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My irony meter goes to 11

2 Aug

This has been an amazing couple of weeks for irony in the autism world and not just from CBS. Just when I thought it was calming down, CBS News responds to Voices for Vaccines. As a recap–CBS news ran a short piece on potential conflicts of interest by groups and people who support vaccines (discussed AutismVox, Autism News Beat, LeftBrainRightBrain, Orac, . V4V called defamatory the Sheryl Attkisson piece.

Well, CBS news has responded…to an Orange County blogger. (presumably, a version of this was sent to V4V as well). (It’s worth noting that the Orange County blogger, not being satisfied with the mistakes that CBS had made, pushed the limits of misinterpretation a tad further–see the comments here)

Our report last Friday represents one part of the extensive reporting CBS News has done, and will continue to do, on the issues surrounding vaccines and possible links to autism. That continuing coverage has repeatedly reported on the critical importance of the nation’s maintaining a robust vaccination program for children. Reporting on what critics, including members of Congress, believe to be potential conflicts of interest for vaccine advocates who receive funding from vaccine makers is also an entirely legitimate aspect of our overall coverage. We believe our report was in no way defamatory of any institution or individual, and that no retraction is warranted.

Oh, kay. CBS decided internally that they had acted properly in their piece.

This is of course being trumpeted in the usual quarters. Let’s say we did a cut and paste, switching, say, CBS for CDC? That’s right, shouts of “Conflict of Interest” would echo the virtual halls of the blogosphere.

But apparantly no conflict of interest in CBS deciding that CBS acted appropriately.

This didn’t peg the Irony Meter 2000 (which goes to 11). But, it is amusing.

I don’t know the legal term for a news piece that reports inaccurate information, and other information in a leading way due to lack of analysis. That part is not amusing. The days of Walter Cronkite are long gone, I’m afraid.

Yet another look at CBS's view of Offit's COI's

2 Aug

Paul Offit has been much in the news and blogOsphere lately (Say, here , here and here. Dr. Offit is a vaccine researcher and vocal supporter of vaccines. This makes him a target amongst some groups, leading to a recent example of the “investigative reporting” that CBS news’ Sheryl Attkisson brings to the public.

A big question comes up as to Dr. Offit’s conflicts of interest. Ms. Attkisson’s story brings up a few. Let’s take a look. First we have the fact that Dr. Offit holds an endowed chair:

Offit holds in a $1.5 million dollar research chair at Children’s Hospital, funded by Merck. He holds the patent on an anti-diarrhea vaccine he developed with Merck, Rotateq, which has prevented thousands of hospitalizations.

OK, simple fact check: the endowed chair is $2M, with $500,000 seed money put in by Children’s Hospital of Philidelphia and the University of Pennsylvania.

Not many people have reason to know the details of what an endowed chair is. If I didn’t know better, the above quote makes it sound like the $1.5M from Merck is something akin to a grant, giving Merck some leverage on Dr. Offit. Actually, chair endowments are basically trust funds. In this case, Merck donated $1.5M to CHOP and Penn, who manage the money independent of Merck. These institutions use the proceeds of the endowment to pay for salary and research funds for the chair holder. CHOP and Penn decide who get the chair after Dr. Offit leaves or retires. It is not “His” chair, but the institutions’.

Remember that bit about “research funds”? This is money that allows a the chair holder (Dr. Offit in this case) to do independent research. He doesn’t have to apply for grants, but has a constant supply of money. Merck doesn’t have a say in how he spends those funds.

Isn’t that a good thing? Independent researchers, not beholden to funding agencies?

So, the endowed chair is not a conflict of interest at all.

What other conflict of interest did Ms. Attkisson “unearth”? Well, she noted in the above quote that Dr. Offit is a co-inventor of a patent on a Rotavirus vaccine. She goes on to state:

And future royalties for the vaccine were just sold for $182 million cash. Dr. Offit’s share of vaccine profits? Unknown.

OK, I am going to be picky on details again. Yep, I make a lot of mistakes too, but I gotta get this one out. Dr. Offit doesn’t “hold” a patent on the vaccine. He is an “inventor”. He “assigned” the rights to:

The Wistar Institute of Anatomy and Biology, Philadelphia, PA
The Children’s Hospital of Philadelphia, Philadelphia, PA

I’ll also point out that he is listed as an inventor on about 24 patents worldwide, with about 10 on Rotavirus. Of those, there are multiple US Patents. (I’ll note that Dr. Offit does not list all his patents on his resume.)

I’m sure I’ve made the “holds patent” mistake a lot. I would venture to guess that you might even find the mistake in statements by Dr. Offit. In general, I wouldn’t think “holds patent” is a big deal. He may discuss it as “his” patent because the ideas are “his” and his co-inventors. But, in the financial sense, the patent belongs to the assignee. Initially, this was CHOP and the Wistar Institute. So, why bring it up here? Because, (a) a news reporter should be more accurate and (b) I think the language is important in this specific case.

What Dr. Offit (and his co-inventors) proabably [edit–no probably about it, hat-tip to Scwhartz for catching this] “hold” is an agreement with the assignees (CHOP and the Wistar Institute) for some share of license fees or for bonuses based on the successful licensing of the patent.

That’s how research works. The company or institution takes the risks that a researcher’s work will never pan out. They pay salary, they pay the fees to file patents. Typically, researchers’ shares in license fees are determined before research is completed, often when the researcher is hired.

But, that doesn’t sound as interesting as “He holds a patent licensed for $182 million”, does it?

I’m not going to downplay the likelihood that Dr. Offit made money off of the vaccine patents. I hope he did. But, if he were in it for the money, there were a lot of things he could have done to make more in his career once it became obvious that RotaTeq was likely to succeed. Talking about the lack of science behind the autism/vaccine connection isn’t one of them.

And that’s what this is all about, isn’t it? The implication that Dr. Offit is out for the money. People want to make the public think that he speaks out on vaccine safety because he will get more money.

Well, recall that the future royalties on RotaTeq have been sold. What does that tell us about Dr. Offit’s conflicts of interest? It tells us that the financial COI on RotaTeq is basically over!

Consider the world view of those who claim that Dr. Offit speaks out on vaccine safety to line his own pockets. How much money will Dr. Offit make on RotaTeq if he speaks out on autism issues? How much will he make on RotaTeq if he stops speaking out?

They are the same amount.

So, CBS had two potential COI’s on Dr. Offit: the endowed chair and the RotaTeq royalties. Neither of which is an active COI at this time and into the future.

So, what’s missing from the CBS example of “investigative journalism”? How about a discussion of Dr. Offit’s research grants? Where did the money come to support the research into the vaccine? We all know that CBS must have looked into that. Why nothing in the story? Could it be that there is no story there? Uh huh. The National Institutes of Health funded Dr. Offit’s research on rotavirus. Merck took over the development and testing phase of the vaccine in 1991, but the actual creation of the vaccine occurred without industry funding.

So, did Merck do “payback” and fund Dr. Offit’s research since then? (Again, CBS had to have considered that). Not that I can see. No Merck funded projects are listed in his resume with him as principal investigator.

Quite frankly, I am surprised by how few industry funded research projects Dr. Offit has been principal investigator on. Given his expertise, I would have expected much more industry funding. Much more.

That doesn’t make a good story though, does it?

So, how does Dr. Offit act when a COI is in play? Oddly, this discussion recently occurred on this blog.

Dr. Offit was a member of the Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention from 1998 to 2003. During this time he had to vote on a competitor’s rotavirus vaccine (RotaShield). (People seem to have a habit of confusing RotaShield with Dr. Offit (and team’s) RotaTeq)

So, when RotaShield, the competitor’s vaccine, came up for vote, what Did Dr. Offit say? He voted to include it in the schedule. It’s hard to spin that as something that would benefit Dr. Offit, as it clearly meant that the marketability of his own vaccine was reduced.

Rotashield was found to potentially cause intussusception. The numbers affected were too small to detect in the trial, so this concern was raised after the vaccine was added to the schedule. the ACIP took a vote on whether to remove RotaShield from the schedule–a move that clearly had potential benefits for Dr. Offit, so he abstained.

I guess that didn’t fit in the CBS story either.

Why are we talking about Dr. Offit again? We can all speculate, but the good folks at the Age of Autism answer the question for us:

Paul Offit is quickly coming under suspicion for his pharma ties and losing his usefulness as a vaccine promoter in the press.
It’s a little hard to pretend that all you do is work at Children’s Hosp. of Philadelphia, when you’ve gotten coverage on CBS and in the
Wall Street Journal because of serious conflicts of interest. Offit’s new book,
“Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure,” is due out this fall but I hardly think anyone will think of him as a credible independent expert.

Anne Dachel
Media editor

Yep, they realize that “Autism’s False Prophets” is soon to hit the shelves of bookstores. I wish I had a copy now, as it must be pretty scary to the Generation Rescue crowd since they are putting on such a big preemptive strike.

I’ve already asked my library to order a copy.

By the way, I love how everyone at Age of Autism is an editor

Sullivan
LeftBrain/RightBrain Antarctic Bureau, Sports Desk.

Stop the presses: Paul Offit's resume is WRONG!

1 Aug

If you check Dr. Offit’s resume, you will find that he list three patents:

Clark, HF., Offit, P., Plotkin, S.A. Rotavirus reassortant vaccine. United States Patent #5,626,851. Issued May 6, 1998.

Speaker, T.J., Clark, H.F., Moser, C.A., Offit, P.A., Campos, M., Frenchick. P.J. Aqueous-based encapsulation of a bovine herpes virus type-1 subunit vaccine. United States Patent #6,270,800. Issued August 7, 2001.

Clark HF, Speaker, T.J., Offit, P.A. Aqueous solvent encapsulation method, apparatus and microcapsules. United States Patent number 6,531,156. Issued March 11, 2003.

In preparing a post, I found that the above is not accurate. I feel I must note the mistakes. Yes, there are multiple mistakes. If you do a patent search for “vaccine” with “Offit” as the inventor, you get 24 patents and applications. I list them below:

ES2216242T3 ENCAPSULACION DE VACUNA SUBUNITARIA CONTRA EL VIRUS DEL HERPES BOVINO TIPO 1 EN BASE A UN DISOLVENTE ACUOSO.

PT0873752T ENCAPSULACAO COM BASE EM SOLVENTE AQUOSO DE UMA VACINA DE UMA SUBUNIDADE DO VIRUS DO HERPES BOVINO DE TIPO-1

DK0873752T3 Vandigt oplesningsmiddel-baseret indkapsling af vaccine af en bovint herpesvirus type-1-underenhed

EP0873752B1 Aqueous solvent based encapsulation of a bovine herpes virus type-1 subunit vaccine

US6531156 Aqueous solven encapsulation method, apparatus and microcapsules

CA2065847C ROTAVIRUS REASSORTANT VACCINE

US6290968 Rotavirus reassortant vaccine

US6270800 Aqueous solvent based encapsulation of a bovine herpes virus type-1 subunit vaccine

EP0873752A3 Aqueous solvent based encapsulation of a bovine herpes virus type-1 subunit vaccine

US6113910 Rotavirus reassortant vaccine

AU0713639B2 AQUEOUS SOLVENT BASED ENCAPSULATION OF A BOVINE HERPES VIRUS TYPE-1 SUBUNIT VACCINE

ZA9803327A AQUEOUS SOLVENT BASED ENCAPSULATION OF A BOVINE HERPES VIRUS TYPE-1 SUBUNIT VACCINE.

DK0493575T3 Vaccine af reassortant rotavirus

JP10316586A2 CAPSULATION OF BOVINE HERPES VIRUS TYPE-1 SUBUNIT VACCINE ON BASIS OF AQUEOUS SOLVENT

NZ0330251A BOVINE HERPES VIRUS TYPE-1 (BHV-1) SUBUNIT VACCINE IN AN AQUEOUS SOLVENT BASED ENCAPSULATION

AU6351198A1 AQUEOUS SOLVENT BASED ENCAPSULATION OF A BOVINE HERPES VIRUS TYPE-1 SUBUNIT VACCINE

EP0873752A2 Aqueous solvent based encapsulation of a bovine herpes virus type-1 subunit vaccine
CA2229430AA AQUEOUS SOLVENT BASED ENCAPSULATION OF BOVINE HERPES VIRUS TYPE-1 SUBUNIT VACCINE

EP0493575B1 ROTAVIRUS REASSORTANT VACCINE

US5750109 Rotavirus reassortant vaccine

US5626851 Rotavirus reassortant vaccine

GR3018262T3 Rotavirus reassortant vaccine.

EP0323708B1 Rotavirus reassortant vaccine

EP0493575A4 ROTAVIRUS REASSORTANT VACCINE

Why would someone leave all those patents off of a resume? A lot of these patents are international versions of US patents (Note the first two letters in each patent number US=United States, EP=European Patent, GR=Great Britain, etc.). Some of the US patents are “picture patents”. They are non-obvious variations, but similar to other, more fundamental patents.

Oh, yeah. There was another mistake. He lists patent #5,626,851 as Issued May 6, 1998. Actually, it was issued May 6, 1997. Obviously a part of some plot. I can’t tell how exactly it benefits him, but it must somehow. Just like the fact that he left patents off his resume, must be a plot. Nefarious.

Well, curiosity got the best of me. I emailed Dr. Offit to ask why these are missing from his resume. He responded that yes, indeed, they are “picture patents”, and that including them all seemed like resume padding.

There is a saying amongst old timers (in any field): “I’ve forgotten more about this subject than you will even know”. It appears that Dr. Offit has left more pertinent qualifications off his resume than his detractors (combined) will ever have.

How many of us have resumes so good that we can leave off 21 patents and cherry pick the really fundamental ones? How many of us can only list the invited talks we’ve given in the recent past (as Dr. Offit does)?

CBS news: can I have a job? I’ve “unearthed” more than you did. Oh, but it doesn’t fit with the “conflict of interest” theme, does it?

Sharyl Attkisson's long history of anti-vaccinationism

1 Aug

As blogged by Mike, Liz, Autism News Beat, Kristina and Orac, CBS reporter Sharyl Attkisson seems to the prime suspect in the matter of how a fax sent to CBS News by Voices for Vaccines turned up on the Age of Autism blog less than 1 day later.

This matters. Reporters are supposed to be independent. They are supposed to give a balanced view. The very act of forwarding this fax to Age of Autism simply confirms that someone at CBS News, mostly likely Ms Attkisson, is deeply affiliated with Age of Autism. This makes her conflicted and she is totally the wrong person to be investigating the autism/vaccine hypothesis.

I went looking to see what else I could find to support my opinion that Ms Attkisson is someone who is not a reporter, but someone presenting her opinion in the name of investigative news. I found plenty.

Take this ‘interview‘ with Rep. Dave Weldon about the Poling case. I put the word interview in single quotes because it really isn’t an interview, its more a series of questions to allow Weldon to trot out a series of inaccuracies supportive of the idea vaccines cause autism. This is the sort of journalist who would ask God ‘tell me God, do you believe in creationism?’ And then give God a five minute run to explain how he does.

She was also the CBS employee (it seems wrong to keep saying she is a reporter) who interviewed Bernadine Healy in which the former Philip Morris shill said we should re-examine the autism/vaccine idea.

Over on the ‘No Mercury’ website, there is a long list of videos of Ms Attkisson (35 in total, dating back to March 2002) of which all seem to be ‘investigations’ into vaccines and other pharma related activities.

This piece which relates some of the most common and mind-numbingly stupid antivax canards around is just about the clearest indication of her loyalties. Anyone who states the following is not impartial and should not be investigating this story:

Non-profits which dispel any vaccine/autism/ADD link have ties to vaccine makers.

How the Hidden Horde were hidden

1 Aug

One of the (many) controversies within the autism community is the question of the hidden horde. The basic argument is:

1) Autism diagnosis have ‘increased’ massively in recent years. Prevalence now stands in the UK at approx1 in 100 and approx 1 in 150 in the US.

2) Something(s) must have caused this large scale increase.

This is where the division point is. Devotee’s of the ‘autism is vaccines/TV/mobile phones/whatever’ ideas say that the increase is not in diagnosis but in autism itself. That there really is a massive increase since the early 90’s in the amount of autistic people. They call this ‘the epidemic’.

People like me think that there may be a small ‘real’ increase but it is very small and what we are seeing is the effect of (to quote an authority on the subject):

The shift in how we view autism….is part of a broader set of shifts taking place in society.

…..

Doctors now have a more heightened awareness of autism and are diagnosing it with more frequency, and public schools….which first started using the category of autism during the 1991 – 1992 school year are reporting it more often….Epidemiologists are also counting it better.

…..

Still, these rates may not be proof of an epidemic. Why? Because the old rates were either inaccurate….or based on different definitions of autism than the ones we use now.

Interestingly, in the Autism Omnibus hearings, the families are now arguing (after years of ‘epidemic’ talk) that the amount of children allegedly poisoned by vaccines is so small as to be undetectable. Hardly a hallmark of an epidemic.

One of the arguments used by people who believe there has been an epidemic of autism is to say ‘if there has _not_ been an epidemic, then where are all the adult autistics?’ meaning that if the rate of autism has always been 1 in 100 or 1 in 150 then there should be an equal number of adult autistic people to children.

Its a logical thought but it doesn’t take into account one crucial fact; as far as I know, *no* epidemiological study has tried to count the adult autistic population in any country. So we have no real idea how many adult autistic people there are.

We have some clues – such as the 2004 Scottish audit that revealed that 45% of local authorities in Scotland considered adult prevalence grossly underestimated. For example, Perth and Kinross commented:

Figures for adults reflect the national findings that the numbers known to services/diagnosed represent a significant underestimate of those individuals likely to be affected. For example day centre managers locally consider a number of people to be on the spectrum who have had no formal diagnosis.

And this year, the UK Gvmt announced the would be undertaking the first ever audit of autistic adults in England.

But we do have the odd clue thrown to us now and again that shows where the so-called Hidden Horde might be. As the Scottish Audit suggests, they live amongst us, unrecognised or wrongly diagnosed.

Two recent studies from the Netherlands have shed a bit more light on what may be happening with adults.

In ‘Autistic Spectrum Disorders in Adults‘, the abstract states:

The expression of impairments in social interaction, communication, imagination and mental flexibility changes during development into adulthood.

Autism spectrum disorders in adults may mimic, or be overshadowed by, other psychiatric disorders.

Almost a direct agreement with the Perth and Kinross statement from the Scottish Audit.

The second paper ‘Recognition of autism spectrum disorders in adults‘ has an Abstract worth quoting in full;

Autism spectrum disorder was diagnosed in three adults. The first patient, a married man aged 41, was referred to a psychiatrist with ‘impending burn-out’. The second was a 32-year-old male student with schizophrenia and a depressive disorder who was referred to a centre for autism because a friend of his mother’s knew someone with Asperger’s syndrome. The third patient was a 25-year-old woman with a ‘fixation on food’ who was referred by her general practitioner to a psychiatrist for evaluation of longstanding use of antidepressant medication. Autism used to be thought of as a condition of childhood. Only recently has the diagnosis and treatment of autism spectrum disorders become the focus of attention in adult psychiatry. It is made all the more difficult as during development into adulthood, the expression of disorders of reciprocal social interaction, communication, imagination and repetitive stereotypical thinking and actions, change.

This again shows how autism can be ‘masked’ and how diagnostic tests suitable for children may not be suitable for adults. It also touched on another key issue – that only recently have adults begun to be looked at. It also thirdly touched on another issue – comorbidity. All these three people had ‘other’ psychiatric issues. I have no idea if their diagnosticians considered their autism to be comorbid or if their other diagnoses were considered comorbid to their autism. In the end it doesn’t really matter, except in one important regard: By failing to help these people properly when they were children, did their other psychiatric issues grow so pronounced that their autism was ‘eclipsed’ until a suitable diagnostic test was undertaken? If that is the case then we need to be very aware that there is indeed a large population of adults who have not got a full and proper diagnosis and thus are missing out on help they need and deserve.

Thimerosal and Autism on Trial: Closing statement by Mr. Matanoski

31 Jul

This is a portion of the government’s closing argument given by Mr. Matanoski. It is found on the audio from Dwyer called Day02-PM3.

First I want to point out on the specific causation … lawyers are kind of slick they move things around, they kind of play a shell game. When I heard the comments about a specific causation case it made it sound like respondent has a burden here to show what actually caused it. Actually the burden is on the petitioners to show that the vaccine caused autism. And respondent doesn’t have to show that it’s genetic in origin.

And I think that the comments about Dr Leventhal’s testimony on that point are a little off the mark. What Dr. Leventhal was saying, essentially, that most practitioners, most folks who study autism as a profession believe that it’s largely genetic in nature at that’s where the research has been directed and in fact it’s been fruitful in that regard. There’s still much more to do. But everything that has come out has pointed to genetics as very strongly associated with autism and most of the research that has been done has shown that autism would have a prenatal course. That it can essentially be seen, that the preconditions, if you will, for autism are in place beginning before birth, in most instances.

I think there also is a little bit of a misconception about what the force of Dr. Leventhal’s testimony was. He basically was saying that Colin’s case really is sadly no different than many of the cases that he sees, where there is a gradually emerging picture of difference, perhaps delays, but at least difference in the quality of behavior in the child as the child develops. It’s not necessarily apparent right from the start. That’s very rare. Most of the cases it’s apparent later and it may seem that a child has reached certain milestones has subsequently had trouble keeping those milestones. As the condition progresses there often is an improvement. That’s the natural course of the condition. What Dr. Leventhal was saying is, as time has gone on, more and more of the researchers have realized that if you look back in cases, that apparently seemed to have a normal trajectory and then there seemed to be a loss, that you see earlier signs and symptoms that all was not on a normal trajectory from the beginning.
That was the force of his testimony, and that testimony was backed up by other testimony by other testimony that the court has heard before he took the stand.
Dr. Lord who has specifically studied regressive autism made that point quite clear, that as this has progressed the concept of regressive autism has become more encompassing, that autism itself seems to have a progression where it appears that there is a loss but when one goes back, one sees that there is unusual, or differences in development earlier on in almost every case. And what Dr. Leventhal was saying is that as they gotten better, folks who do this for a living, folks who make their lives studying about studying autism they’ve realized that more and more of those cases they can see earlier on. And in very few instances when they’ve studied quite closely do they see that there isn’t some sign that the trajectory or the course is not the same as other children’s.

Dr. Mumper’s testimony which really wasn’t really much of the focus in the closing argument here. She seems to be relying on isolated lab results to come up to a conclusion that vaccines are the cause here. She’s been asked in this case and in other cases what would that pattern be, what do we need to look at? And in fact there doesn’t seem to be a particular pattern. In the King case certain test results were relied upon to draw the conclusion that thimerosal in vaccines were associated with autism in that case, or caused autism in that case. In the Mead case other results were looked at and thought to be, by Dr. Mumper, indicative that vaccines were causing, or evidence that vaccines were causing autism. And now in Colin’s case, we see yet a different pattern of test results being relied upon to reach that conclusion.

In fact those test results, with really no pattern, how can one say that there is any kind of clinical evidence from these test results that one can rely on to make that .. to draw those kinds of conclusions that Dr. Mumper is relying on.

And as you’ll see when you go through the testimony, we believe that she largely moved away from relying on any specific test result when questioned about each specific one she said that essentially that the mercury test result, the positive provocation, was really the only test that she had that showed that the mercury was there, and she was relying on to implicate thimerosal as a cause in this case, but then she admitted that she really didn’t know what the normal range would be for that test.
How can one say that this is an abnormal result when one doesn’t know what normal is?
Her testimony seems to be formed largely by the Defeat Autism Now world view which is that toxins and heavy metals are implicated in autism. And to use the example that Mr. Powers used of Tycho Brahe I think that comes to bear with her testimony as well. It doesn’t matter which test results she’s looking at it always comes back to a heavy metal or a toxin, when it could be that the acidosis that the lactic acid build up could be because the child was crying when the blood was taken. (35 min 30 sec)

…

I’m going to touch now on the general causation because that was a matter of some discussion by Mr. Williams. I see that the glutathione theory which is where we started with this general causation case seems to have dropped out. It wasn’t in the opening statement, it wasn’t in the closing statement. It seems that the theory of causation now is neuroinflammation and largely seems to be neuroinflammation alone. That was a theory that Dr. Kinsbourne recently advaced in this case. It obviously wasn’t present until just a couple of weeks before the trial in May.
This is something after six years in the making, this seems to have come up kind of at the very end.

Mr. Powers and Mr Williams have focused on the causation burden, and say that the information they have given on neuroinflammation meets that burden, that would be the causation burden under Althen and Grant, the specific criteria that they need to meet under that test that the court has articulated, the federal circuit’s has articulated.

Respondent starts a little earlier than that if you will in the calculation and that is about what evidence feeds into Althen and Grant. We start out with the analysis under Daubert about whether there is good scientific evidence to even meet that burden. So obviously the evidence that you have or the evidence that is being offered does not meet the criteria of good scientific or reliable evidence then you have nothing at all to test about whether you’ve met your legal burden under Althen.

Our position has been throughout this that the petitioners’ evidence that they have offered, the testimony that they’ve offered, fails to meet that standard of reliability that is set out under Daubert and that this court applies. Daubert stands for the proposition that there are not multiple kinds of scientific evidence. A kind for scientists to use and a kind for judges to use. There is only one kind of scientific evidence. It is the kind that scientists use. That is the kind that judges are supposed to be looking for as well. …

Kathleen Seidel’s neurodiversity weblog has more from the Dwyer case, including audio excerpts.

Elizabeth Mumper – Autism Omnibus, Dwyer vs HHS

When I heard Mr. Matanoski say, “when one doesn’t know what normal is,” it occurred to me that it could be used as a slogan or strapline for the autism/biomed organization that is led in part by Dr. Mumper.

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David Kirby, he's making a list, he's checking it twice…

29 Jul

As has become apparent in recent weeks, there seems to be a ‘backdoor’ movement underway from the mercury militia.

It all started when Kelli Ann Davis attempted to rewrite US legislative history by stating in a speech to the IACC Working Group that the Combatting Autism Act contained specific phraseology on vaccination. It of course did not. David Kirby repeated this error in a Huffington Post entry. This was, it seems, little more than an attempt to ‘set the scene’ for a coup d’état. The logic seems to be that, since, during the CAA process, vaccines were touted as causes, even though the CAA decided to reject them as being too specific and settled for ‘environmental’, Kelli Ann and David felt that this was sufficient cause for stating the CAA included vaccine language. This seems to me to be akin to saying that, as society once believed the world was flat, it still is.

Anyway, this statement seems to have cut little ice with the IACC and so, the mercury militia unveiled Plan B – getting Brad Miller House Committee on Science and Technology’s Subcommittee on Investigation and Oversight to write a letter to Secretary Leavitt (HHS) to strongly recommend the formation of an advisory ‘board’ that they (in the guise of SafeMinds and Generation rescue) would police and use to control access from the public to the IACC and vice versa.

Personally, the idea fills me with complete horror. I’ve already discussed why but just to recap, the idea of Generation Rescue and SafeMinds being even slightly even-handed or representative of autism parents is like a bad joke. I provided email addresses and names for people to express their displeasure also (and I hope many of you did. If you didn’t, I urge you to right now. Both US and non-US people).

Anyway, the latest chapter in this battle for the scientific soul of the IACC is now underway as we speak. I have it on good authority that David Kirby is in the process of contacting as many members from an IACC strategic planning workgroup as he can to ascertain which way their opinion swung. He is specifically interested in the question of whether anyone among the 20 or so workgroup members other than Mark Blaxill and Peter Bell recommended the IACC include in the strategic plan a separate initiative on vaccines. If you listened to the webinar, you know firsthand that no vote was taken. In fact, since the workgroup’s expressed purpose is just to provide feedback and it has no authority over the IACC, no votes whatsoever were taken. But David is going ahead and asking people anyway. To what end I wonder? I think there are a few possible reasons.

The email David sent around asked people their position on vaccines in the Strategic Plan and to explain how they got on the workgroup (the answer, which anyone at NIMH could tell him, is that each IACC member was allowed to nominate one person) I would hazard a guess that this number would be very low indeed. However, what he could also be doing is seeing how many people don’t seem to care either way. The IACC is made up of some scientists who are, shall we say, ambivalent about all things except their own institute or federal agency. By not really caring either way, they stand a good chance of letting this thing happen via the backdoor. David will of course (being the excellent author he is) know exactly how to phrase this to make it sound irresistible.

And then of course there is the third and more Machiavellian option. That a ‘hit list’ is being compiled to intimidate the members. We have seen time and time again on the Age of Autism blog how its authors post the names and contact numbers/addresses of those it doesn’t like or who feel have wronged it. Would David be so nasty as to post the names of people who may inform him they intend to voice their opposition? I hope not. I would like to think better of him than that.

Protecting Public Trust in Immunization

28 Jul

That’s the title of a special article in Pediatrics:

Public trust in the safety and efficacy of vaccines is one key to the remarkable success of immunization programs within the United States and globally. Allegations of harm from vaccination have raised parental, political, and clinical anxiety to a level that now threatens the ability of children to receive timely, full immunization. Multiple factors have contributed to current concerns, including the interdependent issues of an evolving communications environment and shortfalls in structure and resources that constrain research on immunization safety (immunization-safety science). Prompt attention by public health leadership to spreading concern about the safety of immunization is essential for protecting deserved public trust in immunization.

It is quite bizarre that something that is overwhelmingly good for society and good for individuals should become the scapegoat for just about every ailment the modern world has. I’ve seen vaccines blamed for (aside from autism) asthma, AIDS, heart disease, obesity amongst other things and portrayed as part of a global Illuminati agenda to control the world population. I’ve seen people tie it in (or try anyway) to the events of 11th September 2001 and threaten scientists associated with their manufacture with death for them and their children. How the hell did we get here?

The paper from which I’ve included the Abstract above is an attempt to try and recognise how these things have happened and how the medical/science establishment can regain public trust in vaccination.

The paper opens with a little bit of self-chastisement:

Every time a mother holds her healthy infant to be immunized, she is demonstrating great faith in the potential benefit and safety of the vaccine and trust in the clinician who recommended it. Over past years, clinicians and public health leaders have taken for granted the magnitude of that act of trust. We also have basked in the praise that comes with being a participant in the success of immunization in dramatically reducing morbidity and mortality in childhood and changing the practice of
pediatrics.

For doctors, who are by and large subscribers to the scientific mentality, the benefits of vaccination are obvious. Their error has been to not notice that 99.99% of their case load are not subscribers to the scientific mentality and therefore they will not look at things with the same lack of emotion. It is in fact very difficult to do so. Particularly for something like vaccination when we are essentially treating our kids for things they haven’t got. Also difficult to see for emotional rather than scientific people are things like keeping up herd immunity:

“Vaccines are victims of their own success” is the shorthand now used to reflect the reality that, in the absence of vaccine-preventable disease, many parents fear vaccines more than the diseases known to them only vaguely.

Its true. Getting the message through that just because the vaccine-preventable disease is not right here right now doesn’t mean its gone for ever is difficult. And here is another place in which the scientific community have fallen down: they have not got the message through. Until very recently, they have not even tried.

Over the past 10 years the Internet, particularly the web, has grown to every corner of the globe and over the years, those who used to be anti-vaccine cranks have now become trusted gurus to the parents who think that looking on whale.to is the same as doing research. The scientific community has failed to keep up with this. Their solutions (the NHS website for example) whilst very informative are stilted, formal and do not speak to the emotional side/needs of parents.

The Pediatrics paper lists a number of ways for science to regain the trust of parents.

One area that needs increased investment is immunization-safety science;

…….

What is immunization-safety science? Or, more accurately, what are the sciences necessary for protecting public trust in the safety of vaccines? Most of the biological, social, and communication sciences have roles.

Some of these sciences are more central and obvious than others, such as allergy/immunology, epidemiology, and infectious diseases, but anthropology, ethics and political science also have important roles given the multiplicity of questions. Research on the short- and longer term risks and benefits of combinations and timing of multiple vaccines requires a different profile of disciplines than does the question of “what is the value of mandates in public immunization programs?”

Yes. Definitely. These are science based questions that need addressing.

Invest more in public awareness and genuine public engagement around immunization issues. Recognize the number and heterogeneity of publics to be served and the diversity and legitimacy of their questions and concerns.

? Educate the public on the elaborate, already existing US system for research and testing of vaccines, including the responsibilities of the vaccine industry and, particularly, the independent and interdependent functions of industry, the US Food and Drug Administration (FDA), the CDC, the Health Resources and Services Administration, and all their advisory bodies for prelicensure and postlicensure evaluation.
? Educate the public on the function, membership, and selection process for members of key advisory bodies.
? Increase the number and diversity of citizen members on advisory bodies without reducing scientific expertise.
? Give the public sufficient information and adequate time to understand the rationale for any new vaccines before embarking on immunization campaigns, which can be done without delaying protection.
? Engage local communities and parent groups as advocates of new vaccines.
? Avoid the hyperbolic marketing practices of overselling.
? Improve the communication skills of public and private health leaders to present information in perspective, including benefits, risks, and gaps in knowledge. Avoid obfuscation, admit gaps in knowledge, and be available and candid in answering the questions asked, building comfort even when the circumstances are uncomfortable. Take the time to explain changes in recommendations/policy. Such explanations are essential for reducing charges of waffling, indecision, and hidden agendas.
? Invest in research on what is truly driving parents’ questions and concerns and what may be needed to earn/keep their trust in vaccines.
? Decrease reliance on state mandates and in no case push for mandates before evaluating the results of voluntary immunization programs.

Yes, again, good points. However, to me, the key question is not being addressed. How do you intend to do this? What needs to change is how you get these things over to the general public. For example, parents of autistic people generally trust other parents of autistic people. I’m sure that there are some Paediatricians who are also parents of autistic people. Maybe they are even AAP members! Or work for the CDC. Give these people a voice.

Lets see some voxpop ‘interviews’ on YouTube. Nothing stilted, nothing formal, just people doing their job, speaking their minds. If there’s fault, let them admit it.

And you’re going to have to accept I think that there is a generation of parents here who are never going to see it your way. They’re lost. Concentrate on the new parents. If they’re having vaccinations, hold a Q&A but be ready for the hardcore anti-vaxxers. If they’re in for an autism assessment for their kids (or themselves) talk to them, don’t just diagnose and dismiss, let them express their fears. Yeah, it’ll take more time but it’ll be worth it in the long run.

Said the Brit, daring to comment on US health policy 😉

Conflicts of interest, whats good for the goose…

28 Jul

As recently blogged by Autism News Beat, CBS Evening News (an American news outlet) recently performed an investigation into ‘how independent are vaccine defenders’? Something of an exercise in futility, it concluded that:

Ideally, it [vaccines] makes for a healthier society. But critics worry that industry ties could impact the advice given to the public about all those vaccines.

So, CBS say that the vaccine schedule makes for a healthier society but that the advice given about vaccines could impact the advice given.

Uh…so? Lets go through that again. It makes for a healthier society. Would CBS rather it didn’t? Bizarre.

Specifically, they attack the AAP, the Every Child By Two website and Paul Offit. The AAP has conferences funded by vaccine manufacturers, ECBT takes money from the vaccines industry….in fact, hold on…CBS say in their report (assume breathless excitement reporter voice)

Every Child By Two, a group that promotes early immunization for all children, admits the group takes money from the vaccine industry, too…

Oh do they? They admit it do they? Under the rigour of your intrepid journalism no doubt? Except that information is clearly available for all on their website. I do wonder if anyone from CBS even spoke to ECBT.

And of course there is Paul Offit – the official poster boo-boy for anti-vaccinationists everywhere. The man who dares to make a profit from his inventions! CBS took him to task for holding a patent on a vaccine. Shall we look at another man who made a patent application for a vaccine? That’s right – Andrew Wakefield. Except, unlike Dr Offit, who made no attempt to hide his association with the vaccine he was responsible for, Andrew Wakefield’s solicitors said that ‘Dr Wakefield did not plan a rival vaccine’.

How about other people who make a tidy income from the anti-vaccine industry? The Geier’s maybe who invented their own IRB to make sure that their ‘science’ was unhindered by ethical considerations…..or maybe Dr. Jay Gordon who thinks that the Polio vaccine could be replaced by simply not eating cheese. How much do you charge your clients Dr Jay? How about Laura Hewitson who’s husband works for the Wakefield owned Thoughtful House and who seems to be part of the Autism Omnibus hearings….how independent can her science be? How about the ARI/DAN group who are led by people who clearly have no clue at all as to the medical science they are making a large profit on. How much do each of these people make? How about Rashid Buttar who lists non-existent memberships on his CV and who charges upwards of $800 for a 1 hour consultation fee and who’s ex-patients report being out of pocket by about $20,000 in about a year.

Its up to you Dear Reader – are these things we should be worried about? Are these things CBS should be worried about? Are these conflicts of interest? Does the act of making any sort of money either from treating people or from existing business interests mean you cannot and should not talk about these things? Should we assume that only certain people have an agenda?

In my humble opinion, it should only become an issue when attempts are made to hide these things. Or deny them when they are clearly true. That cannot be said of the AAP, ECBT or Paul Offit. Maybe CBS should be asking to see the balance sheets of DAN doctors or vaccine litigation specialists. What have they got to hide? Maybe CBS should be inspecting the credentials of people who claim to be able to cure autism and reverse old age. Maybe CBS should be looking at the disturbing increase in ties between autism/anti-vaccinationists and scientology.

But I would think in the meantime that CBS will take the easy route of producing crap that informs no one about anything. Lets hope it doesn’t turn around and bite them on the arse eh?

Elsewhere
Orac weighs in too.

Elizabeth Mumper – Autism Omnibus, Dwyer vs HHS

25 Jul

Some highlights, courtesy of a Guest Blogger, er Transcriber 🙂

Beau Johnson DoJ lawyer: Neither the myelin basic protein nor the IGM neuro filament antibody test is diagnostic of any disease is that right?

Mumper: That’s correct.

Johnson: They are very nonspecific findings.

Mumper: That’s correct.

Johnson: And isn’t it true that these antibodies have been reported as elevated in normal individuals with no disease?

Mumper: That is true in some cases. Exactly.

Johnson: And because these markers were measured in the serum rather than the CSF they provide no direct evidence of what is going on in Colin’s central nervous system is that right?

Mumper: I guess I would quibble with how you get direct evidence, in this case in order to get direct evidence of neuroinflammation I guess we’d would really needed to have done a brain biopsy on him in 2002. I can tell you from personal experience that even wanting to look at CSF in children with autism for the presence of inflammatory markers is widely perceived as an invasive procedure. So those of us who might want to be able to document it more directly are constrained from doing so by standards of care criticisms. So we have to rely on other markers, and it’s not a direct marker but I would argue that a clinician would not have the ability to do a direct assessment in a living child.

Johnson: For whatever reason that evidence is just not present in this case, is that correct?

Mumper: That’s true

Johnson: Do you know what protocol Immunosciences used to perform these two lab tests?

Mumper: You know I don’t. I have visited the immunosciences labs on two occasions and talked to the director and viewed their facilities. But I am not a lab scientist. I can tell you that when I visited and had it explained to me it made sense at the time, but I could not reproduce the protocol.

Johnson: Do you know how Immunosciences established it’s references ranges?

Mumper: I do not know the details of that, no.

Johnson: Do you know whether these reference ranges take the age factor into account?…

Mumper: I do not think they are normed for children, but for things like neurofiliment antibodies and myelin basic protein antibodies the values for children would be expected to be less than people as they aged…

Johnson: But you don’t believe that these reference ranges are normed for children?

Mumper: I do not think that they are. That’s correct.

Johnson: Do you know if immunosciences lab ever been accredited by the College of American Pathologists?

Mumper: I do not know if they have. I do know that their work, their lab reports come disclaimers about use for research and careful clinical applicability and those types of things.

Johnson: Do you know if immunosciences is currently performing any clinical testing?

Mumper: I believe they are not.

Johnson: I’m going to show you what we’ve marked as respondent’s trial exhibit 14 and it is a letter that I found on the Immunosciences website.

Mumper: OK.

Johson: Doctor have you seen this letter before?

Mumper: Yes I have.

Johnson: And does this letter reflect that Immunosciences has in fact stopped performing clinical testing as of July 21, 2007?

Mumper: Yes, as i just testified to.

Johson: Do you know why it stopped performing clinical testing?

My understanding from talking to Dr. Vodjani and some health department officials, is that his lab was investigated for their testing as related to mold. Looking for mold evidence of chronic mold exposure as a potential cause of chronic illness. My understanding from Dr. Vodjani that the investigation was perhaps precipitated by a court case in which mold testing had been used and the plaintiff who had claimed damage from mold had won a huge settlement and the health department was concerned about the possibility of on the basis of that mold test and wanted to investigate the lab with regard to that.

Johnson: So its your understanding that the problems with Immunosciences lab were limited to its mold testing?

Mumper: That is my understanding, but I have not investigated all the depth of the investigation, nor read any of the official documents, so I really do not have full knowledge of that.

Johnson: I’m now going to show you respondents trial exhibit 15 which is another letter that I found on Immunosciences website.

Mumper: OK. Thank you.

Johnson: Doctor have you seen this letter before?

Mumper: I believe I have. Yes.

Johnson: Did you receive this letter since it is addressed to “Our valued clients and associates”? Was this sent to you?

Mumper: Yes.

Johnson: This letter is signed by doctor Vodjani?

Mumper: That’s correct.

Johnson: I believe you testified in May that you have an article in press (which has) Dr. Vodjani as the lead author?

Mumper: That is correct.

Johnson: Do you know what CLIA stands for?

Mumper: … I can’t remember…

Johnson: OK and just for the record it’s Clinical Laboratory Improvements Amendments of 1988 and we’ll just refer to it as CLIA for ease of reference.

Mumper: OK

Johnson: Do you know what CMS is?

Mumper: According to the letter it might be Centers for Medicaid and Medicaid Services?

Johnson: That’s correct. CMS regulates all laboratory testing on humans in the United States through CLIA in order to insure quality laboratory testing, is that right?

Mumper: Uhuh.

Johnson: Dr. Vodjani’s letter states in the third paragraph that “CMS had found deficiencies during a 2004 CLIA survey of Immunosciences that led it to conclude that the lab’s test results since 2002 may not be accurate and reliable.” Were you aware of those findings by CMS?

Mumper: Uhm, yes, since I got this letter.

Johnson: I’m not going to show you respondents trial exhibit 16. This is a letter from CMS. Doctor have you seen this letter before?

Mumper: Yes I have.

Johnson: Did you receive this letter?

Mumper: Yes I did.

Johnson: And this letter does in fact say at the beginning of the second paragraph on the first page that: We are writing both to inform you of the current sanction action and to alert you that test results that you received since June 2002 from Immunosciences lab might not be accurate or reliable. Is that what that says?

Mumper: I would like to add that… I did call Mary Jew as suggested in this last line. I can’t remember the details now, but I talked to three different people on the staff. I tried to get information about what particular concerns they had because I was trying to figure out for the labs that I had done on my patients if this were a global concern or if it was related to the mold or if there were tests that I was using that I may still be able to rely upon, and I was very frustrated in not being able to find out from those people who I think their hands were tied as far as talking about an ongoing investigation, what the problems were.

Johnson: We may be able to provide some of that information now. I’m going to show you now what is marked as respondents trial exhibit 17. And this is the CLIA annual laboratory registry from 2005. Have you seen this document before?

Mumper: No I have not.

Johnson: Look on page 5 of this document. Does this indicate that Immunosciences’ CLIA certification was being revoked due to condition level noncompliance?

Mumper: Uhm, cancellation of a approval to receive medicare payment due to noncompliance. Yes.

Johnson: Now I’m going to show you respondents trial exhibit 18. And these are actually excerpts from a much larger report. And this is the, a report from the survey that CMS did of this lab. … does that appear to be correct to you?

Mumper: Based on my thirty second review that does appear to be correct.

Johnson: If you’ll turn to the fifth page of the trial exhibit. This document lists a number of findings in connection with Immunosciences general immunology testing. Is that correct?

Mumper: It appears that that is correct.

Johnson: Were you aware that CMS noted problems at Immunosciences lab in connection with its failure to follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems in the pre-analytic systems?

Mumper: No I did not have access to that information.

Johnson: And were you aware that the CMS found that the laboratory
failed to determine calibration procedures and control procedures based upon established performance applications?

Mumper: No I was not aware of the specifics.

Johnson: And were you aware that the CMS found that Immunosciences laboratory failed to verify the continued accuracy of the test systems throughout the laboratory’s reportable range of test results? …

Mumper: … I was not aware of the specifics.

Johnson: And under sub paragraph I, the CMS found that the Immunosciences laboratory failed to establish the statistical parameters of the unassayed control materials used for it’s various in-house ELISA test systems?

Mumper: I was not aware of that.

Johnson: Ok and these findings all relate to Immunosciences general immune testing is that correct?

Mumper: It would appear that that is the case.

Johnson: And if you will look at the next to the last page of the trial exhibit. Were you aware that CMS found with respect to the anti MPB and neurofilament test in particular that Immunosciences failed to have written policies and procedures, for patient preparation, specimen collection, specimen storage and preservation, conditions for specimen transportation and specimen acceptability and rejection?

Mumper: And what was the date of that that it was not in place? Because it seemed to be on the website when you cited it earlier. And when we sent specimens in 2003 we were able to obtain written instructions about the specimens submitted, they came actually in the test kit.

Johnson: I believe this was from a survey from 2004 …

Mumper: What I was trying to explain to you that as a clinician the test kits came in a box, and there’re the tubes and a series of explanations about how the specimens need to be prepared. … So I can only testify as to what I know… we had procedures to follow when we submitted our blood samples in 2003.

Johnson: And all I’m asking you is that at the time that CMS performed this survey it found that those aspects of Immunosciences laboratory practice to be inadequate. Is that correct?
…

Johnson: Look at the last page of the trial exhibit…at the time it performed this survey with respect to the anti MPB and neurofilament test that Immunosciences failed to provide documentation the laboratory director’s review and approval for those procedures?

Mumper: It does suggest that there was no documentation to show his review and approval… so how much this was a matter of paperwork versus actual analysis, I can’t say.

Johnson: And Dr. Vodjani’s letter of January 16th, 2006 ,he indicates that Immunosciences had planned sue over the survey results.

Mumper: I believe he said he planned to vigorously fight or something to that effect …

(Special Master: And that was trial exhibit 15? …)

Johnson: We have a copy of the settlement agreement from that lawsuit it’s been marked as respondents trial exhibit… Focusing on paragraphs 1, 2 and 3. …

Mumper: OK

Johnson: It appears that one of the conditions of the settlement that Immunosciences would obtain accreditation through the College of American Pathologists or else it would voluntarily withdraw from the CLIA program and cease testing on human specimens, is that correct?

Mumper: That does seem to be the case.

Johnson: Based on the fact that Immunosciences is no longer performing clinical testing, isn’t it reasonable to assume that they did not receive accreditation through the College of American Pathologists…

Mumper: (interrupting) or that they chose not to pursue it I would think would be the two possibilities.

Johnson: Doctor based on this information do you have any concerns about the reliability of the Immunosciences test results?

Mumper: I was not aware that the MBP or neurofilament testing was under contention, and if that were the only thing that I was relying upon to make my judgement I would be concerned that I had over-read the labs. I would give relatively less credence or perhaps even be forced to discount those particular lab tests given  the information in the settlement agreement that I wasn’t privy to knowing the details of.

Johnson: The next test results that you discuss in your report are results from Great Smokies lab that purport to show abnormal glutathione, lipid peroxide and cysteine levels.  Is that correct?

Johnson: … That would have been when Colin was about 3 1/2 years old… So to the extent that these results indicate anything about whether Colin was under oxidative stress at the time … they don’t tell us if he was in oxidative stress at the time of his immunizations. Is that correct?

Mumper: That’s correct.

Johnson: These tests were blood tests is that correct?

Mumper: That’s correct.

Johnson: Do you know if these tests were normed for children?

Mumper: I do not know the answer to that question.

Johnson: And as you note in your report a number of other factors can explain oxidative stress such as poor nutrition. Is that right?

Johnson: Would you agree that a mercury efflux disorder is still a hypothesis at this point

Mumper: Yes.

Johnson: So low cysteine and plasma sulfate levels can’t be diagnostic of that disorder..

and those levels can be explained by a number of other factors is that right?

Mumper: That’s correct.

Johnson:… I’d like to go through all the mercury testing if you don’t mind.

…

Mumper: It would appear that 4-19-02 was the time of the very first visit to Dr. Bock. So there is not evidence that he would have been on a chelating agent at that time.

Johnson: And the result for this test of mercury was that it came back the non-detectable limit … Is that correct?

Mumper: Right.

Johnson: The next test that we found was the December 2002 test and that was a urine toxic metals test… although the report says that there was a chelating agent administered, you don’t believe there was, is that correct?

Mumper: Yes that’s correct.

Johnson: and the result shows no detectable mercury.

Mumper: Yes that’s correct.

Johnson: and the result shows no detectable mercury.

The next test was the December 22, 2002 …The next test was the December 22, 2002 test which is at petitioner’s exhibit page 90 and … this was post provocative test … and this test result showed that mercury was at 17 mcg per gram of creatinine. Is that correct?

Mumper: That’s correct.

…

Johnson: And the report indicates that DMSA was administered in connection with this test … and again the result from this test for mercury was nondetectable. Is that correct?

Mumper: That’s correct.

…

Johnson: There’s only test that showed mercury outside the reference range is that correct?

Mumper: That’s true.

The next test was the December 22, 2002 test which is at petitioner’s exhibit page 90 and … this was post provocative test … and this test result showed that mercury was at 17 mcg per gram of creatinine. Is that correct?

Mumper: That’s correct.

…

Johnson: And the report indicates that DMSA was administered in connection with this test … and again the result from this test for mercury was nondetectable. Is that correct?

Mumper: That’s correct.

…

Johnson: There’s only test that showed mercury outside the reference range is that correct?

Mumper: That’s true.

Johnson: And that was the provoked test from December 22, 2002. … Doesn’t Doctor’s Data say in bold right on the test report that reference ranges are representative of a healthy population under non-challenged or non-provoked conditions?

Mumper: That’s true.

Johnson: So we just don’t know what the normal range would be for a provoked test. Is that right?

Mumper: It is difficult to know…

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