Philip Alcabes discusses myths of health, disease and risk.

Autism and the MMR Vaccine

There’s quite a furor this week over the British General Medical Council’s censure of Dr. Andrew Wakefield for his research at the Royal Free Hospital, purportedly showing a link between MMR (measles-mumps-rubella) immunization and autism (Lancet 1998; 351(9103): 637–41).

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.

Revolving door? Official agencies and the private sector

In late December, Effect Measure reacted to former CDC director Dr. Julie Gerberding’s hiring as President of Merck Vaccines. With customary cogency and insight, Revere addresses the problem of the so-called Revolving Door.

At The Great Beyond, Daniel Cressey notes that Dr. Gerberding, while at CDC, was accused of promoting the Bush Administration’s agendas at the cost of scientific accuracy.  Naturally, now that she is heading for Merck, many are concerned about what looks like a cozy relationship between official agencies and pharmaceutical companies.

Merck says that its vaccine arm is worth $5 billion.  It “markets vaccines for 12 of the 17 diseases for which the U.S. Advisory Committee for Immunization Practices currently recommends vaccines,” according to the company’s press release.

Dr. Gerberding was close to the vaccine world as head of CDC. In fact, during her tenure there CDC’s   Advisory Committee on Immunization Practices (ACIP) called for the implementation of immunization against human papillomavirus and varicella zoster (chicken pox) virus and the agency pushed for expanded immunization against seasonal flu; within 10 months of her (January ‘09) departure from CDC, the ACIP had issued recommendations for the use of anthrax vaccine and Cervarix and Gardasil vaccines against HPV.  Gardasil  is a Merck product.

But the problem is more than the “revolving door” metaphor implies.  To have a door there must be a wall — a clear demarcation between inside and out.   As if corporations (pharmaceutical companies among them) were outside of the official system, eager to get the ear of those inside.

Whereas it seems that there isn’t really much of a wall between official health agencies and big business at all.  To be an official today means taking a veritable oath of loyalty to corporate solutions.  The official has to deal in risk.  She has to be ready to sell risk as a kind of debt:  people should want to avoid risk, just as they avoid debt; but if their behaviors put them “at risk,” they can relieve it through “lifestyle” correction.  You can refinance if you know how.

The correction that allegedly relieves risk usually involves the use of better products. Cut out trans fats,  lower your cholesterol, elevate your mood, hop on a treadmill, lose weight, drink responsibly, get seasonal flu vaccine, get swine flu vaccine, wait patiently while the full-body scanners are used at the airport, eat more vegetables, wear sunblock, use hand sanitizer.  Health officials’ job is to get the means for personal risk reduction to the sorry at-risk population.  Have hand-sanitizer dispensers installed in public buildings.  Distribute condoms.  Publish recipes for healthy meals.

Notably, health officials are not supposed to argue for any of the things that would actually make a difference to the public’s overall health:  redress wealth disparities, provide excellent primary care for everyone (including immigrants), or build more decent and affordable housing.  When was the last time you heard a health official call for a campaign against poverty?

The official has to pitch personal risk reduction, in other words.  She has to be ready to support high-cost, individualized approaches to improving the public’s health — or well-being, which, Dr. Michael Fitzpatrick astutely notes at Spiked!, has replaced health as the main objective of modern Good Works .

Health officials keep faith with the dogma of risk avoidance.  Corporations preach risk reduction and peddle the wares by which people can restructure their lives — and avoid risk.  The wall separating government policy makers from corporate solutions gets more and more flimsy.

Avoiding Panic: The Imagined Crisis

The Global e-Forum, a Japanese site interested in world issues, posed this question to a number of professionals in the public health and public policy field:

In dealing with the issue of a pandemic, if we stick to finding out how to block the infection completely, we may take extreme measures and, as a result, trigger a pandemic panic. Is there a way to avoid the pandemic without adding to people’s concern more than necessary? (full text of query here).

Since the question of balancing response with panic promotion is on many minds, this seems worth addressing.  But there’s the larger problem:  do we need even to ask this question?  Is there a crisis on hand with flu?

We think not.

“Marx claimed that great events of history occur twice, first as tragedy and then as farce,” we pointed out.

“The swine flu of 2009 certainly looks like a farcical replay of the great influenza outbreak of 1918…. [It's] not a funny farce…but death from contagion is a normal part of life in an unpredictable universe.”  A few thousand deaths in the course of six months is lamentable, certainly.  But it’s hardly out of the ordinary for flu.

The collusion of officials and big corporations has been allowed to construct a global crisis. The farce is that the imagined flu crisis will benefit exactly the people who constructed it.

The vaccine manufacturers can expect to see a great expansion of markets (don’t miss Brownlee and Lenzer on flu immunization in the Nov. ‘09 Atlantic).

The antiviral-medication manufacturers, the makers of Tamiflu especially, are already bringing in plenty of money for a treatment that is useful in rare clinical situations but has never been shown to stop the spread of flu in large populations.

Officials benefit, too.  They claim they must roll out flu vaccine and provide frequent information updates in order to  “prevent panic.”  And then they’ll look like they’ve done a good job — since, there being no crisis, people are staying calm.

Read the full post here.

Already Apologizing…

It looks like the Preparedness crusaders, anticipating flak on the swine flu immunization, are already preparing their defense.

In this week’s Lancet, Dr. Steven Black, from Cincinnati Children’s Hospital, and colleagues present calculations of the expected frequencies of adverse consequences (abstract at link; subscription required for full text) likely to result from flu immunization.  The intent being to provide a basis for comparison, so that when events do occur following immunization, the vaccine won’t be blamed for them.

“Widespread beliefs that such false associations [of adverse events with vaccination] are true can and do disrupt immunization programs, often to the detriment of public health,” the authors write.

Testament to the persuasiveness of the rhetoric, an experienced and knowledgeable Reuters reporter is taken in.  Covering the Lancet article, Maggie Fox writes:

People have special fears about Guillain Barre Syndrome (GBS). a rare neurological condition that was linked to a 1976 U.S. swine flu vaccination campaign. Although no case of GBS was ever linked to the vaccine, a belief that the vaccine was worse than the illness remains widespread.

Not exactly.  At least 500 cases of GBS were linked to flu vaccine in 1976 — “linked” in the sense that Fox uses the word in the first sentence:  they occurred in vaccine recipients and were in excess of the number of GBS cases likely to have occurred had there been no adverse effect of vaccination.  Thirty-two of those cases were fatal.  That they were not “linked” in her second sentence means that the criteria for association have shifted, or can shift.

The method by which the 1976 GBS cases were linked to vaccine was exactly the same as the method Black and his colleagues propose as the test for determining whether adverse events are linked to the 2009 immunizations.

But if the nature of association can shift, then Black and company can play a double game.  On the one hand, no illness or death can be attributed to vaccine if it occurs at a rate less than that expected in normal times, sans vaccination.  That’s the premise of this week’s Lancet article.

On the other hand, no illness or death that occurs at a rate greater than expected can be attributed to vaccine unless there is some additional proof — not just statistics but, we imagine, pathology results from surgery or autopsy — demonstrating a link between vaccine and illness, or vaccine and death.  That’s the conclusion that the Reuters correspondent drew after talking with Black and company.

In other words, the vaccine “scientists” have already demonstrated that you’re wrong if you think vaccine has done anything bad.   Don’t bother alleging that vaccine harmed your child, spouse, or parent.

We have to wonder why physicians (the main authors of the Lancet paper are all MDs, as are the public health officials who are promoting mass immunization as a flu-control strategy) are mounting their defense of flu vaccination, when hardly anyone has been immunized yet.

And we have to wonder why physicians call themselves scientists when they don’t want to deal with evidence — only their own certainty that vaccination is a good public health strategy.  A strategy whose inevitable shortcomings they’re already defending.

No Meeting of Minds on Flu

As the story of the flu pandemic of 2009 matures, it brings out the characteristic traits of each of the  many spheres of interest that it touches.  The physicians are certain that the news is bad, the social critics are skeptical, the official agencies are — in their usual collusion with biotech corporations (especially pharmaceutical companies) — happily promoting high-cost, high-tech responses.  And so on.

Joshua Holland’s post at AlterNet yesterday tries to explain why H1N1 swine flu shouldn’t be cause for hysteria.  He puts this outbreak in the context of flu history and the threat posed by other, more harmful, conditions — malaria for instance.  Holland plays a little bit fast and loose with the numbers:  it probably isn’t accurate to extrapolate, from the number of confirmed flu deaths so far, to get a total number of deaths that will be caused by the swine H1N1 strain this year — more efficient spread in the  cities of the Northern hemisphere in the coming few months is likely to produce fatalities at a higher rate than the more sporadic outbreaks here in April and May.  And he’s overly critical of the media — a point brought out by Revere in a response to Holland at Effect Measure today.

But, as Frank Furedi has been telling us (recently in Erasmus Law Review, for example), try to explain how people’s deep-seated anxieties drive perceptions that risk is extraordinary and unprecedented (and contribute to demands for more and better high-cost technology to deal with it) and you get some people riled up.  Disappointingly, even Effect Measure, whose assessments are consistently level-headed and cogent, slips here, flashing the moral-entrepreneur card at Mr. Holland:

Joshua Holland has never cared for a critically ill person with Acute Respiratory Distress Syndrome (ARDS), which is often the terminal event for flu patients. So I’ll tell him. It doesn’t matter if it’s caused by bacteria (many are). Half of them die no matter what you do and no matter what intensive care unit you have available to you or what antibiotic or what computer controlled respirator. We still can’t do much.

Nobody thinks it’s a good idea to let people get ARDS, and Holland acknowledges that flu is a problem that should be dealt with.  But that’s not always enough.  Question the intensity of perceived risk or the need for all the technology, and you find this out fast.

But Revere is back on track when noting that lots of problems — including malaria — are horrendous and deserve attention, and probably don’t get it because they happen to people far away.

Where would the impetus to deal with global problems besides flu come from?  A global organization that can keep things in perspective would be useful.  Poor W.H.O. isn’t positioned to do that.  Yesterday’s flu advisory from W.H.O. emphasizes the use of antivirals (oseltamivir and zanamivir) to treat people with severe or possibly severe flu:

Early treatment is especially important for patients who are at increased risk of developing complications, those who present with severe illness or those with worsening signs and symptoms.

Yet, the W.H.O. also warns against hastening the development of resistance.  This agency gets a lot of flak for not doing more and for panic-mongering when it does do more.  But, really, it’s only doing its job:  offer advice, and support interventions when invited.  It isn’t consistent, naturally.  It can’t make binding policy.  It faces a limitless and essentially insuperable legitimation problem.  In a way, W.H.O.’s hardest job is simply to maintain its own legitimacy.

Still, in a world poised to interpret signs of illness as evidence of risk and eager for technical fixes to alleviate the sense of vulnerability risk instills, the W.H.O.’s announcements can seem authoritative — and look like beckoning to the drug makers.  A Reuters story yesterday is entitled “Early Use of Antivirals Key in H1N1 Flu: WHO,” and highlights the value of the two antiviral medications more than the caution W.H.O. wants to instill.

Meanwhile, agencies that should be making real policy are focusing on immunization.  In today’s Washington Post, Rob Stein reports on health care workers’ resistance to mandatory flu vaccination.  New York State made flu immunization mandatory early on, not only for salaried health care workers but for anyone — including medical and nursing students — who might come in contact with patients, and is putting teeth into the requirement with sanctions for refuseniks.  The state resorts to high  moral rhetoric to justify its policy.  The state’s health commissioner told Stein that “the rationale begins with the health-care ethic, which is: The patient’s well-being comes ahead of the personal preferences of health-care workers.”

And at CDC, the director is cautioning that there might be a rough start-up to the swine flu immunization campaign, as the first doses of vaccine will be made available in early October.  According to the NY Times, there should be 40 million doses of vaccine available by mid-October.

We wonder whether immunization will be of any public health value at all, by the time there’s enough vaccine that it can be offered to anyone other than health care workers and a few of the people who really need protection (young people, infants’ caregivers, and pregnant women, especially — DemFromCT’s round-up at DailyKos is always worth reading).  Given the rapidity of spread of flu — in 37 U.S. states, H1N1 spread is already regional or widespread; flu is spreading locally in 12 more states, Puerto Rico, and Washington, D.C. — and based on the usual course of flu outbreaks, it seems possible that this outbreak will peak by mid November.  There’s no knowing if that will be so, obviously.  Even if it is, immunization would continue to be useful to prevent severe cases among people who are likely to get very sick if infected.

But mass immunization would no longer be of much use in preventing further incidence of infection on a population level if high levels of acquired immunity are reached across much of the population by the time vaccine is widely available.

That’s the problem with relying on mass immunization as the centerpiece of public health response: as in the old joke about comedy, timing is everything.  In 1976, there was too much immunization, too soon.  It might turn out that this year, there’s too little, too late.  The dynamics of vaccine availability and the dynamics of flu spread have to be watched in tandem, and policy updated accordingly.

In any case, with vaccine at the center, the rest of the story — the complex environmental interactions that allow flu genomes to recombine, the trade in animals and feed that allow viruses to move around, the problems of affordability and immune status and competing viral subtypes, the health care facilities to handle severe cases, and so on — gets shoved to the side.