While it would be foolish to dismiss such warnings as this latest one on bird flu, it is important we keep a sense of proportion and not let them distract us from countering the unfashionable but widespread potential killers such as tuberculosis, HIV/Aids, diabetes, cancer, dengue and malaria. These are the diseases already causing widespread illness and economic harm….

Rather than competing for cash, the threat from newer diseases should serve as a catalyst to combat existing epidemics.

Competing for cash is key.

Funding for TB languishes, dengue incidence expands, more people with the AIDS virus are getting treated but new infections continue to occur, water scarcity (and displacement because of wars and natural disasters) makes diarrheal illness a persistent problem, and malaria transmission continues to threaten billions of people who live in tropical and subtropical regions — but flu preparedness dominates the public health scene.   Why?

Here’s the infernal logic of WHO and the public health officers of wealthy countries (U.S., U.K., etc.):  (a) At the start of the H1N1 outbreak in 2009, a sensible worst-cast forecast was about a million deaths worldwide; the more likely scenario was well under 500,000 deaths.  (b) TB + malaria + diarrhea + AIDS together kill 6 or 7 million people a year.   (c) Immunization against flu is notoriously variable in its effectiveness and mass immunization is almost never effective (except if instituted in an isolated population well before the flu virus makes inroads into the population).

Sounds like it would be worth it to pump lots of resources into reducing the incidence of malaria, TB, AIDS, and diarrhea.  But that’s hard.  It takes political will.  Whereas immunizing against flu is easy: it just takes money.  And national health officials were eager (it turned out) to transfer billions of dollars, pounds, and euros into the hands of vaccine manufacturers in order to be able to immunize their populations against H1N1 flu.

To an official whose job is to watch out for the needs of the economic machine, immunization pays.

One flu vaccine manufacturer estimates that in the U.S., employers lose $2.1 billion each year in productivity because of flu-related absences from work.  Let’s be skeptical about this estimate, coming as it does from one of the beneficiaries of federal largesse in response to flu fears.  But the point is clear enough:  it was a great boon to the private sector to have the federal government spend $1.6 billion of taxpayer money on flu vaccine in 2009 even though the outbreak was mild and vaccine did virtually nothing to stop it.  Because with the feds footing the bill, the burden on corporations was slight, whereas the private sector would have lost a lot of money if many Americans had fallen ill with flu.

It’s not just the vaccine manufacturers and pharmaceutical companies who stand to capitalize on the absurd calculus of protecting American businesses instead of poor people’s lives:  scientists do, too.

Robert Webster is an eminent virologist who has become dean of those American scientists who purport to be able to foresee a future flu catastrophe.  Perhaps he’s right, but of course nobody knows.  So when Webster says

We may think we can relax and influenza is no longer a problem. I want to assure you that that is not the case,

as he just did in a meeting in Hong Kong, it’s a good sign that the preparedness crusaders are worried about their funding.  They should be.

The preparedness crusaders have been unmasked as shameless shills for the private sector,  even if the vaccine and antiviral manufacturers aren’t paying them directly.  And the ones who are scientists have been revealed as self-important promoters of their own research — so fiercely protective of their own turf that they might use their prestige and the imprimatur of science to hoodwink officials into ignoring the more serious, and more certain, problems of the developing world.

Let’s hope that more opinion makers take the stand that the editors in Bangkok just did.

At H5N1 yesterday, Crof picked up the U.K. government’s announcement that it would sponsor an independent review of decision making in response to H1N1 swine flu last year.  The U.K.’s Minister of Health, Liam Donaldson, told WebMD that it is

vital that we learn from what we have seen in this pandemic, for the sake of those who find themselves tackling … the next. It is likely to be worse.

Anybody who claims to know what the next pandemic will be like is asserting a special ability to read mysterious auguries that nobody else can see.  So it’s all the more shocking that Donaldson goes on to obfuscate his own failure to ask critical questions by claiming to have been using expert predictions:

Would it have been acceptable to hide and conceal statistical projections provided by statistical modellers of international standing, even though releasing them publicly caused alarm in some quarters?

As if the flak he had taken last July were for a perfectly rational assertion, not an apocalyptic forecast — when he said that there could be 65,000 deaths from flu in Britain.  Donaldson later dropped the forecast to 19,000 deaths.  (The actual number was less than 400 during 2009, 457 to date.)

And as if Donaldson had not made the same off-base prediction back in October 2005, when he said that there would be an avian flu outbreak in the U.K. with 50,000 deaths.  That was Donaldson’s excuse to use public money to purchase two and a half million doses of antivirals for stockpiling.

As if, that is, the problem were that people are just benightedly opposed to science — not genuinely concerned about malfeasance.

To its credit, the Parliamentary Assembly of the Council of Europe continues its investigation of decision making around the H1N1 outbreak response, holding a second public hearing on Monday.  Briefs of experts’ statements at the first hearing, back in January, are available here, and links to full statements and video are at the PACE site here.

Some of my friends and colleagues in public health wonder if this kind of questioning comes from misunderstanding the seriousness of flu and others are fearful that it will diminish the authority of public-health physicians.  A few, but too few, back the redoubtable Tom Jefferson, who has been questioning the reliance on flu vaccine for a long time.  Shouldn’t scientists — especially scientists — question authority?

Officials’ legitimacy ought to be diminished if they’re not serving the public.  Particularly when their decisions mean that private companies benefit from taxpayers’ monies.  Clearly, the transfer of funds is what happened with the H1N1 flu response.  Was it based on sound decision making?  More transparency would be a good thing.

Now that the Council of Europe and the U.K., are investigating official responses to H1N1 flu, could we please hear from the United States?

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.

Is it the Advertisement?

A full-page ad taken out by DHHS in the main news section of today’s NY Times sounds very defensive when it claims that “H1N1 Flu Vaccine is Safe and Effective.”

The advertisement makes it seem like getting immunized against swine flu is a kind of patriotic duty.

Fighting the flu is a shared responsibility.  We ask you to join this fight to protect yourself and your community by getting the H1N1 flu vaccine.

And it’s signed by leaders of 35 health- or safety-related organizations — “top medical professionals,” according to the page’s header — who seem to be collaborators in a DHHS attempt to guilt the public into getting a flu shot.  Do it for your neighbors if you won’t do it for yourself, the text seems to say.

The clumsy production of the ad itself makes it all the more abject:  there’s a quarter page of grey text in a swimmy, sans-serif font, below which are two stacks of logos (of the 35 organizations) — vaguely impressive as a color border to the text in the version posted at flu-dot-gov, but just visual noise spilling down the Times page in black and white.

And some of the logos are trademarked or registered — requiring a tiny-type footnote reminding any reader intrepid enough to have reached the bottom of the page that DHHS doesn’t endorse private enterprises.  (It’s a little hard to understand how the collaboration on flu vaccination does not constitute an endorsement of private enterprises, but let’s not get bogged down.)

Is it the armada of PSAs and posters?

The ad is just the latest attempt by DHHS to muster enthusiasm for the flu campaign.  It makes available a panoply of printed material at its flu website, intended for Spanish-speaking Americans, African Americans, Asian and Pacific Islander Americans, “asthma patients,” and others.  With a separate flotilla of posters and publications for parents, many bilingual (“I’ll protect my baby/Protegeré a mi bebé” and others), plus additional ones meant for older people, diabetics, and travelers.

It’s hard to escape the feeling that DHHS is trying too hard.  And hard to avoid wondering why.

Is it the information itself?

The second sentence of the Times ad tells the sad story:  Over 136 million doses of H1N1 vaccine are now available.   Since the number of flu vaccine doses actually administered so far is probably about 60 million, it takes only grade-school arithmetic to realize that the federal government purchased much more H1N1 vaccine than Americans are willing to take.

DHHS’s desperate need for everyone to get vaccinated is disheartening.  After all, this is the organization that created and carried out the previous swine flu fiasco entirely on its own:  the 1976 immunize-every-American campaign to prevent the Flu Outbreak That Wasn’t.

So it’s bad enough that CDC, with more experience and research findings than it had in ’76,  badly overestimated the intensity of the 2009 H1N1 flu outbreak.  It’s worse that DHHS  grossly overestimated the ardor of the American people for media-heavy health crusades at a time of tight budgets and high unemployment.  Most dispiriting of all is that the agency finally resorts to wheedling the public to get immunized against swine flu.

Which gives us a glimpse of another contributor to the sense that DHHS is floundering:

There is a widespread feeling that official agencies overplayed their hand on swine flu.

Everywhere, it seems, doubts are being voiced about the decisions by both U.S. authorities and WHO — declaring the pandemic, publicizing the unprecedented danger, supporting mass immunization, purchasing and distributing Tamiflu, and so on:

• There are concerns about conflicts of interest on the part of flu experts.
• There are suspicions, reflected in the resolution introduced by Wolfgang Wodarg and passed by the Assembly of the Council of Europe (thanks to Ed Silverman for covering that) to launch an inquiry into the influence of vaccine makers on WHO’s flu policy.
• There are the accusations of hype coming from both the democratic left and libertarian right, from vaccine supporters who feel that the overstatement of the swine-flu threat diminishes the public’s faith in immunization in general, and from those who believe vaccines induce autism.

A conclusion:  it feels like DHHS is drowning because it is.  Officials made bad choices, fell for the preparedness charade, lost sight of what it would mean to protect the public’s health and strove instead to protect the professional organizations’ campaigns for attention and the pharmaceutical companies’ ploys for profit.

An appeal to Secretary Sibelius:  just say “We goofed.”

Say “We should have used the resources to help people quit smoking or to control MRSA or to verify the safety of pharmaceuticals. We didn’t; we overestimated flu.  We meant well but we loused up.  We’ll try to do better next time.”

Say “At least we didn’t kill people with vaccine, like in ’76″ (okay, for legal purposes, you probably have to say “…allegedly kill people,” since the U.S. government has not admitted that the 1976 vaccine actually caused the deaths from Guillain-Barré syndrome).

Say “How much better to have prepared by urging hospitals to consider surge capacity and then to find it wasn’t needed, than to have done nothing and seen people die who could have been saved by administering antivirals.”

Say “We know that vaccines are not the answer to flu.  We know that the flu vaccine isn’t very effective, we know that immunization against flu is not very useful as a public health intervention unless everyone is immunized, we know that it’s impossible in this country to force everyone to be immunized, we know that immunization is good for people who stand to get very sick if infected but that all it offers to the majority of the population is a reduction in the odds of getting sick.   We know that we need to take a more complex approach to flu control.  We’re working on all that.”

But please spare us the embarrassing advertisements.

May CDC become a force for real public health, not an advocate for the risk-avoidance canard.  May the new director, Dr. Frieden, stop favoring pharmaceutical companies’ profit making through expansion of immunization.  And may he direct the agency to begin to address legitimate public needs, like sound answers about vaccines and autism, and clear communication about what is — and isn’t — dangerous about obesity.

May WHO officials stop playing with the pandemic threat barometer.  May WHO begin demanding that the world’s wealthy countries devote at least the same resources to stopping diarrheal diseases, malaria, and TB as they do to dealing with high-news-value problems like new strains of flu.   Diarrheal illness kills as many children in Africa and Asia in any given week as the 2009 swine flu killed Americans in eight months.  So does malaria.   Direct policy, and money, toward sanitation, pure water free of parasites, adequate treatment of TB, mosquito control, and prevention of other causes of heavy mortality in the developing world — not just flu strains that threaten North America, Europe, and Japan.

May public health professionals lose their obsessions with bad habits. May the public health profession return to the problem of ensuring basic rights — access to sufficient food, clean water, decent housing, good education, a livable wage, and adequate child care — and ease up on its moralistic obsessions with nicotine and overeating (for recent examples of the preoccupation with tobacco, see this article or this one (abstracts here; subscription needed for full articles) in recent issues of the American Journal of Public Health).

May science be what Joanne Manaster does at her incomparable website: looking at the world with wonder, asking without dogmatic preconceptions how it works, and accepting that its irrepressible quirkiness makes it impossible to know the world perfectly.  May science not be the crystal-ball-gazing thing whose so-called “scientific” forecasts are really doomsday scenes worthy of the medieval Church — predictions of liquefied icecaps and rising seas,  hundreds of millions of deaths in a flu pandemic, or catastrophic plagues sparked by people with engineered smallpox virus.  There are plenty of reasons to be concerned about both the environment and disease outbreaks based on sound here-and-now observations; leave the forecasts of Apocalypse to the clergy, who know how to handle dread.

A new year’s wish (from the valedictory exhortation in Tony Kushner’s Angels in America):  “More life!”

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.

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.

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.

The PCAST’s 2009-H1N1 Working Group has some illustrious names, and some great scientists.  So did the Advisory Committee on Immunization Practices which met in early March 1976, resolving to recommend mass immunization against swine flu.  And the parallels don’t end there.

This month’s PCAST report has some strengths.  One is its emphatic assertion that we are not looking at a reprise of the 1918 flu.  Another is its reminder that America must occupy a generous place in the world — offering advice or help to countries whose structures or resources don’t allow them to purchase vaccine or otherwise organize themselves for a bad flu outbreak.

But some of the report’s pieces just don’t quite connect up.

For one, the third chapter “Anticipating the Return of H1N1,” makes clear that the PCAST’s flu working group aimed to develop scenarios for a second wave of H1N1 cases in the U.S.   It set out to look at possibilities, not to make predictions.  “We emphasize again that the baseline scenario and the alternatives above are given as examples for planning purposes; they are not predictions of what will happen,” reads a caveat on p. 18.

Fair enough — but that begs two questions.

First, what’s the distinction between a scenario and a prediction?  Surely, when a Washington Post article is published within hours of the report’s release, with the lede that “Swine flu could infect half the U.S. population this fall and winter, hospitalizing up to 1.8 million people and causing as many as 90,000 deaths,” the PCAST is understood to have made a prediction — not just projected possibilities in an academic way.

Second, what predictions the PCAST makes!  By the day after the report was released CDC was expressing doubts about the estimate (sorry, “scenario”) of 90,000 deaths.  As VaccineEthics reports, CDC officials distanced themselves quickly — one telling Don McNeil, Jr. of the NY Times that “if the virus keeps behaving the way it is now, I don’t think anyone here [at CDC] expects anything like 90,000 deaths.”  And the estimate of 50% of Americans being infected by H1N1 would require much greater infectivity than we’ve seen so far.

The report doesn’t address the caution about the timing of H1N1 “waves” offered by Morens and Taubenberger in their recent JAMA article “Understanding Influenza Backward” (JAMA.2009; 302: 679-680) — PCAST’s scenarios simply assume that H1N1 will be back in the fall.  With WHO now explicit about a “second wave,” there will be even less impetus to (as Morens and Taubenberger suggest), look back.

The PCAST report also features a disconnect between the infectivity estimate and the mortality estimate.

It’s hard to explain how, if flu transmissibility really were to become high enough that a third to a half of all Americans were infected with H1N1 flu, virulence would remain so low that only 0.03% of the population would die of it.  If PCAST’s scenario of 150 million infections came to pass, then surely PCAST would want to caution authorities to watch for the development of high-virulence viral variants, either arising spontaneously within the genome of the current strain or through recombination with other circulating human or animal flu viruses.

Why bother to get people worked up over a horror scenario of 150 million infections if you aren’t going to remind flu watchers that your darkly viewed future  would allow for even further horrors in the form of new strains?

Narrative seems relevant here.  The PCAST report, its weak disclaimers about scenarios-not-predictions aside, sometimes seems to aim at crafting the leading narrative more than at practical planning.

The narrative, as told by PCAST, involves inevitable return of swine flu, America unprepared, special needs that can only be met by vaccine manufacturers and pharmaceutical companies, and vulnerable groups who need special administrative attention.

Here, too, the PCAST report is reminiscent of the 1976 swine flu episode.  The main effect of the meetings held by officials in the Department of Health, Education, and Welfare (the predecessor of today’s Health and Human Services) in March of ’76 was to create a narrative of inevitable return of a dreadful flu strain, America unprepared, and special needs that can only be met by immediate production of vaccine.

One lesson we learned from 1976 was the danger of allowing the narrative to precede the facts.

A concern at first glance is whether this panel of estimable scientists is repeating an error of commission made by an earlier panel of also-estimable scientists — in 1976.

As DemFromCT points out at DailyKos today, “timing is everything” when it comes to response to this flu outbreak.

Along this line the PCAST report is clear:  Having made the point that a return of swine flu this fall could infect a great many Americans, PCAST suggests that the federal government might decide to accelerate production of H1N1 vaccine.

The idea, generated by the PCAST’s 2009-H1N1 Flu Working Group, is that an early resurgence of flu would encounter an essentially unimmunized population — based on current expectations about availability of H1N1 vaccine.  On p. 18, the report states that

“if an increase in severity is detected with the expected rate of transmission, broader administration of vaccine before complete clinical trial data are available may be appropriate…”

But here we note a disturbing replication of a disturbing history.  The Advisory Committee on Immunization Practices, meeting on 10 March 1976, voted to recommend rapid preparation of swine flu vaccine and mass immunization of the American public in response to findings of H1N1 flu at Fort Dix, NJ.

At the March ’76 meeting, Russell Alexander of the U. of Washington School of Public Health asked how, if there were to be a mass immunization program, federal officials would know when to abandon it.  What was the bail-out point to be?  Would the committee specify a level of adverse vaccine events beyond which mass immunization would be suspended?  Would it specify an incidence of H1N1 cases, or deaths, below which vaccine would be stockpiled but not administered?

The answer to Alexander was No.  The directors of the CDC and other federal agencies did not want to be caught stockpiling usable vaccine if people were getting sick and dying of flu.

As it happened, Alexander’s suggestion might have saved a few lives, a lot of money, and a few officials’ jobs.  By the time the 1976 immunizations began, it was known that there had been very limited spread of the swine flu strain beyond Fort Dix.  Watchful waiting might have forestalled the 1976 fiasco.

If flu vaccine is again to be rushed into production and disseminated early, how should officials know when to put the program on hold — or to bail out entirely?

Schafer is arguing for a precautionary-principle approach:  why would you take the chance of exposing a lot of people to a vaccine too new to allow its long-term effects to be known perfectly?  Especially, we might add, when the flu outbreak you are confronting is very mild, thus far?

Not everyone finds this satisfying, though.  In fact, some people feel there’s a duty to protect the public against the eventuality of widespread virulent flu. (Two facts should trouble this argument:  the historical fact that such a flu outbreak has happened exactly once in history, and the ancillary fact that, even in 1918, before flu immunization existed, the outbreak spared over 99% of the American public. But they don’t.  We’ll ignore them for now, just as most people do.).

Of course, if you really think there’s a duty to protect then you make immunization mandatory.  There’s precedent, and it’s been upheld by the nation’s highest court of law — in Jacobson v. Massachusetts (1905).  Justice Harlan, writing for the majority, held that the state of Massachusetts was within its rights to require Henning Jacobson to undergo smallpox vaccination when an outbreak threatened the city of Cambridge, and to fine him $5 for his refusal to be immunized.

The Jacobson case is taught in schools of public health as a prime assertion of the police power, i.e., the right of states to make laws to protect the public’s health.  And to validate the reach of such laws, even to mild intrusions on individual liberty. Harlan writes that “the liberty secured by the Constitution of the United States to every person within its jurisdiction does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint.”

But the nuances of Justice Harlan’s decision are instructive.  He made the point that the state’s legislature deemed smallpox vaccination to be effective and of minimal harm, and allowed the city to require vaccination only when a properly constituted board of health determined that that was necessary for public health.  In other words, the police power allows a state to limit liberty in the name of public health, but not for just any excuse, by any means, or without considering consequences.

And, we note, Harlan’s decision hinged on the legislative power.  That is, mandatory vaccination wasn’t  okay just because a board of health had said so; it was okay because the legislature had passed a law allowing the board to make such a decision, and the law was reasonable and sound.

Harlan’s basic standard was the “necessity of the case.”   Cambridge could make Mr. Jacobson undergo vaccination because the state law gave the board of health the power to decide when universal vaccination was necessary, in view of the situation.  And the board had looked at the situation, and decided that vaccination was indeed necessary

What should we make of that today?  In view of the current swine flu situation, should we then stand with Schafer, and argue that the most basic of the tenets — necessity — on which the police power is predicated has not yet been met?

Or should we say that the potential for a severe flu outbreak — a possibility not yet realized but, well, possible — creates a necessity to vaccinate?

Or is Jacobson simply out of date?

Alex Jones reports that the proposal was ratified early this month, over the objection of the NY State Nurses’ Association.

Word on the street is that NYC’s Department of Health and Mental Hygiene is now getting into mandatory vaccination in a big way.  It is strong-arming medical centers into forcing their staff to undergo flu vaccination, telling administrators, we hear, that they would be required to fire employees who refuse to undergo flu immunization.   And the mandate would extend beyond direct-care personnel, to include general staff — anyone who might come into contact with a patient.

Since specific vaccine against H1N1 flu is not yet ready, the current plans are said to be for mandatory vaccination against seasonal flu; presumably swine flu vaccine would be added if it becomes available.

No official substantiation yet of the NYC officials’ actions — in fact, we really hope we’re wrong on this.  But we notice that requiring universal vaccination for health care workers would not be out of line with the city’s Pandemic Influenza Preparedness and Response Plan — especially chapter 7, “Vaccine Management.”

Clearly, a plan to require immunization of all health care workers — in a city whose health care workforce numbers in the hundreds of thousands — could be a boon to the vaccine makers.

Would it help the public?   If this coming flu season is mild, universal immunization of medical-center staff will be at least partly superfluous.

If there’s a widespread outbreak of virulent flu, the effectiveness of mandatory vaccination in health care centers would depend on the current level of flu-immunization coverage among med-center staff.   As many caregivers routinely undergo seasonal-flu immunization anyway, it isn’t clear that mandatory immunization orders would add any public health value to the current situation.

So far, there hasn’t been much outcry from the public health profession. Perhaps that will change as we get into autumn.