[t]he most popular contraceptive for women in eastern and southern Africa, a hormone shot given every three months, appears to double the risk the women will become infected with H.I.V.

and almost everybody else (as diversely situated in newsworld as the Atlantic, CNN health blog, Catholic News Agency, and Voice of America) joined the NYT in failing to examine it critically.

Gerdts and Vohra add the essential context that was missed by the newsmedia:  about a half-million women die during or because of childbirth each year, almost all of them in poor countries.

At RH Reality Check, Jodi Jacobson summarizes the main cautions about the Heffron study, and points to a Guttmacher Institute white paper.  She takes into account concerns about high maternal and infant mortality in parts of Africa, the harms associated with complications of pregnancy and unsafe abortions, and, of course, the substantial possibility of vertical transmission of HIV in places where antiretroviral therapy isn’t universally available.

To claim that poor women should give more weight to the rather remote risk of acquiring a virus that might cause serious illness years down the road than to the dangers of pregnancy itself in the near term is to reduce real women to automata.  Facing dire straits they might be, but they’re supposed to be reasoning machines, programmed to engage in the AIDS industry’s preferred calculus, risk.

A quick summary of the shortcomings of the Heffron et al. research:  comparing users of hormonal contraception to nonusers, the difference in actual risk of acquiring or transmitting HIV was very small, amounting to 1 to 3 new infections per one hundred contraceptive users over and above the infection rate for nonusers.  And it’s impossible to say that these excess infections were actually attributable to the contraceptive — because the study wasn’t a clinical trial.  A great many aspects of social setting, relationships, health, and welfare of the study subjects would have been different between contraception users and nonusers, some of which would undoubtedly account for differences in rate of HIV transmission.

And since all of the subjects were in so-called discordant couples — one partner infected with HIV, the other not — it would be unusual to expect no HIV transmission at all.

Unless, of course, the subjects had been offered antiretroviral therapy, ART.  But this the researchers did not do.  They referred eligible subjects to HIV clinics.  They seem not to have checked whether people who needed ART were getting it.  They seem not to have offered ART to women who got pregnant, either.  Certainly, their Lancet article makes no report of doing so.

I wondered if this was too much to expect of researchers — so I asked the students taking my course on global AIDS and human rights.  Undergraduates, I find, generally have a clearer sense of ethics than most medical researchers.

Even the students who felt that the Heffron study was worth doing and basically sound were troubled by the researchers’ lack of curiosity as to whether HIV-infected subjects were getting the ART drugs they needed.  And most of the students thought this was a disabling ethical fault, which should have caused human subjects committees to make the researchers redesign the study.  One student pointed out that the Bill and Melinda Gates Foundation, one of the study’s funding sources, could easily afford to pay for antiretroviral therapy for all of the roughly 2,000 HIV-infected people in the study.

In the end, my students had the questions that Marcia Angell raised in her editorial in the New England Journal of Medicine in 2011 (PDF at this link angell editorial nejm 2000 ):  Don’t physician researchers have the same responsibility to study subjects that they do to their own patients?  And therefore, when their subjects lack resources to obtain effective therapy for treatable conditions, don’t the researchers have a moral obligation to make the therapies available?

Heffron et al. didn’t do this.  They watched HIV-infected people transmit HIV to their partners (the researchers provided HIV testing and counseling about avoiding transmission — but they don’t make clear whether they notified uninfected partners that they might be in harm’s way).  They did little to prevent transmission.  Notably, they didn’t offer ART to people with low CD4 counts.  Nor did they offer post-exposure prophylaxis to uninfected people who had had intercourse with an infected partner.  They just watched.

On this account, the Heffron study wasn’t only flawed — it was so questionable on ethical grounds that the Lancet should be ashamed to have published it.  And the funders — the NIH as well as the Bill & Melinda Gates foundation — censured.

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

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

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

The Battle Against Anti-Vaccinationism

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

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

Wow:  TV and the web.  Sounds satanic alright.

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

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

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

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

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

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

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

A High Priest of Vaccine “Science”

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

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

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

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

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

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

“Tragic” Consequences of Unbelief

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

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

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

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

The Ramp-up of Aggression by the Vaccine Crusaders

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

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

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

It’s Not a War

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

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

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

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

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

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

So, could someone please call off the crusade?

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

Probably both.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What is the value of mass immunization of children against flu?

CDC claims that flu is dangerous for children and recommends immunization.  This claim seems to be based on the 50 to 150 pediatric deaths attributed to flu each year.  Preventing children’s deaths is a good reason to immunize those who might get very sick were they to be exposed to influenza.

But to translate a small number of possibly preventable deaths into a national policy of mass immunization?  That takes a special relationship with the vaccine manufacturers (see here and here and here and here for my comments on the collusion of officials with pharmaceutical interests).

The evidence that flu vaccine is effective in children is shaky, as Dr. Tom Jefferson’s exhaustive scrutiny of study data reveals.  Immunization of children seems to be weakly effective at reducing influenza-like illnesses in a general population, as Ritzwoller et al. showed in a study published in Pediatrics in 2005.  Partial immunization was ineffective — an issue worth considering if more than a single dose is required.

A few studies suggest that mass immunization of children is a way to prevent flu among young adults.

A community trial of immunization of children against flu, published in Vaccine in 2005, showed the ineffectiveness of immunizing children:  there was no reduction in acute respiratory illnesses among children in the concurrent or subsequent flu seasons, compared to communities where kids were not immunized.  There were slight reductions in ARI incidences among adults in the community where children were immunized — but this study wasn’t designed to show whether it was the immunizing of kids that protected the adults, or something else.

Similarly, a 2000 study published in JAMA by Hurwitz et al. showed that flu immunization of children in day care had the effect of reducing acute febrile illnesses among household contacts, compared to household contacts of daycare attenders who were not immunized (abstract here, full article requires subscription).  So immunizing children in daycare might help their parents to avoid getting sick.

In general, there’s suggestive evidence that mass immunization of small children against flu lessens the impact of flu outbreaks among young adults.

But few young adults die of flu.  It’s an annoying and sometimes serious illness.  The reason the public health authorities are interested in preventing flu among young adults isn’t to reduce suffering; it’s to keep them from staying out of work.  Should we immunize children so that the nation’s economic machine doesn’t slow down?

To put it a little differently:  should we shift large amounts of taxpayer money into the hands of pharmaceutical and vaccine manufacturers for the purchase of flu vaccine for children, basically in order to spare employers the loss in profits that would arise when workers stay home?

The news from ProPublica this week, that they and associated journalists found many cases of physicians taking money from big pharmaceutical companies, is alarming but comes as no surprise.  ProPublica’s new searchable database shows that the seven pharmaceutical companies (collectively accounting for 36% of market share) that provided data together made $257.8 million in payments to physicians.

What’s more alarming is that pharmaceutical companies often don’t even have to bother paying to push their products.  That’s especially true when the product is a vaccine.  Even flu vaccine, despite its limited and highly variable effectiveness.  Policy decisions made by the Advisory Committee on Immunization Practices and CDC, practice decisions by medical organizations, research-grant funding, and so on are thoroughly organized around immunization.  Despite the evidence.

What I value about H5N1 is the tracking of the mosquito-borne viral diseases, like dengue and chikungunya as well as H1N1, that reveal the effects of the elision of ecosystem boundaries; the close attention to outbreaks that stem from changes in human-animal interactions — like the recent outbreak of plague in Tibet and, of course, H5N1; and the watch it keeps on the vaccine trade, as in yesterday’s post picking up a report in The Nation on the purchase of flu vaccine from France and one last week on a US tech company’s trials of a new flu vaccine (which won’t help the public but is, apparently, already helping the company to get richer).

The kind of close attention to the details of complex interactions amongst humans, animals, and both the natural environment and the economic one that H5N1 shows is indispensable.   It should spur more interest in wresting public health away from the simple-minded mass-vaccination schemes of medical officials in the U.S. and other wealthy countries — the point of which is usually to transfer public monies into the hands of pharmaceutical companies.  And move us to toward a more complex and inclusive view of the nature of health.

Henrietta Lacks died of cervical cancer in the “colored” ward at Johns Hopkins Hospital, in 1951.  From samples of her cervical tissue, the immortal cell line called HeLa was developed (by Dr. George Gey, at Hopkins).  Skloot’s story covers the family’s travails before and since, but also digs deep into the problem of race in the business of American medicine.  Her account challenges, or should move us to challenge, the smug certainties about our supposedly post-racial society, and the convenient formulae about “informed consent” and “access to care.” I guess I should say, The Immortal Life should make us ask just what “care” means in today’s system.

Henrietta Lacks and her family members were almost never taken seriously as humans with real problems.  First, they were poor and uneducated black people from tobacco country relocated to Baltimore; then, they were the bearers of the same genes as a woman (Henrietta) who had died of a remarkably aggressive, and therefore medically interesting, cancer; later, they were background and local color to the story of the origin of the thriving, and therefore scientifically interesting, HeLa cell line.

To Skloot’s credit, she’s taken to heart, and acted on, the problem:  she founded the Henrietta Lacks Foundation to help raise funds for education and medical expenses for Henrietta Lacks’s family.  Skloot’s blog, Culture Dish, carries updates about some of the achievements of the foundation and sometimes takes up issues germane to the book, especially regarding personal rights to genetic information (here, for instance).

It’s also impressive that Skloot interweaves in her narrative (and takes up more fully and explicitly in an Afterword) the vexing question of ownership of tissue samples.  She highlights how the expanding capacity to extract information from genetic sequencing ups the ante on the questions of privacy of tissue samples — since it’s now possible to ascertain potentially identifying information from genetic sequences even in a sample from which the usual verbal identifiers (name, address, and so forth) have been removed.  And she asks how the profits potentially available from exploitation of new discoveries should be shared.

The intersection of these problems with the matter of race makes The Immortal Life of Henrietta Lacks, like James Jones’s Bad Blood and Harriet Washington’s Medical Apartheid, a book that should be required reading for everyone involved in the health sector today.

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.

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.

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.

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.

This month’s American Journal of Public Health brings us a primer (abstract here; subscription required for full text), written by lawyers supported by the Robert Wood Johnson Foundation, teaching “policymakers to avoid potential constitutional problems in the formation of obesity prevention policy.”

The article isn’t exactly a Steal This Book for the anti-obesity crusaders, but the authors’ stated aim is to help those crusaders skirt legal challenges to statutes that might, for instance, ban fast foods or require the posting of accurate calorie counts on restaurant menus:  “This primer is meant not to deter obesity prevention efforts but to foster them,” the authors adumbrate.

Of course, the anti-obesity crusade is well on its way to using the law to tighten the control of behavior already.  And the failure of restaurant calorie counts to show any effect on eating patterns isn’t dampening enthusiasm, it seems.

Brian Elbel of NYU and colleagues just reported in Health Affairs that the calorie counts now posted by law in New York (another piece of legislation backed by our bluenose mayor) don’t affect how much people eat,  based on a study of over a thousand New Yorkers from minority neighborhoods (abstract here, full article here).  At Freakonomics, Stephen Dubner surmises that this sort of program only helps people “who are already the most vigilant about their health and well-being.”  But it’s hard to find anyone in public health who is opposed.

They should be.   The public health industry, which likes to claim its main interest is human dignity, should be lobbying for less regulation of human appetites, not more.

But public health is often the pre-eminent paradigm of control in our society. Rename the acts or traits you find morally repugnant as diseases, and you can hand them to the health sector for management.   Once you say you’ve got an epidemic on your hands, you can count on the public health industry to respond.  Alcoholism, addiction, smoking, obesity, social anxiety… there seems to be a big supply of epidemics that used to be moral offenses or threats to the social order and are now opportunities for your doctor or your health commissioner — not your clergyman — to tell you how to act.

The neat thing about the control exercised through public health is that you never have to sermonize, read Bible verses, or prophesy Apocalypse.  The rhetoric of risk is a lot easier for the self-professed progressives in public health to swallow than religious sermonizing would be.  Even when the sermon and the risk rhetoric have the identical goal: wiping out the moral offense.

From Junkfood Science, we learn that

Employers will now perform random tests of employees for evidence that they’ve smoked outside of work and will weigh employees in the workplace and report their BMIs to the state. Employees deemed noncompliant with the State Health Plan’s employer wellness initiative, will pay one-third-more for health insurance. Employers believed that eliminating smokers and fat people would lower health costs.

And from WSJ Health Blog, that the CEO of pharmaceutical corporation Schering-Plough agreed (at a meeting at the Cleveland Clinic) that people with unhealthy behavior should pay more for health insurance.  Sure — you certainly wouldn’t want the wealthy to pay more.

That’s not the only problem with the public health industry’s vigorous embrace of behavioral control, but it’s a big one.  Start classifying people based on how they behave, and you begin discriminating against the ones who don’t act right.  But the ones who you think don’t act right are almost always the ones society was already discriminating against — the poor, most of all.

And even when the poor aren’t getting shafted in the crusade against the unhealthy, inquiry about how a just society should work is going down the tubes.  The profound moral-philosophical questions of what is the right way to live a life, the right way to raise children, the nature of liberty, and so forth, are surrendered in the public health paradigm – replaced with the simple dichotomy:  healthy vs. not-healthy.

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 NEJM paper argues that there would be health benefits of a tax on sugar-sweetened drinks — preferably to take the form of about a penny’s worth of excise tax levied per fluid ounce for any beverage containing “added caloric sweetener” (possibly to be defined as more than 1 g of sugar per 30 ml of beverage).

There’s much to be learned by the response.  The NY Times article, in its Business section Wednesday, was titled “Proposed Tax on Sugary Beverages Debated” but was generally slanted strongly in favor of the proposal.  If you read only the Times, you would think that objections to the tax come only from industry, which obviously has an economic interest in keeping sales of soda and sport drinks up by keeping the price down.

Shirley S. Wang at yesterday’s WSJ Health Blog adds some insight.  She points out that a 2-liter bottle of soda subject to the proposed tax, assuming the tax is entirely passed along to consumers in the form of higher prices, would still be much cheaper than a half-gallon of orange juice.

James Knickman of the NY State Health Foundation, writing in the NY Daily News last week, acknowledged that a soda tax would be essentially regressive, affecting the poor more powerfully than it does the wealthy.  He urges that

To counteract the soda tax’s regressive nature, revenue generated from the tax should go to health-related programs that benefit the poor – essentially putting the money back into their pockets. The revenue could be used for myriad initiatives, including subsidies for federal health reform – which is estimated to cost $1 trillion over the next 10 years – subsidies of fresh fruits and vegetables and other healthy foods in low-income community grocery stores, and food stamp increases for the purchase of fresh fruit and vegetables.

Knickman gets at one of the main purposes of a tax like this:  to get the poor to pay more of the costs of doing business.

But what isn’t being discussed, it seems, is the underlying logic.

First, there’s the assumption that obesity is uniformly and intensely bad.  The NEJM article begins with the statement “The consumption of sugar-sweetened beverages has been linked to risks for obesity, diabetes, and heart disease,” citing three articles — two of them authored, in part, by the same men who helped write this week’s soda-tax NEJM article.

What’s the point of the misleading opening in the NEJM paper (apart from getting some additional citations for the authors’ other work)?  The line suggests that drinking sugar-added beverages causes heart disease, yet no evidence suggests that.  Extra calories might add up to extra weight, some people (less than half) who have BMIs in the “obese” range report having diabetes, and diabetes can predispose to heart disease — but the NEJM authors make it seem that the sugar-heart connection is somehow direct.  The point is to create an impression of uniform and unavoidable harm. Who would want to be for heart disease?

The supposition that obesity is a terrible illness responsible for broad impairments to Americans’ health — a premise that the soda tax depends on –  is amply and cogently criticized in a series of posts by Sandy Szwarc at Junkfood Science (start here, for instance, or here).  In fact, epidemiologic studies point to a relatively small effect of obesity on mortality, primarily at the upper end of the weight-for-height (body mass index, BMI) scale.  A careful analysis of national survey data from a few years ago (Flegal et al., JAMA 2005) shows that the effect of high BMI on mortality has been declining over time and almost entirely vanishes after age 70.  In fact, some studies point to a protective effect of high BMI for older Americans.

And the claim that increasing the price of sugary beverages is a suitable inducement to Americans to change their behavior rests on standard — but flawed — economists’ analysis.  It’s rational choice theory come home to roost at your refrigerator door.  If you know that it’s going to cost two bucks and a half to replace that 2-liter bottle of root beer in the fridge, you’ll drink it more sparingly than if it cost only $1.29, the theory goes.  Here is where the regressive aspect comes in.  It’s primarily to the poor that coming up with $2.50 for a bottle of root beer seems substantially more difficult than $1.29.  Here, the soda tax reveals itself as just another attempt to get members of what is perhaps America’s most despised ethnicity — the poor — to “fix” their behavior.

And it all rests on a premise so common we might call it the American assumption:  that people only do things that might harm their health because they don’t know any better or because they can’t stop themselves.  Ergo, laws and rules, to make sure everyone knows where and how to draw the line — taxes, bans on smoking in restaurants (or, perhaps soon, parks) and bans on serving trans fats, removal into foster care of kids whose mothers use drugs, prosecution of parents whose kids are too fat, et cetera.  And of course, we need the products that will provide substitute enjoyment or relief.  Thus:  sugar-free soda, trans-fat-free potato chips, Prozac and other SSRIs, diet books, gyms, alcohol-free beer, and so on.

And we need it all to be wrapped up and rationalized in the language of avoiding risk.

Apparently, it isn’t plausible to the doctors and scientists who wrote the NEJM paper, or the legislators who are eager to institute the proposed soda tax, that people might drink too much soda — or eat too much, or smoke, or stay home and watch TV instead of jogging — with full awareness of the possible consequences.   In the risk-free zone of America as envisaged by the public health industry, only the insane and the uninformed would engage in “risky behavior.”

Nobody, in risk-free America, does anything because it feels good, knowing it might be harmful.  Nobody overeats because it brings her pleasure, nobody screws without a condom because it turns him on, nobody smokes because she had a bad day or a good day or because the day hasn’t started but it looks unpromising, nobody rides her bike without a helmet because she likes the feel of the wind in her hair.  It’s risky.  We all know better.

The libertarians think it’s big government you give up your private choices to, and the progressives think it’s big business.  But really, it’s neither — or both, working together.  And the public health and medical industries are complicit.  It’s not a conspiracy.  It’s more like religion.

“Deadly Choices” is heartbreaking.  It recounts a situation that was miserable, terrifying, and in some cases, fatal.  Fink reports that, among 45 Memorial Medical Center patients who died in the days during and immediately following the storm, 17 were deliberately administered lethal doses of morphine, sometimes along with a sedative, by physicians who apparently intended to hasten the patients’ deaths.  (Many of these 17 were patients at a hospital-within-the-hospital, a long-term care hospital under separate ownership that shared some staff with MMC.  At Slate today, Josh Levin discusses some of the troubling truths about the financing of long-term care hospitals, and Fink fills in some more of the blanks with a response at ProPublica.)

As Fink explained to Amy Goodman in an interview with Democracy Now earlier this week, at least one of the patients who were killed was not in extremis; he had not given up.  He was

“Ready to rock and roll, wanted to get out. And apparently, according to several people who later spoke with investigators, a discussion was had in which they talked about how they might get him out, and they decided that because he was so heavy and it was so hot and people had—I mean, just imagine….They had been going on no sleep for days, the medical workers. They were tired. They were terribly disturbed by all the suffering that they felt that they saw around them. And so, in this sort of moment, they apparently decided that [the patient] could not be brought down, could not be evacuated, that there was no way to get him out.”

The story of what happened at MMC is also profoundly disturbing.  It moves us to ask what sort of moral world physicians are expected, and allowed, to operate in.  And to wonder why moral boundaries should be so elusive to exactly the people who, with access to the means to both prolong life and hasten death, walk on morally fraught territory more often than anyone.

The horrifying events at MMC are especially  germane today — because they highlight a vexing question about health care reform that is very hard to answer:   Is our doctors’ job to alleviate suffering, or is it to improve health?

A favored guru on health care ethics, Ezekiel Emanuel, is explicitly in favor of the latter.  In “Justice and Managed Care” (subscription) in Hastings Center Report in 2000, he writes

“The allocation of health care resources should aim at and be justified by the improvement in people’s health…. The special aim or purpose of health care is curing disease, relieving pain and suffering, promoting public health, pursuing research to improve health, and so on.”

The “and so on” means that improving health — the obligation of a health care system, Emanuel asserts — amounts not just to the relief of pain and suffering but also to research and public health, and other tasks as well.  The relief of suffering might not be a priority, that is.  Or it might be a contingent priority, of importance for a limited time, or in certain circumstances — but not the only thing to worry about.

The point is not to vilify Emanuel.  He has opposed euthanasia and physician-assisted suicide, so we should assume that he was as appalled by the actions of the chief physicians at MMC as others were.

But the Emanuelian sensibility is that the system in which physicians work is not meant to be dedicated to the relief of suffering alone.  Rather, it bears other duties as well:  a broad obligation to the public to promote health, and another obligation to contribute (through research) to the future of health care.

In this narrative, the physician is marshal of a campaign — not merely joined in a series of caring relationships with each of a number of patients, but commander of troops who have a long-term goal and territory to win.   By implication, the rights of patients might take second seat to the needs of the public, or to the desire to learn more about how to improve health in the future.  Patients shouldn’t be killed, this thinking goes, but they will have to understand that the prolongation of life is a luxury commodity to which physicians have the keys — and not everyone can have access.

The sense of the physician as a responsible manager, not merely a giver of care, connects with the utilitarian credo, “the greatest good for the greatest number” — a phrase that occurs three times in Fink’s piece as she strives to characterize the sensibility of MMC providers.

But the killings at MMC should, at the very least, make us ask whether it’s a good idea to have doctors making decisions about the greater good — or whether we want them to recognize individual persons above all.

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.

“We all want to believe that a pill or potion that comes from sea coral or from the Amazon jungle will cure that pain for which little else has worked,” Verghese writes.  The “flip side,” he says, “is that we are extraordinarily sensitive to any suggestion that someone is taking away something we think is good for our health.”

And magical thinking’s influence isn’t limited to cruising the natural supplements aisle or reading the ads in a health magazine.  Sometimes it’s part of expert opinion — and so it becomes part of widespread belief.

Consider how the flu experts talk about the possibility of swine flu’s return this fall. In Monday’s Washington Post, the experts’ words wax electric.  Dr. William Schaffner, chair of Preventive Medicine at Vanderbilt U.’s medical school, asserts that “The virus is still around and ready to explode…. We’re potentially looking at a very big mess.” And Dr. Arnold Monto, a physician epidemiologist at U. Michigan’s School of Public Health, worries “about our ability to handle a surge of severe cases.”

So, even as H5N1 reports that an article in The Independent finds scientists skeptical as to whether there will be a so-called second wave of serious flu outbreaks in the northern hemisphere this fall, we’ve got American scientists suggesting — in high-voltage terms — that something awful is going to happen.

They’re not wrong: something bad might happen.  That’s always true.

But language matters.  And language coming from so-called experts matters a lot.  It has magic.

Vigorous metaphors promote popular fears.  The last time swine flu came around, in early 1976, respected virologist Edwin Kilbourne published an influential op-ed piece in the NY Times (13 Feb 1976), called “Flu to the Starboard! Man the Harpoons! Fill with Vaccine! Get the Captain! Hurry!” Kilbourne urged officials to prepare for an “imminent natural disaster.” Fair enough:  a serious H1N1 flu might have happened in ’76 (it didn’t) — but his whaling metaphor appealed to more than just preparation.  It was about power and authority (“get the captain!”).  Presumably, the authority of science, industry, and government.

And so with other metaphors that are meant to be calls to arms.  There were the warfare metaphors about the alleged threat of bioterrorism, and the plague metaphors about AIDS.  Now, there are explosive metaphors about obesity.

Last year, acting U.S. Surgeon General Dr. Steven Galson called childhood obesity a “national catastrophe,” for instance.  And Dr. Risa Lavizzo-Mourey, president of the Robert Wood Johnson Foundation, warned of obesity’s “corrosive” effects, which, she asserted, imperil a generation of America’s youth.  According to Dr. Matthew Gillman of Harvard “You build [obesity] up over generations” — like an electrical charge in a capacitor, like explosive potential, the reader has to presume.

Talking about childhood obesity, Dr. Eric Hoffman of Stanford told the Washington Post that “we have taught our children how to kill themselves.”

Invoking metaphors to create magical thinking isn’t just an American habit.  Childhood obesity is a “time bomb,” according to physician Howard Stoate, chair of Britain’s All-Parliamentary Group on Primary Care and Public Health.

Verghese’s right.  People can be afraid to let go of what they believe they need for their health — however magically.  And magical thinking is inside the way our experts talk to us about health.  That sort of magic can run deep.