Real Guys Immunize is a new Facebook Group set up specifically for Fathers Day. There’s also a Twitter page @guysimmunize
I think this is a great initiative and if you’re on Facebook all you need to do is ‘Like’ the Group and you can comment and follow on etc.
Part of the United States Court of Federal Claims includes the “vaccine court”, where claims against the government are heard regarding vaccine injuries. Probably the most well known activity of the vaccine court, especially to readers of LeftBrainRightBrain, is the “Omnibus Autism Proceeding“. The Omnibus comprises over 5,000 families claiming vaccine injury resulted in autism. Rather than hear all these cases individually, both sides agreed to first hear “test cases” where the stories of six children were heard to answer the question of whether vaccines induced autism in those children and to decide whether the general question of whether vaccines cause autism could be addressed. The first three test cases presented the argument that the MMR vaccine, either alone or with thimerosal from other vaccines, could cause autism. The next three cases presented the argument that thimerosal alone could cause autism.
The Omnibus is back in the news, in a small way, after another appeal for the Cedillo test case was heard last week. The attorneys and the bloggers are concentrating on whether the testimony and expert reports of Prof. Stephen Bustin should have been allowed. I’ll go into the detail about this argument below. It is worth saying at the outset that this argument is likely to accomplish nothing, whether they win or lose. The Special Master who decided the Cedillo case and the judge who heard the first appeal both stated, clearly, that the decision to deny the Cedillo claim would be the same without Prof. Bustin’s testimony and report.
That is worth repeating: win or lose on this point in the appeal, the Cedillo’s still do not have a compelling case that the MMR vaccine causes autism.
Before going any further, it is worth stopping and recognizing the human side of this proceeding. The “test cases” are six children whose families agreed to let their stories be heard and analyzed in public. They went into this with faith in their positions, but without the knowledge of the legal outcome. When the decisions were handed down against them (yes, they lost), they didn’t have the opportunity to change their arguments. They were committed. So, in two big ways, these are brave families. Agree or disagree with the science they depend upon, they had some guts to step forward as they did.
It is also worth noting that no one gets wealthy from successful claims in the Court. Settlements are typically around US$1 million. While this sounds like a lot, the purpose is to pay for the needs of the injured and to set up an annuity which will supplement the government support already in existence for the disabled. Most readers to this blog will have an idea to how far that support goes.
The Omnibus hearing and the appeals
The first of the test cases heard was that of Michelle Cedillo. Miss Cedillo is a severely handicapped girl with multiple disabilities. Her case was heard in June 2007. The decision, by Special Master Hastings, was handed down in February 2009. The Cedillo family appealed and the case was heard by a Judge in the U.S. Court of Federal Claims, Judge Wheeler, whose decision in August 2009 went against the Cedillo family. The Cedillo family appealed again, this time to the U.S. Court of Appeals for the Federal Circuit. Their appeal was heard on June 10 before judges Newman, Linn and Dyk.
The Court of Appeals for the Federal Circuit is probably the last appeal for the Cedillo family. Should this go against them, they have the right to appeal to U.S. Supreme Court. But the Supreme Court is not required to hear their case. In fact, the Supreme Court usually chooses cases which decide points of law. The arguments by the Cedillo family are more questions of procedure and, as such, I would expect the Supreme Court would refuse to hear any appeal. But, that is getting ahead of ourselves. Right now, we still haven’t heard the decision from the Appeals Court.
Public Responses to the Recent Appeal
What we have heard is some minor publicity about the hearing in the Appeals Court. The Age of Autism blog has Olmsted on Autism: Day in Court and one of the Examiner blogs has Oral arguments made in Cedillo Omnibus Autism Proceeding mercury and MMR vaccine test case appeal.
I haven’t heard the arguments made in court. I wish I had because in my experience there is a fairly large gap between what I’ve heard in past proceedings and how they are portrayed on the net. A fairly egregious example was in the portrayal of an expert witness for the Cedillos, Dr. Vera Byers. When she testified in 2007, someone was portraying her as coming across with the gravity of Dame Judi Dench (who plays “M” in the James Bond movies, amongst other roles). During the hearing, Dr. Byers was found to have seriously padded her resume, claiming she worked at the prestigious University of California San Fransisco when, in fact, she only used their libraries and attended their parties. She also accused the Department of Justice lawyer of “making faces” at her. I did not think of Dame Judi Dench when I heard her testimony.
Following the original hearings for the Cedillo case, many bloggers in the vaccines-cause-autism groups were optimistic. They felt that they had made a strong case and they would prevail, complete with imagery of “Dark Towers” being brought down by bolts of lightening. From my perspective, such cheer-leading seemed to border on cruel given the very weak case made to support the general question of MMR causing autism.
Given this background you would probably not be surprised that I look at the optimistic reports coming out of last week’s appeal with a somewhat skeptical eye. Which begs the question, “what was said” by these bloggers? From Mr. Olmsted’s piece, here are two quotes.
The first is from one of the attorneys working with the Cedillo family:
“I have a very positive feeling about the federal judges,” said Sylvia Chin-Caplan, who argued the appeal.
The second quote comes from an attorney who blogs for the Age of Autism blog and who, I believe, has a child who is a claimant in the Omnibus:
“I leave with the sense that the judges were very troubled that the government had not acted in good faith,” said Mary Holland. “Those judges were very troubled by what the government’s done – very troubled.”
The argument for the appeal: Prof. Bustin’s testimony
So, what are the judges supposedly “troubled” by? Well, this has to do with part of the appeals argument by the attorneys for the Cedillo family: the testimony of Prof. Stephen Bustin.
Professor Bustin is a world expert on a technique called polymerase chain reaction (PCR) which he describes as
Real-Time PCR is a variation of the polymerase chain reaction (PCR) that allows simultaneous (i.e. in real-time) amplification and detection of DNA templates. Because it is used to quantitate DNA, it is often abbreviated to qPCR, although that abbreviation is not universally accepted.
PCR played an important rule in the Omnibus. PCR was used in attempts to identify measles in tissue samples taken from autistic children’s bowels. One of the key papers for the families in the Omnibus was written by Uhlman et al. Potential viral pathogenic mechanism for new variant inflammatory bowel disease. The Uhlman paper concluded “The data confirm an association between the presence of measles virus and gut pathology in children with developmental disorder. ” One of the co-authors on that paper is Professor J J O’Leary, whose laboratory, Unigenetics, performed the tests on samples sent from the group headed by Andrew Wakefield in London. The same laboratory was used to test samples taken from Michelle Cedillo.
The presence of measles virus in the tissues is key to the theory argued in the Omnibus. This was made very clear when the expert reports were filed, in February of 2007. At that time, the Department of Justice attorneys sought information to rebut the “persistent measles in the gut” argument. One source they sought was information filed in the United Kingdom for the MMR litigation that was held there. In specific, they sought the report by Prof. Bustin, who had testified in that litigation. Those reports are sealed and require special permission to obtain. The DoJ attorneys received the first of those reports on May 31, 2007, 1 hour after receiving it, but only 12 days before the start of the Cedillo hearing. One week later, the DoJ filed two more reports by Prof. Bustin.
The attorney’s for the Cedillo family argued that they didn’t have time to assimilate such technical information and prepare a good response. Further, they argued that the reports were submitted after a deadline imposed by the Special Master. The Special Master allowed Prof. Bustin to testify and to submit his expert reports. The Special Master argued that the admissibility of the testimony and reports could be decided after the hearings.
This history and greater detail are summarized in the Wheeler decision denying the first Cedillo appeal.
Was Prof. Bustin’s Testimony Damning to the Case?
Professory Bustin is possibly the word’s number one expert on PCR. Not only that, he was given access to the Unigenetics laboratory and the notebooks they kept. He found that the Unigenetics laboratory was missing a key step in the process. PCR tests DNA. Measles is an RNA virus. So, there must be a step to turn the RNA into DNA or PCR won’t work.
At the time Unigenetics were testing samples for the Uhlmann paper and the sample from Michelle Cedillo, they weren’t using RNA–>DNA step. Whatever they were detecting, it wasn’t an RNA virus and, hence, it wasn’t measles.
Prof. Bustin also testified that at that time Unigenetics was not using “controls” correctly, making interpretation of their results problematic at best.
Prof. Bustin also testified that the laboratory notebooks had been altered after the fact.
Prof. Bustin also testified that Unigenetics found the same results from two different types of samples (fresh-frozen and formalyn fixed). That could only happen if they were detecting contaminants.
And the list of errors at Unigenetics goes on. (There is an extensive summary in the Hastings decision for the Cedillo case)
These are only parts of the testimony. But, yes, it is safe to say that Prof. Bustin’s testimony hurt the case the attorneys for the Cedillos were trying to make.
Would the case have been decided for the Cedillos had Prof. Bustin’s testimony been excluded?
As noted at the outset of this piece, Prof. Bustin’s testimony is not key to the decision to deny the claim of the Cedillo family. It also isn’t key to denying the question of general causation (does MMR, in general, cause autism).
Special Master Hastings has a section of his decision entitled, “Even if I were to disregard Dr. Bustin’s expert reports and hearing testimony, all my conclusions in this case would remain the same.” I quote that section in its entirety below:
Finally, even if I were to completely exclude and disregard all of Dr. Bustin’s reports and all of his hearing testimony, nevertheless all of my conclusions in this case would remain exactly the same.
First, the testimony and reports of Dr. Bustin were relevant chiefly in establishing my conclusion discussed at pp. 58-60 above, i.e., that there were severe problems with the facilities and procedures of the Unigenetics laboratory. But even concerning this narrow point, Dr. Bustin’s testimony was not the only evidence. Dr. Rima provided extensive, convincing evidence to the same effect, and Dr. MacDonald provided some corroboration as well. (See discussion at pp. 52-54, 58-59 above.) I would have reached the same conclusion, that there were severe problems with the Unigenetics facilities and procedures, based just on the evidence supplied by Dr. Rima and Dr. MacDonald, even without any information from Dr. Bustin.
Second, even if there had been no testimony from Dr. Bustin, Dr. Rima, Dr. MacDonald, or any other expert who participated in the British litigation, concerning the problems with the Unigenetics procedures and facilities, nevertheless I still would have concluded that the Unigenetics testing was not reliable. That is, as explained above (p. 77), the most important points in my rejection of the Unigenetics testing were (1) the fact that the laboratory failed to publish any sequencing data to confirm the validity of its testing, (2) the failure of other laboratories to replicate the Unigenetics testing, and (3) the demonstration by the D’Souza group that the Uhlmann primers were “nonspecific.” The testimony by Drs. Bustin, Rima, and MacDonald, about the many problems with the Unigenetics laboratory and procedures, was merely a secondary, additional reason to doubt the reliability of the Unigenetics testing. Accordingly, I would still have found the Unigenetics testing to be unreliable even if there had been no reports or testimony at all from Drs. Bustin, Rima, or MacDonald.
Accordingly, for all the reasons set forth above, I conclude (1) that there is no valid reason for me to disregard the evidence supplied by Dr. Bustin, and (2) that even if I did disregard that evidence, my conclusions concerning all of the issues in this case would remain the same.
Testimony of Nicholas Chadwick
One reason that the Special Master could be so decisive on the unreliability of the Unigenetics laboratory was the fact that other groups were unable to replicate those findings. One of those researchers was Nicholas Chadwick, a post doctoral researcher in Wakefield’s own group. Dr. Chadwick used PCR to test biopsy samples from autistic children–many of whom were a part of the now-retracted Lancet paper by Wakefield’s team–and found that they were negative for measles virus.
Dr. Chadwick’s Ph.D. thesis includes results from “Autistic enteropathy samples. Biopsies, PBMCs and Vero/PBMC cocultures were analysed from 22 patients with autistic enteropathy and 6 controls.”
He found
Results. Hybrid capture and RT-PCR could detect 104 molecules of a measles RNA transcript added to control tissue homogenates. The fidelity of NASBA, in terms of its nucleic acid error rates, was found to be comparable with that of RT-PCR. All samples were found to be positive for a housekeeping RNA species and internal modified positive control RNA. None of the samples tested positive for measles, mumps or rubella RNA, although viral RNA was successfully amplified in positive control samples.
Conclusion. The results do not support previous data implicating persistent measles virus infection with the aetiology of IBD or autistic enteropathy.
He studied gut biopsy samples, cerebral spinal fluid samples and blood samples.
This isn’t a separate group and different children. This is Mr. Wakefield’s own hospital, someone he was in contact with. It is likely that some of these children’s samples were also tested by Unigenetics and with false positive results.
Dr. Chadwick’s expert report and testimony are online.
Should Prof. Bustin’s Testimony have been Allowed?
Prof. Bustin’s report was submitted very close to the start of the Cedillo hearing. In fact, it was past a deadline imposed by the Special Master. The attorneys for the Cedillos have argued that they were unable to prepare a response to such a technical report and that they didn’t have access to the lab notebooks which Prof. Bustin relied upon.
Let’s take this in stages.
First, yes the report was submitted past the deadline. So were reports submitted by the attorneys for the Cedillos. The vaccine court is supposed to be flexible in allowing evidence in.
How about the idea that the attorneys for the Cedillos were unable to prepare a case in time? First, page back and recall how all this got started. The Cedillo’s attorneys submitted expert reports which relied upon the results of the Unigenetics laboratory results. Not only that, but the expert who submitted that report, Dr. Ronald Kennedy. Kent Heckenlively, blogger for the Age of Autism, wrote in a post following Prof. Kennedy’s testimony, “Dr. Kennedy is familiar with the Unigenetics Lab of Dr. John O’Leary and Dr. Laura Shields at Trinity College in Dublin, Ireland where measles virus RNA was diagnosed in the cerebral spinal fluid of Colten Snyder.” (Colten Snyder was one of the other “Test Cases”)
So, the attorneys for the Cedillos not only had an expert on their team to discuss PCR, but their expert was familiar with the Unigenetics laboratory. Their report was filed four months before Stephen Bustin’s reports and, presumably, their team had access to information from well before that.
How about the idea that the attorneys for the Cedillos didn’t have access to the lab notebooks which Prof. Bustin reported upon? First, it is clear that Prof. Bustin’s analyses did not rely solely on the lab notebooks. Some of the problematic results were public (from the paper) and other information he obtained in his 1,500 hours spent analyzing the Uhlmann work. Yes, 1500 hours.
The whole argument begs the question: how are the Cedillo’s attorneys and their expert (Prof. Kennedy) so confident of the Uhlmann results if they haven’t seen the notebooks?
One of those attorney’s is quoted:
Chin-Caplan told Examiner.com, “Two reports that he submitted on behalf of the government were of such technical matter and so incomprehensible that at the very least a motion to continue the hearing should have been entertained and it wasn’t.”
I am again at a bit of a loss. Why were Ms. Chin-Caplan and her team unprepared to respond to Prof. Bustin’s reports? She and her team were the ones who were admitting PCR testing as evidence.
Ms. Chin-Caplan is also quoted:
“The fact that they went over there (to the U.K.) secretly four months before the hearing to try and get these documents without giving me notice that they were going to do this leads me to think that they wanted to examine those documents without me being present,” Chin-Caplan told Examiner.com. “And that violates the concept of fundamental due process as far as I’m concerned.”
The idea of obtaining information from the U.K. litigation was not a surprise to the Cedillo’s attorneys. They had attempted as early as 2004–three years before the hearing–to obtain reports from the U.K. The idea that the DoJ attorney’s “wanted to examine those documents wihout me being present” is totally at odds with the fact that the DoJ submitted the first report 1 hour after receiving it. One hour.
One might ask why Ms. Chin-Caplan didn’t call upon, say, Andrew Wakefield or others to write reports or to serve as an expert witness. Mr. Wakefield is on the list of potential experts. Mr. Wakefield is one of the authors of the Uhlmann paper. Of course, the answer is that Mr. Wakefield, father of the MMR causes autism hypothesis, is not a very credible witness.
Friend of the Court Brief
Much of the argument for the appeal is summarized in a “Friend of the Court” brief.
That brief concentrates much space to the reliability of the O’Leary lab results. It introduces new “data”
Michelle submitted further compelling evidence of the reliability of the O’Leary lab results in her motion for reconsideration. She submitted a new study on the recovery of measles RNA from the gut tissue of autistic children. The multi-center Hornig study,57 relying on laboratories at HHS’s own Centers for Disease Control, Columbia University and Dr. O’Leary’s laboratory at Trinity College were all concordant in finding measles RNA in one clinical subject and one control, again showing the O’Leary laboratory’s reliability.
The Hornig study was an attempt to recreate some of the Wakefield group’s studies. The study was much more careful than Wakefield’s team’s efforts. It was discussed on this blog at that time.
I am always amazed when people try to use the Hornig study to support the MMR-causes-autism hypothesis. The paper concluded:
This study provides strong evidence against association of autism with persistent MV RNA in the GI tract or MMR exposure
As far as supporting the idea that the O’Leary laboratory was reliable, it is far from convincing. There is a vast difference between how a laboratory performs in, say, the late 1990’s and ten years later after facing much criticism and while under intense scrutiny for accuracy. In other words, it is very possible that the O’Leary laboratory’s methods were different for the Hornig study than used for the Wakefield/Uhlmann studies.
Summary
It seems unlikely to this observer that the Cedillos will win this appeal. They rely on discounting the testimony of Stephen Bustin. The arguments to throw out his testimony have not proven persuasive in a previous appeal. More importantly, the Court made it extremely clear that the decision would be the same whether or not Prof. Bustin’s testimony was allowed. The public statements being made about this appear to be coloring the facts somewhat to create an image of impropriety by the government. Also, those making public statements appear to ignore the fact that even without Prof. Bustin’s testimony, the case was not close.
At every step along the process of the Omnibus Proceedings, public statements have been heard suggesting the families had a strong case. In my opinion, this has been a disservice to those families. I worry that this is yet another instance of building up false hope for the families in the Omnibus.
I just received this notice. The Interagency Autism Coordinating Committee (IACC) prepares the “Strategic Plan” for the government’s efforts in autism research and is charged with advising the Secretary of Health and Human Services on issues involving autism
The Interagency Autism Coordinating Committee (IACC) Subcommittee for Planning the Annual Strategic Plan Updating Process and the IACC Services Subcommittee will be holding a joint conference call to discuss plans for a fall 2010 IACC Scientific Workshop on the topic of ASD services on Friday, June 18, 2010 from 10:00 AM – 12:00 PM ET.
The purpose of the conference call is to discuss plans for a fall 2010 IACC Scientific Workshop on ASD services research.
Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard. This phone call may end prior to or later than 12:00 PM, depending on the needs of the subcommittees.
To access the conference call:
USA/Canada Phone Number: (800) 369-3340
Access code: 8415008The latest information about the meeting can be found at: http://iacc.hhs.gov/events/2010/subcommittee-for-planning-the-annual-strategic-plan-updating-process-mtg-announcement-June18.shtml
You received this announcement because you attended a previous meeting of the IACC or joined the IACC mailing list. We apologize for duplicate notices. For more information on this meeting, or the IACC, please visit: http://iacc.hhs.gov/
The IACC also can now be found on Twitter (www.twitter.com/IACC_Autism).
Please note: The meeting may end prior to or after 12:00 PM, depending on the needs of the committee.
Andrew Wakefield has been much in the news lately. “Much” is a relative term. He hasn’t been in the news to the level of his hey-day when the his MMR hypothesis was new and given some credibility. But with the decision of the GMC to remove him from the medical register, he has been back in the news. Mr. Wakefield apparently decided to ride this expected wave of publicity by timing his book to coincide with the decision.
Mr. Wakefield’s book tour was not very extensive, and involved some minor and strange outlets, including “Coast to Coast“, a late-night American radio show that bills itself as “Coast to Coast AM – UFOs, strange occurrences, life after death and other unexplained phenomena. Overnight talk radio with daytime ratings”
His tour has not gone unnoticed by the mainstream media. The Sunday Telegraph has a story about him (unfortunately not online as yet):
Needle and Dread
In Britain he’s been struck off and widely discredited. In the US Andrew Wakefield, MMR Pariah, has been reborn–as an unapologetic figurehead for the ‘anti-vaccine’ movement. It’s a long way from Harley Street, reports Alex Hannaford.
If that title isn’t clear enough, the article opens with a picture of Mr. Wakefield with the caption: “Poster boy Andrew Wakefield continues to spark religious-like fervour among supporters
Once, Mr. Wakefield was able to obtain favorable press at least somewhere in the mainstream press.
Times have changed.
A recent study by the autism genome project has been gathering a lot of publicity. Kev interviewed one of the principle investigators. But, we haven’t really presented a discussion of the science here. With that introduction, you might be surprised to read: and that isn’t going to change. A few good presentations have been written on this paper. Far better presentations than I can do. So I will refer you to:
The Simons Foundation SFARI blog has Autism marked by copy number changes in coding regions. (note: I added this link after the initial publication of this blog post)
P.Z. Myers in Autism and the search for simple, direct answers and Respectful Insolence with, More evidence for a genetic basis for autism.
The paper itself is Functional impact of global rare copy number variation in autism spectrum disorders, appears in the journal Nature.
Here is the abstract:
The autism spectrum disorders (ASDs) are a group of conditions characterized by impairments in reciprocal social interaction and communication, and the presence of restricted and repetitive behaviours1. Individuals with an ASD vary greatly in cognitive development, which can range from above average to intellectual disability2. Although ASDs are known to be highly heritable (~90%)3, the underlying genetic determinants are still largely unknown. Here we analysed the genome-wide characteristics of rare (<1% frequency) copy number variation in ASD using dense genotyping arrays. When comparing 996 ASD individuals of European ancestry to 1,287 matched controls, cases were found to carry a higher global burden of rare, genic copy number variants (CNVs) (1.19 fold, P = 0.012), especially so for loci previously implicated in either ASD and/or intellectual disability (1.69 fold, P = 3.4?×?10-4). Among the CNVs there were numerous de novo and inherited events, sometimes in combination in a given family, implicating many novel ASD genes such as SHANK2, SYNGAP1, DLGAP2 and the X-linked DDX53–PTCHD1 locus. We also discovered an enrichment of CNVs disrupting functional gene sets involved in cellular proliferation, projection and motility, and GTPase/Ras signalling. Our results reveal many new genetic and functional targets in ASD that may lead to final connected pathways.
Stephen Scherer is co-author on the recent paper ‘Functional impact of global rare copy number variation in autism spectrum disorders‘. I caught up with him via email to ask a few questions:
1) What is the ‘bottom line’ message readers can take away from your work?
I am always frustrated when I hear at the end of most news stories…’and we don’t know what can cause autism’. Data from the past few years including our new study show alterations in genes can cause autism. We have not found all of the genes yet, and not all autism cases can be accounted for (the genetics can be complex) but genes can cause autism. For the specialists, through our new study we show either de novo or rare inherited copy number variations as one form of genetic alteration involved in autism. The genes affected are often linked together in a connected functional pathway and may of these molecules dictate how brain cells (neurons) develop and communicate. Some of the autism genes we found have already been found to cause intellectual disabilities, which is not entirely surprising since many individuals with autism also have these challenges.
2) How does your paper tie in with other gene/autism studies?
We validate many previous findings, but also find dozens and dozens of new autism risk genes. Our data furthers the hypothesis that rare genetic alterations contribute much more relative risk to developing autism than common genetic variations.
3) What should future researchers use your study for in terms of direction to take their own work?
I think one of the most important impacts of the study is the design itself. Nature really wanted us to include the Figure 1, which outlines the design and analysis. CNV studies are still quite tricky to do and the data has to be of the highest quality to make sense of it. I think our study on autism will set the standard for all other studies going forward, so they should follow it. Moreover, many of the functional pathway studies published before may have been either underpowered, flawed by low resolution arrays or high false discovery rates, or incomplete study designs. We spent alot of time thinking of how to best do this properly so if others are interested they should read the Supplementary Information carefully. Use it as a guide. Finally, for the functional biologists look at the long list of genes we present in the Supplementary Information since they may find their favorite gene to be an autism candidate gene!
4) How difficult was it managing the input from such a very large amount of co-authors?
The Autism Genome Project has some 120 scientists from 11 countries involved (see the authorship list). We selected a ‘writing team’ comprised of genome scientists, statisticians, medical geneticists, psychiatrists and developmental pediatricians. Interesting, everyone saw their own story in the data. I pretty much new in advance what I wanted to see in the final manuscript so much of my job was bring focus to the many other good ideas (note that there are five other papers spinning out of this larger study presenting some of these other data and interpretations). In took about 12 solid months of analysis of the data, three months of writing and editing, alot of cursing, and then submission to Nature (with even more cursing). The review time from submission to publication took ~six months. This was the hardest for me (except other than constantly changing the author list….and affiliations). The reviewers were very very thorough and Nature can (rightfully) be very demanding. In the end we are very proud of the manuscript. Dalila Pinto who is the first author and a post-doc in the lab was the driving force behind the analysis and deserved a lions-share of the credit. Would I do it again? I’ve had two Senior Author papers in Nature this year, which have been very draining. But I would do it again!
Much time is spent discussing whether a study of autism and vaccination status could or should be undertaken. Generation Rescue has been trying to get funding for such a study, but their proposal is weak and vague. The question arises, why doesn’t any group with real strong credentials consider this project?
Would you be surprised to find out that it is already ongoing? And that the principle researcher is someone with mainstream credibility?
It turns out that potential environmental causation of autism, including vaccines, are a part of a study which (if all went according to schedule) just finished the data collection phase. The NIH funded project, GENE-ENVIRONMENT INTERACTIONS IN AN AUTISM BIRTH COHORT, was headed by Prof. Ian Lipkin of Columbia University. The project started in 2003 and was prospectively monitoring a cohort of children diagnosed with ASD’s and another cohort of controls.
The project is discussed below:
Reports of increasing prevalence of autism spectrum disorders (ASDs), a set of highly genetic conditions, are intensifying interest in the role of environmental exposures, including infectious, immune, and toxic factors. Retrospective studies exploring associations between environmental factors and ASDs are compromised by selection bias, small sample sizes, possibly invalid diagnosis, and absence of biologic measures. This prospective study will employ an unselected birth cohort of 75,500 in which cases are ascertained through screening of the entire population, diagnoses established using uniform procedures, extensive histories and clinical data obtained, and biologic samples collected serially throughout pregnancy and early childhood. The application of high throughput laboratory assays to derive maximal information from developmentally-influenced, finite, and nonrenewable biologic samples, and inclusion of early screening and diagnostic assessments, will permit an unprecedented, rich view of the longitudinal trajectory and nascent signs and symptoms of ASDs, facilitate discovery of biomarkers, and afford unique insights into the role of gene:environment interactions in ASD pathogenesis. Specific aims are to: (1) establish the autism Birth Cohort (ABC) through ascertainment of cases of autism spectrum disorder (ASD, N=150-233) and selection of controls (N-1000) from the Norway Mothers and Child (MoBa) cohort; (2) examine biologic pathways that may predispose to ASD, through evaluation of immune, endocrine, and neuroregulatory factors in mothers during early gestation or at birth and in children, at birth or 30 months postnatal; (3) identify environmental factors that may be directly or indirectly associated with ASD, including pre- or postnatal infection, vaccination, very low birth weight or other obstetric risk factors in which infections are implicated, dietary and/or environmental exposure to methylmercury; (4) describe the natural history of clinical, anthropometric, and neurobehavioral features of ASD; and (5) explore genotypic influences that may be directly or indirectly associated with ASD by testing associations of ASD and/or its endophenotypes with family history of autoimmune disease or selected candidate genes, and investigating conditional gene-environment effects using antecedent factors found to influence ASD risk.
Emphasis added.
Prof. Lipkin was a member of the team which looked at children with gastrointestinal disorders, Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study. Amongst other findings, they found that (a) regression was not correlated with MMR vaccination and (b) persistent measles infections are not present in the guts of autistic kids more than in non-autistic kids. Basically it was the study that most closely replicated some of Mr. Wakefield’s team’s efforts and showed that Mr. Wakefield’s results were not reproducible.
Another study, THE CHARGE STUDY: CHILDHOOD AUTISM RISKS FROM GENETICS AND THE ENVIRONMENT, includes “vaccines” in the project terms. This study has been funded to the tune of about US$5,000,000 and is headed by Prof. Irva Hertz-Picciotto, who has stated that vaccines should be considered for research into autism causes.
If you are wondering if mercury is being investigated, AUTISM IN A FISH EATING POPULATION continues study on methyl mercury exposures in the Seychelles. Also, the University of Washington has a study ongoing, NEUROIMMUNOTOXICOLOGY OF MERCURY. Johns Hopkins has a study now going on 4 years, GENETIC SUSCEPTIBILITY TO MERCURY-INDUCED IMMUNE DYSFUNCTION IN AUTISM & ASD. Also, the University of Texas has a study, EPIDEMIOLOGICAL RESEARCH ON AUTISM IN JAMAICA, which also is monitoring heavy metal exposures.
I have two questions. First, why do groups like Generation Rescue, SafeMinds, the National Autism Association and TACA claim that vaccine-autism and mercury-autism research isn’t being done? They are represented on government committees. Second, what do they hope to learn from doing their own study that isn’t going to be done better and sooner by other groups?
A very broad coalition of disability groups has sent a letter to the secretary of the U.S. Department of Health and Human Sevices, Kathleen Sebelius. Amongst those groups is the Autistic Self Advocacy Network (ASAN). A statement from ASAN in an email announcing this letter is below:
In the United States, people with disabilities often face barriers to obtaining adequate health care, and one of the major difficulties is a lack of adequately trained primary care providers. The Autistic Self Advocacy Network has signed a joint letter from cross-disability organizations calling on the U.S. Health Resources and Services Administration to include representation of the cross-disability community in designating medically underserved populations. The letter has been published on the main ASAN website
The letter in full is reproduced here:
June 9, 2010
To:
Kathleen Sebelius
Secretary
Health and Human ServicesMary Wakefield
Administrator
Health Resources and Services AdministrationPam Hyde, JD
Administrator
Substance Abuse and Mental Health AdministrationWe the undersigned disability advocacy groups urge you to include representation of the cross-disability community on the Negotiated Rulemaking Committee (NR) that will establish a comprehensive methodology and criteria for designation of “Medically Underserved Populations” (MUPS) and Primary Care Health Professions Shortage Areas. As a cross-disability community, we are stakeholders in the task you will undertake. However, we do not fit within the geographic census track data that has been used in the past to designate medically underserved populations. More than 54 million Americans with disabilities, including individuals with physical, mental health, sensory, environmental, cognitive, intellectual, and developmental disabilities experience inadequate health care because of a lack of primary care providers trained to treat them. In 2000, Healthy People 2010, cautioned that “as a potentially underserved group, people with disabilities would be expected to experience disadvantages in health and well-being compared with the general population.” They have and the data is startling.
Basic primary care is not a guarantee for anyone in the disability community. (Drainoni M, Lee-Hood E, Tobias C, et al., 2006) Three out of five people with serious mental illness die 25 years earlier than other individuals, from preventable, co-occurring chronic diseases, such as asthma, diabetes, cancer, heart disease and cardiopulmonary conditions. (Colton & Manderscheid, 2006; Manderscheid, Druss, & Freeman, 2007) Inaccessible medical equipment and lack of trained physicians, dentists, and other health professionals prevent individuals with disabilities from receiving the basic primary and preventive care others take for granted, such as getting weighed, preventative dental care, pelvic exams, x-rays, physical examinations, colonoscopies, and vision screenings. (Kirschner, Breslin, & Iezzoni, 2007; Chan, Doctor, MacLehose, et al. (1999); Manderscheid R., Druss B., & Freeman E . 2007).
People who are deaf or experience significant problems hearing report they were three times as likely to report fair or poor health compared with those without hearing impairments. (NCD, 2009). They have difficulty communicating with primary care providers who don’t want to pay interpreters or “bother” with a Telecommunication Device for the Deaf (TDD). Children with ADD may have difficulty getting examined by primary care providers untrained to treat them. People with significant vision loss are more likely to have heart disease and hypertension, experience a greater prevalence of obesity, and smoke more than the general population. (NCD, 2009). Further, people who are blind often miss out on the prevention handouts and booklets given to patients by primary care providers. Even providers report they have difficulty communicating with patients who are deaf or have severe visual impairments. (Bachman S., Vedrani, M., Drainoni, M., Tobias, C., & Maisels L., 2006)
27% of adults with major physical and sensory impairments are obese, compared with 19% among those without major impairments (Iezzoni, 2009). Research shows that individuals with intellectual disabilities must contact 50 physicians before they can find one trained to treat them. (Corbin, Holder, & Engstrom, 2005)
According to the National Council on Disability (NCD), 2009 report, The Current State of Health Care for People with Disabilities, “[p]eople with disabilities experience significant health disparities and barriers to health care, as compared with people who do not have disabilities.” Further, “[t]he absence of professional training on disability competency issues for health care practitioners is one of the most significant barriers preventing people with disabilities from receiving appropriate and effective health care.”
Members of the disability community experience a broad spectrum of functional limitations that result from their disabilities. Many experience secondary chronic conditions. As the recent draft “A Strategic Framework 2010-2015 – Optimum Health & Quality of Life for Individuals with Multiple Chronic Conditions “ by the HHS Working Group on Multiple Chronic Conditions” (May, 2010) reported, functional limitations can often complicate access to health care and interfere with self-management. The Institute of Medicine noted there is evidence that patients actively receiving care for one chronic condition may not receive care for other unrelated conditions.
The 1997 IOM report Enabling America bluntly stated that federal research effort in the area of disability was inadequate. On July 26, 2005, the U.S. Surgeon General issued a Call to Action warning that people with disabilities can lack equal access to health care. Though some funds are available for developmental and intellectual disabilities through the CDC, Maternal and Child Health, and the Developmental Disabilities Act, the 2007 IOM report, The Future of Disability in America states that research spending on disability is miniscule in relation to current and future needs. In this Report the IOM also warns that the number of people with disabilities is likely to rise, fueled by aging baby boomers.
We need to assure adequate numbers of primary care providers are trained to treat the population of people with disabilities; people with disabilities from across the disability community have access to adequate primary care; and funding is available for research and programs to end the health disparities people with disabilities face. With the passage of health care reform and the formation of the NR Committee to redefine “medically underserved populations,” HRSA can finally work to rectify the problem for all people with disabilities. Collectively, we are an underserved population and we are not adequately represented on the proposed NR Committee. We urge you to appoint someone to represent the cross-disability community, recognize people with disabilities as a constituency stakeholder within the definition of medically underserved populations, and include subject matter experts who represent the health care needs of the cross-disability community. Our groups are glad to serve as resources for HRSA. Thank you. (References below signatures.)
Sincerely
Access Living
ADAPT
ADAPT Montana
Alpha-1 Association
Alpha-1 Foundation
American Association of People With Disabilities
American Association on Health and Disability
Amputee Coalition of America
American Medical Rehabilitation Providers Association
American Network of Community Options and Resources
American Speech-Language-Hearing Association
The Arc of the United States
Association of Maternal & Child Health Programs
Autistic Self-Advocacy Network
Bazelon Center for Mental Health Law
Brain Injury Association of America
Bronx Independent Living Services
California Foundation Independent Living Centers
Center for Disability Rights (Rochester)
Center for Independence of the Disabled, NY.
Center for Self-Determination
Center for Women’s Health Research at UNC
CHADD – Children and Adults with Attention-Deficit/Hyperactivity Disorder
COPD Foundation
Council for Exceptional Children
Disability Health Coalition
The Disability Network
Easter Seals
The Epilepsy Foundation
First Signs
Hearing Loss Association of America
Life Skills Institute and Life Skills, Inc
Little People of America
Mental Health America
National Association of County Behavioral Health and Developmental Disability Directors
National Association of Head Injury Administrators
National Association of Councils on Developmental Disabilities
Khmer Health Advocates, Inc.
National Coalition for Mental Health Recovery
National Council on Independent Living (NCIL)
National Down Syndrome Society
National Organization of Nurses with Disabilities
National Association of Private Special Education Centers
National Association of the Deaf
National Center for Environmental Health Strategies, Inc.
National Multiple Sclerosis Society
National Spinal Cord Injury Association
New York Association of Psychiatric Rehabilitation Services
Not Dead Yet
Physician-Parent Caregivers
Regional Center for Independent Living (Rochester, NY)
Rochester ADAPT
Spina Bifida Association
Statewide Independent Living Council of GA, Inc.
Stop CMV – The CMV Action Network
Substance Abuse Resources and Disabilities Issues Program (SARDI), Boonshoft School of Medicine
TASH
Tourette Syndrome Association
Tuberous Sclerosis Alliance
Master of Public Health Program, Tufts University School of Medicine
United Cerebral Palsy
United Spinal Association
Center on Independent Living, University of KansasReferences:
Bachman S., Vedrani, M., Drainoni, M., Tobias, C., Maisels L., , Provider Perceptions of Their Capacity to Offer Accessible Health Care for People With Disabilities J Disabil Policy Stud.; Winter 2006; 17, 3; 130-136
Chan L, Doctor JN., MacLehose RF., et al. (1999) Do Medicare patients with disabilities receive preventive services? Arch Phys Med Rehabil. 80:642-646
Colton CW., Manderscheid RW.. (2006, April). Congruencies in increased mortality rates, years of potential life lost, and causes of death among public mental health clients in eight states. Preventing Chronic Disease: Public Health Research, Practice and Policy. 3(2), 1-14. Available at http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=16539783.
Corbin S., Holder M., Engstrom K. (2005) Changing attitudes, changing the world: the health and health care of people with intellectual disabilities. Washington, D.C.: Special Olympics International.
Drainoni M, Lee-Hood E, Tobias C, Bachman S, Andrew J, Maisels L. (2006) Cross-disability experiences of barriers to health-care access. J Disabil Policy Stud. 17:101-115.
HHS Working Group on Multiple Chronic Conditions. (2010, May) Strategic Framework 2010-2015 – Optimum Health & Quality of Life for Individuals with Multiple Chronic Conditions. (Draft) Available online at:
Iezzoni, L.I., (2009, January 27) Testimony before the Senate Health, Education, Labor, and Pensions Committee, by Lisa I. Iezzoni, MD, Professor of Medicine, Harvard Medical School and Associate Director, Institute for Health Policy, Massachusetts General Hospital, Boston, MA.
Iezzoni LI, McCarthy EP, Davis RB, Siebens H. Mobility impairments and use of screening and preventive services. Am J Public Health. 2000;90:955-961.
Institute of Medicine, (1997) Enabling America, National Academies Press, Washington, DC
Institute of Medicine, (2007) The future of disability in America. National Academies Press, Washington, DC.
Kirschner K.L., Breslin, ML., Iezzoni, LI., (2007, March 14) Structural impairments that limit access to health care for patients with disabilities. JAMA,. 297:10:1121-1125
Manderscheid R., Druss B., Freeman E . (2007, August 15). Data to manage the mortality crisis: Recommendations to the Substance Abuse and Mental Health Services Administration. Washington, D.C.
National Council on Disability (NCD), (2009) The Current State of Health Care for People with Disabilities. Available online at: http://www.hhs.gov/ophs/initiatives/mcc/federal-register051410.pdf
US. Department of Health and Human Services. Health People 2010. 2nd ed. With Understanding and Improving Health, and Objectives for Improving Health. 2 Vols. Washington, DC: U.S. Government Printing Office, November 2000
Reginald Latson, an 18-year-old Virginia man with Asperger’s syndrome, faces one count of malicious wounding of a law enforcement officer, one count of assault and battery of a law enforcement officer, and one count of knowingly disarming a police officer in performance of his official duties, following an incident in a high school parking lot.
Stafford County deputies received a report of an armed person outside of a library, which prompted a lock down of six schools in Stafford County, including a high school.
Stafford County Sheriff’s Office spokesman Bill Kennedy says it all began at 8:38 a.m. with the report of an armed person in the parking lot of a library across from Park Ridge Elementary. The threat prompted a lockdown of six schools in Stafford County, including the high school, which is separated from the library and elementary school area by a wooded area.
Kennedy says deputies saturated the area after the call. About 20 minutes later, a Stafford High School resource officer spotted a man matching the description of the lookout. While the man was being questioned, he became irate and attacked the school resource officer, who is also a sheriff’s deputy, investigators said.
The man repeatedly struck the deputy, who pepper-sprayed the man, according to the Sheriff’s office. During the struggle, the assailant was able to wrest the pepper spray for the deputy and sprayed him, investigators said.
The man then fled. The deputy, Thomas Calverley, suffered head laceration, cuts, abrasions and a broken ankle. He was scheduled for surgery on the ankle this afternoon.
Latson was located in the woods about 45 minutes later by a canine officer and his dog, Vader. Investigators never found a gun, and now say the initial caller never actually saw a weapon.
Latson is currently being held at the Rappahannock Regional Jail under no bond.
You can read more about the case at this website started by Neli’s family.
“The actions that were taken by the police that day were excessive in the least and grossly mishandled,” writes Neli’s mother. “Someone says I see a suspicious black male and he “could” have a gun, while all my son was doing was sitting in the grass at the library. And you shut down six schools and go out on a manhunt for this dangerous black man who was sitting in the grass. Anyone reading this story can read between the lines and see that this just doesn’t add up.”
You can read the Stafford County Sheriff Dept. news release here.
I have to ask–did that make you cringe? Are you thinking, “Now what?” Here’s the story: a kid was choking in a school cafeteria. A teacher tried to help but was failing. In rushed in Marken Suaza, a 9 year old diagnosed with Asperger syndrome, to perform the Heimlich maneuver.
Story is here, Boy With Autism Saves Choking Friend.
Somehow that story hit a good spot today for me.
Left Brain Right Brain 
Recent Comments