POLS 632 – Biotechnology and Political Structures

Fall 2008

Andrea Bonnicksen, Zulauf Hall 401, 753-7059, albcorn@niu.edu

Office hours:  T 1:00 - 1:50; T, TH 3:30 – 4:30, and by arrangement

 

Knowledge gained from the human genome project is likely to expand considerably in the 21st century in ways that affect daily life. Among other things, pharmacogenomics will allow the targeting of drug therapies to the genotypes of individual patients; genetic testing will enable individuals to learn about their predispositions to a growing array of diseases and conditions; and DNA data banks will present new uses for criminal prosecutions. Although genetic information holds promise, it has also generated spirited debate about its ethical and policy dimensions. This seminar will focus on selected policy issues raised by medical genetics. It aims to convey to its members a substantive understanding of a particular policy area, look critically at the extent to which genetic information is different from other medical information for policy purposes, and examine to what extent genetic advances warrant new oversight and legislation. Members of the seminar will have the opportunity to explore particular areas of interest by writing a paper related to genetics and public policy.

 

READINGS

James D. Watson and Andrew Berry, DNA: Secret of Life. New York: Alfred A. Knopf,

            2003.

Matt Ridley, Nature Via Nurture: Genes, Experience, and What Makes Us Human. New

            York: HarperCollins Publishers, 2003.  

John Harris, Enhancing Evolution: The Ethical Case for Making Better People. Princeton

            University Press, 2007.

Mark L. Winston, Travels in the Genetically Modified Zone. Cambridge MA: Harvard

            University Press, 2003.

Most of the readings below are available on electronic reserves (ER). Information on

            gaining access to electronic reserves will be given on August 28 in class.

Readings from governmental websites are optional for background information.

 

I.  HISTORY AND OVERVIEW   (AUGUST 28, SEPTEMBER 4)

 

Genetics in art and culture

Suzanne Anker and Dorothy Nelkin, Molecular Gaze: Art in the Genetic Age. Cold

            Spring Harbor Laboratory Press, 2004, pp. 1-7. ER

 

Optional browse:

- Genomic Art Gallery http://www.genomicart.org/offerings.htm

- http://www.vanderbilt.edu/AnS/english/Clayton/273-F01.htm

            - Henry Fountain, Song of Myself: DNA Ditties. New York

              Times August 8, 2008. http://www.algoart.com/music.htm

 

Genetic literacy

Bruce Jennings, “Genetic Literacy and Citizenship: Possibilities for Deliberative

            Democratic Policymaking in Science and Medicine.” The Good Society 13(1):38-

            44 (2004).  ER

 

DNA discoveries  

James Watson and Andrew Berry, DNA: Secret of Life, chapters 1-5

 

Robert Cook-Deegan, The Gene Wars: Science, Politics, and the Human Genome. New

            York: W.W. Norton and Co., 1994, pp. 13-47. ER

 

Human Genome Project

James Watson and Andrew Berry, DNA: Secret of Life, chapters 7-8, 13

 

National Human Genome Research Institute. “Understanding the Human Genome

            Project.” http://www.genome.gov/25019879

 

U.S. Department of Energy. “The Science behind the Human Genome Project.”             www.ornl.gov/sci/techresources/Human_Genome/project/info.shtml

 

“About ELSI.” www.genome.gov/10001754

 

U.S. Department of Energy. “Human Genome Project Presentation

            Materials” (click on Beyond the Human Genome Project).             www.ornl.gov/sci/techresources/Human_Genome/graphics/slides/talks.shtml

 

R.C. Lewontin, “The Dream of the Human Genome.” New York Review of Books. May

            28, 1992.  ER

 

Eugenics

Diane Paul, Controlling Human Heredity: 1865 to the Present. Humanities Press, 1995,

            pp. 1-21. ER

 

Buck v. Bell, 274 U.S. 200 (1927). ER

 

See, e.g., “Eugenics Archive.” Type in www.eugenicsarchive.org/eugenics  

 

II. GENETIC EXCEPTIONALISM (SEPTEMBER 11)

 

Differing perspectives

George J. Annas, “Genetic Privacy: There Ought to be a Law.” Texas Review of Law &

            Politics 4(1):9-15 (1999). ER

 

Douglas H. Ginsburg, “Genetics and Privacy.” Texas Review of Law & Politics 4(1):17-

            23 (1999). ER

 

Mark A. Rothstein, “Why Treating Genetic Information Separately is a Bad Idea.” Texas

            Review of Law & Politics 4(1):33-37 (1999). ER

 

Michael J. Green and Jeffrey R. Botkin, “’Genetic Exceptionalism’ in Medicine:

            Clarifying the Differences between Genetic and Nongenetic Tests.” Annals of        Internal Medicine 138(7):571-75 (2003). ER

 

Mark A. Rothstein, “Genetic Exceptionalism and Legislative Pragmatism.” Hastings

            Center Report 35(4):27-33 (2005). ER

 

Matt Ridley, Nature Via Nurture: Genes, Experience, and What Makes Us Human. New

            York: HarperCollins Publishers, 2003, pp. 1-6, 98-124, 249-75.

 

Genetic Information Nondiscrimination Act (GINA)

Genetic Information Nondiscrimination Act of 2008 (H.R. 493). ER

 

Kathy L. Hudson, et al., “Keeping Pace with the Times – The Genetic Information

Nondiscrimination Act of 2008.” New England Journal of Medicine 358(25):2661-63 (June 19, 2008). ER

 

Russell Korobkin and Rahul Rajkumar, “The Genetic Information Nondiscrimination Act

        A Half-Step toward Risk Sharing.” New England Journal of Medicine

        359(4):335-7 (July 14, 2008). ER

 

III.  GENETIC TESTING AND SCREENING  (SEPTEMBER 18, 25)

 

Nature of gene-linked disease

Yudhijit Bhattacharjee, “Friendly Faces and Unusual Minds.” Science 310:802-4

            (November 4, 2005). ER

 

U.S. Department of Energy Genome Projects, “Genetic Disease Information.” 

            www.ornl.gov/sci/techresources/Human_Genome/medicine/assist.shtml

 

U.S. Department of Energy Genome Projects, “Gene Gateway.”  

            www.ornl.gov/sci/techresources/Human_Genome/posters/chromosome

 

U.S. Department of Energy Genome Projects, “Genetic Disease Profile: Cystic Fibrosis.”

            www.ornl.gov/sci/techresources/Human_Genome/posters/chromosome/cf.shtml

 

James Watson and Andrew Berry, DNA: Secret of Life, chapters 11-12

 

Gene testing and development of genetic tests

U.S. Department of Energy Genome Projects, “Gene Testing.” 

            www.ornl.gov/sci/techresources/Human_Genome/medicine/genetest.shtml 

 

U.S. Department of Energy Genome Projects, “Pharmacogenomics.”              www.ornl.gov/sci/techresources/Human_Genome/medicine/pharma.shtml

 

Optional. “Pharmacogenetics: Is This Drug for You?” Video panel discussion from             www.dnapolicy.org/news.past.php?action=detail&past_event_id=36

 

Karen Peterson-Iyer, “Pharmacogenomics, Ethics, and Public Policy.” Kennedy Institute

            of Ethics Journal 18(1):35-56 (March 2008). ER

 

“ASHG Statement on Direct-to-Consumer Genetic Testing in the United States.”

American Journal of Human Genetics 81:635-37 (September 2007). ER

 

Francis S. Collins, “What we do and don’t know about ‘race’, ‘ethnicity’, genetics and

            health at the dawn of the genome era.” Nature Genetics 36:S13-S15 (2004). ER

           

Jennifer Couzin, “Probing the Roots of Race and Cancer.” Science 315:592-94 (February

            2, 2007).  ER

 

Lundy Braun, “Race, Ethnicity, and Health: Can Genetics Explain Disparities?”

            Perspectives in Biology and Medicine 45(2):159-74 (Spring 2002). ER

 

Genetic privacy

U.S. Department of Energy Genome Projects, “Genetics Privacy and Legislation.”

            www.ornl.gov/sci/techresources/Human_Genome/elsi/legislat.shtml

 

Optional. “Genes in Uniform: Don’t Test, Don’t Tell.”Video panel discussion from

            www.dnapolicy.org/news.past.php?action=detail&past_event_id=25

 

Roberta B. Meyer, “The Insurer Perspective.” In Mark A. Rothstein, ed., Genetics and

            Life Insurance. Cambridge MA: MIT Press, 2004, pp. 27-47. ER

 

Mark A. Rothstein, “Policy Recommendations.” Mark A. Rothstein, ed., Genetics and

            Life Insurance. Cambridge MA: MIT Press, 2004, pp. 233-65. ER

 

Dena S. Davis, “Genetic Research and Communal Narratives,” Hastings Center Report

            34(4):40-49 (July-August 2004). ER

 

Genetic screening of newborn infants

George Cunningham, “The Science and Politics of Screening Newborns.” New England

            Journal of Medicine 346(14):1084-85 (2002). ER

 

Browse. Save Babies Through Screening Foundation, “Diseases Screened for in Illinois.”

            http://www.savebabies.org/states/illinois.php

 

Marvin Natowicz, “Newborn Screening – Setting Evidence-Based Policy for

            Protection.” New England Journal of Medicine 353(9):867-70 (September 1,

2005). ER

 

Mary Ann Baily and Thomas H. Murray, “Ethics, Evidence, and Cost in Newborn

            Screening.” Hastings Center Report 38(3):23-31 (2008). ER

 

Virginia A. Moyer, et al., “Expanding Newborn Screening: Process, Policy, and

            Priorities.” Hastings Center Report 38(3):32-39 (2008). ER

 

IV.  PREIMPLANTATION GENETIC TESTING  (OCTOBER 2)

           

Attitudes and practices in the U.S.

Susannah Baruch, et al., “Genetic Testing of Embryos: Practices and Perspectives of US

            in Vitro Fertilization Clinics.” Fertility & Sterility 89(5):1053-58 (May 2008). ER

 

Henry T. Greely, “An Introduction – and Some Conclusions.” Fertility & Sterility

            85(6):1631-32 (June 2006). ER

 

Rebecca Dresser, “Preimplantation Genetic Diagnosis as Medical Innovation: Reflections

            from The President’s Council on Bioethics.” Fertility & Sterility 85(6):1633-37

            (June 2006). ER

 

Kathy L. Hudson, “Preimplantation Genetic Diagnosis: Public Policy and Public

            Attitudes. Fertility and Sterility 85(6):1638-45 (June 2006). ER

 

Optional. “Custom Kids? Genetic Testing of Embryos” (see Laurie Goldberg Strongin).

            Video panel discussion from

            www.dnapolicy.org/news.past.php?action=detail&past_event_id=20

 

Practices in Canada and the U.K.

Erin L. Nelson, “Comparative Perspectives: Regulating Preimplantation Genetic

            Diagnosis in Canada and the United Kingdom.” Fertility & Sterility 85(6):1646-

            52 (June 2006). ER

 

PAPER PROPOSALS DUE (OCTOBER 9)

 

MIDTERM EXAM DISTRIBUTED (OCTOBER  9)

 

V.  GENE THERAPY AND ENHANCEMENT (OCTOBER 9, 16)

           

Somatic cell gene therapy

Amanda Griscom, “Take these Genes and Call Me in the Morning.”

            http://www.wired.com/wired/archive/10.09/gvaccines_pr.html ER

 

Browse www.genome.gov (National Genome Research Institute)

 

Germ-line gene therapy

Nelson A. Wivel and LeRoy Walters, “Germ-Line Gene Modification and Disease

            Prevention: Some Medical and Ethical Perspectives.” Science 262:533-38

            (October 22, 1993). ER

 

Julie Gage Palmer and Robert Cook-Deegan, “National Policies to Oversee Inheritable

            Genetic Modifications Research.” In Audrey R. Chapman and Mark S. Frankel,

            eds. Designing Our Descendants. Baltimore: Johns Hopkins University Press,

            2003, pp. 275-95. ER

 

Genes and enhancement

John Harris, Enhancing Evolution, entire book

 

Optional. “Gene Doping: Human Genetic Technologies and the Future of Sports.”

            Video panel discussion from

            www.dnapolicy.org/news.past.php?action=detail&past_event_id=17

 

Optional. President’s Council on Bioethics, Beyond Therapy: Biotechnology and the

            Pursuit of Happiness. ReganBooks, 2003, chapter 2. Available at

            www.bioethics.gov

 

MIDTERM EXAM DUE (OCTOBER 16)

 

VI.   FORENSICS AND CRIMINAL DATA BANKS  (OCTOBER 23)

           

James Watson and Andrew Berry, DNA: Secret of Life, chapter 10

 

Optional. Greggory LaBerge, Denver Police Department Crime Laboratory. PowerPoint

presentation from www.dnapolicy.org/news.past.php?action=detail&past_event_id=42

 

Margaret A. Berger, “Lessons from DNA: Restriking the Balance Between Finality and

            Justice.” In David Lazer, ed., DNA and the Criminal Justice System: The

            Technology of Justice. MIT Press, 2004, pp. 109-31. ER

 

Barry Steinhardt, :Privacy and Forensic DNA Data Banks.” In David Lazer, ed., DNA

            and the Criminal Justice System: The Technology of Justice. MIT Press, 2004, pp.

            173-96. ER

 

Shiela Jasanoff, “DNA’s Identity Crisis.” In David Lazer, ed., DNA and the Criminal

            Justice System: The Technology of Justice. MIT Press, 2004, pp. 337-55. ER

 

U.S. Department of Energy Genome Projects, “DNA Forensics.”

            www.ornl.gov/sci/techresources/Human_Genome/elsi/forensics.shtml  

 

VII.    BEHAVIOR AND GENETICS (OCTOBER 30, NOVEMBER 6)

 

Matt Ridley, Nature Via Nurture. Remainder of book

 

John R. Alford, Carolyn L. Funk, and John R. Hibbing, “Are Political Orientations

            Genetically Transmitted?” American Political Science Review 99(2):153-67

            (2005). ER 

 

Jaime E. Settle, et al., “Friendships Moderate an Association Between a Dopamine Gene

            Variant and Political Ideology.” ER

            http://jhfowler.ucsd.edu/friends_drd4_and_political_ideology.pdf

 

James H. Fowler and Christopher T. Dawes, “Two Genes Predict Voter Turnout.”

            Journal of Politics 70(3):579-94 (July 2008). ER

            http://jhfowler.ucsd.edu/two_genes_predict_voter_turnout.pdf

 

Optional. John R. Alford, Carolyn L. Funk, and John R. Hibbing, “Beyond Liberals and

            Conservatives to Political Genotypes and Phenotypes.” Perspectives on Politics

            6(2):321-28 (June 2008).

 

VIII.   ANIMAL AND PLANT BIOTECHNOLOGY (NOVEMBER 6, 13)

 

Animal organisms

HHMI. “A Brief Guide to Model Organisms.” www.hhmi.org/genesweshare/e300.html

 

NHGRI. “Background on Mouse as a Model Organism.”

            http://www.genome.gov/10005834

 

Agricultural biotechnology

Mark Winston, Travels in the Genetically Modified Zone, entire book

 

Lee Ann Jackson and Michele T. Villinski, “Reaping What We Sow: Emerging Issues

            and Policy Implications of Agricultural Biotechnology.” Review of Agricultural

            Economics 24(1):3-14 (Spring-Summer 2002). ER

 

www.ornl.gov/sci/techresources/Human_Genome/elsi/gmfood.shtml

 

www.who.int/foodsafety/publications/biotech/20questions/en

 

PAPERS PRESENTED  (NOVEMBER 20, DECEMBER 4)

 

FINAL EXAM DISTRIBUTED (DECEMBER 4)

 

FINAL EXAM DUE (DECEMBER 11)

 

Some websites:

            www.genome.gov

            http://www.genome.gov/PolicyEthics

            http://bioethics.georgetown.edu/nirehg

            www.dnapolicy.org

            http://gslc.genetics.utah.edu/units/basics/tour/

            www.rarediseases.org

            www.dnai.org

www.geneticalliance.org

www.clinicaltrials.gov

www.geneclinics.org

www.lawgenecentre.org/update/newsletter

www.newdrugs.com/stemcells (stem cell blog)

www.phrma.org

www.nuffieldbioethics.org (UK bioethics group)

http://cbac-cccb.ca (Canadian Biotechnology Advisory Committee)

www.ncsl.org/programs/health/genetics/charts.htm (states’ genetic laws)

 

Grades will be based upon 2 take-home exams, a research paper, and participation, for a total of 220 points. Grades will be determined on a percentage scale as follows: 180 – 200 = A; 160 – 179 = B; 140 – 159 = C; 120 – 139 = D

 

            ITEM                          DATE DUE    POINTS

Research proposal       October 9              -

Midterm exam             October 16      50 points

            Research paper            November 20  80 points

            Final exam                   December 4     50 points        

Participation                      -                 20 points

 

The research paper will give you the opportunity to explore in detail a subject in genetics policy that is of particular interest to you.  The paper should be 15-18 double-spaced, typed pages with one-inch margins and regular spacing between paragraphs. It will be due in written form on October 16. Class presentations will be November 20 and December 4. More information about the papers will be presented in class.

 

PAPER PROPOSALS

Paper proposals are worth l0 points. The proposal is important because it is a road map for your research. I recommend working on it carefully; a well-formulated proposal will make the research and writing easier. Proposals often have the following problems:  too general, too broad, no clear research question, conclusions already reached, sources not found or read, sources inadequately cited, signs of having been written with great haste. To avoid these problems, please write a proposal of ~ 2 pages that includes the following:

 

  1. Title and outline
  2. 3-4 paragraph summary that answers basic questions: what is your research question, why is it important, how will you examine it, and what is your working hypothesis (what you expect to find)?
  3. A sufficiently narrow research question about which you are genuinely quizzical
  4. A carefully cited list of 6-8 scholarly sources that you have already found. This includes journal articles. Look to the citations in the syllabus for examples. If you take something from the internet, include a detailed enough citation so your reader can find it easily.

 

PAPERS

The paper should relate to a specific issue in genetics (biotechnology) and policy. Preferably this issue will be based in the U.S., but policies in other nations may be used if you at some point consider the implications for U.S. policy. One way to arrive at a topic is to identify a manageable policy problem. Then ask questions about it until you narrow them down to a paper topic. For example, how serious is the problem? What evidence is available for evaluating its seriousness? Have policies been proposed for addressing the problem? Is one more appropriate than others? If so, what are its strengths and weaknesses? Should it be implemented? What are difficulties in implementing it?

 

Here are sample general topic areas:

            Regulation of gene tests

            Overload of DNA data banks for criminal procedures

            Research incentives for targeted gene therapy studies

            Oversight of pharmacogenomic clinical trials

            Variation in newborn screening laws across states

You may also want to look at the policy process – e.g., some aspect of the politics of GINA, how issues in genetics are framed for policy purposes, or how the process of agenda setting has unfolded for a particular issue in genetics and policy. It might help to look at books that describe different models for studying public policy, such as:

 

John W. Kingdon, Agendas, Alternatives, and Public Policies. Boston: Little Brown and

            Company 1984 (a second edition is also available).

Paul A. Sabatier, Theories of the Policy Process. Westview Press, 2007.

Thomas A. Birkland, An Introduction to the Policy Process. M.E. Sharpe Inc., 2001.

 

EXAMS

The midterm and final exams will be distributed one week before their due dates. It is expected that you will integrate (with APA-style citation) at least 3 different class readings into each essay. To prepare, you are encouraged to take notes on the readings.

 

PARTICIPATION

Participation will be based on attendance (with special attention to the days the papers are presented) and a demonstration that you have read the readings and have synthesized and analyzed them.  When you have been asked to present an article in class, please do the following:

 

1. Briefly summarize the article or chapter. What is the author’s purpose in writing it? What is the author’s main theme? What is the research question?

2. Next, engage us with the article or chapter. What is unique or important about the article? Does it provoke curiosity? Is it well argued? How does this article further our knowledge about the topic?

 

Keep in mind that everyone will have read the article so we don’t need all the details. Prepare separate notes and do not read directly from the article.