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Chelation study 'called off'

17 Sep

CHICAGO – A government agency has dropped plans to test a controversial treatment for autism that critics had called an unethical experiment on children.

The National Institute of Mental Health said in a statement Wednesday that the study of chelation (kee-LAY’-shun) has been discontinued. The statement says the agency decided the money would be better used testing other potential therapies for autism and related disorders.

The study had been on hold because of safety concerns . A study published last year linked a chemical used in the treatment to lasting brain problems in rats.

The treatment removes heavy metals from the body and is based on the fringe theory that mercury in vaccines triggers autism — a theory never proved and rejected by mainstream science.

Yahoo News

Back in June, I blogged about the possibility of the delayed chelation study being released. It had been delayed due to the same ethical concerns that now seem to have scuppered it. I can only view this development with relief. As I said at the time:

Lets be clear. This study is being touted about for one reason and one reason only – to appease the anti-vaccine/autism groups. In the mainstream medical/scientific community (and notably in the toxicology community) it is well known that autistic kids aren’t toxic.

Click on the link above to see some quoted testimony from Dr Jeffery Brent, world renowned Toxicologist. His opinion on the need for chelation of autisitic children is thoroughly discussed. Basically, when you do the provoked, non-standard tests from labs that make a good living from charging for these tests, they come back positive. When experts like Dr Brent do the gold standard tests, 100% of the time they come back normal.

There is no reason to chelate autistic children.

The most bizarre conspiracy theories yet

17 Sep

Two new conspiracy theories this week. The first one is an eye-roller. The second is an eye-popper.

The first one is the alleged hacking of Ray Gallup’s Vaccine Autoimmunity Project. I came across this email from JABS regular John Stone:

Unincidentally, I was appalled to hear today that VAP website has been hacked into and is likely to be down for an extended period.

If this is how people like Offit, not to mention Berners-Lee [more on this later – Kev] and Ghosh (see my previous post) think the future should be, our politicians ought to consider what is tolerable in an alleged free society.

As the poet Heinrich Heine noted in 1823: “Where they burn books, they will in the end burn people”.

“Dort, wo man Bücher verbrennt, verbrennt man auch am Ende Menschen.”

These people already have the advantage of media domination, but they will not allow a word of dissent. If their science is so perfect, why cannot they discuss it?

So, following Stone’s train of thought, he seems to be stating that Paul Offit thinks that its OK that websites are hacked? I really doubt that.

But the really pointed allusion is in his last paragraph. He seems to be suggesting that ‘they’ (Offit et al) ‘will not allow’ oppositional views.

Did Paul Offit put out a contract on VAP? Somehow I really, really doubt it.

Ray Gallup’s reply was even more paranoid.

John,

Thank you very much.

I suspect that certain people had a hired gun to do this virus thing to VAP like I’m sure you have the same suspicions. Lots of PharmaMafia people out there that want to silence VAP by screwing up the VAP website with a virus including their surogates at such sites as Neurodiversity.com, etc.

Ray Gallup

My, my. Ray thinks someone from Neurodiversity.com (i.e. Kathleen or Dave) trojaned the VAP website.

I’m going to go out on a limb and go for user error. The server error (Directory Listing Denied) does not speak of a hack to me. Hacks are usually defacements of the original page which are non-destructive. This looks more to me like ahem, ‘someone’ has accidentally deleted the root file. If that is the case, simply asking the host (ixwebhosting.com) to restore the page from a backup (assuming they take them) would sort the problem out immediately. You can thank me later Ray.

So, thats the eye-roller. The eye-popper is way better.

On Monday, inventor of the web Tim Berners-Lee said:

Talking to BBC News Sir Tim Berners-Lee said he was increasingly worried about the way the web has been used to spread disinformation.

……..

The use of the web to spread fears that flicking the switch on the LHC could create a Black Hole that could swallow up the Earth particularly concerned him, he said. In a similar vein was the spread of rumours that the MMR vaccine given to children in Britain was harmful. Sir Tim told BBC News that there needed to be new systems that would give websites a label for trustworthiness once they had been proved reliable sources.

Ooooh, you can imagine how well _that_ went down in certain quarters, right? A few hours later, the following was posted to EoH:

Group With Big Pharma Ties Wants to Shut Down Vaccine “Conspiracy Theories”

So, first inaccuracy: Sir Tim didn’t mention ‘shutting down’. He mentioned providing a label for trustworthiness.

But anyway, I was intrigued as to who this ‘group with Big Pharma ties’ were. So I read on:

Kingpins of Military-Industrial complex say they will “brand” websites they consider “trustworthy and reliable sources of information” A foundation populated by the giants of business, banking, government and military wants to “vet” websites and limit the spread of information that it says creates “conspiracy theories”. The World Wide Web Consortium (W3C), fronted by Internet creator Sir Tim Berners-Lee, says it is worried about the way the web has been “used to spread disinformation”.

Wait…what? W3C??? Kingpin of Military-Industrial complex???

For those that don’t know W3C (World Wide Web Consortium) is:

The World Wide Web Consortium (W3C) is an international consortium where Member organizations, a full-time staff, and the public work together to develop Web standards. W3C’s mission is:

To lead the World Wide Web to its full potential by developing protocols and guidelines that ensure long-term growth for the Web.

In my job as a web developer I have a lot of dealings with the standards developed by W3C. They helped develop the code that that is used in _all_ websites and they helped develop the ‘rules’ that allow web browsers such as the one you are using right now to view those websites.

Those ‘rules’ help make sure that code is used responsibly. It made Microsoft behave and develop the vastly improved browser of IE7. Its code is responsible for the fact that many, many more websites are accessible to people with disabilities than they used to be.

In a nutshell, what they do is draw up standards for code use for people like me and people like software developers. The idea of them being a ‘Kingpin of Military-Industrial complex’ is hilarious.

Here’s the full member list. Being a member ensures you one thing and one thing only: a say in how the standards of the future are shaped. I assure you there are no Illuminati lizards running around in Black Helicopters.

In all of the utterly crazy conspiracy theories I’ve seen so far, this one is right up there at the top of the tree.

Better dead than autistic

15 Sep

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

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

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

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

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

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

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

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

Death may be better than autism in some cases….

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

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

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

Arthur Allen – vaccine skeptics vs your kids

11 Sep

Whilst, I’m not sure that the people Arthur is writing about are skeptics as I understand the term (having a scientifically valid basis for not accepting an argument or position), I know what he means. And he’s right that it is this group of people vs the health of people everywhere.

The sub-header is even more accurate ‘immune to reason’. One only has to take a look over at the recent rantings on a certain blog we all know about where the latest themes are:

1) Presidential candidate Barack Obama is now a big pharma shill because he told one of them: “I am not for selective vaccination, I believe that it will bring back deadly diseases, like polio.”.

2) The latest study in a long line of studies that show once more there is no link between MMR and autism is both flawed and exonerates one of their heroes.

3) Kathleen Seidel is wrong because….uh….well, no one knows why but she must be. Apparently.

Immune to reason indeed.

As Arthur points out, there is a great deal at stake:

…in the last trimester of her pregnancy, Helena Moran caught a cough that she couldn’t get rid of. She figured she’d picked up the germ—whatever it was—from one of her patients at a Boulder dentist’s office. But the real nightmare began after her daughter, Evelina, was born: The baby began to cough and cough, and then she’d curl up in a little ball and turn blue. At the emergency room, she was diagnosed with whooping cough. She spent the next five weeks in intensive care and suffered permanent lung damage.

Now, this isn’t *all* the fault of the so-called autism community, but as I’ve discussed before, I’m ashamed to say that a lot of it is.

….the movement got a huge boost from the controversy over the mercury-laden preservative thimerosal, which some theorized might be linked to autism. That link has been disproven—by, if nothing else, the fact that autism rates remained steady after pediatricians and public health authorities told manufacturers to stop making thimerosal-containing childhood vaccines in 1999. But the anti-vaccine movement has kept going, finding ever new reasons to distrust immunization.

The are a lot of zealots out there who have fed upon the autism community. A parent who might not believe vaccines case autism listens to horror stories and reads links sent to them from such places of quackery as whale.to who are nothing to do with the autism community but who market their own brand of ridiculousness (the owner of whale.to believes dolphins can manipulate gravity and has the pictures to prove it!) regarding vaccines and the autism parent greedily sucks it down.

Arthur discuss the practice of abusing ‘religious exemption’ by these people:

Right now, in many states, all it takes to get an exemption from vaccine requirements is signing a form. Some, including a group of doctors at Johns Hopkins University, have proposed making it harder—allowing a philosophical exemption only after parents demonstrate a good-faith effort to educate themselves.

But an article I read in yesterdays ‘Edmond Sun’ stated:

….a person “who has reached the age of majority and is mentally competent to do so may justifiably refuse immunizations for himself or herself, but may not impose this refusal on a child, who has no choice in the matter.” Courts have consistently upheld this principle.

That makes sense to me. Who would want to refuse such a simple thing that has no link of any kind to autism?

Arthur closes with the following:

But while questioning authority is healthy, facts are facts. If vaccines really were responsible for autism, it would be too much to ask parents to do the altruistic thing. But more than a dozen studies have failed to discover such a link—and not a single legitimate study has shown that one exists.

He’s spot on. All the celebs and all the money in the world cannot change that simple fact. We need to get past this. Those who believe autism is caused by vaccines need to put up or shut up. They are holding up progress on autism research and causing the health of our societies to suffer.

I urge readers to visit Arthur’s piece and read the comments. The first few demonstrate exactly the sort of mindset Arthur is talking about – the one’s who bring shame on the autism community. They truly are immune to reason.

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?

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

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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