Thursday, November 17, 2011

Book review: Vaccine Safety Manual

A friend of mine, during a lengthy discussion about the safety and effectiveness of vaccines, sent me a book called Vaccine Safety Manual. I read the Introduction and two chapters and wrote the following review in a personal email to explain why I found the heavily footnoted arguments made in the text unpersuasive. The letter has been lightly edited to remove personal references and clarify certain arguments not clear outside the context of the broader discussion.

To [my friend],

Thank you for sending me the Vaccine Safety Manual. I can see that it is the source of many of your concerns about vaccination.

I have read the Introduction, Measles, and MMR sections, and wanted to share my thoughts with you. (All quotations and page references are from the second edition, published in 2010. All italics are in the original text.)

But first, a little context.

I am not a scientist - I studied mathematics, computers, drama, and business, none of which are particularly relevant to the topic of vaccinations. I have a basic understanding of science, but within that biology is easily my weakest subject area. I have taken only one course in it (Biology 101 or its equivalent) so I am in no way an expert. I am skilled at logical inference but must defer to experts I trust on the details of any biological or medical issue.

The key word in the previous sentence is trust. Because my knowledge is only cursory, it would not be difficult for someone who has a deep understanding of biology to bamboozle me. If someone bluntly claimed humans didn't need oxygen to survive, I would walk away from the conversation knowing that person was a crank. But I probably could not refute a similar argument that got into the details of how the lungs extract only oxygen from air that contains mostly nitrogen, the chemical pathways of how that oxygen is converted into energy for our muscles to use, and a substitute substance that under certain circumstances replace oxygen as fuel during respiration.

My concern is that I may not be able to distinguish between a sophisticated, coherent, and accurate argument that should change my opinion about vaccinations, and a sophisticated, coherent, and fallacious argument that managed to mask its flaws (to my amateur eyes).

So I need to trust that whatever source I read has intellectual integrity.

Intellectual integrity does not simply mean that a person does not lie. It means that the proper context is established to give as complete and accurate a description of an event, process, or issue as humanly possible, with the relevant pros and cons, with each factor given the appropriate weight.

Let me give a completely non-medical example.

Michael Moore is a skilled and often entertaining filmmaker. His recent works are called documentaries, but I think they would be more accurately classified as propaganda (whether you agree with his take on issues or not). In Fahrenheit 9/11, there is one scene where he is interviewing a US Senator or Congressman. The elected official says something along the lines of, "If my constituents ever want to talk to me, they can call my 1-800 number and be connected directly to my office."

Just after he says that, there are some added subtitles: "Senator X doesn't have a 1-800 number. But you can call his office at (123)456-7890."

Assuming that Michael Moore was not lying in the subtitled text, this is a great Gotcha! moment. The Republican guy was caught fibbing on camera!

Except he wasn't. Not really. He had a toll-free number that started with 1-888. So while, technically, Michael Moore was not lying (the politician did not have a 1-800 number - though he did have a toll free number), he certainly was not presenting a portrait of this person with any form of intellectual integrity.

The key point is: you would never know about this sleight-of-hand tactic if your sole source of information was Fahrenheit 9/11. In order to have an accurate understanding of the situation, you need to have more knowledge than was presented in Michael Moore's polemic.

I fear I must conclude that, in a similar fashion, Neil Z. Miller lacks the intellectual integrity for me to trust him. I will assume from the outset that Mr. Miller does not lie outright. In fact, I find him refreshingly forthcoming. On page 17, he writes, "I never intended to ratify traditional beliefs regarding vaccine safety and efficacy." On page 26, he writes, with considerable understatement, "this book does not emphasize vaccine benefits." I do not have access to many of the studies he quotes or summarizes, and even if I did, I do not have the time to follow up every reference. But here, on the first and last pages of the Introduction, he bluntly states that he did not conduct his research with an open mind and let the weight of evidence determine his conclusion. He had an agenda, which he explicitly sets out, and would report on whatever he could find that matches his already fixed decision. And having read three sections of the book, I conclude he writes about ONLY those things that support his predetermined viewpoint.

The book may be many things, but it is certainly not a fair, dispassionate, objective, or reliable guide to the risks of vaccinations (according to Mr. Miller, there are few if any benefits).

On page 18, he writes, "one-third of highly cited original clinical research studies were eventually contradicted by subsequent studies." The clear implication is that the conclusions of highly cited studies are suspect. There are a few reasons why this is misleading: 
  1. This means that two-thirds of such studies have withstood the test (and re-test) of time.
  2. The paper had nothing to do with vaccinations. It was written by Dr. Ioannidis, who was profiled in a November 2010 Atlantic article (about which I wrote: "“It has been said that democracy is the worst form of government except all those other forms that have been tried from time to time.” - Winston Churchill, 1947. Could the same be said for double-blind studies and medical science? Kudos to the medical community for welcoming his Dr. Ioannidis' research and results - but its implications are staggering.").
  3. This is roughly what one would expect with scientific progress. We learn more; we get better; previous results/theories/methods are refined, or in some cases, rejected. Either Miller doesn't understand this basic principle of science, which makes me wonder whether there are other fundamental gaps in his knowledge, or he does understand this, but is happy to deliberately mislead his readers, which does not make me inclined to trust him.
  4. I had hoped that Miller would apply a similar standard of excellence to the studies he cites that initially supported his position, if any of them were contradicted by later research. He does not, as we'll see below. 
Also on page 18, he writes, "The media is loathe to publish anything that challenges the sacrosanct vaccine program." This made me laugh. Does Miller live in an alternate universe where Jenny McCarthy, Oprah Winfrey, and many others are not given plenty of air time and print space? The purported vaccine -> autism link has been given enormous media attention. He's not accurately representing reality.

Page 19: "3 percent of all children six months to one year of age who received the vaccine ended up in the hospital with respiratory problems!" 3% may be bad, but perhaps not. What is the rate for infants who didn't receive the vaccine? One percent? 10%? We don't know, because Miller doesn't tell us. And because it is supplied in isolation, absent the relevant context, the 3% figure is useless.

Page 19: "A whopping 62 percent [...] had systemic reactions," which could be any of a long list of symptoms including headaches and muscle aches. It's clear that Miller is implying that vaccines cause "systemic reactions" in a majority of people. But that's not fair. When I get a needle in the arm, it aches for a couple days, no matter what it contained (including when the needle contains nothing, such as when I donate blood). The needle itself causes some discomfort. Given the muscle ache criterion, I'm surprised the number was below two-thirds. Plus, vaccines are often weakened viruses. So a mild reaction is often to be expected. That's probably why doctors consider it "normal," not because (as Miller implies) doctors are all part of a vast vaccine conspiracy. Miller does not mention that a getting a headache might be preferable to contracting meningitis.

Page 21: "The pure and innocent baby is overdosed with 38 vaccine-drugs". There is just so much wrong with this sentence. The opening is clearly inflammatory language - "pure and innocent" is not there to convey information, it's there to provoke a strong positive emotional reaction, to contrast with the damage one must be doing by subjecting this beautiful being to an "overdose". There is no explanation of "overdose" - why is 38 (over the course of a year and a half) an overdose? Would 3 be an overdose? Why or why not? Would 300? I don't know, and if Mr. Miller knows, he isn't sharing. Note too the invented hyphenated compound word "vaccine-drugs", because one associates overdosing on drugs, not on vaccines. This isn't honest writing - it's pure propaganda.

Here's the analogy in the text, all he provides by way of explanation (referring to the combined Measles, Mumps, and Rubella (MMR) vaccine): "If you pour three separate glasses of whiskey, gin, and rum into one bottle, you're still ingesting three alcoholic drinks with all of the expected effects." Well, yes. If this wasn't the case, then consolidating separate measles, mumps, and rubella vaccines into a single injection would rather defeat the purpose, wouldn't it? Miller takes an argument that favours current immunization practices and tries to spin it to sound negative.

Page 21: "The United States is the most vaccinated country in the world, yet it has a poor infant mortality rate." The latter is definitely true, and I will assume the former is as well. But what are the most relevant factors determining infant mortality? I would propose that childhood poverty or the tens of millions of people/families/children without health insurance (who therefore have limited access to health services) are far more responsible for the poor showing of the US in this regard. I would guess that Canada or Sweden have a similar vaccination rates as the US, but very different infant mortality rates. The argument is a red herring.

Page 21: "There is evidence that when children are young and exposed to disease naturally, and then recover, the immune system is stimulated and strengthened." True. The immune system is also stimulated and strengthened when children are young and exposed to attenuated versions of diseases via an immunization program. And with immunization, you have far fewer children that are exposed to the disease and do NOT recover. Which is better for a society? Once again, Mr. Miller does not lie. But he guides the reader to a false conclusion that he does not explicitly state. I cannot characterize his writing on page 21 as honest.

Page 23: Miller here argues, curiously, that vaccines work. He accurately says that when you vaccinate a population for one strain (of six) haemophilus influenzae, the other five are more prevalent in those who get the flu. Similarly, he argues that preventing seven strains (of 90) of pneumococcal disease is *worse* than preventing none. The logical extension would be that until vaccines have been developed for every strain of every disease, they are somehow bad. I truly do not follow his argument here at all. What is he trying to say? (He applies the same bizarre logic to the HPV vaccine in Figure 81 on page 257.)

Page 24: "Sadly, our lawmakers are impotent to effect meaningful change." Baloney. See my media comment above. Mr. Miller seems to confuse "unable" with "unwilling" - lawmakers, with some exceptions, do not want to see a vast increase in preventable childhood disease.

Page 26: "I never give advice." HAHAHAHA! I thought he had to be joking, but apparently he's earnest. What does he call the previous nine pages?

Miller lists a large number of horrible side effects, up to and including death, on page 114 and in Figure 30 on page 115 that have been "linked to" the measles vaccine. If the vaccine caused these side effects, I'm reasonably confident Mr. Miller would have said so. So what does "linked to" mean? I don't know, and Mr. Miller doesn't define the term.  He also doesn't give any indication of how many people experience adverse reactions. It is one in ten million? One per hundred thousand vaccinated? One in ten? The book doesn't say. Mr. Miller omits crucial information that could greatly strengthen his argument or render it utterly moot (he does so again in Figures 48, 60, and 79). One cannot possibly make an informed decision based solely on the data provided in this book.

On page 117 and again on page 149, Miller refers to Wakefield's discredited 1998 Lancet paper. This book was published in 2010, so I don't expect the book to contain references to the fact that Wakefield lost his medical license in May 2010 and that the paper was formally retracted in February of that year. But he writes on page 149 (and uses the identical phrase on page 158), "Wakefield and his world-class team of medical experts" without mentioning that 10 of the 12 authors retracted their names from the paper in 2004 - six years before this edition of the book was published. Either he knew that over 80% of this "world-class team" denounced the paper's findings and did not disclose this information, or he was not aware of a major change to a landmark study that received considerable publicity at the time. Either way, Miller is highly irresponsible.

Page 159: Miller approvingly repeats Wakefield's contention that "thirty-one children is too small a number" to draw any conclusions. Yet Miller refers to the 1998 Lancet paper at least twice, in glowing terms, without mentioning that it studied only 12 children. The double standard is glaring, and galling.

On page 160, Miller refers to an *interim* report from the Immunization Review Committee, quoting "models linking MMR vaccination to autism spectrum disorders, although far from established, are nevertheless not disproved." Two things: It is nearly impossible to prove a negative. The committee was stating a truth, but Miller invests it with far greater weight than is warranted. But the final report, issued in 2004, stated clearly that the "evidence favors rejection of a causal relationship between the MMR vaccine and autism." This is known as quote-mining - selecting quotations out of context to make it appear the author is supporting a stance other than intended to support your own argument - and I strongly suspect that this is not the sole instance of this practice in the Vaccine Safety Manual.

At this point I deemed Miller's credibility to be irreparably damaged.

Doctors and the medical profession do not automatically and blindly condemn and ostracize those that criticize the profession. Look at the example of Dr. Ioannidis. The medical community embraces his stinging critique of the gold standard of medical research. On the other hand, Wakefield is not persecuted because he dared to stand up to the establishment. Wakefield is persecuted because he abused children in his care and committed multiple counts of fraud. Medical professionals are highly critical and disdainful (quite rightly, in my view) of shoddy research methods, lax methodology, gross conflicts of interest, and bad science.

Miller assuredly makes many claims that I have not refuted here; but I hope I have demonstrated why I do not trust that Miller is intellectually honest - that is, that I can take him at his word that he is portraying the risks of vaccinations accurately. As Miller himself states, he is only interested in presenting one side of the argument.

For a more balanced view, read the Immunization Review Committee report where they describe their approach: "The committee begins from a position of neutrality regarding the specific immunization safety hypothesis under review. That is, there is no presumption that a specific vaccine (or vaccine component) does or does not cause the adverse event in question. The weight of the available clinical and epidemiologic evidence determines whether it is possible to shift from that neutral position to a finding for causality (“the evidence favors acceptance of a causal relationship”) or against causality (“the evidence favors rejection of a causal relationship”)."

That's how science should be done - allow the evidence to determine your conclusion. Miller had already decided what his conclusion was, and sought the evidence to back it up. The difference is crucial. And that is why I will trust the Immunization Review Committee report, but not the Vaccine Safety Manual.

I took notes and wrote all of the above to demonstrate that I have not rejected Miller's arguments lightly. I am not a doctor, have no firm grounding in biology, and only the most cursory knowledge of how vaccines work. But even so I am convinced that the Vaccine Safety Manual, supposedly an authoritative tome on questioning the wisdom and efficacy of vaccinating a nation's children, is (at best) misleading. One cannot trust the author to honestly inform the reader on significant points. Rather than using evidence to build a rational justification for questioning the efficacy of vaccines, Mr. Miller engages in half-truths, misleading arguments, and emotionally laden language to advocate for his ideological position.


  1. Hi Leslie. I came over from Respectful Insolence. With Regard to "The United States is the most vaccinated country in the world, yet it has a poor infant mortality rate."
    The US uses a much broader definition of Live Birth than most other countries. That is why it at first seems poor. If other countries used the US definition of Live Birth, their statistics would also look quite bad.

  2. Thank you, autismjungle. This additional piece of context is good to know. I am not surprised that Miller omitted this relevant piece of information from his book; it is consistent with how he wrote other parts of it.

    It only adds to my opinion that Miller is dishonest in his writings. It is unlikely that he conducted sufficient research to determine that the US had higher infant mortality rates than other countries without also realizing that definitions differ across nations. Instead of acknowledging this, however, he tries to blame vaccines. The man lacks intellectual integrity.

  3. It won't surprise you then that Neil Z. Miller's 2011 paper "Infant mortality rates regressed against number of vaccine doses routinely given: Is there a biochemical or synergistic toxicity?" was equally mendacious.

    See the analysis at the blog Just The Vax Infant Mortality and Vaccines and a slightly different take at Respectful Insolence.

    1. Thank you, Liz Ditz. Clearly, presenting data in a misleading manner is endemic to Neil Z. Miller's writings, and not limited to the Vaccine Safety Manual.

      I was not inclined to believe his arguments before, but now I am convinced he is a thoroughly unreliable source for anyone seeking a genuine understanding of medical issues.

  4. Dr. Amy Tuteur, aka the Skeptical OBGYN and a rather polarizing figure certain communities, has a post whose first point is a discussion of why the US infant mortality rates appear higher than many other countries.

    You might also want to revisit the book to see if the adverse effects "linked to" vaccines came from the VAERS database, which is a questionable source since it can be used by anyone to report any side effect, including being turned into the Incredible Hulk.

    1. Dr. Tuteur says infant mortality, which measures death within the first year, is the wrong statistic to measure obstetric care (and one should use perinatal mortality, which deaths from 28 weeks of pregnancy to 28 days after birth).

      This seems reasonable enough for her purposes, but since the first vaccines are not usually administered until infants are at least two months old, infant mortality is the better measurement if one wants to make an argument against vaccines.

      Assuming Dr. Tuteur's assertion, "The US has one of the lowest rates of perinatal mortality in the world" is true (and this report backs up the claim - only a few countries, such as Canada and some western European nations fare better), isn't it interesting that the US has among the lowest perinatal mortality rate but an alarmingly high infant mortality rate? (According to the United Nations, the US ranks 34th; the CIA factbook claims the US is 50th.)

      Interesting as this observation is, I do not think vaccines are a relevant factor having a significant impact on either statistic.

  5. After reading your analysis of Miller's book, all I can say is that you are one smart person, Leslie.

    I wish more people (including myself) would think more critically from time to time about what we read, hear, and see.

    1. Ha! Great comment. How much did you get paid to write it? If that's the best you can do you aren't worth the money.

  6. Leslie, thank you for this thoughtful analysis! I stumbled upon it searching for information after a friend posted a quote of Neil Z. Miller's. I knew my skeptical alarm went off for good reason.

    1. Thank you for your comment. Reaching out to people like you was a primary motivation for starting this blog. I am glad you found it useful. You brought a large smile to my face today.

  7. Thankyou Leslie for your review. Critical thinking in todays society is not done by enough people and I see this problem occurring more and more. Especially on internet forums. Your review is really good and shows well how people market there agenda's by only including information that supports what they are saying.

  8. That leaves only one question left unanswered. Wgat was your friend's response to this,

  9. I would like to print off your review and slide it into copies of the "Vaccine Safety Manual" at all my local bookstores... just so people get a bit more balanced view should they chose to read it. Too many people lack the critical thinking skills that you do in order to make actual "informed" decisions, which is why so many childhood diseases that were once eradicated in the western world are now making a come-back.

  10. Kat mac is a troll