A Blogging Catch Up

Over the last few months a number of bloggers have discussed some important and disturbing things happening in the realm of autism science. I want to provide a round up of the main features of these posts and discuss the implications for the thiomersal hypothesis.

Mady Hornig’s Rain Mouse

Briefly, Mady Horning conducted a study wherein she claimed to have developed a mouse model for autism which she then used to test how the model responded to the introduction of thiomersal. According to Hornig, the study showed that:

1. The mice they used are a good model for autistic people
2. The ‘vaccine’ schedule they used successfully mimicks childhood immunization programs
3. That the outcomes from Auto-immune disease sensitive mice were consistent with autism
4. That this indicates a genetically influenced sensitivity to thimerosal in autistic people

Autism Diva took this study apart when she pointed out that:

Did Dr. Hornig and colleagues find these features [diagnostic criteria for autism] in the ‘SJL Thim” mice?’ No.

Prometheus also had reservations about the design of the study:

So, the human experiences a maximum blood level of 1.63 (arbitrary units) and the mouse – since it is being dosed at a smaller fraction of its half-life – sees a maximum blood level of 2.61. In short, the mouse gets to a blood level 60% higher than the human……I found myself wondering, “Why didn’t they use the 50th percentile (50% weigh more than this weight, 50% weigh less – sort of an ‘average weight’)?” I have no answer – but I have an idea. By using the 10th percentile, they were able to give the baby mice an even bigger dose of mercury……So, by using the 10th percentile weights, the authors were able to give the mice about 15% more thimerosal. This goes nicely with the dosing schedule to significantly raise the dose the mice receive.

One of the big talking points from this study was reported by David Kirby in Evidence of Harm:

… putting up a photo of two mice. “He has groomed through the skull, and eventually destroys his partner,” Hornig said. Every parent of an autistic kid in the room could be seen grimacing in dark recognition of such destructive behavior.”(page 312)

Uh-huh, or maybe they were just grimacing as its not nice looking at mice chewing through the skulls of other mice?

Anyway, hyperbole aside, why did Hornig choose those particular mice? Here’s what else Autism Diva found out.

Why did Hornig pick the SJL/J mice in particular?….Besides being an “autoimmune disease-sensitive” breed what else is known about the SJL/J mice?

Good question. Diva found the answer highly revealing:

Behavior
1. High spontaneous fighting….
2. Severe fighting among males housed together, beginning at about 8 weeks.
3. Most males will be killed by 4-5 months unless caged separately….

Diva also found a separate source that showed that:

…some breeds do a kind of agressive grooming of other mice called, “barbering”

So, it seems that Hornig sourced a set of mice known to be aggressive, she then systematically overdosed them and then reported the fact that this aggression was indicative of autism. Right.

Holmes, Blaxill and Haley First Baby Haircuts

This study claimed that there were reduced levels of mercury in autistic children’s first baby haircuts. The authors claimed this was due to an inability to excrete mercury.

Prometheus took an initial look at this study and found numerous methodological errors that would question both conclusions. These problems included:

1. Storage of the hair in unknown conditions for a median of 5 and a half years.
2. The calculation of the mothers mercury exposure was made on the basis of recollection of events between 5 and 16 years in the past.
3. A formula derived from the data to calculate the amount of mercury the kids were exposed to in the womb.
4. The data they collected was used to come up with the formula they used to calculate the mercury exposure – which they then used to explain the data they came up with. Prometheus compared this to ‘a puppy chasing its own tail’.

Prometheus also noted that the conclusions in the paper referred to _measured_ exposures, which he noted never occurred – they _calculated_ remember? Prometheus went on to note:

[1] There are no data or citations provided to support the implied assertion that mercury is actively excreted in the hair. – The reason for [1] is that there are abundant data and studies showing that mercury enters the hair – in all studied species – passively from the blood, attracted by the sulfur-containing amino acids in hair. The only way to “impair excretion” is to cut off the blood supply to the hair – which causes it to fall out.

[2]There are no data citations provided to supports the assertion that mercury elimination in the hair is a significant means of clearing mercury in humans – especially infant humans, who have little hair relative to their body weight. – The reason for [2] is that humans, and especially human infants, have a very small mass of hair relative to their body weight – a much lower relative amount than many of the other species studied (e.g. rodents and primates). For this reason alone, excretion in the hair cannot be a major route of mercury excretion in humans.

Prometheus later went on to discuss more about this studies shortcomings.

[Holmes et al]….concluded that, since the autistic children had lower hair mercury than the controls, that autistic children were unable to excrete mercury….Mind you, they offered no data to support that startling (if not ridiculous) conclusion, nor does anything known about mercury “excretion” in hair support that line of “reasoning”. As far as I can tell, they just made it up rather than face what the data (such as it was) told them – that mercury had nothing to do with autism

Prometheus compared their hair/mercury findings with another hair study into autistic kids:

The autistic children in the Holmes et al study had over twice the mean hair mercury level of the NHANES group (of 838 children) and the Holmes et al controls had hair mercury levels of over sixteen times the NHANES level….the only conclusion that you can draw from that data is that the Holmes et al study is garbage. My suspicion is that their laboratory – Doctor’s Data – is the cause of the outrageously high levels of mercury found in the children – especially the control children.

Recently, Dad of Cameron has been looking long and hard at James Adam’s and discovered an intriuging paper written by him also about hair/mercury and autism.

In the discussion section of the Adam’s paper DoC found the following:

Overall, it appears that the children with autism do not have major differences in their levels of toxic metals compared to controls….Thus, our results are not necessarily inconsistent with the results of Holmes et al.

Hmm. Interesting. It seems to me to be the polar _opposite_ of the Holmes et al paper.

The crux of the issue is what is defined as ‘normal’ levels e.g. the control groups. The Holmes paper found that the autistic kids had a mercury level one eighth of the control group. However, when one compared the average to the control group of the much larger NHANES study then the Holmes results were very close to the NHANES normal level. DoC also found that the Holmes control group had a mercury level of over 15 times the NHANES control group.

When one also looks the Adams study then, as DoC says:

they had a level quite similar to, or higher than the NHANES average, and higher than the average of both typical and children with autism published in Adams et al. This probably suggests that the “inability to excrete mercury” hypothesis could possibly, if not more likely, be post hoc correction

Post hoc correction roughly means a desire to keep the hypothesis alive at all costs……or deriving the formula from the data. DoC concludes with:

It should be pointed out that mean values found by Adams et al. for typical children are nearly identical to the findings of the 1999–2000 NHANES study of 838 children – Adams et al. This does in fact suggest that the Adams et al. data is valid. It should also be pointed out that both Holmes et al. and Adams et al. apparently had hair samples analyzed at Doctor’s Data. It’s possible that both studies were even conducted around the same time (somewhere near 2002) presumably, or at least possibly with the same epuipment and methods too, yet they both got vastly different control group results…..it’s pretty clear that Holmes et al. probably didn’t find unusually “low levels” in baby hair. It would seem that what they found was an unusual control group.

In other words, there’s no ‘inability to excrete mercury’ on behalf of the kids in the Homes et al paper. There’s certainly nothing put forward to justify that hypothesis and there’s lots of good reasons to suspect the methodology Holmes et al employed and the near as dammit certainty that the Holmes autistic group ‘suffered by comparison’ to an abnormal control group.

The Geier’s Misrepresentations

If there’s one blogger who has approached blogging pulitzer prize status its Kathleen. Her in depth (and continuing) placing of the Geier’s under the microscope of basic honesty is simply stunning not just in its style but in the meticulous attention to detail and most of all the genuinely worrying implications for how the Geier’s have behaved.

Kathleen’s first post on the subject concerned the way that the Geier’s claimed an affiliation with George Washington University in at least one of their published works:

A Clinical and Laboratory Evaluation of Methionine Cycle-Transsulfuration and Androgen Pathway Markers in Children with Autistic Disorders. Geier DA, Geier MR. Department of Biochemistry, George Washington University, Washington, D.C., USA.

According to the conventions of academic publishing, this would generally imply that Mr. Geier is a member of the faculty at GWU, or a graduate student publishing with a thesis advisor or other faculty member in the same department; and that GWU is the venue at which Mr. Geier’s share of the research took place.

Puzzled and confused by this claim, Kathleen contacted Dr. Allen Goldstein, Chairman of the GWU Department of Biochemistry and Molecular Biology who …

…stated unequivocally that David Geier has never served on the faculty of the Department of Biochemistry and Molecular Biology at GWU; that neither the “Institute for Chronic Illnesses” or its Institutional Review Board….are in any way associated with GWU; and that none of the research described in the article was sponsored by GWU or conducted in the GWU laboratories. He described the affiliation with the Department of Biochemistry in the Hormone Research article as “fallacious,” and stated that it conveyed a “significant misrepresentation” of Mr. Geier’s position in the field of biochemistry.

The Geier’s later claimed that this was a publishing error on the part of Hormone Research. However, when I emailed the Editor of Hormone Research, he refused to confirm this and stated that the Geier’s paper would be subject to an investigation.

Kathleen’s second post in the series showed how the Geier’s apparently gain ethical approval for their studies. A paper of their Kathleen was reading said:

The Institutional Review Board of the Institute for Chronic Illnesses approved the present study.

Kathleen had never heard of this IRB so she set out to investigate it.

Before I related what she found, its important that people understand just what an IRB is. For this I turn to surgeon blogger Orac who informs us that:

After the horrors of Nazi medical experimentation…it was clear that rules were needed to protect human research subjects from such abuses. A historic document in the development of such rules in the U.S. was the Belmont Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research….This report identifies three essential and fundamental ethical principles for human subject research. It is essential reading for anyone doing human subject research in this country. In 1991, these regulations were codified into what is now known as The Common Rule. All institutions doing federally funded research are required to adhere to The Common Rule. Moreover, some states, such as Maryland (where the Geiers have their businesses) require that all human research, regardless of funding source, must conform to the Common Rule.

A key aspect of The Common Rule is the IRB. The IRB is in essence a committee that oversees all human subject research for an institution and makes sure that the studies are ethical in design and that they conform to all federal regulations. Basically, IRBs are charged with weighing the risks and benefits of proposed human subject research and making sure that (1) the risks are minimized and that the risk:benefit ratio is very favorable; (2) to minimize any pain or suffering that might come about because of the experimental therapy; and (3) to make sure that researchers obtain truly informed consent. Once a study is in progress, regular reports must be made to the IRB, which can shut down any study in its institution if it has concerns about patient welfare. Indeed, the IRB at my particular institution is like a bulldog; it’s utterly ruthless in how it deals with researchers.

So this is not just a piece of red tape to circumnavigate – it fulfils a vital ethical (and legally obliging) role. Here’s what Kathleen found out about the Geier’s IRB for the study in question. The IRB overseeing the Geier’s research is comprised of:

Mark Geier, Chair, David Geier, Lisa Sykes (Rev. Sykes is a mother of a participant in Dr. Geier’s study). Kelly Kerns (an anti-thimerosal activist and petitioner in vaccine injury complaints for each of her three autistic children). John Young (a newly-minted DAN! practitioner. Anne Geier (wife of Dr. Mark Geier and mother of David Geier. Clifford Shoemaker (A vaccine injury lawyer, a member of the Vaccine Injury Alliance, and a member of the Omnibus Autism Proceeding Petitioners’ Steering Committee. Dr. Geier has testified on behalf of his clients in Price v. Wyeth et al, Platt v. HHS, Jenkins v. HHS, Lewis v. HHS, Raj vs. HHS, Jefferies v. HHS, and other cases.). The address for the IRB is the Geier’s family home.

Kathleen concludes:

according to The Common Rule, Mark Geier and David Geier would be ineligible to vote on any of their own research proposals. Anne Geier would be ineligible to vote on any research proposed or conducted by her husband or son. Rev. Lisa Sykes would be ineligible to vote on any study in which her son is a participant. As a co-investigator with Mark and David Geier in their Lupron research, John Young, too, would be ineligible to vote on any IRB supervising that research. Of the seven members of the IRB, only a minority of two — Kelly Kerns and Clifford Shoemaker — would be eligible to vote on the research described in the article — and only if they are free of any personal or financial interest in its outcome.

But why would the Geier’s need to invent their own IRB? Kathleen tackles this in part three of her investigation.

By definition an IRB should have:

“the professional competence necessary to review specific research activities, […] to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice”

Now, its worth remembering this all this is taking place against the background of a Lupron study. Lupron was being used by the Geier’s to treat (according to them) Precocious Puberty (CPP). Neither of the study authors Geier Snr and Jnr have any experience whatsoever with this condition and hence an objective IRB would not allow them to proceed. Possibly this is why they needed their own personal IRB.

Why Precocious Puberty? Well, its not because these kids actually have it. The Geier’s claim to be treating 50 kids for this condition. However in a strange anomaly, Kathleen found that its a rare enough condition that:

European endocrinological research consortium found it necessary to pool data from The Netherlands, Italy and France in order to accumulate 26 male subjects for a study

Yet the Geier’s found 50 in little under 1 year. Amazing.

The rest of Kathleen’s entry deals with the way in which the Geier’s mangled the diagnostic criteria for CPP in order to justify diagnosing kids with it and hence justify prescribing them with Lupron.

As one participants parent put it:

[T]he labs, according to the Geiers are ONLY an attempt to determine CPP and get insurance coverage for Lupron Depot.

…which sounds very much like orchestrated insurance fraud to me.

And, surprise surprise, it must’ve seemed that way to a couple of other people to because Kathleen’s next instalment revealed some curious terminology alterations. Suddenly, the Geier’s scrubbed all mention of CPP and instead were referring to hyperandrogenicity. However, old habits die hard:

In spite of the new prominence of “hyperandrogenicity” in the Powerpoint presentation, a verbal slip during the lecture revealed Mr. Geier’s lack of familiarity with the term, and suggested that he regarded “hyperandrogenicity” and “precocious puberty” as interchangeable.“…and then we talk about clinical symptoms of premature or hyperandrogenicity in these children — premature puberty or hyperandrogenicity…”

and in a lovely catch, Kathleen noted that:

The header to Table 1 (of a supporting data table to a presentation) had been altered after it was originally prepared. “Hyperandrogenicity” had been inserted into a white space exactly large enough to accommodate the phrase “precocious puberty.”

All of these changes and inconsistencies raise the question — have Dr. Geier and Mr. Geier begun to use terms such as “hyperandrogenicity” and “testicular hyperfunction” in journal articles and public presentations about their testosterone hypothesis and the “Lupron protocol,” while they and cooperating doctors continue to enter the more reimbursement-friendly diagnosis of “precocious puberty” on their patients’ insurance claims?

Good question. In Kathleen’s next instalment she discusses how the Geier’s use a method of recruiting parents who are already allies of their’s and who are active on internet forums to their initial groups. they then let those parents spread their message to all and sundry, despite having no medical knowledge whatsoever.

Prominent amongst those people is Erik Nanstiel who once told me that chelation would cure his daughter in 18 months. he had no doubt about it whatsoever. He ‘knew’ this because the Geier’s told him.

Erik now sings a different tune.

The Geiers have recommended we take M[…] off chelation…for now. When we reported that the chelator caused regression away from the gains we got with Lupron alone… they looked at her chart and said that, consistently, her urinary porphyrins have been lower than most kids they treat. They think that it’s possible (POSSIBLE) that M[…]’s two years of DMPS chelation has depleted most of her toxic metals. We think Her regression could have been a result of the chelator feeding yeast in her gut and affecting nutrient absorption … and possibly not so much because it was stirring up a lot of heavy metals. They also mentioned to me that a LOT of the kids they treat are doing wonderfully on Lupron alone… without the chelator. So we’re going to try it.

So now the Geier’s say that chelation _won’t_ cure Erik’s daughter in 18 months (gasp!). No, now they say Lupron will.

Erik has also repeated the Geier’s verbiage that:

Testosterone and Mercury bind weakly end to end…and then go on to form sheets. The mercury is trapped in these lattices which hamper chelation. They claim to have verified that with x-ray crystallography imaging

Thats from March this year. In June this year he said:

The mercury/testosterone sheets was just a theory that isn’t panning out.

So in March its verified. In June its just a theory that isn’t panning out. Despite this tendency to fail to engage his brain before opening his mouth Erik feels fine about dispensing medical advice:

I can say with a great degree of confidence that your child has Precocious Puberty caused by autism

Same confidence that led him to state that chelation would cure his daughter in 18 months or that testosterone bound up mercury in sheets no doubt.

In part six of the series Kathleen uncovered some fairly obscure and disturbing relationships and possible beliefs of the Geier’s.

On June 23, 2006, Dr. Geier returned to Radio Liberty to discuss vaccines and autism, and to give an update on the progress of his research into the “Lupron protocol.”

As readers of my blog will know I’ve talked about Radio Liberty before. Dr Geier was interviewed by Dr. Monteith who also interviewed Dr David Ayoub in a segment entitled _’Linking mercury in vaccines to global population control.’_

Monteith, like Ayoub, believes that the global population is being controlled by the Illuminati partly by vaccines. It seems that Geier has similar beliefs:

And as you said, it [autism] not only destroys the kids’ lives, it destroys the family, it destroys the siblings, it destroys the neighborhoods, it destroys the educational system. And if we are not careful it’s going to destroy the United States, because it’s going to hard for us to be the number one nation in the world. What do we produce? What makes us number one? Is it our oil? Is it our nuclear energy? Is it our science? You know what it is? It’s our brains. And if we have one in six children, even using their figure, that have brain damage, and we end up, there’s three hundred million Americans, and we end up with one in six of them having brain damage, that’s fifty million Americans, we’re not going to be the number one country in the world anymore. And I have great fear for that. I love this country, and we’ve got to not let that happen.

Whereupon Dr Monteith replied:

Why are these things going on? Well, if you’d like to know why they’re going on, you need to get my talk on planned population reduction… And ladies and gentlemen, I hate to say this, but there really are people who want to hurt children… And if you doubt that, you need to get my book, Brotherhood of Darkness… Our government is poisoning us.

Right.

Moving swiftly on, Kathleen’s next part of the series discussed how the Geier’s were taking mainstream science and misappropriating it for their own ends.

Each of Dr. and Mr. Geier’s articles and presentations on the “Lupron protocol” have included references to the work of British researchers Dr. Simon Baron-Cohen, John Manning and their colleagues on the possible relationship between fetal testosterone levels and the development of autism. From The potential importance of steroids in the treatment of autistic spectrum disorders and other disorders involving mercury toxicity:

The Geier’s said of this study that:

The authors demonstrated that the more severely affected the children were the higher the levels of prenatal testosterone.

In fact, what the Geier’s had actually done was take a graph that Baron-Cohen et al had used to demonstrate that it was impossible to directly detect pre-natal testosterone and _re-label the axis_ so that it ‘demonstrated’ their own pet theory.

Whereas the left axis of the chart had originally been labeled, “Mean 2D:4D,” Dr. and Mr. Geier had deleted that label and replaced it with “Lower testosterone/higher estrogen” and “Higher testosterone/lower estrogen.” The summary above the chart on Dr. and Mr. Geier’s Powerpoint slide stated unequivocally that the study reported in The 2nd to 4th digit ratio and autism had found a direct relationship between levels of fetal testosterone and the severity of autistic symptoms, when this was not the case; as noted above, the investigators in that study had clearly stated that it was impossible to directly test the prenatal testosterone levels of their subjects.

Kathleen contacted Professor Baron-Cohen about this misrepresentation. He replied thusly:

I am aware that the Geiers are citing our work to justify their treatments involving lowering testosterone levels in autism. I have never advocated for this treatment, and indeed am opposed to such treatments on two grounds: ethical (manipulating hormones affects many systems in the body and mind, many of which do not stand in need of ‘treatment’) and safety (such treatments may carry risks, many of which are unquantified).

Yesterday, Kathleen posted the latest in her series on the Geier’s. In this post she notes the curious similarities between whole swathes of studies of the Geier’s and other researchers.

Thomas Verstraeten, Robert Davis, Frank DeStefano and their colleagues, published _’Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases’_in November 2003. Advocacy group SafeMinds got hold of a 2000 draft of this study to show that the study had been ‘doctored’ to clear the reputation of thiomersal (of course it hadn’t). However, Kathleen noted something odd about this draft and a subsequent Geier paper.

From Verstraeten 2000 (p. 2-3)

We selected a cohort of infants from the Vaccine Safety Datalink (VSD) database. VSD was created in 1991 by the National Immunization Program of the Centers for Disease Control and Prevention (CDC). The project links medical event information, vaccine history, and selected demographic information from the computerized clinical databases of four staff model health maintenance organizations (HMO)s: Group Health Cooperative of Puget Sound (GHC) in Seattle, Washington; Kaiser Permanente Northwest (NWK) in Portland, Oregon; Kaiser Permanente Medical Care Program of Northern California (NCK) in Oakland, California; and Southern California Kaiser Permanent (SCK) in Los Angeles, California. HMO members have unique HMO identification numbers that can be used to link data on their medical services within the HMO. Vaccination data are derived from computerized immunization tracking systems that are maintained by each of the HMOs. Quality control comparisons of the computerized immunization data with information recorded in paper medical records have shown high levels of agreement. For medical encounters, each of the HMOs maintains computerized databases on all hospital discharges and emergency room visits; diagnoses from outpatient clinic encounters ard available from some of the HMOs for certain years.

From Geier 2005 (p. CR163)

In this study, the VSD database and CDC-VSD database research materials were analyzed. VSD was created in 1991 by the NIP of the CDC. The project links medical event information, vaccine history, and selected demographic information from the computerized clinical databases of four health maintenance organizations (HMO)s: Group Health Cooperative of Puget Sound (GHC) in Seattle, Washington; Kaiser Permanente Northwest (NWK) in Portland Oregon; Kaiser Permanente Medical Care Program of Northern California (NCK) in Oakland, California; and Southern California Kaiser Permanente (SCK) in Los Angeles, California. HMO members have unique HMO identification numbers that can be used to link data on their medical services within the HMO. Vaccination data are derived from computerized immunization tracking systems, maintained by each of the HMOs. Quality control comparisons of the computerized immunization data with information recorded in paper medical records have shown high levels of agreement. For medical encounters, each of the HMOs maintains computerized databases on all hospital discharges and emergency room visits; diagnoses from outpatient clinic encounters are available from some of the HMOs for certain years [17-19].

As Kathleen notes, aside from the first sentence and the manner in which the National Immunization Program and the Centers for Disease Control were identified, these two passages are identical.

Kathleen goes on to find _over ten more instances_ of near identical passages of text. She then goes on to note that the Rev. Lisa Sykes (IRB member and Mum to a child undergoing the Geier’s Lupron protocol) was very familiar with the 2000 draft of the Verstraeten paper having cited it numerous times in submissions of her own. She is also thanked by the Geier’s in the notes of the paper that bears such an uncanny likeness to the Verstreten paper:

Acknowledgement: We wish to thank Lisa Sykes for her kind efforts in helping us to review and edit our manuscript.

Incredibly, Kathleen has indicated that there is more to come.