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.
As soon as you mentioned "Group Health"... (Score:5, Informative)
... 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.
FluMist (Score:5, Informative)
The live attenuated flu vaccine, FluMist is substantially more effective than the inactivated injected vaccine (something that's blindingly obvious to those of us who've studied basic immunology). It provides a potent T-cell response, and a large pool of memory cells. Furthermore, it has been shown to be effective against viruses that have undergone some genetic drift.
For anyone who is old enough, has no respiratory problems, and who isn't immunosuppressed, the live nasal spray vaccine is a much more sensible choice.
For additional data refer here: http://www.cdc.gov/flu/professionals/acip/efficacycomparison.htm [cdc.gov]
There are randomized controlled trials (Score:4, Informative)
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.
There are many obstacles to overcome (Score:4, Informative)
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.
The one crucial point (Score:0, Informative)
That fact tends to get lost in the fear-mongering. It's probably the main reason why we're making such a big deal out of the swine flu when the regular flu still kills thousands more people per year than the swine flu. The explanation for that is pretty simple: popular panic about a virus sells vaccines for that virus. The more I see the media and others telling us how afraid we should be of the swine flu, the more convinced I am that they are using this angle because there is no rational reason for most people to buy this vaccine. This is like the security theater that Schneier warns us about, except this time it isn't about airports, it's about medicine.
Re:article is BS (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.
Re:The one crucial point (Score:5, Informative)
The WHO and CDC are driving the H1N1 vaccines, not the vaccine companies. No matter how good the lobbyists for the vaccine companies are, they aren't good enough to get the government to step in and bear the liability without some government agency agreeing that there is actually something there to address.
(The issue with H1N1 is not its lethality once it has infected a person, but how good a job it does of infecting those who are exposed)
Re:There are randomized controlled trials (Score:2, Informative)
Re:There are randomized controlled trials (Score:5, Informative)
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.
Re:FluMist (Score:3, Informative)
You say, "Furthermore, it has been shown to be effective against viruses that have undergone some genetic drift." But there's nothing about that in the CDC site.
Comment removed (Score:3, Informative)
Re:All I have is an anecdote (Score:4, Informative)
Logic doesn't help you if you don't understand the biology of influenza. It's not like there are several strains of influenza just waiting around, hiding in trash cans for the poor sap that gets immunized against it. During a given season, Influenza comes in waves of a particular strain, and in some cases, a couple of strains. It is a bit of a dance to figure out which strains are going to hit a given area six months in a year to advance. You can google for the particulars but epidemiologists have had a reasonable measure of success getting it right.
Even with that knowledge, we've known that influenza vaccines aren't all that good. What you have is a treatment with few downsides (and there are complications from the vaccines, they just aren't all that common) and a few upsides basically a modest benefit. This sort of treatment, while depressingly common from an epidemiology standpoint, makes "soundbite medicine" rather difficult and makes it hard to argue for any given protocol.
Something that seems to be missing from this whole affair is the built in experiment that this creates. If you can deliver the vaccine to a very broad spectrum of a population and let the individual decide if they want the vaccine, then you'll have large numbers of both cases - vaccinated and unvaccinated. IF you had a mechanism to track this (and that's where we fail here), then in six months and one year, you query those people, see if they're still alive. After all, we don't care if you died from influenza or the marthambles - if the vaccine keeps you out of the grave, then it's a win. That would answer the bottom line question of whether or not the vaccine actually helped you. You need big numbers to prevent a number of pre selection biases, but it's sort of doable.
Re:As soon as you mentioned "Group Health"... (Score:3, Informative)
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. Nixon I think. A government cost cutting technique. Like living wills and the current health reform plans. Now the typical HMO use the general prac docs as a gateway barrier to seeing a specialist. Group Health does not use that technique.
But they are what is called an evidence based medicine approach. You will not get experimental procedures there. For instance, stomach stapling has been around for quite a while. Only in the past few years has it become an approved procedure at group health. Evidence based medicine virtues and defects could generate quite a little debate. For instance, Obahma likes it and presumedly the way he would implement it would discredit the concept for a generation. But I kind of think Group Health is honest about analyzing the evidence. But I do not really know. But I do know I do not want my doc trying out the latest fad on me or deciding on my drugs based on drug company marketing campaigns. Drug company marketing techniques to docs could be a subject in itself.
Re:All I have is an anecdote (Score:3, Informative)
You're oversimplifying. Generally speaking, the flu strains that are going around in any given year are related. Yes, there are different strains, but they usually have very similar surface proteins. So it's true that the vaccine you get in any given year is not guaranteed to exactly match the strains you are exposed to. Nobody even pretends that it will. Mass vaccination is all about statistics - reducing the number of people who get infected so that the spread of the disease is limited, and people who are vulnerable aren't exposed in the first place.
So yeah, the flu vaccine you get may not necessarily protect you. Indeed, in any given year there's a significant chance (something like 30%) that they'll guess wrong and put the wrong strain in the vaccine, and it won't protect anybody. But 70% of the time it does protect, and that's worth the 30% of the time when it doesn't.
Re:FluMist (Score:5, Informative)
The live attenuated flu vaccine, FluMist is substantially more effective than the inactivated injected vaccine (something that's blindingly obvious to those of us who've studied basic immunology). It provides a potent T-cell response, and a large pool of memory cells. Furthermore, it has been shown to be effective against viruses that have undergone some genetic drift.
I happen to have worked in the influenza vaccine business before. For children and younger recipients, what you've said has been clinically demonstrated to be true -- live attenuated influenza vaccine (LAIV, you may also see it referred to as CAIV in some literature) gives a more intense response, and better protection against mismatched strains.
However, things get a little iffy when it gets to the adult population, where there doesn't seem to be any superiority for LAIV in that group (your link shows that).
While it's not exactly known why, last I heard the theory was that, in contrast to the naive response in children, adults already have pre-existing responses to various wild influenza strains, that (although not matched to the target strains) cross-react with the LAIV and neutralize it too quickly, before it has a chance to replicate a little and provoke a stronger response (that matches the targeted strains).
I haven't seen this last part in print anywhere (although I also haven't been looking), it was just an idea that was being passed around by some researchers who were working at MedImmune (company that makes FluMist).
Re:FluMist (Score:3, Informative)
You say, "Furthermore, it has been shown to be effective against viruses that have undergone some genetic drift." But there's nothing about that in the CDC site.
It's in there, in this part: "...An open-label, nonrandomized, community-based influenza vaccine trial conducted during an influenza season when circulating H3N2 strains were poorly matched with strains contained in the vaccine also indicated that LAIV, but not TIV, was effective against antigenically drifted H3N2 strains during that influenza season..."
LAIV = Live Attenuated Influenza Vaccine
TIV = Tri-valent Influenza Vaccine
this article has many problems and is bad science (Score:5, Informative)
Placebo study has already been done, in a way (Score:3, Informative)
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.
Re:Or....built up? (Score:1, Informative)
What? They don't even work that way. The shot is different every year and could even vary by location. The shot would have to be the same from year to year for any kind of build up if it's even possible.
One of the other reasons that it may be a total waste to get the seasonal flu shot is that they are only guessing at what "the flu" will be like each year.
Here is a CDC update on this flu season's (09-10) shot.
http://www.cdc.gov/flu/flu_vaccine_updates.htm It covers only three of dozens of strains/variations. The swine flu is a mix of two different strains making a whole new one problem but, version of the flu may be around for years and years before it even effects enough patients to become noticed.
Here is a article on how the flu strains are named or defined.
http://flu.emedtv.com/flu/types-of-flu.html
Re:The one crucial point (Score:5, Informative)
Pandemic: An epidemic (a sudden outbreak) that becomes very widespread and affects a whole region, a continent, or the world.
Influenza A Virus Subtype H1N1(commonly called the swine flu) erupted suddenly, became widespread, eventually being found on all continents(save Antarctica).
Therefore, yes, H1N1 is, by definition, a pandemic.
Re:life expectancy (Score:3, Informative)
Basically, what I am saying is that you cannot trust the Bible(a religious, not scientific, book) to tell you the average age of people.
Re:this article has many problems and is bad scien (Score:2, Informative)
gr8_phk: Considering your personal experience with the individuals you happen to have known is not a scientifically valid way of determining the severity of the threat that seasonal flu or H1N1 pose to different demographic groups. Only scientific studies of large groups and retrospective studies of particular groups (e.g. reviewing the demographics of those who die of flu/H1N1 vs. demographics of the population as a whole) can accurately determine risk levels. See http://www.flu.gov/individualfamily/parents/pregnant5tips.html [flu.gov], which notes "Pregnant women, even ones who are healthy, can have medical complications from the seasonal and H1N1 (Swine) flu."
You are correct that infants do get a partial immune boost from antibodies they receive from the mother. However, you are not correct in concluding that infants therefore have "very good immunity" to seasonal flu, H1N1, or pathogens in general. In fact, infants younger than 6 are both more generally vulnerable to disease (because they have not yet been exposed to germs and developed the diverse immunity of an adult) and also particularly vulnerable to seasonal flu and H1N1. That is why cdc.gov notes that "people who live with or care for children younger than 6 months of age" are one of the priority groups for H1N1 vaccination: not to protect them, but to reduce the risk of transmission to their infants under 6 months who are especially vulnerable. See http://www.cdc.gov/media/pressrel/2009/r090729b.htm [cdc.gov]
It's true that you could volunteer to participate in a study, and I'm glad you're willing to help advance science in that way. However, consent from the subjects is not (alone) sufficient to guarantee that conducting a study is ethical. Scientific ethics guidelines require that the study be deemed inherently ethical by a Human Subjects Research review board. Regardless of what level of risk the subjects are willing to accept, it's only ethical to conduct a study that exposes them to a level of risk that is commensurate with the scientific benefit to be achieved, and not in excess of some absolute limits as well. For example, even if there were human subjects willing with full informed consent to allow their syphilis to go untreated, it would not be ethical to conduct a study that studied the long-term effects of untreated syphilis by deliberately denying available treatment to participants with syphilis (a la the infamous Tuskegee study, which of course compounded the injustice further by using prison inmates as subjects, not getting their informed consent to boot, and selectively using subjects from a particular ethnic group rather than others, among other issues).
Re:The one crucial point (Score:3, Informative)
H1N1 is a particular strain of influenza A that has made its way around the world and vaccination against this strain is being done separate from the seasonal flu shot. Concern over this strain is related to its virulence and early reports of death amongst young, immunocompetent individuals - people normally not adversely affected by influenza.
The common cold and the flu are not the same thing - there is a believed to be a high mortality from influenza ( http://aje.oxfordjournals.org/cgi/content/full/163/2/181 [oxfordjournals.org] ) as compared to the cold (corona virus (with exception of SARSCoV, rhinovirus - deaths generally related to asthmatic patients). 40,000+ deaths per year is a significant mortality rate. Morbidity from influenza would be much more. It makes it difficult to believe that it should be overlooked.
Re:The one crucial point (Score:2, Informative)
It doesn't have to be serious. Hell, it doesn't even have to be deadly. H1N1 is nether infectiously stable nor seasonal, thus it qualifies as a pandemic.
The word only raises fears among the ignorant who think they know what it means.
Re:All I have is an anecdote (Score:4, Informative)
There was something that went around in 1979 of that sort -- you could watch it hopping from person to person as exposure occurred. Two or three days incubation, sick as hell for 24 hours (everything emptied out both ends), then it went away as suddenly as it came, with no aftersymptoms.
However, most short-term stomach/intestinal upsets are not flu. Per some hospital studies, about 90% of presented cases are actually food poisoning.
Re:The one crucial point (Score:3, Informative)
The problem is that H5N1 is rattling around out there, and it can cross-breed with H1N1 strains. So far H5N1 doesn't spread well in humans, but it *is* quite deadly. If someone gets two strains of flu at the same time, they're likely to hybridize. So it's important to keep flu infections to a minimum. Given time, H5N1 will become less deadly as it evolves to live with people, but it needs to have it's numbers kept down until it does. And that means don't give it the genes that H1N1 uses for spreading.