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Medicine

On the Efficacy of Flu Vaccine 430

The Atlantic is running a major article questioning the received wisdom about flu vaccines and antivirals, for both seasonal flu and H1-N1. "When Lisa Jackson, a physician and senior investigator with the Group Health Research Center, in Seattle, began wondering aloud to colleagues if maybe something was amiss with the estimate of 50 percent mortality reduction for people who get flu vaccine, the response she got sounded more like doctrine than science. 'People told me, "No good can come of [asking] this,"' she says... Nonetheless, in 2004, Jackson and three colleagues set out to determine whether the mortality difference between the vaccinated and the unvaccinated might be caused by a phenomenon known as the 'healthy user effect.' Jackson's findings showed that outside of flu season, the baseline risk of death among people who did not get vaccinated was approximately 60 percent higher than among those who did, lending support to the hypothesis that on average, healthy people chose to get the vaccine, while the 'frail elderly' didn't or couldn't. In fact, the healthy-user effect explained the entire benefit that other researchers were attributing to flu vaccine, suggesting that the vaccine itself might not reduce mortality at all." Read below for more excerpts from the article.

The annals of medicine are littered with treatments and tests that became medical doctrine on the slimmest of evidence, and were then declared sacrosanct and beyond scientific investigation. ...

This is the curious state of debate about the government's two main weapons in the fight against pandemic flu. At first, government officials declare that both vaccines and drugs are effective. When faced with contrary evidence, the adherents acknowledge that the science is not as crisp as they might wish. Then, in response to calls for placebo-controlled trials, which would provide clear results one way or the other, the proponents say such studies would deprive patients of vaccines and drugs that have already been deemed effective. ...

In the absence of better evidence, vaccines and antivirals must be viewed as only partial and uncertain defenses against the flu. And they may be mere talismans. By being afraid to do the proper studies now, we may be condemning ourselves to using treatments based on illusion and faith rather than sound science.
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On the Efficacy of Flu Vaccine

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  • by rcolbert ( 1631881 ) on Saturday October 17, 2009 @04:46PM (#29779757)
    It really seems the data can be massaged to draw any conclusion that is desired. In my case, up until three years ago I had never had a flu shot. During a typical winter I would be sick at least twice on average, usually missing about four or five days of work in total. Since I've started having seasonal flu shots I have not had any winter illness and missed no time from work. While hardly scientific, it seems to me that the downside/upside in my personal case weighs heavily towards receiving the vaccine. There are clearly other viruses in human history where vaccination has had a profound and measurable effect which is beyond debate.
    • by MichaelSmith ( 789609 ) on Saturday October 17, 2009 @04:49PM (#29779773) Homepage Journal

      If its four or five days from two illnesses then its not Flu. Thats a cold.

    • If you missed 2-3 days work then it wasn't the flu anyway. So it must have been coincidental.

      Personally, I've never ever had a flu vaccine. But I don't think I've ever had the flu either, certainly not in the last 15 years. Sure, flue-like-symptoms but only for a few days at a time.

      Well one time went for longer, but that turned out to be sinusitis, and my god did those headaches hurt.

    • Re: (Score:3, Insightful)

      What else changed when you started getting the flu shot? If you now have a mind to protect your health by getting the shot, then you're probably also doing more things like washing your hands, eating better, etc

    • I have an anecdote for you, the four years I received a flu shot I didn't get the flu until the next March or April. And it happened all four times! So I consider them useless for me, just postpones influenza until the weather is much nicer. I'd rather have my flu when the snow is piled high and its below freezing thanks

    • Not that the medical establishment even gets trained to do this. The last thing a sick person wants to hear is "we haven't got a clue what's happening".

      Anecdotes are all we have in everything except the exact sciences. All other sciences is based on anecdotes and stories, or their similar, but more systematic brother : data. Only things confirmed by controlled and direct experiments is real, trustworthy data, only such things lend themselves to real predictions. And most sciences, like medical science, clim

      • Re: (Score:3, Insightful)

        by John Allsup ( 987 )

        I mainly agree with you. Just a few quick points.

        1. Funding issues will, for evolutionary reasons (i.e. whether a scientific career 'lives' or 'dies') have a profound effect on prevailing attitudes in the mainstream of various areas of the sciences (i.e. if your research group generally turns out pro-drug papers in journals, you are more likely to get pharmaceutical sponsorship than if you don't.)

        2. The 'no scientific evidence' argument appears many times in an attempt to discredit an unpopular idea. The

    • I have +1 anecdote. My employer has started providing flu shots to staff some years ago. There has been a dramatic reduction in time off due to illness in winter on the order of about half the number of sick days used accross the board. Interesting when there's a good third of staff that don't get the jab. Since I've had flu jabs myself I haven't had a serious flu in years other than mild symptoms that clear in a day or two.
    • by SuperKendall ( 25149 ) on Saturday October 17, 2009 @11:23PM (#29781721)

      During a typical winter I would be sick at least twice on average, usually missing about four or five days of work in total. Since I've started having seasonal flu shots I have not had any winter illness and missed no time from work.

      Since we're going into anecdotes I can say I used to get a bit more sick than that, about three times a winter with usually one incredibly bad illness lasting about a week.

      I stopped drinking soda, and drink water instead, and now I might get one mild cold a winter but sometimes not. I get about the same level of exercise and eat about the same (i.e. whatever the hell I want) with perhaps a touch more vegetables.

      That's also all without ever having a flu vaccine shot. You have to wonder if just a few simple lifestyle changes across the U.S. would not totally eclipse any benefit from flu shots. And since I am not getting sick as often, I'm also not getting other people sick as often - the exact same benefit some claim for the vaccine approach. Only my overall health in all other matters is better too, unlike a flu vaccine which prevents only one thing, and temporarily at that (I have nothing against things like polio vaccines which make a ton of sense because they last forever).

  • by Anonymous Coward on Saturday October 17, 2009 @04:54PM (#29779793)

    The flu shot is not about preventing you from dying. It's to avoid you from getting sick and infecting other people who may have weaker immune systems and have higher risk of dying if they get sick.

    • question for you: (Score:3, Interesting)

      by maillemaker ( 924053 )

      >The flu shot is not about preventing you from dying. It's to avoid you from
      >getting sick and infecting other people who may have weaker immune
      >systems and have higher risk of dying if they get sick.

      It's been a long time since biology classes in high school.

      Even if I'm immunized, can't I be a carrier?

  • Ok, maybe just statistics, that sometimes are worse if not interpreted correctly. That 'healthy people', the one that takes seriously enough prevention to, between other measures, get the vaccine, are less exposed to disease risks in general, and even when they get the flu (seasonal or not) they usually take measures to make it less deadly. The point is, between equaly exposed people vaccine lower the risks? In a widely spread pandemy we all could get a chance of exposion, and there is where vaccines will
    • In a widely spread pandemy we all could get a chance of exposion, and there is where vaccines will make a difference.

      Even with modern antiviral and antibacterial drugs, vaccines, and prevention knowledge, the return of a pandemic virus equivalent in pathogenicity to the virus of 1918 would likely kill >100 million people worldwide. A pandemic virus with the (alleged) pathogenic potential of some recent H5N1 outbreaks could cause substantially more deaths.


      [T]he 1918 virus is the likely ancestor of all 4 o

  • Editorializing (Score:4, Insightful)

    by Gudeldar ( 705128 ) on Saturday October 17, 2009 @04:57PM (#29779831)
    While this does raise some questions about the efficacy of the vaccine. It doesn't prove conlusively it does nothing. Not that you would know that from the editorializing the author does.
    • Re:Editorializing (Score:4, Insightful)

      by Threni ( 635302 ) on Saturday October 17, 2009 @05:22PM (#29779979)

      All you have to do is look up Vaccine on Wikipedia to see some people don't like vaccines for whatever reason ("it's god's will that we die" or whatever). Not worth giving those freaks any more attention, really, unless these claims are different in some way.

      • by SuperKendall ( 25149 ) on Saturday October 17, 2009 @10:57PM (#29781611)

        All you have to do is look up Vaccine on Wikipedia to see some people don't like vaccines for whatever reason

        It's stupid to inject yourself with something that does nothing. Especially when the thing that may not do anything for you, also has a non-zero chance of side effects that are much less pleasant than the original thing you were trying to prevent. That's a pretty good reason.

        This article points out that we don't really know if the flu vaccine (any flu vaccine) does anything.

        Since there is no good evidence either way, "better to be safe than sorry" can apply either way too. Which makes your heavy-handed dismissal of those questioning the flu vaccine every bit as faith based as the "freaks" you look down on with such contempt.

        Meet the enemy, for he is you.

    • Re:Editorializing (Score:5, Insightful)

      by mellon ( 7048 ) on Saturday October 17, 2009 @06:22PM (#29780409) Homepage

      The problem with this article is that Ms. Jackson isn't even asking the right *question*. Of *course* healthy people don't get a significant personal benefit from being vaccinated. Nobody ever said they did. If all you care about is yourself, and you are healthy as an ox, then by all means don't get vaccinated. Not getting vaccinated is a great way to get your inheritance early. Just get H1N1, then visit your elderly uncle to cheer him up. You'll transmit the virus to him, he'll die, and you'll be rich. But if you want your elderly uncle to live, or, worse luck, he's already written you out of the will, then you might as well get vaccinated.

      IOW, the point of the vaccine is to prevent the pandemic, not to protect you. So the *right* question to ask is, does the H1N1 vaccine confer any immunity to the recipient? This is a question that can readily be answered by an epidemiology study, and that can also be ethically studied in a double-blind study - just vaccinate half of a healthy population, don't vaccinate the other half, and see how many get H1N1 and how many don't. The problem is that if the vaccine works, you don't know until it's too late. So it's good for checking your work, but no good for making the decision as to whether to do mass vaccinations - mass vaccinations are pointless after the pandemic has run its course.

      I suspect that epidemiology studies are just as good for evaluating the efficacy of the vaccine *after* the pandemic has passed anyway, so that's probably why they don't do double blind studies. But I'm not a virologist, so that's just a WAG.

      What I really wish people would do would be to stop coming up with conspiracy theories about vaccines - these are really harmful. Information is what we need, not panicked hyperbole.

  • by 93 Escort Wagon ( 326346 ) on Saturday October 17, 2009 @04:58PM (#29779835)

    ... I became biased against any conclusion. Up here in the Pacific Northwest, the common nickname of this HMO is "Group Death". They're not exactly known for high quality care or cutting edge research - they're mainly known for denying treatments as "experimental" for years after those treatments have become the norm in most medical circles.

    I remember an acquaintance (husband of a co-worker) who kept getting denied treatment for (IIRC) a persistent and very painful hydrocele. The Group Health doc told him nothing could be done - surgical correction of this was "experimental and dangerous". Finally out of desperation they consulted with an outside doc, who told them this was a very simple routine procedure! They paid out-of-pocket for the surgery, and the problem was quickly rectified.

    I know nothing about the particular doctor who did this flu vaccine study - but, given her employer, I have very little confidence that she is particularly knowledgeable. I'm sure Group Health would love to save the 15 or 20 bucks per patient they're currently having to spend on this vaccine.

    • by pdabbadabba ( 720526 ) on Saturday October 17, 2009 @05:29PM (#29780045) Homepage

      But bear in mind that if she's wrong the company's costs, on balance, will be much higher when their insured start showing up in the hospital not having gotten the vaccine. The vaccine, if it works, should be a cost saving measure for them.

      It seems to me that they'd want to get this right.

      (This is all subject, of course, to speculation on my part regarding the cost of the vaccine, versus the cost and likelihood of hospitalization in its absence. Though I'd point out that, if the vaccine isn't cost effective for the insurer, they could elect not to cover it regardless of its effectiveness.)

    • Re: (Score:3, Informative)

      by astar ( 203020 )

      I was a group health member for many years. I would speak well of it,. But mainly I wanted to speak to the perjogative "group death". It happens group health started up about 1948. The local AMA hated it. They did things like kick the group health docs out of the chapter. And so on. This phrase "group death" was their invention. So consider the source.

      Oh group health is a coop, One thing you might approve of is that they do not pay inflated salaries to their executives.

      HMOs are a recent invention.

  • Or.... (Score:5, Insightful)

    by plague911 ( 1292006 ) on Saturday October 17, 2009 @05:01PM (#29779861)
    There are so many conclusions which can drawn from those statistics its silly. Here is another example. Healthy people dont die as often period. If you are sickly you are more likely to still get a disease even if you were given the immunization short. Followed by the fact that sickly people die more often when they do get sick.

    Also a second situation which would lead to the similar results. That people who got the shot...*gasp* likely got the shot the previous year and *shock* have some built up immunity due to the previous years shot.

    This physician... not a biologist. Sounds like shes not very good at what shes supposed to be doing. The information she presented proves nothing. She randmly concludes just 1 or many possible scenarios based on her predisposition. Poor poor science.

  • by Anonymous Coward on Saturday October 17, 2009 @05:02PM (#29779873)

    Randomized, controlled trials have shown the effectiveness of flu vaccines, contrary to the claims of the article. (Example: Wilde et al., "Effectiveness of Influenza Vaccine in Health Care Professionals." [ama-assn.org])

    In addition, research into mortality reduction already takes into account comorbid conditions and age. (Example: Nordin et al., "Influenza Vaccine Effectiveness in Preventing Hospitalizations and Deaths in Persons 65 Years or Older in Minnesota, New York, and Oregon: Data from 3 Health Plans." [uchicago.edu])

    The article is at best poorly researched and at worst intentional FUD.

    • Mod parent up! This is better data than a magazine article

    • by dmoore ( 2449 ) on Saturday October 17, 2009 @05:40PM (#29780119)
      The article acknowledges this:

      Only four studies were properly designed to pin down the effectiveness of flu vaccine, he says, and two of those showed that it might be effective in certain groups of patients

      The article seems to be primarily advocating double-blind, controlled clinical trials among the elderly, since that is the group where death is the primary concern rather than just getting sick.

  • by irtza ( 893217 ) on Saturday October 17, 2009 @05:02PM (#29779875) Homepage

    Due to a long history of unethical behavior in the medical field, there are stringent requirements that require one to show a need for research and to demonstrate safety concerns before one can begin an investigation.

    This often means that simple experiments that could show benefit and harm of an intervention will not be done because of a large body of circumstantial evidence.

    There has to be a fairly even view of outcomes on both sides of a trial before it will be approved - or other studies showing possible efficacy of the side that is under question will need to be done first.

    When these situations arise, one can often perform the experiment in a subset of the population in which vaccine efficacy is questioned and benefits are unknown.

    The population of HIV infected individuals is one such population and there are double-blind placebo controlled trials done in this group.
    The annals of internal medicine (an American College of Phyicians publication) http://www.annals.org/cgi/content/full/131/6/430 [annals.org] published an investigation showing the efficacy of the influenza vaccine in a population that was least likely to benefit from it. While mortality data is not available here, its results stand on their own as a testament to the clinical efficacy of the vaccine.

  • article is BS (Score:5, Insightful)

    by wizardforce ( 1005805 ) on Saturday October 17, 2009 @05:05PM (#29779895) Journal

    Influenza causes only a small minority of all deaths in the U.S., even among senior citizens,

    36,000 die of complications from the flu annually in the US. That's very nearly as many as die from car accidents.

    There is a very simple way to test the effectiveness of a vaccine and that is to carry out a double blind study utilising placebos alongside the active vaccine. Any effect that is solely due to the "healthy user effect" would be virtually eliminated.
    further problems: the article has no references, no real hard data from relevant studies and several studies contradict the article's assertions.

    • And that study is exactly what they proposed doing, but it was declared to be unethical and hence can't be done.

      • Re: (Score:3, Informative)

        nonsense. These kind of studies are done all the time, there is absolutely nothing unethical about them! Now it would be a different story if you were to force people into studies but that is a separate issue entirely.

      • Not sure if this is the case here, but something to keep in mind is that there are limited resources for conducting medical studies and sometimes they are simply rejected on the grounds of being superfluous or not well thought out or unnecessary for whatever other reason, in which case the proponents sometimes like to claim some sort of conspiracy to hide the truth etc. Few posts above somebody posted links to perfectly good studies that show efficacy of the vaccines in question.
  • Comment removed (Score:5, Insightful)

    by account_deleted ( 4530225 ) on Saturday October 17, 2009 @05:06PM (#29779897)
    Comment removed based on user account deletion
    • some kind of stunt by Group Health or other elements of the private health industry to wriggle out of paying for flu shots.

      Presumably if vaccines were either effective or ineffective the insurance companies would want to know which is which, right? Or is there some sort of calculus that says that vaccines could be effective for a given individual, but not cost effective for a larger group? I, a lay, would assume that "effective" and "cost effective" are the same, but I may be missing something.

    • It's not it being profit-focused that's the problem. I too mixed this up at first.
      But then I heard about how it's handled in China: There doctors only get money for healty clients in the group they are assinged to.
      Let's say they are assigned to 5000 people. And for every sick one, they get X Yuán less, so that if badness of the percentage of sick people is parallel to the badness of the money they will get. Then they will be very motivated to keep people healthy, and to earn money, because it will be t

    • Re: (Score:3, Interesting)

      by astar ( 203020 )

      Group Healthy is a coop. I find it hard to consider them profit-focused.

    • Re: (Score:3, Insightful)

      by Vexorian ( 959249 )

      When Lisa Jackson, a physician and senior investigator with the Group Health Research Center, in Seattle, began wondering aloud to colleagues If maybe something was amiss with the estimate of 50 percent mortality reduction for people who get flu vaccine, the response she got sounded more like doctrine than science.

      Basically, it was done with me taking it seriously after reading this. Excuse the generalization. But this is so much following the manufactroversy pattern so much... Let it be a guy claiming tha

  • The flu shot is tested annually through peer-reviewed clinical trials. The shot is compared to its protective factor year over year. I believe the data shows it works.

  • Part of the research I've read recently claims we have no solid definition of the mortality rate of the "flu". The problem is unless you take a culture and analyze it in a lab, you can't tell if the disease is really influenza or one of a hundred or so others that cause similar symptoms. But people who report to their doctor about symptoms aren't always lab tested to see exactly what they have. It'll get noted as "the flu", when it may not be influenza at all, skewing all the statistics.

    The article I was [theatlantic.com]

  • by PieSquared ( 867490 ) <isosceles2006&gmail,com> on Saturday October 17, 2009 @05:23PM (#29779995)
    I'm all for testing the conventional wisdom, and when combined with my tendency to avoid medicine where it isn't necessary it appears that I should support this kind of article. But when it comes to vaccines there's a problem - antivaxxers. Regardless of the chance that one particular vaccine might not really be worth taking, it's frankly irresponsible to put out this kind of article without firm proof. Show me where the clinical trials for the vaccines went wrong and how everyone else who looked at the efficacy of the flu vaccine missed it. Otherwise... and I really hate to say this... shut up. There are people out there who will use this as ammunition in their irrational campaign against vaccines in general, and those people will get other people killed. Not just people who choose not to get themselves vaccinated for the flu, but their children, and the children of other people who for are unable to get the vaccine due to an allergy, or for whom the vaccine had no effect. Those people would normally be protected by group immunization that kept them from ever being in contact with the virus in question, but when there's a real movement in our country to avoid vaccines... well we start to slip below the threshold in some places.

    We killed smallpox outright, but every vaccine since then has been prevented from achieving its final goal through the effort of anti-vax forces of one kind or another. That's the reason I have to be against this sort of article - even the chance that it might be correct isn't worth the near-certainty that it will be another blow for vaccination in general. If they had any sort of actual firm proof, it would be different, but this sort of conjecture *is* dangerous - and not to the person doing the conjecturing.
  • Even if the flu vaccine does nothing to reduce mortality directly, it would still be a societal benefit if it, on average, delays infection by a few days as it would spread out the infections over time giving the medical infrastructure a better chance of not being overwhelmed during a pandemic.

    Additionally, retrospective studies (as opposed to randomized trials), really suck at identifying the magnitude of conflating factors (but can be good in indicating that there ARE conflating factors).

  • I read that article before. The fatal weakness of its reasoning is that it only focuses on fatalities. The reality is that even if you got ill with the flu, you almost never died (under 0.1% fatality rate). Even the super-fatal pandemic flu of 1918 was about 5% fatal among those sickened. I doubt if it is feasible to get a statistically significant count of fatalities in a controlled study sample.

    But even if you do not die, flu is pretty costly. It is costly in the time you spend miserable, sick and out of

  • What i learned: doctors shouldn't over prescribe Tamiflu because resistance might develop - even though it doesn't work.

    Flu spreads could be reduced if the government wasn't always scaring "flu-sufferers" into going to the emergency room (and giving the bug to others) even though only almost none of them (93%) actually have the flu.

    I learned other things too. That basically the writer is looser with factual logic than those he accuses of same.

    Mostly anti-vaccine agit-prop, and not not very good either.

    - js

  • by Posting=!Working ( 197779 ) on Saturday October 17, 2009 @08:04PM (#29780943)

    In 1968 and 1997, the vaccine produced was the wrong one, it didn't match the prevalent strains for the following winter. People who got vaccinated were effectively receiving a placebo for the strain that they were most likely to come in contact with. There was not a corresponding spike in the number of deaths. It could be argued that those strains were less deadly than usual, but it would be an amazing coincidence if it just happened to correspond to the two years no one got an effective vaccine.

    If the flu vaccine reduces the number of deaths by 50% as is claimed, there should have been a 33% rise in deaths when no one was immunized. There wasn't.

    More of the people most at risk are getting vaccinated, 15% of people over 65 vaccinated in 1989, 65% today. That should have caused a significant reduction in mortality. But the number of deaths is rising. Again, an amazing correspondence is claimed, that the strains are more deadly every year.

    These are the two reasons that further study is needed, regardless of how strong your faith in vaccination is.

One man's constant is another man's variable. -- A.J. Perlis

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