The document discusses the issues surrounding direct-to-consumer genetic testing. It begins with an overview of the history of human genome sequencing projects and their goals of understanding genes and their functions. However, genomic research also raises ethical concerns. Currently, regulation of direct-to-consumer genetic testing varies by state. While increased accessibility can enhance individual autonomy, these tests also lack oversight and often make misleading health claims. Both advocates and critics debate how to balance consumer protection against restricting individual choice. Overall, the document examines the complex policy challenges around direct-to-consumer genetic testing and its implications.

1. TOPIC: Fighting Harmful Effects of Food and Drink Marketing
Overview:
Food marketing to children and adolescents is a major public health concern. The U.S food
industry spends $1.8 billion per year on marketing targeted to young people. On television
alone the average U.S. child sees approximately 13 food commercials every day, or 4,700 a
year; and teens see more than 16 per day, or 5,900 in a year. Majority of these ads are for
unhealthy products, high in calories, sugar, fat, and/or sodium that are obtained from candy,
sugary drinks, cereals, and fast food restaurants. In comparison, children see about one ad
per week for healthy foods such as fruits and vegetables, and bottled water. Companies
increasingly market to young people anywhere they spend their time, including in schools,
on the Internet, and on mobile phones. They continually find new and creative ways to
reach children through campaigns that encourage children to send marketing messages to
their friends through YouTube, Facebook, and other social media. Food company websites
targeted to children usually contain entertaining content to keep them engaged with the
brands as long as possible. Their messages portray positive outcomes from consuming
high-calorie, nutritionally-poor foods. To children it appears cool, fun, and exciting to eat
these unhealthy products anytime, anywhere. Food marketing has a direct and powerful
impact on young people's food preferences and eating behaviors and negatively influences
their diet, weight, and health.
Historical Background:
According to a 2003 expert by the WHO, increased television viewing contributes to the
excessive intakes of saturated fats, cholesterol and salt by children which leads to a higher
risk of high blood pressure and diabetes in adulthood. A near success attempt to ban
television advertisement to children under 8years was stalled in 1978. This attempt was
made by the Federal Trade Commission (FTC) which used its authority on unfair practices
to propose a ban on television advertisement of sugary foods to children 8 – 11years old.
However, this was opposed with a counter-argument that the law would violate their First
Amendment Rights. Till now, there have only be dissolved attempts to create a legislation
that reduces food marketing. In fact in 2004 and 2005, legislators proposed two similar bills
titled Personal Responsibility in Food Consumption Act and Commonsense Consumption
Act, which protected fast food restaurants from law suits of consumers claiming damages.
Although these bills failed, it sparked up lobbying from the National Restaurant Association
and a spill-over effect to state bills which sometimes got passed.
Current Background:
Presently, there have been actions made at the Food Industry, Federal, State and Local
Levels to place regulations that somewhat curtail the harmful effects of food and drink
marketing on children. In 2006, the Better Business Bureau established the Children’s Food
and Beverage Advertising Initiative (CFBAI) to lead the food industry in self-regulation.
Since then, the CFBAI has increased participation by food and drink companies in pledges
that aim at reducing the marketing of unhealthy food to children below 12 years. However,
exclusions and limitations show that these pledges are unlikely to produce major changes to
existing marketing practices. For instance, participating companies have created their own

2. definitions of “better-for-you” foods that include products dietitians may regard as unhealthy.
Similarly, participating companies have declared that widely used forms of marketing
designed specifically to appeal to children are not child-targeted advertising and thus not
subject to limitations, including product packaging, advertising on prime-time television
shows popular with children.
In 2011, Federal efforts were made to regulate marketing via the establishment of the
Interagency Working Group (IWG). The IWG proposed voluntary nutrition and marketing
standards to guide industry self-regulatory efforts. It proposed that the industry should
“children” as 12-17year olds. It also proposed amounts of acceptable sodium, saturated fat
and sugar in food. However, these two suggestions were met with great opposition by
industry heavy weights as it was argued that maturity comes at 16 years and the food will
become less palatable.
Regardless, there has been more space for marketing restrictions in state and local levels.
In some states, schools have the ability to make their own School Wellness Policy, which
designate policies on food marketing on school grounds given parental agreement. These
policies can prohibit the sale and advertisement of foods using brand names on school,
fundraisers where branded products are sold, amongst others. Although, the state and local
government retain some power to regulate marketing on school grounds, their impact is little
and dependent on the pro-activeness of the community members, hence, the only real
wide-spread impact is elicited through food industry self-regulations and its limitation,
exclusions make it ineffective. Recent evaluations of the effects of the CFBAI pledges on
the volume and types of foods advertised to children demonstrate limited changes in the
foods advertised to children. Reviews on the self-regulatory effects on food industry by
public health professionals have suggested that industry self-regulatory efforts provide more
public relations benefit to the food industry than real health benefits for children.
A common refrain among opponents of public health regulations is that government should
not impede individual liberty to benefit the general public. The US Constitution addresses
this concern: provisions of the Bill of Rights and the Fourteenth Amendment — including
those regarding free speech, due process, equal protection, and property ownership —
mandate that a balance be struck between the government’s obligation to serve the general
welfare and the interest of individual citizens and organizations in freedom, fairness, and
self-determination. And anyways, the national laws cannot protect children from
international content imported from other countries. More so, the wealth of heavy weights in
the food industry are used to lobby against these regulation influencing the political agenda.
Questions To Consider:
1) What can the government do to fill in the gaps left the self-regulatory limitations and
exclusions of the food industry?
2) Is it responsible for the government to make public health regulation that impede
individual liberty in order to benefit the general public? How can the government
strike a balance between these two – individual liberty and general public?
3) How can the U.S ensure that it is also protected from international harmful marketing
strategies on the sale of food and drinks?

3. 4) How can other organizations such as the WHO pitch into this dilemma that not only
the U.S faces?
Appendix:
http://www.yaleruddcenter.org/what_we_do.aspx?id=4
http://www.yaleruddcenter.org/resources/upload/docs/what/advertising/FoodMarketingYouth
ThreatsOpportunities_CO_4.12.pdf
http://whqlibdoc.who.int/trs/WHO_TRS_916.pdf
http://www.cdc.gov/pcd/issues/2011/sep/10_0272.htm
http://www.yaleruddcenter.org/resources/upload/docs/what/advertising/MarketingChildhood
ObesityARPH4.09.pdf
TOPIC: Human Genome Sequencing
Overview:
Ever since scientists discovered that genetic material was made of DNA and not protein as
previously believed, there has been various attempts to solve the Herculean task of
sequencing the human genome. The human genome is a collection of genes built with four
basic units of nucleotides which fold and refold into constricted loops. At any given time, the
body translates the information contained in those loops by making proteins with specific
functions that elicit a body process. The concept behind the human genome sequencing
project was to obtain a clearer understanding of these genes, their functions and
consequently their dysfunctions. This was done to ultimately provide information that could
lead to earlier diagnostics and treatment of illnesses leading to a higher quality of
healthcare.
However, genomic research brings with it an array of social, legal and ethical implications.
There has been several unresolved debates on how the information gotten from genetic
research is to be used when it comes to genetic testing and counseling along with gene
therapy. For example, should health care practitioners perform genetic testing of an unborn
fetus when the results might lead its parents to abort the pregnancy? Although the gains of
the human genome project is great, it could be misused and so its implications must be
assessed.

4. Historical Background:
The first successful attempt at sequencing a genome was done in 1990 by a group of British
scientists who sequenced the genome of a nematode. Before then, there were several
discussions about its applicability on the human genome. With funding from the US National
Institutes of Health (NIH) and Department of Energy in collaboration with the Wellcome
Trust Foundation, best practices from the nematode sequencing experiment were a team of
scientists in the Sanger Institute and around the globe to sequence different short segments
of the human genome. Among the goals of the project was to discover genes and their
nucleotides, store the information in a database and address the ethical, legal and social
implications (ELSI) that may arise from the project(1). To this effect, the US Congress in its
National Institute of Health Revitalization Act 1993 mandated that “not less than” 5% of the
NIH Human Genome Project budget be set aside for research on the implications of
genomic research. As a result, the ELSI Research Program was birth.
Although after thirteen years of research the Human Genome Project was concluded,
issues still rise from its data analysis and will continue for years to come. One major debate
is on its application in the field of health specifically in the areas of marketing specifically in
the direct to customer marketing of genetic tests. Usually, people who want genetic tests
receive it via health practitioners and genetic counselors. These personnel order the tests
from the labs, then collect and analyze the DNA samples. However, now there is a growing
market for direct-to-consumer genetic testing whereby the sales of testing is advertised via
radio, television and other media. Then, people order the tests on their own and send to
these companies for analysis. Although the accessibility is increased, there is a higher risk
of consumers being misled by the results of unproven/invalid tests as the likelihood of a
disease occurring has other factors such as family history, environment and lifestyle choices
attached to it. In July 2006, there was a year long investigation of direct-to-consumer (DOC)
marketing of genetic testing carried out by the Government Accountability Office (GAO). In
this investigation the GAO submitted 14 fictitious consumer profiles, generated from just two
sources, to four different Web sites offering genetic tests. The companies' results included
predictions for diseases such as cancer, heart disease, or "brain aging." The GAO study
concluded that the information passed on to consumers was "misleading" because of the
ambiguous language used to describe the results as well as the inconsistent predictions of
diseases for identical samples. Furthermore, supposedly "personalized" nutritional
supplements offered by some of the companies were in fact not customized, as evidenced
by different consumer profiles receiving similar, if not identical, supplement regimens. The
GAO reported one Web site's supplements costing approximately $1,200 per year, while
experts consulted by the GAO said that over-the-counter multivitamins have similar
contents and would only cost $35 per year.(2)
In the case of an important decision such as the abortion of a child or the amputation of a
body part, for example the breast in breast cancer, the inaccuracy of these results will pose
more dangers instead of benefits. This issue along raises the question of informed consent,
which is the process of educating a person about the methods, risks, benefits and
consequences of testing. It also involves the person’s, or legal guidance, voluntary
agreement to undertake the test given that he/she could opt out at any time. In the 2009

5. Protection of Human Subjects law, under Title 45, there are requirements that must adhered
to in writing a consent form. This is to ensure that the subject is fully aware of the process.
In a situation of the indirect testing where the doctor is present, consumers can ask
clarifying questions as to the meaning of the results, however, in direct-to-consumer genetic
testing, this information source is absent and the consumer is left to speculate(4).
Current Situation:
Presently, the requirement for an authorized healthcare provider to obtain a genetic or
laboratory test is determined by the state law. Some states explicitly authorize laboratories
to accept carry out specific tests, such as cholesterol and pregnancy tests, without
authorization from a health care provider. Other states prohibit any sort of Direct To
Consumer (DTC) testing. And still other states are silent on the issue, which leaves it up to
individual laboratories to decide whether to offer DTC testing. Currently, 25 states and the
District of Columbia permit DTC laboratory testing without restriction, whereas 13 states
prohibit it. The Federal Trade Commission (FTC) is charged with protecting consumers
against unfair or deceptive trade practices, including false or misleading advertising claims.
While the FTC has asserted that it has jurisdiction over genetic testing advertising, it
appears to have taken no action against any genetic test advertisements, even those that
would appear clearly false and misleading on their face. In 2006, FTC issued a consumer
alert warning consumers to be skeptical of claims made by DTC test providers and to
discuss test results with a health care provider. State Law could prohibit direct patient
access to genetic testing by requiring a healthcare provider to order the test and receive the
results. However, relying on state law may be ineffective as it would lead to inconsistent
requirements for Internet-based genetic testing which easy escapes a state’s oversight and
hence is difficult to regulate.
More so, the problem of the limited resources of the FTC makes it difficult in taking action
against false advertisements made on invalid genetic testing. Worse still, illegal claims on
the advertising companies can only be made through the First Amendment on “commercial
speech” whereby the government will have to prove that the speech is harmful and that
restrictions are needed to prevent such harms. More still, an intervention from The Food
and Drug Administration (FDA) is limited because FDA regulates only those genetic tests
that are sold as “test kits” and used by laboratories to perform testing. FDA considers test
kits to be medical devices and requires that they undergo premarket review before they can
be made commercially available. Since the vast majority of direct to consumer genetic tests
are instead developed by the laboratory, neither tests nor claims made about them is
subject to FDA regulation (5).
Another reason why some policies do not restrict the DTC marketing is due to the debate of
Razian Autonomy which holds the view that a person with appropriate mental capacity
should have the freedom to make a choice from different options, without influence from
others. In this case, the Direct To Consumer advertisers believe that the easy access to
genetic testing gives them autonomy over themselves by allowing them make valuable
health and lifestyle decisions. Hence, in the presence of informed consent, accurate
advertisement, privacy protection and aid in coming to a conclusion, the DTC method would

6. enhance autonomy. Nonetheless, the pro and con of this heated debate continues in policy
institutions and the bioethics world (7).
Questions to Consider:
1. Do you feel that genetic testing should be made easily accessible to the public
through direct to consumer (DTC) marketing? What would be the implications of a
policy pro DTC marketing? What would be the implications of a policy con DTC
marketing?
2. What role could the U.S federal and state government take to regulate genetic
testing? What would be the economical implication of this regulation on the biotech
industry?
3. Is it ethically sound to restrict genetic testing to solely laboratories when the
information contained in them may lead to a life-saving decision? Should the
laboratories be allowed to keep information from the patient knowing there is no cure
for the disease that genes predict?
Appendix:
1) https://www.sanger.ac.uk/about/history/hgp/
2) http://www.annualreviews.org/eprint/eDSR5xjQy7XjwMQ9VDXs/full/10.1146/annure
v-genom-090413-025327
3) http://www.genome.gov/19518344
4) http://ghr.nlm.nih.gov/handbook/testing/directtoconsumer
5) http://www.dnapolicy.org/policy.issue.php?action=detail&issuebrief_id=32
6) http://www.dnapolicy.org/resources/Issues_in_Science_and_Technology.pdf
7) http://jme.bmj.com/content/early/2014/05/05/medethics-2014-
102026.full?g=w_jme_open_tab#sec-7