DrftRevuPrt2: FL DoH Report from Task Force on ASDs

[Guest guest]

ALL,

RE: DrftRevu

Attached is Part 2 of a draft review of a Sept. 2008

report by the Florida Department of Health titled:

>A Draft Review of: 'Florida Governor's Task Force

>on Autism Spectrum Disorders -Task Force Requests

>to the Florida Department of Health', Part 2

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Because of the files's size, the " doc " file is

being provided in this e-mail (the " pdf " file

for this part of the review will be posted

later this month in the " Documents " web page

on the CoMeD web site

http://www.mercury-freedrugs.org/

[along with the " pdf " file of the Florida re-

port] for those wishing to study all of the

ommitted figures, tables and references, and/or

read the original report).

RE: THOSE NOT ACCEPTING E-MAIL ATTACHMENTS

For those who do not get SUCH, the follow-

ing is the rough-text of the DrftRevu's

content without the figures and some of

the tables in the full review.

The report's text are quoted using the e-mail

standard " > " and the reviewer's remarks are

indented from the margin to differentiate

them from the report's statements.

_____________________________________________________

A Draft Review of: 'Florida Governor's Task Force on

Autism Spectrum Disorders -Task Force Requests to the

Florida Department of Health', Part 2

Part 2 of 2 Parts

> requests 4 and 5

>A list of all vaccines and the years they were intro-

>duced into the schedule of Florida Pre and post 1980

>vaccine schedules (comparison, list of all vaccinations

>received since 1980 and when added to the vaccine

>schedule)

>

>Florida adopts the same Routine Childhood and Adoles-

>cent Vaccination Schedules as published by the Centers

>for Disease Control and Prevention (CDC) and Advisory

>Committee on Immunization Practices (ACIP).

>· The schedules contain recommended vaccinations,

> ages and spacing to assist healthcare providers

> plan preventive healthcare with parents for their

> children.

>· Vaccinations are provided as a standard of care by

> the healthcare provider irrespective of school en-

> try requirements.

>· Vaccination is one of a small group of medical

> interventions with direct and simultaneous bene-

> fits to individuals and communities. The more

> vaccinated individuals there are in a community,

> the greater the protection against disease. This is

> called herd immunity.

>· School vaccination laws were first established to

> control outbreaks of smallpox and are now used to

> avoid epidemics of vaccine-preventable contagious

> diseases, such as measles and pertussis (whooping

> cough) that can be spread in the close contact of

> the classroom.

>· It is important to note that not all of the vacci-

> nations on the routine schedule are required for

> child care and schools in Florida. There is often

> confusion between what is recommended as part of

> medical care and what is required for school.

>

>The table below illustrates the increased number of

>vaccines since 1980 that are available to prevent a

>greater number of communicable diseases and the

>complications that may develop.

>

>

> Vaccines in the Routine Childhood and Adolescent

> Schedule Pre and Post 1980

>

> REPORT'S TABLE OMMITTED

>

Except for correcting the use of the words " immuni-

zation " and " immunizations " when " vaccination " and

" vaccinations " are more accurate and adding a foot-

note to the table, this reviewer accepts that these

paragraphs accurately reflect the policies and views

of the Florida Department of Health (DoH) though this

reviewewr finds some of these are problematic.

>

> request 6

>

>Investigate other states' opt-outs for non-fatal vacci-

>nations that have been added in the last 20 years.

>

>While there are no states to date that have laws in

>place for an 'Opt-Out' for a specific vaccine, 18 states

>have laws allowing philosophical exemption for vaccina-

>tions.

>

More importantly, unlike nations where parents

and guardians are free to choose vaccines and

when to vaccinate and the national government

freely provides those vaccines that have been

proven to be safe and in-use health-cost effec-

tive, the States, Commonwealths, Districts,

Territories and Protectorates that comprise the

USA have elected to mandate vaccination and pro-

vide limited exemptions that may allow some to

decline vaccination on medical, religious, and

philosophical.

The real reason that any path to exemption is

provided is that having such exemptions protects

the states from being directly held financially

responsible for any harm that may occur as a re-

sult of vaccination - which would be the case,

under U.S. law, if the " states " were to provide

no " choice " .

In the fairer states, the exemptions provided

include a philosophical exemption but, as with

the other exemptions provided, some states erect

onerous requirements that discourage people from

freely exercising this exemption option.

Should the apparent vaccination-fueled chronic-

disease epidemics continue to increase and the

vaccine apologists, public health officials, vac-

cine makers, healthcare providers and elected

government officials continue to ignore these

and/or claim that they have no known causes or

that the causes are complex, then, this reviewer

predicts that the public outrage will grow to the

point that all demand that: a) the laws in all

states be changed to " opt in " laws and there be

no vaccination requirements for attending any

school, engaging in any lawful activity and/or

activity or holding any position or office.

When this occurs, then the governmental agencies

will become the providers of only those vaccines

that have truly been proven safe and truly cost-

effective for the individual.

Given this possibility, this reviewer would strong-

ly counsel the Florida DoH and all other similar

agencies to determine, based on their own active

surveillance programs, which vaccine components are:

a) truly in-use effective for their state's popula-

tion, provide long-term protection to almost

everyone vaccinated, and c) meet, or exceed, the

U.S. safety standards.

Then, they should eliminate all vaccine components

that do not meet the preceding requirements from

the Florida required vaccination programs.

Moreover, this reviewer strongly suggests that all

those involved in any facet of the vaccine estab-

lishment had better prove, in appropriate human

case studies and animal-model toxicity studies:

Ø What the underlying vaccine-related causal fac-

tors are in the epidemic increase in various

chronic diseases and

Ø Unequivocally reveal the truth about the causal

links found, or face the loss of all credibility

and the wrath of the inflamed public, who will

demand that they be appropriately tried for

their malfeasances and, if found guilty, appro-

priately sentenced.

>

>In contrast, 47 states provide exemptions for religious

>beliefs and one state provides for religious exemption

>from vaccinations in child care and pre-K only.

>· Florida provides exemptions from vaccination for re-

> ligious beliefs and medical reasons as identified by

> the child's healthcare provider.

>· Public health balances its responsibility to provide

> appropriate vaccination exemptions while also protec-

> ting the susceptible, un-vaccinated students from ex-

> posure in the classroom. If this balance is lost, the

> possible outcome would be pockets of diseases that

> should be prevented by vaccine. While most people do

> not suffer severe complications, all vaccine-preven-

> table-diseases may result in a fatal outcome.

>

>The vaccination coverage rate for the MMR vaccine is

>high in Florida and nationally as well. However, public

>health remains vigilant to any significant drop in

>these coverage rates in order to protect children and

>adults from measles, mumps and rubella. Florida has

>experienced small outbreaks in communities that have

>low or no vaccination coverage rates. Great Britain

>has experienced a rise in measles and mumps case reduc-

>tion because fewer parents are immunizing their chil-

>dren.

>· Vaccination rates in England dropped and the number

> of measles and mumps cases rose significantly fol-

> lowing a publication in The Lancet of a 1998 paper

> and the subsequent media coverage that suggested an

> association with the combination measles, mumps and

> rubella vaccine-MMR-and the development of autism.

>

Though the initial statements only misuse the word

" immunization " and related forms thereof, the pre-

ceding statements on measles andd England are a

craven distortion of the facts.

Factually, the uptake rates for the MMR vaccine used

in England were falling before the 1998 paper was

published in The Lancet.

The uptake rates were falling in the United Kingdom

because MMR vaccine that had been being offered to

the English public contained a virulent strain of

mumps, the Urabe strain, that Canada had already

stopped using on safety grounds since a safer vac-

cine MMR vaccine, Merck's MMR II, was available.

Apparently, the UK public health officials elected

to provide the less safe Urabe-mumps-containing MMR

vaccine because it was less expensive than the safer

MMR vaccine.

>

>· 2007 saw the highest number of measles cases recorded

> in England and Wales since the current method of

> monitoring the disease was introduced in 1995.

>

While this reviewer accepts that the report's state-

ment is correct, he notes that the report failed to

provide the case numbers or the corresponding number

of deaths for 1995 and 2007 so that an assessment of

this statement's significance could be made.

>

>· The Lancet article was withdrawn following further

> scientific review.

>

The report knowingly misrepresents the facts about

the article in question:

Factually,

1. The UK medical establishment attempted to blame

the paper for the decline in vaccination when

the adverse outcomes from the less-safe MMR

vaccine containing the more virulent Urabe

strain of mumps was the culprit;

2. There was no scientific review but rather a

medical witch hunt against the article's prin-

ciple author, Dr. Wakefield (and those

who refused to speak against the paper) that is

still going on in 2008;

3. In 2004, eight years after the Wakefield et al.

study was published in The Lancet, 10 of the 13

original authors signed a statement that only

repudiated the study's " Interpretation " of the

findings but nothing else; and

4. The paper was not withdrawn.

>

>· Low vaccine uptake over the past decade means there

> is now a large group of children who either haven't

> been vaccinated or who have received just one dose.

> These children are susceptible to not only measles

> but to mumps and rubella as well.

>

Again, the statement made here distorts the facts

because:

1. Many of the unvaccinated have had mumps, rubella

and/or measles and are no longer vulnerable to

the diseases with which they contracted and then

recovered;

2. All those who are vaccinated are abnormally in-

fected with measles mumps and rubella so that

the immunity developed, if any, is incomplete

and does not last as long as the natural immunity

acquired from having the disease; and

3. Some children who did not receive the MMR vaccine

have been given the MR vaccine, or the individual

measles, mumps, and/or rubella vaccines.

>

>· While vaccination levels were reduced from 92% to 85%,

> measles cases increased from 112 to 958 for the years

> 1995 to 2007.

>

First, there seems to be a disconnect between the

information reported in cases data and the years for

the measles data because the maximum number of measles

cases on the report's " measles " graph on the next page

appears to be about 1100 cases in the 2004 - 2005 and,

based on the apparent " 50 " cases from the graph for

the 2006 - 2007 period, the probable number of measles

cases in " 2007 " should have been closer to 100 than to

1,000 cases.

Moreover, based on the " measles " graph, there was no

significant rise in measles cases until the single-dose

uptake rate in 2-year olds dropped below 82 %

Though there are other concerns, this reviewer finds

these apparent discrepancies are very troubling and

they need to be addressed and corrected.

Additionally, this reviewer finds that this report

fails to mention the actual number of children repor-

tedly killed or seriously injured when they were given

the MMR vaccine - in the U.S., this is a considerable

number.

Since most of the vaccine-related deaths are not re-

ported, one can presume that the " true " measles death

rate (from contracting measles " naturally " or by being

injected with the live measles virus in the MMR vac-

cine) may not have changed significantly.

As the population of England was increasing because of

a large influx of immigrants from other nations during

this period, without population-segment rate breakouts

for native and immigrant populations and for the dif-

ferent socioeconomic groups, it is not possible to as-

sess how much of the increase in measles cases is from:

a) decreased vaccine uptake, the influx of immi-

grants bringing new strains of measles against which

the MMR vaccine used was/is not fully protective, or c)

other factors (like a favorable climate for transmis-

sion).

Finally, no report was made of the serious adverse

events, including death, that are known to be associ-

ated with the MMR vaccine.

Given all of the preceding realities, this reviewer

must: a) discount this statement and request that

the Florida DoH provide the missing information.

>

>· Fearing the vaccine more than the disease: the graphs

> on the following page reflect the decrease in the per-

> cent of 2-year-olds in England who received at least

> one dose of MMR, and the rise in the cases of measles

> and mumps reported. Source: Health Protection Agency,

> United Kingdom.

>

First, this reviewer finds it curious that the report

failed to include a graph for rubella cases - perhaps

there was no significant effect even when the uptake

fell below 82 %.

Second, this reviewer finds it curious that the num-

ber of mumps cases in the " mumps " graph provided does

not track the time and uptake-level trends in the

" measles " graph.

At a minimum, the " mumps " graph indicates that fac-

tors other than uptake among 2-year olds were affec-

ting the number of cases reported.

Finally, these graphs provide no evidence the public

feared " the vaccine more than the disease " - only

that the English parents and guardians of different

cohorts of " two-year-olds " , for whatever reasons,

had different levels of vaccine acceptance.

Hopefully, the Florida DoH will address and resolve

the apparent anomalies in the " measles " and the

" mumps " graphs provided as well as address the

" rubella " cases during the same time period.

>

> Percent of 2-year-olds in England who Received at

> Least One Dose of MMR and the Number of Measles

> Cases Reported

>

> REPORT'S GRAPH OMMITTED

>

>

> Percent of 2-year-olds in England who Received at

> Least One Dose of MMR and the Number of Mumps

> Cases Reported

>

> REPORT'S GRAPH OMMITTED

>

Factually, MMR uptake in the UK was dropping

before the paper by Wakefield et al. was pub-

lished in 1998.

This drop was precipitated by the public con-

cern caused by the UK government's decision to

license an MMR vaccine that contained the high-

ly virulent Urabe strain of the mumps virus

because it was less expensive than the MMR vac-

cine containing a safer mumps strain.

This choice resulted in a sudden surge in ad-

verse outcomes, including death, shortly after

that vaccine was given to the child.

Thus,

Ø The UK government's actions,

Ø The subsequent sharp increase from the MMR

vaccine with the Urabe strain of mumps and

Ø The public's concern about the increased

vaccine harm caused by that MMR vaccine

were largely responsible for the fall in

MMR uptake, and not the Wakefield et al.

paper.

Finally, this decrease in MMR uptake was slow to

turn around even after the UK's government finally

" recognized " the vaccine problem, but, without

informing the public about this Urabe-strain prob-

lem, chose to cover it up and to simply offer MMR

vaccines that had a safer strain of mumps.

>

>Public confidence in England for the MMR vaccine is now

>high with more than 8 out of 10 children receiving one

>dose of MMR by their second birthday. While the percen-

>tage of children being vaccinated is rising again,

>England has had to declare measles and mumps endemic

>again as it will take years to reverse the disease trend.

>

Again, this reviewer finds the report's statements

here to be somewhat problematic because, from the

graphs, measles cases are close to the low levels

seen before the start of 2004 and, since rubella

cases are not mentioned, the low vaccination rates

for MMR apparently did not adversely affect the

number of rubella cases.

This leaves the problematic and perplexing " mumps "

cases data which: a) does not appear to track the

data for the " MMR " uptake and , even when the

vaccine uptake levels were close to 90%, indicates

that there were 2,000-plus to 6,000 cases annually

in England while, for the period 1999 through 2005

in the USA where the population is roughly 6 times

larger, there were less than 400 cases annually -

levels 5 to 15 times lower than in the UK, but in

2006, with uptake levels higher than 92%, there were

more than 6,000 cases in the USA, while, in England

with apparently 80+ % uptake levels, there were more

than 35,000 cases - more than 5 times the cases in

the USA.

Taken together, these facts indicate that some factor

other than uptake, perhaps viral strain related, has

a significant impact on the number of cases in both

the USA and the UK.

Hopefully, after reviewing this reviewer's concerns,

the report's authors will address and resolve the in-

congruities in the information provided.

>

> request 7

>Which vaccines given to children under the age of

>two still have thimerosal? Flu shot has thimerosal?

>

>Did DOH mandate that all vaccines have none? How

>long has this been in place?

>

>Which vaccines given to children under the age of

>two still have thimerosal? Flu shot has thimerosal?

>Routinely recommended childhood vaccines have not

>contained thimerosal as a preservative since 2001.

>

Since: a) the CDC's ACIP added the Thimerosal-

preserved influenza vaccines to U.S. schedule

for the routinely recommended childhood vaccines

as well as pregnant women in 2002 and the

expiration dates for some lots of some of the

other routinely-recommended Thimerosal-preserved

vaccines extended into 2004, if not later, the

LAST statement here is factually inaccurate,

to say the least.

Fortunately, unlike New Jersey, Florida has not

yet mandated the less-than-effective influenza

vaccines or a vaccination exemption for this

vaccination, as a prerequisite for attending

childcare facilities and schools for children 6

months to 59 months of age.

>

>All vaccines for children under the age of two are

>available without thimerosal. Table 1, produced by

>the U.S Food and Drug Administration, lists all vac-

>cines routinely recommended for children 6 years of

>age and younger. This table illustrates the absence

>of thimerosal as a preservative in childhood vac-

>cines.

>

Factually, the most recent FDA/CBER Table 1, shown

below and on the next page, contains two Thimerosal-

preserved vaccines, highlighted in bolded italics,

that are clearly listed in the FDA's " Table 1 " ,

rendering the report's " This table illustrates the

absence of thimerosal as a preservative in childhood

vaccines " statement factually inaccurate.

REVIEWER'S COPY OF FDA TABLE 1 OMMITTED

SEE http://www.fda.gov/

>

>· According to data, there is no convincing scienti-

> fic evidence of harm caused by the low doses of

> thimerosal in vaccines, except for minor reactions

> like redness and swelling at the injection site.

>

First, the maximum allowed " nominal " dose of Thi-

merosal in a 0.5-mL dose of a Thimerosal-preserved

vaccine is about 50 micrograms [50 µg] of Thimerosal

(100 ppm Thimerosal), which translates into a mer-

cury concentration of about 50 µg of mercury per mL:

Ø A concentration that is about 250 times the EPA

maximum concentration for hazardous liquid

" mercury " waste (0.2 µg of mercury per mL [0.2

ppm]), and

Ø A dose that, on the mercury toxicity scale, is

anything but a " low " dose.

Moreover, Eli Lilly documents (furnished in now-

sealed court cases involving Eli Lilly and Thi-

merosal-containing drugs) reported Thimerosal

toxicity from vaccine doses of 1-ppm Thimerosal

(0.5 ppm mercury) - a level that still 2.5 times

the EPA's toxic-waste threshold (0.2-ppm mercury).

Based on the EPA's threshold of 0.2 ppm for the

total concentration of mercury species in a

liquid that classifies that liquid as a hazardous

waste, no dose of mercury in a Thimerosal-pre-

served vaccine is a " low " dose and, in vaccines

containing a lesser level of Thimerosal, a low

dose of mercury might be a 0.5-mL dose that

contains less than 0.001 micrograms of mercury

(< 2 nanograms of Thimerosal).

>

>However, in July 1999, the Public Health Service agen-

>cies, the American Academy of Pediatrics, and vaccine

>manufacturers agreed that thimerosal should be reduced

>or eliminated in vaccines as a precautionary measure.

>

Factually, the bulk of the scientific toxicity

evidence shows that the 100-ppm level of Thi-

merosal in most-Thimerosal-preserved vaccine is

more than 100 times higher than the level of Thi-

merosal that, in developing animal studies (using

fertilized chicken eggs, hamsters, mice, pheasants,

pigs, rats, and monkeys), multigenerational

studies (using rodents), developing studies, human

cell studies, and human tissue studies, has been

shown to cause adverse health effects in the

animals, developing cell systems, and skin tissues

treated with a simple covalently bonded ethyl

mercury compound or with Thimerosal, the sodium

salt of ethylmercury thiosalicylate.

>

>· There are licensed flu vaccines available for infants

> 6 months and older that are thimerosal free.

>

Factually, there is only a limited number of doses

(roughly 8 - 10 million doses) of one " no Thimero-

sal " FDA-licensed human influenza vaccine that is

available for infants 6 months of age and older,

Sanofi's " no Thimerosal " Fluzone.

The other FDA-licensed " thimerosal free " flu vac-

cines that are approved for use in children are:

1. The " no Thimerosal " live-virus MedImmune

FluMist vaccine, which:

a. is also only available in a limited

number of doses (roughly 5 million

doses),

b. is currently licensed for those 2 to

49 years of age, and

c. because it is a live-virus vaccine,

can infect those who are inoculated

with the vaccine as well as those

have contact with the inoculees for

up to 3 weeks (21 days) after the

inoculees receive the vaccine, and

2. The currently unavailable Novartis " trace

Thimerosal " inactivated-virus flu vaccine

for those who are 4 years of age and older.

Given the reality that the CDC's current

recommendation is for " every " child 6 months

to 18 years of age to get one flu vaccination

dose and for some children to get 2 doses, a

month (for the inactivated vaccine) to 6 weeks

(for the live-virus vaccine) apart, it is clear

that there is not enough FDA-approved childhood

" Thimerosal free " influenza doses to meet the

about 75 million doses needed for this age group.

>

>How long has this been in place?

>· As a precautionary measure, the U.S. Public Health

> Service (including the FDA, National Institutes of

>Health (NIH), Centers for Disease Control and Preven-

>tion (CDC), Health Resources and Services Adminis-

>tration (HRSA)), and the American Academy of Pedia-

>trics issued two Joint Statements, urging vaccine

>manufacturers to reduce or eliminate thimerosal in

>vaccines as soon as possible (CDC 1999 and CDC 2000).

>The U.S. Public Health Service agencies have col-

>laborated with various investigators to initiate fur-

>ther studies to better understand any possible health

>effects from exposure to thimerosal in vaccines.

>

First, for better accuracy, the report's narra-

tive here should be revised to read:

" As a precautionary measure, the U.S. Public

Health Service, U.S. Food and Drug Adminis-

tration (FDA), National Institutes of Health

(NIH), Centers for Disease Control and Preven-

tion (CDC), and the Health Resources and Ser-

vices Administration (HRSA) along with the

American Academy of Pediatrics (AAP) issued

two Joint Statements, the first (CDC 1999)

urging manufacturers to remove all the Thimer-

osal from vaccines as soon as possible, and

the second (CDC 2000) changing the 'remove'

request to simply reducing the level of Thi-

merosal in vaccines as soon as possible. The

CDC has overseen retrospective epidemiological

studies, which have been 'iteratively revised'

[30] to minimize the chance of finding any link

between the administration of Thimerosal-pre-

served vaccines (and/or the MMR vaccine) and

any neurodevelopmental disorder, including

'autism' (autistic spectrum disorder). To date,

the comprehensive Thimerosal toxicity studies

actually required to better understand any

possible health effects from exposure to Thi-

merosal in vaccines, that were originally as-

signed to the National Institute of Mental

Health (NIMH) in 1999 were put on hold in 2000

and, as of mid-September 2008, not complete -

most of the required studies have not even been

initiated. "

Factually, the U.S. Public Health Service (USPHS),

FDA, NIH, CDC, and HRSA are equal-rank agencies

in the Department of Health and Human Services

(DHHS); and all report to the Secretary of Health

and Human Services (HHS).

Additionally, numerous independent studies, con-

ducted outside of the CDC's oversight, have found

and reported causal links between: a) the level

of exposure to Thimerosal-preserved vaccines, or

their equivalent, in developing human and develop-

ing animal studies and the risk of neurodevelop-

mental disorders, including autistic disorder, as

well as other developmental conditions in develop-

ing children.

Further, case studies have established that most

of the children who have a diagnosis in the " autism

spectrum " are mercury poisoned and many of these

children are either poor excretors, or non-excretors,

of the mercury in serums and vaccines to which they

were exposed from conception through the first 12

months of life.

In fact, the causal link between Thimerosal and

autism had become so well accepted that Dr. Larry

Needham, Chief, Organic Analytical Toxicology Branch,

Nat'l Center for Environmental Health, CDC presented

a slide that showed Thalidomide, Lead, Ethanol,

'Retinoids', Valproic Acid, and Thimerosal as causal

agents for autism spectrum disorders in his April

2007 presentation to Institute of Medicine [31].

Finally, in the Fall of 2007, medical professionals

in the Department of Health and Human Services con-

ceded [32] that the vaccinations given to Hannah

Poling when she was 19-months of age were causal

factors in the regressive autism she subsequent de-

veloped before her case, scheduled to be heard as

a test case in the ongoing Omnibus Autism Proceeding

in the U.S. Court of Federal Claims for the hypothe-

sis: Thimerosal in vaccines is a causal factor in

autism, could be heard and even before the peti-

tioners' experts, Drs. Zimmerman and Mark R.

Geier, testifying on behalf of Hannah Poling and her

parents, were scheduled to file their formal reports

confirming that:

v Hannah had developed regressive autism and, later,

seizures, as a result of adverse reactions to the

vaccinations she received at 19 months of age, and

v She was mercury poisoned by the Thimerosal-pre-

served vaccines she received at that time.

Given all of the preceding realities and the suppor-

ting studies published in 2008, this reviewer finds

it hard to believe that anyone would continue to

misrepresent the state of knowledge concerning the

proven causal links between:

v Some children's receiving bolus doses of organic

mercury from Thimerosal-preserved vaccines and

v The subsequent onset of regressive autism in

children, who, like Hannah Poling, are poor

excretors of mercury, for whatever reasons,

during their early developmental period (from

conception through three to five years post

partum).

________________________________

[30] One of the fundamental tenets of sound epide-

miological study is that, once the study is

designed, the study's design should not be

revised when the findings are not what those

designing the study hoped they would be. In

the U.S. studies of the Vaccine Safety Data-

link (VSD) by CDC researchers, the Verstraeten

et al. studies, repeatedly violated this

fundamental tenet and, after seeing results

strongly associating the level of early-

developmental Thimerosal exposure with the

risk for autistic disorder and other neuro-

developmental disorders, these researchers

repeatedly revised the study design until the

computed link became non-statistically signi-

ficant. Furthermore, the CDC overseen studies

in Canada, United Kingdom (UK), Denmark and

Sweden have been similarly compromised.

[31] April 2007 (PowerPoint Presentation) by Dr.

Larry Needham, Chief, Organic Analytical

Toxicology Branch, Nat'l Center for Environ-

mental Health, CDC, " Exposure (To Stressors)

and Autism Spectrum Disorders " to the IOM.

[32] Hannah Poling v. Sec. HHS, VICP case 02-1466V,

vaccinations as a causal factor in child's

autism was conceded by DHHS medical profes-

sionals in a report filed with the " Vaccine

Court " on November 9, 2007.

>

>· At present, all routinely recommended vaccines for

> U.S. infants are available only as thimerosal-free

> formulations or contain only trace amounts of thi-

> merosal (>=1 micrograms mercury per dose), with

> the exception of inactivated influenza vaccine.

> Inactivated influenza vaccine for pediatric use is

> available in a thimerosal-preservative containing

> formulation and in formulations that contain either

> no thimerosal or only a trace of thimerosal, but

> the latter is in more limited supply (see Table 1).

> All [other] pediatric vaccines in the routine infant

> vaccination schedule are manufactured without thi-

> merosal as a preservative. As of January 14, 2003,

> the final lots of vaccines containing thimerosal as

> a preservative expired. These changes have been ac-

> complished by reformulating products as more expen-

> sive single dose vials that do not contain a preser-

> vative.

>

While the report's first statement here is true, the

realities are:

Ø For the inactivated influenza vaccines, Thimerosal-

preserved inactivated influenza vaccines: a) are

still approved for infants from 6-months of age

onwards and , in all but a few states, can

" legally " be given to pregnant women at any time

during their pregnancy (even though all inacti-

vated influenza vaccines are Pregnancy C drugs

indicating that safety for the developing fetus

has not been established),

Ø Thimerosal is a proven human teratogen, mutagen,

carcinogen, and immune-system disruptor at levels

below 1 ppm, and

Ø Retrospective population studies have shown that

the children born to mothers who received a Thi-

merosal-preserved inactivated flu shot during

pregnancy had significantly increased risks for

certain birth defects (cleft palate when the flu

shot was given to the mother in her first tri-

mester of pregnancy; and hydrocephaly and pyloric

stenosis across the pregnancy) [33].

With respect to the report's statement:

" As of January 14, 2003, the final lots of vaccines

containing thimerosal as a preservative expired " ,

it is obvious, given the Thimerosal-preserved influ-

enza vaccines in the childhood vaccination schedule,

that this statement is not true.

Furthermore, some lots of other formerly Thimerosal-

preserved vaccines expired well after January 14,

2003.

____________________________________

[33] Heinonen OP, Slone D, Shapiro S. Birth Defects

and Drugs in Pregnancy. Littleton, Massachusetts:

Publishing Sciences Group, Inc., 1977.

>

>Did DOH mandate that all vaccines have none?

>There is no DOH mandate regarding thimerosal in vac-

>cines. Bills were introduced by the legislators dur-

>ing the last few sessions and were not passed. The

>Florida Department of Health provides and recom-

>mends thimerosal-free vaccine for children. "

Since there are about 12 million U.S. children under

three years of age needing up to 14 million doses

of influenza vaccine, not to mention about 20 mil-

lion more children between 3 and 8 years of age and

about 40 million children between 8 and 18 who all

need a flu shot under the current CDC recommendations

and, for the 8 million children under 2, needing 10

million doses of Sanofi's " no Thimerosal " vaccine

(where only 8- to 10-million doses are produced -

leaving a probable deficit of available doses of that

vaccine for these children and " none " for children

from 3 years to 18 years of age).

Moreover, there are only about 5 million doses of

FluMist for those 2 years of age and up, needing

3-plus million doses a year for each age cohort

from age " 2 " up to " 18 " , it seems that there is a

net-deficit for " no Thimerosal " vaccines for chil-

dren of on the order of 35-plus million doses of

" no Thimerosal " vaccine, because, this year, no

" trace Thimerosal " Fluvirin influenza vaccine ap-

pears to be available.

Thus, unless the percent coverage is less than 25%

and the states, like California (where ~15% of

American children reside), that have outlawed giving

anything but " no Thimerosal " and " trace Thimerosal "

flu vaccines to children under 3 years of age and

needing about 10 million doses of flu vaccine for

all of their children, or, in some states, the need

for " no/trace Thimerosal " vaccines is up to age 8,

haven't pre-ordered all of the available " no

Thimerosal " vaccine doses (Fluzone and FluMist) for

their children, it would seem that Florida will have

a hard time getting sufficient doses of " no

Thimerosal " vaccine that is approved for use in chil-

dren (because only Fluzone, Fluvirin and Flu Mist are

approved for administration to children).

Therefore, this reviewer finds the report's statement:

" The Florida Department of Health provides and recom-

mends thimerosal-free vaccine for children " ,

is less than credible given the scarcity of thr " no

Thimerosal " doses approved for children (Sanofi's " no

Thimerosal " Fluzone) and the apparent ongoing unavail-

ability of " trace Thimerosal " doses approved for chil-

dren (Novartis' " trace Thimerosal " Fluvirin).

>

>Thimerosal. Thimerosal is a mercury-containing organic

>compound. Since the 1930s (, 1931), it has been

>widely used as a preservative in a number of biological

>and drug products, including many vaccines, to help

>prevent potentially life threatening contamination with

>harmful microbes. It has been used to kill bacteria and

>prevent contamination in antiseptic ointments, … "

Here the report is a master of both understatement

and distortion.

Factually, Thimerosal is a highly toxic organic mer-

cury compound whose metabolites bioaccumulate in the

human body and, in normal excretors of mercury, ac-

cumulate in the brain with a half-life of about 20

years and in other organs with half-lives of 10 to

20 years.

Thimerosal and its ethylmercury metabolites are also

known human teratogens (inducers of birth defects

when administered to pregnant women), mutagens, car-

cinogens and immune system disruptors at levels below

1 ppm.

Without toxicological proof that the Thimerosal level

used is:

v Safe to use,

v Truly effective as a preservative in the product

formulations to which it has been added, or

v Since 1968, " sufficiently nontoxic … " to the ex-

tent specified in 21 C.F.R. Sec. 610.15(a),

drug manufacturers, including vaccine makers, have:

a. Used Thimerosal in the manufacture of their drug

products without the required proof of safety,

and

b. Claimed that, at levels between 10 and 100 ppm,

depending on the formulation, Thimerosal is a

" preservative " .

Given the preceding, since January 1968, when the

current good manufacturing practice (CGMP) safety

minimum requiring proof that the " preservative

used " is " sufficiently nontoxic so that the

amount present in the recommended dose of the

product will not be toxic to the recipient " and

the vaccine makers failed to provide the toxico-

logical proof that their vaccines were safe to

this standard, all Thimerosal-preserved vaccines

have been adulterated drugs under 21 U.S.C. Sec

351(a)(2)( because, as both the FDA and the vac-

cine manufacturers have repeatedly admitted, the

manufacturers have knowingly failed to comply

with the current good manufacturing practice (CGMP)

safety minimum for proof that it is " sufficiently

nontoxic … " , as currently set forth in 21 C.F.R.

Sec. 610.15(a), and thereby rendered their Thimer-

osal-preserved vaccines adulterated under 21 U.S.C.

Sec. 351(a)(2)(.

>

>… creams, jellies, and sprays used by consumers and in

> hospitals, including nasal sprays, eye drops, contact

>lens solutions, immunoglobulins, vaccines, antivenins,

>and tattoo inks. Thimerosal does not reduce the potency

>of the vaccines that it protects (Baker 2008).

>

With respect to the report's statements:

" It has been used to kill bacteria and prevent contam-

ination in antiseptic ointments, creams, jellies, and

sprays used by consumers and in hospitals, including

nasal sprays, eye drops, contact lens solutions, im-

munoglobulins, vaccines, antivenins, and tattoo inks.

Thimerosal does not reduce the potency of the vaccines

that it protects (Baker 2008) " ,

this reviewer notes that the requisite " proof of safety "

to the standard " sufficiently nontoxic … " has not been

provided for any of these products, and studies attemp-

ting to verify safety in " antiseptic ointments, creams,

jellies, and sprays used by consumers and in hospitals "

led to a 1982 FDA report recommending banning its use as

an antiseptic and, in 1998, to the FDA's banning the use

of Thimerosal in all over-the-counter " antiseptic oint-

ments, creams, jellies, and sprays " and in vaginal con-

traceptives because Thimerosal was found to be: a) in-

effective and unsafe for use in such products.

Additionally, Thimerosal has not been used as a preser-

vative in plasma products and infused " immunoglobulin "

products for more than 3 decades because serious pa-

tient mercury intoxication (poisoning) was observed in

the 1940s in the first instance, and in the 1970s in

persons receiving multiple-milliliter doses of these

drug products in the second instance.

While the existing stocks of FDA-approved antivenins

contain Thimerosal or, if they are lyophilized, phenyl-

mercuric acetate in the diluent, current manufacture

has been suspended because the antivenin makers have

committed to producing mercury-free antivenin products.

Moreover, though not yet banned from " nasal sprays, eye

drops, contact lens solutions " , most of the manufactur-

ers of such products voluntarily removed Thimerosal

from their formulations in the late 1990s/early 2000s.

Finally, except for 10 vaccine formulations, 5 of which

are for inactivated influenzas (four human and one

avian), all of the current FDA-approved vaccine formula-

tions nominally provide not more than 1 µg of mercury

per dose and most their doses are " no Thimerosal " and

" no preservative " formulations although the FDA has,

as yet, failed to revoke the licenses of the replaced

Thimerosal-preserved vaccine formulations or, as re-

quired by law, declare all of the existing Thimerosal-

preserved vaccine formulations adulterated drugs under

21 U.S.C. Sec. 351(a)(2)( and force them off of the

market.

Thus, because of repeated studies showing lack of

proof of safety and product-lifetime effectiveness and

public pressure, most all vaccines and other drug pro-

ducts with a declared level of Thimerosal have been

either banned or " voluntarily " removed from the U.S.

market.

>

>Thimerosal is metabolized or degraded to ethylmercury

>and thiosalicylate. Ethylmercury is an organomercurial

>that should be distinguished from methylmercury, a

>substance that has been the focus of considerable

>study.

>

The information provided here is, at best, inaccurate.

Factually, when dissolved in water, Thimerosal, sodium

ethylmercury thiosalicylate, slowly disproportionates

into ethylmercury hydroxide and sodium thiosalicylate.

In the presence of trace levels of metal ions, par-

ticularly, copper, and dissolved oxygen, common com-

ponents found in living systems and vaccine formula-

tions, this disproportion reaction is driven by the

removal of the thiosalicyclate formed by its being

oxidized to the disulfide.

When Thimerosal is dissolved in sterile saline, the

basis solution for many vaccine formulations, the

disproportionation reaction produces both ethylmer-

cury chloride and ethylmercury hydroxide.

Moreover, in the presence of direct sunlight, the

" mercuric " mercury, Hg2+, in Thimerosal can be

photolytically converted to metallic mercury, Hg0,

and, though this reaction has not been fully

studied, possibly S-ethyl thiosalicylate.

While the report's glib statement:

" Ethylmercury is an organomercurial that should be

distinguished from methylmercury, a substance that

has been the focus of considerable study "

is essentially true, Thimerosal and other ethylmer-

cury compounds, including those also used as agri-

cultural fungicides from the 1930s through the 1970s,

have been the subject of more study than the vaccine

apologists are willing to admit or cite.

> CORRECTED TABLE

>Ethylmercury is not methylmercury-Significant Differences

> Methyl Mercury Ethyl Mercury

>Health risk Toxic chemical; Scientific evidence

> scientific evidence of health risk has been

> of health risk accumulating since the

> 1930s and the current

> body of toxicological,

> case study and legal

> case concessions by the

> medical professionals in

> the Poling case have

> clearly proven that

> Thimerosal is a health

> risk at levels below 1

> ppm and probably below

> 0.01 ppm in those who

> are " non-excretors " .

>Sources Toxic chemical found Thimerosal (used as a

> in the environment preservative in vaccines)

> and food: o All early childhood

> o Biotransformed vaccines have thimer-

> products from the osal-free versions

> emissions of coal-

> fired power plants,

> mercury-diaphragm

> chlor-alkali plants,

> crematoria, and

> cement kilns & dental

> waste emissions in

> air, soil and water

> o Seafood

>Amount 60 µg in one 6 oz can 0 or not more than

> of albacore tuna 1 µg per dose in

> BUT: a " trace Thimerosal

> a. U.S. children < 12 vaccine or 24.5-25

> months of age do µg per dose in Thi-

> not eat tuna. merosal-preserved

> b. Light tuna typically vaccines

> has < 25 µg of mer-

> cury per can.

> c. Typically, < 25% of

> the mercury in ingested

> fish is absorbed into

> the body; ~ 70-80 % is

> bound up in the gut &

> is excreted without

> being absorbed.

>Metabolism Accumulates in body Accumulates in body

> Based on Burbacher et al., Data from animal

> methylmercury hydroxide is studies in monkeys

> less bioaccumulative in and hamsters and

> the brain than Thimerosal's post-mortem autopsies

> ethylmercury hydroxide/ of the brains of

> chloride metabolites since children diagnosed

> 9 of the 17 test subjects with an autism

> failed to have a detectable spectrum disorder have

> level of " inorganic " mer- proven that mercury

> cury whereas all 17 injec- from any Thimerosal

> ted with Thimerosal had accumulates in the

> detectable levels of both body's organs to

> organic mercury and " inor- varying degrees

> ganic " mercury. (see below).

> From the findings in

> developing monkeys &

> hamsters, the level

> of accumulation in

> the brain varies by

> more than factor of

> 10 in a given strain

> of monkey or hamster.

> Based on studies by

> Sugita (Sugita M. The

> biological half-time

> of heavy metals. The

> existence of a third,

> " slowest " component.

> Int Arch Occup Environ

> Health 1978; 41(1):

> 25-40), the half-lives

> of accumulating mercury

> in tissue is on the or-

> der of 10 to 20 years.

>Exposure 1.5 months in blood Less than 1 week in blood

>(half-life) The value reported ap- Again half-life reported

> pears to be the half- here appears to be for

> life in the monkey brain mercury in blood from

> or blood? Factually, in the INJECTED Thimerosal

> Burbacher et al., the metabolized into ethyl-

> portion of the methylmer- mercury hydroxide and

> cury hydroxide, which was ethylmercury chloride.

> fed to young monkeys, found Here, the data from

> in the brain & metabolized Burbacher et al. indi-

> there into " inorganic mer- cates that, on average,

> cury had an indeterminate up to 3 times as much

> half-life (see Burbacher TM, " inorganic " mercury ac-

> et al. Comparison of blood cumulated in the brains

> and brain mercury levels in of the monkeys injec-

> infant monkeys exposed to ted with Thimerosal as

> methylmercury or vaccines compared to methylmer-

> containing Thimerosal. cury hydroxide force fed

> Environ Health Persp 2005; to another group of

> 113(8): 1015-1021). these monkeys. Again,

> the " inorganic mercury's

> half-life was indeter-

> minate and clearly much >

> 180 days.

>

>

In animal feeding studies, the comparative toxicity

data indicate that though the acute toxicity of

these alkyl mercury compounds are similar.

However, studies designed to feed developing animals

less than lethal doses of these compounds have, in

some instances, found the ethyl mercury compound used

was significantly more toxic than the methyl mercury

compound to which it was compared [34].

Hopefully, after reviewing this reviewer's remarks

and the paper in question, the authors of this report

will, at least, correct their misuse of the half-life

data for mercury in blood as if it were the half-life

of mercury in the body as a whole or in any organ,

including the brain.

Factually, for bioaccumulative poisons like the alkyl

organic mercury compounds in the preceding study by

Tryphonas et al., studies injecting an appropriate

dose of Thimerosal that contains a small percentage

of Thimerosal that has radiolabeled mercury atoms; and

then collecting and monitoring all of the body's elimi-

nation products until the data from the radiolabel in-

dicates half of the mercury dose injected was recovered

outside of he body would be needed to establish the

half-life of the mercury in Thimerosal or methylmercury

hydroxide injected into the test subjects.

____________________________________

[34] Tryphonas L, Nielsen NO. Pathology of chronic alkyl-

mercurial poisoning in swine, " American Journal of

Veterinary Research. 1973; 34(3): 379-392.

Turning to the table of vaccines presented in this

report for children under 6 years of age, this

reviewer simply notes that two (2) of the vaccines

listed in that " Table 1 " are Thimerosal preserved

vaccines.

>

> Table 1. Thimerosal Content of Vaccines Routinely

> Recommended for Children 6 Years of Age and Younger

> (FDA website:

> http://www.fda.gov/cber/vaccine/thimerosal.htm

> - accessed 8/1/2008)

>

> REPORT'S TABLE OMMITTED

>

>

>

>References

>

>Baker JP (2008), " Mercury, vaccines, and autism:

> one controversy, three histories, " Am J Public

> Health 98 (2), 244-53.

>Burbacher TM, Shen DD, Liberato N, Grant KS,

> Cernichiari E, son T, " Comparison of blood

> and brain mercury levels in infant monkeys ex-

> posed to methylmercury or vaccines containing

> thimerosal, " Environmental Health Perspectives

> Volume 113, Number 8, August 2005.

>Federal Register, January 19, 1979, 44: 3990.

>Federal Register, November 19, 1999, 64:63323-63324.

> " Mercury in plasma-derived products, " U.S. Food and

> Drug Administration (2004-09-09),

> http://www.fda.gov/cber/blood/mercplasma.htm

>Kerper, L.E.; N. Ballatori & T.W. son (1992),

> " Methylmercury transport across the blood-brain

> barrier by an amino acid carrier, " Am. J. Physiol,

> 262 (5 Pt. 2): R761-R765,

> http://ajpregu.physiology.org/cgi/content/abstract/262/5/R761.

>, K., MD, Schwartz, MD,

>Todd, MD and Larry K. Pickering, MD, " Thimerosal-Con-

> taining Vaccines and Autistic Spectrum Disorder:

> A Critical Review of Published Original Data, "

> PEDIATRICS Vol. 114 No. 3, September 2004, pp.

> 793-804.

> HM, son WA, " Merthiolate as a Germicide, "

> Am J Hyg 1931, 13:296 -310.

>Centers for Disease Control and Prevention, " Notice

> to Readers: Thimerosal in Vaccines: A Joint

> Statement of the American Academy of Pediatrics

> and the Public Health Service, " Morb Mort Wkly Rep

>1999, 48:563-565.

>IOM (Institute of Medicine). " Thimerosal-containing

> vaccines and neurodevelopmental disorders, "

> Washington DC: National Academy Press, 2001.

>

>Internet resources

>http://www.fda.gov/cber/vaccine/thimerosal.htm

>http://www.cdc.gov/flu/about/qa/thimerosal.htm

>http://www.vaccines.mil/default.aspx?cnt=adverseEvents/Thimerosal

>http://www.immunizationinfo.org/thimerosal_mercury_detail.cfv?id=136

>http://www.immunizationinfo.org/thimerosal_mercury_detail.cfv?id=3

>http://iaomt.org/testfoundation/thimcontent.htm

>

In addition to the pertinent references in this

reviewer's list of references at the end of this

review, this reviewer recommends the following

website:

http://www.mercury-freedrugs.org

as a resource for information on Thimerosal in

vaccines and other drugs, and related issues as

well as some information on vaccines and vacci-

nation.

>

> request 8

>The Task Force wanted data on numbers of vaccine

>preventable diseases for the 18 states with philo-

>sophical exemptions.

>

>Vaccine-preventable disease levels have been suc-

>cessfully reduced in the U.S. with the advent of

>vaccines. However, these diseases still exist and

>can once again become common-and deadly-if vaccina-

>tion coverage does not continue at high levels.

>Even though most infants and toddlers have received

>all recommended vaccines by age 2, many undervacci-

>nated children remain, leaving the potential for

>outbreaks of disease.

>

>The following table reflects the numbers of vaccine-

>preventable diseases for the 18 states [36% of

>states] with philosophical exemptions for vaccina-

>tion. This data was provided by the Centers for

>Disease Control and Prevention (CDC). Florida data

>correspond with the data from the 18 states with

>philosophical exemptions.

>· It is not possible to draw any conclusions about

> the effect of philosophical exemptions on disease

> rates from these data alone. Incidence rates (cases

> per 100,000 children per year) would have to be

> compared between states with and without philoso-

> phical exemptions.

>· Such a comparison must take account of other fac-

> tors in addition to the size of the population of

> children, such as introductions of disease from

> outside the U.S., and socio-economic factors.

>

In general, this reviewer agrees that comparisons

between states with and without any category of

exemption, not just philosophical, is complicated;

but, though not without some uncertainty, the com-

parison between a) California or all of the

states with a philosophical exemption as well as

large population, diverse ethnic and socioeconomic

groups and significant immigration and c) the U.S,

as a whole, might be of some use.

>

>· Experience has shown that, while reported case numbers

> may be low one year, introduction of a disease into a

> susceptible community can escalate into an outbreak

> very quickly.

>

This reviewer accepts the general premise here.

However, he notes that, in fully vaccinated popula-

tions, any outbreak would be localized and not spread

provided the vaccine and the vaccination program are

truly effective.

Thus, the recent focus on measles outbreaks in a

population with high levels (>92%) of MMR vaccina-

tion is problematic because the level of measles

and congenital rubella cases has remained very low

on this population while, in the U.S., the levels

of mumps cases has remained at a significantly

higher level and, in 2006, jumped to 6,000+ cases

without any CDC explanation of the reason for the

sudden increase in mumps cases.

Moreover, with only a slightly lower uptake level,

the tolerated level of annual mumps incidence is

more than an order of magnitude higher in England,

based on the data provided in this report, than it

is in the USA, based on CDC's annual notifiable

disease reports.

Finally, this reviewer notes that, for MMR vaccina-

tion in both the USA and England, there seems to be

much less concern about mumps " resurgence " than

measles, even when the uptake percentage in England

dipped to near 80%.

These and other anomalies makes this reviewer con-

cerned about whether the intent of the information

being broadcast about measles by the CDC: a) is

based on a genuine concern or is rather inten-

tional fear mongering designed to herd the public

into the acceptance of even more vaccines and/or

distract them from the epidemic rise in children

of a number of chronic diseases that the CDC and

public health officials seem not to even see and a

bout which they are almost silent.

>

>· The CDC's Morbidity and Mortality Weekly Report (MMWR)

> reported in its August 23, 2008, issue about the US

> measles experience for the first half of 2008. They

> state: >The number of measles cases reported during

> January 1-July 31, 2008, is the highest year-to-date

> since 1996. This increase was not the result of a

> greater number of imported cases, but was the result

> of greater viral transmission after importation into

> the United States, leading to a greater number of im-

> portation-associated cases. These importation-asso-

> ciated cases have occurred largely among school-aged

> children who were eligible for vaccination but whose

> parents chose not to have them vaccinated. "

>· 2006 paper published in the Journal of the American

> Medical Association (Omer SB, Pan WKY, Halsey NA et al:

> " Non-medical Exemptions to School Immunization Re-

> quirements: Secular Trends and Association of State

> Policies with Pertussis Incidence, " JAMA 2006, 296:

> 1757-1763) showed that pertussis (whooping cough) in-

> cidence was 50% higher in states with easier availa-

> bility of non-medical exemptions to school immuniza-

> tion requirements, and with available personal belief

> exemptions.

>· A 2000 paper in the same journal (Feikin DR, Lezotte

> DC, Hamman RF, Salmon DA, Chen RT, Hoffman RE: " In-

> dividual and Community Risks of Measles and Pertussis

> Associated with Personal Exemptions to Immunization, "

> JAMA 2000, 284:3145-3150) showed that in Colorado,

> which has had a philosophical exemption since 1977,

> the risk of measles and pertussis is elevated 22-fold

> and 6-fold, respectively, in exemptors compared to vac-

> cinated children. They also showed that the rate of

> measles in vaccinated children was higher in counties

> with high proportions of exemptors. "

>

First, this reviewer notes that the preceding three

bullet points are clearly examples of biased reporting.

This is the case because they apparently do not re-

flect the impact of the findings on the overall health

of the children affected.

Second, if the measles vaccines were " herd protective " ,

why would we see " the rate of measles in vaccinated

children was higher in counties with high proportions of

exemptors " even though the overall rates exceed 90%?

Third, absent any reporting of the absolute rates, how

can anyone interpret the importance of the relative

numbers reported (e.g., if the rate is " <1 in a million " ,

then even a 100 % increase translates into a risk of " <

2 in a million " - a change of little population concern).

Based on his understanding of reality, this reviewer

finds that these bullet points are, at best, pro-vac-

cine-biased warnings that are of little, or no, impor-

tance when it comes to the fundamental issue, which

this report again avoids discussing: the overall health

of our children and ourselves.

Is the overall health of the public improving, holding

steady, or declining?

This reviewer clearly sees that, when both acute and

chronic medical conditions are considered:

a. The health of American children is declining,

b. Infant mortality in the USA is unacceptably high

in comparison to Japan's,

c. Life expectancies in the USA are below those of

the other advanced industrial nations and appar-

ently starting to decline, and

d. Any past gains from the suppression of disease

by vaccination in the USA have been more than

offset by the increases in chronic disease that

are clearly mostly attributable to the current

inclusion of childhood vaccines that:

i. Are not for acute life-threatening and once

highly contagious diseases (e.g., measles

and diphtheria), but

ii. Are rather for lifestyle and/or rarely im-

mediately fatal diseases that mostly affect

adults (e.g., hepatitis B, herpes zoster

varicella as shingles, and HPV).

Given the reality of the declining overall public

health in the USA and its apparent connection to

the overall increases in vaccine doses and vaccines,

the CDC's recommended vaccination programs and

Florida's vaccination requirements are obviously in

need of an urgent review and reassessment.

Hopefully, after reading this review, the Florida

DoH and the public will recognize the same realities,

do the necessary review and appropriately alter the

Florida vaccination requirements across the board.

Based on the review of the data for California in

which a significant fraction of the population of

the USA resides and the overall disease numbers

reported for these 18 states and the USA, it seems

that, for MMR, having a philosophical exemption ap-

pears to " lower " the disease risk both in California

and in the 18 states with a general philosophical

exemption as a whole compared to the overall number

of 2006 cases in the USA for measles, mumps and rubella.

However, for the diphtheria and pertussis (and hepa-

titis cases data, the disease risk appears to be

slightly higher.

>

>2006 Comparison of Vaccine-Preventable Disease Cases,

>Among States with Philosophical Exemptions for Immuni-

>zations, Florida and U.S.

>

>REPORT'S TABLE OMMITTED ALING WITH REVIEWER ANNOTATIONS

>

Since the table provided in the report fails to

furnish the separate numbers for the cases occur-

ring in children:

Ø Too young to be vaccinated,

Ø Who are partially vaccinated,

Ø Who were exempt, and

Ø The corresponding categories for adults,

this reviewer finds that the information provided

cannot be used to address the real impacts on

disease incidence in a population, if any, of a

philosophical exemption, where such exemptions are

available.

>

> request 9

>Provide a state breakdown of school entry immunization

>exemptions, broken down by type and uptake rate.

>

>All fifty states have medical exemptions to vaccines,

>such as a serious allergy to a vaccine component. Forty-

>eight states, including Florida, provide for religious

>exemptions. Additionally, there are 18 states that have

>philosophical exemptions for school entry. Two addi-

>tional states have a philosophical exemption for child

>care entry only.

>· Vaccines are recommended by the Centers for Disease

> Control and Prevention (CDC) and professional soci-

> eties, such as the American Academy of Pediatrics.

> These organizations make science-based recommenda-

> tions; states set requirements, usually when children

> enter child-care centers and elementary schools as

> entry requirements. These requirements help prevent

> the spread of communicable diseases in these group

> settings.

While, the narrative here clearly presents the views

of the Florida Department of Health, this reviewer

notes that the current recommendations made by the

CDC and/or by the American Academy of Pediatrics (AAP)

are clearly not science-based decisions.

Factually:

1. To be added to the list of vaccines covered by the

National Vaccine Injury Program (NVICP), the vac-

cine only needs to be recommended by the CDC for

inclusion into the national program.

2. In the past, the CDC has, in at least one ins-

tance, recommended a vaccine for inclusion in the

national vaccination program even before the FDA

approved the vaccine (e.g., Wyeth's RotaShield

rotavirus vaccine) without having any U.S. data

on post-approval in-use experience and, less than

2 years later, this vaccine was removed from use

because of the in-use harm that it actually

caused.

3. In 2006, the CDC recommended a new rotavirus vac-

cine (Merck's recently approved RotaTeq) be added

to the national childhood vaccination program -

again without any U.S. post-approval in-use ex-

perience that it was safe to do so - and, in spite

of serious in-use adverse events (intussusception

and Kawasaki's disease) has continued to recommend

this vaccine as well as a 2008-approved rotavirus

vaccine, KlineBeecham's Rotarix.

4. Worse, the CDC has added Merck's Gardasil HPV vac-

cine to the national childhood vaccination sched-

ule at the time it was approved, without any in-

use U.S. data and, in spite of thousands of reports

to VAERS of serious adverse reactions, including

death, continues to recommend it.

Obviously, since there was no in-use experience for

the aforementioned vaccines, there can be no valid

science-based decision to recommend a vaccine for

the national program because the small groups of chil-

dren used in the clinical trials to obtain the FDA

approvals for these vaccines do not match the popula-

tion of American children for whom these vaccines are

being recommended.

Worse, for RotaShield, the CDC's decision was made

before the FDA approved the vaccine.

Moreover, when the CDC made its recommendations for

all of the rotavirus vaccines, it was clear that these

national vaccination programs were not, and, even

without any serious adverse reactions, would not be

cost-effective for the American public.

Based on the preceding realities, the CDC obviously

added these vaccines to the national childhood vacci-

nation schedule in order to place them under the NVICP

and thereby shield the vaccine's makers and the health-

care providers from the civil lawsuits for the harm

the CDC knew that these vaccines would, based on the

results from the biased clinical trials conducted,

cause.

With respect to the AAP, it simply appears to act as

a virtual rubberstamp for the CDC's and the vaccine

makers' wishes, often publishes CDC-recommended papers

without critical scientific review, and has repeatedly

refused to publish critiques of those studies by in-

dependent scientists.

With respect to the report's " states set requirements,

usually when children enter child-care centers and

elementary schools as entry requirements " , this re-

viewer finds that, increasingly the CDC and the vac-

cine makers lobby the health departments and politi-

cians who, ignoring:

Ø The fact that the vaccination program is not cost-

effective on any basis,

Ø The absence of sufficient in-use experience with

the vaccine,

Ø The potential adverse impacts on the overall

health of the population, and

Ø The concerns of the people of their state,

add the vaccine to their entry requirements for

" child-care centers and … schools " .

In this regard, this reviewer finds that the

Florida DoH is to be commended because it:

Ø Seems to have been more resistant to this lob-

bying than some states and

Ø Has not yet mandated some of the recent CDC-

recommended vaccines as entry requirements

to " enter child-care centers and … schools " .

>

>· School vaccination requirements have largely

> contributed to a significant drop in diseases

> and the complications that can be prevented by

> vaccinations. Before the measles vaccine, mea-

> sles caused 100,000 American children to be

> hospitalized and 3,000 to die every year. In

> the early 1970s, public health officials found

> that states with vaccine mandates had rates of

> measles that were 50 percent lower than states

> without mandates.

>

First of all, though this reviewer accepts that

the data presented is valid, he again notes

that: a) there is no report of a comparative

assessment of the overall health of the chil-

dren in these two groups of states, and

absent the average incident rates in the group

of states with vaccine mandates and the popu-

lation sizes of the to groups of states as

well as the baseline average measles rates in

each group of states before the measles vac-

cine was introduced, there is no way anyone

can assess the import of this relative " 50

percent lower " claim.

Second, since the count for " measles cases "

ignores those " measles cases " caused in those

inoculated with a live-virus measles vaccine,

the actual percentage of this decrease in

measles cases is probably significantly less

than the percentage claimed.

Further, this example fails to address today's

vaccination program realities for, for example,

hepatitis A.

Therefore, this reviewer finds that the gen-

eral assertions:

" School vaccination requirements have large-

ly contributed to a significant drop in dis-

eases and the complications that can be pre=

vented by vaccinations " ,

made here, while they may be substantive, a)

again, BEFORE CORRECTION, misrepresented vac-

cinations as " immunizations " ; are overly

broad; and c) are NOT supported by the evi-

dence presented.

In addition, with respect to the report's

assertion:

" Before the measles vaccine, measles caused

100,000 American children to be hospita-

lized and 3,000 to die every year " ,

this reviewer notes that, since the early

1960s death rates from measles were less

than 1,000 per year (see reviewer's Figure

" 1 " ) before an effective measles vaccine

was introduced in 1963, the report's

" 3,000 to die every year " statement, to

say the least, misrepresents the annual

measles deaths in the period just prior

to the introduction of an effective mea-

sles vaccine [35].

________________________________

[35] From the graph in reviewer's Figure " 1 " , it

appears that one has to go back into the late

1930s to find years where " 3,000 " died of mea-

sles; by 1950, annual measles deaths had drop-

ped below " 1,000 " .

>

>· Florida balances the need to protect the health

> of students in the classroom while respecting

> those with a religious opposition to immuniza-

> tions vaccinations. During an outbreak, any child

> who does not have protection against that specific

> disease is excluded from school. This includes

> children who have either medical or religious ex-

> emptions.

>

First, this reviewer finds the statements here

to be misleading because, if one were truly

balancing competing imperatives, the balance

would be a two-way street and not, as presented

here, a one-way one.

Furthermore, the statements here would have also

addressed these same issues for the staff and

visitors.

Moreover, the statement:

" During an outbreak, any child who does not have

protection against that specific disease is ex-

cluded from school " ,

intentionally misrepresents what Florida schools

do.

In general, Florida schools exclude those who lack

proof of vaccination against the specific disease

unless they can prove they are protected from con-

tracting that specific disease (generally by hav-

ing proof that they have had that specific disease),

while allowing those children who are vaccinated

according to Florida requirements to attend school

without requiring any proof that the vaccinations

the children have received are protecting each

child from contracting that specific disease.

Moreover, unless the day-care centers and schools

also exclude all, including staff, who have been

recently vaccinated with any live-virus vaccine

from attending for a period of not less than 21

days after vaccination, Florida day-care centers

and schools are ignoring the need to protect the

health of its " unprotected " (the unvaccinated who

have not had the disease and those vaccinated but

not protected) attendees or students, and staff

and visitors from those attendees or students,

staff and visitors who may be shedding live virus

and may thereby infect these unprotected indi-

viduals with whom they interact.

Thus, the report's language here should be revised

to simply state what Florida is actually doing.

Finally, this reviewer can only hope that the

Florida DoH will upgrade the information it pro-

vides to address the live-virus vaccine, live-

virus disease, staff and visitor quarantine and

risk issues he has raised.

>

>· The finding that lower vaccination rates caused

> higher rates of disease shouldn't be surprising.

> In 1991 a massive epidemic of measles in Phila-

> delphia centered on a group that chose not to im-

> munize vaccinate their children; as a consequence

> nine children died from measles.

>

While this reviewer is saddened by the death of

any child, this reviewer finds that the account

presented is at odds with the facts on several

points.

A quick Google search found:

A quick Google search found:

http://stason.org/TULARC/child-parent/vaccinations/1-3-What-is-herd-immunity

..html

which contained the following text:

" The nation [u.S.] has experienced a marked

increase in measles cases during 1989 and

1990. Almost one half of all cases have oc-

curred in *unvaccinated* preschool children.

(JAMA. 1991 Sep 18. 266(11). P 1547-52.)

'Beginning in October, 1990, a large measles

outbreak involving predominantly *unvaccinated*

preschool age children occurred in Philadelphia.

By June, 1991, 938 measles cases had been repor-

ted to the Philadelphia Health Department. In

addition to these cases, 486 cases and 6 measles-

associated *deaths* occurred between November 4,

1990, and March 24, 1991, among members of 2

Philadelphia church groups that do not accept

vaccination.' (Pediatr-Infect-Dis-J. 1993 Apr.

12(4). P 288-92.) "

Factually, the " 1991 a massive epidemic of measles

in Philadelphia " was only a large measles outbreak,

that outbreak spanned the period from October 1990

to June 1991, and involved 1,424 cases of measles.

In the 2 churches that did not accept vaccination

there " 486 cases of measles and 6 measles-associ-

ated *deaths* " - meaning that 98.77 % of those in

these churches recovered and only 1.23 % died.

Absent the ages of those who died and the exact

cause of death listed on their death certificates,

one cannot make any further presumptive statements

other than to say that the 480 who recovered had/

have near lifetime immunity from being infected

from that point forward.

Presuming the overall measles-associated death toll

was 9 and the overall cases were 1,424, this trans-

lates into a 99.74 % survival rate and, since the

account that this reviewer found did not mention

the other three measles-associated deaths indicates

that these may have been individuals who had been

vaccinated and still contracted a case of measles

to which they ultimately succumbed.

Returning to the literature, this reviewer found:

Morbidity and Mortality Weekly Report 1993 May 21;

42(19): 378-381, which states:

" Measles -- United States, 1992

As of January 2, 1993 (week 53), local and

state health departments reported a provi-

sional total of 2200 * measles cases for 1992

(1) -- a 77% decrease from the 9643 cases re-

ported for 1991 (2), and a 92% decrease from

the 27,786 cases reported for 1990 (3). Cases

were reported from 36 states and the District

of Columbia. This provisional total is one of

the lowest annual totals reported in the

United States; fewer cases were reported only

in 1982 (1714 cases) and 1983 (1497 cases) (4).

This report summarizes epidemiologic charac-

teristics of measles cases reported for 1992

and compares them with cases reported during

1989-1991.

From 1989 through 1992, the median age of per-

sons reported with measles declined steadily

(12.0 years in 1989, 5.7 years in 1990, 5.2

years in 1991, and 4.9 years in 1992), while

the proportion of cases among infants in-

creased. Of measles cases in 1992, 22.2% oc-

curred among children less than 12 months of

age, an increase from 19.2% in 1991 and 17.0%

in 1990; 27.9% of reported cases were among

children aged 1-4 years, compared with 30.1%

for 1991. Persons aged greater than or equal

to 5 years accounted for 49.7% of reported

cases, compared with 50.6% in 1991. A provi-

sional total of three measles-associated

deaths was reported in 1992 for Texas (two)

and Alaska (one).

Texas and Kentucky reported the largest out-

breaks (990 and 443 cases, respectively)

during 1992. The outbreak in Texas continued

the pattern of outbreaks reported during 1989-

1991 affecting predominantly unvaccinated pre-

school-aged children (2,3). Seventy-one per-

cent of cases in this outbreak were reported

from Nueces and Hidalgo counties; the other

cases were reported from 22 (9%) of 254 coun-

ties in the state. Most (75%) cases were

among children aged less than 5 years; 35% of

cases were among children less than 12 months

of age. In comparison, in Kentucky, measles

transmission occurred predominantly among chil-

dren aged 5-19 years (218 cases {49%}). Fifty-

one percent of cases from the Kentucky outbreak

were reported from Jefferson County (Louis-

ville); the remaining cases were reported from

34 (28%) of 120 counties in the state.

Reported by: State and local health depts. Div

of Immunization, National Center for Prevention

Svcs, CDC.

Editorial Note

Editorial Note: During 1989-1991, a period of

increased measles transmission, approximately

55,000 cases and 132 suspected measles-associated

deaths were reported. However, from mid-October

1992 through January 1993, no outbreaks of mea-

sles (i.e., five or more epidemiologically re-

lated cases) were reported, suggesting that the

measles resurgence in the United States has

ended. During the first 18 weeks of 1993, 80

measles cases were reported, representing only

13% of the number reported for the same period

during 1992. Possible explanations for the end

of the measles resurgence include a decrease in

susceptible populations following widespread

transmission of the virus; improved vaccination

coverage in the susceptible population; an over-

all decrease in the occurrence of measles in

the Western Hemisphere (5); and the periodic

cyclicity in measles transmission that has been

noted since the prevaccine era.

The magnitude of the recent resurgence is not

likely to have substantially reduced suscepti-

bility (2), even in cities with the highest

incidence of measles. For example, retrospec-

tive surveys of school enterers in 15 cities

indicated that coverage against measles ranged

from 51% to 79% at the time of the second

birthday (6,7); based on these findings, ap-

proximately 800,000-2 million U.S. children

aged 12-23 months would be susceptible. How-

ever, during 1989-1992, approximately 9300

cases of measles were reported among children

aged 12-23 months -- a number insufficient

to have substantially reduced overall sus-

ceptibility in this age group.

A reduction in measles susceptibility may

have occurred through increased measles vacci-

nation levels among preschool-aged children.

From 1971 through 1985, the United States Im-

munization Survey (USIS) demonstrated that

measles vaccine coverage among children aged

1-4 years ranged from 61% to 66% (CDC, unpub-

lished data, 1986). By comparison, the Nation-

al Health Interview Survey (NHIS) in 1991 tar-

geted the same population as the USIS and doc-

umented measles vaccine coverage to be 78%

among children aged 1-4 years -- the highest

level ever reported (CDC, unpublished data,

1993).

The estimates of increased vaccine coverage,

based on the NHIS, are consistent with data

indicating increased measles vaccine adminis-

tration in the public sector. During 1991 and

1992, 1,358,117 and 1,344,901 doses, respec-

tively, of measles vaccine were administered

in public clinics to children aged 12-23

months -- a 42% and 41% increase, respective-

ly, when compared with 1988 (953,535 doses),

the year before the measles resurgence (CDC,

unpublished data, 1993). In addition, in 1992,

provisional totals of reported mumps (2433)

and rubella (147) (1) were the lowest since

reporting began in 1968 and 1966, respectively,

reflecting the contribution of increased vac-

cination with combined measles-mumps-rubella

(MMR) vaccine.

In contrast to vaccination coverage for mea-

sles, mumps, and rubella, coverage against

other diseases has not increased substantial-

ly. In particular, NHIS findings for 1991

indicated that only 66% of children aged 1-4

years had received three or more doses of diph-

theria and tetanus toxoids and pertussis vac-

cine (DTP), and 51% had received three or more

doses of oral poliovirus vaccine (OPV) (Table 1)

-- coverage comparable to or lower than that

reported in previous years. Overall, only 42%

of preschool-aged children had received all

age-appropriate vaccinations **, although this

level may underestimate coverage because parents

may have failed to recall some doses of multiple-

dose vaccines (8). However, this level is sub-

stantially lower than the national health objec-

tive for the year 2000 of 90% complete series

coverage by the second birthday (objective 20.11)

(9).

Strategies to improve vaccination levels include

1) reducing barriers to vaccination (e.g., in-

creasing the number of clinic hours when vaccina-

tions are given and the availability of walk-in

vaccination services); 2) taking advantage of all

opportunities to vaccinate (e.g., simultaneous

use of multiple vaccines whenever possible, ex-

cluding from vaccination only persons with valid

contraindications); 3) using innovative vaccine

delivery techniques (e.g., vaccination in hospi-

tal emergency departments); 4) increasing the

number of children who return for vaccination at

the appropriate age by improving follow-up and

recall systems; and 5) providing education about

vaccination to parents (10).

A major comprehensive childhood vaccination ini-

tiative is under way to improve levels among pre-

school-aged children. The principal components

of this initiative are 1) improving the vaccine

delivery infrastructure through increased federal

funding for this purpose (e.g., increasing vacci-

nation clinic personnel and hours of operation,

particularly in the inner cities); 2) assuring

universal access to vaccination services; and 3)

assuring that computerized systems are estab-

lished in each state for tracking the vaccina-

tion status of all children.

To sustain the decrease in transmission of mea-

sles in the United States, and to achieve similar

results with other vaccine-preventable diseases,

age-appropriate vaccination coverage efforts must

be improved -- particularly among preschool-aged

children living in inner-city areas. Transmission

of measles among preschool-aged children is like-

ly to recur unless measles vaccine coverage is

improved and age-appropriate vaccination is en-

sured.

References

1. CDC. Table II. Cases of selected notifiable

diseases, United States, weeks ending January

2, 1993, and December 28, 1991 (53rd week).

MMWR 1993; 41: 981.

2. CDC. Measles surveillance -- United States,

1991. In: CDC surveillance summaries (Novem-

ber 20). MMWR 1992; 41(no. SS-6): 1-12.

3. CDC. Measles -- United States, 1990. MMWR

1991; 40: 369-72.

4. CDC. Summary of notifiable diseases, United

States 1991. MMWR 1992; 40(no. 53): 57-62.

5. Pan American Health Organization. Reported

cases of EPI diseases. EPI Newsletter 1992;

14: 7.

6. CDC. Measles vaccination levels among selec-

ted groups of preschool-aged children --

United States. MMWR 1991; 40: 36-39.

7. CDC. Retrospective assessment of vaccination

coverage among school-aged children -- selec-

ted U.S. cities, 1991. MMWR 1992; 41:103-107.

8. Valadez JJ, Weld LH. Maternal recall error

of child vaccination status in a developing

nation. Am J Public Health 1992; 82: 120-122.

9. Public Health Service. Healthy people 2000:

national health promotion and disease preven-

tion objectives. Washington, DC: US Depart-

ment of Health and Human Services, Public

Health Service, 1991; DHHS publication no.

(PHS) 91-50213: 76.

10. CDC. Standards for pediatric immunization

practices. Atlanta: US Department of Health

and Human Services, Public Health Service,

1993. "

Based on the preceding document, it is clear that,

at the end of the 1980s and extending into the ear-

ly 1990s, there was a general resurgence in mea-

sles in the USA that peaked at 27,786 cases in 1990,

and that the coverage level (in the high 60s to 70s

in percentage in those age 1 to 4 years of age) was

insufficient to prevent measles cases surging from

a background of about 2000 before (1987) and after

(1992) the resurgence peaking in 1990.

Given the much higher vaccination level to day, the

surge in measles cases in late 2007 through mid-2008

may be but another cyclic up-tick in an environment

where the background rate for annual measles cases

is, with 2 doses of MMR and >90% coverage, current-

ly about 50 cases/year instead of the <2400 cases/

year seen in 1980's and early-1990's America.

Moreover, except for the 1989 - 1990 outbreak in the

Philadelphia area, very few measles-associated deaths

have since occurred and, apparently because of vacci-

nation-related factors, the percentage of measles

cases in those who are too young to be vaccinated

(under 1 year of age increased) from 17.0% in 1990

to 22.2 % in 1992.

However, the preceding realities indicate that this

example has little to do with today's world where

the uptake level is >90 % for 2 doses of MMR instead

of <70% for 1 dose of measles vaccine.

>

>And in 2005, a 17-year-old unvaccinated girl who un-

>knowingly brought measles back with her from Romania

>attended a church gathering of 500 people in Indiana

>and caused the largest outbreak of measles in the

>United States in ten years; this outbreak was limited

>to children whose parents had chosen not to vaccinate

>them.

>

As this reviewer has previously reported in other

reviews addressing the outbreak in Indiana referred

to in this report, this outbreak was not " limited

to children whose parents had chosen not to vacci-

nate them " .

In fact, the person most seriously affected was the

hospital lab worker in his 30s who, though vaccina-

ted, contacted measles and then developed measles-

related pneumonia.

Blatant factual distortion, such as reported here:

Ø Does little to increase public confidence in

our vaccination programs and

Ø Undermines the credibility of public health

officials and other vaccine apologists who

continual make such statements.

>

>These events showed that, for contagious diseases

>like measles and pertussis, it's hard for unvacci-

>nated children to successfully hide among herds of

>vaccinated children.

>

First, since the only events reported here are

for measles, it is somewhat disingenuous to

associate the contagiousness of pertussis with

that of measles.

Second, these events only show that it is dif-

ficult for unprotected, including the never

vaccinated and the vaccinated who fail to be

protected by the vaccinations they have re-

ceived, individuals to avoid contracting mea-

sles when they are exposed to live measles

virus, including, in some cases, the live mea-

sles virus shed by those who have been vacci-

nated with any live-virus measles vaccine.

Furthermore, it is not appropriate to speak of

" herds of vaccinated … " here because both of

the examples provided here speak to exposure in

population segments where the most affected

groups mentioned were comprised of mostly unvac-

cinated children and adults.

>

>The following table reflects school entry exemptions

>and school population data for the states with a

>philosophical exemption.

>

Accepting that the information provided in this

table is correct, this reviewer notices that, in

those states with complete surveys at both grade

levels, the % of philosophical exemptions de-

clines in the " Grade School " survey from the

" Kindergarten " survey's percentages.

In Florida, where most children were surveyed and

there is no philosophical exemption, the religious

exemption also declines from 0.6 % to 0.4%.

Since, for the philosophical exemption, these de-

clines are the confounded confluence of several

factors, this reviewer only notes that those fac-

tors include:

v Use of an exemption by parents to delay the

timing of vaccinations that they eventually

have administered to their children, and

v Increased use of an exemption to avoid all

or certain vaccines as vaccination concerns

grow for these vaccines.

>

> School Immunization Assessment Survey Results,

> 2006/2007 School Year

>

> REPORT'S TABLE OMMITTED

>

>

> request 10

>DOH/DOE: The number of unvaccinated people in Florida

>and incidence. Funding an epidemiological study.

>

>Data is not available to provide the number of unvac-

>cinated people in Florida. Reporting of all vaccina-

>tions administered in Florida into the centralized

>vaccination registry is voluntary and not mandated

>by law. The following provides a description and con-

>siderations for designing a study of vaccine exposure

>and autism spectrum disorders.

>

For conditions that are subpopulation related, as

neurodevelopmental disorders seem to be, straight

raw epidemiological studies of the unvaccinated

versus those who have received even one dose of

vaccine using the outcomes " autism " and/or " autism

spectrum disorders (ASDs) " should be recognized as

exercises designed NOT to find significant evidence

of a linkage.

>

>Summary

>

>This document reviews options available for an epide-

>miologic study to address the question, " Is the rate

>of autism or autism spectrum disorders (ASDs) signi-

>ficantly lower in Florida children who have received

>no doses of any vaccine, than in children who have

>received one or more doses of vaccine? "

>

If the goals was to answer the question about the

rates for autism and/or ASDs in Florida children

where reasons for no vaccination were not related

to a pre-existing health issues as compared the

rates in Florida children where the children have

been fully vaccinated until age 6 or they are

diagnosed with an ASD, then this reviewer might

support such studies provided they were NOT de-

signed by a person or persons who, because of

their position or patronage, were predisposed to

minimize any link that such studies might find.

>

>The smaller the difference one wants to detect in a

>study, the larger the needed number of study subjects

>is. Also, sample size has to be very large for a study

>where both the exposure (no vaccines) and the disease

>(autism) are uncommon. Such a study requires an ade-

>quate number of subjects who have both the exposure

>and the disease. Autism spectrum disorders taken to-

>gether have a cumulative incidence of 5 to 10 children

>per 1000 by age 8, and receiving no vaccines is quite

>rare, at 1% or less of all children at age 2 to 3 years

>old. A study would likely have to include most, or all,

>autistic children in the state. There is no central

>registry of all these children, or of the vaccine sta-

>tus of all children.

>

>The best option is an alternative cohort study design,

>in which immunization histories are obtained for all

>autistic children in a certain age range in a defined

>geographic area, and the size of the population of

>children with no or some doses of vaccine received by

>that age living in that area is estimated from immuni-

>zation surveys. If a wide enough age range of children

>is included, and if significant data access issues can

>be resolved, it might be possible to do such a study in

>the geographic area covered by the CDC-sponsored Univer-

>sity of Miami ASD prevalence project.

>

>Because of the large sample sizes needed for any of

>these studies, they are likely to be expensive to carry

> out. While an exact dollar amount cannot be estimated

>without knowing precisely which question is to be an-

>swered, and thus what the details of the study design

>would be, it would be wise to assume such a study would

>take at least two years to complete.

>

The Case-Control Alternative

Rather than even attempt to conduct the types of retro-

spective studies outlined above, the Florida DoH would

do well to identify as many children with an ASD that

they can find, assign them to the appropriate cohort

year, and then, as part of a full differential diagnos-

tic workup, including genetic screening, screen all of

these children for the following markers:

1. For those who have not received prolonged effective

mercury-specific chelation treatments with DMPS or

DMSA that are designed to lower level of tissue-

bound mercury and/or lead in the body, mercury and/

or lead poisoning based on the LabCorp random-sam-

ple urine porphyrin profile analysis " UPPA " ,

2. Full panel hormones assessment in blood, with spe-

cial focus on the androgen levels, DHEA, DHEA-S,

and the hormones that control their levels in un-

affected children,

3. Transsulfuration metabolites in blood and bile

levels,

4. Levels of glutathione, reduced glutathione, cys-

teine, homocysteine,

5. The strength assessment and mitochondrial func-

tion markers in blood, and

6. Methylation markers.

As controls, the researchers should choose matched

children with no evidence of neurodevelopmental def-

icit or behavioral problems and perform the same

work ups.

Next, the researchers should compare the findings

from the group with an ASD diagnosis to the diagnos-

tic outcomes for the control group.

Then, those markers for each ASD diagnosis that are

the most significantly elevated or depressed in the

test group over the levels in the matched controls

not only identify those markers as the key markers

for each ASD but can also be used to appropriately

screen all Florida children for assessing their ASD

risk.

Since the ASDs are conditions where the diagnosed

child has significant deficits, the goal should be

to use the key markers developed to identify future

children who may be at risk of developing an ASD and

appropriately intervene to stop that development or

lessen its impacts on the child's development.

One advantage of these studies is that children new-

ly diagnosed with a given ASD could be dynamically

added to the test cohort as they are identified and

the appropriate differential diagnostic workups used

to confirm the causal factors for the ASD diagnosis

assigned.

>

>Study questions

>

>One interested party has described the study question as

>whether autism ever occurs in children who have received

>no vaccines. Since autism was first described as a syn-

>drome in the early 20th century, before vaccines came in-

>to use, receipt of vaccines is not a necessary precursor

>to or cause of autism or autism spectrum disorders.

>

First, serums for diphtheria and tetanus were in use

in the USA in the 1930s, and the vaccina (cowpox) vac-

cine for smallpox had been in widespread use and the

rabies vaccine had been in use in humans since the

late 18th/early 19th centuries.

Thus, contrary to the narrative in the report, vac-

cines obviously predate autistic disorder (autism)

or the other autism spectrum disorders in all but

the surreal history created here by those who fab-

ricated it.

However, this reviewer concedes the reality that " re

ceipt of vaccines is not a necessary precursor to or

cause of autism or autism spectrum disorders " although

the evidence is, and medical professionals have con-

ceded, that the receipt of vaccines can be a suffi-

cient causal factor for a child to be diagnosed with

autistic disorder or another autism spectrum disorder.

Moreover, looking into American history, autism was

diagnosed after the start of the use of organic mercury

compounds as biocides (mainly alkylmercury fungicides)

in agriculture in the 1930s through the 1970s - a use

that abruptly ended when researchers recognized the bio-

accumulative toxicity of these compounds.

In addition, starting in the 1930s, organomercurials

were used as antiseptics (mainly, Thimerosal and Mer-

curochrome) until being banned from over-the-counter

[O-T-C] antiseptic drugs in 1998.

The FDA also banned the use of Thimerosal in vaginal

O-T-C contraceptives in 1998.

The use of organomercury compounds (mainly Thimerosal

and, to a much lesser extent, phenyl mercury acetate)

as preservatives in biological preparations, injected

and infused medicines (vaccines, plasma, immunoglobulin

products, antisera [principally, snake and spider anti-

venins], and other biopharmaceutical products) also

began in the 1930s.

However, the use of Thimerosal in all but vaccines and

possibly some monoclonal antibody products, was volun-

tarily discontinued by the manufacturers starting in

the 1950s with plasma, then proceeding to most immuno-

globulin, antisera, and other drug products so that

most uses had been abandoned by the start of the 21st

century.

Thus, by 2002, the principal remaining disclosed use

of alkylmercury compounds in medicine in the USA was

the use of Thimerosal in vaccines.

Given:

v The strong temporal and proximity connection be-

tween organic mercury compound use starting in

the 1930s and the definition of " autistic disorder "

by Dr. Kanner in the USA in the 1940s as well as

v The strong probable link between the use of Calomel

(inorganic mercury; mercury (I) chloride [Hg2Cl2])

and " Pink " disease, which disappeared a few years

after all Calomel-containing medicines were taken

off the market in the 1940s in the USA but not un-

til 1956 in Australia,

the link between the inadvertent or adverent exposure

to alkyl (organic) mercury compounds in the mid 1930s

and the characterization of " autistic disorder " in the

early 1940s seems to clearly establish that " autistic

disorder " , a cause-unknown disorder, and the other

ASDs are simply various manifestations of subacute

mercury poisoning in a genetically diverse population

of developing children exposed to low but toxic and

bioaccumulative doses of Thimerosal from before birth

onwards.

If the reader wishes to pursue this line of reasoning,

he or she should consider visiting the Internet web-

site:

http://www.mercury-freedrugs.org

and read the evidence presented there in the many

pertinent documents discussing this issue that are

posted there by this reviewer in the " Documents "

webpage

Based on all the research papers that this reviewer

has studied, the evidence is overwhelming that vac-

cine-derived Thimerosal mercury poisoning has been

and, to a somewhat lesser extent, still is a major

causal factor in most of the children who have an

ASD diagnosis.

Moreover, the recent reduction in the average level

of Thimerosal exposure from the removal Thimerosal

of, or the reduction in the level of Thimerosal in,

some vaccines has been offset by adding the mostly

Thimerosal-preserved influenza vaccine to the vac-

cination recommendations for pregnant women as well

as for children 6-months of age to:

Ø 23 months of age in 2002,

Ø 36 months of age in 2003/4 with 2 doses the first

time vaccinated,

Ø 59 months of age in 2005/6,

Ø 59months/107 months of age in 2007, and

Ø 18 years of age in 2008/9 [36].

_____________________________________

[36] Coincidentally, as the total maximum level of

Thimerosal-derived mercury exposure from the

non-influenza vaccines has declined, the CDC

has broadened the recommendations for the use

of influenza in children.

The CDC has done this even though several

studies have clearly established that the in-

fluenza vaccines are not effective in protec-

ting those vaccinated from contracting influ-

enza and there is a proven dietary influenza

preventative ( " daily " intake of (or sun-expo-

sure to produce) 1,000 to 5,000 IU [25 to 125

micrograms] of vitamin D-3, a vitamin that has

recently been proven to have other significant

health benefits).

Moreover, the CDC's recommendations that

pregnant women should be given a flu shot that

can be Thimerosal-preserved (and, when it is,

exposes their developing fetus to a 25-micro-

gram bolus of Thimerosal-derived mercury) is

even more troubling because: a) all inactivated

influenza vaccines are Pregnancy Class C drugs

having unknown fetal safety, studies pub-

lished in a 1977 book, Birth Defects and Drugs

in Pregnancy, by Heinonen et al., clearly es-

tablished that pregnant women given Thimerosal-

preserved flu shots were an associated factor in

the increased levels of severe birth defects

(cleft palate, hydrocephaly, pyloric stenosis)

seen in their offspring, and c) Thimerosal is a

proven human teratogen at levels below 1 ppm

(levels more than 100 times lower than the level

of Thimerosal in a Thimerosal-preserved vaccine).

Based on the preceding realities, it seems

clear to this reviewer that the CDC is adding

Thimerosal to offset the drop in mercury exposure

so that the number of children diagnosed in the

ASD spectrum will not decline precipitously.

Supporting this reality are the general obser-

vations by those who treat children with an ASD

diagnosis that the severity in each category,

autistic disorder, PDD-NOS, and Asperger's, is

dropping and, in some states, a percentage shift

from autistic disorder to PDD-NOS and from PDD-

NOS to Asperger's is being observed.

Perhaps that explains the reason the CDC has

refused to do any " autistic disorder only " or

separate category surveys or to update their 2002

surveys of 8-year-olds nominally born in 1994 in

New Jersey, the state with the highest ASD rate,

as reported in 2007, to a 2007 survey of 6-year

olds born in 2001 in New Jersey before, coinci-

dentally, the New Jersey mandate to vaccinate all

children up to age 3 became effective.

>

>So perhaps the question can be reformulated as, " Is the

>rate of autism or autism spectrum disorders (ASDs) sig-

>nificantly lower in children who have received no doses

>of any vaccine, than in children who have received one

>or more doses of vaccine? "

>

As those who are posing these questions know all too

well, the questions asked need to be much more speci-

fic and to be population-segment targeted if one seeks

to find causal links.

However, when possible causal links have been estab-

lished, attempting to answer questions such as this

is a waste of resources better spent in assessing

the magnitude of the risk for each possible causal

factor identified using case-control studies to elu-

cidate the probable impact for each of the estab-

lished causal factors.

>

>A closely related question would be, " Is the rate of

>autism or ASDs greater in children in proportion to the

>number of doses of vaccines received?' While this latter

>question would have to be refined in an actual study

>design, the question would be whether children who have

>received 4 different injections have a higher rate than

>those who have received 3 injections, which in turn is

>higher than in those who have received 2, 1, or 0 injec-

>tions. The measurement of vaccine exposure in such a

>study would also have to be refined to take account of

>the number of different antigens contained in each vac-

>cine dose received. "

Since independent researchers have already conducted

these studies using both VAERS and the VSD and found

causal linkages between the cumulative dose of mer-

cury and the risk for various neurodevelopmental dis-

orders including autistic disorder (autism), this

reviewer sees no need to more of such studies.

Perhaps more studies looking at the impact of measles

doses on neurodevelopmental disorders would be helpful

since, for the current MMR vaccine, the measles com-

ponent has the most potential to cause neurodevelop-

mental damage to the central nervous system and, for

the current DTaP/Tdap vaccines, perhaps a similar

doses study for the effect of the dose of pertussis

toxin might be informative.

>

>The material that follows is based on answering the

>original question, about ASD risk associated with no

>vaccine versus any vaccine. Different questions may be

>of interest, for example comparisons of ASD risk in re-

>lation to the age at first dose of vaccine, or number

>of doses of vaccine or number of antigens received by

>a certain age, or the maximum number of antigens admin-

>istered on any one visit. Addressing these would in-

>volve similar study designs and sample size considera-

>tions as those described here, but the details would

>be different. In particular, the needed level of detail

>about exact immunization histories needed for these

>alternative questions may not be available in the

>statewide 2-year-old survey and thus the best option

>mentioned above may not be feasible.

>

Since valid UPPA testing in children with an ASD

diagnosis have established that >75% of those with

an ASD diagnosis are mercury poisoned, it would

seem better to set up a screening program to perform

a valid UPPA test on all Florida children who are 8

years of age and younger and who have not been pre-

viously extensively chelated with DMSA or DMPS to

reduce their body burden of mercury and other heavy

metals, and then do a differential diagnostic work

up designed to find all medical conditions on the

children who the UPPA test results indicating they

have indications of heavy-metal toxicity (body bur-

den) from mercury, and/or lead, and/or arsenic.

>

>Study design options

>

>In general, epidemiologic studies fall into three cate-

>gories: cohort studies, case-control studies, and

>cross-sectional studies. All are designed to see if

>there is an association, not due to chance, between

>particular exposures and particular disease outcomes.

>In cohort studies, people are enrolled based on whether

>they do or do not have a particular exposure or charac-

>teristic of interest, and then are followed over time

>to determine whether they develop the outcomes of in-

>terest. If there is an association between the expos-

>ure and the disease, there will be an increased rate

>of the disease in those with the exposure compared to

>the rate in those not exposed. Subjects must be en-

>rolled as exposed or unexposed without any knowledge

>of their eventual outcome. Cohort studies can be pro-

>spective, where subjects are enrolled now and followed

>into the future, or historical, where subjects are

>enrolled retrospectively, often many years after the

>fact, and then followed until the present.

>

Since the ASD epidemic seems to be at, or near, its

peak, and there are many other childhood medical

conditions that may be vaccine related and are al-

ready at epidemic levels, cohort studies would waste

valuable time in which properly diagnosed children

could be treated before the harm from their medical

condition becomes non-reversible.

Thus, cohort studies should have the least priority.

Moreover, retrospective epidemiological population

database surveys should be limited to those medical

conditions where there is no established/conceded

link between the medical condition and one or more

vaccines/vaccine components (e.g., childhood asthma

or childhood idiopathic cardiomyopathy).

>

>In case-control studies, people are enrolled based on

>whether or not they have a particular disease, and are

>then studied to determine whether they had certain

>exposures of interest in the past. If there is an

>association between the exposure and the disease, the

>proportion of those with the disease who have the

>exposure will be higher than the proportion among

>those without the disease. Subjects must be enrolled

>as cases or controls without knowing whether they had

>the exposure of interest.

>

While this reviewer supports the use of case-control

studies and finds that, when the medical condition

is at epidemic levels as it is for autistic disorder,

the other ASDs, and many other childhood disorders

that, in the 1960s, were unknown or virtually un-

known, (e.g., childhood type 2 diabetes), this is

the preferred approach that should be used in all

such studies.

>

> In cross-sectional studies, people are enrolled from a

>population without knowing whether they are exposed or

>not, and without knowing whether they have the disease

>of interest or not. This approach is commonly used in a

>random sample questionnaire survey of people from a pop-

>ulation, for example the population of people who par-

>took of a meal that was followed by a gastroenteritis

>outbreak, or the population of a town with a suspected

>waterborne disease outbreak.

> Cohort studies are particularly useful with reasonably

>common diseases, and can be used to study multiple out-

>comes. They usually take a long time to complete, un-

>less done as historical cohort studies. If the study

>is historical, the investigator usually has much less

>control over how exposure was measured or assessed.

>Cohort studies are very inefficient for rare diseases,

>because large numbers of subjects have to be enrolled

>to be reasonably sure an adequate number of cases will

>occur for study. Case-control studies are particularly

>useful with rare diseases, but again retrospective ex-

>posure assessment can be limiting. Case-control studies

>also require large sample sizes if the exposure is also

>rare.

>

Since this reviewer has no problem with the state-

ments being made here, he sees no need to review

them in depth.

>

>Baseline data for Florida

>

> Data from the Florida DOH annual random sample of two-

>year-old immunization levels show that quite consis-

>tently, from year to year, about 1% of Florida chil-

>dren aged 2 to 2.9 years old have received no doses

>of vaccine. A federal telephone survey carried out

>nationally each year suggests that the Florida per-

>centage is much lower, with around 0.3% of children

>having no vaccine doses on board at age 2 to 2.9

>years. That same federal study shows that children

>with no vaccines fall into three quite diverse groups:

>children with low-education, low-income parents who

>do not have access to health care services; children

>with high-education, high-income parents, who have

>access to health care services but do not vaccinate

>their children for religious or philosophical reasons;

>and children with medical contraindications to vacci-

>nation.

> While we do not have exactly comparable data avail-

>able at school entry, the percentage with no vaccines

>on board cannot be lower for any birth cohort than it

>was at age 2 to 2.9 years old.

> The expected prevalence of autism and ASD by age 8

>years, using the methods of the CDC-sponsored autism

>surveillance sites, is about 5 to 10 children per 1000,

>or 0.5 to 1%. If the percentage with no immunizations

>is 1%, then for each one-year birth cohort of 220,000

>live births, there would be about 2200 unimmunized

>children at age 2. The expected number of autistic

>children (that is, children with a diagnosis of an

>autism spectrum disorder) by age 8 in that cohort of

>2200 children would be 11 to 22. If we were to combine

>5 one-year birth cohorts, the expected number would be

>55 to 110 autistic children by age 8. These children

>would amount to approximately 0.5 to 1.0% of all

>autistic children in Florida, if there was no protec-

>tive effect of non-vaccination.

> These calculations would have to be refined to ac-

>count for children who move in or out of Florida be-

>tween birth and age 8 years. Also, by age 8 some of

>the children with no doses of vaccine at age 2 to 2.9

>years will have received one or more doses of vaccine,

>perhaps for attendance at daycare or school. For pur-

>poses of this proposed study, the investigators would

>need to be clear about what they would consider to be

>a child not exposed to vaccines: never exposed before

>autism diagnosis, or not exposed prior to a particular

>age.

>

This reviewer finds the information reported here

to be plausible and helpful even if the true rate

for all ASD cases is closer 1.5 to 3 % of children

than it is to 1% or less.

>

>Cohort study options

>

> A straightforward cohort study would involve iden-

>tifying all the totally unvaccinated children who

>had been born in Florida in a certain time period,

>verifying they have received no doses of vaccine by

>age 2 or 3, and then determining if they have devel-

>oped autism by some specified age. A similar cohort

>of vaccinated children would also be followed up.

>This is not practical, as there is no central regis-

>try of children at this age who have not received

>any vaccines.

> An alternative approach to a cohort study might be

>to gain access to a complete list of Florida-born

>autistic children in Florida, such as might be the

>result of applying the methods of the current Miami-

>Dade county prevalence study to the entire state.

>The entire population of live-born infants for a

>five-year study period could be considered to be the

>cohort of interest. We would then ascertain the com-

>plete vaccination history of all these autistic

>children, and thus identify all those who have never

>received doses of any vaccine, only a few doses, or

>a full complement of vaccines. The denominators for

>these two incidence rates would be the estimated

>number of children who had zero and any doses of

>vaccine by age 3, from the annual Florida vaccina-

>tion survey.

> We can then estimate incidence rates in the birth

>cohort, for those who have received no doses of vac-

>cine by age 3 and those who have received one or

>more doses of any vaccine by age 3.

> One weakness of this approach is that we have two

>conflicting estimates for the percentage of Florida

>children aged 2 to 2.9 years old, one from a Florida

>Department of Health survey and one from a national

>survey with many Florida respondents. One would have

>to decide which of these to rely on. The fact that

>the vaccination histories of the autistic children

>would have been derived from a different methodology

>than either of the surveys would also be a methodo-

>logic issue.

> Another weakness is that there is currently no

>state-wide autism registry using the CDC/University

>of Miami methods. If this study were to be done with

>just Miami-Dade County subjects in the CDC-funded

>University of Miami prevalence study, it would have

>only about 15% as large a sample size as a statewide

>study. This reduction in sample size would result in

>about a tenfold reduction in statistical power to

>detect a two-fold difference in incidence between

>the two groups.

> It is important to do a study of this type in a set-

>ting where the probability of inclusion in the study

>is the same for all persons with the same condition

>(ASD here). Including data from the health and special

>education information systems of many different school

>systems is not advisable, without the kind of quality

>control that is included in the CDC-sponsored preva-

>lence study area projects.

> Study size would likely be further reduced by exclu-

>sion from the numerator and denominator of the rates

>of some or all of the children who had medical contra-

>indications to some or all vaccines. Such children

>might be at increased risk of developing ASDs or other

>neurodevelopmental conditions, and thus would not be

>a good population to include in the proposed study.

> Any study of this type would need to account for num-

>erous potential confounders of the relationship be-

>tween vaccine receipt and ASDs, since healthy children

>who receive no vaccines are different in many ways from

>those who do receive vaccines. One way to recruit chil-

>dren who have received no doses of any vaccine would be

>from religious communities who object to vaccination.

>In some states, such communities are highly visible and

>localized and it would be relatively easy to recruit

>families systematically from such communities. In Flori-

>da, however, families with such beliefs can be found in

>all parts of the state in relatively small numbers. The

>impression of county health department staff is that the

>parental decision to request a religious exemption at

>school entry is highly individual, even among families

>who belong to religious communities that have objections

>to vaccinations.

> At school entry, approximately 0.6% of children entering

>kindergarten (in 2007, this was 1,362 children) are enrol-

>led with religious exemptions, as well as 0.4% of children

>in seventh grade (925 children). DOH does not know the

>identities of these children. Children attending school on

>religious exemptions may have received some doses of vac-

>cine. It would probably be worth determining how many chil-

>dren could be recruited for an epidemiologic study in

>Florida through religious congregations and religiously-

>oriented schools, and how many of those would be totally

>unvaccinated. If the number is sufficient, such children

>could serve as the basis for a cohort study.

>

Given the reality that cohort studies take time, it is

or should be obvious that, when diseases are at epidemic

levels: a) the cohort-study approach should not be pur-

sued and discussing it in detail, in this section,

detracts from this report's real-world relevance.

>

>Case-control study options

>

>In a case-control study, we would select a group of

>autistic children (cases), and a group of non-autis-

>tic children (controls) of the same age, and deter-

>mine their immunization histories. A project of

>this type could be done by sampling the case sub-

>jects from the records of one or more large autism

>treatment centers or school systems, and selecting

>control subjects at random from the same communities

>from which the cases came.

> Sample size issues are also important here, however.

>It would take approximately 7,000 subjects (2,000

>cases and 5,000 controls) to have an 88% certainty

>of being able to detect an odds ratio of 2.0 (that

>is, the odds of disease are twice as high in the

>exposed as in the non-exposed), for the association

>between " any vaccine receipt " and ASD. In Florida,

>in each one-year birth cohort about 1,100 to 2,200

>autism cases are expected. If five one-year birth

>cohorts are included in the study, about 5,500 to

>11,000 children would be available for study, so

>from 10 to 40% of all autistic children in the

>state would have to be included as cases in the study.

>

While this reviewer finds the narrative provided

initially useful, when it begins to discuss

sample size considerations, the discussion veers

from reality into the surreal because the small

(<100 cases) case-control studies on children

with ASDs and their matched controls that have

been published have, for the factors assessed,

found that the magnitudes of the effects identi-

fied have been anything but small so far.

In addition, since the state public health of-

ficials have access to most of Florida's chil-

dren and each vaccine's disorder-causing ef-

fects extend beyond ASDs in specific and neu-

rodevelopmental disorders in general to en-

compass many other identified chronic child-

hood medical conditions where the apparent

odds ratios exceed 5.0, it would seem that

the Florida DoH should start these studies

as soon as possible.

Moreover, given its access and reach, the

Florida DoH should be able to complete the

requisite studies in less than 18 months -

since independent researchers, with much

less access and reach, have been able to

complete their definitive case-control

studies in less than a year.

Hopefully, after reading the existing peer-

reviewed case-control studies published

in 2006, 2007 and 2008, the authors of

this section of the report will appropri-

ately revise this section.

>

>Cross-sectional study options

>

>In a cross-sectional design, we would enroll chil-

>dren in the study in some region of the state,

>for example at school entry, without knowing either

>their vaccination or their autism diagnosis status.

> The assumption here is that all children who reach

>school-entry age are registered for school, even

>if they are moderately or profoundly disabled. The

>biggest challenge of a study of this type would be

>assuring uniform diagnostic criteria for ASDs

>across multiple schools and school districts.

> School personnel already ascertain vaccination sta-

>tus at the moment of school entry, which in princi-

>ple should allow identification of children with no

>doses of any vaccine. This may or not be recorded

>unambiguously for children seeking enrollment under

>medical or religious exemptions; this would have to

>be explored further. Also, if the desire is to iden-

>tify children who had received no doses by a parti-

>cular cut-off age like 2 or 3 years, then full vac-

>cination histories would have to be obtained for all

>children, to find those who had received at least

>some vaccines between age 3 and school entry but none

>before.

> Sample size considerations would argue strongly

>against this study design. Unless a very large frac-

>tion of the state or the whole state was included

>in the project, the number of subjects enrolled for

>the study who turned out to be autistic would be too

>small to allow for adequate study power to detect a

>small increase in risk.

>

This reviewer agrees with the report's findings

that the Florida DoH should not attempt to use

a cross-sectional design to attempt to assess

the causal links between each vaccine in the

Florida vaccination program and ASDs because of:

v The large population size required,

v The complexity in establishing the true level

of exposure for some vaccine components that,

for nominally the same vaccine, have had mul-

tiple formulation changes, with overlapping

distribution, in the period from 1999 through

2008, and

v The need to include CDC-recommended vaccines

that some Florida children received and are

receiving even though they were/are not " re-

commended " .

>

> request 11

>

>What is the risk of waiting until 24 to 30 months

>to introduce vaccinations?

>

>In general, infants are our most vulnerable popu-

>lation to infectious diseases. Their ability to

>fight off potential deadly diseases has not fully

>developed in comparison to older children and

>adults. Any delay in providing this necessary

>prevention increases the risk of their contrac-

>ting these life-threatening diseases and develop-

>ing severe complications or death.

>

Here, this reviewer finds that the narrative

is much too simplistic.

Case 1: The Nursing Naturally Immune Mother

If the child is carried by and, after delivery,

nursed by a mother who, by having been exposed

and developed " natural " immunity to the dis-

eases to which her child may be exposed, sup-

plies full antibody protection to her child

through her breast milk, that child may be

" fully " protected from these diseases while

the child's immune system develops until his or

her immune system can handle exposure to these

diseases without being significantly harmed by

these diseases.

Thus, for these mothers, delaying any conside-

ration of vaccination while nursing and/or

feeding her child her expressed milk may not

increase " the risk of their contracting these

life-threatening diseases and developing severe

complications or death " .

Moreover, since the natural period of nursing

extends to from two to four years, a mother

who nurses and/or feeds the child her expres-

sed milk until she starts to dry up may be easi-

ly able to wait until her child is 24 to 30

months of age to begin vaccination with those

vaccines she thinks are appropriate.

Given the first live-virus vaccines are recom-

mended for 12-15 months of age, it would proba-

bly be best that lactating mothers nurse for at

least 12 months if at all possible.

If vaccination is planned for her children, a

lactating mother who plans to nurse longer than

12 months may want to consider starting the plan-

ned vaccinations at least 6 months prior to the

intended end of nursing.

Case 2: The Nursing Mother with Both Natural

and Vaccine-acquired Immunities or Only Vaccine-

acquired Immunities

For the diseases for which she has natural im-

munity and/or the ones for which vaccination

confers long-term protection, the reality is

that it may be safe for these mothers to delay

vaccination for these diseases until she stops

nursing.

For those disease for which the vaccines do not

confer long-term immunity and having the commu-

nicable disease does, then, these parents should

not be too worried about having her child con-

tract these diseases while breastfeeding.

However, even while nursing, if she plans to

vaccinate her children, she may want to con-

sider starting some of the vaccinations for

them before she stops nursing.

Case 3: Children Who Are Neither Nursed Nor Fed

Human Milk

These are the children for whom there is a

significant early disease risk that only in-

creases if vaccination is significantly de-

layed.

However, as a recent study on the effect of

delaying the start of the DTaP vaccine series

by " 2 months " showed, short delays can signi-

ficantly reduce the risk of adverse vaccine

effects associated with the development of

chronic medical conditions.

Given the trade-offs inherent in these deci-

sions, the parents or guardians of children

who are not breastfed face difficult choices

for which there are no guaranteed right an-

swers.

However, these parents or guardians may be

able to use the background case rates in the

USA for children under 1 and children 1 to 4

as an aide in making these decisions.

In addition, for these children, the risks

for disease increase if they are placed in a

childcare environment and, in these cases,

significantly delaying vaccination may signi-

ficantly increase their risk of infection

before their immune systems may be able to

provide an effective defense against the

disease they have contracted.

Hopefully, these broad generalizations will

help the reader to frame their risks in terms

of how at one with nature their feeding and

care choices are as well as how much exposure

risk that the parents, caregivers, and the

children may have.

>

>· Many of the diseases vaccines protect against are

> very dangerous to infants. Newborns, babies, and

> toddlers can all be exposed to diseases from par-

> ents, other adults, brothers and sisters, at child

> care, on a plane, or even at the grocery store.

> International travel is easier than ever-an infant

> can be exposed to diseases from other countries

> without a parent knowing.

>· Infants and children stand to benefit the most from

> vaccines, as they are the most vulnerable to disease

> and the least likely to have been previously exposed

> to infection and acquired natural immunity.

>· Waiting until a child is 24 to 30 months of age to

> be immunized exposes the young infant to serious and

> possibly deadly diseases that can be prevented.

>

Here, this reviewer finds that the three preceding

bullets present the biased views of those who neither

recognize nor appreciate all of the advantages/pro-

tections that extended breastfeeding provides to the

developing infant nor even see the problems presented

by replacing breastfeeding with formula feeding.

>

>· Many people think that they don't have to vaccinate

> their children because the risk of vaccine-preventable

> diseases is so low. However, lapsing immunization

> rates are the reason why epidemics begin-both in this

> country and abroad. It has happened in our time, and

> can happen again if children fail to be vaccinated.

> --Between 1989 and 1991, lapsing rates of MMR vaccina-

> tions among preschoolers in the US led to a sharp jump

> in the number of measles cases. 55,000 people became

> sick and 120 died. "

Here, this reviewer finds that the writers of this

report are again attempting to rewrite history.

As the excerpt from the Morbidity and Mortality Weekly

Report 1993 May 21; 42(19): 378-381 stated:

" Possible explanations for the end of the measles

resurgence include a decrease in susceptible popu-

lations following widespread transmission of the

virus; improved vaccination coverage in the sus-

ceptible population; an overall decrease in the

occurrence of measles in the Western Hemisphere (5);

and the periodic cyclicity in measles transmission

that has been noted since the prevaccine era " ,

there was no lapses in " rates of MMR vaccinations

among preschoolers in the US " between 1989 and 1991,

though improved coverage and the subsequent introduc-

tion of a second dose of the MMR vaccine did finally

reduce the " baseline " measles rates to the current

< 60 cases per year background measles rate.

>

>--From January 1 through April 25, 2008, CDC received

> a total of 64 reports of confirmed measles cases

> in nine states-the highest number for the same time

> period since 2001.

>--Of the 64 people infected by the measles virus, on-

> ly 1 had documentation of prior vaccination. Among

> the other 63 case patients were 14 infants who were

> too young to be vaccinated.

>--Many of the cases among US children occurred in chil-

> dren whose parents claimed exemption from vaccination

> due to religious or personal beliefs, or in children

> too young to be vaccinated. Disease transmission

> occurred in a variety of community and healthcare

> settings, including homes, childcare centers, schools,

> hospitals, emergency rooms, and doctors' offices.

>

What this narrative fails to note is that others

may have been vaccinated but lacked " documenta-

tion of prior vaccination " or that these cases

and the others that have raised the total to 130+

cases:

Ø Occurred in multiple disjoint locales,

Ø Were caused by exposure to imported cases of

measles from outside of the USA in almost

all of the reported instances of measles

" outbreaks " ,

Ø Contrary to CDC definitions, which require

at least 3 cases for the cases to be con-

sidered an outbreak, included instances

where 2 cases occurred in a given locale

were called an outbreak, and

Ø Occurred against a background average of 50+

cases annually, where, based on recent his-

tory from 1989 through 2007, an isolated

cases level of 250+ cases in a given 12

months would be needed before any alarm

should be considered and 1,000+ cases would

be needed before there might be a genuine

concern.

Based on the preceding realities, it is clear

that the report's narrative here is a not-so-

subtle form of fear mongering.

>

>· For almost all of the diseases that are vaccine-

> preventable, incidence and mortality rates were

> very high in infants and toddlers before vaccines

> were introduced. The major exceptions would be

> hepatitis A and B, and even there, transmission

> from mother to unborn baby was an important route

> of transmission. Even polio, which we sometimes

> think of as a disease of school-age children

> because of the epidemics in that age group in the

> early 1950s, was originally named " infantile

> paralysis.

>

Ignoring the fear mongering, this reviewer is

pleased to find that hepatitis A and hepatitis

B are recognized as exceptions to the " very high "

incidence and mortality rates in " infants and

toddlers before vaccines were introduced " , al-

though this reviewer is disappointed that chic-

kenpox was not also mentioned.

However, this reviewer is disappointed that the

reasons for the low incidence and mortality

rates for hepatitis A and hepatitis B in chil-

dren were not stated.

Instead, the report focuses on the " route of

transmission " , which, per se, has little to do

with the incidence and mortality rates for

these diseases, when the principle source of

the transmission to the children is mothers

who, as a group, have very low levels of trans-

missible disease.

Overall, this reviewer finds that the report

would be improved if this passage were simply

deleted.

>

>· During 1997-2000, out of 28,187 reported cases of

> pertussis (whooping cough), one quarter were in

> children under age 6 months. Almost 81% of the

> hospitalizations, 57% of the pneumonias, 58% of

> the encephalopathies, and over 93% of the deaths

> were in children under 6 months old. (CDC. Per-

> tussis-United States, 1997-2000. MMWR 2002; 51:

> 73-76).

>

First, given the current vaccination program for

the DTaP/Tdap vaccines, most all of the pertussis

cases in children under 6 months would probably

have occurred even if the vaccination rate were

almost 100%.

Moreover, to the extent that the current DTaP

vaccines are designed to only protect all of

those vaccinated from the adverse effects of

the pertussis toxins but does not effectively

protect those vaccinated from being carriers

for the pertussis bacteria, most all of those

with severe adverse effects will disproportion-

ately fall on those who contract pertussis but

are too young to be protected from the pertus-

sis toxins by vaccination.

>

>· Most children are protected from measles by anti-

> bodies passively transferred from their mother until

> they are about a year old. Incidence of the infec-

> tion then rises rapidly after the first birthday.

> This is why measles vaccine is recommended to be

> given at the first birthday, and, even earlier, dur-

> ing outbreaks. Waiting until children are 2 years

> old to give measles vaccine would allow development

> of a very large pool of unimmunized unvaccinated

> and unprotected children aged 12 to 24 months-about

> 200,000 at any one time in Florida alone-who could

> easily maintain an extensive measles epidemic. Among

> 67,032 measles cases occurring in the United States

> in 1987-2000, 43% were under 5 years old. Among

> these children, 41.4 % had one or more complications,

> 26% were hospitalized, and 0.3% died (97 children).

> Complication rates were much lower in people aged 5

> to 9 years (18.1%), and 10 to 19 years (12.8%), and

> then were higher in adults aged 20 to 29 (29%) and

> aged 30 and over (34.1%).

>

Accepting that the preceding are the realities for

measles in a population that does not breastfeed

its children for extended periods of time, simply

encouraging Florida mothers to breast feed their

children for at least 2 years (by providing the

appropriate support and, for those who cannot nurse

for medical reasons, wet nurses) rather than the

current " 6 months " :

Ø Would:

· Reduce the risk that children younger than

2 years of age would contract measles or

other common contagious disease and

· Improve the overall health of Florida's ba-

bies as well as the mental health of Florida's

nursing mothers, and

Ø Could reduce the risk for vaccine-related

childhood chronic diseases in those whose

parents decided to appropriately postpone the

start of the " Florida required " vaccinations.

Perhaps the outcomes from having an extended-breast-

feeding program might encourage the reintroduction

of other natural childrearing practices that produce

happier and more healthy babies, and happier mothers

with stronger maternal protective bonds to their

children.

>

>· In the 1920s, more than 125,000 diphtheria cases,

> with 10,000 deaths, were reported annually in the US,

> with the highest fatality rates among the very young

> and the elderly. " ( Textbook of Pediatrics,

> 18th Edition, Saunders, 2007, page 1153).

>

Since, in the early 21st century, the current sani-

tation/hygiene/diet/antibiotic/vaccination-driven

reality is " 0 " cases of diphtheria, this reviewer

sees little reason to include this isolated bullet

point - especially, because the data for this bac-

terial disease seems to indicate that, unlike per-

tussis and tetanus, the risk of being exposed to

diphtheria and contracting diphtheria is nearly " 0 " ,

and, with the advent of antibiotics, there are now

effective antibiotics that can be used to effec-

tively treat an isolated case should one be identi-

fied unlike in the 1920s example tossed in here.

>

>· The following chart reflects the decline in the dis-

> ease rate of measles, mumps and rubella in Florida

> with the date of vaccine licensure.

>

> Florida Reported Cases of Measles, Mumps, and

> Rubella in 5 year Averages

>

> REPORT TABLE OMMITTED

>

While this chart is informative, it is also mis-

leading because it does not indicate the date for

the MMR vaccine was licensed (1971) nor the date

(1989) at which, to control measles in a highly

vaccinated population, the CDC added a recommen-

dation for administering a second dose of the

now MMR II vaccine to children attending grades

K-12 as well as to those in college

(http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5522a4.htm).

This addition was made in recognition of the fail-

ure in a highly vaccinated (>95%) populations of

the single-dose of MMR to provide adequate protec-

tion from contracting measles and mumps for those

who were only given a single inoculation with the

MMR II vaccine.

Furthermore, in apparent recognition of the failure

of the MMR vaccine to provide long-term immunity

even with two (2) doses of MMR vaccine in some, the

CDC now (as of 2006) recommends:

Ø The titers for measles be checked when a women

completes or terminates a pregnancy and

Ø When the titers are low or absent, the woman

should be given an MMR shot before being dis-

charged - even though a measles-only vaccine

would be more appropriate if the only low ti-

ters were those for measles.

If measles antibody titers are important, then, it

would be better if a women had her titers checked

BEFORE trying to conceive and, if they were low,

be offered a measles-only vaccine to boost titers

before attempting to conceive.

>

>· While the risk of infants and children coming into

> contact with vaccine-preventable diseases is lower

> since the advent of vaccinations, the best way to

> keep that risk down is to keep those vaccinations up.

> Any decline in vaccinations --either on a community,

> national or even an individual basis-can open up a

> window on vaccine-preventable diseases that immuni-

> zations vaccinations have done such a great job keep-

> ing closed.

>

This reviewer can only support this position for those

vaccine that are safe and truly cost-effective even

when the costs of caring for those injured by that

vaccine are fully reflected in that vaccine's costs.

>

>· Before the Haemophilus influenzae type b (Hib) vaccine

> was introduced, mortality rates from meningitis due to

> that organism in the early 1980s were 5 times as high

> in children under one year of age as in children one

> to four years old. (Schoendorf KC, Kiely JL, WG,

> Wenger JD, " National trends in Haemophilus influenza

> meningitis mortality and hospitalization among children, "

> 1980 through 1991).

>

This reviewer again finds the narrative here does not

address the reality that the Hib vaccines have been

a failure in preventing Hi cases and Hi deaths in

young children - even though these vaccines did reduce

the annual cases of Hib.

Factually, the Hib vaccines: a) are clearly not cost-

effective; may be a causal factor in the increases

in Hi cases; and c) have caused adverse changes in the

strains of bacteria and the nature of the bacteria

occupying the Hib niche.

Thus, as this reviewer has previously pointed out in

detail, Hib vaccines are poster children for vaccines

that do not protect the physical and financial health

of American children but are significant financial

contributors to their manufacturers' and healthcare

providers' bottom lines.

>

>· The problem is even a low risk of contact with vac-

> cine-preventable diseases places unvaccinated infants

> and children at-risk. The only disease that has been

> completely wiped out in the world is smallpox (which

> is why smallpox is the only vaccine that is no longer

> needed). The rest of the diseases that children are

> vaccinated against still make occasional appearances

> and may pose a risk to anyone who isn't fully vacci-

> nated.

This reviewer agrees with the report's view that

low-risk of exposure is still a risk.

>

>· Experts frequently say that the diseases that are un-

> common in the U.S. are only a plane ride away. That's

> because outbreaks in this country often begin when an

> unvaccinated person travels to a country where vacci-

> nation isn't routine, and where diseases like polio,

> diphtheria, or measles still occur. The traveler then

> picks up the disease, and brings it home-a dangerous

> souvenir that can then be passed around to anyone who

> isn't vaccinated or hasn't yet been fully vaccinated

> (including those who are at greater risk, such as in-

> fants and pregnant women). Foreign visitors can also

> bring diseases into the country.

Given the stated realities stated here and the avai-

lability today of rapid screening tests for incipient

infection, why is it that the CDC still refuses to

implement a visual check of all passengers arriving at

American ports, borders, and airports for disease on-

set symptoms, and, for those showing any disease symp-

toms, quarantining them until the screening tests find

that they are not contagious?

>

>· Why immunize vaccinate infants? Today's low risks could

> potentially grow into high risks. If enough parents stop

> vaccinating their children, diseases that have been un-

> der control for years can actually make comebacks,

> causing epidemics.

>

This reviewer can only warn those who are promoting vac-

cination that their continued misrepresentation of the

facts about diseases and the vaccines that purport to

safely and effective, but are not, continues to erode

the public's trust in their written statements and the

vaccination programs they are promoting.

Thus, this reviewer must again recommend that the wri-

ters of this section of the report cease and desist

from such fear mongering, clean up your act, and only

present factually accurate and complete information

that is pertinent to today's world - not to the world

of the 1920s.

>

>supporting documents

>

>The following Florida Statutes and Administrative

>Codes assure provision of immunizations for eli-

>gible children and details immunization require-

>ments for childcare and school.

>

>Medicaid and Insurance Benefits for Eligible

>Children

>

>Section 409.815, F.S., lists Medicaid benefits and

>also lists benchmark benefits (KidCare) which in-

>clude preventive health services including services

>recommended in the " Guidelines for Health Supervi-

>sion of Children and Youth " as developed by the

>American Academy of Pediatrics and immunizations

>and injections.

> Medicaid policy for the Child Health Check-up

>(EPSDT is a mandatory Medicaid service) lists

>the periodicity of visits and addresses the con-

>tent of care, including routine immunizations.

>In addition under OBRA 89, states must provide all

>medically necessary services identified during and

>EPSDT screen (known as child health check up in

>Florida) without regard to whether those services

>are included in the state's Medicaid state plan.

>Section 627.6579, F.S., addresses requirements for

>commercial insurance regarding child health super-

>vision and also includes routine immunizations.

>

>Mandated School Immunizations

>

>The following is a summary of required school

>immunizations, which are detailed in the " Immuni-

>zation Guidelines- Florida Schools, Child Care

>Facilities and Family Day Care Homes, " which are

>referenced in Rule 64D-3.046, Florida Administra-

>tive Code.

>Requirements: Prior to entry, attendance or

>transfer to preschools, schools (K-12), licensed

>childcare facilities, and family daycare homes,

>each child shall have on file a Florida Certifi-

>cation of Immunization, DH 680, documenting the

>following:

>

>PUBLIC/NON-PUBLIC SCHOOLS K-12 (CHILDREN ENTERING,

>ATTENDING, OR TRANSFERRING TO FLORIDA SCHOOLS):

>Four or five doses of diphtheria, tetanus, and per-

>tussis vaccine; three or four doses of polio vac-

>cine; two doses of measles, mumps, and rubella vac-

>cine; two or three doses of hepatitis B vaccine;

>one dose of varicella vaccine (kindergarten effec-

>tive school year 2001/2002, then each year an

>additional grade); two doses of varicella vaccine

>(kindergarten effective school year 2008/2009,

>then each year an additional grade

>

>PUBLIC/NON-PUBLIC SCHOOLS SEVENTH GRADE: one dose

>tetanus diphtheria (TD) vaccine; Effective with

>the 2009/2010 school year, one dose of tetanus-

>diphtheria-pertussis vaccine (Tdap)

>

>PUBLIC/NON-PUBLIC PRE-K (AGE-APPROPRIATE DOSES

>AS INDICATED): diphtheria, tetanus, and pertussis

>vaccine; polio vaccine; measles, mumps and rubella

>vaccine; hepatitis B vaccine; varicella vaccine

>(effective school year 2001/2002); Haemophilus

>influenzae type b (Hib) vaccine

>

>LICENSED CHILDCARE FACILITIES AND FAMILY DAYCARE

>HOMES: Children entering or attending licensed

>childcare facilities and family daycare homes

>shall have received as many of the following

>age-appropriate immunizations as are medically

>indicated in accordance with the current Recom-

>mended Childhood Immunization Schedule: diph-

>theria, tetanus, and pertussis vaccine; polio

>vaccine; measles, mumps and rubella vaccine;

>varicella vaccine; Haemophilus influenzae type b

>(Hib) vaccine; Pneumococcal Conjugate vaccine

>

>AUTHORITY: K-12: section 1003.22, Florida Sta-

>tutes, and Rule 64D-3.046, Florida Administra-

>tive Code

>

>LICENSED CHILDCARE FACILITIES, FAMILY DAYCARE

>HOMES AND SPECIALIZED CHILDCARE FACILITIES FOR

>THE CARE OF MILDLY-ILL CHILDREN: sections

>402.305 & 402.313, Florida Statutes, and Rules

>65C-22.006 and 65C-25.002 and 25.008, Florida

>Administrative Code

>

>

>2008 Bibliography: The Potential Association be-

>tween Vaccines and Autism, by Eartha S.

>Florida Agricultural and Mechanical University,

>College of Pharmacy and Pharmaceutical Sciences,

>Institute of Public Health Intern

>

>1. Akshoomoff, N., Pierce, K., & Courchesne, E.

> (2002). The neurobiological basis of autism from

> a developmental perspective. Development and

> Psychopathology, 14, 613-634.

>2. American Academy of Pediatrics. Facts for par-

> ents about autism and vaccine safety from the

> American Academy of Pediatrics 2008. 1-3.

>3. American Academy of Pediatrics. Study fails to

> show a connection between thimerosal and autism.

> American Academy of Pediatrics, 2003. p. 6

>4. s, N., , E., Grant, A., Stowe, J.,

> Osborne, V. & , B. (2004). Thimerosal

> exposure in infants and developmental disorder:

> a retrospective cohort study in the United

> Kingdom does not support a causal association.

> Journal of the American Academy of Pediatrics,

> 114, 584-591.

>5. Baker, J. (2008). Mercury, Vaccines, and Autism.

> American Journal of Public Health, 98(2), 244-

> 252.

>6. Ball, L., Ball, R. & Pratt, D. D. (2002). An

> Assessment of Thimerosal Use in childhood

> vaccines. Journal of the American Academy of

> Pediatrics, 107(5), 1147-1153.

>7. Barbarsi, W. J., Katusic, S. K. & Voigt, R. G.

> (2006). Autism. Archive of Pediatric Adolescent

> Medicine, 160, 1167-1175.

>8. Bower, H. (1999). New research demolishes link

> between MMR vaccine and autism. British Medical

> Journal, 318, 1643.

>9. CNN TV. " Vaccine case draws new attention to

> autism debate. " World Autism Day. April 2, 2008.

> 2 p. Retrieved June 25, 2008, from

> http//:www.cnn.com.

>10. , E. (2003). Ethylmercury in vaccines.

> Journal of the American Academy of Pediatrics,

> 111, 922-923.

>11. Colgrove, J. & Bayer, R. (2005). Could it happen

> here? Vaccine risk controversies and the specter

> of derailment. Health Affairs, 24(3), 729-739.

>12. DeStefano, F. & , W. W. (2004). MMR

> vaccine and autism: an update of the scientific

> evidence. Expert Review of Vaccines, 3(1), 19-

> 22.

>13. DeStefano, F., Bhasin, T. K., , W. W.,

> Yeargin-Allsopp, M. & Boyle, C. (2004). Age at

> first measles-mumps-rubella vaccination in chil-

> dren with autism and school-matched control sub-

> jects: A population-based study in Metropolitan

> Atlanta. Journal of the American Academy of

> Pediatrics, 113(2), 259-266.

>14. D'Souza, Y., Fombonne, E. & Ward, B. J. (2006).

> No evidence of persisting measles virus in per-

> ipheral blood mononuclear cells from children

> with autism spectrum disorder. Pediatrics, 118

> (4), 1664-1675.

>15. Fitzpatrick, M. (2004). MMR: Risk, choice,

> chance. British Medical Bulletin, 69, 143-153.

>16. Folb, P., Bernatowska, E., Chen, R., Clemens,

> J., Dodoo, A. N., Ellenberg, S. S., et al.

> (2004). A global perspective on vaccine safety

> and public health: The global advisory committee

> on vaccine safety. American Journal of Public

> Health, 94(11), 1926-1931.

>17. Fombonne, E. & Chakrabarti, S. (2001). No evi-

> dence for a new variant of measles-mumps-

> rubella-induced autism. Journal of the American

> Academy of Pediatrics, 108(4), 1-8.

>18. Fombonne, E. (2008). Thimerosal disappears but

> autism remains. Archives of General Psychiatry,

> 65(1), 15-16.

>19. Fortin, J. Despite medical advances, kids'

> shots still important. 2008. Retrieved June

> 25, 2008, from http://www.cnn.com.

>20. Geier, M. R. & Geier, D. (2003). Neurodevelop-

> ment disorders after thimerosal-containing

> vaccines: A brief communication. Experimental

> Biology Medicine, 228, 660-664.

>21. Gottlieb, S. (2004). Study finds no connec-

> tion between MMR vaccine and autism. British

> Medical Journal, 328, 421.

>22. Halsey, N. A., Hyman, S. L. & Conference Wri-

> ting Panel. (2001). Measles-Mumps-Rubella vac-

> cine and autistic spectrum disorder: Report

> from the new. Journal of the American Academy

> of Pediatrics, 107(5), 1-23.

>23. Harmon, A. (2004). How about not 'curing' us,

> some autistics are pleading. The New York

> Times, pp. 1-4.

>24. Heron, J. & Golding, J. (2004). Thimerosal

> exposure in infants and developmental disor-

> ders: A prospective cohort study in the United

> Kingdom does not support a casual association.

> Journal of the American Academy of Pediatrics,

> 114, 577-583.

>25. Hviid, A., Stellfeld, M., Wohlfahrt, J. and

> Melbye, M. (2003). Association between

> thimerosal-containing vaccine and autism.

> Journal of the American Medical Association,

> 290(13), 1763-1766.

>26. Immunization Action Coalition & Offit, P. A.

> Vaccines and Autism 2006. 1-3.

>27. Jick, H. & Kaye, J. A. (2004). Autism and DPT

> Vaccination in the United Kingdom. The New

> England Journal of Medicine, 350(26), 2722-

> 2723.

>28. Withdrawal of Rotavirus vaccine recommendation.

> Journal of American Medical Association. (1999).

> 282(22), 2114-2115.

>29. Kaye, J. A., del Mar Melero-Montes, M. & Jick,

> H. (2001). Mumps, measles, and rubella vaccine

> and the incidence of autism recorded by general

> practitioners: A time trend analysis. British

> Medical Journal, 322, 460-463.

>30. Kimmel, S. R. (2002). Vaccine adverse events:

> Separating myth from reality. American Family

> Physician, 66(11), 2113-2120.

>31. Kirby, D. (2008, February 28). The vaccine-

> autism court document every American should

> read. The Huffington Post, pp. 1-5. Retrieved

> June 25, 2008, from

> http://www.huffingtonpost.com.

>32. Kirby, D. (2008, March 22). Obama climbs on

> the vaccine research band wagon. The Huffington

> Post, pp. 1-3. Retrieved June 25, 2008, from

> http//:www.huffingtonpost.com.

>33. Landa, R. J., Holman, K. C. & Garrett-Mayer, E.

> (2007). Social and communication development in

> toddlers with early and later diagnosis of

> autism spectrum disorders. Archives of General

> Psychiatry, 64(7), 853-864.

>34. Larsson, H. J., Eaton, W. W., Madsen, K. M.,

> Vestergaard, M., Olesen, A. V., Agerbo, E., et

> al. (2005). Risk factors for Autism: Perinatal

> factors, parental psychiatric history, and

> socioeconomic status. American Journal of

> Epidemiology, 161(10), 916-925.

>35. LeBaron, C. W., Bi, D., Sullivan, B., Beck, C.

> & Gargiullo, P. (2006). Evaluation of poten-

> tially common adverse events associated with

> the first and second dose of measles-mumps-

> rubella vaccine. Journal of the American

> Academy of Pediatrics, 118(4), 1422-1430.

>36. Maclntyre, C. R. & Maclntyre, P. B. (2001).

> MMR, autism and inflammatory bowel disease:

> Responding to patient concerns using an evi-

> dence-based framework. Medical Journal of

> Australia, 175, 127-128.

>37. Madsen, K. M., Hviid, A., Vestergaard, M.,

> Schemed, D., Wohlfahrt, J., Those, P., et al.

> (2002). A population-based study of measles,

> mumps, rubella vaccination and autism. The

> New England Journal of Medicine, 347(19),

> 1477-1482.

>38. Madsen, K. M., Lauritsen, M. B., Pederson,

> C. B., Thorsen, P., Plesner, A., ,

> P. H., et al. (2003). Thimerosal and the oc-

> currence of autism: Negative ecological evi-

> dence from Danish population-based date.

> Journal of the American Academy of Pedia-

> trics, 112(3), 604-606.

>39. Manjoo, F. McCain, Obama, Clinton push dan-

> gerous vaccine-autism myth. May 5, 2008.

> Retrieved June 25, 2008, from

> http://www.salon.com.

>40. , D. S. Vaccine-autism question divided

> parents, scientist. 2 p. Retrieved June 24,

> 2008, from http://www.cnn.com.

>41. Meadows, M. (2004). IOM Report: No link be-

> tween vaccines and autism. Food and Drug

> Administration Consumer Magazine, pp. 1-3.

>42. Mutter, J., Naumann, J., Schneider, R.,

> Walach, H. & Haley, B. (2005). Mercury and

> autism: Accelerating evidence? Neuroendo-

> crinology Letters, 26(5), 439-446.

>43. , K. B. & Bauman, M. L. (2003). Thimero-

> sal and autism? Journal of the American Acade-

> my of Pediatrics, 111, 674-679.

>44. Newschaffer, C. J., Fallin, D. & Lee, N. L.

> (2002). Heritable and nonheritable risk fac-

> tors for autism spectrum disorders. Epidemi-

> ologic Reviews, 24(2), 137-153.

>45. Palmer, R. F., Blanchard, S., C. R. &

> Mandell, D. S. (2005). School district re-

> sources and identification of children with

> autistic disorder. Research and Practice,

> 95(1), 125-130.

>46. -Pope, T. " Will a 9-year-old change

> the vaccine debate? " The New York Times.

> 2008.

>47. Parmet, W. E., Goodman, R. A. & Farber, A.

> (2005). Individual Rights versus the pub-

> lic's health-100 years after son v.

> Massachusetts. New England Journal of

> Medicine, 352(7), 652-654.

>48. Pichichero, M. E., Gentile, A., Giglio, N.,

> Umido, V., son, T. & Cernichiari, E.

> (2008). Mercury levels in newborns and in-

> fants after receipt of thimerosal-containing

> vaccines. Journal of the American Academy of

> Pediatrics, 121, e208-e214.

>49. Rimland, B. (2004). Association between thi-

> merosal-containing vaccine and autism. Jour-

> nal of American Medical Association, 29(12),

> 180.

>50. Schechter, R. & Grether, J. K. (2008). Con-

> tinuing increases in autism reported to

> California's developmental services system.

> Archive of General Psychiatry, 65(1), 19-24.

>51. Schuchat, A. & Trevathan, E. Commentary: A

> view from the CDC on autism. 2 p. Retrieved

> June 25, 2008, from http://www.cnn.com.

>52. Shattuck, P. T. (2006). The contribution of

> diagnostic substitution to the growing ad-

> ministrative prevalence of autism in US

> special education. Journal of the American

> Academy of Pediatrics, 117, 1028-1037.

>53. Smeeth, L., Cook, C., Fombonne, E., Heavey,

> L., Rodrigues, L. C., , P. G., et al.

> (2004). MMR vaccination and pervasive

> developmental disorders: A case-control study.

> The Lancet, 364, 963-969.

>54. , M. J., Ellenberg, S.S., Bell, L.M., &

> Rubin, D.M. (2007). Media coverage of the

> measles-mumps-rubella vaccine and autism con-

> troversy and its relationship to MMR immuniza-

> tion rates in the United States. Pediatrics,

> 1098-4275, 836-843.

>55. Stern, A. M., & Markel, H. (2005). The his-

> tory of vaccines and immunization: Familiar

> patterns, new challenges. Health Affairs,

> 24(3), 611-621.

>56. Sugarman, S.D. (2007). Cases in vaccine court-

> Legal battles over vaccine and autism. The New

> England Journal of Medicine, 357;13, 1275.

>57. Tanne, J.H. (2002). MMR vaccine is not linked

> with autism, study says. British Medical Journal,

> 325, 1134.

>58. , B., , E., Farrington, C. P.,

> Petropoulos, M., Favot-Mayaud, I., Li, J., et al.

> (1999). Autism and measles, mumps, and rubella

> vaccine: No epidemiological evidence for a causal

> association. Lancet, 353, 2026-2029.

>59. , B., , E., Lingam, R., s, N.,

> , A. & Stowe, J. (2002). Measles, mumps,

> and rubella vaccination and bowel problems or

> developmental regression in children with autism:

> Population study. British Medical Journal, 324,

> 393-396.

>60. , W. W., Price, C., Goodson, B., Shay,

> D. K., Benson, P., Hinrichsen, V. L., et al.

> (2007). Early thimerosal exposure and neuro-

> psychological outcomes at 7 to 10 years. The New

> England Journal of Medicine, 357(13), 1281-1292.

>61. Verstraeten, T., , R. L., DeStafano, F.,

> Lieu, T. A., , P. H. & Black, S. (2003).

> Safety of thimerosal-containing vaccines: A two

> phased study of computerized health maintenance

> organization databases. Journal of the American

> Academy of Pediatrics, 12(5), 1039-1048.

>62. Wakefield, A. J., Murch, A., Linnell, J., Casson,

> D. M., Malik, M., Berelowitz, M., et al. (1998).

> Ileal-lymphoidnodular hyperplasia, non-specific

> colitis, and pervasive development disorder in

> children. The Lancet, 351, 637-641.

>63. Wallis, C. Case study: Autism and Vaccines.

> (2008). 1-4. Retrieved June 25, 2008, from

> http://www.time.com.

>64. Willingham, V. Autism's mysteries remain as num-

> bers grow. (2008). 1-2. Retrieved July 1, 2008,

> from http://www.cnn.com.

>65. , K., Mills, E., Ross, C., McGowan, J. &

> Jadad, A. (2003). Association of autistic spec-

> trum disorder and the measles, mumps, and rubel-

> la vaccine: A systematic review of current epi

> demiological evidence. Archives of Pediatric

> Adolescent Medicine, 157, 628-634.

>66. Woo, E. J., Ball, R., Bostrom, A., Shadomy, S.

> V., Ball, L. K., , G., et al. (2004). Vac-

> cine risk perception among reporters of autism

> after vaccination: Vaccine adverse event repor-

> ting system 1990-2001. American Journal of

> Public Health, 94(6), 990-995. "

>

>

>acknowledgements

>

>This publication is produced through the combined

>efforts of many individuals within the Florida

>Department of Health.

>

>Deputy Secretary for Health-Public

>Health Programs

> L. Kline

>Division of Disease Control

> Dr. Eggert

> Dr. Hopkins

> Dr. Gill

>

> Cameron Noblit

> Phyllis Yambor

> Janet Hamilton

> Leah Eisenstein

> Kate Goodin

> Keegan

>Childrens Medical Services

> Dr. ph Chiaro

> Dr. Phyllis Sloyer

>Family Health Services

> Annette Phelps

> Dr. Bill Sappenfield

> Vivienne Treharne

>County Health Department Directors

>and Administrators

> Dr. Sherin

> Dr. Lanza

> Dr. Gladys Branic

>Statewide Research Office

> Dr. L. Hood

>Planning, Evaluation and Data Analysis

> Meade Grigg

>General Council

> Greif

>Office of Marketing

> Georgia

>Thank you to those who volunteered and pulled

>this information together with special atten-

>tion to Georgia who put all the infor-

>mation into this document. "

>

Documents Relied Upon By Reviewer

[REVIEWER'S LIST OMMITTED]

About the Reviewer

The reviewer, G. King, PhD, is a PhD Analyti-

cal Chemist with a MS in Inorganic Chemistry, a

technical degree in Computer Programming and Sys-

tems Analysis and 30-plus-year career in the bio-

cides and pharmaceuticals industries.

Dr. King is a recognized expert in the areas of

quality control, quality systems, and CGMP compli-

ance, who has been involved with various projects

addressing general drug and vaccine issues, re-

lated nutrition issues, including, since 1999,

vaccines and mercury poisoning in developing chil-

dren from conception onwards, where Thimerosal

bolus dosing is a major causal factor.

For more information on his credentials, back-

ground, activities and interests, you can visit

his web site:

http://www.dr-king.com.

End of Part 2 of 2 of the Review

APPENDIX A

REVISED VACCINATION RECOMMENDATIONS

PREFACE

This document contains information designed

to provide pregnant women, parents and guar-

dians of children alternative vaccination

approaches based the fundamental factors

that should be considered in choosing the

set of long-term safe and long-term effec-

tive vaccines that may be safely given from

birth until they are 18 years of age to

developing children who reside in the

United States of America.

The recommendations being made are based on

an in-depth review of the available safety

and effectiveness information published by

the CDC and independent researchers on the

vaccines in the current CDC-recommended vac-

cination program for U.S. children.

[[ BODY OF APPENDIX A HAS OMMITTED FROM

THIS TEXT LISTING ]]

End of Appendix A

APPENDIX B

DRAFT FLORIDA INFORMED-CONSENT FORM

FOR VACCINATION

[[ BODY OF APPENDIX A HAS OMMITTED FROM

THIS TEXT LISTING ]]

End of Appendix B

____________________________________________

Hopefully, most will find this part of this

draft review to be informative.

*******************************************

*The information provided in this email *

*and any attachment thereto is just that *

* -- information. *

* *

*It is not medical advice and it does not *

*require any specific action or actions. *

* *

*While the information is thought to be *

*accurate, no representation is made as *

*to the accuracy of the information posted*

*other than it is my best understanding of*

*the facts on the date that this email and*

*any attachments thereto are posted. *

* *

*Everyone should verify the accuracy of *

*the information provided for themselves *

*before acting on it. *

*******************************************

Respectfully,

Dr. King

http://www.dr-king.com

+++++++++++++++++++++++++++++++++++++++++++