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Parents vs. the Science? Ask Geraldine Dawson and Autism Speaks.

Posted Jan 25 2010 12:00am

Reach out By J.B. Handley

For the first time ever, I’m more hopeful that Autism Speaks may be headed in the right direction. I don’t care too much for their advocacy. Yes, they have absolutely increased the awareness of autism. Yes, they have raised a war chest of funds to support autism research. Yes, they have positioned themselves as committed to the science of autism above all else. These are all good things.

But, I also feel Autism Speaks has really, really let down our kids. They turn a blind eye to stories of recovery, and I still don’t understand why. The have wasted boatloads of money on useless genetic research. And, when it comes to the dreaded “V” word – vaccines – Autism Speaks appears to behave more politically than scientifically. They seem to toe the line, never warning parents of vaccine risks, while trying hard not to alienate our community too much. Are they worried about alienating their donors? Damn straight.

I want Autism Speaks to be a great organization. I want them to end this senseless epidemic. I truly believe that Autism Speaks and the AAP are the only two organizations that can put an end to the autism epidemic, and the AAP is hopelessly devoted to vaccines.

My hope comes from a letter, written almost a year ago, that an AoA reader pointed out to me. A letter buried in the feedback to the National Vaccine Advisory Committee that I never noticed and have been unable to find anywhere online, except buried in a lengthy pdf document (HERE). So, for the first time I know of, the letter, written by Autism Speaks Chief Science Officer Geraldine Dawson, is printed below in its entirety so it can be found on the web.

Journalists and our opposition work very hard to portray the vaccine vs. autism debate as one that pits “Science” versus “Parents.” They pretend this debate is over and they want to ridicule our side and make it look like we are all flat-earthers. It’s why a letter like the one below is so refreshing. The next time a journalist, friend, or relative annoys you with their ignorance, just send them this link – the letter is filled with a remarkable number of nuggets, insights, and truths. All written by a PhD scientist, not a parent.

To make life easier for AoA readers, I have also included my Top 17 list of quotes from Autism Speaks’ letter to the Department of Health and Human Services National Vaccine Advisory Committee (NVAC). (It perhaps goes without saying that nearly one year after Dr. Dawson wrote this letter, our government has done nothing to address any of the great ideas included here):

Top 17 quotes from Autism Speaks’ Letter to the NVAC

1. “In the past several years, the prevalence of ASD has increased dramatically, underscoring the potential role of environmental factors in its etiology.”

2. “Recent studies point to a key role of the immune system in the biology of ASD, raising questions about the effects of the significant immune challenges associated with vaccinations, particularly when delivered in combination and early in life.”

3. “We believe that the question of whether immunization is associated with an increased risk for ASD is of extremely high priority.”

4. “Still other studies point toward subgroups of children with ASD with genetic vulnerabilities than can amplify the adverse effects of environmental exposures, including vaccinations, on brain development and function”

5. “There is a need to describe the nature and prevalence of vaccine adverse events in children with metabolic disorders and assess risk factors for these events.”

6. “As mentioned in the draft scientific agenda, many key questions have not yet been adequately addressed. Many of the studies to date have relied on data from the Vaccine Adverse Effects Reporting System (VAERS). While this system has clear strengths such as its broad coverage, it nevertheless has substantial limitations (Ellenberg and Braun, Drug Safety, 2002). Because the system relies on passive self‐report, a major limitation is under‐ reporting such that only a small fraction of adverse events are reported. Furthermore, events that occur weeks following vaccination are less likely to be reported than those that are proximal to the vaccination.”

7. “Many fundamental questions have not been addressed, such as whether the use of combination vaccines confers increased risk for adverse events and whether there are subgroups in the general population that are more vulnerable to serious adverse effects of vaccines, including ASD.”

8. “Research has shown that children with metabolic disorders, including mitochondrial disorders, may experience neurological decline when physiologically challenged. There have been reports of metabolic crisis after receiving vaccinations”

9. “As noted in the draft agenda, preliminary results from a VSD study underway found that children aged 12‐23 months who received MMRV vaccine were about 2 times more likely to have febrile seizures during the 7‐10 days after vaccination than children who received separate MMR and varicella vaccines at the same visit (CDC MMWR, 2008). In a population‐based study, there has been a report of an increased risk for ASD after infantile seizures during the first year of life”

10. “Studies that can address the current questions raised by parents are feasible. Clinical studies of individuals with ASD can address whether certain metabolic conditions associated with ASD are correlated with increased risk for serious adverse effects. Case‐control studies and randomized clinical trials can be conducted to address whether there are differences in adverse effects associated with a combination vaccine versus individually administered components”

11. “Fever after vaccination is common and can induce seizures in vulnerable children”

12. “For example, a recent study identified mutation in a sodium channel gene in children who developed encephalopathy after pertussis vaccines, suggesting that genetic factors may influence the risk for neurological deterioration after vaccination”

13. “Children with metabolic diseases are at higher risk of health complications from diseases that are prevented by immunizations”

14. “Such research could have wide‐ranging effects on clinical practice/vaccination policy.  For example, it could allow pediatricians to identify subgroups of children who may benefit from a different vaccine schedule or for whom careful monitoring of adverse effects is warranted.”

15. “Over the past decade, parental concerns, both in the general population and the autism community, over the possible link between immunization and increased risk for autism spectrum disorders (ASD) have only increased despite concerted and persistent efforts by the medical community to reassure the public about the safety of vaccines.”

16. “It is Autism Speaks’ position that the best way to ensure that parents are confident in the safety of our vaccine program and, at the same time, protect the minority of children who may be at increased risk for serious adverse effects of vaccinations, is to foster collaborative, trusting relationships among the general public, the medical and scientific communities, and the federal government whose mandate it is to conduct research on the safety of vaccines.”

17. “Establishing and maintaining a trusting relationship and providing answers to parents’ questions cannot be achieved by one set of studies addressing one set of questions, but rather it will require an on‐going process of scientific discovery as medical science continues to uncover individual differences that predict differential responses to vaccines and other medical interventions. We need to embrace our obligation to address new questions with an open mind, adequate resources, and renewed commitment.” 

Appendix: complete letter from Autism Speaks to the NVAC

January 25, 2009

National Vaccine Advisory Committee
National Vaccine Program Office
U.S. Department of Health and Human Services
200 Independence Avenue SW, Room 443‐H
Washington, DC 20201
 
Dear Members of the National Vaccine Advisory Committee:
 
This letter concerns the Center for Disease Control and Prevention’s (CDC) Immunization Safety Office (ISO) draft scientific agenda that identifies vaccine safety issues for scientific study over the next five years. We understand that the draft agenda is currently being reviewed by the National Vaccine Advisory Committee (NVAC), which  is responsible for coordinating and ensuring collaboration among the Federal agencies involved in vaccine and immunization activities, including the National Institutes of Health. The committee has requested input from community stakeholders in three broad areas: (1) concerns about vaccines and immunization safety, (2) comments on what values and factors are considered most important in prioritizing scientific research, and (3) what scientific issues should be included in the ISO scientific agenda. We will address each of these areas below.
 
Concerns about vaccines and immunization safety
 
As the nation’s largest autism advocacy organization whose mission is to promote autism awareness, increase services, and fund biomedical research on the causes, prevention, treatments, and cure for autism, Autism Speaks has a strong stake in the priorities set forth in the ISO scientific agenda on vaccine research. Over the past decade, parental concerns, both in the general population and the autism community, over the possible link between immunization and increased risk for autism spectrum disorders (ASD) have only increased despite concerted and persistent efforts by the medical community to reassure the public about the safety of vaccines. Indeed, recent research suggests that approximately 28% of parents in the general population feel doubtful about vaccines, with close to 20% choosing to delay or refuse vaccinations for their child (Gust et al., Pediatrics, 2008). The percentage of parents who are delaying or refusing to vaccinate their children means that the U.S. is alarmingly below the recommended 85‐90% “herd immunity” levels that are an important component of protecting our society against communicable diseases.

As outlined in Autism Speaks’ policy statement posted on our website (see
http://www.autismspeaks.org/policy_statements.php), we are “committed to the health and well‐being of all children. As such, we support the programs that ensure the public health, including an effective and safe immunization program designed to prevent major diseases.” It is Autism Speaks’ position that the best way to ensure that parents are confident in the safety of our vaccine program and, at the same time, protect the minority of children who may be at increased risk for serious adverse effects of vaccinations, is to foster collaborative, trusting relationships among the general public, the medical and scientific communities, and the federal government whose mandate it is to conduct research on the safety of vaccines. Studies reveal that the key issue identified as contributing to parental willingness to have their child vaccinated is having a trusting relationship with the medical community, including their own physician (Benin et al., Pediatrics, 2006). Autism Speaks’ position is that the most effective means of establishing trust between the general public and the medical community is to directly and immediately address the on‐going questions that parents have regarding the safety of vaccines. Even though studies addressing safety require time and resources, the willingness of the government to quickly address these questions will install a sense of trust, respect, collaboration, and transparency. 
 
Values and factors considered most important in prioritizing scientific research
 
We believe that the question of whether immunization is associated with an increased risk for ASD is of extremely high priority. We reference here the criteria with which the CDC itself establishes priorities for research, as described in the draft scientific agenda: 
 
Criteria for prioritization (see pg. 42, CDC ISO draft scientific agenda):
 
1. Clinical severity of the adverse event in terms of seriousness and duration. 

ASDs are a group of severe developmental disabilities characterized by lifelong impairments in communication and social interaction. Many individuals with ASD never speak or live independently, have severe cognitive disabilities, and suffer a wide range of associated medical conditions. In the past several years, the prevalence of ASD has increased dramatically, underscoring the potential role of environmental factors in its etiology. Currently, ASD is a highly prevalent disorder, estimated to occur in 1 out of every 150 individuals. The total annual societal per capita costs of caring for and treating a person with ASD in the U.S. is estimated to be $3.2 million and approximately $35 billion of the entire birth cohort of people with ASD (Ganz, Archives of Pediatric and Adolescent Medicine, 2007). 
 
 2. Biological plausibility
 
The causes of ASD remain poorly understood, but it is generally agreed that both genetic and environmental factors play a role in the etiology of ASD. It is well established that there are connections between the immune system and brain development, with neuroimmune interactions persisting throughout the lifespan. Recent studies point to a key role of the immune system in the biology of ASD, raising questions about the effects of the significant immune challenges associated with vaccinations, particularly when delivered in combination and early in life. Among the immune abnormalities found to be associated with ASD are abnormal cytokine profiles, decreased lymphocyte numbers, decreased T cell mitogen response, and an imbalance of immunoglobulin levels (Ashwood et al., J. Leukocyte Biology, 2006;). Abnormalities in the expression of immune‐related molecules such as cytokines in the brain and cerebral spinal fluid have been documented in individuals with ASD, suggesting that ASD is associated with chronic neuroinflammation (Vargus et al. Annuls of Neurology, 2005; Zimmerman et al. Pediatric Neurology, 2005). Other studies highlight the impact of maternal immune challenge on the fetal brain and potential pathological consequences on brain and behavioral development (Patterson, Behavioral Brain Research, 2008). Still other studies point toward subgroups of children with ASD with genetic vulnerabilities than can amplify the adverse effects of environmental exposures, including vaccinations, on brain development and function (Pessah et al., Neurotoxicology, 2008).  The question of whether the genetic and immune vulnerabilities contribute to increased risk for adverse effects of vaccines, including fever, seizures, and ASD, has not been well studied.

In addition to abnormalities of the immune system, ASD has also been found to be associated with inherited metabolic diseases (Manzi et al. J. of Child Neurology, 2008), including mitochondrial disease (Weissman et al., PLoS ONE, 2008). There is a need to describe the nature and prevalence of vaccine adverse events in children with metabolic disorders and assess risk factors for these events.
 
3. Population exposed to the vaccine
  
The vaccines of concern are recommended for all children below the age of two years. 

4. Level of public concern
 
Studies show that when parents are unsure or refuse to vaccinate, the most common reason for parents’ doubt about vaccines is a concern about safety and adverse effects (Gust et al., Pediatrics, 2008).  Cases of measles in England and Walesa, where there is a high level of parental concern about the safety of the MMR vaccine, are the highest in 13 years (Kmietosicz, British Medical Journal, 2008). Clearly, it is crucial that parental concerns are addressed so that confidence in the safety of vaccines can be increased.

5. Feasibility of designing and implementing study
 
Studies that can address the current questions raised by parents are feasible. Clinical studies of individuals with ASD can address whether certain metabolic conditions associated with ASD are correlated with increased risk for serious adverse effects. Case‐control studies and randomized clinical trials can be conducted to address whether there are differences in adverse effects associated with a combination vaccine versus individually administered components (e.g. Guerra et al., Pediatrics, 2009). Studies of infant siblings of children with ASD, who are at higher risk for developing the disorder, offer an opportunity for studying gene‐environment interactions. The National Children’s Study is examining the influences of a wide range of environmental and genetic factors on risk for health outcomes. This resource can provide another means for studying whether vaccines are associated with increased risk for neurodevelopmental disorders in subsamples of the general population.
 
6. Adequacy of current scientific knowledge
 
As mentioned in the draft scientific agenda, many key questions have not yet been
adequately addressed. Many of the studies to date have relied on data from the Vaccine Adverse Effects Reporting System (VAERS). While this system has clear strengths such as its broad coverage, it nevertheless has substantial limitations (Ellenberg and Braun, Drug Safety, 2002). Because the system relies on passive self‐report, a major limitation is under‐ reporting such that only a small fraction of adverse events are reported. Furthermore, events that occur weeks following vaccination are less likely to be reported than those that are proximal to the vaccination. This limits information on non‐acute events, such as neurocognitive sequelae, whose onset may be delayed. Information that is essential for determining background incidence of adverse events is not readily available. The calculation of age‐specific adverse event rates is not possible, for example. It is crucial that the quality of data in VAERS be improved. Specific questions regarding the prevalence of seizures, loss of language, regression, ASD, and other neurocognitive outcomes need to be added. Standard adverse effect recording needs to extend beyond the traditional 4 week time period. This will require improvements in the VAERS infrastructure; currently, less than 20 percent of reports to VAERS are electronic, making data management and analysis difficult. The inclusion of a full family medical history in the VAERS would allow identification of subgroups that may be genetically or medically vulnerable to adverse effects of vaccines. Ideally, collection of biomaterials, including DNA, would allow the VAERS to identify genetically vulnerable subgroups. Many fundamental questions have not been addressed, such as whether the use of combination vaccines confers increased risk for adverse events and whether there are subgroups in the general population that are more vulnerable to serious adverse effects of vaccines, including ASD.
 
 7. Potential to influence clinical practice/vaccination policy
 
Such research could have wide‐ranging effects on clinical practice/vaccination policy.  For example, it could allow pediatricians to identify subgroups of children who may benefit from a different vaccine schedule or for whom careful monitoring of adverse effects is warranted. Ideally, by continuing to conduct rigorous scientific research that addresses parents’ ongoing questions about vaccine safety, parents will develop increased confidence in the medical community and vaccines, be more likely to have their child vaccinated, and improve health outcomes for all children. 
 
Scientific issues that we believe should be included in the ISO scientific agenda 
 
The following are questions, many of which are currently included in the ISO scientific agenda, which we view as high priority:
 
1. Is exposure to thimerosal associated with increased risk for ASD?

Some well‐designed studies that address whether thimerosal is associated with increased risk of neurocognitive impairments, such as Thompson et al. study (NEJM, 2007), excluded children with a diagnosis of ASD, as well as children who were born prematurely. Prematurity has been shown to be a risk factor for ASD (Limperopoulos et al., Pediatrics, 2008). Two studies are currently being conducted (VSD and CDC) examining whether thimerosal is associated with ASD, including regressive autism.
 
2. Is immunization associated with increased risk for neurological sequelae in children with certain metabolic conditions, including mitochondrial disorders?

Research has shown that children with metabolic disorders, including mitochondrial disorders, may experience neurological decline when physiologically challenged. There have been reports of metabolic crisis after receiving vaccinations (Yang, Pediatric Neurology, 2006; Brady, Pediatrics, 2006; Kingsley, Pediatrics, 2006). 
 
3. Is the combination measles, mumps, rubella, varicella (MMRV) vaccine associated with increased risk for febrile seizures and if so, are there other clinically important sequelae? 
As noted in the draft agenda, preliminary results from a VSD study underway found that children aged 12‐23 months who received MMRV vaccine were about 2 times more likely to have febrile seizures during the 7‐10 days after vaccination than children who received separate MMR and varicella vaccines at the same visit (CDC MMWR, 2008). In a population‐based study, there has been a report of an increased risk for ASD after infantile seizures during the first year of life (Saemundsen et al., Epilepsia, 2008). In February 2008, the Federal Advisory Committee on Immunization Practices reversed its previous position of recommending the MMRV over MMR and Varicella vaccines (CDC, MMWR, 2008). Simultaneous vaccination is not well studied at the time of licensure. As pointed out in the ISO report, under the current infrastructure, prelicensure studies do not assess safety of two unlicensed vaccines administered simultaneously. 
 
4. What are the potentially clinically important outcomes related to post‐immunization fever?

Fever after vaccination is common and can induce seizures in vulnerable children (Kohl, CID, 2004; Dale, ACIP Medicine, 2008; Brady, Pediatrics, 2006). As mentioned above, in a population‐based study, there has been a report of an increased risk for ASD after infantile seizures during the first year of life (Saemundsen eta l., Epilepsia, 2008). There have been anecdotal reports from parents of children with ASD that their child experienced high fever directly after immunization. There needs to be careful study of the pathophysiology and clinical consequences of fever after vaccination, including a possible association with ASD. 
 
5. What is the relationship between specific rare genetic mutations associated with ASD and risk for serious adverse effects of vaccination?

For example, a recent study identified mutation in a sodium channel gene in children who developed encephalopathy after pertussis vaccines, suggesting that genetic factors may influence the risk for neurological deterioration after vaccination (Berkovic, Lancet Neurology, 2006). In several studies, a susceptibility locus for ASD has been mapped near a cluster of voltage‐gated sodium channel genes on chromosome 2 (e.g. Shao et al., American J. of Human Genetics, 2002). Furthermore, mutations in SCN1A have been observed in ASD families (Weiss et al., Molecular Psychiatry, 2003). Research examining the association between ASD susceptibility genes, including SCN1A, and adverse effects of vaccination is clearly needed. 
 
6. Finally, there are four special populations which we view as high priority for assessing the risk of serious adverse effects of vaccinations: 
 
a. Premature and low birth weight infants. There has been an increase in the number of premature and low birth weight infants in the US. Furthermore, prematurity has been found to be a risk factor for ASD (Limperopoulos et al., Pediatrics, 2008). There is a need to understand the immune response and prevalence and nature of vaccine adverse events after vaccination in infants who were born prematurely or with low birth weight.
 
b. Pregnant women. As noted in the ISO report, pregnant women are usually excluded from vaccine trials and data on vaccine safety during pregnancy are lacking. ACIP recommends that pregnant women routinely get vaccinated from influenza. What are the risks? The offspring of women who experience infection during pregnancy have an increased risk for ASD and schizophrenia (Brown, et al. Archives of General Psychiatry, 2004). Evidence indicates that the maternal immune response, rather than infection of the fetus, is responsible for the increased incidence of schizophrenia and ASD in offspring of mothers who experience infections during pregnancy (Patterson, Neuropsychopharmacology, 2005). The effects of maternal immune activation via influenza vaccination during pregnancy on the offspring of vaccinated women are presently unknown. 
 
c. Children with inborn errors of metabolism. Children with metabolic diseases are at higher risk of health complications from diseases that are prevented by immunizations (Brady, Pediatrics, 2006; Kinsley, Pediatrics, 2006). However, as noted above, there is a need to describe the nature and prevalence of vaccine adverse events in children with metabolic disorders and assess risk factors for these events.
 
d. Infant siblings of children with ASD. Siblings of children with ASD are at much higher risk for ASD than the general population. Estimates of risk rates range from 3‐7%, with recent prospective studies reporting even higher rates (Bryson et al., J. Autism Devel. Disorders, 2007). Are infant siblings at higher risk for adverse effects of vaccination? This question is of great concern to parents of children with ASD; a recent report indicates a disturbing trend of reduced uptake of vaccination in younger siblings of children with ASD (Kuwaik et al., Pediatrics, 2008). Approximately 73% of parents were reported to refuse to vaccinate their younger siblings with the MMR vaccine, for example. Thus, it is crucial that questions regarding the safety of vaccines for younger siblings be addressed. 
 
Autism Speaks believes that a fruitful strategy for moving forward would be to establish a working group comprised of key representatives of the stakeholder, medical, and scientific communities and the federal agencies involved in vaccine safety research. The goal would be to work collaboratively to review and prioritize the scientific questions that need to be addressed in light of the most recent scientific findings and public concerns.  Issues to be addressed include what scientific questions can be feasibly addressed given current knowledge, resources, and infrastructure and what are the additional resources that are needed to address questions of high priority? Discussion and consensus regarding how results of scientific studies should be interpreted and inform future public policy and practice would also be helpful.
 
We greatly appreciate the opportunity to provide input on the CDC ISO draft scientific agenda for vaccine safety research. In this letter, Autism Speaks has described significant concerns and remaining questions about vaccine safety we consider to be most important, not only for the CDC’s scientific agenda, but for the federal government as a whole. The past decade has witnessed increased polarization and diminished respect and trust between the autism parent community and the medical establishment. As a result, families of children with ASD and the general public are suffering the consequences of parents’ lack of confidence in our nation’s vaccine program.  Establishing and maintaining a trusting relationship and providing answers to parents’ questions cannot be achieved by one set of studies addressing one set of questions, but rather it will require an on‐going process of scientific discovery as medical science continues to uncover individual differences that predict differential responses to vaccines and other medical interventions. We need to embrace our obligation to address new questions with an open mind, adequate resources, and renewed commitment. 
 
Sincerely,
 
Geraldine Dawson, Ph.D.
Chief Science Officer
Autism Speaks 
 
 
 
 




 

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