mandatory vaccine program,
and the legal system supports it as well. In fact, the US has a 100-year
jurisprudential tradition of informed consent. But what is informed consent?
Medical associations themselves have set standards for informed consent. More
than 30 years ago, the American College of Obstetricians and Gynecologists
(ACOG) recognized the patient’s right to informed consent. In their 1974
Standards for Obstetric-Gynecologic Services, informed consent is defined as: 1)
The patient is informed about the processes contemplated by the physician as
treatment, including whether the treatment is new or unusual. 2) The patient is
informed of the risks and hazards of the treatment. 3) The patient is informed
of the chances of recovery after treatment. 4) The patient is informed of the
feasibility of alternative methods of treatment.
The physician is not justified in failing to inform the patient because the
patient might decline the recommended treatment. In fact, the right to decline
is the fundamental right specifically protected by the doctrine of informed
consent. But parents are seldom offered enough information about vaccines to
sufficiently inform any consent they might give. In fact, new parents are kicked
out of medical practices for even asking questions about vaccinations.
It is thimerosal, however, which is at the heart of the current vaccine
controversy. Thousands of parents have claimed that their previously perfectly
normal children regressed to autism after receiving vaccinations. Blood tests
show that these children have elevated levels of mercury in their bloodstreams
that remain otherwise unexplained.
Many of these parents are suing the federal government and the vaccine
manufacturers. Normally in such cases, the parents’ doctor would notify the
Vaccine Adverse Events Registration System (VAERS) of an adverse event
associated with a vaccine. The parents would file a claim with the Vaccine
Injury Compensation Program (VICP), and their claim would be heard. In order for
a vaccine-adverse event to be compensated by the VICP, however, it must be
listed on the Vaccine Injury Table, which includes only specific vaccines.
Autism is not listed on the table, and is not recognized by the VICP as an
injury for which the government compensates. Because the cost of taking care of
an autistic child is $3 to $5 million over the child’s lifetime, parents see the
courts as their only recourse.
Autism is not listed on the Vaccine Injury Table because the Institute of
Medicine (IOM) has failed to find evidence that thimerosal in vaccines causes
autism. They have said that while the causal link is “plausible,” the evidence
does not warrant further investigation. The IOM has been widely criticized for
this conclusion because they considered only epidemiological evidence, while
controlled studies offer ample evidence of a possible association. In fact, two
studies of the CDC’s own Vaccine Safety Datalink (VSD) show that thimerosal may
Mass vaccines are, in many ways, a recent experiment. They began in the 1950s
and were heralded by a horrific event. In 1955, 70,000 people got polio within
days of being vaccinated; 200 were paralyzed and 10 died. Cutter Laboratories
had failed to kill the polio in the vaccine.
According to Offit, author of a new book, The Cutter Incident, this event
was the beginning of modern liability awards. Offit bemoans the fact that
vaccine manufacturers can be found liable even if they are not guilty of malice.
While his point is well taken, the alternative of a government compensation
program, the VICP, has thus far not been successful for parents of
vaccine-injured children. The VICP was intended to be an easy, no-fault way for
parents to receive compensation for vaccine injuries. In fact, the process of
compensation is costly and denies most petitioners.
Of the 5,652 cases that have so far been concluded, only 32 percent of
petitioners to the VICP have been awarded compensation. The process takes at
least two years, and legal fees can run into the hundreds of thousands of
dollars. Since its inception, the VICP has received a total of 8,237
vaccine-injury claims, of which 3,854 have been dismissed, 2,585 are pending,
and 1,798 have been granted awards, for a total compensation of $1.4 billion. Of
the 8,237 claims filed, 4,261 were for vaccine injuries that occurred before
1988—primarily from the whole-cell pertussis component of the DPT vaccine. The
average compensation is $778,643. Currently, more than $1.8 billion of the
VICP’s trust fund remains unused.
Choice is important for many reasons. First, informed consent is a doctrine of
US health policy and US jurisprudence. Second, we live in a country in which
health care is a business, which makes us simultaneously patients and clients.
Third, it has been parent advocacy that has resulted in safer vaccines. Most
important, however, is that you choose in order to live peacefully with the
outcome of your choice, no matter what it is. Only when your choice is not
coerced can you live with the inevitable regrets that come when things do not
turn out as you’d hoped they would.