Regulate the diet industry!

By Razib Khan | August 3, 2012 10:15 am

Brandom Keim leaves this comment:

It’s easy to see genomic data regulation in romantic narrative terms — The plucky little guys who want to be free! The big, bad institutions who want to control them! — and it’s also a trap. Interpreting genomic information in a medically useful way is very, very complicated. It’s easy to do badly — and people may make life-altering decisions based on bad information.

Gene-testing companies already have a track record of offering tests unsupported by unsupported by clinical evidence, such as CYP450 testing to determine antidepressant dosage. A let-the-market-regulate-itself, buyer-beware approach isn’t any more desirable than it would be for new drugs.

We’re discussed this before. The shorter perspective from me is that on principle I don’t object to regulation, but when viewed across the constellation of things which our government regulates, I don’t see the case for direct-to-consumer genomic services being monitored closely. A result from 23andMe will not kill you, though it may lead to a sequence of actions which may kill you. But this is unfortunately a problem with the whole diet industry, which is often based on unsupported fads and fashions, and has a much larger social impact. Nutrition is very complicated with incredible real life consequences, and yet regulating it would frankly be a fool’s errand. You may destroy the American diet publishing industry, but you can’t prevent internet message boards. Similarly, the SNP-chip results themselves are commodities, and with client and server analytic software proliferating in the next few years the reality is that the market will regulate itself! And unfortunately, the impact on peoples’ lives will be the same, for good or bad, as the diet industry.

For a firm like 23andMe I can see how getting cleared by the FDA makes sense. It probably protects them more against liability, because they are going to offer services with medical relevance, and that is going to result in good & ill. In contrast, if you write an application which hooks into public databases like SNPedia you probably aren’t going to be sued. So in the future I see a two-tiered system emerging. The regulated sector, which is going to be expensive, and probably have costly doctors on staff who don’t add genuine value, but reassure gullible customers as to the veracity of the results. And a more unregulated (“open source”) market segment where people run their genotype through algorithms. Because of the large scale lack of power of personal risk prediction I doubt there’s going to be much difference in either case in terms of health outcomes.

Oh, and last year I released my genotype into the public domain. I just got this email yesterday:

I am writing to you as I have been developing a program that looks at 23andMe data in a different way from ‘Promethease’, see:

And, as you have placed your 23andMe results on the Internet I have run them through my program.

23andMe with their V3 chip test around 960,000 SNPs and my program at the present time looks at around 900,000 of these and searches out the ‘rarest’ SNPs – hoping to identify something special.

As your results are still in a ‘2011 format’ from 23andMe I have not been able to run your results quite as I would wish – but I do get some results. (And, if you do upload a current Raw Data file I’ll be able to get some additional results.)

The data below this email shows that you carry the ‘minor allele’ for about 15 SNPs that are both uncommon and do cause missense mutations.

Fortunately, you are not homozygous for any significant SNP

(excepting rs11541183 – which I think the data is poor & misleading).

Therefore, so far I haven’t find anything very exciting for me, or of any real concern to you.

It maybe that looking at 960,000 SNPs is too small a number to be giving significant results, and perhaps what I am doing is really just preparing the way for the future when 23andMe test several hundred millions of SNPs.

Another thing the results from the program show is that we know very, very little about most of the proteins.

I’ll be interested in your comments.


Dr Ian Logan

Unfortunately I bet I do have some homozygous deleterious loci (though obviously not lethal). Will be happy to find out at same point in the future. Unfortunately I can’t provide updated raw data, because 23andMe’s frozen downloads for a week (new build).

CATEGORIZED UNDER: Personal Genomics
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  • pconroy

    Interesting – I think Ian Logan released a build of his code first about 6 months to a year ago. I know I played with it a long time ago and didn’t find much of interest, though my sister has some deletion or other.

    However 23andMe released a new SNP report for Hemochromatosis just this week that was of interest.

    I’ve known for a few years that in the HFE Gene linked to Hemochromatosis, my father and one sister carry one positive allele:

    rs1800562 C282Y G to A AG

    Now I find that my mother and a different sister carry a different positive allele:

    i3002468 S65C A to T AT

    I myself am NOT positive for either. But now I feel I should reach out to my other 4 siblings who are not tested and inform them of these results.

    23andMe test 3 SNP’s as follows:
    rs1800562 – high risk
    rs1799945 – low risk
    i3002468 – low risk

    You are in danger of developing Hemochromatosis – much of which goes undiagnosed – if you carry either:
    2 x high risk alleles
    1 x high risk + 1 x low risk

    So any of my other 4 untested siblings would have a reasonable high risk of developing Hemochromatosis.

    That’s the first negative results of interest for me/family so far!

    BTW, my father’s mother used to have very painful joints, especially knees, which was attributed to Arthritis – and which inadvertently caused her death, when she stumbled and fell – but now I wonder if she actually suffered from Hemochromatosis, as that is also a symptom.

  • ohwilleke

    FWIW, the diet industry is subject to some regulation, but mostly by the Federal Trade Commission and state attorneys general charged with implementing state deceptive trade practices acts. The issue is not so much that they are unregulated, but that much of the diet industry would be better off regulated by the Federal Food and Drug Administration, and by state professional licensing authorities.

    There are boundary line issues between mere general purpose healthy cooking and food preparation, and genuine quasi-medical health programs, of course, which is why this mostly hasn’t been done so far. Defining what constitutes a “diet” isn’t easy. And, of course, there are free speech issues associated with regulating the dispensing of information that is factually true, but which comes a gloss of opinion that is currently viewed as unreasonable or unsubstantiated but isn’t really a fact.

    This concern about CYP450 isn’t troubling at all from a regulatory perspective because that information gets evaluated through the screen of a medical doctor or nurse practitioner or psychologist with additional special certification and training pertinent to prescribing psychiatric drugs, and continuing education requirements for all of those professions (the details of who can prsecribe vary from state to state, but almost all such professions have some continuing education requirements) provide a ready means to quickly disseminate to the pertinent medical professional communities any problems with relying on outfits like 23andMe that have emerged.

    From the point of view of outfits like 23andMe, I suspect that the issue is less one of liability (it is easy enough to include sufficient disclaimers and warnings to avoid that as a consequence of the First Amendment), than it is one of marketing – being able to say that you are the only consumer genomic test approved by the FDA for medical use, even others do the same thing within a few months, is a great way to boost your credibility and is probably more of a marketing plus than a regulatory cost minus over the several years period that it takes to get approved and earn back the regulatory costs. It probably pays for itself within a year or two of getting approval.

    Witness the huge economic success of the handful of diet programs that have received FDA approval for comparison sake.

    This is a comparison that I have little doubt has been made in the disclosures made to the investors who are financing this one time, moderately expensive, time consuming expense that comes with ongoing albeit modest regulatory costs that require it to do things like keep of file of published academic journal articles that support each of its medical effect claims that is subject to inspection on short notice by government regulators, establish a quality control regime at their lab, put in place a system to alert customers if a mistake is discovered, implement a privacy policy, designate privacy and record keeping officers, and put a lawyer on retainer to review any changes in the relevant regulations every year or so. For them, FDA approval is closer to Sarbanes-Oxley than it is for a typical pharma company.

    Why does FDA approval have marketing value? Because the fairly smart consumers who are interested in purchasing test results recognize that 23andMe is a for profit company and that there are incentives for unregulated for profit companies providing services that customers are in a poor position to monitor to cut corners, just as there was in the bad old days of snake oil salesmen, and government regulation puts a third party that is harder to buy off than a private certification company with no track record of its own to reassure customers (Underwriters Laboratories if one of the only credible ones out there and this isn’t exactly its thing) monitoring the company with inspectors who are qualified to build trust. Unregulated industries can be subject to product liability after the fact, but the right to sue a small company with one or two products and few assets after it provides you with a defective product or an inaccurate result or an unsubstantiated medical opinion when it has probably done the same thing to thousands of other people is cold comfort once you’ve already relied on the inaccuracy and suffered some kind of harm.


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About Razib Khan

I have degrees in biology and biochemistry, a passion for genetics, history, and philosophy, and shrimp is my favorite food. In relation to nationality I'm a American Northwesterner, in politics I'm a reactionary, and as for religion I have none (I'm an atheist). If you want to know more, see the links at


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