Vaccinating Maine Children: Doing it Better, Doing it Honestly / Meryl Nass

LD 754, a bill to require that a list of vaccine
ingredients be provided to parents when their children are vaccinated, has
stirred up a hornet’s nest in Augusta.  The gist of what was written in a Bangor
Daily News opinion piece and in a paper circulated by Representatives Pringle
and Volk is:
          
If parents were given a list of vaccine ingredients, a large
number might choose not to vaccinate their children. 
          
Parents might feel the medical provider did not support
vaccinations.  
          
Parents might take this as a veiled warning, rather than
neutral information.
          
The end result could be loss of herd immunity, leading
diseases to circulate throughout the population in increasing numbers.
The assumption is
that if people knew more about how vaccines are made and what they contained,
more parents would not want to vaccinate their children.  
The implication is
that the public must be protected and protection requires that parents remain
ignorant of some possibly unpleasant facts, unless they make an independent
effort to find those facts for themselves.
There are two elephants in the room that underlie the
strong feelings engendered by the vaccine issue
*  Elephant
#1:  People who vaccinate their
children do not want to be put at risk by those who choose not to vaccinate, or
who delay vaccinations
.  According to CDC, only one percent of American children are unvaccinated, and ten
percent receive delayed vaccinations or are partially unvaccinated.
Do these children put others at risk?  Ninety percent of US children are fully
up to date with their vaccines. This should be more than sufficient to maintain
herd immunity, if the vaccines they receive convey strong, persisting
immunity.  But other factors should
be considered:
  1. Some
    vaccine antigens only induce weak, short-term immunity
  2. A
    growing number of Americans do not develop immunity from the vaccines they
    receive or cannot safely receive them, due to being too young, receiving
    immune suppressing drugs, including corticosteroids, for cancer or
    autoimmune diseases or because they have an immunodeficiency disorder.
Partially or wholly unvaccinated children are wrongly
being blamed for disease outbreaks. The US has had increasing numbers of cases
of mumps, measles and whooping cough in recent years, but not for the reasons
you might think.
According to CDC, over 75% of recent US cases of mumps and whooping cough
have occurred in fully vaccinated
individuals. Because these vaccines are relatively weak, vaccine-induced
immunity, unlike the immunity derived from an infection, wanes rapidly. One
recent study showed
that only 3 years after receiving the recommended 2 lifetime doses of MMR
vaccine, only 93.8% of children had measurable mumps antibody.
Even after receiving 5 doses of the childhood vaccine for
whooping cough, immunity
is often gone by the next recommended dose 6 years later.
  Adding more doses does not fix this
problem.
Even if the US were to achieve 100% vaccination rates, this would
not prevent vaccine-induced immunity from wearing off, nor would it prevent
disease importations from overseas.
Although the material you were given implies that the
vaccinated are at risk from the unvaccinated, this is not the main cause of
“vaccine-preventable” disease outbreaks in the US.
*  Elephant
#2 is very threatening and confusing to parents, as well as to experts:  Do vaccines cause autism?
  It is simpler to believe that a British doctor, Andrew
Wakefield, who posited this connection in 1998 in the Lancet and then had his medical license revoked, was dead
wrong.  But according to recent
figures from CDC, a
growing number of American children–2%–now carry an autism diagnosis
.  Some of them (30%) developed
normally, then regressed
into autism at about 18-24 months
, sometimes days after a vaccination.  There is still no explanation for this
epidemic.  Its cost to society
dwarfs those of childhood infectious diseases.
Many parents are understandably scared to vaccinate and
scared not to vaccinate. No one has enough information to know what is best to
do.  But the fact remains that some
vaccines cause permanent neurologic disorders in some children.  The DHHS Vaccine Injury
Table
lists many disorders that the federal government accepts are the
result of vaccine injuries.
It is established that vaccines may cause neurologic
disorders and death.  What is
not clear is how big the risk is for each child.  Without this information it is impossible to calculate the
risks and benefits for vaccines.
Some families pay a terrible price for devastating vaccine
injuries.  If serious vaccine
injuries are a one-in-a-million-child occurrence, there is probably large
benefit from vaccination.  But if
they are a common occurrence, it might be safer to omit certain vaccinations.
Yet no definitive research has clarified the frequency of vaccine injuries.  
Vaccine Safety and the Duty to Warn
Congress, the FDA and Supreme Court acknowledge that as a
class, vaccines are “unavoidably unsafe.”  As noted in the DHHS Vaccine
Injury Table
, vaccines in some cases cause paralysis, encephalopathy,
encephalitis, brain damage, anaphylaxis, chronic arthritis, polio, measles, and
other serious medical problems, including death.
The dissenting Supreme Court opinion in the 2011 Brusewitz v Wyeth
case, which removed all potential liability from vaccine manufacturers, points
out the importance of proper directions and warnings for vaccines. The absence
of adequate warning to consumers is considered a labeling defect.  “Congress created a
presumption that, for purposes of §22(b)(1), “a vaccine shall be presumed to be
accompanied by proper directions and warnings if the vaccine manufacturer shows
that it complied in all material respects with” federal labeling requirements.
42 U. S. C. §300aa–22(b)(2).”
 
Finding vaccines unavoidably unsafe, Congress specified
that manufacturers had a duty to warn consumers.
Now that many people are being vaccinated in supermarkets and drug
stores, precluding any discussion with a medical provider, the duty to warn is
even greater than when first required by Congress. Parents receive vaccine
information sheets when their children are vaccinated, but often not
until after
the vaccine is
administered
.
The Future of US Vaccines
Clearly, what are needed are better vaccines:  those that will offer reliable,
long-lasting immunity and reduce serious side effects to the lowest possible
level. However, neither goal will be achieved under the current system, as
there is no incentive for vaccine manufacturers to improve their products while
the vaccines are mandated and their manufacturers protected from any liability
by law.
Achieving this will require research into the causes and
rates of vaccine injury, untainted by vested interests.
Furthermore, there is no incentive to create the very best
vaccines for diseases of the future. To the contrary, some future vaccines are
likely to be more dangerous than currently licensed vaccines. 
Although a swine flu vaccine used in Europe (Pandemrix) caused over 800 cases of severe narcolepsy in
children, the vaccine adjuvant that most experts suspect was the culprit, ASO3,
may soon be included in a US vaccine. 
According to Reuters:
“The adjuvant in the Pandemrix
vaccine is very potent and we think it may have played a role,” says
Markku Partinen, a neurologist at the Helsinki Sleep Clinic in Finland who has
spent the past few years investigating what might be behind the link between
the vaccine and narcolepsy.
If it is the reason for the spike
in the disease, Partinen and other researchers think it may be because the
adjuvant’s strength boosted not just a good immune response but possibly an
adverse one too.
Partinen was one of the first
scientists to pick up a signal that something might be going awry in children
in Finland vaccinated with Pandemrix in a nationwide immunization campaign
against the H1N1 flu.
Since then studies in Sweden,
Finland, Ireland and now Britain have found the risk of developing narcolepsy
is between seven and 13 times higher in children who were immunized with
Pandemrix than in those who were not.
Among the 800 cases of
Pandemrix-related narcolepsy reported so far across Europe, many are children
who say the life-long and incurable disease has all but wrecked normal life.”
Scientists believe AS03 may be the
culprit in the narcolepsy cases though they have yet to decipher the precise
nature of the association.
That uncertainty poses a challenge
for the U.S. Food and Drug Administration, which is considering an
AS03-containing vaccine for use in the event of an H5N1 bird flu epidemic. Like
Pandemrix, which has not been approved in the United States, it is made by GSK
and is almost identical in structure.
A 14-member panel of advisors to
the FDA voted unanimously in November to recommend the vaccine to protect
against bird flu. The panel considered early studies from Europe showing an
increase in the number of narcolepsy cases but concluded that the potential
benefit of the vaccine outweighed the risk…’’
Opportunities
What should the Maine Legislature do?  Consider the following:
Ø    Manufacturers
face zero risk of liability for vaccine injuries.  Many vaccinations are now given in the absence of medical
providers, eliminating possible discussion of risks and benefits.  How can Maine best support the duty to
warn consumers of potential vaccine risks and benefits? This duty falls on the
manufacturer, but should also fall on the state when it mandates childhood
vaccinations.  
Ø    Should
the vaccine information statement be given to parents before their children are vaccinated?  Should parents sign a form that says
they have read the statement before their children are vaccinated?  Should parents be given a list of
ingredients in the vaccine?  Should
parents be informed when ASO3 or a similar novel adjuvant is included in a
vaccine?
Ø    Can
Maine establish a data collection for regressive autism cases, to assess the
temporal relationship between vaccinations and neurologic changes?
Ø    Maine
is one of a small number of states that initiated school-based flu
vaccine clinics
in 2009.  Their
value is questionable
and cost significant.  The federal
CDC grant for these clinics covered the last two flu seasons and has expired.
Should the state continue to support them?  Perhaps the money saved could be spent on a study of
vaccinations and their relationship to neurologic disorders in Maine.
Ø    Should
the Maine legislature suggest to Congress that it revisit the issue of vaccine
liability, in order to create incentives for better and safer future vaccines?

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