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?

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

  1. Catherina June 16, 2011 at 09:41 #

    Thank you Sullivan for the clear account of what kind of research the Geiers are abusing to “support” their ludicrous claims.

  2. MikeMa June 16, 2011 at 11:53 #

    I winder if the Autism One conference material contained any last minute notices concerning the Geier’s current medical troubles. One might expect that if a practitioner had his license pulled, the audience might be well served to know that. I suppose the fact was known to many but chalked up to conspiracies by big pharma/big medicine as a way to ‘keep our children sick’.

    Poor ddeluded fools. They listen to the Greiers spout unsupported crap about a drug that can cause real harm while believing vaccines, true miracles in the fight against childhood disease, cause autism without a shred of evidence.

  3. JimK June 16, 2011 at 13:02 #

    Then again, you have never had your children treated by the Geiers with the Lupron (for the girl) and Aldactone (for the boy) and seen dramatic improvements in behavior. In fact, the psych meds were no longer needed. You have your institutional bias. Fine. I’m sure you would never accept the idea that their practises yield results. So rock throwing brings you more street cred which shows how chirlish and small minded you are.

    • Sullivan June 16, 2011 at 14:29 #

      “Then again, you have never had your children treated by the Geiers with the Lupron”

      And I am very grateful to have avoided them. I notice that you use the phrase “treated by the Geiers”. You are aware that only one (singular) Geier is able to treat, don’t you?

      I don’t have an institutional bias. I am a parent. I want what’s best for my child. I do have the scientific background to read the Geiers’ papers and realize that they are the work of people with very little understanding of what real science is.

      In fact, it was a Geier paper that originally sent me down the path of strongly questioning papers in autism science. I recall reading a paper by them and realizing that the paper had a strong agenda and poor science.

      JimK, I notice that you have not actually taken on any of the points of the article above. Neither have you demonstrated an understanding of what the Geier theory of why to use Lupron is based upon.

      As to whether there are effects–sure, remove testosterone from a human’s body and you see changes in behavior. Who is surprised by this? Even the Geiers say it’s temporary. And, they give no evidence that there is anything specific to autism that they are “treating”.

      Can you explain this to me: If I thought my kid had precocious puberty, why would I take him/her to the Geiers? Why not take my kid to an endocrinologist? Doesn’t my kid deserve the most experienced, well trained person in the relevant field? Mark Geier has no training in endocrinology and David Geier has no training in medicine. Why, exactly, should I have taken my kid to them?

      That’s a serious set of questions, not “throwing rocks” as you would have it. Can you answer them? I’ve never seen anyone even try, and I’ve posted variations of the above numerous times.

  4. MikeMa June 16, 2011 at 13:38 #

    I have never had a child treated, no. But I am very aware when using any medical procedure, what the effects, side effects and downsides are. Chemically castrating my child to gain a bit of behavior improvement seems a bit over the top.

    The Lupron protocol is not approved for the use Greier made of it. His theory has been refuted. He has lost his license in MD over it. Any of those items alone would have me look elsewhere for a solution.

    I have no institutional bias. It is a reality bias. I understand and trust science and the scientific method.

    For the 3000th time The plural of anecdote is not data.

  5. Caroline June 16, 2011 at 14:08 #

    I question where the mercury for this wild batsh!t crazy claim is supposed to come from? Are we still playing that tired old song about mercury in vaccines? Because thiomersal/thimerosal/mercury/ “evil autism causing stuff” is actually not in any childhood vaccines in most developed countries…

    • Sullivan June 16, 2011 at 14:45 #

      Catherina,

      After your blog covered the way Mr. Wakefield abuses references, I started checking other people’s references more closely.

      Caroline,

      they are now claiming that 40% of the mothers they see got a thimerosal containing flu shot. Also, mercury from power plants and other sources. They banned thimerosal in vaccines for pregnant women and young children in my state. No indication of a drop in autism rates that I’ve heard so far. Studies have looked at prenatal exposure to thimerosal from RhoGam like products, and found no link. These get brushed aside by the Geiers. They are still pushing Simpsonwood and some never-made-public stack of government documents Mark Geier supposedly had access to. With apologies to those who think I am “throwing stones”, but I don’t trust the Geiers based on the facts I can check. I certainly am not taking their word on what is in a bunch of documents that I can’t see.

  6. Kathleen Seidel June 16, 2011 at 20:15 #

    It’s telling to me that Geier père et fils and Rev. Sykes made their claim of instantaneous improvement in a publication aimed at prospective customers, whereas the description of the tire swing incident that appeared in the patent application was somewhat more conservative. It would seem that they’re trying to make their recipe for recovery seem even more miraculous than it isn’t. The kid deserves credit for developing a new skill; it’s a damned shame that both his mother and his doctors want to attribute it to the drug.

    It’s also telling that JimK states that “psych meds were no longer needed,” since administration of Lupron to children was followed by changes in their behavior. In fact, the Geiers have been using Lupron as a short-acting psychopharmaceutical. What they’re doing is no more “natural” than pumping autistic kids full of antipsychotics.

    • Sullivan June 16, 2011 at 21:13 #

      Kathleen Seidel,

      A cynical view:
      false information on a patent application could invalidate the patent. False information in what amounts to an advertisement for the Geier business could lead to more business.

      It’s worth noting that the patent rights, should the patent be issued, have been assigned to the Geiers. In 2010, Abbot Endocrine (Abbot are the makers of Lupron) assigned the U.S. patent rights to the Geiers.

      Assignment (ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ABBOTT ENDOCRINE, INC.;US-ASSIGNMENT DATABASE UPDATED:20100309;REEL/FRAME:24051/519) (ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ABBOTT ENDOCRINE, INC.;US-ASSIGNMENT DATABASE UPDATED:20100309;REEL/FRAME:24051/519)(New owner: GEIER, MARK R.,MARYLAND 2009-08-25 )

      Your writing, as I recall, showed the link between the Geier team and TAP pharmaceuticals (hence the prominent use of the trade name Lupron in publications, rather than the drug’s generic name). In case you are wondering, TAP Pharmaceuticals was the original assignee. They transferred it through Lake Products, Inc. to Abbot Labs in 2008. Very strange, but it appears that Lake Products changed name to Abbot Endocrine at about the time of the transfer of the patent from TAP.

      All that aside–the companies have removed themselves from the U.S. patent.

      The patent application: “US20060058241A1: Methods of treating disorders having a component of mercury toxicity” leaves me wondering what patent examiner would allow this. Even the Geiers in their interview are not stressing the supposed mercury level reduction with Lupron.

      The title of the patent “Method for lowering level of mercury in subject suffering from mercury toxicity e.g. disorder selected from autism involves administration of luteinizing hormone releasing hormone composition followed by chelating agent” Have they ever demonstrated lowering the mercury levels with this drug? Their interview is focused on the reduction of testosterone. They claim that other drugs used to treat autism are really reducing testosterone (e.g. risperdol, in their view). “Obvious” is a key phrase in obtaining a patent. It is clearly obvious that applying Lupron and similar drugs, drugs invented to reduce testosterone, will reduce testosterone levels in a person. Where’s the invention? It’s like saying, “I’m going to patent the use of aspirin to reduce pain”. Obvious. Already demonstrated.

  7. David N. Brown June 18, 2011 at 07:31 #

    I have covered some new developments here:
    http://groups.google.com/group/mystery-bolen-theater/browse_frm/thread/7c85e0386421b962#

    In summary, three of Geier’s licenses have now been suspended, and two more will be lost at the end of the month if renewal isn’t applied for and granted. And Tim Bolen, who claims to be representing the Geieres, has started making litigious threats on their “behalf”.

    Also, I have offered a someone apologetic take on the Geiers’ Autism One appearance: The meeting space and time slot given to their talk strikes me as rather poor, suggesting that even the conference planners didn’t think much of the Geiers and/or their ability to attract an audience. Publishing the Geiers’ article seems rather less equivocal, though I would reserve judgment without knowing the timetable on which it was received, accepted and sent to the printer (something I investigated with care before calling out Neurotoxicology for accepting a Wakefield paper back in Fall 2009).

  8. daedalus2u June 19, 2011 at 04:44 #

    If anyone should be worried about being sued it is TAP Pharmaceutical. Encouraging off-label use for a non-FDA approved treatment is a no-no. For something as wacky as chemical castration of children it is a slam-dunk. The kind of case that you settle because you will lose if you go to trial.

    The company that acquired TAP Pharmaceutical is taking a beating. Not sure if that is related.

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