One Libertarian’s Dilemma: Genetic Testing or the FDA

An advantage astrologers have over genetic testing is that the prediction of astrologers are personally verifiable. An astrologer once emphatically stated that I had no chance of a career in international cricket or Bollywood. So far both claims have turned out to be remarkably accurate.

How does one personally verify a “12.5 %” increased chance of lung cancer, the sort of number the vendor for genetic testing 23andMe produces? If one develops lung cancer how would one know that the chances were indeed 12.5 %, not 6.25 % or 25 %?

We die only once. Whether one ends up with lung cancer or doesn’t, the veracity of the claim can be made only empirically. Meaning we need to see how many develop lung cancer out of 10, 000 people just like us.

Yet there is an element of scientific precision in the number, augmented by the decimal point. And it is precisely because genetic testing tends towards science not metaphysics that it falls within the dominion of the Food and Drug Administration (FDA). FDA does not regulate palm readers.

FDA has asked 23andMe to stop sales of its genomic testing.

As a libertarian seeped in the Austrian school of Economics, I am generally disposed against regulations. I also share the sentiments of the monetarist Milton Friedman that the true costs of the FDA must also include the treatment opportunities foregone in their lengthy review process.

So it hurts me to be somewhat sympathetic of FDA’s stance on 23andMe, even as I think an outright ban was a tad harsh.

Genetic testing falls in that spectrum of the market where one reaps the benefits but spreads the costs. Economists call this a negative externality. Bankers are most familiar with this. Remember the adage “privatize your gains and socialize your losses”.

Who will counsel the person wondering if she should take anti-coagulants for a trans-atlantic flight because her genomic analysis shows an 8 % increase in developing blood clots over the population average?

Who will shoulder the blame for not anticipating the suicidal ideations of a man who takes his life for finding out that he is destined for Huntington’s chorea within ten years?

Who will bear the costs for the over testing and overdiagnosis that will inevitably result when people find out that they deviate from the population mean in the risk of various cancers?

Not 23andMe, which simply gets paid per Pandora’s box it opens.

The additional costs of investigation will be reflected in our insurance premium. The burden and legal risk will fall chiefly upon the already overworked primary care physicians (PCPs).

How will the PCPs advise? Must they advise a woman with a 22.2 % increased risk of ovarian cancer differently from someone with a 6.7 % increased risk? What is the threshold of increased risk of cancer for pursuing more tests? What are the trade offs of such pursuit?

These questions are expected when we are dealing with imperfect information. However, these questions need to be answered rationally and scientifically if genomics truly revolutionizes patient-centered medicine.

That is not to say positive externalities cannot emerge from genetic testing. My attempt at convincing my domestic comptroller to invest in an indoor mountain climber has failed for the third year. I feel I might have succeeded if I had genomic analysis that reported “6.2 % higher than average risk from procrastination-induced heart disease” (of course, it might have backfired and led to tight control of my many Epicurean activities).

The point is that the ban is excessive. Instead, a sort of Pigovian tax could have been imposed on 23andMe for every $99 it collected for issuing a genomic report.

Saurabh Jha, MD (@RogueRad) is an Assistant Professor of Radiology at the University of Pennsylvania. His scholarly interests include the value of imaging and dealing with uncertainty in clinical decision making. Jha views most problems in medicine as problems of imperfect information. He trained in the UK and migrated to USA for more predictable weather and a larger yard.

10 replies »

  1. We might be approaching the same epi-center differently.

    Regulating genetic testing companies gives them a stamp of quality. Banning them will not stop people, as you say, from getting information; that may well be inferior.

    Pigovian tax is simply an opportunity to internalize costs a bit, noting that negative externalities can never be abolished in an inter-dependent society.

    An outright ban may be counterproductive.

  2. I sincerely doubt it will be possible to regulate / tax the ability to get your raw data for $99, which exposes the whole charade. 23andMe is only an easy target because they are bundling raw data and interpretation, but once you think about the two separately, explaining what you are regulating and why and enforcing it starts to become very difficult…

  3. Or forego (at the margins) the test altogether because the cost would then exceed $ 99.

  4. I have other issues with genetic assays — mainly quality control. I cut my professional teeth in the 80’s in a forensic-level radiation lab in Oak Ridge. There are no uniform QC/QA standards pertaining to genetic testing, especially where for-profit clinical labs are concerned.

    to wit:

    “…DNA infallibility is a myth, even though DNA evidence can be highly authoritative and effective in identifying and prosecuting criminals. The following describes eight central myths of forensic DNA evidence. These myths have been identified from media accounts and in exaggerated claims made by individuals who view DNA as the ultimate and incontestable authority within forensic science.     Myth of DNA Consistency   DNA Is DNA Is DNA. All DNA Evidence Is Strong Evidence; There Is Not Much Difference in Quality from One Sample to the Next.   Although DNA is revered as the “gold standard” of forensic science, not all DNA is the same. William C. Thompson has pointed out that there is considerable case-to-case variation in the nature and quality of DNA evidence….”

    Krimsky, Sheldon; Simoncelli, Tania (2010-06-01). Genetic Justice: DNA Data Banks, Criminal Investigations, and Civil Liberties (p. 276). Perseus Books Group. Kindle Edition.

  5. You realize that this kind of interpretation is easily available from Promethease and other services (more to come soon, surely) as long as one has access to the raw data, right? So if you decide to “tax” 23andMe by requiring them to provide genetic counseling (which they have had a referral for for ages now), people will just get data interpreted elsewhere. I am not quite sure that’s improving the situation, frankly.

  6. Agree. Vexing problem.

    I might have been inclined to mandate that 23andme provide the counseling service, instead of an outright ban.

    Then we might have seen whether $99 was really such a bargain.

    The market often, not always, regulates supremely.