Fwd: Burton's Opening Statement 7/18/00 Mercury Hearing

[Guest guest]

In a message dated 7/24/00 8:40:09 AM Eastern Daylight Time,

AuntMares@... writes:

> Subj: [abmd] Burton's Opening Statement 7/18/00 Mercury Hearing

> http://www.house.gov/reform/hearings/healthcare/00.07.18/opening_statement.

> htm

>

> Below is a copy of the statement.

>

> Opening Statement

> Dan Burton (R-IN)

> Chairman

> Government Reform Committee

> “Mercury in Medicine – Are We Taking Unnecessary Risks?”

> July 18, 2000

> 2154 Rayburn House Office Building

> Washington, D.C.

>

>        For the last year, the Government Reform Committee has been looking

> at issues regarding vaccine safety, research, and policy.  A few people

have

> tried to portray this investigation as “anti-vaccine.”  Nothing could be

> further from the truth.  Safe, effective vaccines save lives.  On the

other

> hand, vaccines that have not been thoroughly tested and reviewed can be

> dangerous.  The rotavirus vaccine was a good example.  The Government and

> manufacturers ignored the warning signs.  A lot of babies were injured and

> required surgery.  One baby died before the vaccine was pulled from the

> market.

>

> Is it irresponsible to ask questions about why that happened?  Of course

not.

>

> We have a lot of doctors who serve on Federal advisory committees who have

> serious conflicts-of-interest problems.  They’re allowed to vote on

vaccines

> made by companies that they get money from. 

>

> Is it irresponsible to ask questions about conflicts of interest?  Of

course

> not.

>

> Today we’re holding a hearing about why mercury is put into vaccines that

> are given to children.

>

> Is that irresponsible?  Of course not.

>

> If someone holds hearings about mismanagement of the Department of

Education

that doesn’t mean they’re anti-education.  That means they want our

> education system to be as well run as possible.  That is the way that I

feel about our vaccine policies.  No area is so sacrosanct that the world

will come to an

> end if we ask some sensible questions and expect to get some sensible

> answers. I think this kind of oversight will make our vaccine program

stronger, not

> weaker.

>

> This spring, we held a hearing about possible connections between autism

and

> the MMR vaccine.  We heard lots of testimony on both sides of the issue. 

> After the hearing, I sent a letter to Secretary Shalala.  So did

Congressman

> Waxman.  We both asked her to put together a panel of the best experts in

> the field to look at this issue.  That was May 16 –two months ago.  No

response.

>

> That’s intolerable.  If your position is that we should base our policies

on

good science and good research, then fine.  I agree with you 100

percent. 

> But if you are not willing to do the research, if you’re not even willing

to

> ask the questions, then we have a real problem on our hands. 

>

> I believe that our primary focus in vaccine policy should always be what

is

> best for the children.  We need to insure that only vaccines that are

truly

> needed to protect the public are added to the Childhood Immunization

> Schedule.  At no time should the interests of vaccine developers be a

higher

> priority than our children’s health and well being. 

>

> Vaccines are the only drugs that Americans are required by a Government

> agency to take.  It is thus imperative that the Federal Government ensures

> the safety of these mandated vaccines.  Each state sets a schedule for the

> vaccines a child must receive in order to attend school or day care.  The

> states rely on the Federal Government for guidance on which vaccines

should

> be mandated.  The Federal Government is also the largest purchaser of

> vaccines.

>

> That brings us to today’s hearing topic – mercury in medicine.  This would

> seem to many to be a “no-brainer.”  We all know that mercury is a toxic

> substance.  Long term exposure to low levels of mercury has been linked to

> mental retardation, cerebral palsy, and central nervous system disorders. 

> We assume that the FDA would protect our children from exposure to any

level of > mercury through drugs.  But that hasn’t been the case. Thimerosal

was first

marketed in 1930 and has become the most widely used preservative in

vaccines. 

It is present in over 50 licensed vaccines.  

>

> The FDA recently acknowledged that in the first six months of life

children

> get more mercury than is considered safe by the EPA.  The truth is that

> sometimes kids go to their doctor’s office and get four or five vaccines

at

> the same time.  My grandson received vaccines for nine different diseases

in

> one day.  He may have been exposed to 62.5 micrograms of mercury in one

day

> through his vaccines.  According to his weight, the maximum safe level of

> mercury he should be exposed to in one day is 1.51 micrograms.  This is

> forty-one times the amount at which harm can be caused. 

>

> How much mercury are kids being exposed to at once? 

>

> One would think that the FDA would have moved aggressively to remove

> vaccines that contained mercury from the market immediately.  They did

not. 

>

> On July 9, 1999, the American Academy of Pediatrics and the United States

> Public Health Service issued a joint statement recommending the removal of

> thimerosal from vaccines.[1]  On May 31, 2000, the Food and Drug

> Administration notified vaccine manufacturers that their review of mercury

> compounds in drugs and foods concluded that reducing or eliminating

> thimerosal from vaccines is merited.[2]  However, there has been no

> mandatory action.  These vaccines are still in use. 

>

> The FDA continues to allow the mercury-containing vaccines to remain on

the

> market.  Today, over eight thousand children in America may be given a

toxic

> dose of mercury in their vaccines.[3]   

>

> Many parents who have contacted the committee are concerned about other

> ingredients as well, including formaldehyde, MSG, and aluminum.  We have

> also been contacted by many individuals who have concerns about mercury in

> dental amalgams.  While this is not the focus of today’s hearing, it

certainly

> warrants discussion as well. 

>

> Congress directed the Environmental Protection Agency to contract with the

> National Research Council to prepare recommendations on the appropriate

dose

> for mercury exposure.  That report was released on July 11[4].  While the

> FDA relies on the Agency for Toxic Substances and Disease Registry’s

dosing

> level for mercury of 0.5 micrograms per kilogram of body weight per day is

> significantly higher than the EPA’s dose of 0.1 microgram per kilogram of

> body weight.  In that report, it was confirmed that the EPA’s reference

dose

> is correct.  We will hear from Dr. Vascken Aposhian, University of Arizona

> at Tuscon, one of the scientists who worked on this report. Ramona Trovato

will

testify on behalf of the Environmental Protection Agency.

>

> Section 413 of the Food and Drug Administration Modernization Act of

1997[5]

required the FDA to compile a list of drugs and foods that contain

> intentionally introduced mercury compounds, and provide a quantitative and

> qualitative analysis of the mercury compounds in this list.  The Act also

> requires the agency to compile the list and provide the analysis within

two

> years after the date of its enactment on November 21, 1997.  Dr.

> Egan will be testifying on behalf of the Food and Drug Administration.

>

> While thimerosal has previously been ruled by the FDA to fit the 

“generally

> recognized as safe” standard, when the FDA conducted their Over the Counter

> (OTC) drug review they changed their minds.  The FDA determined that

mercury

> compounds used as active ingredients in Over the Counter drug products were

> not found to be “generally recognized as safe.”  Additionally the FDA has

> not approved any mercury containing compounds as food additives and does

not

> consider any mercury containing compounds to be “generally recognized as

> safe.” [6]  On their own website, the FDA states, “lead, cadmium, and

> mercury are examples of elements that are toxic when present at relatively

low

> levels.”[7] 

>

> How is it that mercury is not safe for food additives and Over the Counter

> drug products, but it is safe in our vaccines and dental amalgams?

>

> Dr. H. Bernier, Associate Director for Science at the National

> Immunization Program, Centers for Disease Control and Prevention will

> testify regarding the recent discussion of the Advisory Committee on

Immunization

> Practices regarding thimerosal. 

>

> Autism is a syndrome characterized by impairments in social relatedness

and

> communication, repetitive behaviors, abnormal movements, and sensory

> dysfunction.  Autism may now affect 1 in 150 U. S. children.   We will

hear

> from Dr. Marie Bristol-Powers of the National Institutes of Health

regarding

> the existing research in autism.  The characteristics of autism and of

> mercury poisoning are strikingly similar.[8]

>

>           Dr. Cave, a physician from Baton Rouge, Louisiana will

> be testifying about the mercury toxicity she is seeing in the 200 autistic

> children she has as patients.

>

>           Autism strikes families from a diverse background.  We will hear

> from five parents today:  Birt of Chicago, an attorney and the

> mother of an autistic child will be testifying about the need to remove

> mercury from all vaccines and a citizens petition that is being presented

to

> the FDA making this request.

>

> Several parents with scientific and medical backgrounds have written a

> report entitled, “Autism: A Unique Type of Mercury Poisoning.” Three of

these

> parents will be testifying today.  The lead author of the report is Sallie

> Bernard of Cranford, New Jersey.  Lyn Redwood of Tyrone, Georgia is a

nurse

> practitioner, and Albert Enayati, of Paramus New Jersey is a chemist.  

Dr.

> Sharon Humiston, a doctor with an autistic child will also be testifying.

>

>           Our children are the future of this country.  As a Government we

> have a responsibility to do everything within our power to protect them

from

> harm, including insuring that vaccines are safe and effective. Every day

> that these mercury-containing vaccines remain on the market is another day

we are putting eight thousand children at risk.

>

> The Record will remain open until August 1, 2000.

> ------------------------------------------------------------------------

> [1]               MMWR Weekly Statement of July 9, 1999/48(26);563-565,

>

> http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/mm4826a3.htm

>

> [2]               CBER Letter – Dear Vaccine Manufacturer, Letter to

Vaccine

>

> Manufacturers Regarding Plans to

>

> Continued use of Thimerosal as a Vaccine Preservative – Update, dated May

31,

>

> 2000, Available on http://www.fda.gov

>

> [3]               In 1999, 11,000 children were born a day.  Of those,

> approximately 73% received all of their recommended vaccines.

>

> [4]                 Available at the National Academy Web Site

> http://www.nas.edu

>

> [5]               Public Law 105-115

>

> [6]               Federal Register Notice of December 14, 1998 (Volume 63,

> Number 239) Page 68775-68777, DOCID fr14de98-67

>

> [7]               Chapter 14, Metals Analysis Training available at

> http://www.fda.gov

>

> [8]               Table A, A Comparison of Mercury the Effects of Mercury

> Poisoning and

> Autism, Autism:  A Unique Type of Mercury Poisoning, Sallie Bernard,

Albert

> Enayati, B.S., Ch.E., M.S.M.E., Binstock, Heidi , Lyn Redwood,

> R.N., M.S.N., C.R.N.P., Woody McGinnis, M.D.

>

>

The link at the committee site for the hearing is up but it didn't work for

me so I sent a note to the web master and he sent back a note to do a SEARCH

and I found Congressman Burton's Opening Statement at

http://www.house.gov/reform/hearings/healthcare/00.07.18/opening_statement.htm

Below is a copy of the statement. It is all I've been able to access so

far~~~~

Opening Statement

Dan Burton (R-IN)

Chairman

Government Reform Committee

“Mercury in Medicine – Are We Taking Unnecessary Risks?”

July 18, 2000

2154 Rayburn House Office Building

Washington, D.C.

       For the last year, the Government Reform Committee has been looking at

issues regarding vaccine safety, research, and policy.  A few people have

tried to portray this investigation as “anti-vaccine.”  Nothing could be

further from the truth.  Safe, effective vaccines save lives.  On the other

hand, vaccines that have not been thoroughly tested and reviewed can be

dangerous.  The rotavirus vaccine was a good example.  The Government and

manufacturers ignored the warning signs.  A lot of babies were injured and

required surgery.  One baby died before the vaccine was pulled from the

market.

Is it irresponsible to ask questions about why that happened?  Of course not.

We have a lot of doctors who serve on Federal advisory committees who have

serious conflicts-of-interest problems.  They’re allowed to vote on vaccines

made by companies that they get money from. 

Is it irresponsible to ask questions about conflicts of interest?  Of course

not.

Today we’re holding a hearing about why mercury is put into vaccines that are

given to children.

Is that irresponsible?  Of course not.

If someone holds hearings about mismanagement of the Department of Education,

that doesn’t mean they’re anti-education.  That means they want our education

system to be as well run as possible.  That is the way that I feel about our

vaccine policies.  No area is so sacrosanct that the world will come to an

end if we ask some sensible questions and expect to get some sensible

answers.

I think this kind of oversight will make our vaccine program stronger, not

weaker.

This spring, we held a hearing about possible connections between autism and

the MMR vaccine.  We heard lots of testimony on both sides of the issue. 

After the hearing, I sent a letter to Secretary Shalala.  So did Congressman

Waxman.  We both asked her to put together a panel of the best experts in the

field to look at this issue.  That was May 16 –two months ago.  No response.

That’s intolerable.  If your position is that we should base our policies on

good science and good research, then fine.  I agree with you 100 percent. 

But if you are not willing to do the research, if you’re not even willing to

ask the questions, then we have a real problem on our hands. 

I believe that our primary focus in vaccine policy should always be what is

best for the children.  We need to insure that only vaccines that are truly

needed to protect the public are added to the Childhood Immunization

Schedule.  At no time should the interests of vaccine developers be a higher

priority than our children’s health and well being. 

Vaccines are the only drugs that Americans are required by a Government

agency to take.  It is thus imperative that the Federal Government ensures

the safety of these mandated vaccines.  Each state sets a schedule for the

vaccines a child must receive in order to attend school or day care.  The

states rely on the Federal Government for guidance on which vaccines should

be mandated.  The Federal Government is also the largest purchaser of

vaccines.

That brings us to today’s hearing topic – mercury in medicine.  This would

seem to many to be a “no-brainer.”  We all know that mercury is a toxic

substance.  Long term exposure to low levels of mercury has been linked to

mental retardation, cerebral palsy, and central nervous system disorders.  We

assume that the

FDA would protect our children from exposure to any level of mercury through

drugs.  But that hasn’t been the case. Thimerosal was first marketed in 1930

and has become the most widely used preservative in vaccines.  It is present

in over 50 licensed vaccines.  

The FDA recently acknowledged that in the first six months of life children

get more mercury than is considered safe by the EPA.  The truth is that

sometimes kids go to their doctor’s office and get four or five vaccines at

the same time.  My grandson received vaccines for nine different diseases in

one day.  He may have been exposed to 62.5 micrograms of mercury in one day

through his vaccines.  According to his weight, the maximum safe level of

mercury he should be exposed to in one day is 1.51 micrograms.  This is

forty-one times the amount at which harm can be caused. 

How much mercury are kids being exposed to at once? 

One would think that the FDA would have moved aggressively to remove vaccines

that contained mercury from the market immediately.  They did not. 

On July 9, 1999, the American Academy of Pediatrics and the United States

Public Health Service issued a joint statement recommending the removal of

thimerosal from vaccines.[1]  On May 31, 2000, the Food and Drug

Administration notified vaccine manufacturers that their review of mercury

compounds in drugs and foods concluded that reducing or eliminating

thimerosal from vaccines is merited.[2]  However, there has been no mandatory

action.  These vaccines are still in use. 

The FDA continues to allow the mercury-containing vaccines to remain on the

market.  Today, over eight thousand children in America may be given a toxic

dose of mercury in their vaccines.[3]   

Many parents who have contacted the committee are concerned about other

ingredients as well, including formaldehyde, MSG, and aluminum.  We have also

been contacted by many individuals who have concerns about mercury in dental

amalgams.  While this is not the focus of today’s hearing, it certainly

warrants discussion as well. 

Congress directed the Environmental Protection Agency to contract with the

National Research Council to prepare recommendations on the appropriate dose

for mercury exposure.  That report was released on July 11[4].  While the FDA

relies on the Agency for Toxic Substances and Disease Registry’s dosing level

for mercury of 0.5 micrograms per kilogram of body weight per day is

significantly higher than the EPA’s dose of 0.1 microgram per kilogram of

body weight.  In that report, it was confirmed that the EPA’s reference dose

is correct.  We will hear from Dr. Vascken Aposhian, University of Arizona at

Tuscon, one of the scientists who worked on this report. Ramona Trovato will

testify on behalf of the Environmental Protection Agency.

Section 413 of the Food and Drug Administration Modernization Act of 1997[5]

required the FDA to compile a list of drugs and foods that contain

intentionally introduced mercury compounds, and provide a quantitative and

qualitative analysis of the mercury compounds in this list.  The Act also

requires the agency to compile the list and provide the analysis within two

years after the date of its enactment on November 21, 1997.  Dr. Egan

will be testifying on behalf of the Food and Drug Administration.

While thimerosal has previously been ruled by the FDA to fit the  “generally

recognized as safe” standard, when the FDA conducted their Over the Counter

(OTC) drug review they changed their minds.  The FDA determined that mercury

compounds used as active ingredients in Over the Counter drug products were

not found to be “generally recognized as safe.”  Additionally the FDA has not

approved any mercury containing compounds as food additives and does not

consider any mercury containing compounds to be “generally recognized as

safe.” [6]  On their own website, the FDA states, “lead, cadmium, and mercury

are examples of elements that are toxic when present at relatively low

levels.”[7] 

How is it that mercury is not safe for food additives and Over the Counter

drug products, but it is safe in our vaccines and dental amalgams?

Dr. H. Bernier, Associate Director for Science at the National

Immunization Program, Centers for Disease Control and Prevention will testify

regarding the recent discussion of the Advisory Committee on Immunization

Practices regarding thimerosal. 

Autism is a syndrome characterized by impairments in social relatedness and

communication, repetitive behaviors, abnormal movements, and sensory

dysfunction.  Autism may now affect 1 in 150 U. S. children.   We will hear

from Dr. Marie Bristol-Powers of the National Institutes of Health regarding

the existing research in autism.  The characteristics of autism and of

mercury poisoning are strikingly similar.[8]

          Dr. Cave, a physician from Baton Rouge, Louisiana will be

testifying about the mercury toxicity she is seeing in the 200 autistic

children she has as patients.

          Autism strikes families from a diverse background.  We will hear

from five parents today:  Birt of Chicago, an attorney and the

mother of an autistic child will be testifying about the need to remove

mercury from all vaccines and a citizens petition that is being presented to

the FDA making this request.

Several parents with scientific and medical backgrounds have written a report

entitled, “Autism: A Unique Type of Mercury Poisoning.” Three of these

parents will be testifying today.  The lead author of the report is Sallie

Bernard of Cranford, New Jersey.  Lyn Redwood of Tyrone, Georgia is a nurse

practitioner, and Albert Enayati, of Paramus New Jersey is a chemist.   Dr.

Sharon Humiston, a doctor with an autistic child will also be testifying.

          Our children are the future of this country.  As a Government we

have a responsibility to do everything within our power to protect them from

harm, including insuring that vaccines are safe and effective. Every day that

these mercury-containing vaccines remain on the market is another day we are

putting eight thousand children at risk.

The Record will remain open until August 1, 2000.

------------------------------------------------------------------------

[1]               MMWR Weekly Statement of July 9, 1999/48(26);563-565,

http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/mm4826a3.htm

[2]               CBER Letter – Dear Vaccine Manufacturer, Letter to Vaccine

Manufacturers Regarding Plans to

Continued use of Thimerosal as a Vaccine Preservative – Update, dated May 31,

2000, Available on http://www.fda.gov

[3]               In 1999, 11,000 children were born a day.  Of those,

approximately 73% received all of their recommended vaccines.

[4]                 Available at the National Academy Web Site

http://www.nas.edu

[5]               Public Law 105-115

[6]               Federal Register Notice of December 14, 1998 (Volume 63,

Number 239) Page 68775-68777, DOCID fr14de98-67

[7]               Chapter 14, Metals Analysis Training available at

http://www.fda.gov

[8]               Table A, A Comparison of Mercury the Effects of Mercury

Poisoning and

Autism, Autism:  A Unique Type of Mercury Poisoning, Sallie Bernard, Albert

Enayati, B.S., Ch.E., M.S.M.E., Binstock, Heidi , Lyn Redwood,

R.N., M.S.N., C.R.N.P., Woody McGinnis, M.D.

------------------------------------------------------------------------

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------------------------------------------------------------------------

[Guest guest]

Our son Mark was diagnosed with Autism in Nov. 1999 . He developed

normally for about the first two years. After reviewing his records , we

noted he had a 105 degree fever two days after his MMR vaccine . After the

vaccine, he had periods of " zoning " and staring into space that we

attributed to fatigue. He developed speech and then lost it. He slowly

withdrew and it has been an uphill battle since! At first, we dismissed the

vaccine-autism link, but are now convinced there is a relationship!

Any mom that received an MMR vaccine after the age of 16 can participate in

a study. Log onto: TLAutStudy@...

Sincerely,

Athena & Ken