Dr Bob Sears' response to Dr Offitt and Pediatrics

[Guest guest]

From Dr. Sears - what I have said all along - he

does not give you information to show you why not to vaccinate

He says " In fact, the book encourages parents to vaccinate their children. "

Sheri

http://www.askdrsears.com/thevaccinebook/

A Response to Dr. Offit’s Misleading and

Inaccurate Review of The Vaccine Book in Pediatrics, January 2009

On December 29, 2008, Dr. Offit published a

special article entitled “The Problem With Dr.

Bob’s Alternative Vaccine Schedule” in the

Pediatrics

(<http://www.pediatrics.org/cgi/doi/10.1542/peds.2008-2189>www.pediatrics.org/cg\

i/doi/10.1542/peds.2008-2189).

Affiliated with the Vaccine Education Center at

Children’s Hospital of Philadelphia and the

University of Pennsylvania School of Medicine, as

well as the co-inventor and co-patent holder of

the RotaTeq vaccine, Dr. Offit has long been

recognized as a prominent and respected leader in

vaccine education and research. He has been one

of the primary spokesmen for the American Academy

of Pediatric’s recent campaign to improve the

public trust in our nation’s vaccination

policy. I appreciate Dr. Offit taking the time

to review The Vaccine Book and offer his

constructive criticisms on it. Dr. Offit and I

agree on many things, including the opinion that

vaccines are extremely important and have been

one of the most valuable public health endeavors in the past several decades.

I would like to take this opportunity to clear

the record regarding The Vaccine Book and my own

professional opinions on vaccines. I believe

that Dr. Offit has greatly misrepresented the

overall message of the book as being

‘anti-vaccine.’ In fact, the book encourages

parents to vaccinate their children. In order to

give parents a complete educational experience,

while presenting all the ‘pros’ of vaccines I

felt it was important to list the ‘cons’ as well

by discussing the potential side effects from the

vaccine product inserts (while emphasizing how

rare any severe reactions are). I also discuss

the reasons why some parents choose not to

vaccinate so that the readers can understand what

these parents’ issues are. I don’t condone such ideas, I simply present them.

However, I believe that Dr. Offit has

misconstrued the book’s overall message by

selectively extracting various phrases and

sentences that discuss anti-vaccine ideas and

worries that parents have and portraying those

ideas as my own. He quotes various areas of the

book that sound anti-vaccine without offering the

pro-vaccine conclusions that I offer on the

subject. I will point out such areas in my

discussion below. I will say that there are a

couple of small items in the book that Dr. Offit

points out are in error, and I appreciate that

clarification he has been able to offer. I will

discuss these areas, and the changes that I will

make in the next edition of the book.

I will admit that the book does offer one major

controversial idea; my alternative vaccine

schedule. However, it is important to note the

context in which I offer that advice. At the end

of the book, I encourage parents to vaccinate

their children according to the CDC schedule if

they feel confident in our nation’s vaccine

system. For those parents who, after reading all

the reasons why vaccines are important in my

book, still believe vaccines aren’t safe and plan

to not vaccinate, I at least ask them to consider

getting the most important infant vaccines so

their babies have protection from the

life-threatening illnesses (HIB, PC, DTaP, and

Rota). Where my alternative schedule comes into

play is for those parents who are still unsure

about vaccines, but they do want to fully

vaccinate. I offer them an optional schedule

that gets their child fully vaccinated, but at a

slower pace. It doesn’t delay any of the most

important shots, but it slightly delays some

shots that are for lower-risk diseases. This

option is really for parents who would otherwise

leave a doctor’s office unvaccinated – parents

who are too torn to make a decision, and

therefore often don’t make any decision to vaccinate at all.

It is my belief that many families go

unvaccinated simply because they aren’t offered a

more gradual option. If they were, many would

vaccinate. I believe this approach would

actually increase vaccination rates, not decrease

them as Dr. Offit suggests. I think that is our main area of disagreement.

The rest of this article will take a look at each

of Dr. Offit’s statements and offer my own view.

This isn’t going to be any sort of “great debate

over vaccines” because we agree on most

things. I will point out the parts of his

article that I agree with, and parts that I

accept his correction on something that I wrote in error.

Open debate and discussion is healthy in the

field of medicine. I welcome it, and I’m sure

Dr. Offit does as well. However, I must take

issue when a person very clearly misrepresents

information in my book, selectively quotes

certain sections out of context, and attributes

statements and ideas to the book and to myself

that I never even wrote. Some of these errors

are so erroneous, it’s almost as if Dr. Offit was

reading some other anti-vaccine book instead of

mine. The purpose of my response is not to

determine who’s right and who’s wrong. It’s

simply a clarification of some false claims made against me.

Doctors Do Not Understand Vaccines

I agree with what Dr. Offit says here, except

that I think parents want their own personal

doctor to have a more thorough understanding of

vaccines. Parents are much more likely to accept

their doctor’s advice if the doctor has a

complete understanding (or nearly so) of all the

vaccine issues, side effects, ingredients, safety

research, and possible drawbacks to a vaccine. If

a doctor can look a patient in the eye and say,

“I’ve spent weeks investigating all these issues

personally and reviewing all the research myself,

and, along with the expert backing of the AAP,

CDC, and ACIP, I believe that the vaccines are

safe and should be given according to the CDC

schedule,” that has much more weight than a

doctor simply saying, “I agree with the AAP, CDC,

and ACIP that vaccines are safe.” Parents aren’t

automatically going to trust such organizations

the way we doctors do. They want us to do our

own homework. Back in the old days when most

patients simply trusted what doctors said, maybe

that wasn’t necessary. But today’s parents want

more from us. They are asking questions that we,

as doctors, should be prepared to answer. If we

are caught off guard by a parent’s question,

because we aren’t familiar with a particular

anti-vaccine argument or a certain vaccine

ingredient or side effect, the parent will lose trust in us.

Public Health Agencies and Pharmaceutical Companies Are Not Trustworthy

Dr. Offit’s words, not mine. I never make this

statement, nor do I try to imply it. Most

vaccine books are ripe with anti-pharmaceutical

company conspiracies. In fact, I tried to steer

clear of any conspiracy theories in this

book. Now, when reading the quote he offers from

the Hep B chapter of the book, in the context of

first reading the above heading, I can see how

one could read some “mistrust of the system” into

my words. But this wasn’t my intent, nor is this

impression given when read within the context of

my book. In fact, on the next page I state,

“These researchers were part of a very

well-respected group – the leaders in their field.”

Now, two of the researchers involved in studying

Hep B rates in children and helping to create

neonatal Hep B vaccine policies did work for

Merck and GSK. Anti-vaccine books love to jump

all over any researcher who has ties to vaccine

manufacturers. But I didn’t. But now that Dr.

Offit has questioned this, I will comment. The

doctors who worked with Merck and GSK and were

part of the research that recommended Hep B

vaccination in infants could be the most

honorable, dedicated, unbiased doctors in the

world. I’ve never met them. But in medical

school we are taught to at least briefly raise an

eyebrow at research funded by a pharmaceutical

company, instead of simply taking it for

granted. I will emphasize that while I did that,

I didn’t do so based on their pharmaceutical

ties. I simply wondered about the findings in

the research. While some people might question

the motives of and advice given by any doctor

with financial ties to the vaccine industry, I

refrain from doing so in my book.

Parents look at Hep B vaccination for their

newborn and wonder, “Why?” Many pediatricians

that I’ve talked to do as well. If Hep B is a

potential risk to children through non-sexual

casual contact, then vaccination would be a

no-brainer. While writing my book I tried to

find proof that non-sexual spread of Hep B is a

significant risk to babies so that I could advise

parents to vaccinate right away. But as a

pediatrician, I’ve never seen it occur. And I’ve

only heard of one case publicized in the media –

an infected child sneezed on a teacher’s hand,

and the teacher contracted Hep B through a cut on

her hand. I’m sure there are many more such

cases. But really, 16,000 kids each year less

than 10 year old? Am I the only doctor that

wonders whether or not that’s true?

I went straight to the source of disease data –

the MMWR 2002 – to see what the actual reported

cases of Hep B used to be in children younger

than 10 years of age (Reference 1) and found that

during the late 80s and early 90s, prior to

introducing Hep B vaccine to infants, there was

only 1 case of Hep B per 100,000 children age 0

to 9 in the U.S. (see chart at the end of the

MMWR report). With 36,000,000 children in the

U.S. in that age range, that only comes out to

about 360 cases per year. The chart doesn’t

differentiate between the perinatal exposures and

accidental exposures. I know that some childhood

Hep B infections will go unrecognized for many

years, but I just can’t believe with such a low

number of reported cases that the estimates of

16,000 cases per year can even be close.

The study that Dr. Offit refers to, as well as

every other study done during the late 80s and

90s that looked at Hep B in young children,

doesn’t actually determine the rate of Hep B by

direct study or by reported cases (References 2 –

5). These studies provide estimates using

population statistics. They look at adult cases,

and estimate what percentage of those may have

come from non-sexual contact during childhood,

and make a logical guess at what the rate in

children might be. Well, in order to really

determine the rate of Hep B in children (to see

if infant vaccination is warranted), all one

would have to do is screen several thousand

children for the disease and see how often it

shows up. Then repeat the study again with a

larger group. That’s what should have been done

decades ago prior to introduction of the

vaccine. The study could be done today on

children who have skipped the vaccine. What hasn’t anyone simply done that?

I have no doubt that Hep B vaccination is

important, especially for pre-teens. And because

there may be some small risk of non-sexual

exposure to the disease during childhood,

vaccinating during childhood may be important as

well. I state this very clearly in the

book. But does it have to be given right away

during the neonatal period? For any family with

a Hep B positive family member, yes – each baby

should be vaccinated. But for the other 99% of

American families, I don’t believe the vaccine

needs to be given to young infants, especially in

the hospital. Why give a less-than-necessary

vaccine to a newborn and risk creating

sepsis-like side effects (Reference 6 and

7)? Any family that asks to delay this vaccine

shouldn’t be treated like they are crazy. They

simply want to give their newborn a break for the first few weeks.

As for the issue regarding parents’ trust in the

vaccine manufacturers, that trust was severely

shaken when it was revealed in the Los Angeles

Times on February 8, 2005, that way back in 1991

a researcher at Merck sent a memo to the

president of Merck’s vaccine division stating

that they had just realized that the cumulative

amount of mercury in vaccines given to infants by

six months of age was about 87 times the safety

limits set by the FDA. And that information was

not revealed to the public until 8 years

later. Now I realize that pharmaceutical

companies do so much good for our health and the

field of medicine, and that such negative

occurrences are rare. As a pediatrician I put my

trust in them everyday by prescribing their

products, including Merck vaccines, to my

patients. But I find it surprising that any

doctors can fault a parent for not completely

trusting Merck after that, or the FDA and CDC

departments that were supposed to be overseeing this type of issue.

Vaccine Mandates Should Be Eliminated

I don’t make any claim that unvaccinated children

have been taken away from the home. I state that

I have heard “rumors” of such, but that I don’t

believe them. I do believe, however, that some

states may actually have that power by law, but I

doubt it has ever been exercised. You may recall

the recent court battle this year on the East

Coast in which parents were refusing the Hep B

vaccine for their teenagers. The parents were

threatened with jail time if they didn’t either

sign the religious waiver or comply with

vaccinations. I don’t know if anyone was ever

jailed, but that is a really scary thing to have

occurred in our free country. I agree with Dr.

Offit that in the event of an outbreak that

significantly puts the public health at risk, the

state should have some authority to step in. But

during the normal course of life, I believe that

parents should have the right to decline vaccines.

Vaccine-Preventable Diseases Are Not That Bad

This is a prime example in which Dr. Offit has

taken one statement out of the book and portrayed

my viewpoint inaccurately. I clearly state how

bad each disease can get as well as the number of

yearly fatalities. At the very beginning of the

PC chapter I share how serious PC disease is. I

also state at the very end of that chapter that I

consider PC “a fairly important vaccine.” At the

end of each chapter I share any personal

experiences I have had as a pediatrician with

each disease, and this was the only one I’ve had

for invasive PC. At the end of the book I

strongly urge parents who are thinking of

skipping vaccines to at least consider PC vaccine

(as well as a few others). On my website, I

dispel a myth that’s been going around that the

PC vaccine is no longer important, and is causing

other emerging strains, and I urge parents to

continue getting the current PC vaccine until an

expanded one comes available.

A word of thanks to Dr. Offit on this issue for

pointing out that I could perhaps improve on my

disease descriptions in the book. In the next

edition I am planning to add a section on each

disease that paints a picture of “a typical

course of this disease”, then a “worst case

scenario of the disease.” Dr. Offit is

absolutely correct. Parents should know how bad each disease can be.

Hide in the Herd

I agree with Dr. Offit here. Herd immunity is

very important. I state the argument in the book

that “the good of the many outweighs the good of

the few.” Nowhere in the book do I encourage

parents to “hide in the herd.” Again, Dr.

Offit’s words, not mine. I clearly state (as Dr.

Offit quoted) the danger to our country if too

many people don’t vaccinate. My comment on “not

sharing your fears with your neighbors” was an

attempt at humor, while trying to teach a very important point.

Natural Infection Is Better Than Vaccination

Again, what book is Dr. Offit reading? Not

mine. I describe chickenpox parties in the book,

but I certainly don’t recommend them. Notice the

“. . .” in Dr. Offit’s quote here. The entire

quote is “Some parents actually want their kids

to catch chickenpox. They may purposely get

their child exposed to get the disease over

with.” I’m simply stating what some parents

do. Not what I think they should do. As for the

risk of acquiring natural immunity to a disease,

I agree with Dr. Offit. It is a risk. And I

clearly state what that risk is for each disease.

A very popular anti-vaccine argument is that

childhood diseases are healthy. They exercise

the immune system. Other authors encourage

parents to allow their kids to catch many of

these diseases. I couldn’t disagree more. My

book tries to dispel that myth. No one wants to

exercise their baby’s immune system with

meningitis or hep B, or most of the other vaccine-preventable diseases.

Vaccination Has Eliminated Infectious Diseases at

the Price of Causing Chronic Diseases

I never even come close to saying any such thing

I my book. Allow me to quote from page 178:

“Critics [of vaccines] worry that many chronic

diseases and other physical and mental problems

like ADHD, chronic fatigue, diabetes, allergies,

asthma, learning disorders, and autism are

triggered by vaccines. I haven’t found any solid

research to support this

contention.” Interestingly, this is the very

sentence that precedes Dr. Offit’s quote

here. As Dr. Offit points out, I go on to say I

found studies that show a “possible link,” but

that’s it. I actually go out of my way to debunk

the myth described in the heading above. By the

way, the peer-reviewed journals that discuss

“possible links” include Revue Neurologigue,

Rheumatology, British Journal of Rheumatology,

Journal of Rheumatology (that’s a lot of

rheumatology!), Lancet, Neurological Science,

Scandinavian Journal of Rheumatology, Acto

Dermato-venereologica, Autoimmunity, Journal of

the American Academy of Dermatology, and Clinical

Rheumatology, Journal of Allergy and Clinical

Immunology. See References 8 through 19.

Vaccine Safety Testing Is Insufficient

I don’t say that safety testing is

insufficient. Again, Dr. Offit left out some of

the words in his quote. I start this particular

chapter with a discussion of the extensive

short-term research that is done with each new

vaccine, describing the research in a similar way

that Dr. Offit states here in his article. As

for his quote from my book, the entire text

reads: “A new medication goes through many years

of trials in a select group of people to make

sure it is safe. These subjects undergo extensive

blood testing and physical evaluations over many

years. If nothing severe or common shows up, the

medication is then released for general

use. Vaccines, on the other hand, don’t receive

that same type of in-depth short-term testing or

long-term safety research . . . Their blood isn’t

tested to check for internal toxic effects.

Doctors don’t do physical exams to look for

problems.” My point here is that the short-term

research could be more hands-on, instead of simply by parent questionnaires.

I agree that vaccine safety testing is very

extensive, and in my mind it is very

adequate. What we could improve is the long-term

safety research. Dr. Offit points out how VAERS

and VSDP are model systems for detecting rare

adverse events. A few paragraphs down, however,

under “Risks From Vaccines,” he states (somewhat

contradictorily, if that’s a word) “VAERS is a

passive surveillance system and cannot be used to

determine the true incidence of adverse events,

which can be determined only by using control

groups.” I couldn’t agree more. We need a large

placebo group of voluntarily unvaccinated kids to

compare to the vaccinated population. I think

that we will see that in the upcoming National Children’s Health Study.

But back to “insufficiency” of safety

research. In the book I refer to a statement

made by the Cochrane Collaboration in Vaccine

2003 (Reference 20) regarding a review of 22

studies on MMR vaccine safety: “the design and

reporting of safety outcomes in MMR vaccine

studies, both pre-and post-marketing, are largely

inadequate.” Their words, not mine.

Public Health Officials Make Recommendations for

the Public and Not for Individuals

I’m pouring through the book right now trying to

find where I may have made such a statement, and

I just can’t find it. Hmmm. What I do believe

is that Public Health Officials view vaccine

issues from two sides – the risk to individuals

as well as the risk to our nation as a

whole. Parents, on the other hand, tend to make

decisions based on their own individual child,

without considering the public’s benefit. I also

state in the book that such a decision is perhaps “selfish.”

As for the polio vaccine, Dr. Offit fails to

include other quotes from the book that state the

importance of the polio vaccine: “I consider this

vaccine very important from a public health

viewpoint. Until the whole world is polio free,

ongoing vaccination will help keep our nation

protected . . . (page 79).” Because there

haven’t been any cases of polio in the U.S. for

decades, I do believe it is correct to say that

we don’t use this vaccine to protect each

particular child from catching the disease (as

compared to every other vaccine we use). Rather,

we use it for herd immunity. I agree with Dr.

Offit that “every individual benefits from

receiving polio vaccine.” There is no “flaw in

logic” here. We are both saying the same thing.

Decision-Making

You know, I do suppose it was a little

presumptuous of me to state that “I have offered

you all the information you need to make this

decision.” That would imply by book is 100%

complete. No book is. I should have said, “I

have given you almost all the information . .

..” As for misinformation, I’m still waiting for some here.

Distinguishing Good Science From Bad Science

Because the science on vaccine safety is not

complete, and never can be, I didn’t undertake

the very tedious task of detailing every

scientific study there is. Who would read such a

book? This is a book for the general

public. Where I state “Reasons some people

choose not to get the vaccine,” I clearly state

the risks that such parents are taking.

I will take this opportunity for the second time

to state my appreciation for an oversight pointed

out by Dr. Offit. I really should have

delineated which studies come from a

peer-reviewed (mainstream) journal and which do

not. This is very important, so parents can

decide whether or not a particular study holds

any weight. This will be corrected in the next edition of the book.

Risks >From Vaccines

Once again, I am respectfully thankful for this

constructive criticism. Dr. Offit is right. We

shouldn’t view reported reactions in VAERS as

actual vaccine reactions, and I shouldn’t have

used such numbers to determine statistical

risks. I do, however, point out in the book that

we don’t know that VAERS reports are actual

vaccine reactions. The problem is, that’s the

only system I have to try to determine what the

risk of a vaccine reaction might be. I think

parents deserve to know that. Until we have an

active surveillance system, instead of a passive

one, we won’t know what that risk is. I could

also add that VAERS only contains reactions that

are reported. Many reactions go unreported. So,

even if only some of the VAERS reactions can be

attributed to the vaccine, not all such reactions

are actually reported. So, my numbers may

reflect something close to reality. But that’s

not scientific. We really need to take a better look at this.

Risks >From Vaccine-Preventable Diseases

Wow. I am now convinced that we are not talking

about the same book here. I not only make it

very clear what the risks are from each disease,

allow me to quote from the meningococcal vaccine

chapter’s list of reasons to get this vaccine:

“Obviously, meningitis is devastating. Getting

the shot during the early teens protects a child

.. . . the chance that a college freshman in a

dorm could catch it is something to consider. In

the chapter’s conclusion: “No one can argue that

MC disease isn’t a horrible thing to see, much

less to actually catch.” That sentence precedes

the one quoted by Dr. Offit here. Yes, I do

comment on the GBS issue, as that was brand new

information when the book came out. I state “If

experts can determine that the risk of GBS is

negligible, the shot will likely become more

widely accepted.” I also predicted that it will

become approved for two-year-olds, and state

“this will become a very important vaccine, since

the disease is more common in younger

children.” I comment on GSK’s combo of HIB and

MC vaccine for 2, 4 and 6 month olds (currently

undergoing trials) and state “this vaccine will

provide much-needed protection during infancy,

when MC disease is most common.” I also describe

MC disease (page 137) as “. . . extremely

serious. This is probably the single most serious

and potentially deadly of all vaccine-preventable

diseases.” I go on to describe in detail the

likely ICU course, with organ fairly and likely

permanent disability. Even though I fortunately

don’t get the “see much of this evil”, I certainly describe it in the book.

Animal Products

I didn’t raise the specter of Mad Cow

Disease. That’s a ploy found in many

anti-vaccine books, and I state that this is an

issue the critics often bring up. Dr. Offit is

right, I should have mentioned that we don’t use

“mad cows” in the U.S., but I though everyone already knew that.

Dr. Offit failed to mention the one time when a

viral disease did contaminate a vaccine. And

this was no small deal either. I open Ch. 16

with this info. In August of 2002 and February

of 2003, the pediatric newspaper Infectious

Diseases in Children published reports of SV-40

viral contamination of millions of doses of polio

vaccine due to the use of monkey kidney tissues

used to make the vaccine. It was estimated that

almost 30 million people were injected with

vaccines containing this virus between 1955 and

1963. Also, in 1980, 150 newborns will given an

experimental Hep A vaccine that was contaminated

with SV-40 virus. This virus has been linked to

several human cancers, although fortunately the

people injected with this virus haven’t been

found to have higher than expected rates of

cancer. Now we know to screen for this virus.

I find it peculiar that Dr. Offit portrays my

book as raising the specter of mad cow, but

completely leaves out the SV-40 virus

problem. It’s not a problem anymore, but I use

it as an example of what happened in the past. I

state that vaccine critics worry that “unknown

infectious particles or . . . foreign DNA in

[human and animal] tissues may cause problems . .

..” I end the section with “At this time, I can’t

offer any good evidence to support these worries . . .”

Thimerosal

Actually, the whole point of my two-page

discussion on thimerosal is that it has been

removed from virtually all vaccines, so you

really don’t have to spend hours researching

whether or not it is harmful. I save the

parents’ time by making it a non-issue. Going

back and reviewing all the research is a moot

point for parents deciding about vaccines

today. I actually thought that I was doing a

great service by dispelling this myth. I guess not?

Aluminum

Ok. Aluminum is a very complicated issue. It

really deserves its own article. In order to

provide you with a full discussion on aluminum, I

am posting that section from the book on my

website in the FAQ section on the right. I ask

you to not pass judgment until you’ve read the

whole thing. I don’t use the 2002 Vaccine study

in my book. Instead I use the 2004 Lancet study

from the Cochrane Collaboration for a thorough

review of aluminum (Reference 21). For those of

you who don’t read the entire aluminum section of

the book, here is the bottom line. We know

aluminum is a neurotoxin. We also know that

humans can ingest huge amounts without harm,

since 99% of it passes out through the

stools. I’m sure Dr. Offit knows that, so I’m

curious as to why he’d use the “babies ingest

tons of aluminum anyway” argument. I would also

point out that the conclusion of the study that

Dr. Offit refers to doesn’t say anything about

proving that aluminum is safe. It simply

concludes that the amount in vaccines didn’t

warrant changing the schedule. Those are two

completely different statements.

I’ve been searching and searching for human

infant studies that determine what a safe level

of injected aluminum is, including looking at all

the studies used in the article quoted by Dr.

Offit, and I can’t find a single one. There is a

lot of animal research, a lot of studies that use

theoretical mathematical models, and one human

adult study, but not a single human infant study

(see Resources 22-30). As a precaution, I show

worried parents how to take precautions to limit

their baby’s aluminum dosing during

vaccinations. This allows these parents to

vaccinate, instead of declining them all.

Other Vaccine Ingredients

Up until December 2007, the albumin used as a

growth medium for the MMR viruses was human

albumin filtered out of human blood. The PI

described how the human albumin is screened for

the absence of adventitious agents, and processed

using the Cohn cold ethanol fractionation

procedure. In December 2007, the MMR PI changes

its description of the albumin to

recombinant. Dr. Offit makes it sound as if I’m

misleading my readers and printing false

information, when in fact my information was

correct in October 2007. I appreciate him

highlighting this change, however. It’s good to

see Merck moving away from using a human blood

product. Not that this was a problem – the

albumin was carefully screened and filtered. Reference 31.

MMR Vaccine and Autism

Actually, in the book I describe in detail six

studies that showed no link between MMR and

autism (References 32-37). As for the MMR

vaccine/intestinal inflammation/autism theory

being debunked, I would now agree with Dr.

Offit. At the writing of my book, however, no

one had yet repeated Dr. Wakefield’s work to

prove him wrong. As of this year, a very well

done study by Harvard, Columbia, Mass General,

CDC, and the AAP has (Reference 38). I have

written an update to this effect on my

website. My initial worries about the MMR and

intestinal inflammation are probably unfounded.

Coincidence Versus Causality

Again, it sounds like myself and Dr. Offit mostly

agree here, although for some reason my agreement

with him would be viewed as “poorly reasoned or

illogical.” One can’t simply group all reported

reactions into two groups: either proven to be

caused by a vaccine or proven to not be cause by

a vaccine. There are so many reported reactions

that haven’t been proven one way or the other

through scientific study. This is a third

category, and as further research is done we will

place each reaction in one of the first two

categories. But until that is done, parents can

only view these reports as somewhere between coincidence and causality.

Scientific Proofs

I agree. This is not a sound scientific

argument. I just really wish we could prove a

vaccine doesn’t cause a particular

reaction. Parents could then worry a lot

less. Although we can’t prove a negative, we can

improve the long term safety research of vaccines

so parents can be more confident.

Context

We’ve already covered this. As for the flu shot,

here’s my opinion. Because mercury is a known

neurotoxin, all the science in the world won’t

convince many parents to give their baby a

mercury-containing flu shot, especially when they

have the option to get a non-mercury version. I

completely agree with Dr. Offit’s statement that

the science shows no evidence that the amount of

mercury in a flu shot causes any harm. But I

just don’t think that parents believe it.

Understanding Risk

I understand the risk of MC disease as well as

any doctor, and I very clearly recommend this

vaccine in my book: “Obviously, meningitis is

devastating. Getting the shot during the teen

years protects a child through high school and

college . . . There are about 250 teen and

college-age cases each year. The ingredients are

among the purest and simplest of all vaccines . .

..” I do discuss how the reported GBS reactions

may worry some parents, and may cause dome

parents to delay the vaccine. But never do I say

not to get the vaccine: “. . . this vaccine is an

important step in eliminating or at least

minimizing the disease among our nation’s teens .

.. .” I also give a very strong recommendation in

favor of it’s use in younger children if it

becomes approved for that age group. I don’t

understand how Dr. Offit could misconstrue my

statements to say that I don’t recommend this

vaccine. I agree that the risk of GBS is much smaller than the disease risk.

The Harm

In my selective schedule, I don’t tell parents

not to get the MMR, VZ, Hep A, Polio, and Flu

shots. That’s their decision. This schedule is

designed to encourage non-vaccinating families to

at least get their baby the DTaP, Rota, PC, and

HIB vaccines, and their teens the HPV and Hep B vaccines.

Dr. Offit makes an incorrect statement regarding

my alternative schedule. He says that children

using this schedule won’t be getting a flu shot

until age 5. On page 236, the flu is very

clearly listed as a recommended vaccine starting

at 6 months and continuing through to age five,

so I’m not sure exactly what book Dr. Offit was looking at. Not mine.

My alternative schedule isn’t necessarily what I

recommend parents do. In the book (page 235), I

encourage parents who trust in our country’s

vaccine system and safety, as recommended by our

nation’s top medical experts and almost every

doctor, to go ahead with the regular vaccine

schedule. “I recommend that you trust your

doctor’s advice, and your own intuition, and go ahead with vaccination.”

The alternative schedule is designed for parents

who are worried about grouping so many shots

together. That is the single most common worry

I’ve heard from parents over the years. They

want to fully vaccinate, they just want to do it

at a slower pace. But up until now such parents

haven’t had any guidance on how to do

this. These are parents who otherwise may not be

vaccinating, or if they do they are cringing and

scared about doing it. Parents should feel

secure and confident in their vaccine

choices. Yes, this schedule is a lot more time

consuming and more work for the parents and the

doctor’s office. It certainly wouldn’t be a

reasonable or practical vaccine schedule for our

country as a whole. Babies would fall behind on

their shots, compliance would wane, and some

could be susceptible to what should be a

vaccine-preventable disease. I agree with Dr.

Offit there. My alternative schedule is simply

an option for parents who want to take the extra

time and effort. It’s just an option. I worry

that if doctors don’t offer an option like this,

some patients will go unvaccinated, and that’s

not good. I believe this schedule will increase

vaccination rates among non-vaccinating families.

The only vaccines that my alternative schedule

delays to any extent are polio (until 9 months of

age), Hep B (until 2 ½ years) and Measles (until

age 3). This is virtually no risk involved in

delaying the first two, but I agree with Dr.

Offit that delaying measles vaccine is a risk,

especially for a child in daycare or with older

siblings. On my website, I encourage such

families, and any family who is worried about

measles exposure, to vaccinate for measles sooner.

Conclusion

The manner in which Dr. Offit has portrayed my

book is erroneous and misleading. A more

accurate discussion of the book would have been

much more constructive. As a fellow pro-vaccine

doctor, if my book had been portrayed correctly,

we would find very little to debate about. I

would expect colleagues within the AAP to have

more respect for each other and double and triple

check to make sure something printed in the

Journal of Pediatrics wasn’t so riddled with

selective, misleading, and inaccurate

quotes. The number one area that we don’t agree

on is whether or not we should offer

non-compliant parents some selective or

alternative options. By doing so, do we increase

or decrease vaccination rates among such

families? That’s the main question. There is so

much to talk about when it comes to vaccines and

how to regain the nation’s trust in the

system. This type of article further damages that trust.

You can find this article posted online tonight

at <http://www.thevaccinebook.com/>www.TheVaccineBook.com

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51(25):549-552, 563. Available online at

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the United States. Need for alternative

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Margolis HS, et al, JAMA 1990;263:1218-22.

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4. Hepatitis B: Evolving Epidemiology and

Implications for Control, Margolis HS, Alter MJ,

and Hadler SC, Seminars in Liver Disease 1991, Vol. 11, No. 2.

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infection in children, Sepkowitz S, The Pediatric

Infectious Disease Journal, Vol. 12, No. 6, June 1993.

6. Hep B vaccine Product Inserts list of report

reactions, Merck and GlaxoKline.

7. Unexplained fevers in neonates may be

associated with hepatitis B vaccine, Linder N. et

al, Archives of Disease in Childhood: Fetal and

Neonatal Edition 1999; 81(3);206-207.

8. Vaccinations and multiple sclerosis, Gout O,

Federation of Neurology, Paris France,

Neurological Science 2001, Apr; 22(2): 151-154.

9. Arthritis after hepatitis B vaccination.

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Scandinavian Journal of Rheumatology, 24 (1), 1995.

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IDDM, Classen JB, Classen DC, Autoimmunity 2003, May;36(3):123.

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Maubec E, et al, Journal of the American Academy

of Dermatology, April 2005; 52(4):623-629.

13. Vaccine-induced autoimmunity, Cohen AD,

Journal of Autoimmunity, 1996 Dec;9(6):699-703.

14. Kawasaki disease in an infant following

immunization with hepatitis B vaccine. Miron D,

Clinical Rheumatology, 2003 Dec;22(6):461-3.

15. Vaccination and autoimmunity-'vaccinosis': a

dangerous liaison? Shoenfeld Y, Aron-Maor A,

Journal of Autoimmunity, 2000 Feb;14(1):1-10.

16. Macrophagaic myofasciitis lesions assess

long-term persistence of vaccine-derived aluminum

hydroxide in muscle, Gherardi M et al. 2001, Brain, Vol 124, No. 9, 1821-1831.

17. Adverse Events Following Pertussis and

Rubella Vaccines, Howson C and Fineberg H, The

Institute of Medicine, Journal of the American

Medical Association, Vol. 267, No. 3, Jan. 15, 1992.

18. Persistent Rubella Infection and

Rubella-Associated Arthritis, Chantler J, et al, The Lancet, June 12, 1982.

19. Is RA27/3 Rubella Immunization a Cause of

Chronic Fatigue? , Medical Hypotheses, 27: 217-220, 1988

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MMR: a systematic review, Jefferson T, et al,

Vaccine 2003, Sept. 8, 21(25-26):3954-3960.

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aluminum-containing DTP vaccines: systematic

review of the evidence, Jefferson T, et al; The

Lancet Infectious Diseases 2004; 4:84-90

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Committee on Nutrition, American Academy of

Pediatrics, Pediatrics Volume 97, Number 3 March, 1996, pp. 413-416.

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Parenteral Nutrition Solutions, Charney P,

Aluminum Task Force, Nutrition in Clinical Practice 19;416-17, August 2004.

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Drug Administration, Document NDA 19-626/S-019,

Federal Food, Drug and Cosmetic Act for Dextrose

Injections. Available online at

<http://www.fda.gov/cder/foi/appletter/2004/19626scs019ltr.pdf>http://www.fda.go\

v/cder/foi/appletter/2004/19626scs019ltr.pdf

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<http://www.fda.gov/ohrms/dockets/98fr/oc0367.pdf>http://www.fda.gov/ohrms/docke\

ts/98fr/oc0367.pdf

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primary cultured neurons and on the aggregation

of beta-amyloid protein, Kawahara M et al., Brain

Res. Bull. 2001; 55, 211-217.

26. Aluminum-adjuvanted vaccines transiently

increase aluminum levels in murine brain tissue,

Redhead K, Quinlan GJ, Das RG, Gutteridge JM.

Pharmacol.Toxico. 1992; 70;278-280.

27. Aluminum impairs the glutamate-nitric

oxide-cGMP pathway in cultured neurons and in rat

brain in vivo: molecular mechanisms and

implications for neuropathology, Canales JJ et

al, Journal of Inorganic Biochemistry, 2001; Nov;87(1-2):63-69.

28. Effects of aluminum exposure on brain

glutamate and GABA systems: an experimental study

in rats, Nayak P, Chatterjee, AK, Food Chem

Toxicology, 2001, Dec:39(12):1285-9.

29. Aluminum neurotoxicity in preterm infants

receiving intravenous-feeding solutions. Bishop

NJ, Morley R, Day JP, Lucas A.,N Engl J Med. 1997 May 29;336(22):1557-61.

30. Neuropathology of aluminum toxicity in rats

(glutamate and GABA impairment), El-Rhaman SS.

Pharmacol. Res. 2003 March:47(3):189-94.

31. MMR vaccine Product Insert, Merck, 2003 and 2007.

32. Vaccines for measles, mumps, and rubella in

children, The Cochrane Database of Systematic Reviews 2005, Issue 4.

33. No evidence for links between autism, MMR and

measles virus, Chen W et al, Psychology Medicine 2004, Apr; 34(3): 543-553.

34. Immunization Safety Review: Vaccines and

Autism, from the Immunization Safety Review

Committee of The Institute of Medicine, 2004.

35. MMR vaccine and autism: an update of the

scientific evidence. DeStefano F; WW,

the Centers for Disease Control,

<http://www.medscape.com/medline/publicationbrowser/123?pmid=14761240>Expert

Rev Vaccines. 2004; 3(1):19-22 (ISSN: 1476-0584)

36.

<http://www.medscape.com/viewarticle/465861>Epidemiology

and Possible Causes of

<http://www.medscape.com/viewarticle/465861>Autism,

Hershel Jick, M.D.; A. Kaye, M.D., D.P.H. Pharmacotherapy, Dec 2003

..

[Guest guest]

Just when I feel confident about my decision not to vaccinate, I read

things like this and it shakes me. I don't have a vaccine injured

child or know anyone who is vaccine injured. I do have a friend whose

sister's baby died after DTP. Sometimes, stuff like this makes me

feel like a conspiracy theorist. My husband is still for getting dd

some vaccines...sigh.

I guess I'll take your classes Sheri and continue to learn.

~Caroline

>

> From Dr. Sears - what I have said all along - he

> does not give you information to show you why not to vaccinate

> He says " In fact, the book encourages parents to vaccinate their

children. "

> Sheri

>

> http://www.askdrsears.com/thevaccinebook/

>

> A Response to Dr. Offit's Misleading and

> Inaccurate Review of The Vaccine Book in Pediatrics, January 2009

>

> On December 29, 2008, Dr. Offit published a

> special article entitled " The Problem With Dr.

> Bob's Alternative Vaccine Schedule " in the

> Pediatrics

>

(<http://www.pediatrics.org/cgi/doi/10.1542/peds.2008-2189>www.pediatrics.org/cg\

i/doi/10.1542/peds.2008-2189).

> Affiliated with the Vaccine Education Center at

> Children's Hospital of Philadelphia and the

> University of Pennsylvania School of Medicine, as

> well as the co-inventor and co-patent holder of

> the RotaTeq vaccine, Dr. Offit has long been

> recognized as a prominent and respected leader in

> vaccine education and research. He has been one

> of the primary spokesmen for the American Academy

> of Pediatric's recent campaign to improve the

> public trust in our nation's vaccination

> policy. I appreciate Dr. Offit taking the time

> to review The Vaccine Book and offer his

> constructive criticisms on it. Dr. Offit and I

> agree on many things, including the opinion that

> vaccines are extremely important and have been

> one of the most valuable public health endeavors in the past several

decades.

>

> I would like to take this opportunity to clear

> the record regarding The Vaccine Book and my own

> professional opinions on vaccines. I believe

> that Dr. Offit has greatly misrepresented the

> overall message of the book as being

> `anti-vaccine.' In fact, the book encourages

> parents to vaccinate their children. In order to

> give parents a complete educational experience,

> while presenting all the `pros' of vaccines I

> felt it was important to list the `cons' as well

> by discussing the potential side effects from the

> vaccine product inserts (while emphasizing how

> rare any severe reactions are). I also discuss

> the reasons why some parents choose not to

> vaccinate so that the readers can understand what

> these parents' issues are. I don't condone such ideas, I simply

present them.

>

> However, I believe that Dr. Offit has

> misconstrued the book's overall message by

> selectively extracting various phrases and

> sentences that discuss anti-vaccine ideas and

> worries that parents have and portraying those

> ideas as my own. He quotes various areas of the

> book that sound anti-vaccine without offering the

> pro-vaccine conclusions that I offer on the

> subject. I will point out such areas in my

> discussion below. I will say that there are a

> couple of small items in the book that Dr. Offit

> points out are in error, and I appreciate that

> clarification he has been able to offer. I will

> discuss these areas, and the changes that I will

> make in the next edition of the book.

>

> I will admit that the book does offer one major

> controversial idea; my alternative vaccine

> schedule. However, it is important to note the

> context in which I offer that advice. At the end

> of the book, I encourage parents to vaccinate

> their children according to the CDC schedule if

> they feel confident in our nation's vaccine

> system. For those parents who, after reading all

> the reasons why vaccines are important in my

> book, still believe vaccines aren't safe and plan

> to not vaccinate, I at least ask them to consider

> getting the most important infant vaccines so

> their babies have protection from the

> life-threatening illnesses (HIB, PC, DTaP, and

> Rota). Where my alternative schedule comes into

> play is for those parents who are still unsure

> about vaccines, but they do want to fully

> vaccinate. I offer them an optional schedule

> that gets their child fully vaccinated, but at a

> slower pace. It doesn't delay any of the most

> important shots, but it slightly delays some

> shots that are for lower-risk diseases. This

> option is really for parents who would otherwise

> leave a doctor's office unvaccinated – parents

> who are too torn to make a decision, and

> therefore often don't make any decision to vaccinate at all.

>

> It is my belief that many families go

> unvaccinated simply because they aren't offered a

> more gradual option. If they were, many would

> vaccinate. I believe this approach would

> actually increase vaccination rates, not decrease

> them as Dr. Offit suggests. I think that is our main area of

disagreement.

>

> The rest of this article will take a look at each

> of Dr. Offit's statements and offer my own view.

> This isn't going to be any sort of " great debate

> over vaccines " because we agree on most

> things. I will point out the parts of his

> article that I agree with, and parts that I

> accept his correction on something that I wrote in error.

>

> Open debate and discussion is healthy in the

> field of medicine. I welcome it, and I'm sure

> Dr. Offit does as well. However, I must take

> issue when a person very clearly misrepresents

> information in my book, selectively quotes

> certain sections out of context, and attributes

> statements and ideas to the book and to myself

> that I never even wrote. Some of these errors

> are so erroneous, it's almost as if Dr. Offit was

> reading some other anti-vaccine book instead of

> mine. The purpose of my response is not to

> determine who's right and who's wrong. It's

> simply a clarification of some false claims made against me.

>

>

> Doctors Do Not Understand Vaccines

> I agree with what Dr. Offit says here, except

> that I think parents want their own personal

> doctor to have a more thorough understanding of

> vaccines. Parents are much more likely to accept

> their doctor's advice if the doctor has a

> complete understanding (or nearly so) of all the

> vaccine issues, side effects, ingredients, safety

> research, and possible drawbacks to a vaccine. If

> a doctor can look a patient in the eye and say,

> " I've spent weeks investigating all these issues

> personally and reviewing all the research myself,

> and, along with the expert backing of the AAP,

> CDC, and ACIP, I believe that the vaccines are

> safe and should be given according to the CDC

> schedule, " that has much more weight than a

> doctor simply saying, " I agree with the AAP, CDC,

> and ACIP that vaccines are safe. " Parents aren't

> automatically going to trust such organizations

> the way we doctors do. They want us to do our

> own homework. Back in the old days when most

> patients simply trusted what doctors said, maybe

> that wasn't necessary. But today's parents want

> more from us. They are asking questions that we,

> as doctors, should be prepared to answer. If we

> are caught off guard by a parent's question,

> because we aren't familiar with a particular

> anti-vaccine argument or a certain vaccine

> ingredient or side effect, the parent will lose trust in us.

>

>

> Public Health Agencies and Pharmaceutical Companies Are Not Trustworthy

> Dr. Offit's words, not mine. I never make this

> statement, nor do I try to imply it. Most

> vaccine books are ripe with anti-pharmaceutical

> company conspiracies. In fact, I tried to steer

> clear of any conspiracy theories in this

> book. Now, when reading the quote he offers from

> the Hep B chapter of the book, in the context of

> first reading the above heading, I can see how

> one could read some " mistrust of the system " into

> my words. But this wasn't my intent, nor is this

> impression given when read within the context of

> my book. In fact, on the next page I state,

> " These researchers were part of a very

> well-respected group – the leaders in their field. "

>

> Now, two of the researchers involved in studying

> Hep B rates in children and helping to create

> neonatal Hep B vaccine policies did work for

> Merck and GSK. Anti-vaccine books love to jump

> all over any researcher who has ties to vaccine

> manufacturers. But I didn't. But now that Dr.

> Offit has questioned this, I will comment. The

> doctors who worked with Merck and GSK and were

> part of the research that recommended Hep B

> vaccination in infants could be the most

> honorable, dedicated, unbiased doctors in the

> world. I've never met them. But in medical

> school we are taught to at least briefly raise an

> eyebrow at research funded by a pharmaceutical

> company, instead of simply taking it for

> granted. I will emphasize that while I did that,

> I didn't do so based on their pharmaceutical

> ties. I simply wondered about the findings in

> the research. While some people might question

> the motives of and advice given by any doctor

> with financial ties to the vaccine industry, I

> refrain from doing so in my book.

>

> Parents look at Hep B vaccination for their

> newborn and wonder, " Why? " Many pediatricians

> that I've talked to do as well. If Hep B is a

> potential risk to children through non-sexual

> casual contact, then vaccination would be a

> no-brainer. While writing my book I tried to

> find proof that non-sexual spread of Hep B is a

> significant risk to babies so that I could advise

> parents to vaccinate right away. But as a

> pediatrician, I've never seen it occur. And I've

> only heard of one case publicized in the media –

> an infected child sneezed on a teacher's hand,

> and the teacher contracted Hep B through a cut on

> her hand. I'm sure there are many more such

> cases. But really, 16,000 kids each year less

> than 10 year old? Am I the only doctor that

> wonders whether or not that's true?

>

> I went straight to the source of disease data –

> the MMWR 2002 – to see what the actual reported

> cases of Hep B used to be in children younger

> than 10 years of age (Reference 1) and found that

> during the late 80s and early 90s, prior to

> introducing Hep B vaccine to infants, there was

> only 1 case of Hep B per 100,000 children age 0

> to 9 in the U.S. (see chart at the end of the

> MMWR report). With 36,000,000 children in the

> U.S. in that age range, that only comes out to

> about 360 cases per year. The chart doesn't

> differentiate between the perinatal exposures and

> accidental exposures. I know that some childhood

> Hep B infections will go unrecognized for many

> years, but I just can't believe with such a low

> number of reported cases that the estimates of

> 16,000 cases per year can even be close.

>

> The study that Dr. Offit refers to, as well as

> every other study done during the late 80s and

> 90s that looked at Hep B in young children,

> doesn't actually determine the rate of Hep B by

> direct study or by reported cases (References 2 –

> 5). These studies provide estimates using

> population statistics. They look at adult cases,

> and estimate what percentage of those may have

> come from non-sexual contact during childhood,

> and make a logical guess at what the rate in

> children might be. Well, in order to really

> determine the rate of Hep B in children (to see

> if infant vaccination is warranted), all one

> would have to do is screen several thousand

> children for the disease and see how often it

> shows up. Then repeat the study again with a

> larger group. That's what should have been done

> decades ago prior to introduction of the

> vaccine. The study could be done today on

> children who have skipped the vaccine. What hasn't anyone simply

done that?

>

> I have no doubt that Hep B vaccination is

> important, especially for pre-teens. And because

> there may be some small risk of non-sexual

> exposure to the disease during childhood,

> vaccinating during childhood may be important as

> well. I state this very clearly in the

> book. But does it have to be given right away

> during the neonatal period? For any family with

> a Hep B positive family member, yes – each baby

> should be vaccinated. But for the other 99% of

> American families, I don't believe the vaccine

> needs to be given to young infants, especially in

> the hospital. Why give a less-than-necessary

> vaccine to a newborn and risk creating

> sepsis-like side effects (Reference 6 and

> 7)? Any family that asks to delay this vaccine

> shouldn't be treated like they are crazy. They

> simply want to give their newborn a break for the first few weeks.

>

> As for the issue regarding parents' trust in the

> vaccine manufacturers, that trust was severely

> shaken when it was revealed in the Los Angeles

> Times on February 8, 2005, that way back in 1991

> a researcher at Merck sent a memo to the

> president of Merck's vaccine division stating

> that they had just realized that the cumulative

> amount of mercury in vaccines given to infants by

> six months of age was about 87 times the safety

> limits set by the FDA. And that information was

> not revealed to the public until 8 years

> later. Now I realize that pharmaceutical

> companies do so much good for our health and the

> field of medicine, and that such negative

> occurrences are rare. As a pediatrician I put my

> trust in them everyday by prescribing their

> products, including Merck vaccines, to my

> patients. But I find it surprising that any

> doctors can fault a parent for not completely

> trusting Merck after that, or the FDA and CDC

> departments that were supposed to be overseeing this type of issue.

>

>

> Vaccine Mandates Should Be Eliminated

> I don't make any claim that unvaccinated children

> have been taken away from the home. I state that

> I have heard " rumors " of such, but that I don't

> believe them. I do believe, however, that some

> states may actually have that power by law, but I

> doubt it has ever been exercised. You may recall

> the recent court battle this year on the East

> Coast in which parents were refusing the Hep B

> vaccine for their teenagers. The parents were

> threatened with jail time if they didn't either

> sign the religious waiver or comply with

> vaccinations. I don't know if anyone was ever

> jailed, but that is a really scary thing to have

> occurred in our free country. I agree with Dr.

> Offit that in the event of an outbreak that

> significantly puts the public health at risk, the

> state should have some authority to step in. But

> during the normal course of life, I believe that

> parents should have the right to decline vaccines.

>

>

> Vaccine-Preventable Diseases Are Not That Bad

> This is a prime example in which Dr. Offit has

> taken one statement out of the book and portrayed

> my viewpoint inaccurately. I clearly state how

> bad each disease can get as well as the number of

> yearly fatalities. At the very beginning of the

> PC chapter I share how serious PC disease is. I

> also state at the very end of that chapter that I

> consider PC " a fairly important vaccine. " At the

> end of each chapter I share any personal

> experiences I have had as a pediatrician with

> each disease, and this was the only one I've had

> for invasive PC. At the end of the book I

> strongly urge parents who are thinking of

> skipping vaccines to at least consider PC vaccine

> (as well as a few others). On my website, I

> dispel a myth that's been going around that the

> PC vaccine is no longer important, and is causing

> other emerging strains, and I urge parents to

> continue getting the current PC vaccine until an

> expanded one comes available.

>

> A word of thanks to Dr. Offit on this issue for

> pointing out that I could perhaps improve on my

> disease descriptions in the book. In the next

> edition I am planning to add a section on each

> disease that paints a picture of " a typical

> course of this disease " , then a " worst case

> scenario of the disease. " Dr. Offit is

> absolutely correct. Parents should know how bad each disease can be.

>

>

> Hide in the Herd

> I agree with Dr. Offit here. Herd immunity is

> very important. I state the argument in the book

> that " the good of the many outweighs the good of

> the few. " Nowhere in the book do I encourage

> parents to " hide in the herd. " Again, Dr.

> Offit's words, not mine. I clearly state (as Dr.

> Offit quoted) the danger to our country if too

> many people don't vaccinate. My comment on " not

> sharing your fears with your neighbors " was an

> attempt at humor, while trying to teach a very important point.

>

>

> Natural Infection Is Better Than Vaccination

> Again, what book is Dr. Offit reading? Not

> mine. I describe chickenpox parties in the book,

> but I certainly don't recommend them. Notice the

> " . . . " in Dr. Offit's quote here. The entire

> quote is " Some parents actually want their kids

> to catch chickenpox. They may purposely get

> their child exposed to get the disease over

> with. " I'm simply stating what some parents

> do. Not what I think they should do. As for the

> risk of acquiring natural immunity to a disease,

> I agree with Dr. Offit. It is a risk. And I

> clearly state what that risk is for each disease.

>

> A very popular anti-vaccine argument is that

> childhood diseases are healthy. They exercise

> the immune system. Other authors encourage

> parents to allow their kids to catch many of

> these diseases. I couldn't disagree more. My

> book tries to dispel that myth. No one wants to

> exercise their baby's immune system with

> meningitis or hep B, or most of the other vaccine-preventable diseases.

>

>

> Vaccination Has Eliminated Infectious Diseases at

> the Price of Causing Chronic Diseases

> I never even come close to saying any such thing

> I my book. Allow me to quote from page 178:

> " Critics [of vaccines] worry that many chronic

> diseases and other physical and mental problems

> like ADHD, chronic fatigue, diabetes, allergies,

> asthma, learning disorders, and autism are

> triggered by vaccines. I haven't found any solid

> research to support this

> contention. " Interestingly, this is the very

> sentence that precedes Dr. Offit's quote

> here. As Dr. Offit points out, I go on to say I

> found studies that show a " possible link, " but

> that's it. I actually go out of my way to debunk

> the myth described in the heading above. By the

> way, the peer-reviewed journals that discuss

> " possible links " include Revue Neurologigue,

> Rheumatology, British Journal of Rheumatology,

> Journal of Rheumatology (that's a lot of

> rheumatology!), Lancet, Neurological Science,

> Scandinavian Journal of Rheumatology, Acto

> Dermato-venereologica, Autoimmunity, Journal of

> the American Academy of Dermatology, and Clinical

> Rheumatology, Journal of Allergy and Clinical

> Immunology. See References 8 through 19.

>

>

> Vaccine Safety Testing Is Insufficient

> I don't say that safety testing is

> insufficient. Again, Dr. Offit left out some of

> the words in his quote. I start this particular

> chapter with a discussion of the extensive

> short-term research that is done with each new

> vaccine, describing the research in a similar way

> that Dr. Offit states here in his article. As

> for his quote from my book, the entire text

> reads: " A new medication goes through many years

> of trials in a select group of people to make

> sure it is safe. These subjects undergo extensive

> blood testing and physical evaluations over many

> years. If nothing severe or common shows up, the

> medication is then released for general

> use. Vaccines, on the other hand, don't receive

> that same type of in-depth short-term testing or

> long-term safety research . . . Their blood isn't

> tested to check for internal toxic effects.

> Doctors don't do physical exams to look for

> problems. " My point here is that the short-term

> research could be more hands-on, instead of simply by parent

questionnaires.

>

> I agree that vaccine safety testing is very

> extensive, and in my mind it is very

> adequate. What we could improve is the long-term

> safety research. Dr. Offit points out how VAERS

> and VSDP are model systems for detecting rare

> adverse events. A few paragraphs down, however,

> under " Risks From Vaccines, " he states (somewhat

> contradictorily, if that's a word) " VAERS is a

> passive surveillance system and cannot be used to

> determine the true incidence of adverse events,

> which can be determined only by using control

> groups. " I couldn't agree more. We need a large

> placebo group of voluntarily unvaccinated kids to

> compare to the vaccinated population. I think

> that we will see that in the upcoming National Children's Health Study.

>

> But back to " insufficiency " of safety

> research. In the book I refer to a statement

> made by the Cochrane Collaboration in Vaccine

> 2003 (Reference 20) regarding a review of 22

> studies on MMR vaccine safety: " the design and

> reporting of safety outcomes in MMR vaccine

> studies, both pre-and post-marketing, are largely

> inadequate. " Their words, not mine.

>

>

> Public Health Officials Make Recommendations for

> the Public and Not for Individuals

> I'm pouring through the book right now trying to

> find where I may have made such a statement, and

> I just can't find it. Hmmm. What I do believe

> is that Public Health Officials view vaccine

> issues from two sides – the risk to individuals

> as well as the risk to our nation as a

> whole. Parents, on the other hand, tend to make

> decisions based on their own individual child,

> without considering the public's benefit. I also

> state in the book that such a decision is perhaps " selfish. "

>

> As for the polio vaccine, Dr. Offit fails to

> include other quotes from the book that state the

> importance of the polio vaccine: " I consider this

> vaccine very important from a public health

> viewpoint. Until the whole world is polio free,

> ongoing vaccination will help keep our nation

> protected . . . (page 79). " Because there

> haven't been any cases of polio in the U.S. for

> decades, I do believe it is correct to say that

> we don't use this vaccine to protect each

> particular child from catching the disease (as

> compared to every other vaccine we use). Rather,

> we use it for herd immunity. I agree with Dr.

> Offit that " every individual benefits from

> receiving polio vaccine. " There is no " flaw in

> logic " here. We are both saying the same thing.

>

>

> Decision-Making

> You know, I do suppose it was a little

> presumptuous of me to state that " I have offered

> you all the information you need to make this

> decision. " That would imply by book is 100%

> complete. No book is. I should have said, " I

> have given you almost all the information . .

> . " As for misinformation, I'm still waiting for some here.

>

> Distinguishing Good Science From Bad Science

> Because the science on vaccine safety is not

> complete, and never can be, I didn't undertake

> the very tedious task of detailing every

> scientific study there is. Who would read such a

> book? This is a book for the general

> public. Where I state " Reasons some people

> choose not to get the vaccine, " I clearly state

> the risks that such parents are taking.

>

> I will take this opportunity for the second time

> to state my appreciation for an oversight pointed

> out by Dr. Offit. I really should have

> delineated which studies come from a

> peer-reviewed (mainstream) journal and which do

> not. This is very important, so parents can

> decide whether or not a particular study holds

> any weight. This will be corrected in the next edition of the book.

>

>

> Risks >From Vaccines

> Once again, I am respectfully thankful for this

> constructive criticism. Dr. Offit is right. We

> shouldn't view reported reactions in VAERS as

> actual vaccine reactions, and I shouldn't have

> used such numbers to determine statistical

> risks. I do, however, point out in the book that

> we don't know that VAERS reports are actual

> vaccine reactions. The problem is, that's the

> only system I have to try to determine what the

> risk of a vaccine reaction might be. I think

> parents deserve to know that. Until we have an

> active surveillance system, instead of a passive

> one, we won't know what that risk is. I could

> also add that VAERS only contains reactions that

> are reported. Many reactions go unreported. So,

> even if only some of the VAERS reactions can be

> attributed to the vaccine, not all such reactions

> are actually reported. So, my numbers may

> reflect something close to reality. But that's

> not scientific. We really need to take a better look at this.

>

>

> Risks >From Vaccine-Preventable Diseases

> Wow. I am now convinced that we are not talking

> about the same book here. I not only make it

> very clear what the risks are from each disease,

> allow me to quote from the meningococcal vaccine

> chapter's list of reasons to get this vaccine:

> " Obviously, meningitis is devastating. Getting

> the shot during the early teens protects a child

> . . . the chance that a college freshman in a

> dorm could catch it is something to consider. In

> the chapter's conclusion: " No one can argue that

> MC disease isn't a horrible thing to see, much

> less to actually catch. " That sentence precedes

> the one quoted by Dr. Offit here. Yes, I do

> comment on the GBS issue, as that was brand new

> information when the book came out. I state " If

> experts can determine that the risk of GBS is

> negligible, the shot will likely become more

> widely accepted. " I also predicted that it will

> become approved for two-year-olds, and state

> " this will become a very important vaccine, since

> the disease is more common in younger

> children. " I comment on GSK's combo of HIB and

> MC vaccine for 2, 4 and 6 month olds (currently

> undergoing trials) and state " this vaccine will

> provide much-needed protection during infancy,

> when MC disease is most common. " I also describe

> MC disease (page 137) as " . . . extremely

> serious. This is probably the single most serious

> and potentially deadly of all vaccine-preventable

> diseases. " I go on to describe in detail the

> likely ICU course, with organ fairly and likely

> permanent disability. Even though I fortunately

> don't get the " see much of this evil " , I certainly describe it in

the book.

>

>

> Animal Products

> I didn't raise the specter of Mad Cow

> Disease. That's a ploy found in many

> anti-vaccine books, and I state that this is an

> issue the critics often bring up. Dr. Offit is

> right, I should have mentioned that we don't use

> " mad cows " in the U.S., but I though everyone already knew that.

>

> Dr. Offit failed to mention the one time when a

> viral disease did contaminate a vaccine. And

> this was no small deal either. I open Ch. 16

> with this info. In August of 2002 and February

> of 2003, the pediatric newspaper Infectious

> Diseases in Children published reports of SV-40

> viral contamination of millions of doses of polio

> vaccine due to the use of monkey kidney tissues

> used to make the vaccine. It was estimated that

> almost 30 million people were injected with

> vaccines containing this virus between 1955 and

> 1963. Also, in 1980, 150 newborns will given an

> experimental Hep A vaccine that was contaminated

> with SV-40 virus. This virus has been linked to

> several human cancers, although fortunately the

> people injected with this virus haven't been

> found to have higher than expected rates of

> cancer. Now we know to screen for this virus.

>

> I find it peculiar that Dr. Offit portrays my

> book as raising the specter of mad cow, but

> completely leaves out the SV-40 virus

> problem. It's not a problem anymore, but I use

> it as an example of what happened in the past. I

> state that vaccine critics worry that " unknown

> infectious particles or . . . foreign DNA in

> [human and animal] tissues may cause problems . .

> . " I end the section with " At this time, I can't

> offer any good evidence to support these worries . . . "

>

>

> Thimerosal

> Actually, the whole point of my two-page

> discussion on thimerosal is that it has been

> removed from virtually all vaccines, so you

> really don't have to spend hours researching

> whether or not it is harmful. I save the

> parents' time by making it a non-issue. Going

> back and reviewing all the research is a moot

> point for parents deciding about vaccines

> today. I actually thought that I was doing a

> great service by dispelling this myth. I guess not?

>

>

> Aluminum

> Ok. Aluminum is a very complicated issue. It

> really deserves its own article. In order to

> provide you with a full discussion on aluminum, I

> am posting that section from the book on my

> website in the FAQ section on the right. I ask

> you to not pass judgment until you've read the

> whole thing. I don't use the 2002 Vaccine study

> in my book. Instead I use the 2004 Lancet study

> from the Cochrane Collaboration for a thorough

> review of aluminum (Reference 21). For those of

> you who don't read the entire aluminum section of

> the book, here is the bottom line. We know

> aluminum is a neurotoxin. We also know that

> humans can ingest huge amounts without harm,

> since 99% of it passes out through the

> stools. I'm sure Dr. Offit knows that, so I'm

> curious as to why he'd use the " babies ingest

> tons of aluminum anyway " argument. I would also

> point out that the conclusion of the study that

> Dr. Offit refers to doesn't say anything about

> proving that aluminum is safe. It simply

> concludes that the amount in vaccines didn't

> warrant changing the schedule. Those are two

> completely different statements.

>

> I've been searching and searching for human

> infant studies that determine what a safe level

> of injected aluminum is, including looking at all

> the studies used in the article quoted by Dr.

> Offit, and I can't find a single one. There is a

> lot of animal research, a lot of studies that use

> theoretical mathematical models, and one human

> adult study, but not a single human infant study

> (see Resources 22-30). As a precaution, I show

> worried parents how to take precautions to limit

> their baby's aluminum dosing during

> vaccinations. This allows these parents to

> vaccinate, instead of declining them all.

>

>

> Other Vaccine Ingredients

> Up until December 2007, the albumin used as a

> growth medium for the MMR viruses was human

> albumin filtered out of human blood. The PI

> described how the human albumin is screened for

> the absence of adventitious agents, and processed

> using the Cohn cold ethanol fractionation

> procedure. In December 2007, the MMR PI changes

> its description of the albumin to

> recombinant. Dr. Offit makes it sound as if I'm

> misleading my readers and printing false

> information, when in fact my information was

> correct in October 2007. I appreciate him

> highlighting this change, however. It's good to

> see Merck moving away from using a human blood

> product. Not that this was a problem – the

> albumin was carefully screened and filtered. Reference 31.

>

>

>

> MMR Vaccine and Autism

> Actually, in the book I describe in detail six

> studies that showed no link between MMR and

> autism (References 32-37). As for the MMR

> vaccine/intestinal inflammation/autism theory

> being debunked, I would now agree with Dr.

> Offit. At the writing of my book, however, no

> one had yet repeated Dr. Wakefield's work to

> prove him wrong. As of this year, a very well

> done study by Harvard, Columbia, Mass General,

> CDC, and the AAP has (Reference 38). I have

> written an update to this effect on my

> website. My initial worries about the MMR and

> intestinal inflammation are probably unfounded.

>

>

> Coincidence Versus Causality

> Again, it sounds like myself and Dr. Offit mostly

> agree here, although for some reason my agreement

> with him would be viewed as " poorly reasoned or

> illogical. " One can't simply group all reported

> reactions into two groups: either proven to be

> caused by a vaccine or proven to not be cause by

> a vaccine. There are so many reported reactions

> that haven't been proven one way or the other

> through scientific study. This is a third

> category, and as further research is done we will

> place each reaction in one of the first two

> categories. But until that is done, parents can

> only view these reports as somewhere between coincidence and causality.

>

>

> Scientific Proofs

> I agree. This is not a sound scientific

> argument. I just really wish we could prove a

> vaccine doesn't cause a particular

> reaction. Parents could then worry a lot

> less. Although we can't prove a negative, we can

> improve the long term safety research of vaccines

> so parents can be more confident.

>

>

> Context

> We've already covered this. As for the flu shot,

> here's my opinion. Because mercury is a known

> neurotoxin, all the science in the world won't

> convince many parents to give their baby a

> mercury-containing flu shot, especially when they

> have the option to get a non-mercury version. I

> completely agree with Dr. Offit's statement that

> the science shows no evidence that the amount of

> mercury in a flu shot causes any harm. But I

> just don't think that parents believe it.

>

>

> Understanding Risk

> I understand the risk of MC disease as well as

> any doctor, and I very clearly recommend this

> vaccine in my book: " Obviously, meningitis is

> devastating. Getting the shot during the teen

> years protects a child through high school and

> college . . . There are about 250 teen and

> college-age cases each year. The ingredients are

> among the purest and simplest of all vaccines . .

> . " I do discuss how the reported GBS reactions

> may worry some parents, and may cause dome

> parents to delay the vaccine. But never do I say

> not to get the vaccine: " . . . this vaccine is an

> important step in eliminating or at least

> minimizing the disease among our nation's teens .

> . . " I also give a very strong recommendation in

> favor of it's use in younger children if it

> becomes approved for that age group. I don't

> understand how Dr. Offit could misconstrue my

> statements to say that I don't recommend this

> vaccine. I agree that the risk of GBS is much smaller than the

disease risk.

>

> The Harm

> In my selective schedule, I don't tell parents

> not to get the MMR, VZ, Hep A, Polio, and Flu

> shots. That's their decision. This schedule is

> designed to encourage non-vaccinating families to

> at least get their baby the DTaP, Rota, PC, and

> HIB vaccines, and their teens the HPV and Hep B vaccines.

>

> Dr. Offit makes an incorrect statement regarding

> my alternative schedule. He says that children

> using this schedule won't be getting a flu shot

> until age 5. On page 236, the flu is very

> clearly listed as a recommended vaccine starting

> at 6 months and continuing through to age five,

> so I'm not sure exactly what book Dr. Offit was looking at. Not mine.

>

> My alternative schedule isn't necessarily what I

> recommend parents do. In the book (page 235), I

> encourage parents who trust in our country's

> vaccine system and safety, as recommended by our

> nation's top medical experts and almost every

> doctor, to go ahead with the regular vaccine

> schedule. " I recommend that you trust your

> doctor's advice, and your own intuition, and go ahead with vaccination. "

>

> The alternative schedule is designed for parents

> who are worried about grouping so many shots

> together. That is the single most common worry

> I've heard from parents over the years. They

> want to fully vaccinate, they just want to do it

> at a slower pace. But up until now such parents

> haven't had any guidance on how to do

> this. These are parents who otherwise may not be

> vaccinating, or if they do they are cringing and

> scared about doing it. Parents should feel

> secure and confident in their vaccine

> choices. Yes, this schedule is a lot more time

> consuming and more work for the parents and the

> doctor's office. It certainly wouldn't be a

> reasonable or practical vaccine schedule for our

> country as a whole. Babies would fall behind on

> their shots, compliance would wane, and some

> could be susceptible to what should be a

> vaccine-preventable disease. I agree with Dr.

> Offit there. My alternative schedule is simply

> an option for parents who want to take the extra

> time and effort. It's just an option. I worry

> that if doctors don't offer an option like this,

> some patients will go unvaccinated, and that's

> not good. I believe this schedule will increase

> vaccination rates among non-vaccinating families.

>

> The only vaccines that my alternative schedule

> delays to any extent are polio (until 9 months of

> age), Hep B (until 2 ½ years) and Measles (until

> age 3). This is virtually no risk involved in

> delaying the first two, but I agree with Dr.

> Offit that delaying measles vaccine is a risk,

> especially for a child in daycare or with older

> siblings. On my website, I encourage such

> families, and any family who is worried about

> measles exposure, to vaccinate for measles sooner.

>

>

> Conclusion

> The manner in which Dr. Offit has portrayed my

> book is erroneous and misleading. A more

> accurate discussion of the book would have been

> much more constructive. As a fellow pro-vaccine

> doctor, if my book had been portrayed correctly,

> we would find very little to debate about. I

> would expect colleagues within the AAP to have

> more respect for each other and double and triple

> check to make sure something printed in the

> Journal of Pediatrics wasn't so riddled with

> selective, misleading, and inaccurate

> quotes. The number one area that we don't agree

> on is whether or not we should offer

> non-compliant parents some selective or

> alternative options. By doing so, do we increase

> or decrease vaccination rates among such

> families? That's the main question. There is so

> much to talk about when it comes to vaccines and

> how to regain the nation's trust in the

> system. This type of article further damages that trust.

>

> You can find this article posted online tonight

> at <http://www.thevaccinebook.com/>www.TheVaccineBook.com

>

>

> References:

>

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>

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<http://www.fda.gov/cder/foi/appletter/2004/19626scs019ltr.pdf>http://www.fda.go\

v/cder/foi/appletter/2004/19626scs019ltr.pdf

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>

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> 31. MMR vaccine Product Insert, Merck, 2003 and 2007.

>

> 32. Vaccines for measles, mumps, and rubella in

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>

> 33. No evidence for links between autism, MMR and

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>

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>

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<http://www.medscape.com/medline/publicationbrowser/123?pmid=14761240>Expert

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> 36.

> <http://www.medscape.com/viewarticle/465861>Epidemiology

> and Possible Causes of

> <http://www.medscape.com/viewarticle/465861>Autism,

> Hershel Jick, M.D.; A. Kaye, M.D., D.P.H. Pharmacotherapy, Dec

2003

>

>

>

>

> .

>

>

>

[Guest guest]

Exactly... I was a bit baffled as to why Offit would spend energy and

time fighting this particular battle. Trying to debunk another

pro-vax doc? His arrogance amazes me.

On Tue, Dec 30, 2008 at 7:17 AM, Sheri Nakken <vaccineinfo@...> wrote:

> From Dr. Sears - what I have said all along - he

> does not give you information to show you why not to vaccinate

> He says " In fact, the book encourages parents to vaccinate their children.

> "

> Sheri

>

> http://www.askdrsears.com/thevaccinebook/

[Guest guest]

He can't have any aspect of vaccines questioned, even by someone who is on his

side! After all, if people picked and chose which vaccines to get, they might

skip the ones he has patents on (or does he not have the patent on the latest

rotavirus one?)

It's almost comical that these fools don't realize that more people would

vaccinat if there were more flexible philosophical exemptions, and more

acceptance by the peds to " alternate schedules. " People wouldn't be stuck with

all or nothing, then choosing nothing and discovering that, in fact, they're

healthier than ever. Plus, Offit-types invite distrust--which tends to really

annoy people into publicly fighting back. And now he's raised the ire of Dr.

Bob! I love it.

Winnie

Re: Dr Bob Sears' response to Dr Offitt and Pediatrics

Vaccinations

> Exactly... I was a bit baffled as to why Offit would spend

> energy and

> time fighting this particular battle. Trying to debunk another

> pro-vax doc? His arrogance amazes me.

>

>

>

>

>

> On Tue, Dec 30, 2008 at 7:17 AM, Sheri Nakken

> wrote:

> > From Dr. Sears - what I have said all along - he

> > does not give you information to show you why not to vaccinate

> > He says " In fact, the book encourages parents to vaccinate

> their children.

> > "

> > Sheri

> >

> > http://www.askdrsears.com/thevaccinebook/

>

[Guest guest]

Exactly - " the my way or the highway " approach never goes over too

well with anyone. They are really shooting themselves in the foot

with this tactic.

Sylvia

> > > From Dr. Sears - what I have said all along - he

> > > does not give you information to show you why not to vaccinate

> > > He says " In fact, the book encourages parents to vaccinate

> > their children.

> > > "

> > > Sheri

> > >

> > > http://www.askdrsears.com/thevaccinebook/

> >

>

>

>