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*The Color of Our Genes*
Balancing the Promise and Risks of Racial Categories in Human Biotechnology
by Osagie Obasogie, Science
Progress<http://www.scienceprogress.rsvp1.com/2009/06/the-color-of-our-genes/?mgh=http%3A%2F%2Fwww.scienceprogress.org&mglogexit=1&mgf=1>
June 15th, 2009


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source:
Flickr user hermida

A group of faculty members from Stanford University recently published a set
of guidelines for using race in human genetics
research<http://genomebiology.rsvp1.com/2008/9/7/404?mgh=http%3A%2F%2Fgenomebiology.com&mglogexit=1&mgf=1>.
These guidelines, called the “Ten Commandments of Race and
Genetics<http://www.newscientist.rsvp1.com/article/dn14345-ten-commandments-of-race-and-genetics-issued.html?mgh=http%3A%2F%2Fwww.newscientist.com&mglogexit=1&mgf=1>”
by the *New Scientist*, provide both a descriptive account of the relevance
of race to biomedical research and normative suggestions that call for using
racial categories in a responsible manner.

These recommendations come at a time when the race and genetics conversation
is at a fever pitch. Many hope that advances in human biotechnology will
yield profound medical, scientific, and social advances. But what often goes
unacknowledged is that if we are not extremely careful, commercial and
forensic applications utilizing human biotechnology may resuscitate harmful
ideas about the significance of genetics to understanding racial difference
and the cause of racial disparities. To help mitigate such
misunderstandings, policy tools such as race impact assessments should be
adopted widely across several regulatory agencies. By facilitating greater
engagement between public policy and human biotechnology, race impact
assessments can provide a forum for multiple stakeholders to work with
government to assess the effect race-specific biotechnologies might have on
minority communities.

To understand why public policy must grapple with the impact human
biotechnology might have on racial minorities, we must first take a close
look at how race has informed these technologies’ development and
deployment.

*Race and Genetics: From Research to Main Street*

One of the Human Genome Project’s most heralded findings was that all humans
are over 99.9 percent similar at the molecular level, a discovery that
supports the social rather than genetic character of racial categories.
(Subsequent research has slightly raised the initial estimate of difference,
to around 0.5 percent.[1]<http://www.scienceprogress.rsvp1.com/2009/06/the-color-of-our-genes/?mgh=http%3A%2F%2Fwww.scienceprogress.org&mglogexit=1&mgf=1#_edn1>)
At the time that the HGP’s results became public in 2000, numerous
scientists and other observers predicted that its finding of human genetic
similarity would finally move society beyond biological theories of racial
difference that have fueled centuries of racial
strife.[2]<http://www.scienceprogress.rsvp1.com/2009/06/the-color-of-our-genes/?mgh=http%3A%2F%2Fwww.scienceprogress.org&mglogexit=1&mgf=1#_edn2>The
truths of science, some hoped, could promote racial healing. Yet
almost
as soon as researchers announced this result, several research projects
began to focus on mapping the less than 1 percent of human genetic variation
onto social categories of
race.[3]<http://www.scienceprogress.rsvp1.com/2009/06/the-color-of-our-genes/?mgh=http%3A%2F%2Fwww.scienceprogress.org&mglogexit=1&mgf=1#_edn3>

Since then, biomedical researchers and companies have become increasingly
interested in developing treatments that use race and ancestry (both
perceived and self-identified) as proxies for groups’ genetic
predispositions. Put differently, these efforts presume that social
categories of race reflect medically relevant genetic differences, even when
such differences have not been identified. This is better known as *race-based
medicine*: drugs that are developed, approved, and marketed for specified
racial groups. Only one of these drugs, BiDil (marketed to treat heart
failure in African Americans), has received FDA approval. But others are in
development.

Meanwhile, dozens of biotechnology companies are marketing genetic testing
services directly to consumers, bypassing physicians and other health care
professionals. Combined with the power and reach of the Internet,
direct-to-consumer genetic testing offers people the ability to swab their
cheeks at home, mail the sample (along with a fee ranging from $100 to
$1,000), and receive information a few weeks later.

While much skepticism has accompanied the growth of DTC genetic testing,
there has been less public discussion about the significant concerns
stemming from genetic tests claiming to reveal information about consumers’
ancestral origins, which are often interpreted as tests of racial purity and
mixture. Genetic ancestry tests are gaining popularity, especially among
African Americans who often have these tests pitched to them as a way to
make an end run around the genealogical dead end produced by the slave
trade. But in examining less than 1 percent of a person’s genetic
background, these tests often overstate their ability to say anything
significant about a person’s heritage, giving the impression that social
categories of race and ethnicity are somehow genetically verifiable.

Biotechnology is also making an impact in forensics, a field that uses
techniques such as ballistics, fingerprinting, and toxicology to investigate
crimes. Two decades ago, the United Kingdom’s Sir Alec Jeffrey’s
revolutionized forensics by developing genetic profiling. This capacity to
extract unique identifying information from hair or body fluids left at
crime scenes has given police a powerful tool to catch suspects.

A good part of DNA forensics’ power now comes from massive databases storing
large numbers of genetic profiles. Once a DNA sample is gathered from a
crime scene, it can be checked against stored profiles for matches.

But whose DNA winds up in police databases? Typically, it is people who have
had previous run-ins with law enforcement. And herein lies the risk for
minority communities: given that Blacks and Latinos are disproportionately
policed, arrested, and prosecuted, their profiles are likely to be
over-represented. This means that the significant civil liberties concerns
raised by DNA forensics<http://www.acslaw.rsvp1.com/node/5338?mgh=http%3A%2F%2Fwww.acslaw.org&mglogexit=1&mgf=1>will
disproportionately burden these communities.

*Will Human Biotechnology Revive Biological Theories of Race?*

Like many scholars, the authors of the Stanford guidelines recognize that
there is no scientific basis for the idea that human genetic variation
reflects any sort of racial hierarchy and acknowledge that racial categories
exist within social and political contexts that shift over time. They
discourage researchers from using race as a proxy for biological similarity,
and caution against what they term the “naïve leap” to genetic explanations
of complex social phenomena such as IQ or propensity for violence. Their
guidelines are an important contribution, and should be adopted widely so
that research on race and human genetics can proceed responsibly.

But as I argue in my report, “Playing the Gene Card? A Report on Race and
Human Biotechnology<http://www.thegenecard.rsvp1.com/?mgh=http%3A%2F%2Fwww.thegenecard.org&mglogexit=1&mgf=1>,”
concerns about race and human biotechnologies cannot be limited to
individual research agendas or best practices in clinical settings. Instead,
it is crucial to consider how these technologies, particularly when taken
together, are likely to have a *public* impact. However laudatory, no set of
voluntary guidelines or recommendations can obviate the need for greater
public oversight of how racial categories are deployed—in research, in the
marketing of the resulting products, and in the public understanding of the
research findings.

This point is particularly relevant since the approval of regulatory bodies
such as the Food and Drug Administration and the United States Patent and
Trademark Office can allow *the state* to sanction potentially misguided
claims about the relationship between race, genetics, and social and health
outcomes. Regulatory bodies can play a powerful role in giving misplaced
legitimacy to claims that correlate social categories of race with genetic
variations when the evidence is not yet robust, effectively putting the cart
before the horse.

There is some evidence<http://content.nejm.rsvp1.com/cgi/content/extract/348/12/1170?mgh=http%3A%2F%2Fcontent.nejm.org&mglogexit=1&mgf=1>that
social categories of race may be genetically relevant to the extent
that they may correlate with geographical origin, broadly defined. This, in
turn, may reflect the histories of isolation and evolution experienced by
some groups. Yet there is also evidence that today’s applications in
biomedicine, genealogy, and forensics have treated race in a somewhat
circular fashion; unexamined ideas and assumptions about the genetic
relevance of race, often reflecting lay perspectives, can shape research
questions and methodologies. This is what Troy Duster and others have called
the reification of
race<http://www.sciencemag.rsvp1.com/cgi/content/short/307/5712/1050?mgh=http%3A%2F%2Fwww.sciencemag.org&mglogexit=1&mgf=1>:
transforming race as a social concept into a specific, definite, concrete,
and now presumably genetic category that can feed back into preexisting
assumptions about racial difference.

The potential of race-specific medicine, genetic ancestry tests, and DNA
forensics to revive biological thinking about race is not necessarily due to
any ill intent on the part of researchers working in the area of race and
genetics. To the contrary, many scientists have devoted their careers to
egalitarian and praiseworthy pursuits such as resolving health disparities
and assisting law enforcement. For example, the use of racial categories in
biomedical research has been proposed as a way to make biomedicine more
inclusive. But even with the best of intentions, commercial and forensic
applications of this research can unwittingly create the very difference
they seek to find. As in other areas, racial injustice is best understood as
a matter of systematic outcomes rather than a question of intentions.

The social, political, and economic dynamics surrounding research concerning
race and genetics might allow less-than-robust scientific studies or weak
correlations between genetic variations and social categories of race to be
marketed as commercially viable genetic tests or biomedicines. Our society’s
continued stake in the idea that social categories of race reflect inherent
biological differences—even when faced with substantial evidence to the
contrary—contributes to the acceptance of these products. And this process
might work to reconstitute an inaccurate and unsubstantiated view of racial
difference and disparities.

*Why We Need Race Impact Assessments*

Given the remarkably high stakes involved and the rapid development of
biotech products and services that implicate racial categories, it is time
for policymakers to take these matters under serious consideration.
Responsible regulation and oversight can go a long way towards ensuring that
these products and services are based on sound scientific research, and that
they do not promote unfounded biological theories of racial difference.
Regulators can help protect racial minorities from inappropriate commercial
pressures, less than forthright marketing, and the often-unintentional
re-articulation of folk notions of biological race. The goal is to create an
environment in which research and scientific innovation can move forward
while guarding against potentially harmful social outcomes.

How might this work? In order to encourage more forethought in regulatory
decision-making and implementation, other fields have adopted the use of
impact assessments. One relevant example is the *health impact assessment*,
[4]<http://www.scienceprogress.rsvp1.com/2009/06/the-color-of-our-genes/?mgh=http%3A%2F%2Fwww.scienceprogress.org&mglogexit=1&mgf=1#_edn4>which
is a set of procedures, methods, and tools that, according
to the World Health
Organization<http://www.euro.who.rsvp1.com/document/rc52/ebd3.pdf?mgh=http%3A%2F%2Fwww.euro.who.int&mglogexit=1&mgfromtag=a&mgf=1>
,

…provide a structured framework to map the full range of health consequences
of any proposal, whether these are negative or positive. It helps clarify
the expected health implications of a given action, and of any alternatives
being considered, for the population groups affected by the proposal. It
allows health to be considered early in the process of policy development
and so helps ensure that health impacts are not overlooked.

Public health researcher John Kemm
notes<http://www.scielosp.rsvp1.com/scielo.php?script=sci_arttext&pid=S0042-96862003000600002&mgh=http%3A%2F%2Fwww.scielosp.org&mglogexit=1&mgf=1>that
despite different definitions, two essential characteristics of health
impact assessments are that they “seek to predict the future consequences
for health of possible decisions; and that [they] seek to inform
decision-making.” For example, a health impact assessment of a proposal for
a new factory would look at a number of ways it may affect the local
population’s health, such as whether emissions from the building are linked
to adverse health outcomes and how best to contain them.

Similar regulatory assessments of the possible public impact of an
innovation or initiative may be instructive for identifying and mitigating
their possible adverse effects for racial minorities. *Race impact
assessments*[5]<http://www.scienceprogress.rsvp1.com/2009/06/the-color-of-our-genes/?mgh=http%3A%2F%2Fwww.scienceprogress.org&mglogexit=1&mgf=1#_edn5>could
* *encourage shared responsibility among multiple actors—including
regulators, researchers, internal review boards, and affected communities
and their representatives—in making sure that human biotechnologies are not
used to promote unfounded biological understandings of race and that claims
made about the relationship between race and genetics are based on sound
evidence. Just as health impact assessments aim “to enhance recognition of
societal determinants of health and of intersectoral responsibility for
health,”[6]<http://www.scienceprogress.rsvp1.com/2009/06/the-color-of-our-genes/?mgh=http%3A%2F%2Fwww.scienceprogress.org&mglogexit=1&mgf=1#_edn6>race
impact assessments could promote recognition of the social
construction
of race and the social determinants of racial disparities.

What might such race impact assessments look like in the context of human
biotechnology? As an example, modifications to the traditional role of the
Food and Drug Administration might allow it to convene advisory committees
as part of its review process that look beyond safety and efficacy to
evaluate whether medicines with race specific indications such as BiDil
might reinforce biological understandings of race when no biological or
genetic mechanisms have been identified.

The composition of such a committee would have to accurately reflect the
demographic makeup of the stakeholders and constituent groups affected by
the research. Its assessment would not be limited to reviewing
biostatistical evidence from clinical trials. It would also consider the
effects race-specific medicines might have on broader commitments to racial
justice, specifically in the context of past discrimination based on
biological notions of race. This might encourage narrowly tailored
mechanisms to ensure that a drug’s beneficiaries have access without
prematurely giving legitimacy to biological understandings of racial
difference.

A race impact assessment of ancestry tests might lead federal and/or state
governments to closely scrutinize marketing claims to ensure that they do
not overstate the current state of the science. Such assessments might lead
regulators to require genetic testing companies to limit their advertising
to scientifically verifiable statements, and to give consumers adequate
information about the tests’ limitations.

In the context of DNA forensics, a race impact assessment could shed light
on policy shifts that might disproportionately affect certain communities,
such as familial
searching<http://www3.interscience.wiley.rsvp1.com/journal/118589885/abstract?mgh=http%3A%2F%2Fwww3.interscience.wiley.com&mglogexit=1&mgf=1>,
the use of molecular
photofitting<http://online.wsj.rsvp1.com/article/SB123810863649052551.html?mgh=http%3A%2F%2Fonline.wsj.com&mglogexit=1&mgf=1>,
or including arrestees that have not been convicted in DNA
databases<http://www.nytimes.rsvp1.com/2007/02/05/washington/05dna.html?_r=1&hp&ex=1170651600&en=a2a71de54d113c56&ei=5094&partner=homepage&oref=slogin&mgh=http%3A%2F%2Fwww.nytimes.com&mglogexit=1&mgf=1>.
This assessment might encourage refinements and recalibrations that could
lessen the burden on those communities while ensuring that law enforcement
has the tools it needs.

* *

The overall goal of race impact assessments in human biotechnology would be
the same as its counterparts in public health and other realms: to increase
dialogue between stakeholders and policymakers so as to balance competing
interests though strategic planning that promotes the public good.

*Osagie K. Obasogie is an Associate Professor of Law at the University of
California, Hastings, a Visiting Scholar at the University of California,
San Francisco, and a Senior Fellow at the Center for Genetics and Society.
This article is adapted from his recent Center for Genetics and Society
report entitled “Playing the Gene Card?: A Report on Race and Human
Biotechnology,” available at
**thegenecard.org*<http://www.thegenecard.rsvp1.com/?mgh=http%3A%2F%2Fwww.thegenecard.org&mglogexit=1&mgf=1>
*.*

*Notes*

[1] Samuel Levy et. al. write “Comparison with previous reference human
genome sequences, which were composites comprising multiple humans, revealed
that the majority of genomic alterations are the well-studied class of
variants based on single nucleotides (SNPs). However, the results also
reveal that lesser studied genomic variants, insertions and deletions, while
comprising a minority (22%) of genomic variation events, actually account
for almost 74% of variant nucleotides. Inclusion of insertion and deletion
genetic variation into our estimates of interchromosomal difference reveals
that only 99.5% similarity exists between the two chromosomal copies of an
individual and that genetic variation between two individuals is as much as
five times higher than previously estimated. … [Therefore] we can, for the
first time, make a conservative estimate that a minimum of 0.5% variation
exists between two haploid genomes.” Samuel Levy, “The Diploid Genome
Sequence of an Individual Human,” *PLoS Biology* 5:10 2113–44. (Cited
passages at 2114 and 2132).

[2] *The New York Times*’ Amy Harmon writes that “When scientists first
decoded the human genome in 2000, they were quick to portray it as proof of
humankind’s remarkable similarity. The DNA of any two people, they
emphasized, is at least 99 percent identical. But new research is exploring
the remaining fraction to explain differences between people of different
continental origins.” Amy Harmon, “In DNA Era, New Worries About Prejudice,”
*New York Times*, November 11, 2007,
http://www.nytimes.com/2007/11/11/us/11dna.html?_r=1&hp&oref=slogin.

[3] Duana Fullwiley, “The Molecularization of Race: Institutionalizing Human
Difference in Pharmacogenomic Practice,” 16 *Science As Culture* 1 (2007).

[4] While an examination of health impact assessments is most relevant for
the purposes of this discussion, it is important to acknowledge that health
impact assessments have “much in common with and builds on “environmental
impact assessment” and also has less recognized but salient links with the
field of “health and human rights” and the concept of “human rights impact
assessment.” Nancy Krieger et. al., “Assessing Health Impact Assessment:
Multidisciplinary and International Perspectives,” *J Epidemiol Community
Health* 2003;57:659–662.

[5] Racial impact statements or assessments have been proposed in other
contexts such as mitigating sentencing disparities. See e.g., Marc Mauer,
“Racial Impact Statements As a Means of Reducing Unwarranted Sentencing
Disparities,” 5 *Ohio State Journal of Criminal Law* 19 (2007).

[6] Nancy Krieger et. al., “Assessing Health Impact Assessment:
Multidisciplinary and International Perspectives,” *J Epidemiol Community
Health* 2003;57:659–662.