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Mark Geier: My therapy is unconventional, but it works

17 Jun

Dr. Mark Geier is appealing the suspension of his medical license. The license suspension order includes (as summarized by Kathleen Seidel at Neurodiversity.com):

• In six out of nine of these cases, the board determined that the children were misdiagnosed with precocious puberty. Children were diagnosed with precocious puberty without the benefit of a physical examination; some were too old to qualify for the diagnosis.

• Medical records and medical necessity letters prepared by Dr. and Mr. Geier indicated that children were diagnosed not only with precocious puberty, but also with pituitary dysfunction, insomnia, aggression, mitochondrial disorder, metabolic dysfunction, and “heavy metal toxicity” when neither test results nor parent reports suggested anything of the sort.

• In one case, the only record of the diagnosis of precocious puberty was a code number entered onto a standing order for lab tests. In another, no note was made in the medical records of the date the child began treatment with Lupron. Yet another patient’s file contained no indication that Dr. Geier reviewed any of the results of the numerous, burdensome diagnostic tests he had ordered.

• The order describes claims submitted to at least one insurance company for a psychiatric interview and “prolonged evaluation and management” services that were never rendered.

• The order further describes an occasion when David Geier, who is not licensed to practice medicine, conducted a medical evaluation and diagnostic tests, made diagnoses, and recommended treatments for an autistic boy in Dr. Geier’s absence.

• Additionally, the Board determined that Dr. Geier misrepresented his qualifications as a geneticist, and misrepresented the ability of his Institutional Review Board to conduct oversight of his research.

Dr. Geier has taken his case to the public in an opinion piece in the Baltimore Sun: Autism doctor: My therapy is unconventional, but it works. He certainly has the right to present his case to the Sun, and while I would not have published the letter were I editor, the Sun is within its rights to host the letter. I am within my rights to comment on the letter, and I took that opportunity in the comments as you will see (complete with typos) if you follow the link.

Dr. Geeir opens with a simple statment “If there’s a single statement that everyone who works in the field of autism can agree on, it’s that there is so much that we still don’t know.” This is incomplete: there is much we do know. We know that the theories Dr. Geier has proposed are wrong. We know that the rise in autism is not due to mercury. Certain tests should be performed before a child is diagnosed with precocious puberty. Tests which the charges indicate Dr. Geier failed to do on many occasions. We know that treatment for precocious puberty should stop at an age when puberty is expected. Dr. Geier is charged with initiating and/or continuing treatment in children too old to be diagnosed with precocious puberty.

Dr. Geier has published many papers in the literature, this is true. These papers have been widely criticized by researchers. Not because the ideas are unconventional, but because the ideas are ill founded and the experimental methods are poor. Dr. Geier has been described as “intellectually dishonest” for his work as an expert witness. The Institute of Medicine has referred to Dr. Geier’s papers as suffering from “serious methodological flaws and their analytic methods were nontransparent, making their results uninterpretable”

There is much we do not know. On thing we do know: we deserve better than Mark Geier

Perhaps it is the frustration of having read the recent article by the Geiers in the new “autism science digest”. Perhaps it is the fact that I listened to a podcast interview with the Geiers in preparing my recent response to the article. Perhaps it is just the years of reading bad science and waiting for someone to act against these people, but my patience is worn rather thin, as you will see in the comments.

AutismOne throws their support behind the Geiers in “Autism Science Digest”

16 Jun

When news came out about the legal troubles Mark and David Geier are facing, there was some hope expressed that maybe, just maybe, some of the groups that have supported the father/son team would take the chance to distance themselves. The Generation Rescue/Autism One conference was at that time still in the future, and the Geiers were scheduled to speak. Dr. Mark Geier had his license suspended for the “therapy” he was planning to tout at AutismOne, and that David Geier was facing the charge of practicing medicine without a license.

As we have seen, the optimism was ill founded. The Geiers presented their talk at AutismOne. And, as it turns out, AutismOne had already in-press their new magazine, the “Autism Science Digest”, which included an article by the Geiers. Someone forwarded it to me and it is frankly painful to read.

It is a nice glossy advertisement for the Geiers and their testosterone/autism theory. I don’t throw that out lightly. It is pseudo-science generated to promote an idea. and idea which really doesn’t stand up to real science.

For example, they present the article like a science study, complete with references. It makes it seem as though what they say is backed up by legitimate science. But citations do not make a study. Especially when they are misused.

It is difficult to describe the Geier hypothesis. This is for two reasons. First, it is hard to accept that they actually believe their own work, it is so bad. Second, it has morphed dramatically over the few years of its existence.

Let me explain. When they first proposed their idea that testosterone was somehow important, they claimed that testosterone was binding mercury in the brain, rendering it difficult to remove through chelation. If you listen to Lisa Sykes talk about the Geiers (the Rev. Sykes being a major spokesperson for the Geiers over the years), she tells how David Geier told her, “We figured something new out…..we think we can get rid of the mercury by lowering the testosterone”.

By the way, the Rev. Sykes mentions that she tested her child for testosterone. The range was 0 to 25 and her kid was “at the top of the range”. Not above it. At the top. As in, high but within normal.

If you listen to the Geiers speak now (and, again, I find this painful to do), they are still pushing the idea that mercury is the main causation factor in autism. But, here’s the shift with Lupron, they are downplaying the idea that is part of a chelation protocol. It’s all about reducing testosterone.

Is anyone surprised that if you change the testosterone levels in a person you will see changes in behavior? Does this have anything to do with autism? Does it have anything to do with mercury?

The Geier article relies heavily on the work of Dr. Simon Baron-Cohen’s group. They cite Dr. Baron-Cohen’s group 5 times in their article. It makes the article look legitimate. The first paragraph states, “In fact, ASD’s have even been described as the result of an “extreme male brain” by psychologist Dr. Simon Baron-Cohen”.

At this point, it is worth recalling what Dr. Baron-Cohen had to say about the work the Geiers are doing:

Simon Baron-Cohen, a professor of developmental psychopathology at the University of Cambridge in England and director of the Autism Research Center in Cambridge, said it is irresponsible to treat autistic children with Lupron.

“The idea of using it with vulnerable children with autism, who do not have a life-threatening disease and pose no danger to anyone, without a careful trial to determine the unwanted side effects or indeed any benefits, fills me with horror,” he said.

Some how “fills me with horror” was not included in the Geier article.

Dr. Baron-Cohen’s theories include the idea that fetal testosterone levels affect the development of the brain. This is a prenatal process. The Geier notion is that autistics have high testosterone levels (even though they have documented cases of children they treated who do not have high levels). It is intellectually (and otherwise) very dishonest to claim that the work of Dr. Baron-Cohen in any way supports the Geier’s application of the drug Lupron to autistic children.

It isn’t just Dr. Baron-Cohen’s work that is misused to sell this therapy. The Geier’s write, “”Also, some investigators have found that leuprolide acetate administration resulted in improvements in cognition” ( Bryan et al. , 2010)”

Here is the abstract for Bryan, et al.:

Down-regulation of serum gonadotropins is as effective as estrogen replacement at improving menopause-associated cognitive deficits.
Bryan KJ, Mudd JC, Richardson SL, Chang J, Lee HG, Zhu X, Smith MA, Casadesus G.
Source

Department of Neurosciences, Case Western Reserve University, Cleveland, Ohio, USA.
Abstract

Declining levels of estrogen in women result in increases in gonadotropins such as luteinizing hormone (LH) through loss of feedback inhibition. LH, like estrogen, is modulated by hormone replacement therapy. However, the role of post-menopausal gonadotropin increases on cognition has not been evaluated. Here, we demonstrate that the down-regulation of ovariectomy-driven LH elevations using the gonadotropin releasing hormone super-analogue, leuprolide acetate, improves cognitive function in the Morris water maze and Y-maze tests in the absence of E2. Furthermore, our data suggest that these effects are independent of the modulation of estrogen receptors alpha and beta, or activation of CYP19 and StAR, associated with the production of endogenous E2. Importantly, pathways associated with improved cognition such as CaMKII and GluR1-Ser831 are up-regulated by leuprolide treatment but not by chronic long-term E2 replacement suggesting independent cognition-modulating properties. Our findings suggest that down-regulation of gonadotropins is as effective as E2 in modulating cognition but likely acts through different molecular mechanisms. These findings provide a potential novel protective strategy to treat menopause/age-related cognitive decline and/or prevent the development of AD.

The short version: the authors removed the ovaries from mice, putting them into a menopause state. They found that these mice decline cognitively, but that they can treat this with a leuprolide acetate (a drug similar to lupron).

Yes, somehow the animal model for autism to the Geiers are post-menopausal mice.

This study has nothing to do with improving cognition in children, or autistic children in particular. Don’t take my word for it. I contacted one of the researchers who wrote the paper:

Well… The principle of gonadotropins working on cognition in menopausal women or patients with AD has nothing to do with autism nor with improving cognition via the depletion of gonadal steroids such as testosterone or estrogen. For example, we know that when women that are in reproductive age (and men to a lesser extend) are given leuprolide their cognition is impaired, indicating that gonadal steroids are important for cognition. However, we have shown that after menopause, gonadal steroids can be by-passed by downregulating gonadotropins to improve cognition.

If you want the message in a single sentence:

The beneficial effects of leuprolide on cognition in ovariectomized (menopausal) female mice has nothing to do with the treatment of autism in children.

Another study the Geiers cite: “Increased marble-burying behavior in ethanol-withdrawal state: Modulation by gonadotropin-releasing hormone agonist”

No, I am not kidding. It is a study about alcoholic mice burying marbles. Here’s the abstract:

A characteristic behavior in alcohol abstinence state indicates the possibility of obsessive–compulsive behavior in alcoholics. Ethanol is known to reduce hypothalamic synthesis, release, and mRNA expression of gonadotropin-releasing hormone (GnRH) that modulates serotonergic, dopaminergic, and glutamatergic systems, which experience adaptive changes on chronic exposure to ethanol. Such changes are also evident in obsessive–compulsive disorder. Therefore, it was proposed to investigate the effect of ethanol-withdrawal on marble-burying behavior in mice, particularly because it simulates some aspects of obsessive–compulsive behavior; further, the influence of GnRH agonist was studied on the same. Ethanol-withdrawal state was induced after its chronic administration, and marble-burying behavior was observed at 0, 6, 24, 48, and 96 h interval. Further, the influence of leuprolide—a GnRH agonist (50–600 ?g/kg, s.c.) or fluoxetine (5–30 mg/kg, i.p.) was investigated on ethanol-withdrawal-induced changes in marble-burying behavior. The results indicated that ethanol-withdrawal led to a gradual increase in marble-burying behavior upto 48 h with peak at 24 h interval. Administration of leuprolide (100–600 ?g/kg, s.c.), 30 min prior to 24 h interval, dose dependently reduced ethanol-withdrawal-induced increase in marble-burying behavior, and this effect was comparable to that of fluoxetine (15 and 30 mg/kg, i.p.). Further, twice daily administration of leuprolide (50 ?g/kg, s.c), concomitant with ethanol, prevented the gradual increase in marble-burying behavior after ethanol-withdrawal and this effect was comparable to fluoxetine (5 mg/kg, i.p.). In conclusion, ethanol-withdrawal on chronic administration increases marble-burying behavior in mice; its development and expression is attenuated by leuprolide.

The researchers gave mice alcohol over a long period. When they made the mice stop, cold turkey, they exhibited behaviors such as burying marbles. While the mice are going through the first stages of withdrawl, the researchers gave them a lupron like drug and found that the mice didn’t bury marbles as much.

Once again, who finds this to be a valid animal model for autism? Is your child an alcoholic, marble-burying mouse?

But you don’t see this if you just read the article. What you read is, “similarly, other investigators have used an anti-androgen medication called leuprolide acetate, which reduces the production of male hormones, in the treatment of anxiety, hyperexcitability, depression, impaired social interaction, and obsessive compulsive behaviors in laboratory animal species”.

The Geiers have obviously felt the need to respond to the criticism that they are using a drug used for chemical castration. They write

Finally, the administration of anti-androgen medications to individuals diagnosed with an ASD is not intended to deprive the individual of their sexuality nor to alter their normal developmental trajectory, but rather to regularize a process that was proceeding in an abnormal fashion and producing adverse effects and, thereby, improve the health of the patient and reduce the clinical symptoms associated with abnormally elevated androgen levels.

Here is an example patient from the patent application the Geiers submitted (US20070254314A1: Methods of treating autism and autism spectrum disorders):

Laboratory analyses did not reveal elevated levels of mercury or elevated levels of at least one androgen. Specifically, undetectable levels of mercury were present in Child D’s urine and minimal levels of mercury were in Child D’s blood (1.5 ?g/L, reference range=0.0-14.9 ?g/L). Additionally, analyses of Child D’s blood androgen metabolites revealed a serum testosterone=153 ng/dL (age- and sex-adjusted LabCorp reference range=0-350 ng/dL) and serum/plasma DHEA=291 ng/dL (age- and sex-adjusted LabCorp reference range=183-383 ng/dL) within their respective reference ranges.
After extensive discussions with his parents concerning the risks, benefits, and alternative treatments available, a decision was made to place Child D on a course of LUPRON® therapy.

Yes, Child D has testosterone well within the normal level. And, yet, the child was treated with Lupron. How, exactly, does this fit with improving “…the health of the patient and reduce the clinical symptoms associated with abnormally elevated androgen levels”?

Also, in the Autism Science Digest article itself, the authors note:

The child underwent antiandrogen therapy until the age of 13, when he entered puberty at an age typical of his sibling

Age 13 is within the normal range to start puberty. So is 9. Why did they delay this child 4 years? As of age 9, the child was not in central precocious puberty.

The Geiers make this comment in their recent article:

Two months prior to his 9th birthday, he was given a test dose of leuprolide acetate. After administration, he went outside and began to swing on a tire swing using his feet to push – a neurotypical behavior never seen before.

Dramatic, isn’t it? First shot, and the kid goes outside and uses the swing for the first time. This caught my eye, because they mention swinging in their patent. In the patent they note, “Within a few days of the second shot of LUPRON DEPOT®, Child X learned to swing by himself using leg timing for propulsion”

I’m betting that this is the same kid. If so, did the kid get his first shot and go outside and start swinging, or did he go a few days after his second shot?

One issue the Geiers (and others) have faced is inflation of credentials. David Geier, for example, listed himself as a “diagnostician” to get on the Maryland Autism Commission. The Autism Science Digest article is no different. Mr. Geier gives as his credentials that he “Has been a research scientist at the National Institutes of Health in the laboratory of Biochemical Genetics.”

Take a moment, if you will, and think what that statement means to you, ” research scientist at the National Institutes of Health in the laboratory of Biochemical Genetics”. I ask you to do this before we see what his job really was.

We can read Mr. Geier’s resume here, which lists his experience including:

I. T. R. A. Summer Fellow Appointment at The National Institutes of Mental Health (under Laboratory Chief [Redacted] of The Laboratory of Biochemical Genetics)
Projects:
(1) Protein Gel and Phage Research

That was in the summer of 1998. That’s the summer before he entered college, if I read the rest of his resume correctly. At this point I have to do something I rarely do, point out my own credentials. I’ve been a summer intern. I’ve been a research scientist. I’ve been a research scientist supervising summer interns. While I find the work of my summer interns has been valuable and of high quality, they weren’t “research scientists” in the way that is clearly implied in the article. Sure, it would have taken more space to write, “He was an intern the summer of his freshman year at the NIH”, but it would have made his position much more clear.

Dr. Mark Geier lists as part of his credentials, “His extensive research has resulted in him being invited to address the Institute of Medicine at the U.S. National Academy of Sciences on six occasions.” I find it remarkable that he uses this to build credibility, given the fact that the IOM clearly was not impressed by his work.

Let’s look at what the Institutes of Medicine had to say about the Geiers’ research:

The first was an ecological study (Geier and Geier, 2004a) that reported a potential positive correlation between the number of doses of measles-containing vaccine and the cases of autism reported to the special education system in the 1980s. The second was a study of passive reporting data by the same authors (Geier and Geier, 2003c) that reported a positive correlation between autism reports in the Vaccine Adverse Events Reporting System (VAERS) and estimated administered doses of MMR. However, these two studies are characterized by serious methodological flaws and their analytic methods were nontransparent, making their results uninterpretable, and therefore noncontributory with respect to causality (see text for full discussion).

It isn’t news that the Geiers are poor scientists. It isn’t news that the Geiers have been called out for their ethical lapses multiple times over the years. It is fairly recent news that the Geiers have actually faced charges. And, yet, AutismOne and Generation Rescue continue to support this team by inviting them to speak at conferences and giving them space in their magazines to promote the same bad medicine that has cost Dr. Geier his license.

Dr. Geier has lost his license to practice medicine. To which I can only say, what took so long? What do they have to do to lose the support of the alternative medical community?

Autism and vaccines, 911 truths and fluoridation

9 Jun

Yes, I’m ramping down on discussing Andrew Wakefield. Let this stand as an example why. He’s joined in with 911 truthers and anti-fluoridation advocates in a series of talks in Ireland. The talk is billed as “The Master Plan” and “The Hidden Agenda for Global Scientific Dictatorship”.

If Andrew Wakefield feels like he has any credibility left, why is he lending it to these groups?

For more information, check Seth Mnookin’s post. He’s pulled in some of the 911 truthers who want to discuss their points. I see parallels between the truthers on the net and the vaccine “skeptics” in how they respond.

A Positive Association found between Autism Prevalence and Childhood Vaccination uptake across the U.S. Population

8 Jun

A Positive Association found between Autism Prevalence and Childhood Vaccination uptake across the U.S. Population is the latest in a long series of studies purporting to show a link between vaccines and the rise in autism prevalence. Like many of these studies, this one has major flaws. There was a time when I would take the effort to go through such studies in detail. There is enough bad in this one to take so long that I just can’t see taking the effort.

They claim that for every 1% increase in vaccination (defined in a very strange way, as you will see) their study shows that the autism rate (defined in an even stranger way) rises 1.7%.

Look at the title again: A Positive Association found between Autism Prevalence and Childhood Vaccination uptake across the U.S. Population

But, strangely enough, the author doesn’t study autism prevalence. Seriously. The author studies “To determine autism prevalence by U.S. state, the number of 8-year old students classified with either (1) autism or (2) speech or language impairments (speech disorders) was divided by the total number of 8-year-olds in the state.”. Yep, the author lumps autism with SLI. Consider, say, California in 2002 (one of the study years). There were 1,664 8-year-old students receiving services under the disability category “autism”. On the other hand, there were 22,702 8-year-old students in the SLI category. The autism data are basically swamped by the SLI data. Begs the question: what did the analysis show for autism alone? Could it have shown a protective effect of vaccination. Don’t get me wrong, the study isn’t strong enough to show a real association one way or another, but you really got to ask yourself why the author chose to bury autism this way.

In case you are wondering, the autism+SLI “prevalence” for California was about 5% for 8 year olds/3rd graders in 2001 (using 488.633 3rd graders)

Here is the abstract:

The reason for the rapid rise of autism in the United States that began in the 1990s is a mystery. Although individuals probably have a genetic predisposition to develop autism, researchers suspect that one or more environmental triggers are also needed. One of those triggers might be the battery of vaccinations that young children receive. Using regression analysis and controlling for family income and ethnicity, the relationship between the proportion of children who received the recommended vaccines by age 2 years and the prevalence of autism (AUT) or speech or language impairment (SLI) in each U.S. state from 2001 and 2007 was determined. A positive and statistically significant relationship was found: The higher the proportion of children receiving recommended vaccinations, the higher was the prevalence of AUT or SLI. A 1% increase in vaccination was associated with an additional 680 children having AUT or SLI. Neither parental behavior nor access to care affected the results, since vaccination proportions were not significantly related (statistically) to any other disability or to the number of pediatricians in a U.S. state. The results suggest that although mercury has been removed from many vaccines, other culprits may link vaccines to autism. Further study into the relationship between vaccines and autism is warranted.

Here are a few more important points from the paper:

1) They use the “prevalence” of autism or SLI from special education numbers. These data are just not reliable for this sort of work. This has been gone over and over. The best discussion of this is from Jim Laidler in 2005. US Department of Education Data on “Autism” Are Not Reliable for Tracking Autism Prevalence

2) Note that they use cohorts from the mid 1990’s, soon after autism was first added as a special education category. They are pretty much guaranteed that the “prevalence” they calculate will go up.

All they need is to link this to changes in the vaccine uptake. Easily done. The vaccine uptake rate is changing dramatically during the first couple years of the study. For example, Alabama goes from 46 to 76% in two years. Why is that? That brings us to point (3):

3) Here’s a trick bit: the author uses the vaccine schedule from 1995. A brand new vaccine schedule was rolled out and states and pediatricians picked it up over the next couple of years. Of course the vaccine uptake, by this measure, was low at the start.

Yes, they chose a very artificial measure of “vaccine rate” to insure that they had big changes in the “rate” during the study period.

How often do we hear SafeMinds (the author is a member by the way) ask “where’s the study of the vaccinated vs. unvaccinated?” Even when they have the data, they don’t do the comparison. They compare children who got the full 1995 schedule of vaccines vs. children who didn’t (missing one or more vaccines). My guess is there isn’t enough non-vaccinated data to make the study. But, that doesn’t explain why they went ahead with this really bad study.

How about a “too many too soon” study, comparing the total number of vaccines vs. autism rate? Again, not done in this study.

Of course the author is aware of the vaccinated/unvaccinated question. A few quotes from the paper:

A child who missed only one shot was different from a child who was completely unvaccinated, yet in this study both children were classified as not fully vaccinated.

and

A child who received all but 1 vaccination on time might be different from a child who received no vaccinations, yet both were in the group of children who did not receive timely vaccinations. Had the researchers examined fully vaccinated versus completely unvaccinated children, the results might have been different.

and

A follow-up study could investigate the prevalence of autism among unvaccinated children. Other children who typically are not vaccinated could be surveyed. These groups include the Amish and children served by Homefirst, a health clinic near Chicago (Eisenstein, 2009), as well as some homeschooled children or younger siblings of children with autism whose parents decided not to vaccinate.

“Eisenstien, 2009” is a link to the HomeFirst website, which includes unsupported claims. What is the point of a citation to an unsupported claim? For example, in the cited link, Dr. Eisenstein makes the unsupported claim:

“Since 1973, The Homefirst physicians have been offering vaccine choice and awareness Unlike most doctors, the Physicians of Homefirst are honored to serve your family if you give all some or none of the vaccines.

They have virtually no asthma, allergies, ADHD, ADD or Autism in their more then 35,000 un-vaccinated children. “

Where’s the data on how many of their patients have ADD, autism, or the other conditions? Also, I’ve seen the quoted number of “unvaccinated” at Homefirst vary through a very large range.

But back to the actual paper. What does the study claim as a result?

The results suggest that if a given U.S. state has a 1% higher vaccination rate than another U.S. state, then the state with the higher vaccination rate might have, on average, a 1.7% higher prevalence of autism or speech disorders.

Remember, this is using the strange definition of “vaccination rate” is how many children got the full series vs. how many missed any one or more vaccines.

Here you can see their data. Yes, “vaccination rates” and “autism or SLI rates” both go up with time. But it is how they go up that show us how bad this study is:

Take a close look at the vaccination rates for the first two years. That’s when there are the big increases. This is expected because, again, they measuring vaccination rates as the percentage of kids who got the full 1995 schedule, and they start in 1995 when the schedule was just introduced.

The autism/SLI rate, on the other hand, shows a slower, more steady increase (ignoring the noise).

Take a look at table 1. again. Take a look at the first couple of years in, for example, Alabama. The vaccination rate they quote increased from 46% (1995) to 65% (1996), rising again the next year to 76.5% (1997). What did the autism+SLI rate do? It went down.

Recall the result:

Further, if a given U.S. state decreases its vaccination coverage by 1% from one year to the next, prevalence of autism or speech disorders may, on average, fall by 1.7%. If 100% children received this series of vaccinations, the prevalence of autism or speech disorders would be 1.7%

Since the “vaccination rate” went up 20 points (from 46% to 65%), we would expect autism/SLI to go up a lot too: 0.34%, from 4.6% to 4.92%. You can see the same sort of trends in the first two years state by state–big increases in the vaccination rates, small or negative changes in the autism/SLI rates.

It’s only after many years go by that there are notable changes in the autism/SLI rates. Even then it isn’t consistent. Again, look at Alabama. Over the entire study period, the autism/SLI rate went down. Same for the next state on the list, Alaska.

The next state on the list (yes, it’s alphabetical) is one of the “winners” in the study. Autism/SLI rates went up notably over the study period, from 3.8 to 6.2%. But, strangely enough (if you believe the author that is) this didn’t happen for the cohorts which saw the big increases in vaccine rates. A big jump in autism/SLI rate is seen for the last year (a 0.8% jump), but this is for years when the change in vaccination rates was relatively modest.

To put it simply, the result of the study just doesn’t make sense given the data that we (and the referees who cleared this paper) can plainly see. This is a prime example of exactly the sort of paper that really has shown over the years the sort of intellectual dishonesty which has promoted the vaccine-epidemic notion.

Autism vs Symptoms of Autism Part II

25 May

If this is the case it is rather hard to see what we are arguing about. With all the semantic ingenuity in the world children on the autistic spectrum are surely autistic and so are children who have autistic behaviour.

So states John Stone on Age of Autism.

Its meant to point out to us the linguistic convolutions some people go to in order to seperate people who have autism and people who display autistic symptoms. We’re meant to roll our eyes on this stupidity.

But I can’t. Because its not stupid. Because there _is_ a difference between having enough of the symptoms to qualify for a diagnosis of autism and _not_ having enough of the symptoms of autism to qualify for a diagnosis of autism. In one scenario a person has autism as medically defined. In the other scenario, they don’t.

Far from John Stones ‘semantic ingenuity’, what we are in fact talking about is ‘semantic precision’. Lots of people display some of the symptoms of autism yet simply don’t have enough to get a diagnosis. This phenomenom has even got a name: Broader Autism Phenotype. In a paper from as long ago as 1997, the authors states:

Studies of families ascertained through a single autistic proband suggest that the genetic liability for autism may be expressed in nonautistic relatives in a phenotype that is milder but qualitatively similar to the defining features of autism.

Note the use of the word qualitatively there. In that, people with enough symptoms have autism share qualities with those who don’t.

Autism has a long and painful history of being sculpted into a set of beliefs that reflect the position of the believer rather than the objective truth of the matter. The thing is, we _have_ an objective (if medical) truth on the matter, its set down in the DSM or the ICD, pick your poison. John Stone is merely the latest in a long line of people who want autistic people to be ambiguous enough to reflect their beliefs. However, by its very definition, you cannot _be_ autistic (again medically speaking) if you don’t meet the criteria, or even _enough_ of the criteria.

I see nothing of semantic igenuity in this. Stone is, of course, attempting to whip up support for the latest terrible study – this one legal – that claims to have found 83 people compensated for autism via vaccine injury. When you apply John Stone et al’s loose, ambiguous definition of what autism medically is then they’re quite right. Thing is, I suspect I, John Stone and various others could all show _some_ symptoms of autism. Much trickier is to display _enough_ symptoms of autism to be diagnosed as autistic. Something I think about 1% of these 83 were. In other words, no different in amount than the rest of any other population.

David Geier ousted from autism commission

24 May

O’Malley ousts David Geier from autism commission is an article at the Baltimore Sun.

Appointee, who works at father’s practice that offers controversial autism treatment, charged with practicing without a license

Gov. Martin O’Malley removed David A. Geier from Maryland’s Commission on Autism on Friday, telling his one-time appointee in a letter that “you do not at the present time qualify to serve.”

O’Malley told Geier, who has only a bachelor’s degree, that he does not qualify under Maryland law to serve as a “diagnostician,” the title he held on the advisory commission. The governor also cited charges brought against him this week by the Maryland Board of Physicians.

More at the Baltimore Sun, including:

“I regret that you were not willing to withdraw from the Commission and that this action is therefore necessary,” the governor said.

Yes. He was asked to leave. He didn’t. Now he’s being told.

David Geier is part of the father/son team which has promoted the “Lupron protocol” as a therapy for autism. The idea was incredible (as in, not credible) from the start. Their practice appears to have been using false diagnoses of precocious puberty in order to apply Lupron, a drug which shuts down sex hormone production.

Personally, I find it very strange that David Geier was placed on the autism commission to begin with. He clearly lacks expertise or connection to the community (other than financially, of course). This is before one factors in the facts that his entire model of autism is wrong from the word go.

AutismOne, potentially the largest parent-convention promoting the bad science of the Geiers and others starts on the 25th (the day after this post goes live). Mark and David Geier are scheduled to speak. One could hope that AutismOne would pull these speakers. Instead, 2 days ago, they posted a new interview. Complete with the message:

“These top researchers are at the forefront of helping to treat the “Tough Cases”. The symptomology of Precoscious Puberty and its safe treatment for ASD.”

“Top Researcher”

“At the forefront”

“symptomology of precocious puberty”

This is a team that has been charged with serious ethical violations, including the misdiangosis of the “symptomology of precocious puberty”. This is a team which has failed time and again to produce quality research.

But, this is a team which promotes the vaccines-cause-autism hypothesis.

Safety of disable children apparently comes second to ideology for Autism One.

Sorry to have dropped my usual rather dry reporting, but this is just plain wrong. But, these are the people who gave Andrew Wakefield an award after he was found guilty of multiple ethics violations. What can we expect?

Study by NYU and PACE: another failure in obtaining ethical approval?

20 May

One issue that has come up more than once in autism research is the failure to obtain ethical approval for human studies research. Andrew Wakefield started his studies on autistic children before the Royal Free Hospital granted ethical approval. Mark and David Geier failed to obtain Institutional Review Board (IRB) approval before starting one of their studies. According to an article on neurodiversity.com:

None of the IRB members have declared expertise in the field of pediatric endocrinology. Whereas the IRB was registered in March 2006, the research described in the article was conducted between November 2004 and November 2005.

Not only did none of the members of the IRB have expertise in the field, the IRB included the researchers (Mark and David Geier), the mother of one of the children on the “Lupron protocol”, an attorney specializing in vaccine injury, and Anne Geier (wife to Mark, father to David).

Apparently following in these footsteps are the team who recently brought us a study purporting to show a high prevalence of autism amongst children compensated by the vaccine court (for more on this, see 2 ½ Studies: Autism Prevalence and the “Hidden Horde”). The vaccine-court study author list is Mary Holland, NYU School of Law, Louis Conte, Robert Krakow, and Lisa Colin. The study was published in the PACE Environmental Law Review. Further, “Pace Law School provided significant research support for this study” as noted in the footnotes of the paper:

* Mary Holland, Research Scholar and Director of the Graduate Legal Skills Program, NYU School of Law; Louis Conte, independent investigator; and Robert Krakow and Lisa Colin, attorneys in private practice. Pace Law School provided significant research support for this study. The authors thank former Environmental Law Dean Alexandra Dunn and law students Jillian Petrera, Kyle Caffrey, Sohad Jamal, Alison Kaplan, Georgine Bells, Jonne Ronquillo, Lisa Hatem, Allison Kazi and Adrienne Fortin. The authors also thank volunteers who worked under the direction of Louis Conte. For purposes of disclosure, Robert Krakow and Lisa Colin represent clients and have claims on behalf of family members in the Vaccine Injury Compensation Program.

Ken Reibel, journalist and proprietor of Autism News Beat has an article published today: Unanswered Questions from Pace Law journal study: Ethical Standards for Research on Human Subjects. He poses some very important questions:

1) Does the study methods meet the standards of “human subject” research?
2) Did NYU or PACE (or anyone else) obtain IRB approval?

The answers appear to be yes to the first, no to the second.

From Autism News Beat:

“Human subject” is defined by the DHHS as “a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information.”

and,

When asked if the Pace study had IRB approval, Pace Law spokesperson Lauren Rubenstein referred the question to the study’s co-author, Louis Conte. In an email, Rubenstein wrote “Louis Conte has told me that there was no human subjects research in this study.”

Which I interpret to mean that they don’t have IRB approval as they don’t believe they require it. My read is that, yes, they did require IRB approval.

It will be interesting to see what, if anything, comes of this. Will PACE and NYU investigate and let the public know if their people went ahead with human subject research without IRB approval?

For more details: Unanswered Questions from Pace Law journal study: Ethical Standards for Research on Human Subjects

Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine

20 May

The father-son team of Mark and David Geier have been charged with violations of medical practice. Mark Geier is a physician and his son, David, holds a bachelor of arts degree. Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine is the most recent post by Kathleen Seidel of Neurodiversity.com. This follows the suspension of Dr. Mark Geier (Maryland Medical Board Suspends Dr. Mark Geier’s License).

Ms. Seidel’s post follows her practice of a very thorough, well linked discussion of the topic. Here is her first paragraph (without links):

On Monday, May 16, 2011, the Maryland Board of Physicians charged Dr. Mark Geier with numerous violations of the Maryland Medical Practice Act, and charged his son, David Geier, with practicing medicine without a license. The charges come three weeks after the Board summarily suspended Dr. Geier’s license to practice medicine, in order to prevent harm to the many autistic children entrusted to his care. The suspension was upheld by a subsequent order issued by the Board on May 12, one day after a hearing at which Dr. Geier protested the suspension and submitted affidavits of support from the parents of seven of his patients. These included a statement from James B. Adams, Ph.D., a professor of engineering at Arizona State University who, like Dr. and Mr. Geier, has frequently exceeded the bounds of his academic specialty to conduct medical research premised on the discredited hypothesis that autism is a consequence of vaccine injury.

It is well worth the time to read the entire post: Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine

Childhood Vaccinations and ASD: No Relationship Between Number or Schedule of Vaccinations and Diagnostic Outcome or Severity

13 May

The International Meeting For Autism Research will be held in May. Abstracts for the conference are public now. One search that will be common amongst the online parent community is to see what research has been done on the question of vaccine causation.

Here is an abstract looking directly at the question. They compared siblings of autistics, children at risk for developmental delays and children expected to develop typically. They found–no evidence of increased risk from vaccination:

A. Margolis1, J. D. Jones2, A. Trubanova2, W. Jones2, K. Chawarska3 and A. Klin2, (1)Yale Child Study Center, Yale University School of Medicine, New Haven, CT, (2)Marcus Autism Center, Children’s Healthcare of Atlanta & Emory School of Medicine, Atlanta, GA, (3)Child Study Center, Yale University School of Medicine, New Haven, CT
Background: Recent increases in the number of recommended childhood vaccines have raised public concerns about the potential side effects of immunizations on children’s health. Because of the increasing prevalence of autism diagnoses over the last 15 years, this disorder, in particular, has become the focus of much of the attention and concern surrounding childhood vaccines. As a consequence of this debate, the use of childhood vaccines, especially the measles-mumps-rubella vaccine (MMR), has decreased significantly, and this decrease has led to numerous outbreaks in diseases previously prevented by vaccines. Furthermore, research addressing the relationship between vaccines and autism has relied primarily on retrospective population studies, with little power to determine the role of immunizations in individual outcomes.

Objectives: The primary goal of this study is to examine the relationship between the frequency and number of childhood immunizations and the subsequent likelihood of developing autism. In addition, this study aims to investigate the relationship between childhood vaccines and disorder severity in children who do go on to develop autism.

Methods: Immunization data were collected for 91 children divided among the following three groups: (1) siblings of children with an autism spectrum disorder diagnosis, (N =48; gender = 37M); (2) children at risk for developmental delays (N = 7; gender = 5M); and (3) children expected to develop typically (N = 36; gender = 19M). All children were at least 2 years of age when their immunization records were collected. Individual immunization data were recorded and then compared with diagnostic outcome and behavioral data.

Results: Tests of association and linear multiple regressions revealed that neither a greater number of childhood vaccines nor a higher rate of vaccination had a positive relationship with subsequent autism spectrum diagnosis (N=8; gender=7M) or disorder severity, which was assessed in all participants. In addition, comparison of immunization data to behavioral indicators at 2 years of age did not reveal any relationship between either higher frequency or greater number of childhood vaccines and subsequent negative behavioral outcomes. Likewise, neither vaccination with MMR nor the age of MMR vaccination was significantly related to outcome. Instead, because siblings of children with autism were less likely to be vaccinated according to the recommended schedule, both correlations and multiple regressions revealed a significant relationship between higher rates of vaccination and non-ASD behavioral outcomes.

Conclusions: These results suggest that childhood vaccines do not increase children’s risk of developing autism and do not exacerbate the disorder severity in children who are later diagnosed with autism. Children who receive a greater number of vaccines overall, who receive the MMR vaccine, or who receive immunizations at a higher rate, do not differ significantly on subsequent behavioral measures from children who receive vaccines on an alternative schedule or children who do not receive vaccines. Instead, the results of this study emphasize heritability in risk for autism, and also indicate that siblings of children with an autism diagnosis are less likely to be vaccinated, which actually increases their risk for contracting other illnesses.

Here’s an observation that has often been predicted: ” Instead, because siblings of children with autism were less likely to be vaccinated according to the recommended schedule, both correlations and multiple regressions revealed a significant relationship between higher rates of vaccination and non-ASD behavioral outcomes.” I believe this very point has been predicted by blogger Prometheus a number of times.

The study is relatively small in my opinion. With 91 participants, the number of autistics is likely small. Also, this will focus on familial autism. There may very well be a difference between the types of autism which run in families and that which is more sporadic.

Note–I originally posted this in April when the abstracts were first put online. They were online in error, as there was an embargo in place. The post was taken down at that time and I’ve now made it live again since the embargo is lifted.

So what do parents really think causes autism?

12 May

According to the MIND institute, presenting at IMFAR:

The two most common causes of autism cited among all parents was an environmental cause (51%) and/or a genetic cause (51%). Vaccines (22%) were the third most commonly believed etiological factor, followed by 20% of parents who did not know or have a guess as to what may cause autism.

This is an interesting set of results to me. I’m frequently told that the overwhelming majority of parents believe vaccines cause autism. Turns out less than a quarter do.

Also of interest was the following statement:

Vaccines are commonly cited as a cause by parents in all ethnic groups despite a clear lack of scientific evidence demonstrating a relationship between autism and either the measles, mumps, rubella (MMR) vaccine, or thimerosal containing vaccines

Wasn’t that long ago that autism anti-vaxxer supermo Rick Rollens was basically in charge of MIND. How times have changed.

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