The Problem With Dr Bob's Alternative Vaccine Schedule

I find it interesting that Dr. Offit talks about babies receiving more aluminum from formula or breastmilk than they would from a vaccine. I would like to point out that Dr. Sears does address the difference between parental administration of aluminum and ingesting aluminum. Perhaps physicians could discuss this with their "scared" parents instead of badmouthing Dr. Sears. Get your language right.

Conflict of Interest:

None declared

I am a pediatric nurse with 12 years of clinical practice and I am also the mother of a child with autism. I have read everything I could get my hands on regarding the issue of immunization over the last 7 years, pro-vaccination and anti-vaccination. I read this article with an open- mind. I was following your authors' line of reasoning and their critical examination if Dr. Bob's ideas/recomendations on immunization until I came to the comments regarding mercury and heavy metals. I will not except the argument that because children have other means by which they ingest or are exposed to heavy metals, it is okay to receive more in their shots.

I think there is valid clinical data to suggestions that there is such a thing as heavy metal toxicity. (Do you remember the MSDS book required by law in every clinical setting that utilizes metals/chemicals?) And don't we rountinely screen our pediatric patients for elevated lead levels? Do we not limit the amount of fish that we reccomend for pregnant women? ( yes, ethyl mercury versus methyl mercury, I know) It is possible that we do not know what level of exposure to metals results in neurotoxic effects for children. That is hard to study, too many variables. The amount and duration of exposure is a complex equation of factors which includes a child's individual biochemistry as well things like maternal dental history, maternal tuna consumption and what kind of wood they used when they built their deck. When you fail to acknowledge to possibility of an environmental component, like heavy metal toxicity, in the increasing incidence of certain childhood medical problems, you lose the public trust. We all know that pollution of the environment poses health risks.

I agree with ninty-five percent of the authors' refutation of Dr. Sears' ideas. I think some of his ideas are far-fetched and baseless. I support immunization as a necessary part of public healthy policy. I believe that vaccines save lives. So I am truly disappointed with your assertion that the amount of heavy metal contained in products ingested by or injected into our children is unilaterally acceptable. Why not place the flu vaccine into single dose vials and end the debate? Cost. That is the point again in which medicine loses the public trust.

I know that pediatricians are becoming more and more frustrated by parents' questions about altering the vaccine schedule. But if there is any good news, in the eve of pandemic flu (H1H1), it is that H1N1 may put this discussion on the backburner for a long time while we depend on the promise of vaccines to save lives. In America, this generation of parents has been blessed to live in the antibiotic age, relatively free from major pandemics. It gives us the ability to pick vaccine safety apart. But when a vaccine stands between our children and mass catastrophy, I think the graphic illustration of vaccines' role in public health will speak for itself. Similar to the way that the polio epidemic influenced our parents. As my pediatrician said, "Erin, there are worse things to happen to your child than autism." Nonetheless, if, as pediatricians, your role is to safeguard the health of America's children, I implore you to advocate for the elimination of heavy metals from all vaccines.

Thank your for your article and for your time in considering this response.

Best Wishes, Erin Keith-Chancy RN BSN CCRN 10500 W 54th St Shawnee KS 66203 [email protected]

Conflict of Interest:

None declared

I read with great interest the previous article about Dr. Sears book 'The Vaccine Book: Making the Right Decision for Your Child' Although I am a health care professtional by trade, I have also, almost believed what he has to say. The only way to conteraact this information is by education to the general public. If the ACIP and all of their recomminations keep receiving good press or at least be constantly in the press with correct information the medical society may one day come out in front.

Conflict of Interest:

None declared

To Dr Malak's assertion that a critique of Dr. Sears' book was published in Pediatrics because the AAP and Dr. Offit are in cahoots with Merck, the manufacturer of the Rotateq vaccine, I would offer the following : Dr: Sears singles out Rotateq as an important vaccine for parents to give their children, despite the fact that rotavirus disease is easily the least deadly of all the vaccine-preventable diseases protected against in a standard vaccine schedule. Does this mean that Dr. Sears is allied with the AAP/Offit/Merck conspiracy ? 35,000 daily web viewers are keen to know.

Conflict of Interest:

None declared

I am also not a health care professional, but I have been interested in this debate after running across Dr. Goldacre's site on bad science (badscience.net).

To my companion lay contributor, who is concerned about the title of the subject article, I suppose the easiest explanation for why the phrase "Dr. Bob" shows up in the title is found in the abstract:

'At the back of the book, Sears includes �Dr Bob�s Alternative Vaccine Schedule,� a formula by which parents can delay, withhold, separate, or space out vaccines.'

I think Dr. Bob must get credit for that particular moniker.

Conflict of Interest:

None declared

I obviously don't expect to see my letter in print since I am not a member of the health profession.

Nevertheless, I wish to express my dismay, with the editors of Pediatrics, as I have never before seen a doctor referred to by his nickname aka "Dr. Bob" in a professional journal. The fact that Pediatrics would allow Dr. Offit to do so - in the headline, no less - underscores the bias of this journal. Dr. Robert Sears deserves to be referred to as Dr. Robert Sears, and nothing less. Allowing him to be referred to as "Dr. Bob" in Pediatrics is a transparent attempt to trivialize his message and hurt his credibility with his colleagues.

I don't think Dr. Sears would have signed his letter in Pediatrics "Dr. Bob" had Dr. Offit not taken this inappropriate liberty with his name.

One more point: many parents would like to see Pediatrics address Dr. Paul Offit's claim that a baby can tolerate 10,000 or even 100,000 vaccines. Does the journal Pediatrics support his statement? I have asked many health professionals who support the current vaccine program this question, and most will not or cannot answer it. Please comment. Thank you.

Conflict of Interest:

None declared

The review of Dr. Sears books points out the weaknesses of his argument and should stand. The excerpts speak for themselves. The recent increase in measles, HIb and other preventable diseases is partially a consequence of poor guidance that parents have received, making our job of protecting children more difficult.

Thank you, Dr. Offitt, for your courageous stand.

Conflict of Interest:

None declared

In my original letter (the first one on the list above) I referred to Dr. Offit's article as appearing in the Journal of Pediatrics. Obviously, that is not the case. The article is in Pediatrics. I would like to clarify that point. The words "the Journal of" and on the next line, "the Journal" should be ignored, and instead simply read "Pediatrics". Thanks.

Conflict of Interest:

Author of The Vaccine Book

What is unfortunately missed by Offit and Moser's (2009) recent essay is the informing context for the current vaccine debate�-shifting parental trust in medical institutions with implications for patient (and particularly, parent) doctor relationships. The vaccine debate plays out against a backdrop�-not only of facts vs. falsehoods, refereed vs. non- mainstream journals and studies, science vs. speculation, a complicated enough arena�-but of conflicting cultural �facts,� which may be equally important as the science. For instance, parental concerns over the safe cumulative levels of thimerosal (ethyl mercury) in vaccines were unwittingly validated by the American Academy of Pediatrics (AAP) and the U.S. Public Health Service and others� recommending their removal (which largely occurred in 2001)�even while these organizations were steadfast in public declarations of no causal link between the preservative and various neurotoxic or neuropathological ill-effects. What did parents learn from this decision? Aside from the fact that the preservative had been long removed in many countries of the world (i.e., the UK and even Russia), or that infants may have received doses exceeding EPA recommendations, they learned that organizations designed to serve the public trust were contradictory in their words and deeds. They also learned that these same organizations did not value parents as partners in children�s health enough to speak forthrightly with them or to address all sides of a complex issue. Ultimately, whether or not the known neurotoxin ethyl mercury had an impact on developing brains, or whether or not new or available scientific research would prove this, was beside the point. The larger �lesson learned� by parents was to fear the decision making processes of medical and public health institutions and to become critically engaged with them using whatever tools at one�s disposal (i.e., online information, reading scientific studies, discussion groups, etc.).

The thimerosal debate is only one (still relevant) example of the �lessons learned� by parents today in their opinion of members of the medical community and institutions of public health. (The FDA�s recent and multiple blunders in the drug approval process do not help with this impression). Vaccine manufacturers play a role in undermining public trust when they do not practice accountability or when the FDA and CDC in their oversight role do not see that they do. The Merck internal memo which attested to the cumulative mercury in vaccines for infants at 87 times safe FDA limits (disclosed by The Los Angeles Times, 8 Feb 2005) and the Aug 2002 and Feb 2003 reports in Infectious Diseases in Children of SV -40 viral contamination of millions of doses of polio vaccine from monkey kidney tissues (also found in the experimental Hep A vaccine) feed this view. Unfortunately, other issues of current debate (i.e., safety, especially of MMR live viruses, lack of long-term studies, research by scientists employed by pharma firms, use of pre-World War II data to set benchmarks, etc.) are being handled in the same way and convey the same lesson: parents are not equal partners and decision makers in their children�s health, and they should exhibit blind trust in institutions that many perceive as marred.

One of the significant differences between Offit and Moser (2009), who reiterate this view, and the Dr. Sears series of books, is this realization. The Sears books have done exceedingly well at engaging this cultural phenomenon, addressing parents as peers and decision makers, a deliberative response that becomes more important when scientific opinion is unclear, in flux, or insufficient. Offit and Moser (2009), by contrast, seem unaware-�or unwilling to see�-this as a problem. The most obvious example of their blindspot is demonstrated by the fact that Offit, designated in the article as �the co-inventor of and co-patent holder for RotaTeq,� tries to make the case for the trustworthiness of public health agencies and pharmaceutical companies when his own professional situation, arguably a conflict of interest by any meaningful standard, belies the very distinction between public oversight agencies and profit-motivated companies. Moreover, Offit and Moser (2009) are out of touch and even condescending with respect to parent�s concerns on various vaccine-related issues. They write: �given that young infants currently receive 14 different vaccines, requiring as many as 5 shots at a single visit and 26 inoculations by 2 years of age, the concern that children might be overwhelmed by too many vaccines is understandable.� It is unacceptable that they found no need to know the current recommended CDC (and AAP) childhood immunization schedule which suggests not, �up to 5� vaccines at once, but 9 at 12 or 15 months. Moreover, many parents are not, �overwhelmed,� but are in fact offering critiques of the policies, protocols, institutions, and practices of childhood vaccination and the institutions that regulate them on a range of substantive grounds (from science, to safety, health and prevention issues, to long term effects, etc.). It is easy to reduce parents� concerns to �conspiracy theories,� as opposed to institutional critiques, or to simplify parents� attempts to enter this public debate as a false choice of �pro/anti-vaccines� (where does safety and improving vaccines fit in?). Such moves do nothing to redress or restore public trust and, to the contrary, relay the falsehood that children�s health is a matter confined only to the exclusive ranks of health professionals�and not to public deliberation. Beyond science, which is only part of the problem, only when organizations such as the AAP, the CDC, and others choose to recognize this new cultural phenomenon, that patient-physician relationships have irrevocably changed from the 1950�s �doctor as god� model, will a real dialogue of equals and, hence, public trust be restored.

Conflict of Interest:

None declared

Dr. Offit presents the reader with his disclosure that he is the co-patent holder for RotaTeq. While Dr. Offit notes: �it is not difficult in today�s society to appeal to the notion of corporate or government malfeasance,� he is disingenuous to suggest that malfeasance does not occur; or to overlook the fact that such �notions� are appealing in part because they are so often true. He also ignores another common phenomenon in American culture: greed. Repeatedly, reports emerge that pharmaceutical companies have withheld data that are contrary to their financial goals. By their own behavior, the pharmaceutical industry has eroded the trust of large swaths of the American population. Dr. Offit is a member of the vaccine manufacturing community. As such, his ability to present an unbiased opinion on this topic is suspect.

The author is quick to attack Dr. Sears� logic, but Dr. Offit leaves gaps in his own thought process. In his estimation of risk versus benefit, Dr. Offit makes a specious claim: �therefore, every individual benefits from receiving polio vaccine.� He bases this conclusion upon statements qualified with terms such as �if an outbreak occurred� and �the unimmunized child might later travel to a country where polio is endemic� [emphasis mine]. To deduce that �every individual benefits� barring the unlikely widespread domestic outbreak of Polio, is unsupported. Furthermore, the live attenuated oral polio vaccine (OPV) would better protect that child who travels to an endemic area. However, due to legitimate safety concerns, OPV is no longer a part of the routine vaccination schedule.

Dr. Offit further weakens his position with his assertion that VAERS is a �model system� of detecting adverse events, exhorting the manufacturers of other pharmaceuticals to adopt similar mechanisms. He calls that statement into question, on the same page (e166) wherein he asserts: �VAERS reports often represent coincidental and not causal associations,� and �furthermore, the source of VAERS reports can be misleading. For example, many of the recent VAERS reports of autism after receipt of vaccines came not from parents, doctors, nurses, or nurse practitioners but from personal-injury lawyers.� Dr. Offit causes the reader to wonder: are we, the vaccine receiving public, protected or not? Is the scientific community collecting useful data or not?

Finally, I find his defense of mercury and aluminum in the vaccine supply disturbing. To opine that the small amount of mercury in vaccines is acceptable simply because there are so many more profound sources of mercury in the world is absurd. To carry this logic further, my inflicting one bullet wound is excusable if there are many other people shooting at this hypothetical victim. Perhaps Dr. Offit would remind us that lead is a naturally occurring environmental toxin as well. If the vaccine industry is motivated to do the highest and best for its consumers, it seems appropriate to explore ways to remove the heavy metals from the manufacturing process altogether. The market would reward such behavior. As evidence, observe the voluntary and overwhelming shift to remove bisphenol-A from baby bottles and other consumer products, despite divergent opinions on the need for such a change.

Dr. Offit�s opinion rings alarmingly close to propaganda. Yet it is his opinion. Dr. Sears offers a counterpoint to an audience that craves it. Where his facts are demonstrably wrong, correct him. Where he blurs the line between fact and opinion, clarify that line. Nevertheless, to castigate him for offering information to the laity is to fall prey to the same mindset as the early church. By controlling access to the Bible, the leaders of the church exerted control over all.

We must tailor everything we do to the needs of the individual patient. To paraphrase Osler, it is important to learn what sort of patient we are vaccinating before we decide what vaccines to offer the patient. Parents are given wide latitude in directing the care of their children and this is rightly so. As long as this is true, providers of healthcare must support their plans with a logical and reasonable explanation. Where a parent has concerns, a reasonable approach to compromise is necessary. To do otherwise we risk alienating a substantial population from any care at all.

Conflict of Interest:

Paid Consultant: Daiichi Sankyo and Schering-Plough Pharmaceuticals. Parent of four children, two of whom suffered complications from routine vaccinations.

I read with great interest Dr. Offit's article, The Problem With Dr Bob's Alternative Vaccine Schedule. While I may not agree with every claim or suggestion made in the book, I do appreciate the utility of his alternate vaccine schedule.

As a general pediatrician in private practice I can think of many examples of families who would have declined all vaccines in the first 2 years of life had there not been an alternative schedule. I also know of many families that have elected to create there own delayed/partial vaccine regimen that at times leaves out higher priority vaccines. It is my belief that this schedule increases the vaccine rate in the population that I serve.

I am also somewhat dismayed at the tone of the article. A critical review of this book and schedule was absolutely warranted. However, a more balanced collegial review would have been more productive. This could have included correspondence between Dr. Offit and Dr. Sears or at the very least more accurate critique of the schedule. One glaring example is the claim that the book discourages the influenza vaccine until age 5 year-old, which I did not glean from my reading of it.

I would love to see the CDC or AAP create an alternative schedule for families who would prefer to come to the office more often.

Sincerely, Bryan Kono

Conflict of Interest:

None declared

Dear AAP Pediatricians,

As a physician, scientist, and father of a vaccine-injured child, I have many issues with Offit and Moser�s critique of Dr. Sears vaccine book, particularly its authoritarian tone and content. Offit is certainly entitled to his opinion, but it must be recognized as that. We must stick to the science and recognize the open questions with regards to vaccine safety.

Excerpt from Offit and Moser article: {Sears has a poor grasp of the scientific method. "Some studies have been published in recent years that have failed to show statistical proof of a relationship between vaccines and autism," he writes. "However, by the same token, it is also difficult to prove that there is not a connection." Using the scientific method, investigators form the null hypothesis. Good epidemiological studies are powered to reject or not to reject the null hypothesis. However, the scientific method does not allow investigators to accept the null hypothesis. Said another way, scientists can never prove never. The most that scientists can show is that 2 events are not associated statistically; scientists cannot prove that the events can never be associated statistically. In stating that it is "difficult to prove that there is not a connection," Sears is suggesting the impossible.} End Excerpt

In their assault on Dr. Sears, Offit and Moser confuse scientific methodology. Even more dangerous than not having an understanding of science, is the presumption that one does �grasp the scientific method.� Actually, in designing an epidemiological study, one must have a good estimate of the effect size, in order to determine the power of a study. Offit misuses the statistical term �power� to suggest that this allows one to �reject or not to reject the null hypothesis.� This is incorrect.

If one mistakenly rejects the null hypothesis (usually assigned <5% probability related to the alpha probability), than one has committed a Type I error. On the other hand, if one mistakenly does not reject the null hypothesis, this is called a Type II error�the probability of a Type II error, 1-beta, is described as the �power� of a study.

�Said another way, scientists can never prove never,� according to Moser and Offit. In truth, science does not �prove� negative or positive; it can only determine, in statistical terminology, the strength of conclusions derived from the data. Actually, if one has powered a study appropriately, then a negative result can be stated with a low probability of Type II error. Due to the complexities in effect size and power determination, generally negative and neutral studies do not warrant publication, particularly in high quality journals. This has not been the case in the peer reviewed neutral studies in relation to vaccination and autism, leading many to speculate that these studies are proof against causation.

Regarding the epidemiological studies that have not shown a link between vaccines and autism, one must take a step back. What is the probability that by saying �vaccines don�t cause autism,� you have committed a Type II error. Offit and others frequently cite 15 well positioned studies in the literature as proving that the vaccine-autism connection is a myth. Unfortunately, one cannot derive from these studies any estimate of effect size or power, so the probability of Type II error is completely unknown.

The Institute of Medicine�s final 2004 report on vaccines and autism recognized this major shortfall, and clearly stated that without biological markers of autism subpopulations at risk, further epidemiology would not be helpful. In other words, they did not say that vaccines don�t cause autism�-since without knowing what autism is, science cannot determine what it is not. Etiological determination is greatly encumbered by behavioral rather than medical characterization the disorder. It is highly probably that there are multiple autism(s) with multiple genetic and environmental triggers (Depakote being recently added to the list). This simple truth about autism greatly reduces the stastical power of even the largest epidemiological studies.

As a Neurologist that saw his normally developing daughter regress into autism before turning 2 years old, co-incident with immunization, I obviously have an inherently different bias than Offit, the wealthy vaccine inventor and patent holder. One in my situation must ask�What is post-vaccination encephalopathy? What are the mechanisms? Is there any treatment? Can it look like �autism?� There are many unknowns here, as no concerted effort has been made to understand the scope of post- vaccination encephalopathy. This leads to the next logical conclusion which is, since science does not understand post-vaccination encephalopathy, then we don�t know what factors could increase or decrease its incidence (thimerosal, aluminum, live virus combinations, diet/metabolic factors, multiplicity of vaccines). We can now perform genetic screening to determine who may react poorly to smallpox vaccine�this strategy might also benefit children with genetic susceptibilities similar to my child, thus preventing injuries like hers in the future.

Autism studies aside, there are several recent studies linking vaccination practices to autoimmune disorders-- like the recent Manitoba study demonstrating that a short delay in DTP administration reduces the rate of asthma by 50% and the AAN Neurology publication showing that one brand of HepB vaccine increases the risk of childhood MS by almost 3 times.

As physicians we took an oath to �first do no harm� to our individual patients. Dr. Sears offers a pro-vaccine individualized approach to childhood immunization that acknowledges the risks, benefits, and uncertainties of this medical intervention. Dr. Sears should be applauded for his efforts to provide safe vaccination alternatives to his patients, given the void of randomized controlled trials to support continued growth of the current CDC/AAP schedule.

Rather than personal attacks, let�s turn to science to provide the answers. The enormous public benefit of vaccination cannot be used to stifle open discourse on critical vaccine safety issues. One size does not fit all.

Sincerely,

Jon S. Poling MD/PhD

Conflict of Interest:

Dr. Poling is a practicing neurologist also holding a PhD in biophysics with focus on neuroscience. He is the father of a vaccine-injured child.

Non-participation in vaccination would be or should be considered in light of the overriding imperative of maintaining herd immunity, accepted as long and only at what is currently regarded as the bearable fringes, not undermining herd immunity. From Realpolitik or utilitarian stances, fairness and just distributions of burdens (submitting to vaccination and their possible side effects) and benefits (immunity) seems less of a concern as long as herd immunity is preserved, or free riding is unobtrusive. In face of augmenting exemptions, policymakers could either employ a hard line or resort to policy design that would lead to lower exemption. To this end, behavioral tools, which usually attract less criticism, should also be employed. Here are some illustrations of how these tools may be put to work, together with traditional policy measures to promote herd immunity.

Several countries have introduced central immunization registries to help the government, local authorities, and importantly parents to follow the clinical guidelines and immunization programs. Reminders, exemption- verification and statistical information are all useful and productive means.

Social norms are powerful and most people strive to align with the choices within their reference group. Therefore, information on peers' choices is an essential tool in reinforcing cooperation and signaling the level of reciprocity. In this regard, Dr. Bob's advice � "don't tell your neighbor" is both enlightening and alarming. How can we inform the public about the behavior of their peers? Possibilities for informing the populace about the level of participation in vaccination programs range from publicizing immunization rates in the general population or in smaller localities or even within demographic groups.

In addition, people�s choices tend to be influenced by the "availability heuristics", whereby a risk is perceived as greater than it actually is due to recent exposure. Therefore, the general success of vaccines make parents susceptible to the influences of vocal resistance without the opposing influence of now-avoided complications of childhood infections. This phenomenon suggests that providing noticeable and effective information on recent outbreaks and the grim sequelae of preventable infectious diseases could balance the perception of risks of non-immunization.

Policymakers throughout the world rightly chose the opt out default. By setting the default as "all children will be immunized unless their parents explicitly opt out", several benefits arise: the default conveys a strong societal norm favoring vaccination (everyone should immunize), individual retain the right to choose (the importance of autonomy even when regarded as a wrong); and the burden of moving away from the status quo position of participation is passed on to those who elect a less favorable option. However, exemption should not be easy, and parents should be individually confronted with the ramifications of their choice.

Finally, a number of legal tools are available to provide incentives for participation and disincentives for non-participation, but the effects of such rules must be carefully assessed to avoid unintended consequences. Leveraging school entry rights should remain the golden rule.

Conflict of Interest:

None declared

The Frustration of Vaccine Shortages

During my pediatric residency over thirty years ago infections due to the bacteria Haemophilus Influenza were not uncommon. It seemed as if every week there were infants and children on the ward at the old Primary Childrens Hospital with H. Influenza meningitis, pneumonia, or cellulitis. These were not necessarily simple or uncomplicated infections. The sequelae, consequences of a significant infection, were not insignificant; some children ended up with hearing loss or her neurologic defects, scarring or sequestrations in their lungs, and occasionally resistant infections that were difficult to clear with antibiotics.

Over ensuing years with the advent of HIB vaccine in 1998 these diseases have nearly disappeared. Since then Haemophilus cases are rare because of the use of vaccines: ActHIB (Sanofli Pasteur) , PedvaxHIB (Merck), and Comvax (a combined vaccine of HIB and Hepatitis B made by Merck).

As a solo practitioner one of the banes of my existence is ordering and keeping our supplies of vaccines in good shape. It is a lot to keep in mind. Vaccine companies are quirky. Merck, for example, requires a minimum $600 purchase to avoid the penalty of a $20 shipping charge; thus, you are prevented form ordering just a small amount of a particular vaccine a one time. There are also frustrating moments when certain vaccines suddenly become unavailable. A recent example is the Merck Hepatitis A, Vaqta. Questioning Merck did not provide any rationale for the problem. I assumed it was a manufacturing issue.

More recently, the Merck product Pedvax HIB became unavailable. Supplies are unlikely to resume until after the first quarter of 2008. A discussion with a Merck representative indicated the problem was a manufacturing issue, the specific nature of which was deemed �proprietary information�. Our practice ordered 210 doses this year. When the Merck product became unavailable I tried to order Sanofl-Pasteur�s Act HIB but discovered that because of the increased demand on their vaccine and the fact that I had ordered only 10 doses a year from them I would be permitted only 5 doses a month.

I considered this a frustrating conundrum and called CDC to chat about the situation. They indicated that, in light of the supply problems, they would be releasing some of their government stockpile to alleviate the situation. I was unable to reach anyone at the American Academy of Pediatrics to discuss the dilemma.

The thought of even a minor resurgence of HIB infections is depressing, perhaps even outrageous in a country as seemingly prosperous as ours, but public health has never been our strength as far as we can glean from posturing in the 2008 presidential campaign.

My solution? Remove access and control of immunizations from the hands of free-market capitalism, the vaccine manufacturers. They companies should sell their vaccines to the CDC which would distribute them accordingly. They should be free for all who need or want them. Perhaps the private sector (insurers) could underwrite the cost through insurance reimbursement if necessary. In any case responsibility for assuring our population gets what it needs in a timely manner should be removed from the pressure of market forces. When I voiced this plan to a friend recently he said, �Well that would be socialized medicine.�

I laughed at his misapprehension and said, �So be it.�

12/7/07

Conflict of Interest:

None declared

Why did Dr. Offit write this �special article?� Why did the AAP publish it? Straightforward. They both are funded by Merck. That little conflict of interest was understandably not cited. Dr. Sears has credibility and integrity. His website gets 35,000 hits per day. That is where parents are going for advice. This attack will probably push that number higher.

Conflict of Interest:

AAP fellow, but also parent of two children

I read with great interest Dr. Offit's editorial/book review of Dr. Sears' The Vaccine Book. As a "front-line" pediatrician seeing many new families and babies each day, as a parent of young children, and as an active, concerned citizen of the U.S., vaccines of course are a daily part of my life. I welcome these conversations with families, as I am encouraged they are comfortable enough to discuss their fears and hopes with me. My strong belief is that by allowing these conversations, more families actually vaccinate than would have otherwise. Would it be better that they seek non pediatric primary care in support of no vaccination or would it better for me to tolerate their concerns and "allow" them to vaccinate flexibly? What is the "right thing" to do? This is what many of us struggle with.

As I become more involved in the AAP at a leadership level, I become more and more aware of the divide between pediatricians. What I fear is that we as a profession and the AAP as an institution may be discouraging honest and open dialogue about one of the most important public health issues of our times. I find it highly unusual that a fellow AAP pediatrician is roundly critized in Pediatrics (the flagship journal of the AAP) without a chance to address the claims. Perhaps some at the AAP find his book that threatening. Is fear of information the direction we want to support? Should we not be using this as an opportunity for discussion?

Whether we want to admit it or not, public trust in the immunization program and in pediatricians in general is eroding. And while we can debate whether aluminum and mercury in vaccines is the same or different as what we eat/drink/breathe (my personal bias is that we should reduce all exposures when possible), we must all agree that the only way to save the U.S. vaccine program - and trust in our profession by the families who need us most - is to encourage public conversation in a non judgmental manner. And it has to start here, with us.

- A plea for intentional dialogue.

Conflict of Interest:

Vice-Chair of the AAP Section on Complementary and Integrative Medicine

Dr. Sears,

I have taken the time to read your book, Dr. Offit's letter and your response. As a general pediatrician working in the community, I can say without hesitation that your book has done more to harm my efforts to educate families on vaccines and to give vaccines than to help them.

While time often is our enemy in general pediatrics, I never shy away from time spent to discuss vaccines with worried parents. My time spent of late, however, has shifted away from what has been discussed by Hollywood celebrities and more to parents wanting to follow your recommendations. You must understand that the timbre of your book, and your inability to offer the explicit truth regarding vaccines, their safety and the disease they prevent supports the unfounded fears of parents. It does not assuage them. They don't want to hear from me that there is more aluminum in formula than vaccines, they point at your book, and say that your book tells them it is not safe.

I have one misguided family that has chosen not to vaccinate their infant with DTaP despite a local outbreak in the community because I don't have "the right one" with lower aluminum. Here is a stark example where your book has become an impediment to vaccination.

Your premise that giving parents "unbiased" information will help them make an informed decision is maybe your worst logic. Parents are inundated daily with internet "news", discussions with their friends or "heard from somebody" information that strikes at their fears. They also see talk show programs with both celebrities and "experts" who are emotional and influential. While you may think otherwise, they partner that information with your book that tells suggests it's ok for them to wait. They feel relieved, and come to my office wanting me to do exactly as you suggest. Since I feel your advice is inappropriate and ignores stark realities well detailed in Dr. Offit's article, the ensuing discussions can become emotional and confrontational... even with well-established patients. My 15 minutes with them carries little weight, especially when a published pediatrician offers other advice.

I can understand your desire to offer balanced information regarding vaccines to parents as they choose to protect their children. I do the same at my office. If a parent chooses to delay vaccines -despite- overwhelming information against their decision, then they have made an informed decision. They understand the gravity of their choice. When they base this decision on information they have gleaned from your book, they feel comforted that there isn't a risk to take, and feel no gravity in the situation. In my opinion, your advice is tantamount to malpractice.

Conflict of Interest:

None declared

I would like to take this opportunity to clear the record regarding The Vaccine Book and my own professional opinions on vaccines. I believe that Dr. Offit has greatly misrepresented the overall message of the book as being �anti-vaccine.� In fact, the book encourages parents to vaccinate their children. In order to give parents a complete educational experience, while presenting all the �pros� of vaccines I felt it was important to list the �cons� as well by discussing the potential side effects from the vaccine product inserts (while emphasizing how rare any severe reactions are). I also discuss the reasons why some parents choose not to vaccinate so that the readers can understand what these parents� issues are. I don�t condone such ideas, I simply present them. Without giving BOTH sides of the story, parents wouldn�t trust the information.

However, I believe that Dr. Offit has misconstrued the book�s overall message by selectively extracting various phrases and sentences that discuss anti-vaccine ideas and worries that parents have and portraying those ideas as my own. He quotes various areas of the book that sound anti-vaccine without offering the pro-vaccine conclusions that I offer on the subject. I will say that there are a couple of small items in the book that Dr. Offit points out are in error, and I appreciate that clarification he has been able to offer. I will make such changes in the next edition of the book.

I will admit that the book does offer one major controversial idea; my alternative vaccine schedule. However, it is important to note the context in which I offer that advice. At the end of the book, I encourage parents to vaccinate their children according to the CDC schedule if they feel confident in our nation�s vaccine system. For those parents who, after reading all the reasons why vaccines are important in my book, still believe vaccines aren�t safe and plan to not vaccinate, I at least ask them to consider getting the most important infant vaccines so their babies have protection from the life-threatening illnesses (HIB, PC, DTaP, and Rota). Where my alternative schedule comes into play is for those parents who are still unsure about vaccines, but they do want to fully vaccinate. I offer them an optional schedule that gets their child fully vaccinated, but at a slower pace. It doesn�t delay any of the most important shots, but it slightly delays some shots that are for lower-risk diseases. This option is really for parents who would otherwise leave a doctor�s office unvaccinated � parents who are too torn to make a decision, and therefore often don�t make any decision to vaccinate at all.

It is my belief that many families go unvaccinated simply because they aren�t offered a more gradual option. If they were, many would vaccinate. I believe this approach would actually increase vaccination rates, not decrease them as Dr. Offit suggests. I think that is our main area of disagreement.

Open debate and discussion is healthy in the field of medicine. I welcome it, and I�m sure Dr. Offit does as well. However, I must take issue when a person very clearly misrepresents information in my book, selectively quotes certain sections out of context, and attributes statements and ideas to the book and to myself that I never even wrote. Some of these errors are so erroneous, it�s almost as if Dr. Offit was reading some other vaccine book instead of mine. The purpose of my response is not to determine who�s right and who�s wrong. It�s simply a clarification of some false claims made against me.

A more accurate discussion of the book would have been much more constructive. As a fellow pro-vaccine doctor, if my book had been portrayed correctly, we would find very little to debate about. I would expect colleagues within the AAP to have more respect for each other and double and triple check to make sure something printed in the Journal of Pediatrics wasn�t so riddled with selective, misleading, and inaccurate quotes. I would also expect the Journal to allow a published article that clarifies these issues. The number one area that we don�t agree on is whether or not we should offer non-compliant parents some selective or alternative options. By doing so, do we increase or decrease vaccination rates among such families? That�s the main question. And that is a matter of opinion, which we are all free to disagree on. But when it comes to the actual facts about vaccinations and diseases, there is very little disagreement. There is so much to talk about when it comes to vaccines and how to regain the nation�s trust in the system. This type of article further damages that trust.

I have posted a very thorough 10-page response on The Vaccine Book website. I look forward to hearing your comments there.

Dr. Bob

Conflict of Interest:

Author of The Vaccine Book