Statement of Rep. Dave Weldon, M.D. Member of Congress Before the Institute of M

[Guest guest]

Statement of Rep. Dave Weldon, M.D.

Member of Congress Before the Institute of Medicine

On the Mercury-Vaccine-Autism controversy.

February 9, 2004

Good morning. I appreciate the opportunity to address you again.

I continue to be guided by a strong desire to get at the truth in

these matters and I believe passionately that we need to protect the

integrity of our national vaccine programs. In my clinical practice I

dispensed thousands of vaccines. I know that tremendous benefits to humanity

of vaccines, and the risks associated with an undermined confidence in

vaccines.

However, I continue to be the focus of a great number of phone calls

and inquiries from parents, scientists, autism interest groups, and more

recently members of the media. All are seeking information and answers to

the questions before you.

I am very disturbed by the continued number of reports I receive from

researchers regarding their experiences in pursuing these answers. It is

past time that individuals are persecuted for asking questions about vaccine

safety - we have recognized error before in the case of live polio,

whole-cell pertusis, and rotavirus.

Many have described encountering apathy from government officials

charged with investigating these matters, difficulty in getting their papers

published, and the loss of other research grants.

Others report overt discouragement, intimidation and threats, and have

abandoned this field of research. Some have had their clinical privileges

revoked and others have been hounded out of their institutions.

An example of the latter is Dr. Andy Wakefield who has described to me

how the intellectual climate at the Royal Free in London became intolerable

for him and he was forced to depart.

Virtually all of his ongoing research now has to be privately funded,

while those seeking to disprove him receive government money.

I witnessed some of this first hand at a hearing, when a Dr, Brent

made repeated inappropriate comments about Dr. Wakefield and his work

causing me to seriously question Dr.

's integrity and motives.

Mind you, half of Dr. Wakefield's theory has been proven correct and

accepted in the medical community. Hundreds of children with regressive

autism and GI dysfunction have been scoped and clinicians are seeing the

inflammatory bowel disease he first described. The NIH is finally funding an

attempt to repeat Dr. O'Leary's findings of measles RNA in Wakefield's

biopsy specimens, though I am disappointed it has taken this long.

A clinician in New York was poised to repeat Wakefield's work two

years ago, but he ultimately was refused by his IRB and then subsequently

had his clinical privileges withdrawn.

This atmosphere of intimidation even surrounds today's hearing. I

received numerous complaints that this event is not a further attempt to get

at the facts but rather a desire to sweep these issues under the rug. I

shared these with Dr. Gerberding. Last week she called me to assure me that

this is not the case. She informed me that she wants to meet with me and

some of the parents, clinicians, and researchers to work with them to get

the proper answers.

I understand that such outreach was attempted prior to her arrival,

but that effort turned out not to be a serious endeavor. Perhaps new

leadership will yield better results.

I stand ready to help with any funding issues. Though I must say that

in recent years both NIH and CDC have seen dramatic increases in their

funding, which unfortunately has not been matched with the will to fund the

research you called for.

I have considerable confidence in Secretary , and Dr.'s

Zerhouni and Gerberding.

However, they have not been well served by the people under them. I

was assured by Dr Gerberding over a year ago that she would welcome outside

researchers into the Vaccine Safety Datalink (VSD). It then took me over a

year to secure access for independent researchers.

Once in, it was quickly discovered that if you sort the VSD looking at

the children who in 1997 and later received thimerosal-free DTaP verses

those who received thimerosal-containing DTaP, there is a dramatic

statistically significant increase in autism for those receiving thimerosal.

Unfortunately, the CDC has hampered further research, by refusing to

make available post-2000 data.

Last Wednesday I read an article by Dr. Deth in Molecular Psychiatry

showing a possible biomolecular mechanism whereby thimerosal may act as a

neurodevelopmental toxin.

This article was very intriguing. However, I did not expect this

article to receive public attention. Amazingly the next morning my secretary

told me she heard this study discussed on a local country music station. It

has also received widespread attention in Canada.

A thorough medical literature search yields thousands of articles on

thimerosal many of them delineating its highly toxic nature, including

several recent studies reporting that thimerasol is as toxic as

methylmercury. Amazingly, some of these have actually been published by

government officials. Yet other officials claim the toxicity of thimerosal

is unknown, or not likely harmful.

Thimerosal and Neurodevelopmental Disorders In 2001 you concluded that

"exposure to thimerosal-containing vaccines could be associated with

neurodevelopmental disorders." I urge you not to retract from this

conclusion, but to build upon it.

Your recommendation in 2001 that there be an immediate effort to end

the administering of thimerosal containing vaccines to infants was wise.

Unfortunately, it was ignored. Existing stocks and new lots of such vaccines

were administered to millions of infants. Furthermore, the CDC is poised to

recommend thimerosal-containing flu vaccine to 6, 7 and 23 month old babies.

Some recent literature gives me further reason for concern: . Deth

provides a plausible mechanism to explain why some children are more

susceptible.

.. Bradstreet found that with chelation children with Autism excrete

more mercury than controls.

.. Holmes found less mercury in first baby haircuts for autistic

children verses controls.

.. Geier has found in VSD an association between higher mercury

exposure levels and Autism.

.. Even the much-maligned Verstraeten study found an association

between higher exposures to thimerosal and neurodevelopmental disorders in

some HMO populations.

Some have argued that there is no need for concern because methyl- and

ethyl-mercury react very differently in the body and that ethylmercury

exposure levels were too low to cause harm.

There is very little science to back up claim of no harm. In fact, a

review of the medical literature appears to show just how harmful thimerosal

is. Even Dr. Neal Halsey's evaluation of the Pichichero (Pediatrics 2003)

data found toxic exposure levels in some children.

In 2001 you recommended studies to compare children receiving

thimoersal with those who did not. You urged a monitoring of the prevalence

of neurodevelopmental disorders as thimerosal was removed.

Unfortunately, government officials have done neither. Outside

researchers have made some progress, but they have been hampered in gaining

adequate access to the VSD.

MMR and Autism With regard to MMR and Autism, I urge the Committee to

build upon its 2001 conclusions and recommendations. A strong signal from

you could lessen the intimidation obstructing this research. You concluded

that since the MMR was mandatory it was the responsibility of the government

to ensure its safety, even if hypothesized adverse outcomes are rare. I

concur.

As with thimerosal, my concerns about MMR have not subsided: . The NIH

is presently funding an effort to duplicate Wakefield.

.. Vaccine strain measles virus has been identified in the inflamed GI

tract of children with regressive autism . Measles virus antibodies have

been found in the CSF of children with regressive autism.

.. Rechallenge cases of children with regressive autism have been

observed and documented.

.. The medical community has largely accepted a new form of bowel

disease in children with regressive Autism.

Federal research funding has not been directed to investigating many

of your MMR research recommendations.

Also, a significant shortcoming of today's meeting is that Dr.

Wakefield was not invited. In 2001 you found that cases of MMR "rechallenge"

would provide evidence in favor of causality.

It is my understanding that Dr. Wakefield has developed such a case

series. The lack of an invitation is puzzling.

CDC Built-In Conflict of Interest While I have considerable respect

for Dr. Gerberding, I am concerned about the ability of the CDC's National

Immunization Program to objectively investigate this matter. The CDC has a

built-in conflict of interest that is likely to bias any reviews.

CDC is tasked with promoting vaccination, ensuring high vaccination

rates, and monitoring the safety of vaccines. They serve as their own

watchdog - neither common nor desirable when seeking unbiased research. This

has been a recipe for disaster with other agencies.

Congress recently saw the wisdom of splitting the FAA because its dual

functions left it conflicted between promoting flying and regulating the

flying public.

In the aftermath of the Space Shuttle Columbia accident, The Gehman

Comisssion found that a critical problem in the Shuttle program was that the

same individuals were responsible for flying the shuttle on time and flying

it safely.

This same conflict is inherent in the CDC. Unfavorable safety reports

lead to lower vaccination rates. An association with between vaccines and

autism would also force CDC officials to admit that their policies

irreparably damaged thousands of children.

Who among us would easily accept such a conclusion about ourselves?

Yet, this is what the CDC is asked to do. Also, the relationship between the

CDC and vaccine manufactures has become extremely close.

Given these facts, studies conducted for or by the CDC should be

evaluated with in this context.

Evaluating how best to eliminate this conflict of interest would be a

worthwhile endeavor for the IOM. I urge the IOM to take this matter under

review.

Further undermining my confidence in the CDC's ability to monitor

safety is the experience I had in assisting an independent researcher gain

access to the VSD and what we have discovered subsequently. The CDC erected

excessive barriers and has imposed severe limits on access to the data.

.. Researchers are not provided data collected beyond December 2000 -

seriously limiting the ability to provide for independent research to

observe the effects of the removal of thimerosal.

.. The IRB approval process forces researchers to receive approval from

as many as 7 IRBs - each with its own requirements.

.. CDC places strict limits on what data is available to researchers,

access to the complete database is virtually impossible, and the data is

made available on an inadequate PC.

.. Raw datasets used by the CDC to conduct their studies are not made

available to independent researchers - only altered datasets are provided,

thus the CDC's work cannot be evaluated by outside researchers. Does science

not demand the ability to fact check and replicate work? Conclusions To

summarize: Last week, Dr. Gerberding shared with me that she would be

devoting additional time personally to this issue and that she believed the

research should not end with this meeting. She indicated her desire to see

this research continue and emphasized that we should let the truth prevail,

regardless of the consequences.

.. I urge you to build on the recommendations and findings of possible

associations established in your 2001 reports on MMR and Thimerosal. There

are increased reasons for concern.

.. The evidence of persistent measles infection in the GI tract and CSF

of children with regressive autism continues to expand and further research

should be encouraged.

.. Many of the research recommendations you set forth in your 2001

reports have been ignored by federal research agencies.

.. Results of the Wakefield duplication study will not be known until

this summer.

.. Studies conducted by or in conjuction with the CDC should be

considered in the context of the CDC's inherent conflict of interest.

.. Neither the entire VSD, nor the datasets used by the CDC for their

studies are being made available for independent review.

.. More investigation is needed to answer these questions with the

degree of certainty that science demands.

In closing I would quote from the Verstraeten study. While I have

serious concerns about some of the findings in that study, I do concur with

one of their closing recommendations. The authors stated: "We believe that

additional investigation is required because of the widespread exposure from

vaccinating virtually the entire birth cohort of the United States and the

importance of speech and language disorders among children and adolescents.

For elucidating further whether a causal association exists between

thimerosal exposure and neurodevelopmental conditions, additional studies

with different designs will be needed."

I concur full with these remarks and encourage you to adopt this

recommendation by calling for a redoubling of these research efforts.