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H1N1 Update

I know we have been focusing on the vaccine issue extensively, but this is crunch time and the anti-vaccine forces are relentless. We are now facing a regular seasonal flu spiked with the H1N1 pandemic. Our best weapon against morbidity and mortality caused by the flu is information, and yet the public is being barraged with misinformation designed to encourage poor choices and thereby result in maximal morbidity and mortality.

I confess I was never impressed with FDR’s famous quip, “All we have to fear is fear itself,” – I think there is plenty else to fear. But his sentiment is very appropriate to the current situation – fear mongering around the seasonal flu and H1N1 vaccines is what we have most to fear.

And of course, as is almost always the case, accurate information is complex and requires a nuanced understanding. This creates uncertainty, which is easy to exploit to manufacture unreasonable fear.

The anti-vaccine fear mongers are playing every card in the deck. They are arguing (falsely) that H1N1 is not severe enough to warrant getting the vaccine, that the vaccine does not work anyway, and that there are unacceptable or unknown risks to the vaccine. In the most extreme cases, bizarre conspiracy theories are brought to bear, but I will not discuss these here as anyone compelled by such fantasies is likely beyond the reach of any information I could provide.

Mark Crislip has already provided an excellent overview of the evidence for seasonal flu vaccine efficacy in adults. To summarize – the evidence is complex and mixed, but there is compelling evidence that the flu vaccine works as designed, in that it produces protective antibodies against influenza. There is also evidence that it decreases morbidity and complications from the flu, although it is less clear if it decreases the number of flu cases. Further, the efficacy of the vaccine depends highly on how well the strains vaccinated against match the circulating strains.

Efficacy also depends highly on compliance – the percentage of the population (especially those likely to spread the flu to vulnerable populations) who get the vaccine.

The bottom line is that the vaccine works enough to make it worthwhile, and it is extremely safe. At a time when health care costs are crushing our economy, it is also worth pointing out that it is cost effective.

And yet confidence in the H1N1 vaccine is decreasing under the onslaught of scare mongering and misinformation. A recent survey of UK nurses found that 47 percent do not plan on getting the H1N1 vaccine, while only 23 percent said they would. This is concerning because health care workers are perceived as having more authority with the public, and because protecting the sick and elderly likely depends most on their health care providers getting vaccinated.

It is also important to note that the H1N1 vaccine has a big advantage over the seasonal flu vaccine – the match between the vaccine and the circulating virus is high. This is perhaps the biggest predictor of efficacy for the flu vaccine.

How Bad Is It?

The evidence so far indicates that, as predicted, H1N1 is now making its second circuit through Western countries, including the UK, Canada, and US. The CDC reports that flu cases are increasing rapidly, and are exceeding the normal number of cases that would be seen at this time of year from the seasonal flu. By all reports, we are in for a heavy flu season. It does not look like the 1918-1919 pandemic, but a bad flu season is still a concern. The average flu season kills 30,000 Americans and 500,000 worldwide.

Statistics from August 30 to October 3 in the US indicate: Influenza and Pneumonia Syndrome – 12,384 hospitalizations and 1,544 deaths, of those influenza was confirmed in laboratory tests in 3,874 and 240 respectively.

Compared to the seasonal flu H1N1 is about as deadly overall, but kills a higher proportion of those who are otherwise young and healthy, and also is more deadly for pregnant women. About 1% of people infected with H1N1 get a severe form of the flu likely requiring hospitalization and at high risk of death.

Is the vaccine safe?

There is a range of concerns that have been raised about the vaccine. These range from those that are reasonable and should be raised about any new intervention at one end, to outrageous conspiracy mongering at the other. Of course, those who raise appropriate concerns hate to be painted with the same brush as the conspiracy theorists, and so I will make that distinction at the outset. And, as stated above, the conspiracy theories are beyond the scope of this entry.

I would file under appropriate concerns the fact that the previous H1N1 pandemic vaccine from 1976 resulted in an increased risk of Guillain Barre Syndrome (GBS) – about 1 per 100,000 people vaccinated. The seasonal flu vaccine in the last 32 years has resulted in excess cases of GBS of about 1 in 1 million. While we expect that the H1N1 vaccine will likely have the same risk of GBS as the seasonal flu vaccine, the US and UK have instituted monitoring systems (essentially encouraging doctors to report cases of GBS following vaccination) as an early warning if the H1N1 vaccine has a higher risk of GBS.

I discuss the issue of GBS in more detail here, but the bottom line is that the risk of GBS ranges from low to very low, and it will be monitored. Also, early experience with the H1N1 vaccine has not resulted in any cases of GBS, so at the very least the risk is not high.

Most of the concerns brought up about the H1N1 vaccine I consider to be unreasonable fear mongering. For example, anti-vaccinationists have tried to raise fears about adjuvants in the vaccine. They consistently fail to point out that the versions of the vaccine approved by the FDA for use in the US do not contain adjuvants.

Adjuvants are substances added to vaccine to increase the immune response. This allows for the use of less viral material in the vaccine. Vaccine adjuvants are all extensively tested and are generally safe. Any reactions are extremely rares, and certainly much less likely than morbidity from the disease the vaccine is targeting.

Harriet Hall has already addressed the fear mongering surrounding squalene and other adjuvants here, and David Gorski addresses similar concerns here.

Another concern that is brought up is that one can get sick from the vaccine itself. Bill Maher infamously stated recently on his show that the vaccine “injects disease” into the arm. The injectible version of the vaccine does not contain “disease” – it is a killed virus vaccine, and it is impossible to get the flu from the vaccine. The nasal spray vaccine does contain a live virus, but it is an attenuated virus – meaning that it is weakened so as not to cause illness but only to provoke an immune response. There is a small risk that attenuated viruses will spontaneously mutate and revert back to a more virulent form, but the risk is very small.

And, of course, the now classic vaccine scare mongering regarding thimerosal, a mercury-based preservative, is being trotted out. These claims are wrong on multiple levels. We have already dealt extensively with the false claim that thimerosal is unsafe. A thorough review and reference list can be found here. Thimerosal is safe in the doses used in vaccines.

Further, the single-shot version of the seasonal and H1N1 flu vaccines, and the nasal vaccine, all do not contain any thimerosal. Thimerosal is only used in the multi-shot version of the vaccine, to prevent contamination.

Conclusion

While there is uncertainty and reasonable concerns regarding the flu vaccine, and more research is welcome, current evidence is sufficient to recommend that the vaccine is safe and effective. The bottom line with any medical intervention is risk vs benefit. The benefit of the H1N1 vaccine far outweighs the minimal risk.

Further, the more people who get the vaccine the more effective it will be. At this rate, we are unlikely to achieve herd immunity, but everyone who gets vaccinated will not only provide themselves with a level of protection, but will also protect those around them.

It is still too early to tell how severe the H1N1 pandemic will be, but at least it will result in a bad flu season. It is also clear at this point that the pandemic will be significantly worsened by fear-mongering against the most effective defense we have against the flu – the vaccine.

There is a body count attached to this unreasonable fear, justifying FDR’s famous words.

Posted in: Public Health, Vaccines

Leave a Comment (132) ↓

130 Comments

  1. wales October 16, 2009

    I read Dr. Crislip’s article last week, as you can see from my comments there. I looked at the Ontario study and realized that it did not include vaccination rate data for those under 12 years of age or the institutionalized elderly. There are other drawbacks as well. That doesn’t mean the study should be dismissed out of hand, of course. But especially regarding children <12 and the institutionalized elderly, both populations most likely to experience disease complications and mortality and both populations exhibiting lower vaccine efficacy in the Cochrane systematic reviews, we can draw no conclusions. I’ll take another look.

  2. wales October 16, 2009

    btw cheglabratjoe, please point out my misuse of latin terms.

  3. cheglabratjoe October 16, 2009

    Lotta persecution complexes on SBM today!

    An ad hominem argument is the following: “statement X is wrong because person Y said it, and that person has bad characteristic Z.” That’s it! The following things are not ad hominems: insults, name-calling, and swearing. Real ad hominems are rare, because they sound ridiculous and even discriminatory.

    This would be an ad hominem: “what Jefferson said was wrong because he is anti-vaccine.” No one said that. The closest anyone came to that was Gorski saying he was suspicious of Jefferson’s intent because of the Atlantic article and his acceptance of the invitation to speak at an antivax event. That isn’t an ad-hom, and moreover it’s prudent. I’d be suspicious of someone’s knowledge of evolution if they spoke at an intelligent design event, or of their thermodynamics if they spoke at a perpetual motion event. So what?

  4. wales October 16, 2009

    Webster’s ad hominem definition:

    1: appealing to feelings or prejudices rather than intellect
    2 : marked by or being an attack on an opponent’s character rather than by an answer to the contentions made

    I believe Dr. Hall characterized Gorski’s comments on Jefferson as ad hominem as well.

    No matter.

  5. Dr Benway October 16, 2009

    Wales, quoting the dictionary is rather weak.

    Surely a smart person like yourself can recognize the difference between an ad hominem, which is a logical fallacy, and an insult, which is an expression of personal feeling.

  6. Todd W. October 16, 2009

    @wales

    cheglabratjoe had the definition of an ad hominem, at least according to several different sites on logical fallacies. It is saying the the person is wrong because of some characteristic about the person, rather than some characteristic of the argument being made. E.g., “You clearly could not be right about vaccines because you make money from pharma companies.” or “You’re a religious wing-nut, therefore your argument about evolution must be wrong.”

    It’s not merely an appeal to emotions or attacking the person (e.g., “You’re an idiot”). The former is a different logical fallacy and the latter may simply be an insult, but not necessarily a logical fallacy.

    At least, that’s what I gathered from reading about ad homs at a few different sites.

  7. wales October 16, 2009

    Yeah right, quoting the dictionary is weak. At least it prevents me from indulging in deranged splenetic outbursts.

  8. wales October 16, 2009

    btw, quibbling about semantics is just another distraction from the topic. but I have had enough of the topic for now.

  9. Draal October 16, 2009

    This thread has so veered there’s no redeeming it and should be locked.
    That said, I’m going to ignore that and further go off topic.

    Making fun of the use of a reputable source is illogical. An legitimate, established dictionary is a much better source that say wikipedia. That being said, no one definition is 100% correct in every situation. It only matters that the person using the word is understood by the other person. Definitions change over time too. A word used 100 years ago is not guaranteed to mean the same thing today. In the context of this skeptical blog, I’d say the definitions of the logical fallacies being tossed around on this blog are explained here: http://www.theness.com/neurologicablog/?p=499.

    Generally, insults are not considered strictly logical fallacies, but it does reflect the level of civility of the person. However, here’s an example from a skeptic website that cites insults as being a logical fallacy, specifically an Abusive ad hominem. http://atheism.about.com/library/FAQs/skepticism/blfaq_fall_abusive.htm

  10. Draal October 16, 2009

    K, here’s a pointless thought and question:
    In the 1940s, the flu vaccine was first developed. At the time, I’m assuming, it was believed that the vaccine would just work because of success with other vaccines. There were no clinical trials (probably used on military personal first) that proved their efficacy; in fact, they weren’t very effective.
    Say we were in the 1950s (and only in this case): On a strictly skeptical stand point, should a skeptic get a flu vaccine? Let’s assume we know that other vaccines work, we know the theory on how they should work, but there is no overwhelming evidence to support the use of the flu vaccine. keep in mind the bulk of the flu efficacy studies were performed in the 70s and 80s.
    Another way to look at it is… if skeptics ruled the world, should the flu vaccine not have been used until it was first proven safe and effective? Sure it’s been proven now but it was used for decades without the evidence we have now.

  11. weing October 16, 2009

    That’s like asking if a skeptic should use a parachute? Please, we’ve been through that already. It may work, it may not, but it’s the best shot you’ve got. Anyway, that’s how I see it. The choice seems obvious to me, it may not be to you. Our backgrounds and understanding of the issues differ. Ask your doctor, and take or leave his advice. He might say you can’t get the shot. I don’t give flu shots to people who have egg allergies.

  12. Draal October 16, 2009

    Please, it’s not the same thing as a parachute. You’ve avoided my question. Historically speaking, am I wrong that vaccines were used without the clinical evidence backing them up? Should they have been used with the knowledge at hand?

    I don’t know how many times I have to say that I’m not against the vaccine. I whole heartedly believe in the use of vaccines. I just like challenging some of the claims that are used to support certain arguments.

    It just tickles me that the arguments presented these days would have destroyed pro-vaxxer claims when the flu vaccine was first invented (in my opinion). It makes me grin at the irony.

    Another irony was the fact that doctors purposefully did not administer antivirals to pregnant women to avoid complications with the fetus. And we know know that was the wrong decision since an unexpected number of those women died. Now the recommendation is to get those antivirals administered ASAP.

  13. Draal October 16, 2009

    Just to be crystal clear in what I said… arguments that support the use of vaccines today (efficacy, safety, so on and so forth), would have worked against those who were in favor of the flu vaccine in the 40s, 50s and 60s because that information on safety and efficacy was not present then. Hence, I would think a skeptic using today’s standards would have called shenanigans on the unsupported claims way back when.

  14. cheglabratjoe October 16, 2009

    If you’re not anti-vaccine, what is the point of your question? Yes, before widespread testing was done, I suppose flu vaccines were used based on their safety, the stunning success of other vaccines, and the soundness of their mechanism of action. So the hell what? The same could be said of ANY preventative procedure.

    Are you also “tickled” by the fact that antivax-type arguments would’ve destroyed the pro-hand-washing claims when they were first proposed.

    Also, are you grinning at the second irony you mentioned (pregnant women dying due to mistaken concerns about their fetus), too? Yeah, that’s really freaking hilarious, pal.

  15. Dr Benway October 16, 2009

    Draal, we are always reasoning from incomplete and imperfect information. We estimate the probabilities of competing hypotheses as best we can, then pick the causal explanation that seems most likely. We’re always learning more and our estimations are always changing. We seek to live gracefully with this constant uncertainty around us.

    Now some argue that because we don’t know a lot of things, making shit up to suit is fine. You like country; I like rock-n-roll. You like the mercury-causes-autism idea; I like the inflammation-causes-autism idea.

    No! There are rules. Here’s a biggie, it’s called “Bayes’ theorem”:

    P(H|O) = P(H) * P(O|H)/P(O)

    The probability of a hypothesis given an observation equals
    the prior probability of the hypothesis
    times the probability of the observation given the hypothesis
    divided by the prior probability of the observation.

    Note that confidence in the prior probability of H has a HUGE impact upon the equation above.

    To estimate prior probabilities, you need to understand all the science that surrounds an idea. n00bs have trouble sifting through the mountain of related facts for those most relevant to the problem at hand. I think it’s here that the pseudoscience mind gets stuck.

    With respect to vaccines, we’re lucky. We know a tremendous amount about antigen-antibody relationships. In a nutshell:

    1. Expose the body to certain antigens and it will make antibodies. Maybe not always as many as we’d like, but we can tweak that.

    2. The more individuals with antibodies to a pathogen, the smaller and weaker the disease outbreak.

    3. Because the body is swimming in foreign antigens all the time, the risk of exposing the body to a few more is hardly worth mentioning. Yes, one in a million people have a bad reaction to a vaccine. But one in a people have a bad reaction to perfume or carrots or incense or sushi or whatever.

    The epidemiological surveys confirm the above, even when the data are kinda noisy or otherwise kinda crappy.

    There are many therapies in medicine that rest upon a very sketchy understanding of how they work in the body. Vaccines aren’t one of those therapies.

  16. weing October 16, 2009

    Historically speaking, am I wrong that vaccines were used without the clinical evidence backing them up?
    I don’t know. Could be. Clinical evidence had to be acquired somehow.

    Should they have been used with the knowledge at hand? You could test them if you have a plausible hypothesis. Whenever a new drug comes out. I first try it on the family pet. If it survives, I try it on the in-laws. If they survive, I can try it on myself. If I survive, then I can try it on my patients.

  17. Draal October 16, 2009

    If you’re not anti-vaccine, what is the point of your question?

    Sorry for not drinking the kool-aid and believing everything that’s posted on this blog immediately. I’ll ask questions and not “parachute” before getting as much info.

    So the hell what? The same could be said of ANY preventative procedure.

    Uh, because cranks make that same claim. Have some homeopathic water or snake oil, it’s been said they prevent all your ails.

    Are you also “tickled” by the fact that antivax-type arguments would’ve destroyed the pro-hand-washing claims when they were first proposed.

    I’m in stitches.

    pregnant women dying due to mistaken concerns about their fetus…Yeah, that’s … hilarious

    You’re just sick. You need your head examined. Try not to make a straw man out of something I never said.

  18. Draal October 16, 2009

    And one more thing cheglabratjoe, if you want to be ignorant of past mistakes, be my guest. I’d rather be aware of them to avoid them in the future.

    Those who cannot learn from history are doomed to repeat it. -George Santayana

  19. cheglabratjoe October 16, 2009

    Did you read what I wrote, champ? You’re hardly worth responding to.

    Here’s what I said about vaccines: “Yes, before widespread testing was done, I suppose flu vaccines were used based on their safety, the stunning success of other vaccines, and the soundness of their mechanism of action.”

    Your response to that was: “[C]ranks make that same claim. Have some homeopathic water or snake oil, it’s been said they prevent all your ails.”

    Really? Homeopathic water has theoretical backing? Snake oil is safe? Past homeopathic remedies worked well? Your response is nonsense.

    As for me being the one who needs his head checked, I think thou doth protest too much. Could you really not tell that I was being sarcastic, or that *you* made it seem like pregnant women’s deaths were comically ironic?

  20. Dr Benway October 16, 2009

    I have an hypothesis: When I post from locations that aren’t my home base, I get caught in the spam filter.

    Well I’m home now. And this post has no naughty words nor any linkies.

    Let’s see if we can reject the null hypothesis: “I will be spam canned just as I was earlier when I tried posting from the office.”

  21. Dr Benway October 16, 2009

    Failed to reject the null. Ha!

    My science kicks ass.

  22. Dr Benway October 16, 2009

    Durp. I mean, reject dat null sucka!

    My brain does oppositie stuff to me from time to time.

    I should fix a confusing sentence in the post way up there that someone nicely scooped from the trash:

    “Yes, one in a million people have a bad reaction to a vaccine. But one in a million people have a bad reaction to perfume or carrots or incense or sushi or whatever.”

  23. Peter Lipson October 17, 2009

    I dug it outta the spam filter

  24. Dr Benway October 17, 2009

    Why thank ye, Dr. Lipson.

    Say, you otta be in bed. Nurse Ratchet may require your assistance as to the meaning of “MOM prn no BM” prior to change of shift at 06:30.

  25. yeahsurewhatever October 18, 2009

    I guess I missed the party.

    To clarify the matter on what’s an argumentum ad hominem, “you’re wrong because you’re ugly” is argumentum ad hominem, whereas “you’re wrong plus you’re ugly” is not. Pretty obvious distinction.

    There’s also the argumentum ad dictionarium, but wales seems to be very familiar with that.

    As for his claim that “doctors have a fiduciary obligation to individual patients”, I don’t think he quite understands what that fiduciary duty entails. He’d be hard-pressed to successfully argue in any court of law in the United States that a physician is breaking a fiduciary duty by giving you a flu shot. He’d also be hard-pressed to find an attorney willing to touch that claim, since it can easily be interpreted as frivolous and vexatious.

  26. Draal October 19, 2009

    Watched 60 Minutes last night and there was a report on the H1N1 pandemic and interviews with the heads of the CDC.
    Two things I learned that I wanted to express and see if anyone else agrees.

    1. The secondary bacterial infections, bacterial pneumonia, is what is killing young adults. This is occurring b/c the “virus and flu” are damaging the lungs and make the lungs more susceptible to infection (like an open skin cut is susceptible to infection).
    — I figure the virus is killing cells in the lungs as it replicates, hence the damage, but I’m unclear how the flu itself damages the lungs. If anyone knows the answers, please inform me.

    2. The H1N1 is related to the 1918 Spanish Flu. Between 1930s-1950, there were other Spanish Flu related strains circulating in the general public. Anyone born before 1950, exposed to a Spanish Flu related virus, therefore has antibodies that are protecting them. Hence, older people born before 1950, are less likely to affected by the novel swine flu.

    Sounded very plausible. Can any one provide further support to the 60 Minutes claims?

  27. wales October 19, 2009

    I go away for a few days and some of you are still jabbering about the meaning of ad hominem.

    It appears that the types of ad hominem are more varied and nuanced than the personal opinions so generously proffered here. The types are explored here (including the non-fallacious types).

    http://www.phaenex.uwindsor.ca/ojs/leddy/index.php/informal_logic/article/view/2475

    As the authors state “It is not at all easy to classify ad hominem arguments by sharp and unambiguous criteria.”

    Call it what you will, unscientific personal opinion attempting to generate suspicion of bias on the part of T. Jefferson based upon a cancelled speaking engagement is strange. Why? Such appeals to emotion in lieu of valid criticism of the science appear odd coming from self-declared science mavens in a supposed science based venue. They also appear to be no different than similar comments intended to generate suspicion of Paul Offit’s objectivity based upon his vaccine patent ownership and former ACIP membership. I note that such comments about Dr. Offit are always vigorously criticized here (and I daresay have been at times characterized as ad hominem attacks).

    When the S is missing from SBM all that’s left is BM.

  28. weing October 19, 2009

    Draal,

    When cells die or undergo lysis, they release substances that evoke an inflammatory response. This consists of swelling, heat, redness, pain, and loss of function. Imagine this happening all over in the lining of your lungs.

  29. Draal October 20, 2009

    Heard a new one I heard today from a coworker.

    She was told that “they” are recommending that Tylenol not be given to children before taking them to the doctor’s office to receive the flu shot. Tylenol serves to lessen the swelling and mild fever post-shot. Apparently, Tylenol suppresses the immune response and the immune response/number of anitbodies is lower as a result. Without the Tylenol, the kids are supposedly very cranky, sore and run a mild fever.

    http://www.kold.com/Global/story.asp?S=11326081

    Although fever is part of the normal inflammatory process after immunisation, prophylactic antipyretic drugs are sometimes recommended to allay concerns of high fever and febrile convulsion. We assessed the effect of prophylactic administration of paracetamol at vaccination on infant febrile reaction rates and vaccine responses. In two consecutive (primary and booster) randomised, controlled, open-label vaccination studies, 459 healthy infants were enrolled from ten centres in the Czech Republic. Infants were randomly assigned with a computer-generated randomisation list to receive three prophylactic paracetamol doses every 6-8 h in the first 24 h (n=226) or no prophylactic paracetamol (n=233) after each vaccination with a ten-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with the hexavalent diphtheria-tetanus-3-component acellular pertussis-hepatitis B-inactivated poliovirus types 1, 2, and 3-H influenzae type b (DTPa-HBVIPV/ Hib) and oral human rotavirus vaccines. The primary objective in both studies was the reduction in febrile reactions of 38.0°C or greater in the total vaccinated cohort. The second objective was assessment of immunogenicity in the according-to-protocol cohort. These studies are registered with ClinicalTrials.gov, numbers NCT00370318 and NCT00496015. Fever greater than 39.5°C was uncommon in both groups (after primary: one of 226 participants [<1%] in prophylactic paracetamol group vs three of 233 [1%] in no prophylactic paracetamol group; after booster: three of 178 [2%] vs two of 172 [1%]). The percentage of children with temperature of 38°C or greater after at least one dose was significantly lower in the prophylactic paracetamol group (94/226 [42%] after primary vaccination and 64/178 [36%] after booster vaccination) than in the no prophylactic paracetamol group (154/233 [66%] after primary vaccination and 100/172 [58%] after booster vaccination). Antibody geometric mean concentrations (GMCs) were significantly lower in the prophylactic paracetamol group than in the no prophylactic paracetamol group after primary vaccination for all ten pneumococcal vaccine serotypes, protein D, antipolyribosyl-ribitol phosphate, antidiphtheria, antitetanus, and antipertactin. After boosting, lower antibody GMCs persisted in the prophylactic paracetamol group for antitetanus, protein D, and all pneumococcal serotypes apart from 19F. Although febrile reactions significantly decreased, prophylactic administration of antipyretic drugs at the time of vaccination should not be routinely recommended since antibody responses to several vaccine antigens were reduced.

    Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials
    Lancet, Volume 374, Issue 9698, Pages 1301-1392, Pages 1339-1350

  30. Citizen Deux November 6, 2009

    A great site with a point by point counter to the viral video from Sr. Teresa Forcades, MD PhD. Talk about using your credentials for the wrong purposes!

    English Translation