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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.

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?

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

Do we have to wait for someone to be injured to call a practice unsafe?

5 May

Mark Geier has had his license to practice medicine suspended in his home state of Maryland. The Chicago Tribune (which has discussed Mark Geier and his “lupron protocol”) has a story discussing this: Trib Update: Md. suspends autism doctor’s license.

These paragraphs stood out when I read them:

In some cases, the board found that Geier diagnosed the children with precocious puberty and prescribed Lupron and other hormone-disrupting drugs without examining them or conducting proper tests. Some of these children were within the normal age range for puberty, so they couldn’t have qualified for such a diagnosis, the board found.

Geier, who is not allowed to practice in Maryland while the case is pending, declined comment, instead referring questions to an attorney. The attorney, Joseph A. Schwartz III, said that at the root of the complaint was a “bona fide dispute over therapy” rather than a case of a doctor who is an immediate threat to patients.

“If you read the (complaint), you say, ‘Holy God, this is awful.’ But if it were so awful they should have an injured child, and they don’t. I would hope that the board would step back and say, ‘Maybe there’s a lot of controversy and he’s not in the mainstream.’ But let’s test these allegations in a fair hearing. It’s just like shadow-boxing with allegations that sound awful but when you delve into the facts of them you say, ‘What’s the big deal here?’” Schwartz said.

“But if it were so awful they should have an injured child”

Do we really have to wait for someone to be injured? Clearly, the answer is no. “An immediate threat” is different from “has already caused harm”.

Let’s address this question: “What’s the big deal here?” Let’s address it in short, easily digested statements, centering around the fact that this is a breach of ethics, not a question of treatment modalities.

Here are a few “big deals” which come to mind readily:

1) diagnosing children with a condition they do not have (precocious puberty)
2) not performing the follow through to see if children have brain tumors, which would be possible if the diagnosis were real.
3) doing (1) to justify a very serious medication for the disabled children
4) allowing an untrained/unlicensed person to perform examinations

Mr. Geier is very lucky that no one was injured. His original methodology included giving

Here is the paragraph on “use” for Lupron:

LUPRON DEPOT?PED® (leuprolide acetate for depot suspension) 7.5 mg, 11.25 mg and 15 mg are prescribed for the treatment of children with central precocious puberty (CPP). Doctors may diagnose children with CPP when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of 9. Doctors will also perform tests to rule out possible causes of CPP that would require different treatment (e.g., tumors).

One issue that came up was Mr. Geier’s lack of followup testing. Having diagnosed precocious puberty, he should have ordered tests to rule out brain tumors. These were not performed. This makes one question: did he actually believe the diagnoses himself or was he just negligent in calling for the brain scans?

Something caught my eye that I hadn’t seen before. Notice the pediatric dosage: 7.5, 11.25 and 15 mg. This is the same dosage that the Geiers note in their patent application: US20070254314A1: Methods of treating autism and autism spectrum disorders.

Check the dosages given to some children:

On Nov. 24, 2004, Child X was given a single shot of LUPRON DEPOT® (leuprolide acetate, Takeda Pharmaceutical Company Limited, Osaka, Japan) in the amount of 22.5 mg.

On Apr. 2, 2005, Child Y was given a single shot of LUPRON DEPOT® (leuprolide acetate, Takeda Pharmaceutical Company Limited, Osaka, Japan) in the amount of 22.5 mg.

Perhaps the pediatric doses were larger back then. I’d be very interested to know, as these children were given dosages above the maximum listed values.

In an interesting side note in this story. Mark Geier’s son, David, was appointed to a position on the Maryland state’s autism commission as a “diagnostician”. Apparently his position is being reviewed and he has been asked to resign:

Gov. Martin O’Malley appointed David Geier in 2009 to the state’s Commission on Autism as a “diagnostician,” a decision state officials are now reviewing. David Paulson, a spokesman for the state health department, said David Geier declined Wednesday to resign from the position.

Maryland Board of Phyicians: Mark Geier “endangers autistic children and exploits their parents”

4 May

Dr. Mark Geier is well known in the world of alternative medicine and autism. He, together with his son David, work a medical practice and publish papers. They are long-standing proponents of the vaccine-causation hypothesis, presenting pseudo-epidemiological studies as support. Dr. Geier has worked as a witness in the vaccine court, has has a long history of criticism for his work there.

One of the stranger notions Dr. Geier has put forth involves testosterone. In their model of autism, testosterone binds with mercury in the brain and makes it difficult to remove through chelation. For many, many reasons, this was just plain wrong. Based on their mistaken hypothesis, the Geiers have promoted a treatment for autism based on reducing testosterone in autistic children. In short, they put children on an injected drug: Lupron.

This idea has met with much criticism. Probably no one has studied the Geier’s and their actions more closely than Kathleen Seidel on her blog at Neurodiversity.com. Five years ago and more she exposed the “Lupron Protocol” in a sixteen partseries called

Significant Misrepresentations: Mark Geier, David Geier & the Evolution of the Lupron Protocol.

Well, it isn’t just one of the best bloggers saying it anymore. The Maryland Board of Physicians has investigated Dr. Geier and Dr. Geier has now had his license suspended.

Here is part of the Order for Summary Suspension:

The Respondent misdiagnosed autistic children with precocious puberty and other genetic abnormalities and treated them with potent hormonal therapy (“Lupron Therapy” or “Lupron Protocol”), and in some instances, chelation therapy, both of which have a substantial risk of both short-term and long-term adverse side effects. The Respondent’s treatment exposed the children to needless risk of harm.

The introduction goes on.

The Respondent, in addition to being a physician, is certified as a genetic counselor. His assessment and treatment of autistic children, as described herein, however, far exceeds his qualifications and expertise. The extensive and expensive batteries of laboratory studies the Respondent initially orders, many of which he orders to be repeated on a monthly basis, are outside the standard of quality care for a work-up for an autistic patient or to determine the underlying cause of autism. The Respondent failed to conduct adequate physical examinations of any of the patients and in several instances, began his Lupron Protocol based merely on a telephone consultation with the child’s parent and the results of selected laboratory tests he ordered. The Respondent’s omission of a comprehensive physical examination constitutes a danger because his treatment is based on a diagnosis that requires documentation of sexual development beyond that expected for the age of the child. Moreover, his treatment may constitute more of a risk to a child with an underlying medical condition.
The Respondent failed to provide adequate informed consent to the parents of the autistic children he treated. In one (1) instance, he misrepresented that his treatment protocol had been approved by a federally approved IRB.
There are no evidence-based studies to support either the Respondent’s Lupron Protocol or his administration of chelation therapy to autistic children; he relies in large part on his own studies which have been wholly discredited by the Institute of Medicine and denounced by the American Academy of Pediatrics. The Respondent’s treatment of autistic children with his Lupron Protocol and chelation therapy is not limited to Maryland. Indeed, in a recent article in the Chicago Tribune, the Respondent stated his intent to open clinics all over the United States, H[w]e plan to open everywhere. I am going to treat as many as I can.

The introduction ends with this paragraph:

The Respondent endangers autistic children and exploits their parents by administering to the children a treatment protocol that has a known substantial risk of serious harm and which is neither consistent with evidence-based medicine nor generally accepted in the relevant scientific community.

Pretty much sums it up. There are numerous counts and details listed in the full document. Below I’ll highlight some specific statements.

Patient A, a child whose mother stated aggression was not a problem, was reported as having aggression and self-injurious behaviors:

Notwithstanding Patient A’s mother’s report that aggression was not a problem with Patient A, the Respondent noted in the “Precious (sic) Puberty Evaluation” section of the form that Patient A, “bites and punches others; hits head with hands.”

As with many (if not all of the children) listed in the order, the diagnosis of precocious puberty was not considered valid:

45. The Respondent misdiagnosed Patient A with premature puberty. Significantly, Patient A did not meet the age criteria for premature puberty.
46. In addition, the results of Patient A’s laboratory studies do not support the Respondent’s diagnosis. The Respondent reported that Patient A’s testosterone metabolites were “significantly increased;” however, the results of Patient A’s luteinizing hormone (“LH”) were only marginally elevated, and his free testosterone and DHEA were within range for a ten (10) year old male.

One question that is often raised with alternative medical practitioners is the validity of their diagnoses. Quite often this involves diagnoses of “heavy metal toxicity” using non-standard tests. In the case of the Geier’s, there is also the validity of diagnoses of “precocious puberty”. There are standards for age, and for tests which should be performed. Reading the order, it is clear that age requirements were often ignored. Bone density tests were often not performed:

The Respondent failed to assess Patient B’s bone age, assess the child’s growth velocity or order a GnRH test to confirm the presumptive diagnosis of precocious puberty.

Also, the signs of precocious puberty could be due to a brain tumor. Yet brain scans were not performed. This from Patient E:

In addition, the Respondent failed to assess Patient E’s skeletal maturation by ordering an x-ray of her left wrist and he failed to order a scan of her brain in order to rule out a tumor.

Another question that often comes up with the Geier practice is what role David Geier plays. David Geier holds only a bachelor’s degree. He is not a physician. Patient C appears to have been examined by David Geier, with Dr. Mark Geier absent:

Patient C’s mother returned to the Respondent’s office on May 19, 2008 because of the worsening of Patient C’s aggressive behaviors. According to her complaint, the Respondent was not present during this office visit, She saw only his unlicensed son.

And, yet, the child was given “comprehensive” abdominal and thyroid ultrasounds at the visit:

The note of the visit indicates that “comprehensive” abdominal and thyroid ultrasounds were performed. Patient C’s physical appearance is described as suggesting “advancement from his chronological age” and that he appeared to be “potentially significantly physically aggressive to himself and/or others.”

and something akin to a diagnosis was rendered:

A portion of the “Psychological Examination” section of the note states, “It is apparent based upon examination of the DSM-IV criteria that [Patient Crs present symptoms are compatible with a diagnosis of pervasive developmental delay – not otherwise specific (sic).”

One problem with research performed by the Geier’s is the lack of an appropriate IRB–institutional review board. Dr. Geier placed himself, his wife and his son on the IRB. Not noted in the Order is the timing of the IRB. If memory serves correctly, there is evidence that the IRB was put into place after research began.

An IRB must consist of at least five (5) members. The ICI IRB’s members include the Respondent, his son and the Respondent’s wife. The ICI IRB is inconsistent with the requirement that a member should not have a conflict of interest in the research project.

The Order includes discussion that “The Respondent [Mark Geier] Misrepresented His Credentials”. When the investigative board interviewed him, here is how Dr. Geier described himself:

On November 6, 2007, in furtherance of the Board’s investigation, Board staff interviewed the Respondent. During the interview, the Respondent stated that he was a board-certified geneticist and a board-certified epidemiologist. The Respondent stated that he had been board-certified in epidemiology in 2007.

However, “board certified” and “geneticist” seem to be incorrect:

As to being a board-certified epidemiologist, this appears to be inaccurate:

166. By letter dated March 29, 2011, the Respondent, through counsel, submitted to the Board a “Fellowship Certificate” from the American College of Epidemiology (“ACE”). The ACE is a professional association whose policy on admission is “inclusiveness.” An ACE fellow is not required to have a degree in epidemiology, a degree in a “related field” is sufficient.
167. The Respondent knew, or reasonably should have known, that he was not board-certified in epidemiology.

As to being a “geneticist”, Dr. Geier is a “genetic counselor”, a different creature:

168. By letter dated March 29, 2011, the Respondent, through counsel, also submitted to the Board a certificate issued by the American Board of Medical Genetics on September 15, 1987 certifying the Respondent as a Genetic Counselor.
169. The term “genetic counselor” is not synonymous with “geneticist.” A geneticist, or medical geneticist, is a physician who evaluates a patient for genetic conditions, which may include performing a physical examination and ordering tests. A genetic counselor is an individual with a masters degree who helps to educate the patient and provides an assessment of the risk of the condition recur in the family.
170. The Respondent knew, or reasonably should have known, that he was not a board-certified geneticist.

Geneticist/genetic counselor and whether he is board certified in epidemiology or not are interesting but minor questions compared to the board findings of misconduct in treating disabled children. So it comes as no surprise that it is ordered:

Based on the foregoing, it is this 27th day of April , 2011, by a majority of the quorum of the Board:
ORDERED that pursuant to the authority vested by Md. State Gov’t Code Ann., § 1 0-226( c)(2), the Respondent’s license to practice medicine in the State of Maryland be and is hereby SUMMARILY SUSPENDED;

Mr. Mark Geier is at present unable to practice medicine in his home state of Maryland.

kathleen Seidel has already blogged this: Maryland Medical Board Suspends Dr. Mark Geier’s License

Eli Lilly halts two clinical trials of an experimental Alzheimer’s treatment

19 Aug

This has been reported in a number of places, including the New York Times in their article Lilly Stops Alzheimer’s Drug Trials.

From the NY Times:

Eli Lilly halted two late-stage clinical trials of an experimental Alzheimer’s treatment on Tuesday, representing a setback to one leading theory on treating the degenerative disease and a new blow to Lilly’s business prospects.

One defining feature of Alzheimers disease is the presence of amyloid plaque in the brain. The now-halted clinical trial was for a drug which reduces this plaque.

The basic idea is fairly straightforward: if plaque is present in the brains of those with Alzheimer’s, removing the plaque may help reduce or reverse the symptoms. Instead, researchers were finding that the drug was making symptoms worse. Again from the times:

The company said patients who had taken the drug, intended to reduce plaque in the brain, actually showed worse cognitive functioning and less ability to perform daily living tasks than patients who had taken a placebo.

Why bring this up on an autism blog? Because this trial gives a good example of why I am very concerned about the use of untested therapies on autistics. It isn’t because of some objection to a “cure”. There is no existing autism cure. There is no autism cure proposed or in any stage of a clinical trial. While there is some very good and important discussions about any potential cure, it is for the present a hypothetical discussion. No, it isn’t the cure debate which drives me. It is safety. Plain and simple.

Consider autism therapies (both alternative and off-label) from a viewpoint of safety for the moment with the lessons learned from the Alzheimer’s trial.

Clinical trials are all about safety and efficacy. Is the therapy (drug) safe? Does it work? Before a clinical trial is even started, there has to be some reason to believe that the therapy would be safe and effective. Researchers have to ask the question, “what will this do?” In the Eli Lilly Alzheimer’s trial, they had reason to believe that the drug would reduce amyloid plaque. They had (I assume) some earlier trials to prove the drug reached some level of safety. With that in hand, Eli Lilly went forward to large-scale testing with people and they found that, at least for their test group (people with somewhat advanced Alzheimer’s disease), the drug was harmful.

From the NY Times story:

Lilly’s drug was intended to reduce production of so-called amyloid beta plaques in the brain by inhibiting the activity of an enzyme called gamma secretase.

Dr. Siemers of Lilly said the failed trials might indicate that too much reduction in amyloid beta unexpectedly harms cognitive functions, or it may be that the problems arose from the drug’s effect on some 20 other proteins.

Unintended and unforeseen consequences.

Consider alternative therapies being applied to autistics. For example, consider anti-inflammatory drugs. These are existing drugs used off-label, so some safety data are available. There is evidence of inflammation in the brains for some autistics, so why not treat it?

Because we don’t understand why there is inflammation in the brains of autistics. Because of that, we don’t know if there are any unintended consequences of anti-inflammatory therapies. From a story last year in the Chicago Tribune, this section discussing the team from Johns Hopkins/Kennedy Krieger which first published on neuroinflammation in autistics:

“THERE IS NO indication for using anti-inflammatory medications in patients with autism,” the [Johns Hopkins] team wrote.

Meddling with neuroinflammation could actually be a terrible mistake, said co-author Dr. Andrew Zimmerman, director of medical research at the Center for Autism and Related Disorders at the Kennedy Krieger Institute in Baltimore.

“It may actually be an attempt of the brain to repair itself,” said Zimmerman, a pediatric neurologist. Suppressing the immune response “could be doing harm.”

There are other classes of alternative therapies used in autism. Therapies which most likely are doing nothing beyond the placebo effect are in one class. For example, homeopathy. I don’t spend a lot of time writing about homeopathy. In fact, I don’t know if I have blogged about it at all. Even though it is bad science, it isn’t really dangerous. Another class of alternative therapies are those based in really bad science and which carry the potential of harm. Lupron comes readily to mind. Lupron therapy is based on two levels of very bad science. First, that autism is caused by mercury poisoning. Second, that reducing testosterone in the body will aid it in eliminating mercury. Lupron has been through clinical trials (not for autism) demostrating some level of safety, there are serious known side effects. Worse, the manner in which it is used in autistic children is very problematic–delaying puberty.

Back to the Alzheimer’s trial–I actually welcome the trial itself. I consider those who undertake clinical trials to be very brave individuals. I for one hope there are effective therapies for Alzheimer’s and other forms of dementia soon. It is a great fear for most, if not all, of us that we spend the last years of our lives with dementia. For the parent of a disabled child, this fear is only compounded. The thought of spending my last years draining resources I would rather leave to my child is one of the worst futures I can imagine.

Trine Tsouderos and Patricia Callahan honored by the Association of Health Care Journalists for autism series

23 Mar

The Chicago Tribune has run a series of articles lately on alternative medicine and autism. The stories include OSR#1: Industrial chemical or autism treatment? (about a chelation chemical invented for mining operations, now labeled as a supplement and sold for “oxidative stress relief”), the self explanatory titled Autism treatment: Science hijacked to support alternative therapies, Autism’s risky experiments Some doctors claim they can successfully treat children, but the alternative therapies lack scientific proof and Autism treatment: Success stories more persuasive to some than hard data One dad, a doctor, says he was “fooled”

This is part of a series that won the Chicago Tribune one of two awards. Writers Patricia Callahan and Trine Tsuderos were honored.

“This powerful series combines first rate medical writing and rigorous investigative reporting to expose doctors who perform what the authors rightly call “uncontrolled experiments on vulnerable children” with autism,” commented the judges. “Writing with the authority that comes from total command of the material, Tsouderos and Callahan bring new clarity to a notoriously murky subject-autism treatments. They document a horrifying brand of bad science perpetrated by bad doctors on desperate families, but they do it without a hint of hyperbole or sensationalism. Their straightforward, professional tone lets the facts tell the story. The result is an important-and devastating-piece.”

With a tip of the hat to Autism News Beat for his story, Tribune investigation takes first place

addendum:

here is the text of the announcement about the Tribune team:

Chicago Tribune reporters examine Lupron – a testosterone inhibitor used to treat precocious puberty and to chemically castrate sex offenders – and its reputed ability to be a “miracle medicine” for a disease with few mainstream medical answers: autism. In looking into Lupron, the Tribune found a world of alternative treatments for autism with fervent supporters who made big claims they said were backed by science. But when reporters evaluated the treatments, painstakingly analyzing each claim, each paper, each therapy through a lengthy dialogue with scores of medical experts, parents and doctors, they found the therapies were risky and unproven and the science backing them was junk. The Tribune provided readers and parents with hard evidence and some difficult truths, concluding that thousands of children with autism are being subjected to mass uncontrolled experimentation every day.

Judges comments: This powerful series combines first rate medical writing and rigorous investigative reporting to expose doctors who perform what the authors rightly call “uncontrolled experiments on vulnerable children” with autism. Writing with the authority that comes from total command of the material, Tsouderos and Callahan bring new clarity to a notoriously murky subject-autism treatments. They document a horrifying brand of bad science perpetrated by bad doctors on desperate families, but they do it without a hint of hyperbole or sensationalism. Their straightforward, professional tone lets the facts tell the story. The result is an important-and devastating-piece.

For their piece Dubious Medicine

A Nasty Little Franchise

15 Feb

Wakefield may have the highest public profile but he is just one of many who seek to profit from autism and he is by no means the worst. Remember the Geiers? This father and son team from Silver Springs in Maryland have an unsavoury record that makes Wakefield seem almost reasonable.

Wakefield breached the terms of his hospital’s ethics committee. The Geiers, operating out of the family home, invented their own IRB and granted themselves ethical approval for experiments on children with a powerful drug called Lupron. Lupron is used to treat precocious puberty, a rare condition in young children. It is also used is also used to treat prostate cancer in men, to treat endometriosis in women, and to chemically castrate sex offenders. The Geiers use it on autistic children and young adults.

Kathleen Seidel has catalogued their bad science, plagiarism, inflated academic resumes, the fraudulent IRB, cruel and unnecessary blood draws, attempted deals with TAP pharmaceuticals and the Lupron Protocol itself on her Neurodiversity website. Trine Tsouderos at the Chicago Tribune covers all the basics in her recent profile of the Geiers,  ‘Miracle drug’ called junk science.

The most disturbing part of Tsouderos’ story was the news that the Geiers were rolling out a franchise for others to cash in on their unproven and dangerous protocol. According to their website they offer the following

  • Genetic Markers (DNA Fragile X Syndrome, Blood Chromosome, Chromosome Microarrays, DNA Rett Syndrome, Angelman/Prader Willi Syndrome)
  • Mitochondrial Dysfunction (Carnitine, Lactic Acid, Ammonia, Hand Muscle Testing)
  • Hormone Imbalances (Total Testosterone, Free Testosterone, DHEA, DHEA-S, Androstenedione, Dihydrotestosterone, Total Estrogens, Estrone, Estradiol, ACTH, Aldosterone, Prolactin, FSH, LH)
  • Oxidative Stress/Inflammation (Neopterin, Lipid Peroxides)
  • Detoxification Pathways (Glutathione, Cystathionine, Homocysteine, Methionine)
  • Immune System Function (Immune Deficiency Profile, HLA-Testing, Immune Complexes, Food Allergies, Celiac’s Disease)
  • Heavy Metals (Porphyrins, Blood Metals, Urinary Metals)
  • Neurological Dysfunction (Brain MRI scans, Brain SPECT scans)
  • General Health Status (Comphrensive Metabolic Panel)

And this is the team that will deliver these services.

  • Maryland: Mark Geier MD, geneticist and David Young MD, Obstetrician and gynaecologist.
  • Springfield, llinois: Mary Young MD, psychiatrist and neurologist.
  • Ft. Lauderdale, Florida: David Claymore, neuroradiologist.
  • Parsippany, New Jersey: Paul King, industrial chemist.
  • Indianapolis, Indiana: Melissa Troutman, radiologic technologist.
  • Dallas, Texas: Janet Kern, RN, neuroscientist.
  • Louisville, Kentucky: Janet Pope, RN

And that is it. The only member of the American Academy of Pediatrics is Mary Young who has worked as a child psychiatrist. There are no board certified endocrinologists or anybody with the board certification to diagnose and treat precocious puberty in children.

And what of David Geier BA? He remains vice-president of the non-profit 501(c)3 Institute of Chronic Illnesses, Inc. and the non-profit 501(c)3 CoMeD, Inc. Much of the profit from the franchise will be directed to “these corporations dedicated to
autism research and advocacy efforts.” sure. So families or their insurers will be paying for treatments for their children that have been condemned by real autism experts as junk science. And the profits from this enterprise will be used to fund more junk science. Do they have a GMC in America? Do they want to borrow ours?

Pity for the Rankins

26 Jan

Its no secret that Wade and I were once pretty good internet pals. We regularly communicated despite our staunch opposition to the others beliefs regarding vaccines role in autism. That changed however as Wade sunk deeper and deeper into the bad science surrounding autism.

Wade and his wife Sym have recently been the subject of a piece by the Chicagoist following Wade’s open letter to the Trib. The Chicagoist reporter (one Mr Carlson) had obviously read both the Trib articles and Wade’s open letter before writing his own piece.

And now Wade has been obligated into writing yet another blog piece as it seems the Chicagoist has taken a similar line to the Trib. Wade says:

Reading through Mr. Carlson’s brief post gave me the distinct impression that somehow the meaning of our letter had gotten lost,

A brief digression. Wade and his family used to live in the South and were affected very badly by Hurricane Katrina. Once the dust had settled they decided to resettle in Chicago. Once there I learned they had become aquainted with the infamous Erik Nanstiel and David Ayoub, both hardcore believers of the vaccine causes autism idea. Not long after that Wade’s own beliefs on the subject hardened and it wasn’t difficult to see where this hardening of beliefs was being hardened from. I found it increasingly difficult to accept the things Wade was saying. An intellegent man, his new beliefs can be summed up in his opinion of Lupron and OSR.

…we have not, as yet, utilized either the Lupron protocol or OSR #1, both of which were the subjects of Tribune smear pieces. That is not to say, however, that those interventions may not be appropriate treatments in particular circumstances. On the contrary, we know families that these interventions have helped…

The old Wade would not have ever considered using these snake oil treatments. The old Wade would not have described the Trib articles as ‘smear pieces’. The old Wade wouldn’t have described knowing families who did use them and would have been much less credulous about their effectiveness.

SO, back to Wade’s statement that he believed the meaning of his open letter had been lost. It was lost, he’s right. It was totally lost on Carlson, it was totally lost on the commenters to the site and its totally lost to people like me. Not that I’m singling myself out for any special praise – thats kind of the point. I’m just an ordinary person with no special agenda and yet Wade’s point is totally lost on me and I very much suspect the vast majority of people who read Carlson’s piece or either of Wade’s long pieces on the subject. (Its hard to say which of the two points of the Somerset Maugham quote Wade utilises for his blog ‘Have common sense and … stick to the point’ that Wade has more strongly abandoned).

I miss the old Wade very much – a strong, principled and funny man, Wade has become just another sad foot soldier in Jenny McCarthy’s Bimbo Brigade alongside his fellow Chicago hardcore believers. His child is 10 years old and I doubt very much that xe is anywhere even approaching the level of ‘cure’ or ‘recovery’ that Wade has been promised by the various DAN doctors and new friends I have no doubt xe has been worked through. Wade’s tone in both of his blog pieces is a sad, tired sort of bewilderment – a bewilderment that the world just can’t see what he can apparently see. Sadly – pitifully – the viewpoint that he has adopted only means he’s going to become more bewildered.