Monday, December 29, 2008
A response to the misleading and Inaccurate review of The Vaccine Book in Pediatrics.
On December 29, 2008, Dr. Paul Offit published a special article entitled “The Problem With Dr. Bob’s Alternative Vaccine Schedule” in Pediatrics(www.pediatrics.org/cgi/doi/10.1542/peds.2008-2189). Affiliated with the Vaccine Education Center at Children’s Hospital of Philadelphia and the University of Pennsylvania School of Medicine, as well as the co-inventor and co-patent holder of the RotaTeq vaccine, Dr. Offit has long been recognized as a prominent and respected leader in vaccine education and research. He has been one of the primary spokesmen for the American Academy of Pediatrics’ recent campaign to improve the public trust in our nation’s vaccination policy. I appreciate Dr. Offit taking the time to review The Vaccine Book and offer his constructive criticisms on it. Dr. Offit and I agree on many things, including the opinion that vaccines are extremely important and have been one of the most valuable public health endeavors in the past several decades.
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 believe that vaccine books that only show one side of the issue aren’t an effective educational tool. That’s why I present both sides.
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 would expect colleagues within the AAP to have more respect for each other and double and triple check to make sure something printed in Pediatrics wasn’t so riddled with selective, misleading, and inaccurate quotes. I will point out such areas in my discussion below. 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 discuss these areas, and the changes that I will make 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.
The rest of this article will take a look at each of Dr. Offit’s statements and offer my own view. This isn’t going to be any sort of “great debate over vaccines” because we agree on most things. I will point out the parts of his article that I agree with, and parts that I accept his correction on something that I wrote in error.
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 anti-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.
Doctors Do Not Understand Vaccines
I agree with what Dr. Offit says here, except that I think parents want their own personal doctor to have a more thorough understanding of vaccines. Parents are much more likely to accept their doctor’s advice if the doctor has a complete understanding (or nearly so) of all the vaccine issues, side effects, ingredients, safety research, and possible drawbacks to a vaccine. If a doctor can look a patient in the eye and say, “I’ve spent weeks investigating all these issues personally and reviewing all the research myself, and, along with the expert backing of the AAP, CDC, and ACIP, I believe that the vaccines are safe and should be given according to the CDC schedule,” that has much more weight than a doctor simply saying, “I agree with the AAP, CDC, and ACIP that vaccines are safe.” Parents aren’t automatically going to trust such organizations the way we doctors do. They want us to do our own homework. Back in the old days when most patients simply trusted what doctors said, maybe that wasn’t necessary. But today’s parents want more from us. They are asking questions that we, as doctors, should be prepared to answer. If we are caught off guard by a parent’s question, because we aren’t familiar with a particular anti-vaccine argument or a certain vaccine ingredient or side effect, the parent will lose trust in us.
Public Health Agencies and Pharmaceutical Companies Are Not Trustworthy
Dr. Offit’s words, not mine. I never make this statement, nor do I try to imply it. Most vaccine books are ripe with anti-pharmaceutical company conspiracies. In fact, I tried to steer clear of any conspiracy theories in this book. Now, when reading the quote he offers from the Hep B chapter of the book, in the context of first reading the above heading, I can see how one could read some “mistrust of the system” into my words. But this wasn’t my intent, nor is this impression given when read within the context of my book. In fact, on the next page I state, “These researchers were part of a very well-respected group – the leaders in their field.”
Now, two of the researchers involved in studying Hep B rates in children and helping to create neonatal Hep B vaccine policies did work for Merck and GSK. Anti-vaccine books love to jump all over any researcher who has ties to vaccine manufacturers. But I didn’t. But now that Dr. Offit has questioned this, I will comment. The doctors who worked with Merck and GSK and were part of the research that recommended Hep B vaccination in infants could be the most honorable, dedicated, unbiased doctors in the world. I’ve never met them. But in medical school we are taught to at least briefly raise an eyebrow at research funded by a pharmaceutical company, instead of simply taking it for granted. I will emphasize that while I did that, I didn’t do so based on their pharmaceutical ties. I simply wondered about the findings in the research. While some people might question the motives of and advice given by any doctor with financial ties to the vaccine industry, I refrain from doing so in my book.
Parents look at Hep B vaccination for their newborn and wonder, “Why?” Many pediatricians that I’ve talked to do as well. If Hep B is a potential risk to children through non-sexual casual contact, then vaccination would be a no-brainer. While writing my book I tried to find proof that non-sexual spread of Hep B is a significant risk to babies so that I could advise parents to vaccinate right away. But as a pediatrician, I’ve never seen it occur. And I’ve only heard of one case publicized in the media – an infected child sneezed on a teacher’s hand, and the teacher contracted Hep B through a cut on her hand. I’m sure there are many more such cases. But really, 16,000 kids each year less than 10 year old? Am I the only doctor that wonders whether or not that’s true?
I went straight to the source of disease data – the MMWR 2002 – to see what the actual reported cases of Hep B used to be in children younger than 10 years of age (Reference 1) and found that during the late 80s and early 90s, prior to introducing Hep B vaccine to infants, there was only 1 case of Hep B per 100,000 children age 0 to 9 in the U.S. (see chart at the end of the MMWR report). With 36,000,000 children in the U.S. in that age range, that only comes out to about 360 cases per year. The chart doesn’t differentiate between the perinatal exposures and accidental exposures. I know that some childhood Hep B infections will go unrecognized for many years, but I just can’t believe with such a low number of reported cases that the estimates of 16,000 cases per year can even be close.
The study that Dr. Offit refers to, as well as every other study done during the late 80s and 90s that looked at Hep B in young children, doesn’t actually determine the rate of Hep B by direct study or by reported cases (References 2 – 5). These studies provide estimates using population statistics. They look at adult cases, and estimate what percentage of those may have come from non-sexual contact during childhood, and make a logical guess at what the rate in children might be. Well, in order to really determine the rate of Hep B in children (to see if infant vaccination is warranted), all one would have to do is screen several thousand children for the disease and see how often it shows up. Then repeat the study again with a larger group. That’s what should have been done decades ago prior to introduction of the vaccine. The study could be done today on children who have skipped the vaccine. Why hasn’t anyone simply done that?
I have no doubt that Hep B vaccination is important, especially for pre-teens. And because there may be some small risk of non-sexual exposure to the disease during childhood, vaccinating during childhood may be important as well. I state this very clearly in the book. But does it have to be given right away during the neonatal period? For any family with a Hep B positive family member, yes – each baby should be vaccinated. But for the other 99% of American families, I don’t believe the vaccine needs to be given to young infants, especially in the hospital. Why give a less-than-necessary vaccine to a newborn and risk creating sepsis-like side effects (Reference 6 and 7)? Any family that asks to delay this vaccine shouldn’t be treated like they are crazy. They simply want to give their newborn a break for the first few weeks.
As for the issue regarding parents’ trust in the vaccine manufacturers, that trust was severely shaken when it was revealed in the Los Angeles Times on February 8, 2005, that way back in 1991 a researcher at Merck sent a memo to the president of Merck’s vaccine division stating that they had just realized that the cumulative amount of mercury in vaccines given to infants by six months of age was about 87 times the safety limits set by the FDA. And that information was not revealed to the public until 8 years later. Now I realize that pharmaceutical companies do so much good for our health and the field of medicine, and that such negative occurrences are rare. As a pediatrician I put my trust in them everyday by prescribing their products, including Merck vaccines, to my patients. But I find it surprising that any doctors can fault a parent for not completely trusting Merck after that, or the FDA and CDC departments that were supposed to be overseeing this type of issue.
Vaccine Mandates Should Be Eliminated
I don’t make any claim that unvaccinated children have been taken away from the home. I state that I have heard “rumors” of such, but that I don’t believe them. I do believe, however, that some states may actually have that power by law, but I doubt it has ever been exercised. You may recall the recent court battle this year on the East Coast in which parents were refusing the Hep B vaccine for their teenagers. The parents were threatened with jail time if they didn’t either sign the religious waiver or comply with vaccinations. I don’t know if anyone was ever jailed, but that is a really scary thing to have occurred in our free country. I agree with Dr. Offit that in the event of an outbreak that significantly puts the public health at risk, the state should have some authority to step in. But during the normal course of life, I believe that parents should have the right to decline vaccines.
Vaccine-Preventable Diseases Are Not That Bad
This is a prime example in which Dr. Offit has taken one statement out of the book and portrayed my viewpoint inaccurately. I clearly state how bad each disease can get as well as the number of yearly fatalities. At the very beginning of the PC chapter I share how serious PC disease is. I also state at the very end of that chapter that I consider PC “a fairly important vaccine.” At the end of each chapter I share any personal experiences I have had as a pediatrician with each disease, and this was the only one I’ve had for invasive PC. At the end of the book I strongly urge parents who are thinking of skipping vaccines to at least consider PC vaccine (as well as a few others). On my website, I dispel a myth that’s been going around that the PC vaccine is no longer important, and is causing other emerging strains, and I urge parents to continue getting the current PC vaccine until an expanded one comes available.
A word of thanks to Dr. Offit on this issue for pointing out that I could perhaps improve on my disease descriptions in the book. In the next edition I am planning to add a section on each disease that paints a picture of “a typical course of this disease”, then a “worst case scenario of the disease.” Dr. Offit is absolutely correct. Parents should know how bad each disease can be.
Hide in the Herd
I agree with Dr. Offit here. Herd immunity is very important. I state the argument in the book that “the good of the many outweighs the good of the few.” Nowhere in the book do I encourage parents to “hide in the herd.” Again, Dr. Offit’s words, not mine. I clearly state (as Dr. Offit quoted) the danger to our country if too many people don’t vaccinate. My comment on “not sharing your fears with your neighbors” was an attempt at humor, while trying to teach a very important point.
Natural Infection Is Better Than Vaccination
Again, what book is Dr. Offit reading? Not mine. I describe chickenpox parties in the book, but I certainly don’t recommend them. Notice the “. . .” in Dr. Offit’s quote here. The entire quote is “Some parents actually want their kids to catch chickenpox. They may purposely get their child exposed to get the disease over with.” I’m simply stating what some parents do. Not what I think they should do. As for the risk of acquiring natural immunity to a disease, I agree with Dr. Offit. It is a risk. And I clearly state what that risk is for each disease.
A very popular anti-vaccine argument is that childhood diseases are healthy. They exercise the immune system. Other authors encourage parents to allow their kids to catch many of these diseases. I couldn’t disagree more. My book tries to dispel that myth. No one wants to exercise their baby’s immune system with meningitis or hep B, or most of the other vaccine-preventable diseases.
Vaccination Has Eliminated Infectious Diseases at the Price of Causing Chronic Diseases
I never even come close to saying any such thing I my book. Allow me to quote from page 178: “Critics [of vaccines] worry that many chronic diseases and other physical and mental problems like ADHD, chronic fatigue, diabetes, allergies, asthma, learning disorders, and autism are triggered by vaccines. I haven’t found any solid research to support this contention.” Interestingly, this is the very sentence that precedes Dr. Offit’s quote here. As Dr. Offit points out, I go on to say I found studies that show a “possible link,” but that’s it. I actually go out of my way to debunk the myth described in the heading above. By the way, the peer-reviewed journals that discuss “possible links” include Revue Neurologigue, Rheumatology, British Journal of Rheumatology, Journal of Rheumatology (that’s a lot of rheumatology!), Lancet, Neurological Science, Scandinavian Journal of Rheumatology, Acto Dermato-venereologica, Autoimmunity, Journal of the American Academy of Dermatology, and Clinical Rheumatology, Journal of Allergy and Clinical Immunology. See References 8 through 19.
Vaccine Safety Testing Is Insufficient
I don’t say that safety testing is insufficient. Again, Dr. Offit left out some of the words in his quote. I start this particular chapter with a discussion of the extensive short-term research that is done with each new vaccine, describing the research in a similar way that Dr. Offit states here in his article. As for his quote from my book, the entire text reads: “A new medication goes through many years of trials in a select group of people to make sure it is safe. These subjects undergo extensive blood testing and physical evaluations over many years. If nothing severe or common shows up, the medication is then released for general use. Vaccines, on the other hand, don’t receive that same type of in-depth short-term testing or long-term safety research . . . Their blood isn’t tested to check for internal toxic effects. Doctors don’t do physical exams to look for problems.” My point here is that the short-term research could be more hands-on, instead of simply by parent questionnaires.
I agree that vaccine safety testing is very extensive, and in my mind it is very adequate. What we could improve is the long-term safety research. Dr. Offit points out how VAERS and VSDP are model systems for detecting rare adverse events. A few paragraphs down, however, under “Risks From Vaccines,” he states (somewhat contradictorily, if that’s a word) “VAERS is a passive surveillance system and cannot be used to determine the true incidence of adverse events, which can be determined only by using control groups.” I couldn’t agree more. We need a large placebo group of voluntarily unvaccinated kids to compare to the vaccinated population. I think that we will see that in the upcoming National Children’s Health Study.
But back to “insufficiency” of safety research. In the book I refer to a statement made by the Cochrane Collaboration in Vaccine 2003 (Reference 20) regarding a review of 22 studies on MMR vaccine safety: “the design and reporting of safety outcomes in MMR vaccine studies, both pre-and post-marketing, are largely inadequate.” Their words, not mine.
Public Health Officials Make Recommendations for the Public and Not for Individuals
I’m pouring through the book right now trying to find where I may have made such a statement, and I just can’t find it. Hmmm. What I do believe is that Public Health Officials view vaccine issues from two sides – the risk to individuals as well as the risk to our nation as a whole. Parents, on the other hand, tend to make decisions based on their own individual child, without considering the public’s benefit. I also state in the book that such a decision is perhaps “selfish.”
As for the polio vaccine, Dr. Offit fails to include other quotes from the book that state the importance of the polio vaccine: “I consider this vaccine very important from a public health viewpoint. Until the whole world is polio free, ongoing vaccination will help keep our nation protected . . . (page 79).” Because there haven’t been any cases of polio in the U.S. for decades, I do believe it is correct to say that we don’t use this vaccine to protect each particular child from catching the disease (as compared to every other vaccine we use). Rather, we use it for herd immunity. I agree with Dr. Offit that “every individual benefits from receiving polio vaccine.” There is no “flaw in logic” here. We are both saying the same thing.
You know, I do suppose it was a little presumptuous of me to state that “I have offered you all the information you need to make this decision.” That would imply by book is 100% complete. No book is. I should have said, “I have given you almost all the information . . .” As for misinformation, I’m still waiting for some here.
Distinguishing Good Science From Bad Science
Because the science on vaccine safety is not complete, and never can be, I didn’t undertake the very tedious task of detailing every scientific study there is. Who would read such a book? This is a book for the general public. Where I state “Reasons some people choose not to get the vaccine,” I clearly state the risks that such parents are taking.
I will take this opportunity for the second time to state my appreciation for an oversight pointed out by Dr. Offit. I really should have delineated which studies come from a peer-reviewed (mainstream) journal and which do not. This is very important, so parents can decide whether or not a particular study holds any weight. This will be corrected in the next edition of the book.
Risks From Vaccines
Once again, I am respectfully thankful for this constructive criticism. Dr. Offit is right. We shouldn’t view reported reactions in VAERS as actual vaccine reactions, and I shouldn’t have used such numbers to determine statistical risks. I do, however, point out in the book that we don’t know that VAERS reports are actual vaccine reactions. The problem is, that’s the only system I have to try to determine what the risk of a vaccine reaction might be. I think parents deserve to know that. Until we have an active surveillance system, instead of a passive one, we won’t know what that risk is. I could also add that VAERS only contains reactions that are reported. Many reactions go unreported. So, even if only some of the VAERS reactions can be attributed to the vaccine, not all such reactions are actually reported. So, my numbers may reflect something close to reality. But that’s not scientific. We really need to take a better look at this.
Risks From Vaccine-Preventable Diseases
Wow. I am now convinced that we are not talking about the same book here. I not only make it very clear what the risks are from each disease, allow me to quote from the meningococcal vaccine chapter’s list of reasons to get this vaccine: “Obviously, meningitis is devastating. Getting the shot during the early teens protects a child . . . the chance that a college freshman in a dorm could catch it is something to consider. In the chapter’s conclusion: “No one can argue that MC disease isn’t a horrible thing to see, much less to actually catch.” That sentence precedes the one quoted by Dr. Offit here. Yes, I do comment on the GBS issue, as that was brand new information when the book came out. I state “If experts can determine that the risk of GBS is negligible, the shot will likely become more widely accepted.” I also predicted that it will become approved for two-year-olds, and state “this will become a very important vaccine, since the disease is more common in younger children.” I comment on GSK’s combo of HIB and MC vaccine for 2, 4 and 6 month olds (currently undergoing trials) and state “this vaccine will provide much-needed protection during infancy, when MC disease is most common.” I also describe MC disease (page 137) as “. . . extremely serious. This is probably the single most serious and potentially deadly of all vaccine-preventable diseases.” I go on to describe in detail the likely ICU course, with organ failure and likely permanent disability. Even though I fortunately don’t get to “see much of this evil”, I certainly describe it in the book.
I didn’t raise the specter of Mad Cow Disease. That’s a ploy found in many anti-vaccine books, and I state that this is an issue the critics often bring up. Dr. Offit is right, I should have mentioned that we don’t use “mad cows” in the U.S., but I though everyone already knew that.
Dr. Offit failed to mention the one time when a viral disease did contaminate a vaccine. And this was no small deal either. I open Ch. 16 with this info. In August of 2002 and February of 2003, the pediatric newspaper Infectious Diseases in Children published reports of SV-40 viral contamination of millions of doses of polio vaccine due to the use of monkey kidney tissues used to make the vaccine. It was estimated that almost 30 million people were injected with vaccines containing this virus between 1955 and 1963. Also, in 1980, 150 newborns were given an experimental Hep A vaccine that was contaminated with SV-40 virus. This virus has been linked to several human cancers, although fortunately the people injected with this virus haven’t been found to have higher than expected rates of cancer. Now we know to screen for this virus.
I find it peculiar that Dr. Offit portrays my book as raising the specter of mad cow, but completely leaves out the SV-40 virus problem. It’s not a problem anymore, but I use it as an example of what happened in the past. I state that vaccine critics worry that “unknown infectious particles or . . . foreign DNA in [human and animal] tissues may cause problems . . .” I end the section with “At this time, I can’t offer any good evidence to support these worries . . .”
Actually, the whole point of my two-page discussion on thimerosal is that it has been removed from virtually all vaccines, so you really don’t have to spend hours researching whether or not it is harmful. I save the parents’ time by making it a non-issue. Going back and reviewing all the research is a moot point for parents deciding about vaccines today. I actually thought that I was doing a great service by dispelling this myth. I guess not?
Ok. Aluminum is a very complicated issue. It really deserves its own article. In order to provide you with a full discussion on aluminum, I have posted that section from the book on my website in the FAQ section on the right, click here to read. I ask you to not pass judgment until you’ve read the whole thing. I don’t use the 2002 Vaccine study in my book. Instead I use the 2004 Lancet study from the Cochrane Collaboration for a thorough review of aluminum (Reference 21). For those of you who don’t read the entire aluminum section of the book, here is the bottom line. We know aluminum is a neurotoxin. We also know that humans can ingest huge amounts without harm, since 99% of it passes out through the stools. I’m sure Dr. Offit knows that, so I’m curious as to why he’d use the “babies ingest tons of aluminum anyway” argument. I would also point out that the conclusion of the study that Dr. Offit refers to doesn’t say anything about proving that aluminum is safe. It simply concludes that the amount in vaccines didn’t warrant changing the schedule. Those are two completely different statements.
I’ve been searching and searching for human infant studies that determine what a safe level of injected aluminum is, including looking at all the studies used in the article quoted by Dr. Offit, and I can’t find a single one. There is a lot of animal research, a lot of studies that use theoretical mathematical models, and one human adult study, but not a single human infant study (see Resources 22-30). As a precaution, I show worried parents how to take precautions to limit their baby’s aluminum dosing during vaccinations. This allows these parents to vaccinate, instead of declining them all.
Other Vaccine Ingredients
Up until December 2007, the albumin used as a growth medium for the MMR viruses was human albumin filtered out of human blood. The PI described how the human albumin is screened for the absence of adventitious agents, and processed using the Cohn cold ethanol fractionation procedure. In December 2007, the MMR PI changes its description of the albumin to recombinant. Dr. Offit makes it sound as if I’m misleading my readers and printing false information, when in fact my information was correct in October 2007. I appreciate him highlighting this change, however. It’s good to see Merck moving away from using a human blood product. Not that this was a problem – the albumin was carefully screened and filtered. Reference 31.
MMR Vaccine and Autism
Actually, in the book I describe in detail six studies that showed no link between MMR and autism (References 32-37). As for the MMR vaccine/intestinal inflammation/autism theory being debunked, I would now agree with Dr. Offit. At the writing of my book, however, no one had yet repeated Dr. Wakefield’s work to prove him wrong. As of this year, a very well done study by Harvard, Columbia, Mass General, CDC, and the AAP has (Reference 38). I have written an update to this effect on my website. My initial worries about the MMR and intestinal inflammation are probably unfounded.
Coincidence Versus Causality
Again, it sounds like myself and Dr. Offit mostly agree here, although for some reason my agreement with him would be viewed as “poorly reasoned or illogical.” One can’t simply group all reported reactions into two groups: either proven to be caused by a vaccine or proven to not be cause by a vaccine. There are so many reported reactions that haven’t been proven one way or the other through scientific study. This is a third category, and as further research is done we will place each reaction in one of the first two categories. But until that is done, parents can only view these reports as somewhere between coincidence and causality.
I agree. This is not a sound scientific argument. I just really wish we could prove a vaccine doesn’t cause a particular reaction. Parents could then worry a lot less. Although we can’t prove a negative, we can improve the long term safety research of vaccines so parents can be more confident.
We’ve already covered this. As for the flu shot, here’s my opinion. Because mercury is a known neurotoxin, all the science in the world won’t convince many parents to give their baby a mercury-containing flu shot, especially when they have the option to get a non-mercury version. I completely agree with Dr. Offit’s statement that the science shows no evidence that the amount of mercury in a flu shot causes any harm. But I just don’t think that parents believe it.
I understand the risk of MC disease as well as any doctor, and I very clearly recommend this vaccine in my book: “Obviously, meningitis is devastating. Getting the shot during the teen years protects a child through high school and college . . . There are about 250 teen and college-age cases each year. The ingredients are among the purest and simplest of all vaccines . . .” I do discuss how the reported GBS reactions may worry some parents, and may cause dome parents to delay the vaccine. But never do I say not to get the vaccine: “. . . this vaccine is an important step in eliminating or at least minimizing the disease among our nation’s teens . . .” I also give a very strong recommendation in favor of its use in younger children if it becomes approved for that age group. I don’t understand how Dr. Offit could misconstrue my statements to say that I don’t recommend this vaccine. I agree that the risk of GBS is much smaller than the disease risk.
In my selective schedule, I don’t tell parents not to get the MMR, VZ, Hep A, Polio, and Flu shots. That’s their decision. This schedule is designed to encourage non-vaccinating families to at least get their baby the DTaP, Rota, PC, and HIB vaccines, and their teens the HPV and Hep B vaccines.
Dr. Offit makes an incorrect statement regarding my alternative schedule. He says that children using this schedule won’t be getting a flu shot until age 5. On page 236, the flu is very clearly listed as a recommended vaccine starting at 6 months and continuing through to age five, so I’m not sure exactly what book Dr. Offit was looking at. Not mine.
My alternative schedule isn’t necessarily what I recommend parents do. In the book (page 235), I encourage parents who trust in our country’s vaccine system and safety, as recommended by our nation’s top medical experts and almost every doctor, to go ahead with the regular vaccine schedule. “I recommend that you trust your doctor’s advice, and your own intuition, and go ahead with vaccination.”
The alternative schedule is designed for parents who are worried about grouping so many shots together. That is the single most common worry I’ve heard from parents over the years. They want to fully vaccinate, they just want to do it at a slower pace. But up until now such parents haven’t had any guidance on how to do this. These are parents who otherwise may not be vaccinating, or if they do they are cringing and scared about doing it. Parents should feel secure and confident in their vaccine choices. Yes, this schedule is a lot more time consuming and more work for the parents and the doctor’s office. It certainly wouldn’t be a reasonable or practical vaccine schedule for our country as a whole. Babies would fall behind on their shots, compliance would wane, and some could be susceptible to what should be a vaccine-preventable disease. I agree with Dr. Offit there. My alternative schedule is simply an option for parents who want to take the extra time and effort. It’s just an option. I worry that if doctors don’t offer an option like this, some patients will go unvaccinated, and that’s not good. I believe this schedule will increase vaccination rates among non-vaccinating families.
The only vaccines that my alternative schedule delays to any extent are polio (until 9 months of age), Hep B (until 2 ½ years) and Measles (until age 3). This is virtually no risk involved in delaying the first two, but I agree with Dr. Offit that delaying measles vaccine is a risk, especially for a child in daycare or with older siblings. On my website, I encourage such families, and any family who is worried about measles exposure, to vaccinate for measles sooner.
The manner in which Dr. Offit has portrayed my book is erroneous and misleading. 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 Pediatrics wasn’t so riddled with selective, misleading, and inaccurate quotes. 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. 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.
You can find this article posted online tonight at www.TheVaccineBook.com
1. Achievements in Public Health: Hepatitis B Vaccination, United States, 1982 to 2002.Morbidity and Mortality Weekly, June 28, 2002; 51(25):549-552, 563. Available online athttp://www.cdc.gov/mmwr/preview/mmwrhtml/mm5125a3.htm
2. The changing epidemiology of hepatitis B in the United States. Need for alternative vaccination strategies, Alter MJ, Hadler SC, Margolis HS, et al, JAMA 1990;263:1218-22.
3. Prevention of hepatitis B virus infection in the United States: a pediatric perspective, West DJ, Margolis HS, Pediatric Infectious Disease Journal, 1992; 11:866-874.
4. Hepatitis B: Evolving Epidemiology and Implications for Control, Margolis HS, Alter MJ, and Hadler SC, Seminars in Liver Disease 1991, Vol. 11, No. 2.
5. Estimated and reported cases of Hepatitis B infection in children, Sepkowitz S, The Pediatric Infectious Disease Journal, Vol. 12, No. 6, June 1993.
6. Hep B vaccine Product Inserts list of report reactions, Merck and GlaxoSmithKline.
7. Unexplained fevers in neonates may be associated with hepatitis B vaccine, Linder N. et al, Archives of Disease in Childhood: Fetal and Neonatal Edition 1999; 81(3);206-207.
8. Vaccinations and multiple sclerosis, Gout O, Federation of Neurology, Paris France, Neurological Science 2001, Apr; 22(2): 151-154.
9. Arthritis after hepatitis B vaccination. Report of three cases, Gross K, et al, Scandinavian Journal of Rheumatology, 24 (1), 1995.
10. Atopic dermatitis is increased following vaccination for measles, mumps and rubella or measles infection, Olesen AB, et al, Acta Derm Venereol. 2003;83(6): 445-450.
11. Clustering of cases of insulin dependent diabetes (IDDM) occurring three years after hemophilus influenza B (HiB) immunization support causal relationship between immunization and IDDM, Classen JB, Classen DC, Autoimmunity 2003, May;36(3):123.
12. Vaccination-induced cutaneous pseudolymphoma, Maubec E, et al, Journal of the American Academy of Dermatology, April 2005; 52(4):623-629.
13. Vaccine-induced autoimmunity, Cohen AD, Journal of Autoimmunity, 1996 Dec;9(6):699-703.
14. Kawasaki disease in an infant following immunization with hepatitis B vaccine. Miron D, Clinical Rheumatology, 2003 Dec;22(6):461-3.
15. Vaccination and autoimmunity-’vaccinosis’: a dangerous liaison? Shoenfeld Y, Aron-Maor A, Journal of Autoimmunity, 2000 Feb;14(1):1-10.
16. Macrophagaic myofasciitis lesions assess long-term persistence of vaccine-derived aluminum hydroxide in muscle, Gherardi M et al. 2001, Brain, Vol 124, No. 9, 1821-1831.
17. Adverse Events Following Pertussis and Rubella Vaccines, Howson C and Fineberg H, The Institute of Medicine, Journal of the American Medical Association, Vol. 267, No. 3, Jan. 15, 1992.
18. Persistent Rubella Infection and Rubella-Associated Arthritis, Chantler J, et al, The Lancet, June 12, 1982.
19. Is RA27/3 Rubella Immunization a Cause of Chronic Fatigue? Allen, Medical Hypotheses, 27: 217-220, 1988
20. Unintended events following immunization with MMR: a systematic review, Jefferson T, et al, Vaccine 2003, Sept. 8, 21(25-26):3954-3960.
21. Adverse events after immunization with aluminum-containing DTP vaccines: systematic review of the evidence, Jefferson T, et al; The Lancet Infectious Diseases 2004; 4:84-90 \
22. Aluminum Toxicity in Infants and Children, Committee on Nutrition, American Academy of Pediatrics, Pediatrics Volume 97, Number 3 March, 1996, pp. 413-416.
23. A.S.P.E.N. Statement on Aluminum in Parenteral Nutrition Solutions, Charney P, Aluminum Task Force, Nutrition in Clinical Practice 19;416-17, August 2004.
23 a. Department of Health and Human Services, Food and Drug Administration, Document NDA 19-626/S-019, Federal Food, Drug and Cosmetic Act for Dextrose Injections. Available online at http://www.fda.gov/cder/foi/appletter/2004/19626scs019ltr.pdf
24. Department of Health and Human Services, Food and Drug Administration, Document 02N-0496, Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition. Available online at http://www.fda.gov/ohrms/dockets/98fr/oc0367.pdf
25. Effects of aluminum on the neurotoxicty of primary cultured neurons and on the aggregation of beta-amyloid protein, Kawahara M et al., Brain Res. Bull. 2001; 55, 211-217.
26. Aluminum-adjuvanted vaccines transiently increase aluminum levels in murine brain tissue, Redhead K, Quinlan GJ, Das RG, Gutteridge JM. Pharmacol.Toxico. 1992; 70;278-280.
27. Aluminum impairs the glutamate-nitric oxide-cGMP pathway in cultured neurons and in rat brain in vivo: molecular mechanisms and implications for neuropathology, Canales JJ et al, Journal of Inorganic Biochemistry, 2001; Nov;87(1-2):63-69.
28. Effects of aluminum exposure on brain glutamate and GABA systems: an experimental study in rats, Nayak P, Chatterjee, AK, Food Chem Toxicology, 2001, Dec:39(12):1285-9.
29. Aluminum neurotoxicity in preterm infants receiving intravenous-feeding solutions.Bishop NJ, Morley R, Day JP, Lucas A.,N Engl J Med. 1997 May 29;336(22):1557-61.
30. Neuropathology of aluminum toxicity in rats (glutamate and GABA impairment), El-Rhaman SS. Pharmacol. Res. 2003 March:47(3):189-94.
31. MMR vaccine Product Insert, Merck, 2003 and 2007.
32. Vaccines for measles, mumps, and rubella in children, The Cochrane Database of Systematic Reviews 2005, Issue 4.
33. No evidence for links between autism, MMR and measles virus, Chen W et al, Psychology Medicine 2004, Apr; 34(3): 543-553.
34. Immunization Safety Review: Vaccines and Autism, from the Immunization Safety Review Committee of The Institute of Medicine, 2004.
35. MMR vaccine and autism: an update of the scientific evidence. DeStefano F; Thompson WW, the Centers for Disease Control, Expert Rev Vaccines. 2004; 3(1):19-22 (ISSN: 1476-0584)
36. Epidemiology and Possible Causes of Autism, Hershel Jick, M.D.; James A. Kaye, M.D., D.P.H. Pharmacotherapy, Dec 2003
37. Unintended events following immunization with MMR: a systematic review, Jefferson T, et al, Vaccine 2003, Sept. 8, 21(25-26):3954-3960
38. Lack of Association Between Measles Virus Vaccine and Autism with Enteropathy, Hornig, et al., Public Library of Science, One 3(9): e3140