California and Direct-to-Consumer Genetic Testing:
California's decision to send cease-and-desist letters to thirteen direct-to-consumer genetic testing companies (including 23andME, deCODEme, Knome, and Navigenics) ignited a blogging wild-fire of mostly outraged responses. Some of the more widely read expressions of protest were blogged at Wired Science and include Thomas Goetz's much-echoed Attention, California Health Dept.: My DNA Is My Data (17 June 2008). For an alternative reaction see Steve Murphy's posts on the topic at Gene Sherpa, which include: Do you hear that sound Mr Anderson? (15 June 2008), A$$ Kicking (17 June 2008), and R'Uh-R'Oh Shaggy!!! (17 June 2008). Although many of the replies to Murphy's posts offer only more expressions of outrage, Daniel MacArthur at Genetic Future engages Murphy in a thoughtful exchange beginning with California cracks down on genetic testing companies (15 June 2008) and Cat-fight over California (18 June 2008). Finally, for a good overview of the news and blogging on the subject, see Blaine Bettinger's recent post The Genetic Mess in California - A Round-Up, and My Thoughts (30 June 2008) at The Genetic Genealogist.
Employee Wellness
Matt Mealiffe of DNA and You writes in response to the news that Japan will require companies and local governments to "measure the waistlines of Japanese people between the ages of 40 and 74 as part of their annual checkups" with the standard of "33.5 inches for men and 35.4 inches for women" (see Norimitsu Onishi, Japan, Seeking Trim Waists, Measures Millions. The New York Times. 13 June 2008). In Mealiffe's assessment (14 June 2008), mandatory waistline measurement is "bold social policy" which may be, however, genetic discrimination.
In an unrelated post on a similar topic, Jane Sarasohn-Kahn of Health Populi reports employee attitudes regarding the privacy risks of employers' wellness programs. Writing in Is worker wellness a privacy issue? (5 June 2008), Sarasohn-Kahn summarizes the findings of a recent report: "Employees are concerned that this information could be used to reduce benefits or for even more egregious purposes". An overview of the findings, "Health and Wellness: the shift from managing illness to promoting health" is available from the Center for Studying Health System Change [PDF].
Law & Policy
Andrew W. Torrance of BioLaw: Law and the Life Sciences reflects on the sometimes presumed amoral status of patent law in U.S. – a status that is not presumed in Europe. In Patently Immoral Genes (2 June 2008), Torrance shares the recent, related work of the European Society of Human Genetics ("ESHG") which "has issued recommendations that would severely limit patents on genes in the European Patent Office (EPO) and member states of the EPC." According to Torrance, "the ESHG recommends that the EPO establish an 'ethics committee' to police the patentability of controversial technological innovations". He believes that this news may be of interest to policy makers in the States, including: California Democrat, Xavier Becerra, a sponsor of the "Genomic Research and Accessibility Act" (H.R.-977 – Thomas | GovTrack.us).
Nick Agar writes at What Sorts of People on a report by The Bioethics Council of New Zealand on the completion of its program Who gets born? Pre-birth testing. The report responds to the New Zealand government's decision to fund pre-implantation genetic diagnosis for couples with a high risk of conceiving a child with a genetic disorder. In NZ bioethics council (27 June 2008), Agar notes that "the emphasis is very much on facilitating parental choice, with health professionals given the role of supplying parents with the information they need to make choices consistent with their values". He observes that the Council made a deliberate effort to solicit participation from a wide range of "interested parties", but cautions that there may be "a bit of fallacy of bureaucratic representativeness here – if a committee’s composition approximately matches the representation of various communities in the general population then its pronouncements must be representative of the viewpoints of those different communities".
Personalized Medicine
Reflecting, in part, on the prevalence of "Personalize Medicine" in the recent 2008 BIO Convention, Jennifer Miller at Bioethics International defines the topic and introduces some of the ethical and legal issues. She identifies six ethical issues in Personalized medicine: an introduction, its promises and the ethics (26 June 2008):
(1) just access to, allocation and application of the new technologies, (2) privacy concerns, (3) respecting parties’ autonomy, (4) obtaining quality informed consents, (5) intellectual property rights, particularly in connection with bio-banking, (6) overall resource allocation and prioritization questions ….
Reviews
Bonnie Green, writing for BioethicsBytes (17 June 2008), reviews "An Adventure into Ourselves", the third episode of a four-part television series entitled DNA: The Human Race (Channel 4, 2003). [BioethicsBytes hosts and reviews resources for ethics education. The project aims "to assist in the teaching of bioethics, with particular emphasis on multimedia materials (film, TV, streamed media) as case studies".] Green's thorough review of "An Adventure into Ourselves" marks interesting quotations and highlights the social and political context of the Human Genome Project (HGP). She observes that the series and the episode form "an excellent basis for teaching both the science and bioethics of the HGP and large scale sociotechnical projects". The post also includes YouTube footage from related programming about the X-Prize.
Writing for Gene Expression, "Herrick" reviews Heredity and Hope: The Case for Genetic Screening, by Ruth Schwartz Cowan (Harvard University Press: 2008. 270 pp. $27.95, £18.95). This blogger points to three aspects of Cowan's book on genetic screening. In Heredity and Hope by Ruth Schwartz Cowan (11 June 2008), "Herrick" observes that Cowan distinguishes contemporary genetic medicine from mid-20th century eugenics by 1) showing that "genetic screening is a bottom-up social phenomenon, not a top-down mandate", 2) highlighting the "pro-natalist" aspects of contemporary genetic screening, and 3) sharing happy-ending stories about the proper use of this technology. In conclusion, "Herrick" observes:
Functionally, Cowan does the same thing for genetic screening that The New Republic did for tough-on-crime policies in the 80's and 90's: Cowan does some liberal hand-wringing while telling the reader that no, you're not becoming a Brownshirt if you agree to an amnio.
Showing posts with label blogs. Show all posts
Showing posts with label blogs. Show all posts
Monday, June 30, 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.
Wednesday, May 7, 2008
One Year of PredictER Blog
PredictER Blog turns one today! To mark the date, here is a list of the 10 most popular posts:
1. HIPSA: The Health Information Privacy and Security Act of 2007 - Thursday, July 19, 2007
2. Texas: Your Boss, Your Medical Records and the Information Economy - Saturday, March 22, 2008
3. Get Your Genetic Test Results Online and Who Needs a Physician? – Katherine Drabiak, Thursday, November 15, 2007
4. Predictive Health Legislative Update: GINA, HIPSA and more ... - Monday, December 17, 2007
5. Smith-Lemli-Opitz Syndrome and a Florida “Wrongful Birth” Case - Wednesday, July 25, 2007
6. Biomedical Research Ethics 2.0: MySpace and Pediatrics - Tuesday, January 8, 2008
7. Minnesota and Genetic Privacy: Why the Rule of Law is Good for Research – Katherine Drabiak, Wednesday, September 26, 2007
8. Navigenics Enters Personal Genomics Game ... Meanwhile: "What's a SNP?" – Katie Carr, Wednesday, April 16, 2008
9. Health Risk Assessments in the Workplace: Clarian Health, Indianapolis. - Sunday, August 19, 2007
10. Newborn Screening: An Update on Minnesota – Katherine Drabiak, Friday, November 16, 2007
1. HIPSA: The Health Information Privacy and Security Act of 2007 - Thursday, July 19, 2007
2. Texas: Your Boss, Your Medical Records and the Information Economy - Saturday, March 22, 2008
3. Get Your Genetic Test Results Online and Who Needs a Physician? – Katherine Drabiak, Thursday, November 15, 2007
4. Predictive Health Legislative Update: GINA, HIPSA and more ... - Monday, December 17, 2007
5. Smith-Lemli-Opitz Syndrome and a Florida “Wrongful Birth” Case - Wednesday, July 25, 2007
6. Biomedical Research Ethics 2.0: MySpace and Pediatrics - Tuesday, January 8, 2008
7. Minnesota and Genetic Privacy: Why the Rule of Law is Good for Research – Katherine Drabiak, Wednesday, September 26, 2007
8. Navigenics Enters Personal Genomics Game ... Meanwhile: "What's a SNP?" – Katie Carr, Wednesday, April 16, 2008
9. Health Risk Assessments in the Workplace: Clarian Health, Indianapolis. - Sunday, August 19, 2007
10. Newborn Screening: An Update on Minnesota – Katherine Drabiak, Friday, November 16, 2007
Wednesday, April 30, 2008
Predictive Health: Best Ethics Blogs - April, 2008
This issue of the "best" predictive health ethics blogs includes entries on education, eugenics, genetic counseling, genetic testing, personal genomes and privacy.
Education
More on the need for science education. Sue Trinidad, Women's Bioethics Blog. 11 April 2008.
How will tomorrow's voters make informed decisions about the predictive health research and medicine. Sue Trinidad looks at the results of a recent evaluation (see: PMID: 18245328) of submissions to the DNA Day essay contest for high school students; the forecast is not good. After reading comments like:
Genetics create a perfect being. Change the genes. Make that child perfect. There's no better solution to an impending health care crisis. … What we can have is a sea of people who all look brilliant, who are all smart and who all have perfect eyes, nose and lips. It's a perfect society, what more could we want?
Trinidad calls for improved K-12 science education:
[T]hese are the responses of students who were willing to participate in an essay contest about genetics. What must be the level of understanding among those who wouldn't bother? Clearly, CLEARLY, we need to do a better job of K-12 science education.
Eugenics?
Genetic DisEnhancement -- Does reproductive autonomy extend to choosing a disability? Linda MacDonald Glenn, Women's Bioethics Blog. 13 April 2008.
Following the recent news from the UK that the government will remove references to deafness from the proposed Human Fertilisation and Embryology Bill, a decision that will permit couples to use preimplantation genetic diagnosis to select a child with congenital deafness, Glenn questions the broader implications of the decision:
My concern about removing the clause banning the creation of disabled children entirely, is why stop at deafness? Aren't the primary purposes of medicine to heal, to cure diseases, restore, and alleviate suffering? … So the question is how far does reproductive autonomy go? Nobody wants to see a fellow human being struggle or suffer, especially in the name of 'reproductive autonomy.'
Whose Normality? D. Joy Riley, bioethics.com. 17 April 2008.
After reading that a economically disadvantaged couple in India accepted a child with Craniofacial Duplication as potentially a reincarnated deity, Riley wonders about Western notions of "normal" in the context of prenatal genetic diagnosis. Riley is alarmed by the concept that prenatal screening for Huntington's Disease "could eliminate this entire population!" The author asks:
Who defines ‘normal’? Is normal equal to “without disease or abnormality”? If so, when? Is normal to be born without disease, or to be born with no disease or disorder present at birth, AND no genes for known disorders that will develop later in life, like breast cancer, familial polyposis of the colon, or Huntington’s Disease?
Genetic Counseling
Now this is why we need genetic counselors. SciPhu. 25 April 2008.
After writing (in an earlier post) that reliable predictive testing may render the job the genetic counselor obsolete, the author of SciPhu reads a paper by lead author Kimberly Quaid (a PredictER team member). SciPhu calls the experience "eye-opening". When it comes to "high risk tests", such as a test for Huntington's Disease, SciPhu concludes:
The final take home message must be that not testing for a condition has significant value, especially when treatment options are scarce or non-existent. … Hope is sometimes a life saver. Knowledge on the other hand, can put peoples lives in ruins.
Genetic Testing
Over-regulation. Steve Murphy, Gene Sherpas: Personalized Medicine and You. 8 April 2008.
In this "follow-the-money" assessment of genomic medicine, Murphy points to the disproportionate influence of the business sector: "Genomic Medicine is being driven by business. Why? Because academia has failed to take the bull by the horns. Why? They are comfortable in their own realm. This is a stretch for them." In Murphy's view, while business sees potential money in testing, less emphasis is placed on genetic counseling and other genetic services. In the long run, however, this lop-sided approach may hurt the life sciences industry. Murphy cautions that the direct-to-consumer genetic testing push may be annoying all the wrong people—some of the big names on the beltway: "AMA, ACP, SACGHS, FDA, CMS, GAO, US Senate, Department of HHS, FTC, ACMG, NHGRI..." In other words, "over regulation" may be on the way.
The gap is widening on genetic testing, too. Ricki Lewis, blog.bioethics.net. 14 April 2008.
Following a post on the widening gap between public perceptions and the reality of the current state of the art in stem cell science, Ricki Lewis writes on a similar gap in the genetic testing industry. Lewis warns that whole-genome association tests may not be ready for the consumer market:
The truth is, and the direct-to-consumer company websites actually say so in the fine print ... Consumers may not be aware of these limitations, nor realize that “link,” “marker,” and “association,” have precise scientific meanings.
After reciting the disclaimers, Lewis doubts the services provided by 23andMe, Navigenics, and deCODEme are legitimately non-medical and asserts:
It isn’t ethical to market DNA tests based on whole genome population-based studies without randomized, controlled clinical trials, replication, and validation. ... Whether considering stem cells or DNA tests, that’s simply the way that good medical science is done.
The Ethics of Genetic Testing. William Martin, Free and Wandering Thought. 18 April 2008.
After reporting his less than stellar performance on a recent "biopsych test", Martin shares a few free thoughts on the ethics of genetic testing for diseases like Huntington's and Bipolar disorder. Martin worries about where our society will draw the lines for the appropriate use of genetic information. Like many, he anticipates that trouble in the insurance industry and asks:
"What happens when insurance companies find out you are XX% likely to develop a disease?"
With this in mind, Martin applauds Paul Wellstone's drafted "Mental Health and Addiction Equity Act", which, as Martin reports, might have some impact on how insurance companies will (or will not) use genetic information to determine coverage for mental health disorders.
Personal Genomes and the Bioscience Industry
The Personal Genome discussion. Sandra Porter, Discovering Biology in a Digital World. 24 April 2008.
Porter provides a summary of panel discussion at the University of Washington. At the event Bill Gates, Eric Lander, Maynard Olson, Leena Peltonen, and George Church fielded questions from the audience about the personal genomics revolution. Porter summarizes responses to some really interesting questions, including:
Should people be given information about genes that are related to diseases if there's nothing that can be done?
What are options for the personal genome to benefit third world populations?
How will personal genomics affect privacy?
Are we going to make designer babies?
Also see Deepak Singh's thoughts on the discussion at bbgm.
Personal Genomics Takes a Bashing on Physician Oversight, Financial Backing, and Privacy. Hsien-Hsien Lei, Eye on DNA. 21 April 2008.
Lei reviews the "snarky" news coverage of the consumer genomics industry published in Forbes and BusinessWeek. While Forbes reports that New York's State Department of Health has sent threatening letters to some direct-to-consumer genetic testing companies ("jail-time"!), BusinessWeek focuses on Google's role in supporting the industry. Lei concludes: "If anyone ever organizes a biosciences startup school, they need to put regulatory affairs, investment choices, and privacy concerns on the syllabus!"
Privacy
A new model for genetic privacy: you don't have any. Daniel MacArthur, Genetic Future. 20 April 2008.
After perusing a perspective piece in Nature Reviews Genetics, MacArthur notes that the authors call for a paradigm shift in the approach to research subject privacy, he comments: "Essentially, they argue that 'the reality of the new genetics and genomics urges us to abandon the traditional concept of medical confidentiality …'." In MacArthur's assessment, the authors:
[A]rgue for a strategy of "maximizing data protection while informing people about its limits". In other words, doing your best to limit disclosure of individual health data, while clearly informing participants of the fact that their privacy can't be guaranteed.
Although he sees the value to the science and acknowledges the risk to privacy, MacArthur wonders how these changes might influence the future of human subjects research:
[W]ill such a policy discourage people with a clear family history of genetic disease from participating in large-scale cohort studies (for insurance reasons), thus reducing the power of such studies to detect disease-associated variants? Will it create a generation gap in research participation, with conservative older people shunning studies while the children of the Facebook era - who engage in public disclosure of information with a willfulness that seems shocking to their elders - embrace participation?
Education
More on the need for science education. Sue Trinidad, Women's Bioethics Blog. 11 April 2008.
How will tomorrow's voters make informed decisions about the predictive health research and medicine. Sue Trinidad looks at the results of a recent evaluation (see: PMID: 18245328) of submissions to the DNA Day essay contest for high school students; the forecast is not good. After reading comments like:
Genetics create a perfect being. Change the genes. Make that child perfect. There's no better solution to an impending health care crisis. … What we can have is a sea of people who all look brilliant, who are all smart and who all have perfect eyes, nose and lips. It's a perfect society, what more could we want?
Trinidad calls for improved K-12 science education:
[T]hese are the responses of students who were willing to participate in an essay contest about genetics. What must be the level of understanding among those who wouldn't bother? Clearly, CLEARLY, we need to do a better job of K-12 science education.
Eugenics?
Genetic DisEnhancement -- Does reproductive autonomy extend to choosing a disability? Linda MacDonald Glenn, Women's Bioethics Blog. 13 April 2008.
Following the recent news from the UK that the government will remove references to deafness from the proposed Human Fertilisation and Embryology Bill, a decision that will permit couples to use preimplantation genetic diagnosis to select a child with congenital deafness, Glenn questions the broader implications of the decision:
My concern about removing the clause banning the creation of disabled children entirely, is why stop at deafness? Aren't the primary purposes of medicine to heal, to cure diseases, restore, and alleviate suffering? … So the question is how far does reproductive autonomy go? Nobody wants to see a fellow human being struggle or suffer, especially in the name of 'reproductive autonomy.'
Whose Normality? D. Joy Riley, bioethics.com. 17 April 2008.
After reading that a economically disadvantaged couple in India accepted a child with Craniofacial Duplication as potentially a reincarnated deity, Riley wonders about Western notions of "normal" in the context of prenatal genetic diagnosis. Riley is alarmed by the concept that prenatal screening for Huntington's Disease "could eliminate this entire population!" The author asks:
Who defines ‘normal’? Is normal equal to “without disease or abnormality”? If so, when? Is normal to be born without disease, or to be born with no disease or disorder present at birth, AND no genes for known disorders that will develop later in life, like breast cancer, familial polyposis of the colon, or Huntington’s Disease?
Genetic Counseling
Now this is why we need genetic counselors. SciPhu. 25 April 2008.
After writing (in an earlier post) that reliable predictive testing may render the job the genetic counselor obsolete, the author of SciPhu reads a paper by lead author Kimberly Quaid (a PredictER team member). SciPhu calls the experience "eye-opening". When it comes to "high risk tests", such as a test for Huntington's Disease, SciPhu concludes:
The final take home message must be that not testing for a condition has significant value, especially when treatment options are scarce or non-existent. … Hope is sometimes a life saver. Knowledge on the other hand, can put peoples lives in ruins.
Genetic Testing
Over-regulation. Steve Murphy, Gene Sherpas: Personalized Medicine and You. 8 April 2008.
In this "follow-the-money" assessment of genomic medicine, Murphy points to the disproportionate influence of the business sector: "Genomic Medicine is being driven by business. Why? Because academia has failed to take the bull by the horns. Why? They are comfortable in their own realm. This is a stretch for them." In Murphy's view, while business sees potential money in testing, less emphasis is placed on genetic counseling and other genetic services. In the long run, however, this lop-sided approach may hurt the life sciences industry. Murphy cautions that the direct-to-consumer genetic testing push may be annoying all the wrong people—some of the big names on the beltway: "AMA, ACP, SACGHS, FDA, CMS, GAO, US Senate, Department of HHS, FTC, ACMG, NHGRI..." In other words, "over regulation" may be on the way.
The gap is widening on genetic testing, too. Ricki Lewis, blog.bioethics.net. 14 April 2008.
Following a post on the widening gap between public perceptions and the reality of the current state of the art in stem cell science, Ricki Lewis writes on a similar gap in the genetic testing industry. Lewis warns that whole-genome association tests may not be ready for the consumer market:
The truth is, and the direct-to-consumer company websites actually say so in the fine print ... Consumers may not be aware of these limitations, nor realize that “link,” “marker,” and “association,” have precise scientific meanings.
After reciting the disclaimers, Lewis doubts the services provided by 23andMe, Navigenics, and deCODEme are legitimately non-medical and asserts:
It isn’t ethical to market DNA tests based on whole genome population-based studies without randomized, controlled clinical trials, replication, and validation. ... Whether considering stem cells or DNA tests, that’s simply the way that good medical science is done.
The Ethics of Genetic Testing. William Martin, Free and Wandering Thought. 18 April 2008.
After reporting his less than stellar performance on a recent "biopsych test", Martin shares a few free thoughts on the ethics of genetic testing for diseases like Huntington's and Bipolar disorder. Martin worries about where our society will draw the lines for the appropriate use of genetic information. Like many, he anticipates that trouble in the insurance industry and asks:
"What happens when insurance companies find out you are XX% likely to develop a disease?"
With this in mind, Martin applauds Paul Wellstone's drafted "Mental Health and Addiction Equity Act", which, as Martin reports, might have some impact on how insurance companies will (or will not) use genetic information to determine coverage for mental health disorders.
Personal Genomes and the Bioscience Industry
The Personal Genome discussion. Sandra Porter, Discovering Biology in a Digital World. 24 April 2008.
Porter provides a summary of panel discussion at the University of Washington. At the event Bill Gates, Eric Lander, Maynard Olson, Leena Peltonen, and George Church fielded questions from the audience about the personal genomics revolution. Porter summarizes responses to some really interesting questions, including:
Should people be given information about genes that are related to diseases if there's nothing that can be done?
What are options for the personal genome to benefit third world populations?
How will personal genomics affect privacy?
Are we going to make designer babies?
Also see Deepak Singh's thoughts on the discussion at bbgm.
Personal Genomics Takes a Bashing on Physician Oversight, Financial Backing, and Privacy. Hsien-Hsien Lei, Eye on DNA. 21 April 2008.
Lei reviews the "snarky" news coverage of the consumer genomics industry published in Forbes and BusinessWeek. While Forbes reports that New York's State Department of Health has sent threatening letters to some direct-to-consumer genetic testing companies ("jail-time"!), BusinessWeek focuses on Google's role in supporting the industry. Lei concludes: "If anyone ever organizes a biosciences startup school, they need to put regulatory affairs, investment choices, and privacy concerns on the syllabus!"
Privacy
A new model for genetic privacy: you don't have any. Daniel MacArthur, Genetic Future. 20 April 2008.
After perusing a perspective piece in Nature Reviews Genetics, MacArthur notes that the authors call for a paradigm shift in the approach to research subject privacy, he comments: "Essentially, they argue that 'the reality of the new genetics and genomics urges us to abandon the traditional concept of medical confidentiality …'." In MacArthur's assessment, the authors:
[A]rgue for a strategy of "maximizing data protection while informing people about its limits". In other words, doing your best to limit disclosure of individual health data, while clearly informing participants of the fact that their privacy can't be guaranteed.
Although he sees the value to the science and acknowledges the risk to privacy, MacArthur wonders how these changes might influence the future of human subjects research:
[W]ill such a policy discourage people with a clear family history of genetic disease from participating in large-scale cohort studies (for insurance reasons), thus reducing the power of such studies to detect disease-associated variants? Will it create a generation gap in research participation, with conservative older people shunning studies while the children of the Facebook era - who engage in public disclosure of information with a willfulness that seems shocking to their elders - embrace participation?
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?"
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.
Sunday, August 5, 2007
PredictER Blog on Break This Week
Readers,
PredictER Blog will not post during the week of August 5. If you are interested in other blogs on bioethics, genetics research, predictive and personalized medicine, visit PredictER's Blog Roll:
Adaptive Complexity
blog.bioethics.net
The Daily Transcript
Eye on DNA
Gene Expression
The Genetic Genealogist
The Personal Genome
Philosophy and Bioethics
ScienceRoll
Tuesday, July 31, 2007
Web 2.0 + Medicine = Medicine 2.0: Featured Blogs
ScienceRoll and Medicine 2.0
Readers interested in casual discussions on the future of medicine at the cross-roads of genetics research, electronic medical records, and the internet will find plenty to read in recent blog entries using the terms "Medicine 2.0" or "Health 2.0". Advocates of the subject, include Bertalan Meskó, a medical student at the University of Debrecen (Hungary). Meskó, who monitors and writes about the topic in his blog ScienceRoll, holds that "the new generation of web services, will [play] (and already is playing) ... an important role in the future of medicine. These web tools, expert-based community sites, medical blogs and wikis can ease the work of physicians, scientists, medical students [and] ... medical librarians". In addition to regular posts on his blog, Meskó also edits a weekly blog carnival (an index or review of blog entries) on the subject, entitled Medicine 2.0. Mesko's ScienceRoll also contributes entries on genomics, clinical genetics, genetic testing, and personalized medicine.
"Medical Ethics 2.0"
Science Roll, July 19, 2007 and Medicine 2.0, hosted recently by J.C. Jones at HealthLine Connect were among several blogs citing "Medical Ethics 2.0", published July 16th by Jason Bobe at The Personal Genome . [Others citing Bobe include: Philosophy and Bioethics and The CEP Library.] Bobe discusses the possibility that future users of online genealogy services may begin to add medical information to their family trees. Following his review of the BMJ “Head-to-Head” feature: “Should families own genetic information?” [BMJ 2007;335:22 (7 July), doi:10.1136/bmj.39252.386030], he questions how user-generated genetic information and Web 2.0 technologies would complicate the ethical problems of privacy and disclosure.
Medical Ethics 3.0?
In "Health care eyes Web 3.0" (Government Health IT, 16 July 2006), Brian Robinson reports on developing Semantic Web technologies and their anticipated impact on the medical formatics and health care provision. The Semantic Web uses Resource Description Framework (RDF), Web Ontology Language, and other ontologies to "ascribe meaning to data depending on the context in which it is used". The Semantic Web is expected to provide, for example, the ability to "identify data related to age, weight and diseases, and ... then deliver that data based on the context of a query". Projects in development include: rules-based diagnostic decision-support systems for Partners HealthCare System (Boston) and a public health surveillance system under the direction of Parsa Mirhaji at the University of Texas Health Science Center at Houston.
In addition to Mirhaji, comments are provided from Dean Giustini (Biomedical Branch Library, University of British Columbia), Vipul Kashyap (Partners HealthCare), and Bob Shimp (Oracle's Global Technology Business Unit). The story does not, however, explore the social and ethical implications of the Semantic Web for medical research.
Readers interested in casual discussions on the future of medicine at the cross-roads of genetics research, electronic medical records, and the internet will find plenty to read in recent blog entries using the terms "Medicine 2.0" or "Health 2.0". Advocates of the subject, include Bertalan Meskó, a medical student at the University of Debrecen (Hungary). Meskó, who monitors and writes about the topic in his blog ScienceRoll, holds that "the new generation of web services, will [play] (and already is playing) ... an important role in the future of medicine. These web tools, expert-based community sites, medical blogs and wikis can ease the work of physicians, scientists, medical students [and] ... medical librarians". In addition to regular posts on his blog, Meskó also edits a weekly blog carnival (an index or review of blog entries) on the subject, entitled Medicine 2.0. Mesko's ScienceRoll also contributes entries on genomics, clinical genetics, genetic testing, and personalized medicine.
"Medical Ethics 2.0"
Science Roll, July 19, 2007 and Medicine 2.0, hosted recently by J.C. Jones at HealthLine Connect were among several blogs citing "Medical Ethics 2.0", published July 16th by Jason Bobe at The Personal Genome . [Others citing Bobe include: Philosophy and Bioethics and The CEP Library.] Bobe discusses the possibility that future users of online genealogy services may begin to add medical information to their family trees. Following his review of the BMJ “Head-to-Head” feature: “Should families own genetic information?” [BMJ 2007;335:22 (7 July), doi:10.1136/bmj.39252.386030], he questions how user-generated genetic information and Web 2.0 technologies would complicate the ethical problems of privacy and disclosure.
Medical Ethics 3.0?
In "Health care eyes Web 3.0" (Government Health IT, 16 July 2006), Brian Robinson reports on developing Semantic Web technologies and their anticipated impact on the medical formatics and health care provision. The Semantic Web uses Resource Description Framework (RDF), Web Ontology Language, and other ontologies to "ascribe meaning to data depending on the context in which it is used". The Semantic Web is expected to provide, for example, the ability to "identify data related to age, weight and diseases, and ... then deliver that data based on the context of a query". Projects in development include: rules-based diagnostic decision-support systems for Partners HealthCare System (Boston) and a public health surveillance system under the direction of Parsa Mirhaji at the University of Texas Health Science Center at Houston.
In addition to Mirhaji, comments are provided from Dean Giustini (Biomedical Branch Library, University of British Columbia), Vipul Kashyap (Partners HealthCare), and Bob Shimp (Oracle's Global Technology Business Unit). The story does not, however, explore the social and ethical implications of the Semantic Web for medical research.
Friday, July 13, 2007
Recent Blogs on Predictive Health Topics: Gene Expression; The Daily Transcript; Eye on DNA ...
Medical Records
A top-down approach to genetic networks. July 5, 2007. From p-ter at Gene Expression.
Comments on data mining health records to correlate hereditary disorders.
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Reviewing ENCODE
ENCODE. July 4, 2007. From Alex Palazzo at The Daily Transcript. A summary and critique, for the general reader, of: “Identification and analysis of functional elements in 1% of the human genome by the ENCODE pilot project”. Nature 447, 799-816 (14 June 2007) doi:10.1038/nature05874.
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Ownership and Genetic Information
One Big Happy Family Genome, July 7, 2007. From Hsien-Hsien Lei at Eye on DNA. Lei comments on the BMJ “Head-to-Head” feature: “Should families own genetic information?” BMJ 2007;335:22 (7 July), doi:10.1136/bmj.39252.386030.AD.
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Translation
Towards a World without Genetic Diseases July 7, 2007. From Bertalan Meskó at ScienceRoll.
Mentions recent genetic research advances on muscular dystrophies and potential technologies to speed translation.
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Genetic Databases
Indian genetic database offers R&D advances, July 7, 2007. From Albin Paul at Microarray Blog. Describes the work of The Indian Genome Variation Consortium, including: “data on the genetic codes of over a 1,000 genes from among 15,000 individuals belonging to Indian sub-populations”.
A top-down approach to genetic networks. July 5, 2007. From p-ter at Gene Expression.
Comments on data mining health records to correlate hereditary disorders.
==========
Reviewing ENCODE
ENCODE. July 4, 2007. From Alex Palazzo at The Daily Transcript. A summary and critique, for the general reader, of: “Identification and analysis of functional elements in 1% of the human genome by the ENCODE pilot project”. Nature 447, 799-816 (14 June 2007) doi:10.1038/nature05874.
==========
Ownership and Genetic Information
One Big Happy Family Genome, July 7, 2007. From Hsien-Hsien Lei at Eye on DNA. Lei comments on the BMJ “Head-to-Head” feature: “Should families own genetic information?” BMJ 2007;335:22 (7 July), doi:10.1136/bmj.39252.386030.AD.
==========
Translation
Towards a World without Genetic Diseases July 7, 2007. From Bertalan Meskó at ScienceRoll.
Mentions recent genetic research advances on muscular dystrophies and potential technologies to speed translation.
==========
Genetic Databases
Indian genetic database offers R&D advances, July 7, 2007. From Albin Paul at Microarray Blog. Describes the work of The Indian Genome Variation Consortium, including: “data on the genetic codes of over a 1,000 genes from among 15,000 individuals belonging to Indian sub-populations”.
Monday, July 2, 2007
Other Blogs of Interest: The Personal Genome; Eye On DNA; The Genetic Genealogist
From Jason Bobe's The Personal Genome: Genomics as a medical tool and lifestyle choice:
"Camping Around Health Insurance Discrimination".
From Hsien-Hsien Lei's Eye On DNA:
"Amerindian DNA Sells for 55 Dollars".
From Blaine Bettinger's The Genetic Genealogist:
The Genographic Project Public Participation Mitochondrial DNA Database:
"Camping Around Health Insurance Discrimination".
- People who offer solutions to the genetics and health insurance issue, tend to fall into three camps:
- 1. the patient advocates
2. the free-market purists
3. the ignotarians
From Hsien-Hsien Lei's Eye On DNA:
"Amerindian DNA Sells for 55 Dollars".
- Clearly, scientists and others asking indigenous populations to donate biological samples need to do a better of job of communicating the overarching goals and benefits such studies can achieve. Judith Greenberg, director of genetics and developmental biology at the National Institute of General Medical Sciences:
- This is sort of a balancing act. We don’t want to do something that makes a whole tribe or people unhappy or angry. On the other hand, the scientific community is using these samples, which were accepted and maintained under perfectly legitimate procedures, for the benefit of mankind.
Legitimate for us maybe, but not necessarily for the Karitiana people.
From Blaine Bettinger's The Genetic Genealogist:
The Genographic Project Public Participation Mitochondrial DNA Database:
- An overview of-- The Genographic Project Public Participation Mitochondrial DNA Database. Behar DM, Rosset S, Blue-Smith J, Balanovsky O, Tzur S, et al. PLoS Genetics Vol. 3, No. 6, e104. doi:10.1371/journal.pgen.0030104.
Bettinger notes: "This paper is all about the mtDNA sequences they have obtained through the project. In the first 18 months of the project, they have collected an amazing 78,590 mtDNA genotypes!!"
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