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When the science fails you, turn to the legal option

10 May

A news conference today will confirm that autism/anti-vaccine groups have lost the scientific battle for the idea that vaccines cause autism as they turn to the legal battle instead.

…a new report in a New York law school journal, the Pace Environmental Law Review, could reignite the often-inflammatory debate over the issue. Based on a sampling of cases in which plaintiffs won settlements or awards in vaccine court, the authors found that many of the victims demonstrated evidence of autism – even though, perhaps as a legal tactic, their lawsuits emphasized other injuries.

Readers of this site might be forgiven for looking and yawning – here we go again. This is nothing but re-hash of already discussed material. But lets look at the main claim of this issue:

Of the 170 cases the report’s authors examined, 32, or 19 percent, provided documented evidence of autism or autism-like symptoms. The evidence in some cases included findings by the court that the children had autism, “autism-like symptoms” or “symptoms and behavior consistent with autism.” In other situations, third-party medical, educational or other court records confirmed an autistic disorder.

The report – at least in this news story – doesn’t seem to mention how many children were compensated for having autism. As we all kow ‘autism like symptoms’ or ‘symptoms and behavior consistent with autism.’ might be just that – but they are not autism. If they were I’m sure the court would’ve reported it.

And thats not all. Nobody seems to be giving an estimate for how many of these kids actual autism (not autism-like symptoms etc) was actually caused by an actual vaccine.

And thats *still* not all. One of the most problematic issues for this new ‘line of attack’ is this.

Daubert. This is the standard of science that should be used in legal cases. When Daubert is applied, the bottom line is that the best science must be applied. In _none_ of these cases was Daubert applied. In fact, in only one instance was Daubert applied – the Autism Omnibus hearings. And as we all know, they failed.

So here we have a fairly desperate roll of the dice. Eschewing science completely, the autism/anti-vaxxers have decided to turn their attention to the law. By muddying the legal waters, they are attempting to make it appear as if autism by any other name has been compensated in at least 19% of the cases they looked at.

The truth is, it hasn’t. The truth is that in no cases I can see has a case been established scientifically to show vaccines cause autism.

That’s not for our kids

28 Apr

A recent Guardian Roundtable touched on an interesting subject for those of us who are responsible for children with learning difficulties. The article was written, sourced and published in the UK but I believe it applies everywhere in the world where there are children with learning difficulties.

Just 6.4% of people with learning disabilities are in paid employment and that stark statistic – and the shocking waste of financial (and human) resources behind it – formed the backdrop for a recent Guardian roundtable discussion.

This issue has its root, I believe, in the way we are led to think about our children from birth:

When it comes to setting expectations for a child with learning disabilities, things can start to go wrong the moment they are born. The roundtable heard how health staff use their “breaking bad news” training to counsel parents, leaving them with the impression that there’s not much incentive to look forward to the future.

I remember the day we received the news that our child was autistic with profound learning difficulties. There were 3 calm staff members and a box of tissues on the table. By the time we left, the tissues had been used – and although the staff were gentle, kind and wonderful people who clearly were fond of our child – they too fell into that trap of ‘breaking bad news’ mode. A mode that, by its very tenor, fulfills the expectation of _being_ bad news.

The truth is, in my opinion, that with a little effort from health care agencies we can move from:

staff at one special school who, when the issue of employment was raised, replied: “That’s not for our kids.”

to a de facto position as espoused by agencies like Remploy who are the UK’s leading provider of employment services to people with disabilities.

But we’re not anywhere near that yet. In my own experience too many parents of people with special needs are content to wallow in the comfort of ‘putting it off’ – their children are still young. But consider this – we are far longer a time adults than we are children. Our children need to learn how to function in the world. This won’t be brought about by sham cures and ideaslistic fights against a strawman army. Neither will it be brought about by those who insist on misrepresenting the nature of what autism is to all rather than some.

One speaker summed up the fundamental question underpinning the whole debate: “Do we believe that people with learning disabilities and their families are worth it?”

Are they worth the upheaval and political effort it would take to transform a system that often fails them when it come to finding work?

In any society that claims to be fair, children with learning disabilities surely deserve the same life chances as other young people, the roundtable heard. They should be encouraged to have ambition

Questions in advance of study analyzing vaccine court cases for autism

20 Apr

A study is in review looking at the records of the vaccine court and, purportedly, showing that a large number of the cases compensated involve autistics. Robert Kennedy Jr. was prepared to give a press conference on the paper, but this got called off. There has been chatter about a study like this for a few years now and I’ve been curious about what the results would be. I was then curious why the chatter basically died down.

The big question I would have for the author of this study and for Mr. Kennedy should he get his press conference is: how many of these children were compensated for a residual seizure disorder following DPT vaccination?

Why ask that question? The “table” is a list of reactions which the Court will assume are vaccine-caused if they happen within the prescribed time after vaccination. The table is created with the best knowledge available at the time. What happens when the best knowledge available changes? After much deliberation, the table changes. That’s what happened to residual seizure disorders as an injury for DPT vaccines. It was part of the original table, but as new research came out showing that residual seizure disorders were not a risk from DPT vaccines, it was removed from the table.

This isn’t a small issue. The idea that residual seizure disorders could be caused following DPT vaccination are basically what created the Vaccine Act, the special Court and the rest of the program as we know it today.

As of today, there have been 2,699 cases compensated within the program. Of those, by far the largest share is due to the DPT vaccine, with 1,267 compensated claims. That’s 47%. Pretty high percentage especially when you consider the DPT (the whole cell vaccine) was discontinued 15 years ago.

Let’s say that there are a lot of cases in the court where autistics have been compensated for injury. How many of these people were compensate for what was an incorrect assumption of fault? Epilepsy is common in autistics. It is certainly reasonable to think that a number of autistics were compensated for residual seizure disorders.

It will be interesting to see how they address this question in the paper, if they address it at all. It will be interesting to see how Mr. Kennedy addresses this problem, if he addresses it at all.

If you want more details on the history, here is some of it, with some links.

Take a look at the original vaccine injury table (from the mid-late 1980’s) for the DPT vaccine:

DTP; P; DTP/Polio Combination; or Any Other Vaccine Containing Whole Cell Pertussis Bacteria, Extracted or Partial Cell Bacteria, or Specific Pertussis Antigen(s).
Illness, disability, injury, or condition covered: Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration:
A. Anaphylaxis or anaphylactic shock 24 hours
B. Encephalopathy (or encephalitis) 3 days
C. Shock-collapse or hypotonic-hyporesponsive collapse 3 days
D. Residual seizure disorder in accordance with subsection (b)(2) 3 days
E. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed

Take a look at the table now for pertussis containing vaccines:

I. Tetanus toxoid-containing vaccines (e.g., DTaP, Tdap, DTP-Hib, DT, Td, TT)
A. Anaphylaxis or anaphylactic shock 1 0-4 hours
B. Brachial neuritis 6 2-28 days
C. Any acute complication or sequela (including death) of above events 4 Not applicable

It’s a lot shorter. Note specifically that “Residual seizure disorder” is now gone. Here is how residual seizure disorderwas defined:

(B) in the case of any other vaccine, the first seizure or convulsion occurred within 3 days after administration of the vaccine and 2 or more seizures or convulsions occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit.

The change came in 1995. The reasons were not arbitrary, as noted here in the announcement in the Federal Register. They were working from recently published and studies:

During the process of analyzing the comments received in response to the NPRM, the Agency became aware of the imminent publication of a 10-year follow-up study to the National Childhood Encephalopathy Study (NCES) (Madge N., Diamond J., Miller D., Ross E., McManus C., Wadsworth J., Yule W. The National Childhood Encephalopathy Study: A 10-year follow-up. A report of the medical, social, behavioural and educational outcomes after serious, acute, neurologic illness in early childhood. Developmental Medicine and Child Neurology 1993; Supplement No. 68;35(7):1–118; Miller D.L., Madge N., Diamond J., Wadsworth J., Ross E. Pertussis immunization and serious acute neurological illness in children. British Medical Journal 1993; 307:1171– 1176, hereinafter ‘‘Miller study.’’).

Because the Miller study looked specifically at the relationship between vaccine administration and subsequent neurological damage, the Department determined that it should not proceed with publication of the final rule until there had been a sufficient opportunity to consider the conclusions of the new Miller study. Accordingly, the Department asked the IOM to convene a Committee for purposes of evaluating the Miller study in light of the conclusions of its initial report. On March 2, 1994, the Institute of Medicine issued a report entitled ‘‘DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis.’’

The pubmed link to the NCES study (Madge et al) is here. The Miller study is available in full here. The IOM report is here.

To pull one short quote out as to why the table changed:

The consensus of the Commission was that the original table in the statute requires modification to make it consistent with current medical and scientific knowledge regarding adverse events associated with certain vaccines.

Basically, they found that the research which had been used for the first Vaccine Injury Table was wrong to assume cause for residual seizure disorders following DPT vaccines. Again, I await the chance to see if the upcoming paper addresses this important issue. If a large number of the autistics were compensated for an injury which modern science says isn’t really an injury, the readers of the study need to know this.

Mother who withheld cancer treatment from autistic son sentenced

16 Apr

Kristen LaBrie was sentenced today to 8 years in prison in the death of her son. Her son was autistic and developed cancer. Doctors thought the cancer (non-Hodgkins lymphoma) was treatable, and gave the child a 90% chance of surviving. His mother didn’t give him the chemotherapy and he developed leukaemia. In the end, the leukaemia killed him.

Courtroom video is here (I can’t figure out how to embed the video).

The announcer in that video states “her mental state was weakened after providing 99% of his care”

Her attorney is shown towards the end of the video stating: “She made a decision in her mind to stop the medication. But the decision was not made consciously. It was a result of her losing her ability to be objective”

From the Boston Herald:

LaBrie’s lawyer, Kevin James, told the jury LaBrie was depressed and overwhelmed by caring for her son. She made a “tragic mistake” in stopping her son’s at-home medication, James said, but her actions were not criminal.

From the Boston Globe:

LaBrie, 38, told the jury she stopped giving him the medications because she couldn’t bear to see how sick the side effects made him.

Prosecutors portrayed her as a single mother seething with resentment because she had to care for Jeremy alone.

TIME Magazine posed this question:

Was justice done? It’s hard to know. Certainly, disabled children have rights. But moms do too, and it appears that LaBrie did not have adequate support. Being a single mother of a healthy child is tough enough. Factor in autism and a kid who can’t communicate makes it that much harder. Add non-Hodgkin’s lymphoma, and the burden is fierce.

Do autistics get enough support? No.
Do parents get enough support? No.
Is this an excuse for withholding medication? No.

There are cases through the years of parents of disabled kids either actively or passively assisting in the deaths of those children. How can we as a people figure out ahead of time that these parents are making these tragic, and criminal, decisions?

Reassessing the role of mitochondrial DNA mutations in autism spectrum disorder.

12 Apr

Autism and mitochondrial medicine have become a very hot topic in recent years. What the connections are between autism and mitochondrial disorders has yet to be clarified. Mitochondria are little structures within cells that produce much of the energy required. Mitochondria have their own DNA (mtDNA) in addition to the nuclear DNA (nDNA) of the cell. nDNA is what most people think of when we hear “genes” or DNA. Given the focus on mitochondrial dysfunction and autism, it is natural to consider the question: are there mutations in the mtDNA which increase the risk of autism?

A new paper takes a look at the question. They studied 148 patients with ASD and found, well, no support for a link to mtDNA mutations. Here is the abstract:

BMC Med Genet. 2011 Apr 6;12(1):50. [Epub ahead of print]
Reassessing the role of mitochondrial DNA mutations in autism spectrum disorder.
Alvarez-Iglesias V, Mosquera-Miguel A, Cusco I, Carracedo A, Perez-Jurado LA, Salas A.
Abstract
ABSTRACT:
BACKGROUND: There is increasing evidence that impairment of mitochondrial energy metabolism plays an important role in the pathophysiology of autism spectrum disorders (ASD; OMIM number: 209850). A significant proportion of ASD cases display biochemical alterations suggestive of mitochondrial dysfunction and several studies have reported that mutations in the mitochondrial DNA (mtDNA) molecule could be involved in the disease phenotype.

METHODS: We analysed a cohort of 148 patients with idiopathic ASD for a number of mutations proposed in the literature as pathogenic in ASD. We also carried out a case control association study for the most common European haplogroups (hgs) and their diagnostic single nucleotide polymorphisms (SNPs) by comparing cases with 753 healthy and ethnically matched controls.

RESULTS: We did not find statistical support for an association between mtDNA mutations or polymorphisms and ASD.

CONCLUSIONS: Our results are compatible with the idea that mtDNA mutations are not a relevant cause of ASD and the frequent observation of concomitant mitochondrial dysfunction and ASD could be due to nuclear factors influencing mitochondrion functions or to a more complex interplay between the nucleus and the mitochondrion/mtDNA.

PMID: 21470425 [PubMed – as supplied by publisher]Free Article

This is consistent with previous studies, as noted in a recent review article which was itself summarized at The Thinking Person’s Guide to Autism by Emily Willingham as Mitochondrial Disease and Autism: Linked?

Ms. Willingham noted there:

Thus, tracking down mitochondrial dysfunction in the context of ASD to a specific mutation has remained an elusive goal. Two scenarios are likely for this lack of mutational findings: (1) there are mutations, but we just haven’t found them yet; or (2) the environment is largely responsible for any mitochondrial dysfunction that abnormal marker levels might indicate.

This paper is available as a free manuscript online. Here is the

Although it is widely accepted that some forms of ASD appear concomitantly with the impairment of mitochondrial energy metabolism, there are reasons to believe that the cause of these mitochondrial disorders does not systematically rest on mutations or variants in the mtDNA molecule. Pathogenic mtDNA mutations have been reported in ASD patients, but this seems to be the exception rather than the rule. It is more likely that the real causes of mitochondrial deficiencies in some ASD cases are due to the intervention of several nuclear factors acting alone (additively or epistatically) or through a complex interplay with mtDNA variants. For the time being, while the cause for mitochondrion dysfunction in ASD remains unclear, there is no reason to indicate systematic screening for mtDNA mutations in ASD patients unless a mitochondrion disorder is suggested by a clear phenotype.

What is also interesting to me is the table of characteristics of the study subjects. In particular, there is a big difference in the percentage with epilepsy and dimorphism between adults and children:

Mitochondrial dysfunction is listed as mild and somewhat infrequent (about 10%). Not the very high prevalences of mitochondrial dysfunction that some have suggested are present in autitics. This does beg the question: should this genetic study be performed on those with some measure of mitochondrial dysfunction?

This doesn’t mean that mitochondrial dysfunction isn’t an important area for autism research, or that a genetic study such as this shouldn’t be done on a larger group with some measure of mitochondrial dysfunction.

Of course it would be great to hear that there is something definitive in this study. As in, “this is it!” rather than “this probably isn’t it”. Mitochondrial DNA mutations “probably isn’t it” when it comes to the etiology of ASD in most people.

Robert F. Kennedy Jr. not holding a press conference on Monday

9 Apr

My guess is that you are reading this thinking: this is news? Doesn’t pretty much every day go by without Robert F. Kennedy holding a press conference? Well, yes. But there was a press conference planned for Monday. Yes, the man who brought you “Deadly Immunity” (an article promoting the mercury/autism link that was so flawed that it was retracted by Salon.com and quietly removed from the Rolling Stone website) has something so new and important that he wants to tell the world about it from in front of the White House.

The subject? A study purportedly showing that many autistic kids have been compensated over the years by the National Vaccine Injury Compensation Program (a fact that has been public knowledge for 9 years or more). The article, under review by his University’s law journal, appears to be the one which was touted as ongoing a few years ago (I recall this being on a piece by David Kirby on the Huffington Post before he focused on his new project of food safety).

That press conference, from what I’ve heard, has been put off until after the paper is actually accepted and published.

Here’s the background history:

1) The US adopts a National Vaccine Injury Compensation Program in the mid-late 1980’s.

2) Autistic kids are amongst those compensated.

3) The concept of a vaccine-induced autism epidemic gains momentum in the late 1990’s.

4) Enough cases are submitted to the Program that an Omnibus proceeding is started to cover all the cases.

5) The first item added to the docket, Autism General Order #1, tells attorneys to be aware that autistics with table injuries should be handled outside the Omnibus for faster processing. (year 2002)

One important caveat, however, is drawn to the attention of all petitioners and their counsel! There may be cases involving autistic-like disorders which manifested following an injury defined in the Vaccine Injury Table. That is, a vaccine may have suffered an episode involving a severe acute encephalopathy within 72 hours after a pertussis vaccination (DTP or DTaP), or 5 to 15 days after an MMR vaccination. If so, such an acute encephalopathy and any residual effects thereof would be presumed to be vaccine-caused pursuant to the Vaccine Injury Table.

and

Autism cases involving Table Injuries have been compensated under the Program. If in a particular case there exist medical records demonstrating that such a qualifying “acute encephalopathy” occurred within the appropriate time frame, petitioner or counsel should bring that to the assigned special master’s attention so that, if appropriate, the case can be processed without delay as a Table Injury.

6) The government concedes Hannah Poling’s case as a table injury (late 2007) and the Hannah Poling concession was leaked while still in process. (Feb. 2008).

7) Given the news focus generated, then Chief Special Master Gary Golkiewicz was quoted:

“Years ago, actually, I had a case, before we understood or knew the implications of autism, that the vaccine injured the child’s brain caused an encephalopathy,” he said. And the symptoms that come with that “fall within the broad rubric of autism.”

And there are other somewhat similar cases, Golkiewicz says, that were decided before autism and its symptoms were more clearly defined.

8) Kathleen Siedel found a number of cases which were in the public record involving vaccine injury cases compensated. This list then appeared in many places, including a journal paper.

9) it was signaled that a new study was in the works where the prevalence of autism was notably higher amongst people compensated in the vaccine-injury program.

10) The autism prevalence estimate in the US was increased to 1 in 100, up from 1 in 150. Whether this had an impact on the apparent delay of (9) I can’t say.

Short form: we’ve been waiting for years for the study which will show us that the fraction of kids compensated by the Court is higher than expected. Now it appears that the study is in process and in a law journal. And that Robert F. Kennedy wanted to tell us all about it on Monday. But that won’t happen now, apparently. Apparently even law journals have embargoes.

Even though the press conference seems to be canceled for now, I guess that sometime in the near future Robert F. Kennedy will confirm what is and has been public knowledge. This will be followed by a blog storm acting as though this is news. Perhaps I’ll be surprised and something new will be in the announcement.

So far, the fraction of children with ASD diagnoses who have been compensated by the Autism Omnibus Proceeding is 1 in 838. This isn’t a fair estimate of what the final fraction will be, as many of those cases dismissed are for procedural issues like failure to prosecute and timeliness of filing. For that one compensated case, there is the note:

*May include case(s) that were originally filed and processed as an OAP cases but in which the final adjudication does not include a finding of vaccine-related autism.

**HHS has never concluded in any case that autism was caused by vaccination.

Proton Magnetic Resonance Spectroscopy and MRI Reveal No Evidence for Brain Mitochondrial Dysfunction in Children with Autism Spectrum Disorder.

16 Mar

A study published today looks for mitochondrial dysfunction in autistic children. In specific, the researchers are looking directly at the brains of autistic children. The team, from the University of Washington, used both MRI (Magnetic Resonance Imaging) and proton magnetic resonance spectroscropic imaging (HRMS). MRI gives structural information on soft tissues. HMRS is a “spectroscopic” techinque: it gives chemical information on
Here’s a good reference with a discussion of HMRS on brain tissue (as a spectroscopy, not an imaging technique): Quantitative neuropathology by high resolution magic angle spinning proton magnetic resonance spectroscopy

With that background in hand, here is the abstract from the recent study on autism:

Proton Magnetic Resonance Spectroscopy and MRI Reveal No Evidence for Brain Mitochondrial Dysfunction in Children with Autism Spectrum Disorder.

Corrigan NM, Shaw DW, Richards TL, Estes AM, Friedman SD, Petropoulos H, Artru AA, Dager SR.

Department of Radiology, University of Washington, Seattle, WA, USA.
Abstract

Brain mitochondrial dysfunction has been proposed as an etiologic factor in autism spectrum disorder (ASD). Proton magnetic resonance spectroscopic imaging ((1)HMRS) and MRI were used to assess for evidence of brain mitochondrial dysfunction in longitudinal samples of children with ASD or developmental delay (DD), and cross-sectionally in typically developing (TD) children at 3-4, 6-7 and 9-10 years-of-age. A total of 239 studies from 130 unique participants (54ASD, 22DD, 54TD) were acquired. (1)HMRS and MRI revealed no evidence for brain mitochondrial dysfunction in the children with ASD. Findings do not support a substantive role for brain mitochondrial abnormalities in the etiology or symptom expression of ASD, nor the widespread use of hyperbaric oxygen treatment that has been advocated on the basis of this proposed relationship.

Does this mean that mitochondrial dysfunction never occurs in autistics? No. But it makes it very unlikely that more than a fraction of autistics have mitochondrial dysfunction in their brains.

Beyond that, the use of spectroscopic imaging is very impressive to me. MRI structural data is quite valuable on its own, but adding chemical information is very powerful.

At State-Run Homes, Abuse and Impunity

14 Mar

So reads the title of a very disturbing piece in the New York Times. At State-Run Homes, Abuse and Impunity discusses problems with the group homes in New York.

Nearly 40 years after New York emptied its scandal-ridden warehouses for the developmentally disabled, the far-flung network of small group homes that replaced them operates with scant oversight and few consequences for employees who abuse the vulnerable population.

Not only is there abuse, but perpetrators are often not charged.

A New York Times investigation over the past year has found widespread problems in the more than 2,000 state-run homes. In hundreds of cases reviewed by The Times, employees who sexually abused, beat or taunted residents were rarely fired, even after repeated offenses, and in many cases, were simply transferred to other group homes run by the state.

Sounds like the stories of abuse by Priests in the Catholic Church in a way, doesn’t it? Abuser is uncovered and moved rather than fired or prosecuted.

The Times puts a good share of the blame for protecting the perpretrators on the uniion:

The state initiated termination proceedings in 129 of the cases reviewed but succeeded in just 30 of them, in large part because the workers’ union, the Civil Service Employees Association, aggressively resisted firings in almost every case. A few employees resigned, even though the state sought only suspensions.

The story is fairly long, and very saddening to say the least. While a difficult read, it is an important one.

Mitochondrial Disease and Autism: Linked?

11 Mar

Mitochondrial disease and autism. I don’t read about it as much as during the peak of the Hannah Poling story, but it is a big topic. Emily Willingham at
Thinking Person’s Guide to Autism has put together an excellent post on the subject. Here’s the first paragraph:

Hannah Poling’s family entered the national spotlight when they revealed that Hannah’s autism-like symptoms may have been linked to a reaction to several childhood vaccines at once in combination with her mitochondrial dysfunction. Her case was not the first revelation of a possible mitochondrial disorder (MD)-autism spectrum disorder (ASD) link, but because of her ultimately successful vaccine injury suit, she became the avatar of the vaccines-cause-harm movement — which almost eclipsed the real scientific and therapeutic feature of her case: the mitochondria.

I’d love to do a wholesale copy of the post, but that’s hardly fair now, is it? So, I’ll send you all to the Thinking Person’s Guide to Autism and Mitochondrial Disease and Autism: Linked?

Bullying Revisited: Retarded?

4 Mar

There’s a good article on the Huffington Post that I want to draw some attention to. Tim Shriver Jr. and Soeren Palumbo wrote a piece, Bullying Revisited: Retarded?. They discuss the
Spread the Word to End the Word campaign by Special Olympics (and supported by about 200 more organizations).

I know it is pretty much preaching to the choir here talking about the harmful message in words like “retarded” as it is commonly used today. But, perhaps the choir could go over there and show some support. I’d like to see the Huffington Post host more pieces like this than, well, some of the material they host.

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