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The alternative health industry is widely broadcasting that so-called dangerous genetic variation is lurking in the human population, causing a public health crisis that is ignored by the medical community.
This curious forewarning appears to have emerged out of an explosion of direct-to-consumer genetic testing and health gurus preaching that “natural” remedies can override our genetic make-up. Look no further than Deepak Chopra, who has gone deep down the rabbit hole in suggesting that our thoughts can rewire our biology.
Alternative practitioners are now forging highly profitable businesses based on patients coming to them with raw genetic data provided by testing companies, typically 23andMe, and walking away with hundreds if not thousands of dollars in nutritional supplements.
But scientific and medical experts recommend against blindly screening for genetic variants called single-nucleotide polymorphisms (SNPs). They warn that these tests carry problems of false results, over-diagnosis and meaningless information. Alternative medicine promoters argue otherwise, and they are spreading the message while churning big profits.
Ben Lynch, a naturopathic doctor in Washington state, has built an online empire centered on selling genetic analysis and naturalistic treatments for particular genetic variants, which are highly common and have almost no impact on health or disease. In an email, Lynch told me that he recommends screening for genetic polymorphisms to everyone who “wants to optimize their life and reduce risk.”
Based on his own reading of the scientific literature, Lynch created an online platform, StrateGene, that flags SNPs from genetic raw data provided by direct-to-consumer testing companies 23andMe and Genos Research. On another site, Seeking Health, he sells products marketed to “target” biochemical pathways involving genes containing SNPs that StrateGene recognizes.*
Ricki Lewis, an author of genetics books (her latest coming out next month) and licensed genetic counselor who holds a Ph.D. in human genetics, cautions that any health practitioner who sells such services “is a modern-day version of a snake oil salesperson.”
In 2007, Lynch graduated from Bastyr University, an accredited naturopathic program, outside Seattle. Naturopathy comprises a variety of alternative medicine practices including homeopathy, herbal medicine and healing touch. As a naturopathic doctor in Washington state, Lynch is considered to be a primary care physician. But it is important to note that graduates of accredited naturopathic programs only complete a minuscule portion of the training received by medical doctors.
Lynch reported to me that he no longer directly sees patients. He stated he is now “busy researching and educating,” which includes teaching continuing education courses and speaking at conferences hosted by Bastyr.
Thanks to @DrBenLynch for his in depth talk, Folic acid, MTHFR, and Folate: Clinical Insights. pic.twitter.com/a3DzhqptB6
— Bastyr University (@Bastyr) May 24, 2016
Lynch is also the founder of Seeking Health Educational Institute (SHEI), which provides him with another revenue stream. Here, Lynch sells virtual courses to health practitioners wanting to implement genetic screenings, consultations and treatments into their businesses. These courses are also available directly to patients. He claims to teach how to create a million-dollar online business, as he allegedly did for himself while "in medical school." And through a pyramid-like incentive scheme, Lynch gives commission to SHEI members who recruit others into buying StrateGene and SHEI products.
SHEI operates using a referral program to connect StrateGene and Seeking Health clientele with practitioners who have taken his online courses and paid annual membership fees. The practitioners listed on the site’s directory include acupuncturists, chiropractors, naturopaths, nutritionists, nurse practitioners and a few physicians. Lynch’s own brand of polymorphism screening and subsequent sales of supplements is often reproduced on the practice websites of his SHEI members.
Debra Doyle, the genetics coordinator for Washington State Department of Health, is highly concerned that practitioners are selling such treatments and highlights that there is a “significant conflict of interest in any clinician who recommends or prescribes a therapy or treatment regimen that he or she would profit from directly.” In her opinion, "such practice would be highly unethical."
So much of this alternative practice zooms in on one gene in particular: MTHFR.
Lynch runs yet another website affiliated with SHEI and StrateGene called MTHFR.net. He boasts that this site is the “leading resource for unbiased, researched information strictly about the MTHFR mutation [sic].” Despite numerous errors in his use of genetic terminology, Lynch benefits from the fact that his ideas are widely consumed in the alternative medicine community.
Don't miss a great webinar on #MTHFR essentials with @DrBenLynch and Dr. Paul Anderson http://t.co/wpbI6PASMj Great price and CEUs offered!
— CNDA (@CNDA_ND) January 11, 2014
The MTHFR gene encodes an enzyme called methylenetetrahydrofolate reductase. This enzyme is part of the metabolism of folic acid—an important B vitamin for many biochemical pathways, including the processing of some amino acids.
Testing for MTHFR SNPs, what Lynch is calling “mutations,” is not recommended by any professional medical organization. Some organizations have taken a step further and published statements against ordering tests to identify MTHFR polymorphisms.
In April 2015, Doyle co-authored a Washington State Department of Health newsletter that was broadly circulated to medical professional organizations in the state, including the Washington Association of Naturopathic Physicians, in order to curtail wasteful genetic testing.
The newsletter bluntly reminded health practitioners that screening for common MTHFR polymorphisms is an example of “genetic test overutilization.” It outlined the American College of Medical Genetics (ACMG) guidelines, which explicitly state that MTHFR SNP testing should not be ordered to evaluate diseases.
Some of the associations between MTHFR SNPs and diseases include recurrent pregnancy loss or bleeding disorders. But this evidence is so flimsy that ACMG recommends against testing patients in the presence of symptoms for these conditions, and concluded that the SNP test results have no impact on treatments. This makes screening for MTHFR SNPs that are possibly related to other diseases highly dubious.
But alternative practitioners like Lynch insist that they know better than the experts. Lynch told me that he is aware of the ACMG guidelines but “strongly disagrees” with them, stating they are “missing the point.” He cites that the Centers for Disease and Control “Genopedia database has over 638 disease terms associated with MTHFR.” He writes that addictions, fibromyalgia, schizophrenia, Down syndrome, cancer and autism “may all be linked to a MTHFR gene mutation [sic].” This misinformation is spreading:
How MTHFR mutations are related to cervical dysplasia and cancer. https://t.co/C5OaWhiomk
— Dr. Doni Wilson (@glutenfreedoc) July 10, 2016
The fact is that many of the associations between MTHFR SNPs and diseases are meaningless and methodologically flawed. “[MTHFR] variants are so prevalent, and folate metabolism associated with so many aspects of human metabolism, that these correlations are often spurious,” says Doyle.
Diseases known to be related to polymorphisms in the MTHFR gene include neural tube defects, such as spina bifida, and homocystinuria—high levels of the amino acid homeocysteine detected in urine. A complex mixture of environmental and genetic factors causes neural tube defects, and there are several genetic mutations in addition to MTHFR SNPs that can cause homocystinuria.
Most people with MTHFR polymorphisms have no health consequences. “A person can have a polymorphism in the MTHFR gene that lowers the enzyme level and be perfectly fine,” says Lewis.
Of course, Lynch told me he disagrees, likely because his business depends on it. Lynch proposes that MTHFR SNP testing can identify patients that need to supplement with methylated folic acid to bypass the reaction performed by the MTHFR enzyme. He seems to believe that this supplementation can lead to a reduction in those hundreds of diseases that are, according to him, associated with MTHFR SNPs.
“There is no credible evidence to support the benefit of nutritional supplements as a treatment for single nucleotide polymorphisms in the MTHFR gene,” says Doyle.
Lynch appears to have one last trick up his sleeve. He argues that his supplementation regimens don’t deal with the downstream effects of SNPs per se, but act as epigenetic therapies that override genetic predispositions.
Epigenetics is a cutting-edge scientific field that studies the expression of genes unrelated to the genetic sequence. One of the mechanisms proposed for epigenetic modification is DNA methylation, when a single-carbon molecular group is added onto the backbone of the DNA sequence. Lynch and his disciples link the MTHFR enzyme directly to this activity, but this is flat-out wrong and appears to be yet another scheme to sell product.
Besides wasting money, Lewis warns that telling patients they need to test for and then treat for alleged genetic abnormalities can lead to “unwarranted anxiety.” And this damage can last a lifetime. This means patients are being permanently branded with a bogus genetic problem and having to buy supplements from naturopaths and other integrative practitioners who are knowingly practicing against the recommendations of experts in medical genetics.
Many of the supplements may not even be safe. There is worrisome evidence that taking too much folic acid and related forms may promote the development of cancer and increase the chances of dying from it. But this should not be interpreted to undermine the well-documented benefits of taking a recommended daily dose of 400 mcg of folic acid before getting pregnant and during early pregnancy. In contrast, many practitioners who utilize genetic testing to sell supplements recommend anywhere from 800 mcg to 50,000 mcg per day for patients with genetic polymorphisms that they have deemed problematic.
Currently, it is not easy to estimate the size of the market carved out by Lynch and others who subscribe to his genetic scheme. He claims to be making a six-figure income with his online platforms, and there are others out there aspiring to be like him.
Get the genetic test done and find out if you have a defect in the MTFHR gene. It can change your life! http://t.co/5ZVsV0CKfA
— Chris Deszynski N.D. (@NorthamptonND) March 13, 2015
StrateGene’s raw genetic data analysis service is not regulated by the U.S. Food and Drug Administration (FDA). This may eventually pose a problem for those who use it and other similar platforms. In 2013, 23andMe was ordered by the FDA to stop analyzing people’s genetic data for disease risk factors until the tests could be validated. The test was off the market for two years. In February 2015, 23andMe launched a new genetic testing kit, this time with FDA approval, that identifies SNPs for particular heritable conditions, like cystic fibrosis. The FDA prohibits the company from providing customers with information about any future risk of developing other diseases.
It is hard to see how StrateGene differs from what 23andMe offered before 2013. Individuals who probably do not have an elevated risk for inherited diseases are analyzing their genetic raw data, still provided by 23andMe, with Lynch's StrateGene tool. He and others in his affiliate network are then profiting off of the sales of supplements that allegedly circumvent enzymatic deficiencies linked to SNPs. This appears to be an effective strategy for the supplement industry to get large volumes of unregulated product to customers. And many supplement companies are directly funding the political lobbying of these alternative practitioners who desperately want to be recognized as legitimate medical professionals.
None of these rogue genetic analyses and supplements is necessary, according to genetic experts. Patients should be skeptical of anyone claiming to divine health information from direct-to-consumer genetic testing. Only licensed genetic counselors and doctors who are board certified in medical genetics are qualified to provide genetic health information.
Instead of getting caught up in genetic screening by alternative practitioners, patients should simply eat well, exercise and not smoke. Lewis says, “You don’t need an expensive genetic test for that practical advice.”
*This sentence has been updated for accuracy.
