20.09.2013

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Objectives: This study was performed to determine whether trends in national sales of children's aspirin and acetaminophen products were associated with trends in reported cases of autistic disorder.
Methods: This is an ecologic study using published annual national sales of childrena€™s acetaminophen and aspirin products between 1979 and 1985 and the number of children with autistic disorder eligible for services from the California Department of Developmental Services. Results: There was a marked decline in childrena€™s aspirin sales and concomitant rise in sales of childrena€™s acetaminophen products beginning in 1980, which corresponded to an increase in children with autistic disorder eligible for services in California. Conclusions: Decreased national sales of childrena€™s aspirin and increased sales of childrena€™s acetaminophen were significantly associated with an increased number of children with autistic disorder eligible for services in California. A report from the California Department of Developmental Services (DDS) [4] shows a marked increase in the number of individuals with AD who are eligible for services. There are several theories about possible environmental triggers for AD including childhood vaccinations, mercury exposure, and viral infections. While the link between the MMR vaccine and an elevated risk of AD is controversial, it is possible that some factor temporally related to the MMR vaccination increases the risk for AD in some children. There are three pathways for the metabolism of acetaminophen: glucuronidation, sulfation, and the cytochrome P-450 system. The present study was performed to determine if national sales patterns of acetaminophen could be associated with the number of individuals with AD who were eligible for services from the California DDS.
Figure 1 shows the number of eligible persons with AD by year of birth adapted from the 1999 report to the legislature by the California DDS.[24] The figure shows a notable increase in the number of eligible persons with AD born after 1980.
As previously detailed, there was an increase in acetaminophen sales beginning in 1980, which corresponds to an increasing trend in the number of eligible individuals with AD born after 1980. The sales of childrena€™s aspirin products declined and the sales of childrena€™s acetaminophen products rose after an aspirin-Reye Syndrome link was reported in 1980.[26] Using data abstracted from the report by the California DDS [24], the increasing trend of AD cases for the period after 1980 was significantly greater than for the period before 1980. However, the changing trend in AD registration in California may be due to many other factors and does not necessarily indicate an increase in AD incidence. In 1969, the Lanterman Mental Retardation Services Act established regional centers of care in California for persons with mental retardation. Linear regression of national sales of childrena€™s aspirin tablets, acetaminophen tablets, and acetaminophen liquid with the number of eligible individuals with AD in California yielded significant associations.
For each of four historical events related to acetaminophen, there is a corresponding inflection in the number of eligible individuals with AD in California as shown in figure 1. Other environmental factors may also be involved in the apparent increase in AD seen in this study.
The significant differences seen in this study should be viewed with caution, as this is an ecological study with no measured acetaminophen exposures in any of the individuals with AD. The views expressed in this article are those of the authors and do not reflect the official policy or position of the Department of the Navy, Department of Defense, or the United States Government.
This report shows the number of persons with AD increased in their client population from 2,778 to 20,377 for the years 1987 to 2002.


Children are often given acetaminophen if they have symptoms such as fever or irritability, and the MMR vaccination can cause these symptoms. These events were compared with the number of eligible persons with AD from a 1999 report to the legislature by the California DDS.[24] This data was collected by 21 regional centers that provide services to children with developmental disabilities. Linear regression models were developed to determine if annual sales of childrena€™s aspirin or acetaminophen products were associated with year of birth for eligible individuals with AD in California.
In 1982 and again in 1986, acetaminophen capsules were tampered with by replacing the contents with cyanide. In other words, there is a significant difference in the slope of the AD trend in California before and after 1980. This significant difference could be due to increasing sales of childrena€™s acetaminophen products which would presumably lead to more use by young children. Better diagnosing of AD or the increased availability of services may have caused an increase in registration. In 1973 this act was amended to include persons with autism and other developmental disabilities, and in 1976 this act was again amended to establish a right to treatment and habilitation services for children and adults with developmental disabilities.[34] The availability of these services may have contributed to the increasing trend in the number of eligible individuals with AD who were registered in California.
Sales of childrena€™s aspirin decreased and sales of childrena€™s acetaminophen increased as AD increased. Although these events may be related, it is also possible that these are coincidental findings and that AD has no relation to changing analgesic sales. National childrena€™s analgesic sales were abstracted from a graph in a published study.[27] Although the principal investigator of this study was contacted, the raw data for this graph was no longer available.
These inflections would be expected if acetaminophen exposure is related to development of AD. For example, low levels of breastfeeding could decrease immune protection in infants by decreasing mother to child transfer of IgA. The purpose of this study was to explore a possible correlation between acetaminophen sales and AD. Perhaps the administration of acetaminophen is associated with the development of AD in these children. One study found that children with AD had significantly lower plasma levels of glutathione than the control group.[23] The possible model for the relationship of acetaminophen to AD is a buildup of NAPQI which in theory could be an environmental trigger for AD. Because this report only contains information on children whose parents had registered for assistance, it is not a complete ascertainment of all cases. In 1977 a Food and Drug Administration (FDA) panel recommended a warning label be placed on acetaminophen products due to the association of acetaminophen use and liver damage.[28] This corresponds to a drop in the number of eligible individuals with AD for a birth year of 1977.
Linear regression was also performed to determine if sales of childrena€™s analgesics were related to the number of enrolled individuals with AD in California by birth year. No national figures for the numbers of individuals with AD were available for the study years, and this study relied on the number of individuals with AD abstracted from a California report.24 Further, although sales of childrena€™s analgesics vary from year to year, the observations are not independent, and sales from any given year will be correlated with sales from the previous year.


However, the drop in the number of individuals with a birth year of 1977 could be an artifact since it occurred in only one year. Decreased immune protection could make a child more vulnerable to viral infection which in theory could lead to AD.
The authors have further explored this possible relationship in a case-control study and have found a significant difference in acetaminophen use in those with and without AD.[19] The authors hope that this report is followed by additional case-control and cohort studies to confirm these findings.
Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children.
Detection and sequencing of measles virus from peripheral mononuclear cells from patients with inflammatory bowel disease and autism.
Colonic CD8 and gamma delta T-cell infiltration with epithelial damage in children with autism. No evidence for measles, mumps, and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study. Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association.
Acetaminophen after Measles-Mumps-Rubella Vaccination and Autistic Disorder: The Results of a Parent Survey. Metabolic biomarkers of increased oxidative stress and impaired methylation capacity in children with autism. Changes in the population of persons with autism and pervasive developmental disorders in Californiaa€™s Developmental Services System: 1987 through 1998.
Correspondingly, there are inflections in the increasing AD trend in the number of eligible individuals for the years 1982-1984 and 1986-1987. The third edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM), published in 1980, separated the diagnosis of autism from childhood schizophrenia and placed it under a new category of pervasive developmental disorders.[32] DSM III criteria included onset before 30 months of age, lack of responsiveness to other people, gross impairments in communication and language, and bizarre responses to the environment.
This correlation could lead to errors in a linear regression analysis but should have been suitable for this preliminary study. Also, the increase in the trend for AD that began in 1980 could be due to other factors as previously detailed. More interesting are the apparent effects of historical events in 1982 and 1986 when eight people were murdered with cyanide-laced acetaminophen capsules. The apparent effects from both of these events (from the graph in Figure 1) continued for more than one year and precipitated declines in an AD trend that had been increasing and which afterwards continued increasing after 1987 through 2002.[4] Of course, other events could be responsible for the decreases in the number of eligible individuals with those birth years.



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