Philip Alcabes discusses myths of health, disease and risk.

Transparency on Pandemics

How bad would it be for officials to be more open about how they make decisions on “preparedness”?  Should the public know more about how so-called experts forecast coming danger?  What’s the influence of media reports, like the coverage of last year’s flu outbreak which suggested, from day one, that it would resemble the 1918 flu?  How influential are the pharmaceutical companies and other vaccine makers?

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?

Autism and the MMR Vaccine

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

As New Scientist points out, the GMC’s finding removes any impediment to charging Wakefield and two of his colleagues with misconduct.  GMC may rule on that score in a few months, according to the BBC.

By and large, the talk about the verdict hasn’t been about the substance of the contentious vaccine-autism link.  At Autism Science Foundation, Alison Singer (the group’s president) writes that

Anti vaccine autism advocates continue to see Wakefield as a hero who remains willing to take on the establishment and fight for their children.  In the meantime, Wakefield’s actions have had a lasting negative effect on children’s health in that some people are still afraid of immunizations. In some cases, the younger siblings of children with autism are being denied life saving vaccines. This population of baby siblings, already at higher risk for developing autism, is now also being placed at risk for life threatening, vaccine preventable disease, despite mountains of scientific evidence indicating no link between vaccines and autism. This is the Wakefield legacy.

On the other side, Generation Rescue writes in support of Wakefield at Age of Autism.  GR isn’t as cogent as Singer, but brings up the point that tends to complicate this and most discussions of autism:    “Do you think pharmaceutical companies have too much influence in the laws, policies, and regulations of our government?  We do.”

Liz Ditz provides a great service, compiling blog posts pro-Wakefield and, separately, those criticizing Wakefield and/or supporting the GMC’s decision.  (As of today, the Wakefield critics seem to have been more prolific.)

Thursday’s BBC report concludes with a graphic showing a decline in MMR coverage in the UK between 1996-97, when it stood at around 90%, and 2004, when it bottomed at around 80%.  Superimposed is the number of measles cases, which increased from a few dozen in 2005 to over 1200 in 2008.  The implication is that Wakefield’s report was somehow responsible for the drop in coverage in the late ’90s and that that decline led to a sharp uptick in measles incidence.  The graphic also implies that after Lancet retracted the original paper in 2004, public acceptance of MMR vaccine improved after Wakefield had been repudiated — but too late to prevent the measles upsurge.

Without supporting Wakefield’s methods, it’s still worth asking whether his 1998 paper should be held accountable for the decline in vaccine acceptability.  As early as February 1998, England’s Communicable Disease Surveillance Centre was reporting on the drop in MMR coverage from 1996 and ’97 data and BMJ reported in 2003 that the British trend was consonant with declines in MMR uptake in Europe generally:

[T]he experts say that coverage is substandard across Europe owing to a surprising lack of political will to implement an effective disease prevention programme, given the region’s stated goal to eliminate measles by 2007.

A decline in nationwide vaccine coverage to 80%  is probably less important as an explanation for increasing measles incidence in the U.K. than two other factors:  locally deficient MMR coverage and immigration from countries with lower vaccination rates.  In fact, measles increases in the UK seem to have been attributable to outbreaks in the northern part of the country and to high incidences among very young children in London, according the UK’s Health Protection Agency.

What’s to be learned from the Wakefield mess?

1. The role of pharmaceutical companies (including vaccine makers) in setting scientific agendas and moving policy remains an issue for many people.  Defenders of Big Public Health, like Mark Honigsbaum who writes an interesting piece in The Guardian today, tend to be dismissive of allegations that public health has become a game for technocrats in which corporations have too much sway.  But the defenders misunderstand those critiques.  The critics are not saying that government predictions are wrong where they should be right, nor that officials are on the take; the critique is this:  the relationship between profit makers and public agencies is sometimes awfully cozy and the attentiveness to real suffering is remarkably slight.

2. The pre-eminence of ethics boards, like Britain’s GMC, doesn’t always sit well.  With the Wakefield case, the MMR-autism controversy steps onto the slippery terrain of moral decision making in regard to research.  Many people don’t feel perfectly reassured about the ethics of medical practice when the overseers are themselves physicians, and the moral reasoning often seems restricted to “did the physician follow the rules?”

3. The stance of official agencies on autism doesn’t inspire confidence.  Vaccination is hard to exonerate as a cause of autism as long as the official approach is that autism is a disease, and by implication preventable — rather than a disability, which might or might not have a cause but whose sufferers, in either case, can be afforded decent lives.  To make matters worse, official agencies’ stance doesn’t defuse the controversy.  In the U.S. and U.K., they respond to anti-immunization claims with assertions about the safety of MMR in particular.  But they don’t seem to want to support the research that would test whether some children might be susceptible to damage incurred cumulatively by undergoing the numerous vaccinations that are scheduled for children today.  It’s unlikely that the scrutiny of immunization, or the controversy, is going to go away unless officials soften that stance.

We’ll probably hear more on this if the GMC rules to disbar Wakefield from practicing medicine.

Revolving door? Official agencies and the private sector

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

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

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

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

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

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

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

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

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

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

Avoiding Panic: The Imagined Crisis

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

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

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

We think not.

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

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

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

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

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

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

Read the full post here.

Already Apologizing…

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

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

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

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

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

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

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

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

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

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

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

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