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Vaccines on the Hill part 2

25 Sep

We recently discussed the Malony briefing where she hosted David Kirby and Mark Blaxill in a discussion of autism and vaccines. As part of that post, I included a letter from Amy Pasani of Every Child By Two.

On a hunch, I checked with another organization, Voices For Vaccines, to see if they had contacted legislators. Lo and behold, they did:

Dear Senator or Representative:

The organizers of a briefing being held later today have listed your office as one from which a staff member will be in attendance. I would like to supply some information which may place the content of the briefing in context.

Today’s event, sponsored by Rep. Carolyn Maloney, will feature Mr. David Kirby and Mr. Mark Blaxill speaking on the claim that vaccines cause autism. This is a notion which is not supported by scientific evidence. It is also one that has been recognized by the mainstream medical community as posing a threat to the health of Americans.

I am attaching an Open Letter to Congress, issued last June, in which 84 national, state, and local organizations emphasized their support for immunization as a cornerstone of United States public health, and made clear their desire for Congress to follow a sound, evidence-based course in evaluating legislation related to vaccines. As you are undoubtedly aware, this year brought a sharp upswing in cases of measles, most of which were associated with importation of the virus by unvaccinated individuals. These outbreaks reflect vaccine reluctance borne of misplaced fears. The agenda for today’s briefing indicates that it will fan, rather than quell, those fears.

While the presenters will no doubt couch their claims in scientific-sounding language and the rhetoric of impending doom, you can rest assured that no new information has emerged to lead credible scientists to raise concerns about vaccine safety. The popular concept of an “autism epidemic” is largely, if not wholly, an artifact of diagnostic shifts and a broadened definition of autism. There has been no government concession that vaccines cause autism, only that they might have hastened the appearance of autistic-like features in one Vaccine Injury Compensation Program claimant. What autistic people need and deserve is funding for legitimate research and programs that will improve their quality of life — not distractions that squander resources and promote panic.

For further information on these topics, I recommend the following sites:

Centers for Disease Control and Prevention – Autism http://www.cdc.gov/ncbddd/autism

Centers for Disease Control and Prevention – Immunization http://www.cdc.gov/vaccines

American Academy of Pediatrics – Autism http://www.aap.org/healthtopics/autism.cfm

American Academy of Pediatrics – Immunization http://www.aap.org/healthtopics/immunizations.cfm

Vaccine Education Center, Children’s Hospital of Philadelphia http://vaccine.chop.edu

Best regards,

Lisa H. Randall, J.D.
Interim Executive Director
Voices For Vaccines
325 Swanton Way
Decatur, GA 30030
http://www.voicesforvaccines.org

If the reaction to Ms. Pisani’s letter is any guide, one sentence in the letter above will be particularly targeted by some vaccine-autism advocacy groups:

What autistic people need and deserve is funding for legitimate research and programs that will improve their quality of life — not distractions that squander resources and promote panic.

Some may complain about that, but not me.

Keeping the theme used for the previous post, I’ll close with this statement:

Why reproduce the Lisa Randall’s letter here? Because many in the greater autism community agree with Ms. Randall. This blogger certainly does. I hope that legislators know that members of the autism community side with Voices for Vaccines on this subject.

Vaccines on the Hill

25 Sep

With a hat-tip to Kim Stagliano at the Age of Autism blog. They got ahold of an email sent by Amy Pisani of Every Child by Two to legislators who were sending staffers to a briefing by Mark Blaxill and David Kirby on vaccines and autism.

Mr. Kirby promised to talk about, amongst other topics, Hannah Poling. That’s not what I would call a good briefing. A good briefing would be if the legislators asked HHS to talk to them about what the concession meant. Somehow, I think the two briefings would be significantly different. Then again, I suspect a briefing by the doctors who are studying that potential cause of developmental regression via mitochondrial dysfunction would also have a very different story to tell than Mr. Kirby. I strongly suspect that.

But, I digress, as I often do. You see, Every Child by Two thought that the legislators who were sending staff to the Kirby/Blaxill briefing should be informed that the information provided by that team was, well, not accepted by the mainstream.

The letter, respecfully written, respectfully submitted is quoted below. One reader of this blog asked Ms. Pisani for permission to reproduce it here. I am using the text from the AoA blog.

Why reproduce it here? Because many in the greater autism community agree with Ms. Pisani. This blogger certainly does. I hope that legislators know that many members of the autism community side with Every Child by Two on this subject.

So, after much delay, here is something written much better than the ramblings I’ve put together:

Today you have been invited to attend a briefing to provide “updates on the recent autism-vaccines debate”. While I recognize that most of you will likely be dealing with other priorities and will not attend the Maloney briefing, I write to you this morning because I feel it is critical to clarify that there is no debate among the scientific community regarding vaccines and autism. Instead, the debate rages on in the media due to the efforts of those who wish to sidetrack critical research away from finding the true cause(s) of autism and treating children and their families struggling with this condition.

‘Last week Dr. Paul Offit’s new book “Autism’s False Prophets, Bad Science, Risky Medicine, and the Search for a Cure” was published by Columbia University Press. This book is a must read for all those concerned with children dealing with autism. The Philadelphia Inquirer writes that “Offit’s account, written in layman’s terms and with the literary skill of good storytellers, provides important insight into the fatal flaws of the key arguments of vaccine alarmists, including such well-known names as Robert F. Kennedy Jr., Sen. Joseph Lieberman (I., Conn.), and Sen. John Kerry (D., Mass.).” And the Wall Street Journal writes “Ever since psychiatrist Leo Kanner identified a neurological condition he called autism in 1943, parents whose children have been diagnosed with the most severe form of the illness — usually in the toddler stage, before age 3 — have found themselves desperately searching for some way not to lose their children to autism’s closed-off world. Unfortunately, such parents have often found misguided doctors, ill-informed psychologists and outright charlatans eager to proffer help.”

In 1999 I was pregnant with my first son just as the questions first arose regarding the MMR vaccine and subsequently the thimerosal in vaccines. After attending Congressman Burton’s hearings (quite pregnant I might add) I too became alarmed. Fortunately, as the Executive Director of Every Child By Two I had at my disposal the scientific research and advice of the world’s leading experts on vaccines and I was able to confidently vaccinate my son without fear of side effects. As of today, eleven studies now show that the MMR vaccine doesn’t cause autism, six have shown that thimerosal doesn’t cause autism, and three have shown thimerosal doesn’t cause neurological problems.

I urge you to read a few of the reviews of Dr. Offit’s book which are listed below and contact us if you wish to have a copy sent to you.

I also ask that you please visit our new website www.vaccinateyourbaby.org – this site was unveiled in August with our new spokeswoman Actress Amanda Peet specifically for parents who have questions about vaccine safety.

at the risk of making this an extremely long blog post, let me do what the Age of Autism did not do: list some of the reviews of the book.

A definitive analysis of a dangerous and unnecessary controversy that has put the lives of children at risk. Paul A. Offit shows how bad science can take hold of the public consciousness and lead to personal decisions that endanger the health of small children. Every parent who has doubts about the wisdom of vaccinating their kids should read this book. — Peter C. Doherty, Ph.D., St. Jude’s Children’s Research Hospital and Nobel Laureate in Medicine for fundamental contributions in Immunology

As a parent it is my job to protect my children. Hearing all the rumors about vaccine side effects made me question the right thing to do. This book makes it clear that vaccines save lives, and that they clearly do not cause autism. — Amy Pisani, mother

In his latest book Paul A. Offit unfolds the story of autism, infectious diseases, and immunization that has captivated our attention for the last decade. His lively account explores the intersection of science, special interests, and personal courage. It is provocative reading for anyone whose life has been touched by the challenge of autism spectrum disorders. — Susan K. Klein, MD, Ph.D., Case Western Reserve Hospital, and Rainbow Babies and Children’s Hospital, Case Medical Center

No one has been more vocal-or courageous-than Paul A. Offit in exposing the false and dangerous claims of the growing antivaccine movement. Offit’s latest book lays waste to the supposed link between autism and vaccination while showing how easily Americans have been bamboozled into compromising the health of their own children. Autism’s False Prophets is a must read for parents seeking to fully understand the risks and rewards of vaccination in our modern world. — David Oshinsky, winner of the Pulitzer Prize in History for Polio: An American Story

All good reviews. But, dang, a Nobel Laureate in Medicine. Not just medicine but immunology? Plus a Pulitzer prize winner? Begs the question of why the Age of Autism didn’t include them.

I am so glad that they offered Dr. Offit’s book to the legislators. I hope that the legislators, or their healthcare legislative assistants take them up on the offer. It’s a well written book, and fairly concise. It really explains how we (the autism communities) got here (into a big mess where vaccines are such a high profile subject–at least in the media) even though we shouldn’t be (because the science has been done repeatedly and shown no link).

Word back on the briefing is that about 75 people attended–a mix of staffers, parents, possibly even a member of the press. One representative was noted. Mr. Kirby gave the short version of his talk (the full version is quite long–take a look at his power point presentations sometime!). But, we can all rest assured that Mr. Kirby is there to save the vaccine program (I do hope that autism-one puts this briefing on their website. I need to hear that claim by Mr. Kirby with my own ears). Mr Blaxill took on the “sickest generation ever” theme, common to the vaccine rejectionists (a claim that has been addressed ably by epiwonk).

But, again, I digress. Let me bring you back to what I see as the one message I think you should take home from this post (repeated from above):

Why reproduce it [Ms. Pisani’s letter] here? Because many in the greater autism community agree with Ms. Pisani. This blogger certainly does. I hope that legislators know that many members of the autism community side with Every Child by Two on this subject.

Whilst Mother Warrior McCarthy Oprahed…

25 Sep

David Kirby, who recently had a puzzling and somewhat inexplicable spat with Dr Rahul Parikh was carrying the torch for the male contingent of the autism/antivax crusaders along with Mother Fu…sorry..Worrier Dad…sorry…chief of the quackosphere (term not coined by me but too good not to use) Mark Blaxill at a meeting set up by a political person called Maloney in Washington.

It reminded me quite a lot of the meeting David tried to have with MP’s and Lords over here in June. Then, nobody showed except my MP who I asked to attend to protest on my behalf. What would happen this time?

Well, according to David himself 135 people showed up including 2 US Reps in person (these are the people David wanted to speak to. If I’m right, the event organiser, Carolyn Maloney is a Congresswoman in the House of Reps so, if thats true, there was really 1 US rep other than her) 58 Reps sent staffers (staffers are bottom feeders sent by people who can’t – or don’t really want to – make it. Like glorified gophers.) and 30 Senators sent staffers. So that’s 90 politicals (of whom – lets be honest – only 2, possibly 1, actually count).

Other people there included AAP, CDC, FDA etc.

Anyway, AoA posted two images of the event:

Now, is anyone else looking at those pictures and thinking ‘135 people? Really?‘. It reminds me a little of the odd maths that resulted in an attendance of 8 – 10,000 at the green our vaccines rally.

This event is trumpeted at AoA as ‘standing room only’. Really? Because I can count quite a lot of available sitting room in those photos. Maybe a thought for next time would be to not exaggerate your claims and then post photographs that contradict them.

There was also a very interesting comment left on AoA by a guy called David Atkinson who said:

I happen to be in town on business and I just came back from this meeting. It was a pretty small room but yes it was packed. I am guessing about 50-70 were there. From the looks of it, most were staffers and there were a few parents like myself. I know there were at least 2-3 senators and I am not sure how many if any representatives. David presented very well as usual and then Mark added his piece as well. After this, there were questions taken from the staffers. There were a few pointed questions. I felt that they were quite divisive and loaded questions. This was really dissapointing to me. Mark did a great job at defending and taking these questions on. I was quite impressed with his eloquence as I would have probably killed the snotty little staffer that was quesioning Davids slides. Overall it was a useful meeting. However, for me who doesnt participate in this type of thing very often, I dont feel it was hugely impactful. It didnt seem like this meeting will be any type of game changer for our community but I am a rookie at this. Hopefully I am wrong on that. Great job to David and Mark. I am more inspired now to try to be more active and help out……I would like to help more in future.

Looking at the photos, I would agree with Atkinson that there were about 50 – 70 people there. I would also agree that this not much of a game changer.

Anyway, I guess 1 or 2 US reps is better than the zero that turned up in London. To me though its just growing evidence to support my view that the autism/vax ideas have truly jumped the shark. Anti-vaccine related deaths in the UK, hundreds of anti-vaccine related hospitalisations in the US and ever growing studies showing no association get the message across.

Salon – Inside the vaccine scare

22 Sep

Salon redeems itself from producing what Orac at the time called biggest, steamingest, drippiest turd ever dropped on the web.

Three years ago Salon published the notoriously innacurate ramblings of RFK Jr. After uproar in the web science community and numerous fixes and amends to the original piece, what was left was still an awful piece of credulous rubbish.

It seems that Salon learnt their lesson. This time, they have ensured that the person talking about vaccines and autism is a _scientist_ as oppose to a crowd-pleasing politician.

Rahul Parikh has published a review of Paul Offit’s Autism’s False Prophets which differs so wildly from the RFK Jr debacle that its almost impossible to think of them being in the same publication.

I don’t want to do a review of a review as that would be bizarre and unnecessary but Parikh makes some key points that I want to address. The first one is the way the book starts.

Early in Dr. Paul A. Offit’s new book, “Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure,” he describes a threatening letter he received from a man in Seattle. “I will hang you by you neck until you are dead!” it read. The FBI deemed the threat credible, assigning Offit a protective officer who, for the next few months, followed him “to and from lunch, a gun hanging at his side.” He then recalls a suspicious phone call from a man who recited the names of Offit’s two children and where they went to school: “His implication was clear. He knew where my children went to school. The he hung up.” These days, the hospital he works in regularly screens his mail for suspicious packages.

Such stories usually come from pro-choice physicians on the front lines of the abortion debate. But Offit is no obstetrician. Rather, he is a baby doctor — the chief of pediatric infectious diseases at the Children’s Hospital of Philadelphia. The threats against him and his family have come not from antiabortion advocates, but rather from anti-vaccine crusaders who believe that vaccines cause autism. Offit, it turns out, has been targeted by them because he helped to develop a vaccine that prevents rotavirus, a serious gastrointestinal infection in children, and because he has been staunchly pro-vaccine in a time when there are many doubts about their safety.

It is amazing that we should be in a situation where a doctor who is actively saving lives is being targeted for that very fact. What is even more amazing is the fact that the very antivaxers who hate Offit so much simply don’t believe he _is_ being targeted. A few comments from Lisa Jo Rudy’s piece on Offit’s book illustrate this perfectly:

It’s very hard to judge the seriousness claims like Offit’s….

Mark Blaxill, Safe Minds.

I have heard Dr. Offitt make his claims of threats, etc. on more than one occasion. But I have never seen any real evidence of those alleged threats.

Wade Rankin, autism/antivax blogger

I would suggest that a reference to the possibility that some agency or company would harm one’s children in the future could be construed and repeated as a “threat” to one’s children if that threat would help to garner sympathy and label an opposing side as nuts.

Mike B

An amazing reaction. They genuinely hate Paul Offit so much that they think he is making up threats made to his children. And they think he’s doing it to ‘garner sympathy and label an opposing side as nuts’. This is the type of denial and refusal to see their own shortcomings that has led to the sorry state of autism/vaccine science in the first place.

Parikh also documents the reality of the science today and the reality of how the wider world views the autism/anti-vaccine community.

Despite what Wakefield claimed in his paper, his hospital’s ethics committee never approved his experiments to put children to sleep under general anesthesia, do spinal taps on them, take biopsies of their intestines (one of the children was hospitalized after his colon perforated in several places) and take volumes of blood from their veins. Deer also discovered serious conflicts of interest: Wakefield’s research was secretly bankrolled by a personal injury lawyer whose clients were suing MMR makers. Wakefield himself was given close to a million dollars to prove that the MMR caused autism. He had filed a patent for a new MMR vaccine at the same time he was doing his research. Upon learning this, Lancet retracted his paper, and he was charged with professional misconduct in 2005. If he is found guilty of misconduct, he will never practice medicine in the U.K. again.

The people in the autism/anti-vaccine community see Wakefield as a persecuted hero. Everyone else in the entire world who takes an interest in the matter sees him as a weak man who tried to game people – and did. Possibly he still is.

This level of disconnect between what those in the autism/antivax community see as the reality and the _actual_ reality is sometimes shocking. Even for me who has been in the front line of this debate for five years now, some of the things I read about and see from these people make my jaw drop.

I blogged about an example of this not long ago when Safe Minds Board Member Heidi Roger stated that Polio could be preferable to autism – and even that death could be better than autism.

This is a sadly far from uncommon opinion amongst a certain type of autism/antivax believer. To sum up their personality type would, I think, bring a sizeable minority of them very close to Munchausen syndrome by proxy/ Fabricated or induced illness , the indications of which seem very familiar to me from reading the Yahoo groups over the last few years:

* A child who has one or more medical problems that do not respond to treatment or that follow an unusual course that is persistent, puzzling and unexplained.
* Physical or laboratory findings that are highly unusual, discrepant with history, or physically or clinically impossible.
* A parent who appears to be medically knowledgeable and/or fascinated with medical details and hospital gossip, appears to enjoy the hospital environment, and expresses interest in the details of other patients’ problems.
* A highly attentive parent who is reluctant to leave their child’s side and who themselves seem to require constant attention.
* A parent who appears to be unusually calm in the face of serious difficulties in their child’s medical course while being highly supportive and encouraging of the physician, or one who is angry, devalues staff, and demands further intervention, more procedures, second opinions, and transfers to other, more sophisticated, facilities.
* The suspected parent may work in the health care field themselves or profess interest in a health-related job.
* The signs and symptoms of a child’s illness do not occur in the parent’s absence (hospitalization and careful monitoring may be necessary to establish this causal relationship).
* A family history of similar or unexplained illness or death in a sibling.
* A parent with symptoms similar to their child’s own medical problems or an illness history that itself is puzzling and unusual.
* A suspected emotionally distant relationship between parents; the spouse often fails to visit the patient and has little contact with physicians even when the child is hospitalized with serious illness.
* A parent who reports dramatic, negative events, such as house fires, burglaries, or car accidents, that affect them and their family while their child is undergoing treatment.
* A parent who seems to have an insatiable need for adulation or who makes self-serving efforts for public acknowledgment of their abilities.

I might catch some flak for making this comparison but whilst I am not suggesting that everyone autism/antivax adherent is MSbP or FII, I do think – as I say – a sizeable minority are. In the list above I have emboldened the characteristics I personally have seen lots of evidence of.

At any rate, whether there is genuine evidence of MSbP or FII or not, there is definitely an ongoing unreality to a certain group of peoples lives with autism. Why? To pretend to themselves they have total control over something that they do not understand? To medicalise something in order to keep alive the hope of a medical cure? To fuel their pre-existing lust for conspiracy theories? All of the above? None? Something else?

It gets to a point when it starts to not matter. When autistic children are literally being experimented on with absolutely no control in place like they are being with chelation, like they are being with Lupron and like they now are being with OSR we have to do something. When children in the UK are dying of vaccine preventable disease and children in the US are being hospitalised then we need to do something.

Paul Offit did something.

Better dead than autistic

15 Sep

This is Heidi Roger who is the Treasurer and a founding member of SafeMinds.

Heidi is a firm, firm believer that vaccines cause autism. No shock seeing as she’s a member of SafeMinds.

What is a shock though is her attitude to human life. In an online debate regarding the book Autism’s False Prophets Rogers made the following astounding claim:

…AUTISM is no joke, it is not “oh well” so their kid will work at McDonalds instead of Trump tower, it is a nightmare without end, it is post traumatic stress disorder every day, it is not better than measles, mumps or rubella and maybe even not better than polio.

That’s right, autism is worse than Polio which can leave some kids needing an iron lung is better than autism.

Measles which has left two teenagers in the UK dead in the last two years and still kills hudreds of thousands worldwide is better than autism.

I beg to differ. Its my opinion that my autistic child is in a much better place than some poor child in an iron lung.

But then, later on, Roger topped even this heartless statement with one so heartless and chilling it made me catch my breath:

Death may be better than autism in some cases….

Is that an official position of SafeMinds I wonder? That death ‘may’ be better than autism. If anyone has any doubts about why I and others feel it necessary to devote so much time blogging against these peoples beliefs you have it encapsulated right there. Death is not better than autism.

On the homepage of this site is a pink ribbon. If you click on that ribbon you will see some photos of Katie McCarron. Katie was murdered by her mother. Her mothers defence was that death was better than autism.

Katie’s family didn’t feel that way. Her Dad, her grandma and her grandpa didn’t feel that way. I have had the pleasure of meeting her dad and grandpa and I know that they loved Katie just as she was and that what was done to Katie was a violation. To even discuss the idea that death is better than autism is a violation. How someone who is parent to an autistic child can even suggest that death is better than autism is quite frankly beyond me.

Really bad blogging by Sharyl Attkisson

9 Sep

As I noted before, My fax complaining that Ms. Attkisson missed the big story in the autism/vaccine discussion just about the same time she was posting on exactly that story (the Hornig MMR paper).

Ms Atkisson’s blog post is titled

New Study Disproves Vaccine/MMR/Autism Link

Wow. I didn’t expect to see that from Ms. Attkisson.

Below is the full extent of Ms. Attkisson’s contribution to the piece

There’s a new study in the Public Library of Science regarding vaccine measles and autism which purports to disprove a vaccine/MMR/autism link.

Also, researchers at ThoughtfulHouse wrote an opposing analysis:

She then posts the ThoughtfulHouse press release. No kidding, of the blog piece, 90% (an estimate on my part) of the words are written by someone else! And, not even the researchers involved.

Dang. Recently we have seen a lack of homework on the Dr. Offit conflict of interest story, and now this.

At least there was some effort put into the story on Dr. Offit.

What happened to the CBS I grew up with? I can’t see Walter Cronkite getting paid for “Richard Nixon has resigned in disgrace. Now, here is Mr. Nixon’s press release verbatim.”

The exoneration of John O'Leary

5 Sep

Since the publication of the latest MMR study to refute any connection to autism, the principal believers in the idea that vaccines _simply must_ have some connection to autism have been floundering to spin some positives from the study. They have decided to concentrate on getting this study to exonerate Unigenetics (the lab of Professor John O’Leary). A little backstory is necessary here.

The idea that MMR leads to autism was first perpetuated by Andrew Wakefield. The idea goes that the MMR is injected, the measles component travels to the gut where it persists and causes severe gastric issues. It travels on to the brain and causes autism. Hence, it is – in the Wakefield scenario – the measles virus component of the MMR that causes autism.

In order to test this hypothesis, Wakefield tested for the presence of measles virus in the gut of autistic kids and lo and behold found loads. The way he found them was to send his biopsy samples off to the lab of John O’Leary, Unigenetics, in Dublin. Unigenetics ran the tests on the Wakefield samples and reported they had found measles RNA in significant percentages in Wakefield’s samples. They tested the samples using a technique called PCR.

So, later on, as study after study failed to replicate Wakefield’s – except, tellingly, for studies that went through Unigentics – investigators became suspicious of the results being generated at Unigenetics. As part of the UK litigation into MMR Professor Stephen Bustin – quite possibly _the_ world expert in PCR – went in and spent over 150 hours examining the methods used at Unigenetics to get their results. What he found was a bombshell.

Two things clearly arose from Bustin’s investigation. The first was a clear error of methodology. They forgot to perform an ‘RT Step’. What this was and what it meant is cleared up nicely here by commenter Brian:

The RT stands for “Reverse Transcriptase”, an enzyme that makes a DNA copy of an RNA molecule.

Measles virus exists as an RNA molecule. The polymerase chain reaction (PCR) assay amplifies DNA. Thus to detect an RNA molecule in a PCR assay, the RNA must first be copied (by the reverse transcriptase enzyme) into DNA, which can then be amplified.

Bustin showed that the O’Leary lab reported positive results even when they could not possibly have detected an RNA molecule because they had left out the step to copy that RNA into DNA. Thus the positive results reported for such assays were undoubtedly false positives.

Its worth noting here that Bustin found this methodological error by following Unigenetics lab manual if I recall correctly.

Here is Bustin himself:

If you detect a target that is _apparently_ measles virus in the absence of an RT step by definition it can’t be measles virus because it has to be DNA [measles virus does not exist as a DNA molecule]. It’s a very simple concept. At least it is to me. It’s not to everyone else.

So what were they reporting as measles virus? Lab contamination. That was the second error.

OK, so now back to today and the new MMR paper and the drive to make it exonerate O’Leary.

The new study used three labs to perform its detection. All three performed excellently. One of the labs was (you guessed it) John O’Learys in Dublin.

So, two new press releases have hit since then. I’ll quote from them both.

This is from Thoughtful House (Andrew Wakefield’s Texan fiefdom):

This new study confirmed that results from the laboratory of Professor John O’Leary….were correct, and identical to the results obtained by the laboratories of the Centers for Disease Control and Prevention (CDC) and Dr. Ian Lipkin of Columbia University.

In that this new study affirms the reliability of Professor O’Leary’s laboratory and therefore of his previous findings, a major impact upon the current hearings in vaccine court is likely, wherein the government’s defense relies largely on the claim that Professor O’Leary’s finding of measles in the intestinal biopsy of Michelle Cedillo (a child with severe autism and epilepsy) was unreliable. The historical reliability of the measles assay used in Professor O’Leary’s laboratory is now confirmed.

And SafeMinds:

One of the three labs involved in the Hornig study was led by John O’Leary who conducted the testing for the Wakefield study. The three Hornig study labs validated each other,
confirming the rigorousness of Dr. O’Leary’s work. Dr. O’Leary conducted the testing for one of the autism test cases now in the Federal Court for Vaccine Claims. The child, who regressed into autism
and bowel disease after receiving the MMR, tested positive for measles virus.

So, you can see that this is the spin – exonerating Unigenetics work that Stephen Bustin had demolished.

They take a rather simplistic viewpoint of things – that because the lab performed well now, it did then. I think that’s rather a large assumption.

I also think that they have forgotten the timeline of events surrounding the Cedillo case.

Michelle Cedillo’s positive measles virus finding was in 2002:

From the cross examination of Arthur Krigsman:

Q: OKay, now in support of your opinion that Michelle has persistent measles virus in the lymphoid tissue of her bowel, you cite to the positive finding in *2002* by the Unigenetics in Dublin, Ireland of measles RNA in the tissue sample tested in Michelle, correct?

A: By the published report, of their findings.

Q: But from Unigenetics, specific to Michelle?

A: Right.

(Page 531, line 9 – 18)

Stephen Bustin did not enter the lab until January 2004.

From the Direct examination of Stephen Bustin:

Q:…..Now, you were granted physical access to the Unigenetics laboratory?

A: I was, yes.

Q: When?

A: In January 2004 and then again in May 2004.

(Page 1964, line 12 – 16)

In other words, Michelle Cedillo’s test results were generated by Unigenetics, _before_ Stephen Bustin (or anyone else) had discovered the catastrophic errors that made it impossible they were detecting measles.

The question becomes – if you were John O’Leary and someone had made it perfectly clear that you had done bad work two years earlier would you then carry on missing out the RT step? Or would you not? By the time 2008 rolled around, would you hope that your lab staff could do their jobs properly? Or wouldn’t you really care?

The idea that this new MMR study somehow exonerates the work of Unigenetics prior to 2004 is a joke. Unfortunately, Michelle Cedillo’s testing was done prior to 2004. Two years prior, back to a time when Unigenetics weren’t so good at lab work.

New MMR study makes the NAA angry

4 Sep

Oh dear.

As I posted yesterday, MMR still doesn’t cause autism – as reported by yet another group of researchers.

And yet there was something special about this group of researchers. The lead author is Dr Mady Hornig who it seems is trying to turn over a new leaf and recapture her place as a good scientist.

As the link I supplied shows, it was not always thus and for a long time Dr Hornig was a card carrying member of the mercury militia. In fact, she was a regular speaker at conferences organised by SafeMinds and the NAA.

Which makes the press release about this new MMR study by the NAA all the more painful to read.

A Centers for Disease Control and Prevention (CDC) study released today claims there is no link between the MMR vaccine and autism

Thats how the NAA refers the Hornig study all the way through its press release. ‘The CDC study’. Its a little like reading the decree nisi in the lead up to a divorce you just know is going to be long and bitter.

Anyway, lets have a look at the rest of the points the NAA try to make.

…In a 2002 paper where the majority of autistic children were found to have measles in their intestines, the children examined showed a clear temporal link between MMR exposure and regression. The CDC’s attempt to replicate the 2002 study fell far short of proving the safety of the MMR vaccine.

No reference is supplied for this ‘2002 paper’ so I have no idea what to talk about here. Thats not very smart NAA. Also, as discussed yesterday in the press conference, the intent was to replicate Wakefield’s original study. In 1998. Not 2002.

The CDC study was designed to detect persistent measles virus in autistic children with GI problems. The assumption being if there is no measles virus at the long delayed time of biopsy, there is no link between autism and MMR. But NAA says this underlying assumption is wrong. The questions should have been: Do normally developing children meeting all milestones have an MMR shot, develop GI problems and then regress into autism? Do they have evidence of measles and disease in their colons compared to non-vaccinated age and sex matched controls?

Ahhh, I _see_ – so when you don’t like the answer, change the question? Nice one. The NAA are obviously South Park fans, seeing as they just introduced the Chewbacca defense.

In the current CDC study, only a small subgroup of children was the correct phenotype to study……Only 5 of 25 subjects (20%) had received MMR before the onset of GI complaints and had also had onset of GI episodes before the onset of AUT (P=0.03).” The other 20 autistic children in the study had GI problems but the pathology developed before the MMR vaccine.

This really does take the piss in an extreme way. The NAA love the 1998 study by Wakefield which had a group of 12 participants. Now they suddenly don’t like small numbers?

And really, that is besides the point. The authors took some autistic kids with GI issues and then looked to match them to a hypothesis. The fact that the only found a very, very small number who actually fit the description that the NAA would _like_ them to fit is extremely telling. The vast majority of the kids had GI issues _before administration of MMR_ . Now, what does that tell you? Its not difficult to work out.

Inflammatory bowel disease in the absence of MMR RNA does not mean that MMR shot didn’t precipitate the GI disease and didn’t precipitate autism…

Oho…is that the rumble of some goalpost shifting I can hear? I think it is.

Lets be clear. For literally a decade now, the NAA and the groups like it have been claiming that their kids had the MMR, developed gastric issues, then developed autism all as a result of the measles vaccine RNA contained in the measles component of the MMR. This is the hypothesis that the Autism Omnibus plaintiffs are arguing for right now. This study has thrown yet another large, cold bucket of reality over that nonsense. So now, thats _not_ the hypothesis?

Public confidence in the safety of vaccines is at risk until safety studies are performed that are required by law, ethics, and science….blah blah blah

Is it? If that _was_ the case then the only people who have put the public confidence of vaccines at risk are groups like the NAA. There is no way to keep saying the same thing without appearing repetitive: what you believe is wrong. The MMR vaccine does not cause autism. Shut up. Start working _for_ autism.

And is it really the case that public confidence is slipping? I recently wrote about a phone survey that had found that:

….66 percent had heard that “some parents and researchers say vaccines have side effects that may lead to autism, asthma, diabetes, attention deficit disorder and other medical problems.” About 33 percent had not heard of these concerns, and 1 percent was uncertain.

Seventy-one percent of the adults said “the benefits of immunizations outweigh the risks,” while 19 percent “have questions about the risks of immunization,” and 10 percent were uncertain or gave other responses such as “it depends upon the kind of immunization.”

So, its clear that people (in the US at least) are beginning to get some confidence back in vaccines and see the need for them. That is backed up by an article by the American Academy of Family Physicians who report:

Although the alleged link between childhood autism and the vaccine preservative thimerosal still sparks occasional controversy, the good news is that by and large, parents don’t seem to be buying into the hype. According to the latest reports available from the CDC, overall childhood immunization rates in the United States continue to steadily increase.

This is good news. Partly anyway. It is good news for herd immunity and the general level of the health of the US.

However, this is never going to be good news for autism and for autistic people whilst we have the various conspiracy theory addled groups who claim to represent the autism community continually burying their collective heads in the sand whenever yet another study comes out to show them how silly they’re being. I urge two things to happen.

1) Doctors and scientists – please don’t stop talking about this issue once vaccinations reach safe levels. Your job is only part done at that stage. You *must* continue to talk to reach new parents and the parents who can be reached from the autism community. Don’t let these kooks get the control back.

2) So-called autism advocacy groups in the US and UK. You know who you are. You’re doing nothing to help autistic people. Change your ways or shut up.

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…

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