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The Thimerosal Connection to Autism and Other Developmental Disorders

Jonathan Campbell, 4/29/2004

Abstract

There appears to be a positive correlation between thimerosal-preserved childhood vaccinations and a dramatic increase in profound autism and other mental developmental abnormalities in the United States. This article reviews past and current research supporting that view, and outlines attempts by the pharmaceutical industry and government officials to discredit this idea.

Introduction

The incidence of profound autism and other central nervous system developmental abnormalities, referred to collectively as Autism Spectrum Disorder (and hereafter referred to in this article as simply "autism"), has dramatically increased in the United States. While some researchers may attempt to attribute this to better reporting mechanisms, the sheer number of affected children makes this attribution extremely unlikely: in the four-year span December 1998 to December 2002, for instance, there was a 97 percent increase in just strictly-defined autism cases in California (DSM III and DSM IV autism, excluding children with other PDDs such as Asperger’s Syndrome). (California, 2003)

Until 2003 there was no hard data linking autism to vaccines, and, in particular, thimerosal-preserved vaccines; the data up to then was sketchy and anecdotal. Federal agencies refused to recognize any correlation and no research was funded. Then in spring 2003 two researchers, Dr. Mark Geier and his son David Geier, published a peer-reviewed article that clearly showed a strong correlation between use of thimerosal-preserved vaccines and autism incidence.

The response of the government, pharmaceutical industry, and the medical profession has been an attempt to discredit the Geier and Geier study, including publishing a CDC-funded study that appeared at first to counter the Geiers’ claims, but was then discovered to have used invalid data, and outright fraud is suspected. As of this writing, the position of official federal government agencies, published on their public websites, is that there are no valid studies showing any correlation. The Institutes of Medicine held a public meeting of the Immunization Safety Review Committee on February 9, 2004 to hear testimony on the association of autism with thimerosal. The results of that meeting will be published officially in May or June, 2004, though unofficial transcripts are already available.

In this article I cite data from the Geier and Geier study and prevalence data from other studies directly as well as the public statements from the federal agencies involved. In addition, I analyze public refutations of the Geier and Geier study by several organizations of the medical establishment, and present the evidence of fraud in the CDC study that purported to refute the Geiers’ correlational data.

Autism Description

Autism is a profound developmental disorder that appears in infancy, usually by age three. Seemingly with no explanation, children experience a developmental "crash," sometimes quite suddenly losing many, and in some cases most of their normal mental faculties. Reports of these abnormal developments (or apparent reversals) vary widely, but most frequent are loss of eye contact with parents, speech deficits or absence, lack of emotional reaction, deficits in social interaction or total withdrawal, super-sensitivity to auditory and tactile stimuli, self-stimulation, and intellectual impairment. (Carson, 2002)

Diagnosed Autism Incidence

For more than a decade parents, doctors, and others have grappled with the increasing and alarming diagnosed incidence of autism. Geier and Geier cite statistics that indicate that the incidence of autism increased from 1 in 2500 in the mid-1980s to 1 in 300 in 1996 to one in 150 in 2003. (Geier, 2003; Geier, 2004). Looking at it another way, the organization Fighting Autism has published an autism incidence graph based directly on raw statistics provided by U.S. Department of Special Education. Their graph indicates that autism incidence increased from just over 15,000 in 1992 to more than 118,000 in 2002, an astonishing tenfold increase in just ten years (Fighting Autism, 2004). Several comprehensive studies of autism have rejected confounding factors as an alternative explanation for the dramatic increase.(California, 2003; Blaxill, 2003; Yeargin-Allsop, 2003) In the California Study, for instance, the authors state that neither immigration nor shift in diagnostic criteria could explain the dramatically increased prevalence, and concluded that:

The study supported the interpretation that the increased prevalence of autism in California is a valid phenomenon and is driven by factors beyond improved identification and diagnosis. (California, 2003).

Thimerosal is an organic mercury compound used to preserve multi-use vaccine vials from bacterial infection since the 1930s, when the first vaccines were developed and, perhaps not coincidentally, when the first incidence of autism was reported (Kanner, 1943). From that time through the 1960s, however, the number of vaccines administered to infants was small to nonexistent. Children born in the 1940s and early 1950s, for instance, received only smallpox vaccine. By the 1970s the number of vaccines had increased dramatically, so that infants received single or multiple vaccinations at each "well-baby" visit to the pediatrician. The number of vaccinations then doubled in the early 1990s. (Geier, 2004).

Recognizing mercury’s historical significance as a severe neurotoxin (Carroll, 1865) that may interfere with brain development, and citing EPA regulations that limit occupational mercury exposure, some parents have drawn their own conclusions about what has happened to their children. Lyndelle Horne Redwood, for instance, testified before the Government Reform Committee in July, 2000 that her son developed autism after receiving several hundred times the EPA allowable exposure to mercury from vaccines given him as an infant. (Redwood, 2000) Redwood later worked with Sally Bernard and others, hypothesizing that autism was the outcome of mercury neurotoxicity in the developing brain. (Bernard, 2001)

The Geier Study

In 2002 two researchers, Dr. Mark Geier and his son David Geier, decided to assemble and quantify adverse effect data from the CDC’s VAERS (Vaccine Adverse Event Recording System), comparing event incidence from thimerosal-preserved vaccines and those preserved by a non-mercurial chemical formulation. This was apparently the first time that any researchers had attempted to quantify or correlate any toxicological causation for autism.

Their results were startling: "We showed that there was from a 2 to 6-fold increased incidence of neurodevelopment disorders following an additional 75-100µg dosage of mercury from thimerosal-containing childhood vaccines in comparison to thimerosal-free childhood vaccines." (Geier, 2003 EBM)

Further analysis of the data confirmed their previous findings: there was a clear positive (and greater-than-linear) dose-response curve, correlating autism with cumulative dose of thimerosal. (Geier, 2003 JAPS 8)

Later that same year, a doctor named Jeffrey Bradstreet who was treating autistic children worked with the Geiers and other researchers and discovered what is perhaps the most significant finding regarding mercury and autistic children. Bradstreet and the other researchers found that when a mercury "chelating agent" – a chemical that binds and excretes mercury – is administered to autistic and non-autistic children who had similar doses of thimerosal, that autistic children excrete significantly more mercury than non-autistic children. (Bradstreet, 2003)

This study confirmed that mercury concentration in these children’s bodies is correlated with their autism, and, further, provides a probable explanation of why only some children exposed to thimerosal may develop autism. For if autistic children who have received the same dosages of thimerosal as non-autistic children, but excrete more of it when chelation agents are administered, it means that these children lack the ability to excrete it on their own. The developmental neurotoxicity hypothesis by Bernard et al (see below) would then appear to be plausible.

At this time the reason for this differential excretory capacity are unknown. Two possibilities are a genetic defect or defects in the detoxification/excretory mechanisms and differential nutritional factors during childhood. (Geier, 2004)

Autism as a result of mercury toxicity during development

The hypothesis of neural damage by mercury is supported by a hypothesis by Sally Bernard, et al. The authors show that the symptoms of autistic children have symptoms of mercury poisoning, citing medical studies and descriptions of children and adults exposed to mercury through accidents, contamination of foodstuffs, and industrial exposure. A broad range of neurological and psychological deficits typical to autism is presented: social deficits and withdrawal, repetitive and obsessive-compulsive behavior, flat affect, lack of eye contact, loss of speech, sound sensitivity, and many others.

Exposure to mercury can cause immune, sensory, neurological, motor, and behavioral dysfunctions similar to traits defining or associated with autism, and the similarities extend to neuroanatomy, neurotransmitters, and biochemistry. (Bernard, 2001)

Mercury and neural degeneration – a cause for developmental problems

While the neurotoxic nature of mercury has been known for more than 100 years, it is only recently that researchers at the University of Calgary Medical School have found iron-clad physical proof of mercury-facilitated neuron degeneration. (Lorscheider, 2001)

The Empire Strikes Back

The response to the Geiers’ research findings indicated that powerful interests were at stake. Concurrently with the publication of the Geiers’ initial communication, a spate of articles and press releases appeared, bemoaning the increase in autism but citing every study except the Geiers’ paper. It was as if the Geier paper did not exist. The Harvard Mental Health Letter, for instance, reported "To the relief of public health officials and parents concerned about contagious diseases, it is becoming increasing clear that immunization is not the problem." [their emphasis] (Harvard, 2003)

Once the Geier paper had been published in spring 2003, it underwent a five-pronged attack. First, and in some cases even before the paper was published, virtually every federal agency associated with vaccines and their safety published press releases and public web pages affirming the safety of vaccines and dismissing any evidence to the contrary. The FDA, CDC, NIH, and WHO published similar information in a concerted fashion. (NICHD/NIH, 2003; CDC, 2003; WHO, 2003; NIAID/NIH, 2003; FDA 2003)

For example, the NIAID/NIH website stated:

Several important results have been obtained from this study. Mercury levels in blood and urine were low in all infants studied and in many cases too small to measure. There was no observed dose-dependent relationship between the level of thimerosal received through vaccination and the level of mercury in the body. Mercury levels in blood did not exceed, at any time, the blood levels that correspond to the Environmental Protection Agency's (EPA) guidelines for exposure. (NIAID/NIH, 2003)

Second, the major physician organizations – the American Association of Pediatricians (AAP) and the AMA – as well as some medical journals issued statements affirming vaccine safety. (AAP, 2003; AMA 2003; Kastner 2003) The AAP published a scathing denunciation of the Geier study attacking its foundations and scientific method. The primary basis of the refutation was that the database that the Geiers used – VAERS – was not intended to be used to draw conclusions about associations or causality. AAP also challenged the similarity between autism and mercury toxicity, as well as the toxicity of thimerosal. (AAP, 2003; Nelson, 2002)

Third, Senator Bill Frist, the Senate Majority Leader who has personal and economic connections to the pharmaceutical industry, had already introduced legislation in 2002 (S 2053) to limit liability of manufacturers of vaccines from lawsuits by parents, and in April 2003 began negotiating to in earnest to get the bill passed. (Benjamin, 2003)

Fourth, two studies from Denmark were published, both of which found no correlation between thimerosal and autism diagnoses. The authors used a time-line approach, comparing children who had been vaccinated before and after thimerosal was removed from vaccines by the Danish government. (Madsen, 2003; Hviid, 2003)

Finally, the CDC published a study in July, 2003 that concluded that "No consistent significant associations were found between TCVs [Thimerosal-Containing Vaccines] and neurodevelopmental outcomes." This study had begun in 1999 by a group of researchers convened in 1999 by the Institute Of Medicine; their task was reportedly to study the safety of thimerosal in vaccines and any possible correlation to autism or other developmental disorders. (Verstraeten, 2003)

The onslaught was apparently not unexpected by the Geiers or by Sally Bernard at Safe Minds, a coalition of parents and autism researchers. A careful analysis of the AAP denunciation by the Geiers and Bernard revealed that that it was completely without merit, making claims about the Geiers’ study, the CDC VAERS database, and the vaccine supply that were patently false.

For instance, the AAP criticized any statistical use of the VAERS database, yet the Geiers were using it in a way that was recommended by CDC. The AAP claimed that thimerosal was now out of the vaccine supply, yet most doctors and vaccine suppliers still had huge stocks of thimerosal-preserved vaccine that were still being sold and used. Even more ominously, the product label had now been modified in some batches to remove reference to thimerosal, even though thimerosal was still in the vaccine.

Regarding the similarity of mercury poisoning and autism, it was pointed out that the article cited that supposedly disputed the similarity between mercury toxicity and autism was an invited commentary rather than a peer-reviewed article. The AAP itself has a vested interest in denying the possibility that vaccines administered for decades by their members might be unsafe. (The article is also, by my own superficial analysis, flawed inasmuch as it mostly compares acute mercury toxic effects in gross poisoning cases with autism symptoms attributed to relatively small intravenous doses of mercury in vaccines during infant development.)

Finally, Geier pointed to several studies that verified that the toxicity of thimerosal was similar to that of methylmercury, but in any case the Bradstreet study verified that autistic children specifically did not excrete it rapidly, thus allowing it to accumulate in the developing brain. (Geier 2004; Bernard, 2003; Bradstreet 2003)

What was most disturbing, however, was the July 2003 CDC/IOM study, which purported to use data sets similar to those used by the Geiers. Suspicious that something other than good scientific methods had been used, the Geiers filed a Freedom of Information Act request and obtained the raw data used in the CDC study as well as the proceedings of the research group.

What they discovered could be construed, at best, as conflict of interest, and, at worst, fraud:

Thomas Verstraeten, the leader of the study, was an employee of a Glaxo, a vaccine manufacturer facing numerous product-liability lawsuits over thimerosal-preserved vaccine use, during the latter part of the study. This constituted conflict of interest that was unreported in the study.
In the summer of 2002, a meeting was held to discuss the initial data from the HMOs collected in the study. The researchers had found a correlation nearly identical to that reported by the Geiers. One participant of the meeting was quoted as saying that this data needed to be "managed."
New data from a bankrupt HMO (Harvard Pilgrim of Massachusetts) with record-keeping that varied from poor to nonexistent – making it an unreliable source of data – and an adverse event coding system that was completely incompatible with that VAERS was then added to the study. (In fraudulent use of statistics, this is a technique referred to as "adding to the denominator," that is, adding null-hypothesis cases. Because the CDC research team had access to the result data, they could easily have chosen an HMO that had small numbers of reported autism cases). When questioned, Verstraeten had no reasonable answer as to why a bankrupt HMO with an unreliable reporting system was chosen. (Geier, 2004; O'Meara, 2003)

The Geiers also analyzed the Danish data, and found that the amount of thimerosal in the vaccines then used in Denmark, combined with the number of vaccinations, was much lower than in the U.S. In combination, it was the amount typically injected into infants in the U.S. in the 1970s, before the beginning of the dramatic increase in autism diagnosis. Thus it was irrelevant to the current controversy. Additionally, the authors of the studies apparently made no attempt to verify that thimerosal-containing vaccines had in fact been completely used up at the point in time when they claimed that children were receiving thimerosal-free vaccine.

Current events

The controversy reached a crescendo in fall and winter of 2003-2004. An international autism conference convened by IOM in fall 2004 provided a government-sponsored public forum for researchers such as the Geiers to present strong evidence that mercury and especially the thimerosal-preserved vaccines were at the root of ASD in the United States. The official response by the CDC was a formal hearing in February 2004 in which the compromised CDC study was promoted as the government’s official position on the controversy, with little comment or questioning allowed. Official publication of this meeting is scheduled for May-June 2004.

As a result of pressure by Senator David Weldon, who is also a physician, Mark and David Geier were given access to the Vaccine Safety Database. Their results, currently pending publication in two medical journals, shows that children who received thimerosal-preserved DTP vaccines were twenty-seven times more likely than children who received non-thimerosal-preserved vaccines to be later diagnosed with autism. (McIlwain, 2004)

Correlation or Causation?

When taken together with the evidence of thimerosal’s neurological developmental toxicity and the similarities between the symptoms of mercury poisoning and those of autism, this extremely significant statistical correlation is as close to a cause-and-effect relationship as one could ever find.

The obvious analogy is the correlation between cigarette smoking and lung cancer. No victim has ever been able to conclusively prove that the substances in their lungs from the cigarettes they smoked actually caused their cancer. However it is accepted both legally and logically that since the chemicals from cigarettes cause cancer and a large proportion of cigarette smokers get cancer that there is a cause-and-effect relationship.

Conclusion

The case for thimerosal as a probable causative factor in autism is clear. Historical data, neurological proof, and correlational studies indicate that the current epidemic of autism in the United States has likely been caused, at least in part, by the mercury in vaccines.

The controversy, however, is still in the headlines as of this writing. The CDC is standing by their study even though it has been exposed as probably fraudulent. The law limiting liability of vaccine manufacturers is going to be voted upon imminently, pressed again by Senator Bill Frist. And even though the FDA requested in 1999 that the vaccine manufacturers not use thimerosal in children’s vaccines, these manufacturers have not removed old stocks and have in some cases removed thimerosal from the label, thus making it difficult or impossible for parents to know whether their children will not be exposed. In the words of Mark Geier:

…the authors stated that thimerosal was removed from most childhood vaccines by 2001 as a precautionary measure. In reality, as the CDC has recently conceded in a recent communication with Dr. Weldon, a Florida Congressman, some of the routinely recommended childhood vaccines contained the full amounts of thimerosal even as late as 2003, and many vaccines given to children even today contain 25 micrograms of thimerosal including: pediatric Diphtheria-Tetanus (DT) vaccine, Tetanus-diphtheria (Td) vaccine, tetanus toxoid vaccine, meningitis vaccine, and influenza vaccine. Many of these vaccines have expiration dates towards the end of 2005, and there is no reason to think that the manufacturers are planning to completely remove thimerasol anytime soon. In fact several documents recently obtained from WHO state that is their policy to lobby strongly for maintaining thimerosal in childhood vaccines for the foreseeable future because they say it is necessary for use in third world counties and if it is removed from US vaccines these countries may refuse to use thimerosal containing vaccines. (Geier, 2004)

Finally, as of this writing all federal agency websites still claim that there is no danger from vaccines. The struggle for safe vaccines is not over.

References:

AAP (No author), Study Fails to Show a Connection Between Thimerosal and Autism, AAP: http://www.aap.org/profed/thimaut-may03.htm, May 16, 2003, p. 1

AMA (no author), No Relationship Found Between Childhood Vaccination With Vaccines Containing Thimerosal and Development of Autism, News From the AMA, http://www.medem.com, October 1, 2003

Benjamin M, Deal on Frist vaccine bill may be set, Washington Politics and Policy Desk, UPI, 4/18/2003

Bernard S, Safe Minds Commentary on AAP Critique of Geier & Geier Thimerosal Paper, Safe Minds, June 10, 2003

S. Bernard, B.A., A. Enayati, M.S.M.E., L. Redwood, M.S.N., H. Roger, B.A., T. Binstock, Autism: a Novel Form of Mercury Poisoning, Medical Hypotheses 2001 56(4) 462-471.

Blaxill MF, Baskin DS, Spitzer WO. Commentary: Blaxill, Baskin, and Spitzer on Croen et al. (2002), the changing prevalence of autism in California. J J Autism & Dev Dis 2003 33:223-226.

Jeff Bradstreet, M.D., David A. Geier, B.A., Jerold J. Kartzinel, M.D., James B.Adams, Ph.D., MarkR. Geier, M.D., Ph.D., A Case-Control Study of Mercury Burden in Children with Autistic Spectrum Disorders, Journal of American Physicians and Surgeons, Summer 2003p. 76-79

California Department of Developmental Services. Autistic spectrum disorders: um Changes in the California caseload an update: 1999 through 2002. Sacramento, CA: California Health & Human Services Agency, 2003.

Lewis Carroll, The Mad Hatter in Alice’s Adventures in Wonderland, 1865. "Mad Hatter’s Syndrome" was common among hatters at the time, the result of occupational exposure to mercury salts used to preserve felt.

Robert C. Carson, Susan Mineka, James Neal Butcher, Fundamentals of Abnormal Psychology and Modern Life, Pearson Education, July, 2001

CDC (No author), Thimerosal & Vaccines, CDC: http://www.cdc.gov/nip/vacsafe/concerns/thimerosal/faqs-thimerosal.htm, May 20, 2003, p. 1

FDA (No author), Thimerosal In Vaccines, FDA: http://www.fda.gov/cber/vaccine/thimerosal.htm, October 6,2003, p. 1

Fighting Autism (No author), Autism Incidence, U.S. School Years 1992-2002, data provided by the US Department of Special Education, graphed with the Individual with Disabilities Education Act (IDEA) graphing tool, http://www.fightingautism.org/idea/index.php?, 2004.

Mark Geier and David Geier, Thimerosal in Childhood Vaccines, Neurodevelopment Disorders, and Heart Disease in the United States, Journal of American Physicians and Surgeons 2003 8:6-11

Geier MR, Geier DA. Neurodevelopmental disorders following thimerosal-containing vaccines. Experimental Biology and Medicine 2003 228:660-664

Geier MR, Geier DA, Response to Critics on the Adverse Effects of Thimerosal in Childhood Vaccines, Journal of American Physicians and Surgeons, Summer 2003, p. 68-70

Geier MR, Geier DA, From Epidemiology, Clinical Medicine, Molecular Biology, and Atoms, to Politics: A Review of the Relationship between Thimerosal and Autism (slides and prepared text), Submitted to the Institute of Medicine, of the US National Academy of Sciences, January 2004

Geier M, Post-publication Peer Reviews to: Thomas Verstraeten, Robert L. Davis, Frank DeStefano, Tracy A. Lieu, Philip H. Rhodes, Steven B. Black, Henry Shinefield, Robert T. Chen, and for the Vaccine Safety Datalink Team, Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases Thimerosal VSD study phase I (2/29/00). Obtained via Freedom of Information Act request. New England Journal of Medicine 2002 347:1735-6.

Harvard (No author), The persisting autism mystery, Harvard Mental Health Letter, April 2003, 4-5

Anders Hviid, MSc; Michael Stellfeld, MD; Jan Wohlfahrt, MSc; Mads Melbye, MD, PhD, Association Between Thimerosal-Containing Vaccine and Autism, JAMA. 2003 290:1763-1766.

Kanner L, Autistic disturbances of affective contact. Nervous Child 1943 2:217-250.

Kastner JL & Gellin BG, Measles-mumps-rubella vaccine and autism: The rise (and fall?) of a hypothesis, Pediatric Annals, July 2001, p. 408-415.

Fritz Lorscheider, Naweed Syed, Christopher Leong, How Mercury Causes Brain Neuron Degeneration, NeuroReport (UK) April 2001

Kreesten M. Madsen, MD*, Marlene B. Lauritsen, MD, Carsten B. Pedersen, Msc, Poul Thorsen, MD, PhD*, Anne-Marie Plesner, MD, PhD, Peter H. Andersen, MD and Preben B. Mortensen, MD, DMSc, Thimerosal and the Occurrence of Autism: Negative Ecological Evidence From Danish Population-Based Data, Pediatrics, September 2003, p. 604-606

McIlwain L, Press Release: CDC Vaccine Data Leads Scientists to Shocking Discovery, National Autism Association, February 9, 2004

Karin B. Nelson and Margaret L. Bauman, Thimerosal and autism?, Pediatrics, March 2003, p. 674-679

NIAID/NIH (No author), NIAID Research on Thimerosal, NIAID/NIH: http://www.niaid.nih.gov/factsheets/thimerosal.htm, December 2003, p. 1

NICHD/NIH (No author), Autism and Vaccine Research, NICHD/NIH: http://www.nichd.nih.gov/publications/pubs/autism2.htm, July 2001, p. 1

Kelly Patricia O'Meara, CDC vaccines study slammed as cover-up, http://www.wnd.com/news/article.asp?ARTICLE_ID=36023 World Net Daily, December 9, 2003, p. 1

Lyndelle Horne Redwood, Are We Taking Unnecessary Risks? Testimony Before the Government Reform Committee, Mercury in Medicine, July 18, 2000, p. 1

Verstraeten T, Davis RL, DeStefano F, Lieu TA, Rhodes PH, Black SB, Shinefield H, Chen RT; Vaccine Safety Datalink Team, Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases, Pediatrics. 2003 Nov;112(5):1039-48

WHO (No author), MMR and autism, WHO: http://www.who.int/vaccines-diseases/mmrautism.shtml, 2003, p. 1

Yeargin-Allsopp M, Rice C, Karapurkar T, et al. Prevalence of autism in a US metropolitan area. JAMA 2003;49-55.5.

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