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May 16, 2005

Kirby's "Evidence of Harm," Evidently Stoking Fear

By Aubrey Noelle Stimola

Government conspiracies and industry cover-ups make gripping plots for books and movies, never mind arresting media headlines. That may be what motivated journalist David Kirby to write Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy (St. Martin's Press, 2005). Undoubtedly, the story will sell many copies. I heard there is even a movie deal in the works. But I fear it will cause parents to balk at vaccinating their children against a host of preventable diseases for fear of autism.

Indeed, the rise in diagnoses of autism spectrum disorders -- the causes of which are not known -- is striking and worthy of investigation, with some incidence estimates at one in 166 children. However, the large majority of reputable scientists and physicians agree that available data do not support a causal relationship between the ethylmercury-based vaccine preservative thimerosal and neurodevelopmental disorder. As a result, Kirby's Brockovich-esque page-turner, featuring a group of parents of autistic children as David and big pharma/big government bureaucrats as Goliath, must be taken for what it is, a story of parental love and determination -- and not for what it isn't, an instructional and unbiased medical text.

Early suspicions of a link between vaccines and autism were based on observations that symptoms of autism generally manifest around the age at which children receive many routine vaccinations. The 80s saw a failed attempt to link autism with the diphtheria-pertussis vaccine. In 1998, a study published in The Lancet, which was later renounced and retracted, hypothesized that autism was brought on by an atypical response to the measles-mumps-rubella (MMR) vaccine.  Now there are stirrings of a scare blaming aluminum. 

Meanwhile, motivated by a study about similarities between symptoms of autism and symptoms of mercury poisoning, a group of distraught parents began investigating thimerosal. Used since the 1930s, when safety studies were not required for new pharmaceutical products, thimerosal never underwent the current rigorous drug approval process and was essentially grandfathered into use. Anxiety understandably worsened in 1999 when the Academy of Pediatrics suddenly recommended that thimerosal be phased out of pediatric vaccines. This move was based on the realization that changes to the pediatric immunization schedule had caused children to receive bolus doses of ethylmercury in excess of the established safety doses for its more toxic cousin, methylmercury. Thus, the battlefield was set.

Evidence chronicles the journey of the parents who began the crusade to prove a causal relationship between thimerosal and autism. On their quest they encounter countless beasts and obstacles, all of which serve to heighten their suspicion of conspiracy: unfazed pediatricians, deaf politicians, defensive drug makers, even a rider added surreptitiously to the Homeland Security Bill that would provide indemnity to pharmaceutical companies and the FDA against vaccine-related suits. In light of those factors alone, who wouldn't worry there was something to hide?

But despite the unsavory, self-protective actions of the above parties, at the end of the day, the best scientist will only rely on objective, hard, and replicable scientific data, which Kirby, as a journalist, simply does not. Alas, though even the most heartless readers might find themselves hoping these families will find unequivocal proof that thimerosal caused the current "autism epidemic," even Kirby himself admits that there is at best evidence of harm, and that ultimately, temporal correlation does not equal causation.

In my effort to confirm the consensus arrived at by most reputable members of the medical community, that thimerosal does not cause autism, I have attempted to analyze whatever currently available, objective, and scientifically-sound studies I can get my hands on. In April, in an attempt to keep up-to-date on the current research, I attended a Vanderbilt University event, "Living with Autism: Rates, Causes and Treatment." The position held by each and every one of the prestigious presenters -- all renowned in the fields of genetics, epidemiology, pediatrics, toxicology, neuroscience, psychology, cognitive development, or statistics -- was the same: there is no proof that thimerosal, or even mercury in general, plays a causal role in autism's development.

I was not surprised, as readers of Kirby's book might be, that little time was spent at the conference examining the vaccines/autism link, other than one lecture on the lack of evidence to support it. Additionally, ten parents of autistic children from around the country attended the four-day seminar, nine of whom gave short shrift to the thimerosal theory, merely using it as an example of a distraction from finding real treatments and interventions. (Even activists who remain convinced of thimerosal's culpability should be pleased to know thimerosal was removed from all pediatric vaccines in 2001, with the exception of some influenza vaccines; the last lots of thimerosal-containing vaccines should have expired by 2003.)

While Kirby's page-turner reads like a Clancy novel, conjuring fear that something is rotten in Denmark -- particularly within the insensitive medical and federal establishments encountered by the parents Kirby describes -- readers should be reminded that Evidence is not a medical text or a resource for scientific information about autism. Unfortunately, it may be construed as such by desperate parents, the population most vulnerable to buying into conspiracy theories and media hype.

Regrettably, a book written instead on the data presented at Vanderbilt by CDC pediatrician and epidemiologist Marshalyn Yeargin-Allsopp (whose study of autism prevalence trends indicates that the "epidemic" may be attributable to better and broader diagnostic criteria) would probably sit on bookstore shelves gathering dust. As we all know, cries of "the sky is falling!" turn far more heads than "all's well!"

Like many others, I almost find myself wishing that thimerosal was to blame, providing us with a clear-cut perpetrator to hold accountable and forever banish. As yet, there is no such culprit we can point to, but there has been progress, more of which will be made as attention shifts from thimerosal to other avenues of inquiry. For example, a recent UCLA study indicated that a region of DNA on chromosome 17 may be involved in autism. Interestingly, the gene mostly affects boys, which may help explain autism's low incidence in girls.

Generally speaking, most experts agree that autism is likely due to numerous and complex genetic factors, many of which may be acted upon by environmental influences. Perhaps it will even be determined one day that some of these genetic factors predispose some autistics to particular sensitivities, maybe even to heavy metals, casein, gluten, loud noises, bright lights, infectious diseases, or any of the countless other environmental influence that have been associated with autism. And perhaps awareness of these sensitivities, all of which should be researched, will be the basis for the alleviation of symptoms. But the fact will remain that these factors are not causative in and of themselves.

Those who have fought against the demonizing of thimerosal have to put up with absurd accusations of being industry shills. In actuality, many of those who are fighting against the fear -- some of them parents of autistic children themselves -- strive to make clear the value of vaccinations. Ironically, while the incidence of vaccine-preventable illness goes down, as a direct result of the vaccination program, so too does faith that vaccines are necessary. Suddenly, they are accused of doing more harm than good. But one need only look at the increases in pertussis cases in the U.S. and the spread of polio in Africa to realize that we need vaccines still. False and misleading attribution of harm, regardless of intent, only impairs our ability to improve public health. This must be kept in mind as Evidence is read.


Aubrey Noelle Stimola is Assistant Director of Public Health at the American Council on Science and Health.  Her letter in the New York Times about Kirby's book appeared on May 15, 2005.

Visitor Responses

Anne Van Rensselaer (May 16, 2005)

Please allow me to reprint a letter from an M.D. on the topic of thimerosal being already "eliminated" from pediatric vaccines: An excerpt from a letter-to-the-editor dated April 4, 2005 from Dr. Julia Whiting of Charlottesville, VA to Craig Westover, Pioneer Press, MN “....The truth is that the American Academy of Pediatrics and the Public Health Service issued a joint policy statement in july 1999 declaring the goal of removing the preservative thimerosal ‘as soon as possible’ from infant vaccines. Vaccine manufacturers then began developing vaccines without the preservative, but there was never a recall of the mercury -containing ones already on the shelves, or in production at that time. According to the Johns Hopkins’ Institute for Vaccine Safety, Merck was still producing the full-dose (12.5 mcg ethyl mercury) Hepatitis B vaccine, Recombivax, in April 2004. To further confuse the issue, Recombivax was available in two versions, in single-dose preservative free vials, and multidose vials containing thimerosal. Likewise, the HibTITER vaccine by Wyeth-Ayerst was available in two versions till at least June of 2003 (source again, Hopkins’ Institute for Vaccine Safely), with the multidose vial containing 25 mcg of ethyl mercury. Both Wyeth-Ayerst and Baxter made DPT vaccines containing 25 mcg of ethyl mercury at least as late as February 2002. How long did these vaccines remain on the shelves ? According to the CDC on a website being maintained for historical purposes’ (http://aepo-xdv-www.epo.cdc.gov/wonder/prevguid/p0000075/P0000075.asp) the shelf life for the standard pediatric vaccines is up to three years. Finally, the latest addition to the vaccine schedule is the influenza vaccine, for children 6-23 months. Again, according to the Institute for Vaccine Safety, the mercury is there too: both the Fluzone (Aventis-Pasteur) and Fluvirin (Evans) are available with and without thimerosal. Because the thimerosal-free shot requires single dose vials, it is more expensive, providing a significant incentive for medical clinics to use the multidose vials. Dr. Hull, which type is dispensed in Minnesota’s Health Departments ? Doses of 12.5 or 25 mcg of mercury per shot are not ‘tiny’ but, in fact, massive overdoses for infants and toddlers, if we are to adhere to the EPA limit of 0.1mcg/kg/day. As Mr. Westover pointed out, an infant would have to weigh 275 pounds to get a shot containing 12.5 mcg of mercury. The math is simple. What to do if concerned parents are right about the autism-mercury connection is much harder. “ Julia Whiting , MD Charlottesville, VA

Anne Van Rensselaer (May 17, 2005)

Ms. Stimola says in her letter to The New York Times (letters to the editor, May 15, 2005) that she recently attended a "Vanderbilt University event intended to educate journalists on the issue (presumably the issue of a thimerosal-autism connection, based on the content of the preceding paragraph)," and bafflingly goes on to say in the next sentence that, "little time was spent examining the vaccine-autism link, other than one lecture on the paucity of evidence to support it." If that was the task of the event, one must wonder what they were discussing the rest of the time?? For transparency on the subject, I suggest going to www.DANWebcast.com for free downloads of 25 hours of the April ARI symposium in Boston. That's where you'll find reporting on the cutting-edge research. Her position seems to ignore that there is new evidence pouring in all the time, from many sources, such as Dan Olmstead's series "The Age of Autism" at www.washtimes.com. He is currently exploring the interesting dearth of autism among the Amish, who traditionally do not vaccinate. Someone has asked me to point out that the mercury theory does not claim that every baby who receives mercury will be autistic, but that there are genetic and other factors that make one in 166 babies susceptible to neurological damage from mercury poisoning. And why not? It is, after all, second only to plutonium as the most toxic substance on earth. Why anyone would want to defend the stuff, aside from the possible autism relationship, is beyond imagining.

David Cohen (May 25, 2005)

The vaccine-and-autism lobby sometimes appears to subsist on the old 'post hoc, ergo propter hoc' argument ("after this, therefore because of this"). You know, the one that assumes that because an event occurs first, it is the cause of a later event: the cock crows, the sun rises over Manhattan; therefore, the cock caused the sun to rise. In this case, the argument additional support on account of overtones of faceless corporate types putting profit ahead of humanity. If only it were so simple! From where I sit, as the father of a classically autistic 5-year-old, I don't see much else in the intellectual argument here other than an understandable, well-honed sense of moral outrage. But when you think about it, moral outrage isn't a terribly intellectual quality. Back in the real world, every indicator we're getting from researchers in the field is that autism occurs before birth. Certainly, my own experience suggests as much: Both of my young boys were vaccinated. One of them is autistic, the other is not. In both cases, I can say without ANY fear of contradiction that their respective conditions were evident well before they received their shots; Certainly, there was no evidence of change in either from the time before and after they got vaccinated. Parents of autists need all the support they can get, not least in coming to grips with the anguished question, "Why?" Because this question is so desperately felt in many cases, the burden is all the greater for those who can supply the possible answers to do so responsibly, empathetically and with compassionate skepticism. In American academe, there's a great tradition of insisting on one question above all others: "Where's the data?" No data, no dice. And that's pretty much where I come down on on both snake-oil theory to do with vaccines and neurological disorders as well as roosters causing the sun to rise. --David Cohen is the Asia-Pacific Correspondent for the Chronicle of Higher Education, and the author of the following article: Men, Empathy, and Autism A British researcher offers a new theory about the developmental disorder that has skyrocketed among children http://chronicle.com/free/v50/i26/26a01201.htm

aubrey stimola (May 25, 2005)

The following is a letter I received from Dr. Susan McGrew, a pediatrician at the Vanderbilt Children's Hospital's Treatment and Research Institute For Autism Spectrum Disorders (TRIAD): Aubrey, I think you have done an excellent job at separating fact from belief or other agendas and I think you are doing an invaluable service to the community by publicizing these pieces.  You will continue to receive some criticism until we find the cause for autism.  Remember that Dr Leo Kanner, who first described autism thought it was from poor parenting.  He thought this because he observed broader autistic phenotype (personality traits) in some of the parents and mistakenly assumed these were causal.  Where would we be in autism treatment if he had not realized his mistake and recanted? As far as I am concerned the strongest evidence refuting the thimersal and autism link is the absence of any decline in autism rates with the removal of thimersal from most vaccines.  There should have been a rapid decline in new cases of autism which paralled the decline in exposure to thimerosal with at most a two year lag. I am still not sure if autism is all genetic or if there are some environmental factors which contribute.  All of us need to keep an open mind on this subject. Do you mind if I hand you piece out to patients?   It is well done. Susan McGrew, MD information about TRIAD can be found here: http://www.mc.vanderbilt.edu/reporter/?ID=675 and here: http://www.vanderbiltchildrens.com/interior.php?mid=302

Stacy Mintzer Herlihy (May 25, 2005)

Subject: A hearty thank you to Aubrey Noelle Stimola Dear Ms. Stimola, I read your review on the new David Kirby book. I must commend you for your reasoned response to it. You had the courage to state that Mr. Kirby is simply wrong rather than simply accepting his book at face value. Vaccines are an important health care measure. It is sad that vaccine usage is under attack from certain irresponsible and ill-informed special interests. Sincerely yours, Stacy Mintzer Herlihy A concerned parent who is NOT employed by the pHARMaceutical industry ;) BTW, I've seen the Dan Olmstead articles in the Washington Times. Olmstead points out that the Amish don't use some vaccines. What he fails to point is that one in fifty Amish children suffers from congenital Rubella.

Jay Brooks (June 15, 2005)

I will disclose at the outset of my comments that I am the father of an almost four-year old son who was diagnosed as mildly autistic one year ago. I am not an active member of any autism groups, but passively belong to the National Autism Association. I am currently about two-thirds of the way through Evidence of Harm (my wife finished it first) and have several comments to make regarding Ms. Stimola's review of the book and her remarks on the subject. Ms. Stimola states that "the large majority of reputable scientists and physicians agree that available data do not support a causal relationship between the ethylmercury-based vaccine preservative thimerosal and neurodevelopmental disorder." I don't know what the definition of a "reputable" scientist or doctor is, but she seems to imply that a reputable one is one who disagrees with Mr. Kirby whereas a disreputable one does not. It seems that she is suggesting that "reputable" scientists and doctors are never wrong. The history of scientific discovery is replete with long held dogma completely overturned by scientists considered disreputable in their day. Such luminaries as Issac Newton and Albert Einstein have been shown to be wrong about their theories which were thought to be sacrosanct in their day. "Reputable" doctors once used leeches and bled sick people as a cure. People whose lives depend upon the status quo are always resistant to change. Remember all those doctors on TV saying that smoking was good for you because it relaxes you. I'm pretty sure they were considered reputable in their day, too. This does not, of course, mean Mr. Kirby's assertions are correct but it certainly does not automatically follow that he is wrong just because so-called reputable people say so. I would suggest that you read "Trust Us, We're Experts" by Sheldon Rampton and John Stauber to remind yourself how big business has co-opted most objective science. Early in the review, the parents who began the investigation against overwhelming opposition and difficult odds are characterized as "distraught." Yet they do not appear either 1. Deeply agitated, as from emotional conflict, or 2. Mad; insane. Concerned perhaps; and certainly determined to find some answers. But by calling them distraught from the outset Ms. Stimola tells us her sympathies can never lie with the Mercury Moms regardless of whether or not they are shown to be correct or not at some date in the future. This is unfortunate since I prefer a book review to be objective and not shaded by an agenda to protect the industry to which the author ostensibly belongs, especially when she herself places such a lofty opinion on objectivity. There is a telling irony in her not being objective while stating that the best scientists only rely on objectivity. As Ms. Stimola later claims, "the best scientist will only rely on objective, hard, and replicable scientific data." This had me laughing in my chair. Evidence of Harm, if it does nothing else, highlights a startling lack of objectivity on the part of the medical community and the pharmacutical industry with studies, meetings and decisions that strongly appear to have been undertaken to further an agenda rather than find any objective truth. The CDC's use of a fourth generation of numbers to reduce the causal link between thimerosol and vaccines is just one notable example of the total opposite of objectivity she believes her reputable colleagues never stray from. It it hard to express the disgust I feel for her when I am told that as a "desperate parent," I am in "the population most vulnerable to buying into conspiracy theories and media hype." How does one respond to such a blatant and condescending attack on my character. She has resorted to blaming the victims. While I am not as convinced as the Mercury Moms, I am certainly more open to the possibility of a causal link than most members of the medical community appear to be, especially when most of the so-called "media hype" she mentions has for years tried to reassure me that I have nothing to worry about, that there is no link, and I should go back to sleep and let her and her colleagues tell me what is best for my son. Well I have one word for Ms. Stimola: Thalidomide. Didn't the so-called reputable scientists and physicians of the day say A-Ok to this one? I find it deplorable that the way to attack any controversial theory today is to call its exponents "conspiracy theorists" thereby stripping any credibility from their argument in one fell swoop. It removes any requirement that the theory be attacked on its merits. But any time this tactic is employed, I can't help but be suspicious of the motives behind its use. I guess that puts me in the vulnerable population after all. Even more regrettably, Ms. Stimola tells us about a book by a CDC MD touting the reason for the rise in cases of autism as "attributable to better and broader diagnostic criteria." That it isn't selling better she finds as cause for lament and she explains that the reason for this is that nobody wants to hear a story about how things are just great, people prefer doom and gloom. A perusal of any bookstore will show that people indeed love a story that tells them all is well. Personally, I think the reason it's not selling is that it doesn't take a genius to ask where are all the adult autistics hiding if the perceived epidemic is merely the result of better diagnostics? If there's no rise in the incidence of cases, then there should be many thousands of undiagnosed people with autism living amongst us. Where are they? In the last reel, Ms. Stimola states that "[t]hose who have fought against the demonizing of thimerosal have to put up with absurd accusations of being industry shills." Who but an individual with either ties to the industry or some other related agenda could argue that the second most toxic substance after plutonium should remain in injections we give infants, even in trace amounts? What is "absurd" about that? Mercury has been known to be toxic for so long now that it boggles the mind that anyone could defend its continued use, regardless of causal claims. It now seems remarkable that it was once used in teething powders for children. But when it was found to be doing them harm, it was removed and prohibited from being put on a person's skin. To argue that it may still be acceptable to inject it into an infant, now that's the very definition of absurd.


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About the Editor:
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