Clarifying my views on chicken pox vaccination

First of all, let me say that the discussion with Dr. Novella and Orac has been partly enjoyable, as in sharpening my debate skill, and partly like a school yard brawl, which I will invariably lose because I am not interested in that kind of a zero-sum game. It is all well and good to say that your tone is your tone, but it is an altogether different matter when personal attacks are involved. I know, I started it. But did I really? Well, no matter, that is quite unimportant.

Here are a couple of interesting bits. First of all, go to this blog, where Eddy Jenner, a clinician in Australia, blogs about his encounters with EBM at the bedside -- he provides a fascinating, well-reasoned and well-read perspective. His most recent post is illuminating particularly in the context of the current discussion. It reminded me that I am much more interested in general in improving everyone's understanding of how we do clinical research than debunking alternative approaches. 

Next, I want to articulate why it is I think that chicken pox and HPV vaccines strike me as being less straight-forward than, say smallpox, polio or pertussis. There are 3 things to remember about medicine as a science:

1. With every intervention's benefit there is also a risk of an adverse event.

2. What we think we know today will be different in a decade.

3. It is the obligation of medicine first to do no harm.

None of the 3 statements is particularly controversial or new, and I think everyone can agree on them. So, what? 

Here is the so what. Since what we know today is necessarily incomplete, it is quite probable that there are many risks to our treatments, which today we just do not have the data to understand, but will be known in the future. Alas, we do not have a crystal ball to see what is coming down the pike, so, being circumspect about what we are so sure about today should be the norm. For example, when the risk of serious complications from a disease is extremely high (think smallpox, polio, diarrheal diseases in Africa, etc.), then, if the treatment (vaccine) diminishes this risk substantially (how about no more smallpox?), and there is no immediate reason to think that the risk of that treatment is overwhelming, then the risk-benefit equation is hard to tilt away from the benefit. However, when the risks of the complications or death from a particular disease are not that high (relatively speaking, of course), then one really has to examine the risks of the intervention with a much finer lens. And indeed, here is a study on chicken pox vaccination and deaths that showed that from pre-vaccination period to post-vaccination period deaths declined on average from 145 to 66 per year. So, that's pretty good, if there were absolutely no deaths associated with the vaccine itself. But invariably, there are, and this is less a function of the vaccine safety than it is of the human substrate that is being injected. In fact if you check CDC Wonder's VAERS, you will see that on average there are about 14 annual deaths that may be related to varicella vaccination. Now you may say that the balance of this intervention is in the direction of the benefit, and you will be correct. But the magnitude of this benefit makes me a bit cautious. If we were talking in purely scientific terms, I would worry about the possibility of type I error, where the difference is really there by random chance. But we also know that we are not all rationality and science, and there is a lot of emotion involved in this debate. So, it is easy to see how these numbers lead to a variety of interpretations and opinions. And add to this the idea that it is not inconceivable that some other safety signal may come along in the future, and it becomes patently obvious why the issue is difficult to reduce to either ethics or idiocy when one is really committed to science and its principal nostrum of "first do no harm".      

A teachable moment

There are two things I want to discuss in this post. Though at first glance seemingly unrelated, they will fit together in the end.

As I already mentioned here, I utterly delighted in Dan Ariely's erudite account of our predictable irrationality. In this book, he reminded me of a thought experiment initially conceived by the recently deceased philosopher Philippa Foot. The problem is usually referred to as "the trolley problem", and can be presented in several ways. Here is how Joshua Greene at Harvard formulates it:

   First, we have the switch dilemma:  A runaway trolley is hurtling down the tracks toward five people who will be killed if it proceeds on its present course. You can save these five people by diverting the trolley onto a different set of tracks, one that has only one person on it, but if you do this that person will be killed. Is it morally permissible to turn the trolley and thus prevent five deaths at the cost of one?   Most people say "Yes."

   Then we have the footbirdge dilemma:  Once again, the trolley is headed for five people. You are standing next to a large man on a footbridge spanning the tracks. The only way to save the five people is to push this man off the footbridge and into the path of the trolley.  Is that morally permissible?  Most people say "No."

    These two cases create a puzzle for moral philosophers:  What makes it okay to sacrifice one person to save five others in the switchcase but not in the footbridge case?  There is also a psychological puzzle here:  How does everyone know (or "know") that it's okay to turn the trolley but not okay to push the man off the footbridge?

Indeed, if the sum total of deaths is the same, how is it that one seems OK, while the other does not? Is this just a bunch of irrational emotional baloney, or is there science that can shed some light on it? Well, as it turns out, Greene has postulated the "dual process theory" of moral judgment. He has performed brain imaging to understand better what is happening physiologically, and here is what he is finding:

   According to my dual-process theory of moral judgment, our differing responses to these two dilemmas reflect the operations of at least two distinct psychological/neural systems.  On the one hand, there is a system that tends to think about both of these problems in utilitarian terms:  Better to save as many lives as possible.  The operations of this system are more controlled, perhaps more reasoned, and tend to be relatively unemotional.  This system appears to depend on the dorsolateral prefrontal cortex, a part of the brain associated with "cognitive control" and reasoning.

  On the other hand, there is a different neural system that responds very differently to these two dilemmas.  This system typically responds with a relatively strong, negative emotional response to the action in the footbridge dilemma, but not to the action in the switch dilemma.  When this more emotional system is engaged, its responses tend to dominate people's judgments, explaining why people tend to make utilitarian judgments in response to the switch dilemma, but not in response to the footbridge dilemma.

So, here is the science to explain what we already know intuitively. It underscores just how difficult risk-benefit decisions are, and that if we only take into account our rational selves, we will always walk away puzzled as to why it is that there is controversy about stuff, such as, say, interventions in healthcare.

So, this is point one. Point two illustrates how counterproductive acrimony can be in trying to achieve some common ground. There is a response from Orac on Dr. Novella's site here, which calls me on the use of the adjective "rabid" to describe vaccination "defenders". Without explicitly stating it, he also continues to equate me with "anti-vaxers". But also does something else: he provides a link to a previous post that I did in the middle of the H1N1 pandemic. Please, indulge me for a moment while I quote myself:

The H1N1 pandemic is bringing into focus not only the world's vulnerabilities vis a vis the spread of an infectious disease, but also our complete lack of a framework in which to make rational choices about prevention. The cornerstone of preventive efforts for any significant infectious disease is vaccination of a large swath of the population. The rapid development and approval of the H1N1 vaccines is both a blessing and a curse, given the sophomoric level of discussion about its risks and benefits.

Does this look like I am anti-vaccination? Indeed, it looks to me, and this reflects my intellectual stand, that I am in fact advocating for vaccination, as well as for bringing our vaccine discussion to a more scientifically literate level. Feel free to read the entire post, if you do not believe me. But what is obvious is that my name-calling resulted in people, who consider themselves otherwise rational, paying attention only to the insult. Thus, I negated the substance of my post just with one poorly chosen word. Is this a rational reaction to what is otherwise a perfectly pro-vaccination stand? I do not think so, but what it is is a human reaction, and in that it is perfectly understandable and, dare I say it, predictable.

In fact, the post in question ties the two seemingly unrelated ideas, as promised at the beginning.  Although admittedly not very skillfully, in my vaccination post I illustrated the trolley problem, where the accounting of the balance of risk-benefit is not at all straight-forward. I will probably address it more extensively in a future blog post. On the other hand, I also showed how one single insult in a 500-word essay can become the only take-away, thus detracting from the overall message. This is exactly the reason for us to stop the name-calling by both sides, and engage in a discussion to arrive at some mutual understanding of what is really a worthwhile exchange of ideas.  

   

Addressing the comments

A very lively discussion indeed! Thanks to everyone who contributed, and thanks for keeping it civil, mostly.

A couple of thoughts on some of the comments:

1. Craigmont: "Between the testable and the untestable; between science and woo; there can be no middle ground. You're going to have to pick a side."

Really? There is no middle ground? I have to choose a side? Really? I am pretty sure that this is how we advance a discussion or knowledge. Seems to me that this is a good way to get elected to office these days, as well as sell news. But does it really get us to a better, more advanced place? I think not.

2. Timm: "You may not have meant the term "allopathic medicine as derogatory, but that is indeed, what it is. It is a slight, a slur, a marginalization.Many people these days recognize what it refers to and do not (as you) intend it as a slur, but it remains a belittling term."

OK, Timm, the point is clear, even though there is nothing that seems to suggest its derogatory nature other than who coined it. This notwithstanding, I am perfectly happy to respect your experience of the word and not use it in any way. But here is what I need from you: 1). Please, tell me what term you would like me to apply to Western medicine that differentiates it from other? and 2). Do you think that "woo" is a respectful way to refer to the other side? Or perhaps you think that "those people" do not deserve your respect, so it is OK to use derogatory shorthand. Either way, if we are interested in advancing the issue in some direction, there has to be a civil conversation between the opposing sides. So, I would suggest that we aim for that, and the way to start is to stop calling each other names, knowingly or not, as you pointed out.

3. Liz Ditz: "To me, high uptake rates for all vaccine-preventable illnesses, including those you characterize as minor (varicella or chicken pox) are a social justice issue. The social and economic costs burden of vaccine-preventable diseases falls disproportionately on those least able to pay for them: the poor and the working poor."

Liz, can you please say more about what you mean? I think that I understand, but want to be sure that we are talking about the same thing. Thanks.

4. Ian Monroe: "They are constantly talking about what a complicated process science is. And it is a process, not an answer. Of course the media is pretty much a four-letter word on their blog."

Yes, Ian, and I am constantly talking about it on my blog as well. And to me, even though I share similar understanding of evidence as the SBM group, my conclusions are different. And they are not only my conclusions. And this is why it is important to have this conversation: in science, as in anything else, you can look at the same data, and walk away with very different lessons. This is why I advocate an open-minded conversation between the opposing sides, rather than just throwing grenades at each other across an imaginary separating line.

5. Calli Arcale: "Homeopathy, in the traditional sense, should be harmless except insofar as it causes people to delay effective treatment. However, what is sold today is not strictly homeopathy in the traditional sense."

Dear Calli, can you show me a study or a body of evidence that indicates the presence of a delay, the magnitude of that delay and the real consequences of it (i.e., morbidity and mortality)? Something that can be specifically attributed to it, rather than the patient's own reluctance to present to a physician for a work-up? In other words, I am interested in the attributable outcomes of what you are referring to. As for your second point (and this was brought up by several commenters), can someone tell me how the mechanism of recalling the harmful stuff from the market is different from these preparations than it is for conventional pharmaceuticals? Thanks.

6. Opit: "Sorry. You've lost."

 Really? Somehow I do not feel like I've lost. Somehow I feel like I've won. The discussion is enriched, the tone is more constructive, and we are actually getting to the issues. Contrary to our political discourse, this is not a zero sum game. My aim is not to walk away with the same opinions that I started out with or making the chasm between us more prominent. My desire is to understand the issues better and to have a respectful conversation about stuff that we feel is important. So, while I thank you for your strategic advice, I will not be following it.

7. moderation: "As to the varicella vaccine, I think you have fallen victim to 'I have not seen it, so it must not exist' syndrome."

Dear moderation, while it seems to be the habit to draw inferences about people in the conversations that I have seen in other blogs, I would prefer it if you did not do so here. Most of the time, as I try to teach to my students, these inferences will be incorrect. I think we should stick to the arguments that have been made, and if you want to extend it to inquiring as to whether or not I have fallen victim to denying the invisible (in this case a bad thing), please, inquire away first. Now you have to go back and come up with a different hypothesis, alas. And if you sense a little bit of snideness in my remark, please, forgive me this transgression, as I am so wary of people assigning labels to others based on what they want to see only and not in what is really there. 

8. Orac: "Ah, yes, the 'just asking questions' gambit."

Really? Come on! You don't mean that asking questions is anti-science, do you?

I am grateful to see that Dr. Novella has posted a response to my response. His response seems measured and inviting to a respectful discussion, and I particularly appreciate that. I will take the time later to address some of his points further in a different post. In the meantime, let the discussion continue. I would love the answers to my questions above, so that I can get educated further on these issues.

As ever, thanks!  

 

  

  

   

Furthering the discussion

My original intent was to go through Dr. Novella's and Orac's criticisms individually and take it from there. On second thought I decided not to take that approach. Instead, here is my response.

Firstly, I am grateful that there has been so much discussion about our views. Amid many valid points in their posts made with a skillful turn of the phrase, I saw quite a lot of sarcasm as well. I am sure that the tone of my original post is what incited it, and for that I am sorry: I really do want to have a civil discussion about these ideas, as I realize that we are all learning all the time, and the only way to gain a better understanding of a topic is through discourse. So, again, I apologize for setting the confrontational tone, and will try to avoid it in the future.

I do believe our views are more same than different. We both (SBM group and I) understand that science evolves, that evidence is not stagnant and the sense of certainty frequently conveyed to the lay public by the media is oftentimes misplaced. We simply disagree on the extent to which there is uncertainty in evidence. While it is true that the oft-cited 5-20% number representing the proportion of medical treatments having solid evidence behind them is very likely outdated, the kind of evidence we are talking about is a different matter.

In the hierarchy of evidence, depending on where you look, it is either meta-analyses or the randomized controlled trial that is the gold standard. The latter is a great proof of concept tool, but it is necessarily limited in its external validity, or generalizability. The reason for this is that these trials, frequently done for regulatory purposes, very limited types of patients, exert extremely stringent controls on the total care of the patient (or else are criticized for not doing so if they fail to do so), focus on short-term and surrogate outcomes (hence, the use of cholesterol lowering as a marker for cardiac mortality, for example), and do a fairly abysmal job as a rule considering the sources of heterogeneity of response. The interventions come to market and are typically used in a much broader population based on the evidence of the RCT. This paper, one of many in the same vein, is a nice illustration of a perennial problem with trial evidence, where real-world use of a therapy goes far beyond the available evidence. And although this paper addresses issues with evidence used for reimbursement, these are the same studies that feed guideline recommendations. Certainly meta-analyses, which are a way to combine the data from multiple RCTs in a systematic way, when done well can give us greater confidence of the direction and the magnitude of the treatment effect, but they in no way overcome the generalizability issues of their component RCTs.

The next rung of the evidence ladder is observational data, specifically cohort studies first prospective, then retrospective. I am actually a great fan of observational data, as I have mentioned in the past. Cohort studies give us the opportunity to examine what happens in the real world without imposing artificial conditions necessary in a clinical trial. Observational data can be great when describing epidemiology of a particular disease, the frequency of a given exposure, how different characteristics can modify the relationship between the exposure and the outcome. One of the most attractive features of cohort studies is that the population can be observed over long period of time -- just look at the Nurses' Study, the Framingham Cohort, and others. But these types of studies also have important limitations, and these are readily acknowledged as a heightened susceptibility to bias (especially in the retrospective studies), the possibility of misclassifying important events, and, despite our best efforts to adjust for it, residual confounding. I will come clean and admit my affection for observational data, even despite the fact that it is lower on the totem pole of evidence than an RCT. I really love this paper by Rothman and Greenland that takes a bird's eye view of our research debates. The whole paper really tickles the brain, but I will quote from a section of it briefly here:

Impossibility of Proof

Vigorous debate is a characteristic of modern scientific philosophy, no less in epidemiology than in other areas. Perhaps the most important common thread that emerges from the debated philosophies stems from 18th-century empiricist David Hume’s observation that proof is impossible in empirical science. This simple fact is especially important to epidemiologists, who often face the criticism that proof is impossible in epidemiology, with the implication that it is possible in other scientific disciplines. Such criticism may stem from a view that experiments are the definitive source of scientific knowledge. Such a view is mistaken on at least two counts. First, the nonexperimental nature of a science does not preclude impressive scientific discoveries; the myriad examples include plate tectonics, the evolution of species, planets orbiting other stars, and the effects of cigarette smoking on human health. Even when they are possible, experiments (including randomized trials) do not provide anything approaching proof, and in fact may be controversial, contradictory, or irreproducible. The cold-fusion debacle demonstrates well that neither physical nor experimental science is immune to such problems.

Some experimental scientists hold that epidemiologic relations are only suggestive, and believe that detailed laboratory study of mechanisms within single individuals can reveal cause–effect relations with certainty. This view overlooks the fact that all relations are suggestive in exactly the manner discussed by Hume: even the most careful and detailed mechanistic dissection of individual events cannot provide more than associations, albeit at a finer level. Laboratory studies often involve a degree of observer control that cannot be approached in epidemiology; it is only this control, not the level of observation, that can strengthen the inferences from laboratory studies. Furthermore, such control is no guarantee against error. All of the fruits of scientific work, in epidemiology or other disciplines, are at best only tentative formulations of a description of nature, even when the work itself is carried out without mistakes.

What follows in the hierarchy of evidence are case-control studies, done for some very specific reasons, then case reports and finally expert opinion. When evidence-based guidelines are developed, a comprehensive systematic literature review is undertaken, and all the evidence is examined and ranked. Based on these papers, a recommendation is made and a strength of this recommendation is reported based on the quality of the underlying evidence. This is an arduous and costly process, and it is commendable that it is undertaken. At the same time, given the limitations of the components of the guideline, the final product can be quite inconclusive or even misleading (I hate to bring it up, but look at the screening mammography debate, as well as the recent HRT recommendation reversal). I think it is obvious that I believe in the scientific method, I am simply not convinced that we have done such a great job generating trustworthy evidence in many instances. At the same time, I am not totally nihilistic about what we know, but am somewhere between thinking we have good evidence for a lot of stuff vs. not having any for anything at all.

Allow me one more piece of evidence, if you will, though this is merely anecdotal coming from my dual experience as an author and peer reviewer. I am occasionally floored by the quality of peer review. I have had reviews say on the one hand that of course the paper should be accepted, since it comes from such a reputable group, and on the other reject out of hand papers based on the reviewers' profound lack of understanding of the methods employed. And lest I sound like a crybaby, let me say that I welcome a well-reasoned rejection. What I am talking about is not that. And this is not a surprise, since pretty much anyone can sign up to be a peer reviewer, since, to the best of my knowledge, there is no set of qualifications that journals ask for in their reviewers. And this, so far as I know, applies even to such high caliber publications as JAMA.

So, these are my thoughts on evidence-based medicine. I welcome responses to this, as my understanding of this science is constantly evolving, and differing well-reasoned opinions really help me get a better handle on this stuff.

I will try to tackle my CAM argument next. If I in any way implied in my remarks that I encourage allopathic physicians (by the way, I am not using it in a derogatory way, but merely as it is defined here; in fact, until today I was blissfully unaware of its negative connotation) to be purveyors of CAM, I sincerely apologize. I am pretty sure, however, that I have never made such a statement, as this is not what I believe. My belief is that all modalities that may impact what happens to public's health need to be evaluated for safety, not question. I think we both agree, since there is really no reason to think that something like homeopathy has anything that can help, by the same token we do not believe that it have anything that can hurt. Same with healing crystals, reiki and prayer. So, if a person wants to engage in these activities, and they are perfectly safe physically, be my guest. Other modalities, such as chiropractic, acupuncture, herbalism and the like, definitely need to be evaluated more stringently, as there is reason to think that they may cause harm. And the decisions about their use must be made based on the probability of harm vs. the perceived probability of benefit. Why do I think that these should not be regulated the same way as allopathic treatments? Well, herbs grow naturally and I dare say we have little to say about what our patients grow in their back yards, unless of course the thought is to regulate them the way we do marijuana. As for chiropractic, it is already regulated, though to what extent I am not sure, and would love to hear from someone who knows. Since its techniques most resemble surgical interventions, the level of evidence for them should perhaps be the same as that which we demand in the surgical literature. This is just a thought, and I am not sure that I am correct in this, so other views are, as always, welcomed. What is coming through for me is that perhaps my call to equipoise was a little over the top, as I do not seem to be approaching the above CAM issues in a frequentist, but more in a Bayesian way (though I remain committed to equanimity). Yet, there is something to be said about the frequentist approach, even though it is not my way generally. The frequentist approach, which is what underlies the bulk of our traditional clinical research, does not rely on differential prior probabilities for different possible associations, but treats them all equally. Despite many disadvantages, one obvious advantage is that we do not discount potential associations that do not have biologic plausibility, given our current understanding of biology, and sometimes help us stumble on brand new hypotheses. So, clearly, there is a tension here, and I am still working on what is the better way, if any.

My final words will be about vaccination. It is disheartening to be lumped with "anti-vaxers", as has been done in the comments to Dr. Novella's and Orac's posts. While my bruised ego will survive this insult, I would like to question this assertion. Nowhere have I said that vaccinations are a bad idea or present a real danger to our children. The hype surrounding the vaccination-autism "debate" is abhorrent to me. What I have stated, however, is that I am of the opinion that we have gone a bit overboard with some of them, one being the chicken pox vaccine. Now, this does not make me an "anti-vaxer"; this just makes me a bit skeptical. The way I view the data is that the advantages for this vaccine are mostly economic, in that they prevent parents from missing days at work. Now, I am certainly not opposed to making such a vaccine available to parents who desire it, but I am not convinced that it should be a prerequisite for my kid to go to school. Given that there is always a possibility of an adverse reaction, no matter how small that possibility is, if the risk of it may outweigh the benefit (and here I do not mean the benefit of having mom show up at work), it has to be weighed very carefully. And even though the question asked by one of the comments raises the issue of an immunocompromised child worrying about potentially being exposed to chicken pox, given the known issues with breakthrough disease, I am not sure that immunizing all of his/her contacts would produce anything other than a false sense of security. My sentiment about the HPV vaccine is similar, to respond to another comment. For reasons laid out here and elsewhere on my blog, I am pretty convinced that it would be a compete subversion of the intent of vaccinations to make it into another mandated shot. To date HPV is merely a recommendation, whose validity I am free to question, though last I heard there was movement afoot to make it mandatory. If in your informed opinion your daughter should get vaccinated against HPV, well then I have very little to say about it. But if I were to counsel an individual patient in the context of my understanding of the data, I would be very upfront with my view.

To me the fact that there are such heated debates about this stuff is a testament exactly to how NOT straightforward our science is. I do understand that as a researcher I can afford a certain amount of analysis paralysis that is unacceptable at the bedside. However, I think we (and the press) do a disservice to the patients, to ourselves and the science if we are not upfront about just how uncertain much of what we think we know is. I could not have said it better than this story about Dr. Devereaux's presentation at the recent ASA meeting did here:

It would be nice if we could all agree that science is not static, but rather progresses and regresses. We learn, and then find out that some of what we thought we had learned was wrong, and set about using that information to seek the next level of truth. Repeat, ad infinitum. Personally, I’d love it if my doctors couched every bit of advice with, “Here’s what we think we know today.”

But I suspect that wouldn’t sit well with many patients, who want certainty (as if there is such a thing). And it especially seems like a difficult proposition in our contentious society, where anti-science nay-sayers like to jump on contradictory findings to challenge the basic value of science overall.

That is exactly NOT what I am trying to do. I am merely reflecting on many of the issues that threaten the validity of what we think we know. I am confident that disclosure and transparency not only lead to better science, but they also lead to science that can withstand the test of nay-sayers.

I have come to the end. I am not sure that I have addressed each and every one of the criticisms, though I hope that I have addressed the majority; I am sure you will point out what I missed. A couple of things about comments: Tomorrow I will be in the air most of the day and may not have the opportunity to sign on to approve comments. So, please, if your comment does not go up until Wednesday, do not think that it has been rejected. Also, I really would like to keep it civil and, though I did not apply this rule today, I will not accept any overt insults or name calling from either side of the debate.

I am sincerely looking forward to continuing this discussion!                

          

Are vaccines safe?

The H1N1 pandemic is bringing into focus not only the world's vulnerabilities vis a vis the spread of an infectious disease, but also our complete lack of a framework in which to make rational choices about prevention. The cornerstone of preventive efforts for any significant infectious disease is vaccination of a large swath of the population. The rapid development and approval of the H1N1 vaccines is both a blessing and a curse, given the sophomoric level of discussion about its risks and benefits. By coincidence this discussion has extended into the world of HPV vaccination, with a high profile death of a 14-year-old girl in the UK one hour following inoculation with Cervarix, the GSK's HPV shot. Though upon a post-mortem examination it is clear that the girl's death was a result of a malignant tumor invading her chest and not of Cervarix, the level of panic and skepticism about the vaccine is illustrative of the polarization of public opinion on the very philosophy of vaccination itself.

Why do we even have vaccines? To put it simply, vaccines are there to prevent highly infectious agents from causing mass morbidity and mortality. In the US, states mandate that children undergo certain vaccinations as a prerequisite for attending school. In fact, save for a handful of states where parents can express intellectual objections to some vaccines, in most states, including my own, the only acceptable reason for not vaccinating a child is a religious objection. And this is an all-or-nothing situation, where you are forced to either get the entire panel of shots or nothing. These laws, written decades ago, have taken individual decision making out of the public's hands. They leave no room for engaging in an educated risk-benefit analysis for the individual situation.

Rabid vaccine advocates would argue that there is never a need to make individual decisions in diseases where a vaccine is available. Well, let's take the chicken pox vaccine. Here is a childhood disease that is indeed highly contagious, but only causes a self-limited nuisance illness with a very low risk of complications in the pediatric age group without underlying conditions. In the US the disease was associated with ~10,000 hospitalizations and on average 105 deaths annually in the pre-vaccine era. So, is this really a big deal? Well, yes, from the perspective of those families suffering the 105 fatalities. But what about the societal concern? This is well summarized in the recommendation rationale from the American Academy of Family Physicians: 

Because chickenpox is so contagious, a child with chickenpox shouldn't go to school or day care until all the sores have dried or crusted. Many parents miss work during the time their child has chickenpox. Because of the lost time from work, chickenpox can be a significant cost to parents of children who get the illness. [emphasis mine]

So, there is clearly an economic risk that drives at least some of the rationale for requiring this vaccine. This then begs the question: should economic considerations ever drive a government mandate for vaccination? Note, economic considerations do not fall into what I put forth as the rationale to vaccinate: to prevent spread of highly contagious disease that causes wide-spread morbidity and mortality. Now it becomes about the money. So, does it not stand to reason that I as a parent should be able to take into account my personal situation with respect my aversion to missing work days to stay home with a sick child and make this vaccination decision myself?

Unfortunately, I do not believe that most citizens are equipped with the skills to make these informed choices. Since we have broadly accepted the government's judgment as to who should get vaccinated with what, we have not been taught systematically to make these choices rationally. And here we are, in 2009, faced with the swine flu and HPV choices: to vaccinate or not?

Ignorance is fertile ground for breeding fear. Hysterical rhetoric on both sides, anti-vaxers and vaccine apologists, is promoting a climate of confusion. When a radio program polls its listeners on whether or not they believe the H1N1 vaccine is safe, what are they looking to accomplish? As scientists we know that the concept of safety does not exist in a vacuum. How do you define safe? Safe for whom? Is there a gradient of safety? And what do the loud and often non-sensical caller responses accomplish but to create more noise at the margins?

A more constructive approach in the short-term would be to present the populace with facts -- both risks and benefits of both the diseases and the vaccines against them. (And yes, the reality is that diseases AND vaccines will have risk-benefit profiles that differ for different people.) But this short-term tactic will not solve our general inability to make rational choices when faced with complex ideas. This shortcoming needs to be addressed in our educational institutions. This knowledge will serve us in far more ways than just deciding whether or not to vaccinate our kids against chicken pox.      

   

CDC's H1N1 public engagement dialogue, day 1

On August 31 and September 1, the CDC in conjunction with the Keystone Center and WestEd held a web based discussion centering around implementation of and communication about H1N1 vaccination efforts. In addition to the sponsors, over 150 members of the public from different regions of the US participated. The discussions were structured around 3 distinct approaches to vaccination:


1. With the "go easy" approach a few extra sites for vaccination are planned. The goal is to meet an expected low public demand for vaccine and to do so throughout the flu season without rushing to vaccinate early on. 



2. The goal of the "moderate effort" approach is to raise the expected low public demand for vaccine by promoting vaccination to eligible groups, setting up extra vaccination sites, and vaccinating relatively quickly a large number of the eligible groups. 



3. The goal of a "full throttle" approach is to create and respond fully and speedily to significant public demand for vaccination even if the severity of the illness is initially perceived to be low.


The discussions were guided by the following questions/points:
--What are your questions and concerns about each approach? 

--As you weigh the pros and cons for this approach what values influence your thinking? 

--What additional pros/cons do you think should be considered? 

--If you feel this option is the best for the assumptions and circumstances, talk about why. 

--If this option is not acceptable to you, share why not.

Here is the summary of day 1 as kindly provided by the conference organizers.

PANELISTS:

Roger Bernier, Senior Advisor For Scientific Strategy and Innovation,
National Center for Immunization and Respirat, CDC
Anthony Fiore, Medical Epidemiologist, MD, MPH, Captain, Public
Health Service, Influenza Division , Centers for Disease Control and
Prevention
Frank Malinoski, President and Principal Partner, TD Consultancy, LLC
Martin Meltzer, Senior Economist and Distinguished Consultant,
Division of Emerging Infections and Surveillance Serv, CDC
Eleanor Peters, Epidemiology Specialist, St. Louis County Department
of Health
............................................................

FOCUS POINT DISCUSSION SUMMARIES:

Pros and cons of a "GO EASY" approach to a vaccination program

With the "go easy" approach a few extra sites for vaccination are
planned. The goal is to meet an expected low public demand for
vaccine and to do so throughout the flu season without rushing to
vaccinate early on. Program activities in the areas of communication,
volunteer involvement, partnerships, safety, disease, and coverage
monitoring will be slightly increased over those undertaken during a
regular flu season.

What are your questions and concerns about the "go easy" approach? As
you weigh the pros and cons for this approach what values influence
your thinking? What additional pros/cons do you think should be
consider? If you feel this option is the best for the assumptions and
circumstances, described in the Discussion Guidelines, talk about
why. If this option is not acceptable to you, share why not.

Some pros of the Go Easy approach

* Given the fairly low complication and case fatality rates in New
Zealand, perhaps the "go easy" approach is the most rational one.
This seems sensible particularly because the vaccine development and
approval are such a rush job, and we will be learning about their
efficacy and safety once they are on the market.

* We need to be developing risk stratification schemes for who is
likely to develop complications. If we can risk-stratify, we may not
need to have a shotgun approach to vaccination.

Some cons of the Go Easy approach

* It's just a matter of time before a severe pandemic will happen. If
we fail to respond appropriately to this, it could have far more
lasting, more adverse effects.

* Although a pandemic of some sort is a foregone conclusion, it's not
clear if this is the one. In looking at the Southern hemisphere, so
far it is not as bad as predicted. If the second wave does not
materialize this season, this may give us time to test the vaccines
more extensively for both efficacy and safety before advocating the
full throttle vaccination approach.

* Other effective, inexpensive health strategies have been overlooked
as we have a medical system that seems focused solely on the idea of
vaccination to deal with disease. I would suggest the CDC look at the
research on the use of probiotics and Vitamin D supplementation to
enhance immunity and incorporate that into any level of approach to
the H1N1 response.

* I believe the time has passed for Go Easy approach. The Go Easy
approach gave way to the Moderate Effort approach over the summer. If
we fail to respond Moderately now, we may not be able to respond more
aggressively later, say in October when we will have a clearer
picture of what we are dealing with.

* The Go Easy plan would make it too hard to find and get the flu
shot, even for those who would really like to get it.

* If the Go Easy approach were applied, there is no possible way to
provide vaccination to those who would want it, or in time to
minimize hospitalization and death. Resources would be stretched
beyond their capacity and fatalities would increase.

* I prefer the Go Slow option where everyone that wants a vaccine can
have it, and people who do not want it do not have to take it. I do
not feel any schools should be centers for administering the vaccine
(if the live form) because of possible shedding to the unvaccinated
children.

* A public health crisis is not the time for our government to "Go
Easy." We have had the benefit of buying time since H1N1 showed in
May to learn about the virus and of watching the Southern hemisphere
go through their influenza season. If we Go Easy and wait, I think
there will be a devastating impact.

* The government has already committed so much to the study and
development of the vaccine that to treat this virus as if it's a step
above a seasonal influenza will undercut the government's perceived
competence. Truth be told, this isn't the same as seasonal influenza
nor are all the parameters known--it could end up being much ado
about nothing.


Pros and cons of a "MODERATE EFFORT" approach to a vaccination
program

The goal of a "moderate effort" approach is to promote vaccination to
eligible groups, set up extra vaccination sites beyond those used in
a regular flu year, and to vaccinate relatively quickly a large
number of the eligible groups. An aim of the program is to raise the
expected low public demand for vaccine. Regular program activities
are considerably enhanced to accomplish this especially in the area
of communication, but other program areas such as volunteer
involvement, partnerships, and program monitoring are also
intensified.

What are your questions and concerns about the "moderate effort"
approach? As you weigh the pros and cons for this approach what
values influence your thinking? What additional pros and cons for do
you think should be considered? If you feel this option is the best
for the assumptions and circumstances, described in the Discussion
Guidelines, talk about why. If this option is not acceptable to you,
share why not.

Some pros for the Moderate Effort approach

* Given history, and the events that have transpired since the Novel
H1N1 appeared last Spring, the most logical and practical approach is
the moderate approach. The current virus, appears to resemble the
effects of the 1957 Asian Bird Flu Pandemic rather than the 1918
Swine Flu Pandemic. The Moderate approach provides a balanced,
credible avenue for dealing with a mild to moderate pandemic.

* The moderate effort could be the best approach. Getting the
infrastructure in place and working at some capacity will allow
either scaling back or ramping up as the situation unfolds. According
to the Discussion Guide, enhanced communication is part of the
Moderate approach. Providing sufficient, accurate and timely
information so that the public, government, and health care providers
can make informed decisions should be a fundamental activity,
regardless of the approach taken.

* I am advocating the Moderate Effort approach. People who are
staunchly against vaccination won't agree to be vaccinated (or have
their kids vaccinated), no matter how much time is put into studying
the safety and efficacy of a vaccine. The vast majority of people
will want to know the costs/benefits of the vaccination and will
weigh if it's worth taking the risk in a situation where everything
can't be known. A moderate approach communicates the seriousness of
the H1N1 threat without suggesting that people should be panicked.

* Moderate effort is the best choice overall for the reasons already
indicated. Additionally, it places you in the middle of preparedness
making it easiest to respond appropriately to developments, which can
result in de-escalation or escalation. Flexibility in the plan is a
must.

There were no cons for the Moderate Effort approach.


Pros and cons of a "FULL THROTTLE" approach to a vaccination program

Significant additional federal, state, and local funds are invested
in creating numerous extra vaccination sites in both the public and
private sectors. The aim of a "full throttle" approach is to create
and to respond fully and speedily to significant public demand for
vaccination even if the severity of the illness is initially
perceived to be low. Extensive communication activities are
undertaken to stimulate public demand, and extensive networks of
volunteers and partners are identified and ready to spring into
action. Monitoring of the program activities is carried out
aggressively to collect timely data and take any corrective actions
needed to improve the ongoing program or to protect public safety.

What are your questions and concerns about the "full throttle"
approach? As you weigh the pros and cons for this approach what
values influence your thinking? What additional pros/cons do you
think should be considered? If you feel this option is the best for
the assumptions and circumstances, described in the Discussion
Guidelines, talk about why. If this option is not acceptable to you,
share why not.

Some pros of the Full Throttle approach

* The only real positive for the Full Throttle approach seems to be
the Rapid Response feature to vaccinate the population quickly should
the severity increase.

* I favor the Full Throttle approach. The H1N1 virus is here to stay.
Those who want to vaccinate will, those who don't, won't. Another
consideration to the vaccination strategy is the economy. If 40% of
the population is sick, how is this country going to continue to get
out of this economic recession?

Some cons of the Full Throttle approach

* A full throttle approach that would inject mercury into pregnant
women and young children is not safe. Any approach that fails to warn
the general public about these hazards is not taking into
consideration the health and welfare of the whole person.

* We shouldn't go full throttle unless we have the vaccine supply to
cover the top tier.

* Use of resources during an economic hardship. Given the resources
are for the safety of the people and the fact that they have spent
far more bailing out businesses elsewhere - this is a non-issue for
me. The people of the United States of America are worth the
investment.

* Less possible for the U.S. to donate vaccine elsewhere. Not
necessarily true. If it turns out to be less severe here and more
severe elsewhere, we will of course send what we have.

* Risk of reaction. This is a legitimate concern - expressed
emotionally and at length by others here. I would prefer to have
factual studies cited to read for myself, however. This is too
serious a subject to be laced with subjective opinion and conjecture.

* If we go full throttle, and it turns out to be a mild flu season,
we will have lost a lot of public credibility by "crying wolf" and
people will be less willing to gear up the next time there is the
possibility of a pandemic.

* I am not in favor of a full-throttle response because increased
subjective demand for a vaccine is not necessarily correlated to
increased objective need for a vaccine in order to protect vulnerable
people. As long as the media reports on H1N1 in the sensationalized
and alarmist way it did this spring, people will not get the
information they need to know whether they should be demanding a
vaccine. Therefore, I am in favor of the CDC going slow and using
their expertise to decide whether to ramp up the response.

* I am dis-inclined to support the Full-Throttle approach for the US
because of our recent experience with non-severe symptoms, low
mortality rate, and last swine flu episode. I agree with a strong
readiness posture concerning health education, vaccine production,
and vaccination for high-risk individuals, but would caution against
a Full Throttle initiative for the Nation at this time.

* I'm not sure that we need to start with the "full throttle" mode of
operation as the availability of the vaccine doesn't appear to be
able to keep up with the demand in this mode of operation.