3/31/2010

Age of Autism Proves It Has a Reading Comprehension Problem

Anne Dachel and Teresa Conrick are downright confused over there at AoA. That's okay, as the folks commenting aren't any better off.


They're both busy going a wee-bit off the deep end on this clinical trial by Curemark.


In a press release regarding Curemark, autism, and the revolutionary enzyme that's going to cure autism (get it-- curemark), it is revealed that: "Dr. Fallons paper, entitled, The Role of a Dearth of Amino Acids in the Pathophysiology of Autism details the groundbreaking discoveries regarding autism and its possible origins. This research is the focus of Curemarks plans for entering into clinical trials."


Okay, so what are these groundbreaking discoveries? Well, stand back and be prepared to be amazed: "Dr. Joan Fallon, the company's founder and CEO, observed that many autistics show a strong preference for foods high in carbohydrates and low in protein."  Okay, my husband is right that this is my new favorite saying, but holy crap on a cracker, folks! It's got all the earmarks of the woo the AoAers love to hear. It's just confusing the hell out of them that there's actually a clinical trial registered with the government. Somehow, they've twisted this to be a federal endorsement, and they can't believe a study by Wakefield is cited as background literature. Guys, the government didn't approve this study, it's a registry, not an endorsement, and it's Curemark's scientist who's provided Wakefield. This should have been your signal that this was one of your woo-posse, but no, you've confused something actually getting studied with being big pharma. Instead it's a start up company, like Boyd Haley's, only Curemark is taking it a step further and actually examining whether it works.


Business Week covers Curemark in an article back in January: "One of the most promising treatments in this category is a drug called CM-AT made by a startup called Curemark. Dr. Joan Fallon, the company's founder and CEO, observed that many autistics show a strong preference for foods high in carbohydrates and low in protein. A diagnostic test revealed that some autistic children lack enzymes that digest protein. As a result, these children produce fewer of the essential amino acids that are the building blocks for brain development and neuroreception. Fallon believes this deficiency is linked to the most severe symptoms of autism, and she says an early observational study of CM-AT, an orally ingested powder that delivers protein-digesting protease, showed "significant improvements." Curemark is enrolling patients in phase III clinical trials at 10 to 12 sites—the largest autism trial to date."   Hah, no scientific evidence offered as to why this is a promising treatment and Business Week hardly connotes scientifically valid.


And, in a press release, Curemark announced that it had been granted FDA fast track and then explained : "Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and those that fill an unmet medical need, providing a therapy where none exists or are potentially superior to existing therapy, according to the FDA Web site.  Fast Track designation provides for early and frequent communication between the FDA and the drug company to resolve questions and issues quickly, obtaining an expedited review and faster access by patients."


Does this prove that FDA and Big Pharma are in cahoots with each other or that the overwhelming majority of researchers are saying, oops it's the guts? No. It means a "doctor" has decided to branch out into a niche field, like Haley, the Geiers, Wakefield and Krigsman did. And the rich, rich irony is that the AoAers missed it and have decided it's a big pharma gambit and validation of all their conspiracy theories, because of course it's all about the money to be made.


Again, holy crap on a cracker (Big Bang Theory fans will recognize this). Guys, how did you miss Dr Fallon's 2006 publication to the esteemed (sarcasm) journal Medical Hypotheses: "Could one of the most widely prescribed antibiotics amoxicillin/clavulanate "augmentin" be a risk factor for autism?" This is her one and ONLY publication citing with pubmed.


This is yet another case of media covering a story without assessing its legitimacy, and the AoAers picking up on it and running with it without taking the cursory amount of time necessary to assess the legitimacy of the story. 


I mean, if they'd done any digging, they'd have found this:


"Dr. Joan Fallon, member of the ICA Pediatrics Council Board of Directors and Immediate Past Council Chair was recognized by the New York State Senate with a citation for her research demonstrating that children with ADD, ADHD and autism have a similar biological defect and that pancreatic enzyme therapy is efficacious in the treatment of these children. Dr. Fallon has been awarded a patent for her enzyme therapy treatment by the US Patent and Trademark Office. The presentation was made by NY State Senator Nicholas Spano. In his proclamation Sen. Spano commended Dr. Fallon for her compassion and care and for sharing with others her knowledge and expertise “as well as her never ending commitment to the quality of health care.” Dr. Fallon’s research as well as her care of children with chiropractic adjustments were also cited in a debate in the Canadian Parliament as something that should be looked at when considering treatment options for children with autism in Canada. Dr. Fallon is a full-time practitioner in New York."


And this:


"Dr. Fallon is a Fellow of the International Council on Chiropractic Pediatrics.She is a former Assistant Professor at Yeshiva University in New York City, and the author of numerous professional papers and texts.She is the coordinator of a post-graduate program in pediatrics, and on the faculty of numerous Colleges and Universities.She has lectured extensively around the world on the subject of children with problems, and she has traveled numerous times to Romania to work with the children of the orphanages.She is the director of a multidisciplinary center in Westchester County, New York, that specifically works with children with problems, and prides herself on outreach and networking with other professionals to bring the best possible care to all children."


A little more, you ask? "A 1983 graduate of Palmer College, Dr. Fallon has a B.S. in biology and obtained her diplomate international council of chiropractic pediatrics (DICCP) through the ICA's program at Palmer.
She is an assistant professor in the natural sciences and mathematics department of Yeshiva University in New York, is on the postgraduate faculty at Palmer West, and is vice chair of the ICA Council on Pediatrics." --1996 Dynamic Chiropractor
I'm sorry, could someone please explain how a chiropractor is qualified to deal with pancreatic enzymes, let alone autism?


Yeah, AoA, she's one of yours, so will you be backpeddling and claiming her?


Anne Dachel (the media editor) writes: "Are we to simply accept that the medical/scientific community suddenly recognizes that autism is related to GI disorders, despite having previously denied a link?" Umm, pretty sure the medical and scientific community is going to go with Buie's studies, and not with some chiropractor who has patented an enzyme and is doing a clinical trial with what they hope will be 170 kids. That's not enough for statistical validity, for one, and this won't be a prescription drug, either, but will allow the company to claim it actually does something.


Even better is when Anne writes that Business Week covered it because of all the money to be had: "I'm sure BusinessWeek covered this because of the great profit potential for any drug that could be used to treat hundreds of thousands of American children." I'm sorry, but I really do have to laugh.


Now, tell me, if you actually go take a gander at the comments and the two articles over there at AoA, if this isn't proof that they are so far into their conspiracy theories that they read into stuff what they want to?



11 comments:

storkdok said...

Hmmm, Dr. Buie actually tried my son on pancreatic enzyme replacement when he was first diagnosed with inflammatory bowel disease, gastritis and partial pancreatic insufficiency. It was a prescription. He couldn't tolerate it, he couldn't swallow pills, and it caused a burning sensation in his mouth and esophagus. So then he recommended trying some of the Kirkman digestive enzymes. They didn't help. And Dr. Buie was't trying to treat my son's autism, just his GI disorders.

Wonder if they will include the already developed and tested digestive enzymes as a control? There were at least two prescription digestive enzymes on the market back in 2003, which already were approved and tested. I'm wondering how different or the same this one could be.

When will AoA get the message that autistic kids have the same rate and kinds of digestive disorders as the general population of kids? It is to be expected that if a GI problem causing pain is treated properly, the child will function better overall. The "morphine like peptide" theory has already been debunked.

Can't see that anything new is going to be found here.

Nostrum said...

Yeah, I was just reading that in between snickering at their moral indignation that someone made a Downfall parody.

Enzymes are the new secretin.

KWombles said...

Stork, nope, it will be a placebo control. This appears to be not much different than Haley deciding he could cash in.

And if the chiropractor were simply looking to see if this enzyme would help with GI issues, that'd be one thing; it's a completely different ballgame to assert the inability to digest protein causes autism. Sigh.

What was funny was how sanctimonious they all were over there at big pharma making bucketloads of money and here it is a chiropractor trying to cash in.

Ah well, what are you gonna do. :-)

It'd be lovely if enzymes were enough to fix GI issues. I would be in line for that. :-)


Nostrum, they do provide diversions, don't they, like playing solitaire. I wish they'd focus on their kids and making the world a better place, though (I know, they probably think they are). I'd be pure-dee tickled to never have to wade through their bad science and problems with doing a quick google search. Or their martyr-me posts.

Sadderbutwisergirl said...

@storkdok: "autistic kids have the same rate and kinds of digestive disorders as the general population of kids"
I'm not sure that that's exactly the point here. That statement may not be entirely true, per se. I'm not saying that autistic kids are more likely than non-autistics to have digestive problems or less. I think the problem here is that AoA is making autism to be synonymous with digestive problems when it really isn't. There are examples of autistic kids who don't have digestive problems and kids with digestive problems who aren't autistic. In addition, they are not only making autism out to be synonymous with digestive problems, they are also using it to monger fear.

Sarah said...

....so what does AoA think their sponsor, Lee Silsby is making money from? Jelly beans?

David said...

I have a new story up on Thorsen at evil possum. Something I explain there that could have significant relevance here: All it takes to become "principle investigator" of a CDC project is filling out a form and being approved for a grant.

Sheldon said...

I blogged about this trial and did not realize how much woo is behind it.

On the face of it, it looks pretty good. Take some pancreatic enzymes and coat them with another company's proprietary product so they survive the stomach and are released in the gut.

The drug is a powder taken with meals. When the drug and the food reach the intestines, the coating is cracked and the extra enzymes help break up proteins so kids with autism get higher levels of amino acids. This, in turn, is supposed to help autistic kids.

This trial is being carried out at 6 sites in the US that certainly seem legitimate.

There are two problems that I now see. One, the age range of 3-8 is very wide. Two, GI symptoms or disease or the lack of them are not inclusion/exclusion criteria.
As well, now that I think of it, there are liquid products that contain the already broken down amino acids.

What's new is the trial is using a product that is supposed to survive the stomach and get released in the intestines because of a special coating.

David said...

One thing I find a bit fishy: As I understand it, secretin is a pancreatic enzyme. This makes me wonder if we are looking at an attempt to revive that defunct "wonder".

Squillo said...

Nice job, Kim.

@storkdok--we had my diabetic cat (don't start on me y'all--I am a crazy cat lady just like Kim) on a similar enzyme protocol. Didn't help much with that, either.

storkdok said...

@Sadderbutwisergirl

That was my point. The digestive issues are not related specifically to autism, especially reading the recent consensus statement in Pediatrics of which Dr. Buie chaired:

http://pediatrics.aappublications.org/cgi/content/full/125/Supplement_1/S1

I was referring to the lingering beliefs in the biomed community about the "morphine like peptides" that cause the kids to be "doped up" and that the belief was that using digestive enzymes would break these down to stop the "autism". This theory has, of course, been demolished by the evidence, best explained at A Photon in the Darkness by Prometheus. That is what I think they are basing their theory on. That and the old secretin studies.

Since there are already several pancreatic enzyme replacements out there, I can't see that there would be any difference in a comparison of this "new enzyme" with any of the old ones in people who actually did have pancreatic insufficiency, such as in cystic fibrosis. These enzymes do have special coatings to survive the stomach acids and work in the duodenum. They have already been demonstrated to work in other populations of children. The claim of a "special coating" is baloney. It may be different, but that doesn't mean it will be better. And since a lot of autistic kids have been treated with the previous digestive enzymes and secretin, and not been cured of their autism, this just looks like another attempt to pull a Haley on the biomed community.

There are legitimate GI diagnoses in autistic children. It irritates me to no end that the DAN! quackery is actually preventing kids from authentic diagnoses and treatments.

There is nothing really new in this "trial". If anyone read the literature they could see that.

@Squillo
I've had a cat with inflammatory bowel disease that we treated with the vet with steroids. Had diabetic cats, one now with mild renal failure on a renal diet. Several dogs with cancer. A cat with polycystic kidney disease. My 16 yr old dog, deaf and mostly blinded by cataracts, has hypothyroidism and is on thyroid replacement. We have gone so far as to have a male guinea pig neutered so he didn't impregnate his mother when the kids wanted to keep him. Cost me $100 for that one. I must be out of my mind. ;0)

@David, secretin is a hormone which is released when you eat, it stimulates the pancreas to excrete the digestive enzymes.

DrKeithCurrie said...
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