Archive | News RSS feed for this section

Fax to Katie Couric

4 Aug

As you may have guessed if you’ve been reading this blog lately, the recent CBS story on the independence of vaccine supporters bothered me.

It bothers me that a news organization I grew up with would act the way they have.

Today I sent a fax to Katie Couric at CBS.  The text is below:

August 4, 2008

Katie Couric, Managing Editor
CBS Television Network
524 West 57th Street
6th Floor
New York, NY 10019-2902

VIA FACSIMILE

Dear Ms. Couric,

It is with great dismay that I, a parent of a young child with autism, have watched the ongoing series on autism by Sharyl Attkisson. This series’s angle was illustrated in her interview with Dr. Healy, which was tainted by the unfounded statement, “There is a completely expressed concern that they don’t want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people.” I feel a good journalist would have asked for Dr. Healy to support this statement. Given the stakes involved, that would be the minimum required before airing it.

I expect you will not be surprised that I also have concerns over the recent piece questioning the independence of vocal supporters of vaccines. In particular, the part discussing Dr. Paul Offit was lacking in facts and in real analysis of those facts .

A) The statement by Dr. Offit that a child can theoretically handle 10,000 vaccines at once was made, but with no discussion. This is often quoted out of context by Dr. Offit’s detractors, intended to create the impression that his views are somehow extreme. Nothing could be farther from the truth: the statement shows the minimal demands that vaccines make on the immune system, even that of a young infant. In fact, given the number of immunological challenges in the human environment, children do receive the equivalent of thousands of vaccines every day. Dr. Offit’s statement is also not a mere opinion: it is based on calculations he has performed and published in the peer reviewed literature. No one has published a paper showing this calculation to be false or exaggerated in any way.

Given that, I would ask that if CBS wishes to present this statement in the future, they either discuss it in context or, should CBS disagree with Dr. Offit’s analysis, present a reasoned discussion of why they disagree.

B) The statement that Dr. Offit holds an endowed chair joint with the University of Pennsylvania School of Medicine and the Children’s Hospital of Philidelphia (CHOP) was presented as a potential conflict of interest, because much of the funding for this chair came from Merck. (Unreported by Ms. Attkisson was the fact that CHOP supplied the rest of the endowment.) As stated, it implies that this is some form of a grant, giving Merck leverage over Dr. Offit. Those of us familiar with academia know that the opposite is true: the endowment is a gift to the University, not to the individual who holds the chair, and the donor (Merck in this case) retains no control over the disbursement of funds. The recipient of the chair is chosen in a competitive process. Thus, the holder of the chair is fully independent – both of any obligation to the donor and of the continuing obligation to cover one’s salary with research grants. Ms. Attkisson’s piece implied exactly the opposite.

C) It was noted that future royalties from Dr. Offit’s patents have been sold for $182 million. First, it is worth noting that Dr. Offit and his co-inventors do not “hold” the patents, but assigned the rights to their institutions: the Wistar Institute and the Children’s Hospital of Philadelphia. These are the groups which have negotiated the sale of future royalties. Second, it is worth noting that this sale of future royalties means that whatever statements Dr. Offit makes about vaccines can no longer have even the possible influence on his finances implied by the story.

I will not discount the fact that Dr. Offit likely has benefited financially from his efforts to produce a vaccine. Frankly, I hope he did. His vaccine saves lives throughout the world. But, the point for this discussion is that the value of these financial gains has already been determined.

Of note is the fact that no other patents or patent applications are published at present. His laboratory is closed down. Thus, there is no future vaccine which could present a possible conflict of interest for Dr. Offit.

Given these facts, what we have is a scientist who has over 25 years’ experience researching vaccines and infectious diseases, and has no financial conflicts of interest in the present or future. Isn’t this exactly what we want in a spokesperson?

This is a key point. The reason why Dr. Offit is being targeted in some quarters is that he has a book about to be published, “Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure.” Not only is it obvious that non-mainstream autism organizations like Generation Rescue would like to defuse the impact of this book before it hits, but leaders of the organization have baldly stated their plans to attempt to discredit Dr. Offit and the findings revealed in the book. The fact that Dr. Offit is willing to face their attacks, with no prospect of personal gain, bespeaks a purity of intent, not only in this venture, but also in his past statements about vaccines.

The recent incident whereby a fax from Lisa Randall of Voices For Vaccines was given within hours to Generation Rescue, an organization outside of CBS, begs the question: what is the connection between Ms. Attkisson or members of the CBS News staff and Generation Rescue? This is a serious question which I hope CBS News publicly addresses.

It also seems appropriate to ask in closing: Does Ms. Attkisson or other members of the CBS news staff involved with these stories have any conflicts of interest, real or potential, in discussing autism and/or vaccine injury? Again, I would hope that CBS News would publicly address this.

CBS made a highly unprofessional decision in sharing the fax from Ms. Randall with Generation Rescue, an organization which insults, smears and attempts to intimidate those with whom they disagree. This is unfortunate, because I would like to demonstrate the fact that I have no ties whatsoever to the pharmaceutical industry by giving my full identity. Instead, I will sign simply:

Sullivan
Autism Parent
LeftBrainRightBrain.co.uk
SullivansJourney@gmail.com

Sharyl Attkisson is slowly catching up to Neurodiversity.com and Arthur Allen

2 Aug

Sharyl Attkisson has posted yet another in her series on vaccines in autism.

It’s the first time we know of that the government has “conceded” an autism case in vaccine court. But CBS News has learned the government has previously been court-ordered to pay on other vaccine injury cases in which a child ended up with damage including autism or autistic symptoms.

And then discusses the case involving a child with Tuberous Sclerosis (TS).

Sharyl Attkisson would do well to read (if she hasn’t already) the Neurodiversity.com blog where previous cases. In specific, the post “a not so hidden history“. One of the cases there, Suel v. HHS involves a child with TS and autistic symptoms. While the case Ms. Attkisson is discussing appears to be a different one (from 1986), it uses the same expert witness (Gomez).

Will Ms. Attkisson now “discover” the other cases of compensated vaccine injury involving people with autism or autistic symptoms?

Maybe in her extensive research she missed Arthur Allen’s piece on the same subject? He cleverly hid it under the title “Recent Vaccine-Autism Award Not the First“.

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.

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.

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…

Michael Savage – bottom lip trembling

22 Jul

The Michael Savage autism saga carries on as he issues a whiny please to ‘please don’t judge me’.

I grabbed his latest whine so you don’t have to visit his site. As I said, he starts off with a plea (you can almost hear the tears in his voice) not to rush to judge him. In my view, you should judge him. I know I do.

He then goes on to say that the _truly_ autistic child (apparently there are no autistic adults) – that 1% of all diagnosed autistic people that is left over from Savage’s 99% of fakers – need as much help as they can get. I would agree with that included in that help they need to be shielded from ultra-stupid cowards who don’t even have the balls to stand by their self professed opinions for a week.

He then goes on to say that its the falsely diagnosed, the misdiagnosed and the outright fakers (???) – the 99% of all autistic people in Savage’s opinion if you recall – who need to be ‘found out and turned out’ so that the money can go to the right people. A direct quote:

that was the essence of my conversation last week

Uh, no it wasn’t. You said (and I quote) that autism was:

a fraud, a racket……What do you mean they scream and they’re silent? They don’t have a father around to tell them, ‘Don’t act like a moron. You’ll get nowhere in life. Stop acting like a putz. Straighten up. Act like a man. Don’t sit there crying and screaming, idiot.’

My autistic child screams and is silent. If you came round to my house and call xyr an idiot, I’d kick your arse square. You sell T-shirts on your website that read ‘Peace through superior firepower.’ I therefore judge you to be a person who respects violence. I also wager (and feel free to come and discuss it in person) that my foot is harder than your arse.

You then ask, rhetorically, ‘why would I chose to attack defenceless children, when I have never done so in my life?’ Only you know the answer to that, but I would imagine the word ‘ratings’ have quite a lot to do with it. But I think this time it has bitten you on the arse, coward. You have firmly established yourself as a ‘man’ who _does_ attack children. Disabled children at that.

Savage seem to be one of these new type of celebs that have sprung up in both the US and my country – famous for having a big mouth and little substance to go with it. After all, scum floats on the top. Personally, I think these are the people who should be found out and turned out.

Happy Birthday Katie

22 Jul

Today, Katie McCarron should have been six. Just about three years older than my youngest and two years younger than my oldest pair of girls.

Its still difficult – impossible – to think of Katie without thinking that in a fair and just world, we would never have heard of Katie and she would be just another little girl, one amongst billions, anonymous and safe.

I know that Katie’s family will be going to her grave today and so I ask you that, if you are the kind of person who prays to pray hard for them. They must go through the pain soon of an appeal hearing as Katie’s killer seeks once more to escape her responsibilities. If you not the sort who prays, then send them good thoughts.

If you look on the home page of this site you will see a pink ribbon on the left hand side. This is my best graphical representation of the pink ribbon, chosen by Kassiane and worn by the McCarrons every day of the killers trial and by me too during those days as Mike and Paul brought some over to us when they visited us last year. Please click that ribbon for photographs of Katie. Remember her.

There is also a memorial grove where you can donate money for a grove of trees for Katie. Her dad and grandad visited the grove and saw the young living saplings that her life had inspired to be planted. They grow wild and free, as should a little girl from Illinois in whose memory they thrive.

David Kirby vs Accuracy

20 Jul

As I’ve said before, I like David Kirby personally. We exchange friendly emails. We even recently discussed the idea of having a private blog – readable by all but one that allowed only two posters (David and I) and no commenters. This would, I suggested, give us the opportunity to have a civil debate.

Unfortunately, David was too busy, which was a shame. However, the offers always open should he find a bit more time.

He did have time yesterday to blog a piece for the Huffington Post in which he discussed Amanda Peet and said she was ‘against the medical establishment’ for taking the stance she did. He cited a few things to support his point. I’d like to discuss these things but before I do I’d like you Dear Reader to take note: someone who was at the IACC meeting David talks about (he wasn’t there) will hopefully be posting their account of proceedings on LB/RB.

Anyway. Lets proceed. David’s first piece of rhetoric to support the idea Amanda Peet was against the medical establishment was:

A workgroup report of the IACC (the Interagency Autism Coordinating Committee, which includes HHS, CDC, NIH and others) says that some members want “specific objectives on vaccine research” included in the new, multimillion-dollar national autism research program, as mandated by Congress in the Combatting Autism Act.

I’m sure that some members do want this. Lynn Redwood and Mark Baxhill to be precise. As the upcoming IACC account will show, I don’t think any other IACC workgroup members were interested. (Please see this correction of an ignorant Limey’s take on the US system.)

I would also like to correct David on his characterisation of the Combating Autism Act. The Act contains no mention of vaccines. It specifies environmental research but the words ‘vaccine’, ‘vaccination’ ‘immunize’, ‘immunization’, ‘mmr’ or ‘thimerosal’ appear nowhere in the CAA. I hope David will correct his HuffPo piece accordingly.

Notes from the meeting indicate that workgroup members want federal researchers to consider “shortfalls” in epidemiological studies cited as proof against a vaccine-autism association (by Offit, Peet, et al); as well as a specific plan “for researching vaccines as a potential cause of autism.” The workgroup also says that the final research agenda should “state that the issue is open.”

Once again, David’s notes are coming from two people, Lynn Redwood and Mark Blaxill and indeed – they asked for all these things. The account of the meeting I have heard (from someone who was there) differed somewhat. As a flavour of how much the majority of the working group listened to Redwood and Blaxill, I enclose a teaser quote from chairperson Tom Insel:

“Lyn, your community is not the whole community and there are many people with well thought out concerns about ethics of the concept of prevention and if we want to be inclusive we will not do this.”

Back to David:

July 14, 2008 – Rep. Brad Miller (R-NC), Chairman of the House Subcommittee on Investigations and Oversight, (Committe on Science and Technology) writes to HHS Secretary Michael Leavitt to complain that current federal autism research “shows a strong preference to fund genetic-based studies,” even though there is, “growing evidence that suggests a wide range of conditions or environmental exposures may play a role” in autism.

I blogged that episode here. Suffice it to say that a _politician_ is not representative of the medical establishment. I would urge everyone reading this to read that piece as it suggests amongst other things that Generation Rescue and SafeMinds be responsible for a Board that would serve as a liaison between the IACC and parents of autistic people and autistic people themselves!. After reading that I would urge everyone to contact the following people to express your thoughts (politely!) to the decision makers:

HHS Sec Mike Leavitt (mike.leavittAThhs.gov)
NIMH director/IACC director Tom Insel (tinselATmail.nih.gov)
Everyone here: http://science.house.gov/about/members.htm

Once again, back to David:

Dr. Bernadine Healy, former head of the NIH and the American Red Cross and current Health Editor of US News & World Report tells CBS News that, “Officials have been too quick to dismiss the hypothesis as irrational,” and says they “don’t want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people.”

I still can’t get over the fact that David is using this person to back up his points! He continues to trumpet the opinion of Bernadine Healy who actually did assert that cigarettes do not cause cancer and worked closely with Philip Morris to do so. She also totally reneged on her stance on fetal tissue research when she found herself in the same camp as President Bush. In AoA language she’s a shill.

David then goes on to cite al three Presidential Candidates – as if a politicians opinion in an election year means anything! I definitely fail to see what any of them have to do with being part of the medical establishment.

Onwards:

March 29, 2008 – Dr. Julie Gerberding, Director of the CDC, speaking about the Hannah Poling case on CNN says: “If a child was immunized, got a fever, had other complications from the vaccines, and was pre-disposed with the mitochondrial disorder, it can certainly set off some damage (including) symptoms that have characteristics of autism.”

Er, so? I’m really not sure how this is a ‘point’ for David (or anyone else who thinks its supportive of the idea vaccines cause autism). If she’d said ‘yes, vaccines caused autism in Hannah Poling’s case’ (which no-one ever has by the way, despite statements to the contrary) than _that_ would be a bombshell. As it was Dr. Gerberding was simply speaking what is obvious.

David again:

The CISA Network (Clinical Immunization Safety Assessment), headed by the CDC, receives a report from top researchers at Johns Hopkins University that 30 typically developing children with mitochondrial dysfunction all regressed into autism between 12 and 24 months of life. At least two of them (6%) showed brain damage within one week of receiving simultaneous multiple vaccinations.

Now, I can’t answer this as much as I’d like to. I have spoken to people involved in the preparation and writing of this report (as has David) and I was given two take home points from our email chat:

1) The science is _not yet complete_ . The paper is not published.
2) The authors feel ‘disappointed’ in the slant David has put on their work and are loth to discuss it with anyone else due to that. I was told that David might be rather surprised when everything comes out later in the year.

David once more:

Medical Personnel at HHS concede an autism case filed by the family of Hannah Poling in the federal Vaccine Injury Compensation Program, before the claim can go to trial as a “test case” of the theory that thimerosal causes autism. Though portrayed by some (ie, Dr. Offit) as a legal decision, it is in fact a medical decision. HHS doctors admit that the “cause” of Hannah’s “autistic encephalopathy” was “vaccine-induced fever and immune stimulation that exceeded metabolic reserves,”

First of all, I beg to differ with David. The concession was a legal one. By definition the phrase “autistic encephalopathy” does not exist in mainstream science so if it was used (a fact which has yet to be determined – I invite David once more to link through to the document where this is stated). A simple test of its non-existence is to search for the phrase on PubMed. I got:

Quoted phrase not found.

So we have a multitude of uncertainties here:

1) Nowhere (except in David’s writings) can we find evidence of HHS apparently saying “autistic encephalopathy” caused Hannah Poling’s autism.

2) The phrase itself (“autistic encephalopathy”) does not appear in the entire PubMed database, thus causing me to doubt its use by the medical establishment.

3) Is the concession legal or medical? If a diagnosis does not exist but is used in a legal document then by definition it must be legal – thats my opinion anyway.

David also mentions a HHS Vaccine Safety Working Group meeting but I know next to nothing about that so can’t comment.

I have to say that based on the above, David seems to be attempting nothing more than an intellectual ‘land grab’ i.e. to attempt to paint those who claim vaccines cause autism as part of the medical establishment and those who stand against them as not. Its a good political idea but I don’t think its going to work. There are just too many holes in this particular boat for it to float for long.

← Older Entries
Newer Entries →