23andMe Is Terrifying, but Not for the Reasons the FDA Thinks

Since late 2007, 23andMe has been known for offering cut-rate genetic testing. Spit in a vial, send it in, and the company will look at ... SkiptomaincontentGetUnlimited.Save40%SubscribeShareonFacebookShareonTwitterShareonRedditShareonLinkedInShareviaEmailPrintCredit:ThinkstockAdvertisement SAForumisaninvitedessayfromexpertsontopicalissuesinscienceandtechnology. Ifthere’sageneforhubris,the23andMecrewhascertainlygotit.LastFridaytheU.S.FoodandDrugAdministration(FDA)orderedthegenetic-testingcompanyimmediatelytostopsellingitsflagshipproduct,its$99“PersonalGenomeService”kit.Inresponse,thecompanycooedthatits“relationshipwiththeFDAisextremelyimportanttous”andcontinuedhawkingitswaresasifnothinghadhappened.Althoughtheagencyisrighttosoundawarningabout23andMe,it’sdoingsoforthewrongreasons. Sincelate2007,23andMehasbeenknownforofferingcut-rategenetictesting.Spitinavial,senditin,andthecompanywilllookatthousandsofregionsinyourDNAthatareknowntovaryfromhumantohuman—andwhichareresponsibleforsomeofourtraits.Forexampleasiteinyourgenomenamedrs4481887cancomeinthreevarieties.IfyouhappentohavewhatisknownastheGGvariant,thereisagoodprobabilitythatyouareunabletosmellasparagusinyoururine;thoseblessedwiththeGAorAGvarietiesaremuchmorelikelytoberepulsedbytheirownpeeafterhavingafewspearsatSpargelfest. Atfirst,23andMeseemedtoangleitskitasafunwaytolearnalittlegeneticsusingyourselfasatestsubject.(“Ourgoalistoconnectyoutothe23pairedvolumesofyourowngeneticblueprint...bringingyoupersonalinsightintoancestry,genealogy,andinheritedtraits,”readthecompany’swebsite.)TheFDAhadlittleproblemwiththecompanytellingyouwhyyouhaddryearwax(rs17822931)orwhetheryou’relikelytosneezewhenyoulookatabrightlight(rs10427255). Thatphasedidn’tlastforlong,becausethereismuchmoreinterestingstuffinyourgenomethannoveltyitems.Certainregionssignalanincreasedriskofbreastcancer,theimpendingonsetofmetabolicdiseases,andsensitivitytomedications.23andMe—aswellasanumberofothercompanies—edgedcloserandclosertomarketingtheirservicesasawayofpredictingandevenpreventinghealthproblems.Andanykitintendedtocure,mitigate,treat,prevent,ordiagnoseadiseaseis,accordingtofederallaw,a"medicaldevice"thatneedstobedeemedsafeandeffectivebytheFDA.Sincemid-2009,23andMehasbeennegotiatingwiththeagency,andinJuly2012,thecompanyfinallybegantheprocessofgettingclearancefromtheFDAtosellthekitthatithadalreadybeensellingforfiveyears. Everythingseemedrosyuntil,inwhataveteranForbesreportercalls“thesingledumbestregulatorystrategy[hehad]seenin13yearsofcoveringtheFoodandDrugAdministration,”23andMechangeditsstrategy.ItapparentlyblewthroughitsFDAdeadlines,effectivelyannullingtheclearanceprocess,andabruptlycutoffcontactwiththeagencyinMay.Addinginsulttoinjurythecompanystartedanaggressiveadvertisingcampaign(“Knowmoreaboutyourhealth!”),leavinglittledoubtabouttheunderlyingmedicalpurposeof23andMe’sPersonalGenomeService.Thislefttheagencywithlittlealternativebuttotakeaction.“Aspartofourinteractionswithyou,includingmorethan14face-to-faceandteleconferencemeetings,hundredsofemailexchanges,anddozensofwrittencommunications,”theagencycomplained,“weprovidedyouwith…statisticaladvice,anddiscussedpotentialriskmitigationstrategies.”Itisthetoneofaspurnedspouse,exasperatedandangrythat23andMeisputtingnoeffortintosalvagingtheirrelationship. ButastheFDAfretsabouttheaccuracyof23andMe’stests,itismissingtheirtruefunction,andconsequentlytheagencyhasnoclueabouttherealdangerstheypose.ThePersonalGenomeServiceisn’tprimarilyintendedtobeamedicaldevice.Itisamechanismmeanttobeafrontendforamassiveinformation-gatheringoperationagainstanunwittingpublic. Soundparanoid?ConsiderthecaseofGoogle.(Oneofthefoundersof23andMe,AnneWojcicki,ispresentlymarriedtoSergeiBrin,thefounderofGoogle.)Whenitfirstlaunched,Googlebilleditselfasafaithfulservantoftheconsumer,acompanydevotedonlytobuildingthebesttooltohelpussatisfyourcravingsforinformationontheweb.AndGoogle’ssearchenginedidjustthat.Butaswenowknow,thefundamentalpurposeofthecompanywasn’ttohelpussearch,buttohoardinformation.Everysearchqueryenteredintoitscomputersisstoredindefinitely.JoinedwithinformationgleanedfromcookiesthatGoogleplantsinourbrowsers,alongwithpersonallyidentifiabledatathatdribblesfromourcomputerhardwareandfromournetworks,andwiththeamazingvolumesofinformationthatwealwaysseemwillingtosharewithperfectstrangers—evencorporateones—thatdatastorehasbecomeGoogle’srealasset.Byparcelingoutthatinformationtohelpadvertiserstargetyou,withorwithoutyourconsent,Googlemakesmorethan$10billioneveryquarter. WhatthesearchengineistoGoogle,thePersonalGenomeServiceisto23andMe.Thecompanyisnotexactlyhidingitsambitions.“Thelonggamehereisnottomakemoneysellingkits,althoughthekitsareessentialtogetthebaseleveldata,”PatrickChung,a23andMeboardmember,toldFastCompanylastmonth.“Onceyouhavethedata,[thecompany]doesactuallybecometheGoogleofpersonalizedhealthcare.”Thecompanyhasloweredthepriceofthekitagainandagain,mostrecentlyfrom$299toamere$99,practicallymakingitastocking-stuffer.Allthebettertoinducevolunteerstogive23andMethedataitsodesperatelywants.(Currently,thedatabasecontainsthegeneticinformationofsomehalfamillionpeople,anumberWojcickireportedlywantstodoublebyyearend.) Whatdoes23andMewanttodowithallthatdata?Rightnowthetalkisallaboutmedicalresearch—and,infact,thecompanyisdoingsomeinterestingwork.Ithasbeensiftingthroughitsgenomicdatabase,whichiscombinedwithinformationthatvolunteerssubmitaboutthemselves,tofindpossiblegeneticlinkstopeople’straits.(Thebright-light/sneezegenetictagisa23andMediscovery.)Morepromisingare23andMe’sattemptstorecruitpeoplewhosufferfromcertaindiseases,suchasParkinson’sandafewtypesofcancer.Simplythroughbrute-forcepatternmatching,thecompanyhasachanceoffindinggeneticcausesoftheseailments,whichcouldleadtoawaytocombatthem.(Andperhapsablockbusterpatentorthree.) That’sjustthebeginning,though.23andMereservestherighttouseyourpersonalinformation—includingyourgenome—toinformyouabouteventsandtotrytosellyouproductsandservices.Thereisamuchmorelucrativemarketwaitinginthewings,too.Onecouldeasilyimaginehowinsurancecompaniesandpharmaceuticalfirmsmightbeinterestedingettingtheirhandsonyourgeneticinformation,thebettertosellyouproducts(ordenythemtoyou).Accordingto23andMe’sprivacypolicy,thatwouldn’tbeanacceptableuseofthedatabase.Although23andMeadmitsthatitwillshareaggregateinformationaboutusersgenomestothirdparties,itadamantlyinsiststhatitwillnotsellyourpersonalgeneticinformationwithoutyourexplicitconsent.   We’veheardthatonebefore.BackwhenGooglewasfirstlaunched,thefoundersinsistedthatthecompanywouldneversellyououttoadvertisers.Thecompanyadmittedthatitwouldshareaggregateinformationaboutusers’behaviorwithanyonewhoponiedupenoughmoney,butthecompany’sprivacypolicypromisedthat“[i]ndividuallyidentifiableinformationaboutyouisnotwillfullydisclosedtoanythirdpartywithoutfirstreceivingyourpermission.”Adecadeandahalflater,aftercountlessminusculefrog-in-boiling-waterchanges,Google’sprivacypolicyiscraftilyworded,dilutingtheword“consent”sothatit’simplicitinmostcases.(Thereareafewexceptions;thecompanyhasgraciouslyagreednottorevealthatyouareahomosexualorthatyouhaveheartdiseaseunlessyouexplicitlyoptin.Butinmattersnotrelatedtoyourmedicalconditions,race,ethnicity,sexuality,oryourpoliticalorreligiousbeliefs,thereisnosuchguarantee.)Notthatyourconsentreallymatters,implicitorexplicit.Googlehasrepeatedlyproventhatitismorethanwillingtobreakitspromisesandignoreitsownprivacyruleswhenitsuits. Whyshouldwebelievethat23andMe’spromisesareanymorebinding?Earlysignscertainlyaren’tencouraging.Eventhough23andMecurrentlyaskspermissiontouseyourgeneticinformationforscientificresearch,thecompanyhasexplicitlystatedthatitsdatabase-siftingscientificwork“doesnotconstituteresearchonhumansubjects,”meaningthatitisnotsubjecttotherulesandregulationsthataresupposedtoprotectexperimentalsubjects’privacyandwelfare. Thoseofuswhohavenotvolunteeredtobeapartofthegrandexperimenthaveevenlessprotection.Evenif23andMekeepsyourgenomeconfidentialagainsthackers,corporatetakeovers,andthetemptationsoffilthylucreforeverandever,thereisplentyofevidencethatthereisnosuchthingasan“anonymous”genomeanymore.Itispossibletousetheinternettoidentifytheownerofasnippetofgeneticinformationanditisgettingeasierdaybyday. Thisbecomesaparticularlyacuteproblemonceyourealizethateveryoneofyourrelativeswhospitsina23andMevialisgivingthecompanyanot-inconsiderablebitofyourowngeneticinformationtothecompanyalongwiththeirown.Ifyouhaveseveralcloserelativeswhoarealreadyin23andMe’sdatabase,thecompanyalreadyessentiallyhasallthatitneedstoknowaboutyou.Itisdoubtfulthat23andMewouldbeabletoprotectthatinformationevenifitweresoinclined. WhiletheFDAconcentratesonthequestionofwhether23andMe’skitisasafeandeffectivemedicaldevice,itisfailingtoaddresstherealissue:what23andMeshouldbeallowedtodowiththedataitcollects.For23andMe’sPersonalGenomeServiceismuchmorethanamedicaldevice;itisaone-wayportalintoaworldwherecorporationshaveaccesstotheinnermostcontentsofyourcellsandwhereinsurersandpharmaceuticalfirmsandmarketersmightknowmoreaboutyourbodythanyouknowyourself.Andas23andMewarnsonitswebsite,“GeneticInformationthatyousharewithotherscouldbeusedagainstyourinterests.YoushouldbecarefulaboutsharingyourGeneticInformationwithothers.” Presentcompanyexcepted,ofcourse.   Rights&Permissions ABOUTTHEAUTHOR(S)CharlesSeifeisaprofessorofjournalismatNewYorkUniversityandtheauthorofthenewbookHawkingHawking:TheSellingofaScientificCelebrity. Credit:NickHigginsRecentArticlesbyCharlesSeifeTheMythofStephenHawkingTheTrumpAdministration'sMisinformationMachineInWashingtonSpeak,CensorshipIsCalled"Transparency"PersonalizedMedicineintheGenomicEraBiologyGenomeSequencingfortheRestofUsKatherineHarmonBiologyVaccinomics:ScientistsAreDevisingYourPersonalVaccineMelindaWennerMoyerHealthVaccinesDerivedfromPatients'TumorCellsAreIndividualizingCancerTreatmentEricaRexBiologyAgenomestory:10thanniversarycommentarybyFrancisCollinsFrancisCollinsHealthWhatFetalGenomeScreeningCouldMeanforBabiesandParentsDinaFineMaronHealthBigPrecisionMedicinePlanRaisesPatientPrivacyConcernsDinaFineMaronAdvertisement NewsletterGetsmart.Signupforouremailnewsletter.SignUpSupportScienceJournalismDiscoverworld-changingscience.Exploreourdigitalarchivebackto1845,includingarticlesbymorethan150NobelPrizewinners.SubscribeNow!ScrollToTop Supportsciencejournalism.ThanksforreadingScientificAmerican.Knowledgeawaits.SeeSubscriptionOptionsAlreadyasubscriber?Signin.ThanksforreadingScientificAmerican.CreateyourfreeaccountorSignintocontinue.CreateAccountSeeSubscriptionOptionsContinuereadingwithaScientificAmericansubscription.SubscribeNowYoumaycancelatanytime.Signin.