Tuesday, July 20, 2010

Autism and Biomed Protocols: A Primer on Pseudoscience

Emily Willingham and Kim Wombles

Emily's family has kept their biomed treatment -- or any treatment excepting occupational and behavioral therapies -- to a minimum, primarily because of some inherent skepticism. Their current biomedical interventions are limited to fish oil, probiotics, and some vitamins. 

The Wombles brood has generally taken a similar approach, although they spent four years gluten and dairy free (with Kim worried she was getting ALS every time she ate her own GFCF baking! Cough cough -- dry stuff) before admitting that it made no difference for them whatsoever, except that there were five much happier people once they went off the diet.

Many autism parents investigate biomedical or "biomed" approaches as a way to ameliorate negative manifestations of their child’s autism. These parents can also find themselves overwhelmed by biomedical protocol possibilities. Sorting through these protocols can be a daunting task, which is, of course, one reason for having a Thinking Person’s Guide to Autism.

What follows are analyses of three of the most overpromising biomedical approaches: the Cutler Protocol, the Yasko Protocol, and the Bioset Protocol. We urge readers not to rely solely on what they read here: please review these protocols on your own. We also strongly recommend that you do so in the context of pseudoscience awareness, as detailed at UK-Skeptics.com and Quackwatch.org. Pseudoscience signs include:
  • A clear monetary reward
  • Requirements for paying more as you go along
  • A central personality rather than a core science supporting the therapy
  • Use of sciency-sounding but often nonsensical terms
  • A promise to cure a number of unrelated disorders 
Understanding what constitutes pseudoscience versus true science or scientific practice will help you avoid a number of biomed pitfalls.

The Cutler Protocol

The Cutler Protocol, created by research chemist Andy Cutler, is based on the premise that autism is mercury poisoning -- which can be cured by Cutler’s specially timed chelation system. If an individual has any dental amalgams containing mercury, these amalgams will have to be removed before the protocol can be begun. In fact, Cutler has made available a book and a special term (pseudoscience alert!) about “Amalgam Illness.” Cutler claims that he himself “got mercury poisoning” from his fillings, as detailed at his site www.noamalgam.com.

Cutler asserts that:
“Many conditions, from Parkinson's disease and autism -- widely recognized as terrible afflictions -- to those like chronic fatigue and fibromyalgia which, though equally serious, are disparaged as 'Yuppie flu,' can be undiagnosed mercury poisoning.” 
This laundry list of disorders is a key sign of a practitioner of pseudoscience. Naturally, his protocol for removing mercury from your body is available in his book, which he describes as a “practical guide to getting well.” Plus, if you add up what he recommends as a timeline for “treatment,” Cutler’s protocol may take years.

We won’t get into Cutler's list of things that “mercury does to you” or the distinction between the chronic and acute effects of mercury poisoning that he describes on his site, because mercury poisoning is not a viable causative agent in the development of autism. For a recent study finding no elevations of mercury in autistic children compared to non-autistic children (a first requirement for it to be causative), please check out this freely available, full-text 2009 paper in Environmental Health Perspectives, a well-respected, peer-reviewed journal: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2831962/?tool=pubmed.

The Cutler Protocol involves the chelators DMSA and DMPS and alpha lipoic acid (a fatty acid), which will supposedly reach the mercury deposited in the brain. The Protocol requires some testing of hair and/or urine to demonstrate that you have high levels of mercury. Unfortunately, these tests are basically useless as they don’t produce worthwhile information. Hair testing is entirely unreliable and misleading, while urine testing for mercury will give you one of two outcomes, depending on the circumstances:
  1. You will have mercury in your urine because everyone does; we carry it in relatively steady states, and your urine tells the story of your past mercury burden.
  2. You’ll do the test after a chelation protocol, which releases an abundance of heavy metals, including mercury, into circulation for dumping in the urine, so you’ll get elevated levels that aren’t a valid indicator of what you’re experiencing on a daily basis without chelation. 
This kind of provoked testing is common in the biomedical world, and it’s a poor guide for anyone to use in determining a treatment for mercury poisoning. And as long as we’re on the topic, chelation can kill, and the FDA recently warned consumers about another form of chelation involving the chelator OSR#1.

Let’s put it this way: If you’ve got mercury poisoning, you’ll know it. It’s not subtle. You won’t be looking online for a book to order; you’ll be at the doctor or hospital. Symptoms include “impairment of the peripheral vision; disturbances in sensations ('pins and needles' feelings, usually in the hands, feet, and around the mouth); lack of coordination of movements; impairment of speech, hearing, walking; and muscle weakness” (from http://www.epa.gov/hg/effects.htm).

If you’re looking for more information on mercury toxicity, see Medscape's eMedicine. Note that the Public Health Service has concluded that dental amalgams are not a threat to public health.

The Yasko Protocol

The Yasko Protocol (www.dramyyasko.com) is a costly protocol sold by Amy Yasko, who has determined that something called the "methylation cycle" can have defects that contribute to a whole host of diseases and disorders (pseudoscience alert!), and autism is one of these disorders. If you want to know more, you’ll have to buy her books and DVDs (pseudoscience alert!). To select the appropriate individualized treatment plan, customers can order health tests (some for hundreds of dollars) and then base their ordering of various supplements and RNA products (also hundreds of dollars) on the test results.

We note here that legitimate biotech companies specializing in “RNA products” do so at great expense  and with a great deal of accumulated laboratory expertise to ensure that the products retain their RNA integrity. Yasko has to know this; she once was involved in such a company, called Oligo. RNA is a molecule notorious for its ability to degrade, and the things you have to put it in to keep it from degrading are not things you want to ingest. Yet her website gives the impression that she does not know the first thing about RNA; it is full of nonsensical terms and assertions that don't make scientific sense. What she appears to be doing, given her involvement with Oligo, is willfully and randomly tossing out a lot of sciency-sounding terms because she knows that most of her readers won’t recognize them as nonsense. That’s a pseudoscience red flag.

It’s easy to see how Yasko attracts people, though. Her site includes a few complex-looking graphs that purport to show the “methylation cycle,” which appears to involve in some mysterious way the amino acid methionine and the Krebs cycle, which is one of the steps of harvesting energy from glucose. What she’s really talking about, in a very roundabout manner, appears to be folic acid deficiency. The solution to that is usually to take more folic acid.

Yasko (or “Dr. Amy,” as she warmly calls herself) does offer a nice example of the way practitioners of pseudoscience reel you in and keep you. According to Discover Magazine: “She monitors biomarkers of detoxification in the urine as often as every week or two and tweaks supplements accordingly.” So in case the things she’s sending you aren’t producing any noticeable effect, send in some urine and a whole lot of money -- as often as every week or two -- and she’ll respond by tweaking the supplements you need to purchase. Parent bloggers have noted that they’ve paid thousands of dollars each month to comply with this protocol.

Whenever a “personality” like Dr. Amy is involved in something like this, first consider that a sign of a pseudoscience, and second, do some looking into the personality. A search on PubMed, the scientific literature database, yielded no hits on “methylation cycle” and “Yasko.” A PubMed search also turns up no hits for Amy Yasko; neither do searches of Medline, Health Source: Nursing/Academic Edition, Science & Technology Collection, or Academic Search Premiere. In her list of publications on her website, she provides only one that appeared in a peer-reviewed journal. It’s a great and highly respected journal: Cell. We tracked down the original paper. Yasko is an author on the paper (under the name Amy Arrow), but she is one of three, and she is neither first nor last. In scientific publications, her second-place listing means she didn’t play a significant role in the work, yet on her website, she posts the paper as though it is her own, first-author paper.

We found three (http://www.ncbi.nlm.nih.gov/pubmed/12202239) other (http://www.ncbi.nlm.nih.gov/pubmed/8915497) papers (http://www.ncbi.nlm.nih.gov/pubmed/2828865) with Amy Arrow as an author on PubMed, and she is not first author on any of them. She appears on these papers in her capacity as a functionary with Oligo, the former biotech company with which she was involved. In other words, there are red flags for skepticism all over this one, including efforts to make work that isn’t her first-author or lead-author work appear to be so. That suggests an effort to magnify a limited scientific resume.

The Bioset Protocol

The Bioset Protocol is sometimes recommended by DAN! (Defeat Autism Now!) doctors as a supplementary treatment for food intolerance or allergies. It was originated by Dr. Ellen Cutler -- or Dr. Ellen, as she calls herself, unless she’s calling herself “The Empress of Enzymes." Dr. Ellen promises that her “system” will help the buyer with a laundry list of ills, ranging from herpes to migraines to “childhood illnesses or recurring infections.” This is a pseudoscience alert. These disorders, vague as the list is, have nothing in common -- neither causes nor treatments. "Bioset" also turned up no hits in the scientific literature databases listed above. Cutler offers a list of articles on her website, but not one is a peer-reviewed research publication. 

According to AllergyEscape.com, Bioset, or "Bioenergetic Sensitivity and Enzyme Therapy," is an energy-based allergy elimination method:
"Originated by Dr. Ellen Cutler, this allergy elimination method views the body holistically, similar to the Chinese approach. This view accepts the fact that there is an energy system in the human body that is separate from the cardiovascular system and nervous system. This system, which is comprised of “meridians,” has everything to do with the way the body maintains its overall health."
AllergyEscape.com goes on to further explain Bioset:
“Bioset practitioners utilize Meridian Stress Assessment (MSA), for allergy testing, or they may use muscle testing (applied kinesiology), two non-invasive techniques that are both safe and reliable. MSA is computerized device that detects energy variations in the body.”
The concept of meridians has been debunked, and based on Dr. Ellen's own website and our searches in scientific literature databases, there is no evidence to demonstrate a physiological basis for the Bioset protocol, much less effectiveness with respect to Dr. Ellen's laundry list of Bioset-treatable disorders.


As a parent or a spiritual person, you may be thinking that there are more things in Heaven and Earth, Emily and Kim, than are dreamt of in the philosophy espoused here. Indeed, there are. But there are also many clearly established scientific standards, ones that have been demonstrated repeatedly. Examples include the disease-development pathways of many of the disorders that the above practitioners claim to cure.

What has not been demonstrated in any way -- and could not be, even if we moved Heaven and Earth to do so -- is that these peddled protocols, along with affiliated books and pills, have any effect whatsoever. All they ultimately do is take money from the pockets of parents desperate to do something for the children they love.

Please, if you’re considering any of these protocols, or any therapy or intervention -- take a critical look at it, as we have done here, before you reach into your pocket -- or inject or dose your child.