A new study finds a correlation between infant exposure to aluminum-containing vaccines and the risk of developing childhood asthma, but the evidence is underwhelming.
Good analysis Dr. Hollander. It is a very murky subject, contentious at times, and not for the faint of heart physician to tackle. So thank you for grappling with it publically, for all of us to bear witness. I agree with your interp and conclusions, with one caveat. I strongly suspect that if we were to adjust for genetic polymorphisms that predispose towards an IgE mediated diathesis (eczema, asthma, anaphylaxis/hives, food allergies, etc.) that we would find that kids who are genetically predisposed are the ones whose immune systems respond adversely to injectable aluminum in these bolus dosing patterns. Certainly, if we look at the rainbarrel theory that the allergy world often refers to, there is thought to be a tipping point with which the rainbarrel begins to overlow once a specific immunologic threshold has been surpassed. The overflowing represents the onset of symptoms, be it eczema, asthma, but the exposure represents a 'trigger.' This is confused as a toxicity effect because heavy metals are thought of as toxins, and you poignantly address the fact that Aluminum is present everywhere in nature, including within our bodies at baseline, so it is not a toxin by nature. In fact, any inert substance such as water and air can become toxic to our bodies and quickly become fatal in excess doses. I've been, not so secretly, hoping/praying for genetic polymorphism screening of everyone, for a panoply of reasons (choosing the best suited medications and foods/diet, etc.), but mostly because it is tech that is no longer prohibitively expensive, and only serves to improve health outcomes by helping shed light on some of our frustrating blind spots in medicine. I can't think of a more appropriate population to screen than infants. Let's face it, vaccinations are elective preventative interventions that work really well in general and have saved millions of lives over the relatively few decades since the oral polio vaccine emerged (okay, it was actually the cowpox vaccine first). But we need to do better to minimize harm from such preventative interventions. The way I see it, we have two options. We either perform routine genetic screenings to identify the relatively few kids who react adversely to vaccines and then put them on delayed schedules, OR, we put everyone on a slow schedule to reduce the risk of the few. We have the tech, the resources, and the inventiveness to carry this out, we just need to decide that it will be equitable and worth the upfront expense of universal testing (elective of course). I believe that we owe this to our kids.
Thanks for the thoughtful comment, Justin. I think we are a long ways away from having anything like a vetted means for identifying infants at risk of adverse reactions, and am dubious all the genetic testing in the world would accurately predict vaccine AE risk in a large longitudinal study. I’d love to be proven wrong in the future. As to spacing out vaccines, I wrote this in another response: “Probably because I write articles like this, I have a fair number of pediatric patients whose parents favor broad spacing in their immunization schedule, and it’s not w/o problems. A) These kids learn to hate me as EVERY SINGLE MONTH I am coming at them with needles!; b) that’s a lot of extra car trips and time spent in doctor waiting rooms, neither of which are w/o risks; c) the longer the delay the greater the “window of vulnerability” — esp with the diseases like PC, pertussis and Hib which can kill infants — and the less the benefit of vaccination in the first place. So, while I support informed parental autonomy and can see the possible benefits of this approach, it would take some stronger evidence to merit a global shift in recommendations, in my opinion. I hope someone gets funded to explore this, though.”
I don’t have any ready solutions to this; I would just like more thoughtful data on risks:benefits of the current immunization schedule and possible feasible alternatives.
I agree with your assessment of spacing out Hib, PC, pertussis in particular, in the first couple years. This is in fact what we are up against, trying to mitigate risk by giving as many of these important vaccines as quickly as possible, which then potentiates a different type of risk that is even harder to measure or correlate, due to comparatively limited data. It’s a classic ‘damned if you do and damned if you don’t’ situation for either party. There is one thing that we have not yet mentioned in this discussion. The older a child’s immune system is when first inoculated, the fewer booster injections are required in order to achieve immunity. If you look at the CDC immunization schedules, you’ll see the catch-up schedule is quite different, depending on age at first inoculation. This doesn’t solve the problem of increased risk to small infants from those 3 pathogens in particular, but it addresses several important points, including lower cumulative aluminum exposure and fewer doctor visits by virtue of fewer overall injections needed to achieve full immunity. Having said all of this, in my former practice I was involved with following the CDC schedule for quite a few patients and never saw any adverse reactions other than the occasional low-grade fever that was short-lived, usually only one evening. I likewise had quite a few families who opted to vaccinate according to a modified schedule, and some who opted not to vaccinate their children at all. I never saw a case of vaccine preventable infection, probably due to herd immunity.
These are not easy conversations but I didn’t feel like it was ethical to fire a family for not following the CDC schedule as some of my pediatrician colleagues were doing. There are no easy answers for this subject, each family has to be able to sleep at night with their decisions, and it is up to physicians to take the time to fully educate families about the very clear risks of vaccine preventable diseases and the many unknowns involved with modifying the CDC schedule or not vaccinating. There is fairly significant genetic data for polymorphisms in detoxification genes that would be a good place to start in the pursuit of data pertaining to risk from exposure to vaccines. This data could help parents feel more at ease in their decisions. There’s also a fair amount of counseling involved with what measures can be taken to protect under-vaccinated or unvaccinated children, such as an ongoing education about signs of meningitis or severe infection, breastfeeding, hygiene and protective measures, the adults in the household getting a Tdap booster, and possibly paying out-of-pocket for a pneumococcal vaccine, even if risk stratification doesn’t meet criteria for the parent.
Thank you for having the courage to explore the issue of vaccine safety. We know that some FDA medications are safe and effective while there is a long history of medications that turned out to be harmful ( Vioxx, thalidomide, but there are literally hundreds). So why is it a taboo to question any vaccine, ever? How can anyone say "vaccines are safe"? That is like saying " medications are safe." Some are, some aren't. There should be a risk/benefit analysis.
Hepatitis B is routinely given to newborns. Why? most newborns are not exposed to HepB. The mother could be tested to see if she has it before routinely giving the vaccine. It's time to become more honest about vaccines. In 1961 most children got about 5 vaccines total. Today the recommended schedule is 72 vaccines. Thats a lot of aluminum by the way!
Thanks; and I agree that nothing should be taboo in medicine. I am encouraged that this study was even funded in the first place; and hope better designed studies with an aim towards “best vaccine practices” are forthcoming. Call me naive.
A good start would be studies of placebo vs vaccine which are never done in vaccine trials! They use another vaccine or sometimes the adjuvants. Another very important study would be study several thousand entirely unvaccinated kids ( religious exemption or just "anti-vaxx" parents) and look at their health outcomes vs a similar socioeconomic group of vaxxed kids. Do the unvaxxed kids have less autism, fewer allergies and less autoimmune and other diseases? What about mental health and ADHD? By making sure both groups have parents with similar incomes, similar rates of obesity, and similar geographical locations, confounding factors could be controlled for.
Further research is warranted, but will it be funded?
If funded, by whom and for what purpose?
We have recently seen studies expressly designed to provide predetermined outcomes. Those dealing with equivocal case study data for instance, of early treatment. When the observational reporting expressly maintained that efficacious results were observed when a treatment was imposed within seventy-two hours of symptom onset, studies conducted on patients with advanced illness skew the results.
There are multiple unanswered questions in vaccination. The one common them is that answering the question may interfere with the lucrative income streams generated by mandatory vaccination schedules. The prediction is that they will never be examined.
There are multiple questions contained in the above. Perhaps each vaccination by itself is relatively harmless, but multiple vaccinations given simultaneously are not. Perhaps multiple vaccinations given simultaneously are okay, if the schedules are farther apart. Perhaps one component is more adverse than another.
There is no question that certain diseases have risen dramatically in the last few decades. In childhood, asthma and autism.
Association is one thing but a good place to look. Establishing a mechanism is a different thing. Association without mechanism is weak. Association with mechanism is a step towards proof. But to find the mechanism requires much effect. In the time lapse, the failure to establish a mechanism is used by pharma marketing to argue the inherent safety of the vaccine schedule and the foolishness of those who oppose the current vaccination schedule.
Our understanding of the inflammasome (the inflammatory complex of the immune system) has markedly improved over the past decades. Perhaps the most important is that vaccination induces the inflammasome and this action can cross the blood brain barrier. Who knows how much damage is done to the subtle developmental modifications done to the brain at critical points? This would b the mechanism for autism.
We can be assured that such articles as "aluminum inducing asthma" will be well publicized and mocked; and in the meantime, widespread vaccination of young children will be done, blissful in the ignorance that may be being done.
Thank you for a very interesting article. I also thought Offit’s points were rather weak. No observational study however powerful can ever escape the potential criticisms that it has not adequately controlled all possible confounders. The more relevant point is can the critics point to uncontrolled variables that would be potentially powerful enough to plausibly account for the effect observed, and are there data to support this. As for theoretical mechanisms – well, … yes, … but we need to bear in mind that many powerful effects in science were first identified empirically before any theoretical mechanisms were proposed that would account for their action, so it’s not a very good objection. I would have thought that a finding such as this while not yet conclusive by any means would nevertheless give considerable force to Sears very sensible sounding proposal that these childhood vaccines be well spaced to avoid any possible adverse effects, at least until new research has resolved the issue conclusively. As someone who was trained in the scientific method a long time ago, the last few years have made me seriously wonder about the quality of scientific training given to medical researchers today. I can’t help also feeling that the big problem underlying all this is the interpenetration of the pharmaceutical industry with both regulatory bodies and medicine itself, and that vaccine skepticism is at least partly due to the distrust in these bodies that has resulted.
I really agree with all of your points - especially the hazards of the medical industrial complex - and really my only rejoinder is that spacing out vaccines has its costs, too. Probably because I write articles like this, I have a fair number of pediatric patients whose parents favor broad spacing in their immunization schedule, and it’s not w/o problems. A) These kids learn to hate me as EVERY SINGLE MONTH I am coming at them with needles!; b) that’s a lot of extra car trips and time spent in doctor waiting rooms, neither of which are w/o risks; c) the longer the delay the greater the “window of vulnerability” — esp with the diseases like PC, pertussis and Hib which can kill infants — and the less the benefit of vaccination in the first place. So, while I support informed parental autonomy and can see the possible benefits of this approach, it would take some stronger evidence to merit a global shift in recommendations, in my opinion. I hope someone gets funded to explore this, though.
Thank you for that. Those are very good points. I was chatting to my wife, who worked as a GP for about 15 years before doing psychiatry, about this and she made the following suggestion. Maybe doctors should have a handy little "fact sheet" to give parents noting all the probable pros and cons of spacing so they can think about it and make a reasonably informed decision on what they think is best for them and their child. Of course many may throw this back to the doctor with "What do you think is best doctor, and what would you do it it were your child?" in which case one can then simply say what one would do, and they would no doubt mostly follow that. Even then, however, they would probably value having been given the option of making the best decision for them.
Good analysis Dr. Hollander. It is a very murky subject, contentious at times, and not for the faint of heart physician to tackle. So thank you for grappling with it publically, for all of us to bear witness. I agree with your interp and conclusions, with one caveat. I strongly suspect that if we were to adjust for genetic polymorphisms that predispose towards an IgE mediated diathesis (eczema, asthma, anaphylaxis/hives, food allergies, etc.) that we would find that kids who are genetically predisposed are the ones whose immune systems respond adversely to injectable aluminum in these bolus dosing patterns. Certainly, if we look at the rainbarrel theory that the allergy world often refers to, there is thought to be a tipping point with which the rainbarrel begins to overlow once a specific immunologic threshold has been surpassed. The overflowing represents the onset of symptoms, be it eczema, asthma, but the exposure represents a 'trigger.' This is confused as a toxicity effect because heavy metals are thought of as toxins, and you poignantly address the fact that Aluminum is present everywhere in nature, including within our bodies at baseline, so it is not a toxin by nature. In fact, any inert substance such as water and air can become toxic to our bodies and quickly become fatal in excess doses. I've been, not so secretly, hoping/praying for genetic polymorphism screening of everyone, for a panoply of reasons (choosing the best suited medications and foods/diet, etc.), but mostly because it is tech that is no longer prohibitively expensive, and only serves to improve health outcomes by helping shed light on some of our frustrating blind spots in medicine. I can't think of a more appropriate population to screen than infants. Let's face it, vaccinations are elective preventative interventions that work really well in general and have saved millions of lives over the relatively few decades since the oral polio vaccine emerged (okay, it was actually the cowpox vaccine first). But we need to do better to minimize harm from such preventative interventions. The way I see it, we have two options. We either perform routine genetic screenings to identify the relatively few kids who react adversely to vaccines and then put them on delayed schedules, OR, we put everyone on a slow schedule to reduce the risk of the few. We have the tech, the resources, and the inventiveness to carry this out, we just need to decide that it will be equitable and worth the upfront expense of universal testing (elective of course). I believe that we owe this to our kids.
Thanks for the thoughtful comment, Justin. I think we are a long ways away from having anything like a vetted means for identifying infants at risk of adverse reactions, and am dubious all the genetic testing in the world would accurately predict vaccine AE risk in a large longitudinal study. I’d love to be proven wrong in the future. As to spacing out vaccines, I wrote this in another response: “Probably because I write articles like this, I have a fair number of pediatric patients whose parents favor broad spacing in their immunization schedule, and it’s not w/o problems. A) These kids learn to hate me as EVERY SINGLE MONTH I am coming at them with needles!; b) that’s a lot of extra car trips and time spent in doctor waiting rooms, neither of which are w/o risks; c) the longer the delay the greater the “window of vulnerability” — esp with the diseases like PC, pertussis and Hib which can kill infants — and the less the benefit of vaccination in the first place. So, while I support informed parental autonomy and can see the possible benefits of this approach, it would take some stronger evidence to merit a global shift in recommendations, in my opinion. I hope someone gets funded to explore this, though.”
I don’t have any ready solutions to this; I would just like more thoughtful data on risks:benefits of the current immunization schedule and possible feasible alternatives.
I agree with your assessment of spacing out Hib, PC, pertussis in particular, in the first couple years. This is in fact what we are up against, trying to mitigate risk by giving as many of these important vaccines as quickly as possible, which then potentiates a different type of risk that is even harder to measure or correlate, due to comparatively limited data. It’s a classic ‘damned if you do and damned if you don’t’ situation for either party. There is one thing that we have not yet mentioned in this discussion. The older a child’s immune system is when first inoculated, the fewer booster injections are required in order to achieve immunity. If you look at the CDC immunization schedules, you’ll see the catch-up schedule is quite different, depending on age at first inoculation. This doesn’t solve the problem of increased risk to small infants from those 3 pathogens in particular, but it addresses several important points, including lower cumulative aluminum exposure and fewer doctor visits by virtue of fewer overall injections needed to achieve full immunity. Having said all of this, in my former practice I was involved with following the CDC schedule for quite a few patients and never saw any adverse reactions other than the occasional low-grade fever that was short-lived, usually only one evening. I likewise had quite a few families who opted to vaccinate according to a modified schedule, and some who opted not to vaccinate their children at all. I never saw a case of vaccine preventable infection, probably due to herd immunity.
These are not easy conversations but I didn’t feel like it was ethical to fire a family for not following the CDC schedule as some of my pediatrician colleagues were doing. There are no easy answers for this subject, each family has to be able to sleep at night with their decisions, and it is up to physicians to take the time to fully educate families about the very clear risks of vaccine preventable diseases and the many unknowns involved with modifying the CDC schedule or not vaccinating. There is fairly significant genetic data for polymorphisms in detoxification genes that would be a good place to start in the pursuit of data pertaining to risk from exposure to vaccines. This data could help parents feel more at ease in their decisions. There’s also a fair amount of counseling involved with what measures can be taken to protect under-vaccinated or unvaccinated children, such as an ongoing education about signs of meningitis or severe infection, breastfeeding, hygiene and protective measures, the adults in the household getting a Tdap booster, and possibly paying out-of-pocket for a pneumococcal vaccine, even if risk stratification doesn’t meet criteria for the parent.
Over and out.
Thank you for having the courage to explore the issue of vaccine safety. We know that some FDA medications are safe and effective while there is a long history of medications that turned out to be harmful ( Vioxx, thalidomide, but there are literally hundreds). So why is it a taboo to question any vaccine, ever? How can anyone say "vaccines are safe"? That is like saying " medications are safe." Some are, some aren't. There should be a risk/benefit analysis.
Hepatitis B is routinely given to newborns. Why? most newborns are not exposed to HepB. The mother could be tested to see if she has it before routinely giving the vaccine. It's time to become more honest about vaccines. In 1961 most children got about 5 vaccines total. Today the recommended schedule is 72 vaccines. Thats a lot of aluminum by the way!
Thanks; and I agree that nothing should be taboo in medicine. I am encouraged that this study was even funded in the first place; and hope better designed studies with an aim towards “best vaccine practices” are forthcoming. Call me naive.
A good start would be studies of placebo vs vaccine which are never done in vaccine trials! They use another vaccine or sometimes the adjuvants. Another very important study would be study several thousand entirely unvaccinated kids ( religious exemption or just "anti-vaxx" parents) and look at their health outcomes vs a similar socioeconomic group of vaxxed kids. Do the unvaxxed kids have less autism, fewer allergies and less autoimmune and other diseases? What about mental health and ADHD? By making sure both groups have parents with similar incomes, similar rates of obesity, and similar geographical locations, confounding factors could be controlled for.
The big question, Doctor, is economic.
Further research is warranted, but will it be funded?
If funded, by whom and for what purpose?
We have recently seen studies expressly designed to provide predetermined outcomes. Those dealing with equivocal case study data for instance, of early treatment. When the observational reporting expressly maintained that efficacious results were observed when a treatment was imposed within seventy-two hours of symptom onset, studies conducted on patients with advanced illness skew the results.
There are multiple unanswered questions in vaccination. The one common them is that answering the question may interfere with the lucrative income streams generated by mandatory vaccination schedules. The prediction is that they will never be examined.
There are multiple questions contained in the above. Perhaps each vaccination by itself is relatively harmless, but multiple vaccinations given simultaneously are not. Perhaps multiple vaccinations given simultaneously are okay, if the schedules are farther apart. Perhaps one component is more adverse than another.
There is no question that certain diseases have risen dramatically in the last few decades. In childhood, asthma and autism.
Association is one thing but a good place to look. Establishing a mechanism is a different thing. Association without mechanism is weak. Association with mechanism is a step towards proof. But to find the mechanism requires much effect. In the time lapse, the failure to establish a mechanism is used by pharma marketing to argue the inherent safety of the vaccine schedule and the foolishness of those who oppose the current vaccination schedule.
Our understanding of the inflammasome (the inflammatory complex of the immune system) has markedly improved over the past decades. Perhaps the most important is that vaccination induces the inflammasome and this action can cross the blood brain barrier. Who knows how much damage is done to the subtle developmental modifications done to the brain at critical points? This would b the mechanism for autism.
We can be assured that such articles as "aluminum inducing asthma" will be well publicized and mocked; and in the meantime, widespread vaccination of young children will be done, blissful in the ignorance that may be being done.
Thank you for a very interesting article. I also thought Offit’s points were rather weak. No observational study however powerful can ever escape the potential criticisms that it has not adequately controlled all possible confounders. The more relevant point is can the critics point to uncontrolled variables that would be potentially powerful enough to plausibly account for the effect observed, and are there data to support this. As for theoretical mechanisms – well, … yes, … but we need to bear in mind that many powerful effects in science were first identified empirically before any theoretical mechanisms were proposed that would account for their action, so it’s not a very good objection. I would have thought that a finding such as this while not yet conclusive by any means would nevertheless give considerable force to Sears very sensible sounding proposal that these childhood vaccines be well spaced to avoid any possible adverse effects, at least until new research has resolved the issue conclusively. As someone who was trained in the scientific method a long time ago, the last few years have made me seriously wonder about the quality of scientific training given to medical researchers today. I can’t help also feeling that the big problem underlying all this is the interpenetration of the pharmaceutical industry with both regulatory bodies and medicine itself, and that vaccine skepticism is at least partly due to the distrust in these bodies that has resulted.
I really agree with all of your points - especially the hazards of the medical industrial complex - and really my only rejoinder is that spacing out vaccines has its costs, too. Probably because I write articles like this, I have a fair number of pediatric patients whose parents favor broad spacing in their immunization schedule, and it’s not w/o problems. A) These kids learn to hate me as EVERY SINGLE MONTH I am coming at them with needles!; b) that’s a lot of extra car trips and time spent in doctor waiting rooms, neither of which are w/o risks; c) the longer the delay the greater the “window of vulnerability” — esp with the diseases like PC, pertussis and Hib which can kill infants — and the less the benefit of vaccination in the first place. So, while I support informed parental autonomy and can see the possible benefits of this approach, it would take some stronger evidence to merit a global shift in recommendations, in my opinion. I hope someone gets funded to explore this, though.
Thank you for that. Those are very good points. I was chatting to my wife, who worked as a GP for about 15 years before doing psychiatry, about this and she made the following suggestion. Maybe doctors should have a handy little "fact sheet" to give parents noting all the probable pros and cons of spacing so they can think about it and make a reasonably informed decision on what they think is best for them and their child. Of course many may throw this back to the doctor with "What do you think is best doctor, and what would you do it it were your child?" in which case one can then simply say what one would do, and they would no doubt mostly follow that. Even then, however, they would probably value having been given the option of making the best decision for them.