A-CHAMP LETTER TO NIEHS OBJECTING TO VSDL PANEL PROCESS

[Guest guest]

http://www.a-champ.org/documents/NIEHSltrExpmld5-2-06.pdf

A-CHAMP

May 2, 2006

By Fax: (919) 541-2260 and

E-mail: schwartzd@...

And U.S. Postal Service Express Mail

Director A. Schwartz, M.D.

National Institute of Environmental Health Sciences

111 T.W. ALEXANDER DRIVE

P.O. Box 12233

Research Triangle Park, NC 27709

Re: NIEHS VSD Panel Meeting Scheduled for May 4, 2006

Dear Dr. Schwartz:

We write to voice our concerns regarding the process employed by the

National Institute of Environmental Health Sciences (“NIEHS”) to

organize a meeting scheduled for May 4, 2006. Our understanding is that

invited participants to the meeting will review the use of the

CDC-supported Vaccine Safety Data Link (VSDL) to address questions

about changes in autism rates and their potential association with

thimerosal exposure through childhood vaccination.

A-CHAMP, Advocates for Children’s Health Affected by Mercury

Poisoning, is a not-for-profit organization founded and operated on a

volunteer basis by parents of children with neurodevelopmental

disorders and autism. Our organization consists of many leaders and

members of the autism community, including approximately 5,000 active

subscribers and 10,000 participants in one or more of our campaigns,

most of whom have children with autism or neurodevelopmental disorders.

Our constituency is actively engaged in advocating on the state and

Federal level to improve the welfare of their children.

We learned on April 29, 2006 about the details surrounding the planned

May 4, 2006 VSDL Panel meeting (hereinafter referred to as the “VSD

Panel meeting). As an organization dedicated to the welfare of

children with neurodevelopmental disorders, we object to the process by

which the meeting has been planned, the projected role planned for

officials of the Centers for Disease Control (“CDC”) in the meeting and

the failure of the NIEHS to conform to the recommendations contained in

a letter from Senator ph Lieberman and other members of Congress to

you dated February 22, 2006.

First, we submit that the manner in which the VSDL Panel meeting has

been established violates the spirit and legislative intent of the

statutory language that recommended a critical examination of the VSDL.

In the colloquy that occurred in connection with the Congressional

Joint Conference Report of the legislation urging study of the VSDL by

the NIEHS Senator ph Lieberman stated,

…ecause transparency of research has been an issue in this debate,

NIEHS cooperating with CDC would be able to put together a panel of

toxicologists, doctors, and expert representatives from the autism

community, and public health advocates to advise the study. They did

this with the NIEHS’ Breast Cancer Research Centers Program. That is,

they involved the affected community.”

In the Congressional letter of February 22, 2006 members of Congress

amplified their concerns and recommendations, stating that,

[w]e ask that NIEHS adhere to Congressional intent to convene a

workshop bringing together the various thimerosal-autism stakeholders,

including…the autism community and members of the public concerned

about vaccine safety research…

The process in which the NIEHS has engaged in developing the VSDL

Panel has been anything but transparent. A-CHAMP and many other

organizations in the autism community were neither consulted about

“representation” at the VSDL Panel meeting nor even informed that a

meeting was planned. Once we became aware that a meeting might be

planned we were unable to obtain meaningful information about the

meeting – such as the date and location, agenda, identity of

participants – until 3 business days prior to the scheduled meeting

date. To our knowledge, as of the writing of this letter, there has

been no public notice of the May 4, 2006 meeting.

We have no knowledge of the process undertaken, if any, to include

members of the “affected community.” In addition the Congressional

request that “thimerosal-autism stakeholders” be included has been

ignored. As far as we are concerned the process utilized to establish

the meeting is flawed and as a result we are not represented. When

there exists no process and no transparency there can be no meaningful

“representation” if that word is to have any meaning.

We have additional concerns based on the history of the CDC’s past use

of the VSDL. As emphasized by several members of Congress in their

February 22, 2006 letter,

…a CDC-led study on thimerosal and autism could be viewed with much

skepticism and may not be accepted by the growing number of parents

with concerns about vaccine safety and the possible links between

thimerosal and autism. If the federal government is going to have a

study whose results will be broadly accepted, such a study cannot be

led by the CDC. It is for these reasons we believe that NIEHS is the

most appropriate entity to lead such an investigation.

In direct opposition to the Congressional concerns reported in the

Congressional letter the NIEHS has accorded the CDC an inappropriately

prominent role in the VSDL Panel meeting. We are concerned that the

VSDL Panel meeting agenda permits Dr. , a co-author of the

CDC’s VSDL study published in Pediatrics, the opportunity to lead the

VSDL Panel and Dr. DeStefano, a co-author of the CDC Pediatrics

article, an opportunity to charge the panel. The NIEHS planned role for

Dr. , Dr. DeStefano and other key members of the CDC would place

the CDC members of the VSDL Panel in control of the NIEHS meeting. The

CDC would thus be in a position to investigate their own actions,

defeating the very purpose and spirit of the legislation that urged the

establishment of the VSDL Panel. Drs. and DeStefano will, in

effect, be investigating themselves. In this context, we note and ask

you to be mindful of the serious criticism of the CDC in its handling

of the VSDL made by the Institute of Medicine.

In sum, the process and the participants chosen by NIEHS cast great

suspicion on the credibility of the VSDL Panel meeting and will

undermine its ability to deliver a report that is honest and impartial.

We respectfully ask you to be mindful that the role played by the CDC

in NEIHS’s work on the VSDL will cause great difficulty in establishing

broad acceptance for the NIEHS work in this area with the autism

community. The NIEHS’s chosen path in giving the CDC a prominent role

in the face of its past record may erode the credibility of the NIEHS

and other agencies involved in this endeavor.

We also have concerns that conflicts of interest exist with respect to

some panel numbers and that they cannot objectively participate in the

VSDL Panel meeting. We trust that the NIEHS will resolve this matter in

a manner consistent with its past record of independence and honesty.

We also have serious concerns about the role accorded to the autism

organization participants who were invited by the NIEHS to participate

in the VSDL Panel. We have learned that no autism organization

participant is going to be presenting or speaking at the VSDL Panel

meeting. This raises further concerns about the fairness and openness

of the process created by the NIEHS for the meeting.

Our criticism of the VSD Panel meeting and the objection we register

in this letter to the organizational process used by the NIEHS is

limited to the VSD Panel meeting only and to the NIEHS’s implementation

of the legislation and Congressional recommendations regarding

epidemiology in utilizing the VSDL. Our criticisms do not extend to any

other activities of the NIEHS that have, over the years, been of

enormous value and import for our nation and for our children in

particular. We in no way attribute the problems with the VSD Panel

meeting process to the actions of any autism organization or their

participation in the planning of the VSD Panel meeting. We commend the

NIEHS for its support, which we understand is continuing, of work

related to investigation of the role of environmental factors,

including mercury in vaccines, in children’s health that is being

pursued in conjunction with some of our fellow autism organizations. In

our view this work is historic and it would be regrettable if we allow

the problems with the VSDL Panel meeting to affect that important work

in any way. We urge the NIEHS to continue its work with our brother

and sister organizations.

Based on all the foregoing factors we object to NIEHS’s plans to

conduct its meeting of the VSDL Panel. We submit that the process

utilized to convene the VSDL Panel meeting is fatally flawed. Further,

we respectfully request that the planned meeting be reorganized. The

NIEHS must immediately engage in discussions with all the

“stakeholders” and “affected communities” to construct a meaningful

plan to fulfill the helpful recommendations contained in the

Congressional letter of February 22, 2006 and the legislation calling

for transparent and honest use of the VSDL.

Respectfully submitted,

Bobbie Manning,

Vice-President,

Board of Directors

A-CHAMP

BM/rkac