Over the last few days, I have heard two discussions – one on the radio and the other at the Indiana University Center for Bioethics – that have given me a new and deeper understanding of the meaning of health insurance and of the challenges of incorporating Predictive Health information into healthcare. These two presentations came together to give me a new understanding of the spiritual dimension of health insurance.
The first discussion occurred on the NPR program "Speaking of Faith," hosted by Krista Tippett. This week the program featured an interview with Parker Palmer, a Quaker writer and educator, and focused on themes related to the current economic meltdown. When discussion turned to the role of greed in causing the crisis, Palmer commented that greed stems at least partly from a sense of isolation and a lack of feeling of being part of a community. If a person feels that he cannot rely on others for help at times of need, he will understandably develop the impulse to acquire as much as possible, to attempt to amass a sort of fortress against possible danger to him and his family.
This immediately reminded me of the state of healthcare and health insurance in this country. As premiums rise and increasing numbers of businesses cut back on health insurance for employees and retirees, more and more Americans are living without health insurance or facing the very real possibility of this. And what could cause a greater feeling of isolation – of living without support from others – than finding yourself without available or affordable health insurance? Even those of us who do have health insurance must feel insecure as we observe the growing ranks of uninsured and underinsured people. The historic economic downturn has made the trend only worse, of course.
Palmer’s comment highlights one of the many destructive effects of fearfulness. And it highlights the importance of making health insurance available and affordable. In short, universal health insurance, in my view, would play a significant role in helping to combat the feeling of isolation and helplessness that many feel in the current situation.
And here’s where Predictive Health information comes into the picture. Predictive Health Research (PHR) promises to provide new ways to identify individuals’ specific level of health risk and provide new, more targeted medical care. A healthcare system that provided excellent preventive care, guided by breakthroughs in PHR, could greatly reduce mortality and morbidity. We could improve the sense of safety and trust that supports a healthy spiritual life. But here’s where the fly lands in the ointment. At our biweekly meeting of the PredictER program this week at the IU Center for Bioethics, Eleanor Kinney JD, MPH, and Jennifer Girod JD, PhD, RN, presented a talk about the ways that Predictive Health information threatens to undermine the current system of health insurance. In short, identifying people’s risk levels creates perverse incentives for patients and for insurance companies. Individuals with lower risk have less reason to join the insurance “pool,” since their premiums disproportionately support care for others, rather than themselves. At the same time, insurance companies have the incentive of excluding those at higher risk, or at least charging them higher premiums. As Kinney and Girod pointed out, there are various schemes for blocking this destructive dynamic, although things get difficult pretty fast.
But sitting there listening to them, I realized that once again we were talking about the challenge of how to bind us together as a society and take care of everybody – the high risk and the low risk alike. How tragic if the same scientific breakthroughs that could allow for improved preventive care for all were to result in worse care and isolation for those at the highest risk. That would truly be a situation where isolation, not trust and community, would have its day.
Peter Schwartz, MD, PhD
Showing posts with label predictive health. Show all posts
Showing posts with label predictive health. Show all posts
Thursday, December 18, 2008
Thursday, September 4, 2008
Personalized Therapeutics at IU
In August 2008, the Indiana University Department of Medicine’s Division of Clinical Pharmacology began a new series of compelling seminars that may be of great interest to those involved in predictive health research ethics. The Personalized Therapeutics Seminar series commenced on August 5th with a presentation on the FDA’s Sentinel System for Post-market Drug Safety Surveillance given by Barbara Evans, J.D., Ph.D. from the Health Law and Policy Institute at the University of Houston Law Center. Additional speakers this fall, all from the Indiana University School of Medicine, have included Dr. Noah Hahn presenting on the Indiana University Cancer Biomarker Study, Dr. David Haas addressing PREGMED and the search for individualized pharmacotherapy in pregnancy, Dr. Zeruesenay speaking about emerging in vivo phenotyping methods and Dr. Tatiana Foroud addressing the results of whole genome association studies and how they may change our approach to medicine. The next seminar, entitled Personalized Therapeutics in Breast Cancer: A Model for Translating Pharmacogenomics, will be presented Dr. David Flockhart, Chief of the Division of Clinical Pharmacology, on September 9th. All seminars in this series are held on Tuesdays from 12:00pm – 1:00pm, in room W7120 on the 7th floor of the Wishard Myers Building.
For a complete schedule, please see: http://medicine.iupui.edu/clinpharm/PMG/PT_Seminars.asp [link edited 9-18-09]
Amy Lewis Gilbert
For a complete schedule, please see: http://medicine.iupui.edu/clinpharm/PMG/PT_Seminars.asp [link edited 9-18-09]
Amy Lewis Gilbert
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.
Friday, April 25, 2008
Disclosing Risk: Good Communication or "Doctor-Knows-Best"?
A newly published paper from PredictER's Peter H. Schwartz and Eric M. Meslin, examines the challenges of balancing beneficence and the respect for autonomy in preventive and predictive medicine. In "The ethics of information: absolute risk reduction and patient understanding of screening" (J Gen Intern Med. 2008 Apr 18; [Epub ahead of print] | PMID: 18421509) the authors question whether providing absolute probabilities of risk based, for example, on genetic screening for breast cancer, is always in the best interest of the patient's health. While many argue the respect for the patient's autonomy demands that risk is communicated numerically or graphically, Schwartz and Meslin argue that the disclosures should be made "in the light of careful consideration of patient understanding and possible impacts on uptake and well-being".
Thursday, April 10, 2008
Gene Sherpas for CME
Steve Murphy at Gene Sherpas: Personalized Medicine and You has often asserted that physicians will need continuing medical education to understand the latest advances in genetic research and to interpret clinical genetic information. In a recent post, however, he provides a few hints about what he will be doing to make these educational opportunities a reality. Murphy writes:
There is a new hope. An institution being set up by myself and others. We are currently looking for donors and we endeavor to set up educational events and group sessions. We will work with Corporate Genomics, Academic Genetics, Corporate Labs, Academic Medicine to develop training workshops. Interested?
Well Steve, I'm interested (obviously), PredictER has been working on continuing medical education programs for physicians with patients participating in genetic research. We have made plans to offer two initial programs in local clinics here in Indianapolis this summer—we hope to stream these programs to a wider audience as well. While this is one step removed from the clinical use of consumer genomics (we're really focusing on research ethics in the clinic), I hope that our work on the ethical issues of genetic medicine will be of use to your hoped for institution. At the very least, don't forget the ethicists and community advocates when designing your curriculum. Good luck finding donors and keep us posted! – J.O.
There is a new hope. An institution being set up by myself and others. We are currently looking for donors and we endeavor to set up educational events and group sessions. We will work with Corporate Genomics, Academic Genetics, Corporate Labs, Academic Medicine to develop training workshops. Interested?
Well Steve, I'm interested (obviously), PredictER has been working on continuing medical education programs for physicians with patients participating in genetic research. We have made plans to offer two initial programs in local clinics here in Indianapolis this summer—we hope to stream these programs to a wider audience as well. While this is one step removed from the clinical use of consumer genomics (we're really focusing on research ethics in the clinic), I hope that our work on the ethical issues of genetic medicine will be of use to your hoped for institution. At the very least, don't forget the ethicists and community advocates when designing your curriculum. Good luck finding donors and keep us posted! – J.O.
Friday, March 14, 2008
Insurance and Incentives: Private or Public?
[Sam Beasley, a law and bioethics student here at Indiana University, is a new member of the PredictER team. I asked him, as a way of introducing himself to PredictER's readers and friends, to share his thoughts on any topic relevant to the future of predictive health and personalized medicine. I think this is a good post and I hope that we will see more of Sam's contributions to PredictER Blog in the weeks to come. – Jere Odell]
Now, before I begin, I need to state upfront that this is the first blog post I have ever written and I am in no way an expert in politics, public policy, health care provision, insurance. I am also new to the PredictER project, and will be working with Jennifer Girod to investigate the legal and policy implications of predictive medicine. I hope that this experience will broaden and deepen my understanding of health care and public policy. Jere asked me to share what's on my mind, so here it is:
Following the publication of "Insurance Fears Lead Many to Shun DNA Tests" in The New York Times (24 February 2008), the blogosphere lit up with comments on the need to protect people from discrimination—protection that would be, presumably, provided by S. 358, the Genetic Information Nondiscrimination Act (GINA). A few, like David Dooling of PolITiGenomics, observed that the status-quo of insurance provision in the United States may seriously discourage the progress of medical research and personalized medicine. I'd like to take this discussion and move it an inch or two away from the worthy topic of discrimination. Let's think about the research and health care climate:
Which insurance system provides the most incentive to pursue predictive and preventative forms of medicine: a public-funded system or the current private system—one, in which private companies sell insurance to individuals?
As I said, I am certainly not an expert on these issues, but it seems to me that the major means of preventing chronic disease are, in large measure, socially, culturally and politically influenced (think food subsidies, health education in public schools, etc.). If eating a healthy diet, exercising regularly, getting scheduled medical exams, and avoiding unhealthy habits such as smoking and drug abuse are indeed foundational in the pursuit of life-long health, then public ownership would seem to be the way to go.
Public is superior to private because by spreading the bill for health care over the entire population, you would provide increased incentive for voters to support public programs that promote preventative health measures. In private systems where like-situated individuals are pooled together, the healthy will remain concerned about their own health, and not the health of their neighbors. Only when the health of all affects the individual, will the individual begin to care. And if we’ve learned anything in America, the quickest way to get people to care is through their wallet.
I am not arguing here that this is the “fairest” way to do things, (although my liberal leaning makes me inclined to think that basic health care for all is a social good worth our investment) to the contrary; some may abuse the system and choose not to pursue healthy living practices simply because they know that the cost to them will be subsidized by everyone else. I merely intend to say that if we want to stem the tide of deteriorating health in this country, we have got to find a way to make healthy living a social value. Broad-reaching social programs can do a lot to influence individual practices. If we can teach people to live in a way conducive to health, provide incentives for doing so, and get them the care that they need before minor problems turn into major ones [note: emergency room care will never be the most cost-effective means of providing basic health care needs], then we might be able to turn things around. Of course, this is just one piece in a complicated puzzle, but we have got to do better by ourselves, and if a public health care system is a step in the right direction, then we should pursue it. – Sam Beasley
Now, before I begin, I need to state upfront that this is the first blog post I have ever written and I am in no way an expert in politics, public policy, health care provision, insurance. I am also new to the PredictER project, and will be working with Jennifer Girod to investigate the legal and policy implications of predictive medicine. I hope that this experience will broaden and deepen my understanding of health care and public policy. Jere asked me to share what's on my mind, so here it is:
Following the publication of "Insurance Fears Lead Many to Shun DNA Tests" in The New York Times (24 February 2008), the blogosphere lit up with comments on the need to protect people from discrimination—protection that would be, presumably, provided by S. 358, the Genetic Information Nondiscrimination Act (GINA). A few, like David Dooling of PolITiGenomics, observed that the status-quo of insurance provision in the United States may seriously discourage the progress of medical research and personalized medicine. I'd like to take this discussion and move it an inch or two away from the worthy topic of discrimination. Let's think about the research and health care climate:
Which insurance system provides the most incentive to pursue predictive and preventative forms of medicine: a public-funded system or the current private system—one, in which private companies sell insurance to individuals?
As I said, I am certainly not an expert on these issues, but it seems to me that the major means of preventing chronic disease are, in large measure, socially, culturally and politically influenced (think food subsidies, health education in public schools, etc.). If eating a healthy diet, exercising regularly, getting scheduled medical exams, and avoiding unhealthy habits such as smoking and drug abuse are indeed foundational in the pursuit of life-long health, then public ownership would seem to be the way to go.
Public is superior to private because by spreading the bill for health care over the entire population, you would provide increased incentive for voters to support public programs that promote preventative health measures. In private systems where like-situated individuals are pooled together, the healthy will remain concerned about their own health, and not the health of their neighbors. Only when the health of all affects the individual, will the individual begin to care. And if we’ve learned anything in America, the quickest way to get people to care is through their wallet.
I am not arguing here that this is the “fairest” way to do things, (although my liberal leaning makes me inclined to think that basic health care for all is a social good worth our investment) to the contrary; some may abuse the system and choose not to pursue healthy living practices simply because they know that the cost to them will be subsidized by everyone else. I merely intend to say that if we want to stem the tide of deteriorating health in this country, we have got to find a way to make healthy living a social value. Broad-reaching social programs can do a lot to influence individual practices. If we can teach people to live in a way conducive to health, provide incentives for doing so, and get them the care that they need before minor problems turn into major ones [note: emergency room care will never be the most cost-effective means of providing basic health care needs], then we might be able to turn things around. Of course, this is just one piece in a complicated puzzle, but we have got to do better by ourselves, and if a public health care system is a step in the right direction, then we should pursue it. – Sam Beasley
Friday, February 29, 2008
Predictive Health: Best Ethics Blogs - February 2008
This second, monthly installment (see January's Best Ethics Blogs) includes blogs on the ethical issues of biobanking, the risks of genetic testing and discrimination, responses to a recent New York Times article, and thoughts about Google Health and HIPAA compliance. Entries are listed below by topic and date.
Biobanks
Biobanking, part 3: returning research results to participants. Sue Trinidad, Women's Bioethics Blog. 4 February 2008.
Continuing her excellent series on biobanking, Sue Trinidad, asks readers to consider the following scenario: "Let's say that--20 years after you consented to participate in a breast cancer study--researchers working on a different project discover that you carry a genetic mutation that has been definitively linked to Serious Medical Problem X. ... Do the researchers have a professional and/or moral obligation to share this information with you?"
More on BioBanking. Sue Trinidad, Women's Bioethics Blog. 6 February 2008.
In a fourth post on biobanking, Trinidad responds to a BBC News story ("Change planned on cloning consent", 2 February 2008). The story reports that the UK government may allow the use of tissues donated for research for embryonic cloning without requiring the explicit consent of donors. Sue asks: "[J]ust what should be the scope of allowed activities under a 'blanket' or 'one-time' consent? Also, should the research imperative (and perhaps the common good) outweigh individuals' preferences in such cases?"
[Also see Trinidad's posts on the clinical utility of genetic tests (1 February 2008) and beneficiaries of prenatal genetic diagnosis (22 February 2008).]
Consumer Genetics
While The DNA Network provides a constant stream of quality blogs on the ups and downs, ins and outs of direct-to-consumer, genetic medicine, two caught my attention this month for demonstrating creativity and gumption.
Polls Closed, Myriad Tallies Up and We await Navagenics! Steve Murphy, Gene Sherpas: Personalized Medicine and You. 11 February 2008.
In an informal survey of his readers, Murphy discovers that most think 23andMe is the most likely to be sued first. In assessing the litigious environment, the Sherpa (Murphy's pithy alter-ego) comments: "If I had a law degree … I would bone up on genetics legal precedent, corporate protections and genetic discrimination. If you think a certain ex-candidate for president made a bundle suing OB/Gyns, you haven't seen the beginning of the legal fortune to be made in genomics."
DNA Videos: Genetic Testing on NBC Nightly News. Hsien-Hsien Lei, Eye on DNA. 13 February 2008.
In this post Lei embeds videos from the Robert Bazell NBC Nightly News series "The Truth About DNA". One of these features Stanford's Hank Greely, who expresses his worries about the genetic testing market place. In a follow-up blog post, Bazell laments a "frightening lack of government regulations". After wondering if Greely and Bazell are "easily scared", Lei takes the advice of a genetic counselor (Ellen Matloff) and writes a sample letter for "Johnny" to open a discussion of his genetic test results with his family members. Will his parents be surprised to discover that he blames them for everything? Maybe someone should persuade Johnny's "parents" to write a reply.
Discrimination
Q&A with MDV’s Bill Ericson: On PacBio’s origin, why Gattaca isn’t our future, and throwing out your statins. David P Hamilton, VentureBeat: Life Sciences. 15 February 2008.
In this interview with Bill Ericson of Mohr Davidow Ventures, Hamilton asks: "What about the potential downsides, such as genetic discrimination that could leave many people uninsurable, or even the possibility that society could end up stratified by genetic caste, as in the movie Gattaca?" Ericson responds, in part, "I worried a lot about those negative implications when we started investing, but American society is, I think, mature enough to deal with the information, whether by legislation or via general social norms."
Rewarding Ignorance. Doug Masson, Masson's Blog – A Citizen's Guide to Indiana. 24 February 2008.
Doug Masson was among the many bloggers (including Steve Murphy and Sue Trinidad) responding to Amy Harmon's New York Times article "Insurance Fears Lead Many to Shun DNA Tests" (24 February 2008). After describing how the insurance industry needs a degree of "ignorance" to survive, Masson observes: "as our knowledge of a person’s likely health care profile increases, paying for medical treatment becomes less about managing risk through insurance and more about determining what our obligations might be toward our fellow humans in subsidizing their ability to live and/or remain healthy".
Bipolar Blood Test? Let The Bloodbath Begin. Philip Dawdy, Furious Seasons. 28 February 2008.
Dawdy, a patient, reacts to the latest research news about the search for psychiatric biomarkers. Research at Indiana University School of Medicine has isolated blood markers to identify mood disorders. Lead author, Alexander B. Niculescu III, M.D., Ph.D. (a future guest at our weekly PredictER meeting), hailed the research as "a major step towards bringing psychiatry on par with other medical specialties that have diagnostic tools to measure disease states and the effectiveness of treatments". If, however, a test is developed, Dawdy declares, "I am going nowhere near that test because its results--unless you do the test privately--will follow me the rest of my life and be used to discriminate against me and people like me in insurance (health and life), employment, schools, housing and God knows what all".
Health IT and Medical Records
Of Slelling and Men. Steve Murphy, Gene Sherpas: Personalized Medicine and You. 3 February 2008.
After defining "slelling" and recounting the scandals that have limited the possibility of selling health data without the explicit consent of patients, Murphy cites Emanuel EJ, Wendler D, and Grady C (2000) to summarize how "ethicists feel" about data acquisition in clinical research.
Engineering Grand Challenges – Advancing health informatics. Deepak Singh, bbgm. 19 February 2008.
In reviewing an article published on the National Academy of Engineering website, Deepak Singh notes that the technological challenges of health informatics are inseparable from some common ethical concerns. Singh's notes that "[w]hile the article refers to privacy and security, it does not address the issues of content ownership and data portability". Among the questions the Singh would like to see answered are: "Who owns someones medical data? How does it move from one system to another? What parts can a physician have access to? [And] what are the dangers of a system controlled by the user … [?]"
Google PHR roll-out: how personal will a personal health record be? David Harlow, HealthBlawg. 24 February 2008.
Although any news about Google's developing personal health records platform "Google Health" results in an avalanche of blog posts, David Harlow was among the rare bloggers to recognize and speculate about the medical research potential of these records. In reflecting on the privacy and HIPAA challenges that Google's personal health records may bring, Harlow remarks:
So let's assume the worst: Google will sell ads to the highest bidders for keywords in your PHR (kinda OK so long as there's adequate disclosure up front), will sell aggregated de-identified data for population-based health studies (ditto, but this seems more like a good thing, and is really at the heart of the value of EHRs and PHRs generally -- though the utility depends on how much data really finds its way into the PHR, and how it's organized) and worst of all, will mistakenly convert your PHR into an RSS feed that ends up on every computer in America (eek! . . . but is that worse than dropping a paper record behind a file cabinet and never finding it again?) … Every innovation comes with a set of benefits and burdens.
Politics
One gene, two genes; red genes, blue genes. Jesse Reynolds, Biopolitical Times. 14 February 2008.
Reynolds responds to an article published in New Scientist, "Two tribes: Are your genes left-wing or right-wing?" (2 February 2008). Following a critical assessment of the media coverage and a skeptical review of efforts to study the genetics of political attitudes and behavior, Reynolds identifies a potential "disturbing" social implication for such research: "accepting that genes determine political orientation could cause deepening political apathy … Heck, why bother voting when you could just have your cheek swabbed?"
Biobanks
Biobanking, part 3: returning research results to participants. Sue Trinidad, Women's Bioethics Blog. 4 February 2008.
Continuing her excellent series on biobanking, Sue Trinidad, asks readers to consider the following scenario: "Let's say that--20 years after you consented to participate in a breast cancer study--researchers working on a different project discover that you carry a genetic mutation that has been definitively linked to Serious Medical Problem X. ... Do the researchers have a professional and/or moral obligation to share this information with you?"
More on BioBanking. Sue Trinidad, Women's Bioethics Blog. 6 February 2008.
In a fourth post on biobanking, Trinidad responds to a BBC News story ("Change planned on cloning consent", 2 February 2008). The story reports that the UK government may allow the use of tissues donated for research for embryonic cloning without requiring the explicit consent of donors. Sue asks: "[J]ust what should be the scope of allowed activities under a 'blanket' or 'one-time' consent? Also, should the research imperative (and perhaps the common good) outweigh individuals' preferences in such cases?"
[Also see Trinidad's posts on the clinical utility of genetic tests (1 February 2008) and beneficiaries of prenatal genetic diagnosis (22 February 2008).]
Consumer Genetics
While The DNA Network provides a constant stream of quality blogs on the ups and downs, ins and outs of direct-to-consumer, genetic medicine, two caught my attention this month for demonstrating creativity and gumption.
Polls Closed, Myriad Tallies Up and We await Navagenics! Steve Murphy, Gene Sherpas: Personalized Medicine and You. 11 February 2008.
In an informal survey of his readers, Murphy discovers that most think 23andMe is the most likely to be sued first. In assessing the litigious environment, the Sherpa (Murphy's pithy alter-ego) comments: "If I had a law degree … I would bone up on genetics legal precedent, corporate protections and genetic discrimination. If you think a certain ex-candidate for president made a bundle suing OB/Gyns, you haven't seen the beginning of the legal fortune to be made in genomics."
DNA Videos: Genetic Testing on NBC Nightly News. Hsien-Hsien Lei, Eye on DNA. 13 February 2008.
In this post Lei embeds videos from the Robert Bazell NBC Nightly News series "The Truth About DNA". One of these features Stanford's Hank Greely, who expresses his worries about the genetic testing market place. In a follow-up blog post, Bazell laments a "frightening lack of government regulations". After wondering if Greely and Bazell are "easily scared", Lei takes the advice of a genetic counselor (Ellen Matloff) and writes a sample letter for "Johnny" to open a discussion of his genetic test results with his family members. Will his parents be surprised to discover that he blames them for everything? Maybe someone should persuade Johnny's "parents" to write a reply.
Discrimination
Q&A with MDV’s Bill Ericson: On PacBio’s origin, why Gattaca isn’t our future, and throwing out your statins. David P Hamilton, VentureBeat: Life Sciences. 15 February 2008.
In this interview with Bill Ericson of Mohr Davidow Ventures, Hamilton asks: "What about the potential downsides, such as genetic discrimination that could leave many people uninsurable, or even the possibility that society could end up stratified by genetic caste, as in the movie Gattaca?" Ericson responds, in part, "I worried a lot about those negative implications when we started investing, but American society is, I think, mature enough to deal with the information, whether by legislation or via general social norms."
Rewarding Ignorance. Doug Masson, Masson's Blog – A Citizen's Guide to Indiana. 24 February 2008.
Doug Masson was among the many bloggers (including Steve Murphy and Sue Trinidad) responding to Amy Harmon's New York Times article "Insurance Fears Lead Many to Shun DNA Tests" (24 February 2008). After describing how the insurance industry needs a degree of "ignorance" to survive, Masson observes: "as our knowledge of a person’s likely health care profile increases, paying for medical treatment becomes less about managing risk through insurance and more about determining what our obligations might be toward our fellow humans in subsidizing their ability to live and/or remain healthy".
Bipolar Blood Test? Let The Bloodbath Begin. Philip Dawdy, Furious Seasons. 28 February 2008.
Dawdy, a patient, reacts to the latest research news about the search for psychiatric biomarkers. Research at Indiana University School of Medicine has isolated blood markers to identify mood disorders. Lead author, Alexander B. Niculescu III, M.D., Ph.D. (a future guest at our weekly PredictER meeting), hailed the research as "a major step towards bringing psychiatry on par with other medical specialties that have diagnostic tools to measure disease states and the effectiveness of treatments". If, however, a test is developed, Dawdy declares, "I am going nowhere near that test because its results--unless you do the test privately--will follow me the rest of my life and be used to discriminate against me and people like me in insurance (health and life), employment, schools, housing and God knows what all".
Health IT and Medical Records
Of Slelling and Men. Steve Murphy, Gene Sherpas: Personalized Medicine and You. 3 February 2008.
After defining "slelling" and recounting the scandals that have limited the possibility of selling health data without the explicit consent of patients, Murphy cites Emanuel EJ, Wendler D, and Grady C (2000) to summarize how "ethicists feel" about data acquisition in clinical research.
Engineering Grand Challenges – Advancing health informatics. Deepak Singh, bbgm. 19 February 2008.
In reviewing an article published on the National Academy of Engineering website, Deepak Singh notes that the technological challenges of health informatics are inseparable from some common ethical concerns. Singh's notes that "[w]hile the article refers to privacy and security, it does not address the issues of content ownership and data portability". Among the questions the Singh would like to see answered are: "Who owns someones medical data? How does it move from one system to another? What parts can a physician have access to? [And] what are the dangers of a system controlled by the user … [?]"
Google PHR roll-out: how personal will a personal health record be? David Harlow, HealthBlawg. 24 February 2008.
Although any news about Google's developing personal health records platform "Google Health" results in an avalanche of blog posts, David Harlow was among the rare bloggers to recognize and speculate about the medical research potential of these records. In reflecting on the privacy and HIPAA challenges that Google's personal health records may bring, Harlow remarks:
So let's assume the worst: Google will sell ads to the highest bidders for keywords in your PHR (kinda OK so long as there's adequate disclosure up front), will sell aggregated de-identified data for population-based health studies (ditto, but this seems more like a good thing, and is really at the heart of the value of EHRs and PHRs generally -- though the utility depends on how much data really finds its way into the PHR, and how it's organized) and worst of all, will mistakenly convert your PHR into an RSS feed that ends up on every computer in America (eek! . . . but is that worse than dropping a paper record behind a file cabinet and never finding it again?) … Every innovation comes with a set of benefits and burdens.
Politics
One gene, two genes; red genes, blue genes. Jesse Reynolds, Biopolitical Times. 14 February 2008.
Reynolds responds to an article published in New Scientist, "Two tribes: Are your genes left-wing or right-wing?" (2 February 2008). Following a critical assessment of the media coverage and a skeptical review of efforts to study the genetics of political attitudes and behavior, Reynolds identifies a potential "disturbing" social implication for such research: "accepting that genes determine political orientation could cause deepening political apathy … Heck, why bother voting when you could just have your cheek swabbed?"
Friday, February 8, 2008
Genetic Research - Up to the Task? Educating Health Care Providers
In lively exchanges between bloggers from Gene Sherpas, Genetic Future, and Venture Beat, the ethical implications of private genetic testing and personalized medicine were explored and a number of issues were spotted (see comments from Steve Murphy, David P. Hamilton, and Daniel MacArthur). I find Steve Murphy’s compelling suggestion that physicians in clinical practice lack the time and interest to provide thoughtful guidance to patients on genetic testing and test interpretation both relevant to PredictER's program and worth further assessment.
Like nearly every other academic medical center in the United States, Indiana University (PredictER's home) is interested in determining what a large scale predictive health study would look like. More clearly, researchers are asking: what needs to be in place for a large study to successfully combine genetic information along with other health data and biographical information? To be sure, it could serve as a platform for researchers in almost any biomedical research field, but more to Steve’s point, is it practical or possible to role out a study of this kind in clinics and doctors offices? Is there enough interest and enough time for a primary care doctor to attend to this new type of information?
If there's a deficit of interest and time, this is the moment in which the life sciences community should work to develop both. This not so much a disagreement with Steve’s suggestion as a statement about the ultimate goals of predictive health--there is no doubt that the clinical world of primary care is already pressured to the point of precluding physicians from developing new interests or allotting additional time in their schedules, but balance this fact with the knowledge that the outcomes of predictive health remain to be measured. As the prevalence and usage of these tests increases, so will the understanding of how they are being used and interpreted. So, while many are interested in fostering new research platforms to identify targets for new tests, others (including PredictER) are interested in laying a foundation of ethics outreach, education, and assessment to guide the realization of translational science and personalized medicine. One strategy might be to engage busy, primary care doctors with incentives to pursue relevant continuing medical education prior to initiating fully integrated predictive health projects. To do so, one would need a flexible, responsive curriculum (perhaps an online learning module) available for any physician whose patients are or might be enrolled in a predictive health research study ... but what would issues and subjects would such a curriculum need to address? Here are a few that leap to mind:
- Structure of Predictive Health Studies
A bank containing genetic samples and future research projects drawing on this
- Longitudinal research: from Framingham to today
- Impact on Practice in Primary Care
Personalized medicine: prevention, prognosis, pharmacogenetics
- Ethical Issues
Informed Consent
Vulnerable populations
Confidentiality
Recontacting patients
Withdrawal
Return of genetic information
Selling genetic information
I'd be interested to see how PredictER Blog's readers would change this list. What do primary care physicians need to know? Any ideas?
Like nearly every other academic medical center in the United States, Indiana University (PredictER's home) is interested in determining what a large scale predictive health study would look like. More clearly, researchers are asking: what needs to be in place for a large study to successfully combine genetic information along with other health data and biographical information? To be sure, it could serve as a platform for researchers in almost any biomedical research field, but more to Steve’s point, is it practical or possible to role out a study of this kind in clinics and doctors offices? Is there enough interest and enough time for a primary care doctor to attend to this new type of information?
If there's a deficit of interest and time, this is the moment in which the life sciences community should work to develop both. This not so much a disagreement with Steve’s suggestion as a statement about the ultimate goals of predictive health--there is no doubt that the clinical world of primary care is already pressured to the point of precluding physicians from developing new interests or allotting additional time in their schedules, but balance this fact with the knowledge that the outcomes of predictive health remain to be measured. As the prevalence and usage of these tests increases, so will the understanding of how they are being used and interpreted. So, while many are interested in fostering new research platforms to identify targets for new tests, others (including PredictER) are interested in laying a foundation of ethics outreach, education, and assessment to guide the realization of translational science and personalized medicine. One strategy might be to engage busy, primary care doctors with incentives to pursue relevant continuing medical education prior to initiating fully integrated predictive health projects. To do so, one would need a flexible, responsive curriculum (perhaps an online learning module) available for any physician whose patients are or might be enrolled in a predictive health research study ... but what would issues and subjects would such a curriculum need to address? Here are a few that leap to mind:
- Structure of Predictive Health Studies
A bank containing genetic samples and future research projects drawing on this
- Longitudinal research: from Framingham to today
- Impact on Practice in Primary Care
Personalized medicine: prevention, prognosis, pharmacogenetics
- Ethical Issues
Informed Consent
Vulnerable populations
Confidentiality
Recontacting patients
Withdrawal
Return of genetic information
Selling genetic information
I'd be interested to see how PredictER Blog's readers would change this list. What do primary care physicians need to know? Any ideas?
Wednesday, January 30, 2008
Predictive Health: Best Ethics Blogs - January 2008
This is the first in a series of monthly posts in which I share some of my favorite posts on the ethical, legal and social issues of predictive health research and medicine. A public and open discussion of these issues will increase the likelihood that individuals and communities will realize the benefits of advances in genetic and personalized medicine, human genome sequencing, predictive neuroimaging, biobanking, and health IT. PredictER Blog commends the following blogs for doing their part to inform and foster dialogue.
Listed by Topic and Date:
Biobanks
Biobanking and you. Sue Trinidad, Women's Bioethics Blog. 19 January 2008.
In the one of the first of what I hope will be long series, Sue Trinidad asks good questions about informed consent and reminds us that even "anonymized" DNA samples might be identifiers. She writes: "nothing is a more precise identifier of who you are than your so-called genetic fingerprint. Is this worrisome?"
Should genetic researchers be able to share your DNA? Sue Trinidad, Women's Bioethics Blog. 23 January 2008.
In her second post on ethical issues of genetic research and biobanks, Trinidad adds additional compelling questions, including: "If you'd consented to participate in that study at your local research university, how would you feel about your (de-identified) information being used by researchers somewhere else?" and "Say the researchers did [a] breast cancer study, and in the course of that work they noticed that there seemed to be a correlation between certain genetic patterns and alcoholism or schizophrenia. Would it be ok with you for them to pursue this line of inquiry using your genetic information?"
Consumer Genomics
American Society of Human Genetics (ASHG) Statement on Direct-to-Consumer Genetic Testing. Hsien-Hsien Lei, Eye on DNA. 2 January 2008.
Getting the month off to a good start, Hsien-Hsien Lei reviews the ASHG's policy statement [PMID: 18055737 excerpt] on Direct-to-Consumer Genetic Testing. Lei makes the following observation:"With increased competition in the field of direct-to-consumer personal genomics in 2008, I predict that only companies that can fully address the [ASHG] recommendations ... will survive .... Consumers are getting up to speed on what genetic testing can offer them and won’t settle for fuzzy, incomplete information."
Also see Lei's related posts on the subject, including: "The New England Journal of Medicine Gives Direct-to-Consumer Genome Scans Thumbs Down" (Eye on DNA, 10 January 2008).
Do I need a personal trainer or a personal genetic counsellor? Myles Axton, Free Association. 11 January 2008.In the editor's blog of the journal Nature Genetics, Myles Axton reviews the NEJM editorial “Letting the Genome out of the Bottle--will we get our wish?” (Hunter DJ, Khoury MJ, Drazen JM. N Engl J Med 2008; 358 (2):105-7. PMID:18184955 excerpt) Axton appreciates the skepticism and applauds "efforts to build genetics into every stage of medical education", but adds: "The authors have some good points, but largely ignore the unpredictable motivational potential inherent in handing people their genomes and asking them to participate in finding out more about their variation and phenotypes. Sometimes, the best doctor will say “we don’t know yet, let’s find out together”.
Privacy Issues
Your personal health: The internet and privacy. Deepak Singh, businessbytesgenesmolecules (bbgm). 2 January 2008.
Singh compares the success of Web 2.0, which relies, in part on "the forfeiture of privacy" to the rise of consumer genomics. Singh writes: "the moment you leave your footprint online, you are giving away some of your privacy. The moment you sign up for a genomic service, you are giving away some of your privacy. The question we need to answer is a simple one in a way. Is the benefit we get from being online, or getting yourself genotyped, worth the loss of privacy?" Singh has obviously traded some of his privacy for the benefits of Web 2.0; will he do the same for consumer genomics?
Respecting patient privacy preferences. John D. Halamka, Life as a Healthcare CIO. 21 January 2008.
Halamka is Chief Information Officer of CareGroup Health System and Harvard Medical School, a practicing Emergency Physician, a participant in the Personal Genome Project, and (among many more things) a vegan. Halamka writes: "One of the greatest challenges for healthcare information exchanges is to ensure continuity of care for patients while also respecting patient privacy preferences." He envisions a future in which electronic consent wizard will support a truly itemized process for sharing personal medical records and health data. Patients and research participants, might provide very specific consent statements, for example: "If I'm unconscious in an emergency room, share everything including mental health, substance abuse and HIV status data. If I'm visiting a Minuteclinic do not include my mental health and substance abuse history. If I'm sharing my data for a population-based research study, do not include my HIV status."
Whole Genome Sequencing
The ethical challenges of whole-genome sequencing part 1. Daniel MacArthur, Genetic Future. 22 January 2008.
In the first of a two(?) part post reviewing "Research ethics and the challenge of whole-genome sequencing" (McGuire AL, Caulfield T, Cho MK. Nat Rev Genet 2008; 9 (2):152-6. PMID:18087293), MacArthur summarizes advances in whole-genome sequencing technologies and evaluates the authors' comments on: the return of genome data to participants, the provision of clinical follow-up, and the integration of genome data and medical records. If you've read the NRG commentary, you'll be interested in this post; if you don't have a subscription to journal, you'll value MacArthur's outline of the issues. In his forthcoming part 2, MacArthur plans to "discuss the other major ethical challenges discussed in the NRG commentary: obligations to close relatives of study participants, and future uses of samples and data." Stay tuned! -J.O.
Listed by Topic and Date:
Biobanks
Biobanking and you. Sue Trinidad, Women's Bioethics Blog. 19 January 2008.
In the one of the first of what I hope will be long series, Sue Trinidad asks good questions about informed consent and reminds us that even "anonymized" DNA samples might be identifiers. She writes: "nothing is a more precise identifier of who you are than your so-called genetic fingerprint. Is this worrisome?"
Should genetic researchers be able to share your DNA? Sue Trinidad, Women's Bioethics Blog. 23 January 2008.
In her second post on ethical issues of genetic research and biobanks, Trinidad adds additional compelling questions, including: "If you'd consented to participate in that study at your local research university, how would you feel about your (de-identified) information being used by researchers somewhere else?" and "Say the researchers did [a] breast cancer study, and in the course of that work they noticed that there seemed to be a correlation between certain genetic patterns and alcoholism or schizophrenia. Would it be ok with you for them to pursue this line of inquiry using your genetic information?"
Consumer Genomics
American Society of Human Genetics (ASHG) Statement on Direct-to-Consumer Genetic Testing. Hsien-Hsien Lei, Eye on DNA. 2 January 2008.
Getting the month off to a good start, Hsien-Hsien Lei reviews the ASHG's policy statement [PMID: 18055737 excerpt] on Direct-to-Consumer Genetic Testing. Lei makes the following observation:"With increased competition in the field of direct-to-consumer personal genomics in 2008, I predict that only companies that can fully address the [ASHG] recommendations ... will survive .... Consumers are getting up to speed on what genetic testing can offer them and won’t settle for fuzzy, incomplete information."
Also see Lei's related posts on the subject, including: "The New England Journal of Medicine Gives Direct-to-Consumer Genome Scans Thumbs Down" (Eye on DNA, 10 January 2008).
Do I need a personal trainer or a personal genetic counsellor? Myles Axton, Free Association. 11 January 2008.In the editor's blog of the journal Nature Genetics, Myles Axton reviews the NEJM editorial “Letting the Genome out of the Bottle--will we get our wish?” (Hunter DJ, Khoury MJ, Drazen JM. N Engl J Med 2008; 358 (2):105-7. PMID:18184955 excerpt) Axton appreciates the skepticism and applauds "efforts to build genetics into every stage of medical education", but adds: "The authors have some good points, but largely ignore the unpredictable motivational potential inherent in handing people their genomes and asking them to participate in finding out more about their variation and phenotypes. Sometimes, the best doctor will say “we don’t know yet, let’s find out together”.
Privacy Issues
Your personal health: The internet and privacy. Deepak Singh, businessbytesgenesmolecules (bbgm). 2 January 2008.
Singh compares the success of Web 2.0, which relies, in part on "the forfeiture of privacy" to the rise of consumer genomics. Singh writes: "the moment you leave your footprint online, you are giving away some of your privacy. The moment you sign up for a genomic service, you are giving away some of your privacy. The question we need to answer is a simple one in a way. Is the benefit we get from being online, or getting yourself genotyped, worth the loss of privacy?" Singh has obviously traded some of his privacy for the benefits of Web 2.0; will he do the same for consumer genomics?
Respecting patient privacy preferences. John D. Halamka, Life as a Healthcare CIO. 21 January 2008.
Halamka is Chief Information Officer of CareGroup Health System and Harvard Medical School, a practicing Emergency Physician, a participant in the Personal Genome Project, and (among many more things) a vegan. Halamka writes: "One of the greatest challenges for healthcare information exchanges is to ensure continuity of care for patients while also respecting patient privacy preferences." He envisions a future in which electronic consent wizard will support a truly itemized process for sharing personal medical records and health data. Patients and research participants, might provide very specific consent statements, for example: "If I'm unconscious in an emergency room, share everything including mental health, substance abuse and HIV status data. If I'm visiting a Minuteclinic do not include my mental health and substance abuse history. If I'm sharing my data for a population-based research study, do not include my HIV status."
Whole Genome Sequencing
The ethical challenges of whole-genome sequencing part 1. Daniel MacArthur, Genetic Future. 22 January 2008.
In the first of a two(?) part post reviewing "Research ethics and the challenge of whole-genome sequencing" (McGuire AL, Caulfield T, Cho MK. Nat Rev Genet 2008; 9 (2):152-6. PMID:18087293), MacArthur summarizes advances in whole-genome sequencing technologies and evaluates the authors' comments on: the return of genome data to participants, the provision of clinical follow-up, and the integration of genome data and medical records. If you've read the NRG commentary, you'll be interested in this post; if you don't have a subscription to journal, you'll value MacArthur's outline of the issues. In his forthcoming part 2, MacArthur plans to "discuss the other major ethical challenges discussed in the NRG commentary: obligations to close relatives of study participants, and future uses of samples and data." Stay tuned! -J.O.
Friday, December 7, 2007
Genealogy, Genetic Medicine and Getting the Story Straight
What is the promise of personalized medicine and predictive health? Here's a rough description: physicians will know more about individual patients and will therefore be better equipped to provide care. But will it be so simple? In any field, the acquisition of more information, even accurate information, does not necessarily lead to successful application. So, let's say we all buy a test from 23andMe or deCode or Navigenics or any of the growing list of direct-to-consumer genomics company ... and we unpack every last bit and byte of our genetic data, will the world be a healthier place? Or, let's say, just a few of us fork over the $1000 to have our genomic fortunes told … are we really ready for the complications that this information may bring?
If the practice of genetic genealogy is any indication, the future of medicine in the genomic era will be suffused with complications. Nancy Berlinger, of Bioethics Forum, provides an engaging and insightful account of a few of these in "And I am Marie of Romania: Genetics, Genealogy, and the Ethics of Storytelling". Berlinger adds to the ongoing commentary on the new Henry Louis Gates, Jr. venture, AfricanDNA. Gates started this venture, in part, because of frustrations with inaccurate and misleading genetic genealogy results. As Berlinger writes, the misinterpretation (that Gates possesses a genetic link to those once living in the ancient North African kingdom of Nubia, and not, as it turns out, to a less impressive European "servant" in the American colonies) might have been the result of poor science, but also, might be attributed to "wish fulfillment on the part of geneticists and their clients".
To the Gates story, Berlinger contributes related accounts of individuals receiving, accurate, but potentially unwelcome, genealogical information. While America still struggles with its racist inheritance, individuals like Bliss Broyard struggle with new found genealogical information (see her new memoir, One Drop: My Father’s Hidden Life — A Story of Race and Family Secrets). Every one has family secrets--information we are not privy to at the moment--and (as Matt Mealiffe reminds us in Who's Your Daddy?) there's no reason to believe that all or even most of these secrets are about race. Clearly, genetic genealogy (as Blaine Bettinger often notes) is no simple task--will personalized, genetic medicine be any easier? Who will hold and who will expose the secrets in your genome? Is it possible, just maybe, that a one or two of the most enthusiastic, early adopters of personalized medicine will discover a few things they'll wish they'd never known? - J.O.
If the practice of genetic genealogy is any indication, the future of medicine in the genomic era will be suffused with complications. Nancy Berlinger, of Bioethics Forum, provides an engaging and insightful account of a few of these in "And I am Marie of Romania: Genetics, Genealogy, and the Ethics of Storytelling". Berlinger adds to the ongoing commentary on the new Henry Louis Gates, Jr. venture, AfricanDNA. Gates started this venture, in part, because of frustrations with inaccurate and misleading genetic genealogy results. As Berlinger writes, the misinterpretation (that Gates possesses a genetic link to those once living in the ancient North African kingdom of Nubia, and not, as it turns out, to a less impressive European "servant" in the American colonies) might have been the result of poor science, but also, might be attributed to "wish fulfillment on the part of geneticists and their clients".
To the Gates story, Berlinger contributes related accounts of individuals receiving, accurate, but potentially unwelcome, genealogical information. While America still struggles with its racist inheritance, individuals like Bliss Broyard struggle with new found genealogical information (see her new memoir, One Drop: My Father’s Hidden Life — A Story of Race and Family Secrets). Every one has family secrets--information we are not privy to at the moment--and (as Matt Mealiffe reminds us in Who's Your Daddy?) there's no reason to believe that all or even most of these secrets are about race. Clearly, genetic genealogy (as Blaine Bettinger often notes) is no simple task--will personalized, genetic medicine be any easier? Who will hold and who will expose the secrets in your genome? Is it possible, just maybe, that a one or two of the most enthusiastic, early adopters of personalized medicine will discover a few things they'll wish they'd never known? - 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, November 8, 2007
Predictive Health Research: What Isn't It?
If you're a regular reader of this blog, if you receive PredictER News Brief, if you have attended any PredictER event; you've probably encountered definitions of "predictive health research". But, let's pretend you're not a regular PredictER Blog reader; imagine that! You might wonder … What's the big deal; aren't all medical professionals predicting health outcomes? Isn't most medical research conducted with the hope of better predicting health outcomes? Well, you're not alone. These are questions I regularly entertain when updating PredictER's shared headlines (see the panel on the right) or when adding items to PredictER's del.icio.us and CiteULike accounts. In fact, two recent news items seemed to be begging to stretch the scope beyond the typically featured genetic and neuroimaging research. First, on the 30th of October, The Washington Post reported "Quality of Life Predicts Lung Cancer Survival". The story relays the news of recent cancer research findings and quotes the lead author, Dr. Nicos Nicolaou of the
"In the past, we've considered the stage of disease or tumor size along with other empirical data to predict how long a patient will survive, but now we know quality of life is a critical factor in determining survival".
The second story, also relaying research news on "survival" factors, appeared Wednesday in MedPage Today: "Mathematical Index Simplifies Survival Prediction After Liver Grafts". In the November 7th report, Judith Groch writes:
The researchers [Michael L. Volk and colleagues at the
Sounds "predictive" to me, but is it relevant to PredictER? I can't say "no", but I have to admit that PredictER Blog has focused on research emphasizing long-term prediction … tests and methods revealing disease years (if not decades) prior to the onset of symptoms. This "predictive" research often requires the latest developments in research knowledge and technology; it also introduces a new emphasis on some familiar ethical and social issues. When research requires biobanks and databases for the collection of tissue samples and genetic data for potentially long-term and unexpected use, the task of assuring subject privacy, dignity, and autonomy faces new challenges. These challenges are multiplied when biobanks are coupled with longitudinal access to personal medical records. Thus, while reserving the opportunity to be inclusive, the interests of PredictER Blog can be distinguished from the "predictive" aspects of all biomedical research (exemplified by the Nicolaou and Volk studies) by a measure of degrees. PredictER Blog is interested in research aims marked by dramatic increase in the power and accuracy of health "prediction", the requisite ethical protections, and the much anticipated benefits ... a more personal "personalized medicine".
Related research:
Volk ML, Hernandez JC, Lok AS,
Nicolaou N, Moughan J, Sarna L, Langer C, Werner-Wasik M, Komaki R, Machtay M, Wasserman T, Bruner D, Movsas B. 2007. Quality of Life (QOL) Supercedes the Classic Predictors of Survival in Locally Advanced Non-Small Cell Lung Cancer (NSCLC): An Analysis of Radiation Therapy Oncology Group (RTOG) 9801. International Journal of Radiation Oncology, Biology, Physics. Volume 69, Issue 3, Pages S58-S59. [doi:10.1016/j.ijrobp.2007.07.107]
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
Monday, September 10, 2007
Predicitive Health & Medical Education: Lost in Translation
When reflecting upon the greatest medical advancements in the last fifty years of medicine, certain broad and worthy categories come to mind. Imaging technology, drug design, and minimally invasive surgery have made great changes in how patients are treated. As a fourth year medical student, I routinely request a CT, suggest a regimen of Gleevac, or recommend a laproscopic procedure. All of these advances have made waves in the practice of medicine, public expectations, and medical education. Predictive health research, however, has not yet fully entered the medical school curriculum.
I doubt whether there is a single undergraduate who gains acceptance to medical school who cannot identify the names Watson or Crick or explain the basic function of DNA. By now, most students are also aware of the recent completion and publication of J. Craig Venter’s genome. Nevertheless, discussions with my peers suggest that medical students may not be fully prepared for the medical and ethical implications of recent genetic research. Predictive health research discoveries are taught, but the potential clinical applications are lost in translation--stuck somewhere on the path from the bench to the bedside . . . or, in my case, from the pages of the textbook to the patient.
For my generation of medical students, predictive health research has the potential to significantly change the practice of medicine. While programs like the Personal Genetics Education Project at Harvard are building interest in predictive health, and while the public is flooded by a confusing array of genetics news reports, what are medical schools doing to prepare future physicians for the predictive health revolution?
Medical students and educators should step up their efforts to join the conversation about the clinical promise and ethical issues of predictive health. We need to start thinking and talking about how we make use of the predictive tools we already have and how we will prepare for future tools. For example, how many of us are ready to explain to new parents the meaning of normal newborn screening results? Are we fully prepared to share the non-watered-down reasons for why we may want a fifty-year old man to get a colonoscopy? Are we ready to address the anxieties of a patient considering a genetic test to better determine her risk of breast cancer? Clearly, students and bloggers like Bertalan Meskó at ScienceRoll are doing their share to spread the word, but we should encourage our mentors and professors to join the discussion. What is the current state of predictive health, and where can we expect it to advance?
[Note: To encourage a public discussion of the ethical, legal and social implications of predictive health research, PredictER Blog will be inviting guest contributions from students, professionals, and interested members of the public. This post from Pat Barrett, a fourth year medical student at the Indiana University School of Medicine and a graduate student of the Indiana University School of Philosophy, is a fitting introduction to this new feature of PredictER Blog. -- J.O.]
I doubt whether there is a single undergraduate who gains acceptance to medical school who cannot identify the names Watson or Crick or explain the basic function of DNA. By now, most students are also aware of the recent completion and publication of J. Craig Venter’s genome. Nevertheless, discussions with my peers suggest that medical students may not be fully prepared for the medical and ethical implications of recent genetic research. Predictive health research discoveries are taught, but the potential clinical applications are lost in translation--stuck somewhere on the path from the bench to the bedside . . . or, in my case, from the pages of the textbook to the patient.
For my generation of medical students, predictive health research has the potential to significantly change the practice of medicine. While programs like the Personal Genetics Education Project at Harvard are building interest in predictive health, and while the public is flooded by a confusing array of genetics news reports, what are medical schools doing to prepare future physicians for the predictive health revolution?
Medical students and educators should step up their efforts to join the conversation about the clinical promise and ethical issues of predictive health. We need to start thinking and talking about how we make use of the predictive tools we already have and how we will prepare for future tools. For example, how many of us are ready to explain to new parents the meaning of normal newborn screening results? Are we fully prepared to share the non-watered-down reasons for why we may want a fifty-year old man to get a colonoscopy? Are we ready to address the anxieties of a patient considering a genetic test to better determine her risk of breast cancer? Clearly, students and bloggers like Bertalan Meskó at ScienceRoll are doing their share to spread the word, but we should encourage our mentors and professors to join the discussion. What is the current state of predictive health, and where can we expect it to advance?
[Note: To encourage a public discussion of the ethical, legal and social implications of predictive health research, PredictER Blog will be inviting guest contributions from students, professionals, and interested members of the public. This post from Pat Barrett, a fourth year medical student at the Indiana University School of Medicine and a graduate student of the Indiana University School of Philosophy, is a fitting introduction to this new feature of PredictER Blog. -- J.O.]
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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