Join us Monday, November 14th at 3:00 p.m. for a presentation by Eric M. Meslin, The Next Ethical Problem in Translational Science: Crossing the "Policy Valley of Death". Location: Indiana University Center for Bioethics, 410 West 10th Street, Suite 3100, Indianapolis, IN.
This presentation will make the case that there are two gaps to be bridged in successful translational science, one between "the bench and the bedside" and another between the "lab and legislature." Without a sturdy bridge from the lab to the legislature, advances in translational science could be lost to the "policy valley of death."
Showing posts with label policy. Show all posts
Showing posts with label policy. Show all posts
Friday, November 11, 2011
Tuesday, February 2, 2010
Direct-to-Consumer Fetal Sex Prediction Tests: the US is Not Immune to Sex Selection
In January, Dutch researchers published a study relating to a new method for screening maternal blood to determine fetal sex as early as seven weeks after conception. Although this test reports 100% accuracy, other direct-to-consumer (DTC) fetal sex prediction tests that advertise online offer similar tests with unregulated accuracy.
Recently, these tests have come under increased scrutiny based on the possibility that consumers both in the US and abroad may purchase the tests as a means obtaining information about fetal sex as the first step in seeking a sex selection abortion. Unlike an ultrasound (performed at 18-20 weeks in the second trimester), these DTC tests advertise the ability to predict fetal sex between 5-10 weeks in the first trimester. This offers parents an opportunity to determine fetal sex and make corresponding planning decisions to produce a child of a specific sex that may have been previously unaffordable (through means such as preimplantation genetic diagnosis or sperm selection) or inaccessible (second trimester sex selection abortions).
Three main countries- China, India, and Korea- are often used as examples of countries with socio-cultural environments that contribute to male child bias in attitude and action. Literature contains extensive discussion on how and why socio-cultural attitudes have traditionally, and still to a large extent, continue to favor male children and perpetuate extensive gender discrimination within the respective countries. The magnitude of bias is reflected in the skewed population ratios such as the 50 million “missing” females that should otherwise exist in the Chinese population. These deeply entrenched reasons for male bias and the pervasiveness of these attitudes means that even despite legal steps to explicitly limit or prohibit sex selection abortions, for decades both parents and practitioners have ignored laws designed to prevent this practice in each respective country.
In recognition of this issue, some DTC fetal sex prediction companies specify that they do not sell the product to consumers in China and or India. However, some companies have not issued such restrictions, and consumers in India or China can locate these products by a simple internet search. In India, scholar and activist Dr. Sabu George filed a lawsuit against Google and Yahoo seeking to enforce an Indian law against advertising products that reveal fetal sex. While the search engines have pulled some advertisements, internet searches still provide links to the DTC fetal sex prediction company websites.
The potential of using fetal sex prediction tests as a means of sex selection is not only a problematic issue limited to other countries. Both attitudinal research and recent litigation suggests that some parents in the US may use these tests for sex selection purposes.
Despite a notion that the general US population does not possess a preference for a child of a specific sex, statistics suggest this assumption may not be correct. Numerous studies demonstrate that members of the US population do possess attitudinal bias favoring male children, either as only children or first born. Some parents not only hold this male child bias, but are also willing to translate these attitudes into practice to achieve the desired outcome.
Another lawsuit against the Baby Gender Mentor product, Duffy et al. v. Acu-Gen Biolabs et al., also confirms these attitudes exist within the US population. Plaintiffs allege the tests were inaccurate and falsely predicted their baby’s sex, which caused them emotional distress and had a “devastating effect.” One plaintiff asserts that the incorrect test results contributed to the demise of her marriage because her husband wanted a boy, while another plaintiff upon learning the results “struggled, needlessly, with whether to keep [the pregnancy.]”
Granted, vast socio-cultural differences exist between counties such as India, China, and the US that could lead to less devastating population wide outcomes. However, does this mean we should be less concerned that only a small percentage of the population may use these tests for sex selection purposes? What can we learn from these countries when formulating our policy relating to how these tests can or cannot be used?
--Katherine Drabiak-Syed
Recently, these tests have come under increased scrutiny based on the possibility that consumers both in the US and abroad may purchase the tests as a means obtaining information about fetal sex as the first step in seeking a sex selection abortion. Unlike an ultrasound (performed at 18-20 weeks in the second trimester), these DTC tests advertise the ability to predict fetal sex between 5-10 weeks in the first trimester. This offers parents an opportunity to determine fetal sex and make corresponding planning decisions to produce a child of a specific sex that may have been previously unaffordable (through means such as preimplantation genetic diagnosis or sperm selection) or inaccessible (second trimester sex selection abortions).
Three main countries- China, India, and Korea- are often used as examples of countries with socio-cultural environments that contribute to male child bias in attitude and action. Literature contains extensive discussion on how and why socio-cultural attitudes have traditionally, and still to a large extent, continue to favor male children and perpetuate extensive gender discrimination within the respective countries. The magnitude of bias is reflected in the skewed population ratios such as the 50 million “missing” females that should otherwise exist in the Chinese population. These deeply entrenched reasons for male bias and the pervasiveness of these attitudes means that even despite legal steps to explicitly limit or prohibit sex selection abortions, for decades both parents and practitioners have ignored laws designed to prevent this practice in each respective country.
In recognition of this issue, some DTC fetal sex prediction companies specify that they do not sell the product to consumers in China and or India. However, some companies have not issued such restrictions, and consumers in India or China can locate these products by a simple internet search. In India, scholar and activist Dr. Sabu George filed a lawsuit against Google and Yahoo seeking to enforce an Indian law against advertising products that reveal fetal sex. While the search engines have pulled some advertisements, internet searches still provide links to the DTC fetal sex prediction company websites.
The potential of using fetal sex prediction tests as a means of sex selection is not only a problematic issue limited to other countries. Both attitudinal research and recent litigation suggests that some parents in the US may use these tests for sex selection purposes.
Despite a notion that the general US population does not possess a preference for a child of a specific sex, statistics suggest this assumption may not be correct. Numerous studies demonstrate that members of the US population do possess attitudinal bias favoring male children, either as only children or first born. Some parents not only hold this male child bias, but are also willing to translate these attitudes into practice to achieve the desired outcome.
Another lawsuit against the Baby Gender Mentor product, Duffy et al. v. Acu-Gen Biolabs et al., also confirms these attitudes exist within the US population. Plaintiffs allege the tests were inaccurate and falsely predicted their baby’s sex, which caused them emotional distress and had a “devastating effect.” One plaintiff asserts that the incorrect test results contributed to the demise of her marriage because her husband wanted a boy, while another plaintiff upon learning the results “struggled, needlessly, with whether to keep [the pregnancy.]”
Granted, vast socio-cultural differences exist between counties such as India, China, and the US that could lead to less devastating population wide outcomes. However, does this mean we should be less concerned that only a small percentage of the population may use these tests for sex selection purposes? What can we learn from these countries when formulating our policy relating to how these tests can or cannot be used?
--Katherine Drabiak-Syed
Wednesday, January 21, 2009
New Technologies and Old Laws: Square Pegs in Round Holes
I sit in a lot of meetings where I people discuss how new health information and technology will fit into existing policy and law. Many of these discussions go over my head, as they are bogged down in minutiae of law and policy far beyond my ken. I have often assumed that these discussions are important, perhaps even necessary, as our system of law is built on precedent, reaching back into the past to inform the future.
And then I read something like this.
New President Barack Obama will have to give up his Blackberry. The entire White House Staff can’t Instant Message. Eight years ago, President Bush sent a message to 42 friends and relatives right before assuming office explaining that he had to give up email. I know what I will say to them if they ever try to come for my iPhone; it’s not fit for print and involves my cold, dead fingers.
Why? It has to do with something called the Presidential Records Act. It turns out that all of the documents that come into contact with a President and Presidency need to be preserved and one day made public. Don’t get me wrong, I understand the importance of such a law, and I am all in favor of it. But even that law recognized that there had to be exceptions. Presidents, and their staff, do need to keep some things private. Conversations aren’t all recorded; neither are telephone calls.
Personally, I hate to talk on the phone. So, given the chance, I will use email, text messaging, or even Instant Messaging to talk to friends and colleagues. For me, and many others, it’s faster, it’s easier, and it’s preferable. I can tell you that I would be much less productive professionally, and much less happy personally, if you told me I had to stop.
Here’s the problem. The Presidential Records Act was written in 1978. No Blackberries. No Instant Messaging. No email. It is simply ridiculous that President Obama can’t have a Blackberry and David Axelrod can’t Instant Message because of a law written thirty years ago. We shouldn’t have to figure out how to make these new technologies fit into law that couldn’t predict them. We need new law.
Which brings us back to health technology. Those old laws and old policies – they too were often written in a time when the issues and difficulties we face today were simply incomprehensible.
It may be just as unreasonable to think that we can use them to inform what we should do today. Sometimes, precedent isn’t enough.
We shouldn’t have to figure out how to make these new technologies fit into policies that couldn’t predict them. We need new policies.
Aaron E. Carroll
And then I read something like this.
New President Barack Obama will have to give up his Blackberry. The entire White House Staff can’t Instant Message. Eight years ago, President Bush sent a message to 42 friends and relatives right before assuming office explaining that he had to give up email. I know what I will say to them if they ever try to come for my iPhone; it’s not fit for print and involves my cold, dead fingers.
Why? It has to do with something called the Presidential Records Act. It turns out that all of the documents that come into contact with a President and Presidency need to be preserved and one day made public. Don’t get me wrong, I understand the importance of such a law, and I am all in favor of it. But even that law recognized that there had to be exceptions. Presidents, and their staff, do need to keep some things private. Conversations aren’t all recorded; neither are telephone calls.
Personally, I hate to talk on the phone. So, given the chance, I will use email, text messaging, or even Instant Messaging to talk to friends and colleagues. For me, and many others, it’s faster, it’s easier, and it’s preferable. I can tell you that I would be much less productive professionally, and much less happy personally, if you told me I had to stop.
Here’s the problem. The Presidential Records Act was written in 1978. No Blackberries. No Instant Messaging. No email. It is simply ridiculous that President Obama can’t have a Blackberry and David Axelrod can’t Instant Message because of a law written thirty years ago. We shouldn’t have to figure out how to make these new technologies fit into law that couldn’t predict them. We need new law.
Which brings us back to health technology. Those old laws and old policies – they too were often written in a time when the issues and difficulties we face today were simply incomprehensible.
It may be just as unreasonable to think that we can use them to inform what we should do today. Sometimes, precedent isn’t enough.
We shouldn’t have to figure out how to make these new technologies fit into policies that couldn’t predict them. We need new policies.
Aaron E. Carroll
Monday, June 30, 2008
The Best Predictive Health Ethics Blogs - June 2008
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.
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.
Friday, June 27, 2008
The BiDiL Debate: Can "race" serve as a proxy for groups with shared "genetic" characteristics?
Following the debate surrounding the FDA's 2005 approval of BiDiL – a drug to be marketed to treat African-Americans at risk for heart failure – David e. Winickoff and Osagie K. Obasogie propose regulatory policy for future race-specific drug development. Writing in a letter published in Trends in Pharmacological Sciences [Race-specific drugs: regulatory trends and public policy. 2008 Jun;29(6):277-9. Epub 2008 Apr 29 | PMID: 18453000 - CiteULike (excerpt)], the authors argue: "race-specific indications should be rejected unless clinical trials can demonstrate convincingly that the drugs are both better than existing treatments for a specific group and no better than existing treatments for non-specified groups". They conclude that these enhanced regulations might help to reduce health disparities while protecting groups from market exploitation: "Race can be used as a proxy for the group most likely to benefit from a drug as long as the effect is not to deny others valid treatments". In other words, "Pharmaceutical science and biomedicine most certainly should not be colorblind. But they also must not be 'color-struck'".
Unlike one's genetic information, racial identity is a social-construct – so, using race as a proxy for individuals with common genetic characteristics is a messy and controversial process. In this case, would it make sense at all to say: genome-specific "indications should be rejected unless clinical trials can demonstrate convincingly that the drugs are both better than existing treatments for a specific group and no better than existing treatments for non-specified groups"?
Would such a standard be useful or does it merely re-state the obvious? – J.O.
Unlike one's genetic information, racial identity is a social-construct – so, using race as a proxy for individuals with common genetic characteristics is a messy and controversial process. In this case, would it make sense at all to say: genome-specific "indications should be rejected unless clinical trials can demonstrate convincingly that the drugs are both better than existing treatments for a specific group and no better than existing treatments for non-specified groups"?
Would such a standard be useful or does it merely re-state the obvious? – J.O.
Wednesday, February 13, 2008
Ethics Meetings at PredictER
PredictER holds a semi-regular weekly meeting to discuss the ethical, legal and social issues relevant to the latest predictive health research. These meetings frequently include presentations from distinguished guest speakers. Recent speakers have included:
Greg Sachs, M.D. - Chief of the Division of General Internal Medicine and Geriatrics, Department of Medicine, Indiana University School of Medicine.
Anantha Shekhar, M.D., Ph.D. - Associate Dean for Translational Research, Indiana University School of Medicine.
David W. Crabb, M.D. - Director of the Indiana Alcohol Research Center, Chair of the Department of Medicine, Indiana University School of Medicine.
Eric Wright, Ph.D. – Director, Center for Health Policy, Indiana University-Purdue University, Indianapolis.
Eleanor DeArman Kinney, J.D., M.P.H. - Hall Render Professor of Law, Co-director of the William S. and Christine S. Hall Center for Law and Health, Indiana University School of Law - Indianapolis.
Jim Wolf, M.S. - Director, Survey Research Center, Indiana University-Purdue University, Indianapolis.
Most recently, Jennifer Girod, J.D., Ph.D., R.N. (IU Center for Bioethics/Sommer Barnard, PC) introduced and moderated a discussion of PredictER’s developing agenda for predictive health policy research. Four domains for potential public policy research were identified: the growing life sciences research and development sector, predictive health information and the future of insurance underwriting, the use and misuse of modestly predictive health information in clinical settings (including patient understanding of risk and related professional liabilities), and the impact of genomic information on public health.
The schedule for the rest of the month includes:
February 18 – 3:00: Elda Railey, Cynthia Burkhardt and Mary Lou Smith from the Research Advocacy Network will present their current activities and will discuss the influence advocates have had on tissue banking.
February 25 – 3:00: Anna Maria Storniolo, M.D., (Director, Catherine Peachey Breast Cancer Prevention Program) will share the progress of the Mary Ellen Tissue Bank.
If you are in the Indianapolis area and would like to attend, visit the Indiana University Center for Bioethics website for more information. - J.O.
Greg Sachs, M.D. - Chief of the Division of General Internal Medicine and Geriatrics, Department of Medicine, Indiana University School of Medicine.
Anantha Shekhar, M.D., Ph.D. - Associate Dean for Translational Research, Indiana University School of Medicine.
David W. Crabb, M.D. - Director of the Indiana Alcohol Research Center, Chair of the Department of Medicine, Indiana University School of Medicine.
Eric Wright, Ph.D. – Director, Center for Health Policy, Indiana University-Purdue University, Indianapolis.
Eleanor DeArman Kinney, J.D., M.P.H. - Hall Render Professor of Law, Co-director of the William S. and Christine S. Hall Center for Law and Health, Indiana University School of Law - Indianapolis.
Jim Wolf, M.S. - Director, Survey Research Center, Indiana University-Purdue University, Indianapolis.
Most recently, Jennifer Girod, J.D., Ph.D., R.N. (IU Center for Bioethics/Sommer Barnard, PC) introduced and moderated a discussion of PredictER’s developing agenda for predictive health policy research. Four domains for potential public policy research were identified: the growing life sciences research and development sector, predictive health information and the future of insurance underwriting, the use and misuse of modestly predictive health information in clinical settings (including patient understanding of risk and related professional liabilities), and the impact of genomic information on public health.
The schedule for the rest of the month includes:
February 18 – 3:00: Elda Railey, Cynthia Burkhardt and Mary Lou Smith from the Research Advocacy Network will present their current activities and will discuss the influence advocates have had on tissue banking.
February 25 – 3:00: Anna Maria Storniolo, M.D., (Director, Catherine Peachey Breast Cancer Prevention Program) will share the progress of the Mary Ellen Tissue Bank.
If you are in the Indianapolis area and would like to attend, visit the Indiana University Center for Bioethics website for more information. - J.O.
Wednesday, October 10, 2007
Medical Records and the VA: Cancer, Laptops, Babies and Bath Water
In Wednesday's New York Times, Gina Kolata reports on the Veteran Administration's new national directive which requires states to agree to conditions prior to acquiring cancer patients’ personal information and health records. State laws often require hospitals to submit data, but these laws do not apply to federal agencies like the VA. This policy will result in less reliable statistics on the prevalence of cancer and will also chill the progress of state administered cancer research. On the other hand, the protection of patient privacy will be enhanced. The VA'S chief of research and development office, Dr. Joel Kupersmith, noted a "dynamic tension between patient privacy and the desire to use patients’ private information to do research", but stressed that the "paramount issue for us is the protection of patient privacy and the protection of patient information."
The impact of these new restrictions on predictive health cancer research will be especially felt in 17 regions that are part of the National Cancer Institute’s network. According to Kolata, these regions use personal health records provided by hospitals to investigate "cancer risk factors and outcomes" and to "provide data to academic researchers who are doing studies and need to interview patients or need genetic information."While a few states have agreed to sign the directive, many others are holding out--most notably, the state California. States complain that the directives place too many restrictions on the use of the data and that complying with these conditions is both expensive and impractical. Tina Clarke, an epidemiologist at the Northern California Cancer Center estimates that the directive will add over a year to the ethics review process. Clarke added, "Privacy concerns are serious … [b]ut at the same time, this is a baby with the bath water problem." -- J.O.
PredictER Notes:
1. In the next few weeks, as the public begins to digest this news, many cancer patients will be surprised to discover that their medical records and personal information are available for research. Will this story reduce public support and willingness to participate in predictive health research?
2. As Kolata reports, the VA'S chief of research and development, noted that "the department was especially sensitive to privacy concerns in light of incidents like the theft by teenagers last year of a laptop computer containing personal information on 26.5 million veterans." The new directive does not, of course, provide information and privacy protections that would have prevented the theft of a laptop. Will the VA's new policy truly provide the information security and privacy protections that patients expect?
Related document:
VHA DIRECTIVE 2007-023 (pdf) - RELEASE OF VA DATA TO STATE CENTRAL CANCER REGISTRIES. 15 August 2007. Department of Veterans Affairs -Veterans Health Administration.
The impact of these new restrictions on predictive health cancer research will be especially felt in 17 regions that are part of the National Cancer Institute’s network. According to Kolata, these regions use personal health records provided by hospitals to investigate "cancer risk factors and outcomes" and to "provide data to academic researchers who are doing studies and need to interview patients or need genetic information."While a few states have agreed to sign the directive, many others are holding out--most notably, the state California. States complain that the directives place too many restrictions on the use of the data and that complying with these conditions is both expensive and impractical. Tina Clarke, an epidemiologist at the Northern California Cancer Center estimates that the directive will add over a year to the ethics review process. Clarke added, "Privacy concerns are serious … [b]ut at the same time, this is a baby with the bath water problem." -- J.O.
PredictER Notes:
1. In the next few weeks, as the public begins to digest this news, many cancer patients will be surprised to discover that their medical records and personal information are available for research. Will this story reduce public support and willingness to participate in predictive health research?
2. As Kolata reports, the VA'S chief of research and development, noted that "the department was especially sensitive to privacy concerns in light of incidents like the theft by teenagers last year of a laptop computer containing personal information on 26.5 million veterans." The new directive does not, of course, provide information and privacy protections that would have prevented the theft of a laptop. Will the VA's new policy truly provide the information security and privacy protections that patients expect?
Related document:
VHA DIRECTIVE 2007-023 (pdf) - RELEASE OF VA DATA TO STATE CENTRAL CANCER REGISTRIES. 15 August 2007. Department of Veterans Affairs -Veterans Health Administration.
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