Ethical Dilemmas in Personalized Medicine:

Direct-to-Consumer Genetic Testing and Clinical Application

Laura J. Bruce
BMH 490 Capstone Project
01 May 2014

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I. Introduction
Personalized medicine has been deemed the future of healthcare (Meyer and Ginsburg).
This strategy promotes the customization of all stages of a patients medical care based on their
personal characteristics, needs, and preferences (vant Veer and Bernards). While personalized
medicine involves systematic strategies such as care coordination and shared decision-making,
an increasingly important factor is the use of genetic testing to tailor medical treatment itself
(Meyer and Ginsburg). The use of genetic testing is by no means new, and has been routinely
employed for decades in forensics, genealogy, fetal and newborn screening, prenatal planning,
and to some extent, disease diagnosis (Brookes).
Recently, however, technological developments and the completion of the Human
Genome Project in 2003 have enabled genomics to become increasingly applicable in the clinical
setting (Peterson-Iyer). This project mapped the entire human genome and shed light on how our
genes influence our physiology. In combination with genome-wide association studies (GWAS),
this project has rendered scientists increasingly capable of understanding the relationships
between genotype, the molecular coding of genes for a particular trait, and phenotype, the
physical manifestation of that particular trait, which can also be impacted by environmental
factors (Crews et al.; Weston and Hood). Therefore, analysis of a patients genetic makeup can
be used, to some extent, to diagnose a current condition, identify mutations that may be
associated with future disease, and recognize variability in drug response and metabolism via
what is known as pharmacogenomics (Peterson-Iyer).
As a result of these advancements, genetic testing has become readily accessible and
affordable for individuals to purchase from private companies. In direct-to-consumer (DTC)
genetic testing, private companies market affordable genetic testing directly to consumers,

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independent of a healthcare provider (Su). Although both services are often marketed together,
this paper focuses on DTC genetic health testing, and not DTC genetic ancestry testing, which is
much less controversial and has little to no clinical application. The main purpose of DTC
genetic health testing is empowerment: allowing customers to obtain wide-ranging personal
genetic information from a single source (Su). Individuals may choose DTC genetic health
testing for a variety of reasons, including to identify disease-related risk information, to
complement healthcare and lifestyle choices, or to fulfill personal curiosity (Caulfield and
McGuire).
Well-known DTC genetic testing companies include 23andMe, Navigenics, deCODE
genetics, Pathway Genomics, Genetic Testing Laboratories (GTL), and GeneDx (Su). After
ordering from a DTC genetic testing company, customers may be sent an at-home saliva kit,
which they must register, spit into, and mail back to the company, or they may be required to
visit a professional laboratory to undergo blood testing (Peikoff). Within about 6 weeks, the
company provides customers with information regarding disease risk, inherited conditions, and
drug response for prices that range from approximately $99 to $2000 (Su).
Once the DTC genetic company has received a tissue or blood sample, the process of
extracting customer DNA, manipulating it in the laboratory, and interpreting the resulting data
can begin. Notably, these services do not rely on full genome sequencing, which is expensive
and can provide data that is currently incomprehensible. Rather, DTC genetic testing companies
employ a technical process that accesses and analyzes interpretable single nucleotide
polymorphisms (SNPs) for an individual (Brookes). These polymorphisms consist of a variation
in only one base pair between nitrogenous bases in DNA. For instance, one type of SNP occurs
when an adenine-thymine pair is converted to a guanine-cytosine pair (International Human

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Genome Sequencing Consortium). Since these variations occur reasonably frequently in a
population, they are not automatically considered to be mutations. While some SNPs do not
cause any changes in an individuals phenotype, other SNPs may be linked to recognizable traits
or serious diseases (Brookes).

II. Ethical Issues
As with many innovations in medical technology, myriad ethical conflicts arise in direct-
to-consumer (DTC) genetic health testing. These conflicts were brought to public attention in
November 2013, when the US Food and Drug Administration (FDA) sent a warning letter to the
DTC genetic testing company 23andMe, mandating that they stop marketing their Personal
Genome Service (PGS) and the associated saliva collection kit. This request was grounded in
the lack of communication between the company and the FDA, and the fact that the FDA had not
authorized the marketing of the saliva collection kit, which is considered to be a medical device
over which the FDA has jurisdiction (Annas and Elias). More specifically, the FDA was
concerned that 23andMe had not analytically or clinically validated the PGS for its intended
uses (Annas and Elias). What intended uses was the FDA referring to? Likely, the agency
was referencing 23andMes television commercial, which states that customers can take charge
of their health by Chang[ing] what you can, and manag[ing] what you can't (Annas and Elias).
Since this implies a clinical application, the agency was concerned about how customers might
act once they received information from 23andMe about their health risks.
Two main ethical dilemmas arise from this discussion and will be explored in this paper.
The first is a question of centralization and the accessing of genetic information. Should a third
party DTC genetic testing company be consulted as a source of clinically applicable health
information, or is it better to centralize all genetic testing under certified healthcare providers?

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While genetic testing is highly regulated for validity and confidentiality when it originates from a
clinical setting, the regulation of private DTC companies is currently inadequate. When third
parties are consulted, the company also has profit-based interests, and the validity of the
provided information can be questionable. Further, third parties might not adequately maintain
customer privacy, especially if customer data is used for research and if explicit guidelines
regarding which stakeholders (physicians, insurance companies) may access the data in future
are not established.
The second ethical issue encompasses the struggle between medical (or government)
paternalism and individuals' right to information about themselves. Should the FDA be able to
prevent individuals from accessing information about their own genetic makeup by restricting
companies like 23andMe, or do individuals have the right to obtain their own information even if
there are risks associated with it? Are DTC genetic testing customers provided with adequate
informed consent?
When considering these important questions, there are many relevant stakeholder groups.
This includes the DTC genetic testing companies, the customers of DTC genetic testing
companies, their healthcare providers (physicians, genetic counselors), their relatives, the
governmental entities (FDA, CMS, FTC) that can regulate DTC genetic testing, legislators who
develop privacy legislation, health insurance companies, and professional organizations such as
the American Medical Association (AMA) and the American College of Medical Genetics
(ACMG), who have an important voice in influencing the government entities (Caulfield and
McGuire).

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III. Central Claim
In light of these ethical issues, I will argue in favor of medical (governmental)
paternalism in the case of DTC genetic health testing. This does not imply that DTC genetic
testing should be prohibited entirely or that the concept of a third party providing genetic health
information is unethical in itself. Rather, the regulation of this industry needs to be expanded
with regards to scope, analytical validity, clinical validity, clinical utility, and privacy in order to
avoid ethical issues and to protect customers. Until these guidelines are developed, I maintain
that DTC companies providing non-validated information regarding health risks are behaving
unethically and that their services should be prohibited due to the potential for clinical damages
and privacy violations. While the FDAs current regulatory span only applies to companies that
market at-home kits (which are considered medical devices), I will argue that the agencys
jurisdictions should be extended to oversee genetic testing which occurs in laboratory developed
tests (LDTs) for DTC companies (Kaye).

IV. Support and Reasoning
In evaluating the ethical issues brought about by DTC genetic health testing, there are
three main areas to consider: (1) the reliability and regulation of data provided by this industry,
(2) the clinical utility and application of the results of the testing, and (3) patient concerns that
arise due to the inherent connection between genetics and healthcare services.

(1) Reliability and Regulation
The process of SNP genotyping makes the reliability of data provided via DTC genetic
testing questionable. Genetics may only account for between 5 and 20 percent of the attributable
risk in developing complex diseases, and beyond that, SNPs are merely a small sampling of the

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entire genome, constituting less than 1 percent of an individuals DNA (Emahazion et al.). Some
SNPs are valuable biomarkers, however. For conditions with low genetic complexity, such as
Huntingtons Disease or certain types of breast cancer, it is easy to identify accurate genetic
origins via a small number of SNPs (Brookes). However, for chronic and heterogeneous
conditions that are affected by a variety of genetic and environmental factors such as coronary
heart disease and Alzheimers Disease, respectively, the multiple SNPs evaluated by DTC
genetic testing companies might not be inclusive or significant. Further, it is not always clear
how these SNP markers are affected by a customers lifestyle (Emahazion et al.).
Because DTC companies use different SNP biomarkers to assess the same conditions, the
results are not always consistent. Individuals have frequently reported receiving varied results
when undergoing testing from different DTC companies (Peikoff). This occurs because there are
no are no widespread standards to determine what constitutes as high, average, or low risk for
assessable conditions based on the different biomarkers. For instance, 23andMe previously
listed the average risk for obesity to be around 60 percent, while GTL reported this risk as only
30 percent (Peikoff). The existence of these discrepancies is unethical, because consumers are
likely to apply DTC genetic testing data to their clinical decision-making. This will be addressed
in the following section.
To avoid these discrepancies, there is a need for governmental paternalism. Currently,
three federal agencies in the US regulate genetic tests. The Federal Trade Commission (FTC)
plays a small role in preventing false or misleading advertising from DTC genetic testing
companies, although the ethical problem is likely not a result of the advertising, but instead a
result of the genetic tests themselves. The Centers for Medicare and Medicaid Services (CMS)
plays a role in regulating the clinical laboratories used for genetic testing. In compliance with

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the Clinical Laboratory Improvement Amendments (CLIA) Act, CMS must certify all clinical
laboratories via verification of the laboratory procedures and the technicians performing the
tests. This applies to clinical laboratories in connection with healthcare providers and those in
connection with DTC genetic testing companies (National Institutes Of Health). However, while
this is beneficial, CMS verification does not measure the validity of the genetic tests.
Under the Federal Food, Drug, and Cosmetic Act, the FDA has authority over the validity
of genetic tests from labs in connection with healthcare providers and those used to process at-
home kits from DTC genetic testing companies, because these tests are considered to employ
medical devices (Kaye). The FDA indicates two measures of validity that genetic tests must
exhibit: analytical validity, or how accurately the test measures the biomarkers that it is intended
to measure, and clinical validity, or how medically accurate the test is in identifying or predicting
the clinical status of individuals (U.S. Food and Drug Administration).
It is difficult for the FDA to regulate the interpretation of genomic data when researchers
are still investigating the connection between genetics and disease, but regardless, the current
regulations are insufficient. The FDA has unique responsibilities in maintaining the ethicality of
DTC genetic testing by ensuring that it is safe and effective, and thus the agency will be
instrumental in determining the future of this industry (U.S. Food and Drug Administration). One
issue is that the FDA does not currently have jurisdiction over DTC genetic testing companies
that use laboratory-developed tests (LDTs), where the customer must visit a laboratory for the
testing (National Institutes Of Health). In 2010, the FDA announced that it was planning to
regulate all genetic tests, including LDTs, but this expansion has not yet occurred. Although the
FDA released a report in October 2013 outlining its role in the path to personalized medicine,
specific rules for direct-to-consumer (DTC) genetic testing still do not exist because the agency

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is still deliberating about the best approach (U.S. Food and Drug Administration; Annas and
Elias). Although adequate regulation of this industry will be challenging to achieve because of
the varied purposes of the testing and the varied risk levels that are reported, the FDA has a duty
to develop this regulation (Caulfield and McGuire). DTC genetic testing industry cannot be
considered ethical until it is properly monitored, even if this requires a stratified, multi-faceted
approach.

(2) Clinical Utility and Application
In addition to analytical and clinical validity, it is also important to assess genetic tests for
their clinical utility, or the usefulness of the test in improving a patients healthcare outcomes.
While methods for evaluating clinical utility are debatable, this measure captures the value of a
medical innovation and will be increasingly pertinent (U.S. Food and Drug Administration). The
reason that DTC genetic testing is unethical without proper regulation is that it has an inherent
clinical application but an unclear clinical utility.
DTC genetic testing companies appeal to customer empowerment by allowing them to
access their genetic information, and by suggesting that such information can allow them to
make better decisions for their healthcare and lifestyle (Caulfield and McGuire). Yet, genetic
insights regarding health risk for conditions such as arthritis, hemochromatosis, schizophrenia,
and others are not truly valuable for a customer healths without input from a healthcare
professional. So, how can DTC customers make better decisions for their healthcare and lifestyle
when provided with DTC genetic testing data alone? Put simply, they cannot, because genetic
health information is unmistakably tied to the medical setting.
To be fair, DTC genetic testing companies do provide ample disclaimers, maintaining
that the health information that they provide should not be considered diagnostic, and that

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healthcare decisions should not be made without consulting a professional first (National
Institutes Of Health). But these disclaimers and statements such as ask your doctor are not
sufficient. The majority of people who purchase DTC genetic testing believe that the results are
equivalent to medical diagnoses (Caulfield and McGuire). This complication, known as
misattributed equivalence, occurs when the patient (or physician) considers the DTC genetic
analysis to be as valid as it would be if it had originated from a more formal clinical setting (Eng
and Sharp).
Further, even if customers do approach healthcare professionals such as physicians and
genetic counselors about their DTC testing results, the aforementioned regulatory deficiencies
for the industry also render the results unusable, because clinicians cannot confirm that the data
is valid, and it is not connected to the health records of their patients (Su). In fact, only around 10
percent of US physicians in 2010 reported feeling prepared to appropriately assist patients who
came to them with concerns about their DTC genetic testing results (Caulfield and McGuire).
DTC genetic testing results that are not validated can also result in unneeded healthcare visits
and expensive, potentially unnecessary follow-up tests (Caulfield and McGuire). For these
reasons, professional organizations including the AMA and the ACMG advise against genetic
testing performed without participation from a healthcare professional (Caulfield and McGuire).
At present, it can be considered unethical for DTC companies to provide customers with
information regarding health risk because of the low clinical utility of the results. Customers
have no means of making better health decisions as marketed by the companies, as the results are
inherently clinical but cannot be medically applied because the data is insufficiently regulated for
validity. This leaves customers subject to unnecessary confusion and uncertainty regarding their
health, which is quite the opposite of empowerment.

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(3) Patient Concerns
One common concern with DTC genetic testing is related to the psychosocial response
that may be evoked when customers receive their results, and how this response might affect
their behavior. This may manifest as anxiety or distress upon receiving unfavorable information,
or as a misinterpretation of the weight of an elevated health risk or a decreased health risk
(Caulfield and McGuire; Su). The presentation of health risks may be affiliated with customer
response. For instance, in one of 23andMes assessments of risk for Lupus (Systemic Lupus
Erythematosus), a risk level of 0.94 percent as compared to the average 0.25 percent risk is
presented to the customer as being 3.81 times higher than average (23andMe). While this may
be statistically accurate, the difference between 0.25 percent and 0.94 percent is likely not
clinically meaningful and might cause unnecessary anxiety to the customer (Caulfield and
McGuire). Currently, however, the psychosocial impacts of DTC genetic testing are unclear,
because sustained psychological and behavioral responses in DTC genetic testing customers are
not well recorded (Su). Still, considering the lack of validity and utility in DTC results, this is a
warranted ethical concern that may also be alleviated by paternalism in the form of regulation.
Notably, knowledge of genetic makeup can not only affect individual customers, but also
their family members (Moldrup). When someone is informed of his or her health risks, this
reveals information about their individual risk profile, but it can also reveal information about
biological relatives, who are genetically similar. This may compromise a family members
personal decision regarding knowledge of their genetic information and can have a psychosocial
impact on them as well.
A more significant ethical issue in DTC genetic testing is related to patient privacy and
the confidentiality of their genetic information. Though all customers must provide consent

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before beginning the DTC testing process, this might not be true informed consent if the
individual does not understand the ramifications about how their information will be used and
accessed in the future, by the DTC company, researchers, medical professionals, and insurance
companies. Without proper informed consent and protection of customer confidentially, it is
DTC genetic testing can be considered unethical. A point of concern highlighted by the AMA
and ACMG is that many consumers wrongly assume that the confidentiality rules for physician-
patient relationships also apply to the DTC company-customer relationship, although they do not
(Caulfield and McGuire). In fact, DTC genetic testing companies are not necessarily subject to
the regulations outlined in the Health Insurance Portability and Accountability Act (HIPAA),
which serves to ensure that medical records are only available to authorized individuals such as
patients and physicians (Annas and Elias).
Moreover, though the Genetic Information Nondiscrimination Act (GINA) was signed
into law in 2008 to prohibit employers or health insurance companies from discriminating
against individuals on the basis of genetic information, the specific coverage details are not
outlined, and the law does not apply to life insurance or disability insurance (23andMe). It is
unclear how genetic information that DTC genetic testing customers share with their physicians,
friends, employers, or family members might be integrated into their medical records and if
insurance companies will be able to access this information in future (Annas and Elias). This is
further problematic because some genetic information that has little meaning at present may
become extremely meaningful in future, depending on scientific research progress. Some DTC
companies, such as 23andMe, are careful to warn customers that their genetic information could
be used against them, but other companies do not, and 23andMe does not offer much support for
customers with regards to privacy. In their Terms of Service, 23andMe rightly alerts customers

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that in future, [i]f you are asked by an insurance company whether you have learned genetic
Information about health conditions and you do not disclose this to them, this may be considered
to be fraud, followed by the recommendation that customers ask a lawyer (23andMe).
In the case of maintaining customer confidentiality in research, clinical genomics and
personalized medicine are rapidly evolving fields that rely on genome wide association studies
(GWAS) with large amounts of genomic data (Weston and Hood). Thus, many DTC companies
have stated that their long-term goals are associated with this research. For example, 23andMe
plans to collect genetic data from customers in order to create a biobank that can be sold for
research and used for the development of profitable discoveries (Annas and Elias). While this is
ethically permissible if consent is obtained and privacy is upheld, these ideals are difficult to
achieve, especially if the buyer of the genetic information does not meet the terms of the original
agreement, or if the DTC genetic testing company goes bankrupt or out of business (Annas and
Elias; Caulfield and McGuire). Consequently, though the future of clinical genomics is difficult
to predict, paternalism is needed in order to ensure that customers are rightfully informed and
that their genetic health data is kept confidential by privacy legislation.
V. Objections
The main objection to supporting medical and governmental paternalism in the case of
DTC genetic testing is the notion of individual autonomy. Proponents of this argument claim that
because an individuals genetic information belongs to them, and especially because DTC
companies provide ample disclaimers, individuals should be able to access their results (even
non-validated or clinically useless results) if DTC genetic testing companies have provided the
means. For instance, Helgasson and Stefnsson argue that, clinical utility is a secondary issue
when balanced against peoples' right to seek information about themselves at their own cost

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(Helgason and Stefnsson). Another related objection to paternalism in this case is that
knowledge is power, and that DTC genetic testing is important for disseminating information
to the public, so that individuals can make decisions regarding their genetic makeup, especially
since psychopathologies have not been entirely proven in DTC genetic testing customers
(Helgason and Stefnsson).
Yet, while individuals do have the right to obtain their genetic information, the
government (mainly via the FDA and writers of privacy legislation) is responsible for ensuring
that this information is regulated for validity, utility, and security (Kaye). The aforementioned
objections rely on the notion that DTC genetic tests are providing customers with what they are
marketing: the ability to use genetic insights to make better decisions about health. However, as
mentioned previously, for most genetically linked conditions, it is near impossible to make any
significantly better decisions about health without a clinicians input (Caulfield and McGuire).
Healthcare providers cannot confidently rely on the DTC testing results without validation, so in
effect, the DTC genetic testing companies cannot fulfill their promise of helping customers to
make better health decisions without the necessary regulations. In other words, preventing
individuals from accessing inaccurate data does not deprive them of useful information, because
non-validated genetic data has an inherent clinical application yet no clinical utility (Annas and
Elias).
Those who object to paternalism may also note that the DTC genetic testing debate is
similar to the debate about patients having full access to their medical records and clinical test
results, which was resolved by granting patients this access (Annas and Elias). However, this is
not a sound comparison because medical records and clinical test results contain clinically
validated, secure information, which is currently not the case with DTC genetic health testing

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results. In future, if the proper regulations are in place and DTC results are validated, clinically
useful, and subject to the full provisions of HIPAA and GINA, then the comparison will be valid,
customers should rightfully be granted this access.
One final objection to paternalism in the case of DTC genetic testing compares this type
of testing to other at-home tests. This argument maintains that DTC testing is beneficial in that it
opens the door to productive discussions and follow-up tests between patients and healthcare
providers, where the analytical and clinical validation can occur. DTC genetic tests are often
compared to pregnancy tests to illustrate this point (Eng and Sharp). If a woman obtained
positive results from an at-home pregnancy test and then consulted her obstetrician, the physician
would order a clinical laboratory test to confirm the at-home test. At-home pregnancy tests are
useful in that they allow women to check for a pregnancy without having to see an obstetrician
each time a pregnancy is remotely suspected, which would overwhelm clinicians. Proponents of
DTC genetic testing at present see this service in a similar way (Eng and Sharp). However, the
flaw in this analogy is that DTC genetic testing is much more comprehensive than an at-home
pregnancy test, and would require extensive, unnecessary testing as opposed to a single
confirmation test. Further, at-home pregnancy tests and clinical laboratory tests for pregnancy
both rely on a similar technology, while for DTC genetic tests and clinical genetic tests, there are
large discrepancies in methodology and regulation. As such, at-home pregnancy tests have a
high clinical utility because they are quite accurate and because a pregnancy elicits certain
clinical treatments, while the results of DTC genetic tests have a low clinical utility that would
not be resolved by simply following up with a physician (Eng and Sharp).


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VI. Implications
Over the next decade, it is predicted that whole-genome sequencing will become
affordable, and that genome reference materials will be adequately developed to make much of
this data clinically useful. Electronic medical records (EMRs) will also likely serve as a means
for individuals to store and access their full genomic data with or without healthcare providers
(Annas and Elias). Considering the heightened complexity of whole genome data as compared
to SNP genotyping, and the increasing importance of genomics in personalized medicine, DTC
genetic testing can be seen as an important catalyst for developing an appropriate regulatory
framework for clinical genomics.
While I have argued in favor of medical (governmental) paternalism in the case of DTC
genetic health testing, this does not mean that the products of this industry are unethical in
themselves or that they should always be prohibited. Rather, widespread regulation is needed to
ensure that application of clinical genomics at present and in future is approached in an ethically
permissible manner: with analytical validity, clinical validity, clinical utility, and confidentiality.
Currently, without the proper regulation, DTC genetic testing is unethical, but the ethical issues
can be resolved if the FDA develops clear guidelines for all genetic tests, and if customer privacy
is upheld by extending the provisions of HIPAA and GINA to this industry.
If these requirements are met, cooperation between healthcare providers and DTC genetic
testing companies will be feasible, and the testing will reach a level of ethicality and of clinical
utility that can provide realistic benefits for customers. If DTC genetic testing is properly
regulated, it can serve as a platform for personalized medicine and whole genome sequencing to
build upon, rendering even more benefits for individuals who desire to unlock their genetic
information. Granted, this relies upon continued patient interest and consent in clinical

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genomics, trained providers that can interpret and assist patients about their genetic data,
established medical infrastructure (such as EMRs) to support the large amounts of data, and
maintained regulations for validity, utility, and privacy. Nonetheless, personalized medicine is
the future of medicine, and it will be greatly impacted by the fate of the DTC genetic testing
industry.

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VII. References
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Problems, and Policy Responses. Annual Review of Medicine 2012 : 2333.
Crews, K R et al. Pharmacogenomics and Individualized Medicine: Translating Science into
Practice. Clinical pharmacology and therapeutics 92.4 (2012): 46775.
Emahazion, Tesfai et al. SNP Association Studies in Alzheimers Disease Highlight Problems
for Complex Disease Analysis. Trends in Genetics 2001 : 407413.
Eng, Charis, and Richard R Sharp. Bioethical and Clinical Dilemmas of Direct-to-Consumer
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Helgason, Agnar, and Kri Stefnsson. The Past, Present, and Future of Direct-to-Consumer
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International Human Genome Sequencing Consortium. Initial Sequencing and Analysis of the
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Kaye, Jane. The Regulation of Direct-to-Consumer Genetic Tests. Human molecular genetics
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Meyer, Joanne M., and Geoffrey S. Ginsburg. The Path to Personalized Medicine. Current
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Moldrup, Claus. Ethical, Social and Legal Implications of Pharmacogenomics: A Critical
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Peterson-Iyer, Karen. Pharmacogenomics, Ethics, and Public Policy. Kennedy Inst Ethics J 18
(2008): 3556. Print.

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Su, Pascal. Direct-to-Consumer Genetic Testing: A Comprehensive View. The Yale journal of
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U.S. Food and Drug Administration. Paving the Way for Personalized Medicine Paving the Way
for Personalized Medicine!: N. p., 2013. Print.
vant Veer, Laura J, and Ren Bernards. Enabling Personalized Cancer Medicine through
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