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Statement on NIP's Procedures and Data Sharing Program

Barbara Loe Fisher, Co-founder & President

National Vaccine Information Center
August 23, 2004

Institute of Medicine Committee of NIP's Procedures
and Data Sharing Program
Keck Center of the National Academy of Sciences
Washington, D.C.

My name is Barbara Loe Fisher. I am the mother of a DPT vaccine injured son and co-founder and president of the National Vaccine Information Center, a national, non-profit organization founded by parents of vaccine injured children in 1982 and dedicated to preventing vaccine injuries and deaths through public education. It was more than two decades ago that parents of vaccine injured children launched a national, grassroots movement to institute safety reforms in America's mass vaccination system, which began in 1985 with the publishing of DPT: A Shot in the Dark followed by passage of the National Childhood Vaccine Injury Act signed into law by President Reagan in 1986 and highlighted by not only the licensing of the acellular DTaP vaccine for babies in 1996 and the replacement of live oral polio vaccine with inactivated polio vaccine in 1999, but now with an expanding public awareness that the ever increasing numbers of vaccines recommended by government health officials over the past quarter century are associated with increases in chronic disease and disability, including learning disabilities, attention deficit disorder, autism, asthma and diabetes.

With heightened public awareness that many of the world's most highly vaccinated children are contracting far fewer infections in childhood but are growing up chronically ill with various kinds of brain and immune system dysfunction, there is careful scrutiny by parents of the science and public policy which supports the mass use of multiple vaccines by all children. And this increased parental scrutiny of vaccine science and policy has resulted in a significant number of parents, whose once healthy children regressed after vaccination, questioning and publicly criticizing the quality and integrity of that science and policy. And with that public questioning and criticism, has come a massive, coordinated defense by the health care professionals, institutions and corporations who operate the nation's mass vaccination program. At stake: the public trust and confidence that what public health officials and doctors tell them is true about the safety and effectiveness of vaccines is, in fact, true.

Trust is a fragile, almost indefinable commodity. Trust is what we do when we believe in something or someone enough to take a risk. It often requires a leap of faith quite separate from the numbers used to come up with statistical benefit and risk analyses. Trust, once lost, is very hard to regain. And so, for institutions and corporations to keep the public trust they must behave and respond to public questions and criticism in ways that reinforce and instill confidence in the truthfulness and integrity of what they are saying and doing, particularly when the lives and health of children are involved.

The responsibility, then, for ensuring public faith in the mass vaccination system lies with those operating the mass vaccination system and not with those who are questioning the integrity of it. Blaming the victim is not an option here, not if the crisis of faith in the system is going to be effectively addressed and solved.

I would like to examine, then, the basis for the eroding trust in the mass vaccination system as it applies to the subject at hand: the ethics and procedures that government is using to share data contained in a government operated vaccine risk assessment database known as the Vaccine Safety Datalink. But before I go to the VSD specifically, I want to review a few facts which precede this IOM Committee meeting and have led to a climate of distrust which prompted six parent groups to hold a press conference outside this building this morning. There is a fear by many parents of children with vaccine associated autism that this IOM Committee has been assembled at the request of government to continue to deny the public access to government held data about vaccine risks and to use the conclusions of this Committee to deny parents of vaccine injured children compensation in the federal Vaccine Injury Compensation Program.

What is the basis of this fear?

SLIDE:   D.A. Henderson, M.D., on DPT Vaccine Reactions:
" We do not find evidence of any long term brain damage, none at all.
We do not see evidence of seizure disorders."
-Transcript of NBC "NOW Show", March 2, 1994

First: There is a long history of denial by government health officials that vaccines cause brain injury, immune system dysfunction and death as evidenced by congressional testimony and public statements by federal health officials beginning in the early 1980's, when they vigorously opposed the National Childhood Vaccine Injury Act of 1986 created by Congress; when they rewrote the definition for brain injury in 1995 to help them fight every vaccine injury claim in the no-fault federal Vaccine Injury Compensation Program and now as they join with industry in the Brighton Collaboration, which is further re-writing the definition of what qualifies as a vaccine reaction leading to permanent injury. This pattern of denial of vaccine risks is most clearly manifested in the refusal by federal health agencies to fund or conduct vaccine risk research into the biological mechanisms for vaccine injury and death in order to develop pathological profiles to separate out what is and is not vaccine-induced as well as identify genetic and other high risk factors to screen out the biologically vulnerable. Instead, the CDC relies almost exclusively on closed government databases as well as methodologically flawed epidemiological studies using retrospective case analyses of old medical records to come up with key vaccine risk assessment conclusions that almost always deny any association between vaccines and significant health problems.

SLIDE:   AUTISM A.L.A.R.M.
1 out of 6 children are diagnosed with a developmental disorder and/or behavioral problem;
1 in 166 children are diagnosed with autism spectrum disorder

Second: This year government health officials and the American Academy of Pediatrics put out an Autism Alarm to the public announcing that 1 in 6 children in America have been diagnosed with a developmental disorder or behavioral problem and 1 in 166 children has been diagnosed with autism spectrum disorder, which represents a stunning 200 to 7,000 percent increase in autism in every state over the past two decades.

Third: More and more parents are reporting that their healthy children are regressing into autism following vaccination and there nearly 5,000 autism vaccine injury cases pending in the U.S. Court of Claims, which administers the federal Vaccine Injury Compensation Program; and

Fourth: Research conducted by independent non-government, non-industry academic researchers at major universities are finding that vaccines can cause brain and immune system damage leading to neurodevelopmental disorders such as autism; and

SLIDE:  Thimerosal Containing Vaccines and Health Problems
Unpublished VSD Data

  • stammering
  • tics
  • sleep disorders
  • eating disorders
  • emotional disturbances
  • attention deficit disorder
  • speech and language disorders
  • coordination problems
  • seizures
  • autism
  • other significant health problems

Fifth: Parents, Congress and the Institute of Medicine have evidence that the government's own vaccine risk assessment database, the Vaccine Safety Datalink, detected a statistically significant association between thimerosal containing vaccines and developmental and behavior disorders, including stammering, tics, sleep disorders, eating disorders, emotional disturbances, attention deficit disorder, speech and language disorders, coordination problems, seizures, autism, and other health problems but this information was withheld from the public; and

SLIDE:   Institute of Medicine Report on Autism and Vaccines

"…the Committee concludes that the evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism…..

The Committee concludes that the evidence favors rejection of a causal relationship between MMR vaccine and autism…

The Committee does not consider a significant investment of studies of the theoretical vaccine-autism connection to be useful at this time."
- Institute of Medicine
- May 18, 2004

Sixth: Despite government and independent scientific evidence that vaccines are associated with autism, in May 2004 the Institute of Medicine issued a report denying thimerosal or MMR vaccine can cause autism. The IOM called for a halt to funding of research into vaccine associated autism stating that "The Committee does not consider a significant investment of studies of the theoretical vaccine-autism connection to be useful at this time."

SLIDE:   U.S. Court of Claims Relies on IOM Reports

"I find it quite appropriate to utilize the 2004 IOM Report as a tool for identifying the items of evidence that are available concerning the general issue of whether MMR vaccines cause autism….the Institute of Medicine seems clearly to be an appropriate source of expert assistance for a special master in a Vaccine Act proceeding……I note that during the 15-year history of the Vaccine Act, special masters have consistently referred to and relied upon [those] reports of the Institute of Medicine."
- July 16, 2004 Special Master Ruling in the U.S. Court of Claims
In Re: Claims for Vaccine Injuries Resulting in Autism Spectrum
Disorder or Similar Neurodevelopmental Disorder

The US Court of Claims relies heavily upon IOM's vaccine risk assessment conclusions in denying or awarding compensation to vaccine injured children. Shortly after the 2004 IOM report on vaccines and autism was issued, one U.S. Special Master stated "I find it quite appropriate to utilize the 2004 IOM report as a tool for identifying the items of evidence that are available concerning the general issue of whether MMR vaccines cause autism….the Institute of Medicine seems clearly to be an appropriate source of expert assistance for a special master in a Vaccine Act proceeding…I note that during the 15-year history of the Vaccine Act, special master have consistently referred to and relied upon those reports of the Institute of Medicine."

Within the next year, the U.S. Court of Claims will conduct an Omnibus hearing on whether nearly 5,000 cases of alleged vaccine induced autism associated with mercury in vaccines will be allowed to proceed.

Is it a coincidence that the Department of Health and Human Services, which is the defendant in the U.S. Court of Claims, has quickly called for the IOM to assemble a Committee to consider if, who, when and why the public can have access to a closed government vaccine risk assessment database that already has been used by government health officials and the IOM to tell the public there is no association between vaccine mercury preservatives and autism?

Many parents of vaccine injured children don't think it is a coincidence, just like they don't think it is a coincidence when a healthy child goes in for vaccinations and then regresses physically, mentally and emotionally and becomes a totally different child. What government health officials are saying is true about vaccine safety conflicts with what parents have experienced with their own children in real life.

Parents want someone, other than corporations selling vaccines or government officials developing, regulating, making policy for and promoting mass use of vaccines, or doctors getting grant money from industry or government, to confirm the truth about vaccine risks. Because the hallmark of good science is replication and the hallmark of good government is transparency, the public has good reason to be appalled at the description of the lengths to which CDC officials have gone to deny independent vaccine safety researchers Mark and David Geier access to vaccine risk information in the publicly-funded Vaccine Safety Datalink (VSD). This kind of behavior on the part of government health officials does not give the public reason to trust what government has said is true about the safety of vaccines. If there is nothing to hide, why are CDC officials going to such great lengths to keep their own data, which they say exonerates vaccines from playing any role in autism, hidden?

There is unpublished data from the VSD which indicates that, in addition to autism, there are other relationships between vaccination and chronic health problems which have been kept hidden from the public, including a relationship between bowel blockage and oral polio vaccine, vaccines and diabetes, among other serious health problems. In 2001, VSD data was used by the CDC to publish an article in the medical literature denying that seizures following DPT and MMR vaccine are associated with permanent brain injury. At that point, we put out a national press release calling for full public access to the VSD, something our organization had been calling for since the late 1990's and Congressman Burton had called for in his congressional hearings and his staff worked on for two years. Even though the VSD published data in that 2001 study showed an elevated risk of seizures following both those vaccinations, even though 25 children in the study were left with neurodevelopmental deficits, even though the CDC never compared the health of those children with those who never had a seizure or who were never vaccinated, the message that was sent to the media and doctors and the public was that it doesn't matter if your child has a seizure after vaccination, keep on vaccinating.

Well, more than 50 years of evidence in the medical literature and 22 years of operating a Vaccine Reaction Registry at the National Vaccine Information Center tells us that it does matter if you vaccinate a child who has seizures following vaccination. Because if you keep on vaccinating in the face of seizures you have a very good chance of ending up with a severely brain damaged child who drools and twitches and can't learn to read or write or go to the bathroom without help or grow up to drive a car and go to college and get a job and be a productive member of society. So what is done with the data in the VSD matters a lot in terms of what is done to children in real life all over this country.

SLIDE:   VSD Unpublished Data Finds Autism-Thimerosal Link

"This analysis suggests that in our study population, the risks of tics, ADD, language and speech delays and developmental delays in general may be increased by exposures to mercury from thimerosal-containing vaccines during the first six months of life. Confirmation of these findings in a different population and further quantification of the dose response effect are needed."
- CDC Unpublished findings
VSD Database
Year: 2000

CDC officials looking at the VSD data in the year 2000 concluded in an unpublished report that "this analysis suggests that in our study population, the risks of tics, ADD, language and speech delays and developmental delays in general may be increased by exposures to mercury from Thimerosal-containing vaccines during the first six months of life. Confirmation of these findings in a different population and further quantification of the dose response effect are needed."

CDC officials, then, appear to be well aware that the hallmark of good science is replication.

SLIDE:  "The CDC recognizes the importance of data sharing when questions are raised regarding a particular study's design and methodology…..the CDC has developed a data sharing process designed to allow an independent researcher to replicate or conduct a modified analysis of a previous VSD study, while maintaining the confidential nature of the data."
- Roger Bernier, M.D., Associate Director for Science
National Immunization Program
Testimony in Congress: 2002

Roger Bernier, associate director for science at the CDC's National Immunization Program stated in congressional testimony in 2002 that "The CDC recognizes the importance of data sharing when questions are raised regarding a particular study's design and methodology." He went on to reassure U.S. House Government Reform Committee Chairman Dan Burton that "the CDC has developed a data sharing process designed to allow an independent researcher to replicate or conduct a modified analysis of a previous VSD study, while maintaining the confidential nature of the data."

Well, then, what is the problem? Let the data sharing begin!

More than a decade ago the Centers for Disease Control created the Vaccine Safety Datalink and paid Health Maintenance Organizations for their cooperation just as it is now, apparently, paying a subcontractor to handle administration of the VSD. The multi-million dollar bill is being paid by all Americans, just like the multi-billion dollar bill for vaccine injuries is being paid by all Americans. What I didn't know until today, is that the participating HMO's can sell the vaccine information they have been paid to collect by the CDC to vaccine manufacturers.

The American government owes it to the people to be open and honest about what it does and does not know about the association between vaccines and chronic disease and disability. Let the people, especially independent researchers free from financial ties to industry and financial and ideological ties to the public health infrastructure, have access to the VSD data to both replicate and confirm the vaccine risk assessment conclusions of government health officials and also to conduct independent research into reported vaccine health risks. The data is the data and if CDC officials are right, the VSD data should confirm for independent researchers what government has been saying all along: vaccines carry few, if any, risks to the long term health and well being of America's children.

The National Vaccine Information Center agrees with the statement issued today by SAFEMINDS and other parent organizations calling on the Secretary of the Department of Health and Human Services to allow full and immediate access to the VSD by independent researchers. We know there are many other parents, grandparents and health care professionals in America who are not represented by these organizations or ours who also agree. The National Vaccine Information Center is therefore launching a national petition drive to obtain the names of citizens around this country who want to make their voices heard on this subject. The petition states:

SLIDE:  "We call on the Secretary of Health, Tommy Thompson, to provide the public, especially non-government, non-industry affiliated vaccine researchers, with full, open and timely access to all government vaccine safety monitoring data, including the Vaccine Safety Datalink (VSD)."

Whereas,

Vaccines are given to healthy children and carry an inherent risk of injury or death; and

Federal officials recommend vaccines for universal use and states base their mandatory vaccination laws on those recommendations; and

National monitoring of vaccine reactions is almost non-existent because there is no enforcement of a 1986 federal law requiring doctors to report adverse events to the federal government; and

The vast majority of vaccine safety studies are conducted by government health officials promoting the mandatory use of vaccines and drug companies selling vaccines; and

The government bases its research and conclusions that licensed vaccines are safe on unpublished data, including data contained in closed government-operated databases, like the Vaccine Safety Datalink (VSD), and

The hallmark of good science is replication and the hallmark of good government is transparency;

Therefore,

We call on the Secretary of Health, Tommy Thompson, to provide the public, especially non-government, non-industry affiliated vaccine researchers, with full, open and timely access to all government vaccine safety monitoring data, including the Vaccine Safety Datalink (VSD).

This on-line petition, called Show Us The Vaccine Data, will be on the internet tomorrow and can be accessed through www.nvic.org/petition.htm for all who want to sign it.

SLIDE:  "The lack of adequate data regarding many of the adverse events under study was of major concern to the committee. Presentations at public meetings indicated that many parents and physicians share this concern….in the course of its reviews additional obvious needs for research and surveillance were identified."
- Institute of Medicine Vaccine Safety Committee
Adverse Events Associated with Childhood Vaccines
1994

In closing, it should not be forgotten that in 1991 and 1994 there was historic acknowledgement by the Institute of Medicine, in reports commissioned by Congress under the National Childhood Vaccine Injury Act, that vaccines can cause brain and immune system dysfunction. The Institute of Medicine, National Academy of Sciences, was the first scientific body in the world to call for more credible basic science research, as well as epidemiological research, into how, why and how frequently vaccines leave some individuals with chronic disease and disability. This was a scientifically responsible and humane action to take more than a decade ago.

SLIDE: Epidemic of Chronic Illness and Disability in Children

· 1 in 6 have development delays or behavioral disorders.
· 3 million learning disabled schoolchildren
· 94,000 autistic schoolchildren
· 4 million with ADHD
· 9 million with asthma
· 300,000 have juvenile rheumatoid arthritis
· 1 in 400 to 500 are diabetic

Today, we stand before you facing the stark reality that 1 in 6 American children have development delays or behavioral disorders. 3 million children in public schools are classified as learning disabled and 94,000 more classified as autistic. 4 million children have been diagnosed with ADHD. 9 million children have been diagnosed with asthma. 300,000 children have juvenile rheumatoid arthritis. And 1 in 400 to 500 children is diabetic. This certainly qualifies as an epidemic of chronic illness and disability in children.

The American people want to know why so many highly vaccinated children are so sick. They want and deserve an answer to that question. Openly and honestly analyzing information on vaccine risks contained in government databases, such as the VSD, is one place to begin. And it is up to all of us, parents and health care professionals, government officials and industry to continue searching for the answer to that question until we have found it. It doesn't matter where we have to look or what we have to spend or how many times we have to examine a biologically plausible but politically incorrect hypothesis to find that answer. All that matters is finding the answer because the biological integrity of our children, and our nation's future, hangs in the balance.
For more information on this meeting and other presentations click here:
nationalacademies.org/hmd/Activities/HealthServices/NIPDataSharing/2004-AUG-23.aspx


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