Philip Alcabes discusses myths of health, disease and risk.

Further Feuding on Flu

My stand on prohibiting flu-virus research hasn’t changed: as I told the NY Times last year, even if flu experimentation is overseen by a group of so-called experts, it’s just not clear who should keep an eye on the experts.

And the question about minding the experts just got more complicated.

The issue has been whether researchers should be allowed to conduct experiments with modified strains of H5N1 (avian) influenza virus, in order to find out more about the potential for bird flu to spread among humans.  Concerned about possible dangers of experimenting with extra-transmissible bird ful, a moratorium on such research was declared.  The moratorium ended in late January of this year.

But now some distinguished scientists are calling for fuller constraints on this kind of research — called gain-of-function (GOF) experimentation, because it involves creating novel strains of viruses with capabilities not known to occur in nature.  The ostensible purpose of such research is to figure out how to prevent harm associated with inevitable genetic changes in viruses.  Think of it as creating disaster scenarios at the molecular level, so as to determine how to avert damage if the disaster comes to pass.

CIDRAP gives a nice summary of the new controversy, reporting that the Foundation for Vaccine Research, an advocacy group, has written to Dr. Amy Guttman, chair of the Presidential Commission for the Study of Bioethical Issues, raising what the Foundation says are “moral and ethical” concerns about GOF research.

An editorial by Simon Wain-Hobson in Nature the other day advances reasons why scientists should get together to limit GOF research.  Wain-Hobson questions the scientific validity of the predictions such research makes (since natural selection in the real world might produce changes in viruses quite unlike those manufactured in the lab), and criticizes WHO for failing to generate a broad discussion on the dangers of GOF research.

Then, he asks what will happen if the viruses created in GOF research leak out of a lab.  Who will take responsibility, who should make decisions, who should own the information arising from the research?  He says,

The global ramifications of GOF research have simply not been sufficiently explored and discussed. Influenza virologists are going down a blind alley and the powers that be are blindly letting them go down that alley, which is tantamount to acquiescing. So let’s be clear: the end game could be viruses more dangerous than the Spanish flu strain.

And Wain-Hobson goes on to propose a suspension of all GOF research until

virologists open up and engage in public discussion of their work and the issues it raises. Given that the flu community failed utterly to use the year-long hiatus to good effect, it is clear that an independent risk–benefit assessment of GOF work is needed.

Here is where it gets complicated.  One group of scientists (Wain-Hobson and the FVR) is angry with another group (the so-called flu community, basically those influenza researchers who conducted the 2011 H5N1 experiments and their defenders).

At the same time, both groups are unwilling to have government regulate research. In fact, Wain-Hobson worries because

Officials in Washington DC are putting the finishing touches to new guidelines for the review, regulation and oversight of this kind of research. The chill winds that we can anticipate blowing from policy-makers as a result could affect all of us who research viruses and their pathology.

The terms of the debate aren’t scientific, that is.  And they surely aren’t about morals, no matter what some self-important researchers claim.   The debate is about who will be able to control scientific research and who will benefit from the consequences (including, presumably, vaccines or other marketable preventive agents).  

Don’t be misled by assertions that the debate over GOF research is about public health, or ethics.  It’s about the usual:  political power and profit making.

Against Universal Flu Immunization

In a strong piece at CNN online yesterday, Jen Christensen points out that no European countries expect the entire population to be immunized against flu — unlike the US, where everyone over the age of 6 months is urged to get flu vaccine every year.

Why does CDC recommend (based on advice by the Advisory Committee on Immunization Practices in 2010) that all Americans — from infancy on up — get immunized against flu?

A few possibilities:

1.  Public health benefit?

No.  Over the past twenty years, flu-vaccine coverage — the proportion of the population that is immunized — has been going up progressively.  But flu hospitalization and mortality rates have been basically constant.  If mass immunization had any public health value, those rates should go down as coverage goes up

(A technical note: this means that coverage remains below the threshold needed to reduce influenza transmission population-wide, i.e., it isn’t high enough for herd immunity.  But that’s the point.  In order to be of public health benefit, flu vaccine would have to be accepted by almost everybody, every year.  And even that might not be enough:  For a nice explanation of why the efficacy of flu vaccine is limited, see Vincent Racaniello’s blog post.)

2.  Exceptional efficacy of the vaccine?

No.  Based on an observational study of acute respiratory illness patients published this month, the effectiveness of this year’s flu vaccine is 55% against illness caused by influenza type A (which accounts for about 80% of flu cases).  Effectiveness is 70% against type B.  Overall, the chances of being protected against symptomatic flu are less than two out of three.

Jefferson and colleagues found that the overall efficacy of  flu vaccines at reducing influenza A or B infection in children aged 2-16 is only about 65%, and that inactivated vaccines (i.e., the usual injection) had little impact on serious illness or hospitalization from flu-like conditions in this age group.

As with this month’s observational study, Jefferson et al.’s meta-analysis of multiple studies on flu immunization found that the inactivated vaccine had about 73% efficacy at preventing infection in healthy adults — but that efficacy can be as low as about 50% in years when the vaccine isn’t well-matched to the season’s circulating viruses.

Importantly, the Jefferson studies found that effectiveness of immunization — the prevention of serious illness or hospitalization from influenza-like illness — is very low.

There’s no sound public health rationale for encouraging everyone to be immunized against flu every year.

People who are likely to develop serious complications if they are infected can benefit from immunization.  But for most of us, immunization only reduces (by two-thirds) the already rather small chance of infection with influenza.  And it doesn’t protect us much from serious respiratory illness during flu season.

I commented in 2011 on public officials striving to help pharmaceutical companies profit from flu fears. And that’s what we’re seeing again this season — with exaggerated warnings and declarations of flu emergencies. Even though the latest national summary from CDC shows that less than 30% of all influenza-like illness is actually caused by flu this season — and that’s likely an overestimate, since it’s based on testing of more severe cases of acute respiratory illness.  And the surveillance data suggest that the season’s flu outbreak might already be past its peak.

Get immunized against flu if you’re worried.  But keep in mind that vaccination against flu is not going to help the public’s health, and it isn’t highly likely to help yours — it’s primarily your contribution to the profits of Sanofi-Pasteur, Novartis, GSK, or Merck.


The Health Department at Work

I was pleased to receive a phone call from the NYC Department of Health and Mental Hygiene  and to be selected to participate in a “health survey.”  The questions offered a fascinating insight into the agency’s preoccupations — and what sorts of impropriety obsess its leadership nowadays.

It’s reassuring that the Department wants to be able to estimate how many New Yorkers lack health insurance and, separately, lack a regular health-care provider, and asked questions about those things.  And I was impressed that the survey designers thought to ask whether, the last time I sought help for a medical problem, it took a long time to get an appointment.

And then came some predictable How Are We Doing? questions:  Have I had a flu immunization in the past 12 months? (No, thank you, I’m not convinced that it works…  Okay, I didn’t say that, the survey taker seemed young and too earnest for serious critique, so I just said “No.”)  At least two doses of hepatitis B vaccine at some time in the past?  When did I last have a colonoscopy?

But there was the question about whether I have used oxocodone or hydrocodone (OxyContin or Vicodin) without a prescription, or outside of the prescribed dosage.  The Department has just announced a new campaign to stop people from using pain killers too much.

There was the question about whether I’m exposed to cigarette smoke in my household.

There was a question on whether my household has a disaster plan.  No, we don’t.  We have a couple of flashlights, some water, and a bottle of scotch.  Will that do?  We’re grown-ups, we don’t have pets or little children to look after.  We’ll work something out.

(But I didn’t say that to my earnest interviewer, either.  I have a feeling they don’t find whiskey to be humorous, over there at the health department.  In fact, they had some very specific questions about alcohol consumption, amount and frequency.)

There were questions about how often I exercise vigorously.  How often I exercise moderately.  How often I exercise lightly.  How long I engage in said exercise when I do do it.  Very interested in exercise, our health department.

There was the question as to how many servings of fruit or vegetables I ate yesterday.

And then, onward to mayor Mike Bloomberg’s white whale:  sugar-sweetened beverages!  Mayor Mike is going to ban serving soda or other sweet beverages in large sizes — and he’s not asking for a new law (which might not pass), just a go-ahead from the city’s eleven-person Board of Health, all appointed by the mayor, chaired by the city’s cheerleader for “healthy lifestyles,” health commissioner Thomas Farley.   A restaurant trade association, the Center for Consumer Freedom, responded to news of the mayor’s intention with an amusing ad in today’s NYT, portraying Bloomberg as The Nanny.

The survey questions:  How often do I drink soda or bottled iced tea?  What about beverages to which I add sugar myself, like tea or coffee?

And, now that we were deep into the zone of health officials’ self-stimulation:  how many (a) women and (b) men had I had sex with in the past year?  Did I use condoms?  And, had I used the Internet to meet a sex partner in the past 12 months?

So much for health.  Now we know what haunts the dreams of the self-righteous mayor and his bluenose health commissioner:

Pain relief.

Fat people.

Vigorous exercise.

Pleasurable foods.


Reading this list, you would have to be forgiven for thinking that these men, Bloomberg and Farley, have been living in a monastery since, say, the 14th century.  In fact, if they were really clergymen instead of officials, they would leave us alone about how we eat and sweat and screw.  At least in between sermons.

But thanks for calling.




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.