Sunday, June 2, 2013

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…’’


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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