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.

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.

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.

How to Think About Vaccination

Over at H5N1, Crof picked up a story from XinHua reporting the concerns of Canadian medical ethicist Arthur Schafer about swine flu immunization.  “There are serious public health issues and issues of ethics as to whether we should be distributing (vaccines) massively to healthy people… when there are really big question marks about their effectiveness and their safety,” Schafer said.

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?

Iconography of Risk

For some time now, watching a ballgame on TV has meant sitting through sappy commercials that advertise remedies for what we’re supposed to call “erectile dysfunction.”  This season, at least in New York, the baseball viewer who isn’t quick with the remote will be treated to gruesome negative advertising about smoking.  If you’re squeamish, you have to move fast to avoid staring at the inside of arteries, hands with amputated fingers, or throats with holes in them.

This week, the city’s health department announces that it wants to require thousands of retailers who sell tobacco products to put up posters with the same disgust-inducing images – as Jennifer 8. Lee noted at the Times’s City Room blog on Wednesday and an AP story (picked up by Newsday) explained on Thursday.

And it won’t be little stickers the stores are required to put up:  these posters would have to be at least a foot-and-a-half square.

It looks like the city’s health agency is going to continue its program of treating New Yorkers like we’re stupid and reckless, despite the departure of the bluenose Dr. Thomas Frieden (who left NYC to become CDC Director this month).  The prevailing view at the health department seems to be that officials have to keep sermonizing or we dumb slobs will slide back into bad habits.

As Jan Barrett noted Thursday, people who smoke nowadays know quite well what they’re doing, and why.

Barrett, an ex-smoker, notes that “every time I lit up a cigarette I was fully aware of what it was doing to my body. I mean how can any smoker not know these days what smoking can do to them? There are warning signs everywhere. I don’t care how many warning signs I saw or heard about I still lit that cigarette every morning.”

The health department claims that negative advertising will help convince smokers they should quit. But smokers don’t need to be convinced — about 70% of smokers have tried to quit, and (as the above comment exemplifies) some of those who don’t quit are aware of the dangers but smoke anyway.

The department also claims the gruesome-ad campaign will dissuade teens from taking up smoking to begin with.  But retail stores wouldn’t be the place to post the ads, then – since the shops aren’t permitted to sell to minors in any case (nor would TV: if it were teenagers who were watching baseball games, there wouldn’t be so many Viagra ads).

We might think that resorting to a signage campaign like this is a cover-up for inactivity, but it isn’t:  the health department already runs a vigorous program of smoking-cessation activities , which can include nicotine-replacement therapies.

No, the new gruesome-poster initiative isn’t about health; it’s closer to religion.  The images of smoking-induced damage are iconography.

Frank Furedi calls this sort of thing secular moral entrepreneurship.

The iconography of the religion of risk avoidance is meant to remind sinners – people who eat the wrong foods, don’t exercise enough, have sex without condoms, fail to take medication for our depression, or smoke cigarettes — that it might be rigorous to follow the True Faith of Health, but it’s worth it.  “Look at how others have suffered in order to learn what you now know,” they say.  “How can you go on with your nasty ways when you’ve got a chance to save yourself?”

The city’s new health commissioner, Dr. Thomas Farley, is apparently as ardent as Frieden about browbeating and hectoring people who fail to comply with health guidelines.  The television advertising and the signage isn’t meant to make the population healthier – its job is to remind us how to behave, and the consequences of impropriety.