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Mark Geier: vaccine lover

7 Sep

Sometimes reality is just stranger than fiction. Consider Mark Geier. He’s the doctor whose license has been suspended in Maryland for his treatment of autistic children with Lupron. He’s been a regular expert witness in the vaccine court for something like 20 years. He’s got multiple papers out on the dangers of mercury in vaccines.

Think that’s enough to please the vaccines-cause-autism crowd? Think again.

Stroll over to Facebook where a heated discussion is ongoing.

…you’re wrong on that one…. from personal experience having dinner with Dr. Geier….he has no problem with the vaccines other than mercury. He told me to my face at dinner that he gave his patients the H1N1 vaccine last year (Hg free of course). Sorry, but that is from personal experience….he’s a hack in my book.

Yep. Giving vaccines makes one a hack. Treating faux precocious puberty, not so much.

the response?

…thanks for saying that…I detected he was a vaccine lover.

Yep, he’s a “vaccine lover”. Mark Geier. That’s his failing.

… I know I’ll probably make some enemies over this but I call em’ as I see em’ and this was NOT hearsay. He told me that to my face at dinner…I got up, called him a moron and didn’t come back to finish my dinner. I fumed all night!

Well, there you have it. Tell the wrong people you gave vaccinations and you are a hack, a “moron” and you make people lose their appetite.

The world never ceases to amaze.

Adverse Effects of Vaccines: Evidence and Causality

26 Aug

The United States Institute of Medicine (IOM) has just published a lengthy report, Adverse Effects of Vaccines: Evidence and Causality.

The short summary, via Reuters, is: “the big take-home message is that we found only a few cases in which vaccines can cause adverse side effects, and the vast majority of those are short-term and self-limiting.”

As to autism? There are two main theories of autism and vaccines: MMR and Thimerosal. The autism and MMR theory is one of the most studied and most clear. The committee found that the research “Favors Rejection”. As in,

The committee concluded the evidence favors rejection of five vaccine-adverse event relationships. These include MMR vaccine and type 1 diabetes, DTaP vaccine and type 1 diabetes, MMR vaccine and autism, inactivated influenza vaccine and asthma exacerbation or reactive airway disease episodes, and inactivated influenza vaccine and Bell’s palsy. The evidence base for these conclusions consisted of epidemiologic studies reporting no increased risk; this evidence was not countered by mechanistic evidence

The epidemiological evidence says there is no increased risk. There is no good mechanism known or postulated whereby MMR could cause autism.

Thimerosal is barely mentioned in the report, with only 7 mentions. As far as autism+thimerosal is concerned, the IOM reviewed the literature years back and found no evidence of a link. Since that time, the evidence has grown greater against a link and thimerosal has been removed from the routine pediatric vaccine schedule (e.g. Price et al. Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism
and, while not specific to autism, Thomson et al. Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years)

Previous IOM reports on Thimerosal: Immunization safety review: Thimerosal -containing vaccines and neurodevelopmental disorders.

Previous IOM report on vaccines and autism (especially MMR and thimerosal): Immunization safety review: Vaccines and autism.

I expect much criticism to be focused on the IOM from some circles. The arguments will likely focus on “look at all the vaccines which have not been specifically studied in relation to autism”. It is a semi valid point. The problems with the argument are many, but include: what mechanism is there for these vaccines to cause autism? (Too many too soon is a slogan, not a scientific argument). Without a mechanism, and without some sort of data showing a possible link, there is such a low possibility of finding anything that resources are best spent elsewhere. In addition, the studies to date give a reasonable proxy for vaccine exposure: the more thimerosal an infant was exposed to, the more vaccines. Thimerosal exposure becomes a proxy for the number of vaccines. It has been shown (multiple times) that there isn’t an increased risk for autism with thimerosal.

Lastly, if you read the criticisms claiming “but they’ve only studied one vaccine and one ingredient”, watch for the intellectual honesty. That’s the part where the critic admits that “they’ve only studied one vaccine and one ingredient, and they found that those don’t increase the risk of autism“. Most critics in this field are cake-eaters. They want their cake (the argument that the studies have only looked in depth at MMR and thimerosal) and they want to eat it too (by denying the results of those studies). It’s predictable.

Ancestry of pink disease (infantile acrodynia) identified as a risk factor for autism spectrum disorders

30 Jul

One of the arguments for the mercury-causes-autism hypothesis is that there are subgroups more susceptible to harm from mercury exposures. It is argued that pink disease gives an example for such a susceptibility group.

Pink disease was a reaction to a teething powder which contained mercury. About 1 in 500 children exposed to the powder reacted with pink disease. Two points are important to keep in mind. First, the levels of mercury exposure from the powder were far greater than from vaccines. Second, the exposures were not the same for all children. Some parents would use more teething powder at a time. Some might use it for longer times. This makes it impossible to claim a susceptibility group as the children who showed signs of pink disease could very likely be the ones who had higher levels of mercury exposure.

In a paper just released, a team of researchers interviewed people who had a history of pink disease. Since that teething powder has been gone for decades, these individuals are now old enough to be grandparents.

This is, at best, a very strange paper. Consider these questions:

1) why aren’t they reporting a high autism prevalence in the people who had very high mercury exposures and who showed signs of pink disease? If there is a genetic susceptibility, why isn’t it seen in those with the greatest exposures?

2) why isn’t there a report of high autism prevalence in the children, just the grandchildren? My guess is that the response from some will be that the grandchildren received higher doses of mercury in vaccines than did their parents. Which again would beg the question of where is the high rate of autism in those exposed to the teething powders, especially those who developed pink disease.

The conclusions of this paper have some major logical hurdles to overcome, to say the least. And this is even before the methods are addressed. For example, this all hinges on reports by the grandparents. Not on an actual prevalence measure of the decendents.

If is already well established that the rise in mercury exposures from childhood vaccines was not the cause of the rise in autism prevalence estimates. It has always been clear that autism is not similar to mercury poisoning symptoms. The mercury hypothesis has been harmful, both to public health and the autism communities The time for papers which pose intriguing questions on this subject has past. Studies with weak methods and poor logic are irresponsible in today’s world.

Here is the pubmed link:
Ancestry of pink disease (infantile acrodynia) identified as a risk factor for autism spectrum disorders.

Here is the abstract:

Pink disease (infantile acrodynia) was especially prevalent in the first half of the 20th century. Primarily attributed to exposure to mercury (Hg) commonly found in teething powders, the condition was developed by approximately 1 in 500 exposed children. The differential risk factor was identified as an idiosyncratic sensitivity to Hg. Autism spectrum disorders (ASD) have also been postulated to be produced by Hg. Analogous to the pink disease experience, Hg exposure is widespread yet only a fraction of exposed children develop an ASD, suggesting sensitivity to Hg may also be present in children with an ASD. The objective of this study was to test the hypothesis that individuals with a known hypersensitivity to Hg (pink disease survivors) may be more likely to have descendants with an ASD. Five hundred and twenty-two participants who had previously been diagnosed with pink disease completed a survey on the health outcomes of their descendants. The prevalence rates of ASD and a variety of other clinical conditions diagnosed in childhood (attention deficit hyperactivity disorder, epilepsy, Fragile X syndrome, and Down syndrome) were compared to well-established general population prevalence rates. The results showed the prevalence rate of ASD among the grandchildren of pink disease survivors (1 in 22) to be significantly higher than the comparable general population prevalence rate (1 in 160). The results support the hypothesis that Hg sensitivity may be a heritable/genetic risk factor for ASD.

Lack of association between autism and four heavy metal regulatory genes

30 Jul

One question that has been discussed for some time is the hypothesized role of mercury as a potential cause of autism. The basic idea is that administrative prevalences of autism went up coincident with increases in mercury exposure from vaccines. Plus, it was asserted that autism symptoms are similar to the symptoms of mercury poisoning (they aren’t).

Part of the mercury model held that there could be a genetic susceptibility to mercury in a subset of children.

Researchers at Vanderbilt University have explored the question by testing autistics for genes involved in how the body processes mercury. They did not find any link between the four genes they screened and autism.

Of course one could argue that some other gene or genes are important. One would then need to explain why mercury exposure from vaccines does not increase the risk of autism.

The paper:
Lack of association between autism and four heavy metal regulatory genes.

Here’s the abstract.

Neurotoxicology. 2011 Jul 20. [Epub ahead of print]
Lack of association between autism and four heavy metal regulatory genes.
Owens SE, Summar ML, Ryckman KK, Haines JL, Reiss S, Summar SR, Aschner M.
Source
Department of Pediatric Toxicology, Vanderbilt University School of Medicine, Nashville, TN, USA.
Abstract
Autism is a common neurodevelopmental disorder with genetic and environmental components. Though unproven, genetic susceptibility to high mercury (Hg) body burden has been suggested as an autism risk factor in a subset of children. We hypothesized that exposure to “safe” Hg levels could be implicated in the etiology of autism if genetic susceptibility altered Hg’s metabolism or intracellular compartmentalization. Genetic sequences of four genes implicated in the transport and response to Hg were screened for variation and association with autism. LAT1 and DMT1 function in Hg transport, and Hg exposure induces MTF1 and MT1a. We identified and characterized 74 variants in MT1a, DMT1, LAT1 and MTF1. Polymorphisms identified through screening 48 unrelated individuals from the general and autistic populations were evaluated for differences in allele frequencies using Fisher’s exact test. Three variants with suggestive p-values <0.1 and four variants with significant p-values <0.05 were followed-up with TaqMan genotyping in a larger cohort of 204 patients and 323 control samples. The pedigree disequilibrium test was used to examine linkage and association. Analysis failed to show association with autism for any variant evaluated in both the initial screening set and the expanded cohort, suggesting that variations in the ability of the four genes studied to process and transport Hg may not play a significant role in the etiology of autism.

Mark Geier: under scrutiny in more states

29 Jul

In Home Autism doctor here under scrutiny, The St. Louis Post Dispatch discusses investigations ongoing in Illinois:

A autism doctor who operates clinics in St. Peters and Springfield, Ill., has been suspended in two states for alleged mistreatment of children.

Dr. Mark Geier has been accused of misdiagnosing children with early puberty and treating them with high doses of Lupron, a drug used to suppress the hormone testosterone.

A hearing will be held on August 22nd to consider Dr. Geier’s license in the state of Illinois.

The Post Dispatch notes that Dr. Geier’s hypotheses and methods are far from generally accepted:

Dr. John Constantino, a psychiatry professor and leading autism researcher at Washington University, said Geier “understands the tools of science but has applied them in questionable ways” to justify specific treatments.

“There is currently no scientific evidence to support the clinical use of Lupron to treat autism in anything other than carefully conducted research trials,” Constantino said.

Autism News Beat in Castration doctor’s license now suspended in four states notes:

Dr. Mark Geier, the Maryland physician who chemically castrates disabled children, is still licensed to practice medicine in seven states, down from eleven. Four states have suspended or revoked his privileges since April 27, when his home state took action against him. Washington followed on May 26, then Virginia on June 9. On June 29, Indiana issued an emergency 90-day suspension, citing the Maryland action.

Generation Rescue: taking another small step away from the brink?

14 Jul

Generation Rescue has over the years been one of the more vocal promoters of the vaccines-cause-autism notion. Like any organization, they have changed over the years and their website reflects that. Their website started out with the title “Autism Mercury Chelation” and a very simple (and wrong) statement:

Generation Rescue believes that childhood neurological disorders such as autism, Asperger’s, ADHD/ADD, speech delay, sensory integration disorder, and many other developmental delays are all misdiagnoses for mercury poisoning.

Of course, later during the early years of Jenny McCarthy, when Generation Rescue became “Jenny McCarthy’s autism organization. By this point, GR had a prominent link on the main page to “vaccines”. This included a page with Generation Rescue recommended vaccine schedules. Their “favorite” being a schedule that offered no protection against many diseases, including measles, mumps, rubella, pertussis, diptheria and tetanus.

They had a page of “science”, including statements claiming that Andrew Wakefield’s 1998 paper linked MMR to autism (a position Mr. Wakefield has tried to distance himself from in the past few years):

“This study demonstrates that the MMR vaccine triggered autistic behaviors and inflammatory bowel disease in autistic children.”

They had a science advisory board, which included S. Jill James, Ph.D., Richard Deth, Ph.D., Woody R. McGinnis, M.D. and Jerry Kartzinel, M.D.. Not exactly heavy hitters, but at least a couple of people who actually publish in journals.

Times have changed again. The website is revamped. And vaccines seem to be much less prominent. For example, in the current version of the Generation Rescue website, I can’t find “recommended” vaccine schedules (they refer people to Dr. Bob Sears). A search for Wakefield shows he is only mentioned once “Studies by researchers: Horvath, Wakefield, Levy, and Kushak highlight a myriad of gut problems present in children with autism, including abnormal stool (diarrhea, constipation), intestinal inflammation, and reduced enzyme function”. The science advisory board is down to one person (Jerry Kartzinel) and an unnamed “cohesive group of professionals committed to healing and preventing autism”.

Sure, it’s still not a place I would recommend to anyone, especially a parent who just found out their kid is autistic. But just a few short years ago the trajectory was increasing with the vaccine discussion, not decreasing.

Underimmunization in Ohio’s Amish: Parental Fears Are a Greater Obstacle Than Access to Care

29 Jun

With apologies for opening the subject of the Amish and autism once again, a recent paper in the journal Pediatrics explores vaccination and the Amish: Underimmunization in Ohio’s Amish: Parental Fears Are a Greater Obstacle Than Access to Care. Seth Mnookin has already discussed this at The Panic Virus at PLoS blogs in Anecdotal Amish-don’t-vaccinate claims disproved by fact-based study.

What is worrisome here is the fact that the nderimmunization amongst the Amish is resulting from parental fears. In a very different study from 2001, Haemophilus influenzae Type b Disease Among Amish Children in Pennsylvania: Reasons for Persistent Disease, most Amish parents who chose to not vaccinate were citing availability and convenience rather than fear as the reason.

To repeat–in 10 years the reasons for non-vaccinating amongst the Amish have changed from convenience to fear. We can’t say exactly why, but it seems quite plausible that the focus on autism, vaccines and the Amish could have played a role.

Given that the “Amish Anomaly” notion seems destined to linger on, I have written up another summary of the history and the facts of the story.

Dan Olmsted, now the owner of the Age of Autism, was once an editor for UPI. It was during his UPI time that he took on the autism/vaccine question that has since dominated his professional life. Back in 2005 he ran a series of stories which investigated the proposed link between autism and vaccines and, in specific, mercury. It was right around the time that the David Kirby/Lyn Redwood book “Evidence of Harm, Mercury in Vaccines and the Autism Epidemic: A Medical Controversy.” was published. This was likely the high water mark for the public’s acceptance of the vaccines-causation idea.

One of the ideas that Mr. Olmsted explored was that of the Amish. He started with the belief that they don’t vaccinate and set out to investigate whether this correlated with a lower autism prevalence. The idea of the Amish being a largely unvaccinated population was set out years earlier. David Kirby describes in Evidence of Harm how Lyn Redwood of SafeMinds discussed this in a presentation she made to congress in the year 2000.

Mr. Olmsted described his investigation starting in a piece, The Age of Autism: Mercury and the Amish . There was plenty of data even then which Mr. Olmsted could have considered which went against his hypothesis. Since then even more data has mounted against the idea.

And, yet, it persists. Often the “Amish don’t vaccinate and they don’t have autism” story pops up in internet discussions following news stories. Books have incorporated the idea. Of course it ends up in alternative medicine books on autism such as Kenneth Bock’s “Healing the New Childhood Epidemics: Autism, ADHD, Asthma, and Allergies”. The idea can be found in other boos as well, including “Timeless Secrets of Health and Rejuvenation” (2007) and “Cry for Health: Health: the Casualty of Modern Times” (2010). Again, this is a reason to revisit the debunking of this myth. The myth lives on, even in the face of facts.

In his 2005 UPI article, Mr. Olmsted started out with the assumption that the Amish don’t vaccinate. He set out to see if he could find autistics amongst the Amish, but didn’t look into the vaccination question with any depth:

So I turned to the 22,000 Amish in Lancaster County, Pa. I didn’t expect to find many, if any, vaccinated Amish: they have a religious exemption from the otherwise mandatory U.S. vaccination schedule.

As is well known now, the Amish do not have a religious exemption from the vaccine schedule. They do not have a religious prohibition against vaccination.

This was something Mr. Olmsted could easily have confirmed at the time. He might have checked the 1993 book Amish Society by John Andrew Hostetler (1993), in which he would have found the following statements about medicine:

“Some are more reluctant than others to accept immunization, but it is rare that an Amish person will cite a biblical text to object to a demonstrated medical need…” ….””If the Amish are slow to accept preventive measures, it doesn’t mean they religiously opposed to them…”

He might have made more than a cursory effort to contact people at the Clinic for Special Children in Strasburg, Pennsylvania. The Clinic, aside from serving special needs children (including autistics) runs vaccine clinics and has for some many years. In a piece explaining Mr. Olmsted’s failures, Mark Blaxill (also of the Age of Autism) explained that the Clinic did not return Mr. Olmsted’s phone call. No mention is given why Mr. Olmsted didn’t go to the clinic in his visits to Lancaster County

Had Mr. Olmsted done so, he would have known that this statement, again from his 2005 piece, was incorrect when he relied on a source who claimed a very low immunization rate:

That mother said a minority of younger Amish have begun getting their children vaccinated, though a local doctor who has treated thousands of Amish said the rate is still less than 1 percent.

He also made a misleading statement:

When German measles broke out among Amish in Pennsylvania in 1991, the CDC reported that just one of 51 pregnant women they studied had ever been vaccinated against it.

What is left vague in this statement was the fact that the 51 pregnant women were those who contracted German measles. Not surprising that those infected were largely unvaccinated. This doesn’t tell us what fraction of the whole population were vaccinated though, and is quite misleading.

One might wonder why Mr. Olmsted was not aware that the Amish participated in the eradication of Polio. Conversely, he might have questioned how polio was eradicated if the Amish did not vaccinate. Here is a March of Dimes photo from a 1959 vaccine clinic:


(from March of Dimes By David W. Rose, 2003)

An article available to Mr. Olmsted at the time of his 2005 article, Haemophilus influenzae Type b Disease Among Amish Children in Pennsylvania: Reasons for Persistent Disease, discussed the reasons why Amish parents did not vaccinate their children. While some did cite “religious or philosophical objections”, the majority said they would vaccinate if “vaccination were offered locally”:

Among Amish parents who did not vaccinate their children, only 25% (13 of 51) identified either religious or philosophical objections as a factor; 51% (26 of 51) reported that vaccinating was not a priority compared with other activities of daily life. Seventy-three percent (36 of 49) would vaccinate their children if vaccination were offered locally.

Since Mr. Olmsted’s original series, more data has come in refuting the “Amish Anomaly”. In 2006, a paper was published: Vaccination usage among an old-order Amish community in Illinois. Here is the abstract:

The Old-Order Amish have low rates of vaccination and are at increased risk for vaccine-preventable diseases. A written survey was mailed to all Amish households in the largest Amish community in Illinois inquiring about their vaccination status and that of their children. In this survey, the Amish do not universally reject vaccines, adequate vaccination coverage in Amish communities can be achieved, and Amish objections to vaccines might not be for religious reasons.

It is clear that the Amish do vaccinate and that it would have been simple for Mr. Olmsted to find accurate information about this at the time. It was certainly more difficult for Mr. Olmsted to ascertain what the prevalence of autism might be amongst the Amish. He made the assertion: ““there are only a few of them [autistic Amish] in the United States”.

Of the “few” Amish autistics Mr. Olmsted could find, six were being treated by Lawrence Leichtman. The children were unvaccinated but the doctor who reported them to Mr. Olmsted attributed their autism to high mercury levels. This is not surprising as Dr. Leichtman was one of the early alt-med practitioners working in autism, being part of the secretin fad of the 1990’s. One wonders if the “elevated mercury” levels in these children would stand up to tests performed by qualified medical toxicologists.

Another six autistic Amish, nearly under Mr. Olmsted’s nose at the time of his article, were being treated by the Clinic for Special Children in Lancaster, PA. Six children who had PDD or Autism were at that time being treated and written up for a study in the New England Journal of Medicine. They were missed by Mr. Olmsted. He has since argued that these children are syndromic and, thus, somehow not as relevant to his story. Those arguments aside, this was a clear miss for Mr. Olmsted.

In 2010, a study was presented at IMFAR: Prevalence Rates of Autism Spectrum Disorders Among the Old Order Amish

Preliminary data have identified the presence of ASD in the Amish community at a rate of approximately 1 in 271 children using standard ASD screening and diagnostic tools although some modifications may be in order. Further studies are underway to address the cultural norms and customs that may be playing a role in the reporting style of caregivers, as observed by the ADI. Accurate determination of the ASD phenotype in the Amish is a first step in the design of genetic studies of ASD in this population.

A preliminary number of 1 in 271 is a far cry from “little” or no autism amongst the Amish. Given the limitations of working within a community like the Amish, it is surprisingly close to the 1 in 100 often cited as the autism prevalence estimate for the general U.S. population. The study was being prepared for submission when I checked with the lead author last fall. It will be interesting to see what the final number is obtained for the prevalence.

The IMFAR abstract was available, I believe, before Dan Olmsted’s book, The Age of Autism, went to press. Instead of including this information, he chose to paint autism as rare amongst the Amish using quotes he obtained in 2005 and unsupported statements like, “the most aggressive possible count of autistic Amish comes to fewer than 20 cases, which would give us a rate of no more than 1 in 10,000.” It seems unlikely, given the low sales figures, that The Age of Autism will be reprinted. If that should happen, I wonder if Mr. Olmsted will correct this misinformation. The facts are clearly against him. Certainly, his review of internet sources and cursory tour of Lancaster County hardly counts as “aggressive”.

The “Amish don’t vaccinate and don’t have autism” idea was never very well supported. Now, with more data in, it is just plain wrong. It would be a good and honorable thing for Mr. Olmsted himself to make this clear. Good. Honorable. And not going to happen.

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?

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?

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