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Autism, HBOT, and the new study by Rossignol et al.

21 Mar

I recently read the BMC Pediatrics article, “Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial1. I know this paper is attracting a lot of attention in the media, and it is certainly being ballyhooed about the internet. Hell, I’ve even received e-mail spam about this study! But I’m sorry to say, I don’t really share the excitement. In fact, I see what looks like a pretty significant error in the methodology of this study. It’s one of those types of potential errors that stand out like a strobe light or a siren – it’s really tough for me to pretend it’s not there.

Once again, I’m going to ask readers to set aside, for the moment, anything they may know about the role of hemoglobin in oxygen transport and how the minute increases (probably around 3-4%) in total blood oxygen content afforded by this kind of hyperbaric therapy, or simple O2 therapy for that matter, are probably pretty likely to be insignificant.

Both the paper and ClinicalTrials.gov2 list the Center for Autism Research and Education, Phoenix, Arizona, as a study location. This is a problem, because the stated treatment pressure in the study (1.3ATM) seems highly unlikely to actually be achievable in Phoenix with the equipment that was apparently used for this study.

As described in the section titled, “Interventions”:

“These procedures included covering control switches, inflating and deflating the chambers to simulate pressure changes, and masking the sounds from the chambers.”

The use of inflatable monoplace hyperbaric chambers, is a clear indication that the actual total pressures (and quite likely results of this study) would have been affected by the ambient air pressures at the times and locations of treatment. In fact, the ambient air pressure is the largest component of the stated treatment pressure in this study (ambient pressure + added treatment pressure = total treatment pressure).

Ambient pressure

Local atmospheric pressure is typically reported as sea-level pressure3 for its utility to aviation, and the meaningful interpretation of weather maps, etc., but the actual station pressure is affected by the elevation. The expected ambient atmospheric pressure, corrected for altitude, (or station pressure) in Phoenix, Arizona4 is 28.69 in Hg (where there is a modest elevation of 1161’ AMSL). Wanting to give this paper the benefit of the doubt, and knowing that “high pressure” weather is typical of the Phoenix climate, I looked at 30-day data5 for actual station pressure in Phoenix at a station of slightly lower altitude than the Center for Autism Research and Education. The 30-day mean station pressure is 28.81 in Hg, so I’ll use that one for calculations, as it will yield results more likely to be in the study’s favor.

Added treatment pressure

The actual operating pressure of the inflatable chambers, as stated by the manufacturer, is 4 PSI. 6,7 This pressure is also indicated on the Center for Autism Research and Education’s website:

“The chambers used at care utilize a pressure of 4 psi.”8

Total treatment pressure

The total treatment pressure can be easily calculated with the following conversions:
in Hg * 0.491 = PSI
PSI + PSIG = Total PSI
Total PSI * .068 = ATA

For Phoenix, Arizona, this gives a calculated total treatment pressure of 1.23 ATA.

28.81 * 0.491 = 14.15 PSI
14.15 PSI + 4 PSIG = 18.15 PSI
18.15 PSI * .068 = 1.23 ATA

Damn, that’s a pretty big difference from the paper’s stated 1.3 ATM – representing an addition of only .23 ATM (instead of .30 ATM) above mean sea-level pressure of 1 ATM.

I’ve corresponded with the lead author of this study in the past, and he stated that he observes gauge pressure of 4.15 PSI. Despite the manufacturer specs, the FDA-cleared medical device premarket notification, and the Center for Autism Research and Education’s website (which all indicate operating pressure of 4 PSI), and wanting to give the benefit of the doubt, I’ll use 4.15 PSI for the next calculation, as it will be more likely to yield results in the study’s favor.

28.81 * 0.491 = 14.15 PSI
14.15 PSI + 4.15 PSIG = 18.30 PSI
18.30 PSI * .068 = 1.24 ATA

It could be argued that treatment pressure for the other study locations were properly rounded up to 1.3 ATM (even though the actual pressures were quite likely to be considerably lower), however, even with all the calculations purposely leaned in favor of a higher number for Phoenix, Arizona, the study’s stated treatment pressure, there, should have properly rounded to 1.2 ATA! This suggests an overstatement of the added treatment pressure for the Phoenix location of 50% (.3 ATM is 150% of .2 ATM). Even if given the benefit of the doubt yet again, and an exception to proper rounding were made for solely for the Phoenix location in this study, the study’s likely overstatement in added treatment pressure for Phoenix is still a full 25%. (.3 ATM is 125% of .24 ATM – 25% more added pressure above 1 ATM was claimed in this paper, than was probably delivered).

I think this is a big enough boo-boo, that the editors of BMC Pediatrics should call for detailed errata. In the interest of scientific accuracy, it would seem prudent for BMC Pediatrics to:

1. Clarify for its readership and the scientific community, that the stated pressure of 1.3 ATM in this study is rounded up, and includes the ambient air pressure, or alternatively, state the estimated pressure in terms of ATA.

2. Clarify for its readership and the scientific community, that the stated pressure of 1.3 ATM in this study is an estimated pressure, since no actual measurements of ambient station pressure for the locations, and dates/times of treatments were reported.

3. Note for its readership and the scientific community, that the stated pressure of 1.3 ATM was not likely to be uniformly achievable across all study locations due to the use of inflatable hyperbaric chambers and changes in elevation (and atmospheric pressure) across study locations, potentially confounding the results of this study.

4. Note for its readership and the scientific community, that estimated pressures in the placebo control group are affected by these same issues that affect the treatment group, potentially confounding the results of this study further.

What do you think?

1 BMC Pediatrics 2009, 9:21doi:10.1186/1471-2431-9-21
http://www.biomedcentral.com/1471-2431/9/21/abstract

2 http://clinicaltrials.gov/ct2/show/NCT00335790

3Federal Meteorological Handbook No. 1 – Table 11-2
http://www.nws.noaa.gov/oso/oso1/oso12/fmh1/fmh1ch11.htm

4 LAT/LON 33.5º N 118.08º W

5 http://www.wrh.noaa.gov/mesowest/getobext.php?wfo=psr&sid=KPHX&num=720

6 Medical device pre-market notification (FDA-cleared)

Click to access K001409.pdf

7 Manufacturer product sheet

Click to access vitaeris-lowres2007-8.pdf

8 http://www.center4autism.org/therapyHBOT.asp

Age of Autism claim 'hundreds of case reports' of recovered children

16 Dec

A post on the Age of Autism about an interview with the New York Times describes how the interviewee believes that:

….none of our health authorities have any explanation of cause or cure [of autism], we have a whole community of doctors and parents who are actually recovering children. And, without ever treating an autistic child, interviewing a DAN! doctor who treats them, or exploring the several hundred case reports of complete recovery and thousands of stories of improvement…

I was fascinated by this. I have not ever seen one published case report of a child recovered by a DAN! doctor in a respected medial journal. In fact, its a common refrain of mine that these things do not in fact exist at all. And here the author of this post is claiming that there are ‘several hundred case reports of complete recovery’. I thought maybe there’d been an upsurge in PubMed so I went to have a look.

I found one case study that referenced DAN! methods: The recovery of a child with autism spectrum disorder through biomedical interventions. This study (for which no abstract is available) is published in ‘Alternative therapies in health and medicine‘ which claims to be a peer reviewed journal and who’s subject matter includes such medical breakthroughs as Reiki, prayer and reflexology. How this magazine got listed in PubMed I have no idea.

Anyway, suffice it to say that it is totally unsurprising that this study got published in such a publication (Eigenfactor here – compare to New England Journal of Medicine for an idea of how good it is).

So, here’s one very dodgy ‘study’. Where are the other several hundred case reports?

It is also well established that those who use Alt-Med and go on to claim recovery also use mainstream therapies (e.g Jenny McCarthy’s child who was on GFCF, some other stuff….and one-to-one speech therapy). In a 2006 study ‘Internet survey of treatments used by parents of children with autism‘, it was established that:

The mean number of current treatments being used by parents was seven….

I haven’t read the ‘study’ in the Altie journal but the experience with Jenny McCarthy’s child, and plenty of others I have read online indicates that this is true for most parents who claim to be recovering their kids biomedically. As such, you have to give weight to the treatments that are established to have some benefit already. And lets also look at the results of the recent Helt study which reported that a non vaccine related, non-biomed set of kids had somewhere between 3 and 25% recovery. This indicates that sometimes, kids just recover. For reasons we are not really aware of yet.

So I am left puzzled as to why the Age of Autism claim there are several hundreds of case reports. I am puzzled as to how they know it was the biomed intervention which precipitated the alleged recovery and I am puzzled as to how they link _any_ sort of treatment to recovery. All in all, it seems like a set of claims that are not reality based are being made. But maybe I’m wrong – if so, please – anyone from AoA – provide a link to the peer reviewed journal published several hundred of case reports that you claim exist.

Stephen M Edelson gets it wrong, wrong, wrong…

25 Nov

Communication is the members mgazine of the UK’s National Autistic Society. In an issue earlier this year, Mike Fitzpatrick, GP and author had an extract from his latest book published.

The extract touched on chelation and the death of Tariq Nadama.

This prompted a bilious response this month from Stephen M Edelson in this months Communication. The level of ignorance in his response is astounding. I have attached the whole response as a Word document to save me getting accused of taking things out of context. BUt for here, I’ll quote selected parts.

Fitzpatrick has been a longtime, outspoken critic of chelation. (Chelation involves a medication, such as DMPS or DMSA, which removes neurotoxic heavy metals, such as lead and mercury, from the body; it is given under the supervision of a doctor.) If an individual tests with very high levels of one or more heavy metals, chelation is the treatment of choice throughout the medical profession.

If test results indicate very high levels in someone on the autism spectrum, isn’t this person entitled to the same medical care as someone without autism?

This is far too simplistic. Of _course_ if someone on the spectrum has test results that indicate high levels of metals they should have the standard treatment. That is a strawman.

The _point_ is rather more complex that that as Mike mentions in his book and I have blogged about numerous times.

The labs that Mr Edelson and his DAN! colleagues recommend test for levels of metals in people on the spectrum very, very often give false results. Take this extract of the testimony of Dr Jeffrey Brent, a sub-specialty board certified medical toxicologist and the former President of the American Academy of clinical Toxicology.

…I have seen a number of patients now come to me because of these ‘doctor’s data’ type of laboratories which are based on urines – chelated urines – and they always have high leads in their chelated urines and I tell them ‘well, lets just do the gold standard test, lets get a blood/lead level and so far, *100% of the time they’ve been normal*.

So when ‘these Doctors Data’ type of labs do the tests they indicate the need for chelation. When _experts_ in the field such as Dr Brent do the gold standard tests ‘100% of the time they are normal’.

Dr Edelson needs to realise that _that_ is why chelation is an invalid treatment for autism. The fact that when taken to an expert in Chelation and Toxicology, the results usually indicate that chelation is not warranted.

Edelson continues:

In his article, Fitzpatrick brings up the accidental death of Tariq Nadama after chelation treatment. What he does not tell the reader is that Tariq was given the entirely wrong drug, one with a similar name and label that was nearby on the office shelf. Regrettably, these drug errors do
happen in hospitals and doctors’ offices and Fitzpatrick has exploited this unfortunate incident several
times in the past without explaining the complete story. (I have already corrected Fitzpatrick in a previous issue of Communication, and I am disappointed that the editor knowingly allowed such half-truths to be disseminated to NAS’ membership once more.)

Once more, Mr Edelson is quite wrong. Tariq Nadama was not given a drug by mistake ‘with a similar label that was nearby on the office shelf’.

When Dr Roy Kerry (who joined Mr Edelsons loose affiliation of practitioners after the death of Tariq Nadama) was prosecuted for the death of Tariq, the following was admitted by him:

70. Respondent admitted that EDTA is very rare to use on children.

71. Respondent admitted to using Disodium EDTA to chelate Tariq.

72. Respondent stated to Investigator Reiser that Disodium EDTA is the only formula of EDTA he stocks in his office.

73. Respondent admitted that CaNa2EDTA is available but that he has never used this agent.

I would recommend that Mr Edelson reads the entire complaint against Dr Kerry.

Edelson continues again:

Over the past 20 years, scientists have clearly documented immune system dysfunction and gastrointestinal problems associated with autism. Many of these problems can be treated successfully using established medical treatments.

Of course, this is twaddle. I challenge Mr Edelson to provide peer reviewed journal published science to back up these statements. As recently documented by Professor Stephen Bustin, the gastrointestnal ‘link’ to autism is not valid and never was.

I wonder why these treatments that so successfully treat autistic peoples autism have never had one single (that I can find) case study published?

Update 28 Nov 2008

An update from Mike who read some of this thread:

It is true that a number of environmental factors have been identified as causing autism in a small number of cases – these include viral infections (rubella, CMV) and drugs (thalidomide, sodium valproate). What is striking is that ‘over the past decade not a single new environmental factor has been identified as playing a significant role in the causation of autism’ (Defeating Autism: A Damaging Delusion, p 81). Indeed, it would be more accurate to say ‘over the past two decades’. By contrast, over this period there have been dramatic advances in the genetics of autism. Meanwhile intensive researches into alleged vaccine-autism links have failed to confirm any causative relationship.

‘The conviction of the biomedical activists that there must be some environmental explanation for the rising prevalence of autism has grown in intensity in inverse proportion to the emergence of scientific evidence in favour of any particular environmental cause.’

I object! (Part 3)

20 Nov

If you’ve been reading these past few days, you know that I find a recent letter sent to the IACC by a number of autism organizations to be, well, objectionable (hence the post titles!). I’ve noted that I don’t like the way they claim backing from a united “autism community”. I don’t like the way they are presenting their arguments in their letter (here and here).

And now, for the last part of their letter.

Bullet point (d), or, we want a bigger say

Provisions for accountability and evaluation for the research spending are absent. Adoption of oversight, review and evaluation mechanisms, such as an Autism Advisory Board and a Department of Defense grant review model, should be added to the plan.

They are asking for an “advisory board” or AAB and a grant review system. Generation Rescue attempted (and apparantly failed) to get an AAB put in place by lobbying he Secretary of Health and Human Services. Now they are pushing the IACC to institute an AAB and also add DoD grant review model.

Let’s look at these proposals one at a time, starting with the AAB.

This is not the time to institute the Autism Advisory Board. President-elect Obama will soon be in office. He has specific ideas on autism and disabilities in general. These include an “autism czar” to coordinate autism activities. Let Mr. Obama and his team make the next changes in the structure of how autism research activities are conducted.

Second, the IACC is already an advisory board. Why are people asking for a second layer, when the IACC process has been working well? OK, you got me, it’s a good bet that these people don’t think the process has been working well. If I were to venture a guess, they are unhappy about the lack of a prominent statement about the “epidemic” and/or “vaccines” within the Plan.

Would an Advisory Board change that? Let’s look at how the Advisory Board is mentioned in the report that accompanied the CAA (note that the “autism advisory board is not mentioned within the CAA language itself):

[congressional report] The committee further re-examined the Interagency Autism Coordinating Committee (IACC). In particular, the committee wanted to increase the amount of public participation (from two individuals) to at least six. In addition, the IACC has been tasked to make recommendations to the Secretary regarding the public participation in decisions relating to autism spectrum disorder. For instance, the committee notes that the IACC may recommend providing other, additional, formal mechanisms, such as an Autism Advisory Board, to provide additional public feedback and interaction. Further, the Secretary may opt to provide such a mechanism without the recommendation of the IACC.

The committee expects that the IACC will be the primary mechanism for the coordination of all research, surveillance, and early detection activities within the Department of Health and Human Services. As agencies implement specific activities related to autism spectrum disorder, they should strongly consider those activities outlined in the Autism Research Matrix.

So, even if an Advisory Board were formed, it would still be the IACC that has the task of coordinating autism activities within HHS.

That would seem to me to be a potential reason why they are now asking for something akin to the DoD grant review process–to add some actual power–oversight and control–to the new “advisory” groups they are proposing.

Again, perhaps someone can correct me here in what I am about to say. But from my perspective I can’t see why the NIH needs a second layer of grant review. For the DoD, an agency that is not primarily involved in medical research, I can see a review board. For the NIH, an agency whose functions already include a peer-review grant process, I don’t see that the case is very clear at all for an additional review board. Let the NIH do what it is chartered to do.

Let’s look at that last bullet point from the letter:

[Letter]The planning process diminished the voices of important segments in the autism community. Future activities related to the SP should ensure integral participation of the diverse community representing families and individuals with autism.

First, I’d switch the wording in that last sentence to “….representing individuals with autism and their families.” (and I wouldn’t object at all to people who would change it to “…representing autistics and their families”)

Second, the very segments of the autism community who are signing this letter were given ample opportunities to be heard. IACC meetings have been dominated by a very few with a vary narrow message. An entire “Town Hall” meeting was held on the West Coast to obtain more input. Letters have been sent, investigations mounted and pressure applied. It is quite a stretch to state that voices were “diminished”.

Having your voice “heard” and having your requests acted upon are very different things, however. And that is the flaw in the logic of this letter: the voices were heard, but it appears that they carried a message that didn’t meet the basic criteria for inclusion in the Strategic Plan: a basis in sound science.

To take a recent example: People can say over and over, “we want research into chelation”. But, if (a) there is no reason to suspect chelation would help as autism is not heavy metal poisoning, (b) there is a possibility that chelation could hurt as demonstrated by recent rodent studies

Conclusion, or, tell them again

[letter]We ask that the IACC approve these specific action items: (a) adoption of amendments to the plan responsive to the above 5 concerns; (b) specification that research spending be at least the CAA minimum and establishment of a workgroup to be convened in January 2009 to develop recommendations to the IACC for increasing the research spending to at least that minimum and adding objectives which will bolster research on the environment, gene-environment and treatment; (c) inclusion of oversight provisions including an AAB and DOD-model review process; and (d) specification that oversight bodies and workgroups have strong and diverse community representation.

Which pretty much summarizes the bullet points above. My eye was drawn to the idea that a workgroup be convened in January 2009. Why? Could it be that they would like this workgroup to be a fait accompli when President Obama takes office? Again, let Mr. Obama put his plans into action.

The final short paragraph caught my eye as well:

[letter]Each day, decisions are being made on autism research by NIH and other federal agencies which are outside of the SP. It is imperative that the plan be improved in the areas noted above at the November 21, 2008 IACC meeting.

The strategic plan (SP) is not approved yet. By definition, decisions are being made that are outside of the Plan. Also, I sincerely hope that decisions continue to be made outside of the Plan. Who can predict what may happen in the next few years that may require action outside of the Plan? As the old saying goes, if we knew what the answers were going to be, it wouldn’t be “research”. I really have a hard time figuring out why they included that sentence in this paragraph.

The letter is then signed:

Autism New Jersey (formerly COSAC)
Autism Research Institute
Autism Society of America
Autism Speaks
Generation Rescue
National Autism Association
Organization for Autism Research (OAR)
SafeMinds
Southwest Autism Research & Resource Center (SARRC)
Talk About Curing Autism (TACA)
Unlocking Autism

Much speculation could be had about what tradeoffs were made in order to get all these groups to sign the above letter. It isn’t much of a stretch to say that the letter doesn’t go nearly as far as many of the signatories would have gone on their own in the area of mercury and vaccines.

It is notable that Autism Speaks signed on to a letter with a number of groups that have been quite negative towards AS (to put it mildly). It is also notable that at least one, and this one major, autism research organization is not represented on this list.

I realize it is just one rather short letter, and my responses have been rather long in comparison. I also realize that many of these points are probably obvious to those at NIH and/or working on the IACC. And, yet, I somehow had to do this!

On to more important topics soon!

I Object! (Part 2)

19 Nov

It’s amazing that a relatively short letter could be so objectionable as to take multiple blog posts to discuss.

And, yet, here I am, on my third post. You can read the other two, I Object (Part 1) and Why should the Strategic Plan include vaccines.

Continuing on with bullet points (b) and (c)…

Bullet point (b), or “you are leaving money on the table”

[Letter](b) The plan fails to allocate commensurate resources. The CAA authorized $645 million for NIH research over five years. The plan falls short by close to $200 million. Given the urgent situation, we consider the CAA allocation to be a minimum requirement for federal agencies and feel that even greater resources are needed.

Who is going to say no to “we should apply more resources to the situation”? Certainly not I. But I’m not an MBA. I count resources in terms of how many good research groups are doing quality research in relevant areas. Counting the money, that comes second.

This is similar to the method used by the IACC. People tend to think–and this letter helps perpetuate–the idea that the CAA appropriated money and that the IACC worked from that budget to create the Plan.

Both ideas are incorrect.

First, in admittedly confusing language, the CAA authorized the appropriations. The CAA states, “…there is authorized to be appropriated..”, not, “this amount is appropriated”. Another way to look at it is to see how often “subject to the availability of appropriations” is used in the text of the CAA. It isn’t as though there is a bank account with $645M waiting to be tapped into.

Second, the IACC did not work from a budget and then decide on a Plan. They didn’t say, “Well, we’ve got $645 million, how will we spend it?” What they did was say, “what needs to get done?”. Near the end of the process, they passed the Plan on to the implementation subcommittee to draft the budgets for the various projects.

This sounds like the much more defensible method. The IACC can go to congress and say, “this is what we need to get the job done.” Had they come up with a budget higher than the CAA allocated, they would have been in a good position to ask for more. They are (I hope) in a good position to get their budget fully funded–they can defend why they came to the total cost in their budget.

That said, of course I’d like to see more research funded. But, I’d like to stay on a friendly partnership with the NIH too. Presenting their actions inaccurately (as this letter appears to do) doesn’t accomplish that in my mind.

let’s look at what the CAA authorized to be “appropriated“:

[Combating Autism Act]`SEC. 399EE. AUTHORIZATION OF APPROPRIATIONS.
(a) Developmental Disabilities Surveillance and Research Program- To carry out section 399AA, there are authorized to be appropriated the following:

`(1) For fiscal year 2007, $15,000,000.
`(2) For fiscal year 2008, $16,500,000.
`(3) For fiscal year 2009, $18,000,000.
`(4) For fiscal year 2010, $19,500,000.
`(5) For fiscal year 2011, $21,000,000.

`(b) Autism Education, Early Detection, and Intervention- To carry out section 399BB, there are authorized to be appropriated the following:

`(1) For fiscal year 2007, $32,000,000.
`(2) For fiscal year 2008, $37,000,000.
`(3) For fiscal year 2009, $42,000,000.
`(4) For fiscal year 2010, $47,000,000.
`(5) For fiscal year 2011, $52,000,000.

`(c) Interagency Autism Coordinating Committee; Certain Other Programs- To carry out section 399CC, 409C, and section 404H, there are authorized to be appropriated the following:

`(1) For fiscal year 2007, $100,000,000.
`(2) For fiscal year 2008, $114,500,000.
`(3) For fiscal year 2009, $129,000,000.
`(4) For fiscal year 2010, $143,500,000.
`(5) For fiscal year 2011, $158,000,000.’.

So, the $645 million number comes from section c. Two things to notice. First, there are large sums in sections (a) and (b) as well. I hope they are getting appropriated. Second, notice that there is money budgeted for 2007 and 2008 in that number. Remember that the CAA hasn’t been funded yet? Has NIH been sitting on their hands, waiting for the budget before they do autism research? Hardly.

The NIH budget for autism in 2007 is estimated at $127 million ($27M more than the CAA called for all IACC sponsored research, which includes CDC and other agencies). Similarly, $128M is the estimated budget for 2008 ($14M above the IACC budget).

Perhaps I am missing something. It is quite possible. But it appears to me that the NIH is working in good faith here.

Again, given the urgent need–to identify and serve the underserved in this country–I would consider there to be a great reason to increase resources applied by the IACC. I just don’t think that is want the signators of that letter had in mind. Consider the next point they make:

Bullet point c, More environmental research, or, what happened to the “V” word?

[Letter]Research on the environment, gene-environment interaction, and treatment are underrepresented in the draft plan. The plan should apply additional resources to these areas.

As already discussed, I found this statement interesting for what it doesn’t say, far more than what it says. What it doesn’t say explicitly is “mercury” or “vaccines”. As noted in that previous blog post: if the signatories of that letter are OK with this wording, it should be OK in the Strategic Plan.

Sullivan’s take

The order of these two bullet points sends a clear message: The Plan doesn’t use all the money “appropriated” and, yet, the Plan should put additional resources into environment and treatment.

Or, “why don’t you take some of the $200 million and spend it on these areas?”

It would be a good question if that was the way the process worked. (A) the money wasn’t appropriated (so there isn’t $200M sitting unused) and (b) the Plan was built on a “what needs to be done” basis, not “how much do we have to spend” basis. The push for more environment/treatment really needs to be justified in terms of “what needs to be done”.

But, again, I’d agree that more resources would be welcome. And, again, I would suggest attempting to meet the great need of serving the underserved. Research into services like the Taft Transition to Independent Living program comes to mind.

more to follow…

I object! (Part 1)

18 Nov

If you’ve been reading LeftBrainRightBrain lately, you know about “The Letter“. If you haven’t, here’s a quick introduction: A number of autism organizations drafted a letter and submitted it to the members of the Interagency Autism Coordinating Committee (IACC). The letter attempted to invoke “the autism community” (see the AoA blog post for more on that) and that was objectionable to me. Kev took up the idea of Who makes up the autism community. It is clearly an important discussion–there are over 100 comments for those two blog posts.

I’ve been told that the letter marks an achievement in advocacy–bringing together all these groups. And it was–someone got Generation Rescue to accept a document that didn’t explicitly call for research on vaccines. Whatever underling who told the top people there, “this is the best you are going to get” was pretty brave.

But, Let’s get back to the letter itself. Because, believe me, I for one have many more objections to that letter. Going through point-by-point takes some, but I present below my views. I’d suggest this: take a look at the letter, see what you may agree with or disagree with, and check back here to see if you agree or disagree with my take.

I’ll be frank. Every section had something objectionable in it.

Let’s take a closer look at the letter, shall we? I’ll add my thoughts section by section, starting in this post with the introduction and the first bullet point.

Introduction, or, “we are united”

[Letter]November 12, 2008

RE: Concerns on Draft IACC Strategic Plan

Dear Members of the IACC:

The Combating Autism Act required the IACC to prepare a strategic plan for autism research in order to enhance the quality, effectiveness, and overall benefits of autism research spending within HHS agencies. While the 2008 planning activities reflect improvements relative to earlier Autism Matrix efforts, ultimately the draft plan and the planning process have fallen short. Autism advocates have identified a range of deficiencies and each may place priorities on different concerns. Nevertheless, as a community we are united in expressing our disapproval of the draft plan for the reasons outlined here.

Ouch–there it is: “Nevertheless, as a community we are united in expressing our disapproval of the draft plan for the reasons outlined here”. For any confused as to what “community” means can read the title of the Age of Autism blog post, “Autism Community “United in Expressing Our Disapproval” of the NIH Strategic Plan for Autism Research.”

That’s been discussed a lot (feel free to join in) here and here.

But, let’s look at the substance of the Letter. They make a number of bullet points, (a) through (e).

Bullet Point (a), or “no Urgency”

[Letter](a) The plan fails to communicate a sense of urgency reflecting the alarming increase in prevalence and autism as a national health emergency. The beginning pages of the plan should embody urgency and the critical need of the government to apply the resources to address a crisis situation.

Variations on the word “urgent” are used at least 5 times in the Draft Strategic Plan.

What do they want? They want the Plan to specifically state that autism causes “considerable human and financial toll”, as support for the greater need for “prevention and treatment”. Those are speculations, those are statements from SafeMinds in complaining about the “Strategic Plan” in a previous letter.

Sullivan’s take on “urgency”
When I think of “urgent” in regards to autism, claiming an epidemic is not high (or anywhere) on the list. Finding better ways to help people with autism, yes, that would be high. In terms of the “alarming increase in the prevalence of autism”, I also see things differently that the authors of this letter. I see great strides in identification more people with autism. But, I see a job that is not complete. Racial and ethnic minorities are vastly under-represented in the current autism counts. Autism counts vary significantly by geography. Lastly, but certainly not least in importance, there is likely a vast pool of undiagnosed, underserved adults in this country. But, that is a topic where the mantra “absence of evidence is not the same as evidence of absence” is ignored in place of promoting an epidemic.

Ignoring the underserved is a truly shameful position that these organizations have taken.

However, I am pleased to see that within the Plan, ethnicity, race and lifespan issues are prominent. There is even a prominent statement in the introduction of the Plan on lifespan issues:

[Strategic Plan] Lifespan Perspective: Historically, ASD has been characterized as a disorder of childhood. Although most individuals with ASD will not outgrow their diagnosis, their symptoms will change in form and severity over time. There was great support during the development of this Plan for more research on ASD in older individuals, especially the need for practical strategies for increasing the quality of life and functioning of adolescents and adults with ASD. As individuals with ASD advocate for themselves and expand our knowledge of their experiences and needs, they become partners in the research effort.

Does that rise to the level of “urgency”? I don’t know, I’ll take “great deal of support” happily.

Urgency or politics?
The issues noted above highlight what I see as a big problem with this letter: it is attempting to make the Plan a political document, possibly acknowledging the “epidemic” of “vaccine injury” autism. I am not naive enough to think that there are no politics involved in government sponsored medical research, but the backbone of the NIH process is scientific peer review of research proposals. I’d rather see the Plan document stay closer to that ideal than become political fodder in a struggle that is ripping our community apart.

Such a short letter, so much to discuss. And, we are only at the first bullet point! But, even at this point, it is clear that this is a letter that doesn’t come close to representing the views of this member of the greater autism community.

More to follow…

Jenny McCarthy's Mother Warriors

24 Sep

Jenny McCarthy’s bullshit-fest starts up again today. Look forward to her and Jim Carrey on various US talk shows.

Her new book is called ‘Mother Warriors: A Nation of Parents Healing Autism Against All Odds’ which is equally amusing (mother warriors?) and, well, bollocks. A nation of parents healing autism? Really? Where? I’ve been having this conversation with the autism/antivax loons for over five years now: show me the kids who were once autistic who are now cured by biomed? And I don’t mean your sisters best friends cousins kid, I mean case studies. I keep hearing that there are _thousands_ of these kids – surely some doctor treating them somewhere thought – hey, a case study would be a good idea.

And this definitely includes Chief Mother Warrior McCarthy herself and her somewhat loose definition of what ‘healing autism’ is. I posted awhile ago about how Chief Mother Warrior McCarthy had described her son as recovered (as oppose to recover_ing_) in April this year and then go on to describe how she was planning to chelate Evan in June 2008. Why? If he’s recovered, why is the poor lad being subjected to chelation?

Meh, cup and ball trick much?

So, I thought – given that Chief Mother Warrior McCarthy is doing it – that we might take a closer look at chelation in the form of quotes from Mother Warrior’s on the CK2 (Chelating Kids 2) Yahoo group. I’ll say up front, it makes pretty grim reading but I think people need to know what exactly being a Mother Warrior entails. These are all from different people.

It just takes time. My twins (almost 8 now) have been doing IV CaEDTA roughly every 2 weeks for over 3 years (71 and 78 IVs). The first half-dozen or so were really traumatic, then the kids started realizing it really wasn’t so bad after all and got to the point where they didn’t need to be held anymore, then they didn’t cry anymore, etc.

My son is 6 and I have to hold him down for the IVs – we’ve done 10. Today he got poked 3 times and has purple hands from blowing veins. As I’m lying on him, both of us sweating with 2 nurses trying to do the IV, I’m thinking is is worth it?

I used to give my son a valium before the IV’s when we first started. We had to give him 15 mgs when he was about 90 pounds.

We give my son 300 mg of L-Theanine 90 minutes prior to the IV…

We are considering IV chelation with our almost 7yr old. We started with nutritional IV’s just to see how he would do. THe first one was rough the second was a piece of cake. My Mom instinct tell me they made him feel better…

We do IV chelation on experienced regression during the first 3 or 4 months. I would consider them “healing” regressions, though because he didn’t stay in a regressed state and always came out of the regression….

Now these are bad. Blown veins, chelation over periods of years, kids being medicated to calm them down from their obvious terror. But these next are worse.

Any thoughts or experiences with chelation on children under 16 months? The child in question was tested moderately mercury toxic….

My 15 month old son had a porphyns test by Phillipe Auguste labs that showed very high lead and mercury that spiked off the page, so our DAN is starting him on DMSA suppositories once his OAT test comes back demonstrating that he’s medically stable enough to chelate…

We actually began chelating our son at age 2

And the absolute crowning horror. There aren’t words for this last one so I’m just going to quote it. Remember – this is an example of McCarthy’s Mother Warriors in action describing a process she was going to try on her own son.

I started chelating my son at 13 months of age w/ IVs. Dr Bradstreet’s office chelates little kids. It was actually easier to give him the IVs before he turned 2. My DAN, Scott Smith, says that kids under 3 chelate much faster and it is a good idea to start early.

Thimerosal and Autism on Trial: Closing statement by Mr. Matanoski

31 Jul

This is a portion of the government’s closing argument given by Mr. Matanoski. It is found on the audio from Dwyer called Day02-PM3.

First I want to point out on the specific causation … lawyers are kind of slick they move things around, they kind of play a shell game. When I heard the comments about a specific causation case it made it sound like respondent has a burden here to show what actually caused it. Actually the burden is on the petitioners to show that the vaccine caused autism. And respondent doesn’t have to show that it’s genetic in origin.

And I think that the comments about Dr Leventhal’s testimony on that point are a little off the mark. What Dr. Leventhal was saying, essentially, that most practitioners, most folks who study autism as a profession believe that it’s largely genetic in nature at that’s where the research has been directed and in fact it’s been fruitful in that regard. There’s still much more to do. But everything that has come out has pointed to genetics as very strongly associated with autism and most of the research that has been done has shown that autism would have a prenatal course. That it can essentially be seen, that the preconditions, if you will, for autism are in place beginning before birth, in most instances.

I think there also is a little bit of a misconception about what the force of Dr. Leventhal’s testimony was. He basically was saying that Colin’s case really is sadly no different than many of the cases that he sees, where there is a gradually emerging picture of difference, perhaps delays, but at least difference in the quality of behavior in the child as the child develops. It’s not necessarily apparent right from the start. That’s very rare. Most of the cases it’s apparent later and it may seem that a child has reached certain milestones has subsequently had trouble keeping those milestones. As the condition progresses there often is an improvement. That’s the natural course of the condition. What Dr. Leventhal was saying is, as time has gone on, more and more of the researchers have realized that if you look back in cases, that apparently seemed to have a normal trajectory and then there seemed to be a loss, that you see earlier signs and symptoms that all was not on a normal trajectory from the beginning.
That was the force of his testimony, and that testimony was backed up by other testimony by other testimony that the court has heard before he took the stand.
Dr. Lord who has specifically studied regressive autism made that point quite clear, that as this has progressed the concept of regressive autism has become more encompassing, that autism itself seems to have a progression where it appears that there is a loss but when one goes back, one sees that there is unusual, or differences in development earlier on in almost every case. And what Dr. Leventhal was saying is that as they gotten better, folks who do this for a living, folks who make their lives studying about studying autism they’ve realized that more and more of those cases they can see earlier on. And in very few instances when they’ve studied quite closely do they see that there isn’t some sign that the trajectory or the course is not the same as other children’s.

Dr. Mumper’s testimony which really wasn’t really much of the focus in the closing argument here. She seems to be relying on isolated lab results to come up to a conclusion that vaccines are the cause here. She’s been asked in this case and in other cases what would that pattern be, what do we need to look at? And in fact there doesn’t seem to be a particular pattern. In the King case certain test results were relied upon to draw the conclusion that thimerosal in vaccines were associated with autism in that case, or caused autism in that case. In the Mead case other results were looked at and thought to be, by Dr. Mumper, indicative that vaccines were causing, or evidence that vaccines were causing autism. And now in Colin’s case, we see yet a different pattern of test results being relied upon to reach that conclusion.

In fact those test results, with really no pattern, how can one say that there is any kind of clinical evidence from these test results that one can rely on to make that .. to draw those kinds of conclusions that Dr. Mumper is relying on.

And as you’ll see when you go through the testimony, we believe that she largely moved away from relying on any specific test result when questioned about each specific one she said that essentially that the mercury test result, the positive provocation, was really the only test that she had that showed that the mercury was there, and she was relying on to implicate thimerosal as a cause in this case, but then she admitted that she really didn’t know what the normal range would be for that test.
How can one say that this is an abnormal result when one doesn’t know what normal is?
Her testimony seems to be formed largely by the Defeat Autism Now world view which is that toxins and heavy metals are implicated in autism. And to use the example that Mr. Powers used of Tycho Brahe I think that comes to bear with her testimony as well. It doesn’t matter which test results she’s looking at it always comes back to a heavy metal or a toxin, when it could be that the acidosis that the lactic acid build up could be because the child was crying when the blood was taken. (35 min 30 sec)

I’m going to touch now on the general causation because that was a matter of some discussion by Mr. Williams. I see that the glutathione theory which is where we started with this general causation case seems to have dropped out. It wasn’t in the opening statement, it wasn’t in the closing statement. It seems that the theory of causation now is neuroinflammation and largely seems to be neuroinflammation alone. That was a theory that Dr. Kinsbourne recently advaced in this case. It obviously wasn’t present until just a couple of weeks before the trial in May.
This is something after six years in the making, this seems to have come up kind of at the very end.

Mr. Powers and Mr Williams have focused on the causation burden, and say that the information they have given on neuroinflammation meets that burden, that would be the causation burden under Althen and Grant, the specific criteria that they need to meet under that test that the court has articulated, the federal circuit’s has articulated.

Respondent starts a little earlier than that if you will in the calculation and that is about what evidence feeds into Althen and Grant. We start out with the analysis under Daubert about whether there is good scientific evidence to even meet that burden. So obviously the evidence that you have or the evidence that is being offered does not meet the criteria of good scientific or reliable evidence then you have nothing at all to test about whether you’ve met your legal burden under Althen.

Our position has been throughout this that the petitioners’ evidence that they have offered, the testimony that they’ve offered, fails to meet that standard of reliability that is set out under Daubert and that this court applies. Daubert stands for the proposition that there are not multiple kinds of scientific evidence. A kind for scientists to use and a kind for judges to use. There is only one kind of scientific evidence. It is the kind that scientists use. That is the kind that judges are supposed to be looking for as well. …

Kathleen Seidel’s neurodiversity weblog has more from the Dwyer case, including audio excerpts.

Elizabeth Mumper – Autism Omnibus, Dwyer vs HHS

When I heard Mr. Matanoski say, “when one doesn’t know what normal is,” it occurred to me that it could be used as a slogan or strapline for the autism/biomed organization that is led in part by Dr. Mumper.

Conflicts of interest, whats good for the goose…

28 Jul

As recently blogged by Autism News Beat, CBS Evening News (an American news outlet) recently performed an investigation into ‘how independent are vaccine defenders’? Something of an exercise in futility, it concluded that:

Ideally, it [vaccines] makes for a healthier society. But critics worry that industry ties could impact the advice given to the public about all those vaccines.

So, CBS say that the vaccine schedule makes for a healthier society but that the advice given about vaccines could impact the advice given.

Uh…so? Lets go through that again. It makes for a healthier society. Would CBS rather it didn’t? Bizarre.

Specifically, they attack the AAP, the Every Child By Two website and Paul Offit. The AAP has conferences funded by vaccine manufacturers, ECBT takes money from the vaccines industry….in fact, hold on…CBS say in their report (assume breathless excitement reporter voice)

Every Child By Two, a group that promotes early immunization for all children, admits the group takes money from the vaccine industry, too…

Oh do they? They admit it do they? Under the rigour of your intrepid journalism no doubt? Except that information is clearly available for all on their website. I do wonder if anyone from CBS even spoke to ECBT.

And of course there is Paul Offit – the official poster boo-boy for anti-vaccinationists everywhere. The man who dares to make a profit from his inventions! CBS took him to task for holding a patent on a vaccine. Shall we look at another man who made a patent application for a vaccine? That’s right – Andrew Wakefield. Except, unlike Dr Offit, who made no attempt to hide his association with the vaccine he was responsible for, Andrew Wakefield’s solicitors said that ‘Dr Wakefield did not plan a rival vaccine’.

How about other people who make a tidy income from the anti-vaccine industry? The Geier’s maybe who invented their own IRB to make sure that their ‘science’ was unhindered by ethical considerations…..or maybe Dr. Jay Gordon who thinks that the Polio vaccine could be replaced by simply not eating cheese. How much do you charge your clients Dr Jay? How about Laura Hewitson who’s husband works for the Wakefield owned Thoughtful House and who seems to be part of the Autism Omnibus hearings….how independent can her science be? How about the ARI/DAN group who are led by people who clearly have no clue at all as to the medical science they are making a large profit on. How much do each of these people make? How about Rashid Buttar who lists non-existent memberships on his CV and who charges upwards of $800 for a 1 hour consultation fee and who’s ex-patients report being out of pocket by about $20,000 in about a year.

Its up to you Dear Reader – are these things we should be worried about? Are these things CBS should be worried about? Are these conflicts of interest? Does the act of making any sort of money either from treating people or from existing business interests mean you cannot and should not talk about these things? Should we assume that only certain people have an agenda?

In my humble opinion, it should only become an issue when attempts are made to hide these things. Or deny them when they are clearly true. That cannot be said of the AAP, ECBT or Paul Offit. Maybe CBS should be asking to see the balance sheets of DAN doctors or vaccine litigation specialists. What have they got to hide? Maybe CBS should be inspecting the credentials of people who claim to be able to cure autism and reverse old age. Maybe CBS should be looking at the disturbing increase in ties between autism/anti-vaccinationists and scientology.

But I would think in the meantime that CBS will take the easy route of producing crap that informs no one about anything. Lets hope it doesn’t turn around and bite them on the arse eh?

Elsewhere
Orac weighs in too.

Dear Mercury and MMR Militia

21 Jun

I want to write you all an open letter to offer you my opinion as to where you are going wrong. Before I do, I fully realise that this is a massive generalisation and that some of you won’t hold all the opinions I’m about to go through. I think though, that many of you do.

Three things prompted this open letter. First of all was David Kirby’s trip to the UK. Second was a comment from Kelli Ann Davies where she expressed surprise that some of us might know/guess/whatever the intentions of the science and medical community. Third was Ginger Taylor’s recent sulk about the AAP. I’ll touch on these things as I go through this.

You have a truly massive credibility issue which grows with every passing year. Once upon a time it was an issue with the science/medical community but now it is an issue with the general public. There are a number of reasons why this is so.

1) You cannot keep your story straight. You have (as I said to Kelli Anne) some first class marketing and PR people. As I recall, Lynn Redwood, Mark Blaxill and Sallie Bernard all have marketing qualifications. You also have numerous leading lights who are very, very rich. This means you have ample opportunity to lever your message into the heart of the US media system.

But that means nothing without a coherent story to sell. You don’t have one. I understand that you have recently talked about how the ‘story of vaccines’ has _evolved_ . That is stretching things more than a little. Its mercury, no its MMR, no its both, no its Aluminium, no its all three, no its all ingredients, no its the very vaccines themselves, no its the schedule they’re given. No – its ALL the above. And don’t forget the mitochondria!

The more ingredients you add to the pot, the more you have to explain why they are causative of autism. You didn’t even manage to do this when you were concentrating on just _one_ thing (thiomersal). The above is not an example of an evolving hypothesis. Its an example of an ever widening hypothesis as one after another, your original ideas have been taken down.

Nowhere is this better illustrated than David Kirby’s stumbling backwards and backwards:

In 2005, David said in a FAIR Autism Media interview:

It’s now 2005…..[W]e should see fewer cases entering the system [cdds] this year than we did last year.

When that didn’t happen he then said:

if the total number of 3-5 year olds in the California DDS system has not declined by 2007, that would deal a severe blow to the autism-thimerosal hypothesis…..total cases among 3-5 year olds, not changes in the rate of increase is the right measure.

That didn’t happen either.

You started off by pointing an air pistol at a target 20 feet away and missing. You worked your way through Magnums, Shotguns and Miniguns and kept missing. You currently have a canon wheeled right up to within a foot of the target and you’re _still_ missing.

2) Your science is weak and getting weaker. Sadly for you, the onus was (and still is) on you to provide evidence that vaccines in any of the myriad of hypotheses cause autism. Lets hypothetically agree with you that vaccines are in fact, fashioned by Satan and are in fact, tools of population control. That is not the point. The point is: _do they cause autism?_

There is not one paper that passes muster as valid science that offers corroborating evidence that any vaccine, any ingredient of vaccines or any schedule they are administered in causes autism. This is after over 10 years of trying to find one. What you are increasingly left with is a double conspiracy theory. In one barrel of the conspiracy theory, brave maverick doctors are having their research suppressed. In the other barrel of the conspiracy theory, Big Pharma shills are publishing science to refute the various vaccine hypotheses.

Of course, neither barrel is true. The brave maverick docs are not having their science suppressed. It is simply not good enough to pass peer review.

A good example of this is the science experts being presented at the Omnibus Autism proceedings. No Geier’s. No Jim Adams. No Boyd Haley. No Andrew Wakefield. At least, not so far anyway. And this is in the Vaccine Court, where standards of evidence are way lower than in a civil court, where – by the way – not a few of these same researchers science was not good enough to even be entered as evidence.

And you have this nasty habit of shooting yourselves in the foot. Only today David Kirby posted on the Huffington Post about how rubbish the VSD database was. The very same database the Geier’s recently used to allege a link between vaccines and neurodevelopmental disorders.

And the list goes on. The Hornig study? Refuted by Rick Rollens MIND Institute. The Nataf paper on Porphyrins? Liz Mumper, head of DAN! medical admits that even ‘normal’ children have raised Porphyrin levels. The Bernard et al paper? Refuted. Richard Deth’s work? Exposed and questioned.

3) Your choice of media people to represent you is doing you harm. I am not sure how the idea of latching onto Jenny McCarthy as a spokesperson for the anti-vaccine/autism connection came up. There are a few other celebs I can think of with more gravitas than McCarthy. In truth, you couldn’t have chosen worse. Already, she has made a public fool of herself (and you). As has her partner, Jim Carrey, with his ‘lazy ass’ FUBAR and calls to notice ‘warnings from the universe‘.

I understand that these events feel terribly cathartic to you but I would urge you to take off your rose tinted glasses and see how the real world perceives these kind of things. Its not good. Don’t take my word for it, go to a _mainstream_ news source, discount the people you know as friends/associates who are leaving comments and then see what people think.

You have also latched onto the words of Bernadine Healy. I can see why but she (is/was) a member of a paid lobby group that advances the ‘science’ of Philip Morris to put forward the idea passive smoking isn’t dangerous. How desperate do you have to be to turn to _this_ ‘authority’ for backup?

4) You cannot see that you are being humoured. I know that some of you have been very proud of your success in getting involved with things like the IACC and y’know, thats great – well done to you. And then there’s the ‘coup’ of getting the AAP to attend a DAN! conference and ‘work with’ them. But there’s one thing you seem to have forgotten. AAP members are medical scientists. They will go with the decent science.

I read a blog post from Ginger Taylor today which seemed to be telling the AAP their ‘window of opportunity’ to work with DAN! et al had closed due to the fact they endorsed a letter that a paediatrician had written on how to tackle parents who were nervous about vaccination.

Amusingly, Taylor also chided the AAP for not turning up to the ‘green our vaccines’ rally:

I warned that the window would only be open for a short time unless we saw real action, and would probably close around the time of the Green our Vaccines Rally if they didn’t show up for us in some respect.

Well the AAP didn’t show up for the rally and well… this certainly signals that the window is closed. They want it closed. And it looks like they may be locking it.

Can you not understand that to expect the AAP will turn up for a rally which touts such anti-science as Aluminium and Formaldehyde being at singularly dangerous levels in vaccines and Anti-Freeze being in them at all is the height of arrogant stupidity? Surely you cannot be that naive?

The truth is – and I get this from speaking to AAP, NIH, FDA and NHS members – that you had, and always will have, an opportunity to impress them with decent, peer reviewed science. That’s all you’ve ever needed. And that’s what you’ve never had.

5) The future. The person you’ve decided will be your public face is writing another book. <a href="http://stopthinkautism.blogspot.com/2008/06/today-autism-recovery-tomorrow-crystals.html"She says that:

It’s really an Indigo book…….We’re definitely the Indigos, you know, breaking down these walls so this, you know, New Earth behind us can happen.

And what’s your role in this?

…But people aren’t quite there yet and I kinda had to, not lower my vibration, change my vibration to focusing on the world hearing that message. Hearing that biomedical treatment does help these kids.

And then, slowly, you know I can put it in my speeches. and then in my last book I talked about the indigos and crystals. And I’m just like, I’m really following source, kind of I felt the need to do that, I’m just kind of dribbling it here and there until people, you know, have that spiritual awakening of spirituality.”

That’s where you’re going. You’re close to abandoning any kind of rational basis for your beliefs and just becoming Jenny’s followers in an Indigo Spiritual Awakening to herald in the New Earth..