Autism Blog - Jon Poling on Paul Offit « Left Brain/Right Brain

07 Aug 2008

Author: Kev
Comments: 74

Jon Poling on Paul Offit

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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Comments

74 Responses to “Jon Poling on Paul Offit”

Autism, Representation, and the Case of Hannah Poling
August 7th, 2008
11:51:45

[...] Poling “personal medical records” (on the disclosure of which, see this post; only two documents about Hannah Poling have been drawn on by the public, regarding her medical information). Dr. [...]
María Luján
August 7th, 2008
15:23:11

Kev
Dr Wallace is also a mitochondrial specialist and his ideas on vaccines are very cautious.
Now, it is more and more going to a discussion between doctors/experts in different medicine fields, many of them with different background and if you want motivations- without any kind of comment about these or interest conflics-financial or not financial. It is not more of the old expert doctor vs parent but now the discussion is being more and more virulent between experts.Therefore more and more it is becoming who is being more credible, with more arguments and with what science behind being discussed- and how and with what tone and with what attitude. It is dogma vs change, more and more, IMHO- with all the problems with the ~~yet~~ unknown to produce the right change because nobody knows for sure what is the right direction to follow. I have more and more echoes from the Kuhnian vs Popper discusion on scientific changes. And further research is needed without doubt.

On this topic, I consider that there is enough information available to have a position. However, also, more and more the issue seems to be the interpretation of a doctor/neurologist that is also the father-with all the information available- and other positions on the topic- with enough information but not all from the sources you mentioned. With my personal experience about how clearly abnormal clinical results were blindly dismissed because of dogmatic positions, at this point it is all in the eyes of the observator- it seems.
isles
August 7th, 2008
15:50:20

Exactly, Kev. The Polings are essentially saying, “Vaccines injured our child, and you’re just going to have to trust us on that, even though we stand to rake in hundreds of thousands of dollars for it.”

If they have the facts, and they want to make this a public issue, they need to let the public in on those facts.

(I thought Jon Poling’s letter was more than a little dramatic, starting out as it did with an ominous reference to a correction, and not acknowledging that this correction related to procedure, not the science at issue.)
90s Outweek Reader
August 7th, 2008
17:31:08

Question re: “expressive language was lost”

I can’t recall; was there video in the Poling case to back up this particular claim?
Kev
August 7th, 2008
20:14:36

Ma,

I’ve read what Wallace said and I don’t think he’s really up to speed with the mainstream of mito specialists. There are two mito specialists who were involved in writing the case study. Dr Wallace was not one of them. I think in terms of Hannah Poling, he has no insight to offer.

Of the two who were involved, one has been gagged by the Poling’s and one disagrees totally with Jon Poling and thinks he’s being irresponsible.
Autism Blog - Jon Poling and Bernadine Healy | Left Brain/Right Brain
August 7th, 2008
21:05:42

[...] As Kev has noted, Dr. Jon Poling has a communication in the New England Journal of Medicine. [...]
María Luján
August 7th, 2008
23:11:09

Well it seems that in terms of mito conditions and dysfunctions, there are a lot of unanswered questions because of what is not known. Therefore we have exactly the situation I presented before.
Dr Wallace being not involved, is for me objective.
You- and me- selected who trust considering personal analysis-I disagree about the lack of insight of Dr Wallace on this topic.
lacshmiybarra
August 8th, 2008
03:07:12

Gee Kevin,

“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”

Da ya think Dr. Offit thought about that when he offers the concession as the basis for his “verbatim” facts? What concession? There is NO official concession to “cite.” Oh, unless it is the one that David Kirby claims is the report. But, I thought none of you believed David Kirby to be reliable. Now he can be cited as an official source? Interesting turn of events. Where in the world is the science in ANYTHING Offit said in his response?

You need to stop being so gullible.

And Kev, be careful about what you imply Shoffner said unless you can actually show the source…If I remember correctly, he is a treating doc and he could get in mega trouble for violating HIPPA talking about this girl.

Things that make you go hmmmmmm
isles
August 8th, 2008
03:47:17

The first clue that someone doesn’t know very much about HIPAA is when he or she writes it as HIPPA.
lacshmiybarra
August 8th, 2008
04:27:10

Dear Isle,

What say you tell me what exactly you think YOU know about it? Just because I made a typo like the one kev made above in his quote, does not an idiot make. Take me on if you dare!
lacshmiybarra
August 8th, 2008
04:28:18

Dear Isle,

How about you tell me what exactly you think YOU know about it? Just because I made a typo like the one kev made above in his quote, does not an idiot make. Take me on if you dare!
isles
August 8th, 2008
05:17:38

Lacshmiybarra,

We could talk about what’s a typo and what reveals an attempt to imply more knowledge than one actually has about a given subject, but I’d rather talk about the substance of this post, wouldn’t you?

Or maybe you wouldn’t, since you seem to be objecting to Kev referencing the court order (the one in which the court acknowledged HHS’s decision not to contest the Poling case) on the grounds that it was distributed by David Kirby. This strikes me as an irrelevancy.

As to whether Dr. Shoffner is in danger of being cited for a HIPAA violation on the grounds of having discussed mitochondrial disorders with Scientific American, well, that seems unlikely to me, but then I did not go back and read the original article. It’s an interesting legal issue, actually, reminiscent of companies and institutions that distribute their legal work among all the major law firms in a given area so that anyone seeking to bring suit against them will find it impossible to obtain counsel from any of these firms.

In any event, I do find the substance of this matter interesting. It seems to me that Dr. Offit’s analysis is correct. It is well established that the immunological challenge posed by vaccines (even several at once) is minimal, and the several ear infections that Hannah Poling is reported to have suffered in the months leading up to her receipt of the vaccines in question seem to constitute a vastly greater stress than the vaccines ever could, even counting the fever and varicella rash she is said to have experienced post-vaccination.

I particularly agree with Dr. Offit’s questioning of whether this was properly described to the public as an autism case. Given the inherent slipperiness of autism diagnostics, the likelihood that any child with cognitive impairment would exhibit some signs of autism, and (as Kev points out) the many and varied symptoms that the case report describes Hannah as having exhibited, it’s not clear that “autistic” is the most useful way to describe her, at least from a diagnostic standpoint. Certainly it could be appropriate for therapeutic purposes, of course.

Dr. Poling’s objection to Dr. Offit’s editorial doesn’t particularly address the science. He just says Dr. Offit didn’t have enough information to draw these conclusions. It seems as though Dr. Poling is trying to have it both ways – to make public assertions about what happened in his daughter’s case, while prohibiting others from holding or stating any opinions. To do so asks for an inappropriate level of trust in someone who is inherently non-neutral. Let the Polings authorize the court to release the medical records if they want to make assertions about what their daughter’s case represents.

Dr. Poling challenges Dr. Offit’s assertion that simultaneous vaccination is safe; it would be more convincing if he’d shown how the math is wrong. (The calculation is detailed in the textbook “Vaccines.”)

I have a few other nits to pick with Dr. Poling’s response, but this is a long enough comment as it is. Suffice to say I’m not convinced Dr. Poling’s criticisms of Dr. Offit are valid.
Sullivan
August 8th, 2008
05:29:19

lacshmiybarra,

Why didn’t the Polings correct their attorney, Clifford Shoemaker when he stated:

“...It did not go to hearing because of this concession.

You can say all you want about what the reasons are for it, and we aren’t really at liberty to talk about what is actually in the document, the concession that was made.”

It sounds to me that an attorney, familiar with the Court of Federal Claims, and intimately familiar with this case considers that document to be a “concession”. Even if he is incorrect, it would seem reasonable for Dr. Offit to use the same terminology, wouldn’t it? Had the Polings wished to correct the record, they could have as they were involved in the same interview.

http://transcripts.cnn.com/TRA.....kl.01.html

As to Mr. Kirby’s accuracy. I have many questions about his interpretation of events and, especially, science. However, I don’t see him going to the extent of forging an official government document, the Rule 4© report. Had he done so, I would expect that we likely would have heard about it by now from the Court. I doubt they would take kindly to that.

Further, the Poling’s have never stated publicly that the document Kirby quotes and which Kev briefly hosted (in a copy of the original) were incorrect. I will grant that they may not be aware of this blog, but surely they would be aware of David Kirby’s blog posts about them.

As to Shoffner—Kev is quoting the story in Scientific American directly

As to his interpretation statement made before the Shoffner quotes, my guess is that Kev is mis-remembering the quote. It is from a statement that the Scientific American author concluded based on statements by Dr. DiMauro or a statement by DiMauro himself—the story isn’t precise on whose interpretation it is. The statement is:

“This means that, scientifically, from the documents presented in the vaccine court, the Polings did not make a case that deserved compensation.”

Of course, I could be misinterpreting what Kev thought.
90s Outweek Reader
August 8th, 2008
06:20:18

Thank-you for this, isles. This fact is extraordinarily important to the case at-large and I wish it were more widely known and the media would reference such when they report on this case. Thanks for your very precise wording in making this most excellent point:

“Given the inherent slipperiness of autism diagnostics, the likelihood that any child with cognitive impairment would exhibit some signs of autism, and (as Kev points out) the many and varied symptoms that the case report describes Hannah as having exhibited, it’s not clear that “autistic” is the most useful way to describe her, at least from a diagnostic standpoint. Certainly it could be appropriate for therapeutic purposes, of course.”
Grace
August 8th, 2008
06:43:39

I’m trying to understand the Scientific American article – is Shoffner saying that Hannah’s autism was probably caused by her mitochondrial disorder?
Kev
August 8th, 2008
09:01:51

Da ya think Dr. Offit thought about that when he offers the concession as the basis for his “verbatim” facts?

Thought about what? That there was a possibility it was illegally obtained?

Now he can be cited as an official source? Interesting turn of events.

Its really very straightforward. Someone (I wonder who?) leaked the document to David. He posted it. I downloaded it and posted it here. I then found out that leaking it to David was illegal so I sent an apology via email to the Special Masters and took it down from my site. I then provided a link to it on David’s post.

Where in the world is the science in ANYTHING Offit said in his response? You need to stop being so gullible.

Its exactly the same science as Jon Poling presented to the world. How is that being gullible? Are you implying Jon Poling is not to be trusted?

And Kev, be careful about what you imply Shoffner said unless you can actually show the source…If I remember correctly, he is a treating doc and he could get in mega trouble for violating HIPPA talking about this girl.

I’m not implying anything. I’m quoting an article in which he is quoted. In case you missed it the first time, its here. Maybe you could tell me which bits I got wrong?
Kev
August 8th, 2008
09:04:50

Grace – he’s saying it could be and there may be evidence to back it up. He’s then saying that there’s no data or evidence to implicate vaccines in that scenario.
Kev
August 8th, 2008
11:40:10

Sully – yep, DiMauro said that – and then the author writes ‘John Shoffner, a mitochondrial disease expert who runs a laboratory in Atlanta, agrees’.
Grace
August 9th, 2008
10:00:06

Kev, thanks for clearing that up! I feel really stupid – perhaps I am – but would you mind explaining the bit about Hannah’s mom likely having the same genetic defect? Sounds to me like they’re saying that they think the mito disorder is from the mito dna & the autism is from the nuclear dna?
Kev
August 9th, 2008
19:16:20

Grace, you’re not stupid, this is an unbelievably complicated area. I don’t think any of us who debate this (unless we happen to be mito specialists) are comfortable with this material.

You’re right that the SciAm article was essentially saying that the vast majority of the mitochondria must’ve come from Terry Poling as mitochondria genes are carried in egg not sperm. So the variation might’ve been carried by both females but Terry Poling is clearly not on the spectrum.

Therefore it seems reasonable to assume that Jon Poling is genetically ‘responsible’ for Hannah’s autism.
isles
August 9th, 2008
20:05:33

Thank-you for this, isles.

You’re welcome, and thank you for the kind words.

Lacshmiybarra was hot to trot for a while there with his challenge to take him on if I dared…maybe he only wanted to talk about HIPAA and not Hannah Poling. (And anyway, I don’t see “HIPPA” in anything Kev wrote, so I don’t know what was up with Lacshmi saying he’d made the same mistake.)
Grace
August 9th, 2008
21:42:12

Kev,
I really appreciate your patience with me. Any idea if a mito disorder is like the theory about autism in that there is a genetic weakness with an environmental trigger? I am wondering why Hannah’s mom doesn’t have a mito disorder, too. Also, I’m not clear why Hannah’s mom not being autistic would prove that it came from her dad since he’s not autistic either?
Sullivan
August 10th, 2008
00:35:44

Kev,

all mitochondrial DNA is maternally inherited. There is one case in the literature of someone inheriting the mDNA from a father, but it is called, “the exception that proves the rule”.

Mitochondrial disorders are not caused always by mDNA. The mitochondria processes material which is determined both by mDNA and nuclear (nDNA). So, if the cell is creating proteins that are incorrect for the needs of the mitochondria, the mitochondria will malfunction.

David Kirby has misinterpreted, I believe, some statements made and has gone so far as to say that the type of mitochondrial disorder that Hannah Poling and the other kids in the upcoming study have is inherited from the father.

This is based on a statement made in, I believe, the conference call he blogged (where Kirby claims that 1 in 50 are ‘at risk’). As I recall, the example was given that for some families, there were paternal cousins that also had autism. This example demonstrates that it is likely a nDNA defect (or defects) that is (are) the causes. Mr. Kirby took this too far and claimed that it is paternally inherited based on the examples.

My recollection is that Jon Poling stated that both sides of Hannah’s family have autoimmune disease, so they should have been more cautious with Hannah. While it is possibly the case, he did not mention that there is autism in Hannah’s paternal cousins. Were this important to her history, I think he would have mentioned it together with or instead of the comments about autoimmune disease.
daedalus2u
August 10th, 2008
01:31:32

I have a blog post about mitochondria failure due to immune system activation. It is the most recent one (as of right now).

Mitochondria have ~1000-2000 proteins in them, all but 13 of those proteins are coded for in the cell nuclear DNA (which is inherited from both parents). The mitochondrial DNA is inherited only from the mother. There are more than 13 genes in mitochondria, there are genes that code for RNA that are used in protein synthesis. These relate to how the mitochondria assemble the 13 proteins that mitochondria synthesize from mitochondrial DNA. It was a polymorphism in one of those protein synthesizing RNA coding genes that Hannah inherited from her mother.

It isn’t clear how much of a “defect” it really is. It may have no effect at all. When it was first diagnosed, it was thought to be pathological and to perhaps explain the mitochondrial defects that were observed in Hannah’s mitochondria. I think that they may have seen the association; polymorphism and mitochondria dysfunction and then simply assumed that the polymorphism caused the dysfunction. The science is moving very fast in this area and the specific defect that Hannah has is more common than was thought at the time it was first diagnosed.

Any kind of mitochondria difficulty is going to make those mitochondria more susceptible to turn-off during severe immune system activation. When ever mitochondria are under stress, they respond by increasing membrane potential and increasing the amount of superoxide they produce. This accelerates ATP production, but at a cost of producing more superoxide and oxidative stress. That makes them more susceptible to the kind of turn-off that I talk about in my blog.

Hannah’s mitochondria are the same now as they were when what ever happened to her happened. Mitochondrial DNA is not something that is “fixed”, or changes over time except to become degraded which renders those mitochondria containing it dysfunctional. Dysfunctional mitochondria are cleared from the cell quite quickly (at most weeks). Normally all mitochondria in a cell turn-over in a month or so. The timing is known in rats, the experiments can’t be done in humans. The tests in rats involved giving radioisotopes to tag when mitochondria were synthesized and then following how the radioactivity decayed in different tissue compartments. In rats the mitochondria in the CNS have the longest lifetime, about a month. It might be a couple of months in humans, it probably isn’t much longer than that.

An environmental exposure can’t cause a specific mutation in a specific spot on mitochondrial DNA. Each cell has many hundreds or many thousands of copies of the same mitochondrial DNA strand. Any chemical induced mutation would affect each strand in each mitochondrion and in each cell differently. It is not possible for the many trillions of strands of DNA to become mutated in the same place.

The only way an individual can acquire a mutation common to all of that individual’s mitochondrial DNA is when that individual was a single cell and had only a few mitochondria in that cell. Any mitochondrial DNA damage that occurs when the organism is multi-celled is confined to mitochondria that are the daughter mitochondria of the damaged mitochondria which are confined to cells that are daughter cells of the cell that contained the damaged mitochondria. Usually mitochondria with sufficiently damaged DNA become dysfunctional and are cleared, if a cell loses too many mitochondria it dies and is also cleared. If an organ loses too many mitochondria and too many cells, the organ dies and you get multiple organ failure (not uncommon in sepsis). If the cell doesn’t die, then it can recover, the organ can recover and the organism can recover. All the damaged mitochondria are cleared, and if there is enough good DNA back-up copies, the cell can fully recover. If there are not enough good copies the cell dies, the organ dies and the organism dies.

That Hannah has seemingly recovered is evidence that what ever her mitochondria difficulty was, it was an acute difficulty and not a chronic one. If she is having muscle weakness as Shoffner states, and if that is due to a chronic problem with her mitochondria, that problem is most likely genetic, epigenetic or ongoing environmental in origin, it cannot be due to residual mitochondrial damage from vaccines years earlier.

I don’t think there is any inconsistency between what Wallace and Shoffner have said. Schoffner had access to aspects of her medical record relevant to the case report he co-authored with Poling and Zimmerman. Wallace is speaking in generalities about people with more severe mitochondrial disorders than Hannah has and all he is saying is that we don’t know.
Kev
August 10th, 2008
07:17:38

There you go Grace – two better answers than mine :)
bundy
August 11th, 2008
03:51:52

Kev,

Saw your posts on Discover and linked over here. Help me out. I don’t know much about this topic but the debate is interesting.

Melissa says Offit deals Poling a concise blow,
Offit says, “Poling claims that I didn’t have access to his daughter’s medical records. My information was based on a verbatim transcript of the DHHS concession”

How did Offit obtain this document or any other document on the case? I cannot find any reference to it except from David Kirby, and that was a leaked (probably illegal) copy.

Offit might have some trouble coming his way if he 1) somehow obtain access to sealed court documents through his connections or 2) used an illegal leaked document as unreferenced material for a New England Journal article.

Maybe I’m wrong and a legitimate copy of these transcripts are out there in the public domain–does anybody have access to these court documents? I would like to see them.

Thanks,
Bundy
isles
August 11th, 2008
06:13:14

bundy,

For right or wrong, the DHHS document is still available for the world to see in David Kirby’s Huffington Post column (above), and it would seem that it the family must have given it to him, so they can hardly complain about people knowing about it.
Grace
August 11th, 2008
08:21:34

Thanks for the info! I haven’t had time to blink this weekend – hopefully I’ll get a chance to sit down tomorrow & actually process what I’m reading, lol!
Sullivan
August 11th, 2008
17:03:33

...and it would seem that it the family must have given it to him, so they can hardly complain about people knowing about it.

To my knowledge, neither the Poling family nor their lawyer has ever complained publicly about Mr. Kirby leaking that document.

For that matter, I’ve never seen the government complain specifically about it. They have noted that it is the government’s intention to try the case in the courtroom, not the press, which I took as a reference to many events including the document leak.

A Special Master has stated directly that that document, and another, are basically already public. The Polings asked that these documents (as well as others) be made public and the Special Master stated that the request is moot.

The document on Kirby’s blog is the concession. I assume it is part of what Dr. Offit used to base his decision.
Schwartz
August 12th, 2008
03:06:39

bundy,

The first document was leaked by David Kirby. There is an amended document that has not been made public to my knowledge. David has written about it, but the specifics and the wording are not public to my knowledge.

Dr. Poling’s point is that Dr. Offit is drawing specific conclusions about Hannah Polings’ case without having read the actual case evidence that led to the concession.

The concession is a legally sanitized document that summarizes the decision of the HHS scientific and legal teams. Additionally, he hasn’t read the amended concession to my knowledge.

Using that alone as a basis for drawing conclusions on the case is questionable according to Dr. Poling.

To me, it is similar to conclusions about a scientific study by just reading the abstract.

Not something anyone in my profession would do. If the full data isn’t available, a responsible professional wouldn’t draw any firm conclusions, and you certainly wouldn’t draw broad based ones.
Sullivan
August 12th, 2008
05:25:07

To me, it is similar to conclusions about a scientific study by just reading the abstract.

You are assuming that Dr. Offit only has access to the same information that you do. That is a bad assumption. For example, you are assuming that Dr. Offit has not spoken with any experts in the field. You are assuming he hasn’t read any literature on the subject besides that which is available to you. You are assuming that experts in the mitochondria field haven’t sought Dr. Offit’s expertise in infectious disease and vaccines. I, for one, hope that they are talking to someone knowledgeable in vaccines.

Isn’t that a bit ironic? You’ve made claims with limited information, claims which could very well be incorrect?
Sullivan
August 12th, 2008
05:28:05

David has written about it, but the specifics and the wording are not public to my knowledge.

Since “David” has seen it, it is public. Mr. Kirby is a member of the public. Hence the comment from the special master that the Poling’s request to make it public is moot.

Before you go into your usual response, yes, he’s seen it.
Schwartz
August 12th, 2008
05:30:47

Sullivan,

I’m not assuming anything. He stated very clearly the evidence he used in his letter. Additionally, we know he did NOT have access to her records.

Making public definitive statements on a specific case without having access to the records that the summary was based is quite unprofessional regardless of the general experts he spoke with. I can make that statement with the facts available

When asked for evidence, all he notes is the concession report. I am basing all of this on the evidence available (not her records) and his own statements. Both the evidence available and his statements point to the same thing.

It doesn’t look like I’m the one who’s speculating here. That’s the irony.
Schwartz
August 12th, 2008
05:33:28

Sullivan,

If it’s public, why don’t you point it out to all the readers here?

Otherwise it’s not public. It’s pretty simple. Just because one person has seen it doesn’t make it public.
Schwartz
August 12th, 2008
05:35:05

Sullivan,

It’s the public document that you and I can’t see or get?

That’s a pretty funny definition of public.

Show us all where the document is publically available and then we’ll believe you.
Sullivan
August 12th, 2008
05:51:28

Schwartz,

legally, it is public. As I said, hence the reason why the SM called the request to make it public “moot”.

Of course, this is one of your famous sidetracks, since the point isn’t whether it is public, but, rather, publicly available.

So, unless David Kirby, the Polings, Clifford Shoemaker, passed that information to Dr. Offit, he doesn’t have it legally. Given that the likelyhood of any of those people giving that information to Dr. Offit is only slightly higher than someone from the Court leaking it, it is a safe bet that Dr. Offit doesn’t have the second concession document.

Which, as we all know, is still a side track because it doesn’t address the issue of whether Dr. Offit has access to a heck of a lot more information than you do. That is a given since, unless I have misjudged you, you didn’t go to medical school. It is highly likely since he is one of the world’s experts on vaccines that people would consult him on the general question of mitochondria, autism and vaccination.

Your presentation makes it seem like he wrote his NEJM communication without serious consideration. That seems highly unlikely to me.
Sullivan
August 12th, 2008
05:54:38

Schwartz,

you made a lot of assumptions, as I noted above. You do not have the exhaustive list of the sources of information Dr. Offit used.

You can make a lot of statements with the facts available to you. That doesn’t make them true or accurate.
Schwartz
August 12th, 2008
06:13:51

Sullivan,

Where was it declared legally public? I didn’t read that from the special masters. They said the request for full was moot based on an earlier disclosure. If you read the earlier disclosure, you’ll find that only the initial Rule 4 report was disclosed (as per their own document). Please point out where they rule the second Rule 4 report Public? It isn’t ruled as legally public at all. Nor is it public since you can’t produce it. Nor does Dr. Offit have access to it.

I don’t need the exhaustive list of resources. Dr. Offit is specifically criticizing a scientific decision using only the documents produced as a summary (legally sanitized ones at that). He is making public statements of criticism of a specific case without ever reviewing the evidence of the case itself.

I guess that’s professional behaviour in medicine?

Like I said, all of my statements are based on the evidence. Even your speculations don’t help his case.
Sullivan
August 12th, 2008
06:20:54

Your statements are based on the subset of evidence available to you. That and whatever you brought to the discussion.

You stick to the statement “..using only the documents…” which is an assumption on your part.

We are going through the Schwartz two-step.

As to the second Rule 4© report…perhaps you would like to look again. The SM’s document is searchable—try the term “moot”
http://www.uscfc.uscourts.gov/.....041008.pdf

As a practical matter, petitioners’ request for disclosure of the two Rule 4 Reports in this case (styled originally as a motion for complete transparency) is moot based on an earlier unauthorized disclosure.

So, yeah, both of the reports are already “disclosed”.

Why do I have to do your homework?
Schwartz
August 12th, 2008
06:46:27

Sullivan,

Funny, a request being moot doesn’t equal legally public in any definition I’ve read.

Read page 4.

“As expressed in the court’s Order, the undersigned subsequently learned that respondent’s Rule 4 Report had become publicly available in an electronic format other than the format of the Public”

Hmm, it doesn’t say supplimentary Rule 4 report. It doesn’t even say Rule 4 reports (plural).

So where exactly does it say that the Supplimentary Rule 4 report (identified clearly on page 4) was made public?

Are you instead using the Sullivan definition of “legally public”? Do I have to do your homework for you?

As for the evidence I’m using. It’s all published.

When charged that he didn’t use evidence to form his conclusions (against the DHHS decision) he states very clearly:

“My information was based on a verbatim transcript of the DHHS concession…”

Verbatim. That’s pretty definitive.
Fact #2: He doesn’t have access to the records used to make the decision he is criticizing.

No speculation, no assumptions. No further evidence is required to draw the conclusion that he is criticizing a scientific decision without reviewing the evidence used to make that decision.

Pretty cut and dry.
Sullivan
August 12th, 2008
17:09:01

Let’s see, I said search for “moot”

As a practical matter, petitioners’ request for disclosure of the two Rule 4 Reports in this case (styled originally as a motion for complete transparency) is moot based on an earlier unauthorized disclosure.

Same quote as above. Notice that “two” reports have been “disclosed”

Is there a reason why you ignored that? Are you now going to do a classic Schwartz and state that “disclose” doesn’t mean public? Or, is it possible that you already read the below quote from the SM:

For the foregoing reasons, the undersigned has determined that certain content in the two Rule 4 Reports filed by respondent, and sought by petitioners to be disclosed to the public, arguably is information as contemplated by the use of that term in section 12(d)(4)(A) of the Vaccine Act.

So, the Polings were asking that the two reports be disclosed to the public. He also found that their request to disclose is moot.

As to your other point—yes Dr. Offit doesn’t have access to Hannah Poling’s records. That doesn’t mean he hasn’t talked to experts in mitochondrial disorders and/or dysfunction about the general concepts involving this field. I don’t know if he did, but it seems reasonable. Doesn’t mean he doesn’t have access to a lot more information than you just by being a doctor. That makes your assertion far from being “cut and dry”.

Now, if you come up with something new, I’d be interested to hear about it. Your track record here doesn’t suggest it, though. You haven’t added any new information in posts, except for a quote mine of the SM report that doesn’t address the actual discussion.

So, I’ll leave you with another quote from the SM:

Based on this understanding, the undersigned construes petitioners’ motion as a request for the public release of the filed Rule 4 Reports, or alternatively, for permission to discuss the two Rule 4 Reports publicly.

This is odd since the title of the entire motion is:

Disclosure of “information” to a non-party to a vaccine proceeding requires consent;

So, the SM seems to be interpreting the
So, the SM has interpreted that “disclosure…to a non-party” is a release of information to the public.

I bring this up because you seem to be missing the point of your own argument. In the language of the court, the question is whether disclosure to a “non-party” is the same as disclosure to “the public”. That would lead you, if you did a little work, to this comment:

To avoid running afoul of the statutory protection against disclosure to a non-party, a party is well-advised to make efforts to secure, prior to a disclosure to a non-party (or to the public), the consent of the person who submitted the information.

At which point you could make the argument that the Court is making a distinction between “non-party” and “public”. But, that’s me doing your homework again. Also, there is the argument I made above. In addition, it would be highly disingenuous to claim that David Kirby is a generic third party, or that the intent was to disclose solely to him. Mr. Kirby is a journalist, and his actions demonstrate clearly that the intent was to disclose fully to the public. He disclosed the first 4© report, and information from the second. You keep accusing me of speculation—here is some: I would bet that there is a draft of the second 4© report somewhere on his computer.

So, unless you come up with some actual information on these subject, I’ll consider them closed. If you wish to do the classic Scwhartz move and restate your assertions in a slightly changed format to get the last word, go ahead. Doesn’t make you right, doesn’t mean I agree, just means you are last.
daedalus2u
August 12th, 2008
18:58:09

In my opinion Poling is being disingenuous. He takes issue with Offit quoting him, saying “Offit misrepresents my position” by this quote:

“the results in this case may well signify a landmark decision with children developing autism following vaccinations.”

In his protestation, Poling repeats his entire quote:

“Many in the autism community and their champions believe that the result in this case may well signify a landmark decision as it pertains to children developing autism following vaccinations. This still remains to be seen, but currently there are almost 5,000 other cases pending.”

I don’t see even a hint of misrepresentation. In contrast, at the end of his letter Poling says:

“A strong, safe vaccination program is a cornerstone of public health. Misrepresenting Hannah Poling v. HHS to the medical profession does not improve confidence in the immunization program or advance science toward an understanding of how and why regressive encephalopathy with autistic features follows vaccination in susceptible children.“

Perhaps Poling doesn’t know the difference between “autism” and “regressive encephalopathy with autistic features”. Or perhaps he is simply confabulating them to bolster his legal case (another word for misrepresentation). They are completely different. Any type of encephalopathy will have “autistic features”. Any type of encephalopathy that occurs in a child will cause “regression”. Encephalopathy in an adult will cause “regression” too, but it isn’t called that in adults.

To use an example people are familiar with, Terry Shiavo had encephalopathy and “regressed” from being a normal adult to being someone who lost language, was unable to communicate and was unresponsive. Terry Shiavo thus had some “autism-like” symptoms. She didn’t have autism because the cause of her encephalopathy was known to be due to her heart stopping for a period of time. Any type of neurological sequelae that causes profound loss in abilities to communicate will cause “autism-like” symptoms.

Offit makes the point quite clearly:

“Indeed, features reminiscent of autism are evident in all children with profound impairments in cognition; but these similarities are superficial, and their causal mechanisms and genetic influences are different from those of classic autism.”

From what I know of the Hannah Poling case, it is misrepresentation to claim it is any type of classic or typical autism. It isn’t. There is plenty in the record that has become public to conclusively conclude that the “regressive encephalopathy with autistic features” that she does have is not representative of many, or most or any but a small minority of autism cases. In my opinion it is Poling who is misrepresenting his daughter’s case to the medical community.

Of course I am only basing these conclusions on information that I am aware of. If the portions of Hannah Poling’s medical records that have been released are in error, as for example in the paper that Poling, Zimmerman et al wrote, then my conclusions may be in error also. If what the public and the medical community thinks about Hannah Poling’s medical records are incorrect, then Poling has the ability to correct it. He may choose to not correct it. In my opinion the medical community has to go with the best information that it has and not with the undocumented assertions of interested parties who refuse to release the documentation they say backs up their otherwise unsupported assertions.
daedalus2u
August 12th, 2008
20:48:26

I just realized, if Poling was not counting himself as one of the “Many in the autism community and their champions” who “believe that the result in this case may well signify a landmark decision as it pertains to children developing autism following vaccinations.” then perhaps he thinks he has a case for Offit misrepresenting his position.

However in my opinion it is disingenuous for Poling to walk like a duck, act like a duck, quack like a duck, disguise himself as a duck, pretend he is a duck and hang out in a flock of ducks and then take offense when people treat him as a duck without explicitly telling us he is not a duck.

In my opinion, if Poling won’t explicitly tell us what his position is, and doesn’t correct others in his flock of ducks who do say what his position is, then he has no case for being misrepresented when by his silence he is consenting to the characterization of his position by others in his flock of ducks.
Schwartz
August 13th, 2008
03:35:54

Sullivan,

“As to your other point—yes Dr. Offit doesn’t have access to Hannah Poling’s records. That doesn’t mean he hasn’t talked to experts in mitochondrial disorders and/or dysfunction about the general concepts involving this field. I don’t know if he did, but it seems reasonable. Doesn’t mean he doesn’t have access to a lot more information than you just by being a doctor. That makes your assertion far from being “cut and dry”.”

You’re repeating the same arguments. It doesn’t matter whether he talked to other experts about general cases or related illnesses. It does not change the following: He is criticizing the DHHS about a specific report and decision without ever reviewing the evidence they used to make their decision.

That is still cut and dry regardless of how you try and spin it. That is also unprofessional.

As I stated earlier a request for disclosure being moot is not a definition of legally public.

If you read the first statement carefully, the plural reports in this sentence refers to the request for disclosure. Obviously the Polings requested full disclosure of both reports. If you read the part about disclosure, it is written in the singular, not plural indicating a single disclosure which is consistent to the quote I provided earlier.

“As a practical matter, petitioners’ request for disclosure of the two Rule 4 Reports in this case (styled originally as a motion for complete transparency) is moot based on an earlier unauthorized disclosure.”

You said:

“So, the Polings were asking that the two reports be disclosed to the public. He also found that their request to disclose is moot.”

That may be the judgement of the SM’s, but that doesn’t qualify as a definition of “legally public”, since we know it wasn’t made public because you can’t produce it. It’s also interesting that the “moot” comment is only referred to as a “practical matter” not a legal one. The legal OPINION they provide is independent of the practical one if you read the report carefully. Remember they deferred a ruling, so these opinions are not final.

Aspects of the second report were discussed publically, without any references. That certainly could qualify as unauthorized disclosure, but sorry, that doesn’t qualify as making the report public.

“So, the SM has interpreted that “disclosure…to a non-party” is a release of information to the public.”

That is a pretty false assumption. The Public certainly qualifies as a non-party. That doesn’t mean a non-party is the public.

If disclosure was made to Kirby, that is clearly a non-party. That is not the public unless David Kirby himself makes the material public.

Last time I checked, only the Rule 4 Document was made public by Kirby. Kirby claims to have seen the Supplimentary Rule 4 report. That would qualify as disclosure to a non-party, but since Kirby did not disclose the Summplementary Rule 4 report to the public, it’s not public.

I find it baffling that you continue to argue that the report is public (or “legally public” despite no mention of such term anywhere) when clearly the report is not available to the public and never has been.

You seem to confuse a fixation on the discussion of practical matters and equate that to a new definition you made up called “legally public”. Why don’t you go search the document for every reference of public and find a single place where they state that the supplimentary report was made public. They did no such thing. They did in fact state the initial rule 4 report was made public.

We know the report is not public. We know there is no term “legally public” anywhere in the document. Spin all you want. The original point (which you’re trying to spin away) is that Offit didn’t use the report, nor did he have legal access to it.
Ms. Clark
August 13th, 2008
04:21:55

A single incident called a “disclosure” can disclose a whole pile of stuff, Schwartz. One doesn’t normally talk about a doctor or lawyer handing over multiple documents to a reporter as “disclosures.” No, that’s one disclosure.

Talk about nitpicking and spinning the obvious meanings of words.
Schwartz
August 13th, 2008
04:56:56

Daedelus2u,

Read Dr. Offit’s rebuttal. He admits to misquoting Dr. Poling. “Poling implies that by omitting his phrase “many in the autism community and their champions,” I unfairly attributed the notion that vaccines might cause autism to him alone.”

That’s an acknowledgement of changing the meaning but rewording Dr. Poling’s complaint to make it sound like he was protesting the unfairness of it.

Next he states:
“However, Dr. Poling’s public announcement of the DHHS concession to the press and his subsequent appearances on national television and at autism conferences suggest that he is, at the very least, a vocal centerpiece of that community.”

That’s the justification.

I don’t know about you, but misquoting someone to change the meaning of the quote—even if you think the new meaning is accurate—is not a proper way to make a point because it attributes the meaning of the change to the wrong person.

Dr. Offit is again acting unprofessional in the public eye.
Schwartz
August 13th, 2008
05:01:19

Ms. Clark,

You are correct. Except we all know what the disclosure was, and we know it didn’t include the Supplimentary Rule 4 report.

If you want to complain about nitpicking, talk to Sullivan. This all started when I noted to bundy that the second report was not made public. Sullivan seems to think that it was “legally public” which is a term that is not used or defined anywhere except by Sullivan. It also has no bearing on the fact that you, or I, or Dr. Offit can’t get the Supplimentary Rule 4 report since it isn’t public.
daedalus2u
August 13th, 2008
12:55:54

The concession was compensation for vaccine injury causing “regressive encephalopathy with autistic features”. Poling, Kirby and all the other anti-vax activists have distorted that into compensation for vaccines causing “autism”. Why the double standard regarding precision of language? Precise when it fits your agenda, imprecise when it doesn’t.

So will Poling and Kirby apologize for misrepresenting what was said in the concession document? A document that was never intended for public release? A document the writers of which never intended to be construed as a concession that vaccines cause autism? A clarification that has been said many times and which has been ignored by the anti-vax activists each and every time?
Schwartz
August 13th, 2008
15:58:11

Daedalus2u,

You’ve already ruined your argument by using the generalized term anti-vax. You also seem to be using the flawed logic by arguing that others have made inaccurate statements, so that means it’s OK. Even worse, you argument consists of stereotypical references which are incomprehensible when debating specific points. What does David Kirby have to do with the NEJM letters?

Either way you’re way off topic of the NEJM letters. The problem is that Dr. Offit deliberately misquoted his colleage in a Peer-reviewed journal, admitted it, and then tried to justify it, even though the justification was reaching. Not forgetting that deliberately misquoting someone is unprofessional to start with.
daedalus2u
August 13th, 2008
17:11:21

So your point is to hold Offit to extreme standards of precision and hold Poling to loose standards? It is ok for Poling to speak in ambiguous terms when speaking to a lay audience in a news conference but it is not ok for Offit to do so when speaking to other medical professionals in a medical journal?

Poling states:

“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.”

Offit responds:

“But studies of concomitant use, which are required by the Food and Drug Administration before licensure to show that new vaccines do not affect the safety or immunogenicity of existing vaccines or vice versa, have clearly shown that multiple vaccines can be administered safely.”

Clearly, according to Offit, Poling’s statement is false.

The only reason the case of Hannah Poling is in the news is because David Kirby released the government concession report and lied by saying that “regressive encephalopathy with autistic features” means exactly and precisely the same as “autism”, and that the concession report exactly amounts to a concession by the government that vaccines cause autism.

Poling has allowed his words and his presence to be interpreted as supporting David Kirby’s lie that “regressive encephalopathy with autistic features” means exactly and precisely the same as “autism” and that the concession report exactly amounts to a concession by the government that vaccines cause autism.

I am not interested in playing “gocha” and who’s statements can be parsed into ever finer shades of nuance and meaning and who can apply spin to what has been said to twist the meaning how they want. You NTs can do that. I have Asperger’s, so I see communication and relationships as pretty black and white. I see the science in terms of the tremendous detail that it is, which all fits together, the complex details that the NTs can’t see and don’t want to see. The detail that “regressive encephalopathy with autistic features” means something completely different than “autism”. I see them as so different that it is impossible for me to confuse them, so different that I have a hard time understanding how anyone could confuse them, so different that for someone to confuse them makes me think that they are acting in bad faith. I saw David Kirby talk about it, and I am pretty sure he is acting in bad faith. Maybe he is just deluded, but the way he selectively reports things out of context and misreports results that have been disproven makes me pretty sure he knows he is lying.

Those who call themselves “pro-safe vaccines” are really anti-vax. They say they are pro-vaccine, but only for “safe” vaccines, but can’t name a single vaccine that is safe enough. They are exactly the same as the racists who say they are not racist, and would vote for an ethnic minority, if that ethnic minority was qualified, but can’t name a single person in the history of the world of that ethnic persuasion that was ever qualified enough to vote for. Maybe they don’t know they are racist. Maybe they have so deluded themselves that they think they are not racist.

There is a religious concept that is apt:

Luk 6:42 Either how canst thou say to thy brother, Brother, let me pull out the mote that is in thine eye, when thou thyself beholdest not the beam that is in thine own eye? Thou hypocrite, cast out first the beam out of thine own eye, and then shalt thou see clearly to pull out the mote that is in thy brother’s eye.
Schwartz
August 13th, 2008
21:21:49

Daedalus2u,

“So your point is to hold Offit to extreme standards of precision and hold Poling to loose standards?”

In the NEJM articles, I’m not holding Dr. Poling to any loose standards. His letter raised specific points about Dr. Offit’s original piece. Each of his points was very specific. I didn’t see him misquote Dr. Offit anywhere.

Which point in the letter are you trying to debate now? You only speak of one specific point in your post that is addressable: concommitant vaccine safety studies that are
required pre-approval.

How come Dr. Offit didn’t reference the Conncommitant safety trial for Rotateq or provide any references? If you read the Rotateq clinical trials, Dr. Offit’s assertion is not backed up. Immunogenicity trials that are monitored for safety are not the same as concommitant safety trials of which there are very few and certainly don’t occur pre-approval as Dr. Offit asserts.

If I’m wrong, please point one out or point out the rule that states that safety trials on concomitant use are required. Dr. Offit certainly didn’t provide any evidence, and as he has demonstrated more than once, he has a history of making inaccurate public statements requiring correction.
alyric
August 13th, 2008
22:55:44

Orac gets quite a bit ruiled by some of the anti vax canards, especially Schwartz’s insistence that no concomitant trials are done. Apparently they are ‘always’ done for every vaccine. So when the anti-vaxxers come out with lies like that – disregard please.

I suppose that because we’re all ‘autism’ oriented in our presence here, woo meisters like Schwartz pretty much get a free pass. But, if you think about it, considering what these folks are probably doing to the kids – chelation and the like and what they’re doing to society – undermining disease prevention big time, they should not be allowed to get away with it.
daedalus2u
August 13th, 2008
23:25:38

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.aappublicati...../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.
Schwartz
August 14th, 2008
03:46:23

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.
Schwartz
August 14th, 2008
03:53:51

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.
Schwartz
August 14th, 2008
03:58:13

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?
daedalus2u
August 14th, 2008
14:07:30

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”?
Schwartz
August 14th, 2008
17:13:42

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.
daedalus2u
August 14th, 2008
19:12:05

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/...../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?
Sullivan
August 14th, 2008
20:34:58

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.
Schwartz
August 15th, 2008
05:22:42

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.
Schwartz
August 15th, 2008
05:29:51

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?
daedalus2u
August 15th, 2008
13:54:11

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.
Schwartz
August 15th, 2008
16:42:46

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.
daedalus2u
August 15th, 2008
18:30:56

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.
Schwartz
August 15th, 2008
22:16:13

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.
daedalus2u
August 16th, 2008
02:20:58

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.
Schwartz
August 16th, 2008
06:06:21

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.
daedalus2u
August 16th, 2008
18:20:02

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.
isles
August 17th, 2008
01:32:14

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.
Schwartz
August 17th, 2008
05:03:58

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.
isles
August 17th, 2008
05:24:30

Big D! You got Schwartz to knuckle! Even he couldn’t stand the inanity of his arguments anymore.
daedalus2u
August 17th, 2008
14:30:41

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”?
commenting
August 17th, 2008
19:59:36

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.