Paul Offit on Hannah Poling and the VICP
May 15, 2008 by Kristina Chew, PhD
Filed under Health
Paul Offit, M.D., chief of infectious diseases at the Children’s Hospital of Philadelphia and professor of pediatrics at the University of Pennsylvania School of Medicine. He is frequently quoted regarding the controversy over a vaccine-autism link; he emphasizes the importance of vaccines for public health. Dr. Offit is, accordingly, not exactly a beloved figure among those who claim that there is a link between autism and vaccines and has even been the recipient of death threats.
In the May 15th New England Journal of Medicine, Dr. Offit revisits the case of Hannah Poling in light of the recent history of the Vaccine Injury Compensation Program (VICP). With the start of another case in “Vaccine Court” on Monday, Dr. Offit’s essay is certainly timely, though I’m sure he’ll receive merciless “jabs” (may as well use the pun at this point) on the web and elsewhere by those who believe that there is, beyond a doubt, a link between autism and vaccines.
Dr. Offit states that the VICP’s consession to Hannah Poling—that vaccines aggravated her underlying mitochondrial disorder and caused symptoms of autism—-was “poorly reasoned” for four reasons:
- “…whereas it is clear that natural infections can exacerbate symptoms of encephalopathy in patients with mitochondrial enzyme deficiencies, no clear evidence exists that vaccines cause similar exacerbations.” It is even recommended that children with these deficiencies receive all their vaccinations, as they are especially susceptible to infections.
- “…..the belief that the administration of multiple vaccines can overwhelm or weaken the immune system of a susceptible child is at variance with the number of immunologic components contained in modern vaccines.”
- “…although experts testifying on behalf of the Polings could reasonably argue that development of fever and a varicella-vaccine rash after the administration of nine vaccines was enough to stress a child with mitochondrial enzyme deficiency, Hannah had other immunologic challenges that were not related to vaccines. She had frequent episodes of fever and otitis media, eventually necessitating placement of bilateral polyethylene tubes.” As Dr. Offit notes, this is not an atypical medical history for a child; just reading “otitis media” reminded me of my son’s ear tube operation, just over nine years ago.
- “…without data that clearly exonerate vaccines, it could be argued that children with mitochondrial enzyme deficiencies might have a lower risk of exacerbations if vaccines were withheld, delayed, or separated. But such changes would come at a price. Even spacing out vaccinations would increase the period during which children were susceptible to natural infections,” including such diseases as chicken pox, pertussis, and pneumococcus.
Dr. Offit compares the concession in the case of Hannah Poling to two earlier cases in which “the VICP seems to have turned its back on science”: In 2005, Margaret Althen was successful in claiming that a tetanus vaccine had caused her optic neuritis; in 2006, Dorothy Werderitsch successfully claimed that a hepatitis B vaccine had caused her multiple sclerosis. Even though the scientific literature did not provide evidence of such claims,
VICP ruled that if a petitioner proposed a biologically plausible mechanism by which a vaccine could cause harm, as well as a logical sequence of cause and effect, an award should be granted.
“Plausible” means
“apparently reasonable and valid, and truthful”
—-and apparently reasonable and valid, and truthful, is not the same as something (a hypothesis of autism causation, for instance) being actually reasonable and valid, and truthful. And perhaps this is why the fate of the vaccine-autism link is being tested, and perhaps decided, in the courtroom rather than the lab. If it’s “a logical sequence of cause and effect” that is needed to explain that “biologically plausible mechanism,” those who can construct the most forceful (but not necessarily true) arguments—those who know best to use language to build a case for a purported vaccine-autism link—have something of an advantage. It seems that it is not science that is going to be the decisive factor here, but the power of argument, and, too, of rhetoric.
It is precisely language that is that has become problematic for scientists in disputing the claims of those who contend that there is a link between vaccines and autism. As Dr. Offit writes at the end of his article:
After the Polings’ press conference, Julie Gerberding, director of the Centers for Disease Control and Prevention, responded to their claims that vaccines had caused their daughter’s autism. “Let me be very clear that the government has made absolutely no statement . . . indicating that vaccines are a cause of autism,” she said.5 Gerberding’s biggest challenge was defining the term “autism.” Because autism is a clinical diagnosis, children are labeled as autistic on the basis of a collection of clinical features. Hannah Poling clearly had difficulties with language, speech, and communication. But those features of her condition considered autistic were part of a global encephalopathy caused by a mitochondrial enzyme deficit. Rett’s syndrome, tuberous sclerosis, fragile X syndrome, and Down’s syndrome in children can also have autistic features. Indeed, features reminiscent of autism are evident in all children with profound impairments in cognition; but these similarities are superficial, and their causal mechanisms and genetic influences are different from those of classic autism.
The CDC did not immediately send out a message proclaiming that “this concession does not mean that the government says that vaccine cause autism”: By not sending out such a clear and direct statement, a great deal of debate arose, and is still raging, about the government “conceding” regarding Hannah Poling’s case.
And, as Dr. Offit points out, what exactly is meant by “autism” in regard to Hannah Poling is not entirely clear, due to what is known about her “global encephalopathy” that was “caused by a mitochondrial enzyme deficit.” While she displayed the “difficulties with language, speech, and communication” that are regularly noted as pointing to an autism diagnosis, the causal mechanisms and genetic influences” for those difficulties are “different from those of classic autism,” as Dr. Offit writes. If the level of autism awareness were not as high as it is now, and if autism were not being said to be more and more common, would Hannah Poling still have been said to display symptoms of autism? Or would some other disorder or dysfunction be emphasized?
And, if the VICP had “more rigorously” defined what it means by a vaccine causing harm, perhaps there would not be such grounds for the cases of Margaret Althen, Dorothy Werderitsch, and Hannah Poling. Dr. Offit indeed calls on the VICP to create such criteria, or further risk eroding “public confidence in vaccines and hurt those whom it is charged with protecting.” Dr. Offit is well aware of the popular press’ and the internet’s role in fanning and refueling the flames of vaccine misinformation. A few days ago, Dr. Offit was quoted in the Washington Post as saying
“I think that what’s so endearing to me about the anti-vaccine people is they’re perfectly willing to go from one hypothesis to the next without a backward glance.”
And, it seems, quite willing to change how “autism” is referred to: As Kev at Right Brain/Left Brain has been noting in his coverage of the latest round of “Vaccine Court,” the lawyers for the petitioners and an expert witness have been carefully defining autism into sub-groups such as “regressive autism” and “clearly regressive autism“: Does this mean there is also “unclearly regressive autism” or “clearly progressive autism”?
These shifts in theories of what causes autism can become the basis for new treatments that are said to potentially “cure” autism. For instance, chelation, in which the body is “detoxified” of “heavy metals” and of mercury via medicines and “chelating agents,” is said to be a treatment specifically for autistic children. As Orac points out in a recent post, chelation has also been suggested as a treatment for other conditions, including atherosclerotic coronary artery and peripheral vascular disease. There’s a multimillion dollar “clinical trial” on chelation as a treatment for coronary artery disease being sponsored by the National Center for Complementary and Alternative Medicine (NCCAM); Orac points readers to an article about Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned—they don’t, as he writes, call it “cheat-lation” for nothing.
And more and more one wonders if, when the last of the 4900 cases in the “Vaccine Court” has been closed, will anyone feel just a little cheated for having made this their focus.
I’m still finding myself confused by the waffling around the definition of autism vs. the autistic-like symptoms referred to in the Poling case. I think Dr. Offit’s distinction about causal mechanisms and genetic influences muddies the water further, if only because we DON’T have a clear picture of the causal mechanisms of autism across the board. The DSM definition of autism says nothing about causation, or am I missing something?
This is particularly important to me because my child has a “causal” diagnosis with a genetic component — linear nevus sebaceous syndrome, a rare neurocutaneous disorder. She also has a “developmental” diagnosis, based on symptoms — autism.
Since we don’t know with any clear certainty what causes autism, and it’s bound to be more than just one thing, it concerns me to see this hint of dismissing certain presentations of the autism collection of symptoms as “not autism” just because there’s another potential box to put it in.
I’d be very interested in hearing more about the dividing line between real true autism and autistic-like-symptoms-that-can-be-blamed-on-something-else. Doesn’t the collection of “something-elses” eventually BECOME the understanding of autism causation?
Kristina;
You should inform the readers of your blog about conflicting interests, especially Dr. Paul Offit. Dr. Offit, like Eric Fombonne is paid high sums for his expert testimony and public opinion pieces on the safety of vaccines. Dr. Offit is an inventor of the retrovirus vaccine for which he receives handsome royalties and has a clear bias when it come to issues related to vaccine safety.
http://www.pharmalot.com/2007/06/vaccine-conflict-disclosure-too-subtle-or-just-right/
Why do the pro-vaccinators question the anti-vaccine scientists with the usual rants about how they are in for the money. The same rants can be applied to the Eric Fombonne and Paul Offits of the world.
I think you are right that autism is a clinical diagnosis and that the DSM is not about causality. If the symptoms are there, you can make a diagnosis of autism. In other words, there may not be a “real true autism,” to use your words, but rather multiple pathways to a common set of strengths and deficits (or symptoms if you prefer that term). When you come to think of it, given how complex the brain is it’s amazing how few manifestations there are! Anxiety, elation, mania, psychosis, depression, etc. This is why Dr. Offit says that children with Down syndrome, cerebral palsy, and other conditions might be diagnosed with autism, though in the old days no doctor would ever have considered doing that.
It is the anti-vaccinationists who lack transparency, not the scientists.
Dr. Offit’s work for Merck is clearly stated at the end of his article. Fombonne has seldom testified anywhere (as opposed to the professional witnesses who work for the anti-vaccine folks — the ones who testified for the Cedillos, etc.) and has never received money or worked for a pharmaceutical company. Fombonne is about as “pure” (lacking conflicts of interest) as you can get as an expert.
It is the anti-vaccinationists who lack transparency, not the scientists.
Hello friends -
What could be a more concise illustration of what bothers me about this debate? If the science were so bulletproof, and the real evidence so concise, why are simple logical fallacies so simple to see in the public proclamations of those arguing against a link?
[Note: the logical fallacies of many proposing such a link are also quite clear; but darn it, the scientists are supposed to be the ones that don't have holes in their arguments!]
““…whereas it is clear that natural infections can exacerbate symptoms of encephalopathy in patients with mitochondrial enzyme deficiencies, no clear evidence exists that vaccines cause similar exacerbations.”
“…although experts testifying on behalf of the Polings could reasonably argue that development of fever and a varicella-vaccine rash after the administration of nine vaccines was enough to stress a child with mitochondrial enzyme deficiency, Hannah had other immunologic challenges that were not related to vaccines. She had frequent episodes of fever and otitis media, eventually necessitating placement of bilateral polyethylene tubes.”
In one sentence, we are told that we know that infection can cause an aggravation of the problem, but have no such evidence of vaccines. In the next, we are told that the child had a history of repeated infections! Whatever our other evidence (or lack thereof); having a history infections without a series of nine vaccinations was not causing this child to miss her milestones. If infections and fevers were going to cause the child to regress, one wonders why it did not show up previously during her extended bouts of fevers and infections?
This also makes the unfounded assumption that it is the infection that increases encephalopathy, as opposed to the immune response to the infection. From what I’ve read, the argument made was that the resultant fever that was the problem. You get that from the infection or the vaccine; it isn’t always about the pathogen, sometimes it is about your bodies response.
“the belief that the administration of multiple vaccines can overwhelm or weaken the immune system of a susceptible child is at variance with the number of immunologic components contained in modern vaccines.”
I am pretty sure that this point was not argued by the petitioners; thus it is irrelevant towards if the judgement was poorly reasoned or not. Different argument.
“without data that clearly exonerate vaccines, it could be argued that children with mitochondrial enzyme deficiencies might have a lower risk of exacerbations if vaccines were withheld, delayed, or separated. But such changes would come at a price. Even spacing out vaccinations would increase the period during which children were susceptible to natural infections,” including such diseases as chicken pox, pertussis, and pneumococcus. ”
It does come at a price, but this has nothing to do with if the judgement was poorly reasoned or not. Again, different argument.
Flame away!
- pD
Yes, it is noted in the article in the NEJM that Dr. Offit “reports being a co-inventor and co-holder of a patent on the rotavirus vaccine RotaTeq, from which he and his institution receive royalties, as well as serving on a scientific advisory board for Merck.”
“The DSM definition of autism says nothing about causation, or am I missing something?”
Yes, it does. It states that autism is a ‘developmental disorder”. That is why it is limited to children who show some signs before age 3. As part of the bigger picture, this is why a person with brain injury who may show ‘autistic features’ is not considered to have autism. This was pointed out by Mrs. Poling in an internet discussion group, by the way.
That brings up a whole big can of worms. One that I hope to address soon.
In one sentence, we are told that we know that infection can cause an aggravation of the problem, but have no such evidence of vaccines. In the next, we are told that the child had a history of repeated infections! Whatever our other evidence (or lack thereof); having a history infections without a series of nine vaccinations was not causing this child to miss her milestones. If infections and fevers were going to cause the child to regress, one wonders why it did not show up previously during her extended bouts of fevers and infections?
pD, so this is your argument that demonstrates there’s a fallacy in the article? In reality, “correlation implies causation” is a common fallacy.
Why did vaccinations trigger regression and not the history of infections? I don’t know. We wouldn’t be discussing this now if it had happened differently, now would we?
How come we happen to live in a planet that supports life? What a coincidence. Anthropic principle. Look it up.
“That brings up a whole big can of worms. One that I hope to address soon.”
In full? With a definite answer?
That, in all seriousness, would be so wonderful, you have no idea.
So, please?
Cliff
Hi Joseph –
pD, so this is your argument that demonstrates there’s a fallacy in the article? In reality, “correlation implies causation” is a common fallacy.
My argument is that we are being asked to ignore some very key pieces of information in order to make the logical leap that the decision reached was ‘poor reasoning’. What’s more, the person asking us to do so provides that information in his own article.
Firstly, we are told that infections are known to increase encephalopathy in people with mitochondrial disfunction; and we have no evidence that a vaccine could do this. Secondly, we are told that previous to vaccines, infections and fever were common in this child.
Now, what has been observed? We know she suffered repeated bouts of infections and fevers, but did not regress until the vaccines. Clearly, just having infections and fevers were not sufficient to make this child regress. What has been observed clearly, clearly does not match with the thrust of the message. That is poor reasoning.
I have no made claims as to correlation and causality. As I stated here, and previously, what bugs me the most about this is the relative weakness of the arguments in place.
“Why did vaccinations trigger regression and not the history of infections? I don’t know. ”
According to Mr. Offit, you are engaging in poor reasoning by saying that the vaccinations triggered the regression.
How come we happen to live in a planet that supports life? What a coincidence. Anthropic principle. Look it up.
As irrelevant towards if the decision being poor reasoning as the belief that vaccines overwhelm the immune system, or if there are other risks involved with a delayed vaccination schedule.
- pD
At first I had some problems with the autism v. autistic features thing until I recalled the various tests we did for Rett Syndrome, Fragile X, TS, neurofibromatosis and some metabolic syndromes.
Why were those done? Because all of those could “look like”/mimic “autism”, but had identifiable disorders with “autistic features” or shared or overlapping behaviors that fit into the current DSM criteria for “autism” .
Now in the big picture, “autism” has some neurologic basis, and I believe probably many different ones, with potentially different trajectories. What they all have in common is being put within the PDDs because of the commonalities based on time of occurrence and behaviors. Eventually as different cause is identified, I imagine we will see more syndromes and disorders added to the above list, each differentiated, but sharing, “autistic features”.
is there anyone who isn’t receiving big pharma money? The government receives money from big pharma via campaign and soft money donations, American Association of Pediatrics receives donations, and, here, eloquent and knowledgeable doctors like Offit are paid as “advisors” to big pharma.
I find Offit’s arguments compelling, but it would be nice if he were disinterested. Ditto for American Society of Pediatrics.
We know she suffered repeated bouts of infections and fevers, but did not regress until the vaccines. Clearly, just having infections and fevers were not sufficient to make this child regress. What has been observed clearly, clearly does not match with the thrust of the message. That is poor reasoning.
I disagree, and I apologize, but believe it is your reasoning that is poor, pD. I don’t think anyone is suggesting that infections guarantee regression in mitochondrial dysfunction. Did anyone say this? I must have missed it.
So is it remarkable that infections did not trigger Hannah’s regression? I don’t see why.
Is there evidence that vaccination triggered Hannah’s regression? Yes, there’s some circumstantial evidence. Is it a proven mechanism? No.
@Sullivan — good clarification about “before age 3″. Also there’s the specific exclusion of Rett. I too would like to hear your thoughts on the big can of worms…
@Regan — thanks for your response. With the exception of Rett (which is accounted for in the DSM), though, I still don’t quite understand why one couldn’t have any of those other disorders and autism too, if indeed autism is a defined collection of symptoms that present before age 3. Does a diagnosis of autism really mean “a certain collection of autistic features presenting before age 3 whose cause we don’t know”?
I’m reminded of the quote (from Augustine maybe?): “If you think you understand, it isn’t God.”
How about this cynical recasting: “If you think you know the cause, it isn’t autism.” !!!
@Annie, I’m still contemplating your questions—”Doesn’t the collection of “something-elses” eventually BECOME the understanding of autism causation?”—–was reading Augustine earlier today, Book 3, whose general theme is how one can be so full of oneself thinking that one knows, and now know, at all.
Annie,
I’m not a neurologist, but in the case of my daughter, that is exactly what it is; a set of diagnostic criteria based on observed behavior which were not able to be attributed to a particular medical cause or association. If she had met fewer criteria on the list, the diagnosis might have been PDD-NOS. The other things that I mentioned were excluded after screening.
To me “autism” is a weird diagnosis because it has been subject to changes in criteria (various DSM revisions, ICD-10 and educational categories) and observationally is able to be applied to children with divergent manifestations, as we experienced in her “autism” classroom.
If I knew a specific “cause”, I might think, and it could be well assessed that Eleanor had autistic behaviors but her underlying and predominant diagnosis might be PKU or tuberous sclerosis, etc.
Just how I see it.
Regan,
I appreciate your perspective as I try to sort out this whole autistic-symptoms distinction. I’m obviously no neurologist myself…
As I mentioned in my first comment, my child’s diagnosis doesn’t fit the exclusionary pattern. We have the one diagnosis from the neurologist (linear nevus sebaceous syndrome) who then sent us to the developmental pediatrician who quite adamantly added the autism diagnosis, knowing full well we had this LNSS diagnosis under our belts already.
So when I hear the distinction between autistic-like symptoms and autism, it makes me wonder where kids like mine with a dual diagnosis will eventually fit into the autism discussion, the autism community, the range of services available for people with an autism diagnosis, etc.
Thanks for the conversation!
Kristina, may I hope the results of your contemplations turn into a post for further discussion? Your writings and the comments they attract have become a favorite online destination for me.