Philip Alcabes discusses myths of health, disease and risk.

Desperation Play on Flu Vaccine

DHHS Secretary Sibelius spoke at Hunter College in New York on Thursday, part of her barnstorming tour to exhort Americans to get immunized against swine flu — and thereby avoid embarrassment to herself and her agency on account of  the extremely poor uptake of swine flu vaccine in the U.S.   As Mike Stobbe of AP reported on Friday, the latest estimates by CDC put the proportion of Americans vaccinated at 20 percent.

Federal agencies are already scrambling to spin the disaster as a victory.  “From our point of view, this looks very successful,” CDC spokesman Richard Quartarone tells Stobbe.  Despite the fact (also noted in the AP story) that vaccine uptake was barely better among the flu-vulnerable groups who were the focus of the immunization effort:  22 percent of personnel at health care facilities, 38 percent of pregnant women.  Some success.

Apparently, New York State Health Commissioner Daines doesn’t want to be left off the victory train.  He announced on Friday that the law requiring immunization of staff of health care facilities would be enforced — even though a restraining order was issued by state Supreme Court Justice Thomas McNamara in October prohibiting enforcement.

(A federal district court judge in San Diego ruled this week in favor of the Rady Children’s Hospital’s union of nurses and technicians, according to San Diego CityBeat.  The union had requested arbitration of the hospital’s mandatory flu-immunization policy which, they claim, violates their collective-bargaining agreement.)

Health officials’ pandemic-flu-disaster story was flimsy from the get-go.  The evidence for a serious flu outbreak was slim, despite the attempts by officials and some reporters to make the situation look dire.  But through autumn 2009, at least there were some hospitalizations and deaths that served to maintain the sense of impending catastrophe that the disaster story sought to achieve.  Now, though, with flu activity in the U.S. less than usual for this time of year and no widespread occurrence of H1N1 flu reported, officials are playing with the numbers in their desperate attempt to peddle vaccine.

In her talk at Hunter College, for instance, Secretary Sibelius noted that “over a thousand” infants and children had died from H1N1 flu.  The CDC’s latest flu update counts 300 pediatric flu deaths from April 2009 through the beginning of the new year.  And it notes that about a third of the 236 pediatric flu deaths in the current season had bacteria cultured from sterile sites — suggesting the question of whether more timely medical care, rather than immunization, might have saved many of those kids.  Where the remaining 700 of Secretary Sibelius’s thousand pediatric flu deaths are to be found remains a mystery.

What’s happening here?  The federal government ordered 250 million doses of swine-flu vaccine last year.   Vaccine makers were looking at terrific earnings from this outbreak.  But they are now worried about losses in the anticipated $7.6 billion worth of global sales — because so much vaccine has gone unused.  Western European countries are stopping their orders and seeking to off-load existing stocks.  Americans don’t want the vaccine, at least not when swine flu seems to be less damaging than regular, seasonal flu and they aren’t feeling reassured about the safety of the rapidly produced vaccine.

Federal and state officials won’t let go, though.  It’s dispiriting.

The disaster in Haiti put the spotlight on suffering this past week.   Not just the tremendous death and damage from the event itself, but the penury and misery in which many Haitians lived even before they had to live with, or die in, the earthquake.  And the earthquake should have reminded anyone who was watching — which is to say, nearly everyone — to be appalled at the amount and degree of suffering in the world, even on days when there are no natural disasters making the news.

The disquieting thing, especially this week, is that people who are in a position to devote themselves to alleviating illness and dispelling misery — health officials, I mean — are preoccupied with covering up for their mistakes on flu and satisfying the needs of the pharmaceutical companies.  Instead of looking at the suffering in our midst.

DHHS: Grasping at Straws

What makes us feel that the once-estimable Department of Health and Human Services is drowning in a big pond of unused flu vaccine?

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:

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.

New Year’s Wishes for Public Health

May 2010 be the year when health officials return to the business of alleviating suffering and stop promoting panic. (Don’t miss Nathalie Rothschild’s “Ten Years of Fear” in Spiked!’s Farewell to the Noughties, recounting the hyped-up panics of the ’00s — from the Y2K bug to swine flu.)

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!”

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.

Council of Advisors’ Flu Report: Does the Narrative Precede the Facts?

Reading this week’s report by the President’s Council of Advisors on Science and Technology (PCAST) on swine flu preparations…

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.