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The questions are arranged in three sections: Use and ownership of cell lines and bodily tissues, gene patents and transgeneic experimentation. They are designed to raise key ethical issues, provide important information on the science, and help you get in touch with your own moral compass. With a nod to the realities of many women’s lives, we have written them in such a way that you can participate in the discussion even if you haven’t read the books.
We suggest you read through the questions and select 5-10 for discussion purposes. After your discussion, we encourage all readers to check out the Policy Questions section of the website for more detailed information on the science, ethical frameworks to consider these issues, and policy options.
Download a printer-friendly copy of the Discussion Questions for Immunity (.pdf format requires Adobe Reader—download a free copy)
Bioethics Book Club Discussion Questions
Bioethical Issue: Bio-defense Research—
Lori Andrews, the author of Immunity, is a well-known bioethicist. Like her heroine, Dr. Alex Blake, Andrews is multitalented. Trained as an attorney, she chaired the government panel charged with keeping an eye on the ethical, legal, and social implications of the Human Genome Project and has consulted with many policy-making bodies in the US and abroad. Her familiarity with the landscape of bioethical issues adds texture and depth to her novels—and Immunity is no exception.
• The heroine of Immunity, Dr. Alex Blake, works for the Armed Forces Institute of Pathology (AFIP). Her “day job” involves sequencing the genomes of pathogenic organisms identified by the Department of Defense as potential bioweapons. Like many other details in the novel, AFIP (www.afip.org) really exists—its mission is to provide consultation, education, and research to the US military and other agencies. AFIP is not the only agency doing such work, either: since 9/11, approximately $50 billion in federal funds has been dedicated to biodefense research.
In contrast to her military colleagues, Alex sees the biodefense dimension of her work as secondary: she chooses to focus on how her work could benefit people in developing countries where many of these pathogens are endemic (p. 23-24). Along these lines, some people believe that public research funds should be directed toward pressing health problems—such as HIV/AIDS, malaria, and dysentery—rather than toward hypothetical risks of bioterror attacks. Others think that US resources should be devoted to US problems—bioterror included—rather than to addressing global health problems that affect few Americans.
• The heroine of Immunity, Dr. Alex Blake, works for the Armed Forces Institute of Pathology (AFIP). Her “day job” involves sequencing the genomes of pathogenic organisms identified by the Department of Defense as potential bioweapons. Like many other details in the novel, AFIP (www.afip.org) really exists—its mission is to provide consultation, education, and research to the US military and other agencies. AFIP is not the only agency doing such work, either: since 9/11, approximately $50 billion in federal funds has been dedicated to biodefense research.
In contrast to her military colleagues, Alex sees the biodefense dimension of her work as secondary: she chooses to focus on how her work could benefit people in developing countries where many of these pathogens are endemic (p. 23-24). Along these lines, some people believe that public research funds should be directed toward pressing health problems—such as HIV/AIDS, malaria, and dysentery—rather than toward hypothetical risks of bioterror attacks. Others think that US resources should be devoted to US problems—bioterror included—rather than to addressing global health problems that affect few Americans.
The past 5 to 10 years have seen an increase in global health efforts, spurred in part by the work of the Gates Foundation (http://www.gatesfoundation.org) to fight diseases like malaria, infectious diarrhea, HIV/AIDS, and tuberculosis. What—if anything—does the US owe developing countries in terms of infectious disease research? Why?
In light of the FBI’s recent announcement that a government scientist (Bruce Ivins, formerly a researcher at Fort Detrick, the Army’s biodefense facility) was behind the anthrax attacks of 2001, some have argued that increased biodefense spending increases the risk of misuse. What do you think?
• Another issue raised by biodefense research is the “dual-use” problem: that is, the risk that research carried out in the interest of public health (such as vaccine development or new treatments) could be used for nefarious purposes—to make a pathogen more dangerous or harder to detect, for example.
Do researchers have a responsibility to consider how their work could be misused by people or groups who intend to do harm?Are there experiments that researchers should not undertake, or should the pursuit of knowledge trump this kind of self-policing?
• Several examples of dual use research are public knowledge: researchers have resurrected the 1918 influenza virus (which is estimated to have killed 50 million people worldwide and, unusually, targeted healthy young people); created—in the lab—a version of the virus that causes polio; and genetically manipulated the mousepox virus (a pathogen analogous to smallpox) to decrease immune response. (You can learn more about dual use issues at the Federation of American Scientists’ website: http://www.fas.org/biosecurity/education/dualuse/).
Some people believe that scientists who work with potentially harmful organisms should be required to submit their work for special review, and that research deemed too risky should be prohibited and/or barred from publication. Opponents argue that academic freedom and open communication are essential to scientific progress.
Some people believe that scientists who work with potentially harmful organisms should be required to submit their work for special review, and that research deemed too risky should be prohibited and/or barred from publication. Opponents argue that academic freedom and open communication are essential to scientific progress.
Should such experiments be allowed?
If so, what kind of regulatory controls should be put in place?
Bioethical Issue: Law Enforcement Use of DNA—
• Thinking about how they can track down Renfrew Alex thinks to herself, “”People leave DNA everywhere.” ( p. 96) Every cell in our bodies contains a complete copy of our unique DNA, and, as Alex notes, we leave traces of ourselves all over the place—on tissues, on drinking glasses, cigarette butts, envelopes.
As you know if you’ve ever watched Law and Order or CSI, law-enforcement agencies increasingly use DNA evidence to help bring criminals to justice. A new trend, called surreptitious sampling, has raised concerns among civil-rights advocates. Imagine that you’ve been identified as a possible suspect in a crime, but the police don’t have sufficient evidence to charge you. They do have a DNA sample from the scene, however, but they would need a court order to get a blood sample against your will. So they set up surveillance and follow you to your neighborhood coffee shop, and when you leave, they confiscate your mug and take it to the lab for testing. If the DNA on the mug matches the crime-scene sample, you’re in trouble.
As you know if you’ve ever watched Law and Order or CSI, law-enforcement agencies increasingly use DNA evidence to help bring criminals to justice. A new trend, called surreptitious sampling, has raised concerns among civil-rights advocates. Imagine that you’ve been identified as a possible suspect in a crime, but the police don’t have sufficient evidence to charge you. They do have a DNA sample from the scene, however, but they would need a court order to get a blood sample against your will. So they set up surveillance and follow you to your neighborhood coffee shop, and when you leave, they confiscate your mug and take it to the lab for testing. If the DNA on the mug matches the crime-scene sample, you’re in trouble.
Should surreptitious sampling be allowed?
Would you want to apply a different standard for different kinds of crimes—for example, it should be allowed in a murder investigation but not to catch a thief?
• Another new issue is coming up at the intersection of law enforcement, genetics, and medical research. Increasingly, federally funded researchers in genetics are being required to make their anonymized study data available to the scientific community. The database of Genotype and Phenotype (dbGaP) is envisioned as an ever-growing repository for de-identified genetic and health status information on research participants. (You can learn more about dbGaP here http://www.nature.com/ng/journal/v39/n10/full/ng1007-1181.html or here http://www.ncbi.nlm.nih.gov/entrez/query/Gap/gap_tmpl/about.html)
The data contained in dbGaP will be stripped of common identifiers, such as participants’ names and dates of birth, but the fact that each person’s DNA is unique means that it is inherently identifiable. If someone has a sample that has identifiers attached to it—say from an ancestry test or a life-insurance exam—it could be matched to the research sample (and any associated health information).
The data contained in dbGaP will be stripped of common identifiers, such as participants’ names and dates of birth, but the fact that each person’s DNA is unique means that it is inherently identifiable. If someone has a sample that has identifiers attached to it—say from an ancestry test or a life-insurance exam—it could be matched to the research sample (and any associated health information).
Should law-enforcement agencies be given access to dbGaP or other research databases that contain genetic information?
If such access were allowed, do you think researchers would have an obligation to disclose this information to research participants as part of the informed consent process?
Bioethical issue: Research Ethics—
• US and international law govern the protection of human subjects in medical research. The Belmont Report, the Declaration of Helsinki, and the Nuremberg Principles all were developed in reaction to terrible research scandals. Among the provisions of these regulations, two principles stand out. First, research participation must be fully voluntary and not coerced. Second, research participation must be informed (meaning that individuals must be given information about the risks, benefits, and alternatives to participation; what they will be asked to do; the duration of the study; who is doing the research and why; and how their samples or information will be used).
Unfortunately, breaches of human subjects protections do still occur, and Alex Blake mentions a few more recent cases, including the story of Jesse Gelsinger (p. 58): Jesse Gelsinger was an 18-year-old with a rare genetic disorder that was controlled by therapy. In hopes of saving the lives of infants born with the disorder, he agreed to participate in a gene therapy trial at the University of Pennsylvania. He died as a result. It later came to light that Jesse and his parents had not been given complete or accurate information. The researchers had ignored numerous red flags—including the deaths of several monkeys receiving the experimental treatment—that should have shut down the project. To make matters worse, the lead researcher had a financial interest in the continuation of the trial. Jesse Gelsinger’s family sued the university, which settled for an undisclosed sum. Since his son’s death, Paul Gelsinger has become an outspoken advocate for increased human subjects protections. (Learn more about the Gelsingers’ story: http://query.nytimes.com/gst/fullpage.html?res=9C03E4DE1F3CF93BA15752C1A96F958260
http://query.nytimes.com/gst/fullpage.html?res=990CE6DC123CF934A15752C0A9669C8B63
http://www.pbs.org/newshour/bb/health/jan-june00/gene_therapy_2-2.html
Unfortunately, breaches of human subjects protections do still occur, and Alex Blake mentions a few more recent cases, including the story of Jesse Gelsinger (p. 58): Jesse Gelsinger was an 18-year-old with a rare genetic disorder that was controlled by therapy. In hopes of saving the lives of infants born with the disorder, he agreed to participate in a gene therapy trial at the University of Pennsylvania. He died as a result. It later came to light that Jesse and his parents had not been given complete or accurate information. The researchers had ignored numerous red flags—including the deaths of several monkeys receiving the experimental treatment—that should have shut down the project. To make matters worse, the lead researcher had a financial interest in the continuation of the trial. Jesse Gelsinger’s family sued the university, which settled for an undisclosed sum. Since his son’s death, Paul Gelsinger has become an outspoken advocate for increased human subjects protections. (Learn more about the Gelsingers’ story: http://query.nytimes.com/gst/fullpage.html?res=9C03E4DE1F3CF93BA15752C1A96F958260
http://query.nytimes.com/gst/fullpage.html?res=990CE6DC123CF934A15752C0A9669C8B63
http://www.pbs.org/newshour/bb/health/jan-june00/gene_therapy_2-2.html
Jesse Gelsinger was doing well and could have continued on his current treatment, had he not volunteered to participate in the study. Should the review board responsible for reviewing the research have allowed him to participate?
Some people have suggested that participation should have been restricted to patients for whom the experimental treatment was potentially lifesaving. Do you agree?
Jesse Gelsinger was 18. Does his age influence the way you think about this story? Would it seem different if he had been 40? 70? Why?
• The novel also references the research Eli Lilly, a pharmaceutical manufacturer, performed on homeless people (p. 71). The news was first reported by The Wall Street Journal in 1996. Reporters learned that the company was paying homeless alcoholics to participate in human-safety trials in Indianapolis. (You can read more about the ethics of research on homeless people here: http://content.nejm.org/cgi/content/full/358/22/2316)
It is illegal and unethical to coerce people into participating in research, or to offer unfair inducements—basically, making people an offer they can’t refuse. Does paying homeless people, or offering them room and board for the duration of the study, meet this criterion?
Special protections are in place for what are termed “vulnerable populations,” for example children, prisoners, and mentally ill or incompetent people. Do homeless people face similar risks of exploitation? What kinds of protections make sense?
• The novel also mentions problems with a human trial of a new monoclonal antibody (p. 159). The TeGenero trial made headlines in 2006, not only for the catastrophic effects of the drug under study—it resulted in multiple organ failure in six healthy young men—but also for the way in which the trial was being conducted.
TeGenero was a German biotech company that was trying to develop new drugs to fight inflammatory diseases. TeGenero outsourced the Phase 1 human safety trials to a Massachusetts company, Parexcel, which conducted the study in London. There have been reports of irregularities in the way the study was conducted (e.g., giving several patients the experimental drug at once, rather than spacing administration out over time, so that any unforeseen reactions could be limited).. (Read more at http://www.iht.com/articles/2006/04/07/news/drug.php)
TeGenero was a German biotech company that was trying to develop new drugs to fight inflammatory diseases. TeGenero outsourced the Phase 1 human safety trials to a Massachusetts company, Parexcel, which conducted the study in London. There have been reports of irregularities in the way the study was conducted (e.g., giving several patients the experimental drug at once, rather than spacing administration out over time, so that any unforeseen reactions could be limited).. (Read more at http://www.iht.com/articles/2006/04/07/news/drug.php)
Critics charge that the study, which required a three-day stay in the study facility, was marketed as an opportunity to make money just for hanging around and playing video games. If this is true, does it raise ethical concerns?
Subjects included unemployed men, students, and recent immigrants—people who needed money. Is it unethical for research companies to deliberately target such groups? Why or why not?
Some would argue that research is a public good, and that competent adults should be free to decide how much risk they are willing to accept, and for what reward (whether money or something else). Do you agree? In what situations, if any, should policy makers limit people’s rights in this respect?
Bioethical issue: Prenatal Testing and Disability—
• Alex’s young friend, Lena, who is deaf, asks about the accuracy of prenatal testing for deafness. (p. 62) Alex explains that there are many genetic mutations that can contribute to deafness, and that some of these changes can be detected in a fetus. “Most parents,” she thinks to herself, “chose to abort deaf fetuses.”
Some people, such as disability scholar Adrienne Asch, oppose this kind of selective abortion. While supporting a woman’s right to terminate a pregnancy for other reasons (eg, she does not wish to be a mother, she is unable or unwilling to support a child), Asch believes selecting “against” fetuses with certain characteristics is wrong. What do you think?On the other hand, some say that certain people who are biologically deaf are members of the Deaf community—a separate culture with its own language, norms, and ways of behaving. Should parents who are members of the Deaf community be allowed to use prenatal testing to select “for” deafness? Why or why not?
Bioethical issue: New Technologies, Privacy Rights, and the State—
• Alex’s colleague, Grant Pringle, is very proud of his new toy—the Peeper—which uses heat imaging to see inside buildings. Alex and her friend Barbara Findlay, AFIP’s chief legal counsel, are appalled at this kind of breach of privacy. But such technologies are, in fact, being developed and tested.
One such technology is functional magnetic resonance imaging (fMRI) of the brain. Researchers are driving toward the technology being able to “read minds”—at least insofar as being able to show whether a person is lying or not. (More here: http://www.wired.com/wired/archive/14.01/lying.html)
And MALINTENT is a technology currently under development for the Department of Homeland Security scans people’s facial features and detects tiny changes in muscle tension to determine whether someone is planning to act out. (See a report here: http://www.foxnews.com/story/0,2933,426485,00.html)
One such technology is functional magnetic resonance imaging (fMRI) of the brain. Researchers are driving toward the technology being able to “read minds”—at least insofar as being able to show whether a person is lying or not. (More here: http://www.wired.com/wired/archive/14.01/lying.html)
And MALINTENT is a technology currently under development for the Department of Homeland Security scans people’s facial features and detects tiny changes in muscle tension to determine whether someone is planning to act out. (See a report here: http://www.foxnews.com/story/0,2933,426485,00.html)
Should the development of such technologies be allowed?If so, what kinds of restrictions—if any—should be placed on their use?
Plot-based Questions—
• What do you think of Dr. Teague’s intentions in taking the children to the Colony?
His “vaccine” ends up killing several hundred people. When Alex initially confronts him about this, he says, “Public health is always a trade-off. Vaccines harm some children while protecting others. This vaccine caused deaths, yes, but think how many other people who drank from the fountains were immunized.” (p. 310)
What do you think about this argument?What do you think about Teague’s changing his mind when he sees what the vaccine has done to Castro?
Alex decides to protect Teague, allowing officials and others to believe that Jeffrey Ossing (who is dead) was poisoning the fountains. Do you think she made the right choice?
