2013 Use and Misuse of Genetic Data Marchant_reprint.authcheckdam

7/27/2019 2013 Use and Misuse of Genetic Data Marchant_reprint.authcheckdam

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Published in The SciTech Lawyer, Volume 1, Number 1, Fall 2013. 2013 American Bar Association. Reproduced with permission. All rights reserved. This information or any portion thereof maynot be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association.

In the recent Supreme Court deci-sion overturning patents on naturallyoccurring gene sequences (Assn

Molecular Pathology v. Myriad Genet-ics), Justice Scalia led an intriguingconcurrence in which he joined in thedecision except or the parts going intone details o molecular biology. I amunable to arm those details on my

own knowledge or even my own belie.O course, understanding the specicso genetic testing was critical to delin-eate the appropriate bounds o patentsor protecting genetic data in that case.So Justice Scalias inability or reusalto engage with that knowledge dem-onstrates the challenges that legal andother decision makers conront in ourera, when genetic data are increasinglyapplied in a growing range o medical,orensic, legal, and other applications.

Going back at least to the time o .D. Lysenko, Stalins agricultural min-ister who overrode modern geneticknowledge with unsupported scientictheories more compatible with his polit-ical ideology, genetic inormation hasbeen prone to hype, exaggeration, raud,and distortion by charlatans using thescience or their own agendas. Discern-ing valid rom invalid uses o geneticinormation is thereore critical or law,government, consumers, and businesses.

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Its CriminalGenetics have long played an impor-tant role in the justice system, goingback to Justice Oliver Wendell Holmessopinion in Buck v. Bellthat three gen-erations o imbeciles are enough. Oneo the notorious abuses o genetics in

criminal law was the claim in the 1960sand 1970s that men with the XYY gen-otype were more prone to aggressionthan men with the more common XYgenotype. Subsequent studies dem-onstrated that this correlation was anartiact o the studies methods, but thisepisode opened the door to the use ogenetic inormation in criminal cases.In an example that many experts thinkgoes too ar, the State o Connecticutrecently announced that it was testing

the genes o Adam Lanza, the deceasedkiller who massacred schoolchildrenin Newtown, Connecticut, in Decem-ber 2012.

Judges can also be prone to the spu-rious construction o genetics. In arecent case (U.S. v. Cossey), the SecondCircuit Court o Appeals overturnedthe district court judges decision toimpose a criminal penalty or a childpornographer that exceeded the pleaagreement, based on the judges sup-position that 50 years rom now the

deendants criminal conduct wouldlikely be discovered to be caused by agene you were born with. And its not agene you can get rid o. Te judge con-tinued that therapy would not succeed,because you cant get rid o it. You arewhat youre born with. And thats theonly explanation or what I see here.

Behavioral ProblemsTere has been a never-ending serieso alleged discoveries o genes or com-

plex human behaviors, such as theanxiety gene, the indelity gene, theintelligence gene, the ree-thinkinggene, the religiosity gene, the shoppinggene, the humility gene, the novelty-seeking gene, the perectionist gene, thebad-driving gene, the cleanliness gene,the wimpiness gene, and many others.Tere are, o course, no single genesor any o these complex humanbehaviors. At most there are genes thatmay inuence or perhaps are merely

Gary E. Marchant is the LincolnProfessor of Emerging echnologies,Law & Ethics, Center for Law, Science& Innovation, Sandra Day OConnorCollege of Law, at Arizona StateUniversity. He can be reached at [email protected].

ideological, or personal reasons. Tus,we must identiy invalid or dubiousapplications o genetics, both to pre-vent contaminating our perceptionso legitimate uses and to provide prec-edents to expose raudsters who seekto exploit genetics growing popularity.

Tis article identies such applicationsand groups them into the categories oracial, criminal, behavioral, medical,and product applications o genetics.

The Sordid History of Raceand GeneticsTere is a centuries-old history o mis-using heredity, and more recentlygenetics, to support racist belies. Fromthe biological determinism that classi-ed and stigmatized races in the 18th

and 19th centuries (documented in Ste-phen Jay Goulds Te Mismeasure ofMan) through the eugenics movementin the United States in the early 20thcentury and in Nazi Germany to morerecent assertions, such as those in TeBell Curve, the consistent theme in theclaims o racial dierences is that theycome more rom preexisting politicaland racial belies o the proponents thanrom scientic data.

Unable to learn the lessons o theseprior abuses, modern actors continue

to play the genetic race card. In 2012, amember o the Hungarian parliamentrom the Far Right Jobbik Party pro-claimed his ethnic purity based on theabsence rom his genome o variantsallegedly attributable to Italian or Jew-ish ancestry. His claim was condemnedby the president o the European Soci-ety o Human Genetics, who criticized itas both scientically and ethically inde-ensible and a scandalous abuse o atechnology that was developed to help

the sick, rather than to promote hatred.In 2007, Nobel Prize-winning geneticistJames Watson got into hot water whenhe stated that he was inherently gloomyabout the prospect o Arica becauseall our social policies are based on theact that their intelligence is the same asourswhereas all the testing says notreally. In response to the controversy thatollowed, Watson apologized or his state-ment and acknowledged that [t]here isno scientic basis or such a belie.

In this regard, the applications ogenetics can be grouped into threegeneral categories. Te rst includeswell-established, clearly benecial, andrelatively noncontroversial applica-tions. Examples include testing or theBRCA gene to predict the risk o can-

cer in women with a amily history obreast cancer, DNA proling to testmatches between criminal suspects andorensic samples le at crime scenes,and DNA testing to prove or disprovepaternity. Tis rst category o accepteduses o genetics, slow to expand ormany years, is now growing rapidly.

Te second category involvesemerging uses o genetics that are bor-derline, the subject o legitimate debateamong experts as to their validity and

utility. In many cases, the evidentiarysupport or such tests is still develop-ing, so their acceptance is shiing.Although some (or, in some cases,most) experts think some such testsmay be premature or ill-advised atthis time, they usually do not dismisstheir potential in the uture. In addi-tion, there are experts (even i only aminority) who advocate such testingnow. Examples in this second cate-gory include pharmacogenetic testingor variations in the response to drugs

such as wararin and Plavix, identiyingindividuals whose poor early environ-ments put them at an increased risko criminality because o their mono-amine oxidase A (MAOA) geneticvariants, and sequencing the wholegenome o asymptomatic individuals.

Te third category o genetic data,the primary ocus o this article, con-tains applications that all under thedenition o pseudoscience. Giventhe implications and growing power

o genetic inormation, it may notbe surprising that genetics has beenthe subject o hype, exaggeration,and deception, be it or commercial,


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training protocol, and testing o telo-meres to determine a clients truecellular age.

Overly exuberant claims about thepower o genetics have been applied intoxic tort cases to evaluate medical cau-sation. A ew years ago the Cytokine

Institute claimed to have developeda proprietary genetic microarray test(msds1M test) that relies on no lessthan 22,000 DNA-based parameters todetermine whether benzene caused aworkers cancer. Te test was apparentlyused in several workers compensationcases. Geneticist Martyn Smith wrotea devastating attack on the test, argu-ing that Tere is no possibility that itcan reliably help us assign causationin relation to benzene exposure and

is clearly junk science. He continuedthat the msds1M test has never beensubject to an analysis o sensitivity,specicity or positive predictive valueand that [n]o knowledgeable scien-tist would accept the msds1M test asuseul inormation in attributing dis-ease causation. In a related context,the Burlington Northern Santa Fe Rail-road was sued aer it secretly tested thegenes o employees who had broughtworker compensation claims, appar-ently in the hope o nding a very rare

gene variant that was associated withcarpal tunnel syndrome.

In addition to dubious health claimsor genetic data, a related problem iserroneous application o valid genetichealth data. Studies have documenteda high rate o misapplication and mis-understanding o genetic inormationby health care providers, most o whomdid not receive signicant educationabout genetics in their proessionaltraining. For example, a study pub-

lished in 2011 by ARUP Laboratoriesound that clinicians ordered the wronggenetic test approximately 30 percento the time over a 10-month period. Aprevious study o individuals who hadbeen genetically tested or their risko colon cancer ound that physiciansmisinterpreted the test results in 31.6percent o the cases. Although theseerrors in applying valid genetic datamay be more innocent than the delib-erate misuse o genetic data discussed

childs inborn talent. You get to knowwhat your childs talents are, how theybehave. Te specic genes tested werenever identied, and the company hasnow apparently gone out o business.

Medical Mischief

Genetics is likely to be most useul inthe medical context. At the same time,many bizarre claims and proposalsor medical genetics have been madeover the years. One o the strangestcame rom double-Nobel Prize winnerLinus Pauling in the 1960s. He calledor legislation that required compul-sory testing or deective genes beoremarriage. Te results had to be publiclydisclosed, perhaps by tattooing themon the orehead o every young person,

so that potential mates could determineon rst meeting the genetic compatibil-ity and risks posed by that person.

Some companies and other actorsmake extravagant, unsupported claimsabout how genetic testing can predictand prevent uture disease. For exam-ple, a company called DNA Dynasty(now apparently out o business)marketed a detailed DNA DiseaseSusceptibility test or over 100 dis-eases to identiy precisely what yourgenetically inherited diseases are. Te

company claimed that the results otheir test would allow the customerto lead a wonderul, active and last-ing healthy lie riding into the sunset,ree rom chronic degenerative dis-eases. Te website urther claimed thatDNA Dynasty takes Health preven-tion to a whole new level. . . . o predictwith 99% accuracy through GeneticAnalysis the probability o a diseaseoccurring in an individual through his/her genetic makeup.

Another dubious medical applica-tion comes rom spas and online sitesoering gene-based treatments or skinand nutritional health. For example,in 2007 the MGM Grand in Las Vegasbegan oering genetic cheek swabs ordietary recommendations based onvariations in six genes linked to nutri-ent metabolism. Other high-end spasoer diverse genetic tests or nutrig-enomic strategies, tness-ocused teststhat allegedly identiy a clients optimal

correlated with specic behavioraltraits. Any human behavior is likely theresult o a complex interaction betweenmany genes and the environment.Eric Lander, one o the nations lead-ing genetic researchers, quoted rom a

European news report that illustratesthe silliness o such genetically deter-ministic perspectives on behavior:

Tese ndings promise tochange the way we live, says Dr.Manuel Paranto o the LisbonResearch Institute in Portugal.When a child is born, we willgive the parents a detailed analy-sis o its genetic makeup so theywill know what kind o educa-tion to provide. Te child will

know rom birth whether he ismore suited to slim redheads orbuxom brunettes, intellectualsor homebodies, to avoid roman-tic heartbreak. Ultimately, thingslike divorce will become extinctas people realize what kind opeople they should marry.

Tese exaggerated claims or behav-ioral genes are not just reported in themedia: they have also been directly

marketed to consumers. For example,the Singapore-based My Gene Pro-le oered to parents or $1,397 itsInborn alent Genetic est that alleg-edly tested 40 gene variants in childrenincluding the optimism gene, risk tak-ing gene, sociable gene, persistencegene, . . . memory gene, intelligencegene, . . . [and] propensity or teenageromance gene. Te companys market-ing materials promised, Rememberyou are getting a blueprint o your

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level o genetic compatibility with theperson they are interested in. Te prob-ability or successul and long-lastingromantic relationships is greatest incouples with high genetic compatibil-ity. Although the website reers to somescientic studies that show a correla-

tion between genetic traits and romanticcompatibility, this service appears to gobeyond the limits o the available science.Yet another company (www.mydnara-grance.com) oers perumes specic toindividual human genetic codes.

Genetically modied (GM) oods arethe subjects o some o the most sensa-tional and egregious distortions o anygenetic application, including the termFrankenoods requently used in themedia. Every reputable scientic body,

including the National Academy o Sci-ences, American Association or theAdvancement o Science (AAAS), andthe European Unions own scienticadvisers that has examined the issue hasconcluded that GM oods are as sae orsaer than conventional oods. Yet mediaattention on this technology has beenswayed by bogus claims, ranging romJeremy Rifins assertion in the 1990s thatinnocuous ice-minus bacteria mustbring global cataclysm by destroying theentire atmosphere, to more recent alse

alarms by the likes o Jerey Smith. He isoen portrayed in the media as an experton biotechnology. Yet prominent scientistBruce Chassy describes him as some-one whose only proessional experienceprior to taking up his crusade againstbiotechnology is [as] a ballroom-danceteacher, yogic ying instructor, and polit-ical candidate or the Maharishi cultsnatural law party.

Conclusion

Te examples provided here o hype,scams, exaggerated claims, and char-latans exploiting the public interest ingenetics are a small sampling o thenumerous misuses o genetic inormationin the media, legal, consumer, and medi-cal realms. As genetics comes to play anincreasingly important, legitimate role inall these spheres, it will become criticalto police the claims made and to exposethose genetic claims, products, and ser-vices that lack validity.u

above, the impact on the patient is thesame: they receive invalid data.

Problematic ProductsA number o products that incorporategenetic testing involve pseudoscience.For example, a number o companies

sold expensive nutraceuticals suppos-edly tailored to the customers owngenotype. Some o these productsclaimed to tailor the supplement basedon testing o the customers DNA. Oth-ers simply claimed the use o DNA orgenetics without any actual data. Forexample, one company sold BioEn-hance with DNAble that claimed to bethe rst multivitamin ormulation thatis also a genetic ormulation, with-out any inormation on how genetics

helped ormulate the product. Nor didthe vendor acquire any DNA rom thecustomer. In 2006 the US GovernmentAccountability Oce (GAO) oundthat the sellers o these products weremisleading consumers. Te products,priced rom $1,200 to $1,800 per year,diered little rom commonly availablemultivitamins. Tough the compa-nies criticized in that GAO report nolonger market products, new busi-nesses have arisen that make equallydubious claims. For example, one web-

site (www.customizednutrients.com)sells geneME Genetically CustomizedSupplements that claim to providea revolutionary, personalized, just-or-you nutritional supplement thatis customized to your unique geneticcode. A red ag or many such prod-ucts is that they identiy neither whichgenes they test or nor the scienticstudies on which they base their con-clusions. All they say is that they usea 12 key gene personalized DNA

ormula.Other examples o genetics-basedproducts with questionable scienticlegitimacy are websites that providegenetic testing to allegedly determineromantic compatibility. For example,GenePartner.coms website claims that itsbiological matching method is designedas a complementary service or match-makers and online dating sites. Basedon the genetic prole o the client, theGenePartner ormula determines the

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2013 Use and Misuse of Genetic Data Marchant_reprint.authcheckdam