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Controlled Evaluation of the Effects of Hyperbaric Oxygen Therapy on the Behavior of 16 Children with Autism Spectrum Disorders

21 Apr

Hyperbaric oxygen treatment (HBOT) has become a big topic in the world of CAM (complementary and alternative medicine) and autism. An upcoming parent convention with a focus on CAM is even sponsored by an HBOT company. A few papers have come out, without much clear evidence of benefit.

A recent paper looks again at HBOT. This paper has a few limitations. Amongst these: there were only 16 participants and, well, I consider papers by Thoughtful House and by Andrew Wakefield in particular to be somewhat problematic.

Here is the abstract:

Controlled evaluation of the effects of hyperbaric oxygen therapy on the behavior of 16 children with autism spectrum disorders.

Jepson B, Granpeesheh D, Tarbox J, Olive ML, Stott C, Braud S, Yoo JH, Wakefield A, Allen MS.

Thoughtful House Center for Children, Austin, TX, USA.
Abstract

Hyperbaric oxygen therapy (HBOT) has been used to treat individuals with autism. However, few studies of its effectiveness have been completed. The current study examined the effects of 40 HBOT sessions at 24% oxygen at 1.3 ATA on 11 topographies of directly observed behavior. Five replications of multiple baselines were completed across a total of 16 participants with autism spectrum disorders. No consistent effects were observed across any group or within any individual participant, demonstrating that HBOT was not an effective treatment for the participants in this study. This study represents the first relatively large-scale controlled study evaluating the effects of HBOT at the level of the individual participant, on a wide array of behaviors.

One problem with HBOT studies in the past is the attempt to use a placebo like therapy. It seems to this observer at least that it would be quite easy to distinguish placebo vs. real HBOT. The current study avoids that. They took data during a baseline period, during the HBOT therapy weeks and a post-HBOT period. They found that there was no benefit.

These findings diverge considerably from those of Rossignol et al. (2009). The current study controls for the potential ‘‘washing out’’ of the effect when group data are averaged (as must be done in a between-groups design) by carefully measuring potential changes in 11 topographies of behavior over time across 16 individuals. If there was a subgroup for which HBOT was effective, it seems likely that at least one such child would have participated in the current study. The lack of an effect for any participant in the current study makes the existence of such a subgroup seem implausible.

The paper concludes:

News programs and community blogs report that many families of children with autism are using HBOT therapy. The cost of such treatment may range up to $150 per hour. Families report using anywhere from 40 to 120 h of HBOT. These hours are in lieu of other therapies such as applied behavior analysis, speech therapy, and occupational therapy and do not include travel time to the medical center where the therapy is provided. Some families purchase the chambers in order to provide therapy in their home. A number of websites focus on renting ($1,395 per month) and selling ($8,495–27,995) chambers to families. Given the financial and time-investment required for HBOT and the conflicting study outcomes to date, we cannot recommend HBOT as a treatment for autism until such time as more conclusive favorable results are demonstrated.

This is consistent with a previous study which included one of the above authors, Randomized trial of hyperbaric oxygen therapy for children with autism, which concluded:

This study found HBOT to have no significant beneficial effect on ASD symptoms. The experimental design of the current study is of a higher rigor than those employed in previous studies which have suggested that HBOT is effective. Further, the dependent measures included were far more comprehensive than those included in previous studies; therefore it is unlikely that an effect was present which was not detected. Based upon the findings of the current study, HBOT delivered at 24% oxygen at 1.3 atmospheric is not recommended for the treatment of ASD symptoms.

Do’C over at the AutismStreet blog has followed the HBOT research pretty closely. Here is his list of articles skeptical about HBOT.

My own view:
HBOT is expensive, time consuming, not effective for treating autism and will continue to be promoted heavily to parents looking for a way to help their children. There is something profoundly wrong with the world of CAM and autism if they don’t move away from therapies like HBOT.

A Systematic Review of Secretin for Children With Autism Spectrum Disorders

15 Apr

The journal Pediatrics has a series of articles out recently on autism therapies. All are review articles: discussions of previous papers rather than new research. One topic that was covered was secretin. I don’t hear much about secretin now, but it was a big event in the 1990’s. Last I checked (which was some time ago) many alternative medical practitioners in the Defeat Autism Now group still were prescribing it. The Autism Research Institute’s webpage still has a prominent link to “The Use of Secretin in Autism: Some Preliminary Answers “, an article from 1998.

A number of studies have been performed on the use of secretin, including randomized control trials (RCT). There is enough data that the authors of this review were able to make a rather definitive statment: not only is there no evidence of having an imact.

CONTEXT: As many as 1 in every 110 children in the United States has an autism spectrum disorder (ASD). Secretin is 1 of many medical treatments studied for treating the symptoms of ASDs, but there is currently no consensus regarding which interventions are most effective.
OBJECTIVE: To systematically review evidence regarding the use of secretin in children with ASDs who are aged 12 years and younger. METHODS: We searched the Medline, PsycINFO, and ERIC (Education Resources Information Center) databases from 2000 to May 2010 and reference lists of included articles. Two reviewers independently assessed each study against predetermined inclusion/exclusion criteria. Two reviewers independently extracted data regarding participant and intervention characteristics, assessment techniques, and outcomes and assigned overall quality and strength-of-evidence ratings on the basis of predetermined criteria.
RESULTS: Evidence from 7 randomized controlled trials supports a lack of effectiveness of secretin for the treatment of ASD symptoms including language and communication impairment, symptom severity, and cognitive and social skill deficits. No studies have resulted in significantly greater improvements in measures of language, cognition, or autistic symptoms when compared with placebo; study authors who reported improvement over time did so equally for both the intervention and placebo groups.
CONCLUSIONS: Secretin has been studied extensively in multiple randomized controlled trials, and there is clear evidence that it lacks benefit. The studies of secretin included in this review uniformly point to a lack of significant impact of secretin in the treatment of ASD symptoms. Given the high strength of evidence for a lack of effectiveness, secretin as a treatment approach for ASDs warrants no further study.

Here is the conclusion of the paper:

Previous studies have demonstrated that secretin is not effective for improving language, cognition, behavior, communication, autism symptom severity, or socialization skills. The strength of evidence for this lack of effectiveness is high. With 7 randomized controlled trials with fair- to good quality scores and 1 case series that contributes to this evidence base, future studies are unlikely to change the estimate of effect for this treatment. Further studies of secretin in children with ASDs are not warranted.

This is pretty strong: “Further studies of secretin in children with ASDs are not warranted”

Chelation: oral not very effective, IV causes brain fog

10 Feb

One very common therapy in the Complementary and Altenative Medicine (CAM) world is chelation. It has been very popular amongst DAN doctors and other CAM practitioners in the autism community, largely based on the mistaken ideas that (a) autism symptoms are similar to mercury poisoning and (b) autism is caused by mercury (from vaccines and elsewhere).

I’ll say it here and I’ll repeat it at the end of this piece: any parent who believes his/her child is a victim of heavy metal poisoning should take that child to a medical toxicologist. Find an expert in toxicology. This is not a project to take on yourself and your child deserves the best. Find someone trained and experienced in toxicology. You can search by state or country.

That said, here are two articles I’ve run across recently which reminded me of why people should seek experts. First, the most common oral chelating agent (DMSA, succimer) is not very effective against mercury. Second, IV chelation can result in “brain fog” lasting days.

An NIH Research Matters article titled “Lead Poisoning Treatment Less Effective for Mercury” discusses measurements of blood mercury levels in children in a trial of chelation for high lead levels.

A drug commonly used to treat lead poisoning is relatively ineffective at removing mercury from the blood. The finding provides insight into a compound currently being used as an alternative therapy for autism.

Here are the concluding paragraphs:

A research team led by Dr. Walter Rogan at NIH’s National Institute of Environmental Health Sciences (NIEHS) sought to investigate whether succimer can also remove mercury from the blood. The team used blood samples and data from 767 children, aged 12 to 33 months, who participated in an earlier clinical trial of children who were treated for high blood levels of lead.

The research team measured mercury concentrations in blood samples collected prior to treatment, a week after beginning treatment with succimer or placebo, and again after 3 month-long courses of treatment. The study was funded by NIEHS, NIH’s National Institute for Minority Health and Health Disparities (NIMHD) and the Centers for Disease Control and Prevention. The results appeared online on October 1, 2010, in the Journal of Pediatrics.

The researchers found that, after 1 week, succimer lowered blood concentrations of mercury by 8%. In contrast, it reduced blood lead concentration by 42%. After 5 months, those taking succimer had blood mercury concentrations about 20% lower than the control group. However, the therapy had only slowed the rate at which the children accumulated mercury.

“Succimer is effective for treating children with lead poisoning, but it does not work very well for mercury,” Rogan says. “Although succimer may slow the increase in blood mercury concentrations, such small changes seem unlikely to produce any clinical benefit.”

In an article in Integrative Medicine, Joseph Pizzorno (a leading naturopath) talks about his experience with IV DMPS.

Unfortunately, my first experience with IV DMPS at the normal dosage (250 mg) resulted in significant “brain fog”. I experienced obvious impaired memory and decreased cognitive capacity for several hours (my wife asserts she noticed effects for a full week).

He goes on to tell that even though he believes that overall he is doing better due to lower mercury levels, his team asked him to refrain from IV chelation before meetings. His colleagues were able to see the obvious adverse effects (Dr. Pizzorno refers these as “adverse IV chelation effects”)

I repeat this here: any parent who believes his/her child is a victim of heavy metal poisoning should take that child to a medical toxicologist. Find an expert in toxicology. This is not a project to take on yourself and your child deserves the best. Find someone trained and experienced in toxicology. You can search by state or country.

2011 – The Last Year For ARI’s DAN! Doctors

2 Jan

As late as just a few months ago, The Autism Research Institute (ARI), promoted their upcoming Fall 2010 Defeat Autism Now! conference in a monthly newsletter. Note the name of the conference:

“Fall 2010 ARI/Defeat Autism Now! Conference”
http://www.ariconference.com/enews/enewsletter_201010.html

Now look at ARI’s promotion of their Spring 2011 conference.

“Spring 2011 ARI Conference
(formerly known as Defeat Autism Now!)”
http://www.ariconference.com/enews/enewsletter_201011.html

Do you see the difference? It’s pretty hard to miss. What about all those practitioners (physicians, nurses, chiropractors, nutritionists, naturopaths, and homeopaths, etc.) who want to participate in the “DAN! Physician Training”, you know, become “DAN! Practitioners”? How does one become a DAN! doctor, if Defeat Autism Now! is a former identity?

A quick look at the ARI Conference website answers that right away.

The Autism Research Institute Conference Formerly known as Defeat Autism Now!

The practitioner seminars are still part of the conference. But there’s something potentially newsworthy here too.

As of 12/31/11, ARI will no longer be maintaining a clinician registry (a.k.a “the DAN list”). No new names will be added to the registry in 2011.

Source

You read that correctly – no new names in 2011, and at the end of this year, it’s over. No more list of DAN! Doctors.

According to ARI’s website, one is best served in finding a “talented clinician” by way a support group – local, or you know, out there on the interwebs.

As recently as 10 years ago it was nearly impossible for parents to find clinicians who approached treating patients with autism from a medical point of view, so ARI started keeping a clinician registry (the “DAN list”). We tried a number of measures to ensure that every clinician on our list provided high-quality care, but we are a small non-profit with limited resources. We have determined that those seeking a talented clinician are best served by connecting with support groups—either locally or online—instead of choosing from a list that cannot be vetted.

Source

I’m not sure what they mean by having tried “a number of measures to ensure that every clinician on our list provided high-quality care”. I understand that there were special “clinician training” sessions at DAN! conferences in the past, but as far as I understood it in the past, becoming a listed DAN! practitioner might have required little more than attend a conference, sign a statement pledging to “conduct their practice in accordance with DAN! philosophy”, and ask to be listed. Although I could be wrong, I find it incredibly difficult to believe that there were in fact any significant measures taken by ARI to ensure the provision of high quality care by clinicians on its list. I seem to recall that Roy Kerry was added to ARI’s list of DAN! practitioners in 2006 after the death of Tariq Nadma in 2005.

ARI’s notes and disclaimers for the remaining year of life for the list of DAN! doctors seem pretty careful:

If someone claims to be “DAN-certified,” they’re overstating; neither ARI nor Defeat Autism Now! has ever had a certification program.

The following are practitioners who have asked to be listed as providing Defeat Autism Now!®- based interventions for patients with autism. Most are physicians, others are licensed health-care professionals in related fields.

ARI has no means of certifying the competence nor quality of practice of any practitioner. The lists are provided as a community service. The Autism Research Institute disclaims and does not endorse or support any individual or entity listed; makes no representations, warranties, guarantees or promises on behalf of or for those listed, and assumes no liability nor responsibility for any service or product provided. ARI does not ‘certify’ practitioners or guarantee competence, skill, knowledge, or experience.

Source

So is that it? Is this really the end of DAN! doctors in less than a year? Isn’t there a D-List celebrity with apparent anti-vaccine leanings , who can save (or may have already saved) the day for all the poor physicians, nurses, chiropractors, nutritionists, naturopaths, and homeopaths who need be available to all those parents who are desperate to recover an “epidemic” of kids from autism, mercury poisoning, or “vaccine-induced” whatever?

Aha! Jenny McCarthy’s Generation Rescue! Where, from the home page, a parent can click on “Find A Doctor” and learn about the NGMD’s.

JMGR

What’s an NGMD according to Jenny McCarthy’s Generation Rescue?

Answer: According to Jenny McCarthy’s Generation Rescue website, an NGMD is a “New Generation Medical Doctor”, and “These clinicians share Generation Rescue’s ideologies, practices, and philosophies of treating the underlying medical issues of individuals with autism.”

Source

I think this is potentially an interesting development, because in the past, a parent brand-new to an autism diagnosis might have assumed scientific credibility from a movement’s (Defeat Autism Now!) list of practitioners associated with a name like “Autism Research Institute”. If nothing, ARI is a scientific sounding name. I don’t think that’s as likely to be the case for the “NGMD’s”, who could be seen by many as simply associated with a fringe anti-vaccine group promoted by Jenny McCarthy.

What do you think?

The Peril of Parent Testimony – Stem Cell Treatment for Autism

15 Dec

It usually begins naively enough – the parent of a newly-diagnosed child launches a search into the Wild, Wild West of the World Wide Web, searching for help and hope for a diagnosis they are still struggling to grasp.

Soon parents may find themselves on internet support forums and in email groups, surrounded by parents promoting everything from the plausibly helpful to the fantastically impossible.

Some parents may become part of a new peer group – an online pack of believers, where pack status is determined by the number of experimental treatments employed and the claims made regarding these treatments. Alpha pack status is achieved when a parent claims to have “recovered” or “almost recovered” their child, often by applying an arbitrary definition of “recovered,” or even an extrapolated percentage of recovery. Every developmental tick is attributed to the most recent treatment addition, adverse reactions are attributed to healing, and anyone questioning the pack interpretation is considered an intruder in the anthill.

The appeal of these claims is obvious. The truth, however, may be another matter. With autism, there are always newcomers to the ranks of the recently-diagnosed, whose parents are unfamiliar with the histories of popularized treatments, fantastic claims, and failed treatment prophecies.

Eventually, even well-meaning parents may be sucked into the vortex of upping the treatment ante and believing their own fantastic claims, and may remember history differently in order to rationalize and justify the invasive and risky treatments their children are forced to endure. The pursuit of treatment itself becomes a drug — impairing objectivity, dulling recollection, and often, even obscuring the truth.

And so it goes with the Faiella family. Daniel and Ruth frequently thrust their son, Matthew, now 10, into the media to promote hyperbaric and stem-cell treatment for autism, and they have done so yet again, in Local Father Says Controversial Treatments For Autism Work. Matthew has previously endured four stem cell transplants, the fourth not only involving lumbar puncture, according to Daniel Faiella’s blog, but also a frightening experience with anesthesia in a developing central American country.

Unfortunately, Mr. Faiella later removed his harrowing account of anesthesia and the stem cell lumbar puncture from his blog, and though left an entry stating that he still “believes” in the clinic, along with plenty of graphic pictures of his son undergoing this procedure. The search results for his original post concerning Matthew’s dangerous experience are all that now remain:

Aug 10, 2010 … I would never do a spinal stem cell injection again! I can’t just write the good without writing the obstacle that we went through! …
recoveringmatthew.blogspot.com/…/i-would-never-do-spinal-stem-cell.html
Aug 10, 2010 … We also believe Matthew got way too much anesthesia! Thankfully, we were able to get these behaviors to go away by doing many hours of deep …
recoveringmatthew.blogspot.com/…/i-would-never-do-spinal-stem-cell.html

Mr. Faiella has also self-published a book, Out of the Darkness: The Faiella Family’s Journey to Recover their Autistic Son, encompassing a number of alternative and questionable treatments. According to the Amazon page where it is sold, the book appears to be endorsed by JB Handley, of Generation Rescue and Age of Autism, as well as a number of individuals in the DAN treatment community. Recognition and notoriety – the mirage of a maverick hero “rescuing” a child — seems to glorify and goad along risky experimentation on children with autism.

The current news article depicting the Faiella family’s upcoming stem cell journey to Panama includes many elements typical of such accounts, such as the dreaded institutional prognosis rendered by the diagnostician. This has been a recurring theme in the Faiella treatment testimony, as has the impression that Matthew only recently acquired particular skills that are then attributed to the current treatments. As in a media article published when Matthew was seven:

“Faiella recently gained the ability to use words and loves to share his passion for drawing pictures.

Matthew’s dad said his son was diagnosed with autism at 18 months, and doctors warned he eventually would need to be institutionalized.

“They gave us really no hope,” Daniel Faiella said. “We broke down and cried, but I looked at the doctor and said, ‘Not my son. Not on my watch. I’m going to do whatever I can.'”

And another — Matthew is turning nine years old:

Published : Monday, 02 Nov 2009, 8:00 PM EST
WILLIAMSVILLE, N.Y. (WIVB) – Like most eight-year-old boys, Matthew Faiella of Williamsville loves playing with his action figures. Unlike most boys his age, he has an incredible talent for sketching, and can also speak Spanish.
It’s hard to imagine, just two years ago, Matthew, who lives with autism, couldn’t even string two words together.
“It was very sad to see, he was in his own little world. Couldn’t speak. Couldn’t communicate,” said Daniel Faiella, Matthew’s father.

The dramatic statements made in media opportunities regarding Matthew’s diagnostic baseline, (institutional) prognosis, and progress have changed significantly from the original parent testimony posted in public internet locations five years ago. According to Matthew’s mother, “momtoMatthew,” the diagnostic baselines and prognoses were quite different then:

When Matthew was four years old, his mother wrote:

“Matthew was diagnosed at age 20 months to have PDD/NOS. This neurologist just doesn’t seem to agree with that diagnosis at all. He says Matthew is just too different to be given that diagnosis. His is very loving, able to learn easily, is learning to read, can write beautifully, and has a great memory to the point of possible photographic memory.”

Several months later (Dec 2005), momtoMatthew explains that:

“Matthew was diagnosed as language delay at 18 months, then that diagnosis was changed to PDD-NOS at 22 months. He had the PDD/NOS label until just a short few weeks ago. […] In the end they told us that NO he is not on the spectrum. However, he does have a SEVERE receptive/expressive language disorder. […] They told me that with TONS of speech therapy he could get to be so typical that no one would know he had ever had a disorder at all.”

Matthew is likely now diagnosed accurately as on the spectrum, as his parents do report. Interestingly, this is apparent in the very youtube video ICM (apparently the stem cell clinic) posted to advertise the treatment. The Faiellas now depict Matthew as “85% recovered” on a charitable site soliciting donations for his additional stem cell transplants. The meaning of “85% recovered” remains unclear, as does the remaining 15% of autism to be eradicated with a 5th stem cell treatment.

Matthew is a charming young man and has made wonderful progress over time. This would understandably pique the interest of a “new” set of parental eyes unfamiliar with the history, especially since his progress is now being attributed largely to hbot and stem cell transplants. However, according to past parent testimony, Matthew has been communicating, speaking in sentences, answering questions, following 3 to 4-step directions, reading, spelling, writing, and drawing long before his hyperbaric oxygen and stem cell treatments:

Dec 2005: Having just turned five years old, Matthew can indeed communicate in sentences, and on this occasion, language progress is attributed to supplements:

“After giving him his supplements, I would say within 15 to 20 minutes he was much calmer and happily playing with some toys. He came over to me a few minutes later and said “excuse me mommy, I want to watch the dog movie.”

Matthew was spelling and reading words at age 3 or 4, and mom states that his handwriting was advanced for his age of 6 at this time:

Despite the parents’ claims that Matthew’s developmental gains are more recent and due to stem cell treatments and hbot, Matthew had made significant progress by the time he was 5, according to mom:

“My ds has come a long way since he was first dx’d. At that time he was completely non-verbal, he could not follow any sort of direction, he would spend at least a quarter of the day spinning in circles or hand flapping (or both).
Today he is a little chatterbox, can follow directions fairly well..even 3 and 4 step directions, he no longer spins or flaps, and his receptive language is much better.”

And also as a five-year-old, mom reports that Matthew was initiating conversation, answering questions, and speaking in sentences:

It is curious that Matthew’s parents later edited and deleted the seemingly contradictory content of these past public posts, following the publication of their book and numerous media articles (checked using an address captured in the screenshots). Perhaps this is most unfortunate for the parents themselves — these at least served as markers along the path that Matthew actually traveled, in case they ever wish to find their way back.

When parent testimonies take on a life of their own, the well-meaning parents responsible may have lost their way, lost their boundaries, and even lost their recollection of the child that actually was – a happy, healthy boy who has been learning, loving, and making progress all along.

Internet testimonies and fantastic treatment claims: approach with caution.

Bring the crazy – Fecal Transplant

9 Dec

There’s a few places around the interweb that you can always count on for a good old dose of craziness. One of those is the Autism Web forums, where the latest trend being discussed is Fecal Transplant.

Yeah. Fecal Transplant.

It is actually a known therapy to attempt to cure

…pseudomembranous colitis (caused by Clostridium difficile), or ulcerative colitis which involves restoration of colon homeostasis by reintroducing normal bacterial flora from stool obtained from a healthy donor.

Feeling a bit icky yet?

But like so many known treatments for known ailments (chelation for example), the extreme biomed party like to put their own unique twist on things:

Ok, you guys, I got some info for you, please do not hate me 🙂
Here is how this procedure was done by that physician in canada who does not practice anymore.
you collect the stool from a healthy relative (mother, father , so on) for a week in a bucket, no preservatives or cooling. Then mix well, fill in a decorating cone (that cloth cone you use to decorate a cake).
Use the cone as an enema to empty all the content in the patient’s colon. The patient needs to hold that as long as possible.

Does that in theory mean no more GFCG diets, yeast treatments, mega supplements if it works right? Is there the potential for this to actually reverse autism, then? With the autism/gut connection it sure makes sense. I’ll admit I didn’t read this post initially because it sounded so gross, but now that I’ve started to look into it…..it may really work.

Hooray!!! Playing ‘doctor’ via the internet and subjecting your kids to it!! Just wonderful.

Hope and False Hope

25 Nov

Hope. It’s a wonderful thing, and something that parents of children with autism deserve to have in their lives. Fortunately, science shows that there is very good reason for hope. It shows that children with autism continue to learn and develop throughout their lives. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2765385/
http://www.ncbi.nlm.nih.gov/pubmed/15666341

But false hope is another matter. As we saw in my guest blog Truth and Consequences – The Anti-Vaccination Movement Exacts a Price from last year, “biomedical support groups” for autism, so prevalent and so active on the internet, provide a sense of hope and community for parents of children with ASD. But, that hope is not real. The case of “Mary” and her son “Saul” illustrates this – Mary joined a multitude of groups, and tried dozens of “treatments” only to be left poorer. And her child, at age 8, had not “recovered”, but still exhibited many of the challenging behaviors which he had at age 2.

Mary is a bit unusual because she has persisted with “biomedical autism treatments” for 6 years. The typical cycle of membership on such “biomedical support groups” is much shorter. A new parent joins, and attempts to follow the protocol or the advice of the other parents, but if this approach does not help their child, the parent simply abandons the group, usually without comment. However, there are always newly diagnosed children, so one sees a continuous influx of new parent members, asking the “newby” questions. Typically, there is a core of self-proclaimed “go-to” people in the group who have devoted themselves to advising these parents.

The purpose of this blog post is to introduce you to one such “go-to” person, a woman called Dana, a resident of California, and the owner of a website http://www.danasview.net.

Here’s how Dana describes herself:

Hello, my name is Dana and I am 41 years old. I am an attorney, I am married, and I have four children. I homeschool all four of my children, and I do legal work part time from home.
When my second child was diagnosed with autism at age 3, I began searching the internet to learn more about him and who he is, and I was surprised to discover that I also qualified as AS, which I will use here to refer to Autistic Syndrome although I am aware it is used for other uses as well. My third child would probably qualify as PDD, but I have not pursued an official diagnosis for him. My first and fourth child are NT.

Notice that Dana makes it clear that she has no medical background, and she is always careful never to present herself as a medical professional. Nevertheless, she has a lot of credibility on the “autism biomedical support groups”. The reason for this credibility is that she is supposed to have “recovered” her second child, or rather both her second and third children. Here is how she describes her second child in 2001 when he was 5 or 6:

My son’s pedneuro told me that he was very low functioning, never developed at all, classic genetic Kanner’s autism, that my best hope for him would be assisted living in a group home some day. Now my son no longer qualifies as autistic, he will be productive and independent some day, and all of it is because of information I read in books and on the internet. Keep going, you are doing the right thing, as you now know!

Wow! a child who no longer qualifies as autistic! That was pretty impressive in 2001, and it made Dana into an authority on biomedical treatments. However, the story has changed quite a bit over the years:
2003, age 7-1/2

My son was not as old as yours when I started biomedical, altho he was older than most kids I read about. He was age 4 when I started, now is age 7-1/2. When I started biomedical, he basically did not tolerate anything.

He is nearly recovered, his last issue is language delay, all his other issues are gone. Chelation was the intervention that provided the final measure of recovery. I did a few other things along the way, but with chelation he can eat all foods now with no problems, he never has a yeast issue any more, stims only very occasionally and voluntarily stops almost immediately. He is now working on catching up with his language delay.

2006, age 10

My son has a Kanner dx, autistic from birth. In reality, he was injured from my dental amalgams plus HepB vax at birth. I chelated him with ALA, and he is almost biomedically recovered now [chelation being one part of that recovery]. Still developmentally delayed, but catching up.

2008, age 12

Well, when he was 3, the pedneuro told me he would never talk or even acknowledge my existence. Today he is 12 and just completed a first grade program. He talks, he reads, he does simple math, he loves giving me hugs, he calls us “mommy” and “daddy” and says “I love you” and lots of other things. He plays well with his siblings, defends them when we gang up on them to tickle them, is concerned when they get hurt, and he is the only child I have who will do his chores without prompting or complaining.

Because he is so far behind and is already 12, I don’t know if he will be age appropriate. But so far I am pleased with his progress. He has gone from “classic Kanner’s autism, severe, low functioning”, to not qualifying as autistic, but definitely developmentally delayed.

2010, age 14

My son has a dx of “classic Kanner’s autism, severe, low functioning”. The pedneuro who dx him, told me he would never talk or even acknowledge my existence. He said his first word at age 6, after I added digestive enzymes.

The things he needed the most for speech, were enzymes, ALA chelation, anti-virals, B vitamins especially B1 and B12, and anti-fungals. There were several other supps that were also helpful.

Today he is 14 and not yet age-appropriate, but sometimes I do need to tell him to be quiet because he is talking too much.

To me it’s clear that her second son is not actually “recovered” from ASD.

Dana is an amazingly prolific poster. When using the handle “danaatty”, between 2001-2003, she made a total of 9882 posts to just four yahoo groups, abmd, Autism-Mercury, EnzymesandAutism and GFCFKids. In 2003, she adopted the handle “danasview”, and since has made a mind-blowing 48,187 posts to just three groups, with the largest number, 23,705 posts to GFCFKids. That’s an average of 17 posts per day, every day, for 9 years!

Dana blames vaccines for her childrens’ ASD, even though she recognizes that she herself is also on the spectrum. And like most parents who blame autism on vaccines, she has an obsession with eliminating both viruses (presumably the residual measles virus from vaccination) and mercury (from thimerosal containing vaccines). There is absolutely no clinical evidence for any of her recommended protocols. Everything is based on her reputation as a parent who has “recovered” her children.

When viewed in isolation, a single piece of her advice may seem reasonable. However, a small sampling of her posts taken together shows a different story. Here are some symptoms that Dana has blamed on viruses or on viruses leaving the body:

plantar warts
molloscum contagium
yeast, which causes constipation
goopy green eye discharge
major red rash
dry patches of skin
bad case of the “chewies”
visual stims
pushing finger joints and cracking knuckles
OCD
low white blood cell count
loud talking
mouth sores
language difficulty
high fever
sore throat
runny nose
aching bones
fine bumps on chest

In Dana’s view, some symptoms of mercury poisoning are:

dilated pupils
headaches
neck pain
sinusitis
asthma
ear infections
tingling down arms/legs
urinary incontinence
jitters
restlessness
can’t sleep very well
heart palpitations or weird feelings around heart
fungus on feet
pain in jaw
ears popping
pressure in ears
pain in intestines/bowels when exercising
food intolerances
lazy eye

Conventional “autism biomedical” wisdom is that “yeast infections” are common in autism. And that “yeast infections” can result from either anti-viral “protocols” or chelation. According to Dana, some of the symptoms of “yeast” are:

symptoms of Tourette
OCD
anxiety
dark circles under eyes
squinting eyes
needing to chew things
eating plastic and rubber
persistent nail biting
redness/bumps around the mouth
sinus infection
hitting oneself
hitting one’s ears
head banging
making pig noises and snorting a lot
standing on the head
hands always in mouth
severe dandruff
biting a parent
yellow bowel movements
yellow finger nails
pee accidents
tics
crying uncontrollably for 20 minutes or more
cystic acne
constant high pitched vocal stims
non-stop talking
low grade fever
loose sounding cough
ringing in the ears
dizziness
constipation
humming
licking things
hyper and giggling
laughing hysterically
flying into a rage
sleep problems
problems falling asleep
sleep walking
teeth grinding
stinking armpits in a five year old
spinning around in circles
balance issues
chapped lips
extra bad handwriting
visual stims
sexual behavior
red ring around the anus
“spaciness”
anger and aggression,
headache
head banging
sound sensitivity [holding the hands over the ears]
climbing on furniture and jumping off
vestibular sensory issues
and
multiple personalities

It strains credulity that such a diversity of symptoms could possibly be attributed with such precision to only three causes. In fact, there are very few things Dana will NOT attribute to these three causes. For example:

Q: What can cause low white blood cell + low red blood cell count? A hematologist has performed blood tests and ruled out antibodies (lupus, rheumatoid arthritis, etc) and now wants to proceed with a bone marrow biopsy. He appears to think he has ruled out everything else and is now looking for Leukemia or Lymphoma.
Could mercury/metal exposure cause these symptoms? Anything else?

A: It is very possibly a mercury toxicity issue. May also be related to a latent virus issue.
Dana

Dana on viruses:

He had a wart that did not go away with high dose vitamin C [which eliminated a lot of cold/flu viruses in his brain], so I tried lysine, which caused more gains.

I watched a cold virus migrate into my son’s brain once. And after starting
anti-virals, I watched the viruses come out one by one.

The above four supplements (Vitamin A, vitamin C, vitamin D, and lysine) eliminated my son’s viruses, they no longer lie dormant.

Dana on food intolerance:

At my house, controlling yeast and bacteria was required to stop raging. Also, most of the SCD-legal foods my son did not tolerate. He tolerated nothing orange or green, and he did not tolerate fats until mito cocktail. That would have caused major problems for him.

Dana on short stature:

One of my kids had this problem. He needed carnitine and thyroid support.

Dana shows her knowledge of chemistry:

Arginine and lysine are “opposites”, sort of like zinc and copper. If
you suspect a herpes virus issue, definitely do NOT give arginine, it will increase the virus.

Dana on yeast:

The yeast is in his head/brain, not in his GI tract. This happened with my son for a few years. Just because you don’t see signs of yeast in the bm/GI tract, does not mean yeast is not present in other areas of the body.

With her prolific posts and her continuous flow of “biomedical autism treatment” advice for parents, Dana has established herself as a guru. She is one of the key people personally responsible for encouraging parents to subject their children to unproven and potentially dangerous experimentation. According to the Office of Dietary Supplements, consumers in the USA spent $20.3 billion on dietary supplements in 2004. Someone is getting rich on her advice.

Addendum:
In researching this story, I encountered something astonishing. Remember “Mary” and her son “Saul”? Saul is very clearly NOT recovered despite all the experimentation performed on him. The ultimate irony was to see “Saul” featured on Dana’s website, touted as an example of a chelation recovery!

Safeminds defends treatments the FDA deemed “dangerously misleading”

18 Oct

The United States Food and Drug Administration (FDA) recently announced that they had sent warning letters to eight groups who were promoting chelation products without prescriptions and with unproven claims of efficacy.

Chelation is a mainstay of many alternative medical practitions, especially in autism. There is a hypothesis that autism is caused by mercury poisoning. Autism symptoms don’t look like mercury poisoning and multiple studies have been performed testing the hypothesis and shown no link. But the idea lives on. Autistics, mostly children, are subjected to chelation “therapy” to remove heavy metals from the body. After over a decade of this practice, there is still no demonstration that chelation does anything to help autistics. There are studies on Peruvian hamsters which are used to support the idea that autism is caused by mercury poisoning. No, seriously, one of the supports for the mercury/autism link is a study on Peruvian Hamsters. Just goes to show how tenuous the “science” backing chelation is.

Here is part of the FDA statement:

Federal regulators are warning eight companies to stop selling so called ‘chelation’ products that claim to treat a range of disorders from autism to Alzheimer’s disease.

The Food and Drug Administration (FDA) says the companies have not proven their products are safe and effective in treating autism spectrum disorder, cardiovascular disease, macular degeneration, Parkinson’s disease or any other serious illness. Some of the companies also claim their products can detect the presence of heavy metals in the body in an attempt to justify the need for chelation therapy.

One of the more vocal organizations promoting the mercury/autism “link” is a group called SafeMinds. So it isn’t a surprise that they would respond to the FDA warnings..

Here is the opening paragraph from the SafeMinds response:

The FDA issued a media release and held a press conference on over-the-counter chelating products. A recording of the press conference was made available this afternoon (recording available at 800-839-7073). FDA issued warning letters to 8 companies promoting over-the-counter nutritional supplements for chelation therapy (HERE). Chelation is a method of removing heavy metals from the body. The FDA warning has no bearing on prescription chelation drugs which are used under the supervision of medical professionals.

“Nutritional Supplements”? How does a chelator count as a “nutritional supplement”? The human body does not produce chemicals like DMSA which are used for chelation. SafeMinds is well aware of the falacy of the “nutritional supplement” argument after the recent debacle over the chelator turned “supplement” OSR, which had to be pulled from production.

So, SafeMinds starts downplaying the fact that chelators are drugs and, as such, should be regulated.

But they quickly change the tune and acknowledge that these are drugs: “The FDA warning has no bearing on prescription chelation drugs which are used under the supervision of medical professionals.”

As I read this, I had to ask myself “Why did SafeMinds chose such imprecise language?” Let me explain:

Assume a medical professional, say a chiropractor or a nutritionist, “supervises” my use of the prescription drug DMSA, but sells the drug to me without a prescription (as these professionals can not write prescriptions). That would fit into the SafeMinds interpretation, but is clearly not the intent of the FDA statement.

Here is an accurate statement: The FDA warning does not have bearing on the use of chelation drugs prescribed by and supervised by a medical professional.

Continuing with the SafeMinds statement:

In its press conference, the FDA implied that chelation products were being used by parents of children with autism without a doctor’s supervision, but on questioning by reporters, FDA representatives were unable to back up the claim with any evidence of use of OTC chelation products by autism parents or of their use without medical supervision. The FDA asserted that the OTC products being promoted were dangerous and could lead to kidney damage, dehydration and death. On questioning by reporters, the FDA admitted that it had received no reports of adverse reactions to the products or to chelation in general, other than 1 death 5 years ago which was due to a medical error and in which a prescription drug was used.

Note that SafeMinds chose their words carefully. They don’t state that the practice doesn’t occur. SafeMinds just states that the FDA didn’t have the evidence on hand of the “use of OTC chelation products by autism parents or of their use without medical supervision.”

Is Safeminds so out of touch with the online autism community that they can’t find groups promoting over-the-counter (OTC) chelators by autism families? The practice is common. Surely SafeMinds members peruse the exhibitor booths at the parent-conventions (like Autism One).

Google search: “how to buy DMSA without a prescription”. Lot’s of hits.

Here is hit #2: dmsachelation.com/autism/. Pretty clear they are targeting autism treatment there, just from the URL. The blurb on Google for this site? “This page IS intended to show you where to buy DMSA without a prescription. You can get DMSA prescribed, however the cost will range from $2-3 per pill. …”

I didn’t capitalize “IS” in that statement, they did. They wanted to emphasize that one could buy chelators without a prescription.

SafeMinds states that the FDA has received no reports of adverse events from chelation in general. I find this odd. The FDA must not follow online autism parent groups such as those on Yahoo. The FDA must not have read transcripts of the Omnibus Autism Proceeding, which included a description of a child who regressed after being given chelation therapy (under the watchful eye of a prominent alt-med doctor). The FDA must not have performed a google search on chelation deaths with site set to CDC.gov.

First hit, “Deaths Associated with Hypocalcemia from Chelation Therapy — Texas, Pennsylvania, and Oregon, 2003–2005“.

When it comes to the question of “why” adverse events are not commonly reported I am again reminded of the OSR fiasco. The company that sold OSR specifically told their clientele to contact the company in case of adverse reactions. No mention was made of contacting the FDA (which can be done here). I guess I could search the websites of the groups that promote OTC chelators to see if they inform their clients of the ability to report their drug/supplements to the FDA. Somehow I feel confident that I would be able to find groups (possibly many or most) do not give that information.

SafeMinds posted their statement on the blog they sponsor, The Age of Autism. Another sponsor of that blog is Lee Silsby, a compounding pharmacy. They list chelators such as DMSA and EDTA under the category “autism treatments” (Specialties | Autism Treatments | Transdermal DMSA Cream, or Specialties | Autism Treatments | EDTA (calcium)). Not under “heavy metal poisoning” treatments, autism treatments.

The Autism Research Institute, a group which promotes much in the way of alternative medicine as therapies for autism, has a chart that is often used to promote chelation. In their survey, they claimed that over 70% of parents reported that their child got better with chelation. The survey has been often criticized as being unscientific and very biased. Even with this biased sample, 3% of parents reported that their child “got worse” with chelation.

A couple side notes are worth mentioning. First, in that survey the ARI list chelation under “Biomedical/Non-Drug/Supplements”. Non drug? Supplement? I doubt the FDA will agree. Second, the ARI survey lists secretin therapy as beneficial for autism. Secretin hit the news in the 1990’s as a potential autism therapy and has since been shown to be no more effective than a placebo. The survey is very, very biased towards “biomedical” treatments.

Surely SafeMinds is aware of this survey. As in, definitely they are aware of it. Just as Safeminds are certainly aware of the child in the Omnibus proceeding who suffered after chelation. But SafeMinds pretend as though there are no adverse reactions. It is disingenuous, to say the least.

SafeMinds ends their statement with this paragraph:

SafeMinds agrees with the FDA that products being promoted as drugs and biologics should have thorough and unbiased assessments for safety and that parents should work with their healthcare professionals when considering health interventions. SafeMinds feels that FDA has tried to cast autism parents in a negative light without any supporting evidence, by implying that autism parents were giving their children dangerous products without medical oversight. Only on questioning by the media did the FDA have to back off from its wild claims. SafeMinds feels the FDA owes the autism community an apology.

Basically, SafeMinds have taken the Human Shield defense. Rather than actually discuss the facts, SafeMinds attacks the FDA for “wild claims” and claims that the FDA owes the autism community an apology.

From the perspective of this autism parent I would say, yes, the FDA owes us an apology: for taking so damned long to address this issue. The abuse of chelation as a “treatment” for autism has been going on for many years. It is about time that the FDA cracked down and made the “wild claim” that a prescription drug should be given by perscription.

Heck, the FDA isn’t even making the “wild claim” that toxicology treatments should be performed by toxicologists. Just someone with a prescription pad.

Why isn’t SafeMinds telling autism families to seek out medical toxicologists to test and treat heavy metal poisoning? The answer is painfully clear. The methods of diagnosis and treatment that groups like SafeMinds promote do not compare to the methods used by those trained specifically to treat heavy metal intoxication.

Should make one pause to wonder.

FDA: Chelation not proven safe or effective in treating autism

14 Oct

Chelation is a process whereby metals are removed from the body using a drug, a chemical which binds to the metals and allows them to be excreted. Because of the incorrect notion that autism is caused by mercury or is a “novel” form of mercury poisoning, chelation is one of the more common alternative medical therapies applied to autistics.

The FDA has recently issued a warning to many of those who market unapproved chelators. Two articles appear on the FDA website today:

FDA Tightens Reins on Unapproved ‘Chelation’ Drugs

and a press release

FDA issues warnings to marketers of unapproved ‘chelation’ products.

They have also issued a printer-friendly pdf: FDA chelation warning pdf

From that pdf:

Federal regulators are warning eight companies to stop selling so called ‘chelation’ products that claim to treat a range of disorders from autism to Alzheimer’s disease by removing toxic metals from the body.

The Food and Drug Administration (FDA) says the companies have not proven their products are safe and effective in treating autism spectrum disorder, cardiovascular disease, macular degeneration, Parkinson’s disease or any other serious illness. Some of the companies also claim their products can detect the presence of heavy metals in the body in an attempt to justify the need for chelation therapy.

The groups that have been warned are:

• World Health Products, LLC: Detoxamin
Oral, Detoxamin Suppositories, and the
Metal Detector test kit
• Hormonal Health, LLC and World Health
Products, LLC: Kelatox Suppositories,
and the METALDETECTOR Instant Toxic
Metals Test
• Evenbetternow, LLC: Kids Chelat Heavy
Metal Chelator, Bio-Chelat Heavy Metal
Chelator, Behavior Balance DMG Liquid,
AlkaLife Alkaline Drops, NutriBiotic
Grapefruit Seed Extract, Natur-Leaf,
Kids Clear Detoxifying Clay Baths, EBN
Detoxifying Bentonite Clay, and the
Heavy Metal Screen Test
• Maxam Nutraceutics/Maxam Laboratories:
PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx,
Anavone, AV-Rx, BioGuard, BSAID, CF-Rx,
CreOcell, Dermatotropin, Endotropin,
GTF-Rx, IM-Rx, Keto-Plex, Natural Passion,
NG-Rx, NX-Rx, OR-Rx, Oxy-Charge,
PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and
the Heavy Metal Screening Test
• Cardio Renew, Inc: CardioRenew and
CardioRestore
• Artery Health Institute, LLC: Advanced
Formula EDTA Oral Chelation
• Longevity Plus: Beyond Chelation
Improved, EndoKinase, Viral Defense,
Wobenzym-N
• Dr. Rhonda Henry: Cardio

I wonder how the FDA chose these groups for the first round of warnings. I also wonder if/when there will be more warning letters.

Also from the FDA pdf:

FDA says consumers should avoid nonprescription products offered for chelation or detoxification. FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as the treatment of lead poisoning and iron overload. The agency says even the prescription medications carry significant risks, and they should only be used with medical supervision.

I don’t know why the FDA has taken so long to step in and take action. Chelation has been going on for years, and has never had a sound basis in science or even a good rationalization for the treatment of autism.

Trine Tsuderous has an article on the Los Angeles Times website, FDA warns about treatments for autism, heart disease.

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

19 Aug

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

From the NY Times:

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

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

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

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

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

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

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

From the NY Times story:

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

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

Unintended and unforeseen consequences.

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

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

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

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

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

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

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

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