23andMe: Regulating the Snake Oil Salesman

by Maddie Davis February 23 2014, 19:48

Crowds would gather when the snake oil salesman came around.1 His magical elixir could cure many ailments, from headaches to kidney problems.2 Before anyone realized that the cure-all was nothing more than mineral oil, the peddler was long gone with their money.3, 4 One of the more famous snake oil salesmen, Clark Stanley, made quite a name for himself in the early 20th century – enough to attract the government’s attention.5 In 1917, federal investigators seized his product, and upon finding that it was not what it claimed to be, Stanley was fined under the Pure Food and Drug Act.6 When the government exercised this FDA-precursor’s power, snake oil sales likely took a turn for the worse.7

The FDA is still cracking down on what it deems to be “snake oil salesmen” in the modern day. Most recently, the FDA has brought this charge upon many companies in the direct-to-consumer genetic testing industry.8 23andMe, one of the more prominent companies offering genetic testing services, has come under much scrutiny lately pursuant to this regulatory campaign.9

Prior to December 2013, 23andMe called itself “the leading health and ancestry DNA service.”10 For just $99, customers could submit a saliva test.11 Then, the company would conduct genetic testing and return a report that estimates the customer’s predisposition to a number of traits and medical conditions, as well as genealogical information.12 There have been a number of other companies that offered similar services, as well.13 As the largest, though, 23andMe has genotyped abut 500,000 customers so far.14

However, the FDA notified 23andMe and 16 other similar companies in late November that their devices required approval and that they must stop marketing their products as a health service.15 The FDA notification told 23andMe that their products “carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment.”16 23andMe is now only selling ancestry DNA services, and many of its competitors have dropped out of the market.17

On the one side, some doctors and scientists are proponents of shutting down these services.18 Like the FDA, they argue that inaccurate results may cause customers to incorrectly change their behavior.19 Moreover, they argue that it undermines doctors’ roles as a medical “gatekeeper” for patients.20 However, many consumers are siding with 23andMe.21 A Change.org petition to reverse the FDA ban has garnered more than 10,000 signatures.22

The FDA’s issue comes down to balancing the need to protect citizens and allowing a business to compete on the free market. But protect citizens from what? A lot of the arguments in favor of shutting down the genetic testing industry are unfounded.23 Many of the concerns about consumers taking rash actions based on their results can be quashed with the disclaimer found on the test: to talk to you doctor about the results.24 Beyond that, there is not much more 23andMe can do to protect its customers. Is the burden on the business to better warn its customers, or on the customers to heed the business’ arguably clear warnings?

Home pregnancy tests provide a modern-day analogy. While these tests are convenient and reliable, they are not, and do not claim to be, one hundred percent accurate.25 If a woman receives a positive result from one of these tests, the tests never advise that she rush out and buy a bassinet. Instead, it is advised that she consult her doctor to get confirmation.26 23andMe and other genetic testing services work in the same vein. They, like pregnancy tests, are simply an impetus for discussion with your doctor. It is hard to argue that is a negative effect on customers. The FDA has yet to prove 23andMe’s services have actually caused injury.27 Evidence actually suggests that predictive genetic testing prompts people to change their behavior in healthy ways and plan for the future.28

Pregnancy tests are, of course, regulated by the FDA, and similar regulations for the genetic testing industry would not necessarily be bad.29 However, the administration’s apparent interest in shutting down the industry altogether, simply because of a lack of accuracy, seems a bit harsh. Ultimately, even if direct-to-consumer genetic testing is snake oil, what does that matter? Absent any showing of actual harm – and, moreover, if the tests motivate customer discussion with their doctors – 23andMe has already provided something of worth to the marketplace.

 

[1] http://www.scientificamerican.com/article/snake-oil-salesmen-knew-something/

[2] http://www.npr.org/blogs/codeswitch/2013/08/26/215761377/a-history-of-snake-oil-salesmen

[3] www.scientificamerican.com/article/snake-oil-salesmen-knew-something/

[4] http://articles.latimes.com/2002/jul/01/health/he-booster1

[5] Id.

[6] http://www.npr.org/blogs/codeswitch/2013/08/26/215761377/a-history-of-snake-oil-salesmen

[7] Id.

[8] http://www.huffingtonpost.com/cecile-janssens/post_6753_b_4671077.html

[9] http://www.forbes.com/sites/matthewherper/2013/12/05/23andme-stops-offering-genetic-tests-related-to-health/

[10] Id.

[11] http://www.huffingtonpost.com/berin-szoka/fda-just-banned-23andmes-_b_4339182.html

[12] http://content.time.com/time/specials/packages/article/0,28804,1852747_1854493,00.html

[13] http://www.huffingtonpost.com/cecile-janssens/post_6753_b_4671077.html

[14] http://mediacenter.23andme.com/fact-sheet/

[15] http://www.huffingtonpost.com/cecile-janssens/post_6753_b_4671077.html

[16] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm

[17] http://www.huffingtonpost.com/cecile-janssens/post_6753_b_4671077.html

[18] http://www.forbes.com/sites/fridapolli/2014/01/14/why-23andme-deserves-a-second-chance/

[19] http://www.huffingtonpost.com/cecile-janssens/post_6753_b_4671077.html

[20] Jessica Elizabeth Palmer, Genetic Gatekeepers: Regulating Direct-to-Consumer Genomic Services in an Era of Participatory Medicine, 67 Food & Drug L.J. 475, 519 (2012)

[21] http://www.huffingtonpost.com/berin-szoka/fda-just-banned-23andmes-_b_4339182.html

[22] https://www.change.org/petitions/fda-don-t-ban-marketing-of-home-genomics-kits-like-23andme

[23] http://www.usatoday.com/story/opinion/2013/12/16/genetic-tests-23andme-editorials-debates/4045823/

[24] http://www.huffingtonpost.com/berin-szoka/fda-just-banned-23andmes-_b_4339182.html

[25] http://womenshealth.gov/publications/our-publications/fact-sheet/pregnancy-tests.html

[26] Id.

[27] http://www.usatoday.com/story/opinion/2013/12/16/genetic-tests-23andme-editorials-debates/4045823/

[28] Jessica Elizabeth Palmer, Genetic Gatekeepers: Regulating Direct-to-Consumer Genomic Services in an Era of Participatory Medicine, 67 Food & Drug L.J. 475, 519 (2012)

 

[29] http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109396.htm

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