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The Genetic Mess in California – A Round-Up, and My Thoughts

On June 9, 2008, the California Department of Public Health sent cease and desist letters to 13 companies that offer genetic testing. According to the letters, the companies are in violation of certain sections of the Business and Professions Code of California, including offering “a clinical laboratory test directly to the consumer without a physician order” since such tests “must be ordered by a physician or surgeon” (according to these officials). Copies of the letters are available here. The companies receiving letters are:

  • 23andMe
  • CGC Genetics
  • deCODEme Genetics
  • DNA Traits
  • Gene Essence
  • HairDX LLC
  • Knome
  • Navigenics
  • New Hope Medical
  • Salugen
  • Sciona Inc
  • Smart Genetics
  • Suracell Inc

I’m entering this discussion late, although I’ve been watching with great interest. What I’ve noticed is that much of the discussion, both in the blogosphere and the media, is confusing or ignoring the fact that there are actually two questions involved here.

Question One:

The first question is solely a legal one: are these companies actually in violation of the California statutes? Ultimately, this question won’t be decided by the California DOH or the genetic companies; it will be up to the courts to decide (if it gets that far). It is important to note that just because officials at the California Dept of Health have interpreted these statutes this way doesn’t mean (1) that their interpretation is correct, or (2) that this type of testing is what the statute was meant to protect or defend against. Craig Manson at GeneaBlogie raises the same point:

The other point is that there is not necessarily a violation of state law simply because a mid-level bureaucrat says there is. There are questions about how the statute was intended to be interpreted and even some constitutional questions here.

Since at least a few of these companies have decided to ignore the cease and desist letters, they must believe that their testing is outside the prohibitions of the statutes, or that the statutes are unconstitutional (e.g. they impinge on an individual’s constitutional rights).

Question Two:

The second question is a matter of opinion: SHOULD genetic testing by these companies without a physician be illegal? This is a question that involves personal philosophy, ethics, and beliefs, and we should each answer this question for ourselves. I know what I believe, and I know what many of my fellow bloggers believe. But I hesitate to force my answer on anyone else. I would rather see a system where people can answer this question for themselves and then order from the appropriate company (i.e. a company with a physician, or a company without a physician).

What About the Uninsured?

And finally, there is one other point that I haven’t seen discussed anywhere else. Although genetic testing is expensive right now, it won’t be for much longer. In the next 5-10 years I’ll be able to send off my DNA and receive my entire sequence for much less than $1000. However, if a company is forced to employ geneticists and physicians to order tests and then interpret them for the customer, the price of testing will remain higher than it otherwise could be. Alternatively, an individual might be forced to visit a doctor who will then order the test for them, and then they’ll have to visit again when the results are returned. In either scenario, the expense of sequencing might be beyond the reach of most low- to middle-class Americans (as it is now). To compound this problem, many of these people do not have health insurance.

I agree completely that people who are uninsured should spend money on proper doctor’s visits rather than genetic testing, but in a few years – as we learn more – that will change. In the future genetic sequencing could have a huge impact on a person’s health and medical care. What happens if the uninsured can’t afford genetic testing because of these potentially expensive regulations? It might be a little far-fetched, and I don’t have an answer, but I thought I’d at least raise the concern.

The Round-Up

Here are some blogosphere reactions:

Here are some articles about the dilemma in California and New York:

Blaine Bettinger

Intellectual property attorney, genealogist, and author of The Genetic Genealogist since 2007

15 Comments

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  3. In requiring a doctor’s referral, aren’t people overlooking the fact that there’s lots of non-disease related information revealed by SNP profiling? Why would you want to put an overworked doctor who isn’t a genetic testing expert(and doesn’t want to be) in charge of this?

    I understand the point about protecting people from being taken advantage of by unregulated practitioners and scared by dubious information, but I don’t see how requiring a doctor’s permission will help this.

    Mr. Gunn’s last blog post..Thompson Scientific has a closed science search engine.

  4. Thank you for the nice comments everyone. Steve, I hope you’re right about the uninsured finding ways to get tested.

    Mr. Gunn, I think that the doctor’s permission requirement would help weed out non-scientific genetic testing, but I also believe there are more efficient ways of ensuring quality.

  5. My opinion is that GGists should stick to tests which do not allow for the positive identification of the persons tested but only of their patrilineage and matrilineage. Haplo tests serve just that purpose. GGists do not need in their work of simple genealogy/ancestrology the use of tests relying on diploid information which permit individual identification.
    If the aim is to do genealogy, then there is no need for tests which are normally reserved to the medico-legal domain or to biomolecular genome research.

    Their use poses at least a deontological problem.

    If people get tested in order to gain knowledge about their atavisms, about their genetic makeup and especially about their susceptibilities to certain “maladies”/behavioral tendencies, then their motivation is not genuinely that of Genetical Genealogy.

    I would prefer that test results relying on diploid information not be considered nor discussed by GG which is after all a scientific hobby, but be left to another discipline which remains to be given a name.

    We cannot fully imagine for the moment the societal consequences of letting ordinary people (wrongly) cultivate the impression of knowing their own genome and that of others.

  6. I don’t think it would, Blaine. CLIA certification and validated reporting methods would do that. Making people get a doctor’s permission to get the test done would make doctors the decision makers regarding which services are high quality and which aren’t, but they’re clearly the wrong people for the job. The average GP is way too busy treating patients. Some would categorically deny permission so they don’t potentially expose themselves to liability, and some would simply rubber stamp the form for whatever service was recommended by the AMA or their state’s health board or whoever the buck gets passed to. That doesn’t protect consumers any better than requiring CLIA certification, it just changes who’s taking responsibility for protecting consumers. Why shouldn’t this continue to be the FDA’s job?

    Nobody wants profiteers selling dubious results to a credulous public, but there are good players and bad players in the field. Simply requiring CLIA certification should be enough to run off the bottom-feeders without creating a suffocating layer of bureaucracy.

    Mr. Gunn’s last blog post..Thompson Scientific has a closed science search engine.

  7. Thanks for the informative sharing information. I think that GGists should stick to tests which do not allow for the positive identification of the persons tested.

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