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Congressional Quarterly - DC Briefing Coverage

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CONGRESSIONAL

QUARTERLY

CQ HEALTHBEAT

THURSDAY, MARCH 30, 2006

CONTROVERSY

OVER AUTISM-THIMEROSAL LINK FLARING ANEW

The self-described

" wait a second " crowd is getting bigger. So named by

parents and

advocates of autistic children who believe the Institute of

Medicine (IoM) has

erred in ruling out a link between a vaccine

ingredient and

autism, it has the ear of a growing number of lawmakers

who agree more

research is needed to resolve whether there is a link.

Rep. Carolyn B.

Maloney, D-N.Y., is the latest member of Congress to

spotlight the

issue, saying Thursday she will introduce a bill in late

April requiring a

study comparing children who have received vaccines

with the

ingredient, the mercury-containing preservative thimerosal, to

those who are

unvaccinated..

Maloney said such a

study is needed because of stories written by United

Press International

editor Dan Olmsted

reporting no cases of autism in

unvaccinated Amish

children and in some 30,000 children seen over the

years by

doctors in a Chicago-area HMO that does not vaccinate children.

" To date, no

autism study of note " has used a control group to compare

children exposed

to thimerosal in vaccines to unvaccinated children, she

said.

However, IoM President

Harvey Fineberg has defended the institute's

review of data

on the link as thorough, saying it's time to focus

research on

other possible causes of autism.

Other lawmakers also

recently called for additional research. In a Feb.

22 letter, Sens. ph I. Lieberman, D-Conn.,

and Debbie Stabenow,

D-Mich,

reminded the new director of the National Institute of

Environmental Health

Sciences (NIEHS) at the National Institutes of

Health about report

language in the fiscal 2006 Health and Human

Services spending bill

(PL 109-149) urging research on a possible

thimerosal-autism link.

The report language

said that conferees on the measure believe that a

database maintained

by the Centers for Disease Control and Prevention

could be

helpful in resolving the issue. But because of skepticism on

the part of

parents " concerned with vaccine safety " about CDC's

credibility on the

issue, NIEHS not CDC should lead a study examining

the Vaccine

Safety Datalink database, the senators said in their

letter,

also signed

by six House members.

Meanwhile, the number

of co-sponsors on a bill introduced by Rep. Dave

Weldon, R-Fla., to bar the marketing of mercury-containing vaccines

to

children and

pregnant women has grown to 72, with the number of

Republican and

Democratic sponsors virtually the same. According to HHS

spokeswoman

Pearson, thimerosal has been removed from all

children's

vaccines other than for flu. Parents can request

thimerosal-free

versions, Pearson said.

Focus on a Best Seller

Helping to fuel the

growing questions about the IoM's May

18, 2004,

study is

" Evidence of Harm, " a New York Times best seller whose author

Kirby

appeared with Maloney at a Washington press

briefing

Thursday. Kirby

noted arguments by parents of autistic children that the

IoM report relied on

broad epidemiological studies rather than on

biological

research examining the impact of thimerosal at the cellular

level.

Four of the five

epidemiological studies examined the use of thimerosal

in Europe, where

lower doses of thimerosal were used in vaccines, Kirby

said. And

the IoM review did not examine subsets of children who for

genetic reasons

might be particularly vulnerable to neurological damage

caused by

mercury, Kirby added.

There has been growing

biological evidence that " in a small subset of

children with a

certain genetic predisposition, they are unable to

properly process

the mercury they were exposed to, " Kirby told TV

newsman Tim Russert in an August

7, 2005, appearance on " Meet the

Press. " At

Thursday's briefing, Kirby highlighted NIEHS-funded study

results

released March 21 linking thimerosal to cellular changes that

could weaken

the immune system in mice. It's important to examine

tissues and

animal models, not just epidemiology, Kirby said.

The IoM's View

IoM spokeswoman

Stencel said Thursday that while there have

been

additional biological studies, " they provide hints, they provide

clues, of

what should be explored further, but they do not necessarily

equate to what

is happening in the human body. "

Fineberg told Russert on the " Meet the Press " broadcast that

Kirby's

emphasis on

biological data was unwarranted. " When you're trying to

assess a

specific association, there are biological studies that are

relevant, and

there are epidemiological studies that are relevant. All

of these

studies are not equally valid, " Fineberg said.

The IoM

committee that

prepared the study " went through very carefully and

assessed each of

those studies representing its strengths and

weaknesses. "

The epidemiological

studies " were carried out in the United

States, in

Great

Britain, in Denmark and Sweden, " Fineberg said. " These studies

covered

hundreds of thousands of individuals, children, in these

populations. They

compared systematically in different ways whether you

received vaccine

with no thimerosal, with some thimerosal, with more

thimerosal, and

they looked at the relationship of those experiences

with the

development of autism. Uniformly, the best of those studies all

show no

association between receiving vaccine of different amounts with

thimerosal or

without and the development of autism. "

Fineberg said

" other avenues of research looking at other possible

causes today

are much more promising ways to spend our precious

resources "

trying to identify the causes of autism.

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The fallacies of epidemiologic studies are reviewed in Analytic Review paper published in Internat. J

Clin Invest. vol 13,Dec. 2006

Sincerely,

H.H. Fudenberg, M.D., D.D.G., I.O.M.

226 Edgewater Road

Inman, SC 29349

864-592-8076

nitrf@hotmailcom

From: " Kirby" <dkirby@...>Reply-EOHarm To: <eoharm >Subject: Congressional Quarterly - DC Briefing CoverageDate: Fri, 31 Mar 2006 16:08:32 -0500

CONGRESSIONAL QUARTERLY

CQ HEALTHBEAT

THURSDAY, MARCH 30, 2006

CONTROVERSY OVER AUTISM-THIMEROSAL LINK FLARING ANEW

The self-described "wait a second" crowd is getting bigger. So named by

parents and advocates of autistic children who believe the Institute of

Medicine (IoM) has erred in ruling out a link between a vaccine

ingredient and autism, it has the ear of a growing number of lawmakers

who agree more research is needed to resolve whether there is a link.

Rep. Carolyn B. Maloney, D-N.Y., is the latest member of Congress to

spotlight the issue, saying Thursday she will introduce a bill in late

April requiring a study comparing children who have received vaccines

with the ingredient, the mercury-containing preservative thimerosal, to

those who are unvaccinated..

Maloney said such a study is needed because of stories written by United

Press International editor Dan Olmsted reporting no cases of autism in

unvaccinated Amish children and in some 30,000 children seen over the

years by doctors in a Chicago-area HMO that does not vaccinate children.

"To date, no autism study of note" has used a control group to compare

children exposed to thimerosal in vaccines to unvaccinated children, she

said.

However, IoM President Harvey Fineberg has defended the institute's

review of data on the link as thorough, saying it's time to focus

research on other possible causes of autism.

Other lawmakers also recently called for additional research. In a Feb.

22 letter, Sens. ph I. Lieberman, D-Conn., and Debbie Stabenow,

D-Mich, reminded the new director of the National Institute of

Environmental Health Sciences (NIEHS) at the National Institutes of

Health about report language in the fiscal 2006 Health and Human

Services spending bill (PL 109-149) urging research on a possible

thimerosal-autism link.

The report language said that conferees on the measure believe that a

database maintained by the Centers for Disease Control and Prevention

could be helpful in resolving the issue. But because of skepticism on

the part of parents "concerned with vaccine safety" about CDC's

credibility on the issue, NIEHS not CDC should lead a study examining

the Vaccine Safety Datalink database, the senators said in their letter,

also signed by six House members.

Meanwhile, the number of co-sponsors on a bill introduced by Rep. Dave

Weldon, R-Fla., to bar the marketing of mercury-containing vaccines to

children and pregnant women has grown to 72, with the number of

Republican and Democratic sponsors virtually the same. According to HHS

spokeswoman Pearson, thimerosal has been removed from all

children's vaccines other than for flu. Parents can request

thimerosal-free versions, Pearson said.

Focus on a Best Seller

Helping to fuel the growing questions about the IoM's May 18, 2004,

study is "Evidence of Harm," a New York Times best seller whose author

Kirby appeared with Maloney at a Washington press briefing

Thursday. Kirby noted arguments by parents of autistic children that the

IoM report relied on broad epidemiological studies rather than on

biological research examining the impact of thimerosal at the cellular

level.

Four of the five epidemiological studies examined the use of thimerosal

in Europe, where lower doses of thimerosal were used in vaccines, Kirby

said. And the IoM review did not examine subsets of children who for

genetic reasons might be particularly vulnerable to neurological damage

caused by mercury, Kirby added.

There has been growing biological evidence that "in a small subset of

children with a certain genetic predisposition, they are unable to

properly process the mercury they were exposed to," Kirby told TV

newsman Tim Russert in an August 7, 2005, appearance on "Meet the

Press." At Thursday's briefing, Kirby highlighted NIEHS-funded study

results released March 21 linking thimerosal to cellular changes that

could weaken the immune system in mice. It's important to examine

tissues and animal models, not just epidemiology, Kirby said.

The IoM's View

IoM spokeswoman Stencel said Thursday that while there have

been additional biological studies, "they provide hints, they provide

clues, of what should be explored further, but they do not necessarily

equate to what is happening in the human body."

Fineberg told Russert on the "Meet the Press" broadcast that Kirby's

emphasis on biological data was unwarranted. "When you're trying to

assess a specific association, there are biological studies that are

relevant, and there are epidemiological studies that are relevant. All

of these studies are not equally valid," Fineberg said. The IoM

committee that prepared the study "went through very carefully and

assessed each of those studies representing its strengths and

weaknesses."

The epidemiological studies "were carried out in the United States, in

Great Britain, in Denmark and Sweden," Fineberg said. "These studies

covered hundreds of thousands of individuals, children, in these

populations. They compared systematically in different ways whether you

received vaccine with no thimerosal, with some thimerosal, with more

thimerosal, and they looked at the relationship of those experiences

with the development of autism. Uniformly, the best of those studies all

show no association between receiving vaccine of different amounts with

thimerosal or without and the development of autism."

Fineberg said "other avenues of research looking at other possible

causes today are much more promising ways to spend our precious

resources" trying to identify the causes of autism.

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