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MMS, Miracle Mineral Solution, CD, Chlorine Dioxide…call it what you will, it’s abusive and it’s fake medicine

3 Jan

I’ve written a few times about MMS. Rather than the long articles on specific topics, I feel it’s appropriate to make a simple, short statement:

MMS, aka Miracle Mineral Solution, aka CD, aka chlorine dioxide is bogus. It’s junk. Worse than that, it’s abusive. Yes, you will find segments of the autism-parent community who promote and use it. But that doesn’t make it actually useful, nor does it make it OK to use.

Here’s the thing–it’s a bleach solution. The idea that this can work to “detoxify” or “kill parasites” is just flat out wrong.

The Autism Research Institute (ARI), a group which has promoted unproven alternative treatments for autism throughout its history, has this to say:

Given these issues, we advise against using MMS at this time. We hope parents will remain critical of unsubstantiated claims that children have recovered or greatly improved in the absence of objective proof. We also strongly encourage any parents who choose to administer MMS to their children to report it to their physician so that side effects can be monitored.

If a group such as ARI, a group favorable to alt-med, comes out with such a strong statement, you know it’s time to question the “scientific” claims and testimonials.

As to why I call this abusive? Used as an enema (one method strongly promoted by MMS activists) it causes people to pass the lining of their intestines. You can find pictures of these “worms” on the web, where people claim they have killed a parasite. (This is just the worst use of MMS. Taken orally it is still abusive).

Again, from the ARI:

The mucous threads that children expel during MMS treatment, which have been touted as worms (though laboratory analysis does not support this claim), are the body’s method of protecting itself from induced oxidative stress in the lower digestive tract equivalent to the mid-day sun in its ability to produce severe sunburn.

Seriously, what else can one call pushing chemicals into disabled children’s digestive tracts until they start passing tissues? Yes, parents subjecting their children to this are not doing so with the intent to abuse, but they are being fooled into a harmful act.

Since I keep getting commenters on this blog defending this practice, I felt the need to make this short and clear statement. MMS is bogus. It’s harmful.

Just don’t do it.

By Matt Carey

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Remember the fake supplement OSR #1? It’s still being developed

5 Apr

A few years ago a fake supplement was marketed to autism parents for use on their children. The “supplement” was called “OSR #1”, OSR for “oxidative stress releif” or something to that effect. The name was a bit of a dodge, just as packaging it as a supplement rather than a drug was a dodge. It was/is a chelator. The chemical used–a novel synthetic chemical–was developed for use in environmental heavy metal polution.

This is obvious but worth noting: one can not “supplement” one’s intake of a chemical that humans have never been exposed to before.

If you remember OSR #1, you probably remember that the drug was pulled from the market. But you may be surprised to hear that it may be about to resurface.

The FDA found out that this chelator, this drug, was being sold as a supplement (which avoids thorough tests for safety and efficacy). The FDA sent the Boyd Haley, whose company was selling the “supplement” a warning letter that made it very clear:

The claims listed above make clear that OSR#1 is intended to affect the structure or any function of the body of man or other animals. Accordingly, OSR#l is a drug under section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1). Disclaimers on your website, such as “OSR#l® is not a drug and no claim is made by CTI Science that OSR#1® can diagnose, treat or cure any illness or disease,” do not alter the fact that the above claims cause your product to be a drug.

Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of OSR#1 without an approved application violates these provisions of the Act.

emphasis added.

Even as a supplement, OSR#1 appeared to be mislabled. Customers were not fully informed of potential side effects, per the FDA letter:

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).

Mr. Haley’s company reportedly sold about $1.5M of OSR#1 as a supplement from his company CTI Science. I saw reports that OSR#1 was selling for about $2/pill so that’s maybe 750,000 pills. That’s a lot for somethiing untested for safety or efficacy. CTI appears to be a shortened version of the original name of the company: Chelator Technologies, Inc.. Chelators are drugs, not supplements.

All this said, CTI Science doesn’t appear to exist any more. If you go to the old website, www.ctiscience.com, you get directed to a non operating website, http://ermesmedical.com/?reqp=1&reqr=.

But obviously I haven’t written all this to say that CTI Science doesn’t exist. It’s not ermesmedical (as their link would suggest), it’s EmeraMed. No idea why they have this confusion over ermesmedical/emeremed. That said, Emeramed describes themselves as:

EmeraMed Limited is a biotechnology firm developing the antidote – heavy metal chelator and antioxidant – Irminix® (Emeramide). The Company is working to obtain marketing authorization in the EU and the US for the treatment of mercury toxicity. Phase 1 and Phase 2a clinical studies have been performed.

They have offices in Ireland, Swedend and the US (Kentucky–home of Boyd Haley). But no mention on the website about who is involved with the company, which I find rather odd. They note that the drug is not yet approved, but that they may be able to supply it to people under an “early access program”. Yes, why wait for actual approval and confirmation of safety and efficacy. This would be for use as a chelator–no mention of work as an autism treatment. There never was a good reason to use this for autism. Boyd Haley was long a proponent that autism is a form of mercury poisoning. Put simply, Boyd Haley was wrong. Very clearly wrong.

Mr. Haley and others may not be named on their website, but on SEC documents, he is named as part of Ermes Medical. If I read this document correctly, they have raised over $3.5M for the company.

As noted in their literature, they have been involved with clinical trials. For mercury poisoning. In Ecuador. No small irony there: many of Mr. Haley’s supporters complain that “big pharma” performs their clinical trials (or experiments, as his supporters would characterize them) in developing countries.

They are still pursuing patents for the treatment neurological disorders. No trial that I have found. Likewise for evidence of efficacy in humans. But a patent application.

A similar patent for treatment of COPD.

Should OSR#1 (under whatever new name) be approved for chelation, we can expect that it will return to the fake autism treatment world. Many still subscribe to the failed idea that autism is caused by mercury poisoning. That idea, pushed by Mr. Haley and others, was based largely on the idea that as mercury exposure from infant vaccines increased, so did the rate of identified autism. Biologically the idea was clearly wrong (autism and mercury poisoning are not similar). Also, even though mercury was removed from infant vaccines, autism rates have not fallen.

All that clear logic said, there still are people who chelate as an “autism treatment” and a new product will almost certainly cause a spike in the numbers trying chelation.

So, yeah, OSR#1 is gone. Except it may return soon under a new name. And likely a higher price tag. And it still won’t be a real treatment for autism.


Matt Carey

Study claims gluten free diet leads to higher levels of heavy metals like mercury

6 Mar

One of the purported treatments for autism is the Gluten-Free/Casein-Free (GFCF) diet. Studies have failed to find a benefit, but the idea persists. Especially among those who believe that autism is a vaccine injury (it isn’t) and that mercury in vaccines contributed to the rise in autism rates (it didn’t).

So there is a huge irony in the possibility, as a recent study suggests, that people on a gluten-free diet have higher levels of mercury and other heavy metals

The study is The Unintended Consequences of a Gluten-Free Diet.

The full study doesn’t appear to be available. This looks like a conference abstract.

That said, check out this table:

table

Total mercury in the blood is 1.7 times higher in people in the gluten-free diet group than in the overall population.

Now, it looks like the units in the table are ng/l, so a total mercury level of 1.3ng/l (that in the gluten-free group) is still well within the normal range (<10ng/l).

Of course it is also worth mentioning that those who promote the gluten-free diet for autistics often have the attitude that no mercury level is safe (which is tough, since there is mercury at some level in just about everything).

So, yeah, ironic but not dangerous. By pushing the gluten-free diet, people may have pushed autistic kids into higher levels of mercury in their blood.

Do we expect Robert Kennedy, SafeMinds, Mark Blaxill, JB Handley, Generation Rescue or any of the others in what was once called the “mercury militia” to inform their groups about this? Sure, if they are really about autism and not about attacking vaccines.

Which is to say, I doubt it.

By Matt Carey

ABC to present “Wacky Church Under Fire Over ‘Miracle Cure’ for Autism”

27 Oct

MMS. Miracle Mineral Solution. CD. Chlorined Dioxide. Call it what you want, it’s a scam. Worse than that, it’s abusive. And thankfully it’s getting some national news attention.

ABC’s 20/20 will present on Friday, Wacky Church Under Fire Over ‘Miracle Cure’ for Autism

Here’s one section of the website for the news segment:

“They’ve got their own Facebook group. There are people admitting to using this stuff on their children. Children are experiencing symptoms,” Eggers said. “You are doing it at the expense of these defenseless children. How, how, how can you not call that evil?”

MMS/CD whatever you want to call it, is sold with a bunch of science-sounding mumbo-jumbo. Believe me (a Ph.D. scientist with 30 years of experience), the explanations given by people like Kerri Rivera and Jim Humble for what MMS does amount to science nonsense.

Thank you ABC for taking this on. Please don’t walk away from this story, keep on it. We need this abuse to end.

By Matt Carey

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

Another study on the gluten free/casein free diet and autism. This time focusing on kids with a sign of “leaky gut”

9 Sep

I recently wrote about a study of the gluten free/casein free (GF/CF) diet and autistic kids. The kids in that study were put on the diet and then given snacks with gluten and/or casein and their behavior was monitored. And nothing happened. Breaking the diet did not cause increases in autistic behaviors. But people complained that the study size was small (valid complaint, but not a killer) and that the kids in the study didn’t have GI disease (again, not a killer for the study. The GF/CF diet is marketed as a very general autism “therapy”).

But I wrote the previous article knowing that another study had just come out. A study focused on kids with “severe maladaptive behavior” and a sign of the so-called “leaky gut” syndrome. Gluten and casein supplementation does not increase symptoms in children with autism spectrum disorder.

The abstract is below. The researchers looked at 74 kids with “increased urinary I-FABP” I-FABP is intestinal fatty acid binding protein. And this is considered a “marker of gut wall integrity“. The study team found this marker elevated in a number of their subjects from a previous study.

While it isn’t clear in the abstract, the autistics in the study were on a GF/CF diet

To our knowledge, our study is the first randomised controlled trial to study the behavioural effects of adding gluten and casein to the diets of children with ASD who were already on a GFCF diet.

So, they had autistic kids who were on the GF/CF diet and they gave some of them gluten and casein snacks and the others GF/CF snacks. For a week. And they looked at the changes in behavior.

Both groups–those given gluten and casein and those who weren’t–saw improvements on measures of behavior. But there was no difference between the two groups on the measures of behavior.

There was no regression. No children made more autistic by gluten and casein.

In other words, no indication that the diet was doing these kids any good.

Here’s the abstract.

AIM:
A gluten- and casein-free diet is often given to children with autism spectrum disorder (ASD). We aimed to determine the effect of gluten and casein supplementation on maladaptive behaviour, gastrointestinal symptom severity and intestinal fatty acids binding protein (I-FABP) excretion in children with ASD.

METHODS:
A randomised, controlled, double-blind trial was performed on 74 children with ASD with severe maladaptive behaviour and increased urinary I-FABP. Subjects were randomised to receive gluten-casein or a placebo for seven days. We evaluated maladaptive behaviour before and after supplementation, using I-FABP excretion, the approach withdrawal problem composite subtest of the Pervasive Developmental Disorder Behavior Inventory and the Gastrointestinal Symptom Severity Index.

RESULTS:
The mean approach withdrawal problem composite score was significantly higher before supplementation than after, both in the placebo and in the gluten-casein group. However, the mean difference was not significant and may have been caused by additional therapy. There was no significant difference in gastrointestinal symptoms and urinary I-FABP excretion.

CONCLUSION:
Administrating gluten-casein to children with ASD for one week did not increase maladaptive behaviour, gastrointestinal symptom severity or urinary I-FABP excretion. The effect of prolonged administration or other mechanisms of enterocyte damage in ASD should be explored.

©2015 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

KEYWORDS:
Autism spectrum disorder; Casein-free diet; Gluten-free; Intestinal fatty acids binding protein; Maladaptive behaviour

There are a lot of limitations with this study, and the authors do discuss them. But, frankly, if the GF/CF diet were as good as people claim, this study would have shown at least some benefit.


By Matt Carey

Gluten Free/Casein Free diet and autism studied…and no sign of a benefit

9 Sep

Perhaps one of the more common alternative medical approach to treating autism is the gluten free/casein free diet. And alternative means–not demonstrated to be beneficial and, very often, not even well founded on sound reasoning. And by common, it appears that about 17% of parents have opted for some form of special diet, so GF/CF in particular is likely less than that.

The GF/CF diet (as it is often known) was first proposed based on the “opiod excess” theory and the “leaky gut” theory. Neither theory has shown itself to be valid.

A previous review found that “Currently, there is insufficient evidence to support instituting a gluten-free diet as a treatment for autism.” The clinical trial just published appears to be based on a study presented at IMFAR a few years ago.

The study was fairly simple–they put children on a GF/CF diet. They then gave the children snacks. Some contained gluten and/or casein. Some did not. The parents didn’t know which snacks were which. The behavior of the children was recorded and correlated against the inclusion of gluten or casein. And no benefit was observed. Here’s the study:

The Gluten-Free/Casein-Free Diet: A Double-Blind Challenge Trial in Children with Autism.

and abstract:

To obtain information on the safety and efficacy of the gluten-free/casein-free (GFCF) diet, we placed 14 children with autism, age 3-5 years, on the diet for 4-6 weeks and then conducted a double-blind, placebo-controlled challenge study for 12 weeks while continuing the diet, with a 12-week follow-up. Dietary challenges were delivered via weekly snacks that contained gluten, casein, gluten and casein, or placebo. With nutritional counseling, the diet was safe and well-tolerated. However, dietary challenges did not have statistically significant effects on measures of physiologic functioning, behavior problems, or autism symptoms. Although these findings must be interpreted with caution because of the small sample size, the study does not provide evidence to support general use of the GFCF diet

The study group is small, so it is possible they missed some benefit. But if the parent survey often quoted were correct and 69% of children showed a benefit, this study should have picked that up.

There are, of course, people who are sensitive to various foods. People both autistic and not. So some fraction of the population will benefit from elimination diets. But the idea that many promote of elimination diets as the first thing to try, no matter what (and there are people who do), is flawed at best.


By Matt Carey