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World Autism Awareness Day is celebrated each year on April 2nd. Unfortunately, we here at SBM are all too aware that Autism Spectrum Disorder (ASD) has been exploited by those profiting from unproven and expensive treatments like few other conditions: Restrictive diets, bogus diagnostic and treatment devices, chelation therapy, bleach therapy, hyperbaric oxygen therapy, homeopathy, herbs, vitamins, naturopathy, and chemical castration, among others. Purveyors of these false hopes sometimes align themselves with fellow promoters of pseudoscience: Antivaxxers, who flog the thoroughly discredited notion that vaccines cause autism. The victims are often children, whose parents are desperate to try anything that might help for a condition with no cure and not a lot of effective interventions.

Today we take a look at Amy Yasko, or “Dr. Amy,” as she calls herself, an unlicensed Maine naturopath who claims, in her self-published book, Autism: Pathways to Recovery:

considerable success in halting and in many cases reversing the effects of debilitating conditions, including ALS, MS, Parkinson’s disease, Alzheimer’s disease, Systemic Lupus Erythematosus (SLE), Myasthenia gravis, and autism.

Developed while she was in private practice as an unlicensed naturopath, she now offers the “Yasko protocol” to all comers through her websites and other media under the auspices of the “Neurological Research Institute,” a for-profit consulting company solely owned by Yasko. We’ll return to her protocol in a moment, but first let’s get to know “Dr. Amy.”

Despite calling herself “Dr. Amy,” and despite her use of diagnostic testing and prescribing therapeutic agents to treat autism and other medical conditions, Yasko is not a licensed medical doctor or naturopathic doctor (in fact, she’s ineligible for licensing) or on the faculty of any university. Nor is she an autism researcher, at least as that term would be understood among actual autism researchers.

According to her resume, Yasko has a Ph.D. in Microbiology/Immunology & Infectious Diseases from Albany State Medical College. In the 1980s through the early 2000s, she did research and published in respectable journals. She helped start two companies involved in the development of drugs and DNA synthesizers and holds several patents. But, sometime in the early 2000s, things seem to have gone off the rails. She veered from respectable science to naturopathy and pseudoscience, even though she knows better.

After working as a researcher and businesswoman, Yasko graduated from Clayton College of Natural Health (CCNH), an unaccredited naturopathic school that taught all manner of quackery and has since ceased operations. (I can’t imagine the cognitive dissonance required for someone with her background to stomach courses in, say, homeopathy.) According to Quackwatch, “the nature of CCNH’s teachings is also reflected in the brazen claims of its graduates,” listing Yakso’s declaration of her ability to “reverse” diseases with no known cure, like autism, as an example.

The Yasko Protocol

So, how does “Dr. Amy” “halt” and “reverse” autism and other diseases which medicine and science have concluded, apparently mistakenly in her view, are presently incurable?

The Yasko protocol starts with her “DNA Nutrigenomic Test,” which she developed. She claims the test can uncover genetic “weaknesses,” or mutations, in the form single nucleotide polymorphisms (SNPs), in a particular nutritional pathway in your body, the methylation cycle. She describes this methylation cycle as “a biochemical pathway that manages or contributes to a wide range of crucial bodily functions, like immune function, mood balancing and controlling inflammation.” Lowered methylation function, says Yasko, “may” contribute to many major chronic conditions, including autism. According to her, autism is “a multifactorial condition, with genetic, infectious, and environmental contributors” and the methylation cycle is “unique” and “critical for health” because it “can” have an impact on all of these factors. Invoking epigenetics, Yasko says that it also is “the system the body uses to edit and correct problems with other genes” and “regulat[es] all other genes in your body” and “having your Methylation Cycle in balance gives you the tools you need to help turn on or off those other genes.”

While she may be solid, as one would expect, on some of the basics of genetics (she likes to impress readers with complicated diagrams and descriptions of gene functions), and her “Nutrigenomic Test” may actually uncover SNPs, it’s what she does with the results that veers from solid science into the wilds of pseudoscience: She runs the test results through a proprietary program, the details of which are apparently secret, generating a long list of dietary supplements which, she claims, address the genetic “weaknesses” uncovered by the test. Once the dietary supplement regimen is instituted per her instructions, regular lab testing is performed, supposedly to monitor and tweak the regimen. (You can find a sample test result and supplement recommendations here.)

Her protocol and its putative rationale are explained in a series of self-published books Yasko authored, including Feel Good Neutrigenomics: Your Roadmap to Health (which I read) and Autism: Pathways to Recovery (which I also read a good bit of), as well as DVDs, workbooks, lectures, and other websites, including CH3nutrigenomics, an “over 18,000 members strong” chat group she runs.

All of these – the genetic test, the supplements, the follow-up testing, as well as her books and DVDs — are sold by an “allied” (her description) company, Holistic Health International, which is solely owned and run by Yasko’s husband and linked to Yasko’s website under the “Our Products” tab. (Some materials are also available for free download.) Holistic Health also owns the copyright to “Dr. Amy’s” website. While the genetic and follow-up tests are purchased from Holistic Health, they are actually processed by two labs known for their unconventional laboratory-developed tests, Doctor’s Data and Genova. Doctor’s Data runs the “Nutrigenomic Test” and, as mandated by the FDA, Doctor’s Data requires a physician requisition for the test. Because the test is ordered directly by the consumer from the Holistic Health website, it is unclear how a physician’s requisition is obtained in the process.

According to Yasko, she has worked with almost 10,000 families worldwide. She also claims she has 71,000 people on her Facebook page, along with the thousands in her chat group.

Autistic children whose families choose to follow the protocol, which can cost thousands of dollars a year and last for years, may down dozens of dietary supplements a day, resulting in doses of micronutrients far exceeding the Recommended Daily Allowances. Their caretakers must regularly collect their urine, stool, and hair and send them in for lab testing, ordered via Holistic Health.

“Dr. Amy” was brought to my attention by a correspondent and I was made privy to an autistic child’s “Comprehensive Methylation Panel with Methylation Pathway Analysis,” the product of the child’s “Nutrigenomic Test,” processed through Yasko’s proprietary program. True to form, the “Analysis,” which bears the name and logo of the Neurological Research Institute, claims to have uncovered genetic “weaknesses” in the child which could be “bypassed” with “proper supplementation.” The results are given in a chart, listing gene names (e.g., “COMT”), the variation identified (e.g., “V158M”), whether there is a mutation, and its call (e.g., “Hetero”).

Based on the genetic test results and their processing through “Dr. Amy’s” proprietary program, recommendations include what Yasko calls “Step One Supplements,” which everyone should take as “nutritional groundwork” for her protocol, including “Basic Methylation Support,” as well as supplements supposedly tailored to mutations uncovered by the “Nutrigenomic Test.” For example, under “COMT V158M (COMT H62H) +/- VDR/Taq Tt” we find recommended two “Mutation Specific Formula RNA” supplements (here and here), 3 different B12 supplements (spray, drops, and tablets), Vitamin D, and “Methyl Max” (which also contains B12 and Vitamin D, along with, among other things, curcumin, ginkgo leaf extract, and an ingredient that comes from pigs).

By my count, Yasko recommended 75 different supplements for this child, plus B12 gum and B12 injections. For most, one or more doses are given per day. I added up the initial investment in these products if ordered from Holistic Health at current pricing and, not counting a few I couldn’t find, came up with a little over $3,500. In addition, the “Neutrigenomic Test” costs $495, plus regular follow up lab testing, which normally includes a hair analysis test ($95), comprehensive stool analysis ($345), and urine toxic and essentials elements test ($208). While Yasko maintains that all products need not be ordered from her husband’s company, many of the recommendations are Holistic Health-labeled products (e.g., “mutation specific” RNA, at $85). Some are Holistic Health formulations she created specifically for the protocol and not available elsewhere.

Yasko’s “Analysis” for this child included over 7 pages of citations from medical and scientific journals and other sources but, tellingly, she never cross-references these citations to her discussion, nor does she otherwise attempt to explain how they support her protocol.

In addition to her penchant for massive doses of dietary supplements, Yasko invokes other CAM tropes in her autism protocol: vaccination and heavy metal fear-mongering, the need to “detoxify,” and complicated diets. One of the purposes of the regular lab testing is to identify the presence and excretion of heavy metals via hair tests, “a cardinal sign of quackery,” according to Quackwatch, as well as urine and fecal tests. According to her book, Autism: Pathways to Recovery, common foods like mayonnaise, mustard, skim milk, croutons, and chocolate should be avoided because they “damage the nerves.” But we’ll have to leave these issues for another time. Today, we focus on the linchpin of Yasko’s autism protocol: her claim that using the right supplements can control how your genes act, in effect bypassing genetic mutations to optimize methylation cycle function, and, from that, positively affect the course of autism.

Experts and evidence belie “Dr. Amy’s” claims

Despite succeeding (if she is to be believed) where the entire scientific and medical community has failed, she has yet to publish a single paper in a respected peer-reviewed journal explaining just exactly how she achieves her miraculous results, no doubt preferring to keep her methods free from critique by those most qualified to evaluate them.

Since she won’t proffer her evidence to the scientific community, let’s compare her claims to what experts say about the evidence regarding genetics and nutrition and their relevance to the treatment of autism. Is there competent and reliable scientific evidence to support her claims?

First, while there are ways to help minimize the symptoms and maximize abilities, there is no cure for autism known to science. Thus, in asserting that her protocol achieves “considerable success in halting and in many cases reversing the effects of” autism, Yasko is claiming progress that has eluded the entire corps of autism researchers for decades. That alone makes her autism protocol lack credibility, to say the least. In fact, as we’ll see below, her assertion that her complicated protocol affects the course of autism in any way, even short of “reversal” or “halting,” isn’t credible either, based on the current state of our knowledge.

Second, the field of nutritional genomics is largely unregulated, with no defined standards. Until standards are developed, commercial firms purporting to give dietary advice based on genetic testing, like “Dr. Amy’s,” should be regarded with extreme caution. In her book, Autism: Pathways to Recovery, Yasko claims:

Once the molecular pathways are detected by specific SNPs are known, Nutrigenomics uses combinations of nutrients, foods, and natural ribonucleic acids to bypass these mutations and restore proper pathway function.

But, according to respected experts in the fields of nutritional genomics, this is simply not possible based on our current understanding of the interplay between genetics and nutrition.

In 2014, the Academy of Nutrition and Dietetics issued a position statement:

The knowledge gained from nutritional genomics requires an evidence-based approach to validate that personalized recommendations result in health benefits to individuals and do not cause harm. Whether or not the knowledge gained from nutritional genomics can be integrated into the everyday lives of consumers is yet unknown. [Emphasis added.]

According to the Federal Trade Commission:

The FDA and CDC say they don’t know of any valid scientific studies showing that genetic tests can be used safely or effectively to recommend nutritional choices or to genetically customize dietary supplements . . .

In 2010, the Governmental Accounting Office issued a report following its investigation of companies offering dietary supplement recommendations based on genetic testing to treat diseases. According to the GAO:

there is no scientific basis for suggesting that supplements, diet, or exercise can be customized to DNA.

As to one company’s suggestion that dietary supplements could address the supposedly subpar performance of certain genes, the GAO’s experts called such claims “nonsensical:”

We have no idea of (a) whether the reduced activity has any real health implications and (b) what one would reasonably do about it if so.

Deficiencies in Yasko’s understanding of the clinical usefulness of genetic tests are evident in a review of her “Nutrigenomic Test” analysis for two autistic children by the medical director of the Autism Speaks Autism Treatment Network, developmental pediatrician Daniel Coury, in an interview by Bloomberg News reporters:

there is no scientific evidence that the recommendations would combat autism. . . Many genetic mutations examined in the these are also found in healthy people and there is no good evidence they cause autism . . . The mutations, while they are real genetic variant, haven’t been linked to nutritional deficiencies in autism patients . . . It sounds scientific, but the connection to autism isn’t there . . . I don’t see any evidence that it is useful.

Third, whether supposedly “customized” based on a genetic test or not, researchers question whether autistic children need dietary supplements at all. A systematic review of dietary interventions studies published in Pediatrics concluded that:

There is little evidence to support the use of nutritional supplements or dietary therapies for children with ASD.

Likewise, a cross-sectional study examining dietary supplement use and micronutrient intake in children with ASD likewise concluded that:

Few children with ASD need most of the micronutrients they are commonly given as supplements, which often leads to excess intake.

Speaking of “excess intake,” just one of the several B12-containing supplements recommended by Yasko, Holistic Health’s “Hydroxy B12 Mega Drops,” is given up to three times a day at 1,000 mcg per one-drop dose. According to a pharmacist I consulted, that’s up to 983% of an eight-year-old’s RDA! Even if not dangerous, it’s a tremendous waste of money.

Of course, excessive dosing is not an issue with Holistic Health’s Yasko-recommended “mutation-specific” RNA. That’s because, as SBM’s own David Gorski, who works with RNA, pointed out, RNA is incredibly unstable and unlikely to make it past your mouth. (Yet, she claims in Autism: Pathways to Recovery, that she has “devised a format in which the RNA stays intact in order to have a positive effect on the body,” although this is another secret method she won’t reveal.) When interviewed by Bloomberg News reporters about Yasko’s protocol, physician James Laidler, whose own son is autistic, called the whole concept of RNA supplements to treat specific gene variants “just laughable.”

And that’s not the only pharmacokinetics problem with Yasko’s dietary supplements. If you want to read more on the daunting prospect of any supplement getting absorbed and distributed to a particular point in the body, where it must be present in sufficient quantity, and for an adequate duration, to have an effect, read Scott Gavura’s excellent SBM post on the subject: “Where science meets supplements.”

Fourth, not only is nutritional genomics in its infancy, the utility of genetic testing in general in providing clinically relevant information is in its infancy. While the “Nutrigenomic Test” may accurately find SNPs (in other words, it may be analytically valid), neither its clinical validity (how well the genetic variant being analyzed is related to the presence, absence, or risk of a specific disease) or its clinical utility (whether the test can provide information about diagnosis, treatment, management, or prevention of a disease) has been established. That’s not just for selecting dietary supplements. That’s true of all genetic testing for most treatment decisions for any disease or condition, including autism. In particular, the genetic components of autism simply aren’t understood well enough for genetic testing to aid in treatment decisions.

Fifth, Yasko recommends that individuals work with their own health care professional, but does not require it. (Of course, what self-respecting physician would sign off her pediatric patient downing dozens of supplements a day and undergoing regular unnecessary lab testing?) This falls far short of the American College of Medical Genetics and Genomics recommendation that a certified medical geneticist or genetics counselor be available to help the consumer determine whether a genetic test should be performed, which test should be performed, and how to interpret the results in light of personal and family history. Yasko’s cookie-cutter approach to genetic testing does none of this.

In sum, not only are Yasko’s claims of “reversing” or “halting” autism not credible, the idea that her supplement protocol could have any beneficial effect on autism is not credible:

  • According to experts in genetics and autism, genetic tests, like the “Nutrigenomic Test,” are not useful in guiding treatment decisions in general and dietary supplement recommendations in particular for autism. We simply don’t know enough about the interaction between genes and environmental factors, like nutrition, to make valid treatment decisions for autistic children.
  • Autistic children usually don’t need to take dietary supplements anyway.
  • If you’re thinking of submitting yourself or your child to a genetic test to guide healthcare decisions, you should do so under the guidance of a properly-credentialed genetics practitioner, who should consider not only the test itself, but also personal and family history.

The Yasko autism protocol ignores all of this, at the same time imposing an incredibly intrusive regimen and great financial cost on already-stressed families of autistic children. On top of that, recommending that patients purchase supplements and tests she recommends through her husband’s company presents a significant conflict of interest.

Yasko apparently sees the testimonials on her website and in her book as “proof” that her protocol “works.” But she was a researcher herself and she knows that’s not how competent scientists go about doing good science. She knows that only a well-designed, well-conducted clinical trial can show whether her protocol is effective. She knows that reputable scientists from the fields of autism, genetics, and nutrition have concluded we don’t have sufficient evidence to claim what she claims. (Far from it!) That makes it especially reprehensible that she is selling this complicated, unproven and expensive regimen to parents desperate to improve their autistic children’s lives.

Notes:
For good information on evidence-based treatments and how to evaluate marketers’ claims, consult the Association for Science in Autism Treatment website.

For science-backed information on genetic testing and its limitations, see the National Library of Medicine: Genetic Testing.

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Posted by Jann Bellamy

Jann J. Bellamy is a Florida attorney and lives in Tallahassee. She is one of the founders and Board members of the Society for Science-Based Medicine (SfSBM) dedicated to providing accurate information about CAM and advocating for state and federal laws that incorporate a science-based standard for all health care practitioners. She tracks state and federal bills that would allow pseudoscience in health care for the SfSBM website.  Her posts are archived here.