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I’m an autism parent. No way I will vote for Robert Kennedy Jr.. He’s gutless.

26 Feb

As an example, I will discuss one particularly egregious “therapy” that was used on autistic children, the so-called “Lupron protocol”. Mr. Kennedy was in a perfect spot to stop or limit this therapy, but he never did. It would have taken courage, and, in my opinion, Mr. Kennedy is gutless.

Robert Kennedy (RFK Jr.) is running for president. He failed to gain the Democratic Party nomination and is now running as a third-party candidate. Since the beginning of his campaign, he’s faced criticism for being anti vaccine and anti-science. As someone who has watched Mr. Kennedy for nearly two decades I will agree: he is, indeed, anti-vaccine and anti-science. But that’s not why I am strongly against the idea of him being president. I oppose his bid for one reason:

He’s gutless.

Let me explain.

Long before Mr. Kennedy reached national prominence with his myriad of bad ideas during the COVID-19 pandemic, he was well known in the anti-vaccine autism-parent community. He was probably most famous for pushing the failed idea that mercury in vaccines caused an autism epidemic (an idea he still won’t abandon). And this is where many discussions focus on how his actions are anti-science and anti-vaccine. But to me, I hurt for the harms Mr. Kennedy’s advocacy has caused autistic people and the autism communities. One can say, “his anti-vaccine views have caused harm to public health”. One would be right. But, the anti-vaccine movement has long used autism and autistic people as the hammer with which they attack vaccines. And, to quote Sancho Panza in Man of La Mancha, “Whether the rock hits the pitcher or the pitcher hits the rock, it’s generally bad for the pitcher”. Being the weapon of choice for attacking vaccines has caused increased stigma and allowed charlatans to sell fake “cures” for autism which range from useless to abusive.

As an example, I will discuss one particularly egregious “therapy” that was used on autistic children, the so-called “Lupron protocol”. Mr. Kennedy was in a perfect spot to stop or limit this therapy, but he never did. It would have taken courage, and, in my opinion, Mr. Kennedy is gutless.

For decades there have been regular autism-parent conventions focused primarily on two things: promoting the idea that vaccines cause autism and promoting fake “cures” for autism as a vaccine injury. And Mr. Kennedy has been prominent at these conventions, serving as a keynote speaker.

Mr. Kennedy speaks primarily on the idea that vaccines cause autism (they don’t). He’s well respected as someone who has been involved for decades in this arena. His name gives some credence to the others at these conventions, including those who push abusive therapies.

I have never heard of Mr. Kennedy speaking out against the fake, even abusive, “therapies” pushed at these parent conventions. Why? In my opinion:

He’s gutless.

Allow me to focus on one of the most egregious fake therapies pushed as part of the vaccines-cause-autism movement. There are more. Many more. But let’s just discuss chemical castration.

If you are thinking, no way that happened, Matt. You must be exaggerating. I’m not.

Doctors were prescribing Lupron in order to reduce the testosterone in autistic children. That’s chemical castration in my lay opinion. Dr. David Gorski, an oncologist, wrote a series of articles about this “treatment” as “why not just castrate them“.

Surely they had a good reasoning for taking such drastic measures, you must be thinking. No, they didn’t. In fact, the “science” behind the therapy is horrifically bad. It would be funny if it wasn’t actually used on children.

How was the “Lupron protocol” justified? First, let’s start with the idea that autism is caused by mercury. It isn’t, but this is the idea that Mr. Kennedy pushed so hard 20 years ago. Mercury intoxication is commonly treated by chelation, which is a way to remove mercury from the body. For years medical practitioners pushed chelation on autism parents (again, often at these autism parent conventions that Mr. Kennedy is known to speak at). Only chelation didn’t work. It didn’t work because autism isn’t mercury intoxication. But to people like the Geiers, the problem was that chelation wasn’t working, the problem was they needed a better way to chelate. They came up with the idea that testosterone was binding to mercury and keeping chelators from working. So, they postulated, remove the testosterone and one can remove the mercury and the kid will stop being autistic. Which brings us to chemical castration: remove or reduce testosterone in the body. Which brings us back to Lupron.

Seriously, it happened. And a father-son team named Geier led the charge.

In order to prescribe the Lupron, the Geier’s needed a diagnosis. Insurance companies aren’t going to allow people to prescribe Lupron for mercury intoxication (even ignoring the fact that the Geiers didn’t have evidence for mercury intoxication). So the Geier chose precocious puberty as the diagnosis. Diagnose a kid with precocious puberty and you can prescribe Lupron.

The Geiers got into trouble for this. In 2013 they were facing disciplinary action as noted by blogger Todd W. at Harpocrates Speaks (among many others). They were facingmedical license suspension. In multiple states. So, you’d think people might be questioning the Geiers’ “protocol”. Perhaps checking the “science” that supported it? Well, not in Mr. Kennedy’s circles, apparently.

A few days after Todd W. wrote his article, two things happened. The Geier’s spoke at a parent convention called AutismOne. And Robert Kennedy was the keynote speaker for that convention.

Think about it. Mr. Kennedy could have told the parents at that convention that he stands apart from the Geiers. He could have just said perhaps people should be cautious, a relatively weak stance. Mr. Kennedy could have taken a stronger stance said that what the Geiers were doing was chemical castration and it was wrong, a much stronger stance.

To my knowledge Mr. Kennedy did not speak out then against the Geiers or any other practitioner of fake autism cures. I have no knowledge of him ever speaking out against charlatans.

It would have taken courage to speak out. It would have taken courage to admit to himself that he’d missed the obviously bogus science before, and that he, a self-professed science expert, was wrong. And it would have made a difference. I don’t consider it hyperbolic to say that I consider chemical castration of disabled (or any) children to be abusive. And Mr. Kennedy could have slowed or even stopped this practice long before Dr. Geier lost his license. He was respected and a frequent speaker at these conventions.

It takes courage to face allies (the Geiers were long known for pushing the mercury-autism link. Mr. Kennedy cites them multiple times in his books) and say they are doing wrong. Mr. Kennedy didn’t even have to admit that the mercury-causes-autism idea was false (which would have taken another step of courage and would have been the right thing to do). Just that chemically castrating disabled children is wrong.

Seriously, how hard is it to say, “Chemically castrating disabled children is wrong”, Mr. Kennedy?

Mr. Kennedy has spoken regularly at the “vaccines-cause-autism” parent conventions. And the Geiers were not the only ones pushing abusive therapies. It would have taken courage to say, “I will not speak and lend my name to a meeting where fake therapies are promoted.” But Mr. Kennedy lacks that courage.

This is largely due, I believe, to the fact that Mr. Kennedy lacks to courage to analyze his own lack of scientific expertise. My belief is that Mr. Kennedy, to this day, doesn’t understand just how bogus the “Lupron protocol” was. But it would take a courage for someone who has branded himself as a person who understands science (even though he lacks any credentials) to say, “You know what, I didn’t catch on to the idea that the science the Geiers were claiming was unsound.”

One might ask, was the Geier science obviously bogus? I would say yes and I would say that someone with the expertise Mr. Kennedy claims to have should have easily seen there was a problem very early on. Let me explain. The Geiers claimed that mercury and testosterone form “sheets”, large complexes, in the brains of autistic children. Sounds very scientific and all, until we found that the study the Geier’s were basing this idea upon involved boiling mercury and testoterone in benzine.

In my opinion, Mr. Kennedy should have known that a child’s brain is not similar to boiling benzine. Yes, this sounds snarky, but it really is that simple. The science behind the Geier’s “Lupron protocol” was really that bad.

But this discussion risks getting back into the realm of “He’s anti-science”. I bring this up not to point out Mr. Kennedy’s lack of science chops, but to point out that the science was so bad that it didn’t really take much analysis to see it.

That is if one has the courage to question. To question one’s allies. To question one’s own expertise. To question whether one’s own inaction led to the abuse of disabled children. And, again, in my opinion this was abuse. And Mr. Kennedy could have helped stop it sooner.

Again, I only picked one example. And this discussion has gone long, so you can understand why I chose only one example. But there are many examples of fake cures promoted at autism-parent conventions that Mr. Kennedy could have stopped. There’s also a lengthy discussion we could have about the stigma the anti-vaccine movement has brought to autistic people (one of Mr. Kennedy’s allies tried to label autism as “mad child disease“, to give you one example.) Mr. Kennedy could have spoken out agains the stigmatizing language. But the fear of autism and autistic people has long been a mainstay of the anti-vaccine movement.

We need a president with courage. While others discuss his anti-vaccine views, his near self-delusional belief in his scientific acument, let me just say this again: Mr. Kennedy lacks courage.

Robert F. Kennedy Jr. is gutless.

_____

By Matt Carey

More discussions
This blog on Mr. Kennedy.
Articles on this blog about the Geiers.
Articles on this blog about Lupron.
Mark Geier’s Wikipedia Page.


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Cochrane review: no clinical trial evidence was found to suggest that pharmaceutical chelation is an effective intervention for ASD

10 Sep

Chelation was never used by the majority of parents on their autistic kids. And that is a good thing. Chelation use is way down in the autism communities, but it hasn’t gone away. Many of those who use chelation are also vaccine antagonistic, and many of those rely upon the Chochrane reviews to support their vaccine-antagonistic arguments (generally by cherry picking and misrepresenting the Chochrane reviews). So, I was intrigued when I saw this abstract come up recently: Chelation for autism spectrum disorder (ASD).

A Chochrane team looked at the evidence for chelation and found that there is none.

A while back there was a plan for a chelation trial at the National Institutes of Health. It was cancelled when animal studies found a drop in cognitive scores when chelation was used without heavy metal intoxication. Which is to say, if you chelate someone needlessly, you could be shaving off IQ points. And since there is no evidence that autism is a form of heavy metal intoxication, chelation may actually have been harming already disabled kids.

I bring this up because the Chochrane review mentions a possible clinical trial in their last abstract sentence: “Before further trials are conducted, evidence that supports a causal link between heavy metals and autism and methods that ensure the safety of participants are needed.”

Yeah, I know that teams of people with MBA’s and other non-related degrees will tell you that there is evidence. As will doctors who sell chelation. Or recommend it (Hello, Dr. Bob Sears, I’m talking to you and your community of non-autism docs). They are wrong. And potentially harming autistic children.

Here is the abstract

Abstract
BACKGROUND:
It has been suggested that the severity of autism spectrum disorder (ASD) symptoms is positively correlated with the level of circulating or stored toxic metals, and that excretion of these heavy metals, brought about by the use of pharmaceutical chelating agents, results in improved symptoms.
OBJECTIVES:
To assess the potential benefits and adverse effects of pharmaceutical chelating agents (referred to as chelation therapy throughout this review) for autism spectrum disorder (ASD) symptoms.
SEARCH METHODS:
We searched the following databases on 6 November 2014: CENTRAL, Ovid MEDLINE, Ovid MEDLINE In-Process, Embase,PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and 15 other databases, including three trials registers. In addition we checked references lists and contacted experts.
SELECTION CRITERIA:
All randomised controlled trials of pharmaceutical chelating agents compared with placebo in individuals with ASD.
DATA COLLECTION AND ANALYSIS:
Two review authors independently selected studies, assessed them for risk of bias and extracted relevant data. We did not conduct a meta-analysis, as only one study was included.
MAIN RESULTS:
We excluded nine studies because they were non-randomised trials or were withdrawn before enrolment.We included one study, which was conducted in two phases. During the first phase of the study, 77 children with ASD were randomly assigned to receive seven days of glutathione lotion or placebo lotion, followed by three days of oral dimercaptosuccinic acid (DMSA). Forty-nine children who were found to be high excreters of heavy metals during phase one continued on to phase two to receive three days of oral DMSA or placebo followed by 11 days off, with the cycle repeated up to six times. The second phase thus assessed the effectiveness of multiple doses of oral DMSA compared with placebo in children who were high excreters of heavy metals and who received a three-day course of oral DMSA. Overall, no evidence suggests that multiple rounds of oral DMSA had an effect on ASD symptoms.
AUTHORS’ CONCLUSIONS:
This review included data from only one study, which had methodological limitations. As such, no clinical trial evidence was found to suggest that pharmaceutical chelation is an effective intervention for ASD. Given prior reports of serious adverse events, such as hypocalcaemia, renal impairment and reported death, the risks of using chelation for ASD currently outweigh proven benefits. Before further trials are conducted, evidence that supports a causal link between heavy metals and autism and methods that ensure the safety of participants are needed.

—
By Matt Carey

Jim Carrey, you are part of the problem for us in the Autism Community

15 Jul

Years back Jim Carrey was and autism were mentioned together regularly in the news.  This was at the height of the vaccine misinformation campaign of his then partner, Jenny McCarthy.  Mr. Carrey went so far as to be a speaker at the “Green Our Vaccines” rally in Washington.  That was 2008. Since then the Green Our Vaccines as a movement has died, Jenny McCarthy has tried to distance herself from her very vocal stance on vaccines, and given that Mr. Carrey and Ms. McCarthy split, it seemed like we had seen the last of Mr. Carrey.

Until recently.

You see Mr. Carrey took offense to new legislation in California.  A bill that will roll back vaccine exemptions to where personal belief exemptions will no longer be accepted in the schools here.  In other words, for the most part one will now need an actual medical reason to avoid vaccination in order to register for public school.

Mr. Carrey took to twitter with his complaints about the new law.  All well and good, free speech and all.  But Mr. Carrey went too far. He decided to take pictures of kids in distress and the implication that this is what happens when you vaccinate your kids. One tweet read ““A trillion dollars buys a lot of expert opinions. Will it buy you? TOXIN FREE VACCINES, A REASONABLE REQUEST!”” and included a picture of an autistic kid (the other pictures he used appear to have been stock images). The story is discussed by Emily Willingham as Jim Carrey Unwittingly Brings Attention To Something Actually Linked To Autism

And Time Magazine in Jim Carrey Apologizes for Using Photo of Autistic Boy in Anti-Vaccination Tweet.

Because, to give him credit, Mr. Carrey did apologize to that family. (Ironically, it turns out that the kid was unvaccinated when he was first diagnosed autistic).

I harken back to Mr. Carrey’s time with the autism community (remember when Generation Rescue was tagged as “Jenny McCarthy and Jim Carrey’s Autism Organization”?). At one speech, probably the Green Our Vaccines Rally, Mr. Carrey made the pseduo-profound statement, “We are not the problem. The problem is the problem.”

So while I do appreciate Mr. Carrey stepping up and apologizing to one family, I do want to point out: Mr. Carrey, you were one of the problems for the autism community. And you apparently still are.

Ms. McCarthy introduced you to a closed group of people, a small sampling of the autism community. You likely came away thinking that they *are* the autism community, because that’s how they think of themselves.

They aren’t.

Most of us autism parents don’t subscribe to the vaccine causation idea. I can provide the links to multiple studies if you like, but it’s just the way things are.

And autism parents are not the autism community. One thing that Generation Rescue and like organizations have done is act like autistics are some sort of second class citizens in the community. Who do you think the community primarily is, autistics or parents?

Here’s the thing: the vaccine-causation idea is probably the most damaging notion to have hit the autism community. Did you hear about the “refrigerator mother” theory during your time at Generation Rescue? It’s second to the vaccine causation theory. Telling generations of disabled kids that they are less than they are, that they should be someone else, is damaging. Mr. Carrey, did you attend any of those parent conventions, like AutismOne? Perhaps you look at alternative medicine favorably. Well, the vaccine causation idea is used to sell “therapies” that aren’t close to being “alternative”. They are just wrong. And, frankly, abusive. Chemical castration of disabled children? This was promoted multiple times at conventions where your former partner was a keynote speaker. Fake diagnoses of mercury poisoning, followed by chelation? Same. And even a major promoter of chelation has a new study showing it doesn’t work. Did anyone tell you why the NIH autism/chelation trial was stopped? Because if you chelate test animals who do not have mercury intoxication, they go down cognitively. If the same happens in humans, tens of thousands of autistic children lost some IQ due to chelation. Think that one over, since GR started out as primarily an org promoting chelation. Daily bleach drinks and bleach enemas? That one is probably new since you dropped out. But, yep, that gets sold as a cure for “vaccine injury”. Shall I go on? Because I can. The autism=vaccine injury idea sells junk medicine which is subjected upon disabled children.

And you added your voice to the vaccine-causation idea.

You’ve apologized to one family. That took guts. Now step up and start making amends to the rest of us. Parents and, especially, autistics.

—
By Matt Carey

Unethical DAN doctor to be supervised by acupuncturist

31 Dec

An Illinois doctor who subjects autistic children to “unwarranted, dangerous therapies” must have her work reviewed by an acupuncturist. The state medical board also fined Dr. Anju Usman $10,000, ordered her to take additional medical education classes, and placed her on probation for at least one year, as part of her plea agreement with state regulators.

The acupuncturist, Dr. Robert Charles Dumont, is a pediatrician, and a member of the faculty of the Integrative Medicine Department of Northwestern University School of Medicine. According to the consent decree, Usman “shall submit ten active patient charts on a quarterly basis” to Dumont. When asked if Usman is allowed to select which charts will be reviewed, a medical board spokesperson referred the reporter to the language in the consent decree.

Usman suggested to regulators the doctor who will be reviewing her charts, according to Usman’s attorney.

drusman

Usman is director of True Health Medical Center in Naperville, Illinois and owner of Pure Compounding Pharmacy. She a is regular presenter at Autism One, an annual gathering of vendors, providers, quasi-researchers and desperate parents.

The Illinois Department of Financial and Professional Regulation says Usman provided “medically unwarranted treatment that may potentially result in permanent disabling injuries” to a boy that Usman started seeing in the spring of 2002, when the child was not quite two years old. Records indicate Usman diagnosed the boy with a calcium-to-zinc imbalance, yeast, “dysbiosis”, low zinc, heavy metal toxicity, and abnormally high levels of aluminum, antimony, arsenic, cadmium, copper, lead, nickel, silver, tin, titanium and selenium. Usman prescribed chelation, a hormone modulator, and hyperbaric oxygen therapy, which regulators describe as an “extreme departure from rational medical judgment.”

The complaint against Usman was filed by the boy’s father in 2009. A year later, he sued Usman and Dr. Daniel Rossignol of Melbourne, Fla. for harming the child with “dangerous and unnecessary experimental treatments.” A Chicago-area lab, Doctor’s Data, was also sued. The plaintiff voluntarily dismissed the suit in 2014, but will reportedly reinstate it in 2015 or later.

Usman was the subject of a 2009 Chicago Tribune investigation into questionable medical practices aimed at treating autism. The article noted that Usman and Rossignol “are stars of Defeat Autism Now!, having trained thousands of clinicians…  They are listed on the group’s online clinician registry, a first stop for many parents of children with autism seeking alternative treatment.”

Usman’s name is also connected to the 2005 death of Tariq Nadama, a five-year-old boy who died at the hands of Dr. Roy Kerry. Usman diagnosed the boy with high aluminum levels, then referred him to Kerry, an ear-nose-throat specialist in Pennsylvania. Kerry treated the child for lead poisoning, even though his blood lead levels were below that which indicates the need for chelation.

—

Cross posted from Autism News Beat

Is Boyd Haley resurrecting OSR#1 as a chelator?

22 Jul

Boyd Haley was a professor of chemistry who was very active in the failed thimerosal-causes-autism movement. He earned extra notoriety for trying to coin the phrase “mad child disease” (yes, a variation of mad cow disease) for autistic children. He also found notoriety for marketing a synthetic chemical as a “nutritional supplement”, calling it OSR#1. Prof. Haley is certainly persistent. He’s working on a clinical trial.

How did this come to pass? Well, one of the professors in Prof. Haley’s department found that a certain compound could effectively treat mining waste, removing mercury. Given his own interests, Mr. Haley started a company with an investor with the intent to bring this chelator to the public. The chelators used in medicine today were developed for lead and have been expanded to also treat mercury. I.e. there is no mercury specific chelator and this new compound would fill that gap.

All well and good, but in his zeal to bring this product to market, Prof. Haley cut a few corners. Chelators are drugs. The compound he was working on was synthetic. But Prof. Haley chose to rush the product to market as a “nutritional supplement”. Instead of calling it a chelator, he called it OSR#1. OSR standing for “oxidative stress relief”. Mr. Haley skipped the process to prove that his drug was safe and effective. Supplements have a much lower standard for safety and efficacy testing.

The FDA was not fooled. Mr. Haley and his company were given a warning letter which pointed out that the compound is not a supplement, it is a drug:

Your firm markets OSR#l as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the Act, 21 U.S.C. § 321(ff). To be a dietary supplement, a product must, among other things, “bear[ ] or contain[ ] one or more … dietary ingredients” as defined in section 201(ff)(1) of the Act, 21 U.S.C.§ 321(ff)(1). Section 201 (ff)(1) of the Act defines “dietary ingredient” as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. The only substance listed as a dietary ingredient on the labeling of OSR#1 is N1,N3-bis(2-mercaptoethyl)isophthalamide. N1,N3-bis(2mercaptoethyl) isophthalamide is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, N1,N3-bis(2-mercaptoethyl)isophthalamide is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. Thus, because OSR#1 does not bear or contain a dietary ingredient as defined in section 201(ff)(1) of the Act, this product does not qualify as a dietary supplement under section 201(ff) of the Act.

Also that the company was making claims that the drug could treat medical conditions and that the labeling was misleading in this regard. Further, that the toxicity was not adequately tested nor reported.

Your website states that” [s]ome reports of temporary diarrhea, constipation, minor headaches have been reported but these are rare and the actual causes are unknown,” as well as “OSR#1 is without detectable toxicity” and “OSR#1® … has not exhibited any detectable toxic effects even at exceptionally high exposure levels.” However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. Based on these animal studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, we believe the use of your product has the potential to cause side effects, and the before-mentioned website statements falsely assert that the product does not have the potential to cause side effects. Therefore, these statements render your product’s labeling false or misleading. As such, OSR#1 is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a).

That was in 2010. Prof. Haley and his company are now back, trying to get a clinical trial started on their compound. Essentially, they are trying to do what they should have done in the first place: get proper approval for a drug. An article in Chemical & Engineering News discusses this effort. Actually, it’s part of the cover story, “Building Pharma Molecules”

buildingpharma

The story on Mr. Haley’s Company, CTI Science, has contracted with another company, PCI Synthesis, to manufacture the new compound.

haley2

The article is, well, a bit of a sales pitch and gets a few facts wrong. There’s a bit of spin on the FDA warning letter, for example:

“The effort to develop the compound as a mercury poisoning therapy accelerated in 2010 when the company received notification from FDA that it couldn’t market NBMI as a nutritional supplement until it underwent the full drug approval process”.

As we’ve just seen above, the compound is not a nutritional supplement at all. It needs the drug approval process because it is a drug.

The CEO of PCI is quoted as stating:

“The main starting material is cysteamine hydrochloride, which is basically an amino acid and found naturally. So it has attributes that could qualify it as a natural product.”

Which was part of the sales pitch for the OSR#1 in the old days and, again, the FDA disagreed. Just because something is synthesized from a natural product, that doesn’t make it a natural product. Otherwise there would be no synthetic products at all. Everything at some level comes from a natural product.

The article discusses how to qualify for a clinical trial the product must meet current Good Manufacturing Practices (cGMP). The article states:

The primary challenge was the removal of impurities to a level that meets cGMP standards

Think about that a moment. Apparently OSR#1 was sold with more impurities than would meet this standard–a standard for food and dietary supplements.

The article notes that, yes, this compound was sold as a product at one time

Sales to date: $1.5 million, as a nutritional supplement

$1.5M in sales. And the only reason it wasn’t higher was because the FDA stepped in. It was only out for about a year, as I recall.

I found this statement interesting, from the Wikipedia page for the compound:

In animal experiments, the amount of mercury in brain tissue was not increased, but also not decreased

So, even if you believe in the failed mercury hypothesis. What exactly were you supposed to get from this compound? I somehow doubt that even the strong believers in the mercury hypothesis think that removing mercury from, say, your liver will cure autism.

It does seem that Mr. Haley and his company are doing some of the right things now. Show that this drug is safe and effective for its intended purpose: chelation. There are some problematical statements that they may market this not as a drug but as a nutritional supplement, which is a non-starter.

—
By Matt Carey

Looking back at two decades of Geier

20 Oct

In the past Mark and (to a lesser extent) his son David Geier were frequently being discussed online. It struck me that given how far back the Geier saga goes, many may not be aware of the myriad stories of the Geiers. How often and from how many angles the news has come about just how bad the Geier legacy is. They’ve been involved in the vaccine court (and from the outset–1993–showing “intellectual dishonesty“), publishing questionable research and running a clinic whose special “therapy” is so clearly wrong.

I went back to an article I wrote in 2007 where a Special Master (the judge in the “vaccine court”) wrote that the Geiers’ work was of such poor quality that the court would no longer pay for them to act as experts. I was going to just re-run that article (and it is copied in full below) when I thought it worthwhile to list some of the more notable actions of the Geier team.

The best writing on the Geiers was done by Kathleen Seidel of Neurodiversity.com (some of the best investigative reporting ever). Unfortunately a server crash took down the site, but one can find the articles on the Wayback Machine (archive.org).

Just a few specific examples:

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

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

A Silent Withdrawal (details behind the withdrawal of a Geier paper).

The withdrawal followed and was likely caused by Ms. Seidel’s investigations, laid out in this letter to the Journal (autoimmunity reviews) in which she noted (among other facts) that the Geiers actions were questionable from an ethics standpoint. In specific, in regard the their IRB (Institutional Review Board) approval for their study:

The Office of Human Research Protection registration of the IRB of the “Institute for Chronic Illnesses” was submitted by Mark Geier in February 2006 — fifteen months after the commencement of the research the Geiers describe in this article, which began in November 2004, the same month in which Dr. Geier testified in court that he had no prior experience in the diagnosis or treatment of autistic children. (13,14) The seven-member IRB consists of Mark and David Geier; Dr. Geier’s wife; two of Dr. Geier’s business associates; and two mothers of autistic children, one of whom has publicly acknowledged that her son is a patient/subject of Dr. Geier, and the other of whom is plaintiff in three pending vaccine-injury claims. The membership of the IRB gives rise to misgivings about the independence of ethical review of Dr. and Mr. Geiers’ research. Every member has discernible conflicts of interest, and none has any discernible expertise in endocrinology — expertise crucial to the competent oversight and conduct of research involving pharmaceutical manipulation of children’s hormones.

Yes, they got “approval” from themselves after they did the research. Just astonishingly bad. Completely circumventing the entire purpose of an IRB.

There’s so much more good work at Neurodiversity.com. But let me switch to articles here at Left Brain/Right Brain:

David Geier ordered to pay $10,000 for practicing medicine without a license

Is Mark Geier finished as an expert witness in the vaccine court? A quote from this vaccine court decision:

I will not likely be inclined to compensate attorneys in any future opinions for consultant work performed by Mark Geier after the publication date of this opinion.

Note that the question is whether to pay Mark Geier as a consultant. This was in 2011, after it was established that he was not an expert and would not be compensated for work as an expert. This didn’t stop attorneys tried to keep him on the payroll as a “consultant”.

How about the Geier theory behind using Lupron to shut down hormone production in autistic kids? It started as a way to enhance chelation. Chelation is without merit in autism treatment to begin with, but the Geiers took it a step further. One of their collaborators, and apparently the parent of one of the first kids to be subjected to the “Lupron Protocol” quoted David Geier as saying, “We figured something new out…..we think we can get rid of the mercury by lowering the testosterone”. The “science” behind the “Lupron Protocol” AutismOne throws their support behind the Geiers in Autism Science Digest is ridiculous. Even the Geiers shifted away from their original theory, leaving out the mercury angle: The Geier Story on Testosterone Shifts Again.

In their research, the Geiers cite Simon Baron-Cohen, whose has worked on the idea that exposure to testosterone in-utero could be a cause of autism. Baron-Cohen’s work had no scientific relevance to the Geier work. But, thankfully, Baron-Cohen was quoted in a news article about the Geiers:

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.

Mark Geier lost his medical licenses. Yes, licenses plural. Lost in many states. He had franchised his Lupron work out. It took a cease and desist order issued to make him really stop practicing medicine.

Criticism of Mark Geier’s “expertise” was not limited to the “vaccine court”. In Boyd Haley and Mark Geier: Experts? we see how he failed to meet the standards of an expert in a civil court.

The Geiers’ have done well, financially. Charging over $50k/year, plus over $10k in tests, could do that. Here’s their home in Florida (The Geiers’ Second Home)

As part of the action to strip Mark Geier of his medical license: Maryland Board of Phyicians: Mark Geier “endangers autistic children and exploits their parents”

In Crist backer Gary Kompothecras bullies Florida health officials, we learned that political pressure was being brought to bear to give the Geiers access to Florida’s health records to perform a study.

The Geiers requested over $100,000 for work on the Hepatitis B Omnibus, including multiple trips to Europe. (almost $24k for one trip alone). Much of the request had no documentation (bills, airline tickets, etc.)

Quotes from the special master in the decision in that case:

I found that the articles authored by Dr. Geier unpersuasive and not scientifically sound, based on my prior reading of the articles and critiques of them. I am also aware that Dr. Geier is trained as a geneticist and obstetrician, not an immunologist, epidemiologist, or rheumatologist, and that my fellow special masters and several other judges have opined unfavorably on his qualifications and testimony as an expert.

and, in regards to David Geier (who holds no advanced degrees):

“In summary, the undersigned finds the costs for David Geier’s efforts to be obviously unreasonable as Mr. Geier is not qualified to address the medical issues involved in the Program and his work was duplicative of the efforts by Dr. Geier. Thus, the undersigned denies the request for costs for David Geier in its entirety.”

The egregious billing activities of the Geiers amount to treating the vaccine program as their personal piggy bank, in my opinion.

In the courts, in their research and in their clinics, the Geiers have time and again shown behavior which is just reprehensible.

Below is the article I wrote in 2007 which prompted this summary: For your own good, don’t use that study!.

____________________________________________

I just read something interesting on the web.  Someone was telling a petitioner in a Vaccine Court trial that she would have a better chance of winning if her expert witness didn’t use a research report by the Geiers.

Was this a blog?  Was this a yahoo group?  Nope, this was a decision on the Vaccine Court’s website.  This was the opinion of Special Master Vowell.

If that name sounds familiar, it’s because she is one of the three Special Masters working on the Autism Omnibus Proceedings.  What exactly did she say?

“I suggested that, in view of the criticisms leveled at Dr. Geier and his research, petitioner would be better served if her expert could opine favorably at the hearing without relying on the cited articles. “

and

“In attempting to assist this petitioner in presenting the strongest possible case for vaccine causation of her illness, I urged her counsel to caution her expert against relying on the Geier articles he cited.”

Ouch.

In case you were wondering, I wasn’t just reading the Vaccine Court decisions for fun.   I was prompted by something that Mark Geier said on NightLine.  Dr. Geier made a comment about “Wining” in vaccine court.

This struck me as a very odd statement.  Petitioners (plaintiffs) win.  Lawyers win.  Expert witnesses?  They can help someone win, but I don’t see them as “winning”.  Besides, there was something in the way he said it.  Something like when a kid says, “of course I did my homework” and you know you have to go check.  So, check I did.

I looked through the published and unpublished decisions and searched for “Geier” in each.  These go back to 1997 for published decisions.   “Decisions” include actual cases as well as pre- and post-trial actions.  The one quoted above is a good example of “pretrial”.  Post-trial Decisions are often about whether everyone should get paid what they billed.  Or, at least, this seems to be the case in more recent times.

Not all Decisions are trials.  Keep in mind, a single trial could have multiple Decisions.  I haven’t tried to group them together by case, I just made a list of all of the ones I could find involving Dr. Mark Geier.

With all that out of the way, what did I find?  There are 31 Decisions posted that involve Dr. Geier.  Of those, three are cases “won” where Dr. Geier was involved.  A further 3 may be considered “mixed” or “neutral”.  Figure that in 80% of the cases, the Petitioner and/or Dr. Geier loses.  I consider that a generous take.  It really is more like 90%.

Let’s look at those “winners”.

1999: The petitioner won the case.  “The court’s decision in this case is not based on Dr. Geier’s testimony, but neither will the court discard his testimony as unreliable.”  Not the most ringing endorsement.

2000: The petitioner won the case.  Dr. Geier submitted an affadavit which was used to “buttress” the case made by the expert witness who actually testified.

2006: Discussion of fees where Dr. Geier’s fees and use is found to be reasonable. ” In the instant case, $1562.50 in expert witness fees for Dr. Mark Geier’s services is reasonable.”

Yes, in the last 10 years, those are the “good ones”.   Not impressive.

I have seen people post that somehow the Special Masters are trying to discredit Dr. Geier because he is so effective.  People seem to imply that his recent stances on mercury and autism caused the Government to try to neutralize Dr. Geier. 

With that in mind I looked to see if the tone of the rejections has changed with time.  I didn’t really see that.  Keep in mind that some of the well known comments about Dr. Geier predate all these decisions.  For example, he was called “intellectually dishonest” way back in 1993!

Here is a sampling of quotes from other decisions through the past 10 years:

1997: Dr. Geier’s opinion, which is in an area outside his expertise, was not persuasive to the court.

1998: The court is unpersuaded by the opinions of Drs. Kinsbourne and Geier.

1999: This conclusion itself effectively renders the rest of Dr. Geier’s theory useless to petitioner in this case.

2002: “First of all, Dr. Geier is wholly unqualified to testify concerning the two major issues in this case”

2003: “Intellectual rigor is missing from Dr. Tornatore’s testimony and the stealth witness Dr. Geier’s submission after trial. ”

2004: “He is however a professional witness in areas for which he has no training, expertise, and experience”

2005: “The Special Master also noted that Dr. Geier’s opinions have been increasingly criticized in other vaccine cases. See Decision at 5. The Special Master identified seven cases in which Special Masters had rejected the expert opinion offered by Dr. Geier because the opinion related to areas outside Dr. Geier’s areas of education, training and experience.”

2006: This was a question of charges.  Dr. Geier charged $29,350.  In the end, they found $8,520 was reasonable.  It was  found that he was (1) not qualified as an expert, (2) charging for work on his own publications and (3) charging for time spent working in a related civil case.

“Since Dr. Geier did not possess the necessary expertise to testify in this case, the Court will reduce his hourly rate from $250.00/hour to $200.00/hour. Petitioner will not be compensated for costs that can be directly attributed to Dr. Geier’s original publications, attorney/lawyer consultations, and physician consultations. Additionally, the work billed for petitioner’s civil cases is not compensable.”

2007: Again Dr. Geier’s payment is cut. 

“For the reasons stated above, the undersigned finds 13.5 hours to be excessive. Dr. Geier  will be compensated for only those hours that are reasonable. Based on the undersigned’s experience with the Vaccine Program, Dr. Geier will be awarded compensation for five hours of  his time which is a reasonable, indeed generous, number of hours for a literature search and review of articles. ”

Again, that is just a sampling,  No attempt was made to be random.  The tone has been increasing against Dr. Geier, though.  As noted in 2005, “The Special Master also noted that Dr. Geier’s opinions have been increasingly criticized in other vaccine cases”.  So it is increasing.  But that is only increasing by going from Bad to Worse. 

You are welcome to go through the decisions and see if I have been quote mining.  One thing you will see is the possible reason why the Special Master has started warning petitioners to avoid Dr. Geier’s studies.  There are statements to the effect of, “If I had known Dr. Geier was useless as an expert witness, I would have hired someone else”.

Sounds like good advice. 

Mark Blaxill on the Geiers: they do sloppy work

13 Oct

Mark Geier and, more recently, his son David have been active promoting autism as vaccine injury for over 10 years (Mark Geier has been active as an expert in, and been criticized for his lack of quality work, the vaccine court on non-autism issues for about 20 years). They have written multiple papers, ranging from bad to worse, attempting to argue the case that vaccines (and especially thimerosal) are a primary cause of autism.

There are multiple discussions over the years of the Geiers here on Left Brain/Right Brain, Respectful Insolence as well as many other places. The best work was done by Kathleen Seidel at Neurodiversity.com, but due to a server crash much of that content is not readily available. (although it is worth searching for the cached versions or the versions on the Wayback Machine).

The work of the Geiers is so poor that it has always been a wonder to me that no criticism has come from anyone promoting the idea that vaccines caused an epidemic of autism. It isn’t that those promoting the vaccine-epidemic idea are not bright, leaving me wondering if they are too biased by their beliefs or just unwilling to speak publicly against an ally. But, recall, these are the same people who closed ranks around Andrew Wakefield in the face of clear and proved ethical violations.

If we are to believe Jake Crosby, former writer for the Age of Autism blog, it appears that the tacit approval of the Geiers has, at least in part, been a case of “circle the wagons”. I.e. people defending an ally over speak their opinions. Mr. Crosby has blaxillwilliams and quotes more emails where Mark Blaxill (former board member of SafeMinds and a long-time proponent of the idea that mercury in vaccines are a primary cause of autism) expresses his views about the Geiers to Mike Williams (attorney involved representing the families in the Omnibus Autism Proceeding).

In an email image on Mr. Crosby’s blog, Mr. Blaxill is reported to have stated:

In the interest of full disclosure. I thought you might like to see my critique of the Geiers’ latest work on VSD. I have not been a big fan of the Geiers. I worry they do not represent our side well. They do sloppy work.

In another email (quoted by Mr. Crosby, the link to the original is nonfunctioning) quotes Mr. Blaxill as stating:

“As to the Geiers, I may be a bit of a minority voice here, but I worry very much that they can do our cause more harm than good. They are not very good scientists, write bad papers (both writing badly and reporting in sloppy fashion) and attract too much attention to themselves as individuals. In this last regard, they don’t show nearly as well as Andy Wakefield but they’re trying to play the same role. Frankly, if I were on the other side and were asked to critique their work, I could rip it to shreds. I’m surprised they haven’t been hit harder. So I think you are wise to diversify.”

Mr. Crosby’s stance is that this constitutes “interference” in the Omnibus Autism Proceeding. I.e. Mr. Crosby seems to imply that the Geiers are not sloppy scientists whose work is poor, but that the Geiers should have been allowed a more active role in the Omnibus.

In this case I find myself agreeing, in part at least, with Mr. Blaxill. The work by the Geiers is poor. Where I don’t agree is Mr. Blaxill’s decision to hold back on making those statement public. Not just because it’s hard to take the stance that one is a only “…interested in the quest for the truth” when one holds back on key information like an entire critique of the Geiers’ VSD paper. No. It goes deeper than that. The Geiers’ junk science went beyond promotion of the idea that thimerosal is a primary cause of autism. The Geiers ran a clinic for many years. Mark Geier was a licensed physician, David Geier worked in the clinic (and has been accused of practicing medicine without a license). Through their papers and their talks at autism parent conventions like AutismOne, the Geiers became well known. One of the “brand name” autism clinics. They reached this level of respect within their community because no one within that community dared to speak out.

I’ve noted on Left Brain/Right Brain many times before that these parent conventions differ markedly from real science conferences in that no one ever seriously challenges the speakers. They can present almost any theory or idea, especially if they tie it to autism as vaccine injury, without anyone standing up and saying, “that makes zero sense”. These aren’t science presentations, they are advertisements. It would be interesting to see how many of these conventions Mr. Blaxill attended and yet remained silent on the “sloppy” work that could be “ripp[ed] to shreds” that the Geiers presented. Instead, parents were presented a view that the Geiers were good scientists who suffered unjust criticism for their “brave” stance on vaccines.

The Geiers were promoters of chelation as a treatment for autism. Not only does chelation have no scientific basis to be an autism treatment, a study just out this week using rodents states that chelation could be harmful if there is no real heavy metal toxicity:

Finally, we also found that succimer treatment produced lasting adverse neurobehavioral effects when administered to non-lead-exposed rodents, highlighting the potential risks of administering succimer or other metal-chelating agents to children who do not have elevated tissue lead levels. It is of significant concern that this type of therapy has been advocated for treating autism.

It is highly likely that Mr. Blaxill would disagree with the statement that chelation has no good scientific basis as a treatment for autism. He’d be wrong, but that’s been covered over and over before. The Geiers moved on from standard chelation to stranger, more dangerous therapies. As an aside, if chelation was a successful treatment one has to wonder why the Geiers were prompted to move on to using Lupron as an autism treatment. Lupron is very serious medicine and it shuts down sex hormone production in the body. Why Lupron, one might ask? The Geiers convinced themselves (or convinced themselves that they could pass off this explanation) that mercury bound itself to testosterone in the brain, making it hard to chelate. They cited a paper showing that if one heats testosterone and mercury salts in benzene, one could form these mercury/testosterone complexes. They actually claim (yes, they tried to patent this idea to make money off it) that this paper shows that “It is known in the art that mercuric chloride binds arid forms a complex with testosterone in subjects”. The “subjects” are beakers of benzene, not animals and not people. Add to that the lack of an explanation of how shutting down hormone production would break up these complexes. The Geier “science” supporting Lupron would be laughably bad if it wasn’t used to subject disabled children to Lupron injections.

Lupron clearly has no basis as an autism therapy. In fact, the “lupron protocol” played a major part in Mark Geier losing his medical licenses. One has to ask, how did the get such traction for such an obviously bad idea? For one thing, the Geiers were considered respected scientists in the vaccine injury/alternative medicine autism community due to their previous and ongoing work trying to link thimerosal and autism. Work which Mark Blaxill considered “sloppy” and worthy of being ripped to shreds. But instead of sharing his views on the Geier papers with the public, Mr. Blaxill shared them privately within his own circle.

It’s worth noting that the email quoted above was written before the “Lupron Protocol” was developed. We don’t know if Mr. Blaxill was alarmed by the emergence of the “Lupron Protocol”. I can’t find where he spoke out against it. We can see that his blog (under a different writer) promoted the idea as “MERCURY, TESTOSTERONE AND AUTISM – A REALLY BIG IDEA!“. Mr. Blaxill doesn’t seem to have commented there. For all the papers the Geiers have published, Mr. Blaxill only mentions them once in his book “Age of Autism. But as we’ve seen, tacit approval (silence) may not be the same thing as real approval.

Mr. Blaxill had the courage to testify before a congressional hearing last year. A hearing where the politicians had been lobbied in advance to be favorable to his cause. When it came to disagreeing with one of his allies, that courage was lacking. He allowed “sloppy” science from an ally to go unchallenged. An example of the fallout of such a decision, in my opinion had he stood up he could have slowed or even stopped the “Lupron Protocol”, a therapy which in my opinion amounts to the abusive treatment of disabled children in an uncontrolled and unapproved experiment.

—
By Matt Carey

Complementary and alternative medicine use in a large pediatric autism sample

9 Nov

The journal Pediatrics has a large number of autism related articles in a recent supplement. One of these covers a topic discussed a great deal by parent groups online: alternative medical approaches to the treatment of autism. In Complementary and alternative medicine use in a large pediatric autism sample, James Perrin (this one of his five articles in the Supplement; Dr. Perrin is the president elect of the American Academy of Pediatrics) and his coauthors use the Autism Treatment Network (ATN) to review parent report of use of complementary and alternative medicine (CAM) in regards to autism.

The authors find that while CAM is used by a significant minority of parents, it is a minority: 28% (896 out of 3173). Special diets are the most common (548 respondents, 17%). Various methodologies are listed below:

Characteristic N
Any CAM 896
Special diets 548
Gluten-free diet 249
Casein-free diet 289
No processed sugars 69
No sugars or salicylates 28
Feingold diet 14
Other specified special diet 293
Other CAM 643
Other vitamin supplements 413
Probiotics 274
Essential fatty acids 171
Digestive enzymes 116
Higher dosing vitamin B6 and magnesium 99
Chiropractic 77
Amino acids 59
Antifungals 58
Glutathione 33
Chelation 19
Hyperbaric oxygen 12
Acupuncture 10
Sulfation 7
Other specified CAM 173

Some of the most talked about methodologies are rarely used. Chelation, for example, had only 19 respondents or 0.6%. Hyperbaric oxygen, 0.4%. Previously, chelation had been reported as being used by about 7% of families. If these studies are comparable, this would indicate that chelation has dropped from low to very low in use by parents.

CAM usage is higher among the wealthy, whites, those with children with autism vs PDD NOS or Asperger syndrome, and higher among those whose children have gastrointestinal complaints and/or seizures. The authors note:

As with other CAM use, it will help to determine more about the potential synergistic effects of CAM with medical treatments as well as ways that CAM use may interfere with improvement in medical conditions.

The full article is available free online including a discussion of limitations of the study. The abstract is copied below:

BACKGROUND AND OBJECTIVE Children and adolescents with autism spectrum disorder (ASD) often use complementary and alternative medicine (CAM), usually along with other medical care. This study aimed to determine associations of ASD diagnostic category, co-existing conditions, and use of medications with use of CAM.

METHODS We used the Autism Speaks Autism Treatment Network patient registry, which collects information on CAM use, medical conditions, and psychotropic medication at enrollment. CAM was categorized as special diets versus “other” CAM; ASD was defined as autism, pervasive developmental disorder (PDD), or Asperger’s. Gastrointestinal symptoms, seizure disorders, sleep problems, and medication use were determined from parent report. Child Behavior Checklist (CBCL) scores were used to measure behavioral symptoms. Logistic regression was used to determine associations of diagnostic category, other medical conditions, and medication use with CAM treatments, controlling for demographic characteristics.

RESULTS Of 3413 subjects in the registry as of April 2011, 3173 had complete data on CAM use: 896 (28%) reported any use; 548 (17%), special diets; and 643 (20%), other CAM. Higher rates of CAM use were associated with gastrointestinal symptoms (odds ratio [OR] = 1.88), seizures (OR = 1.58), and CBCL total score >70 (OR = 1.29). Children with PDD (OR = 0.62), Asperger’s (OR = 0.66), or using medications (0.69) had lower rates.

CONCLUSIONS Children with ASD use more CAM when they have co-existing gastrointestinal symptoms, seizure disorders, and behavior problems. This study suggests the importance of asking about CAM use in children with ASD, especially those with complex symptoms.

Adverse reaction data for alternative therapies for autism?

21 Sep

Edit–Note that ARI has changed their webpage language:

One factor of alternative medicine is that it is impossible to make an informed decision on risks and benefits. Without data on either, all one has is anecdotes. This is especially troublesome, to me at least, when it comes to risks. What are the adverse events associated with a given alternative medicine treatment? This became clear when an industrial chelator was offered as a “supplement” and the proprietor of that business was quoted as telling his clients to report adverse reactions to him, avoiding the FDA.

The Autism Research Institute (ARI) has promoted alternative therapies for autism for some time, even maintaining a list of therapies with survey results claiming high effectiveness. They also maintain a page on adverse reactions. But without any emphasis on informing people about adverse reactions to alternative therapies.

Here is a quote from that page:

Unfortunately, before the drugs are prescribed to their children, parents are not usually informed of the possible dangers related to the drugs. ARI urges all practitioners to inform their clients about the possible adverse effects associated with every treatment or medication that they recommend to their clients.

Many individuals on the spectrum suffer from seizures, and most of the drugs commonly prescribed to these individuals may lower the threshold for having seizures. We have also listed those drugs that are associated with seizures along with a link.

If your son/daughter experiences side effects from receiving prescribed medications, please contact the FDA at: http://www.fda.gov/medwatch or call 1.800.FDA.1088 (1.800.332.1088).

In addition, parents can learn more about possible side effects, as well as benefits, associated with various treatments by reviewing the results from our parent treatment survey. The survey findings are based on over 26,000 responses, and include a large number of biomedical interventions, including drugs, nutritional supplements, and diet.

One is given the information about how to report a reaction from “prescribed medications”, but not for alternative therapies or supplements. Or so they present it. The page they link to isn’t the direct reporting site. Instead, one must follow a link on that page to https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. There you are informed that you may “Click the BEGIN button to report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of:”

FDA-regulated drugs,
biologics (including human cells, tissues, and cellular and tissue-based products)
medical devices (including in vitro diagnostics)
special nutritional products and cosmetics

emphasis added.

So, the same site where ARI sends people to report “side effects from receiving prescribed medications” can be used (and should be used) to report side effects from alternative therapies which are not prescribed. But parents are not encouraged to make such reports. Which, again, limits the public’s ability to estimate the risks involved with these therapies.

On the ARI page are links to adverse reactions (both ARI’s own discussions as well as links to external sites which publish accepted adverse reaction information) for various therapies. Will you learn about the “occasionally severe” skin reactions that occur with the chelator DMSA? No. Deaths from IV chelation? No. Will you hear about the autistic child who was a test case for the Autism Omnibus Proceeding who appeared to have significant adverse reactions to chelation? No. No one in the public would have heard about that were it not for the Omnibus.

ARI makes a major distinction between “Drugs” and “Biomedical/Non-Drug/Supplements” as therapies. Is this a valid distinction? ARI lists “Transfer Factor” as one of their “BIOMEDICAL/NON-DRUG/SUPPLEMENTS”, claiming that autistics “got better” 5.9 times more often than they “got worse”. But no data on what adverse reactions there are. No links. “Transfer Factor” is not a drug to ARI. It is worth noting that it was a drug to Andrew Wakefield. He attempted to patent Transfer Factor as a therapy and as an alternative to the standard measles vaccine.

The question of whether alternative therapies are presented such that one can make an informed decision is an important one. Raising the question is generally guaranteed to garner the reaction: “he’s anti-cure”, or “he’s against treating autism” or the like. But clearly the argument here is simple: are people being given the ability to make an informed decision about alternative medical treatments used for autism? The answer is simple as well: no. They are not.

—
By Matt Carey

Suspension of Mark Geier is upheld

19 Apr

Mark Geier is a name well known in the autism world of alternative medicine as well as a major source of papers purporting to link autism to mercury. He had a medical practice, was licensed in multple states, presented repeatedly at autism parent alt-med conventions, and served as a witness for the vaccine court.

Mr. Geier’s license to practice medicine was suspended last year. Since then he has tried a few avenues to get his ability to practice reinstated, at least while he is pursuing appeals. The Maryland State Board of Physicians has denied his request and issued a (second) cease and desist order informing him to stop practicing medicine.

Mr. Geier and his son, David Geier, took a theory from Prof. Simon Baron-Cohen: the “extreme male brain” concept of autism. Where Prof. Baron-Cohen focused on the effects of fetal testosterone levels on brain development, the Geier team somehow arrived at the idea that autistics have mercury bound in to testosterone in their brains. One can read an analysis of this theory at A Photon in the Darkness, Miscellaneous Mercury Nonsense. As you can imagine from the title of that article, the autism/mercury/testosterone idea was an obviously bad idea from the start.

Unfortunately, the Geiers took this bad idea from theory to practice. They further hypothesized that these mercury/testosterone sheets prevented chelators from removing the mercury. So, they futher hypothesied, by reducing the amount of testosterone in the body, the mercury bound in these supposed mercury/testosterone sheets would be released allowing chelators to remove the mercury. Why lower levels of testosterone would lead to these supposed mercury/testosterone complexes breaking down is not well explained. Which is another way of saying it doesn’t make sense.

It is worth noting that these sheets, or matrices as the Geiers dubbed them, of mercury and testosterone do exist. In laboratories. After boiling mercury compounds in beakers of benzene. As Prometheus wrote back in 2006:

This is not a condition even remotely similar to anything found in living tissue – of any vertebrate species. In other words, it isn’t likely to happen in autistic children unless you dissolve them in hot benzene.

Basically every link in their logic chain was bad. But this did not stop the Geiers from applying Lupron as a treatment. The drugs for reducing testosterone production (such as Lupron) are expensive. Insurance doesn’t pay for Lupron to reduce testosterone levels in disabled children so that non-existent mercury/testosterone sheets will break down by some unexplained mechanism so that chelators can remove the mercury which is not really linked to autism. Probably because of the insurance angle, the Geier’s prescribed Lupron and similar drugs not for the supposed ability to help the chelating process, but to treat precocious puberty. Early onset of puberty.

According to the Maryland Board, based on records and testimony from patient’s parents, the Geiers failed to do the basic work involved in diagnosing precocious puberty and, in some cases, diagnosed precocious puberty in children who were old enough to be going through puberty.

Sound complicated? They were diagnosing precocious puberty without the proper tests in children who didn’t have it in order to prescribe drugs to reduce testosterone levels so that mercury/testosterone sheets which don’t exist in their brains will break down and allow a chelator to remove the mercury which doesn’t cause autism.

Lupron is not a mild drug. It reduces sex hormones and delays puberty. Children are supposed to go through puberty at a given time in their lives and delaying it comes at a cost. In addition the drug itself has side effects. From the recent decision upholding the suspension of Mr. Geier’s license:

Lupron treatment carries a very high risk of skin abscesses and infections, and it is contraindicated in patients with a history of seizures. Dr. Geier nevertheless prescribed it for Patient B, who had a history or uncontrolled seizures. Nor did Dr. Geier perform all of the necessary diagnostic procedures before prescribing Lupron. Nor did Dr. Geier physically examine Patient B until almost three years after he began prescribing for him. See Proposed Decision at 33, 37-38. This is only one example of the truly risky behavior that Dr. Geier engaged in with these patients.

Mr. Geier’s license to practice medicine was suspended last year by the Maryland Board of Medical Practice. He tried to defend himself in a series of actions since, with this action being the final word.

The Board “entirely agrees” with the a previous decision that allowing Mr. Geier to continue to practice medicine while awaiting the determination of formal charges raises the likelihood of serious harm to public health and safety:

The ALJ concluded that “allowing [Dr. Geier] to continue practicing medicine while formal charges are pending raises a substantial liltelihood of risk of serious harm to the public health, safety, or welfare.” The Board entirely agrees. For Dr. Geier to practice medicine at this time would constitute a danger to the patient community.(3)

The footnote (3) in the above statement was already quoted in this artice–look above to the paragraph on “Lupron treatment carries a very high risk…”

The Board repeated this position in their conclusion:

“I conclude that for all these reasons, the Patients’ health, safety or welfare was at risk of serious harm.. Further, the existence of all these problems throughout all the Records raises a substantial likelihood that the risk of serious harm to the Patients was also posed to many other children with autism treated by the Respondent. I find that this meets the necessary standard for summary suspension of the Respondent’s license: allowing him to continue practicing medicine while formal charges are pending raises a substantial likelihood of risk of serious harm to the public health, safety, or welfare,”

One very troubling argument made by Mr. Geier was that he was not required to have an Institutional Review Board for his research. One of the charges against Mr. Geier involved an IRB he instituted–where he, his son, his wife, a patient’s mother and other interested parties were members of the IRB. The Board did not address whether such a board was required, but did dismiss the charge based on the lack of evidence put forth by the State. More discussion on the IRB can be found at Neurodiversity.com in the article An Elusive Institute.

The Respondent argued both that he was not required by federal law to have an Internal Review Board and, that even if he was bound by such a requirement, the State failed to produce any evidence that his board operated in a flawed manner. The State did not dispute this argument in its response to the Motion. I agree with the Respondent that the State failed to produce sufficient evidence to survive a motion for judgment on the allegations related to an Internal Review Board. See COMAR 28.02.01.12E. C’ Md. Rule 2-519. I will recommend that this portion of the Motion be granted and further recommend that paragraphs 157 through 162 of the Order for Summary Suspension be dismissed.

The thought that somene (Mr. Geier in this case) believes that research could be performed on anyone, not just disabled children, without the protection of an IRB is frightening.

In what is to this reader the most ironic statement by Mr. Geier in this action:

Finally, Dr. Geier accuses the ALJ of establishing a new and unwarranted standard for the medical care of children with autism. Again, Dr. Geier fails to acknowledge that the ALJ relied to some extent on the testimony of his own expert witnesses, and on his own sworn statement, to make her findings regarding the standard of care and the deficiencies in Dr. Geier’s practice.

Yes. Dr. Geier accuses the ALJ of establishing a “new and unwarranted standard for the medical care of children with autism.” Mr. Geier, who while he may not have been the first to promote chelation for autism has been one of the primary proponents, Mr. Geier is part of the team who invented the idea of Lupron as a part of a chelation protocol. A “new and unwarranted standard for medical care of children with autism”.

In addition to this decision, and the cease and desist order, Mr. Geier’s licenses to practice have been suspended in California, New Jersey, Indiana, Florida, Ohio, Washington and Virgina.

The Maryland Board accepted James Adams (a materials scientist) as an expert on chelation, at the behest of Mr. Geier. The opinions offered by Mr. Adams differ from those of medical toxicologists (a group of physicians trained and in practice to treat poisoning):

The Respondent [Geier] testified in his sworn statement that he orders chelation therapy for hispatients on “various” schedules “every other day or a few days on and a few days off for a couple of months – three months.” State’s Ex, 8 at 34. Yet, the Respondent’s expert on chelation, Dr. Adams, testified credibly that patients need an even longer break between rounds of chelation: three days of chelation followed by eleven days off. Dr. Adams also testified that chelation therapy should only be initiated after a patient is given a short “challenge” dose of chelation to ensure that the patient actually needs the therapy. If administered to a patient who does not need it, chelation poses serious risks of injury to the brain and other organs. It is imperative, therefore, that a physician only administer chelation on a limited basis to the patients who actually need it. The Respondent not only skipped the challenge step necessary to ensure chelation was even necessary, but then went full force into chelation therapy on an intensive schedule (with an experimental drug.not FDA-approved for that purpose) without appropriate rest breaks. In several cases, moreover, the Respondent failed to regularly monitor the effects of chelation, and in two cases he prescribed it for patients that he knew he could not monitor.

The concept of a “challenge test” for diagnosing mercury intoxication is covered by the American College of Medical Toxicologists in American College of Medical Toxicology Position Statement on Post-Chelator Challenge Urinary Metal Testing. Who concluded:

“It is, therefore, the position of the American College of Medical Toxicology that post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.

I hope that the Maryland Board looks into this issue of challenge testing before ruling again on such issues.

Mr. Geier is scheduled to give a talk at a large annual autism-parent convention. Last year, after the first action suspending his license, he was reportedly given a standing ovation at this convention. This reader is at a loss to understand why.

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