Jon Poling on Paul Offit

7 Aug

Jon Poling writes a letter in the NEJM that says:

Offit’s remarks about Hannah’s case are not evidence-based. He has no access to my daughter’s personal medical records, legal documents, or affidavits. In contrast, physicians from the Department of Health and Human Services (DHHS) who studied this information recommended that the government concede Hannah’s case. The clinical history Offit presents contains significant inaccuracies, and the resulting conclusions are consequently flawed.

This paragraph lies at the very heart of the mystery surrounding Hannah Poling’s diagnosis, concession and the subsequent media-frenzy.

There are two documents regarding Hannah Poling from which all medical information has been forthcoming.

1) Concession Report (This document has been removed due to the possibility of it being illegally obtained). If people really wish to read the document for themselves it can be founf here, at the Huffington post

2) Zimmerman Case Study

These two documents – and only these two documents – have informed *everyone’s* opinion. Aside from these two documents, there is nothing else (aside from Hannah Poling’s medical records). If anyone believes that not to be the case, I challenge them to either link to them or have the Poling’s release them. The Special Masters have made it very very clear that all that needs to happen for *all* records to be released is for the Poling’s solicitor to write and ask.

….in the case that is the subject of the media reports, if the parties who supplied documents and information in the case provide their written consent, we may then be able to appropriately disclose documents in the case.

Until the Polings elect to do this very simple action, they have to assume that people will write about what is available. They will also have to put up with the fact that people like me find it very, very suspicious that they repeatedly claim what they simply cannot back up and then refuse to release information that could clear these issues up straight away.

The Case Report contains _all_ the information necessary to make a judgement on whether:

a) Hannah Poling was diagnosed with autism (she was)
b) Hannah Poling was injured by vaccines (she was)
c) Hannah Poling’s autism was caused by vaccines (it was not)

How do I claim point c) as true? Easily. One takes the symptoms listed in the Case Study as being those caused by vaccines and compares them to the DSM (IV) criteria for autism.

fever to 38.9°C
inconsolable crying
irritability
lethargy
refused to walk
waking up multiple times in the night
having episodes of opisthotonus
no longer normally climb stairs
Low-grade intermittent fever
generalized erythematous macular rash
spinning
gaze avoidance
disrupted sleep/wake cycle
perseveration
expressive language was lost
chronic yellow watery diarrhea
appetite remained poor for 6 months
body weight did not increase
decline on a standard growth chart
atopic dermatitis
slow hair growth
generalized mild hypotonia
toe walking
normal tendon reflexes.

I have emboldened the items which match the DSM (IV). I’ve italicised the items which are repeated.

Hannah Poling’s Case Study was authored by four people. One was, of course, Jon Poling. The other authors are:

John Shoffner. In an interview in Scientific American, Shoffer agreed that the scientific evidence presented in the case did not make enough of a case to warrant compensation. He went on to say:

Shoffner notes that parents and advocates looking to impugn vaccines as triggers for autism—or mitochondrial disease—need direct, not just circumstantial, evidence. “If you were sitting in a waiting room full of people and one person suddenly fell ill or died or something,” he says, “would you arrest the person sitting right next to them?”

….

Jon Poling, says Shoffner, has been “muddying the waters” with some of his comments. “There is no precedent for that type of thinking and no data for that type of thinking,” Shoffner says.

Its worth noting that John Shoffner – unlike Jon Poling – is a mitochondrial specialist.

Andrew Zimmerman: When I attempted to get Zimmerman’s comments about the case, I received the following reply:

Dr. Zimmerman…….is not able to publicly discuss this patient. As a participant in this case, the family provided consent for Dr. Zimmerman to share information with the court, but we do not have parental consent to discuss the patient publicly – as we are bound by HIPAA privacy regulations, as in any healthcare setting in the U.S.

Why? If the Poling’s are so very keen to make an _accurate_ case then surely, giving permission to the doctors involved is the first step? What is it they don’t want Zimmerman to say?

Richard E Frye, as far as I know has not made any public statements on this case.

The report from Dr Offit was not inaccurate. It was accurate to the information we have. If there is more information then I ask the Poling’s once more to _release_ it. They are legally able to and if they really believe in what they claim then they should be doing it right now. Why aren’t they?

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74 Responses to “Jon Poling on Paul Offit”

  1. daedalus2u August 13, 2008 at 23:25 #

    Poling talked about “multiple vaccines”, he didn’t mention Rotateq. Offit never mentioned Rotateq. Why do you bring Rotateq up?

    MMR is 3 vaccines in one shot. MMR was tested in clinical trials before it was used clinically. For Poling to say that multiple vaccines have never been tested for safety is false.

    To say that Offit’s opinion is unsupported by clinical trials is to lie.

    The paper that is often cited (which Poling didn’t cite) is this:

    http://pediatrics.aappublications.org/cgi/content/full/109/1/124

    In this paper Offit has 7 co-authors. As co-authors they are equally responsible for the conclusions of the paper. They cite 9 papers referencing immune responses to 7 different combinations of vaccines, many of the vaccines themselves combinations.

    When Poling says:

    “Offit is frequently cited regarding the “biologically plausible” theory that simultaneous administration of multiple vaccines is safe. His opinion is unsupported by clinical trials, much less investigations in potentially susceptible subpopulations.”

    and I look at the what Offit et. al. actually said, and look at the papers they cite, I can only conclude that Poling is a bold-faced liar to say Offit’s opinion is unsupported. This is not a close call. To say there are no clinical trials that support Offit’s opinion when Offit cited some is simply false. Either Poling knows he is lying, or is delusional and doesn’t.

    When something Poling says is easy to check and is found to be false, that does not give me any confidence that what he says about things that cannot be checked (such as his daughter’s medical records) are correct. To me, what Poling says is unreliable. Why what he says is unreliable isn’t something I need to know or that I really care about. Maybe he has some subtle idiosyncratic way of thinking that makes him believe what he says is true. If so, that is fine for him. It is useless for me and for those of us in the reality based community.

  2. Schwartz August 14, 2008 at 03:46 #

    Alyric,

    Bringing up Orac is pretty funny. Why don’t you speak for yourself?

    Yes, concomitant vaccine tests are done pre-approval. They test to make sure one vaccine doesn’t affect the immune response or effectiveness of the other vaccines given at the same time.

    You’ll also find several post approval trials where they test different combinations to see which ones are more effective across the various diseases they are testing. In the trials I noted, adverse events are always tracked, but safety is not the primary objective of those trials (read them, they usually state it up front)

    However, what you won’t find pre-approval (and rarely post-approval) are safety studies designed to test safety concommitant application. To do such a trial you would test concomitant application in one group and staggered application in a control group. You show me how each vaccine did this kind of safety trial pre-approval, and I’ll believe you and Dr. Offit. Until then, you (and Orac) are talking without evidence. Call it a canard all you want.

  3. Schwartz August 14, 2008 at 03:53 #

    Daedalus2u,

    Didn’t you read Dr. Offit’s response?
    ” But studies of concomitant use, which are required by the Food and Drug Administration before licensure”

    If they’re required, we should be able to look at any newer vaccine and find the trials. I chose Rotateq (Dr. Offits’ own).

    As I just explained to Alyric, Immunogenicity trials are not what Dr. Poling is talking about — that’s an efficacy, not safety question. Remember, a safety trial needs a few more than a couple hundred participants to be meaningful. Please point out the study in for each approved vaccine where they tested concomitant application with a control group that had a staggered application.

    You won’t find it. Dr. Offit is playing word games, and you’re falling for it.

    Like I said, find the study. Then I’ll believe you.

  4. Schwartz August 14, 2008 at 03:58 #

    Daedalus2u,

    I know you have a good grasp of science. Have you ever read Dr. Offit’s justification for stating that the immune system can safely handle 10,000, and now 100,000 vaccine antigens simultaneously?

    Can you seriously tell me that a simple mathematical calculation (which is also what Dr. Poling is referring to) of B cells — being a single component of the immune system — is a good enough analysis to declare that a person can handle that many simultaneous antigens?

    I suppose you agree that all other possible reactions or other systems in the body are irrelevant to such a theoretical calculation?

  5. daedalus2u August 14, 2008 at 14:07 #

    Schwartz, If you want to look up Rotateq, go right ahead. I certainly won’t stop you. The point that Poling was lying about wasn’t about Rotateq, it was about “vaccines”. Poling said Offit’s opinion on multiple vaccine safety wasn’t based on clinical trials. Poling was lying.

    Maybe you can find a vaccine that hasn’t been tested along with others in multiple vaccine trials. If you can, so what. Poling wasn’t saying that there is not data on the safety of every single vaccine in combination with every single other vaccine. If you have 10 different vaccines, looking at all of them in different combinations will take 3,628,800 trials (that being equal to 10!). Have there been 3,628,800 trials on vaccine safety? Should we abandon vaccines until there are?

    The calculation of Offit et. al. was not to justify giving 10,000 vaccines simultaneously. It was to demonstrate that there is a large excess capacity in the immune system that is not easy to overwhelm and that a few vaccines plus or minus is not going to overwhelm it.

    Is their calculation wrong? Did they make a math error? Are their premises of how the immune system works wrong? Is there any data that contradicts the conclusion? Show where the calculation is wrong, don’t just assert that it is and expect us to blindly agree with the opinion of a non-expert in immunology who doesn’t show his reasoning.

    What is your objection to the calculation? That 10,000 is such a big number that it offends your sensibilities? That it contradicts the anti-vax mantra of “too many too soon”?

  6. Schwartz August 14, 2008 at 17:13 #

    Daedalus2u,

    You can’t claim he lied without producing evidence. Neither you nor Dr. Offit have done so. Dr. Offit claimed that all pre-licensure vaccines must undergo that testing. Rotateq is a good test case that failed indicating that his statement was incorrect.

    Dr. Offit’s theoretical limit for simultaneous vaccine tolerance has also not been safety tested by clinical trials at all — consistent with Dr. Poling’s remarks.

    “It was to demonstrate that there is a large excess capacity in the immune system that is not easy to overwhelm and that a few vaccines plus or minus is not going to overwhelm it.”

    First, there were no clinical trials — consistent with Dr. Poling’s assertion — so it isn’t a demonstration, but a theory. Therefore “theorize” is the correct term, not “demonstrate”.

    It’s ludicrous that both you and Dr. Offit feel a single component of the immune system in a complex system is the only consideration when looking at safety.

    And if he didn’t mean to suggest that 10,000 was the actual number, then what is the actual safe number? You don’t know, because no clinical trials have been done to try to test this theory. That’s why it’s called a theory.

    You’ll note that I do not object at all to the math or the calculation. It’s the approach that is seriously flawed.

  7. daedalus2u August 14, 2008 at 19:12 #

    Schwartz, are you incapable of reading, or incapable of understanding what you read? Poling said:

    “Offit is frequently cited regarding the “biologically plausible” theory that simultaneous administration of multiple vaccines is safe. His opinion is unsupported by clinical trials, much less investigations in potentially susceptible subpopulations.”

    In the paper that Offit et. al. wrote

    http://www.pediatrics.org/cgi/content/full/109/1/124

    (which I presume is the one that Poling is referring to), Offit et. al. said:

    “If vaccines overwhelmed or weakened the immune system, then one would expect lesser immune responses when vaccines are given at the same time as compared with when they are given at different times.41,42 However, the following vaccines induce similar humoral immune responses when given at the same or different times: 1) MMR and varicella, 43,44 2) MMR, diphtheria-tetanus-pertussis (DTP), and OPV,45 3) hepatitis B, diphtheria-tetanus, and OPV,46 4) influenza and pneumococcus,47 5) MMR, DTP-Hib, and varicella,48 6) MMR and Hib,49 and 7) DTP and Hib.49 “

    Three of those references had the word “safe” or “safety” in the title.

    41) Simultaneous administration of childhood vaccines: an important public health policy that is safe and efficacious.

    48) Safety, tolerability, and immunogenicity of concomitant infections in separate locations of MMRII, Varivax and Tetramune in healthy children vs concomitant infection of MMRII and Tetramune followed six weeks later by Varivax.

    49) Safety, tolerability, and immunogenicity of concurrent administration of Haemophilus influenzae type b conjugate vaccine (meningococcal protein conjugate) with either measles-mumps-rubella vaccine or diphtheria-tetanus-pertussis and oral poliovirus vaccines in 14- to 23-month-old infants.

    These studies directly address in clinical trials the safety of the administration of multiple vaccines. This is directly counter to the lie that Poling said. Offit’s opinion that multiple vaccines are safe is supported by clinical trials. It is also supported by a theoretical understanding of various parts of the immune system and how that immune system responds to natural infections and also to vaccinations. This is not a close call.

    Poling said Offit’s opinion was unsupported by clinical trials, in Offit et. al.’s published paper they refer to multiple clinical trials. That makes Poling’s statement false. If we grant Poling the benefit of the doubt and assume that he actually read the Offit et. al. paper, then Poling made a false statement knowing it was false. That is lying. If Poling didn’t read the paper, but was just reading from a script that his anti-vax handlers handed him, then he didn’t lie. Offit did cite the paper in the article that Poling was responding to, so it is a reasonable default presumption that Poling has read it. If Poling does admit that he never read the paper and was relying on his anti-vax handlers I will retract my statement that Poling lied and replace it with one that Poling made a false statement out of ignorance.

    No doubt Offit and his other co-authors have read considerably more about clinical trials of multiple vaccines, and these have informed their opinion also.

    Poling didn’t say the idea that 10,000 vaccines is safe is unsupported by clinical trials. Offit would agree with that statement. There have not been 10,000 vaccines ever made, so it is impossible for there to have been a clinical trial that looks at the safety of 10,000 vaccines given simultaneously. No one is suggesting that 10,000 vaccines be given simultaneously. There are not 10,000 vaccines that could be given simultaneously. There are not 10,000 known diseases that could be vaccinated against simultaneously.

    So what is your point? That your anti-vax mindset blinds you to reality? That you can only believe anti-vax rhetoric? That you will believe anti-vax rhetoric regardless of how demonstrably false it is?

  8. Sullivan August 14, 2008 at 20:34 #

    You’ll note that I do not object at all to the math or the calculation. It’s the approach that is seriously flawed.

    write it up and submit to Pediatrics or NEJM.

    I think that you will find it useful to actually know where the source of the statements Dr. Offit has made are. Based on your comments, you haven’t done that homework.

    That would also give you the caveats for the calculation, something you are either lacking or ignoring.

    Please, let us know when your submission is entered, and to which journal. We can then wait with you for the response. If your submission is based on the information you are presenting here, I can say with a very high certainty that it will be rejected.

    The question is, do you realize how you are misrepresenting Dr. Offit’s statements, or are you purposely misrepresenting them?

    My guess is that you don’t understand and are honestly making mistakes.

    And, yes, you are making some big mistakes. And, no, I am not doing your homework for you again.

  9. Schwartz August 15, 2008 at 05:22 #

    Daedelus2u,

    You’re using the title of the study as evidence? That’s a good one.

    Most studies monitor adverse reactions, but that doesn’t count as a study designed to determine the safety of concommitant vaccines does it?

    I can’t get access to #41, so I can’t look it up all I have is the title. Let’s look at #48. Study group size: 101. I imagine you think that a sample size of 101 children is going to give us good results on safety? Oh, yeah, they also restrict their study to healthy children. I guess we can just forget about children like Hannah Poling?

    #49 is an analysis study which compares differet aspects of various conjugate vaccines. Funny, that’s one of the ones I pointed out you would find. No placebo control group here?

    So, no, none of the even come close to adequately studying the safety aspects of applying multiple vaccines, let alone testing the theory of 10,000 vaccines.

    Unless of course, you feel that a study involving 101 children has the power to detect any issues that aren’t blatent? The devil is in the details as usual.

    “No doubt Offit and his other co-authors have read considerably more about clinical trials of multiple vaccines, and these have informed their opinion also.”

    Given the number of frequent mistakes Dr. Offit makes in his public statements (even making the same mistake in repeatedly) I don’t see why he has won your faith (this is a faith based statement of course). Based on his historical errors, I don’t share your faith.

    “Poling didn’t say the idea that 10,000 vaccines is safe is unsupported by clinical trials. ”

    Well, what he said was: “Offit is frequently cited regarding the “biologically plausible” theory that simultaneous administration of multiple vaccines is safe”

    What other statement regarding a biologically plausible theory do you think we can find Dr. Offit repeatedly stating for the public to hear? It sure seems like we found the right quote to me.

    “So what is your point”

    My point is that Dr. Poling’s statements in the NEJM pointed out several legitimate issues with Dr. Offit’s original letter. In some cases, Dr. Offit doesn’t even address the points (meaning Dr. Poling is correct). In other cases, he admits the statement and justifies it.

    My initial point to you was that he misquoted Dr. Poling. I have clearly shown that is correct — since he admits it — making your discussion on that point irrelevant. I also made the point that misquoting someone is unprofessional.

    My next point is that Dr. Offit’s claim that concomitant vaccine safety trials are required for approval. You have provided no evidence to the contrary, and when looking at Rotateq (Dr. Offit’s own), none are to be found indicating that Dr. Offit was again mistaken.

    It seems to me that you’re looking in the wrong place for problems. Perhaps your faith in Dr. Offit is misplaced.

  10. Schwartz August 15, 2008 at 05:29 #

    Sullivan,

    “write it up and submit to Pediatrics or NEJM.”

    That’s a great way of addressing my point. Especially given the article was written in 2002. Coming from someone who complains about many studies in a blog. Did you write up your complaints about Dr. Poling to the NEJM?

    “I think that you will find it useful to actually know where the source of the statements Dr. Offit has made are. Based on your comments, you haven’t done that homework.”

    There we go. “I have a great point to make, but I’m not going to tell you so you should take my word for it”

    Thanks for coming out. Why did you bother posting that if you have no point to make?

    “The question is, do you realize how you are misrepresenting Dr. Offit’s statements, or are you purposely misrepresenting them?”

    Sullivan, the source for everything I’ve stated is in the open. My opinions should be clearly delineated. You’re talking in riddles, so there’s not much point in going any further is there?

  11. daedalus2u August 15, 2008 at 13:54 #

    Schwartz, get the beam of your anti-vax sentiments out of your own eye. Then maybe you will be able to see reality clearly enough to address small points.

    I wasn’t using the title of the papers as data to understand vaccine safety, I was using it as data to show that Poling’s statement that Offit is ignorant of all clinical trials showing safety of multiple vaccines is false. Poling didn’t refer to 10,000 vaccines. He referred to multiple vaccines.

    Poling’s said there were no clinical trails that informed Offit’s opinion on safety of multiple vaccines. That is clearly false. If Poling had been less definitive, if he had said no trials with n greater than 100,000,000 then Offit would have agreed with him because there have been no such trials. Poling didn’t say that. He said there were no clinical trials of safety of multiple vaccines that informed Offit’s opinion.

    Why your anti-vax sentiments have blinded you to reality is something that you should think about. This is not a close call. It is quite plain and clear.

    Maybe there are not enough clinical trials on safety of multiple vaccines. Maybe the clinical trials that there are could be better. There certainly could be more, all it takes is time and money. There is no point in doing them if they will simply be ignored and their existence denied by anti-vax activists such as yourself and Poling. Claiming there need to be more while ignoring every trial that has ever been done, shows that the anti-vax activists are working in bad faith. They don’t want safer vaccines, they want zero vaccines. Their tactic is to make the cost of vaccines so high that manufacturers abandon their production.

  12. Schwartz August 15, 2008 at 16:42 #

    Daedelus2u,

    “I wasn’t using the title of the papers as data to understand vaccine safety, I was using it as data to show that Poling’s statement that Offit is ignorant of all clinical trials showing safety of multiple vaccines is false.”

    You just admited that you’re using it as proxy evidence to show that appropriate safety trials were designed and done. Again, because the word safe or safety is placed in a title, that does not constitute evidence of an appropriately designed safety study. No surprise, when we drill into the details, safety was not the primary design objective of those papers and they don’t address any of the complaints Dr. Poling raises. So your proxy evidence by study title is pretty flawed.

    ” Poling didn’t refer to 10,000 vaccines. He referred to multiple vaccines.”

    You didn’t address the key point, Dr. Poling stated exactly: “Offit is frequently cited regarding the “biologically plausible” theory that simultaneous administration of multiple vaccines is safe.”

    You can’t just ignore half the sentence. The oft quoted “10,000” vaccine theory is about multiple vaccines. Again I ask you — since you avoided the question again — what other oft quoted theory did you think Dr. Poling was referring to?

    “Maybe there are not enough clinical trials on safety of multiple vaccines. Maybe the clinical trials that there are could be better. There certainly could be more, all it takes is time and money. There is no point in doing them if they will simply be ignored and their existence denied by anti-vax activists such as yourself and Poling.”

    Oh, this is a great canard, let me paraphrase: We admit the that the study of safety could be better, but there is no point, since I know ahead of time what the result will be and I know that all you anti-vax people are blind to science.

    Funny, since you haven’t done the studies, how do you know the outcome, and how do you know what the undefined “anti-vax” crowd will think?

    If you can’t see the logical flaws in that position, then there isn’t much point in having any further discussion.

    Instead of waxing poetic and throwing around insults, why don’t you address the specific points, especially since you asked me what they were? There is no point in having a discussion with you if you keep throwing insults, changing the topic, or resorting to broad generalizations. I have better ways to spend my time.

  13. daedalus2u August 15, 2008 at 18:30 #

    Schwartz, when Poling says

    “Offit is frequently cited regarding the “biologically plausible” theory that simultaneous administration of multiple vaccines is safe. His opinion is unsupported by clinical trials, much less investigations in potentially susceptible subpopulations.”

    in the NEJM, I presume that Poling is talking about actual scientific citations and not anti-vax screeds and/or anti-vax polemics where Offit’s quote is distorted and taken out of context and used to frighten people into thinking that Offit is some ogre/vaccine fiend ready to inject 10,000 vaccines into their child.

    A search on Google Scholar shows up 115 citations. 115 citations is enough to be called frequent. Going through the list of them, I don’t see that any of them are obvious anti-vax screeds (from their titles only). Virtually all of them pertain to actual vaccination schedules and not some weird hypothetical thought experiment of giving 10,000 vaccines simultaneously. As I mentioned earlier, there are not 10,000 vaccines available or even 10,000 diseases that can be vaccinated against, let alone vaccinated against simultaneously. At 0.5 mL per vaccination, 10,000 vaccinations would require the injection of 5 liters of fluid. There is no fluid that can be injected at a dose of 5 liters anywhere in the body that would not be fatal. Injecting that much water or saline would be fatal just from mechanical effects. Offit’s calculation that the immunological effects of that many antigens is tolerable is reassuring to me that there is plenty of excess capacity in the immune system.

    The only number of multiple vaccinations that is at all relevant to actual medical practice is the number of multiple vaccinations that are actually given. What does a number a thousand times higher than what is conceivably possible have to do with actual safety?

    Are you saying that Poling expected Offit to run clinical trials where he actually injected 10,000 vaccines into children in a clinical trial before suggesting the thought experiment that he did? Such a trial could not be done for multiple reasons. There are not 10,000 vaccines available, there are not 10,000 diseases to be vaccinated for, the Declaration of Helsinki requires that human experiments be done ethically and for the benefit of the experimental subjects. With no conceivable benefit to those being injected, a clinical trial injecting 10,000 vaccines into children could not be done.

    I doubt that any of those 115 papers citing Offit’s work even mention the 10,000 vaccine calculation. To infer that Poling’s statement that “Offit is frequently cited regarding the “biologically plausible” theory that simultaneous administration of multiple vaccines is safe.” refers to the 10,000 vaccine calculation there would have to be actual citations that mention it. Can you show that more than half of the citations that Offit’s paper received refer to his 10,000 vaccine calculation? If you can’t, then that is not a legitimate inference from Poling’s statement.

    If Poling had referred to the 10,000 number and not “multiple vaccines”, or had referred to anti-vax polemics and not citations, his statement might be legitimate. He didn’t. Taken at face value Poling’s statement is a lie. There is no way it can be parsed into something that is not a lie.

    Maybe Poling was thinking about the 10,000 vaccines but wanted the readers to think he meant multiple vaccines as in the normal vaccine schedule. That is being dishonest, and is clearly a lie in this context. That type of disinformation is unacceptable in a scientific journal. If that is what he meant, then he should retract his statement as it is clearly scientific misconduct.

    Science is all about being honest with ourselves and with our colleagues. Poling and the other anti-vax activists are not being honest.

  14. Schwartz August 15, 2008 at 22:16 #

    Daedelus2u,

    “The only number of multiple vaccinations that is at all relevant to actual medical practice is the number of multiple vaccinations that are actually given.”

    Yes, and in terms of catchups, I have not seen a clinical trial that mimics some of the hefty combinations that are given to children when they have missed previous shots. If you read the FDA and HC publications, they even note this quite clearly.

    Most commonly, the studies are designed to determine if the immune response is as effective in combination A vs B while monitoring adverse events (which is the safety monitoring). From what I’ve seen, these studies usually look at less than 500 children.

    “What does a number a thousand times higher than what is conceivably possible have to do with actual safety?”

    Indeed, so why would Dr. Offit even bring it up? There are a lot more aspects involved in vaccination than the narrow immune response considered in this calculation. Why use it as proof of safety? Even worse, why call it a “practical approach” when it is anything but?

    “in the NEJM, I presume that Poling is talking about actual…”

    And I presume he is referring to the attitude and approach to safety when Dr. Offit disregards such concerns with his 10,000 vaccine theory. He directly uses the words “biologically plausible theory”. Certainly I agree that Dr. Poling doesn’t believe we would test 10,000 simultaneous vaccines, but he is pointing out that using such a theory as an assurance of safety is wrong given that the number hasn’t and can’t be tested — so why bring it up. From a practical perspective, it might as well be an arbitrary number that adds no value to the discussion. I believe he is also pointing out that most combinations are not explicitly safety tested, especially combinations that happen outside of the ideal world of the recommended schedule. Even the recommended schedule isn’t always fully tested.

    I also think Dr. Poling is referring to Dr. Offit’s public statement citations of “theory”, not scientific study citation. He himself brings up the “10,000” vaccine theory on a regular basis in public statements.

    I also think that you’re misreading the context. Remember, Dr. Offit wrote his original piece in the context of public messaging summarized in his conclusion:

    “Otherwise, the message that the program inadvertently sends to the public will further erode confidence in vaccines and hurt those whom it is charged with protecting.”

    Even more context setting occurs in the first line of Dr. Poling’s response where he notes that Dr. Offit made similar errors (or lies as you call them) in his NYTimes op ed piece. In Dr. Offit’s public messaging, the 10,000 vaccine theory is often cited.

    “Taken at face value Poling’s statement is a lie.”
    Only based on your interpretation. Your definition would also classify several of Dr. Offit’s statements as lies, which is not how I would classify them at all.

    “Science is all about being honest with ourselves and with our colleagues. Poling and the other anti-vax activists are not being honest.”

    You may feel that. I feel that he is being more honest than Dr. Offit in this case, as most of Dr. Poling’s points were dead on accurate and only a few of them are even debatable. In fact that is the point of him writing in to the NEJM to correct a number of misconceptions that Dr. Offit wrote into his original piece.

  15. daedalus2u August 16, 2008 at 02:20 #

    Schwartz, you are ignoring the important fact that Poling said Offit’s opinion was informed by zero clinical trials. That is clearly false. Maybe you don’t like the clinical trials that Offit referred to. Maybe you think they are not good enough to draw conclusions from. The fact is, there are clinical trials, and Offit says they did inform his opinion. We know that because Offit cited some of them.

    The point that there is excess capacity in the immune system is not a close call. Is that excess 2,000x times greater, 500 times greater, or “only” 100 times greater? Does it matter if some children have a 579 times excess and some have a 578 excess? If the excess is large compared to our ability to measure it, what does the precision of the measurement matter?

    If Poling was referring to public statements, why didn’t he say so? If he is so hung up on the 10,000 number why didn’t he refute it? Why didn’t he refer to a specific number and not just to “multiple vaccines”?

    The point of the article was that there is no theoretical basis for a few vaccines to overload or overwhelm the immune system. There are multiple methods for appreciating that there is no basis for the assertion that the immune system is overwhelmed by the current vaccine schedule. A point that Poling doesn’t seem to have refuted, he just lied and said there are no clinical trials that Offit could have looked at and then developed that opinion.

    Offit used several lines of reasoning to show that multiple vaccines don’t overwhelm the immune system. He cited clinical trials, he used a thought experiment of 10,000 vaccines, he gave a tutorial on the infant immune system, he explained how more immune cells are generated each day, he cited data on children with immunodeficiencies, he cited data on children with other diseases. Poling didn’t refute any of the data or any of the citations. Poling latched onto one small aspect of Offit’s reasoning (the 10,000 vaccine number) and because there obviously couldn’t be a clinical trial with 10,000 vaccines, declared that no clinical trials informed Offit’s opinion at all. That is complete nonsense.

  16. Schwartz August 16, 2008 at 06:06 #

    Daedalus2u,

    Yes, he reference clinical trials but if you read Dr. Poling he’s talking about studies that are designed to study safety. Those studies, were primarily designed to study efficacy and they monitored safety. None of them were designed to test the safe limit of concomitant vaccines which is what I believe is the point he’s making.

    I know that the theoretical antibody capacity is not a close call, but he’s using that single aspect of the immune system as evidence of safety. That’s the core problem.

    “If Poling was referring to public statements, why didn’t he say so?”
    That is a good question. It’s curious, because it seemed quite obvious to me what Dr. Poling was referring to, but clearly there are different ways of interpreting the statement and not everyone will read it that way. It’s a good lesson on language and perception.

    “A point that Poling doesn’t seem to have refuted, he just lied and said there are no clinical trials that Offit could have looked at and then developed that opinion.

    He certainly didn’t address every point in Dr. Offit’s initial letter. His purpose was to correct several misleading statements in his article. He selectively addressed points that were blatently incorrect, and IMO he addressed the 10K vaccines theory directly. The number of inaccuracies and misleading statements in Dr. Offit’s original letter certainly are problematic from my perspective.

  17. daedalus2u August 16, 2008 at 18:20 #

    Schwartz, you are so completely FOS.

    Let me repeat again for the nth time what Poling actually wrote:

    “Offit is frequently cited regarding the “biologically plausible” theory that simultaneous administration of multiple vaccines is safe. His opinion is unsupported by clinical trials, much less investigations in potentially susceptible subpopulations.”

    Poling is saying that Offit’s opinion is unsupported by clinical trials. That is clearly false.

    You seem to be saying that the only thing that Offit is relying on for his opinion that multiple vaccines are safe is his theoretical calculation that there are at least 3 orders of magnitude factor of safety before the immune system could possibly be “overwhelmed” (and no suggestion of what the failure mode or what the adverse consequence is if the immune system was “overwhelmed”). That is clearly false because Offit et. al. showed multiple lines of reasoning and cited multiple clinical trials to conclude that multiple vaccines are safe.

    Suppose you do a clinical trial, and look at the distribution of the magnitudes of immune system reactions and find that X out of X are self-limiting and well below the limit that would be injurious. From the distribution of the magnitudes of immune reactions, you can estimate that the immune system reactions in a larger population would follow a similar distribution.

    From basic research on the immune system, it is known that 10 vaccines are not stressing the immune system to close to the point of failure. That is the 3 orders of magnitude factor of safety that Offit et. al. calculated. That suggests to a high degree of reliability that modest extrapolation of the distribution of immune system activations is not going to move the results into a totally unusual regime. One can then use the results of small clinical trials to infer the distribution of magnitudes of immune system activation in larger populations.

    Of course it takes a sophisticated understanding of the immune system and how it reacts to be able to do this. A sophistication that anti-vaxers such as you and Poling obviously do not have. Fortunately people who actually work with vaccines such as Offit do have that degree of sophistication.

    Fortunately people such as Offit can look at the totality of what is known about vaccines and the immune system; including basic research, theoretical considerations and clinical trials and use that information to design and implement safer and better vaccines.

    If Poling had said that he didn’t understand how clinical trial information could be used to estimate multiple vaccine safety that would have been a true statement. His statement that Offit didn’t use any data from clinical trials to inform his opinion was clearly false.

    Before you delve into the minutia of wanting to rip apart my suggestion of how safety from a clinical trial might be used, there are many different ways that clinical trial data can be looked at to assess safety of multiple vaccines. We know that such data exists, we know that Offit has looked at it, we know that Offit thinks that such data is important because he cited it when laying out his reasoning. For Poling to say there is no such data, or that Offit didn’t rely on it is clearly either a bold faced lie or a delusional rant.

    This is not a close call. Offit isn’t the only person in vaccine research that is looking into this. He had 7 co-authors on that paper. I suspect that the reason the Offit is the focal point of the anti-vaxers is because he is willing to stand up to the death threats and the heat that the anti-vaxers are dishing out. How many death threats has Poling gotten from pro-vaccine activists? My guess would be zero.

  18. isles August 17, 2008 at 01:32 #

    Daedalus, you’ve got some stamina keeping up with the natterings of Schwartz! He’s like one of those Whack-a-Mole games at Chuck E. Cheese, except a hundred times more annoying.

  19. Schwartz August 17, 2008 at 05:03 #

    Daedalus2u,

    “You seem to be saying that the only thing that Offit is relying on for his opinion that multiple vaccines are safe is his theoretical calculation that there are at least 3 orders of magnitude factor of safety before the immune system could possibly be “overwhelmed” (and no suggestion of what the failure mode or what the adverse consequence is if the immune system was “overwhelmed”).”

    In his public statements on the 10,000 vaccine theory, that’s usually all he says on the topic — we are talking about his public statements on the 10,000 vaccine theory that are often quoted — He rarely notes the caveats in his public interviews. I’ve certainly never read them, despite the fact he notes they exist on at least one occasion. The point is that in public he applies it as evidence for safety. Since the number is not “practical” and only considers one single aspect of the immune system, it’s pretty silly to use it as an argument in public statements. As for the lack study of susceptible subsets, that’s completely unaddressed by Dr. Offit.

    “Poling is saying that Offit’s opinion is unsupported by clinical trials. That is clearly false.”

    To be exact (if you read your own quote again) he’s saying Dr. Offit’s “Plausible biological” theory is unsupported by clinical trials which even you note is impossible to test. Even in his paper, Offit doesn’t cite any studies in that section that are designed to test the safety aspects of concurrent vaccine application let alone any practical safety limits. Any of the studies you talk about are always based on looking first at Immunogenicity (efficacy) in different combinations.

    We do have hard evidence from clinical trials that even small combinations of concomitant vaccine applications do result in higher safety risks. Why do you suppose MMRV was removed from the recommended list?

    “Suppose you do a clinical trial,”
    Conjecture is exactly what Dr. Poling is talking about.

    “From basic research on the immune system, it is known that 10 vaccines are not stressing the immune system to close to the point of failure.”
    Supported by clinical trials? Dr. Poling’s point again. We know smaller specific combinations have caused problems.

    “A sophistication that anti-vaxers such as you and Poling obviously do not have.”

    Very interesting that you are able to make such a qualitative assessment of someone’s qualifications without ever having spoken to him or worked with him.

    “Fortunately people such as Offit can look at the totality of what is known about vaccines and the immune system;”

    But Dr. Offit’s “practical” theory is exactly the opposite of looking at the totality of the system because it considers only a single aspect devoid of practicality, yet he has used the theory in absense of caveats in public statements.

    Since you seem incapable of going more than one post in a row without resorting to broad generalisations, name calling, and insults — all of which are unscientific, and indicate false logic — I wish you good day, and good luck with your interactions with others.

  20. isles August 17, 2008 at 05:24 #

    Big D! You got Schwartz to knuckle! Even he couldn’t stand the inanity of his arguments anymore.

  21. daedalus2u August 17, 2008 at 14:30 #

    Schwartz, I didn’t mean to call you any names, I merely stated my opinion that you were FOS. A condition that I am trying to remedy.

    Let me see if I understand your “anti-vax logic”. Because Offit says something in public, which repeats a calculation he and 7 co-authors made and published in a peer-reviewed journal (available for free download) with citations and backup including citations of multiple clinical trials, and in that public statement doesn’t repeat the entire list of references to clinical trials that he and his co-authors cited, then it is a legitimate “anti-vax conclusion” for a fellow doctor, a medical professional to state that Offit’s opinion that multiple vaccines are safe is unsupported by clinical trials?

    Is this how “anti-vax logic” works? Is this representative of how you anti-vaxers think? Does this represent the highest levels of scholarship and analysis that the most scientific and medically knowledgeable anti-vaxers use?

    You say “We know smaller specific combinations have caused problems.” You wouldn’t happen to have a citation of that to an actual clinical trial that demonstrated that do you? Or is that merely an opinion unsupported by clinical trials? An opinion that you think is legitimate because it is an “anti-vax opinion”?

  22. commenting August 17, 2008 at 19:59 #

    I wonder how many times Offit has actually repeated the statement about 1,000 vaccines or 10,000 vaccines – in public. I wonder if some of the “times” that Schwartz has read the quote it was just something and antivaxer had repeated on an autism bulletin board (which seem to be places that Schwartz likes to hang out). Schwartz seems to go around to antivax sites soaking up the antivax belief system. He starts from a position that vaccines are part of a corrupt or very stupid public health system and vaccines frequently unnecessary or harmful. It looks to me like he assumes that whatever he finds and can package into a somewhat logical statement is true and that he’s much smarter than those who are making the hard decisions about vaccines. It’s not possible that they are taking into account things he is not, though Schwartz may think they are taking into account bribes they are getting from pharmaceutical corporations.

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