Genetic Future

Amway sells genetic tests?

From Emily Singer’s article yesterday in Technology Review:

A number of companies offering direct-to-consumer genetic testing have
cropped up in the past two years to capitalize on these advances, from 23andMe and Navigenics, which offer genome-wide scans to identify specific disease-linked genetic variations, to Knome,
which offers whole-genome sequencing to the wealthy. Any doubts that
personal genomics is making its way into the mainstream can be assuaged
with a look at Interleukin genetics, a startup that sells genetic tests
for heart-disease risk, B vitamin metabolism, and other factors through
Amway, the direct-sales company
. “With minimal advertising, these
companies have captured the imagination of the public,” says Robert Green, a neurologist at Boston University and one of the conference organizers. “The public is eager to know more about genetics.” [my emphasis]

(This paragraph has also been picked up by Slashdot, and pointed to by wyattsgirl.)

What sort of tests are Amway selling? Here’s the low-down:

The Gensona
Heart Health Genetic Test looks for a particular variation in the IL1
gene that is associated with excess inflammation – which is associated
with an increased risk for heart disease.

The Gensona
General Nutrition Genetic Test identifies differences in how your body
metabolizes important nutrients, including B vitamins and antioxidants.

(From here.) Here’s a hint for potential customers: one marker in one gene is not a useful predictor for heart disease risk, and any test that speaks vaguely about “identifying differences” without specifying what those differences are should be treated with extreme caution.

(Added in edit: In the comments, Interleukin Genetics’ Erin Walsh disputes my claim that the test literature “speaks vaguely” about the variants tested; but while it is indeed possible to find more information on the Interleukin Genetics website, it’s difficult or impossible to get this information from the Amway site selling their tests. See my comment below for responses to other points raised by Walsh.)

I found these adjacent segments from the FAQ amusing:

Do Gensona Genetic Tests tell me which supplements I need?

No. The Gensona Genetic Tests do not recommend any supplements. Gensona
Tests are tools to help you understand your risk of certain diseases
and conditions. The tests do not include any supplement recommendations.

Now that I know my genetic test results, what should I do to get a supplement recommendation?
Enter your genetic test results in the Health Questionnaire tests
result modules, obtain your personalized supplement recommendation, and
order your Customized Packets.

Can I buy my gene test and Customized Packets using the same cart?

No. You can place your Gensona Genetic Test order along with your regular Quixtar order. But Customized Packets are packaged exclusively for you at Nutrilite in Buena Park, California. Your Customized Packets are sent separately, by FedEx Ground, to ensure timely delivery.

I guess they want to steer well clear of that classic danger sign, advertising supplements tailored to specific genetic test results (note: any company that tries to do this is scamming you, pure and simple), so they’ve gone to great lengths to separate the test results from the supplement recommendations while encouraging customers to move directly from one to the other.

These are the types of tests that give direct-to-consumer genetic testing a bad name; careful regulation that punishes these bottom-feeders while leaving scientifically supported tests intact (i.e. the major personal genomics companies) is long overdue.

Comments

  1. #1 razib
    June 11, 2009

    ok, genetic testing has now jumped the shark….

  2. #2 Steven Murphy MD
    June 11, 2009

    Daniel,
    Companies have been doing this for a decade. Sciona, Market America, Genovations, suracell.
    This lack of enforcement of these compnies is why we have the aggressive response from the Fed now. I am surprised they are only hitting the radar screen of emily now.

    Steve

  3. #3 Stuart Hogarth
    June 12, 2009

    The Gensona test is produced by Interleukin Genetics, and has been sold through Amway for several years. It will be interesting to see how the older, smaller companies like Interleukin Genetics survive competiton from the newer players in this space. I understand that Sciona have very recently closed down.

  4. #4 Erin Walsh
    June 12, 2009

    Interleukin Genetics welcomes an honest dialog on our genetic tests and values consumer feedback. With that said, I would like to address a few points from this post as it’s valuable to provide some facts and detail to avoid generalizations based on the limited information presented in the post. Interleukin Genetics is a company that has been involved in research and development of genetic tests for complex diseases of aging for over 15 years. We have a superb scientific advisory board and have conducted research studies at major academic centers throughout the world, including the Mayo Clinic, Brigham & Women’s Hospital at Harvard, and the NYU Hospital for Joint Diseases.

    Our IL-1 Heart Health genetic test which Mr. MacArthur refers to has been validated in multiple studies (Iacoviello et al. 2005; Latella et al. 2009; Rogus et al, 2008; and others) to identify overtly healthy individuals who overproduce inflammatory chemicals and have a substantial and significant increased risk for an early heart attack – beyond the risk due to other risk factors. Our test is a pattern of markers within two genes that regulate inflammation and, as such, we are in complete agreement that no single risk factor accounts for the total risk of any complex disease. For example, a significant portion of first heart attacks occur in people without high cholesterol. That is why all of our information emphasizes that this test is focused on one of the risk factors and everyone should evaluate the full-range of risk factors, including LDL cholesterol, smoking, etc. The test is conducted in our CLIA certified lab and is approved in NY state, currently the highest standard for laboratory developed genetic tests. This month, Interleukin Genetics co-published a study in the journal Immunological Investigations supporting our findings that risk for early heart attack is associated with excess inflammation.

    With respect to Mr. MacArthur’s comment that our General Nutrition genetic test speaks vaguely about identifying differences, this is not true. The test describes the specific gene variations that are measured and provides the data supporting that they functionally change the body’s biology such that B-vitamins and anti-oxidants are not as efficiently handled. In fact, recent studies highlight the important role one of the key mutations (SOD2) for oxidative stress in our nutritional needs panel plays in influencing certain diseases and responsiveness to therapies. Most importantly, all of the B-vitamin and anti-oxidant changes due to the gene variations we measure in this test can be overcome by additional B-vitamin and anti-oxidant consumption.

    Finally, in response to concern about language related to the availability through other distributors of nutritional supplements that may be of value based on certain tests, we do not endorse nor recommend particular brands of supplements in our genetic test materials. It is important to provide individuals who purchase our tests with guidance on lifestyle and nutritional choices they can make that will help them lower their risk. Interleukin Genetics did collaborate on the development of one supplement to lower inflammation in people with a genetic tendency to over-produce inflammation. The results of that randomized controlled clinical study (Kornman et al. 2007) was published in a peer-reviewed journal and actually won an award from the European Society of Enteral and Parenteral Nutrition for the best paper in that journal in 2007. That paper is one of three prospective studies proving the value of genetic-nutritional interactions (nutrigenetics).

    We encourage anyone with questions to review our science that is documented on our Website (www.ilgenetics.com), look at our collaborations and publications, including papers in the New England Journal of Medicine, Human Molecular Genetics, and Human Genetics, and carefully read our test information. If you are interested in learning more about our Heart Health and other genetic tests, please feel free to contact me at ewalsh@ilgenetics.com.

    Thank you.

    Erin Walsh, Senior Manager of Public Relations for Interleukin Genetics

  5. #5 Zach
    June 12, 2009

    Non-FDA tested supplements designed to combat a highly polygenic disease phenotype that are sold by a multi-level marketing company?! How can I lose?!?! *facepalm*

    FDA oversight of these modern day mountebanks would put them out of business in a (non-inflamed) heartbeat. Fortunately for them, Orrin Hatch rammed the DSHEA through Congress back in 1994, which deregulated this multi-billion dollar industry.

    It doesn’t matter how many articles you can cite showing that genetic variants are linked to disease phenotypes. You have not demonstrated that your product actually does anything other than make your company money at the expense of undereducated consumers who can’t think critically.

    Seriously, how can you parrot winning an award from the European Society of Enteral & Parenteral Nutrition (which boasts of its connections to Abbott, Nestle, Baxter, Danone, etc. on its website), knowing full well that the American College of Medical Genetics stated in 2004 “Due to the complexities of genetic testing and counseling, the self-ordering of genetic tests by patients over the telephone or the Internet, and their use of genetic “home testing” kits, is potentially harmful.”

    How do you sleep at night?

  6. #6 Jim Smith
    June 15, 2009

    I invite all who have an interest in the subject of DNA testing and how it can be used to promote healthy aging and customized wellness to visit this site.

    A legitimate realization of the promise of DNA for the masses…

    http://LifeMapNutrition.com/BeGreat

    Jim Smith
    714-797-6382

  7. #7 Daniel MacArthur
    June 15, 2009

    Hi Jim,

    That’s pretty funny – I guess you didn’t actually read the post before deciding to advertise your company here? The last two paragraphs should give even casual readers a fair idea that I’m not exactly enthusiastic about the scientific basis of your business strategy.

    Hi Erin,

    Thanks for your lengthy comment. I appreciate you outlining the scientific basis underlying your company’s products, but I’m still rather uncertain about the strength of the evidence supporting your tests. For instance:

    1. It’s widely acknowledged that the widespread failure to replicate both candidate gene association studies and linkage studies means that results from such analyses need to be treated with extreme caution; however, genuine signals from common SNP markers should in most cases be picked up by modern genome-wide association studies (GWAS). Have any of the recent GWAS for heart disease phenotypes identified a significant association with any SNP in strong linkage disequilibrium with any of the markers in your tests?

    2. The results of GWAS analyses have thus far suggested that common SNP markers typically explain only a very small fraction of the variance in heart disease risk. Do you have an estimate of the total variance in risk explained by the markers used in your tests?

    3. While there is a “scientific summary” linked to the “Heart Health” test on your website including a list of related publications, no such summary or publication list is provided for your “General Nutrition” test. Why is that?

    4. More a comment than a question: in the “award-winning” article you cite, the authors looked at three separate nutritional supplements vs a placebo group, but only present data from one of the supplements (noting in passing that the other two supplements were not significantly different from placebo). A large number of statistical comparisons of outcome measures between the remaining supplement and placebo group were then performed. However, nowhere in the text is it stated that P values were corrected for multiple testing for both the multiple unreported study groups or the multiple comparisons. Performing an appropriate (Bonferroni) correction to the stated P values results in non-significant findings. In other words, the published data do not provide statistical support for a genotype effect that is larger than expected by chance. It is extremely surprising to me that this article survived peer review; the fact that it won a prize is downright appalling.

    Oh, and one final point: it’s “Dr MacArthur”, although I prefer simply “Daniel”. Thanks. :-)

  8. #8 Jeff Barrett
    June 15, 2009

    Heh, you beat me to it, Daniel &mdash I was going to point out that it was “Dr” as well. :)

    While I think you pretty much hit all the key points in responding to Erin’s comment, I’d just like to point out that a quick skim of the cited literature is pretty unimpressive (e.g. the 2005 study involved only 134 samples). While there may very well be some link between the variants in question and “overproduction of inflammatory chemicals”, and thus heart disease, the effect size is going to be smaller than most of the various associations reported in the GWAS literature, of which there is a resounding agreement in the field that meaningful predictive value closely approximates nought. (preaching to the choir, I know!)

  9. #9 Daniel MacArthur
    June 16, 2009

    Hey Jeff,

    Good points, and an opportunity for me to re-emphasise – I’m not arguing that the variants tested by Interleukin Genetics are not associated at all with heart disease, although this may be the case (the evidence is fairly unimpressive). Nor am I arguing that DTC genetic testing is inherently wrong; in fact, I’m a consistent advocate of free access to genetic testing.

    My position is basically that any tests that are offered directly to consumers need to have their evidence base and explanatory power clearly labelled. While I don’t support an outright ban on poorly supported genetic tests, I’d like to see independent bodies established to provide certification of such tests as scientifically sound, and to advertise to consumers that only tests with this certification should be regarded as valid.

    Essentially I think the answer here is accurate information; and I suspect if such information was freely available there wouldn’t be many customers left for Interleukin.

  10. #10 Bruce Campbell
    July 10, 2009

    Daniel, (I am not impressed that you are a doctor)
    You fault-finder types all make me ill. I bet you also believe in global warming, the tooth-fairy, and socialized medicine. I don’t know how I ended up on this site. Must be a computer malfunction.

  11. #11 john hammons
    July 11, 2010

    How many of the posters against the genetic tests are medical doctors? Could it be you are afraid of losing business because more people would become healthier in the process?

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  13. #13 Kamuel john nawgiri
    December 29, 2010

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    • I am retired from Indian Navy after 12 years Active Defence Service
    • During Defence Service I met with an accident and lost my right Eye sight with blunt injury and operated for Traumatic Catract in 1983.

    Since 1990 I suffered from sinusitis. It is not continuously and neither season wise but once in a year for continuously for 2/3 months I get my nose blocked for which I used to take nasal drops (Otrivin) and get relief.
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    In 2003 I suffered from Kidney Stone for which I was hospitalized and was given licil etc. within 8 hours I got skin rashes on my Lip and some part of body (skin).
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