A Response to Dr. Offit’s Misleading and Inaccurate Review of The Vaccine Book in Pediatrics, January 2009
Monday, December 29, 2008
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.
Decision-Making
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.
Animal Products
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 . . .”
Thimerosal
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?
Aluminum
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.
Scientific Proofs
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.
Context
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.
Understanding Risk
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.
The Harm
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.
Conclusion
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
References:
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 at http://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
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0003140
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.
Decision-Making
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.
Animal Products
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 . . .”
Thimerosal
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?
Aluminum
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.
Scientific Proofs
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.
Context
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.
Understanding Risk
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.
The Harm
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.
Conclusion
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
References:
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 at http://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
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0003140
Labels: Vaccine News
posted by Dr. Bob Sears @ 7:27 PM
104 Comments:
At December 30, 2008 2:57 PM ,
Pensive said...
Dear Dr Sears,
Interesting review of Dr Offit's article, which was myopic and biased, as normal.
However, I would like to make a constructive criticism of your reply.
Please remove any use of "merely" or "simply". State what you state, because those two words make your reply sound like a reactive cowed obescience. :)
I'm sure it won't be his last swing at you, no matter what you have to say.
At December 30, 2008 3:06 PM ,
Pensive said...
For example:
I simply wondered about the findings in the research.
They simply want to give their newborn a break for the first few weeks.
I’m simply stating what some parents do
I do agree with your assessment though, that your book is provaccine, and would definitely increase the vaccination rate. However, that is impossible in any state which only has religious exemptions for parents to sign (which precludes any vaccines), so you would have to push for a nationwide adoption of philosophical exemption which would allow parents the choice of some vaccines, but not all.
At December 30, 2008 8:05 PM ,
Anonymous said...
This is slander, and shows no understanding of vaccines. An apology is due to Dr Offit.
At December 30, 2008 9:23 PM ,
Anonymous said...
anonymous...please elaborate on your "understanding" of vaccinations!
At December 31, 2008 4:41 AM ,
Catherina said...
More importantly: an apology is due to Dr. Moser, since her contribution to this article is constantly being ignored. I know it is sort of en vogue in the anti-vaccine movement to bash Paul Offit, however, every "Offit" in this blog should be "Offit and Moser" and every "he" should be "they".
At December 31, 2008 10:02 AM ,
Anonymous said...
catherine... Get a life!
At December 31, 2008 10:36 AM ,
Catherina said...
Anonymous - Happy New Year to you, too :)
Obviously, you think it is ok to disregard someone's intellectual contribution - not surprisingly, since you probably have never made one, contrary to Charlotte Moser.
The LA Times gets it right:
http://latimesblogs.latimes.com/booster_shots/2008/12/pediatrics-grou.html
In a scathing critique not often seen in a pediatric journal, vaccine expert Paul A. Offit and coauthor Charlotte A. Moser say the book misrepresents science; supports delaying, withholding or spacing out vaccines; endorses the concept of natural immunity through such methods as chickenpox parties; does not distinguish between solid science and poorly conducted studies; and commits several errors of fact. "In an effort to protect children from harm, Sears' book will likely put more in harm's way," Offit and Moser write.
(they get the content wrong - but that is press coverage for you).
Back to my life...
At December 31, 2008 12:43 PM ,
Dr. Bob said...
Catherina, point about Dr. Moser is well taken, thanks.
I would like to know, however, if you think Dr. Offit and Dr. Moser misrepresented the book in any way? I haven't seen you comment on that.
At December 31, 2008 2:21 PM ,
Catherina said...
Bob, I will do the points one by one - yours and theirs. On first glimpse, I think they could have done a better job and you could have, too. Had surgery yesterday, waiting for my brain to wake up and my knee to stop throbbing...
Happy New Year!
Catherina
At December 31, 2008 10:41 PM ,
Schwartz said...
Dr. Sears,
I agree that Dr. Offit has published a completely misleading review.
I also think you are being far to generous with the two authors.
"Open debate and discussion is healthy in the field of medicine. I welcome it, and I’m sure Dr. Offit does as well."
I disagree with the above statement. The approach Dr. Offit takes in his public statements and writing consistently discourages open discourse. His propensity to misquote and imply his own simplified or stereotyped sound bite to others' position is a pattern consistent with wedge politics.
If you read the NEJM you'll see he did the same to Dr. Poling. In Dr. Offits own rebuttal he practically admits to taking statements out of context, but has the gall to justify his statements.
http://content.nejm.org/cgi/content/full/359/6/655
(read his first paragraph carefully -- he is called out by Dr. Poling for applying his own interpretation to a misquote, but cleverly hides the admission in his rebuttal by justifying the interpretation)
As for your response I agree with Pensive. I think you put far too many conditional statements and weakening words in your response. It's far too long a response for most people to read fully.
If you removed a lot of the extra words and conditional statements your response could be made much shorter, more concise and much stronger. I fully appreciate that you are willing to publically take a stand against an establishment that appears to be stuck in the age where lay people should shut up and blindly follow what their doctor says. Your balanced approach to the discussion is a breath of fresh air and reflects thoughtful clinical experience in contrast to the research specialists that appear to be controlling the agenda and discussion.
At January 1, 2009 8:09 AM ,
Catherina said...
Alright - here come my comments, I am taking it segment by segment. Nothing much to be said about summary and introduction. I am with Moser and Offit there.
Doctors Do Not Understand Vaccines
I disagree with you both. I was honestly very annoyed with the "you feel stupid, hey, I am ignorant, too" approach that you had in your book. Many doctors know a lot about vaccines and not everyone feels overwhelmed with the info that there is. You often miss the chance to explain how certain vaccines/discoveries came about (of course we know where the mumps vaccine virus comes from, from Maurice Hilleman's little girl - what a wonderful story of dedication).
Offit and Moser's "trust the experts" is patronizing and beside the point. The start of the whole controversy is that parents are afraid to vaccinate and don't trust the AAP/are not happy with the recommendations. It is incosequential to acknowledge that in the introduction and then to go on to say "the collective experts know best". Parents do not interact with the collective experts.
Nevertheless, there is damage done by the book here - parents may very well have a harder time establishing a trusting relationship with their pediatrician, because their pediatrician might be contradicting something that is in the Vaccine Book (which the parents have now accepted as the "Universal Truth").
At January 1, 2009 8:19 AM ,
Catherina said...
Public Health Agencies and Pharmaceutical Companies Are Not Trustworthy
The hepB numbers will be difficult to determine in retrospect. I assume they would be between your 360 and their 16000 and since overall hepB burden has been reduced so much since the introduction of the vaccine, you will not be able to determine the risk of infection in early childhood that existed, say in the early 80ies.
You response is good - up to the point where you start your clear anti-vaccine conspirary, canard snippet about some Merck memo. So unnecessary, such a good illustration how deep you are in with the anti-vaccine crowd and how much you actually believe that there is some sort of money driven cover up going on. This last point of your response makes Offit and Moser's point better than they could have.
At January 1, 2009 8:25 AM ,
Catherina said...
Vaccine Mandates Should Be Eliminated
You are right that they are over-interpreting what you have written.
They are right - a mention of the good that the "no shots no school" mandates have done would have been warranted.
Germany is actually thinking of imposing the same, at least for Kindergarten (school attendance is mandatory, so you cannot permanently refuse a child schooling based on their vaccination status. Temporary exclusions are allowed and were executed in the recent measles outbreaks in Europe).
At January 1, 2009 8:44 AM ,
Catherina said...
Vaccine-Preventable Diseases Are Not That Bad
Shame on Offit and Moser for having taken the wrong example out of your book. From what you write in your book and on your board, it is crystal clear that a) you have a lot of respect of invasive pneumoccocal disease and b) you clearly recommend the PCV.
However, you do indeed sell a lot of VPDs as "not so bad", like measles and mumps for example. You have received very strong criticism from your peers on that one, for example here:
http://www.askdrsears.com/forum/message.asp?id=52960
Minimization of the effects of measles by Wilbert Mason MD - posted on 4/3/2008
As a pediatric infectious disease physician I feel I must comment on statements made in your March 27th commentary on the New York Times article. First, you infer that the cases in San Diego did not constitute an outbreak ("...if you can call it that..."). This is a highly contagious infection that spreads by small droplets that remain suspended in a closed room for over an hour. Indeed, 4 of the cases acquired the infection just by being in the pediatrician’s office at the same time as the first case. Three of these were infants and one of them had to be admitted to the hospital for dehydration.
Elsewhere you have observed that “all of the cases of measles passed without complications, as is usually the case with measles”. Let me share with you our experience with measles at Childrens Hospital Los Angeles during the measles epidemic in 1990. We diagnosed 440 cases between January 1st and June 30th. Of these cases 195 (44%) had to be admitted for one or more complications of measles. We documented the complications in all 440 cases and they included 63% with ear infections, 45% with diarrhea, 39% with dehydration, 36% with pneumonia, 19% with croup, and about 3% with other bacterial infections. Three children died all of pneumonia. Measles is not a trivial infection as you inferred. We would not be having a debate about vaccines at all if people realized the tremendous costs in suffering and human life we incurred before vaccines became available. To adequately protect a population against measles >90% of the population must be effectively immunized against the disease. If individuals defer vaccines as you suggest we will rapidly fall below that level putting large numbers of infants and children at risk of an outbreak if measles is introduced into the community. This is a free country but we should all feel some responsibility to our fellow citizens and their children.
We will come back to measles later...
At January 1, 2009 8:47 AM ,
Catherina said...
Hide in the Herd
You "attempt at humor" is repulsive given the magnitude of the potential consequences of postponing the MMR, especially the measles portion. Parents who do not vaccinate, or postpone vaccinations are currently free-riding on herd immunity. Their children pose a threat to the most vulnerable members of the community, infants and sick children and adults.
That you even feel like joking about something like that proves a point (you are either very naive, or very ruthless).
At January 1, 2009 8:49 AM ,
Catherina said...
Natural Infection Is Better Than Vaccination
You do not encourage disease "parties", but I don't think that I have seen you discourage them very strongly either, certainly not in the case of chicken pox. Have I missed something? If yes, that should have gone into your response - if no, why are you not discouraging parents to expose their children to disease?
At January 1, 2009 9:24 AM ,
Catherina said...
Vaccination Has Eliminated Infectious Diseases at the Price of Causing Chronic Diseases
I just reread pages 177 to 179 and I can understand Offit and Moser's irritation with your phrasing.
Vaccine Safety Testing Is Insufficient
You say "I don’t say that safety testing is insufficient." but actually, the whole text on 178 and 179 scream "insufficient". Oh, and look, you say it again in your reply. "internal toxic effects" sound so antivaccine - it is a non-descipt term, ideally suited to scare parents off vaccines (but, but, they have never looked for "internal toxic effects"). Offit and Moser are clearly right on that one.
At January 1, 2009 9:27 AM ,
Catherina said...
Public Health Officials Make Recommendations for the Public and Not for Individuals
Again, I don't think Offit and Moser chose the best example with polio. Rubella would be much better suited to illustrate the "conflict" (if there is one) between "good for the individual" and "good for the herd". I am glad to hear that you do not disagree with them.
At January 1, 2009 9:32 AM ,
Catherina said...
Decision-Making
That is a very very important point. I find often that while you pretend not to tell the parents what to do, you imply which choice you prefer. In you recent MMR blog you essentially scream "do NOT vaccinate with MMR", followed by a token "but of course it is up to you" (translating into "if you do not trust me and are too weak to wait for the monovalents...")
At January 1, 2009 9:44 AM ,
Catherina said...
Distinguishing Good Science From Bad Science
I fully agree with Offit and Moser. They later write Sears has a poor grasp of the scientific method and I think that is true, given that you give the same weight to the likes of Wakefield and the Geiers as to well conducted, valid studies. Your "but the point has been brought up and the parents need all the info" is really a cover for the fact that you yourself are not sure (I think) and tend to the vaccine-critical side.
If you did not, and your interest was merely the worried of the parents, you would advocate the MMR (because there really is no scientific or medical reason to split the MMR) and offer the seperates expressedly for parents who are too scared by the media and the bad science.
At January 1, 2009 9:46 AM ,
Catherina said...
Risks From Vaccines
I understand what you have done, but VAERS is not a tool with which you can do that. I am glad you see Offit and Moser's point and I agree that nevertheless, adverse events occuring after a vaccination should be reported to VAERS.
At January 1, 2009 9:50 AM ,
Catherina said...
Risks FromVaccine-Preventable Diseases
Offit and Moser write:
Sears often counters data on the national incidence of specific infectious diseases with personal experience. For example, in the section on pneumococcal disease, he writes, “I’ve seen only one serious case of [pneumococcal] infection in my office in my ten years of practice.” Regarding meningococcal disease, he writes, “I saw one case during my medical training, and I haven’t seen it since.” Because Sears works in a private practice and not a hospital, he is unlikely to see serious infectious diseases commonly. His individual experience should be enriched by his knowledge of published studies, however, and not used to negate them. This see-no-evil approach only misinforms his readers.
They are spot on - and it is true in the reverse, too. You have never seen a case of wild measles and therefore you think they are harmless (I am paraphrasing what you once wrote to me, cannot find the post at the moment).
At January 1, 2009 9:54 AM ,
Catherina said...
Animal Products
Again, I think Offit and Moser have a point, despite the previous SV40 contamination. While you do an overall good job in simplifying vaccine ingredients and explaining what they are there for, you don't put enough effort in diffusing fears.
At January 1, 2009 9:56 AM ,
Catherina said...
Thimerosal
Given how "mercury in vaccines" was traded for years as the main, if not only culprit for autism, AD(H)D and everything undesirable under the sun, a more thorough treatment would have been warranted. Maybe, if you had done the work for that, you would not have contributed to the Aluminum scare (It is not mercury? Then it must be something else in vaccines!) initiated by the anti-vaccine movement.
At January 1, 2009 10:07 AM ,
Catherina said...
Aluminum
Yes, I was saying...gosh - aluminium is such a non-issue, pushed exclusively by the antivaccine crowd. Your segment on aluminium is so severe that you are scaring the beejeesus out of many parents. And the result is described in one of the e-letters, directed to you, Dr. Bowman writes:
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.
Your responsibility that you assumed when writing the book the way you did.
At January 1, 2009 10:10 AM ,
Catherina said...
Other Vaccine Ingredients
You are right, Offit and Moser are wrong. Germans use Priorix which is without albumin.
At January 1, 2009 10:21 AM ,
Catherina said...
MMR Vaccine and Autism
Your response is entirely disingenuous and hypocritical given your absolutely catastrophic recommendation in your recent MMR blog to delay vaccination to wait for the singles. Either you are convinced that the MMR has nothing to do with autism, and then you would say so and act accordingly, or you don't and your most recent recommendation says you don't. Offit and Moser are spot on for the book.
At January 1, 2009 10:54 AM ,
Catherina said...
Coincidence Versus Causality
I also think that you mostly agree on this point, although sometimes your vaccine critical stance shines through on the board (what was that with adverse events due to DTaP appearing a month after the shot last week?).
At January 1, 2009 10:56 AM ,
Catherina said...
Scientific Proofs
Offit and Moser's assessement matches mine.
At January 1, 2009 11:03 AM ,
Catherina said...
Context
If you agree with Drs Offit and Moser, how would you do it better next time? I would suggest you read:
"Trick or Treatment"by Ernst and Singh
"Bad Science" by Goldacre and
"Autism's False Prophets" by Offit
especially since you said you would be writing an "Autisms" book for the Sears library and those books could really help your understanding of the scientific method and what constitutes evidence and quack treatments before you set off to write that.
At January 1, 2009 11:04 AM ,
Catherina said...
Understanding Risk
I think you are right here.
At January 1, 2009 11:17 AM ,
Catherina said...
THE HARM
Offit and Moser are right here. Read the responses in pediatrics to see why your AAP colleagues may be ticked off. Rethink the MMR issue. As long as your stance is like in your last MMR blog, do not be surprised if people call you anti-vaccine.
Reviewers' comments are always hard to stomach. After a night's sleep or three, you will find that they have a point, or 12.
At January 1, 2009 2:17 PM ,
Schwartz said...
Catherina,
"Many doctors know a lot about vaccines and not everyone feels overwhelmed with the info that there is."
Your response is reasonable, but I disagree with this simple broad brush statement. My personal experience and that of everyone I have spoken to is more in line with Dr. Sears' assessment of medical knowledge of vaccines. So when you state "many" that may mean over 100 but my experience has shown that the vast majority do not understand the topic past a very cursory understanding.
As your regular paediatrician the following questions and see if they can answer them:
1) How many aspects of the immune system are known well to medicine, and how many are involved when vaccinating with X.
2) How do adjuvants work, and why are they required? How does aluminum escalate the immune response? Why is it needed?
3) Why is Thimerosal required in vaccines? What replaced Thimerosal in vaccines?
4) How does the Tenanus vaccine work since you can't receive natural immunity when you contract tetanus?
5) What are the endpoint objectives of the flu vaccine? Of the rotavirus vaccine in North America?
6) Why do younger children require extra doses of vaccine boosters? Why do we need vaccine boosters at all? Why does natural immunity last longer? (I know my Paed got this one wrong)
7) How do vaccines such as Prevnar work? What is the long term effect of targeting a small percentage of strains?
8) How well does Gardasil prevent Cervical cancer? What specifically causes Cervical cancer?
9) Why are febrile seizures post vaccination not considered dangerous?
Very few people I know including doctors can answer the majority of these questions with any authority.
At January 1, 2009 2:32 PM ,
Schwartz said...
Public Health Agencies and Pharmaceutical Companies Are Not Trustworthy
Catherina, I agree with most of your assessment here. The question as to why we relied on rough estimates of incidence rather than doing the due diligence is troubling.
I agree that the memo from Merck is completely uneccessary in Dr. Sears' response as it side tracks into a topic that Drs Offit and Moser raise themselves. It should be avoided.
However I don't agree that a discussion of issues with Pharmaceuticals automatically spells conspiracy as you imply. There are issues with almost every governmental organization, and automatically labelling anyone who discusses these as a conspiracist is pure wedge politics, not logical debate. There are plenty of valid problems with evidence to discuss without needing to apply stereotypes or labels, but this was not the place to discuss them.
At January 1, 2009 2:37 PM ,
Schwartz said...
Vaccine Mandates Should Be Eliminated
I think we all agree on this one. Here is Canada, a parent's right to refuse vaccination for children is enshrined in the constitution and exceptions are executed without issue. We don't seem to be having any problems.
Interesting to note is that during Pertussis outbreaks here in daycares, the boards of health institute the same rules to all members of the daycare regardless of vaccination status (10 days of anti-biotics or 20 days home).
At January 1, 2009 3:26 PM ,
Schwartz said...
Vaccine-Preventable Diseases Are Not That Bad
Catherina, this is obviously one of the most difficult topics to discuss. The post you provided is good information but it only provides a small slice of information and ignores the bigger picture which must be considered. This is how the danger of vaccine preventable diseases is always presented, and it does not promote logical discussion of the overall issues. For the small percentage of children in this particular case that suffered from complications, were there actions that could be taken that would have mitigated or prevented the complications? What was the rest of their medical history? Were they already susceptible to diseases in general?
Without discussing everything you're again turning the discussion into a black and white issue which it is not.
At January 1, 2009 3:39 PM ,
Schwartz said...
Hide in the Herd
I don't think anyone disagrees with the point being made here. Although I wouldn't have used that type of humor the term "repulsive" is quite excessive IMO.
You conveniently avoided Offit and Mosers' misrepresentation though. They have taken the valid point Dr. Sears is making and twist it to sound like he's advising people not to vaccinate. What he's actually doing is IF they've decided not to vaccine, they should be aware that herd immunity is threatened if too many people take their position.
Yet another misrepresentation -- shame on them again.
At January 1, 2009 3:48 PM ,
Schwartz said...
Natural Infection Is Better Than Vaccination
Christina,
Your general argument appears to ignore the following: "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."
In the case of the chicken pox, Moser and Offit offer the standard risk outweighs benefit argument applied generally to all vaccines. How disingenious is that? If they and you want to get specific about chicken pox, they should start producing some numbers. Unfortunately the line "Severe and Fatal Disease" probably isn't applicable to the risk tradeoff here since I understand the primary cost justification of varicella vaccine is actually reduced health care costs, not death.
At January 1, 2009 4:51 PM ,
Schwartz said...
Vaccination Has Eliminated Infectious Diseases at the Price of Causing Chronic Diseases
"I just reread pages 177 to 179 and I can understand Offit and Moser's irritation with your phrasing."
Catherina, your statement would be fine if they merely expressed irritation and gave a reasonable argument. Instead they took a quote out of context... again. If they want to say that Dr. Sears did not put enough emphasis on evidence against a relationship then that's what they should have said. Instead they stated that the title of this section was a key message of Dr. Sears' book and took a quote out of context to back up their assertion.
Shame on Offit and Moser again. Exaggeration doesn't help their case.
At January 1, 2009 5:28 PM ,
Schwartz said...
Vaccine Safety Testing Is Insufficient
Personally, I disgree with everyone on this topic because I feel that vaccine testing is insufficient and combined with poor non-compulsary (compared with infectious disease tracking) adverse event tracking makes the safety study grossly inadequate.
However, focussing on the allegations levelled by Offit and Moser, we clearly see yet another quote taken out of context -- shame again. Catherina, if you feel that the overall text on the pages inferred the statement, that is fair, but taking a quote out of context to invalidly illustrate their opinion is plain unprofessional. Counting points would be far more valid.
I also take issue with their referenced examples in their poor attempt to make their point:
Using the Gardasil trials to show a large study population is a complete misrepresentation when you break down the study group by age compared to the target group of mandated Gardasil vaccinations. If my memory serves me correction < 5000 girls under 12 were studied. Improperly using detailed statistics while applying them to the general case reeks of negligence IMO. The second example of Rotavirus is also not common in vaccine approval because a similar vaccine (after much LESS testing) was found to have serious side effects and resulted in increased scrutiny for Rota vaccine. Implying that this is normal is also disingenious.
I also take issue with your statement: ""internal toxic effects" sound so antivaccine - it is a non-descipt term, ideally suited to scare parents off vaccines". Pointing to some make-belief anti-vaccine playbook is not a logical argument. The use of internal toxic effects was also specific to blood tests. This argument of yours is equivalent to me pointing out that anecdotal descriptions of measles complications is straight is straight from the pharma shill playbook. That's not a logical argument either.
At January 1, 2009 5:30 PM ,
Schwartz said...
Vaccine Safety Testing Is Insufficient
I also forgot to note that Offit and Moser never address the fact that far better placebo and control groups are used in pharma trials compared to vaccine trials. They conveniently avoid all of the embarrassing facts in trying to make their point.
At January 1, 2009 5:40 PM ,
Schwartz said...
Decision-Making
"That is a very very important point. I find often that while you pretend not to tell the parents what to do, you imply which choice you prefer."
Catherina, your point is one thing wrt to MMR, but that is not the point Offit and Moser published. They published that the majority of the information provided by Dr. Sears is largely misinformation.
That is pretty generalized statement without any qualifications. I suppose if they feel all of the sentences they take out of context constitute misinformation they are correct, but the misinformation comes mainly from their review not in the qualified context of the book itself.
At January 1, 2009 5:55 PM ,
Schwartz said...
Distinguishing Good Science From Bad Science
"I fully agree with Offit and Moser. "
It seems kind of strange that a discussion of quality of science is required when explaining "Why some people choose not to vaccinate" The statement itself is pretty descriptive and clearly doesn't pass judgement on the reasons, because the reasons themselves are important to know regardless of what any individual might think of them. Drs Offit and Moser imply that all the alluded evidence against vaccination is junk and that generalized implication is far from justified without extensive discourse into details.
To my amazement Drs Offit and Moser also invoke the false logic that "acceptance by the medical community" = good scientific evidence. Implying that "scientific consensus" is evidence or provides a scientific argument is pretty poor IMO.
Dr. Sears, you should also explain the danger of solely relying on journal name as a measure for quality given that even peer-reviewed journals have a recent history that is mired with problems. You could probably write a whole book on how to judge the quality of evidence, but a chapter might suffice. A discussion of the different study types would be beneficial, and a brief discussion of their weaknesses and strengths would also be in order. My personal advice is to always read the details. You should also point out why science uses peer-reviewed studies and what the outstanding weaknesses in our current peer-review processes are to be complete. The last thing you want to present is that peer-reviewed study = good science, because clearly that logical step is not true.
At January 1, 2009 6:05 PM ,
Schwartz said...
Risks from Vaccines
Here I am disappointed with everyone. Catherina, Drs Offit and Moser brush over a lack of data as if it is a minor issue. Drs Offit and Moser are valid in that VAERS data must be qualified up front. However, when you boil it down, they complain about what Dr. Sears talks about regarding risks, yet don't even address the elephant in the room that there is no good data. The reality is that absent data from properly designed safety trials, we are left with VAERS and anecdote both of which I am interested in. I don't want anyone -- especially those with bias -- retricting the information I see.
I still can't get over the lack of attention on this topic. You can't do a proper risk analysis without having good data. That is the elephant in the room. You can argue all the science on one side of the equation but without the other half a proper decision is impossible to make.
At January 1, 2009 6:15 PM ,
Schwartz said...
Risks FromVaccine-Preventable Diseases
"They are spot on - and it is true in the reverse, too. You have never seen a case of wild measles and therefore you think they are harmless (I am paraphrasing what you once wrote to me, cannot find the post at the moment)."
They are not spot on at all. A paediatrician sees a large cross section of children. Even if they don't personally see an incidence of a serious disease because the patient went directly to the hospital, they would have been notified if one of their patients had fallen ill. Their clinical experience certainly provides some valuable data of incidence in their area of practise.
Catherina, you also gloss over the point that Drs Offit and Moser focus (and quote) only one side that Dr. Sears presents. This is misrepresentation again. They appear to object to any balanced presentation of information. Your use of your earlier quote about hospital experience with measles is just as anecdotal as finding out the incidence of a particular disease within a Paediatrician's practise. Both sets of information are useful.
At January 1, 2009 6:22 PM ,
Schwartz said...
Animal Products
"While you do an overall good job in simplifying vaccine ingredients and explaining what they are there for, you don't put enough effort in diffusing fears."
We are venturing into pure opinion now. Without an active tracking system, potential risks such as these can go undiscovered for much longer periods of time. Without proper tracking I would be hesitant to pass judgement on any particular undefined risk.
At January 1, 2009 6:31 PM ,
Schwartz said...
Thimerosal
"Given how "mercury in vaccines" was traded for years as the main, if not only culprit for autism, AD(H)D and everything undesirable under the sun,"
Not true, MMR was also associated with Autism in the same timeframe.
"a more thorough treatment would have been warranted. Maybe, if you had done the work for that, you would not have contributed to the Aluminum scare (It is not mercury? Then it must be something else in vaccines!) initiated by the anti-vaccine movement."
Dr. Sears' approach was quite fair IMO. To delve into the history of Thimerosal would be far less endearing to the medical science community. Drs Offit and Moser hold up a single study (with a very small study group) as conclusive proof greatly simplifying the debate. The irony is that both that study and another neutral study held up by the IOM (Verstraeten) did find significant correlation with ticks which is a neurological disorder. To say that Thimerosal is exonerated from any problems is very premature. There are many different groups of people that are against the use of Thimerosal in vaccines. Broad brushing everyone with terms like "anti-vaccine" don't make logical arguments.
Like I said, avoiding the gory details in the book is probably a good idea.
At January 1, 2009 6:37 PM ,
Schwartz said...
Aluminum
Catherina,
"... aluminium is such a non-issue, pushed exclusively by the antivaccine crowd. "
There you go with stereotypes and broad brush statements again.
In addition to Dr. Sears' valid points on the study Offit and Moser referenced, let's review Aluminum: 1)Lack of safety study 2)Lack of understanding of how it works 3) Lack of study of how it might interact with other trace metals in other vaccines (like mercury).
Sorry, but I don't take your word for it, and I don't take Offit or Mosers either given the science they presented.
At January 1, 2009 6:41 PM ,
Schwartz said...
Aluminum again
Why do Offit and Moser imply that ingested metal exposure is identical to injection? They provide no pharmacokinetics to show it's the same.
Other Vaccine Ingredients
More misleading statements by Offit and Moser. Shame on them again.
At January 1, 2009 6:56 PM ,
Schwartz said...
MMR Vaccine and Autism
His response is fully justified IMO. As pointed out by the extensive Cochrane review in 2005/2006 the issues raised have not been decided by scientific study at all. In fact, the extensive study done to date was riddled with methodological flaws that any such discussion should bring shame to those who quoted each time that the issue had been conclusively decided. The studies quoted by Offit and Moser also didn't pass the muster of that review. Arguments based on flawed studies (epidemiological to boot) don't help anyone.
At January 1, 2009 7:27 PM ,
Anonymous said...
I am simply happy to have ready Dr. Sears' rebuttal to Offit/Moser article... At least there is someone out there who WE can turn to for some information!
Thank you Dr. Sears for being there and keep up the great work!!!!!
At January 1, 2009 11:08 PM ,
Schwartz said...
Scientific Proofs
Heh, far to little discussion on this topic. Offit and Moser are correct to point out the semantic error of the quote from the book. The word proof should not be used anywhere near epidemiology studies.
Offit and Moser would be good to remind all of their publicists of the same thing.
However, change the word "prove" to "show" and the statement is completely accurate.
Dr. Sears' response here is far too weak IMO. All of the studies are epidemiology based. Offit and Moser fail to note that the study methodologies are almost always the type that suffer from a high risk of false negatives meaning that negative conclusions must be treated carefully. When most of the studies are at a high risk of bias and based on the same flawed data one must be even more careful drawing any firm conclusions.
The complete absense of higher quality studies (RCTs) or followups of adverse reactions is shameful.
The devil is in the details.
At January 1, 2009 11:15 PM ,
Schwartz said...
Context
For decades, science couldn't show any negative effects from low levels of lead exposure either. Not being able to show an issue is not an argument for safety. It is incumbent on the pharmaceuticals to demonstrate safety of these compounds before injecting them into infants. In some cases (like Thimerosal) they didn't even do the most basic due dilgence. Offit and Mosers canards talking about ingested exposure again reveals how they treat these issues from a simplistic perspective. They again infer that ingested metals behave the same way as injected metals.
The whole dose makes the poison argument is great if you've studied what the poisonous dose is. Too bad they can't tell us what the level of toxicity for infants is of EthylMercury. Then maybe the dose makes the poison argument might be meaningful.
At January 1, 2009 11:25 PM ,
Schwartz said...
The Harm
Clearly the responses from Offit and Moser are missing the point as discussed earlier. You can't look at the overall risk assessment in a vaccuum of disease risk alone and that is what their argument solely relies on. Otherwise the recommendation should be to vaccinate everyone for everything at birth (an exaggeration I know).
I firmly think that the practical approach taken by Dr. Sears will increase the overall protection of both his patients.
I know Catherina from other discussions has a lot of good points about Measles. I also know a lot of people would feel much more comfortable with single measles shots at an earlier age. Clearly that would provide more protection for society and individuals compared to completely unvaccinated children. What is the reasoning for denying it's availability then?
The medical community appears to want to play chicken with parents. This is exemplified by the attitude of Drs Offit and Moser.
At January 2, 2009 4:54 AM ,
Catherina said...
Hi Schwartz,
I am not going to go into everything you wrote, just some.
Re: ask your pediatrician - I have discussed vaccines with almost all my doctors. It is a good one to spot the duds (like the one who gave me the infant vaccination schedule when I came in to discuss booster shots for my school age children - the last time I saw him). However, I will not waste their time or mine with decoy questions that busy the vaccine-critical crowd. An anecdote (if I am permited) I recently watched a pediatric tetanus case unfold on a German speaking anti-vaccine board. An unvaccinated child had fallen off his bike, sustaining a deep wound to the knee. The hospital cleaned it out, tetanus prophylaxis was given. About a week later, the boy could not open his jaw and mom worried openly (on the internet) whether this could be an "Impfschaden" (vaccine damage). Not one of the posters there, who regularly ask the "how can the tetanus vaccine leave immunity when the disease doesn't" told her "no honey, your son has tetanus" (he ended up two weeks in hospital, on iv Igs - there - they work :) In this case, it was enough that the doctors who treated the initial wounds, knew how to act when presented with an injured, unvaccinated child.
******************
You are right regarding the discussions about "bad diseases/bad vaccines". A discussion about side effects seems almost impossible at the moment, because the vaccine critical "faction" would pick up on any such thing as an "admission" that "vaccines are horrible". With knowledge of the relative risks involved, the open mention of side effects can actually be quite reassuring (like the 3 cases of MIBE that have made their way into the MMR package insert). The fact that hearing loss very rarely occurs after mumps vaccination, that stroke can be an even rarer adverse effect of varicella vaccination personally makes me more confident to vaccinate, since it becomes crystal clear that these adverse events are a function of the virus rather than the route of administration.
I doubt that apart from the very obvious immune deficiencies, we will ever find something "testable" that predisposes the one child to an adverse vaccine reaction or severe complication from disease. The daughter of a friend of mine who had a varicella induced stroke was turned inside out and found to be completely "healthy".
At January 2, 2009 4:57 AM ,
Catherina said...
"Hide in the herd"
I cannot help it - I find it not funny AND Bob's "joke" is easy to be interpreted the way Offit and Moser did. Other people have taken this sentence exactly the same way (Orac and Kev amongst them). It is a fact that herd immunity is essential to protect the weakest members of the community. A child who carries measles into a pediatric ward is potentially a murder weapon (in the hands of the vaccine critical parents). I know that there are a lot of emotions involved and that no one intends harm on their neighbors, however, there is no sugar coating or joking about the responsibility these parents assume.
I doubt that there are many die hard vaccine opponents are on The Vaccine Book board.Most of them are only concerned about their children (first) and children's health in general. Pointing them *explicitly* to the dangers of delaying vaccines makes most of them think.
At January 2, 2009 5:00 AM ,
Catherina said...
"internal toxic effects" - you say you take issue, Schwartz. Please define "internal toxic effects". Tell me what we would look for in a "blood sample". What is plausible to take place, how would we measure it?
I will tell you that I know several good examples, but I want to hear them specified from Bob, or from you, if you can.
A vague "internal toxic effects" is useless, unless you want to scare parents.
At January 2, 2009 5:11 AM ,
Catherina said...
Dr. Sears, you should also explain the danger of solely relying on journal name as a measure for quality
excellent point, especially since he falls for that himself ;)
************************
"Risks From Vaccine-Preventable Diseases"
Of course they are spot on - I am not saying that anyone is without bias or that anecdotes are useless. Offit himself uses one in the beginning of his book (have you read it? I can highly recommend it!). However, Bob said "we don't see measles anymore, hence we tend to think of measles as harmless" (I will have to find that post again...). That means he is going mainly by personal impression and not by all data available - and since California was hit quite badly with measles in 1989/91, there would have been plenty of colleagues who could have informed Dr. Sears about measles (some post here every once in a while).
At January 2, 2009 5:18 AM ,
Catherina said...
Not true, MMR was also associated with Autism in the same timeframe.
But not in the same country at the same time. If you look at GenRes pages or Kirby's book before they started shifting goal posts when the mercury=only culprit story was no longer tenable, it was mercury (if not mercury from vaccines then from mom's amalgam fillings and if not that, then maybe mercury in fumes from China....).
Most children in Europe are vaccinated with vaccines containing astronomical amounts of aluminum salts by Sear's standards. Our autism rates are not higher than in the US, and the children are generally healthier than in the US. Alternatives to Al salts as adjuvants are being investigated (since they cannot just be omitted like Thimerosal) and my prediction is that nothing will change in terms of autism rates after the introduction of the new vaccines.
Aluminum is a non issue - the latest anti-vaccine fad, it will go down the same route as the thimerosal and MMR scares.
At January 2, 2009 7:14 AM ,
Anonymous said...
Dr. Bob- YOU ROCK! Keep educating people the way you do....
At January 2, 2009 12:58 PM ,
Anonymous said...
I second that!!! Thanks Dr. Bob, I love your book and it really helped me to make an educated decision for my children. You know what they say, "bad press is still good press", Dr. Offit and your colleagues at Pediatrics are doing you a favor. At least, more people will hear of your book because of his critique and more people will read it and be helped by it.
Great work! Keep it up!
At January 2, 2009 4:40 PM ,
Schwartz said...
Catherina,
I found your story about the tetanus case quite interesting as it does illustrate that one should be aware of disease symptoms and recommended actions regardless of vaccination status, since any child can still contract any of these diseases.
It is unfortunate but close friends of ours were told by a young doctor that if they didn't vaccinate, she didn't want to have them as a patient because she might not recognize the symptoms of these now rare diseases. I'd be dropping that doctor in an instant. I also know of a tetanus case in a young child. In that case, the child made a full recovery after being hospitalized.
----------------------------------
"A discussion about side effects seems almost impossible at the moment, because the vaccine critical "faction" would pick up on any such thing as an "admission" that "vaccines are horrible"."
While your prediction may be accurate, it is still no excuse to avoid discussing the topic. That amounts to information hiding (or sugar coating) which is fundamentally contrary to the idea of "informed choice" and ultimately is damaging to children that might otherwise avoid vaccine damage. Your attitude is what drives the scorched earth policy currently employed by the CDC. I know that policy continues to alienate the parent population to the overall detriment of the system.
----------------------------------
"I doubt that apart from the very obvious immune deficiencies, we will ever find something "testable" that predisposes the one child to an adverse vaccine reaction or severe complication from disease."
I'm sorry, but that sounds like a lazy cop out. We certainly won't find anything testable if we don't try. And you mention obvious immune deficiencies. I would argue that nothing is obvious about an infant at birth (Hep B, Flu) or at 2 months old. One of the biggest issues I have is that there is generally little to no study of adverse reactions, even serious ones. The only reason we don't is because it costs money and no one is forced to do it. This is inexcusable IMO. We seem to find more than enough money to perform expensive genetic screening for extremely rare disorders.
At January 2, 2009 4:50 PM ,
Schwartz said...
Hide in the Herd
It is also fact that outbreaks happen even in highly vaccinated populations so any parent regardless of vaccine status has the same responsibility when bringing their infectious child to the doctor. There are several infectious diseases that look like measles. A regular cough could very well be pertussis etc.
"Most of them are only concerned about their children (first) and children's health in general."
The primary responsibility for any parent is to their child first and foremost. As a member of the community, their next responsibility is their neighbours etc. That is why the risk analysis is so critical for a parent to meet their primary reponsibility. Without the proper data an objective assessment becomes very difficult if not impossible. That is why information hiding or avoidance of data collection is so wrong.
As for the humor, you are probably right that it is unadvisable wrt to this topic. But please don't use Orac and Kev as examples because neither have any credibility with me when it comes to bias, the ability to honestly parse the detailed science, or in one case, the ability to hold civilized discourse.
At January 2, 2009 5:14 PM ,
Schwartz said...
Internal Toxic Effects
You have convinced me that your point is valid. Such an alarming sounding statement deserves details.
Risks From Vaccine-Preventable Diseases
Of course they are spot on - I am not saying that anyone is without bias or that anecdotes are useless.
Your example of measles may be accurate but that's not the example Drs Offit and Moser used. The information Dr. Sears provided in their examples was perfectly valid and was couched with the proper caveats. The explanation of their example (Offit and Moser) was also flawed so not only did they use poor examples, they blew the argument. I can't see how they are spot on.
You appear to be referring to posts on a blog, that may be another issue, but this is the review of the book, not the blog.
excellent point, especially since he falls for that himself ;)
:) It is a lesson I suspect the vast majority should spend some time investigating as it equally applies to all sides of this debate. I would add that a quick discussion of conflict of interest should be added to the list as well, as it is oft misunderstood and incorrectly assumed to be irrelevant or fatal.
But not in the same country at the same time. If you look at GenRes pages or Kirby's book before they started shifting goal posts when the mercury=only culprit story was no longer tenable, it was mercury
Now you had to ruin it all by throwing in an insult. Any change in hypothesis could be called a shifting goalpost, yet science itself demands that hypotheses get modified when new information arrives. Throwing out the playbook goalpost insult accomplishes nothing.
In the US, the Pertussis component of the DTP vaccine was also a subject of both books and debate for many years. When I did my initial research, I encountered information on Pertussis in DTP, Thimerosal, MMR, and some preliminary concern about Aluminum. Perhaps because I'm in Canada and we eliminated Thimerosal from the schedule (and wP as well) long before the bruhaha in the US, I was well aware of the MMR debate. I would be willing to wager that many people gathered their information online so the country of debate was less important barring a change in language. You seem to be fixating on a small but noisy segment of the population that focus' solely on Mercury as the silver bullet issue.
At January 2, 2009 5:35 PM ,
Schwartz said...
Most children in Europe are vaccinated with vaccines containing astronomical amounts of aluminum salts by Sear's standards. Our autism rates are not higher than in the US, and the children are generally healthier than in the US.
Applying broad brush epidemiology doesn't make good health science. I wish it did, because life would be a lot easier. Its the same flaw that those who assume that because vaccines increased over the same period as Autism prevalence, vaccines must be the root cause. Similar broad brush epidemiology.
But it's fun to speculate. My speculation is that diets are very different between Europe and the US. I also suspect that there could easily be an interaction between diet and the function of toxins in the body whether they come from external or vaccine sources. But we can both speculate all we want, until some proper research is done, we won't get any answers.
Most people assumed that HRT was harmless as well because the hormones used were already found in the body. There were a small few who were skeptical (my mother included) and when the large long term RCT studies were done, the results were quite unexpected.
Aluminum is a non issue - the latest anti-vaccine fad, it will go down the same route as the thimerosal and MMR scares.
Obviously I disagree with your assessment. You seem to assume that because it's always been used, it must be fine. The studies haven't been done, the mechanisms aren't even understood yet people claiming science as their guide declare conclusively there is no risk? That in itself is illogical. You among others also assume linear assocation of disease with dose. We have learned with other metals that this is not necessarily the most important factor.
At January 2, 2009 5:52 PM ,
Schwartz said...
Other Reading Material
Offit himself uses one in the beginning of his book (have you read it? I can highly recommend it!).
I have not read it yet. I attempted to order it, but it wasn't stocked and would have delayed order of other books. Since that attempt, I have become quite dissatisfied with his public discourse and written statements -- he communicates like a typical devisive wedge politician constantly misquoting out of context and preying to fear. I have little desire to finance his ongoing irresponsible campaign. So I'll have to wait to find a used copy.
I am a long time reader of Dr. Sears' books and have a great deal of respect for his balanced approach to medicine. I don't agree with everything, but he is a refreshing voice of practical and balanced advice in the sea of a mostly patronizing and out of touch medical community.
My Reading Recommendation
I highly recommend the book "In Defense of Food" by Michael Pollan. From the perspective of medicine and health, I think it illustrates the trap that reductionist and epidemiological "science" has led us down. The evolving revelations on how simplified research has led us to horribly wrong conclusions would be a good lesson for the medical community to learn. Life and health are far more complicated than we would like to believe.
At January 2, 2009 10:56 PM ,
Jay Gordon, MD, FAAP, FABM said...
For two generations the Sears family has broken new ground in pediatrics and parenting.
Vaccines, as they are now manufactured and scheduled, can cause harm to children. They should be safer and administered differently.
Bob Sears is a courageous intelligent author, a fine doctor and an honest man.
Jay Gordon, MD, FAAP, FABM
At January 3, 2009 6:46 AM ,
Victor said...
Caterina: "But not in the same country at the same time. If you look at GenRes pages or Kirby's book before they started shifting goal posts when the mercury=only culprit story was no longer tenable, it was mercury."
I would simply piggyback on everything "Schwartz" had to say and add only that the use of a sports analogy is a complete omission that you believe that this is essentially a team sport.
That is not science.
That is why, frankly, the public is losing confidence. Not Dr. Sears' mostly evenhanded book.
What I find so strange is that you casually disregard aluminum - a known toxin - as a problem based on completely unscientific reasoning. Isn't that exactly what you believe non-vaccinating parents are doing - being unscientific? Your defense of it to a worried parent would be completely unconvincing, in my opinion.
What is wrong with a broad set of independent studies to establish, specifically and with intention, the safety of our vaccines? A new task force (not composed of vaccine makers) that investigates our vaccines for safety and could put many parents concerns to bed.
CDC could take back this issue and produce the best literature there is on vaccines.
I actually have already been privy to the counter argument at CDC: Any new, high-profile effort to establish safety would:
1. be viewed as an admission that more testing should have been done at an earlier point (negligence).
2. Become fodder for the anti-vaccine fringe to further misconstrue and misrepresent vaccines and their safety (since these studies could never PROVE that vaccines are safe in every instance).
3. There are already enough studies to establish their safety.
The first two responses are unscientific reasonings based purely on "teamism" and conjecture. The third one is just plain stubborness.
1. The perception of "teamism" and politics is EXACTLY what is driving the lack of confidence by the public. That is why the CDC is screaming that vaccines are safe, yet many parents don't believe it. The issue of distrustful parents did not begin with Dr. Sears.
Frankly, no parent gives a darn about a government agency's reputation, liability, etc.
2.
At January 3, 2009 6:59 AM ,
Victor said...
2. Become fodder for the anti-vaccine fringe to further misconstrue and misrepresent vaccines and their safety (since these studies could never PROVE that vaccines are safe in every instance).
Again...this is a purely political consideration. (Scientists who believe too much science is a bad thing??????) I also say that it completely contradicts a vast amount of research related to public health communication.
An effort to conduct new, highly specific studies, would help CDC regain trust and re-establish its reputation on this issue.
Even from the team perspective, for every "anti-vaccine" doctor who uses it as an effort for unfair attacks, there will be 10 reasonable pediatricians for whom new studies would win their confidence and probably thousands of parents whose fears would be allayed.
Good science sells itself.
3. There are already enough studies to establish vaccine safety.
Stubborn. There are enough to convince "you," but the general public is the issue. We should continue to have steady funding and direction for studies until we obtain the desired goal of near-complete confidence in our system -FROM THE PUBLIC.
Government agencies don't get to close the door and turn out the lights on this one. Parents and their family pediatricians do.
I'm not assigning these arguemnts to anyone here, I'm merely pointing out that these arguemnets seem to be why the federal government isn't really lifting a finger to allay concerns beyond ramping up the propoganda.
At January 3, 2009 9:07 AM ,
Catherina said...
Victor,
in order for science and medicine to follow up an hypothesis, a scientist or doctor should formulate the hypothesis. The *only* scientifically formulated hypothesis about adverse events due to aluminum that has been proposed is macrophagic myofasciitis and it is becoming increasingly clear that this is a localized reaction to vaccination with no correlation to the overall clinical (motor) features.
So where, please, is the evidence for adverse effects specifically from the aluminum in vaccines?
At January 3, 2009 11:51 AM ,
Schwartz said...
Catherina,
When testing new pharmaceuticals for unknown possible adverse events, they do not form a single hypothesis and test for it.
This is a pharmaceutical, and it should be tested accordingly. A large long term RCT where adverse events and general health are closely tracked in the children. That is how you find unanticipated problems. You speak as if we know all there is to know about Aluminum in the body, but they still can't even completely explain how it works as an adjuvant!
At January 4, 2009 2:39 AM ,
Pensive said...
And a large long term RCT where the "control" isn't another similar pharmaceutical with like adjuvants.
Which would mean your controls would be "unvaccinated", since antigens don't work without adjuvants. But to do that would be "unethical", so that will never be done. Even with the rationale that the control group could be hidden in the herd...
BTW Schwartz, in 1999 at a CDC meeting about SV40, this point was raised with Hilleman and the CDC, because a large 30 year long RCT had been started when the Rubella vaccine came out, but the CDC said the data was lost, and did not know how far along the study was, before the data was "lost".
There was some follow up with salk vaccine recipients, but that was primarily to look at antibody response to MPMV and SV40 and a few other permutations along the same lines after the adenovirus vaccine, which had an SV40/stealth combination in it.
At January 4, 2009 9:30 AM ,
Schwartz said...
Pensive,
Interesting information. There are several possibilities however:
1) Compare a vaccine schedule significantly lighter in Aluminum to one higher.
2) Run the trial in adults first to see if any differences emerge.
3) Run the trial in other countries where vaccination is not occurring. (the cynic in me notes that American and International Pharmaceuticals run unethical trials in third world countries today, but that's not what I advocate).
4) Forego patient randomization and ask for volunteers.
I think the ethical question needs to be examined very carefully. All too often it is used as a default excuse to avoid study, or increasingly to stop study.
This article discusses a number of issues with the more prevalent actions of early cessation of studies today due to "ethical" reasons.
http://jco.ascopubs.org/cgi/content/full/22/9/1542?etoc
At January 4, 2009 10:17 AM ,
Catherina said...
Schwartz - find me a "country" in which vaccinations are "not occuring".
Also, I am still wondering about the evidence, "any" evidence, that the aluminum in vaccines is causing additional and specific harm.
At January 4, 2009 7:22 PM ,
Ariel Balter said...
My wife and I had a very hard time deciding whether or not to vaccinate. As you have hoped, your measured, reasoned analysis in your book cut through the fear on both sides. We adopted one of your slower vaccine plans rather than opting out entirely.
A great example of the complexity of the vaccination issue is captured in this recent episode of This American Life (in which you were interviewed):
After a measles outbreak started by one non-vaccinating family, both pro- and anti-vaccination families felt vindicated. On the one hand, the virulence and severity of measles was exposed confirming the need for vaccines. On the one hand, the children that contracted measles survived unharmed, so why are we so scared of it?
This exemplifies the difficulty of finding solid common ground. Both proponents and opponents of standard vaccination are deeply concerned about health and safety. But each express it differently.
Sadly, both sides often base their convictions on fear: Don't vaccinate and horrible diseases will spread like wild fire; Vaccinate and you run the risk of unknown short term and long term side effects that might be worse than the disease itself.
As you again demonstrate in your response to Dr. Offit's article in Pediatrics, you have the ability to walk the line. You maintain a dialogue that acknowledges unknowns and valid concerns regarding vaccines and vaccine science and carefully weigh this against the clear benefits--both to the individual and to society--of reducing infection rates of dangerous diseases.
Thanks for maintaining your poise, and please continue your work and advocacy in this area!
December 31, 2008 12:40 AM
At January 4, 2009 7:22 PM ,
Ariel Balter said...
I had published my comment to the wrong article (next one on pneumococcal) on Dec. 31. Just reposted here.
At January 4, 2009 7:37 PM ,
Ariel Balter said...
I am really happy to see this hearty and intelligent debate. I would just like to add one bit of constructive criticism directed at all parties:
I am a scientist, and the truth is that science is hard. On such complex issues, it is impossible to be right all the time, have completely assimilated all the best information, and always phrase things perfectly (or even well). In all but the hardest sciences, the best we can hope for is a collective understanding hashed out over time.
The more we keep away from debating "who is right", the more we can collectively work towards "what is right".
One way to accomplish this is to actively train ourselves to phrase things more in question form (but without being wishy-washy). For example, we might be inclined to say: A said this about what B said, but I read X in Y, so A does not have her facts straight. Given that we are all really on the same side here (the health and safety of children and adults), we might create healthier dialogue by saying: A said this about what B said, but I read X in Y. Doesn't this appear to support B's statement more? or Doesn't this contradict A's statement?
Thanks to everyone for taking the time to hash out these issues. I many doctors and researchers follow these discussions, and help them contribute to a better collective understanding.
At January 5, 2009 4:58 AM ,
Catherina said...
Ariel Balter,
I would be interested to know, why as a scientist, you were scared/sceptical to vaccinate in the first place?
Thank you.
At January 5, 2009 1:33 PM ,
Pea Pod said...
Dr. Sears,
Thank you so much for your insight on this issue. Thank you to the bloggers as well for the open debate (Schwartz, Catherina, Dr. Gordon, Victor, Ariel). As a new mom to a 4 month old, I have chosen not to vaccinate to this date, but will be considering an alternative schedule.
At January 5, 2009 2:29 PM ,
Victor said...
Catherina,
"in order for science and medicine to follow up an hypothesis, a scientist or doctor should formulate the hypothesis. The *only* scientifically formulated hypothesis about adverse events due to aluminum that has been proposed is macrophagic myofasciitis and it is becoming increasingly clear that this is a localized reaction to vaccination with no correlation to the overall clinical (motor) features.
So where, please, is the evidence for adverse effects specifically from the aluminum in vaccines?"
---
Thanks for the primer on "science," but that is not at all how research procedes in this country.
We do not have to wait for a hypothesis about HOW exactly harm is being caused to test for harm. Studies aimed at finding links between certain diseases and breast implants, plastics, preservatives, etc, all proceded just fine without a hypothetical pathway. That can easily be the basis of further studies.
The insertion of something into the body, given its immense complexity and our incomplete knowledge of human physiology, IS a possible pathway.
I think what I and others have asked for, is better studies to substantiate whether there is or is not harm that can be correlated with these vaccines. Large, studies specifically aimed at detecting the kind of effects associated with aluminum exposure would allay fears.
I've never heard anyone suggest that science requires that we must have strong EVIDENCE about how a problem is occurring before we can test for a problem.
There is well established biologic plausibility for aluminum being harmful. It's perfectly reasonable, then, to look for harm of the type of which aluminum has been linked in products that have aluminum. All sorts of studies have been conducted with just that much information - some with far less.
Hec, the CDC has commissioned epidemiological research on diseases that may not even exist (Morgellons) and have no known pathway or current biologic plausibility.
Under the procedure for research you outline, we would never catch any harmful agent until we had ideas about presicely how that harm was being caused. The only possible problem is a waste of resource, but that seems fairly silly in light of the intense public interest and the fact that these vaccines are practically mandatory for all children.
You argue for the importance of vaccines on one hand, yet seem unwilling to acknowledge the benefit of answering calls for more data.
The very nature of epidemiology is to prove correlation even BEFORE other facts are known.
The correlations, when found in studies with strong design, can help shape the hypothesis you are demanding up front.
The second issue is why you feel you can so easily place the burden of evidence on those who would like more information.
I might ask you...where is the data establishing the statistical safety of aluminum in vaccines across populations, age, weight?
When dealing with a known toxin that is injected into the human body, why would the burden of evidence be on me? Indeed, whether the pediatric establishment likes it or not, the burden is indeed on THEM. They are simply losing public confidence by brushing off their responsibility to win the trust of such a sweeping public health measure.
Even if I agreed that there were not any reasonable theories about how aluminum might cause harm (and I don't), you seem to be arguing against more research.
Honestly, why would you do that!?
Victor
At January 6, 2009 12:23 AM ,
Catherina said...
Victor,
thank you for your post. I do not agree with your description of the scientific process. In order to conduct a study, you need a hypothesis. Otherwise, you do not know what to measure. "Everything" or "anything" is rather vague, don't you think? Of course, the data could be soon available - in Germany, a prospective study looks at the health of *every* child of two (I think) consecutive birth cohorts until the age of two years. As said, German children are vaccinated with a vaccine containing comparatively high amounts of aluminum. Would it satisfy you if that cohort study did not turn up anything more/different than observed in US children?
Post marketing vaccine surveillance is being done and has been done for a long time. Anything that shows up after a vaccination, could, of course, be connected to aluminum in the vaccines. This has been looked at systematically for macrophagic myofasciitis. I am very happy that this research has been done. I would be happy for further research to be done, if there is a proper hypothesis.
Would you describe how you would construct the "ideal" study, the results of which you would accept? What sorts of questions would this study specifically ask? How would they be answered?
At January 6, 2009 10:02 AM ,
Anonymous said...
thanks Dr. Sears for bringing vaccine safety issues and the 'flexibility' of the schedule to the fore!
At January 6, 2009 12:28 PM ,
Ariel Balter said...
Hi Catherina,
While my wife and I were "skeptical", we did want to do some vaccinations. However, we were uncomfortable with the standard approach. In particular, I was skeptical because of a principle I believe in which is: Never let common sense get in the way of science or visa-versa. As a scientist, I also know that absolute scientific truth does not exist, and there is almost never (if ever) a final word.
My common sense says that if we have a way to prevent the spread of highly infectious and dangerous diseases, especially those that affect children, we should do it. My common sense also says that multiple injections of industrially produced substances into infants who are just developing their immune systems cannot be entirely without negative consequence.
As I said before, the two primary voices on vaccinations have very little room for each other, and are both based on fear. If you question vaccines, then you are being a dangerous luddite or a conspiracy theorist. If you don't, then you are in bed with a medical system that hypes-up the dangers from infectious diseases, probably to support pharmaceutical company profits, and could care less about the ill effects vaccines might have on our children.
Dr. Sears' book is the only place I found a discussion that I felt at least begins to address the duality in the choosing how and when to vaccinate.
I needed answers to questions such as:
(1) how dangerous are these diseases in a healthy child in modern society?
(2) what is really in the vaccines, how do they work?
(3) are there ways to minimize whatever hypothetical risks there might be to a child without leaving them unprotected?
We opted to vaccinate more slowly and at a slightly older age than the CDC. We are putting the Polio vaccine off until early teens, and will split up MMR if we can find them separate. Still deciding about CXpox. Probably will vaccinate because I hear it imparts better immunity against shingles. But, we will probably wait a bit to give a good break between shots.
I hope that answers your question.
Best, Ariel
At January 6, 2009 12:37 PM ,
Ariel Balter said...
By the way, I have to say that I agree with Victor about the scientific process. One does NOT need a hypothesis to conduct an experiment (or study). It is possible to look for correlations prior to causality. In fact this often happens inadvertently. A study strives to see if taking agent A is effective on symptom X. During the study it is observed that participants who actually took A as opposed to the placebo reported a statistically significant occurrence of symptom Y, which the study was not designed to look for. Later, more studies confirm that taking A leads to Y. No specific example on that, but I'll get one if I have to.
The technical term for such a study is "exploratory analysis"
Remember: science is about repeatable results, NOT proving or disproving hypotheses. Most of the time we have experiments that show that A leads to B long before we know why.
At January 6, 2009 1:55 PM ,
Anonymous said...
Dr. Bob, I don't understand why you are trying so hard to please your colleagues. You are right to call out your profession on the topic of aluminum. Your alternate vaccine schedule is a good idea, although even one shot containing aluminum would put an infant over the minimum safety amount you mention in your book. At least you are trying to do something about it. I'm surprised that you would still recommend the cdc's vaccine schedule even after learning all you have about aluminum. Why don't you take a stand against your colleageus? Do it for the children in your practice. You are right on this so don't let the criticism scare you.
Christina
At January 7, 2009 2:46 PM ,
Rachel from CT said...
So far, "The Vaccine Book" is the least alarmist, most comprehensive book I've found to help me sort through all of the information about vaccinating my soon-to-be-born babe. As a math teacher with a physics background, I can be "data-oriented" and hesitant to accept a practice or opinion "just because so and so says so". I'm not conspiracy-minded, I just think that scientists, doctors and every other well-meaning person related to vaccines are human, like me. So, I can testify that for at least one person out there, Dr. Sear's book tipped me towards vaccinating simply by being straightforward, honest and undefensive about pros and cons.
At January 8, 2009 2:23 PM ,
Graz said...
Dr. Sears,
Thank you for helping me make informed vaccine decisions regarding my children. My 3 yr old daughter had a bad reaction to her MMR vaccine, which lasted 6 months. It was terrifying and we were all alone.
I have my 4 month old on an alternate schedule. Thank you for arming me with the information I needed to feel good about my decision.
Please never stop your mission. There is so much resistance out there from our doctors. I had the "pharmacist" at my Dr office call me today to tell me that she was popping Dr. Offit's article in the mail to me. She went on and on about how it was published and it discounts you. I was happy to tell her that I am aware of his article and that she should read your response. I plan to send it right back to her.
My point is that now ever Doctor in the country has amunition when a parent comes into their office talking about an alternate schedule. You are right, the trust is broken again.
I am a perfect example of someone who was going to go to the extreme of non-vaccinating, but instead chose an alternate schedule b/c of your book. Thank you again.
At January 9, 2009 9:53 AM ,
Sierra Wilson said...
Dear Dr. Bob,
I am a busy new mom and only skimmed Dr. Offit's article but in response to some of his accusations:
Having worked with autistic children (as a classroom aide), having heard all of my life that vaccines are dangerous, and not knowing much about vaccines, I myself was anti-vaccine.
While pregnant with my first child, I decided not to vaccinate until the baby was at least two because I wanted to wait until his immune system was stronger. I made this decision because I didn't know much about vaccines but was concerned about their side effects. When my son was 3 weeks old someone suggested I read your book and you easily swayed me toward vaccination.
I have heard the same response from other parents but never did I hear that you made them decide NOT to vaccinate.
In the eyes of a previously skeptical parent, your book is quite PRO-vaccine.
As far as his accusations that your message is, "Vaccine-Preventable Diseases Are Not That Bad" and "Vaccine Mandates Should Be Eliminated" I completely disagree. That is how I felt BEFORE reading your book.
And furthermore, I am someone who does believe that pharmaceutical companies are untrustworthy and I probably agree with some of the "messages" that Dr. Offit falsely accuses you of putting forth. And despite all of this it is your book alone that convinced me to fully vaccinate my child.
Lastly, Dr. Offit really takes your words out of context. So if I am confronted by my DR. (who already told me he disagree's with the MMR part of your schedule but agreed to use it anyway for my son) I can easily argue, "Having read his book I know that YES, Dr. Sears IS pro-vaccine. So lets agree to disagree and give my son his shot please."
My son and I are very grateful to you and your research so please take heart and know that there are parents like myself who will stand up to their doctors on your behalf and continue to reccomend your book to parents.
At January 9, 2009 10:19 AM ,
Sierra Wilson said...
An afterthought:
I have written respectfully to Dr. Offit explaining to him how your book convinced me to fully vaccinate my child and would urge other parents to do the same.
At January 11, 2009 8:45 PM ,
Anonymous said...
I am not as up to speed on this topic, but I just read The Vaccine Book. I have to say that it is the most unbias book I have ever read on any given topic. Other people have told me that they didn't like it because it didn't tell them what to do. Well there you have it. It is not supposed to tell you what to do. It allows you to make informed decisions. That is something the CDC does not want you to do.
Thanks to Dr Bob for giving us the facts without bias!
At January 12, 2009 8:30 PM ,
Dr. Bob said...
Catherina, Victor, Pensive, Schwartz - WOW - I think you all win the prize for very thoughtful and thorough back and forth debate. Very enlightening viewpoints and info.
And thanks to the rest of you for your input and supportive comments. It will be interesting to see how this issue continues to play out.
At January 19, 2009 4:58 PM ,
sophia leto (aka Moody Mommy) said...
I enjoyed your book and believed it to be unbiased. I'm so sorry that you had to go to so much trouble and effort to respond to this doctor's review.
At January 29, 2009 2:46 PM ,
Deanna said...
A little late to the foray, but I wanted to state that had I not found your alternative vaccine schedule that we would have been one of those families that completely forewent vaccines. I thank you for the thoughtful and researched alternative.
Do I believe vaccines are a good thing? Yes. Do I believe that it is possible to have too many vaccines at once and overwhelm a small child's immune system to the point of an adverse reaction? Yes. Do I believe that pharmaceutical companies are corrupt and will make poor choices based on finances alone? Yes. (as is the same with many many other large industries in the world) Therefore, I also believe that we should be able to study the information in hand, derive what we may, and make our independent choices.
To the MMR vaccine topic, we were going to start our first of three separate vaccines next week. Now that the possibility exists that we won't ever have the individual measles component, we will evaluate the full MMR possibility. But, we are confident in our child's immune system because we have taken the vaccination schedule slowly and should we do the full MMR, it will be on its own.
At January 30, 2009 8:42 AM ,
Anonymous said...
As a parent (an unvaccinated one at that!) I have been in a dilemma about whether to vaccinate my son. In the UK all the information I was able to find was either completely pro (mostly NHS published with virtually no recognition of risks) or comppletely anti - all anti-pharmaceutical conspiracies. When I found Dr.Bob's book by searching the internet I was really relieved to have found unbiased information that recognised parents fears and tried to allay them. I still haven;t vaccinated at 16 months, for various reasons, but having read Dr.Bobs book I am considering getting at least some of them done soon, and possibly more later. Parent's are going to have fears about all sorts of things as htier children grow up and denying them the opportunity to question things isn't going to make them more compliant. It's about time everyone was more open and honest and people were allowed the freedom to make thier own choices.
At February 3, 2009 12:13 PM ,
Anonymous said...
Dr. Bob, this is the presentation notice for an upcoming lecture at UCI. The lecture will present a mechanism for dialogue on immunizations that may be of interest to you, and to some of the lay readers and professionals who blog here.
University of California, Irvine's Bio Sci is presenting the Howard Schneiderman Memorial Bioethics Lecture at 7:00 p.m. on March 2, 2009 at the Arnold and Mabel Beckman Center of the National Academies.
“Immunization Hesitancy: A Rising Tide that Challenges the Public Health”
Edgar K. Marcuse, M.D., M.P.H.
Associate Medical Director, Seattle Children’s Hospital
Professor of Pediatrics, University of Washington School of Medicine
The societal consensus that has supported our childhood immunization appears to be
eroding. In some communities negotiating the recommended immunization schedule is
becoming normative behavior for parents of newborns. The origins of immunization
hesitancy and resistance will be reviewed; the effects of opting out on the spread of
vaccine preventable disease discussed, and the dilemma of balancing individual’s right
to chose and protecting the public health explored. A strategy will be proposed to use the
principles of motivational interviewing to create a constructive dialogue to assist parents
to make informed decisions to protect their child against vaccine preventable diseases and
to apply the principles of social marketing to promote the public health.
Marc Lerner, M.D. Pediatrician
At February 3, 2009 12:14 PM ,
Leah said...
Before reading Dr. Sears book I was leaning strongly towards not vaccinating my son. I read Dr. Sears book and found it to be informative and easy to understand from a lay person's perspective, especially when compared with other material that I had been researching. After reading the book I then found myself on the fence as to whether to vaccinate or not. I found the book to be unbiased and I was a little disappointed, truth be told, because I was hoping it would 'tell me what to do'. With my husband deployed to Iraq and little time to contribute to the decision, I decided to summarize the book for him in an effort to reach a decision. As I summarized the book it became even clearer to me that the book is unbiased. After summarizing and talking with my husband we decided to vaccinate but at a slower pace that we are more comfortable with. Without Dr. Sears book we probably would not have vaccinated. Furthermore, my son is a patient of Dr. Sears and I have never been able to tell which side of the fence Dr. Sears sits on, again sometimes hoping he would 'tell me what to do' but to his credit he always presents both sides of the argument and remains unbiased.
At February 3, 2009 8:28 PM ,
Kacey said...
Dr. Bob, there are also some of us who are Catholic, who cannot give our child the MMR, because they use aborted fetal cell lines. Merck's separate dose for rubella, Meruvax, uses aborted fetal cell lines and taints the entire MMR II vaccine. The separate doses of Attenuvax (measles) and Mumpsvax (mumps) use chick embryo. Without these separate doses for measles and mumps, there will be no moral alternative for parents!
It's a tragedy, and I hope you will publish my comment.
At February 6, 2009 7:01 AM ,
Ruffle Bikini said...
This has been two stress-filled years, wondering if a cough might turn into whopping cough. We're just glad it's over.
Ruffle Bikini
At February 27, 2009 1:31 PM ,
Mom in MN said...
Dr. Sears don't let Offit & the AAP bully you into backpeddling. You speak for those of us with a voice too small to hear.
Thank You.
At March 1, 2009 9:10 PM ,
Kari said...
I really enjoyed The Vaccine Book. I felt trapped by information from extremists on both sides. It is unfortunate that the 2 typical viewpoints are : vaccines are 100% safe all the time or vaccines are useless and extremely dangerous. This book was the best info I found to help me decide what to do with my child. I probably would have gone with the recommended schedule but am instead choosing the book's alternative schedule. I feel much more comfortable with this choice. I understand that choosing to vaccinate or choosing not to vaccinate each carry their own set of risks and ultimately it is up to me to make the best choice for my family. I have had no problems with my family doctor on this issue. I have diligently shown up for my "shot-only" visits in the off months. Also, I may be the only one who appreciated the herd immunity joke. The ethics of herd immunity greatly influenced my decision to get vaccines for some of the less common diseases.
At March 8, 2009 2:05 PM ,
Anonymous said...
Dr Sears, don't let Dr (Pr)Ofit biased articles get to you.
YOu are a great help to parents like us. Thank you for your informative book.
At March 8, 2009 9:45 PM ,
Fatina said...
Dr. Sears -- THANK YOU for publishing a book that provides sound information and guidance to help parents as they make "real life" decisions concerning whether, and how to vaccinate their children. I am so tired of the scholarly battles that rage on about this issue as parents face the day-to-day decision of how best to protect the health of their children during the pivotal first 5 years of life. We are on the front lines dealing with vaccine issues every day, while physicians like Dr. Offit are off in ivory tower "safe havens" debating whether we are mature enough to handle the truth and make appropriate decision for our families. Your book is, and has sold so well because it filled a void -- you created a layperson's manual to the basics of vaccine safety. THANK YOU for making me a better and more well-informed parent when it comes to the health of my children.
At March 8, 2009 9:45 PM ,
Fatina said...
Dr. Sears -- THANK YOU for publishing a book that provides sound information and guidance to help parents as they make "real life" decisions concerning whether, and how to vaccinate their children. I am so tired of the scholarly battles that rage on about this issue as parents face the day-to-day decision of how best to protect the health of their children during the pivotal first 5 years of life. We are on the front lines dealing with vaccine issues every day, while physicians like Dr. Offit are off in ivory tower "safe havens" debating whether we are mature enough to handle the truth and make appropriate decision for our families. Your book is, and has sold so well because it filled a void -- you created a layperson's manual to the basics of vaccine safety. THANK YOU for making me a better and more well-informed parent when it comes to the health of my children.
At July 24, 2009 2:18 PM ,
Michele Davis said...
Dear Dr. Sears:
I know this is late, but I wanted to thank you for explaining the Hep B data Offit and Moser cite in their article. I was shocked when I read the statistic that 16,000 children under the age of 10 contracted Hep B through non-sexual, person-to-person contact.
I am disturbed by the fact that Offit and Moser did not explain that these estimates were population estimates based on reported adult cases rather than actual child cases. Doing so is very misleading and suspect.
Thank you for your work on behalf of children and their parents.
Blessings,
Michele Jones
Post a Comment
<< Home