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On the Efficacy of Flu Vaccine
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.
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.
... 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.
#DeleteChrome
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
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.")
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.")
The article is at best poorly researched and at worst intentional FUD.
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 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.
When all else fails, try.
Anytime there's a controversy over vaccines or prescription drugs, there is only one thing that needs to be widely understood by everyone: pharmaceutical companies cannot make money from healthy people.
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.
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.
Sigs are too short to say anything truly profound so read the above post instead.
LOL.
When you regurgitate silly right-wing talking points SCREAM AND YELL and STAMP YOUR FEET LIKE THIS, set up straw men and knock them down, it makes you look like the paragon of sensible, common sense, level headed conservatism.
Really!
By the way, all health authorities, public and private, have to ration. I've got no idea where people got the idea that one should pay for an average health plan (whether private or single payer), and then expect to have millions spent on cutting edge, experimental, and extremely expensive medicine when they get sick.
Believing that paying for a bargain-basement health plan in the US and believing that you'll get Herceptin when you get breast cancer, is extremely naive.
Oh, and by the way: even in the SOCIALIST COMMUNIST NAZI government run health systems, if you don't like the basic plan, you're free to go private. Of course, they'll ration too. I've never heard of a country with a single-payer or government run health system not let people go private and pay for gold-plated health cover.
Of course, if were weren't listening to fat, drug-addled idiots on AM radio or FOX News, and actually spent time in the real world, you'd already know this, wouldn't you?
You get nothing for nothing in this world, dumbarse.
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.
Faster! Faster! Faster would be better!
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.
Read the Atlantic article. The researchers' data set was specific to seasonal flu in people 65 and older!!! Yet did the article highlight this or confine the discussion to efficacy against seasonal flu among people 65 and older? No--it mentioned it once and then made general statements about the potential efficacy of vaccination for ALL PEOPLE for both seasonal flu and H1N1! Even if vaccination against seasonal flu doesn't reduce the death rate of people over 65 at all, H1N1 flu is demonstrably lethal to children, healthy young adults, and people under 65 with common preexisting health conditions like asthma or HIV. By getting vaccinated against H1N1, you not only reduce YOUR risk of death, but also the risk that you'll contract and pass on H1N1 to someone else who will then die of it. Get vaccinated!!! Also, look at how the article selectively hypes the credentials of the vaccine skeptics. They say Jefferson "knows the flu-vaccine literature better than anyone else on the planet." Really? There are 7 billion people on the planet; that's a bold statement. They say the Cochrane Collaboration is "a highly respected international network." That may be true, yet they fail to apply corresponding adjectives to Dr. Anthony Fauci, who was highly respected and the director of the NIAID the last time I checked. Selective, arbitrary hyping of the credentials of skeptical researchers on one side of the debate only is a classic pop science writing technique to sell magazines and create controversy. Where have I seen this before? Cecilia Farber's horrendous Harper's magazine article promoting HIV denialism (and nearly all other HIV denialist writing, incidentally). Selective credential hyping makes me doubt the authors' impartiality and trustworthiness on the whole topic. The article also states that young, healthy people "aren’t the people who die from seasonal flu." That's a wild overgeneralization. Young, healthy people have a lower risk of dying from seasonal flu but no guarantee it won't kill them. Many will read that statement and forget that (a) it excludes pregnant women, who are young and otherwise healthy but not defined as "young, healthy people" because they are immune suppressed during their pregnancy and highly vulnerable to death from the flu, and (b) the statement is about seasonal flu, not H1N1 which is already killing healthy young people today! The researchers are reasonable in calling for more studies on this question and pointing out the problem in rolling out treatments not tested in controlled trials, but Fauci is right in pointing out that giving people a placebo in a traditional prospective, double-blinded trial could be unethical. There is a potential perfect solution to this problem alluded to already by ColdWetDog. Since we have a shortage of the H1N1 vaccine at this time anyway, set up a study that looks at the death rate of people depending on what date they are vaccinated, before and after vaccination. The people waiting for vaccination (due to the shortage) become the controls for themselves (after vaccination) as well as for the people who get vaccinated earlier. Since we're UNABLE to vaccinate everyone right away due to insufficient availability of the vaccine, there's no ethical problem. This is called a "waiting list control." This would require a large study size and more statistical care than a traditional treatment/placebo protocol, but would be an ethical way to get the data we want for H1N1. I'd fully support doing such a study. Popular magazines should either stop covering science or should get scientists to review their articles written by lay journalists for scientific and statistical accuracy before they publish. The editors at magazines like The Atlantic and Harper's clearly do not have the scientific or statistical literacy to do the job themselves. I'm sick and tired of seeing popular magazines make selective and incorrect use of data and invalid logic to draw incorrect conclusions that mislead the public and cause people to doubt that HIV is the cause of AIDS, fear and doubt vaccines when they should welcome them, etc. Creating FUD and misconceptions is harmful to public health, leads to the deaths of innocent people who can't decipher misinformation, and drives up health care costs for us all.
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.
This sentence no verb.
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
You forget that people apparently lived to be over 900 years old back in those days. I'm sure that their calendars were perfect, right? Why would they write 70 when they should have written 900 or 400(I know, I know, post Flood vs. pre Flood and all that).
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.
I don't like Linux. This doesn't make me a troll.
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, 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
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).
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.
~REZ~ #43301. Who'd fake being me anyway?