Myriad Genetics May Influence How the FDA Sniffs About Genetic Tests

After I posted about the latest step the Food and Drug Administration (FDA) is taking towards regulating home genetic tests, I happened across this rather strenuous objection to the idea from Razib Khan at Gene Expression.  He’s quite concerned about being denied access to his genetic code, and I see his point.

The reason why I’m not with him on having fewer regulations over home genetic tests is that I lack confidence in companies being able to provide an accurate representation of what the results of these tests mean.  And what’s just as important is whether or not these tests will effectively communicate what they don’t mean.  I’m not keen on people taking actions based on incomplete understanding, particularly when they can affect health care and health insurance costs.

Access to one’s genome, however, should be maintained, and I think the Myriad Genetics case (which will be heard on appeal to the Federal Circuit in April) may be instructive here.  Part of the benefits of invalidating the patent on the gene mutations associated with certain kinds of breast cancer is that folks can obtain a second opinion when their tests come back positive.  Controlling the tests for certain genetic markers should not be extended to control over the associated genetic code.

3 thoughts on “Myriad Genetics May Influence How the FDA Sniffs About Genetic Tests

  1. Hi David, did you get a chance to watch the video? Whatever reasonable regulation might look like I think people of good will can agree this is not the way to do it.

  2. I have watched the video, and absent a specific government regulatory proposal to respond to, I can’t agree or disagree with your statement. It’s also not clear from the video how 23andMe would add value to the genetic tests based on the research. It does seem that they give people an incentive to provide their genome by providing these communities, but that’s not the same thing.

    Simply to re-emphasize my perspective. People need to have access to their own genetic information. I don’t think, however, that this industry as a whole has demonstrated it’s willingness or ability to fully communicate what their tests do and do not say to the public.

    There’s way too little in the video to make an effective judgment about what constitutes 23andme’s research program, and whether it would result in making the genetic tests easier for regular consumers to understand and interpret on their own. Has it contributed to the knowledge base of a disease? Most likely. But that does not mean the same thing as contributing to the value or efficacy of a home genetic test.

    Of the research communities mentioned in the presentation, it would seem that most of them have a greater than average understanding of genetics, at least where the particular condition is concerned. If that’s not true, there is the possibility that subsequent studies will discount initial findings.

    If these tests are to be reasonably successful, they are either going to need to be cheap enough that folks can pick them up without spending a lot out of pocket, or that various insurance companies can be persuaded to cover them. Otherwise, it’s hard for me to see these being terribly widespread. If insurance companies cover them, they are going to want someone to interpret them besides the patient. If they are going to be this cheap, eventually someone is going to sue because they failed to understand an appropriate nuance and acted based on what they thought the test suggested they should do. Absent some guidance on dealing with that possibility, I don’t see the home market lasting very long.

  3. Pingback: Innovation Prizes Aren’t Effective If Nobody Tries to Win Them « Pasco Phronesis

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