A friend recently sent out this blogpost from someone named “Alix”on an email list—it’s now making the rounds on facebook—and I thought an in depth discussion of it would make for a possibly interesting (if long!—go get yourself a snack and a cuppa!) blogpost. Here’s the highlights:
1 – Her math is off. If 1 in 100,000 (or 10 in 1 million) flu shots lead to adverse affects, as they did in 1976, we’d expect (at most!—if all Americans get the H1N1 shot) 3000 adverse effects from H1N1 shots in the US, not that “30,000+ Americans will get Guillain-Barre Syndrome or die” as Alix claims. It is also important to note that about 80% of all GB patients make a full recovery with treatment, and that the 1976 death rate from the swine flu shot (25/40 million, or 0.625 per million) is far lower than the current (and rising) death rate from the 2009 outbreak of H1N1 in the United States (even ignoring 2916 deaths from
influenza and pneumonia syndrome listed at the CDC): 1123 deaths / 308 million people = 3.646 deaths per million.
2 – While some studies show Vit D to have a protective effect on colds and flus, not all do. A recent one found no such effect. I am afraid there are no guarantees in medicine:
http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=6103912
3 – Much of her argument rests on another blogpost of hers, which provides data supposedly showing that flu shots do not work for any groups of people: babies, children with asthma, adults, the elderly. If you go and look at the referenced studies, however, you will find her arguments present the data in deeply misleading ways, such as referencing a paper to argue that flu shots are ineffective in children under two, but conveniently ignoring the fact that that EXACT SAME PAPER shows flu vaccines to be highly efficacious, and of moderate effectiveness, in children over 2—something the authors explicitly state. Could this be why her argument did not look at the effectiveness of flu shots in “children”, but only “children with asthma” (and even those studies are were misused in various ways—see below).
Curious for the details? Here goes, starting with point 3:
If you click on one of the links an Alix’s original page where she backs up her argument, you end up on this page:
http://www.mednauseam.com/2009/09/its-seasonal-flu-shot-seasonbut-shot.html
which claims to show that flu shots don't work for various groups of people (babies, children with asthma, adults, the elderly). And, better than many who make this claim, references are given. So let's start at the beginning:
Babies. Absolutely correct--the studies (very limited—ONE study!) show no better result than a placebo. The authors stress that if public policy is going to be that children 6 months thru 24 months be immunized for flu, we need more evidence--ONE study is simply not enough to base public policy on, for or against. Here's their words:
It was surprising to find only one study of inactivated vaccine in children under two years, given current recommendations to vaccinate healthy children from six months old in the USA and Canada. If immunisation in children is to be recommended as a public health policy, large-scale studies assessing important outcomes and directly comparing vaccine types are urgently required.
ref: http://www.cochrane.org/reviews/en/ab004879.html
Next group: children with asthma (x2)
What? Huh? Why is there no group simply labelled “children”? Would it have anything to do with the fact that the VERY SAME study referenced above for babies says that flu vaccines are highly efficacious and of moderate effectiveness for children older than 2? This seems to me to be a clear case of confirmation bias—mining the data for claims that support your already-decided-upon conclusions, rather than presenting the evidence both for and against and letting folks decide for themselves how to weight competing evidence and what this means for their own decision re: vaccinate or not. Here again are the authors of the above-quoted study:
Fifty-one studies with 294,159 observations were included. Sixteen RCTs [me: randomized controlled trials] and 18 cohort studies were included in the analysis of vaccine efficacy and effectiveness. From RCTs, live vaccines showed an efficacy of 82% (95% confidence interval (CI) 71% to 89%) and an effectiveness of 33% (95% CI 28% to 38%) in children older than two compared with placebo or no intervention. Inactivated vaccines had a lower efficacy of 59% (95% CI 41% to 71%) than live vaccines but similar effectiveness: 36% (95% CI 24% to 46%).
And again:
Influenza vaccines are efficacious in children older than two but little evidence is available for children under two. There was a marked difference between vaccine efficacy and effectiveness. [me: For more on the difference between efficacy and effectiveness, see my original blogpost on H1N1/swine flu and this more recent post]
Ok, so let’s get back to the next group listed on Alix’s page: children with asthma (Christy et al). The title of this study tipped me off, and sure enough, looking it up on the web we discover this study says NOTHING WHATSOEVER about whether or not flu shots work in children with asthma: it says that flu shots do not prevent asthma exacerbation (asthma attacks?), and in fact, may cause an increase in asthma attacks. This is important data, to be sure—and as the parent of an asthmatic I am going to look at this more closely—but the fact remains that this study is IRRELEVANT for the question of whether or not flu shots prevent flu in asthmatic children. Next...
Children in asthma (2). This study is taken from a conference, which may mean it has not yet been published or peer-reviewed according to my hubby who did grad work in science. I am curious if it was the preliminary data on this that led the US to adopt the policy of not giving FluMist to asthmatics. This data, if correct (again, I am unsure if it has been peer-reviewed or shown replicable, but I would accept it for now) shows that FluMist is not preventative for asthmatics wrt hospitalizations for flu. But there is simply not enough evidence from this to say whether or not flu vaccines of the injectible type prevent such hospitalizations, and therefore, we can’t make any large sweeping conclusions about whether or not flu vaccines work for asthmatic children. Or children in general. And again, FluMist is NOT offered to asthmatics in the United States. Next…
In adults. I cannot find the quote Alix gives:
Vaccination of healthy adults only reduced risk of influenza by 6% and reduced the number of missed work days by less than one day (0.16) days. It did not change the number of people needing to go to hospital or take time off work.
provided in the abstract I was able to locate online, but this is what I did find when I looked up the study in question:
Authors' conclusions
Influenza vaccines are effective in reducing cases of influenza, especially when the content predicts accurately circulating types and circulation is high. However, they are less effective in reducing cases of influenza-like illness and have a modest impact on working days lost.
Ref: http://www.cochrane.org/reviews/en/ab001269.html
Yes, despite the authors explicit statement that flu vaccines are “effective in reducing cases of influenza”, this study is being used by Alix to support the claim that flu vaccines are ineffective in adults. Here’s more from the abstract:
Main results
Forty-eight reports were included: 38 (57 sub-studies) were clinical trials providing data about effectiveness, efficacy and harms of influenza vaccines and involved 66,248 people; 8 were comparative non-randomised studies and tested the association of the vaccines with serious harms; 2 were reports of harms which could not be introduced in the data analysis.
Inactivated parenteral vaccines were 30% effective (95% CI 17% to 41%) against influenza-like illness, and 80% (95% CI 56% to 91%) efficacious against influenza when the vaccine matched the circulating strain and circulation was high, but decreased to 50% (95% CI 27% to 65%) when it did not. Excluding the studies of the 1968 to 1969 pandemic, effectiveness was 15% (95% CI 9% to 22%) and efficacy was 73% (95% CI 53% to 84%). Vaccination had a modest effect on time off work, but there was insufficient evidence to draw conclusions on hospital admissions or complication rates. Inactivated vaccines caused local tenderness and soreness and erythema. Spray vaccines had more modest performance. Monovalent whole-virion vaccines matching circulating viruses had high efficacy (VE 93%, 95% CI 69% to 98%) and effectiveness (VE 66%, 95% CI 51% to 77%) against the 1968 to 1969 pandemic
No one here is claiming 100% effectiveness, but they are certainly not saying vaccines are ineffective for adults either, as Alix claims. I found it interesting to note that when data from the 1968-69 pandemic is excluded, effectiveness went down. This must mean, statistically speaking, that for the 1968-69 pandemic the flu vaccine was more effective than normal. I am wondering if the same is true of this year’s vaccine, for the reason that production got started later than usual (hence the current world-wide vaccine shortages). Is this year’s vaccine more likely to be a good match for the circulating strain (novelH1N1) as it H1N1 would have had less time to mutate? I have seen various bodies (WHO, CDC) claim this year’s vaccine is an excellent match, but have yet to see good data. Back to the next group Alix lists...
The elderly. The claim is made that for the elderly living in nursing homes, flu shots were “non-significant for preventing the flu”, whereas for elderly living in the community, flu shots were “not (significantly) effective in preventing flu, ILI, or pneumonia”. Well, right away the observant among you will notice that flu shots are claimed to be “not significantly effective” against different things for the two groups—the nursing home group (flu only) and the community living group of elderly (flu, ILI and pneumonia). Why would this be? From the study in question:
Best effectiveness of current vaccines in preventing clinical illness and its complications was seen in long-term care facilities (for example nursing homes) where vaccines prevented about 45% of pneumonia cases, hospital admissions and influenza-related deaths. This compared to about 25% vaccine efficacy in preventing hospitalisation from influenza or respiratory illness in open community settings. The public health safety profile of the vaccines appears to be acceptable. [from Summary]
Ref: http://www.cochrane.org/reviews/en/ab004876.html
While we’d all like to see higher effectiveness from the flu shot in preventing death in the elderly, if the CDC’s estimates of 36,000 deaths from flu or complications yearly—of which 90% of among the elderly—is correct, this would mean that even a 25-45% effectiveness rate in preventing pneumonia would save THOUSANDS of lives each year from pneumonia, to say nothing of those elderly who die of secondary infections picked up while in hospital. So while strictly correct in the claim that flu vaccines are not particularly effective in preventing flu in the elderly, they are effective (and the authors state so explicitly) in preventing hospitalization, pneumonia and all-cause mortality (which frankly is what does in many of the elderly when they get flu—its the complications from flu, not flu itself). The authors acknowledge that the difference between nursing home and community based effectiveness may be the results of other factors as well. Here again from the study:
Main results
Sixty-four studies were included in the efficacy / effectiveness assessment, resulting in 96 data sets. In homes for elderly individuals (with good vaccine match and high viral circulation) the effectiveness of vaccines against ILI was 23% (6% to 36%) and non-significant against influenza (RR 1.04: 95% CI 0.43 to 2.51). We found no correlation between vaccine coverage and ILI attack rate. Well matched vaccines prevented pneumonia (VE 46%; 30% to 58%), hospital admission (VE 45%; 16% to 64%) and deaths from influenza or pneumonia (VE 42%, 17% to 59%). In elderly individuals living in the community, vaccines were not significantly effective against influenza (RR 0.19; 95% CI 0.02 to 2.01), ILI (RR 1.05: 95% CI 0.58 to 1.89), or pneumonia (RR 0.88; 95% CI 0.64 to 1.20). Well matched vaccines prevented hospital admission for influenza and pneumonia (VE 26%; 12% to 38%) and all-cause mortality (VE 42%; 24% to 55%). After adjustment for confounders, vaccine performance was improved for admissions to hospital for influenza or pneumonia (VE* 27%; 21% to 33%), respiratory diseases (VE* 22%; 15% to 28%) and cardiac disease (VE* 24%; 18% to 30%); and for all-cause mortality (VE* 47%; 39% to 54%). The public health safety profiles of the vaccines appear to be acceptable.
Authors' conclusions
In long-term care facilities, where vaccination is most effective against complications, the aims of the vaccination campaign are fulfilled, at least in part. However, according to reliable evidence the usefulness of vaccines in the community is modest. The apparent high effectiveness of the vaccines in preventing death from all causes may reflect a baseline imbalance in health status and other systematic differences in the two groups of participants.
Two final things about the arguments found on this page of Alix’s:
1 – The vaccine in the United States does NOT contain adjuvants (i.e., squalene)
2—While some studies show a highly protective effect of Vitamin D3 on colds and flus and respiratory tract infections, not all do. Here’s a recent study that found no such protective effect:
http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=6103912
Again, I’m all for folks making the vaccinate or not decision for themselves. And I am also all for folks doing proactive things from washing their hands to getting enough sleep to taking their vitamins (including D3!). But I do not think there is any magic bullet when it comes to H1N1—there is no way to guarantee you will avoid it, nor guarantee you will have only a mild case. This includes being vaccinated! What I do object to, though, is folks combing the data and only reporting back the bits that agree with their foregone conclusions. Please give BOTH sides and assume folks are intelligent enough to sort it out for themselves—whichever side of this debate you personally are on. It is clear to me that the data Alix is quoting, from Dr. Tenpenny, is misleading at best.
And to get back to Alix’s original page re: herd immunity, I actually agree with her overall stance on herd immunity (I’ve never been persuaded by these arguments), and I also agree that the risks of a live vaccine (a la FluMist) are not being properly accounted for. (I am genuinely confused on why this vaccine is being offered in the US given what we now know about the live polio vaccine as the sole cause of the rare cases of polio in the US. I also cannot find any other country using this version of the vaccine). But her assessment of the risks of Guillain-Barre is deeply misleading. The data I see most consistently agreed upon—including by folks who are clearly anti-vaccination, is that the 40-48 million swine flu shots in the US in 1976 led to 500-ish (532 to be precise) cases of GB, and 25 deaths. These stats show 13.3 folks per million injured from the shot (or, indeed, just over 1 in 100,000 as she says) but I think it need to be emphasized that the death rate was 0.625 per million (i.e., less than 1 in 1 million). It also needs to be emphasized that about 80% of folks make a complete recovery from GB with treatment (source: Wikipedia). The 2009 outbreak of H1N1 has killed 1123 Americans thru October 24th, including 114 children. (These are confirmed H1N1 deaths only—593 from April-August, and 530 from Sept-Oct. 24th; they do not include the 2916 deaths from “influenza and pneumonia syndrome”—source CDC):
http://www.cdc.gov/h1n1flu/updates/us/
and
http://www.cdc.gov/h1n1flu/updates/090409.htm
Assuming the population of the US is 307.839 million as of November 1, 2009 (source Wikipedia: http://en.wikipedia.org/wiki/List_of_countries_by_population) this is a death rate of 3.648 per million from H1N1 in the United States for the past (approx.) 7 months. This is far more than the death rate from GB in 1976 (0.625 per million), but far less than the GB rate post-1976 vaccination (13.3 per million), but again, slightly more than the number of those suffering lasting damage from GB (2.675 per million, assuming 80% of the 532 made a full recovery). And if the rate of “negative vaccine reaction” is similar to that of 1976, with 532 GB cases after 40 million shots, or 13.3 per million (0.625 dead), we would expect about 4096 GB cases (of which 80%, or 3276, recover fully), given 308 million Americans (let’s assume everyone gets a shot, and only 1 shot), and 193 deaths. I do not see ANY basis for Alix’s claim that “30,000+ Americans will get Guillain-Barre Syndrome or die.” Again, I can’t decide this for you, but I can give you (more) accurate information on which to base your decision.
And lastly, let me now put my cards on the table. Despite the fact that my family chose to get the H1N1 vaccination--based on our risk/benefit analysis of living with a child under 5 with asthma--I am NOT pro-vaccination. (This was in fact Gareth’s—our 4 ½ year old asthmatic’s—first immunization of any kind). Neither am I anti-vaccination. What I personally believe is that vaccines CAN BE one way to prevent serious illness, but as they can have serious side effects, and they are nowhere near 100% effective, we need to be considering a serious (possibly fatal) illness that at least sometimes leads to death EVEN WHEN PROPER MEDICAL CARE IS RECEIVED for me to even consider vaccinating (i.e., chicken pox, ear infections and rubella for my boys don't make the cut). But I am ADAMANT that folks need to decide for themselves on this, and frankly, they can't do so when data is being presented in misleading ways. I hope this has been helpful to those of you who read this far. Good luck making your own decision, and stay well.