Rep. Dave Weldon's Keynote Address/Autism One

[Guest guest]

“Something is Rotten, But Not Just In Denmarkâ€

Remarks of Rep. Dave Weldon, M.D. (R-FL) Autism One Conference

Chicago, Illinois May 29, 2004

It is a pleasure to be here with you today. I am pleased to see that the Autism

community ismore united today than they have ever been. I have said repeatedly

that the Autism Communityis the 900-pound gorilla that has not had its voice

heard adequately on Capitol Hill.

That is largely due to the endless demands on your time, effort, emotions, and

money in caringfor the unique needs of your children. There is little left to

engage the public at large and theCongress in particular. I see that

changing. Certainly, last week’s Institute of Medicine “report†has had

one positive effect, it has united and reinvigorated you and the parents of

autistic andvaccine injured children across this nation.

I want to make it clear that I support vaccinations. My 5-year-old son has had

all of hisvaccinations. Someone in the media last week tried to portray me as a

“vaccine skeptic.†Afterreviewing my record on this issue and all of my

statements in the past, the newspaper printed a retraction. This however,

seems to be part of a pattern – to vilify those who simply ask if ourvaccines

could be safer.

Friends, I practice what I preach. I support vaccinations and gave them to

thousands of mypatients and my own son. However I also believe it is

appropriate to acknowledge that, like withany medical intervention, different

individuals respond differently. We are all unique, we all have a different

genetic makeup, and what may cause no harm in one individual just might

causeharmful in another.

Since we established the vaccine compensation program in the late 1980s several

thousandindividuals have been compensated for vaccine injuries. We know there

are adverse reactions,and I believe it is important that we dedicate resources

to better understand why some children have them.

For too long, those who run our national vaccination program have viewed those

who have adverse reactions, including those with severe adverse reactions, as

the cost of doing business.Furthermore, the vaccine compensation program which

was designed to be a no-faultcompensation system has become so adversarial that

only the most obvious of cases receive compensation and too many parents feel

that the program is not worth the agony.

The questions that I have raised and continue to raise about vaccines are

several. The number one question has been whether neurological problems were

caused in some children by the highlevels of mercury contained in many vaccines

in the 1990s. Mercury is a neurotoxin. And, in the 1990s children – infants

and unborn children – were exposed to significant amounts of mercuryat the

most critical point of their development.

Is the Autism community united now in their effort to see that research into the

possibleassociation between vaccines and neurodevelopmental disabilities is

investigated? You bet!

Autism One, Defeat Autism Now, Cure Autism Now, Unlocking Autism, The Autism

Society ofAmerica, Unlocking Autism, Moms Against Mercury, The National Autism

Association,No Mercury, and The National Alliance For Autism Research have all

expressed objections to the IOM report and have united behind the need to

ensure that the federal government commitsthe necessary research to fund the

biological and clinical research needed to get at the facts.

Just what is so wrong with the IOM report? What has caused all of the Autism

groups to uniteagainst the IOM?

In my 10 years of service in the US Congress, I have never seen a report so

badly miss the mark.I have heard some weak arguments around Washington and I

can tell you that those in the IOM’srecent report are very weak. Examine

this report in detail. It is plagued with serious flaws.

On January 15 of this year I wrote Dr. Gerberding, the Director of the

CDC, I asked her topost-pone the February 9, IOM meeting and this report

because of my concern that this was notan exercise in discovering the truth but

was instead a meeting “being driven by a desire to shortcircuit important

research and draw premature conclusions. If the purpose of this meeting is

toseriously consider and address these concerns†I wrote, “then this will

not be accomplished.â€

Allow me to quote further from my letter to Dr Gerberding:

“It appears to me not only as a Member of Congress but also as a physician

that some officials within the CDC’s NIP may be more interested in a public

relations campaignthan getting to the truth about thimerosal.â€

“Pressing forward with this meeting at this time, I believe, will further

undermine thecredibility of the Centers for Disease Control (CDC) on matters of

vaccine safety and dodamage to the reputation of the IOM. I believe the

proposed date of this meeting, which you have the ability to change, is in the

best interests of no one who is seeking the truthabout a possible association

between vaccines and neurodevelopmental disorders,including autism.

In a follow-up telephone conversation to me on February 3, 2004, Dr. Gerberding

assured methat the IOM’s February meeting was “not an attempted draw

conclusions†but merely to “updateon the science†of where we are at this

point in time. However, it clearly draws conclusions and in what is perhaps

the greatest outrage it goes further to call for a halt to all further

research.

A public relations campaign, rather than sound science, seems to be the M.O. of

the officials at the CDC’s National Immunization Program (NIP) office. Why

do I say this? Let’s look, not onlyat the timing of the IOM meeting in

February, the content of the IOM report, but also at studies the IOM used as a

basis for their decisions. The IOM bases their decision almost entirely on

five 3 epidemiology studies, all of which were conducted by researchers with an

interest in not findingan association, all of which have short-comings, and all

of which the IOM declares would missan association if it were in a genetically

susceptible subset of children.

Not only the timing of the IOM meeting raises suspicions, but also the narrowing

of the scope ofinquiry, and the emphasis IOM was to assign to epidemiology.

In 2001, the Institute of Medicine concluded that “exposure to

thimerosal-containing vaccinescould be associated with neurodevelopmental

disorders.†The IOM also recommended thatchildren not be given

mercury-containing vaccines. What was the response of the CDC? For this most

recent report they narrowed the IOM’s scope to looking just at Autism. Does

thatsound like an agency interested in understanding whether or not thimerosal

might be harmful, tosome children? Or, does this response lead one to conclude

that they are more interested in designing something to reassure an

increasingly skeptical public?

Unlike 2001, this time the IOM was directed by CDC to only consider the possible

relationship between thimerosal and Autism, rather than NDDs as a whole.

Anyone familiar with theVerstraeten study knows exactly why the IOM’s scope

was narrowed – because the 2003 Verstraeten study found associations between

thimerosal and NDDs and some children with autism may have been misdiagnosed as

having speech or language delay.

By narrowing the scope – which largely went unnoticed by the media – the CDC

has avoided acknowledging that thimerosal very well may have caused NDDs in

some children. This latest IOM report is simply part of a P.R. campaign in my

view. Would we not have had a much moreproductive report if the CDC had

updated the research on possible associations between thimerosal and NDDs as a

whole.

In evaluating thimerosal’s relationship to Autism, the IOM relies almost

exclusively on five epidemiology studies. The principal authors of all five

studies have serious conflicts of interest.All five studies were published in

2003 leading up to the IOM’s February 2004 meeting. Allwere conducted while

the CDC and NIH virtually ignored the IOM’s 2001 biological and clinical

research recommendations.

It is critical to note the instructions that the IOM was given, primarily by the

CDC, which has been funding the IOM. Pages 5 and 6 of the IOM report make it

clear that epidemiology was toreign supreme. In the absence of epidemiological

evidence to support causality, IOM wasinstructed to give biological evidence

little consideration, and was prohibited from allowing biological evidence to

lend evidence toward causality.

Is it any wonder that the CDC has spent the past two years dedicating

significant funding to epidemiology while starving funding for clinical and

biological research? The IOM notes intheir report that the epidemiology

studies they examined were not designed to pick up agenetically susceptible

population. Yet, they attempt to use these five flawed and conflicted

statistical studies to quash further research into the possible association

between vaccines andautism. This report is extreme in its findings and

recommendations. The IOM process becamelittle more than an attempt to validate

the CDC’s claims that vaccines have caused no harm,

while quashing research to better understand whether or not and how the MMR or

thimerosalmight contribute to the epidemic of neurodevelopmental disorders,

including autism.

I would like to turn now to the specifics of these five studies.

Verstraetn Study – Pediatrics, November 2003

The Verstreaten study has been the subject of considerable criticism. This

study, published inNovember 2003 in Pediatrics the journal of the American

Academy of Pediatrics was releasedwith much fanfare and public relations

“spin.†Much has been written exposing the study’s methodological

problems, findings, and conclusions. Most importantly however, is that

thisstudy did not compare children who got thimerosal to those who did not.

Instead, its CDC-employed authors focused primarily on a dose response

gradient.

In addition to the study itself, it is important to note the public relations

“spin†surrounding this study.

On the day the Verstraeten study was released, a top CDC researcher and a

coauthor of the study was quick to declare to the news media that, “The final

results of the study show no statisticalassociation between thimerosal vaccines

and harmful health outcomes in children, in particularautism and

attention-deficit disorder.†Let me repeat that, “The final results of the

study show no statistical association between thimerosal vaccines and harmful

health outcomes in children, inparticular autism and attention-deficit

disorder.â€

The newspaper headlines of the day read:

• “Study Clears Vaccines Containing Mercury†Associated Press and USA

Today,

• “CDC Says Vaccines are Safe...†The Seattle Times

While that was the spin of the day, allow me to quote from the study. “... we

found no consistent significant associations between TCVs [thimerosal

containing vaccines] andneurodevelopmental outcomes. In the first phase of

our study, we found an association between exposure to Hg from TCV and some of

the neurodevelopmental outcomes screened. In thesecond phase, these

associations were not replicated for the most common disorders in anindependent

population.†They did find associations, but as they changed the study most

of the associations, but not all, disappeared.

Furthermore, in a January 2004 article this lead co-author was forced to admit

that many children in the study were too young to have received an autism

diagnosis. He went on to admit that thestudy also likely mislabeled young

autistic children as having other disabilities thus masking thenumber of

children with autism.

The message from the CDC to media was that there is nothing to be concerned

about, but thestudy said something somewhat different. The news media too a

large degree took the CDC’sspin hook, line, and sinker, and largely chose not

to read the study itself.

Five months after the article was published, and largely after the IOM report

had been written,the lead author of the study, Dr. Verstraeten broke his

silence in a letter to Pediatrics stating: “The bottom line is and has always

been the same: an association between thimerosaland neurological outcomes could

neither be confirmed nor refuted, and therefore, more study is required.â€

Dr Verstraeten the lead author of the study says that an association between

TCVs and NDDscannot be refuted based on his study, yet the IOM in their

assessment of the same study state thatit is a basis for concluding that

“there is no association between thimerosal-containing vaccines and autism. "

The IOM acknowledges that Verstraeten would not have picked up an association in

a genetically susceptible population. The IOM also noted that the study was

limited in its “abilityto answer whether thimerosal in vaccines causes autism

because the study tests a dose-responsegradient, not exposure versus

non-exposure.â€

It is also critical to note that the Verstraeten study cannot be validated. The

earlier datasets havebeen destroyed and the only datasets the CDC will make

available to outside researchers are theones that they have already

manipulated. The raw, unaltered data is not available. Additionally, outside

researchers are held to a much more restrictive access to information than are

CDCresearchers. Only one independent researcher has been granted access to the

CDC’s VSDdatabase and the CDC has kicked those researchers out based on

ridiculous reasons. They claimed their research methods might infringe on

privacy. Yet the database contains no names.The researchers do not even know

what HMO the patient is enrolled in. Nor do they know whatstate the subjects

live in. There is no way for an individual to be identified through their

research.

Hviid Study

The IOM sited the 2003 study by Hviid of the Danish Population as one the key

studies uponwhich it bases its conclusions.

Let’s consider first the conflict of interest of the principal author. Hviid

works for the DanishEpidemiology Science Center which is housed at the Staten

Serum Institute (SSI) thegovernment owned Danish vaccine manufacturer. Also,

all of his coauthors either work with him at the Center or are employed by SSI.

Staten Serum Institute (SSI) makes a considerableprofit off the sale of

vaccines and vaccine components and the U.S. is a major market for SSI.SSI has

$120 million in annual revenues and vaccines are the fastest growing business

segment accounting for 80% of its profits. Both the U.S. and U.K. are

important export markets for SSI’svaccines and vaccine components.

Furthermore, if Hviid were to find an association between thimerosal and autism,

SSI with whichhe and his Center are affiliated would face significant lawsuits.

These facts are important andare critical when evaluating this study.

Furthermore, this study only looked at Autism and not neurodevelopmental

disorders as a whole.Mercury exposures in the Danish population varied

considerably from those in the U.S. Danish children received 75 micrograms of

mercury by 9 weeks and another 50mcgs at 10 months. By comparison, children in

the U.S. received 187.5 mcgs of mercury by age 6 months – nearly 2 1/2times

as much mercury as Danish children in just the first 6 months of life.

Dr. Boyd Haley has said that comparing the exposures in the US to those in other

countries is like comparing apples and cows. I think there is a lot of truth

to that.

Hviid states that the rate of autism went up after they began removing

thimerosal from vaccinesin 1992. The numbers in Hviid study are skewed in that

they added outpatient Autism diagnosisto the number after 1992. The IOM notes

other limitations of the study including the differences in the dosing schedule

and the relative genetic homogeneity of the Danish population.

Yet even with these serious limitations, the committee concludes that this study

has a “strong internal validity,†finding an increase in autism after

removal of thimerosal.

Like the Verstraten study, Hviid would not be able to pick up a group of

children who were genetically susceptible to mercury toxicity.

Danish autism rate is about 6 in 10,000 vs. 30 in 10,000 in the U.S. – once

again we are comparing apples and cows. Indeed, I believe it can legitimately

be argued that the lower rate ofAutism in Denmark is attributable to the lower

exposure to mercury in their population

Madsen Study

Next the IOM relies on the study by Madsen et al., once again examining

virtually the same population that Hviid examined. Again, the relevance of the

Danish experience to the U.S.experience is limited in that the Danish

population is genetically homogenous and hadsignificantly lower thimerosal

exposures than children in the U.S.

Let’s consider the conflicts of interest with this study. First of all, two

of Madsen’s coauthorsare employed by the Staten Serum Institute.

Additionally, like Hviid, two of Madsen’s coauthorswork directly for the

Staten Serum Institute (SSI) – the Danish vaccine manufacturer which exports

vaccines and vaccine components to the U.S. and which faces liability if an

association is found. Madsen works for the Danish Epidemiology Science Center

– which is affiliated with SSI.

This study, like Hviid, added outpatient cases into the number of cases of

autism after 1995. The authors acknowledged that this addition might have

exaggerated the incidence of autism after theremoval of thimerosal.

The IOM acknowledged that this limits the study’s contribution to causality

Stehr-Green Study

The IOM relied on the Stehr-Green study which examined the Danish population (do

you see apattern yet?) and Swedish populations and attempted to compare that to

the U.S. population.Furthermore, a key coauthor if this study is employed by

the Danish vaccine manufacturer Staten Serum Institute.

I will not repeat the problems with the Danish data again, but with regard to

Sweden it isimportant to note the children there received even less thimerosal

than children in Denmark –receiving only 75 mcgs by age 2. Furthermore, the

authors included only inpatient autism diagnoses in the Swedish population.

The IOM notes that the ecological nature of this data“limits the study’s

contribution to causality.†But they site it anyway.

et al..

The study examines the population of children in the United Kingdom. This

study is still unpublished which limits a critical and public evaluation of its

findings.

Dr. has actively campaigned against those who have raised questions about

vaccine safety. She and her department receive funding from vaccine

manufacturers, and she reportedlyserves as an expert witness on behalf of

vaccine manufacturers who are being sued.

This study, like the Verstraeten study is a dose response study which is limited

in that it does notcompare children who received thimerosal to those who did

not.

Children in the U.K were exposed to up to 75 mcg of mercury by 4 months of age.

Thisrepresents about one-half of what children in the US would have been

exposed to by this age,plus children in the U.S. got another 50 mcg two months

later at age 6 months for a total exposure in the first six months of life of

nearly 2 1/2 times what children received in the U.K.

The author concludes that the study found no association between increasing

exposures to thimerosal and Autism.

Conclusion on Epi studies.

You can see clearly why the IOM is on very shaky ground in drawing the

conclusions they did.They based their decision on five epidemiology studies:

• Three of them examining the genetically homogenous population of Denmark

• At least one employee of the Staten Serum Institute serves a coauthor of at

least 3 of thestudies.

• Only one study examining the U.S. population – and that study did not

compare thosewith no mercury exposure to those with exposures.

• Four of them with populations receiving less than half of the mercury

exposure thatchildren in the U.S. received

• None of them with any ascertainment of prenatal or postnatal background

mercuryexposures.

• None of them considering prenatal exposures which may have given children

• None of them able to detect a susceptible subgroup that many have had a

geneticsusceptibility to mercury toxicity.

• Three of them failing to address how the addition of outpatient cases of

Autism inDenmark might have perilously skewed the results.

• Four of them examined populations with autism rates considerably below that

in the U.S.

• One of the studies has not been published and not subjected to public

review.

Bio/Clinical Research - Thimerosal

Since the release of the IOM’s report in 2001, public health officials in the

US virtually ignored the biological and clinical research recommendations.

While the CDC had no trouble fundingepidemiology studies – all with their

flaws and inadequacies – several critical biological andclinical research

recommendations were starved of funding:

The IOM recommended that the following studies be done, but the CDC and the NIH

failed todedicate the resources to fund these studies:

• Identify primary sources and levels of prenatal and postnatal background

exposures tothimerosal, including Rho (D) Immune Globulin in pregnant women and

other forms ofmercury (fish) in infants, children and pregnant women – NOT

DONE;

• Compare the incidence and prevalence of NDDs before and after removal of

thimerosalfrom vaccines. NOT DONE and the CDC tells me they will not begin

such studies until2006.

• Research how children, including those with NDDs, metabolize and excrete

metals –particularly mercury- NOT DONE

• Conduct research on theoretical modeling of ethylmercury exposures,

including theincremental burden of thimerosal with background mercury exposures

from other sources– NOT DONE

• Conduct careful, rigorous and scientific investigations of chelation when

used in childrenwith NDDs, especially Autism. NOT DONE though in their latest

report they urge thatthis be highly restricted. • Conduct comparative animal

studies of the toxicity of ethylmercury and methylmercuryto better understand

the NDD effects of thimerosal – ONLY PARTIALLY DONE – butwith very little

federal support.

In 2001 the IOM stated that it is “unclear whether ethylmercury [from

vaccines] passes readilythrough the blood-brain barrier...†The IOM

recommended several biological and clinicalstudies to answer this question and

whether this mercury could cause developmental problems. These studies were in

large part never done. Yet IOM chose to ignore the need for this researchand

instead has focused its analysis on the data available today, most of which is

statistical data.

There is much more research that needs to be done before it can definitively be

said thatthimerosal does not contribute to NDDs. Even today, the IOM cannot

tell you with any degreeof certainty what happens to ethylmercury once injected

into an infant. Does it go to the brain? Does is cause developmental problems?

Who knows?

MMR – Autism Association

Allow me to touch briefly on the IOM’s analysis of the MMR-Autism issue. They

devoted onlyone hour of discussion to this topic at the February meeting and

failed to invite those who weremost intimately involved in this research to

present to the IOM.

As with thimerosal, the IOM relied almost exclusively on epidemiology. They

made theirdecision about whether or not measles may be related to Autism in

children, by reviewing 13 statistical studies in which many of the authors have

conflicts of interest. Some of these authors have been openly hostile in their

assessments, which calls into question their objectivity. Also,remember it is

epidemiology that reigns supreme in this review – even if the studies are

flawedin their design.

The IOM still cannot answer the question as to why measles is in the intestines

of some Autistic children. Why is it there? What is it doing? How did it get

there? Is it contributing to Autism?The IOM attempts to explain this issue

away by saying it’s likely that the presence of measles could just be a co

morbidity to Autism. This cavalier attitude of the IOM, the CDC, and othersin

the public health community is unacceptable. We have a moral obligation to

fully supportresearch to understand why vaccine strain measles is the

intestines and CSF of these children. The government mandated vaccination, the

least we should do is fund research to understandwhy measles is persisting in

these children, what harm it might be causing, and how we mightbest treat these

children.

The NIH is only now attempting to duplicate the work of Dr. Wakefield.

Despite beingvilified for the last 6 years half of Dr. Wakefield’s work has

been demonstrated to be correct.Practitioners across the U.S. and in many other

parts of the world are finding the same inflammatory bowel disease he first

described in Lancet in 1998. Drawing “conclusions†at thistime is

counterproductive. Statistical studies are of little benefit, only a clinical

pathologicalstudy will lay this issue to rest.

A Few Final Remarks Regarding The IOM Report

For the reasons outlined above and other reasons, this report is premature,

perilously reliant on epidemiology, based on preliminary incomplete

information, and I believe may be ultimatelyrepudiated – perhaps in short

order.

This report will not deter me nor the Autism community from our commitment to

seeing thatthimerosal and MMR research is properly done. This report will do

nothing to put to rest the concerns of parents who believe their children

wereharmed by mercury-containing vaccines or the MMR vaccine.

While this report will lead many clinicians to believe that thimerosal is safe

and there is noproblem with the MMR, it may contribute further to an erosion in

the doctor-patient relationship.

This report has dragged the IOM under the cloud of controversy that has

currently engulfedCDC.

Much like the infamous 1989 study by The National Institute of Child and Human

Development(NICHD) which missed the link between folic acid deficiencies and

neural tube defects like spina bifida, the epidemiology studies reviewed by the

IOM in drawing these findings, could easily have missed associations in

susceptible populations.

Finally, let’s remember that the IOM is not immune to error and has been

forced to reverse itselfbefore. Most recently the IOM reversed a long-standing

finding that chronic lymphocyticleukemia (CLL) was not due to Agent Orange

exposures. A similar reversal is a very real possibility here.

H.R. 4169 – The Mercury Free Vaccines Act of 2004

On April 2, I introduced along with Rep. Carolyn Maloney, H.R. 4169 – The

Mercury FreeVaccines Act of 2004. We currently have 15 cosponsors from across

the political spectrum.

H.R. 4169 will phase-out the use of mercury in vaccines over the next 3 years,

giving particularattention to completely eliminating mercury from childhood

vaccines on an expedited schedule.

This bill is in response to the fact that:

• The safety of thimerosal in vaccines is not proven

• Mercury is well-established as a neurotoxin.

• According to the EPA 1 in 6 newborns is born with a blood mercury level

consideredunsafe.

• The FDA and the EPA recently warned pregnant women, nursing mothers, and

youngchildren to limit their consumption of certain fish that are high in

mercury.

• No one at the NIH or CDC can tell you what happens to the mercury once

injected intoan infant – Where does it go? How much goes to critical organs?

How much to the brain?Can it cause damage to the developing central nervous

system? No one can answer these question and they should before infants are

exposed to more mercury.

• The CDC is has adopted a policy reintroducing mercury into childhood

vaccines byrecommending the flu vaccine for infants at 6, 7, and 23 months of

age – most of which contain mercury.If we are going to move this legislation

forward, I am going to need each and everyone of you to go back and get your

member of Congress to cosponsor this bill. You need to call them and askthem

to cosponsor H.R. 4169. And be persistent, but not rude.

New Legislation to Monitor Adverse Reactions to Vaccines

It is critical that we make improvements in how we monitor for and respond to

adverse reactions to vaccines. Today there are three government agencies that

have responsibilities related tomonitoring the safety of vaccines – the FDA,

the CDC, and the NIH.

The Food and Drug Administration (FDA) has a responsibility to monitor vaccine

safety.However, their role is largely limited to ensuring that vaccine lots

that are released meet FDAstandards and collecting information to be entered

into the Vaccine Adverse Events Reporting System (VAERS).

The NIH does not have a concerted effort to fund vaccine safety research. They

provide funding for research in a haphazard manner - if you happen to submit a

proposal and it passes peer review they may fund it. The NIH has funded only a

handful of studies over the past two yearsinvestigating vaccine safety issues.

The CDC has the greatest responsibility in this area. Unfortunately, they also

have the greatestconflict of interest.

The CDC’s vaccine safety program amounts to about $30 Million a year,and half

of this goes to pay HMOs for access to the Vaccine Safety Database.

The biggest conflict within the CDC is that they are also responsible for a

running $1 Billionvaccine promotion program. The CDC largely measures it

success by how high vaccinationrates are. Here lies the largest conflict. Any

study raising concerns that there might be adverse reactions is likely to

result in safety concerns leading to lower vaccination rates. Lowervaccination

rates are in direct conflict with the CDC’s top measurement of success.

Clearly, dueto its overwhelming size and the manner in which the agency

measures its success, the vaccine promotion program overshadows and influences

the CDC’s vaccine safety program.

In fact, rightly or wrongly, the vaccine safety office within the CDC is largely

viewed by outside observers as nothing more than another arm of the vaccine

promotion program, giving support tovaccine promotion policies and doing very

little to investigate and better understand acute andchronic adverse reactions.

Further complicating the CDC’s role and undermining their research is the fact

that the vaccinesafety studies produced by the CDC are impossible to reproduce.

External researchers are notgranted the same level of access to the raw

datasets that the CDC’s internal researchers are granted. The bottom line is

that the CDC’s studies related to vaccine safety cannot be validatedby

external researchers – a critical component in demonstrating the validity of

scientific findings.

The CDC recently announced that a Blue Ribbon Panel will meet to examine how the

CDCmight better review vaccine safety. I do not hold out much hope for this

panel, however, becausethe panel is limited in their scope. Much like the IOM

was limited in the outcome they were allowed to draw, this panel is limited to

deciding where within CDC, vaccine safety monitoringshould be housed. The NIH

recently recognized the importance of moving patient safetymonitoring outside

of NIH – I believe the same should be done with vaccine monitoring. It

should be completely removed from the CDC’s jurisdiction. The CDC is too

conflicted tooversee this function.

In order to ensure that there is a concerted and independent effort within the

federal governmentto monitor for adverse reactions to vaccines, I have prepared

legislation which I will soonintroduce that will ensure that vaccine safety

monitoring is completely independent. It has become clear to me that the

federal government has failed miserably and has not given this issuethe

attention that is needed. Clearly, greater oversight and complete independence

is needed.

My legislation will ensure that those responsible for vaccine safety research

are free from allconflicts of interest and have as their sole focus the

following:

• Determining what these adverse reactions are

• Understanding why some individuals have adverse reactions, and

• How we might best ensure that such reactions are avoided.

Brighton Collaboration

Finally, I want to turn my attention to something known as the Brighton

Collaboration.

I am very concerned about the development of the Brighton Collaboration which

began in 2000.This is an international group comprised of public health

officials from the CDC, Europe, andworld health agencies like WHO, and vaccine

manufacturers.

This first task of the Brighton Collaborations, created several years ago, is to

define whatconstitutes and adverse reaction to a vaccine. They have

established committees to work onvarious adverse reactions to vaccines.

Particularly troubling is the fact that serving on the panels defining what

constitutes an adverse reaction to a vaccine, are vaccine manufacturers. What

iseven worse is the fact that some of these committees are chaired by vaccine

manufacturers. It istotally inappropriate for a manufacturer of vaccines to be

put in the position of determining what is and is not an adverse reaction to

their product.

Do we allow GM, Ford and Chrysler to define the safety of their automobiles?

Do we let airlines set the safety standards for their airlines and determine the

cause of an airlineaccident?

Do we allow food processors to determine whether or not their food is

contaminated or causedharm?

Then, why I ask, are we allowing vaccine manufactures to define what constitutes

an adversereaction to a vaccine?

This collaboration is fraught with pitfalls and merges regulators and the

regulated into anindistinguishable group.

It is critical that the American public look at what is going on here and how

this entity mayfurther erode their ability to fully understand the true

relationships between various vaccines andadverse reactions.

I plan to devote additional attention to this effort.

Concluding Remarks

Finally, Autism is a difficult challenge facing our nation. We have made

considerable progressthrough groups like Autism One and the other autism

organizations represented here. The workyou are doing is work that must

continue. I commend each of you.

I commend the researchers who are engaged to develop a deeper understanding of

what is goingon with these children and how we might improve their treatments.

I am hopeful that the folksdown at the NIH, the CDC, and the IOM will be more

supportive of your work. I will do all that I can to see that critical

research in all areas of autism research continue to receive increasedfunding.

I commend the parents who have failed to give up on their children.

I commend you for yourdedication to want the best for your children and for the

sacrifices you have made for them.

I urge each of you to take your story to your Member of Congress and your

Senator. Share yourstruggles with them. If I, along with the few others who

have made defeating autism a toppriority are to be successful, it is critical

that every Member of Congress know what Autism is and that they have

constituents who are watching them and asking for their help.

I urge you to tell your local television reporters and newspaper reporters your

story and your struggles. Tell everyone who are willing to listen. It is

through your testimony that others willknow of this devastating epidemic

plaguing our children.

I also urge you to share with others what is working in the treatment of your

children. You areblessed with the resources that are available to you at this

conference. Listen and learn from theproviders here who have a lot to offer.

Finally, let me know what I can do to help. I stand in partnership with each of

you.

Thank you for inviting me to join you today. It has been a great honor. ###