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Vaccines and infant mortality rates

ResearchBlogging.orgThe anti-vaccine movement is a frequent topic on this blog, sometimes to the point where it seems to take over the blog for days (or even weeks) at a time and I cry for respite. There are a number of reasons for this, not the least of which being that the anti-vaccine movement is one of the most dangerous forms of pseudoscience, a form of quackery that, unlike most forms of quackery, endangers those who do not partake of it by breaking down herd immunity and paving the way for the resurgence of previously vanquished diseases. However, anti-vaccine beliefs share many other aspects with other forms of quackery, including the reliance on testimonials rather than data. Even so, although the intelligentsia (and I do use the term loosely) of the anti-vaccine movement realizes and exploits the power of anecdotes and testimonials and how human beings tend to value such stories over dry scientific data, leaders of the anti-vaccine movement realize that science is overwhelmingly against them and that testimonials alone are not adequate to counter that science in the realm of public policy and relations.

That’s why, over the years, various anti-vaccine “scientists” (and I use that term very loosely as well) have produced poor quality, sometimes even fraudulent studies, which are then touted as evidence that vaccines cause autism or at least as evidence that there is actually still a scientific controversy when in fact from a scientific standpoint the vaccine-autism hypothesis is pining for the fjords. Examples abound, including the work of Mark and David Geier, whose studies led the to use chemical castration to treat autistic children; Andrew Wakefield, whose small case series almost certainly included fraudulent data; a truly incompetent “phone survey” commissioned by Generation Rescue designed to compare “vaxed versus unvaxed” children; and an even more incompetent “study” in which Generation Rescue used a cherry picked group of nations to try to argue that nations that require more vaccines have higher rates of infant mortality. These efforts continue. For example, last year Generation Rescue requested $809,721 from the Airborne settlement to set up a “vaxed versus unvaxed” study, despite the known difficulties with such a study and the low likelihood of finding anything without huge numbers of children.

Earlier this month, they were at it again.

The return of the revenge of the claim that more vaccines equal more infant mortality

Over the couple of weeks or so, anti-vaccine activists have been busy touting two “studies” or “reports.” I’ve already discussed one of these, a legal opinion piece masquerading as a “study” that managed to bring out the usual suspects completely missing the point about why it’s so bad. That leaves one that I’ve been meaning to apply a bit of the ol’ ultra-Insolence to as a teaching and learning exercise before I try again to move on to other topics. It’s a study that claims to link the vaccine schedule in the U.S. to increased infant mortality and, not surprisingly, was announced by the ever-popular all-purpose quackery website, NaturalNews.com, which touted a study claiming to have found that nations requiring the most vaccines tend to have the worst infant mortality rates:

A new study, published in Human and Experimental Toxicology (http://het.sagepub.com/content/earl…), a peer-reviewed journal indexed by the National Library of Medicine, found that nations with higher (worse) infant mortality rates tend to give their infants more vaccine doses. For example, the United States requires infants to receive 26 vaccines — the most in the world — yet more than six U.S. infants die per every 1000 live births. In contrast, Sweden and Japan administer 12 vaccines to infants, the least amount, and report less than three deaths per 1000 live births.

Before we get to the study itself–which, as you might imagine, has…flaws–let’s take a look at the authors. The first author, Neil Z. Miller, is described as an “independent researcher,” and the second author, Gary S. Goldman, is described as an “independent computer scientist.” This is not a promising start, as neither of them appear to have any qualifications that would lead a reader to think that they have any special expertise in epidemiology, vaccines, or science. Still, I suppose one could look at the fact that these two somehow managed to get a paper published in a peer-reviewed journal as being pretty strong evidence for the democratic nature of science, where you don’t necessarily have to be affiliated with a university or a biotech or pharmaceutical company in order to publish in the scientific literature. On the other hand, even though it is stated that this was not funded by any grants or companies, I still see a conflict of interest. Specifically, the NaturalNews.com article points out that the “National Vaccine Information Center (NVIC) donated $2500 and Michael Belkin donated $500 (in memory of his daughter, Lyla) for open access to the journal article (making it freely available to all researchers).” The NVIC, as you recall, was founded by Barbara Loe Fisher and is one of the oldest and most influential anti-vaccine groups in the U.S., having recently teamed up with Joe Mercola to promote anti-vaccine views through ads on a JumboTron at Times Square. Michael Belkin, you might also recall, is the man responsible for The Refusers, a one man anti-vaccine rock act best known for execrably bad songs with risible titles like “Vaccine Gestapo” and “Get Your Mandates Out of My Body.”

No, definitely not a promising start.

It’s also not surprising. I did a bit of Googling, as is my wont whenever I encounter someone whose name I don’t recognize, and I found abundant evidence in his Wikipedia entry that Miller has a long history of anti-vaccine activism, having written books with titles like Vaccine Roulette: Gambling With Your Child’s Life, Immunization Theory vs Reality: Expose on Vaccinations, and Vaccines: Are They Really Safe and Effective?, among others. But that’s not all; he’s also the director of the ThinkTwice Global Vaccine Institute and in fact is hosting a copy of this study on his website. Gary S. Goldman is even more interesting. It turns out that he is the President and Founder of Medical Veritas, a rabidly anti-vaccine “journal” that is into HIV/AIDS denialism, having published dubious “reanalyses” of autopsy results of victims of AIDS, such as Eliza Jane Scovill. He also notes at his website that he’s written books entitled The Chickenpox Vaccine: A New Epidemic of Disease and Corruption.

Even less promising.

Still, one might wonder why I pointed this out. Isn’t that an ad hominem attack? Not at all. I’m not arguing that this latest paper is wrong because its authors are clearly members of the anti-vaccine fringe. Who knows? They might be on to something. I’m merely pointing out that what’s good for the goose is good for the gander when it comes to pointing out conflicts of interest (COIs) and, as Harriet has recently discussed COIs do not necessarily have to be financial. As I’ve pointed out time and time again, COIs do not necessarily mean that a study is in error, poorly done, or out-and-out wrong. They merely demand a bit more skepticism, particularly when they are not disclosed, which they are not in the actual paper, which fails to list the connection to NVIC, Medical Veritas, and ThinkTwice. Why didn’t Miller list himself as editor or founder of ThinkTwice or Goldman as founder and editor of Medical Veritas? One wonders, one does. Knowing that these two hold those positions is every bit as relevant as knowing when a pharmaceutical company publishes a study about its latest blockbuster drug.

But who knows? Maybe I’m wrong. Well, actually, I don’t think I am, but it will take delving into the actual paper to show why.

Infant mortality as a function of number of vaccines

The first thing you need to know is that this is a really, really simple paper. In fact, I’d go so far as to say it is simple-minded more than just simple. Basically, Miller and Goldman went to The World Factbook maintained by, of all organizations, the Central Intelligence Agency. Noting that in 2009 the U.S. ranked 34th in infant mortality, they looked up the infant mortality rates from the U.S. and all the nations that have lower infant mortality rates than the U.S. and then compared them to the number of vaccine doses each nation require. They then graphed the infant mortality rate as a function of vaccine dose, and this resulted in Figure 1:

That’s it. That really is the “meat” of the paper, such as it is.

Whenever I see a paper like this, I ask myself: What would I say about it if it had been sent to me as a peer reviewer. This graph leads to a number of questions. First, why did the authors use 2009 data? The cited reference notes that the data were accessed back in April 2010. That’s over a year ago. Did it really take over a year between submission and publication. Be that as it may, whenever I see investigators trying to correlate two variables like infant mortality and the number of vaccines I ask: What is the rationale? It’s the “storks deliver babies” fallacy all over again.

I also note that the authors here seem to have pulled the same trick that J.B. Handley and crew like to pull when trying to convince people that U.S. infants are “overvaccinated” by artificially pumping up the apparent number of vaccine doses by counting multivalent vaccines as more than one. For instance, the MMR and DTaP are counted as three each because each vaccine is trivalent; i.e., containing vaccines against three different diseases. In fact, the authors of this gem do this very thing in spades, as Catherina explains:

There are a number of things wrong with this procedure – first of all, the way Miller and Goldman are counting vaccines is completely arbitrary and riddled with mistakes.

Arbitrary: they count number of vaccines in US bins (DTaP is one, hib is separate) and non-specific designations (some “polio” is still given as OPV in Singapore), rather than antigens. If they did that, Japan, still giving the live bacterial vaccine BCG, would immediately go to the top of the list. That wouldn’t fit the agenda, of course. But if you go by “shot” rather than by antigen, why are DTaP, IPV, hepB and hib counted as 4 shots for example in Austria, when they are given as Infanrix hexa, in one syringe?

Mistakes: The German childhood vaccination schedule recommends DTaP, hib, IPV AND hepB, as well as PCV at 2, 3 and 4 months, putting them squarely into the 21 – 23 bin. The fourth round of shots is recommended at 11 to 14 months, and MenC, MMR and Varicella are recommended with a lower age limit of 11 months, too, which means that a number of German kids will fall into the highest bin, at least as long as you count the Miller/Goldman way.

Having used dubious and error-ridden methods for counting the required vaccines and correlated those numbers to infant mortality rates, the authors then move on. After pointing out that the U.S. has a poor infant mortality rate (IMR) relative to its wealth and what it spends on health care, the authors state:

There are many factors that affect the IMR of any given country. For example, premature births in the United States have increased by more than 20% between 1990 and 2006. Preterm babies have a higher risk of complications that could lead to death within the first year of life.6 However, this does not fully explain why the United States has seen little improvement in its IMR since 2000.7

Nations differ in their immunization requirements for infants aged less than 1 year. In 2009, five of the 34 nations with the best IMRs required 12 vaccine doses, the least amount, while the United States required 26 vaccine doses, the most of any nation. To explore the correlation between vaccine doses that nations routinely give to their infants and their infant mortality rates, a linear regression analysis was performed.

This is known as starting with a reasonable observation and then switching to a hypothesis with little or no scientific justification, in essence pulling it out of thin air. The second question I would have is: Why a linear relationship? No justification is given for performing a linear regression analysis. My third question would be: Why this data set?

Actually, this third question is probably the most interesting of all. Miller and Goldman only looked at one year’s data. There are many years worth of data available; if such a relationship between IMR and vaccine doses is real, it will be robust, showing up in multiple analyses from multiple years’ data. Moreover, the authors took great pains to look at only the United States and the 33 nations with better infant mortality rates than the U.S. There is no statistical rationale for doing this, nor is there a scientific rationale. Again, if this is a true correlation, it will be robust enough to show up in comparisons of more nations than just the U.S. and nations with more favorable infant mortality rates. Basically, the choice of data analyzed leaves a strong suspicion of cherry picking. Were I reviewing this paper, I would insist on the use of one or two other data sets. For example, I would ask for different years and/or perhaps the use of the rankings by the United Nations Population Division, which can be found in the Wikipedia entry containing the list of countries by infant mortality rate. And I would insist on doing the analysis so that it includes several nations with worse IMRs than the U.S. Indeed, since the focal point of the analysis seems to be the U.S., which, according to Miller and Goldman, requires more vaccine doses than any other nation, then it would make sense to look at the 33 nations with worse IMRs than the U.S.

Be that as it may, I looked at the data myself and played around with it One thing I noticed immediately is that the authors removed four nations, Andorra, Liechenstein, Monaco, and San Marino, the justification being that because they are all so small, each nation only recorded less than five infant deaths. Coincidentally, or not, when all the data are used, the r2=.426, whereas when those four nations are excluded, r2 increases to 0.494, meaning that the goodness of fit improved. Even so, it’s not that fantastic, certainly not enough to be particularly convincing as a linear relationship. More dubiously, for some reason the authors, not content with an weak and not particularly convincing linear relationship in the raw data, decided to do a little creative data manipulation and divide the nations into five groups based on number of vaccine doses, take the means of each of these groups, and then regraph the data. Not surprisingly, the data look a lot cleaner, which was no doubt why this was done, as it was a completely extraneous analysis. As a rule of thumb, this sort of analysis will almost always produce a much nicer-looking linear graph, as opposed to the “star chart” in Figure 1. Usually, this sort of data massaging is done when a raw scatterplot doesn’t produce the desired relationship.

Finally, it’s important to remember that IMRs are very difficult to compare across nations. In fact, the source I most like to cite to illustrate this is, believe it or not, an article by Bernadine Healy, the former director of the NIH who has over the last three or four years flirted with the anti-vaccine movement (as I have discussed before):

First, it’s shaky ground to compare U.S. infant mortality with reports from other countries. The United States counts all births as live if they show any sign of life, regardless of prematurity or size. This includes what many other countries report as stillbirths. In Austria and Germany, fetal weight must be at least 500 grams (1 pound) to count as a live birth; in other parts of Europe, such as Switzerland, the fetus must be at least 30 centimeters (12 inches) long. In Belgium and France, births at less than 26 weeks of pregnancy are registered as lifeless. And some countries don’t reliably register babies who die within the first 24 hours of birth. Thus, the United States is sure to report higher infant mortality rates. For this very reason, the Organization for Economic Cooperation and Development, which collects the European numbers, warns of head-to-head comparisons by country.

Infant mortality in developed countries is not about healthy babies dying of treatable conditions as in the past. Most of the infants we lose today are born critically ill, and 40 percent die within the first day of life. The major causes are low birth weight and prematurity, and congenital malformations. As Nicholas Eberstadt, a scholar at the American Enterprise Institute, points out, Norway, which has one of the lowest infant mortality rates, shows no better infant survival than the United States when you factor in weight at birth.

It’s ironic that Bernadine Healy, who’s associated herself so heavily with the anti-vaccine movement, to the point of having been named Age of Autism’s Person of the Year in 2008, provided such a nice, concise explanation about why it’s so problematic to compare infant mortality rates between nations. Miller and Goldman claim that they tried to correct for these differences in reporting for some of the nations who do not use reporting methods consistent with WHO guidelines, but they do not say how they did so or what data source they used to do so. Note that these children who die within the first day of life also tend to be the ones who have either received no vaccines yet or only the birth dose of the hepatitis B vaccine (here in the U.S.). Given that infant mortality is defined as the fraction of children who die before one year of age and many infants lost die very early, many of them have had few or no vaccines, given that the bulk of the U.S. vaccine schedule does not really start until two months of age. In other words, no effort was made to determine if there was actually any sort of correlation between vaccine dose number whether the infants who died actually died at an age where they would be expected to have received most of the vaccines required within the first year. Worse, no real attempt was made to correct for many potential confounding factors. Not that that stops the authors from asking:

Among the 34 nations analyzed, those that require the most vaccines tend to have the worst IMRs. Thus, we must ask important questions: is it possible that some nations are requiring too many vaccines for their infants and the additional vaccines are a toxic burden on their health? Are some deaths that are listed within the 130 infant mortality death categories really deaths that are associated with over-vaccination? Are some vaccine-related deaths hidden within the death tables?

Never mind that the authors present no real data to justify such a speculation. They do speculate, however. Oh, how they speculate! The spend two whole pages trying to link vaccines to sudden infant death syndrome and argue that SIDS deaths, hinting at some sort of conspiracy to cover up the number of SIDS deaths by reclassifying them and then cite old studies that suggested a correlation between vaccination and SIDS while neglecting the more recent data that show that the risk of SIDS is not increased after immunization and that, if anything, vaccination is probably protective against SIDS. Indeed, one of the studies the authors discuss is an abstract presented in 1982, not even a paper published in a peer-reviewed journal.

Finally, there is the issue of ecological fallacy. The ecological fallacy can occur when an epidemiological analysis is carried out on group level data rather than individual-level data. In other words, the group is the unit of analysis. Clearly, comparing vaccination schedules to nation-level infant mortality rates is the very definition of an ecological analysis. Such analyses have a tendency to magnify any differences observed, as Epiwonk once described while analyzing–surprise, surprise!–a paper by Mark and David Geier:

To make this jump from group-level to individual-level data is The Ecological Fallacy, which can be defined simply as thinking that relationships observed for groups necessarily hold for individuals.

The ecological fallacy was first described by the psychologist Edward Thorndike in 1938 in a paper entitled, “On the fallacy of imputing the correlations found for groups to the individuals or smaller groups composing them.” (Kind of says it all, doesn’t it.) The concept was introduced into sociology in 1950 by W.S. Robinson in 1950 in a paper entitled, “Ecological correlations and the behavior of individuals,” and the term Ecological Fallacy was coined by the sociologist H.C. Selvin in 1958. The concept of the ecological fallacy was formally introduced into epidemiology by Mervyn Susser in his 1973 text, Causal Thinking in the Health Sciences, although group-level analyses had been published in public health and epidemiology for decades.

To show you one example of the ecological fallacy, let’s take a brief look at H.C. Selvin’s 1958 paper. Selvin re-analyzed the 1897 study of Emile Durkheim (the “father of sociology”), Suicide, which investigated the association between religion and suicide. Although it’s difficult to find Selvin’s 1958 paper, the analyses are duplicated in a review by Professor Hal Morgenstern of the University of Michigan. Durkheim had data on four groups of Prussian provinces between 1883 and 1890. When the suicide rate is regressed on the percent of each group that was Protestant, an ecologic regression reveals a relative risk of 7.57, “i.e. it appears that Protestants were 7½ times as likely to commit suicide as were other residents (most of whom were Catholic)….ln fact, Durkheim actually compared suicide rates for Protestants and Catholics living in Prussia. From his data, we find that the rate was about twice as great among Protestants as among other religious groups, suggesting a substantial difference between the results obtained at the ecologic level (RR = 7.57) and those obtained at the individual level (RR = 2).” Thus, in Durkheim’s data, the effect estimate (the relative risk) is magnified by 4 by ecologic bias. In a recent methodological investigation of bias magnification in ecologic studies, Dr. Tom Webster of Boston University shows that effect measures can be biased upwards by as much as 25 times or more in ecologic analyses in which confounding is not controlled.

The bottom line is that Miller and Goldman’s ecological analysis virtually guaranteed overestimating any relationship found, the way some studies of radiation hormesis have done. Given that the difference between the highest and lowest IMR is only around two-fold, in essence, given this data set it is highly unlikely that there is any relationship there. This is particularly true given that the authors cannot possibly have controlled for the major confounders. Add to that the fact that they only used one data set and didn’t even include nations with higher IMRs than that of the U.S., and I declare this paper to be utterly worthless. It’s an embarrassment to Human and Experimental Toxicology that its peer reviewers didn’t catch all these problems and that an editor let this paper see print. The Editor-in-Chief Kai Savolainen and the Editor for the Americas A. Wallace Hayes ought to be ashamed of themselves.

Conclusion

The current study joins a long list of poorly planned, poorly executed, poorly analyzed studies that purport to show that vaccines cause autism, neurological diease, or even death. It is not the first, nor will it be the last. The question is: How do we respond to such studies? First off, we as skeptics have to be very careful not to become so jaded that knee-jerk hostility predominates. As unlikely as it is, there is always the possibility that there might be something worth taking seriously there. Next off, we have to be prepared to analyze these studies and explain to parents, when appropriate (which is the vast majority of the time) exactly why it is that they are bad science or why their conclusions are not supported by the data presented. Finally, we have to be prepared to provide these analyses fast. The Internet is speed. Already, if you Google the terms “infant mortality” and “vaccine,” anti-vaccine blogs gloating over Miller and Goldman’s study and the study itself appear on the very first page of search results.

Such is the power of a bad study coupled with the reach of the Internet and the naivete of peer reviewers and journal editors who don’t realize when they’re being played. Make no mistake, the editors and peer reviewers of Human & Experimental Toxicology were most definitely played. At the very least the editors should have found reviewers who could check the methods by which Miller and Goldman counted individual vaccines and who know that spurious correlations are not too hard to find. They did not, and in failing to do that they failed their readers.

REFERENCE:

Miller, N., & Goldman, G. (2011). Infant mortality rates regressed against number of vaccine doses routinely given: Is there a biochemical or synergistic toxicity? Human & Experimental Toxicology DOI: 10.1177/0960327111407644

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

65 replies on “Vaccines and infant mortality rates”

Given such a large percentage that includes children who either die just about being born (severely premature or suffering from various developmental defects) – and of course those babies wouldn’t receive a single vaccine, or if the children were sick enough, vaccines are contra-indicated & aren’t given – how could you possibly use infant mortality as any type of indicator in this instance?

Even as a layman, those are the first things that jump out at me that this isn’t a study as much as a means of cooking available data to support a speculative hypothesis.

This was published where? I do some peer reviewing for maternal and child health journals, and if I got this to review, I’d toss it out the window. “Infant mortality” as a category is useful for PR but scientifically not very meaningful, as it combines two distinct phenomena: neonatal mortality (death in the first 28 days) and postneonatal mortality (death between day 29 and one year), which have distinct causes. As you and Lawrence point out, neonatal mortality by definition happens before (hardly) any vaccines have been administered. The major causes of postneonatal death are SIDS, congenital malformations, and unintentional injury. Which of these are they suggesting are caused by vaccines?

Renee – I believe SIDS is mentioned (or has been mentioned by the anti-vax crowd) as being caused by vaccines. So that’s one, I guess. The other two – well, they could blame the mother’s vaccines for developmental defects (and I’ve seen, again, some of the rabid anti-vaxers try to blame autism on the mother’s vaccine status). But, I think they lose on the 3rd – even our trolls would have a hard time linking accidents to vaccines – but I’m sure they will try.

I’m having a very hard time figuring out their justification for running the analysis on only the USA, and nations with lower infant mortality rates. And I can find no justification for how and why the data was put into the 5 groups.

Now I’m itching to redo the work with a proper statistical analysis tool rather then a (perhaps rather nice) graphing tool with some statistical calculators. I wonder if I could even get the same numbers out of JMP, or R.

Binning the data was done almost certainly to make a much nicer, straighter-looking line, because binning the data almost always results in that. As for why they chose the U.S. and the 32 countries with better infant mortality rates, I seriously suspect cherry picking, but I was too busy to take the enormous amount of time that it would take to look up the vaccine schedules for, say, 10 or 20 of the countries with worse IMRs than the U.S. and add them to the analysis.

This is left as an exercise for the reader. 🙂

It’s raining drearily. The storied skyline , usually visible, lies secretly enshrouded behind mists; streams of rainwater run down the road as I drive. No wonder I feel morose.

I feel awfully because I read pseudo-science that presents spurious research to intoxicate its ardent followers and lead them further down the garden path toward useless treatments and throwing their money away on supplements. I notice here:

There appear to be few names that circulate incestuously amongst woo-meisters- Miller is an old fave( *perps*, the “usual suspects”, those who “aid and abet”: the language of bad *noir* suits bad science) and few themes . Yesterday, John Stone (@ AoA)wrote about a young fellow who died as a “pharma victim” -“twice in his short life”- done in by the vax early and by anti-psychotics recently. Anti-psychiatry fits hand in glove with anti-vax. The journal our esteemed host cites features anti-vax and HIV/AIDS denialism. Toxins are frequently the culprit.

Why cite “research”? If you don’t have data – and a law journal or courtroom isn’t handy- you can fabricate it ( why does *that* sound so familiar?). Often our woo-consolidators report how “research” supports their natural health agenda- the “data” comes from tiny, miserable studies done by the usual suspects or arrives from far, exotic locales. These are placed against the weight of scientific consensus, tipping the balance on the the fixed scale. More carefully done research is dismissed as not being independent, awash in COI’s.

Studies enable charlatans to appear scientific to the marks who usually can’t tell the difference. And studies can be used as a multiple testimonial: “*All* of these people were helped by our product”. Long-time woo-generator Gary Null cites the miraculous results of his many studies ( a/k/a “health support groups”)- “People are cured!” Of everthing! AIDS, cancer, MS, Alzheimer’s, diabetes, ASD’s, CV- you name it, he cures it. Then, Adams will cite him. An endless cycle of advertisement and promotion.

Sometimes I truly wish that I didn’t have such a high tolerance for the ins-and-outs of money-generating nonsense: however, it’s a tough job and *somebody* has to do it.

All the above goes without even mentioning the obvious factors that affect infant mortality rates: access to health care, practitioner-patient ratios, health surveillance for infants, access to proper nutrition, risk of traumatic death, rates of parental substance abuse, etc. Comparing a continent-sized nation with a highly diverse population and wide variations in socieconomic status and differing systems for providing health care and public health services to a country such as, say, Japan or Belgium, is full of potential pitfalls.

What a truly execrable study.

If anyone feels like adding some more countries to the data to see what falls out, data on immunization schedules in different countries is available in xls format from the WHO here.

You’re missing the influence of neonatal suicides due to fear of vaccines – vaccines don’t even have to administered to cause death.

Orac mentions about the effect of dropping out 4 smaller countries. How about a more important one: what happens to the correlation if you drop out the US?

Remember, the US data point is completely cherry-picked, and admittedly so: it is chosen as the high end cutoff because the US has the highest vaccination rate. As such, it will, by definition skew the data.

I just did a quick simulation. Only 50 points, but the average r value for a data set consisting of one point fixed at 27, 6.2 and 33 points randomly distributed over a range of 12 – 24 and 2.3 – 6 is 0.14. The highest value I got in this dataset was 0.5. The average slope was 0.4.

No, it doesn’t account for all of the observations in the plot above, but it does illustrate how selectively choosing that ONE point has an effect. Take out that one point, and the correlation drops to zero, as expected.

That they stopped their data selection directly at the US is unacceptable. Any time you choose a dataset, you need to select it based on parameters that are unrelated to what you are measuring. Moreover, you need to do tests to show that the selection of the range does not influence the results. For example, if they decided to examine the top 50, then they would want to verify that using the top 40 or using the top 60 does not alter their conclusions.

Rats – the average slope should have been 0.04, not 0.4

Th1Th2! I choose you!

Tell us. How should we be looking at this data? I need a good laugh …

Couldn’t some of the countries requiring fewer vaccines do so because they never had much of a problem with some diseases? Another country might have higher infant mortality while requiring more vaccines for diseases that are causing—wait for it—mortality.

Orac, thanks for this post and I hope you won’t mind my going a bit off topic.

A local woman I know is touting a talk next week at UNC by a Dr. Pelevsky, MD. He is described as a sought after lecturer and she says he’ll present his “expertise on childhood illnesse and holistic pediatrics and his research on the safety and efficacy of vaccines”. She also says to “bring your questions”.

The talk is Monday the 21st from 9-12 in Carroll Hall. I do hope some of your readers in the area would be able to go and ask some appropriate questions. Is there anything I can do? I certainly don’t feel qualified to ask questions on my own. Maybe some ideas for questions would be helpful. I can attend the talk, but only if I can do something constructive.

@13 The Very Reverend Battleaxe of Knowledge:

That would means that authors of the study confounded correlation and causation.
Nowadays, who would make such a mistake?

🙂

Lynn – I would print out a copy of Todd’s excellent anti-anti-vax website & bring it with you. The information there should handily refute whatever information this “doctor” provides & you may be able to really catch him over a barrel.

Easy to find – just click on Todd’s name on one of his posts.

I hadn’t heard of Gary Null, but it goes without saying that all of his studies will produce a Null result. [ka-bump]

I thank you, ladies and gentlemen. We’ll be here ’til Thursday — try the lamb!

Lawrence wrote:

But, I think they lose on the 3rd – even our trolls would have a hard time linking accidents to vaccines – but I’m sure they will try.

C’mon, that’s trivial. Obviously the parents’ vaccines impair their motor skills, causing them to be more likely to drop their infants into open manholes.

Thanks Lawrence, I saved that one from our last encounter. It is excellent. I hope some other knowledgeable people will attend. Creationists I can handle, MD’s; I don’t know.

The two biggest problems with this study are the cut off point, and the fact that the researchers seem to have pulled the “Total Doses” number out of their posteriors how do infants in the US get 2 doses of the flu shot where in Canada and Singapore there is only one dose? There seem to be major issues in how the number of “doses” were determined. The authors write “Nations differ in their immunization requirements for infants aged less than 1 year.” but only provide indirect, non authoritative references saying that the countries have recommended schedules. We can likely trust the software they used processed their numbers correctly, but that’s it.

Mu: You’re missing the influence of neonatal suicides due to fear of vaccines – vaccines don’t even have to administered to cause death.

Or perhaps the parent’s mere decision to vaccinate harms the children – a kind of Munchausen by proxy. We are indeed fortunate that Wakefield is turning his intellect to that area.

Oops, I got the day wrong on that talk at UNC. It’s not Monday the 21st (that date’s not valid for for a couple of years), it’s Saturday the 21st. How could I forget the day the world is supposed to end? Anyway, I cannot attend at that time as I’ll teaching a landscape class. I’m strangely relieved.

I’d love to see if this guy touts this Miller-Goldman paper.

Another problem with the paper that I didn’t catch a reference to in the post: It uses vaccine recommendations, rather than actual vaccine uptake.

So infant mortality from vaccine-preventable diseases that occurred because the infants (and/or their parents, siblings or other infants they were around) weren’t vaccinated would count as statistical evidence against vaccines.

Neat trick.

Wow Jud – another excellent point against this garbage. If they only used recommend & not actual, then there is no basis to draw any conclusions at all (not that there was in the first place, but hey).

Well, if the authors were trying to find out if vaccines increase Infant mortality rates, they should have looked at vaccination schedules for different countries, and then analyze infant mortality rates, not the other way around. *face-palm*

Dear Lynn Wilhelm
I sent a tweet bat-signal to David Kroll (known skeptic) who blogs at Terra Sigillata & is a professor at a university not far from UNC, but you might want to contact him directly: Gmail to abelpharmboy (the way he gives out his email address on his blog)

Thanks Liz, I’ll contact him, too. It’s nice to find local skeptics, too.

Actually, David Kroll now has a PLoS blog, Take as Directed. He’s a straight-shooter, knows his stuff and is always helpful. His area of expertise is pharmacognosy, or the study of drugs from nature — a fact that might help get past the defense mechanisms of your holistic pediatrician.

Ms. Wilhelm (#14) comments:

“A local woman I know is touting a talk next week at UNC by a Dr. Pelevsky, MD. He is described as a sought after lecturer and she says he’ll present his ‘expertise on childhood illnesse and holistic pediatrics and his research on the safety and efficacy of vaccines’.”

Dr. Palevsky, according to his website, is a paediatrician who describes himself as “holistic”. He has done no research (at least, he hasn’t published any) and is actively engaged in private practise and lists no university affiliations (which generally indicates that he isn’t doing research). If he were doing research on vaccination and children’s health, he might possibly be in violation of state and federal laws concerning human experimentation.

I rather suspect that Dr. Palevsky’s “research” has been done at “Google University”; since his practise advertises itself as having a “holistic advantage”, his statements should be regarded with suspicion by the “alt-med” community, as they are usually quite sensitive to “conflicts of interest”, which Dr. Palevsky clearly has.

Prometheus

All the above goes without even mentioning the obvious factors that affect infant mortality rates: access to health care, practitioner-patient ratios, health surveillance for infants, access to proper nutrition, risk of traumatic death, rates of parental substance abuse, etc. Comparing a continent-sized nation with a highly diverse population and wide variations in socieconomic status and differing systems for providing health care and public health services to a country such as, say, Japan or Belgium, is full of potential pitfalls.
thank scienceblogs antalyahotel

(My comment copied from a similar post on the Science-Based Medicine ‘blog.):

I refer your readers to the following paper:

http://www.cdc.gov/nchs/data/nvsr/nvsr58/nvsr58_19.pdf

In particular, they should look at figure 7 (p 13), which shows the infant, neonatal and post-neonatal mortality rates in the US from 1940 – 2007. Granted, this doesn’t cover the 2009 period (those data are still preliminary, according to the CDC), but it paints an interesting picture.

Covering the time when almost all childhood vaccines were introduced (the major exceptions being the diptheria, pertussis and tetanus vaccines), this graph shows that all three mortality rates (infant, neonatal, post-neonatal) showed significant declines throughout the period when childhood vaccines were rapidly introduced.

Despite the fact that the US has higher infant mortality rates than industrialised nations of similar wealth, this graph makes it painfully clear that vaccines are not a likely cause of that difference.

If you go to the preliminary data on infant mortality for 2008 and 2009, the trend continues gradually downward despite the fact that US children in 2009 (IMR 6.42 per 1000 live births) received more vaccines in the first year of life than they did in 1970 (IMR 20.0 per 1000 live births) or 1960 (IMR 26.0 per 1000 live births).

So, if we compare “apples to apples”, we see that the increased number of childhood – and even infant – vaccines has been accompanied by a significant decrease in infant, neonatal and post-neonatal mortality.

Shame on Human and Experimental Toxicology for publishing such an easily debunked “study”.

Prometheus

Promotheus Vaccinius at all Costus.

Covering the time when almost all childhood vaccines were introduced (the major exceptions being the diptheria, pertussis and tetanus vaccines), this graph shows that all three mortality rates (infant, neonatal, post-neonatal) showed significant declines throughout the period when childhood vaccines were rapidly introduced.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4829a1.htm#fig2

Figure 1

1900 – 1996

This graph shows the drop was initiated and much more substantial BEFORE major vaccine use.

But it appears the death rate does flatten out.

Foolish troll apparently doesn’t realize that “infant mortality” and “all-ages mortality from infectious disease” are not the same thing.

Nice try, though. Maybe one day you’ll manage to say something that’s both supported AND relevant.

Nico’s comment above about how the countries were selected poorly given what they were looking for actually highlights another issue: the highly selective dataset.

There are hundreds of countries in the world with various levels of vaccination requirements. Why shouldn’t they all be included with the study? Why only the ones better than the US? If you looked at the 34 _largest_ countries, for example, is there still a correlation?

The sample that was used had number of vaccines ranging from 12 – 27 (depending on how vaccines are counted – is Prevnar considered 1 vaccine, or 7 (or 13, now)?) There are no countries with less than 12? Of course there are.

So what happens to their plot if they add Ethiopia, for example, a country with an infant mortality rate more than 14 times that of the USA, but with only 7 vaccines on the schedule (and a far lower compliance rate)? Or India, with their 7 vaccines and their IMR that is 9 times that of the US? Botswana also has very few vaccines and 8 times the IMR.

The answer, of course, would be that there are confounding factors. Which is true, of course. But there are confounding factors for all of them, and if you are going to admit there are confounders that you haven’t accounted for, then it is all bullshit.

Little Augie, no one denies that there were other advances in medicine. Things like antibiotics, ventilators, sewage and water treatment, etc. It seems you are the only one who does not understand the world is complicated.

So what grade are you in? Have you learned any math past long division? Perhaps you have had a vocabulary test from your home school teacher, one that tells you the difference between incidence and survival?

Leart Shaka does a good reductio ad absurdum on this by showing that there’s an even higher correlation between car accident deaths and vaccines here.

Augustine writes:

1900 – 1996

This graph shows the drop was initiated and much more substantial BEFORE major vaccine use.

Will wonders never cease! augustine continues to campaign in favor of major government public health interventions, such as the chlorination of public water supplies that gets a major share of the credit for reducing infant (and other) infectious disease mortality in the early part of the 20th century. (Nice to see augustine come out foursquare against the science-deniers who bitterly opposed this government intervention at the time.)

Now I wouldn’t be surprised at all to find a correlation between infant mortality and vaccine recommendations. If vaccine preventable illnesses were killing infants, you would recommend the vaccine against those illnesses, no? Of course to see that you need multi-year immunization recommendation, uptake, and IMR data.

The WHO schedules for all countries (filterable by age range, region, country, and Disease) is available via http://apps.who.int/immunization_monitoring/en/globalsummary/DiseaseSelect.cfm

Dang, I was expecting the US to be the leader of the herd. Castro must be LOLROF.

is Prevnar considered 1 vaccine, or 7 (or 13, now)?

It seems like you didn’t do your assignment pretty well.

So what happens to their plot if they add Ethiopia, for example, a country with an infant mortality rate more than 14 times that of the USA, but with only 7 vaccines on the schedule (and a far lower compliance rate)? Or India, with their 7 vaccines and their IMR that is 9 times that of the US? Botswana also has very few vaccines and 8 times the IMR.

Gambia has more or less 22.

Terrific post and links Promethius. I also posted at that same Science Based Medicine blog about the “birth dose” of hepatitis B vaccine. Only preterm or SGA (small for gestational age) infants whose mothers are infected/carriers of the hepatitis B virus receive the birth dose of hepatitis B vaccine along with HBIG (hepatitis B Immune Globulin) within twelve hours of birth:

General Recommendations on Immunization-ACIP January 28, 2011)

“Infants weighing <2000 g. born to HBsAg-negative mothers should receive the first dose at chronological age 1 month or at hospital discharge”.

This recommendation for hepatitis B “birth dose” has been in place for years. The small percentage of low birth weight infants whose mothers are infected/carriers of the virus should receive hepatitis B vaccine and HBIG at birth or within 12 hours of birth. The “birth” dose for such infants “doesn’t count”…they still must receive the three-dose series of hepatitis B vaccine…for a total of 4 doses.

Attention trolls: Before you go on off-topic rants about the dangers of hepatitis B vaccine in low birth weight infants, google “Immunogenicity Hepatitis B Vaccine Pre-Term Infants”.

Another great internet portal for studies/statistics compiled by the NCHS (National Center for Health Statistics)on Infant Morbidity/Mortality is at:

FASTSTATS-Infant Health

(Second time I’m trying to correct my posting at #40 above)

“Infants weighing less than 2000 g. born to HBsAG-negative mothers should receive the first dose at chronological age 1 month or at hospital discharge”

Promotheus Vaccinius at all Costus.

As opposed to Augustus Probability is useless.

So. I added in the stats for the 26 countries with the worst infant mortality rates. As expected, the statistical tests don’t look nearly as good. I’ll make up the graphs if I ever get around to compiling both the real dose numbers (not that it matters) and the inflated numbers for decent amount of countries http://tinypic.com/r/s47z2v/7

Why did somebody copy and paste my post (#7) and put it here under his/her/its/their own screen name (#32)? What was the point? Who is this creepy individual? Why can’t he/she/it/they have an original thought? I guess I should be flattered that he/she/it/they thought well enough about it to appropriate my words, but I find it strangely disturbing.

Comment spam, ORD, hoping that someone will click on the author link.

We recently compared vaccine schedules USA/Germany over at Greg Laden’s Blog, mainly because I was so surprised that US infants would get so many shots at a time. Comparing the actual diseases against which we vaccinate, we came up with only 3 differences: Flu, Rotavirus and Hep A. The remaining difference is due to the much wider use of combined vaccines such as MMRV

“In Belgium and France, births at less than 26 weeks of pregnancy are registered as lifeless.”

This popped out at me. If my child were French, he would be undead (25.5 weeks gestation).

@49 – When the Zombie Apocalypse occurs we will know who to blame.

But people!!!

IMR is obviously and directly related to the number of vaccines put onto the schedule.

If you don’t believe me, here is a chart demonstrating exactly that:
http://picfront.de/d/8cCI

(Oh, I forgot the word “inversely” before the “related” in my sentence above)

@oldrockingdave
I think that is one of the rogue Turkish spambots that sneaked in. You see them sometimes.

I’ve seen comments on whooping cough vaccines claiming that they won’t work because the vaccine had caused the whooping cough virus to mutate. Continual pointers to bogus studies by Andrew Wakefield…

What I consider one of the more fundamental problem with comparing the US and other nations is this country’s immigration rates. We have a fairly liberal immigration system, and enormous land borders that are relatively easy to cross without authorization. I am sure that, as a result, we have a large proportion of people with lower income and and a history of poorer healthcare that European nations would simply turn away.

David N. Brown
Mesa, Arizona

Graham (#53) states:

“I’ve seen comments on whooping cough vaccines claiming that they won’t work because the vaccine had caused the whooping cough virus to mutate.”

First, pertussis (“whooping cough”) is caused by a bacteria (Bordetella pertussis). Second, bacterial vaccines are – in general – less effective than vaccines against viruses, for a variety of reasons.

Finally, most of the claims about the pertussis vaccine leading to more infections by “mutant” strains (actually, a different species) are based (usually rather loosely) on the fact that the vaccine has reduced the prevalence of B. pertussis and, as a result, we are seeing a larger proportion of “whooping cough” caused by the less dangerous (but still very annoying) Bordetella parapertussis.

This is true and irrelevant – B. parapertussis lacks the pertussis toxin and thus causes a less dangerous disease. No doubt, there is work underway to expand the vaccine coverage to include B. parapertussis, much as the pneumococcal vaccine has been expanded to cover what used to be – before the vaccine – minor subtypes.

This isn’t necessarily an indication that the vaccines have caused an “explosion” of the other types, just that after the vaccines reduced the number of B. pertussis (or major S. pneumoniae subtypes) infections, those that are left are – surprise! – predominantly caused by B. parapertussis.

An analogy would be if you had a bag of jelly beans that was 90% red and 10% green and then removed 90% of the red jelly beans. The remaining jelly beans would be 47% red and 53% green, which might lead some people to say that there were more green jelly beans than before, when the absolute number of green jelly beans in the bag was unchanged.

The same thing is seen with pertussis (the recent California outbreak being an exception) – there is overall much less “whooping cough”, but more of the “whooping cough” that is seen is caused by the less-dangerous B. parapertussis. I see this as a win-win scenario – less disease overall and the disease that does occur is caused by a less dangerous organism.

Of course, that doesn’t fit well into an “anti-vaccine” agenda.

Prometheus

Prometheus,

Second, bacterial vaccines are – in general – less effective than vaccines against viruses, for a variety of reasons.

What does a viral vaccine got to do with B. pertussis anyway?

Finally, most of the claims about the pertussis vaccine leading to more infections by “mutant” strains (actually, a different species) are based (usually rather loosely) on the fact that the vaccine has reducedreplaced the prevalence of B. pertussis, as a result, we are seeing a larger proportion of “whooping cough” caused by the less dangerous (but still very annoying) Bordetella parapertussis.

No doubt, there is work underway to expand the vaccine coverage to include B. parapertussis,[…]

Yeah that’s sounds like a great idea. Replacement and substitution and then proclaim vaccines have reduced diseases. Nice.

This isn’t necessarily an indication that the vaccines have caused an “explosion” of the other types, just that after the vaccines reducedreplaced the number of B. pertussis (or major S. pneumoniae subtypes) infections, those that are left are – surprise! – predominantly caused by B. parapertussis.

Passing the buck.

An analogy would be if you had a bag of jelly beans that was 90% red and 10% green and then removed 90% of the red jelly beans. The remaining jelly beans would be 47% red and 53% green, which might lead some people to say that there were more green jelly beans than before, when the absolute number of green jelly beans in the bag was unchanged.

Your analogy sucks.

The same thing is seen with pertussis (the recent California outbreak being an exception) – there is overall much less “whooping cough”, but more of the “whooping cough” that is seen is caused by the less-dangerous B. parapertussis. I see this as a win-win scenario – less disease overall and the disease that does occur is caused by a less dangerous organism.

Double jeopardy is the game.

Of course, that doesn’t fit well into an “anti-vaccine” agenda.

No, it doesn’t.

in·fec·tion (n-fkshn)
n.
1. Invasion by and multiplication of pathogenic microorganisms in a bodily part or tissue, which may produce subsequent tissue injury and progress to overt disease through a variety of cellular or toxic mechanisms.

The American Heritage® Medical Dictionary Copyright © 2007, 2004 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.

Just sayin’

Thanks for sharing! I really like your post because it is very informative to know this information as it pertains to our health. It a must that we should always ensure our safety.

It is interesting to take the word “require”and search the article above. It seems that autism and death are reputed to be correlated with the “requirement” and not the actual number of vaccines administered. This opens up a whole new arena for research. A new government body could be form to issue “requirements.” And we could suss out which “requirements” have beneficial and which have non-beneficial impacts. Think how much money could be saved by simply issuing the appropriate “requirements.” We could require that everyone go the gym three times a week and see if there was any beneficial health effect. Another “requirement” could be that everyone wake up with a shot of whiskey. Vast vistas lie open before us. And no work to track what actually happens when people wake up with an eye opener. Only the “requirement” matters.

@54 David, so you’re saying the US health stats are screwed up by Mexicans? Because that’s what it sounds like. As someone who emigrated from the UK just last year (my wife is a US citizen) I find the statement that the US has a ‘liberal immigration system’ difficult to swallow given the hoops I had to jump through (including blood tests, and a cxr to check I wasn’t harbouring TB). Many European countries also have large immigrant populations from countries that are less developed in terms of health care infrastructure. Are there studies showing that if you remove such immigrants the national health stats improve in a significant way?

Iain, don’t get your knickers in a knot. LEGAL immigration is a pain in the ass in the US. I know. I hurried up and married my partner because of visa issues.

ILLEGAL immigration is what it is. We have an influx of Mexicans, Guatemalans, Chinese, Indians and various overstays.

While the data may not be skewed nationally, it certain skews on more local levels. I live and work in California. I can tell you that we have certain disease burdens virtually exclusive to immigrants and travelers from particular regions. If you removed these immigrants from our population, that disease burden would virtually vanish.

It happens. Public health tries to control the morbidity. It
is not politically correct to talk about, but sugar-coating the issue doesn’t get it fixed.

With that said, I’m looking at the most recently reported infant mortality stats for California, and Hispanics only have marginally higher rates of infant mortality than non-Hispanic whites (I did not check for significance of difference between groups). Blacks had the highest rates of mortality by a wide margin. It may be worth noting that Hispanics had some of the lowest rates of home births across all races (home birth woo is typically the domain of rich, white hippie chicks).

David seemed to be suggesting the problem is unique to the US. It isn’t. The same is true in the UK – I worked in a London hospital where cases of TB, malaria and HIV were almost all in immigrants or those who regularly traveled to developing countries. You could include sickle cell and thalassemia too. We have large numbers of Poles, Russians and Lithuanians here too now. Economic migration is a global phenomenon and brings both problems and benefits.

Actually, in public health in the United States, we do see some cases of active TB disease in older people who were exposed to TB years ago, when TB was more prevalent.

Anyone who is immune suppressed…the elderly…those undergoing immuno-suppressive cancer treatments and those who have AIDs…are at risk for activation of latent TB disease.

Presently HIV is transmitted via the usual blood-borne routes, but in the United States there is a growing number of older Americans who have been infected by having unprotected sex.

In the United States we have huge black populations, native born…here for generations…who have the sickle cell trait. A much smaller black population has the double whammy of sickle cell disease.

Thalassemia minor is present as well in out native born populations, along with a smaller number thalassemia major (Cooley’s Anemia) cases.

As I recall, the majority of the malaria cases reported to the health department were I worked were acquired by U.S. citizens who traveled to foreign countries where malaria is endemic. Prophylaxis against malaria is a long drawn out medication regimen pre-travel and post-travel. Some people experience some alarming side effects from the medication…that is why some people opt out and risk malaria. That is also why this public health nurse avoids international travel to countries where malaria is endemic. Occasionally, the MMWR and the Emerging Infectious Diseases Journal report cases of “airport malaria” (infection in people who work at or live in close proximity to international airports). The mosquito vector has the ability to hitch rides aboard aircraft.

I recall about 15-20 years ago a new federal law that mandated reporting of immigration status to the INS (Immigration and Naturalization Service) every “undocumented alien” who showed up in hospital emergency rooms and at public health clinics. That law was quickly amended…before its implementation date…by outcries from the private and public health sectors, based on humane access to health care and based on the public health consequences of mandatory reporting.

One does need to take into condsideration however the changes in the mother during pregnancy as they become more succeptable to underlying medical conditions such as gestational diabetes and how this affects baby and mom during and after pregnanacy. What remains important is that both mother and baby are looked after and their best interest is always taken to heart. Each person reacts differently and it is important to treat each person as an individual and not make to many sweeping generalisations.

@60,
Meant to reply sooner… I have been told, regarding refugees in particular, that the US admits more than the rest of the world combined. It is also my understanding that European nations CAN be much stricter than the US in immigration policy.

Regarding healthcare, my main thought would be that the US’s lack of “socialized medicine” is, in theory, more “immigrant friendly”: Recent immigrants don’t have to pay as much in taxes, and the government does not have to pay out as much to support them. Of course, that means the recent immigrants are more likely to receive poor medical care in comparison to the rest of the population. I would hesitate to call either approach “superior”.

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