DrftRevuPrt1: FL DoH Report from Task Force on ASDs

[Guest guest]

ALL,

RE: DrftRevu

Attached is Part 1 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 1

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

*FAIR USE NOTICE: This posting may contain,*

*or have attached to it, some copyrighted *

*(©) material the use of which has not *

*always been specifically authorized the *

*owner or owners of the copyrights. Such *

*material is made available for educational*

*purposes, to advance recipient's *

*understanding of human rights, democracy, *

*scientific, moral, ethical, social justice*

*and other issues. It is believed that this*

*is posting a 'fair use' of any such copy- *

*righted material as provided for in Title *

*17 U.S.C. section 107 of the US intellec- *

*tual property law. This material is being*

*distributed without profit. *

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

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 and tables, 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 1

Part 1 of 2 Parts

Introduction

Lest any take this reviewer's remarks as those of

someone who is anti-vaccine, this reviewer again

reiterates that, given the scientific information

available, he currently supports national vaccina-

tion programs for those vaccines that have truly

been proven to be both generally safe and medically

cost-effective, provided the individual parent's

constitutional right to " due process of law " is

neither abridged nor ignored.

Having made clear his position as an advocate for:

a. Banning the use of mercury compounds in medicine

to safen vaccines,

b. Vaccine safety, and

c. Medically cost-effective vaccines,

this reviewer will now assess the statements made

in this report.

>

>Department of Health Response on Immunization Related

>Issues to the Governor's Task Force on Autism Spectrum

>Disorders

>

The report begins by falsely equating vaccination

with immunization [1].

While the goal of vaccination should be to protect

those vaccinated in the same manner and for as long

as having the disease (that individuals are being

inoculated against) does without causing those

vaccinated to get a clinical case of the disease,

the realities are that vaccination:

Ø Does not provide any immunity in some,

Ø Provides, at best, incomplete immunity in most

instances and

Ø Does not give the long-term immunity that having

the disease provides, even with 2 to 5 doses of

the vaccine or, in the case of the current

in-use-ineffective influenza vaccines, one or

more doses each year.

Thus, this difference needs to be recognized and

the language used corrected to reflect reality.

Factually, people are inoculated with a vaccine

or, simply, vaccinated to hopefully provide them

with some level of some type of immunity that will:

Ø Last for a significant period of time, and

Ø Protect most of those inoculated from having a

clinical case of disease if they are exposed to

the disease some time after being vaccinated.

Unfortunately, whether inhaled, introduced into

the skin or injected, vaccines expose our immune

systems to a number of non-disease-related vaccine

components (serum, adventitious organisms,

antibiotics, toxins [Thimerosal, aluminum adjuvants,

2-phenoxyethanol] and food substances [e.g., gelatin,

MSG, egg albumin]) that present their own immune-

system risks to the people being vaccinated.

_________________________________

[1] If you truly want to be immunized, then, in most

cases, you should contract the native communica-

ble childhood diseases when you are in the

appropriate age range after your parents make

certain that your vitamin and mineral levels

(particularly, for vitamins: oil-soluble A, the

Bs, C, D-3, E, K-2 and, for minerals: magnesium,

potassium, selenium, silica, and zinc) are at

optimal levels and you have a healthy intake of

omegas and DHA as well as a balance nutritious

diet. For chickenpox, your parents should try

to make sure that, after you have and recover

from your initial case of chickenpox, you get

periodic re-exposures to the causative virus,

herpes varicella zoster, from other infected

children or adults having a case of shingles to

re-boost your immunity (exogenous boosting) at

2 - 4 year intervals until you reach puberty and

5 - 10 year intervals thereafter.

>

> Millions of people have benefited from vaccines for

>more than two centuries. The history of vaccines and

>immunization began in the 1790s with Jenner's

>creation of the world's first vaccine for smallpox.

>Before the existence of vaccines, diseases such as

>smallpox, measles, rubella, diphtheria, polio, and

>pertussis (whooping cough) were common childhood killers

>and left many survivors disabled for life. Fortunately,

>in Florida and the United States, these devastating

>diseases have been almost eliminated due to the wide-

>spread use of safe, effective, and affordable vaccines.

>In fact, smallpox, a disease that has caused countless

>suffering and death for centuries, was eradicated world-

>wide through vigorous vaccination programs. There is

>little else in medicine that can compare to this achieve-

>ment. With concerted effort, other diseases, such as polio

>and measles (a disease that infects approximately thirty

>million children per year, killing approximately 750,000

>of them), can similarly be eradicated.

> Public health professionals and the World Health Organi-

>zation (WHO) rank immunizations in the top ten health

>achievements of the past century. Immunization is as

>important as the development of safe drinking water and

>public sanitation practices.

>

Public health officials, no doubt, and, perhaps, " the

World Health Organization (WHO) rank immunizations in

the top ten health achievements of the past century " .

But, for most of the communicable childhood diseases,

clean water, modern sanitation, healthy food, and

decent housing had reduced deaths in the " developed "

nations from these communicable diseases by roughly

91-95 % from their peak levels before an effective

vaccine was even available.

Why is it that articles by those that are pro-vaccine

invariably begin with statements that extol the impact

of the " early " vaccines and equate those impacts to

the greater public health success stories.

Based on the facts, 90% of the impact of these diseases

was removed by the provision of clean potable water,

sanitary sewers, wastewater treatment, and sanitary

garbage collection and disposal as well as improvements

in the provision of adequate shelter and nutrition to

most of the American public?

Accurately, other than smallpox deaths, more than 90 %

of the declines in the level of deaths from the serious

contagious diseases endemic in the United States (e.g.,

cholera, measles, and rubella) occurred before there

were vaccines for them.

For example, the estimated annual average pre-vaccine

cases and deaths from measles that the vaccine apologists

use for their comparisons are usually based on the years

1953-1962, [2] the decade prior to the 1963 introduction

of an effective measles vaccine.

By then (see Figure " 1 " on the next page), the annual

number of deaths in the 1953-1962 period (<800 per year)

had already dropped by more than 93% from the peak annual

deaths in the 1915-1924 period (> 10,000 in 1924).[2]

Ignoring the earlier years inaccurately presents the

magnitude of the decline in measles that is attributable

to vaccination as the most significant factor.

Clearly, the real major factors in the decline in

measles deaths were pre-vaccine factors, such as

significant increases in the availability of safe food

and drinking water as well as major improvement in

sanitation, housing and nutrition, and the general

availability of antibiotic drugs starting in the late

1940s.

Figure " 1 " Measles deaths by year, 1912 to 1993

[see pdf article on-line.]

Lest the reader think that this is an isolated

instance, the data for pertussis deaths from

1922-1999 [3] (see Figure " 2 " ) shows a similar

pattern.

Again, more than 91 % of the drop in annual deaths

occurred before the United States had an effective

standardized vaccine (in the 1950s).

Figure " 2 " Pertussis deaths by year, 1922 to 1999

[see pdf article on-line.]

In addition, since pertussis is a bacterial disease,

the penicillin antibiotics introduced into U.S. medi-

cine after World War II also directly contributed to

the decrease in deaths at the same time as the first

standardized pertussis vaccines were becoming availa-

ble.

Ignoring the earlier years, as this report appears to

do, again inaccurately attributes most of the decline

in deaths and cases to vaccination instead of the

other factors.

Finally, this part of the introduction also ignores

the impact of penicillins and other antibiotics on

bacterial disease rates, pathogen prevalence, and

exposure risk.

______________________________________

[2] Centers for Disease Control (CDC). Reported Measles

Cases, Deaths, Deaths-to-Cases Ratio and Estimated

Population in the United States, 1912-1984.

Provisional Data; Doc #0051m

[3] " Pertussis (Whooping Cough) - Reported cases and

deaths per 100,000 population, by year, United

States, 1922-1981. " [Graph]. In Centers for Disease

Control, Annual Summary 1981: reported morbidity and

mortality in the United States. Morbidity and Mortality

Weekly Report (MMWR). 1982 Oct; 30(54): 65.

>

>Vaccines protect infants, children, and adults from the

>unnecessary harm and premature death caused by a number

>of severe communicable diseases.

>

Factually, vaccines only truly protect most of those

who are vaccinated " from the unnecessary harm and

premature death caused by " a few of the severe communi-

cable diseases for which we have a reasonably safe and

in-use effective vaccine.

These reasonably safe and in-use effective vaccine are

typically the vaccines for some of the once prevalent

American childhood diseases for which we have vaccines

(measles, polio, rubella, and diphtheria) [4] .

In addition, there are no effective vaccines for many

of the worst U.S. communicable diseases (e.g., syphilis,

gonorrhea, AIDS, Chlamydia), or for diseases, like

malaria, that are endemic outside of America.

______________________________________

[4] The vaccines for other childhood diseases, the mumps,

tetanus, and pertussis components of the current

vaccines, have significant problems in that they

provide less-than-effective in-use immunity in the

long-term and, as more vaccine doses are given, the

side effect risks increase rapidly (from the adverse

effects of repeated immune system re-challenge).

Furthermore, the vaccines for hepatitis B are given

at times when there is almost no disease risk appar-

ently to minimize the risk of the autoimmune diseases

these vaccines are known to cause and/or exacerbate.

Aside from the vaccine-associated risks, the Hib,

influenza, meningococcal and pneumococcal vaccines

suffer from the severe long-term problems associated

with incomplete strain coverage.

The live-virus rotavirus vaccines are extremely

problematic because they not only give everyone inocu-

lated with them a case of rotavirus but also, through

shedding, those inoculated spread their previously non-

indigenous bioengineered (previously, monkey-human

[Wyeth's RotaShield®] and, now, human-bovine [Merck's

RotaTeq®] hybrids) and/or " attenuated " [recent Glaxo-

Kline Biochemicals' Rotarix®] rotaviruses through-

out the population.

>

>Vaccination is the single most effective communicable disease

>prevention strategy.

>

Were this report less biased in favor of vaccines, this

overly broad generalization would not have been made.

Also, the validity of this statement depends upon factors

such as:

1. Mode of transmission [5],

2. Prevalence of the disease organism in the population

and/or the environment,

3. Ease of transmission,

4. Barriers to transmission,

5. Ability to disrupt reservoir or vector population,

and

6. For all vaccines, the absence of ingredients that

provoke anaphylaxis in a significant part of the

population, which is targeted for inoculation; and,

for live-virus vaccines, the absence significant

pre-existing B-cell and/or T-cell immune suppres-

sion.

Obviously, here is no need for routine cholera vacci-

nation in the USA because most of the potable water is

treated to remove this water-borne disease organism [6].

Similarly, because Japanese encephalitis is not endemic

to the USA, there is no need to vaccinate the general

population against it.

__________________________________

[5] Modes of Transmission: a) intimate direct [person-to-

person {e.g., syphilis, gonorrhea, herpes simplex 2,

and HPV}], direct environment mediated [person's

excretions or emissions transferred by casual touch

or sneeze {e.g., common cold and influenza}], c) indirect

environment mediated [person-to-the environment-to-per-

son [{e.g., cholera}], d) indirect vector mediated [vec-

tor-to person to vector cycle {e.g., Lyme disease, where

" deer " tick bites humans to transmit Borrelia burgdorferi

to humans}], and e) indirect vector-excrement mediated,

where vector is the reservoir and sheds disease into

environment where humans contact the shed excrement and

contract the disease {e.g., the hanta viruses where humans

contract the disease from rat/mouse droppings}]).

[6] For water-borne diseases, obviously treating the drink-

ing water to remove these is a more effective control

strategy than trying to vaccinate the population with

a vaccine that would not be 100% effective and does

not provide lifetime protection.

Thus, vaccination for cholera need only be carried out

in the U.S. when, because of interruption of the supply

of potable water, there is a disease outbreak.

This approach also ensures that the entire population

is not unnecessarily exposed to the potential adverse

reactions to the cholera vaccine.]

>

>Vaccines are also among the most cost-effective medical

>interventions available, providing huge savings in direct

>medical care costs, as well as indirect costs such as

>lost time from work and school.

>

Again, the preceding statement is a generalization that

is only true for some of the vaccines recommended for

general use today.

Moreover, in some cases, this statement is not true

unless the costs of both the short-term and long-term

harms caused by a given vaccine are ignored.

In some cases, like the early childhood hepatitis B

program, where the protection provided wears off

before the disease risk becomes real, and the influ-

enza program, where the vaccines provide at best

limited protection to most of those vaccinated and

retrospective studies have established that they

lack in-use effectiveness in the USA, the vaccina-

tion programs are clearly not cost effective.

In the case of the influenza vaccines, where the

majority of the doses still contain Thimerosal and

most of these are Thimerosal preserved, these flu

shots add to the cumulative [7] subacute mercury

poisoning of the vaccinated population to the point

that:

Ø Some exhibit some of the clinical symptoms of

mercury poisoning,

Ø Some develop chronic diseases earlier because

mercury poisoning is known to hasten and exa-

cerbate the development of these diseases, and

Ø A small percentage exhibit impaired neurologi-

cal function including, in children, the major-

ity of those diagnosed with neurodevelopmental

disorders and, in an increasing number of older

adults, various adult dementias including Al-

zheimer's disease.

When the costs of the harms caused by vaccines,

including the direct medical care, added educa-

tional costs for the affected children, and long-

term custodial care for the injured elderly, as

well as indirect costs (such as losses to the

capable work force, decreased work productivity,

and shortened productivity lifetimes) are included,

many of the current vaccine programs are not medi-

cally cost effective and a few are not even socie-

tally cost-effective.

For example, the early childhood vaccination program

for hepatitis B is not medically cost effective be-

cause:

Ø The costs of vaccinating the population translate

into more than a million dollars for each case of

childhood hepatitis B prevented, and

Ø More are harmed by, and die from, hepatitis B

vaccination than from having childhood hepatitis

B, which, in the majority of the childhood cases

in children with healthy immune systems, resolves

itself without becoming a chronic disease.

Moreover, the protection provided by the early child-

hood hepatitis B program quickly wears off.

Thus, when children become at risk (by being sexually

active in their " mid teens " or IV drug users in their

late teens), most have less than adequate protection

to from contracting hepatitis B, if exposed.

For the chickenpox vaccine, Merck's Varivax®, the

reality is that the original program was justified

as being barely societally cost-effective by ignoring:

Ø The adverse effects of vaccination,

Ø The increases in shingles cases that would result

and their costs, and

Ø The biological reality that one dose cannot provide

lifetime protection.

Today, when the effectiveness of the national vacci-

nation program with one dose dropped below 75%, the

CDC, ignoring the fact that a subsequent vaccination

program dose would not be even societally cost-effec-

tive, simply recommends two (2) doses.

Thus, the current 2-dose chickenpox vaccination pro-

gram is clearly a waste of the public's healthcare

dollars; but adding the second dose did " double "

Merck's revenue stream for their herpes varicella

zoster vaccine for chickenpox.

Moreover, adding the second dose has failed to return

vaccination effectiveness to the 90+ % level seen

during the one-dose program's " honeymoon " period,

when exogenous boosting by exposure to the native

chickenpox strain was still effective in suppressing

disease recurrence [8].

Further, the CDC, has even now recommended that a

third dose of vaccine may be required, particularly

for those entering college.

Given the preceding realities for HVZ, we should

abandon the CDC's current vaccination recommenda-

tions for herpes varicella zoster and, as rapidly

as possible, return to letting our children natural-

ly acquire chickenpox, usually a mild disease that

very rarely causes death, and, when the naturally

infected mother breastfeeds her child, the mother's

milk seems to provide protective antibodies to post-

pone the risk of contracting the disease until the

child's immune system has matured enough to cope

with having chickenpox.

Then, as the Japanese do, we should provide the

vaccine for the few who may need it as well as

those who understand the tradeoffs and want to

postpone their children's risk of having chickenpox

until their children are older.

Thus, the reality is that only a few of the cur-

rent national vaccination programs are truly medi-

cally cost-effective (e.g., measles, rubella,

diphtheria, polio) and some may be societally

cost-effective (e.g., mumps, tetanus, and pertus-

sis).

Finally, based on the information reported for

the costing of the original 1998 RotaShield vac-

cine, rotavirus was: a) a naturally declining

disease in the USA and confined to the lower

socioeconomic groups mainly in the inner cities,

the current rotavirus vaccines would only be

societally cost-effective if the total cost per

dose were less than about $6.00, and medically

cost-effective if the dose cost were cost were

less than $2.00, provided the costs to the fami-

lies of the children harmed by this virulent

live-virus in the vaccine were simply ignored.

_________________________________

[7] Yes, contrary to the unsupported assertions in

this report, Thimerosal is a bioaccumulative

mercury poison in humans with a half-life of

the end-point metabolic product, " inorganic

mercury " , in body tissues and organs that is

on the order of 10 to 20 years in people who

actually excrete mercury efficiently and, in

those who are poor or non-excretors, are signi-

ficantly longer to lifetime, for those who are

truly non-excretors.

[8] Factually, medical science has recognized that,

to prevent reactivation of the dormant herpes

varicella zoster (HVZ) viral disease organisms

from the initial infections, everyone needs

periodic exogenous (external re-exposure) to HVZ

and, sadly, childhood shingles cases are becoming

increasingly common, and, to address the realized

increase in adult shingles cases, Merck has

introduced Zostavax, essentially a third dose of

their live " attenuated " HVZ virus, clearly render-

ing the overall HVZ vaccination programs only

cost-effective to Merck, the healthcare establish-

ment and public health officials, but not cost-

effective for the physical and financial health

of the public.

>

>Unlike other areas of health care, widespread immuni-

>zation has effectively leveled racial-ethnic dispari-

>ties in this country.

>

Here, the report is being disingenuous, because,

in America, in general, and Florida, widespread

vaccination effectively levels most socio-economic

barriers and not the racial-ethnic ones per se.

The rotavirus vaccines are a " poster child " example

of the socio-economic leveling effect of vaccines.

Absent the live-virus vaccines, clinical rotavirus

infections were confined to the lower socio-economic

groups and a few of those who came in contact with

them.

Yet, as the CDC has reported, though most children

did not have a clinical case of rotavirus, all

children seemed to have acquired long-term immunity

by " 5 " years of age - obviously from low-level

exposures that generated subclinical disease cases.

However, in states where the rotavirus vaccines

have been introduced and/or mandated, children from

all socio-economic groups are getting clinical in-

fections and having the severe outcomes, including

death - outcomes that used to be confined to the

children in the lower socio-economic groups because

the live-virus rotavirus vaccines infect all given

them with a level of rotaviruses sufficient to

induce clinical symptoms in most and severe symptoms

in some.

In addition, in the case of the bioengineered human-

animal hybrid rotavirus vaccines, shedding by the

inoculated child has been found to infect some adults

who were previously " naturally immune " to the native

rotavirus organisms.

Apparently, those who treat vaccination as a " reli-

gion " have forgotten the lessons learned with the

live poliovirus vaccines and the previous now-with-

drawn Wyeth's RotaShield vaccine, and, to profit

Merck and, now, GlaxoKline, have again allowed

our children to be unnecessarily infected with a

live intestinal virus that, in some, is highly viru-

lent even though these vaccines: a) are clearly not

even short-term societally cost effective in the USA,

and will result, and have already resulted in,

increased deaths and disease (intussusception and

Kawasaki's disease for RotaTeq; and intussusception

and pneumonia for Rotarix) because almost all of our

4-million-plus newborns will be infected if the CDC/

AAP recommendations for the rotavirus vaccines [9]

are followed.

_________________________________

[9] To get the rotavirus vaccines approved, liberties

were taken with the clinical trial process by

conducting the trials in populations where sani-

tation was poor and the natural risk of infection

with the native human rotavirus strains was high

to ensure the background disease rates would be

somewhat comparable to the vaccination disease

rates even though, because of sanitation and

hygiene, the risk in the general American popu-

lation is much lower than in the trial areas.

Such practices would seem to be criminal when

the target market for approval was the USA, but

may have been appropriate for developing coun-

tries where the majority of the population lives

in poverty and lacks proper sanitation.

>

>Florida's child care and school entry immunization re-

>quirements ensure that students are protected against

>communicable diseases in settings where such diseases

>are easily transmitted.

>

While this statement is laudable on its face, the

inclusion of the Hib and PCV vaccines in the Florida

requirements is problematic because the long-term

evidence is that the Hib and the PCV vaccines create

more long-term disease problems than they solve.

With a true effectiveness closer to 15% than to 85%

or above, the national use of the Hib has caused

strain drift and alternate organism invasion that,

together, have created a childhood disease condi-

tions that are significantly harder to treat and

are increasing antibiotic resistant.

Consulting the CDC's " Summary of Notifiable Diseases

- United States, 2002 " report,[10] this reviewer finds

the following for reported " Haemophilus influenzae "

cases:

" Haemophilus influenzae, Invasive Disease

In 2002, 331 cases of invasive Haemophilus influ-

enzae disease in children aged <5 years were repor-

ted; 34 (10%) were reported as H. influenzae type B

(Hib), 144 (44%) were reported as other serotypes

or non-typeable isolates, and 153 (46%) were repor-

ted with serotype information unknown or missing.

The continued remarkably low number of invasive

Hib infections in children (down from an estimated

20,000 cases annually in the prevaccine era) is a

result of the successful delivery of highly effec-

tive conjugate Hib vaccines to children, beginning

at age 2 months (1,2).

Because discrepancies in serotyping results have

occurred between laboratories, CDC requests that

state health departments obtain and send all in-

vasive H. influenzae isolates from children aged

<5 years to CDC for serotype confirmation (3,4).

1. CDC. Progress toward elimination of Haemophilus

influenzae type b disease among infants and

children---United States, 1998--2000. MMWR 2002;

51: 234-237.

2. Zhou, F, Bisgard KM, Yusuf H, et al. Impact of

universal Haemophilus influenzae type b vac-

cination starting at 2 months of age in the

United States: an economic analysis. Pediatrics

2002; 110: 653-661.

3. La LL, Tondella ML, Beall DS, et al.

Identification of Haemophilus influenzae

serotypes by standard slide agglutination

serotyping and PCR-based capsule typing.

J Clin Microbiol 2003; 41: 393-396.

4. CDC. Serotyping discrepancies in Haemophilus

influenzae type b disease---United States, 1998--

1999. MMWR 2002; 51: 706-707. "

Moreover, that summary report's " Table 1 " lists

1,743 cases of invasive Haemophilus influenzae and

the total reported cases for children under 5 is

331.

And, the 2002 report's " down from an estimated

20,000 cases annually in the prevaccine era "

statement shows that the government had no solid

data for cases of Haemophilus influenzae, or di-

sease prevalence data for the Hib strain in chil-

dren under 5 before the current Hib vaccines were

introduced in the 1980s.

Next, consulting the CDC's " Summary of Notifiable

Diseases - United States, 2005 " report,11 this

reviewer finds the following for reported " Haemo-

philus influenzae " cases:

Ø Oddly, there is no paragraph discussing

Haemophilus influenzae in the report.

Ø However, this " 2005 " report's " Table 1 " lists:

1. 2,304 cases of invasive Haemophilus influenzae;

a 32% increase from 2002.

2. For children under five:

a. 9 serotype B cases (a 70+ % decrease

from 2002),

b. 135 nonserotype B cases (a 6+ % de-

crease from 2002),

c. 217 unknown serotype cases (a 42 %

increase from 2002), and

d. 361 total cases (a 9% increase from

2002).

Given the increase in unknown serotype cases,

Ø The CDC's 2002 request " that state health departments

obtain and send all invasive H. influenzae isolates

from children aged <5 years to CDC for serotype

confirmation " was ignored, and/or

Ø The CDC did not confirm the serotyping or serotype

the majority of the isolates submitted as " unknown

serotype cases, " and/or

Ø New strains of this disease were emerging that, lac-

king suitable anti-sera, the states and/or the CDC

could not serotype.

Subsequently, consulting the CDC's " Notice to Readers:

Final 2006 Reports of Nationally Notifiable Infectious

Diseases, " [11] this reviewer finds in its " Table 2 "

the following data are reported for " Haemophilus influenzae "

cases:

1. 2,436 cases of invasive Haemophilus influenzae; a

6% increase from 2005 cases.

2. For children under five:

a. 29 serotype B cases (a 320+ % increase from 2005)

b. 175 nonserotype B cases (a 30 % increase from

2005),

c. 179 unknown serotype cases (an 17+ % decrease

from 2005), and

d. 383 total cases (a 6 % increase from 2005).

Based on all the recent published CDC data available to

this reviewer, it appears that the Hib vaccines are

shifting the distribution of serogroups toward other

serogroups.

Furthermore, recent reports indicate that other organisms

that are more difficult to treat than Hib are beginning

to fill the bacterial " niche " left by the Hib vaccine.

In addition, studies have reported that there is a " causal

relationship between the haemophilus b vaccine and the

development of insulin dependent diabetes … 3 - 4 years

after four doses of Hib " . [12]

Since the cost impacts of both the short-term adverse

effects (serious harm) and the long-term adverse effects

to health (e.g., insulin-dependent diabetes) were not

considered in the initial licensing of the Hib vaccines

and there has been a significant increase in infections

by other microorganisms filling the niche created by the

Hib vaccine, rather than continuing this line of reason-

ing, which looks to modify the strains in the vaccine,

the public needs to reconsider whether or not a vaccine

for Hib is medically cost-justifiable because the pub-

lished data seem to indicate that this is not the case.

Turning to the pneumococcal vaccine (PCV-7) for children,

factually, this pneumococcal vaccine, Wyeth's Prevnar®,

may have been very successful in decreasing infections

but only when caused by those 7 strains (of the about

90 strains of Streptococcus pneumoniae) that are present-

ly in the licensed vaccine (estimated as responsible for

" 74 " % of the non-penicillin-resistant strains and " 100% "

of the penicillin-resistant strains based on a 1993-1994

CDC survey).

Using 1999 as the base year, we can see that by the

end of 2001, almost 2 years after the vaccine was

introduced early in 2000, vaccination of those <5

years of age has significantly reduced the total number

of drug-resistant cases for all ages by about 63% and

the actual cases in those <5 are only about 17% of

the total number of the penicillin-resistant cases.

However, in each successive year, not only has the

total number of such cases begun to increase (2004

and onwards) but also the percentage of those cases

in the " < 5 " group increases in every year for which

there are data (see (in Table " 3 " ).

Table " 3 " CDC Data for Invasive Drug-Resistant

Cases of S. pneumonia [13]

[REVIEWER'S TABLE OMMITTED]

Since, from 2001, the percent increase for cases

in the under 5s is about 374 % (or an average

annual percentage increase of about 75%, it is

clear that the vaccine's effectiveness against

antibiotic-resistant S. pneumonia is, for

whatever reasons, significantly declining and

more than 50% of the antibiotic-resistant cases

are now occurring in the under 5s.

Clearly, the PCV-7 vaccines have upset the

previous " natural balance " where penicillin-

resistant cases in the those < 5 were probably

less than 17 % of the total of such cases.

____________________________

[10] http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5153a1.htm

last visited 31 December 2007. MMWR 2004 April 30;

51(53): 1-84.

[11] http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5633a4.htm

last visited 31 December 2007. MMWR, 2007 August 24;

56(33): 851,853-863.

[12] http://www.vaccines.net/newpage112.htm last visited

31 December 2007.

[13] Taken from the appropriate sections of the CDC's

annual " Summary of Notifiable Diseases " reports.

>

>When most children are immunized, even vulnerable children,

>who are not able to be immunized due to medical reasons,

>are protected. This concept, known as " herd immunity, "

>is the key to the low levels of vaccine-preventable dis-

>eases in Florida, nationally and in most developed coun-

>tries. Herd immunity occurs when a large portion of the

>population (85-98% depending on the disease) receives

>vaccine against a disease. Such high immunization coverage

>rates protect susceptible individuals in a group because,

>due to immunity in most of the group, transmission of

>disease cannot be sustained.

>

First, " herd immunity " is at best a theory that, if valid,

is only valid when the vaccine provides adequate long-

term protection for all the current strains of the disease

organism and the disease organism is not capable of

mutating into strains (stereotypes) that are not covered

by the vaccine.

Given the preceding reality, the better term is " herd

protection " since vaccination does not ensure immunity

even in fully vaccinated populations.

Thus, at best, the theory of " herd protection " only ap-

plies to the more simple bacteria and viruses that lack

the ability to rapidly mutate into strains that are not

covered by the vaccine.

However, unless the vaccine provokes the human immune

system in the same exact manner as the disease organisms

covered, then, of necessity, the protection provided is

not only incomplete but also less durable than that

conveyed by being periodically exposed to and, in some

instances, contracting a clinical case of the disease.

Thus, with the possible exception of the current rota-

viruses (which infect everyone with rotavirus strains

claimed to provide complete protection) and the cur-

rently discontinued live-virus vaccina (cowpox) vaccine

used to eliminate the natural smallpox virus, and the

live-virus polio vaccines, the best the other current

vaccines that are recommended for " universal " use can

do is to provide incomplete herd protection - an ob-

viously inferior form of " immunity " , which does not

ensure long-term protection to most of those inocu-

lated with these vaccines.

In nations, like the USA, the western European nations,

Japan and Australia, where the risk of exposure to a

given disease organism is low and restricted to ex-

cursions into the regions where the disease is endemic

or to exposures to immigrants and visitors from those

nations who were infected just before they traveled

to the USA, it is difficult to support the concept

of " incomplete herd immunity " when some who have been

vaccinated contract the disease after being exposed

to these " foreign-origin " infections.

For diseases, like measles, the " incomplete herd

immunity " provided by infection with 2 doses of live-

virus measles and rubella vaccine components seems

to be both long-term and general, since very few,

who have been inoculated with a live-virus measles

vaccine and rubella or a combination measles, mumps

and rubella vaccine and who have recovered, subse-

quently contract measles after exposure to " foreign

origin " measles.

However, for mumps, the live-virus vaccine component

does not seem to provide robust long-term protection

to those who have been vaccinated because, with the

same level of coverage (where more than 93% get two

doses of the MMR vaccine), thousands contract mumps

each year.

In 2006 in the USA according to the CDC [14], for

example, there were 24 " Indigenous " and 31 " Impor-

ted " measles cases (55 cases in total) and only 11

cases of rubella versus 6,584 mumps cases - or

about 120 times as many mumps cases as measles

cases.

Similarly, the current " 5-dose " -plus DTaP regimen

is very effective against diphtheria and effective

against tetanus, where no cases of diphtheria and

only 11 cases of tetanus (mainly in the elderly)

were reported in 2006.

But there were 15,632 reported cases of pertussis,

indicating that the current pertussis vaccine

component does not provide effective long-term

" herd protection " under the current vaccination

programs based on the observed level of clinical

disease cases.

_________________________________

[14] Summary of Notifiable Diseases --- United

States, 2006. MMWR 2008 March 21; 55(53):

1-94.

>

>The fact that early childhood immunization and child

>care/school entry immunization requirements lead to

>herd immunity, is an important reason for their

>effectiveness in reducing the spread of communicable

>diseases. The huge reductions now seen in most of

>the vaccine-preventable diseases did not occur until

>states implemented school and child care immunization

>entry requirements.

>

Even accepting that this generalization is valid

for all the vaccines mandated by Florida, which

the data clearly show is not the case, the growth

in the mandated vaccination programs also seem to

be factor in the appearance of, or large increases

in, chronic diseases during childhood that, prior

to the 1950s, were either unknown or very rare in

children (e.g., asthma, COPD, type 2 diabetes,

IDCM, obesity and MS) as well as large increases

in severe food intolerances and life-threatening

food and environmental allergies to the point that

many of these medical conditions are at epidemic

levels today.

Thus, it would appear that the public health

officials, healthcare establishment and the vac-

cine makers have foisted a Faustian bargain off

on the American public in which, to displace

acute childhood diseases, we have been, and are

being, forced to accept the vaccine-induced or

vaccine-exacerbated burden of chronic diseases

that enriches them and impoverishes the American

public today.

Hopefully, we will:

1. Wake up,

2. Demand independent proof of:

a. Long-term safety,

b. Long-term effectiveness,

c. Overall medical cost-effectiveness, and

d. Very low (< 1 in 100,000 doses) or no

increased chronic-disease risk, for

each existing vaccine component in the

current national vaccination program,

and

3. Only retain those components that are truly

safe, long-term effective, medically cost-

effective, and free from any significant

increased risk of chronic disease.

>

>Without herd immunity, those who are too young to

>be immunized, and/or have medical or religious

>contraindications to immunization, and/or have

>diseases that cause immunodeficiency, would all

>be at much greater risk for infections and their

>sequelae. That is, when fewer children are immunized,

>then children who cannot be immunized are much more

>vulnerable to getting infected with a disease-a

>disease that can be prevented when most people are

>immunized.

>

This ever so carefully crafted scenario sounds

plausible until the reader remembers that vac-

cinating with live-virus vaccines as we do for

many of the diseases (e.g., smallpox, influenza,

measles, mumps, rubella, varicella, and, until

recently, polio) actually increases the risk that

those who are either unvaccinated or vaccinated

but not now protected will contract the disease

from the viruses shed by some of those who have

been recently vaccinated.

Factually, the risks to the unvaccinated and un-

protected vaccinated populations are not known

for most live-virus vaccine components because

we do no active surveillance for clinical and

sub-clinical diseases caused by all vaccines.

Instead of such active population surveillance,

in America, we rely on a voluntary reporting sys-

tem (the Vaccine Adverse Events Reporting System

[VAERS]) that, according to the CDC, receives, on

average, notices for less than 10% of the adverse

events, including death, that are typically only

immediately (within a month of the vaccination

date) associated with vaccine administration.

However, unlike what the adverse events system

should do, this system does not track any segment

of the population for the decades required to

establish possible/probable links between: a)

vaccination and the subsequent manifestation

of some delayed-onset vaccination-related condi-

tion or disease.

Finally, for, for example, mumps and pertussis,

it is clear that the vaccines are not as effec-

tive as advertised in the current vaccination

programs.

Further, for varicella, the current 2-dose regi-

men is not even societally cost-effective and,

when the costs for the harm from vaccination and

the third dose (e.g., Zostavax) are factored in,

it is clear that the national chickenpox program

is a large financial and health loss for the

American public.

Thus, only the healthcare establishment and the

vaccine makers profit from both these programs

and the costs of the consults and medications

needed to treat the adverse outcomes from: a) the

increased occurrence of shingles in adults and

the previously unknown, or very rare, childhood

shingles cases in babies and young children.

>

>Section 1003.22 of the Florida Statutes requires immuni-

>zation for school entry and attendance, and allows for

>medical (temporary and permanent) or religious exemption

>from immunizations. The Florida child care and school

>entry immunization requirements cover public and private

> schools, childcare facilities, and family childcare

>homes. They are in accordance with the recommendations

>from the Centers for Disease Control and Prevention's

>(CDC) Advisory Committee on Immunization Practices (ACIP),

>the American Academy of Pediatrics [AAP], the American

>Academy of Family Physicians [AAFP], and the American

>Medical Association [AMA]. These organizations set the

>standard of care and practice that health care providers,

>health plans, and insurance companies follow with respect

>to providing immunizations.

>

This reviewer accepts that this section of the report

accurately reflects Florida's law and practices with

respect to vaccination, which, as most do, the report's

writers yet again mischaracterize as " immunization " .

Since the vaccine makers and their lobbyists and hang-

ers on exert significant influence on the decisions of

the ACIP, AAP, AAFP and AMA, this reviewer finds that

the report should have included the general recommenda-

tions of the vaccine makers, although, to be fair, the

vaccine makers do provide information on vaccine risks

that the aforementioned groups either: a) do not openly

provide or gloss over.

>

>Florida Statutes require specific immunizations for

>infants and children who attend child care, family

>childcare homes, pre-kindergarten and school. Immuniza-

>tion entry requirements for school and child care set-

>tings relate to factors such as whether the disease is

>communicable in child care and school settings, whether

>the vaccine has been on the market long enough to assess

>for previously undetected side effects, and whether the

>vaccine is covered by insurance and health plans.

>

This reviewer accepts that this section of the report

accurately reflects Florida's rationale for adding

vaccines to the Florida vaccination schedule.

However, this reviewer is surprised that the Florida

considerations for vaccines do not, according to what

is reported here, extend to assessment of the cost-

effectiveness of the vaccines recommended even though

the state and its residents bear a significant part of

the vaccination costs even when " the vaccine is covered

by insurance and health plans " .

>

>Immunization safety is of utmost concern to parents, health

>care providers, the public health community, legislators

>and vaccine manufacturers.

>

While this reviewer would agree that vaccination safety

is of utmost concern to parents and the guardians of

children, this reviewer finds that, as a group, " health

care providers, the public health community, … and vac-

cine manufacturers " have no real concerns about vaccine

safety or vaccine effectiveness because the National

Vaccine Injury Compensation Act of 1986, as amended,

[NVICA] effectively protects them from being sued for

the harm caused by any covered vaccine.

In addition, legislators, who receive significant con-

tributions from these groups and their lobbyists, seem

to be more focused on the concerns of these special

interests than on those of the parents and guardians of

children and, for that matter, the children's concerns.

Finally, only when: a) the parents and guardians make

vaccination an issue that decides who the majority of

the electorate will support in a given election or

the legislator's child or grandchild is significantly

harmed by, or dies from, vaccination do most legisla-

tors seem to be genuinely worried about the safety of

vaccines.

>

>Vaccines undergo rigorous and lengthy testing for both

>safety and efficacy prior to approval by the Food and

>Drug Administration (FDA).

>

Here the report is simply mistaken - the safety tes-

ting is anything but rigorous and lengthy.

Further, efficacy testing is allowed when some effec-

tiveness testing should be required before a vaccine

is approved for inclusion in the national program;

and the efficacy testing conducted does not last long

enough (for at least 10 years) nor, where possible,

require effectiveness challenge in populations experi-

encing a significant disease outbreak.

Factually, the vaccine makers do almost all the tes-

ting of vaccines with little or no active oversight

of the trials.

Moreover, in recent years, the vaccine makers have

been allowed to reduce the depth and length of their

safety studies to the point that most safety studies

only follow the clinical trial patients inoculated

for a few days to a couple of months for safety

effects.

Furthermore, for efficacy, they are allowed to use

surrogate and, in some cases, indirect surrogate end-

points for efficacy in efficacy trials that: a) last

only for a few years and do not actively assess

long-term vaccine safety.

In addition, to save the manufacturers both cost and

time, the FDA has reduced: a) the number of clinical

trials required and the minimum number of subjects

allowed for a given trial.

Unfortunately, these decisions also reduce the clinical

trials' ability to detect uncommon adverse effects or

" rare " adverse effects in certain subpopulations.

Moreover, instead of rigorously requiring that sterile

saline be used as a placebo in all safety trials, the

FDA has allowed the vaccine makers to use the vaccine

formulation without the disease antigens and other

experimental vaccines as the placebo.

Sadly, allowing these alternative placebo choices: a)

minimizes the vaccine's relative risks for the adverse

outcomes observed and artificially inflates the short-

term safety of the vaccine.

Furthermore, the vaccine makers seeking to obtain appro-

vals from the U.S. FDA are increasingly being allowed to

choose clinical trial subjects from locations where the

background disease rate is significant even when these

locations do not reflect the disease risks for the Ameri-

can population.

Because, in such situations, the firms are allowed to

report the relative adverse safety outcomes for the vac-

cine-test arm of the trial to those observed for the

placebo arm of the trial instead of the U.S. background

adverse outcomes' rates, permitting this also: a) mini-

mizes the vaccine's apparent adverse safety profile and

artificially decreases the trial's " relative risk "

with respect to the American public's " relative risk "

for in-use adverse outcomes.

The net result has been that the FDA is approving in-

creasingly less safe and/or less effective vaccines.

In addition, the approvals obtained are increasingly

based on the manufacturer's knowingly biased safety

and/or biased inferential efficacy assessments for

the vaccine.

Moreover, active surveillance, where required, is increa-

singly less concerned about the actual in-use adverse

experiences observed because the U.S. governmental regu-

latory agencies are:

Ø Ignoring the pre-vaccine background rates for the

serious adverse effects linked to the vaccine's use

and

Ø Increasingly framing their views in terms of the

relative observed risk " in use " incidence rates

compared to the corresponding " control arm " adverse

outcomes rates observed in the biased condition

phase-III clinical vaccine trials conducted in

populations with a background disease rate that is

much higher than the general U.S. rate.

>

>Today's vaccines are much more pure than those produced

>decades ago. This increased purity has the effect that the

>total number of antigens (from the vaccines themselves and

>from other substances in the vaccine preparation) intro-

>duced to the body is much less, even as the number of

>recommended vaccines has increased.

>

Since the vaccine makers and the Secretary of Health and

Human Services and his subordinates are under legal man-

dates to do all in their power to safen vaccines, it is

good to know that the vaccine makers and the governmental

agencies have somewhat safened some vaccines.

However, unless:

Ø All of the other substances in all of the vaccines are

the same,

Ø All of the other substances have been proven to be safe

to the standards that have been established for them by

law, and

Ø The vaccines are free of all adventitious viruses and

prions,

increased purity does not assure improved safety as the

number of: a) vaccines, vaccine doses, and/or c) vaccines

given together all increase.

Specifically, the failure to prove that vaccines in which

Thimerosal is a preservative have a preservative level that

is " sufficiently nontoxic … " for the dose of vaccine admin-

istered as required under 21 C.F.R. Sec. 610.15(a), a cur-

rent good manufacturing practice (CGMP) minimum, as the

vaccine makers have admitted they have not done and the FDA

has illegally overlooked, renders these Thimerosal-preserved

vaccines adulterated under 21 U.S.C. Sec. 351(a)(2)( and

makes these drugs illegal and all those involved subject to

legal sanction.

Until the FDA: a) bans the use of Thimerosal-preserved vac-

cines and obtains proof that the level of Thimerosal is

nontoxic to all recipients with at least a 100X safety mar-

gin (because Thimerosal is a highly toxic bioaccumulative

poison that is also a proven human carcinogen, mutagen,

teratogen and immune-system disruptor at levels below 1 ppm),

all Thimerosal-containing vaccines and other Thimerosal-

containing drugs apparently do not meet the safety expecta-

tions set forth in the U.S. Federal Food, Drug, and Cosmetic

Act, as amended.

>

>Concerns about vaccine safety have been addressed since the

>time when vaccines were first introduced. Public health

>authorities and governmental bodies must balance the right

>to immunize for the " common good " with individual rights

>and concerns.

>

In light of the realities discussed in the preceding para-

graphs, this reviewer finds this statement in the report

to be disingenuous, at best.

>

>The U.S. Supreme Court, in 1905, ruled in son v. Massa-

>chusetts that the need to protect the public health through

>compulsory smallpox vaccination outweighed the individual's

>right to privacy. This justification is consistently applied

>to child care and school entry immunization requirements,

>with allowances for religious beliefs and medical conditions.

>

Factually, the Supreme Court ruling only applies to a

condition when there was an actual pandemic smallpox

outbreak (an epidemic) under conditions where: a) there

was much less than adequate sanitation, there were no

effective alternative curative treatments and c) a signi-

ficant percentage (about 30%) of those infected would die

from the disease - conditions that do not apply in America

today.

Moreover, unlike most vaccines, though the vaccina vaccine

does have some risk of death (about 1 in 10,000), inocula-

tion with it and recovery from that one-time inoculation

with vaccina is known to convey near lifetime (> 50 year)

immunity to smallpox to almost everyone vaccinated

Thus, that Supreme Court decision does not apply to " compul-

sory " vaccination:

1. In the absence of an actual disease epidemic for which

there is no alternative curative treatments,

2. For diseases that are not highly infectious and/or

probably spread by a vector for the disease,

3. For diseases that are lifestyle related,

4. For diseases that have no real risk of death, and/or

5. For diseases where there is no proof that the vaccine

provides near lifetime protection.

Therefore, the Supreme Court decision has been consistently

misapplied to mandate vaccination under conditions where

the guarantees of bodily integrity and due process of law

in the U.S. Constitutional should render such mandates

unconstitutional on their face because, contrary to law,

truly informed consent cannot be given.

This is currently the case because the vaccine information

that is provided by today's vaccine, healthcare and public

health establishments: a) inflates the theoretical benefits

and minimizes and/or hides the risks associated with

each vaccine.

>

>Recently, some parents and vaccine safety advocacy groups have

>raised questions about a purported link between Autism Spec-

>trum Disorders (ASD) and vaccines.

>

From November 9, 2007 onwards, there has been no purported

link between ASD and vaccines.

Shortly before that date, after reviewing her medical records,

the testimony of her parents, and her published case report,

medical professionals in the U.S. Department of Health and

Human Services conceded that Hannah Poling's vaccinations at

19 months were a causative factor in her diagnosed autism

spectrum disorder.

Therefore, from that date forward, there is no longer a " pur-

ported link between Autism Spectrum Disorders (ASD) and vac-

cines " but rather a conceded link.

Moreover, before this vaccine injury case was conceded prior

to any hearing, Hannah Poling v. Sec. HHS (02-V-1466) was

designated as a " vaccine Thimerosal is a causal factor in

autism " (Theory 2) case in the Omnibus Autism Proceeding in

the United States Court of Federal Claims.

This case was selected as a " test " case because Hannah Poling

had a diagnosis of autism (autistic disorder) and had been

established to be have been mercury poisoned by the Thimerosal

in the Thimerosal-preserved vaccines she received in her 19-

month vaccinations.

Therefore, those who wrote this report need to get beyond

" purported link " and deal with the reality of: a) a conceded

ASD-vaccine link and a vaccine Thimerosal-ASD link.

>

>Factors such as the preservative thimerosal (previously used in

>diphtheria, tetanus, pertussis, Haemophilus influenzae type b,

>and hepatitis B vaccines); the MMR (measles, mumps, rubella)

>vaccine; and the number, timing and spacing of vaccines have

>all been suggested at one time or another as causing or trig-

>gering ASD.

>

First, let us tell the truth about Thimerosal in vaccines.

Factually, Thimerosal is not a preservative; Thimerosal is

a highly toxic mercury compound whose metabolites are bio-

accumulative poisons that have half-lives of up to 20 years

in the human body [15].

Thimerosal has been, and is still being, used as a preser-

vative in some U.S.-licensed vaccines, including in most

doses of the inactivated influenza vaccines.

Moreover, in many developing countries, Thimerosal is still

being used as a preservative in many of the vaccines and

serum products, for which the U.S. had licensed a Thimerosal-

preserved formulation for use prior to 1999.

Further, ignoring:

Ø Its 1999 promise to remove Thimerosal from vaccine for-

mulations,

Ø Its 2000 promise to reduce the level of Thimerosal in

vaccine formulations,

Ø The vaccine makers' failure to comply with 21 CFR Sec.

610.15(a), and

Ø The mandate to safen vaccines set forth in 42 U.S.C.

Sec. 300aa-27(a)(2),

the FDA has continued to license new Thimerosal-preserved

vaccine formulations, which, without the requisite proof

of safety, the CDC has continued to include in the U.S.

national vaccination schedule.

At present, the list of Thimerosal-containing vaccines

that are FDA-approved and in use in the USA can be found

in the Table " 4 " on the next page.

Examining this table, one finds that, including the " avian

flu " vaccine: a) there are still at least seventeen (17)

FDA-approved vaccines that contain some level of Thimerosal,

ten (10) are Thimerosal preserved, c) twelve (12) can be

given to children of some age, including seven (7) that are

Thimerosal preserved, and d), when you count the fetus as

a developing child, all can be given to developing children.

Having established the on-going presence of Thimerosal in

vaccines given to children from before birth to age 18, this

reviewer can agree that factors such as the Thimerosal-pre-

served vaccines, the MMR vaccine; and " the number, timing and

spacing of vaccines have been suggested as causing or trig-

gering " neurodevelopmental disorders, including any of the

recognized autism spectrum disorders (ASDs).

Table " 4 " March 2008 FDA-licensed Thimerosal-containing

Vaccines

[Taken From: FDA's " Table 3: Thimerosal and Expanded List

of Vaccines - (updated 3/14/2008) Thimerosal Content in

Currently Manufactured U.S. Licensed Vaccines " & Recent

approvals]

[REVIEWER'S TABLE OMMITTED]

________________________________

[15] 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.

>

>Because of these concerns, the medical and public health com-

>munities have sought to rigorously examine the scientific

>evidence for or against an association between vaccines and

>ASD.

>

Though this statement sounds good, the factual evidence

supports the reality that the medical and public health

establishments have joined ranks to avoid rigorous,

scientifically sound assessments of any association

between vaccines and ASD.

Though rigorous science would:

v Demand in-depth toxicological assessment for the

toxicity (acute, short- and long- term chronic,

reproductive, carcinogenic, mutagenic, teratogenic

and immune dysfunction) of Thimerosal in each

vaccine formulation to ascertain the minimum level

at which reproducible toxic effects are seen in

the appropriate Thimerosal-sensitive animal-model

species and then,

v Set a level 100 times lower than the observed

minimum-toxic-effect level to provide an adequate

safety margin for all who may be inoculated with

a Thimerosal-containing vaccine,

the vaccine makers, medical and public health estab-

lishments have avoided doing these toxicity assessment

studies and setting science-based limits based on the

results observed.

Instead, they have attempted to substitute retrospec-

tive population-record epidemiological studies that:

a) are overseen by the CDC and/or CDC/industry-tied

" academic " organizations and can, at best, only

establish the statistical probability of the possibil-

ity of an association between vaccine Thimerosal and

various neurodevelopmental disorders, including ASDs,

as well as other developmental and behavioral dis-

orders.

>

>Authoritative evidence-based recommendations for or

>against medical screenings and interventions increa-

>singly set the standard of care.

>

As independent assessments have repeatedly shown,

those making standard of care recommendations are

increasingly influenced by the deep-pocketed phar-

maceutical, medical and healthcare establishments,

who seem more interested in expanding their markets

than in the health of the public.

>

>The evidence must come from convincing scientific

>studies-i.e., methodologically rigorous, of high

>statistical power and subjected to critical peer

>review prior to publication. Thus, medical inter

>ventions where harms outweigh benefits are quickly

>abandoned, while those demonstrating that the bene-

>fits outweigh harms are adopted and promoted.

>

Factually, for vaccine safety, the evidence in the

case of Thimerosal must come appropriate prospec-

tive toxicity studies in sensitive animal-model

studies that include vaccination-timing studies

designed to match the children's developmental

periods.

For studying the MMR vaccine link to harmful out-

comes, the studies must track the outcomes for

thousands of American children from the date of

vaccination until several years afterward to cap-

ture the true incidence of those adverse events

known to cause harm in some who are vaccinated

with the MMR vaccine according to the package

insert for the vaccine, which reports these adverse

events but does not establish their incidence rates

or the factors affecting the adverse outcomes ob-

served, and, so that we can see the effect, studies

of matched children who, for religious or philo-

sophical reasons, do not receive the MMR vaccine.

In the course of these studies, the adverse effects

of the second dose of the MMR vaccine in humans must

be the subject of in-depth study of the immune sys-

tem response to this immune-system rechallenge to

infection by injection as well as the pathophysio-

logical changes observed in those individuals who

have a " bad " reaction to the second dose.

Then and only then, will the information needed to

understand the links and the factors affecting

these links be available to determine the causal

links, if any, in each case.

Unfortunately, except for Thimerosal in preserved

vaccines, the independent studies and the indepen-

dent review of CDC/industry-influenced studies re-

quired to ascertain the facts have not been conduc-

ted.

In the case of Thimerosal,

Ø Toxicity studies in monkeys, mice, pigs, pheasants,

rats, chicken eggs and hamsters as well as in in

vitro systems and

Ø Studies from the post-mortem biopsies of the brains

of children who died shortly after the external

application of Thimerosal [16] or

Ø In-depth differential medical diagnostic workups

and critical biochemical toxicity marker evalua-

tions of those who had a diagnosis of autistic

disorder, an ASD, and/or other neurodevelopmental

disorders

have clearly established that surface exposure to

Thimerosal-based antiseptics or vaccination with

Thimerosal-preserved vaccines can mercury poison the

recipient to the point that those who are mercury-

poisoned exhibit the set of neurological deficit

symptoms used to diagnose an ASD.

Recent publications from researcher groups on four

continents (Australia, Europe, North America and

South America have clearly established that children

who: a) received the majority of their principal

early mercury exposure from Thimerosal-derived mer-

cury in the vaccines and other Thimerosal-containing

drugs to which they were exposed during gestation

and early childhood and were also diagnosed with

an ASD are mercury poisoned [17-21].

Moreover, recent studies in developing hamsters given

weight and developmental-age proportional doses of

Thimerosal [22] have again established that giving

Thimerosal-preserved vaccines causes pathophysiologi-

cal symptoms and behaviors similar to those exhibited

by mercury-poisoned children with an ASD diagnosis.

_____________________________________________

[16] Fagan DG, Pritchard JS, son TW. Organ mercury

levels in infants with omphaloceles treated with

organic mercurial antiseptic. Arch Dis Child. 1977;

52: 962-964.

[17] Austin DW, Shandley K. An investigation of porphy-

rinuria in Australian children with autism. J

Toxicol Environ Health A. 2008; 71(20):1349-51.

[18] Geier DA, Mumper E, Gladfelter B, L, Geier

MR. Neurodevelopmental disorders, maternal Rh-nega-

tivity, and Rho(D) immune globulins: a multi-center

assessment. Neuro Endocrinol Lett. 2008 Apr; 29(2):

272-280.

[19] Geier DA, Geier MR.A prospective assessment of an-

drogen levels in patients with autistic spectrum

disorders: biochemical underpinnings and suggested

therapies. Neuro Endocrinol Lett. 2007 Oct; 28(5):

565-573.

[20] Nataf R, et al. Poryphyrinuria in childhood autistic

disorder: implications for environmental toxicity.

Toxicol Appl Pharmacol 2006; 214: 99-108.

[21] Geier DA, Geier MR. A prospective assessment of

porphyrins in autistic disorders: a potential marker

for heavy metal exposure. Neurotox Res 2006; 10:

57-64.

[22] te J, Remuzgo F, Ávalos B, Chiquinta J, Ponce

B, Avendaño R, Maya L. Neurotoxic effects of thimero-

sal at vaccines doses on the encephalon and develop-

ment in 7 days-old hamsters. An Fac Med Lima 2007;

68(3): 222-237.

>

>The scientific studies addressing vaccine safety are too

>numerous to describe here but the Department of Health

>has compiled a bibliography (included in the Supporting

>Documents Section) of many of the pertinent studies.

>

In contrast to the selective list provided in the re-

port's bibliography, this reviewer has included a more-

comprehensive cross-section of the pertinent literature

on studies involving Thimerosal and other alkylmercury

compounds (as well as some references that bear on

other issues this reviewer has raised) in a list at the

end of this review.

>

>Similarly, a critique of the quality of the various

>studies is beyond the scope of this document. However,

>in summary, the reviews of the scientific literature by

>recognized medical and public health authorities, such

>as the prestigious Institute of Medicine (IOM), indicate

>that vaccines are not associated with ASD.

>

Unfortunately the studies upon which the IOM committee,

paid and guided by the CDC, relied have all been shown

to be: a) not accessible to independent review and ,

in general, fatally flawed in their design, execution

and/or analysis.

Since:

Ø Independent researchers have been denied access to

the raw datasets used in the studies upon which the

IOM relied;

Ø The datasets for the key U.S. studies (the studies

headed by Verstraeten et al.) have been lost;

Ø A subsequent IOM committee found that the epidemio-

logical studies were problematic and their findings

unreliable, and

Ø Dr. Gerberding, head of the CDC, has testified to

Congress that the types of epidemiological approaches

used in the studies in which the aforementioned IOM

committee [23] relied are unreliable approaches to

addressing the issue of causality,

the 2004 IOM committee's reported findings must be

disregarded as the published epidemiological studies

upon which that committee chose to rely are not only

unreliable but also both non-reviewable and, for the

U.S. studies, non-reproducible.

Finally, other than the justification that that is

what that IOM committee elected to do, there is, and

was, no scientific justification for ignoring the

then-existent body of published peer-reviewed toxico-

logical studies that clearly showed toxicological ef-

fects in animals and developing children from the

equivalent of vaccine-dose exposures and, in many

cases, lower than vaccine exposures to Thimerosal

and/or the other ethyl mercury compounds, like the

alkylmercury compounds into which Thimerosal is

metabolized in the human body (see the pertinent

articles in the reviewer-supplied bibliography).

___________________________________

[23] Institute of Medicine (IOM) meeting held at the

National Academy of Sciences in Washington, DC

on February 9, 2004.

>

>The IOM is part of the United States National Academy

>of Sciences, a nongovernmental, not-for-profit organ-

>ization chartered to provide national advice on issues

>relating to biomedical science, medicine, and health.

>It uses a volunteer workforce of scientists and has a

>formal peer review process. Thus, it works outside the

>framework of the U.S. federal government to provide

>independent guidance and analysis. In their report

> " Immunization Safety Review: Vaccines and Autism, " the

>IOM Immunization Safety Review Committee stated " …the

>body of epidemiological evidence favors rejection of

>a causal relationship between the MMR vaccine and

>autism. The committee also concludes that the body of

>epidemiological evidence favors rejection of a causal

>relationship between thimerosal-containing vaccines

>and autism. The committee further finds that potential

>biological mechanisms for vaccine-induced autism that

>have been generated to date are theoretical only. "

>

For the scientific reasons stated in the previous

discussion and the fact that the " …the body of

epidemiological evidence favors rejection of a

causal relationship between the MMR vaccine and

autism. The committee also concludes that the body

of epidemiological evidence favors rejection of a

causal relationship between thimerosal-containing

vaccines and autism " clearly shows that this IOM

committee only considered the now-discredited

epidemiological studies and, in the case of

Thimerosal, clearly ignored the substantial body

of toxicological evidence that clearly established

that the sub-acute mercury poisoning from vaccine-

level exposures to Thimerosal can and does cause

neurodevelopmental deficits in those children that

it mercury poisoned, which, for some mercury-poi-

soned children, include the set of symptoms used

to diagnose an ASD.

Thus, these statements should be ignored because

they are based on discredited epidemiological

studies.

>

>Similarly, the WHO's Global Advisory Committee on

>Vaccine Safety reviewed the evidence and released

>a July 2006 statement concluding that " there is no

>evidence of toxicity in infants, children or adults

>exposed to thimerosal (containing ethyl mercury) in

>vaccines. "

>

Given the published toxicity studies showing that

infants and children who have been exposed to

Thimerosal-preserved vaccines have been, and are,

mercury poisoned by that Thimerosal exposure (using

a scientifically proven indirect urine porphyrin

profile analysis [uPPA] test that had been proven

to indicate mercury poisoning in those with routine

workplace exposure to metallic mercury, mercury

amalgam materials, and other mercury compounds), it

is obvious that " the WHO's Global Advisory Committee

on Vaccine Safety " conclusory statement: a) is

incorrect and ignores the body of studies showing

neurological harm from subacute exposures to alkyl

mercury compounds, including Thimerosal and various

other ethyl and methyl mercury compounds.

Moreover, lacking in-depth studies in adults, the

data from exposures in infants and children clearly

indicate that toxic effects would be observed in

adults who have received annual inoculations with

Thimerosal-preserved influenza vaccines for several

consecutive years (>3) were the requisite studies

to be conducted.

>

>Despite the many scientific studies that demonstrated

>no causal connection between thimerosal and ASD, in

>July 1999, U.S. Public Health Service agencies and the

>American Academy of Pediatrics recommended that

>thimerosal be removed from vaccines as a precautionary

>measure aimed at reducing any additional exposure to

>mercury. Today, all vaccines recommended for use in

>infants and young children are available in forms that

>have no or only trace amounts of thimerosal. The term

> " trace " in this context means 1 microgram (1 millionth

>of a gram) of mercury per dose or less. To put this

>into context, according to an FDA survey of commercial

>seafood, a 6 oz can of albacore tuna contains, on aver-

>age, 60 micrograms of mercury.

>

First, this reviewer agrees that the July 1999 state-

ment was made.

Second, while true in the USA, the second assertion

ignores: a) the reality some of these vaccines are

still available in Thimerosal-preserved formulations

and the fact that neither the Thimerosal-preserved

nor the " trace Thimerosal " childhood vaccines have

been proven to be safe to give to developing chil-

dren.

Third, how many typical American children under the

age of 13 months eat any albacore tuna?

How many American children under 2 years of age eat

a whole 6-oz can of any tuna?

Moreover, since the general evidence is that: a)

less than 25% of the mercury in the tuna is absorbed

into the body (with the rest being excreted in the

feces) and the absorption is a slow process when

tuna is eaten, the " effective dose " of mercury from

eating this " theoretical " can of " albacore tuna " is

less than 15 micrograms!

So, other than to be disinformative, what is the

point of including this obviously irrelevant

example?

>

>Methyl mercury, from sources such as seafood and

>coal plant emissions, is a well known toxicant.

>It is not readily eliminated by the human body and

>therefore accumulates and poses health risks. On

>the other hand, ethyl mercury (from thimerosal)

>is more rapidly metabolized and eliminated so poses

>much less risk.

>

First of all coal plants do not emit methyl mer-

cury [technically, dimethyl mercury: (H3C)2Hg].

Actually, they emit inorganic mercury salts and,

in some cases, metallic mercury -mercury species,

which enter the environment and are slowly con-

verted into methyl mercury compounds by the bio-

organisms living there.

Second, methylmercury compounds and their metab-

olism products are, in general, not readily

eliminated by the human body and, therefore, do

pose health risks.

However, based on the available material safety

data sheet (MSDS), Thimerosal and the ethyl mer-

cury compounds into which Thimerosal is initial-

ly metabolized as well as the secondary " inor-

ganic " mercury metabolites formed from the ethyl

mercury compounds are as toxic, or more toxic,

to the human body than the corresponding methyl-

mercury compounds.

Moreover, though the human body does metabolize

Thimerosal more rapidly than the methylmercury

compounds typically used in comparative studies

using both, there is no mass-balance-based evi-

dence that the mercury from Thimerosal is " elimi-

nated " from the body - in fact, the evidence from

studies using mercury-radiolabeled [203Hg80] ethyl

mercury chloride clearly shows that the mercury

bioaccumulates and is not eliminated from the

body [24].

Factually, the studies by Burbacher et al. [25],

upon which this report seems to rely, only indi-

cate that INJECTED Thimerosal and its ethyl mer-

cury metabolites clear the blood faster than

INGESTED methylmercury hydroxide.

In addition, unlike the methylmercury hydroxide

and the mercury species sequestered in fish,

Thimerosal is a strong immune-system disruptor at

levels below 0.01 ppm.

______________________________________

[24] Shiraki H, Nagashima K. Essential neuropathy of

alkylmercury intoxications in humans from the

acute to the chronic stage with special reference

to experimental whole body autoradiographic study

using labeled mercury compounds. Neurotoxicology

1977; 1: 247-260.

[25] Burbacher TM, et al. Comparison of blood and brain

mercury levels in infant monkeys exposed to methyl-

mercury or vaccines containing Thimerosal. Environ

Health Persp 2005; 113(8): 1015-1021.

>

>Referring again to the WHO's 2006 statement, " …the phar-

>macokinetic profile of ethyl mercury is substantially

>different from that of methyl mercury. The half-life of

>ethyl mercury is short (less than one week) compared to

>methyl mercury (1.5 months), making exposure to ethyl

>mercury in blood comparatively brief. Further, ethyl

>mercury is actively excreted via the gut, unlike methyl

>mercury that accumulates in the body. "

>

Here the WHO statement speaks in half-truths and is

disinformative.

The half-lives of various compounds of mercury in

blood do differ and the half-life for injected Thimerosal

in blood appears to be significantly shorter than the

half-life of ingested methylmercury hydroxide in blood.

However, unlike the studies using ethyl mercury chloride

containing a radioactive mercury isotope, 203Hg80, the

different modes of administration and the lack of a mass

balance or the determination of the fate and half-lives

of the mercury species in the various tissues of the

human body preclude any valid assessment of the degree

of bioaccumulation in body tissues and the half-lives

thereof for the two compounds used in the most vaccine-

like studies to which this report seems to be referring.

Moreover, in the Burbacher et al. study in developing

monkeys supposedly administered vaccine-equivalent doses

of methylmercury hydroxide (by forced ingestion) and

Thimerosal (by injection) in a protocol designed to

mimic the developmental-age timing comparable to the

1999 vaccination schedule, the imputed [26] average level

for " inorganic mercury " in the brains of the monkeys

given Thimerosal was 3 times the level in the monkeys

that were force fed methylmercury hydroxide (MMH).

In addition, the data showed no decline in the level

of " inorganic mercury " in the monkeys' brains 120 days

after mercury exposure ceased.

Taken together, these data indicate that, in the brain,

injected Thimerosal produces " 3 " times the level of the

long-term brain toxicant ( " inorganic mercury " ) than fed

MMH.

Thus, in this human-applicable study, the data clearly

shows that Thimerosal is significantly more toxic to

the brain than MMH and that Thimerosal's end-metabolite

in the brain, " inorganic mercury " accumulates to a level

that is " 3 " times that for MMH.

Therefore, the excretion of some " ethyl mercury in the

gut " is a red herring that, given the preceding facts,

has no bearing on the relative bioaccumulation of

" inorganic mercury " in the brain, where it causes the

neurodevelopmental harm seen in studies designed to

study the effects of this mercury poisoning on the

developing brain.

Finally, a recent Peruvian study by te et al. [22]

using baby hamsters, an animal more sensitive to the

global effects of Thimerosal than either the monkeys or

the strains of rats and mice typically used, found: a)

significant neurodevelopmental deficits and signifi-

cant adverse effects on overall growth and key organ

development.

This study used a Thimerosal-dosing pattern that was

weight- and developmental-age- adjusted to mimic the

dosing for the Thimerosal doses and developmental age

for American children being inoculated at 2, 4 and 6

months under the recommended 2001 U.S. early-childhood

vaccination program.

The study was a three-armed study where: a) saline, or

saline plus glucose or c) saline plus Thimerosal

was given to the young hamsters in each of the three

groups of hamsters at days: 7, 9 and 11 in the hamsters'

development and, after identical access to the same food

and water, the hamsters were evaluated at " day 25 " to

allow time for Thimerosal to be " fully " metabolized.

When the hamsters were evaluated on " day 25 " , the only

group showing overt adverse developmental effects was

group " c " , which had:

1. An average total weight (11.3 g) that was only about

55% of the average weights for the other two groups

(20.55 g),

2. An average brain weight (0.76 g) that was only about

79% of the average brain weights for the other two

groups (0.965 g), and

3. An average caudal skull length (7.5 cm) that was

only about 86% of the average lengths for the other

two groups (8.7 cm).

Furthermore, significant differences were only seen in

the Thimerosal-injected group for the tissues that were

also examined.

Specifically, neurotoxic effects were also only observed

in the Thimerosal-treated group at the encephalic level

as well as in the hippocampus (regions CA1, CA3 and DG),

cerebral cortex, and cerebellum (Purkinje and granulose

cells); with decrease in neuronal density, neuronal

necrosis, axonal demyelization, and gliosis.

Finally, the data indicated that statistical risk in

developing any of the preceding tissue alterations was

only significant in the animal group receiving saline

plus Thimerosal.

___________________________________________

[26] This average brain mercury levels were compared

after correcting for the fact that about half of

the monkeys fed MMH had undetectable levels of

" inorganic mercury " in their brains while all of

the monkeys injected with Thimerosal had detec-

table levels of " inorganic mercury " that, on

average, were more than twice the level in the

fraction of MMH-fed monkeys that had a detectable

level thereof.

>

>A robust immunization program has tremendous benefit to

>individual and public health. Calls for opposing immuni-

>zations and/or school entry vaccination requirements, or

>for providing easier and more numerous ways to obtain

>exemptions for required vaccinations, are resulting in

>growing numbers of individuals not properly immunized.

>This, in turn, is leading to increases in outbreaks of

>vaccine preventable disease such as measles and pertussis.

>

Since " complete " immunization is an unobtainable goal

for most vaccines, unless they activate the human

immune system in the same manner as the natural

disease does, everyone should start calling most of

these programs vaccination programs because, with the

current exception of the rotavirus vaccines and possi-

bly the live-virus influenza vaccine, that is what

these programs are - vaccination programs that, at

best, only provide incomplete protection from disease.

Moreover, everyone needs to admit that these vacci-

nation programs require multiple exposures (inocu-

lations) to produce protection that is typically

much less complete and of shorter duration than the

protection (immunity) produced by natural exposure

for those diseases, where near lifetime immunity is

the outcome for those who recover from having a

given disease only once in most instances.

Then, everyone needs to:

Ø Admit that recommending universal chickenpox

vaccination is a bad idea and

Ø Abandon this losing approach to minimizing

the health risks and costs associated with

managing this disease.

When:

Ø The ineffective HVZ and human influenza vaccines

are removed from the U.S. recommended vaccination

schedules for children, adults and pregnant women,

Ø Only those vaccine components that are truly safe

and medically cost-effective or, where valid es-

timates for the total direct and indirect costs

of the adverse effects of vaccination are in-

cluded, at least societally cost-effective are

retained in the recommended U.S. vaccination

programs, and

Ø All vaccines are produced in full compliance with

all the applicable CGMP laws, then, and only then,

everyone can begin to discuss the " appropriate "

balancing of societal imperatives against the

individual liberties guaranteed by the Constitution

of the United States of America, provided the

pernicious biasing efforts of the special interests

who profit from ever more vaccines are removed from

the discussion.

Next, absent some immune system evaluation, everyone

should understand that, at the individual level, there

is little or no a priori guarantee that multiple ex-

posures to the current vaccines, the current state of

vaccination, will produce adequate long-term protection

from disease without causing major short-term and/or

long-term adverse effects in that individual - be that

person a developing fetus, neonate, baby, child, or

adult.

This complexity of outcomes in individuals arises be-

cause vaccines contain not only disease organisms or

disease-related antigens but also other substances

that, when injected (as most vaccines are), inhaled (as

the live-virus flu vaccine is) or ingested (as the cur-

rent rotavirus vaccines are), may, or do, also interact

with the human immune system in ways that, in some, may

produce local and global long-term harmful effects

including, in a few instances, inducing life-threatening

allergies and/or chronic disease conditions.

Thus, at the individual level, where prior informed

consent is supposed to be obtained, everyone is faced

with the reality that the benefits of vaccination are

theoretical and, for the individual being inoculated,

not at all assured.

Moreover, the true risks of both: a) vaccinating and

not vaccinating are typically obscured by: i) the over-

whelming pro-vaccine propaganda to which the American

public is exposed today and ii) the lack of accurate

statistics for the probability of each serious risk,

starting from the worst risk, death; listing all the

other risks in descending order of lifetime harm and

the cost of harm, and progressing to the most common

inoculation-related risks that apply to most drugs to

which patients are exposed in the same manner.

Thus, we need to overhaul our current vaccine infor-

mation in a manner where it is truly informative but

devoid of propaganda, and then proceed to openly ad-

dress the group-protection issues for those vaccine

components that are truly safe, long-term effective,

and medically cost-effective.

For the safe, effective, and medically cost-effective

vaccine components, we can then proceed to keep only

these in the recommended national vaccination program,

and, except for those vaccines that are neither safe

nor truly effective, put the other vaccine components

in an optional vaccines program where they remain

available for those who may need, or want to be,

vaccinated with them.

Next, everyone needs to admit that the scientifically

sound data that we have today for vaccination outcomes,

at best: a) only applies at the group level and is

incomplete because:

1. There are no universal active surveillance pro-

grams for adverse vaccination effects and

2. The current passive surveillance programs (VAERS

and MedWatch) are fundamentally designed to ad-

dress only a tiny fraction of the mostly short-

term adverse events, which mainly healthcare

providers and the vaccine companies grossly

underreport.

Tuning to the " imported disease " issues, it would seem

that, given today's rapid screening tests, all those:

a) returning from a country where certain highly con-

tagious diseases are endemic and exhibiting any

signs of infection should be screened for active in-

fection for those diseases that are highly contagious

and those testing positive appropriately quarantined

until they are no longer infectious.

It would seem that this approach would: a) reduce the

risk for imported-disease outbreaks, lessen the

impetus to rush to revaccinate when we do have an

outbreak and c) also reduce the costs associated with

the localized outbreaks we now have.

Moreover, in addition to vaccination, it seems that

we should be investigating the human immune system

to find the optimal ranges for all vitamins, minerals,

and other essential substances and adjusting the

mandated food supplementation levels to ensure that

Americans consuming a balanced diet will have levels

of these nutrients that are in the optimal-health

range.

Further, rather than only relying on vaccination to

fight communicable disease outbreaks, we need to

study the effects of short-term high-dose supplemen-

tation with key vitamins, minerals and other essen-

tial substances on the reduction in the severity

and duration of a given disease [27].

With respect to the report's, " Calls for opposing

immunizations and/or school entry vaccination re-

quirements, or for providing easier and more numer-

ous ways to obtain exemptions for required vaccina-

tions, are resulting in growing numbers of individ-

uals not properly immunized. This, in turn, is

leading to increases in outbreaks of vaccine pre-

ventable disease such as measles and pertussis " :

1. First, this reviewer finds that the report's

" not properly immunized " is, at best, gratui-

tous and, in a society that recognizes the

right to choose an exemption, totally uncalled

for.

2. Factually, though the national percentage of

children with vaccination exemptions has in-

creased, the number of pertussis cases has

actually dropped recently making the report's

attempt to link pertussis case rates to today's

increases in exemptions a specious claim.

3. The failure on the part of those pushing ever-

increasing vaccination programs to recognize

the concomitant increases in chronic diseases

that these programs have apparently created -

effectively attempting to force the public to

accept epidemics of life-long chronic disease

in return for freedom from short-term acute

diseases from which almost all healthy chil-

dren recover without any serious long-term

adverse effects.

4. Finally, those who are on any side of these

issues need to: a) treat each vaccine com-

ponent separately and stop attempting to

make the choices " all or none " decisions.

_________________________________

[27] For example, studies with higher levels of daily

supplementation with vitamin D-3 have recently

shown not only that higher vitamin D-3 levels

reduce the risks for some diseases, e.g., flu,

but also that this supplementation improves

overall health and ones positive outlook on

life.

>

>This is occurring not just in the United States but

>in a number of developed countries such as the

>Netherlands, Great Britain, Switzerland, France and

>Israel. In fact, Great Britain has recently had to

>rescind its 1980's declaration that measles was no

>longer endemic (that is, children in Great Britain

>can now contract measles even if no new cases are

>brought in from the outside). Thus, children and

>adults in developed nations are increasingly suf-

>fering from significant illness, disability and death

>due to vaccine-preventable diseases. With the ease

>and volume of international travel today, Florida

>is highly vulnerable to the importation of such

>diseases, especially if the number of children im-

>munized, and herd immunity levels, decline.

>

While everyone should have some concern for what

is happening in other nations, our principal

concern should be for the realities in America

today.

With this in mind, this reviewer is tired of

hearing fear mongering about the potential harm

from acute childhood diseases that might return

if more Americans choose exemptions from those

who refuse to acknowledge, much less address, the

multiple epidemics of chronic diseases that, based

on our current understanding of how the human

immune system functions, are clearly tied to the

increasing number of vaccines given to our children

before their immune systems have matured to the

point that, in societies that breastfeed their

children, these diseases usually occur (with little

harm to most all children in those instances where

the infectious disease has existed for many genera-

tions) after the child is two years of age.

Until our vaccination programs are changed in a

manner that stops the current chronic disease epi-

demics, then everyone should accept that more

Americans will seek vaccine exemptions and, no mat-

ter the level of fear mongering, choose to risk

their children's having yesterday's acute diseases

to avoid the increasing risks of their child's

having one of today's growing list of chronic

diseases.

When the choice is, for example, vaccinate your

young child against hepatitis B (a disease that he

or she has almost no risk of contracting [< 1 on

~250,000] and, in most instances after they become

sexually active, if exposed, his or her body's

immune system will overcome the disease and develop

complete immunity in most cases) and have a >1 in

~25,000 risk of your child's developing childhood

multiple sclerosis (MS), who could fault that

parent for choosing not to let their child receive

the hepatitis B series?

>

>The suggestion that immunizations might lead to develop-

>mental disorders is troubling to parents. Florida's

>parents have access to and clear explanations of the

>recent findings published in medical journals that

>confirm that there is no causal link between vaccines

>and autism or other neurological conditions.

>

First, this reviewer agrees that the reality that

vaccinations " might lead to developmental disorders

is troubling to parents " .

Second, this reviewer notes that there are many

recent findings published in medical and toxicology

journals that have confirmed a causal link between

vaccines, or some component in some vaccines, and

other neurological conditions.

Moreover, even the U.S. epidemiological studies by

Verstraeten et al., on which the 2004 IOM relied,

found a causal link between Thimerosal exposure

and the group of neurological conditions labeled

" tics " - a group that includes Turrette's syndrome.

Thus, if the Florida Department of Health were truly

concerned about providing Florida parents with the

facts about vaccines, then this report's obviously

biased:

" It is important that Florida's parents have access

to and clear explanations of the recent findings

published in medical journals that confirm that

there is no causal link between vaccines and

autism or other neurological conditions "

would have been stated as:

" It is important that Florida's parents have access

to and clear explanations of the recent findings

published in " scientific peer-reviewed journals

that present the factual information on both sides

of the argument linking vaccines to autism or other

neurodevelopmental, developmental and behavioral

conditions so that they can understand the issues

and decide for themselves based on the evidenced

presented.

Given the biased statement in the report here, it is

clear that the Florida Department of Health is only

interested in presenting its self-serving pro-vaccine

view of this issue.

Moreover, the absence of the recent published studies

establishing links between vaccines and autism or

other neurodevelopmental, developmental and behavioral

conditions clearly supports this reviewer's perception

of this " vaccine education " issue.

>

>The Florida Department of Health supports efforts by

>the CDC and others to identify the biological and

>environmental causes of autism and other developmental

>disabilities. The Florida Department of Health monitors

>all issues pertaining to immunizations and stays

>abreast of all vaccine research in order to stop

>vaccine-preventable diseases without compromising the

>health and safety of children and adults. The Florida

>Department of Health and the CDC place a high priority

>on vaccine safety and the integrity and credibility of

>vaccine safety research.

>

While this reviewer finds the rhetoric here very

" inspiring " , the information in this report

indicates that there is not much substance suppor-

ting the rhetoric.

Given a bibliography that failed to include hundreds

of pertinent studies on both sides of the issues

raised in this report about Thimerosal in vaccines

and the possibility of a causal link between the MMR

vaccine administration and subsequent diagnosis of

an ASD, as well as up-to-date information on the

links between vaccination and various chronic child-

hood diseases (e.g., asthma, type 2 diabetes, MS, and

obesity), lethal allergies, and clinical levels of

intolerance to foods (e.g., gluten, casein, and soy)

and other natural biological substances (e.g., pollens,

and yeasts) that did not exist or were rare occurrences

in the 1950s, 1960s and 1970s, this reviewer finds

that the Florida Department of Health has done a less

than stellar job of staying " abreast of all vaccine

research " .

Finally, since the Florida Department of Health and

the CDC continue to recommend that vaccines that are

deemed to be adulterated under 21 U.S.C. Sec.

351(a)(2)( because their vaccine manufacturer has

knowingly failed to comply with the CGMP requirement

minimum set forth in 21 C.F.R. Sec. 610.15(a) with

respect to ensuring that the Thimerosal used as a

preservative in some FDA-approved vaccines is safe

to the " sufficiently nontoxic … " standard estab-

lished therein, this reviewer finds that neither

agency places " a high priority on vaccine safety " .

>

>Questions and Answers on Vaccinations

>

Let us be clear, the questions and answers provided

in this section are questions and answers on

" Vaccinations " and not " Immunizations " because

vaccination does not ensure that the person, even

when multiply inoculated with the vaccine, has any

protection from the disease/diseases for which that

vaccine may provide protection, much less the near

lifetime protection required to equate it with

disease immunity.

Moreover, it is clear that some vaccines (e.g., the

chickenpox vaccine) do not provide long-term pro-

tection; some are not in-use effective (e.g., the

influenza vaccines); and, under 21. U.S.C. Sec.

351(a)(2)( in the statutes implementing the Federal

Food, Drug, and Cosmetic Act, as amended, Thimerosal-

preserved vaccines that have not been proven to be

safe to the explicit safety CGMP (current good manu-

facturing practice) minimum set forth in 21 C.F.R.

Sec. 610.15(a), " Any preservative used shall be

sufficiently nontoxic so that the amount present

in the recommended dose of the product will not

be toxic to the recipient, … " , are, therefore, adul-

terated drugs.

Given our current understanding of the human immune

system, if " we " truly want to immunize our children,

then, when they were the " appropriate age " , we would:

1. For the common highly contagious communicable

childhood diseases, carefully expose our chil-

dren to other children, who are shedding the

disease or, in the case of smallpox, expose our

children to the surrogate cowpox virus that does

provide full protection against the disease,

2. Allow these exposures under carefully controlled

conditions after: a) ensuring that their bodies

had optimal levels of all vitamins, minerals and

key nutrients and preloading them with those

vitamins (e.g., vitamin A for measles) and miner-

als (e.g., zinc and selenium) that are known to

help our immune systems " resolve " the infection

and develop near-lifetime immunity,

3. Treat their post-exposure disease symptoms appro-

priately, and

4. Rigorously protect our children from exposure to

all life-style-related diseases.

Then, with the exception of chickenpox, our children

would be immune to the diseases that they have had.

With these issues in mind, from this point on, this

reviewer will, as he did in the title for this sec-

tion:

1. Replace each misuse of the word " immunize " , or

any of its forms, from here onwards with the

appropriate derivative of " vaccinate " or " pro-

tect " and then,

2. Address each of the points made by this report.

>

>The best way to protect each of our children is to

>protect all of our children.

>

Who can argue with this statement - certainly not

this reviewer.

>

>Why do we vaccinate our children?

>

>· To protect them from disease, disability, and death.

> In the pre-vaccine era, diseases that are now vac-

> cine-preventable were major causes of life-long

> disability as well as death.

>

Were there no risks of " disease, disability and death "

from any vaccination and were the vaccines in the

current recommended vaccination program restricted

to only those " pre-vaccine era " highly contagious

diseases, then, perhaps, this reviewer would have

no problem with this response.

However, this reviewer notes that this pro-vaccine-

biased answer ignores several important vaccination-

related realities.

To simplify our discussion, let us: a) consider two

vaccine instances, i) the MMR vaccine and ii) all of

the DPT vaccines, and examine: i) the annual mea-

sles and pertussis deaths reported in the CDC's sum-

mary of notifiable disease reports as a measure of

the residual " disease " cases from whatever source and

ii) the appropriate VAERS reports as indirect indica-

tors of the annual harm done by these composite vaccines.

Measles-related Realities

First, as has been previously stated, inoculation of

about 8 million American children annually does seem

to provide near-universal protection for measles and

rubella.

Moreover, based on the measles cases, as summarized

in Table " 5 " , there is no evidence of a significant

Table " 5 " Measles Data 2002-2006

N (%) of

Cases with

Measles an unassigned Measles

Year Cases source Deaths

2002 44 8 (18) 0

2003 56 11 (20) 2

2004 37 4 (15) 0

2005 66 9 (14) 0

2006 55 3 ( 5.4) 0

Average 51.6 7 (13.5) " <1 "

increasing time-trend in measles cases that would

be needed to support a claim that measles has

returned, even though, in the first three quarters

Table " 6 " VAERS Search - Any Measles Vaccine

& Adverse Reports By Category 2002-2006

[REVIEWER'S TABLE OMMITTED]

of 2008, the number of reported U.S. cases is

about 3 times the average for the 5-year period

where CDC summaries of notifiable cases have

been reported.

Turning to the man-made MMR-inoculation-related

infections, based on a simple category search

of the Vaccine Adverse Event Reporting System

(VAERS) database by a knowledgeable epidemio-

logist,

http://wonder.cdc.gov/controller/datarequest/D8;jsessionid=3B462407EBBE8A562

7809C...,

this reviewer reports the results shown in

Table " 6 " in the previous page.

In addition, since:

a. The reporting to VAERS is strictly voluntary,

b. Studies on the percentage of adverse events

that are reported to the U.S. Center for

Disease Control and Prevention (CDC) have

found that there was significant underreporting,

and

c. " Less than 10% " is the general level of repor-

ting used by many researchers when estimating

the actual level of the adverse events reported

in VAERS,

this reviewer has simply multiplied the results

found by 10 to get his guestimated numbers of total

adverse events occurring in a given year and entered

the result in braces, " [ ] " , in Table " 6 " , in a

column that is labeled " 'Guestimated' Total Count " .

Reviewing the reported data for " measles " in VAERS,

this reviewer can only wonder why, at a minimum,

the CDC is not required to report all VAERS measles-

vaccine deaths as a notifiable death and all unique

severe adverse events as a measles case unless the

investigation of the VAERS report proves that the

measles virus was not a causal factor - perhaps in

separate columns labeled " Measles-vaccine-related

Measles Deaths " and " Measles-vaccine-related Cases " ,

respectively.

For the 258 identified clinical measles cases, there

were 2 deaths, indicating a rough death risk of 1 in

129 cases for this data but, when the reported mea-

sles cases for 2007 and the first part of 2008 are

included, the apparent death risk is less than 1 in

400 cases of measles (0.25%).

Beyond that, this reviewer has only presented the

reported information and his guesstimated total count

data:

Ø To prove the validity of this reviewer's claim

that measles have never left America and

Ø As food for thought for those who read this

review to ponder.

Pertussis-related Realities

Since there are no annual cases of diphtheria and

only a few cases annually of tetanus, the pertussis

component is key to the overall effectiveness of

the DTap and DTP vaccines.

In this case, the VAERS reports for all DTaP and DTP

vaccines can be used to estimate the level of harm

inflicted on the population (in the same period,

2002 through 2006, which was used for the evaluation

of " adverse events " to VAERS for measles).

Table " 7 " and the " Pertussis Notes " box that follows

it summarize the information for clinical pertussis

cases reported by the CDC.

The first thing to note is that there are no deaths

reported for cases of pertussis, but the information

reported to VAERS for the DTaP vaccine formulations,

including the Tdap, vaccines, as Table " 8 " shows.

Table " 7 " Pertussis Data 2002-2006

[REVIEWER'S TABLE OMMITTED]

Pertussis Notes:

[REVIEWER'S NOTES OMMITTED]

Reviewing this data and knowing the U.S. timeline for the

phased-in displacement of:

a. Thimerosal-preserved DTaP vaccines with " Trace-

Thimerosal " vaccines (effectively starting in

2001 and complete by 2004) followed by:

b. " Trace-Thimerosal " DTaP vaccines with the " no

Thimerosal " formulations (effectively starting

in 2003 and continuing into 2008),

this reviewer notices that there appears to be a

significant concomitant/parallel decrease in VAERS

for reports of DTaP-related deaths:

Year VAERS Reports of Change from %

Inocu- Deaths Associated 2001 VAERS Change

lated with DTap/Tdap Reports of from

Vaccines Deaths (78) 2001

2002 67 - 11 - 14

2003 61 - 17 - 22

2004 41 - 37 - 47

2005 26 - 52 - 67

2006 20 - 58 - 74

but, there is no similar trend for the other VAERS

categories - indicating that the removal of

Thimerosal from the acellular formulas of the multi-

component diphtheria, tetanus and pertussis vaccines

has apparently reduced the vaccine-related deaths

reported to VAERS.

Table " 8 " VAERS Search - Any DTaP and DTP Vaccine,

And Adverse Reports By Category 2002-2006

[REVIEWER'S TABLE OMMITTED]

Moreover, the number of reported vaccine-associated

deaths was significantly higher for the DTaP/Tdap

vaccines than for the MMR vaccine.

But, the adverse event reports for the MMR and the

DTaP/Tdap vaccines were very similar in the " Life

Threatening " and " Permanent Disability " categories

for the period 2002 through 2006 - indicating that

the reported less-than-death harm attributed to

both categories of vaccines were similar.

Again, these findings lead credence to the acute

toxicity effect of Thimerosal because:

1. The measles vaccines, which did not contain

Thimerosal exhibited no time-related drop

in any of the severe categories of harm, in-

cluding death, but

2. The deaths reported for the DTap vaccines

(including the recent Tdap reports) exhibited

a time-related decrease that appears to track

the removal of Thimerosal from these vaccines.

While not definitive, the preceding findings clear-

ly seem to provide indirect evidence for the toxi-

city of Thimerosal in infants.

>

>· To save on health care costs, including out-of-

> pocket expenses by the family. "

>

Since: a) the lifetime healthcare costs for a child,

" including out-of-pocket expenses by the family " ,

with permanent disabilities in today's America is

in the millions of dollars and with the addition

of additional doses for the older vaccines, the costs

of the annual vaccination programs have risen to the

point that those who are pro-vaccine no longer claim

that our vaccination programs are medically cost-

effective and, in many cases, the overall program is

clearly not societally cost-effective, the " healthcare

savings " argument is clearly a specious argument!

Factually, except for the 2-dose MMR vaccine and the

5-dose DTaP/DT vaccines, which, because of price con-

trols on the vaccines, may be societally cost effec-

tive when all of the real costs are considered, today's

programs do not " save on health care costs " , when the

costs of taking care of those transiently and perman-

ently harmed are considered!

This lack of savings on overall healthcare costs is

so apparent for the newer vaccines (vaccines approved

in 1986 or later) that the pro-vaccine advocates

either do not discuss them or, ignoring the costs to

those families whose children are harmed and the costs

of administration, recordskeeping and adverse-events

reporting, generally only publish studies (typically,

underwritten by the vaccine's manufacturers) that find

these newer vaccines are " societally cost-effective "

at prices above the initial per-dose prices that the

vaccine's manufacturer wishes to establish for each

new vaccine formulation.

>

>· To protect other children who are not " immune " from our

> children if our children develop one of the vaccine-

> preventable diseases. -This includes children for whom

> vaccines are not safe, who are too young to be vaccin-

> ated, in whom the vaccine did not work, or who are not

> vaccinated for other reasons. "

>

If protection of other children were the reason we vac-

cinate our children, then how could we justify using

any live-virus vaccine because, after a child inoculated

with such vaccines, there is some risk that the inocu-

lated child will shed live virus and infect others (the

report's " children for whom vaccines are not safe, who

are too young to be " " vaccinated " " , in whom the vaccine

did not work, or who are not " " vaccinated " " for other

reasons " as well as unprotected adults) with whom the

inoculated child has contact for some period of time

after inoculation with a live-virus vaccine.

The reality of this problem was the reason we abandoned

the use of the live-virus oral polio vaccine (OPV) in

the USA in the late 1990s.

Yet, the U.S. governmental, vaccine, healthcare, and

public health establishments have ignored this hard-

earned lesson, and licensed, recommended, and, in some

states, included the live-virus influenza and rotavirus

vaccines in their " mandated " vaccination schedules -

thereby guaranteeing that: a) some who should not be

exposed to these live-virus vaccines will be exposed,

and some of those so exposed will contract one of

these live-virus vaccines' diseases.

Moreover, the approval of the current rotaviruses is

especially egregious because these live-virus organ-

isms survive and reproduce in the gut, and are ex-

creted into the environment where they survive for

extended periods and virtually guarantee that, like

polio, other will be infected and be at risk of

developing not only the disease but also the worst

complications of the disease-inducing viruses in

the rotavirus vaccines (e.g., intussusception and

Kawasaki's disease, when the vaccine is RotaTeq [28],

or, when the vaccine is Rotarix, intussusception and

pneumonia) with possibly lethal outcomes.

Obviously, because the CDC's current list of recom-

mended vaccines includes the following live virus

components: measles, mumps, rubella, herpes varicella

zoster (which initially causes chickenpox), human

influenza (FluMist, used since 2003), and 5 strains

of bioengineered human-bovine rotavirus (RotaTeq;

approved in 2006) or a single attenuated strain of

human rotavirus (Rotarix; approved in 2008), protec-

ting other's children (who, for whatever reasons,

have not been inoculated) is not the primary reason

" we " are asked to infect " our " children with doses

of these live viruses.

If protecting other's children were the goal of the

vaccinate-at-all-costs advocates, then, at a minimum,

they would be demanding that ALL live-virus vaccines

be replaced with inactivated-virus vaccines - and

this is not what is happening.

_____________________________

[28] Geier DA, King PG, Sykes LK, Geier MR. RotaTeq

vaccine adverse events and policy considerations.

Med Sci Monit. 2008 Mar; 14(3): PH9-PH16.

>

>Why do we keep vaccinating children when the

>diseases are gone?

>· The reason we have so few cases in the US is that

> our vaccination levels are so high.

>

While this reviewer agrees that high vaccination

levels are a reason that the diseases for which

there are approved vaccines that the states in

USA routinely administer, this reviewer notes

that the disease rates for many other communicable

diseases for which:

Ø There is a vaccine but no recommended general

vaccination programs (e.g., cholera, smallpox,

and yellow fever) or

Ø There is no approved vaccine (e.g., malaria,

dengue fever)

also generate no, or few, cases in the USA.

Moreover, there are diseases for which there are

vaccines against which routine vaccination is

recommended even though these vaccines are not

in-use effective in preventing the disease in

the USA (e.g., all of the influenza vaccines).

These realities need to be considered and the

role of sanitation, hygiene, healthy diet and

antibiotic, antifungal and antiviral drugs not

only recognized but also raised and, where

possible, used to replace vaccination.

>

>· All the vaccine-preventable diseases (except

> smallpox) still occur in the rest of the world,

> at rates higher than in the US, and most still

> occur in the US at low levels, especially in

> undervaccinated populations.

>

While the preceding statement is true, this

reviewer notes that the USA vaccinates against

chickenpox even though, because of: a) the

nature of the viral disease organism, herpes

varicella zoster [HVZ], and the means by

which our immune systems suppress resurgence

after initial infection (periodic exogenous

exposure to the live virus), the current vacci-

nation programs are not only less than effective

but also increase the rates of the follow-on

resurgences of the HVZ as shingles and have

apparently disrupted the transfer of maternal

immunity to her offspring since the USA is now

experiencing an " epidemic " of childhood shingles

cases even in those too young to be vaccinated,

when, before the vaccine, childhood shingles

cases were virtually non-existent.

Here, the pro-vaccine advocates have imposed a pro-

gram that costs hundreds of millions of dollars

annually, does not provide effective immunity, and

has increased the costs and prevalence of previously

almost unknown childhood shingles cases as well as

shingles cases in the elderly to the point that

Merck has introduced an FDA-approved HVZ vaccine

formulation, Zostavax, for the elderly - outcomes

much worse than promoting appropriate dietary

supplementation before and during our children's

having chickenpox naturally, and recognizing and

facilitating the needed exogenous boosting post-

chickenpox as well as encouraging prolonged

(natural) breastfeeding of our children (typically,

for a 2-year or longer period).

Those who are pro-vaccine need to stop being fix-

ated on developing and deploying vaccines for

every disease and to focus on the use of vaccines

as a last resort and only for those disease organ-

isms for which there is no effective recuperative

dietary regimen and/or no other effective preven-

tive or curative medical interventions.

The public needs to understand the preceding re-

alities and demand that the existing vaccines that

are neither safe nor effective be banned from the

U.S. market and those that are safe but not medi-

cally cost effective or, at a minimum, independent-

ly determined to be societally cost-effective when

all of the costs, including the adverse-event cost,

are considered for not only the current number of

doses but also at least one additional dose that

seems, based on the history of our current vac-

cines, to be required.

Then and only then, should " we " , in the absence of

significant disease risk, continue the national

vaccination programs for those vaccine components

that are both safe and cost-effective.

Approved vaccines that are not medically safe

should be discontinued.

Those vaccines that are simply not societally cost-

effective should be removed from the CDC's national

recommendations and the states' mandates, and only

offered as an option that, after weighing the pros

and cons, individuals may elect to use.

>

>· Any of these diseases can be reintroduced into

> any community in the US at any time. Florida re-

> ceives very large numbers of visitors, from all

> over the world.

>

Given the large number of visitors, from all over

the world, and the relative few incidents where

they: a) bring in a disease and spread it to

others, this reviewer finds that, given the avail-

ability of rapid (< 4-hour) screening tests for

the most contagious diseases, perhaps it is time

that, on arrival in the USA, we started holding,

screening, and quarantining all visitors and

immigrants who exhibit any symptoms of illness

as a means to help protect the American public

from imported-disease exposure and infection -

if " we " are truly concerned about imported

disease cases.

>

>How do vaccines protect children who have not been

>vaccinated?

>· If almost all children in a population are vacci-

> nated against a disease, a child who is exposed

> and does develop a clinical case of the disease

> will be surrounded by protected children, and

> the spread of infection will probably not occur.

>· With slightly lower immune rates vaccination

> levels, the outbreak may not stop by itself, but,

> when it does not, public health prevention ac-

> tivities such as isolating cases (quarantine)

> and giving antibiotics, antifungals, vitamins

> (e.g., vitamins C and D-3 for influenza), minerals

> (e.g., zinc and magnesium for viral infections)

> and key nutrients (e.g., lysine for herpes viruses),

> antivirals, and vaccines or immune globulins, as

> appropriate, to those who have had contact with

> those actively shedding the disease can be used

> to end the outbreak.

>

[Note: Here, this reviewer has simply corrected

the text to better reflect what is actually true.]

>

>How effective are vaccines?

>· The vaccines in common use against vaccine-preventa-

> ble diseases are all highly effective. Some are

> close to 100% effective, some as low as 85%.

Here, this reviewer finds the response is not only

inaccurate, but also improperly framed because the

question and the answer should have been framed in

terms of the disease-antigen components of each

vaccine.

This is the case because several several vaccines

are multi-component vaccines (e.g., MMR, MMRV, DTaP,

DTaP Hib, and Tdap).

Factually, based on the observed in-use (real world)

outcomes, there are certain single-disease vaccines

and components in multiple-disease vaccines that

are problematic.

For example, the human influenza vaccines are

problematic because their tested level of " efficacy "

may be less than 70% and, because of " strain mismatch " ,

their in-use effectiveness may be close to zero.

For components in multiple-disease vaccines, even

though the " aP " component in the DTaP vaccines have

a claimed " single-dose efficacy " that exceeds 80%,

the in-use effectiveness of vaccines with an aP

component is closer to 70% than it is to 80-plus %,

based on need to give 4-plus doses of " DTaP " vac-

cines containing this component to reduce the number

of pertussis cases to 10,000 to 25,000 cases an-

nually.

Moreover, if any vaccines were " close to 100% effec-

tive " , then only 1 dose would be needed for lifetime

protection and the post-vaccination cases among the

vaccinated would be nearly " zero " .

For the current recommended vaccine components, it

appears that only the measles and the rubella com-

ponents of the MMR vaccine, where the vaccination

program specifies 2 doses, have anywhere near " zero "

annual cases among those who receive only one dose

of the MMR vaccine (a requirement if a vaccine com-

ponent were to be " close to 100% effective " ) and,

perhaps, the diphtheria component in the DTaP vac-

cine - though the total lack of reported diphtheria

cases in those under 6 months of age seems to indi-

cate that diphtheria bacteria are either virtually

non-existent or incapable of triggering a recognized

clinical case of the disease even in American new-

borns.

Thus, excluding human influenza and HVZ vaccine

components, which are less than effective, this

reviewer finds that the long-term effectiveness of

vaccine components in the current U.S.-licensed

vaccines seems to range from about 70 % to 95-

plus %.

>

>· Only vaccines that have been determined to be

> effective at preventing spread of the disease

> in the population are used in the United States.

>

Given the use of:

Ø Inactivated human-influenza-virus vaccines and

the vaccines containing live HVZ, both of which

are ineffective and have been shown not to pre-

vent the spread of disease in the long term and,

for HVZ, actually infect the inoculees with HVZ,

Ø The live-virus human influenza vaccine, which

spreads the disease to contacts and is not in-use

effective in preventing disease spread,

Ø The other live-virus vaccine components, measles,

mumps and rubella, which infect some percentage

of those inoculated with them, and

Ø The rotavirus vaccines, which give clinical cases

of rotavirus to many of those vaccinated as well

as to some percentage of those with contact them

or their feces or their feces-contaminated materi-

als in the United States,

this reviewer finds that the report's assertion ( " Only

vaccines that have been determined to be effective at

preventing spread of the disease in the population are

used in the United States " ) here is a knowing distor-

tion of factual reality.

>

>Before a vaccine is recommended for widespread use, a

>careful assessment is made by a national expert panel,

>based on the best available science. The panel asses-

>ses the seriousness of the disease if it is not pre-

>vented, the vaccine's effectiveness in preventing the

>disease, and the frequency and consequences of adverse

>reactions to the vaccine. A vaccine is recommended to

>be included in the national immunization schedule when,

>on balance, the benefit to the whole community of rou-

>tine immunization inoculation with that vaccine is

>much greater than the risks.

>

Again, the facts are at odds with the statements being

made here.

In the past, the CDC's ACIP (a CDC panel packed with

" experts " with known conflicts of interest and/or

loyalties to vaccine development and/or the vaccine

manufacturers) recommended the now-withdrawn Rota-

Shield for widespread use even before the FDA approved

it.

Currently, the CDC's ACIP is recommending new vaccines

for widespread use: a) before there is any significant

post-FDA-approval in-use experience - just after the

FDA approval (e.g., the RotaTeq rotavirus vaccine) -

or before there is any proof that the vaccine,

Merck's Gardasil®, is effective as a preventive for

the key disease (cervical cancer) that is the sole

justification to recommend widespread use.

To facilitate the ACIP's rubberstamping newly FDA-

approved vaccines, the FDA has allowed the vaccine

makers to: a) use other than saline as the placebo

(e.g., the hepatitis B vaccine clinical trials and

the recent Gardasil clinical trials); conduct

fewer and/or smaller clinical trials in non-repre-

sentative populations (unlike the U.S. population

as a whole) where there is a significant background

disease incidence and, because of poor hygiene and

sanitation, the trial subjects in the control arm of

the clinical trial have a significant risk of contrac-

ting the disease, which, when the vaccine contains

live viruses, can be a case of the virus being shed

by those in the test arm of the clinical trial who

have been inoculated with the candidate vaccine

(e.g., the rotavirus vaccines trials); and c) con-

duct clinical trials using vaccine formulations de-

void of a preservative level and use that safety and

adverse-event data for approval of a Thimerosal-

preserved vaccine (e.g., Sanofi's recently approved

bird-flu vaccine).

Given the preceding, no a fair assessment can be made

for vaccines such as these and, given the chicanery

permitted and notwithstanding FDA-approval, none of

these vaccines should have been recommended for wide-

spread use until: a) the requisite unbiased safety

and effectiveness (not efficacy) studies were conduc-

ted and impartial review by non-conflicted but

knowledgeable experts determined that these vaccines

were safe and effective in preventing the disease or

diseases that were key to determining that " the bene-

fit to the whole community of routine inoculation

with that vaccine is much greater than the risks " .

>

>Why do we require vaccination for attendance in child

>care or public school?

>· Most vaccine-preventable diseases spread easily

> where children are gathered together. Getting the

> vaccination coverage rate close to 100% can stop

> outbreaks from spreading if the disease is intro-

> duced.

>

[Note: Corrections were made in the preceding text

to better align the statements with reality.]

First, the disease-spread statement is overly

broad, because only those diseases easily spread

without intimate inter-personal contact are easi-

ly spread when young children, those under age 6

(the group that receives most of the vaccine

doses), congregate.

Second, getting the vaccination coverage close to

100% can only reduce the risk that, if introduced,

the disease will spread to the children, who are,

for whatever reason, not protected from contrac-

ting that disease.

>

>High vaccination coverage protects the few chil-

>dren who are not protected from contracting a

>clinical case of the disease.

>-Non-immune protected children at child care or

>school include those who have medical reasons why

>vaccines are not safe for them, those in whom the

>vaccine did not work, those with religious exemp-

>tions to vaccination, and those too young to have

>received certain vaccines.

>

[Note: Corrections were made in the preceding

text to align the statements with reality.]

>

>· A few children are not protected against some of

> the diseases they were vaccinated against. Going

> to child care or school with other vaccinated

> children protects these children.

>

[Note: Corrections were made in the preceding text

to better align the report's statements with real-

ity and the context of this portion of the report.]

Provided the vaccinations with live viruses occur-

red at least a month prior to the non-protected

children's or staffer's going to child care or

school with the vaccinated, this reviewer agrees

with these assertions.

However, when vaccination with a live-virus is

given to any member, including those who oversee

the group or class or work with it, of a group

in a childcare or school setting during the

period during a period the group is in child care

or at school, then the person or persons inocu-

lated with the live-virus vaccine should be

quarantined from that group for a period of not

less than 7 days, when the risk of infection and

subsequent viral shedding is low, to 21 days,

when the risk of infection is significant and/or

the virus is shed for a significant period of time

after the person or persons are vaccinated.

>

>Is it fair to require children to be vaccinated to

>attend child care or school?

>· High vaccination levels protect both the vaccinated

> children and the few who are not protected. "

[Note: Corrections were made in the preceding text

to better align the report's statements with re-

ality and the context of this portion of the report.]

First, even with the suggested changes, this state-

ment is overly broad, to say the least.

Factually, high vaccination levels only partially

protects those who, when vaccinated, develop a pro-

tective level of antibodies for the biological

component antigens in the vaccine and not all who

are vaccinated.

Moreover, immediately after vaccination with a

live-virus-containing vaccine, those who are

inoculated may, in some instances, shed the live

virus and may infect some who are not protected,

including those too young to be vaccinated, when

the vaccinees interact with those who are not

protected from the disease organisms being shed.

>

>· Child care and school vaccination laws have been

> shown to be a very effective way to achieve and

> maintain very high vaccination coverage levels.

>

[Note: Corrections were made in the preceding

text to better align the statements with reality.]

First, this statement is valid only for those

vaccines that are truly safe and effective.

Second, IF: a) everyone recognizes the safety and

effectiveness of the recommended vaccines and vac-

cination programs and the appropriate vaccines

are readily available at nominal prices for all

children, THEN there would be no need for any man-

dates (laws) requiring vaccination as a condition

of attendance or employment.

Compulsive laws are only needed when the vaccines

and/or vaccination programs are problematic and/or

the vaccination costs are prohibitive.

Moreover, compulsory vaccination laws are an od-

dity in the truly democratic developed neighboring

nations (Canada on the north, the United Kingdom

on the east, and Japan on the west), which, in

general, have no forced vaccination laws and do not

have any significantly higher overall disease prob-

lems than the USA does and, for Japan, today's over-

all infant mortality is about half of that of the

USA, today's life expectancy is more than 4 years

longer, and the levels of chronic diseases are

significantly lower.

>

>· In effect, society has made an agreement: I agree to

> vaccinate my child if you agree to vaccinate yours.

> All the children benefit from their own protection

> against serious diseases, and also from being sur-

> rounded by immune vaccinated children.

[Note: Corrections were made in the preceding

text to better align the statements with reality.]

Given that the compulsory vaccination laws are the

mandated " children " of the vaccine makers and pub-

lic health officials, who, by whatever means, have

conspired to mandate vaccination even when the

vaccine is neither truly adequately safe (e.g.,

the withdrawn vaccines, like RotaShield and

LymeRix) nor truly effective in preventing those

vaccinated from getting the disease (e.g., the

influenza and chickenpox vaccines):

Ø Society has made no such agreement, and

Ø Since those actually making these decisions

are usually administrative public health

officials who are not even elected, though

some elected official or officials must

concur, there is clearly no such individual

( " I " ) agreement in the USA or the state of

Florida.

Only when there is no legal compulsion, can

individuals, aided by the removal of barrier

to vaccine access and assured of the in-use

safety and effectiveness of the vaccines

approved and recommended by their government,

make the societal agreement reflected in this

report.

Since none of the prerequisite conditions

(lack of compulsory laws, no barriers to

vaccine access, and only vaccines that have

been proven to be in-use safe and effective

are recommended for use) exist, there can be

no such truly consensual societal agreement

about vaccination in the USA today.

>

>· Some children experience side effects to vaccine doses

> they receive. Most are mild, a few rare ones are not.

> No vaccine is totally free of side effects, though all

> have improved over the years as researchers have helped

> manufacturers to refine their manufacturing processes.

>

The preceding is a disingenuous pro-vaccine view

of reality that is intentionally misleading and

knowingly false.

First of all, almost all children experience minor

side effects, including pain, from the inoculations

they receive.

Many have local site reactions, redness at the

injection site, and localized swelling.

Beyond the injection-site side effects, vaccines

cause a wide variety of increasingly dangerous

acute side effects, including death, that today

collectively have helped put the USA at the bottom

of the list of developed nations in terms of 1st-

year infant mortality, as well as some delayed side

effects that take months or years to develop;

typically, are chronic as well as, in most cases,

dehabilitating, quality-of-life damaging, and life

shortening (leading today's American to have a

shorter " average " life span than Cubans and, unlike

many " developed " nations, a declining life expec-

tancy).

With respect to the report's assertion:

" No vaccine is totally free of side effects,

though all have improved over the years as

researchers have helped manufacturers to

refine their manufacturing processes " ,

both the short-term and longer-term outcomes

being observed today paint a far different

picture.

Factually, regardless of the help researchers

have given to vaccine manufacturers, or perhaps

because of it, today's vaccination programs have

clearly traded:

Ø The suppression of: a) acute childhood (measles,

mumps, rubella, diphtheria, tetanus) and

lifestyle (hepatitis B and HPV) diseases using

childhood vaccination programs

Ø For epidemic increases in chronic diseases

(e.g., childhood type 2 diabetes, childhood

asthma, childhood COPD, childhood MS, severe

childhood obesity, precocious puberty, life-

threatening food allergies, food intolerances,

and air-borne pollens, animal danders, and

dusts - to name some) that, though unknown or

very rare in the 1950s, 1960s and early 1970s,

are seen everywhere today.

Since the vaccine makers are effectively shielded

from being sued for the harm their vaccines cause

and are rewarded with the ever-increasing prices

they can charge (with concomitantly increasing

profits), the vaccine makers and their supporters

have no incentive to ensure their vaccines are a

net benefit to the American public.

Moreover, all facets of the " healthcare " establish-

ment have an incentive to support more vaccines

because they are benefiting from the ever-increas-

ing chronic disease customer bases that our current

recommended vaccination programs are creating.

Thus, in today's greed-driven society, those who

effectively control the vaccines and the vaccina-

tion programs and provide us our healthcare are,

as those in the housing and banking establishment,

looking out for their personal financial interests

at the expense of the physical, mental and finan-

cial health of the American public.

Moreover, though some vaccines have " improved "

(e.g., the change form DTwP to DTap vaccines, the

removal of Thimerosal from some vaccines, and the

reduction of the level of Thimerosal in others),

the increasing number of vaccines and vaccine doses

for each type of vaccine have clearly produced

negative effects that have more than offset the

positive effects of improving some vaccines.

As Americans know all to well, when it comes to

vaccines,

Ø " improved " has nothing to do with proven to be

long-term safe and effective,

Ø " safe " has no long-term meaning and, since the

risks are hidden or under reported and the

clinical safety trials are biased to minimize

the relative risks reported, the reported data

is of little comfort to the parent faced with

deciding whether or not his or her child should

receive a vaccine, and

Ø " efficacy " is an advertisers claim that is not

guaranteed to apply to any particular child or

to apply for that child's lifetime, and does not

usually equate to reduced costs or even fair

costs (less than the theoretical costs if a child

contracts the disease) to the American public.

>

>· All children benefit from the vaccines, including the

> doses they have received themselves and the ones

> other children have received, but only a few develop

> severe side effects.

> --Compensation mechanisms are in place for injured

> children and their families-the National Vaccine

> Injury Compensation Program, and compensation lawsuits.

>

This statement is obviously false - because the few, who

develop severe side effects, include those children whom

the vaccine's side effects kill.

q Please, what is the " benefit " to all those previously

healthy children killed by being given a vaccine?

q What is the benefit to those children whose brains

are severely and irreparably damaged from being

vaccinated?

q Finally, why doesn't this report address the odds

for each established severe-side-effect risk for

each vaccine?

With respect to the so-called compensation mechanisms

that " for injured children and their families--the

National Vaccine Injury Compensation Program, and

compensation lawsuits " :

Ø Why does the report fail to mention that the com-

pensation mechanisms provided by the National

Vaccine Injury Compensation Program (NVICP) have

a very short (3-years from the first symptom that

could be linked to the claimed vaccine injury)

window for filing a claim?

Ø Why does the report fail to mention the NVICP

process is anything but non-adversarial, quick,

and fair?

Ø Why not mention that about half of the petitions

for compensation that are filed are dismissed?

Ø Why not mention that the state and federal courts

have increasingly refused to allow individual to

sue outside of the NVICP even where the NVICP

statutes explicitly provide for such lawsuits?

Ø Finally, why not mention that today the NVICP

effectively shields the vaccine maker and the

healthcare establishment from being sued for the

harm caused by giving a vaccine to your child?

>

>Why do we have religious exemptions to immunization vacci-

>nation requirements? "

>

[Note: A correction was made in the preceding text

to better align this statement with reality.]

>

>· Almost all states have such exemptions.

>

First, this " because " answer begs the question.

Factually, after states began to mandate certain

vaccines starting in the early 1900s, in the states

that have religious exemptions, a religious group,

the Christian Scientists, who fundamentally believes

that injecting/infusing a person with any foreign

substance is an abomination to God, sued for a re-

ligious exemption and won their lawsuits in the

courts and/or persuaded their government represen-

tatives to enact such exemptions in the Commonwealth

of Puerto Rico, all other commonwealths, territories,

and protectorates governed by the federal government,

in the armed forces of the USA, and in all United

States of America, except for Mississippi and West

Virginia.

>

>· Having religious exemptions strikes a balance among

> respect for the genuine convictions of some families,

> the desire for all children to have access to public

> schools, and the desire to protect all residents of

> our communities from infectious diseases.

>

While this statement fundamentally speaks to balan-

cing the individual's constitutionally guaranteed

right of religious freedom against conflicting

secular laws, the individual's constitutional right

is misleadingly portrayed as " the genuine convic-

tions of some families " (as if it were a group right);

and the secular laws are misleadingly portrayed as

" the desire to protect all residents of our commun-

ities from infectious diseases " (instead of the de-

sire to force vaccination since, as the report has

already admitted and the CDC's annually reporting

affirms, vaccination does not protect " all resi-

dents of our communities from infectious diseases "

nor even all who have been " fully " vaccinated.)

>

>· As long as the proportion of children in a school who

> receive religious exemptions is very low, it is still

> possible to attain high overall coverage and protect

> all the children in the school.

>

Again, since there are other control strategies for

controlling the risk for and spread of infectious

diseases, the USA can keep disease rates low even if

the " the proportion of children in a school who re-

ceive religious exemptions " were to increase to much

higher levels.

For example, visual examinations coupled with rapid-

disease-screening technologies for those entering

the country as visitors or immigrants who exhibit

any physical symptoms of disease, holding of all

until the results from the screening come back, and

quarantining the few who test positive for an incipi-

ent highly communicable disease and those with whom

they had close contact until those who are coming

down with the disease are no longer shedding the

disease and the close contacts either contract the

disease or test negative 24- to 48- hours later for

incipient disease eruption.

Thus, the report's statements here are simply self-

serving pro-vaccine propaganda - devoid of any real

substance.

>

>· If there are cases of one of the vaccine-preventable

> diseases in a childcare center or school, all unim-

> munized children who are unvaccinated and have no

> proof of having had the disease will be excluded

> for the duration of the outbreak. Children with

> either medical or religious exemptions will be ex-

> cluded. Taking this step reduces, but does not elim-

> inate, the hazard to the other children of allowing

> some children to attend schools without being vacci-

> nated.

>

[Note: Corrections were made in the preceding text

to better align the report's statements with reality

and the context of this portion of the report.]

In addition to the preceding, those who are enrolled

in childcare center or school and receive any live-

virus vaccine while enrolled should be quarantined

from that childcare center or school until they are

shown not to be shedding that virus or at least 21

days, whichever is shorter, so that these live-virus

inoculees do not risk infecting their fellow students.

Yet, this pro-vaccine report fails to even recognize

the preceding live-virus vaccination reality - much

less address it.

>

> request 1

>Develop a side-by-side chart of CDC and Florida vac-

>cinations schedule and recommendations and highlight

>differences

>

>The Florida Department of Health adopts, coordinates,

>and recommends the routine " Childhood and Adolescent

>Immunization Schedules " in accordance with the recom-

>mendations of the Centers for Disease Control and

>Prevention (CDC) and the CDC's Advisory Committee on

>Immunization Practices (ACIP).

>

This reviewer understands that, by taking this

stance, the Florida Department of Health has

abrogated its state's duty to protect the health

and safety of its citizens because these are

duties reserved unto the states.

>

>· The ACIP's " Recommended Immunization Schedules " are

> recognized as a standard of practice by physicians,

> healthcare providers, state vaccination programs and

> other entities involved in vaccinations.

>

[Note: Corrections were made in the preceding text

to better align the statements with reality.]

This reviewer understands that this report is simply

the healthcare, healthcare providers, and public

health establishment's view of what is the current

state of affairs and, if they continue to have their

way, what this " reality " will continue to be.

>

>· There are no differences between the CDC recommended

> vaccination schedule and that of Florida. "

>

[Note: Corrections were made in the preceding text

to better align the statement with reality.]

As the following tables report in the report shows,

though recommended by the CDC, Florida does not

currently require/mandate any hepatitis A, HPV,

influenza, meningococcal, or rotavirus vaccines as

a requirement for childcare or attending grades

K-12.

Furthermore, the report's statement, while seman-

tically correct, only reports the views of those

who prepared this report and not the views of the

people of Florida.

>

>· Vaccination schedules are updated each year for

> healthcare providers to refer to and share with

> parents when planning the medical preventive care

> of their infants and children.

>

[Note: Corrections were made in the preceding text

to better align this statement with reality.]

As the following tables report in the report shows,

though recommended by the CDC, Florida does not

currently require the hepatitis, HPV, influenza,

meningococcal, and rotavirus vaccines.

>

>· While many vaccines are licensed and recommended

> by CDC for routine medical care, it is important

> to note that NOT all of the routinely recommended

> vaccinations are required for entry/attendance

> in Florida schools. It is important to distinguish

> the difference between which vaccinations are

> recommended for routine medical care and which are

> required for school.

>

[Note: Corrections were made in the text to

better align these statements with reality.]

As the following tables in the report show, though

recommended by the CDC, Florida apparently does

not currently require vaccination with the vaccines

for: 1) hepatitis A, 2) HPV, 3) influenza, 4) menin-

gococcal, and 5) rotavirus.

>

>· Vaccination requirements for school are set by grade

> level in contrast to age groups listed on the recom-

> mended schedule. This uniform requirement facilitates

> all children having the most protection as medically

> possible for many diseases that can be transmitted in

> the classroom.

> --One example is the diphtheria-tetanus-pertussis-con-

> taining vaccine (Dtap): While the 5th dose of Dtap is

> recommended for children 4 to 6 years of age, the 5th

> dose is required for entry into Kindergarten. Tradi-

> tionally, children entering Kindergarten are 4 to 6

> years of age. A copy of the routine recommended schedule

> is included in this section.

>

>The following table details the recommended vaccines in

>contrast to those required for school.

>

> Routine CDC/ACIP Florida

> Vaccination Childcare &

> Vaccines Recommendations School Vacci-

> nation Req.s

> REPORT'S TABLE OMMITTED

>

>The following table further illustrates the number of

>vaccines available for prevention of certain communi-

>cable diseases in contrast to the vaccines that are

>required for child care and school and the year the

>requirement was introduced.

>

> REPORT'S TABLE OMMITTED

>

>

> requests 2 and 3

>List of vaccinations generally, then broken down by

>fatal and non-fatal illnesses. List of vaccine-pre-

>ventable illnesses, incidence and outcome (number of

>cases and number of deaths).

>

>While some vaccine-preventable diseases are of short

>duration and without serious complications, the vi-

>ruses and bacteria that cause these diseases can all

>result in serious complications, long-term disabil-

>ities, and even death.

>

While the preceding statement is valid, the report

fails to reflect the reality that the vaccinations

themselves can also result in serious complications,

long-term disabilities, and even death.

>Varicella (chickenpox) is one example: Most children

>and adults experience an uncomfortable inconvenience

>with a low-grade fever and rash and no serious compli-

>cations from varicella. However, a small percent of

>children and adults experience complications such as

>secondary skin infections, pneumonia, meningitis, en-

>cephalitis, and possible death.

>

While the preceding statements are true, the report

fails to point out that some who are vaccinated

with the herpes varicella zoster vaccines can also

experience severe adverse reactions, including

meningitis, encephalitis, and death.

>

>Varicella vaccine was licensed in 1995. When a new vac-

>cine is introduced it is often slow to be fully uti-

>lized, this was the case with varicella vaccine. To

>note: during 1998, Florida reported six deaths from

>acute varicella. Two of the adult deaths were linked to

>children in the home and one child was exposed in the

>classroom. In contrast, one death was reported in Florida

>in 2006 from varicella.

>

Obviously, while this information is informative,

the 1998 deaths in adults are usually not deaths

related to chickenpox but rather to shingles, the

more virulent and deadly form of herpes varicella

zoster (HVZ) infection from the localized eruptive

resurgence in HVZ replication when the person is

not periodically externally exposed to live HVZ

(exogenously reboosted).

Moreover, the information reported fails to state

whether the child's case was a case of: a) chicken-

pox or childhood shingles case, and does not

provide the child's medical history and the official

cause(s) of death.

Further, the nature and status of the other three

cases was not reported.

The preceding case reporting oddities lead this re-

viewer to infer that these may have been cases in

individuals who had been vaccinated with the vaccine

strain of HVZ and then had an eruptive resurgence of

the HVZ virus (shingles).

Moreover, since neither chickenpox, the name of the

initial infection with both the vaccine and native

strains of HVZ, nor shingles, the name given to cases

of the re-eruptive form of HVZ infection, were " noti-

fiable " (reporting required by law) diseases in Florida

for the period in question (1995-2006) nor nationally

for the period 1991-2003, this data cannot be relied

upon to reflect the true state of affairs in Florida

with respect to HVZ disease cases because: a) without

a " notifiable disease " mandate, case reporting is en-

tirely voluntary and voluntary reporting tends to

increase after a new vaccine is recommended and then

to decrease as time passes and complacency sets in.

In addition, this reviewer notes that, in an obvious

but unstated response to the decrease in single-dose

vaccination effectiveness, in 2006, the CDC's ACIP

added a second-dose recommendation (as the CDC repor-

ted in its annual summary report on notifiable

diseases for 2006 [29]).

Had the vaccine been as effective as the reported

Florida data indicates, there would have been no

need for the CDC's ACIP to add a second dose of HVZ

vaccine to the recommended vaccination schedule as

they did in 2006.

Thus, this reviewer finds that the CDC's actions are

clearly at odds with the implied " vaccine reduces

cases and deaths " scenario presented in this section

of the report.

______________________________________

[29] Summary of Notifiable Diseases --- United States,

2006. MMWR 2008; 55(53): 1-94:

" Varicella (Chickenpox)

Since implementation of the varicella vaccine

program in 1995, varicella morbidity and mor-

tality have declined substantially. During

1995--2006, the number of cases declined 85%,

the number of hospitalizations declined 85%,

and the number of deaths declined 82% (1). In

2006, the Advisory Committee on Immunization

Practices (ACIP) updated recommendations for

varicella vaccination to include a second dose

for children and catch-up vaccination for per-

sons without evidence of immunity (2). With

this new recommendation, case-based and outbreak

surveillance for varicella will become increas-

ingly important. In 2006, a total of 33 states

and the District of Columbia reported varicella

data through the National Notifiable Diseases

Surveillance System (NNDSS): 23 (70%) sites re-

ported case-based data and 10 (30%) reported ag-

gregate data. An additional 12 states conducted

either statewide or sentinel case-based varicella

surveillance but did not report these data through

NNDSS. Although varicella was not a notifiable

disease in Indiana in 2006, a total of 910 cases

were reported.

1. Roush SW, TV, Vaccine Disease Table

Working Group. Historical comparisons of

morbidity and mortality for vaccine-preven-

table diseases in the United States. JAMA

2007;298:2155--63.

2. CDC. Prevention of varicella: recommendations

of the Advisory Committee on Immunization

Practices (ACIP). MMWR 2007;56 (No. RR-4). "

>

>The following tables provide a brief description of the

>diseases and case information pre and post vaccination

>for the U.S. and Florida.

>

>Historical Comparison of Vaccine-Preventable Disease

>Cases and Deaths with Vaccine Licensure from 1900 to

>2006. (U.S.: Estimated Annual Averages.)

>

> REPORT'S TABLE OMMITTED

>

Since: a) the pre-vaccine year is not given, the

numbers are " estimates " , and c) the numbers of

vaccine-related cases are not included in 2006 for

the live-virus vaccines (italicized by this review-

er in the preceding table), which cause some of

those receiving them to have the disease, this re-

viewer can only note that the data provided over-

states the " decreases " shown, and also fails to

address the vaccines' harm, as any honest compari-

son would.

>

>Historical Comparison of Vaccine-Preventable Disease

>Cases and Deaths with Vaccine Licensure from 1934

>through 2007. (Florida: Estimated Annual Averages.)

>

> REPORT'S TABLE OMMITTED

>

The Florida table suffers from the same problems

as the table provided for the U.S. data that

precedes it.

>

>Another vaccine success story relates to the preven-

>tion of Haemophilus influenzae type B (Hib) disease.

>Prior to the introduction of an effective vaccine

>to prevent this disease, Hib was the leading cause

>of [bacterial] meningitis among children younger

>than 5 years of age with about two-thirds of all

>cases occurring in children less than 18 months

>of age.

>

While the graph provided does show a decrease in

type B ( " Hib " ) invasive disease cases of Haemo-

philus influenzae ( " Hi) " , the national data show

(see Table " 9 " ) that the incidence and cases of

Hi was increasing in both those under 5-years

old and those over 5-years old.

Thus, the national Hib vaccination programs, in-

troduced in " 1985 " , showed initial positive re-

sults (decrease cases of disease) overall (1992

- 1996) and possibly a decrease in cases in

children under 5 in the same time period.

These outcomes were probably the case because

this period was part of the " nature's honeymoon "

period where the vaccine was having its intended

effect and the effects of strain change and

other factors had not yet overcome the vaccine's

positive effects.

However, starting in 1997 and continuing through

2006, there has been a clear annual increase in

the number of invasive Hi cases overall (at an

average rate of about 11 % per year) as well as

an increase in the total invasive Hi cases in

children under 5 years of age (at a rate of

about 7% per year).

For Hib, the available data do indicate a de-

cline in Hib cases, but, prior to 2002, the CDC

found that the Hib " cases " data is not reliable -

the Hib test used by the state labs gave false

positives.

Moreover, given the sharp 2006 increase in Hib

cases over 2005, 29 in 2006 versus 9 in 2005,

it may be that the Hib strain of Hi has, itself,

mutated and this circulating mutated Hib strain

may have acquired the ability to not be inter-

cepted by the antibodies produced by repeated

inoculation with a FDA-licensed Hib vaccine

component.

Should the upward trend in Hi and Hib cases con-

tinue, then the Hib program may need to be

abandoned and alternative approaches used to

minimize Hi infection.

>

>The following graph demonstrates the decrease in

>Hib disease for children less than 5 following

>the licensure of Hib vaccine.

>

As a more complete review of invasive Hi cases

has shown, this graph and its data insert are,

at best, misleading.

>

>Confirmed Florida Cases (Under Five Years of Age)

>of HIB in Five-Year Averages

>

> (GRAPH OMMITTED)

>

> Average Cases

> for Years HIB<5 Years

> 1981-1985 375

> 1986-1990 344

> 1991-1995 43

> 1996-2000 8

> 2001-2005 1

>

Table " 9 " Invasive-Disease Cases of Haemophilus

influenzae 1992 - 2006

[REVIEWER'S TABLE OMMITTED]

>

>The state of Florida has experienced a large popula-

>tion boom since the early 1900s. In fact, the popu-

>lation in 2007 (18,762,014 residents) was more than

>11 times the population of 1934 (1,585,596 residents).

>This drastic change in population makes it difficult

>to make fair comparisons of the burden of vaccine-

>preventable diseases over time, as a larger popula-

>tion would be expected to have a larger number of

>cases, all else being equal. To address this, we

>have used the 2007 population (18,762,014 residents)

>to estimate the number of cases that would have been

>reported for each year, had the population size been

>comparable to the 2007 population. This " standardized "

>estimate was calculated by dividing the 2007 popula-

>tion by the population for a given historical year

>to get a population ratio. The number of cases re-

>ported for that given year was multiplied by the

>population ratio. For example, the 2007 population

>(18,762,014 residents) was 10.1 times the population

>in 1939 (1,853,660 residents). The number of cases

>reported in 1939 was multiplied by 10.1 to estimate

>the number of cases that would have been reported in

>1939 if the 1939 population was [sic; were] equal

>to the 2007 population.

>

>The following table (Table 1) presents a summary of

>these standardized estimates of select vaccine-pre-

>ventable disease cases occurring in census years

>for 1940 to 2000. These standardized estimations

>are represented in the charts on the following

>pages as a dashed line. The actual number of cases

>reported for each year is represented in the charts

>as a solid line. Note that as the population size

>approaches the 2007 population, the dashed line

>and the solid line converge.

>

>

>Table 1. Summary of Standardized Estimates of Select

>Vaccine-preventable Disease CasesOccurring in Census

>Years 1940 through 2000.(Please see information above

>for an explanation as to how these estimates were

>calculated.)

>

> REPORT'S TABLES OMMITTED

>

This reviewer finds that, while informative, the

reports statements and the graphs provided are

misleading because the report intentionally does

not even mention, much less address, the other

major factors (e.g., improving sanitation, hygiene,

and potable water supply, and better housing and

availability of safe food) that were principally

responsible for the decreases from 1934 to the

late 1940s as well as the major impact of better

antibiotics, antifungals and, more recently, anti-

virals on stopping the spread of disease and re-

ducing not only the number of cases but also the

number of deaths in the USA during the period from

the late 1940s until the present.

Ideally, the reader will remember these other key

factors and consider them.

>

>Vaccine-Preventable Diseases

>

>We have also taken this opportunity to provide descrip-

>tions of the vaccine-preventable diseases.

>

Rather than simply provide descriptions of the

common " vaccine-preventable diseases " , the report

practices selective and self-serving fear mongering.

The report does this by going beyond the descrip-

tion of the disease to include selective informa-

tion on the most adverse outcomes from contracting

a given disease, usually death, without including

the information that describes the current risk of

not being vaccinated in terms of the probability

of that risk or even mentioning the supportive

therapies that, if used, can reduce that risk.

In addition, this report does not provide any in-

formation about the associated adverse outcomes of

vaccination or their risk as any truly informative

report would if it were not simply trying to in-

still fear in the reader - apparently to pressure

the reader toward vaccination.

To the extent possible, this reviewer will attempt

to balance the information presented with some

idea of the risks for the most adverse disease

outcomes.

>

>Measles

>

>Measles is a highly contagious disease that is trans-

>mitted by respiratory droplets and airborne spread.

>Symptoms include rash, high fever, cough, runny nose,

>and red, watery eyes (lasts about a week). The disease

>can result in severe complications, including pneumonia,

>encephalitis, seizures, and death.

>

While the information provided speaks to the adverse

effects of having measles, it does not address, much

even mention the adverse effects, including death,

that some of those inoculated with the vaccine stain

of a live measles virus may experience.

Moreover, the report fails to note that, in the period

from 2002 through 2006, only 2 U.S. children who had a

confirmed case of measles died in 2003 (see Table " 5 " )

as a result of contracting measles, with a crude death

risk probability of less than 1 in 100 million, but

that roughly 50 to 80 children annually died from the

adverse effects of MMR vaccination (see Table " 6 " ),

with a crude annual death risk of about 1 in 6 million.

From Merck's 2006 package insert for their live-virus

measles vaccine, ATTENUVAX®, under " Adverse Reactions " ,

Merck states:

" ATTENUVAX. (Measles Virus Vaccine Live) 9243206

ADVERSE REACTIONS

The following adverse reactions are listed in de-

creasing order of severity, without regard to cau-

sality, within each body system category and have

been reported during clinical trials, with use of

the marketed vaccine, or with use of polyvalent

vaccine containing measles:

Body as a Whole

Panniculitis; atypical measles; fever; syncope;

headache; dizziness; malaise; irritability.

Cardiovascular System

Vasculitis.

Digestive System

Diarrhea, vomiting, nausea.

Hemic and Lymphatic System

Thrombocytopenia (see WARNINGS, Thrombocytopenia);

purpura; lymphadenopathy; leukocytosis.

Immune System

Anaphylaxis and anaphylactoid reactions have been

reported as well as related phenomena such as

angioneurotic edema (including peripheral or

facial edema) and bronchial spasm in individuals

with or without an allergic history.

Musculoskeletal

Arthralgia, myalgia.

Nervous System

Encephalitis; encephalopathy; measles inclusion

body encephalitis (MIBE) (see CONTRAINDICATIONS);

subacute sclerosing panencephalitis (SSPE);

Guillain-Barré syndrome (GBS); febrile convulsions;

afebrile convulsions or seizures; ataxia; ocular

palsies.

Experience from more than 80 million doses of all

live measles vaccines given in the U.S. through

1975 indicates that significant central nervous

system reactions such as encephalitis and encepha-

lopathy, occurring within 30 days after vaccina-

tion, have been temporally associated with measles

vaccine very rarely.28 In no case has it been shown

that reactions were actually caused by vaccine. The

Centers for Disease Control and Prevention has poin-

ted out that " a certain number of cases of encepha-

litis may be expected to occur in a large childhood

population in a defined period of time even when no

vaccines are administered " .29 However, the data sug-

gest the possibility that some of these cases may

have been caused by measles vaccines. The risk of

such serious neurological disorders following live

measles virus vaccine administration remains far

less than that for encephalitis and encephalopathy

with natural measles (one per two thousand reported

cases).30

Post-marketing surveillance of the more than 200

million doses of M-M-R and M-M-R II that have been

distributed worldwide over 25 years (1971-1996)

indicates that serious adverse events such as en-

cephalitis and encephalopathy continue to be rarely

reported.10

There have been reports of subacute sclerosing pan-

encephalitis (SSPE) in children who did not have a

history of natural measles but did receive measles

vaccine. Some of these cases may have resulted from

unrecognized measles in the first year of life or

possibly from the measles vaccination. Based on

estimated nationwide measles vaccine distribution,

the association of SSPE cases to measles vaccination

is about one case per million vaccine doses distri-

buted. This is far less than the association with

natural measles, 6-22 cases of SSPE per million cases

of measles. The results of a retrospective case-con-

trolled study conducted by the Centers for Disease

Control and Prevention suggest that the overall ef-

fect of measles vaccine has been to protect against

SSPE by preventing measles with its inherent higher

risk of SSPE.31

Respiratory System

Pneumonitis (see CONTRAINDICATIONS); cough; rhinitis.

Skin

s- syndrome; erythema multiforme;

urticaria; rash.

Local reactions including burning/stinging at

injection site; wheal and flare; redness (erythema);

swelling; vesiculation at injection site.

Special Senses - Ear

Nerve deafness; otitis media.

Special Senses - Eye

Retinitis; optic neuritis; papillitis; retrobulbar

neuritis; conjunctivitis.

Other

Death from various, and in some cases unknown, cau-

ses has been reported rarely following vaccination

with measles, mumps, and rubella vaccines; however,

a causal relationship has not been established. No

deaths or permanent sequelae were reported in a

published post-marketing surveillance study in Fin-

land involving 1.5 million children and adults who

were vaccinated with M-M-R II during 1982-1993.32 "

Moreover, neither this report nor the Merck insert

address what are the true incidence rates for each

of the serious " side effects " of vaccination stated

by Merck.

>

>Although measles is no longer a common disease in the

>United States, it remains widespread in most countries

>of the world, including some countries in Europe. Cur-

>rent outbreaks in the United States highlight the on-

>going risk of measles importations from other countries

>by people who travel.

>

In spite of the preceding measles disease realities

and the commonness of measles in Europe where some

countries have, for whatever reasons, opted not to

try to vaccinate all their children and allow parents

to choose to have their children contract measles

and, thereby, get natural lifetime immunity to having

a recurrence of measles, this reviewer finds that

there is no evidence that these alternative ap-

proaches have led to either higher total healthcare

costs or death rates provided the adverse effects of

measles vaccination are included in the assessment

of these factors.

>

>Measles causes ear infections in nearly one out of every

>10 children who get it. As many as one out of 20 chil-

>dren with measles gets pneumonia, and about one child

>in every 1,000 who get measles will develop encephalitis.

>(This is an inflammation of the brain that can lead to

>convulsions, and can leave your child deaf or mentally

>retarded.) For every 1,000 children who get measles, one

>or two will die from it. Measles can also make a preg-

>nant woman have a miscarriage, give birth prematurely,

>or have a low-birth-weight baby.

>

While the reports statements are seem accurate, the

risks for the adverse effects seen in measles cases

also appear to be risks to those who are vaccinated

with MMR.

Also, this reviewer notes that, because most natural

measles cases occur in children before they are 7

years of age and measles is highly contagious, there

was little risk that a pregnant woman would contract

measles during pregnancy before there was a measles

vaccine and also, because all mothers had immunity to

measles, their babies were protected from getting

measles while they were being breastfed, which pro-

tected their babies for the first years of life from

contracting measles - an advantage that is obviously

lessened in measles-vaccinated mothers' breastfeeding.

Finally, this report fails to note that vitamin-A

deficiency worsens disease severity in children who

contract measles and that, for vitamin-A deficient chil-

dren, giving an otherwise healthy baby a mega-dose

(50,000 IU) fat-soluble vitamin-A for two days at the

onset of a case of measles lessens disease severity and

seems to be protective against the severe outcomes seen

in a small percentage of cases.

>

>Before the measles vaccine became available, there were

>approximately 450,000 measles cases and an average of

>450 measles-associated deaths were reported each year.

>Widespread use of measles vaccine has led to a greater

>than 99% reduction in measles cases in the U.S. compared

>with the pre-vaccine era.

>

Accepting that the report's " an average of 450 mea-

sles-associated deaths were reported each year " be-

fore the measles vaccine was introduced is accurate,

this reviewer again notes that factors other than

vaccination, like antibiotics for the pneumonia cases,

antivirals for the cases of brain-invasive measles, and

vitamin-A supplementation to aid the immune system in

killing off the live measles virus and immunizing the

body from future infection by measles, have also been

major contributors to the decline observed and, when

the " MMR-associated deaths " reported to VAERS are con-

sidered and a conservative underascertainment factor

is applied, the average decrease in deaths from the

early 1960s may be less than 90%.

Moreover, because a live-virus is given to about 4 mil-

lion children twice and the annual average number of

measles infections is about 8,000,000 with some underre-

ported percentage of these having some adverse clinical

aspects of having measles, the actual annual average

number of " measles cases " may not have declined signifi-

cantly.

>

>Mumps

>

>Mumps is an acute viral illness that is spread through

>direct contact with respiratory secretions or saliva.

>Symptoms include fever, headache, muscle aches, tired-

>ness, and swelling of salivary glands. Severe complica-

>tions are rare. However, mumps can cause encephalitis,

>meningitis, inflammation of the testicles (orchitis),

>ovaries and/or breasts (oophoritis and mastitis), spon-

>taneous abortion, and deafness (which is usually per-

>manent).

>

First, this reviewer is " surprised " that nothing was

said about the success of vaccination against mumps

mostly using Merck's MMR® II vaccine.

Second, this reviewer notes that death is not a symp-

tom of mumps and that inflammation of the testicles

(orchitis), ovaries and/or breasts (oophoritis and

mastitis), and spontaneous abortion are symptoms oc-

curring after puberty, mainly in adults.

With these realities in mind, let us examine the re-

cent, CDC's reported history for mumps cases in the

USA from 1999 through 2006 (as shown in Table " 10 " ).

Table " 10 " CDC's " Summary of Notifiable Diseases "

Report For Mumps (1999 - 2006)

[Cases and Incidence per 100,000 Population]

[REVIEWER'S TABLE OMMITTED]

Though, through 2005, the mumps vaccine cases showed

good control with less than 400 cases per year, the

20-fold increase in 2006 cases from 2005 cases indi-

cates that there are some non-obvious issues with

the mumps control strategy that need to be addressed.

The following are the CDC's views as expressed in

the 2006 " Summary if Notifiable Diseases " :

" Mumps

Since vaccine licensure in 1967, the number of cases

of mumps in the United States has declined steadily.

Since 2001, an average of 265 mumps cases (range:

231--293 cases) has been reported each year (1). How-

ever, in 2006, the largest mumps outbreak in >20 years

occurred, with >5,000 cases reported (1--3). The out-

break began in Iowa in December 2005, peaked in April

2006, and declined to lower levels of reporting during

summer 2006 (3). The majority of cases occurred during

March--May, 2006 (3). The outbreak was primarily focal

in geographic distribution; 84% of cases were reported

by six contiguous Midwestern states (Illinois, Iowa,

Kansas, Nebraska, South Dakota, and Wisconsin) (3).

In contrast to the childhood age range traditionally

associated with mumps disease, young adults aged 18--24

years were the age group most highly affected (1--3).

In 2006, a total of 63% of reported cases occurred in

females; previously, no gender differences in case rates

had been reported (3).

In response to the outbreak, the Advisory Committee on

Immunization Practices (ACIP) updated criteria for mumps

immunity and mumps vaccination recommendations (4). Ac-

ceptable presumptive evidence of immunity to mumps in-

cludes one of the following: 1) documentation of ade-

quate vaccination, 2) laboratory evidence of immunity,

3) birth before 1957, or 4) documentation of physician-

diagnosed mumps. Documentation of adequate vaccination

now requires 2 doses of a live mumps virus vaccine for

school-aged children (grades K--12) and adults at high

risk (i.e., persons who work in health-care facilities,

international travelers, and students at post--high

school educational institutions). Health-care workers

born before 1957 without other evidence of immunity

should now consider 1 dose of live mumps vaccine. Dur-

ing an outbreak, a second dose of live mumps vaccine

should be considered for children aged 1--4 years and

adults at low risk if affected by the outbreak; health-

care workers born before 1957 without other evidence of

immunity should strongly consider 2 doses of live mumps

vaccine.

1. CDC. Mumps epidemic---Iowa, 2006. MMWR 2006;55:366-8.

2. CDC. Update: multistate outbreak of mumps---United

States, January 1--May 2, 2006. MMWR 2006;55:559-63.

3. CDC. Update: mumps activity---United States, January

1-October 7, 2006. MMWR 2006;55:1152-3.

4. CDC. Updated recommendations of the Advisory Commit-

tee on Immunization Practices (ACIP) for the control

and elimination of mumps. MMWR 2006;55:629--30. "

Moreover, the CDC's failure here to report, much less dis-

cuss, the breakdown of the percentages of the mumps cases

in those who were: a) unvaccinated and had not previously

had mumps, unvaccinated and previously had had mumps,

c) vaccinated with one dose, d) vaccinated with two (2)

doses, and e) vaccinated with more than two (2) doses,

clearly indicates that, since most of the cases occurred

in " young adults aged 18-24 years " (nominally born in 1982

- 1988), the vaccination program used failed to be effec-

tive in preventing some who were vaccinated from subse-

quently contracting mumps when exposed " 2 " decades later

to the disease.

When it comes to the vaccination risk, there is no ac-

curate way to apportion the adverse risk for the MMR

vaccine among the component diseases, measles, mumps and

rubella, so that the rough death risk for the MMR vaccina-

tion of about 1 in 5 million applies equally to all three

diseases even though, unlike measles, the CDC reports no

deaths in the period 2002 - 2006 period caused by con-

tracting mump and the death probability is " zero " for

mumps.

Thus, this reviewer finds that the CDC's response

amounts to recommending additional mumps vaccination

(Merck's MUMPSVAX®) when it is clear that, when im-

ported cases of mumps were introduced into a mostly

vaccinated population, " herd protection " failed and,

as the Japanese have realized, unlike the measles vac-

cine, the current mumps vaccines do not confer long-

term protection to most of those vaccinated much less

the near lifetime immunity conferred by having mumps,

a disease that is, for most, only uncomfortable and,

for all, is not lethal.

Certainly, adopting the Japanese control strategy,

which only recommends vaccinating children who are pre-

teens or older who have not had mumps, might be safer

and would certainly be more cost-effective than vacci-

nating almost all children earlier only to find out

that, 2 decades later when the mumps vaccinees are

exposed to the mumps virus, a significant percentage

now have inadequate protection.

>

>Rubella

>

>Rubella is an acute viral disease that causes fever and

>rash and is spread by contact with an infected person,

>through coughing and sneezing. Complications include

>birth defects if the pregnant woman has rubella. An

>infant with congenital rubella syndrome may have the

>following: deafness, cataracts, heart defects, mental

>retardation, and liver and spleen damage (at least a 20%

>chance of damage to the fetus if a woman is infected

>early in pregnancy).

>

The program for rubella has been very successful (see

Table " 11 " ).

Table " 11 " CDC's " Summary of Notifiable Diseases "

Report For Rubella (1999 - 2006)

[Cases and Incidence per 100,000 Population]

REVIEWER'S TABLE 11 OMMITTED.

Moreover, most all the rare congenital rubella cases

seem to be occurring in recent mostly Hispanic immi-

grants who have either not been vaccinated or had

incomplete vaccination/protection.

This data again confirms that only measles and per-

haps rubella should be in the recommended vaccina-

tion program for " all " children in the USA - with

both definitely being recommended for female chil-

dren.

In addition, increased efforts should be made to

check female immigrants of childbearing age for

evidence of adequate protection from rubella in-

fection; and those lacking such evidence should

be offered the vaccine.

Hopefully, after reviewing this reviewer's remarks

and the case data, the Florida Department of Health

will notify Merck and the CDC that the MMR vaccine

should be replaced with the MR vaccine starting in

2010.

Based on the scant information available, the over-

all risk of population death risk for rubella dis-

ease and rubella vaccination are probably less than

1 in 200 million for the disease and, because MMR

is the vaccine, also probably < 1 in 6 million for

the vaccine.

However, because of the risk of severe harm to the

fetus when the mother has rubella during pregnancy,

it is best that females should either contract ru-

bella before puberty or be vaccinated with a rubel-

la vaccine (e.g., Merck's MERUVAX® II) or a vaccine

containing the rubella component (e.g., Merck's MMR

II) and/or have their rubella titers checked before

they try to get pregnant and consider vaccination if

their rubella antibody titers are low.

>

>Tetanus

>

>Tetanus is a disease of the nervous system caused by

>bacteria that enters the body through a break in the

>skin (not just a rusty nail). Symptoms include lockjaw,

>stiffness in the neck and abdomen; difficulty swallow-

>ing followed by severe muscle spasms, seizure-like

>activity, and severe autonomic nervous system dis-

>orders. Death occurs in about 10-20% of cases.

>

The CDC's reported data indicates that the vaccina-

tion program for tetanus is a success - where the

majority of the residual U.S- origin cases occur

in intravenous drug users and those who have either

no vaccination history or no recent (within 20 years)

vaccination history.

Moreover, with this success has come the realiza-

tion that tetanus boosters for adults are probably

needed no more frequently than every decade.

Finally, though 50 cases and no more than 6 deaths

are reported annually (see Table " 12 " ) in an over-

all population roughly 300 million, cases in those

under 12 have become very rare and seem to be found

only in those who have never been vaccinated.

Table " 12 "

CDC's " Summary of Notifiable Diseases "

Report's Cases For Tetanus (1999 - 2006)

Clinical Reported %

Year Cases Deaths Deaths

1999 40 2 5%

2000 35 6 17%

2001 37 6 16%

2002 25 5 20%

2003 20 4 20%

2004 34 4 12%

2005 27 -- 0%

2006 41 -- 0%

Average 32.4 ~ 4.5 13.9%

In the USA today, the average annual death risk

from tetanus disease is roughly 2 in 100 million

and vaccination seems to have been a significant

factor in suppressing death in those who contract

this disease.

Even though the death risk from the combination

vaccines offered today for children (vaccines that

include diphtheria, tetanus and acellular pertussis),

based on the guestimated adverse events from the

actual reports to VAERS, is about 10 times that for

the MMR vaccine, the data seem to indicate that the

acellular pertussis component is the main contributor

to deaths in this group of vaccines.

Provided the vaccine formulation contains no Thimerosal,

it would probably be much safer to use a vaccine that

only contains diphtheria and tetanus (e.g., the DT and

Td vaccines) and address pertussis using an alternative

control strategy.

In addition, a recent study has shown that postponing

the start of the administration of the current DTaP

vaccines significantly reduce the risk for other

serious side effects to these vaccines.

Based on those studies, until the diphtheria, tetanus

and acellular pertussis combination vaccines can be

phased out and the supply of " no Thimerosal " DT and

Td vaccines increased, it may be prudent to at least

change the early DTaP schedule from inoculating at 2,

4 and 6 months of age to start the series at vaccina-

tion at 6 months of age or later to reduce the risk

of vaccinations' inducing a chronic disease (e.g.,

asthma) in American children.

>

>H Flu: Haemophilus influenzae type b (Hib) (Invasive)

>

>H Flu is a disease which is most serious for children

>under age one. It is spread by coughing and sneezing.

>Symptoms are serious and include: meningitis, pneumo-

>nia, epiglotittis (a severe throat infection), skin

>infections, and arthritis. Children who survive Hib

>meningitis may develop permanent neurological disabil-

>ity, including brain damage, hearing loss, and mental

>retardation. 5% to 10% cases of Hib meningitis are at

>risk of dying.

>

Since the problematic nature of Hib has been dis-

cussed at length, this reviewer sees no need to ad-

dress those issues again.

With respect to serious symptoms listed, this re-

viewer notes that these are very rare and, though

the apparent number of Hib cases is falling, the in-

use testing used to identify Hib does not reliably

reflect all Hib cases, and, more importantly, the

overall annual cases of invasive Hi are increasing

as shown in Table " 13 " while the total annual cases

of invasive Hi in children under 5 do not seem to

be declining though the reported cases of Hib may be

declining (the Hib data is clouded by CDC-reported

testing problems).

Table " 13 " Haemopholis influenzae (Hi), Invasive

Disease Cases, Incidence per 100K Cases, and

Deaths (1999 - 2006)

Year Overall Children <5 yrs

Cases Incidnc Cases Incidnc Deaths

1999 1,309 0.48 ~ ~ 1.5 6

2000 1,398 0.51 ~ 1.6 6

2001 1,597 0.57 ~ 1.9 11

2002 1,743 0.62 331 ~ 1.7 7

2003 2,013 0.70 376 ~ 2.0 5

2004 2,085 0.72 331 ~ 1.7 11

2005 2,304 0.78 361 ~ 1.9 ---

2006 2,496 0.82 382 ~ 2.0 ---

Since the percentage of cases of identified annual

Hib cases in the under 5s (as identified in the

CDC's summary reports) are currently on the order

of < 20 per ~ 2,500 total cases (about 0.8%) and

only a tiny fraction of children with Hib get Hib

meningitis (< 0.01%), the current risk of a child's

dying from Hib meningitis is probably < 1 in a mil-

lion - not the misleading and potentially concern-

ing " 5% to 10% cases of Hib meningitis are at risk

of dying " .

>

>Chickenpox (Varicella)

>

>A disease caused by infection with the varicella zos-

>ter virus, which is spread by coughing and sneezing

>(highly contagious) and by direct contact. Symptoms

>include rash with blister-like lesions and fever.

>Serious complications from chickenpox include bac-

>terial infections which can involve many sites of

>the body including the skin, tissues under the skin,

>bone, lungs (pneumonia), joints, and blood. Other

>serious complications are due directly to infection

>with the varicella-zoster virus and include viral

>pneumonia, bleeding problems, and infection of the

>brain (encephalitis). Many people are not aware that

>before a vaccine was available approximately 10,600

>persons were hospitalized and 100 to 150 died as a

>result of chickenpox in the U.S. every year.

>

Here, the report is intentionally misleading.

This is the case because most of the annual pre-

vaccine hospitalizations and deaths were from

cases of shingles (the recurring form of herpes

varicella zoster), and not from chickenpox (the

disease's presentation when first infected by

herpes varicella zoster).

Since, in spite of greater than 95% uptake for

the single dose that, to justify the vaccine's

approval by the FDA, was claimed to provide long-

term protection, the effectiveness of vaccination

dropped to below 75% even as the percentage

vaccinated with one dose of Merck's VARIVAX® vac-

cine exceeded 95%.

Since exogenous boosting is required to maintain

protection after initial infection and the vac-

cine not only provides incomplete protection but,

because the vaccine strain (Oka/Merck) of herpes

varicella zoster is shed at a much lower rate

than the native strain, vaccination also does

not provide the " herd protection " that our chil-

dren's having chickenpox confers to those of all

ages who has already had chickenpox.

In addition, the antibodies passed from VARIVAX-

vaccinated mother to her nursing child do not

seem to provide protection from herpes varicella

zoster's resurgence as shingles because, as

mothers have become mostly vaccinated, the inci-

dence of the once almost unknown childhood shin-

gles cases in the very young (<2 years old) has

become noticeable.

The stopgap measures, adding another dose of

VARIVAX for school-age children or worse a dose

of Merck's PROQUAD® (which apparently causes

more than double the incidence of certain severe

adverse " varicella " reactions than VARIVAX) and

adding an explicit shingles vaccine (Merck's

ZOSTAVIX®) for the elderly, only make the herpes

varicella zoster vaccination program less than

societally cost effective by now a factor of 3

but these also do not stop the increase in cases

of shingles in our babies, children, adolescents,

and younger adults because none of these vaccines

provide the exogenous boosting needed to protect

the " herd " of those infected with herpes varicella

zoster (HVZ) from having the disease recur as

shingles, its more virulent and more lethal form.

Thus, only Merck has benefited, and is benefiting,

because sales of its HVZ vaccines have more than

doubled and the increases in shingles cases have

fueled the market for antiviral drugs to control

shingles.

Here is a case where, except for the drug manufac-

turers, the " cure " is much worse than the disease

to the point that it is clear, to any independent

knowledgeable scientist, that, at a minimum, any

recommended/required HVZ vaccination program should

be immediately abandoned.

Then, every parent should be encouraged to have

their immune-system sound and physically healthy 3-

to 6- year-old children have chickenpox and, once

they are actively shedding, invite all similarly

healthy older children, and all family members,

friends and acquaintances to visit their child to

get the " exogenous " boosting they need if, for

children, they have not been so exposed in the last

2 - 3 years, or, for adults, if they have not been

so exposed in the last 5 to 10 years.

Similarly, when someone has an outbreak of shingles,

adults should be encouraged to consider immediately

visiting with them to help maintain the protection

from HVZ that the shingles outbreak can confer.

Since U.S. experience has shown that HVZ vaccines

are not suitable for use in a mass vaccination

program, the single-component HVZ vaccines should

only be kept on the market for those who, for some

reason, wish to get periodically vaccinated with HVZ

instead of having chickenpox or being periodically

exogenously boosted by coming into contact HVZ-in-

fected persons who are shedding HVZ (options that

Japan has elected to pursue).

>

>Pneumococcal disease

>

>Pneumococcal disease is a leading cause of serious

>illness in children and adults throughout the world

>leading to ear infections, pneumonia, bacteremia

>(an infection in the bloodstream), and meningitis.

>It is one of the most common causes of death in

>America from a vaccine-preventable disease. Children

>less than 5 years old in childcare programs are at

>2 to 3 times more likely to experience invasive

>pneumococcal infections than children in home care.

>

For the sound reasons that this reviewer has pre-

viously discussed, the vaccination programs for

" Streptococcus pneumoniae " should be abandoned and

other strategies used to control the spread of S.

pneumoniae and treat those that are infected with

it.

At the onset of symptoms of any respiratory infec-

tion, for example, one may increase supplementation

with vitamin C, the B vitamins, vitamin D-3,

omega-3 fatty acids containing vitamin E, magnesium,

potassium and zinc as well as the giving of olive-

leaf extract and/or oil of oregano, which both have

strong antibacterial activity.

Again, these mass vaccination programs need to be

stopped because they do not fully protect those

getting these vaccines from getting a bacterial lung

infection with other strains of S. pneumoniae or

other adventitious organisms who, with the suppres-

sion of the vaccine-antigenic strains of S. pneumoniae,

occupy the biological niche formerly occupied by the

vaccine-antigenic strains of S. pneumoniae suppressed

by vaccination, like other strains of S. pneumoniae

and various Serracia species.

>

>Whooping Cough (Pertussis)

>

>Pertussis can be a serious illness, particularly for

>babies and young children. More than 50% of babies with

>reported cases of pertussis must be hospitalized.

>Coughing can be so severe that it is hard for babies

>to eat, drink or breathe.

>· Babies may bleed behind the eyes and in the brain

> from coughing.

>· The most common complication is bacterial pneumonia.

> About 1 child in 10 with pertussis also gets pneu-

> monia, and about 1 in every 50 will have convulsions.

>· Brain damage occurs in 1 out of every 250 children

> who get pertussis.

>· Pertussis causes about 10-20 deaths each year in the

> United States.

>

Historically, like diphtheria and tetanus, the devel-

opment of pertussis vaccines predates the development

of the penicillin antibiotics even though the first

effective standardized vaccines were not available

until the early 1950s.

However, even with the use of 6 doses (5 DTaP and,

recently, 1 Tdap replacing the Td previously recom-

mended) today, the vaccination protection provided

is: a) less than complete and , given the occur-

rence of thousands of cases annually, much less

than long term.

Given the failure of additional doses to translate

into effective long-term protection and the fact

that the major contributor to the adverse effects,

including death, in the vaccine is the acellular

pertussis component's toxins, it may be time to

abandon the vaccination approach and implement an

alternative, more effective strategy for control-

ling pertussis.

Again, the judicious use of vitamin, mineral and

nutrient supplements as well as the better of the

herbal products that are used in complementary and

alternative medicine (CAM) to: a) protect against

whooping cough (e.g., olive leaf extract and oil of

oregano) and/or , in some settings, to treat the

initial symptoms of infection, may be a strategies

that, with targeted antibiotics, given after a rapid

bacterial screening test has identified the organism

and the antibiotics to which it is most susceptible,

may be more effective in treating pertussis and mini-

mizing its possible harmful effects.

However, given the hundreds of annual deaths that

appear to be principally associated with the pertus-

sis component in the current vaccines, it is clear

that the pertussis component in these vaccines is

still highly problematic even though:

a. Replacing the previous whole-cell pertussis com-

ponent with the current " purified " acellular com-

ponent did significantly reduce vaccine toxicity

and

b. Removing Thimerosal from all of the DTaP vaccines

has apparently further reduced the toxicity of

the DTaP vaccines.

Hopefully, after reviewing the scientific evidence,

the Florida Department of Health will reach the same

conclusions and press the CDC to develop a safer al-

ternative approach to replace the pertussis vaccine,

and direct the U.S. Secretary of Health and Human

Services to compel (under the authority granted to

him in 42 U.S.C. Sec. 300aa-27(a)(2)) the vaccine

makers to switch to safer " no Thimerosal " DT (and,

for the older children, Td) vaccine formulations to

replace the current DTaP (and Tdap) vaccine formula-

tions to maintain the relatively safe and highly ef-

fective long-term protections against the toxins

diphtheria and tetanus organisms.

On balance, this reviewer finds that the need for 5

vaccines to provide sufficient long-term protection

and the harm caused by the pertussis component ren-

ders the current DTaP/DTP/Tdap vaccines, which pro-

tect against toxins and not the disease organisms

themselves, not societally cost-effective and in

need of safening in the manner outlined in the dis-

cussion provided here.

>

>Hepatitis B

>

>Hepatitis B is a serious disease caused by a virus

>that attacks the liver and can cause lifelong infec-

>tion, cirrhosis (scarring) of the liver, liver can-

>cer, liver failure, and death. It is contracted when

>someone is exposed to blood from an infected person.

>Infants are at risk if their mother is infected prior

>to or during birth; other risks include occupational

>exposure through needlesticks, having sex with an

>infected person, and by sharing drugs, needles, or

>'works' when injecting drugs. "

First, this reviewer would add is the reality that,

in most children and adults with healthy immune sys-

tems, the exposed person's immune system not only

rids the body of hepatitis B virus to which it is

exposed but also develops early immune-system protec-

tion that minimizes the risk of re-infection.

Second, this reviewer notes that hepatitis B immune

serum (from those who have had hepatitis B and suc-

cessfully overcome it) is required to prevent the

children born to mothers that are infected with hep-

atitis B from being infected with hepatitis B.

Third, this reviewer notes that there is little, or

no, " protect the child from disease " justification

for the current U.S. at-birth and early-childhood

hepatitis B vaccination program because the incom-

plete protection wears off at about the time the

child reaches adolescence - the time when the risky-

sex and drug-use risk factors become a real concern

in children.

Regardless of the vaccine apologists' cover story,

since studies have shown that the at-birth dose pro-

duces no real immunity to hepatitis B one year later,

the real reason an at-birth dose is recommended for

the hepatitis B vaccines is that this practice is an

attempt to imprint the child's nascent immune system

with the active components in the vaccine and, thereby,

reduce the risk that the child will develop childhood

multiple sclerosis (MS), and possibly other " autoimmune "

diseases, which hepatitis B vaccines are known to

" cause " beginning about 3 to 5 years after the last dose

of hepatitis B in the usual vaccination series is given

to the child.

While the " day one " inoculation does reduce the subse-

quent risk of childhood MS, again the realities are

that the current U.S. hepatitis B vaccination program:

Ø Is not population protective,

Ø Provides little, or no, long-term protection to those

who are vaccinated,

Ø Is not even societally cost effective,

Ø May increase the long-term risk that those who are

vaccinated will, if exposed, develop chronic hepatitis

B, and

Ø Chiefly benefits the vaccine manufacturers and the

healthcare establishment.

Given the preceding realities, this reviewer must also

recommend that the current early childhood hepatitis B

vaccination program be removed from the general vacci-

nation schedule.

Moreover, because the at-birth dose has the potential

to cause permanent immune-system damage, the manufac-

turers be told to safen and refine this vaccine to re-

duce the " zero day " risks and provide a vaccine that,

when given in no more than a 3-dose regimen to pre-

teens: a) is safer than the current vaccines, pro-

vides long-term immunity to more than 95% of those

vaccinated, and c) does not carry a long-term risk

that the person vaccinated may develop MS or another

long-term chronic disease (e.g., type 2 diabetes).

>

>Polio

>

>Polio is an infectious disease caused by a virus that

>lives in the throat and intestinal tract. It is most

>often spread through person-to-person contact with

>the stool of an infected person and may also be spread

>through oral/nasal secretions. Polio was one of the

>most dreaded childhood diseases of the 20th Century

>in the United States. There were usually about 13,000

>to 20,000 cases of paralytic polio reported each year

>in the US before the introduction of Salk inactivated

>polio vaccine (IPV) in 1955. Polio peaked in 1952 when

>there were more than 21,000 reported cases. The number

>of cases of polio decreased dramatically following

>introduction of the vaccine and the development of a

>national vaccination program. In 1965, only 61 cases

>of paralytic polio were reported compared to 2,525

>cases reported cases just five years earlier in 1960.

The last cases of naturally occurring paralytic polio

>in the United States were in 1979, when an outbreak

>occurred among the Amish in several Midwestern states.

>From 1980 through 1999, there were 152 confirmed cases

>of paralytic polio cases reported. Of the 152 cases,

>eight cases were acquired outside the United States

>and imported. The last imported case caused by wild

>poliovirus into the United States was reported in

>1993.

>

Though this reviewer finds this part of the report

replete with distortions, half-truths and misrepre-

sentations in the manner in which it portrays the

history of polio and the manner in which it omits

the problems (like SV-40 infection and contamination

with other live animal viruses in both the early

inactivated polio vaccines and the live-virus oral

polio vaccines that, though they were used from the

1960s to through the 1990s in the USA, this report

does not even mention as well as other problems),

this reviewer sees nothing to be gained by rehashing

these issues yet again [30].

Moreover, since the current inactivated polio vac-

cines (IPVs) are grown in human cells and fetal

calf serum, though not eliminated, the risk of vac-

cinee contamination with animal viruses has been

significantly reduced.

Thus, though the long-term risks from viral con-

taminants are unknown, the current vaccination IVP

vaccination program seems to be adequately safe in

the short-term and provides long-term protection

against the current endemic polio viruses, which:

a) are all derived from the viruses in the live-

virus oral polio vaccine (OPV) that the U.S. used

for more than 25 years and being added to by

the imported vaccine strains being shed by travel-

ers from lands where live poliovirus vaccines are

still being used and their poliovirus-related

strains are endemic.

______________________________

[30] For those who wish to read more on the realities

of polio and the polio vaccination programs

" success " , this reviewer recommends that they

read pages 3 and 4 in this reviewer's previous

article, " A Review of: 'Vaccinations are still

needed for kids By Meg Fisher, MD' (27 January

2008; 27 pages) " , which is posted in the

" Documents " section of the CoMeD web site:

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

End of Part 1 of 2 of the Review

______________________________________________________

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

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