In an editorial published today, "This time it's personal" (Nature 453, 697 (2008) | doi:10.1038/453697a ), Nature adds to the many comments on Francis Collins's announcement that he will step down from his 15 year position as head of the US National Human Genome Research Institute (NHGRI). Like most comments on Collins's career at NHGRI, the editorial praises the leader for his ambition, political acumen, and emphasis on the ethical implications of genomic research. In addition to leading the Institute to the successful sequencing of the genome in 2003, Collins helped to initiated the International HapMap Project, ENCODE, and the 1,000 Genomes Project. He also lobbied for the passage of GINA (H.R. 493) and was a constant advocate for the inclusion of public outreach and ethics education in genomic research.
Collins's emphasis on the ethical issues and the NHGRI's ELSI program laid the conceptual groundwork that informs much of the work we do here at PredictER. In fact, thanks to the support of The Richard M. Fairbanks Foundation, Inc, the Indiana University Center for Bioethics has been answering Collins's call to address the ethical implications of genetic and genomic research by focusing on both research ethics and medical ethics as the science is translated into current and future predictive health care.
The editorial also mentions some of the challenges that the next director of NHGRI will face. These challenges include a shrinking budget and waning political support:
Although Collins says he has no concrete plans … the future of NHGRI is more cloudy than his own. The funding situation of the NIH has been gloomy for years, with flat budgets stifling many potentially worthy projects. And with Collins gone, the NHGRI may become more of a target for politicians who feel it has run its course.
Of course, the challenges also include existing and unanticipated ethical and legal issues. As the Nature editorial notes: "Genomics is now at a point where the science and technology are moving much faster than society's ability to assimilate and make sense of the information".
One challenge that this editorial does not mention directly, but seems, nevertheless, to be implied by the shrinking public budget, is the fact that much predictive health research will be (and currently is) receiving commercial support. This should not be a surprise. If we want genomic research to result in better personalized medicine, we should expect that the life science industry will invest in the research. At the same time, however, there's no better moment than now to accelerate the investigation of the specific ethical issues of doing commercially supported genomic and predictive health research. For example, here are a few questions that jump to my mind:
Must a research biobank disclose to donors in the informed consent policy that research results may result in commercial products?
Must or should these biobanks share the income from tissue or data sales with donors?
Should pharmacogenomic companies and other patent holders be expected to share financial rewards with research participants or even with the communities to which these participants belong? - J.O.
Showing posts with label ELSI. Show all posts
Showing posts with label ELSI. Show all posts
Thursday, June 5, 2008
Saturday, May 31, 2008
The Best Predictive Health Ethics Blogs - May 2008
It was a busy month for predictive health news: the president signed GINA, Francis Collins announced his eminent retirement, bloggers reported from important conferences at Case Western and Cold Spring Harbor, and Google announced the debut of Google Health. These events, and others, are reflected in this month's edition of the best blogs on the ethical issues of predictive health.
Are you diseased? Pre-diseased? Potentially diseased? Greg Dahlmann, blog.bioethics.net. 6 May 2008.
In this insightful post, Dahlmann examines how predictive health is changing our concept of disease. When, exactly, does increased risk = illness? Dahlmann writes:
So we're moving from the concept of disease as a state of impaired function to it representing particular sets of probabilities. In the past you were sick when you had a heart attack. Today, you're sick -- or pre-sick, perhaps -- when you have high cholesterol. What about when it's possible to identify constellations of genes that significantly increase your chances of having high cholesterol, or a heart attack. Would that be considered a disease?
Also see Dahlmann's follow up post on "previvors": Blood Matters. Greg Dahlmann, blog.bioethics.net. 11 May 2008.
NHGRI Director Francis Collins to Step Down on August 1. Hsien-Hsien Lei, Eye on DNA. 28 May 2008.
Lei shares the news the Francis Collins will retire from his post this summer and that Alan E. Guttmacher will become acting director. Lei also some thoughts on Collins' book The Language of God.
In All Fairness. Fred Trotter, Fred Trotter: My life and thoughts, often about FOSS in medicine. 23 May 2008.
Following the news coverage on the release of Google Health, Fred Trotter weighs in on the privacy questions. Trotter argues that Google is not a health care provider and is, therefore, not covered by HIPAA. He writes:
Both Google Health and HealthVault are designed to make the process of dissemination of your health information to people you want them to be disseminated to easier. Are they doing that in a secure, privacy respecting way? Excellent question; fodder for further posts. Should they be covered by the same laws that cover your healthcare providers? No.
Workman's Compensation, Stereotypes and GATTACA. Steve Murphy, Gene Sherpas: Personalized Medicine and You. 10 May 2008.
Murphy addresses a few of the potential social consequences of predictive medicine, by examining the following scenario:
Young person goes to 23andME/Navigenics/ETC (They just may add this immediately)....gets predictive testing indicating that he is at a 300 fold increased risk of herniating a disc in his back. Avoids manual labor (plays video games all day) never herniates the disc. Did we do society a service?
23andMe, deCODEme and Navigenics at Cold Spring Harbor. Daniel MacArthur, Genetic Future. 9 May 2008.
MacArthur reports, first hand, from the "Biology of Genomes" meeting at Cold Spring Harbor. In addition to the big players in the consumer genomics movement, the speakers at the event included some ethics and policy experts, like Kathy Hudson from Johns Hopkins. Hudson, MacArthur notes, "responded to the problem of patients being given data of very limited predictive value with a very sensible solution: 'In the absence of demonstrable harm, the default should be to provide the information.'"
Genetic testing ethics - consent forms becoming incomprehensible. Elaine Warburton, Genetics and Health. 7 May 2008.
Warburton covers the Translating ELSI, Ethical Legal Social Implications of Human Genetics Research conference at Case Western University in Cleveland. In this entry she reports on Laura Beskow's comments regarding informed consent and the attitudes and concerns of research participants. Also see Warburton's related coverage of pediatric research ethics discussions at the conference in her post: Genetic Ethics - testing and storing our kids’ DNA. Genetics and Health. 7 May 2008.
The FDA ditches the Declaration of Helsinki. Stuart Rennie, Global Bioethics Blog. 6 May 2008.
Stuart Rennie of Global Bioethics Blog examines the implications of the FDA's decision to abandon the Declaration of Helsinki. While Rennie focuses on the potential impact of this decision on US research overseas, and not specifically on predictive health research, this decision may have far reaching consequences on clinical trials of any sort. Rennie concludes with the following verdict: "the decision would seem to encourage pharmaceutical companies to cut ethical corners when working abroad".
GINA Series: Irrational Bureaucratic Risk Abhorrence [Page 1]. Andrew Yates, Think Gene. 24 May 2008.
This is the first post of a (thus far) four part series on GINA. Each post begins with the introduction:
Recently, President Bush signed GINA, the Genetic Information Nondiscrimination Act, into law. GINA makes it illegal for employers or health insurers to discriminate based on genetics. Virtually the entire genetics community has lauds this legislation, yet few have written why it's wrong that employers and services review objective facts to make decisions. … “It’s not fair…” but why?
The Puzzling Consensus in Favor of the Genetic Information Nondiscrimination Act. Eric Posner, The University of Chicago Law School Faculty Blog. 6 May 2008.
In what may be the most influential post covered in this edition of the best predictive health ethics blogs, Chicago Law professor Eric Posner examines the GINA and asks some compelling questions:
Should the insurance company be permitted to offer the cheap insurance policy only to people who obtain a doctor's certification that a genetic test shows that they belong to the low-risk group? If you think that insurers should be able to discriminate on the basis of visible markers and on the basis of simple doctors' tests for the presence of dangerous diseases, then you should think they should be able to discriminate on the basis of genetic tests. There is no morally relevant distinction between looking at a person's blood for the evidence of infection and looking at his DNA for evidence of susceptibility to a disease. ... The only explanation for the enthusiasm for GINA is that there is an inchoate feeling among people that there is something wrong with the way the insurance market operates.
Medical Genetics Is Not Eugenics. Gabriella Coleman ("biella"), What Sorts of People. 16 May 2008.
Coleman responds to Ruth Cowan’s article in The Chronicle of Higher Education, “Medical Genetics Is Not Eugenics”. Although Cowan sees little value in thinking about the similarities of modern medical genetics and the mid-century eugenics movement, Coleman cautions:
Even if, as [Cowan] rightly states that genetic testing is oriented primarily toward easing human suffering, genetic testing is still entangled with fraught ethical questions about what types of life we value, what is acceptable human life, and what is not—the very sorts of questions central to eugenics.
Are you diseased? Pre-diseased? Potentially diseased? Greg Dahlmann, blog.bioethics.net. 6 May 2008.
In this insightful post, Dahlmann examines how predictive health is changing our concept of disease. When, exactly, does increased risk = illness? Dahlmann writes:
So we're moving from the concept of disease as a state of impaired function to it representing particular sets of probabilities. In the past you were sick when you had a heart attack. Today, you're sick -- or pre-sick, perhaps -- when you have high cholesterol. What about when it's possible to identify constellations of genes that significantly increase your chances of having high cholesterol, or a heart attack. Would that be considered a disease?
Also see Dahlmann's follow up post on "previvors": Blood Matters. Greg Dahlmann, blog.bioethics.net. 11 May 2008.
NHGRI Director Francis Collins to Step Down on August 1. Hsien-Hsien Lei, Eye on DNA. 28 May 2008.
Lei shares the news the Francis Collins will retire from his post this summer and that Alan E. Guttmacher will become acting director. Lei also some thoughts on Collins' book The Language of God.
In All Fairness. Fred Trotter, Fred Trotter: My life and thoughts, often about FOSS in medicine. 23 May 2008.
Following the news coverage on the release of Google Health, Fred Trotter weighs in on the privacy questions. Trotter argues that Google is not a health care provider and is, therefore, not covered by HIPAA. He writes:
Both Google Health and HealthVault are designed to make the process of dissemination of your health information to people you want them to be disseminated to easier. Are they doing that in a secure, privacy respecting way? Excellent question; fodder for further posts. Should they be covered by the same laws that cover your healthcare providers? No.
Workman's Compensation, Stereotypes and GATTACA. Steve Murphy, Gene Sherpas: Personalized Medicine and You. 10 May 2008.
Murphy addresses a few of the potential social consequences of predictive medicine, by examining the following scenario:
Young person goes to 23andME/Navigenics/ETC (They just may add this immediately)....gets predictive testing indicating that he is at a 300 fold increased risk of herniating a disc in his back. Avoids manual labor (plays video games all day) never herniates the disc. Did we do society a service?
23andMe, deCODEme and Navigenics at Cold Spring Harbor. Daniel MacArthur, Genetic Future. 9 May 2008.
MacArthur reports, first hand, from the "Biology of Genomes" meeting at Cold Spring Harbor. In addition to the big players in the consumer genomics movement, the speakers at the event included some ethics and policy experts, like Kathy Hudson from Johns Hopkins. Hudson, MacArthur notes, "responded to the problem of patients being given data of very limited predictive value with a very sensible solution: 'In the absence of demonstrable harm, the default should be to provide the information.'"
Genetic testing ethics - consent forms becoming incomprehensible. Elaine Warburton, Genetics and Health. 7 May 2008.
Warburton covers the Translating ELSI, Ethical Legal Social Implications of Human Genetics Research conference at Case Western University in Cleveland. In this entry she reports on Laura Beskow's comments regarding informed consent and the attitudes and concerns of research participants. Also see Warburton's related coverage of pediatric research ethics discussions at the conference in her post: Genetic Ethics - testing and storing our kids’ DNA. Genetics and Health. 7 May 2008.
The FDA ditches the Declaration of Helsinki. Stuart Rennie, Global Bioethics Blog. 6 May 2008.
Stuart Rennie of Global Bioethics Blog examines the implications of the FDA's decision to abandon the Declaration of Helsinki. While Rennie focuses on the potential impact of this decision on US research overseas, and not specifically on predictive health research, this decision may have far reaching consequences on clinical trials of any sort. Rennie concludes with the following verdict: "the decision would seem to encourage pharmaceutical companies to cut ethical corners when working abroad".
GINA Series: Irrational Bureaucratic Risk Abhorrence [Page 1]. Andrew Yates, Think Gene. 24 May 2008.
This is the first post of a (thus far) four part series on GINA. Each post begins with the introduction:
Recently, President Bush signed GINA, the Genetic Information Nondiscrimination Act, into law. GINA makes it illegal for employers or health insurers to discriminate based on genetics. Virtually the entire genetics community has lauds this legislation, yet few have written why it's wrong that employers and services review objective facts to make decisions. … “It’s not fair…” but why?
The Puzzling Consensus in Favor of the Genetic Information Nondiscrimination Act. Eric Posner, The University of Chicago Law School Faculty Blog. 6 May 2008.
In what may be the most influential post covered in this edition of the best predictive health ethics blogs, Chicago Law professor Eric Posner examines the GINA and asks some compelling questions:
Should the insurance company be permitted to offer the cheap insurance policy only to people who obtain a doctor's certification that a genetic test shows that they belong to the low-risk group? If you think that insurers should be able to discriminate on the basis of visible markers and on the basis of simple doctors' tests for the presence of dangerous diseases, then you should think they should be able to discriminate on the basis of genetic tests. There is no morally relevant distinction between looking at a person's blood for the evidence of infection and looking at his DNA for evidence of susceptibility to a disease. ... The only explanation for the enthusiasm for GINA is that there is an inchoate feeling among people that there is something wrong with the way the insurance market operates.
Medical Genetics Is Not Eugenics. Gabriella Coleman ("biella"), What Sorts of People. 16 May 2008.
Coleman responds to Ruth Cowan’s article in The Chronicle of Higher Education, “Medical Genetics Is Not Eugenics”. Although Cowan sees little value in thinking about the similarities of modern medical genetics and the mid-century eugenics movement, Coleman cautions:
Even if, as [Cowan] rightly states that genetic testing is oriented primarily toward easing human suffering, genetic testing is still entangled with fraught ethical questions about what types of life we value, what is acceptable human life, and what is not—the very sorts of questions central to eugenics.
Thursday, May 8, 2008
Translating ELSI – From a Conference at Case Western to the World
An exciting conference occurred last week in Cleveland, Ohio on the past, present, and future of research into the ethical, legal, and social implications genetics (so-called "ELSI" research). If the large number of interesting presentations at this conference is any indication, the field is flourishing. Although I saw relatively few presentations (I was only there for part of the conference), the discussions, the turnout, and the book of abstracts show the rigor and creative energy of a thriving, international group of scholars.
As part of a panel on Saturday morning (May 3rd), I presented a short talk entitled "PredictER: Indiana University's Experience in Translating Predictive Health Ethics Research into Practice". The presentation covered the work that we've been doing at the IU Center for Bioethics on the ethical and legal aspects of predictive health research. Other speakers in the same session described similar work under way in Kyoto, Japan and in Newfoundland, Canada. Genetics is truly a global field, and, thus, so is the project of examining the ethical, legal and social implications of the science and medicine. If we want to insure the ethical practice of genetic science and the equitable sharing of its benefits, the global participation exemplified by the work at this conference, must become a common feature in the investigation of the ELSI of predictive health research. – Peter H. Schwartz
As part of a panel on Saturday morning (May 3rd), I presented a short talk entitled "PredictER: Indiana University's Experience in Translating Predictive Health Ethics Research into Practice". The presentation covered the work that we've been doing at the IU Center for Bioethics on the ethical and legal aspects of predictive health research. Other speakers in the same session described similar work under way in Kyoto, Japan and in Newfoundland, Canada. Genetics is truly a global field, and, thus, so is the project of examining the ethical, legal and social implications of the science and medicine. If we want to insure the ethical practice of genetic science and the equitable sharing of its benefits, the global participation exemplified by the work at this conference, must become a common feature in the investigation of the ELSI of predictive health research. – Peter H. Schwartz
Tuesday, February 5, 2008
Genetic Research: Groups and Potential Harm
Anyone interested in public engagement and community consultation in genetic research will appreciate Daniel Hausman's article "Protecting Groups from Genetic Research" (Bioethics 2008; 22 (3):157-65). Hausman provides a clear, well-written taxonomy of group types and potential harms to these types as a result of genetic research. He identifies three kinds of groups: structured groups – those with corporate interests distinct from the interests of their individual members (for example, indigenous groups with existing or potential corporate property); identifying groups – unstructured groups (Italian Americans or Ashkenazi women, for example); and potentially identifying groups – those that may be identified as a result of genetic research.
Hausman's taxonomy of harms includes two process-related harms (disrupting and stigmatizing harms) and two outcomes-related harms (undermining and stereotyping harms). Disrupting harms occur, he writes, "when the research process – regardless of its findings – harms a structured group". For example, "taking tissue samples in genetics research might have a ritual significance that could undermine group solidarity". The author thinks that these harms are relatively infrequent in genetic research.
Stigmatizing harms, in contrast, are more common. This process-related harm affects individuals of an identifying group when the mere existence of a genetic research study stigmatizes members of the group.
The third harm, undermining, (an outcomes-related harm) occurs when structured groups are hurt by the findings of genetic research. For examples, Hausman provides the refutation of beliefs about group origins, the loss of potential commercial gain, and the generation or justification of discriminatory treatment.
The fourth kind of harm, also an outcomes-related harm, stereotyping, affects members of identifying groups. If a member of an ethic group were denied insurance coverage because of a genetic susceptibility was perceived to be common to this group, this individual would be the victim of stereotyping.
As would be expected, given the complexities of developing local, national and international research oversight, civic legislation and public consultation, Hausman's proposed protections against these harms are not as well-defined. Here are a few highlights: IRBs - The author does not think that expanding IRB oversight is answer. He writes, "IRBs are not well suited to implement the necessary regulation ... there would be a duplication of oversight, and research would be stymied ... [and they] are not the right bodies to regulate the risks that scientific research poses to third parties." Group engagement – Although he thinks that efforts toward community consultation in genetic research grow "out of an admirable concern to be respectful to individuals and groups that the research may put at risk," the author argues that consultation is primarily valuable when conducting research with structured groups. In contrast, he thinks that consultation with identifying groups facing stereotyping harms (African Americans, for example) is "often infeasible". He writes, "Indeed, by lending salience to social groups, that may in fact be genetically heterogeneous, group consultation may be counterproductive". To protect groups from stereotyping, Hausman hesitatingly (fearing, perhaps, a decline in public support for research) advocates regulation.
Readers looking for more detailed suggestions for protecting groups from genetic research may be frustrated by this article. For example, the author concludes, regarding harms to indigenous groups, that "whoever regulates research (to the extent that research is regulated) should be concerned about the risks of undermining ... and should demand that researchers provide those they study with detailed information and the opportunity to make their concerns heard by political and regulatory authorities". To my ears, such a statement sounds too much like: someone should pick up this trash ... which is not an effective way to motivate people to clean a room. Readers may also wonder if Hausman too quickly dismisses the possibility of protecting the third group type in his taxonomy, "potential identifying" groups. While it is true that one can not consult with a group that is yet to be identified, does this mean that some protections can not be explored or established in advance?
While I hope that Hausman, or someone else, will pick up the loose ends that this article did not have the room to address, his taxonomy of groups and potential harms is very useful. If you can find a copy of this article (subscription required, unfortunately), it's worth reading. –J.O.
Reference: Hausman D. Protecting groups from genetic research. Bioethics 2008; 22 (3):157-65. [Abstract - CiteULike | doi:10.1111/j.1467-8519.2007.00625.x]
Hausman's taxonomy of harms includes two process-related harms (disrupting and stigmatizing harms) and two outcomes-related harms (undermining and stereotyping harms). Disrupting harms occur, he writes, "when the research process – regardless of its findings – harms a structured group". For example, "taking tissue samples in genetics research might have a ritual significance that could undermine group solidarity". The author thinks that these harms are relatively infrequent in genetic research.
Stigmatizing harms, in contrast, are more common. This process-related harm affects individuals of an identifying group when the mere existence of a genetic research study stigmatizes members of the group.
The third harm, undermining, (an outcomes-related harm) occurs when structured groups are hurt by the findings of genetic research. For examples, Hausman provides the refutation of beliefs about group origins, the loss of potential commercial gain, and the generation or justification of discriminatory treatment.
The fourth kind of harm, also an outcomes-related harm, stereotyping, affects members of identifying groups. If a member of an ethic group were denied insurance coverage because of a genetic susceptibility was perceived to be common to this group, this individual would be the victim of stereotyping.
As would be expected, given the complexities of developing local, national and international research oversight, civic legislation and public consultation, Hausman's proposed protections against these harms are not as well-defined. Here are a few highlights: IRBs - The author does not think that expanding IRB oversight is answer. He writes, "IRBs are not well suited to implement the necessary regulation ... there would be a duplication of oversight, and research would be stymied ... [and they] are not the right bodies to regulate the risks that scientific research poses to third parties." Group engagement – Although he thinks that efforts toward community consultation in genetic research grow "out of an admirable concern to be respectful to individuals and groups that the research may put at risk," the author argues that consultation is primarily valuable when conducting research with structured groups. In contrast, he thinks that consultation with identifying groups facing stereotyping harms (African Americans, for example) is "often infeasible". He writes, "Indeed, by lending salience to social groups, that may in fact be genetically heterogeneous, group consultation may be counterproductive". To protect groups from stereotyping, Hausman hesitatingly (fearing, perhaps, a decline in public support for research) advocates regulation.
Readers looking for more detailed suggestions for protecting groups from genetic research may be frustrated by this article. For example, the author concludes, regarding harms to indigenous groups, that "whoever regulates research (to the extent that research is regulated) should be concerned about the risks of undermining ... and should demand that researchers provide those they study with detailed information and the opportunity to make their concerns heard by political and regulatory authorities". To my ears, such a statement sounds too much like: someone should pick up this trash ... which is not an effective way to motivate people to clean a room. Readers may also wonder if Hausman too quickly dismisses the possibility of protecting the third group type in his taxonomy, "potential identifying" groups. While it is true that one can not consult with a group that is yet to be identified, does this mean that some protections can not be explored or established in advance?
While I hope that Hausman, or someone else, will pick up the loose ends that this article did not have the room to address, his taxonomy of groups and potential harms is very useful. If you can find a copy of this article (subscription required, unfortunately), it's worth reading. –J.O.
Reference: Hausman D. Protecting groups from genetic research. Bioethics 2008; 22 (3):157-65. [Abstract - CiteULike | doi:10.1111/j.1467-8519.2007.00625.x]
Tuesday, January 8, 2008
Biomedical Research Ethics 2.0: MySpace and Pediatrics
Much of the excitement about the future of personalized medicine revolves around the creation of consumer managed, personal health records. To acquire a measure of the anticipation, revisit the blogging blitz inspired the by implicit competition between Microsoft's HealthVault and Google Health (see, for example, David Hamilton's reviews of HealthVault at Venture Beat and Bertalan Meskó's coverage of Google Health at ScienceRoll). Although most are interested in the potential these Web 2.0 developments hold for enhanced, individualized health care, others have speculated that personal health information may become a more common feature of social-networking sites. The big names in social-networking (MySpace and Facebook) already host user-generated groups for individuals with shared health conditions; others, such as iMedix and MyOpenCare (for more examples visit Medicine 2.0) have entered the market with an obvious interest in health 2.0 and shared, personal medical records.
Although many worry about how advertisers might data mine personal information to target potential customers, these networks also offer a new source of information for medical research data and research recruitment. With this in mind, "Research Ethics in the MySpace Era" (Moreno MA, Fost NC, Christakis DA. Pediatrics 2008;121;157-161. PMID:18166570) is a very timely publication. The authors explore the ethical implications of using MySpace profiles as: a source for observational research (potentially exempt from IRB oversight); a tool for research recruitment; and a platform for health intervention studies. Although the authors are particularly interested in the risks and benefits of social-networking sites for pediatric research, the investigation could easily be generalized for research with adult users. The authors, however, do not address the ethical implications of using shared, genetic information. Imagine a day in which users update their profiles and replace zodiac signs with significant genetic biomarkers. How would this "shared" information challenge the ethical framework proposed by Moreno, Fost and Christakis? - J.O.
Although many worry about how advertisers might data mine personal information to target potential customers, these networks also offer a new source of information for medical research data and research recruitment. With this in mind, "Research Ethics in the MySpace Era" (Moreno MA, Fost NC, Christakis DA. Pediatrics 2008;121;157-161. PMID:18166570) is a very timely publication. The authors explore the ethical implications of using MySpace profiles as: a source for observational research (potentially exempt from IRB oversight); a tool for research recruitment; and a platform for health intervention studies. Although the authors are particularly interested in the risks and benefits of social-networking sites for pediatric research, the investigation could easily be generalized for research with adult users. The authors, however, do not address the ethical implications of using shared, genetic information. Imagine a day in which users update their profiles and replace zodiac signs with significant genetic biomarkers. How would this "shared" information challenge the ethical framework proposed by Moreno, Fost and Christakis? - J.O.
Monday, November 19, 2007
Engaging the Community in Predictive Health Research: Reporting on PredictER's November 2nd Expert Panel
Research and the Community
In most predictive health projects, researchers need to obtain human biological materials that can be stored for immediate or later use and then linked to detailed health information from medical records. Building biobanks and predictive health research projects requires a supportive public. To succeed researchers need a representative sample of willing participants, good state and institutional policy, and (of course) funding. (This research also benefits from highly motivated advocacy groups such as Susan G. Komen for the Cure.) In a few words, predictive health is one of the most community saturated forms of medical research to date.
Ethical Issues
The great good that will be accomplished by predictive health research, with its ability to forecast a person’s health future with reasonable probability, must be pursued with careful consideration. These studies raise ethical, legal, and social questions beyond the scope of the current paradigm of medical research. Very basic examples of these questions include: What do researchers do when they find that an individual tests positive for a gene or other biomarker that puts them at significant risk for a disease in the future? Can an individual’s biological material be used first to study one type of disease or treatment and then later another? What protections need to be in place to ensure that the sensitive information in an individual’s health record and genes does not result in employment or health insurance discrimination?
The Pace of Translation
While questions like these may seem very scary when rattled off one after the other, the truth is that predictive health is the future of medicine--a future that hopes to fulfill the ambitions of the human genome project, by providing an individual with a personalized assessment of risk and response to treatment. The human genome project succeeded in decoding a great deal of information, but what that information means for individuals with heart disease, a family history of cancer, or a smoking addiction, has not been answered. If current research succeeds, this information will be translated into real clinical applications in the not too distant future. Research looking to define these types of predictors is well underway at most universities--some, as exemplified by Emory's Predictive Health Initiative and the TGen (Translational Genomics) project in Arizona, have worked to establish comprehensive predictive health research programs. Meanwhile, as The Wall Street Journal recently reported many (up to 1,400) genetic tests are already available for individuals interested in assessing their risks for a number of diseases. Moreover, many specific predictive tests are already being used to chart treatment paradigms in hospital care.
PredictER Engaging the Community
Still, the fact that predictive health is occurring does not answer any of the concerns voiced earlier. These are concerns that the PredictER program at the IU Center for Bioethics is working to address. On November 2nd, PredictER convened a panel of 35 experts and community advocates to begin to give shape to many of these concerns and to explore ways to reach out to the community, build collaboration, and encourage research while protecting individual and public interests. While the panel of experts shared an understanding of the progress of predictive health, it took an entire day of brainstorming and discussion to reach consensus on what issues may be present with respect to engaging the community. In the end, it was clear that predictive health will require physicians, researchers, and the community to join in constructive, mutually beneficial work. In the near future a white paper will be published by the Center for Bioethics with a more detailed account of the November 2nd event. This paper will also introduce the next step in PredictER's community outreach mission--a plan to engage central Indiana community leaders and to listen to their concerns about the future of predictive health research. -- Patrick Barrett
In most predictive health projects, researchers need to obtain human biological materials that can be stored for immediate or later use and then linked to detailed health information from medical records. Building biobanks and predictive health research projects requires a supportive public. To succeed researchers need a representative sample of willing participants, good state and institutional policy, and (of course) funding. (This research also benefits from highly motivated advocacy groups such as Susan G. Komen for the Cure.) In a few words, predictive health is one of the most community saturated forms of medical research to date.
Ethical Issues
The great good that will be accomplished by predictive health research, with its ability to forecast a person’s health future with reasonable probability, must be pursued with careful consideration. These studies raise ethical, legal, and social questions beyond the scope of the current paradigm of medical research. Very basic examples of these questions include: What do researchers do when they find that an individual tests positive for a gene or other biomarker that puts them at significant risk for a disease in the future? Can an individual’s biological material be used first to study one type of disease or treatment and then later another? What protections need to be in place to ensure that the sensitive information in an individual’s health record and genes does not result in employment or health insurance discrimination?
The Pace of Translation
While questions like these may seem very scary when rattled off one after the other, the truth is that predictive health is the future of medicine--a future that hopes to fulfill the ambitions of the human genome project, by providing an individual with a personalized assessment of risk and response to treatment. The human genome project succeeded in decoding a great deal of information, but what that information means for individuals with heart disease, a family history of cancer, or a smoking addiction, has not been answered. If current research succeeds, this information will be translated into real clinical applications in the not too distant future. Research looking to define these types of predictors is well underway at most universities--some, as exemplified by Emory's Predictive Health Initiative and the TGen (Translational Genomics) project in Arizona, have worked to establish comprehensive predictive health research programs. Meanwhile, as The Wall Street Journal recently reported many (up to 1,400) genetic tests are already available for individuals interested in assessing their risks for a number of diseases. Moreover, many specific predictive tests are already being used to chart treatment paradigms in hospital care.
PredictER Engaging the Community
Still, the fact that predictive health is occurring does not answer any of the concerns voiced earlier. These are concerns that the PredictER program at the IU Center for Bioethics is working to address. On November 2nd, PredictER convened a panel of 35 experts and community advocates to begin to give shape to many of these concerns and to explore ways to reach out to the community, build collaboration, and encourage research while protecting individual and public interests. While the panel of experts shared an understanding of the progress of predictive health, it took an entire day of brainstorming and discussion to reach consensus on what issues may be present with respect to engaging the community. In the end, it was clear that predictive health will require physicians, researchers, and the community to join in constructive, mutually beneficial work. In the near future a white paper will be published by the Center for Bioethics with a more detailed account of the November 2nd event. This paper will also introduce the next step in PredictER's community outreach mission--a plan to engage central Indiana community leaders and to listen to their concerns about the future of predictive health research. -- Patrick Barrett
Thursday, October 18, 2007
PredictER at the ASBH Annual Meeting
If you are attending 9th Annual Meeting of the ASBH (American Society of Bioethics and Humanities) this weekend in Washington, D.C., do not miss presentations by PredictER's faculty and friends. Scott C. Denne, MD, Timothy Caulfield, LLM, Barbara J. Evans, PhD, JD, LLM, and Peter H. Schwartz, MD, PhD. will address the ethical, legal and social implications of predictive health research, focusing on the essentially collaborative and interdisciplinary nature of research on these issues in their panel session. The panel, Ethics and Regulation of Predictive Health Research: A New Translational Paradigm?, will discuss pediatric biobanks; informed consent; regulatory protections; and patient understanding of risk and genetic information. For a complete abstract, see the American Society for Bioethics and Humanities program description: Sunday, 21 October 2007 - 11:00 AM
Other panel sessions relevant to the ethics of predictive health research include:
Other panel sessions relevant to the ethics of predictive health research include:
- One Hundred Years of Eugenics: From the “Indiana Experiment” to the Human Genome Project. Friday, 19 October 2007: 10:30 AM-11:30 AM
- Who Controls Your DNA? Saturday, 20 October 2007: 10:30 AM-11:30 AM
- Identifiability in Genomic Research: Considerations of Privacy, Autonomy, and Social Identity. Sunday, 21 October 2007: 9:45 AM-10:45 AM
Friday, August 3, 2007
Prediction and Addiction
Pediatrics and Nicotine -
A recent publication on pediatric genetic testing for nicotine addiction reported the results of an attitudes survey of 232 health providers attending a conference on adolescent health. In "Interest in Genetic Counseling and Testing for Adolescent Nicotine Addiction Susceptibility ... ", the authors from the Lombardi Comprehensive Cancer Center at Georgetown University (Kenneth Tercyak, Beth Peshkin, Anisha Abraham and Leslie Walker) examined correlates in providers' interests:
See:
Genetic testing for addiction could have far reaching implications in the criminal justice system. A press release from The University of Texas Health Center at Tyler ("Four researchers at UT Health Center receive grants ... ".News & Information. Thursday, July 19, 2007) announced a four year of $1.76 million from the NIH to study the ethical, legal, and social implications of the non-health use of personal genetic data. Genetic tests could be used, for example, in determining the length of sentences for offenders with genetic risks for addiction. The project will:
A recent publication on pediatric genetic testing for nicotine addiction reported the results of an attitudes survey of 232 health providers attending a conference on adolescent health. In "Interest in Genetic Counseling and Testing for Adolescent Nicotine Addiction Susceptibility ... ", the authors from the Lombardi Comprehensive Cancer Center at Georgetown University (Kenneth Tercyak, Beth Peshkin, Anisha Abraham and Leslie Walker) examined correlates in providers' interests:
- Providers who engaged in more regular tobacco screening behaviors with their adolescent patients ... and those who were more optimistic that biobehavioral research would lead to significant improvements in adolescent smoking prevention and treatment ... , were more interested in counseling and testing.
See:
- Tercyak KP, Peshkin BN, Abraham A, Wine L, Walker LR. Interest in genetic counseling and testing for adolescent nicotine addiction susceptibility among a sample of adolescent medicine providers attending a scientific conference on adolescent health. J Adolesc Health. 2007 Jul;41(1):42-50. [Abstract at PredictER Connotea.]
Genetic testing for addiction could have far reaching implications in the criminal justice system. A press release from The University of Texas Health Center at Tyler ("Four researchers at UT Health Center receive grants ... ".News & Information. Thursday, July 19, 2007) announced a four year of $1.76 million from the NIH to study the ethical, legal, and social implications of the non-health use of personal genetic data. Genetic tests could be used, for example, in determining the length of sentences for offenders with genetic risks for addiction. The project will:
- · Create an open-access online database of the current criminal and sentencing laws employing drug addiction information;
- · Survey the attitudes and information needs of drug-court judges, corrections officers, and drug treatment professionals regarding genetic research and the science of addiction;
- · Engage these stakeholders in public discussions of the issues;
- · Develop an open access, online resource for training, education, and reference materials on the subject.
- We hope that our findings have some influence on the development of state laws and policies for the use of this genetic data in these settings. Right now there’s no uniformity. Jurisdictions may treat this information very differently.
Tuesday, July 3, 2007
Ethics and Regulation of Predictive Health Research: A New Translational Paradigm
PredictER at the Upcoming 9th Annual Meeting (October 18-21, 2007) of ASBH
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