Archive | September, 2008

The IOM and "completely expressed concerns"

11 Sep

If you’ve read my previous posts Dr. Bernadine Healy, you know I have some pretty serious concerns about how she represented the way the Institute of Medicine operated when they produced their report on Vaccines and Autism.  Those statements were made in interviews with Sharyl Attkisson.  Again, if you’ve been reading, you realize that Ms. Attkisson’s methods were a cause of concern for me as well.  I have voiced these concerns with CBS news via fax.

Dr. Healy made some pretty bold assertions, and Ms. Attkisson failed to even attempt to follow up on them.

The prime example is when Dr. Healy proposed that

…“There is a completely expressed concern that they don’t want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people. “First of all,” Healy said, “I think the public’s smarter than that. The public values vaccines. But more importantly, I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show.”

I’ve noted before, that a statement of that magnitude, calling into question the very methods and motives of the IOM deserved followup by Ms. Attkisson.  When someone makes a claim that an organization we all depend on to be independent and unbiased may have acted improperly, and unbiased reporter should make sure of the facts by checking with the real source before going ahead with the story.

Well, bloggers sometimes do the work that reporters fail to do.  In this case, AutismLibrary asked the IOM for comment on some of the way the IOM and its process in handling the 2004 Vaccines and Autism report have been portrayed.  Below (with permission) is the response that AutismLibrary received and blogged:

Thank you for your recent and very thoughtful message. As you know, the IOM’s Immunization Safety Review Committee most certainly did not suggest that scientific inquiry into the role of vaccines in autism should cease because the results could affect public perception of the value of childhood vaccinations. The public deserves better than that.

The committee’s 2004 report, Vaccines and Autism, states:

Determining causality with population-based methods such as epidemiological analyses requires either a well-defined at-risk population or a large effect in the general population. Absent biomarkers, well-defined risk factors, or large effect sizes, the committee cannot rule out, based on the epidemiological evidence, the possibility that vaccines contribute to autism in some small subset or very unusual circumstances. However, there is currently no evidence to support this hypothesis either.

After a paragraph in which the report follows that sentence with a discussion of the sparse literature regarding subsets of autism and the theoretical possibility of a vaccine-susceptible subpopulation, the report states:

While the committee strongly supports targeted research that focuses on better understanding the disease of autism, from a public health perspective the committee does not consider a significant investment in studies of the theoretical vaccine-autism connection to be useful at this time. The nature of the debate about vaccine safety now includes a theory that genetic susceptibility makes vaccinations risky for some people, which calls into question the appropriateness of a public health, or universal, vaccination strategy. However the benefits of vaccination are proven and the hypothesis of susceptible populations is presently speculative. Using an unsubstantiated hypothesis to question the safety of vaccination and the ethical behavior of those governmental agencies and scientists who advocate for vaccination could lead to widespread rejection of vaccines and inevitable increases in incidence of serious infectious diseases like measles, whooping cough, and Hib bacterial meningitis.

The committee urges that research on autism focus more broadly on the disorder’s causes and treatments for it. Thus, the committee recommends a public health response that fully supports an array of vaccine safety activities. In addition the committee recommends that available funding for autism research be channeled to the most promising areas.

Some readers have apparently failed to appreciate the full meaning and intent of the committee’s carefully written text. The report, as supported by the above-quoted paragraphs, clearly acknowledges the possibility that new information in support of hypotheses about susceptible subpopulations could emerge, at which time significant new research efforts might be appropriate. Whether the recent information about mitochondrial dysfunction will be the foundation for a major new research direction remains to be seen. The committee’s comment on the untoward consequences of discouraging vaccination was offered as an elaboration of their concerns about the unsubstantiated vaccine-autism hypothesis and not as support for their recommendations about an appropriate research agenda for understanding autism.

The scientists and clinicians on this committee evaluated the then-available scientific data in an unbiased manner. They reached their conclusions based on where the evidence led them. This principle—making recommendations only if supported by the evidence—guides all studies that IOM undertakes. I reiterate that the committee most certainly did not urge caution about pursuing the vaccine-autism connection in order to avoid frightening the public away from immunizations. The IOM stands ready to re-examine this issue should sufficient and relevant evidence emerge.

I almost put the entire last paragraph in bold for emphasis. Instead I’ll pull two lines out:

I reiterate that the committee most certainly did not urge caution about pursuing the vaccine-autism connection in order to avoid frightening the public away from immunizations

and

The IOM stands ready to re-examine this issue should sufficient and relevant evidence emerge

I read this as: there were no “completely expressed concerns” that affected the IOM’s study and that although they recommended rejecting the vaccine/autism hypotheses (thimerosal and MMR), they haven’t “turned their backs” on the subject. Should good research come forward (as with any subject in science) they will look again.

I do have one simple question: Shouldn’t Sharyl Attkisson approached the IOM for comment before going forward with this story?

IACC Strategic Plan: How can I understand what is happening

10 Sep

We have discussed the IACC Strategic Plan before. They are looking for feedback. We’ve looked at the issues of vaccines, and the first section “When should I be concerned” already.

The second major section of the IACC draft Strategic Plan looks at the question of understanding what is autism.

Again, I am only pulling out the “Research Opportunities” and the “Goals” sections to keep this brief. Please, take a look at the entire document if you have the chance.

That said, I will take the first paragraph from the introduction to this section:

One of the greatest barriers to progress in determining the biological bases of ASD has been the heterogeneity of the spectrum. A clear need exists to advance understanding of the many phenotypes of ASD, including studies that link genotype to phenotype, investigations of natural and treated history, analyses of genetic interaction with environmental exposures, and studies of co-occurring medical conditions.

It’s a big (BIG) undertaking. Here is an outline of how they are going about this. Take a look and, please, send them comments. The IACC website has details, but, basically, it boils down to email them (use the link, the subject line is already filled in!).

Research Opportunities

• Multi-disciplinary, longitudinal, biobehavioral studies of children, youths, and adults beginning during infancy that characterize developmental trajectories and identify ASD risk factors, subgroups, and potential biological targets for intervention. Such studies could include:
o High-risk siblings of children, youths, and adults with ASD, children without a family history of ASD, and typically developing children
o Multi-disciplinary assessments of brain imaging, metabolic and immune markers, microbiomics, electrophysiology, and behavior

• Research on females with ASD to better characterize clinical, biological and protective features.

• Human and animal studies that examine immune, infectious and environmental factors in the occurrence of ASD.

• An international public-private collaboration to expand current postmortem brain and other tissue resources (e.g., skin fibroblasts) to increase the acquisition, quality, type and availability of biomaterials relevant to studying the pathology of ASD.

Short-Term Objectives

• Establish an international network of brain and other tissue (e.g., skin fibroblasts) acquisition sites with standardized protocols for phenotyping, collection and distribution of tissue by 2010.

• Support at least four research projects to identify mechanisms of metabolic and/or immune system interactions with the central nervous system that may underlie the development of ASD during prenatal-postnatal life by 2010.

• Launch three studies that specifically focus on the neurodevelopment of females with ASD by 2011.

Long-Term Objectives

• Complete a large-scale, multi-disciplinary, collaborative project that longitudinally and comprehensively examines how the biological, clinical, and developmental profiles of children, youths, and adults with ASD change over time as compared to typically developing individuals by 2020.
_______________________________________

In many ways, I could see this section getting the least attention from people responding. At the same time, it is the cornerstone for future research. Really, if we understand what is autism (in its many forms) won’t we have a better idea of how to treat it and how it originates?

Take a look and, if you have any thoughts, say “this looks good” or “you should include XXX in this section, email them.

Dan Olmsted suffers by comparison

9 Sep

Ever since his unexplained sudden departure from UPI, Dan Olmsted has been working on his Magnificent Octopus entitled ‘Mercury Rising’.

He keeps his keen investigative journalism skills to the fore by writing the occasional blog piece for Age of Autism. These skills have included the scintillating exposé

“Where are the autistic Amish?” he asked. “I have come here to find them, but so far my mission has failed, and the very few I have identified raise some very interesting questions about some widely held views on autism.”

Except that Dan Olmsted never visited Clinic for Special Children in Strasburg, where

Dr. Kevin Strauss, MD, a pediatrician at the CSC. “We run a weekly vaccination clinic and it’s very busy.” He says Amish vaccinations rates are lower than the general population’s, but younger Amish are more likely to be vaccinated than older generations.

Strauss also sees plenty of Amish children showing symptoms of autism. “Autism isn’t a diagnosis – it’s a description of behavior. We see autistic behaviors along with seizure disorders or mental retardation or a genetic disorder, where the autism is part of a more complicated clinical spectrum.” Fragile X syndrome and Retts is also common among the clinic’s patients.

This is backed up by the fact that in April of last year, a study was published that showed that the Amish vaccinate.

Responses were received by 225 (60%) of the 374 Amish households in the community with children aged <15 years. An additional 120 responses were received by households without children. A total of 189 (84%) households with children reported that all of their children had received vaccinations; 28 (12%) reported that some of their children had received vaccinations; and 8 (4%) reported that none of their children had received vaccinations.

Among all respondents who knew their own vaccination status, 281/313 (90%) reported that they had received vaccinations as children.

As we can see, Dan’s investigative journalism is of the highest order.

Today, he has decided to maintain his high standards by doing what he does best – speculating wildly. This time its an absolute doozy.

Determined to hang on to the thiomersal idea at all costs (despite the fact that thiomersal has been out of all paediatric vaccines since 2002 and autism rates are still climbing in the US, just like the UK and just like Japan), Dan takes every bit of evidence that someone once walked past the house of a man who’s first cousin worked at a paint factory as highly suggestive of metal poisoning. In order to justify his new tome (entitled ‘mercury rising’ – don’t bother looking for it anywhere) he _has_ to keep interest in mercury up. Despite the fact that its quite clear to anyone with an ounce of common sense that the thiomersal hypothesis’ time has come and gone, without it, he has no book, hence no book deal, hence no prestige.

So, back to Dan’s latest genius reportage. Dan has just finished reading Autism’s False Prophets and is quite clearly not pleased with the coverage given to Kathleen.

Kathleen, you see, is everything that Dan Olmsted is not. He is slapdash, she is thorough. She checks sources, he thinks they’re what you pour on your dinner. She uncovers _actual_ wrongdoing, he thinks wrongdoing is solely confined to anyone with the title ‘Dr’.

Offit describes Seidel moving to New York City “where she met her future husband, a guitar player. She worked for Project Orbis, a flying ophthalmalogic surgical teaching hospital. …”
Whoa. A flying ophthalmalogic surgical teaching hospital? I suppose it’s possible she just booked their flights and never set foot on the plane, but assuming she was part of the team, I strongly suspect Kathleen Seidel was exposed to thimerosal occupationally.

Ever the principled and thorough reporter, Dan utterly fails to do what any n00b reporter would know to do – check your facts. There was one easy way Dan could’ve saved himself a fair amount of embarrassment over this blog post: he could’ve (get ready for the novel idea Dan!) _asked Kathleen_ . And when he did, she would’ve told him that booking flights did indeed fall under her remit *as a Secretary*. So did dictation, typing and general filing. Knowing Kathleen’s pretty awesome taste in music, I suspect the closest she got to any kind of metal was attending a LedZep gig or two.

Olmsted goes on to say:

Laugh me off if you want, but I have spent a lot of time looking for plausible links between parents’ occupations and autism in their children, and I know them when I see them.

Please, join with me:

BWHAHAHAHAHAHAHAHAHAHAHA!

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.”

Another fax for Ms. Couric

9 Sep

Note: I didn’t do my homework–Ms. Attkisson has discussed the Hornig paper. She manages to do exactly what we would expect: toe the ThoughtfulHouse line. The blog piece by Ms. Attkisson was posted while I was finishing my fax, given the time stamp.

As you will read below, I didn’t find Sharyl Attkisson’s recent blog post to be what I expected. OK, I wasn’t expecting her to be convinced by the recent study by Hornig et al., (paper here) but I at least expected her to comment on it. Instead, she dodged the issue completely. Worse yet, her post boils down to (a) assuming that the government doesn’t do vaccine safety research then (b) apparently implying that she and Dr. Bernadine Healy are somehow responsible for a “new” effort by the government to study vaccine safety.

So, CBS news has two new pages in their fax machine (to go along with a previous fax). In an effort to save their staffers the time of forwarding the fax, I quote it below.

September 8, 2008

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

VIA FACSIMILE

Dear Ms. Couric,

I have faxed you recently about my concerns with the reporting of Ms. Attkisson. I would love to be writing you now with word that things have improved. But, sadly, they have not.

Ms. Attkisson appears to have avoided the key story of the week (if not month) in vaccines and autism: the study by Hornig et al. which shows (again) a lack of a link between autism and the MMR vaccine. Instead, Ms. Attkisson ran a blog piece that perpetuates the myth that vaccine safety is not a high priority for the nation’s health researchers.

Hornig et al. is precisely the sort of study that Dr. Bernadine Healy (in an interview by Ms. Attkisson) claimed the research establishment was “afraid” to perform: a study looking not at large populations, but specifically at children with autism. In this paper, the study group critera were very narrow: children with autism who regressed and have significant GI problems. The study sought to answer questions raised by Dr. Wakefield’s flawed study, which has caused much distress in the autism community for 10 years. The study found that MMR is not linked to autism: a conclusion accepted by autism advocate Rick Rollens, one of the most vocal spokespeople for the autism/vaccine link.

You can imagine that, yes, I expected Ms. Attkisson to address this study in her blog or reporting. Instead I read with dismay her blog piece on September 4th, “Vaccine Watch”. In her introduction, she references her interviews with Dr. Healy, but avoids the issue of the Hornig MMR study. Instead, she discusses recent NIH grant solicitations in the area of vaccine safety, and presents them as though vaccine safety research is something new. As noted above, this perpetuates the myth that vaccine safety is not being studied.

In addition to the Hornig et al. study, there is another study soon to be released on autism and thimerosal containing vaccines. Again, a targeted study looking at the exact population of interest. I would hope that this one doesn’t escape Ms. Attkisson’s attention. Also, one need look no further than clinicaltrials.gov to find ongoing studies on vaccine safety and adverse events. It is difficult to find a way that will not appear sarcastic to point out that the CDC’s Vaccine Safety Office is a very clear example of the government’s ongoing commitment to tracking vaccine safety.

If you have any question of how important the Hornig study is in the autism community, take a look at the comments on Ms. Attkisson’s own blog post. You will find that, even though Ms. Attkisson avoided the study, the autism community considered the Hornig study to be the news of the week, not the NIH grant solicitations.

Accusations of media bias are often applied too quickly by readers who disagree with the stances taken on certain stories. However, in the case of Ms. Attkisson, I find it difficult to understand how she could avoid a story which not only was so important to the community, but also answered the precise questions she has posed in her previous reporting.

I appreciate your time in this matter, and will gladly clarify any statements above that may not be clear.

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

Strategic Plan: vaccines

8 Sep

I’ve already started a series on the IACC (InterAgency Coordinating Committe) draft Strategic Plan.  We have until the end of September to submit input to the IACC (but why wait?)

One hot topic is how to handle the issue of vaccines or immunizations. OK, this is a hot topic in the greater autism community in general, but many have made how the IACC handles the issue of vaccines into a big issue.

Given that, it is worth looking into how the Draft Strategic Plan address vaccines. Two sections mention vaccines. The first, under “What caused this to happen” the Draft Plan states:

Research on environmental risk factors is less well developed. An Institute of Medicine workshop held in 2007 summarized what is known and what is needed in this field (Institute of Medicine of the National Academies, 2007). Numerous epidemiological studies have found no relationship between ASD and vaccines containing the mercury based preservative, thimerosal (Immunization Safety Review Committee, 2004). Some samples have been collected throughout pregnancy and early postnatal life may be essential for detecting the interplay of environmental exposures and genetic factors that lead to ASD. As a complement to these large-scale studies, research on critical high-risk sub-populations (e.g., subsequent pregnancies in families with ASD, those with elevated exposure to specific environmental factors, older parents) could provide leverage in identifying genetic and environmental risk factors. Some parents, however, remain concerned that ASD is linked or caused by vaccination. In addition, a number of other environmental agents are being explored through research that are known or suspected to influence early development of the brain and nervous system. Recent studies suggest factors such as paternal age, exposure to infections, hormones, and other biological agents may confer environmental risk. These findings require further investigation and testing, some of which is ongoing through the CADDRE Program, the Norwegian cohort study, the CHARGE study, and the Children’s Centers for Environmental Health and Disease Prevention supported by NIEHS and the Environmental Protection Agency (EPA).

Also, one Research Opportunity under “What caused this to happen” states:

Monitor the scientific literature regarding possible associations of vaccines and other environmental factors (e.g., ultrasound, pesticides, pollutants) with ASD to identify emerging opportunities for research and indicated studies.

Reading that, one could argue that this is not a lot of discussion of vaccines. The idea that vaccines are put on a “Monitor the literature” seems appropriate. But, as we’ve seen, some groups are looking at this document and (a) claiming this is not enough and (b) working to get more statements inserted and (c) in my opinion, trying to make the Strategic Plan a political statement than a research plan.

Consider the idea of monitoring the literature for possible associations with autism. Isn’t that basically a given? Seriously, the Strategic Plan isn’t an IEP document. If something comes up–in any area–on autism causation, the NIH will respond. Why do we have to call out vaccines in particular?

You might ask, “then why care what the Plan includes under ‘monitor’?”

Take a look at how the Combating Autism Act is discussed now. Many would like to ignore the fact that major lobbying efforts were made to include statements about vaccines–and yet the Congress chose to leave mention out. The Act specifically does not include the word “Vaccine” or “immunization”. But, when it comes to vaccines, we are talking about the same people who are trying to rewrite the Hornig et al. study as a validation of Wakefield’s research. When it comes to the Combating Autism Act, these people point to the concept that “vaccines were discussed as part of the process” and point to drafts that they themselves wrote as if this has some official status.

Or, to put it more simply: People want to have vaccines be more prominent in the Plan. However, given that (a) they are already covered under the umbrella of the “environment” and (b) the past history of politicizing any government mention of vaccines and autism, should they be mentioned at all in the Plan?

Think about it. If you feel strongly about the idea of vaccines being included in the Strategic Plan, one way or the other, send them email .

Neurodiversity in action

6 Sep

On….(wait for it)…..the Age of Autism blog.

Have you recovered yet?

A new guest piece has been posted on AoA from a student who has Asperger’s Syndrome named Jake Crosby.

Its a very well written piece and Mr Crosby expresses his viewpoints very well. However, I don’t agree with many of them at all although I respect his right as a self-advocate to say them. He begins thusly:

These are the ways I have been impacted by my AS; I can’t think of anything positive it has done other than my sense of accomplishment after overcoming some of its challenges.

Well, you are in good company! I have heard many of the autistic bloggers on the Hub say exactly the same thing. Of course, some go further and say that their right to be who they are and live as they are within a sometimes less than tolerant society is also gratifying. I wonder if Mr Crosby feels the same.

However, a small, new camp is emerging from within the Autistic community of Aspies who believe AS and even Autism in general is a great thing.

Hmmm, I’m not sure I’ve ever seen anyone say autism is a ‘great thing’ with no form of context. I’ve seen it simply referred to as part of who someone is and that it (as an entity) has no properties. In other words, its neither great, nor terrible, it simply is what it is.

I’d also like to educate Mr Crosby about this ‘small new camp’ he refers to. It is neither small, nor new and nor indeed does it refer solely to Aspergers – or even autism. Its first use dates back to 1997 – a year before the emergence of the autism/vaccine hypotheses. It now encompasses tens of thousands of people worldwide and has widened to include people of varying neurological differences such as OCD, Tourettes, Dyspraxia, Dyscalcula, Manic Depression (chest bump) and a multitude of others. See ‘Mad Pride’ for example. I don’t believe any of us are saying that we do not live with a disability. What I gather from conversations with others like me is that the word ‘disabililty’ does not define or limit our existence. That there is good as well as bad and that nothing in life is as black and white as Mr Crosby sadly wants to see it.

Mr Crosby makes a variety of intelligent challenges:

This politically correct group of people says that Autism is not a disorder, but a “way of life.” They deny that any environmental factors such as mercury and vaccines could have caused Autism and they claim they were meant to be Autistic. Most of all, they rail against any potential for a “cure,” and see wiping out Autism as synonymous with wiping out the people themselves. While there are many mildly Autistic people like me who are busy trying to overcome our challenges as much as we can and severely Autistic people who are struggling to even speak a word, this crowd is getting more and more vocal about their staunchly pro-Autism views.

Again, Mr Crosby is attempting to paint life as black and white. Autism _is_ a disorder. It is also a way of life. I also know of at least one neurodiversity advocate who staunchly believes vaccines cause autism, although my personal opinion based on all available evidence is that it does not.

I personally don’t rail against a cure. I have no opinion on one since one does not exist. I know Alex Plank who runs Wrong Planet – a very large online Asperger’s community – feels the same. In 2006, the actor Stephen Fry made a documentary about manic depression. I’m sure if one visited any number of Torrent sites one would find it. At the end of it, he asked all his interview subjects a question: if you could press a button that would remove your manic depression, would you. the vast majority said ‘no’.

Sadly, Mr Crosby’s piece then degenerates into the core anti-vaccinationism we all know exists on Age of Autism:

Despite this, these people are determined to see AS as a positive advance in nature, not a negative impact from toxicity or any other cause. When confronted with the emerging information that the 6000% increase in Autism is related to poisons in vaccines that are overused, they instantly say there’s “no evidence,” citing the pharmaceutical/CDC party line. Similarly, they ignore mountains of independent studies that show the link to Autism just as the CDC has. While the “neurodiversity” advocates and the pharma-goons clearly have separate agendas, they act similarly.

With all due respect to Mr Crosby, these views and statistics are ridiculous and not based in any kind of reality or science. There are in fact, no reputable studies that link vaccines to autism. Unfortunately, a goodly remainder of his piece carries on in this vein. he then reiterates his main theme:

If only they would stop pretending Autism is in any way beneficial, and realize that their true strengths are who they really are, and that their disability is not. I can’t speak for all, but as someone with Autism I can say these people with my same condition who claim to speak for me do not. I do not believe these people speak for the majority of people with AS. No one else I have known with Autism has actually said they liked having it and I have yet to actually meet these people who do.

Mr Crosby seems to be missing the point of self-advocacy. To _some_ autistic self-advocates, their autism _is_ beneficial. To Mr Crosby, it seems it is not. It is largely a matter of perception and choice in my opinion. I have no idea who (if anyone) speaks for the majority of people with Asperger’s and I’m not sure it really matters that much. What matters is that all people with all forms of disability have a right to express their opinions and share their experiences as those who live the daily reality of living with those conditions.

It is great to hear autistic self advocates like Mr Crosby speak out – particularly on a site like Age of Autism where the views of autistic self advocates have never been welcomed before – and aside from the rather embarrassing and unnecessary sections of his post regarding vaccines, he makes some good and interesting points.

However, I feel that he has, like many before him and no doubt many after, misunderstood what neurodiversity is. I’d gladly have a conversation with him regarding neurodiversity and what it actually is, who it affects and what I think it means to me and my family.

Experts comment on Hornig et al.'s MMR paper

6 Sep

It’s been interesting reading the news reports following the Hornig MMR/regression/bowel-disease study. That has been picked up by most major outlets (and minor outlets). It has been extensively blogged (Kev, Orac, Kristina, Anthony, Steve, Phil (bad astronomy), to name a few).

I have enjoyed reading the various experts that have been brought in to comment on the paper. I list some of them here.

CNN

“This really puts this issue to bed,” said Andy Shih, vice president for scientific affairs of “Autism Speaks,” an advocacy group.

ABC News

Dr. Marie McCormick of the Harvard School of Public Health said these results are definitive and significant.

“This is the nail in the coffin,” she said. “The final bit of research we were looking for to finally discredit this link between the measles vaccine and autism” is proven. But there have been dozens of studies over the years debunking a link between vaccines and autism and the controversy has still continued.

WebMD

“This really closes the scientific inquiry into whether measles or MMR vaccination causes autism,” Schaffner tells WebMD. “It is convincing because it takes the original concept of the profoundly flawed [earlier] study and does it the way it should have been done the first time.”

One of the most amazing parts of this event was the participation of Mr. Rick Rollens. Scientific American included some of Mr. Rollens’ statements:

Rick Rollens, who has an autistic son who suffers from a “horrible bowel disorder,” called the new research sound science and praised it for calling attention to an underserved subset of the autism spectrum: those children who also suffer from GI problems. But he insists that it does not give the all clear to all vaccines.

“I’m totally convinced that a vaccine caused the autism my child suffers from,” Rollens says. “This study by itself does not exonerate the role of all vaccines”—only the MMR.

On the stranger side (is it possible to get stranger than using Rick Rollens’ quotes in support of a study unlinking a vaccine from autism?), Sallie Bernard, quoted at WebMD states

“On the plus side, this study has shown a link between gastrointestinal distress and regression in autism,” Bernard tells WebMD. “A lot of people don’t accept this and deny parents’ perspective when they say their kids’ with autism have GI trouble.”

I call this one strange because (a) the study didn’t show this link and (b) she complains that the study size is too small to be significant. Too small for the parts she doesn’t like, just fine for the conclusions she wants to create.

What’s missing so far is a statement from some of the people whom we all expect to not accept this study. The good people at the Age-of-Autism have warned us that they have a “powerful response” from Mr. Olmsted coming out on Friday. It’s 11:38 now on the west coast, I’m gonna go out on a limb and say it didn’t happen. Julie Deardorff (Julie’s Health Club, a blog run by the Chicago Tribune) skipped past it and blogged about the vaccine uptake data that came out the next day. Sharyl Attkisson…well, it doesn’t seem to be on her radar that yes, indeed, researchers have not turned their backs on the question of vaccines and autism. Yes, indeed, they are looking at “the children that got sick”. Odd, since she has a vaccine-oriented blog post dated Sept. 4. It would have been very easy to include this new study there. I guess correcting her old stories wouldn’t be much fun.

What is fun, and totally off topic, was a bit from this blog post by Ms. Attkisson. She was complaining that the CDC wastes money. She talks about

“…grants being awarded to projects that investigators have found in some cases to have “no objectives,” are “not performing,” or have been rated as “abysmal.” In other cases, grants have gone to community-based groups with very little oversight.”

I hope she (and others) apply similar rules when considering whether to include projects in the IACC’s Strategic Plan that are likely to be rated “abysmal”, or are expected to be “not performing”.

I wonder how she would feel about hundreds of thousands of dollars in pork sent to one of autism’s alternative medical groups with no oversight, no results.

Well, I’ve wandered off topic. It is 11:59 and still no “powerful response” from Mr. Olmsted. Time to hit “publish”.

Strategic Plan: when should I be concerned?

5 Sep

No, I’m not asking “when should I be concerned about the Strategic Plan”. Instead, I am taking parts of the Plan and posting them here. The full Plan is 34 pages long. Don’t let that slow you down! It really isn’t that long, and I found it a good read. But, it is hard to discuss the whole thing as a blog post.

Another point I see–there are six sections.  It may be tough to sit down at one time and write a response to all six.  If you think that may keep you from commenting, follow these posts and comment as you go.  It sounds like they would prefer you to write one single email, but I am all for anything that gives them more feedback–especially feedback that encourages using a strong scientific approach to selecting research projects.

With apologies to the people who wrote the Strategic Plan, I am going to only post the sections on “Research Opportunities” and “Short Term Objectives” and “Long Term Objectives”.  Read them and ask, “Is this how I want research dollars and research time spent?”.  If so, send them email and show support for the parts you like.  If not, email them and let them know your concerns.

With that intro, for the section, “When Should I be Concerned”, we have:

Research Opportunities

• ASD screening instruments and approaches for use in community settings to identify individuals who require diagnostic evaluation.

• Sensitive and efficient clinical diagnostic tools for diagnosing ASD in widely diverse populations, including underrepresented racial and ethnic groups, females, younger and older age groups.

• ASD measures that are easy to administer and that are sensitive to incremental changes in both core and associated ASD symptoms. Such measures can be used to help track the clinical course of individuals with ASD, monitor responses to interventions, and provide information about the broader autism phenotype.

• Detailed criteria for specific ASD sub-types in order to better describe the variations in symptoms and severity and study how these variations relate to underlying pathology, intervention strategies, and outcomes.

• ASD subpopulations and associated biobehavioral markers that provide early indication of ASD risk and opportunities for early intervention.

• Protocols for genetic testing in routine clinical practice in order to identify individuals at risk for ASD. Identification of individuals with genetic variations associated with ASD will facilitate intensive studies of ASD subpopulations with shared genetic risk factors to characterize common phenotypic and biological features.


Short-Term Objectives

• Develop, with existing tools, at least one efficient diagnostic instrument (e.g., briefer, less time intensive) that is valid in diverse populations for use in large-scale studies by 2011.

• Validate and improve the sensitivity and specificity of existing screening tools for detecting ASD through studies of the following community populations that are diverse in terms of age, socio-economic status, race, ethnicity and level of functioning by 2012.
o School aged children
o General population (vs. clinical population)

Long-Term Objectives

• Validate a panel of biomarkers that separately, or in combination with behavioral measures, accurately identify, before age 2, one or more subtypes of children at risk for developing ASD by 2014.

• Develop five measures of behavioral and/or biological heterogeneity in children or adults with ASD, beyond variation in intellectual disability, that clearly relate to etiology and risk, treatment response and/or outcome by 2015.

• Identify and develop measures to assess at least three continuous dimensions of ASD symptoms and severity that can be used to assess response to intervention for individuals with ASD across the lifespan by 2016.

• Effectively disseminate at least one valid and efficient diagnostic instrument (e.g., briefer, less time intensive) in general clinical practice by 2016

Again, ask yourself, “Is this how I want research dollars and research time spent?”. If so, send them email and show support for the parts you like. If not, email them and let them know your concerns.

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.

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