Still, it’s hard to avoid wondering:  is Wakefield right when he alleges that he’s being persecuted by the vaccine industry?

Last week, I discussed the BMJ article by Brian Deer asserting that Wakefield’s research was fraudulent, and the accompanying editorial supporting immunization.  At that point, I thought that the BMJ pieces were, together,  a one-off.

I was wrong.  In fact, it looks this week like the vaccine industry has armed some of its main warriors and sent them out to do battle.

The Battle Against Anti-Vaccinationism

In the Jan. 13th issue of the New England Journal of Medicine, two powerful chiefs, Gregory Poland and Robert M. Jacobson, claim that there’s an “age-old struggle” to make vaccines available.  Their aim is to vilify the “antivaccinationists” who “have done significant harm to the public health.” [Note the use of the holy article in this phrase, to signal just how sacred these warrior-priests hold "the" public health to be.]

The Poland-Jacobson piece is pure propaganda.  Theirs is a tale of heroic struggle on the part of ever-embattled Believers against the satanic forces of Antivaccationism — who have been trying “since the 18th century” to shake people’s faith in the vaccine gospel.  And nowadays the nasty antivaccinationists are using scarily modern forms of communications, such as TV and the Internet, in order “to sway public opinion and distract attention from scientific evidence.”

Wow:  TV and the web.  Sounds satanic alright.

I guess I shouldn’t be surprised that a couple of crusaders make their own work sound salvationist.  What troubles me is that they make it sound like they’re disinterested do-good-ers.

In fact, Poland and Jacobson are in bed with Big Pharma.  Poland runs the Mayo Clinic’s Vaccine Research Group.  Although as far as I can tell, Poland and Jacobson are not currently in the direct pay of the vaccine manufacturers, they and the VRG have benefited handsomely from vaccine makers’ largesse.

For instance, Poland’s and Jacobson’s work on human papillomavirus vaccine, as they acknowledge in a 2005 Mayo Clinic Proceedings paper, was funded by Merck, and their co-workers were Merck employees.  Later, in conjunction with a continuing medical education module on meningococcal vaccine in 2009, Poland disclosed the following ties:

Sources of Funding for Research: Merck & Co, Inc, Novavax, Inc, Protein Sciences Corp; Consulting Agreements: Avianax, LLC, CSL Biotherapies, CSL Limited, Emergent Biosolutions Inc, GlaxoSmithKline, Merck & Co, Inc, Novartis Vaccines, Novavax, Inc, PowderMed Ltd

And on his disclosure form for this week’s NEJM article Poland acknowledges funding from Pfizer and Novartis for vaccine studies.

So when Poland and Jacobson write that our society “must continue to fund and publish high-quality studies to investigate concerns about vaccine safety,” they’re really talking about preserving their livelihood.  It’s very much in their interest to ensure a steady flow of such funding.

And when they say that “society must recognize that science is not a democracy in which the side with the most votes or the loudest voices gets to decide what is right,” they’re being completely disingenuous.  Because Poland and Jacobson know quite well why science is not a democracy:  in the type of research they do, it’s the big money that decides what is right.

A High Priest of Vaccine “Science”

Then there’s Paul Offit making the rounds.  Offit has been the subject of lots of attention by Age of Autism, most recently as a “denialist.” Offit probably profited somewhat from the licensing of Rota Teq vaccine, which he helped invent — although AofA’s allegation that he is therefore beholden to Merck seems unsubstantiated.

What’s obvious about Offit is that he is contemptuous of people who don’t agree with his version of truth.

Offit appeared on Lenny Lopate’s radio show in New York yesterday, and presumably will be appearing elsewhere.  His aim is to explain the “grave public health problem of vaccine avoidance.”  The “anti-vaccine movement threatens us all,” he says.  In fact, that’s the subtitle of his new book, Deadly Choices.

Where Poland and Jacobson are militant and sanctimonious, Offit sounds a note at once sentimental and officious.  It’s “tragic” that there have been measles outbreaks because of parents refusing to have their kids vaccinated, he says.  And the problem is that people just don’t understand science.  In fact, Dan Olmsted at AofA gets it quite right when he critique’s Offit’s blinkered version of science:

Anyone concerned about [possible harms of vaccination] fits Offit’s definition of anti-vaccine, because vaccines don’t cause any of them, because Paul Offit says so, a solipsism that is really quite breathtaking: “[B]ecause anti-vaccine activists today define safe as free from side effects such as autism, learning disabilities, attention deficit disorder, multiple sclerosis, diabetes, strokes, heart attacks, and blood clots — conditions that aren’t caused by vaccines — safer vaccines, using their definition, can never be made.”

I had the same reaction to Offit’s self-important — and, to my mind, unscientific — claims.  Offit shows no interest in the open inquiry that marks science.  People who don’t agree with him are uneducated, poorly informed, maybe just stupid.  And, of course, dangerous.

“Tragic” Consequences of Unbelief

On the Lopate show, Offit resorted to the now-common formula of the “tragic” consequences of parents’ belief in Andrew Wakefield.

What’s the tragedy, exactly?   It’s true that there have been outbreaks of measles in the British Isles that have been traced to parents’ refusal to have their children immunized.  An excellent review in BMJ in 2006 provided some of the data for the U.K. — including that one child died in a 2006 measles outbreak that was related to poor immunization coverage.  A few children died in Ireland in 2000.  A CDC account of a measles outbreak in California in 2008 reports that it hospitalized a few children, although none died.

It would be great if nobody ever died from an infection that could be prevented in any way.  It’s surely tragic to the parents of a child who dies from a preventable infection.   The sympathies of each of us should go out to such parents, as to those whose kids are killed by bad drivers, sports injuries, or infections for which there’s no vaccine.

But in what sense is one child’s death more of a collective “tragedy” for all of us than the other deaths that go unremarked every day?   Why is it tragic when one child dies of a vaccine-preventable infection and not when a lot of them die of poorly regulated handguns or as troops fighting wars that never endanger our leaders, only our young?

The Ramp-up of Aggression by the Vaccine Crusaders

Why are the vaccine warriors rampant now?  Perhaps the vaccine makers are terrified that the low uptake of H1N1 flu vaccine despite all the hype in 2009, along with low MMR compliance in some places (the U.K. especially), means that their profits are going to slide.  Maybe their friends, like Offit and Poland, are worried that reduced uptake of vaccines will translate into diminished research funding or fewer conferences in delicious places.

Or maybe the vaccine industry finds Wakefield so obstreperous that they can’t rest until he is destroyed. Wakefield’s no choir boy, but he might not have realized just how much control the pharmaceutical industry can exert in the U.K.

In a review essay in last week’s New York Review of Books, Simon Head points out that Big Pharma is “the only major segment of the British economy that is both world-class and an intensive user of university research,” and implies that it exerts control over both the substance and volume of U.K. research productivity, especially in medicine.  Head sees reason to believe that Pharma will “tighten its hold over scientific research in the UK” in the future.

It’s Not a War

There need be no either-or about vaccines.  If our society can live with guns and automobiles (together accounting for roughly 50,000 American deaths a year), if we tolerate alcohol, processed foods, acetaminophen, high-rise construction, and all the other things that occasionally cause harm but mostly contribute to the way of life we prefer — then we can stop calling it “tragic” when a few parents don’t have their kids immunized.

Because to call one measles death “tragic” is to further the vaccine warriors’ campaign — the campaign that pretends to be on behalf of science or healthy kids, but is really fought to protect the fortunes of vaccine makers.

The campaign protects the power of shiftless public officials who claim to be protecting the public from harm when they serve up millions of taxpayer dollars to vaccine manufacturers for barely useful vaccines (H1N1 2009), or for vaccines that are undoubtedly helpful but might be harmful in some cases and haven’t been thoroughly examined (HPV vaccine).  And who, to this day, won’t even consider the very good question that Andrew Wakefield posed in the 1990s:  is it a good idea to give kids three immunizations in a single preparation?

I had my child immunized when she was the right age for that.    But I’m not certain that absolutely everyone has to do the same.  Neither are the courts, which is why they allow exemptions from immunization for personal belief.

I don’t think measles is a menace to civilization.  I know that only a very tiny percentage of children who contract measles get dangerously sick from it, that flu vaccine doesn’t work for everyone (and isn’t an effective public health measure to stop flu outbreaks even though it can protect individuals from illness), and that varicella vaccine can make the problem of shingles worse even though it reduces the problem of chicken pox.  And so forth.

I mean that immunization is complex and fraught.  Not everyone can be expected to agree with every vaccine recommendation.   Even while some people are opposed to vaccination and refuse to immunize their kids, life will go on, and society will continue to thrive, and Paul Offit can continue to say arrogant things about “science.”

So, could someone please call off the crusade?

Or is it the vaccine-autism connection that’s supposedly being interred?

Probably both.

The BMJ opened the proceedings this week by publishing journalist Brian Deer’s investigative piece on the original Wakefield study of MMR vaccine and autism (Wakefield’s study was published in Lancet in February 1998).   That report had already been repudiated by Wakefield’s coauthors, and retracted in 2010 by the Lancet‘s editors after investigation of Wakefield’s procedures.  Wakefield is no longer allowed to practice medicine in the UK.   The Deer article was a parting shot.

An accompanying editorial by Fiona Godlee, Jane Smith, and Harvey Marcovitch, BMJ editors, was a well-taken and circumspect attempt at restoring confidence in measles immunization — on which, in their view, the work of Wakefield and colleagues had cast a shadow.  The editors might not be right in blaming the 1998 Wakefield study for contemporary parents’ reluctance to get their kids immunized, but their aim is to make a reasonable, if arguable, public health point.   To my reading, they haven’t got much of an axe to grind.

But then the whetstones began to turn.  Jonathan Adler at Volokh cheers, wondering if now the “vaccine-autism charade” will end.  Nick Gillespie is also celebratory, albeit more sedately, at Reason‘s blog.   

At Age of Autism, John Stone tries to undermine the journalist (Deer) who wrote the fraud story.  Stone is so rabid, and so ad hominem, in his attempts to destroy Deer that he manages to touch on not a single one of the reasons why it remains impossible to rule out a link between vaccines and autism.   Elsewhere at AofA, the UK group CryShame’s response is published; it too focuses on Deer’s methods, not the substance.

Evidently, substance is nobody’s concern here.  It’s about how news gets made.  Gary Schwitzer, a really sharp observer of the journalism scene, notes that journalists made Wakefield’s reports newsworthy back in their day, and are now “playing a key role in uncovering and dismantling” the story.

The vaccine-autism connection is news because it continues to get everyone riled up.

The defenders of vaccination (to judge by their vigorous celebration every time some further insult is visited on Andrew Wakefield) keep hoping that the suspicions of such a connection will go away.

The skeptics about governments’ medical policing of private lives invoke the possibility that vaccines are associated with a really high profile Bad Thing — like autism — to further their case.

The people who are crying out for an explanation for why so many kids function autistically remain unsatisfied.  (It’s not hard to see why they can’t get satisfaction:  policy makers, invested in mass immunization, don’t want to do the studies that would really find out whether or not the multiple vaccinations that kids are supposed to undergo today might be related to neurological changes.)

Of course, all of that has to do with the substance of the problem.  And what we’re seeing here, with Wakefield, with the revocation of his medical license last year, with this week’s fraud charge, and so on, isn’t substance at all.  It’s gloating or it’s grumbling.  Really, it’s not new.  But it’s news.

Today, it would be closer to the truth to say that tragedy only counts if it can be diagnosed.   And diagnosis only counts if it’s biological.

That’s been the story of  the conversation about autistic children, and the implication of so-called mitochondrial dysfunction.

Deficiencies of energy metabolism have been rumored in association with the autistic picture for a while now, and emerged in the Hannah Poling case a few years ago.  They were given a boost by a small European case series (abstract here, PDF here) published in 2005 in Developmental Medicine and Child Neurology.  (The authors of the article gave their paper the deceptive title “Mitochondrial dysfunction in autism spectrum disorders:  a population-based study,” even though the research involved no population at all, just 11 kids.  But business is business.)

Another boost came this week with the publication in JAMA of a methodologically careful study of  energy metabolism in 10 California children diagnosed with autism, contrasted with 10 children drawn from a well-matched sample of comparable control children.   The new study found reduced oxidative activity in mitochondria — the tiny energy-chain entities inside cells that produce chemically based, biologically derived power for the cells’ functions.  The reduced oxidative activity was present in most of the 10 autistic children, and they showed a much-altered mean energy metabolism on several different measures.

Thus, altered energy metabolism at the cellular level has been documented in a small handful of children diagnosed with autism.  It seems not to be present in all children with autistic diagnoses.  It might be a result of autistic behavior rather than a cause, or a bystander phenomenon of some kind.  Or it might be a feature that hastens diagnosis (in the ones who have the unusual metabolic pattern, it has not been shown to precede the diagnosis) without actually playing any predisposing role.  Indeed, the authors of the JAMA paper remark that the

mitochondrial dysfunction observed in this preliminary study performed with children presenting with full syndrome autism may or may not indicate an etiological role.

But this minor and still untested finding on mitochondrial energetics, still not of any self-evident significance regarding the cause of autistic behavior, has created a major stir.  Medscape weighed in.  Business Week ran a story written by HealthDay reporter Jenifer Goodwin.  And it’s no surprise that the story has been front page news at the autism blogs, like Age of Autism and Autism Speaks.

So it seems safe to say that we’re looking at the third coming of a fact.

That some children engage with the world differently than do most kids was the first discovery, an old discovery (some think the 18th-century Wild Child of Aveyron was autistic).  It was codified in 1910 when  the psychiatrist Eugen Bleuler labeled one of the varieties of childhood schizophrenia “autistic.”  Identification.

Next came diagnosis – beginning with Hans Asperger in 1938 and Leo Kanner in 1943.   In the grip of modernity, slow acquisition of words, quirky communication, fixity of focus, failure to multitask, preoccupation with parts rather than wholes, and so on, are no longer signs of diabolical possession, thankfully.  But neither do they signal a broadened sense of what human experience is like.  They’re just signs of disease.

Diagnosis has allowed all sorts of theories to summon support:  about parenting, about the toxic environment, about thimerosal in vaccines, or about immunization itself.  Autism is the diagnosis that lets people express their misgivings about modernity.

Now we’re seeing the beginning of step 3:  biologization.

If autism is to stand up to 21st-century modernity, it has to have a biological basis.  Otherwise it will go the way of the obsolete disorders of old, like neurasthenia, hysteria, or frigidity.  The research on mitochondrial dysfunction in California won’t be the last or the only big-dollar expenditure aimed at finding a biochemical basis for the diagnosis of autism.   And there’ll be DNA studies, too.

The sad thing is that the only good way for troubled parents to get services for their children is to have the kids diagnosed, and to help to get them labeled as biologically off-kilter (Autism Speaks was one of the sponsors of the study just published in JAMA).  Get them labeled as dysfunctional, to use the term of art.

There’s no percentage in betting on need, or social disadvantage, or just plain poverty as an impetus to free up funds and services.  The need doesn’t count if there’s no dysfunction.   Your event doesn’t count as world-historic without a biological basis now.  First as tragedy, then as diagnosis, then as biology…

Autism, ADHD, obesity, addiction — each time our society is confronted with a problem it can’t solve or an irritation it can’t salve, we feed the problem into the medical establishment’s diagnosis mill.  Then we turn it over to the biologists to put some science on it.

Once the problem has a name and a diagnosis and a biological mishap to it — then we can see it.

As New Scientist points out, the GMC’s finding removes any impediment to charging Wakefield and two of his colleagues with misconduct.  GMC may rule on that score in a few months, according to the BBC.

By and large, the talk about the verdict hasn’t been about the substance of the contentious vaccine-autism link.  At Autism Science Foundation, Alison Singer (the group’s president) writes that

Anti vaccine autism advocates continue to see Wakefield as a hero who remains willing to take on the establishment and fight for their children.  In the meantime, Wakefield’s actions have had a lasting negative effect on children’s health in that some people are still afraid of immunizations. In some cases, the younger siblings of children with autism are being denied life saving vaccines. This population of baby siblings, already at higher risk for developing autism, is now also being placed at risk for life threatening, vaccine preventable disease, despite mountains of scientific evidence indicating no link between vaccines and autism. This is the Wakefield legacy.

On the other side, Generation Rescue writes in support of Wakefield at Age of Autism.  GR isn’t as cogent as Singer, but brings up the point that tends to complicate this and most discussions of autism:    “Do you think pharmaceutical companies have too much influence in the laws, policies, and regulations of our government?  We do.”

Liz Ditz provides a great service, compiling blog posts pro-Wakefield and, separately, those criticizing Wakefield and/or supporting the GMC’s decision.  (As of today, the Wakefield critics seem to have been more prolific.)

Thursday’s BBC report concludes with a graphic showing a decline in MMR coverage in the UK between 1996-97, when it stood at around 90%, and 2004, when it bottomed at around 80%.  Superimposed is the number of measles cases, which increased from a few dozen in 2005 to over 1200 in 2008.  The implication is that Wakefield’s report was somehow responsible for the drop in coverage in the late ’90s and that that decline led to a sharp uptick in measles incidence.  The graphic also implies that after Lancet retracted the original paper in 2004, public acceptance of MMR vaccine improved after Wakefield had been repudiated — but too late to prevent the measles upsurge.

Without supporting Wakefield’s methods, it’s still worth asking whether his 1998 paper should be held accountable for the decline in vaccine acceptability.  As early as February 1998, England’s Communicable Disease Surveillance Centre was reporting on the drop in MMR coverage from 1996 and ’97 data and BMJ reported in 2003 that the British trend was consonant with declines in MMR uptake in Europe generally:

[T]he experts say that coverage is substandard across Europe owing to a surprising lack of political will to implement an effective disease prevention programme, given the region’s stated goal to eliminate measles by 2007.

A decline in nationwide vaccine coverage to 80%  is probably less important as an explanation for increasing measles incidence in the U.K. than two other factors:  locally deficient MMR coverage and immigration from countries with lower vaccination rates.  In fact, measles increases in the UK seem to have been attributable to outbreaks in the northern part of the country and to high incidences among very young children in London, according the UK’s Health Protection Agency.

What’s to be learned from the Wakefield mess?

1. The role of pharmaceutical companies (including vaccine makers) in setting scientific agendas and moving policy remains an issue for many people.  Defenders of Big Public Health, like Mark Honigsbaum who writes an interesting piece in The Guardian today, tend to be dismissive of allegations that public health has become a game for technocrats in which corporations have too much sway.  But the defenders misunderstand those critiques.  The critics are not saying that government predictions are wrong where they should be right, nor that officials are on the take; the critique is this:  the relationship between profit makers and public agencies is sometimes awfully cozy and the attentiveness to real suffering is remarkably slight.

2. The pre-eminence of ethics boards, like Britain’s GMC, doesn’t always sit well.  With the Wakefield case, the MMR-autism controversy steps onto the slippery terrain of moral decision making in regard to research.  Many people don’t feel perfectly reassured about the ethics of medical practice when the overseers are themselves physicians, and the moral reasoning often seems restricted to “did the physician follow the rules?”

3. The stance of official agencies on autism doesn’t inspire confidence.  Vaccination is hard to exonerate as a cause of autism as long as the official approach is that autism is a disease, and by implication preventable — rather than a disability, which might or might not have a cause but whose sufferers, in either case, can be afforded decent lives.  To make matters worse, official agencies’ stance doesn’t defuse the controversy.  In the U.S. and U.K., they respond to anti-immunization claims with assertions about the safety of MMR in particular.  But they don’t seem to want to support the research that would test whether some children might be susceptible to damage incurred cumulatively by undergoing the numerous vaccinations that are scheduled for children today.  It’s unlikely that the scrutiny of immunization, or the controversy, is going to go away unless officials soften that stance.

We’ll probably hear more on this if the GMC rules to disbar Wakefield from practicing medicine.

Often, we do think about this – but usually by considering what the risks are and how to avoid them.  That means, we ask whether we can make life less harmful by changing something, and then we ask what change to make (and what it will cost).

Rarely do we ask: what sort of health do we expect – especially if we also have to accord that level of health to everyone?

There’s something about the risk question that goes against the concept of health for all.  Almost always, the risk we talk about pertains to us:  what can we affluent, educated people in the U.S. do to make sure we don’t get sick (or die) tomorrow? It’s not very often that we ask about risks for people who can’t get the recommended exercise or eat the recommended fruits and vegetables because they have kids and no job.  Not too often that we are concerned about the risks of medicating adolescents (see below) for people who can’t make such assessments because their kids are incarcerated.  When health = avoidance of risk, we mean “health for people like us.”

Not that the risk question is frivolous.  It gets particularly poignant when it comes to children.  For instance, Liz Borkowski posted a valuable note at The Pump Handle last week about the use of antipsychotic drugs for children.  She was commenting on a post by Alison Bass that was concerned with “shilling for Big Pharma,” about the death of a 12-year-old Florida boy who was on several medications.

Whether the world we’ve made is dangerous to our kids is a question that can’t be ignored.  But we also have to remember that it’s only one side of the story, and it’s only part of that one side (the part that pertains to people like us).

Often, we hear a plea for a deeper conversation about health.  It’s what we are hearing when parents of autistic children ask about vaccine safety, or others ask whether the prominence of the autism epidemic is going to translate into better treatment for autistic adults (as Karl Taro Greenfeld did in “Growing Old With Autism” in the NY Times, 23 May).

It’s what we are hearing when parents of troubled children allege that pediatric bipolar disorder is underdiagnosed or when others argue that it’s overdiagnosed.

These voices aren’t talking about risk; they’re speaking in a different register.  They’re talking about suffering, and the alleviation of suffering, and asking what sort of responsibility the society (or the state) is going to take.

Too often, we can only hear the risk part, not the alleviation-of-suffering part.  We react to the allegations that vaccines cause autism, for instance.  Some people are attracted by the lure of an easy-to-blame culprit (vaccines or other products of Big Pharma, immunization guidelines or other policies of Big Medicine) and join the bandwagon; others are repelled by the anti-immunizationists’ failure to venerate Big Science, and ridicule the parents who don’t want their kids vaccinated.  But not too many people interpret what they’re hearing as a cry for more caring, rather than a demand to identify risks.

In the health professions, we’re especially given to hearing such claims in terms of risk, rather than health-vs.-suffering.  For instance, we take notice when (as Sarah Rubinstein points out at WSJ Health Blog), the pharmaceutical industry talks about having a role in the conversation over the costs of health care  as the WSJ reported on 26 May.

But the reason we’re interested is often because we want to debate how to structure the healthcare industry rather than because we really want to discuss how much caring there should be in healthcare.

This isn’t a matter of idealism or some kind of touchy-feely hippie alternative to industrialized medicine.  It’s a real, and realistic question.  No rational person wants to give up effective medication for people who are suffering, or wants our society to stop doing research that would tell us if certain drugs might be harmful.  But to think only about the risks and not about the suffering part is to blind ourselves to the more difficult – and more essentially human – questions about health.

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At Smallpox2009, Robert posts a note following Abigail Zuger’s review of Dread, which appeared in the NY Times on 26 May.  The post picks up Zuger’s wording as to whether fear of epidemics is “hard-wired” — not the most felicitous term but an apt question to ponder.  More happily, it also picks up her evident fascination with the question of why our society is so intrigued by epidemics.

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At change.org, Kristina Chew wonders about the question of whether autism is an epidemic.  She picks up the idea from Dread that once we call something an epidemic we give it “a story line, with a beginning and an end.”

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Crawford Killian reviews Dread at The Tyee, homing in on the links between the epidemic narrative and social anxieties — and economic disparities.  “Much of what we consider hygiene is little more than an attempt by the anxious middle class to control the dirty, lawless, sexually profligate poor,” he reminds us.