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?"

PredictER News Brief - 25 February 2008

The latest edition of PredictER News Brief (25 February 2008) is now available online. PredictER News Brief is a biweekly digest of news, blogs, and research publications relevant to the ethics, law and policy of predictive health research.

To receive PredictER News Brief as an email newsletter send an email to listserv@listserv.iupui.edu with "subscribe PREDICTER-L" in the message body.

The Genetics & Public Policy Center - Public Consultation Dates

The Genetics & Public Policy Center at Johns Hopkins University recently released the dates for its upcoming town hall discussions to "gather feedback from the public on their views related to a proposed large cohort study on the role of genes and environment in health". Meetings will be held March 8th (Kansas City, MO), April 5th (Phoenix, AZ), April 19th (Jackson, MS), April 24th (Portland, OR), and May 13th (Philadelphia, PA). These meetings follow similar meetings in the same cities last year. The scheduled "town hall" meetings are a part of the second stage in a two-year, $2 million pilot project funded by the National Human Genome Research Institute, "Making Every Voice Count: Public Consultation on Genetics, Environment, and Health". The results of last year's public consultations regarding the feasibility of a pediatric biobank were recently published in the American Journal of Medical Genetics:

Kaufman D, Geller G, Leroy L, Murphy J, Scott J, Hudson K. Ethical implications of including children in a large biobank for genetic-epidemiologic research: a qualitative study of public opinion. Am J Med Genet C Semin Med Genet. 2008 Feb 15;148(1):31-9. PMID:18189289

GINA and the "Axis of Evil"?

Although the status of S. 358, the Genetic Information Nondiscrimination Act (GINA), has not changed, [Senator Tom Coburn (Rep., Oklahoma) continues to block the bill], its place in legislative limbo still draws the attention of editors and bloggers. Earlier this month Nature reminded readers of the struggle to unblock the bill and provocatively named Coburn a "rogue senator". Coburn's expressed opposition to GINA evolves, but his strongest argument may be that he wants to protect insurers and employers from (as Nature writes) "an avalanche of frivolous litigation". Several states, however, have passed similar legislation and have not encountered the predicted avalanche in the civil courts. Many writers, including the editors of Nature, worry that Coburn's opposition to the bill is slowing the progress of personalized medicine. In response, therefore, the Nature editorial implicitly calls for the genetic research community to lobby on behalf of the bill. The editors note that "scientists should tell" Senate Majority Leader Harry Reid to break Coburn's hold. Reid could bring the bill to a vote by allowing 30 hours of Senate debate on the topic. However, as the Senate has many bills to address, Reid is unlikely to find 30 hours for GINA.

Among other responses, a post in a widely read political blog, Daily Kos, picked up the story and (like many observers in the United States) quickly assumed the worst of the health insurance industry: "actuaries across the coverage denial sector are salivating at the prospect of putting your genetic information to work for their bosses". Is the insurance industry really that pernicious? Yes, they make money by gambling on the health of individuals … and sometimes they refuse to take a bet, but are they (with Coburn) really worthy of Bush's "axis of evil" rhetoric. Although I have to admit that I wouldn't volunteer my genetic information (assuming that I had it) to potential insurance providers, do we really know that insurance companies are eager to access our genetic information? Don't they already have good predictors and other data to use when assessing the odds of gambling on our health? (Smoking comes to mind.) In the immediate future, I wouldn't be surprised if the consumer genomics market will result in an increase in purchases of insurance policy upgrades. Given that the "predictive" value of genomic testing is very far from absolute, isn't it possible that many will overact to their new found "risks" and subsequently go impulse-shopping for more insurance? Perhaps the insurance companies would use genetic information to market more aggressive and supplemental coverage … would this be unjust "discrimination"? - J.O.

The Research Advocacy Network

Yesterday (Feb. 18), Elda Railey and Mary Lou Smith from the Research Advocacy Network (RAN) addressed the weekly PredictER meeting at the IU Center for Bioethics. RAN facilitates cooperation between research advocates (often disease survivors) and researchers. With access to the energy and resourcefulness of patient and research advocates, RAN accelerates the translation of clinical research. Researchers receive assistance with participant recruitment, public engagement, and patient and clinician education. In turn research advocates and patients have the pleasure of making a real difference in the progress of biomedical science, while also ensuring enhanced patient care in the future.

For readers interested in patient and research participant education, RAN provides print and electronic resources. Including a booklet for patients on the importance of tissue donation, a tutorial for advocates on the clinical trials process, and a training manual for advocates interested in genetic and genomic oncology research.

Also a guest at the PredictER meeting, Cynthia Burkhardt, a research site coordinator, discussed RAN’s collaboration with the Hoosier Oncology Group.

Visit the Research Advocacy Network website to download these and other RAN publications:

“Why is it important for me to consider donating my tissue for research: A booklet for prospective donors”. Research Advocacy Network, 2005. 12p.

Perlmutter, J. Understanding Clinical Trial Design: A Tutorial for Research Advocates.

Genomics in Cancer: An Advocate’s Guide and Training Manual. [Forward by Francis S. Collins, MD, PhD.] Research Advocacy Network, 120p. Research Advocacy Network, 52p.

Next at PredictER:

CANCELED - February 25 – 3:00 pm: Anna Maria Storniolo, M.D., (Director, Catherine Peachey Breast Cancer Prevention Program) will share the progress of the Mary Ellen Tissue Bank.

March 3 - 3:00 pm: Andrew J. Saykin, M.D., (Director, IU Center for Neuroimaging, IU School of Medicine): Neuroimaging, Cognition and Genetics in the Early Detection of Alzheimer's Disease.

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.

Sharing Patient Health Records: Wisconsin Assembly Bill 793

On February 11 legislators in Wisconsin introduced Assembly Bill 793 [PDF – 25.7 KB], which proposes to reduce restrictions on redisclosures of patient health records in particular circumstances to facilitate electronic sharing of information. Wisconsin’s current law (WI ST 51.30) closely follows requirements set forth in HIPAA such as allowing the patient to authorize the disclosure of health records only after the patient is informed of the following: to whom the records will be sent, for what purpose will they be disclosed, and for what length of time the authorization is effective. The current law also requires recording what records are released and to whom they are released, creating a documentation trail.

AB 793 Section 10(b) would modify these restrictions and allow a covered entity to redisclose a patient’s health care record for a purpose for which a release is “otherwise permitted,” such as: if a patient previously has agreed to its release [see Section 9(4)(b)(1)]. Non-covered entities may redisclose [per Section 10(c)] the patient’s record subject to more qualifications, such as redisclosure for a purpose for which the patient health care record was initially received. Read in conjunction with Section 10(c), Section 10(b) would allow a covered entity to redisclose a patient’s health record in more circumstances without that patient’s consent.

As reported by the Wisconsin Technology Network, the Wisconsin Department of Health and Family Services (WDHFS) Secretary, Kevin Hayden, maintains that AB 793 does not apply to disclosures covered under HIPAA. In general, HIPAA requires a patient to consent to the release of protected health information for treatment purposes by the receiving hospital and would extend this release, for example, if the patient is transferred for continuing treatment (45 CFR 164.502). Compiling and transferring patient records for other purposes (such as research or database compilation) not related to the patient’s treatment plan or administrative health care operations generally requires a patient authorization. A valid authorization (45 CFR 164.508) contains, among other elements: to whom the information will be disclosed, the purpose of the disclosure, and the individual’s right to revoke the authorization.

If the purpose of HIPAA is read to limit the release of patient records with exceptions to facilitate present treatment, then in most instances medical records must be explicitly released by the patient for use by other individuals by means of an authorization. If the patient does authorize additional use of his records, HIPAA envisions that the patient can track the release of that record with some accountability. WDHFS seems to modify how they interpret HIPAA’s requirements as AB 793 would eliminate the requirement to obtain consent to disclose the patient’s record as well as eliminating documentation of these disclosures.

It is uncertain how WDHFS and the drafters of AB 793 are interpreting HIPAA coverage, whether their interpretation relies on assuming a patient’s singular consent is sufficient, or they plan to add measures to ensure compliance if the bill is implemented. Do they contemplate “treatment” in terms of all foreseeable future treatment? Is this framework something more state legislatures should adopt to increase the ability to retrieve patient records?

If WDHFS’s further discussion of AB 793 does in fact comply with HIPAA’s requirements, this move toward compiling health records could increase the efficiency of health care for the state’s residents. In order to ensure compliance, WDHFS may need to place additional restrictions to their records system or change the substance of patients’ initial consent. - Katherine Drabiak

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.

Genetic Research - Up to the Task? Educating Health Care Providers

In lively exchanges between bloggers from Gene Sherpas, Genetic Future, and Venture Beat, the ethical implications of private genetic testing and personalized medicine were explored and a number of issues were spotted (see comments from Steve Murphy, David P. Hamilton, and Daniel MacArthur). I find Steve Murphy’s compelling suggestion that physicians in clinical practice lack the time and interest to provide thoughtful guidance to patients on genetic testing and test interpretation both relevant to PredictER's program and worth further assessment.

Like nearly every other academic medical center in the United States, Indiana University (PredictER's home) is interested in determining what a large scale predictive health study would look like. More clearly, researchers are asking: what needs to be in place for a large study to successfully combine genetic information along with other health data and biographical information? To be sure, it could serve as a platform for researchers in almost any biomedical research field, but more to Steve’s point, is it practical or possible to role out a study of this kind in clinics and doctors offices? Is there enough interest and enough time for a primary care doctor to attend to this new type of information?

If there's a deficit of interest and time, this is the moment in which the life sciences community should work to develop both. This not so much a disagreement with Steve’s suggestion as a statement about the ultimate goals of predictive health--there is no doubt that the clinical world of primary care is already pressured to the point of precluding physicians from developing new interests or allotting additional time in their schedules, but balance this fact with the knowledge that the outcomes of predictive health remain to be measured. As the prevalence and usage of these tests increases, so will the understanding of how they are being used and interpreted. So, while many are interested in fostering new research platforms to identify targets for new tests, others (including PredictER) are interested in laying a foundation of ethics outreach, education, and assessment to guide the realization of translational science and personalized medicine. One strategy might be to engage busy, primary care doctors with incentives to pursue relevant continuing medical education prior to initiating fully integrated predictive health projects. To do so, one would need a flexible, responsive curriculum (perhaps an online learning module) available for any physician whose patients are or might be enrolled in a predictive health research study ... but what would issues and subjects would such a curriculum need to address? Here are a few that leap to mind:

- Structure of Predictive Health Studies
A bank containing genetic samples and future research projects drawing on this
- Longitudinal research: from Framingham to today
- Impact on Practice in Primary Care
Personalized medicine: prevention, prognosis, pharmacogenetics
- Ethical Issues
Informed Consent
Vulnerable populations
Confidentiality
Recontacting patients
Withdrawal
Return of genetic information
Selling genetic information

I'd be interested to see how PredictER Blog's readers would change this list. What do primary care physicians need to know? Any ideas?

Genetic Research: Groups and Potential Harm

Anyone interested in public engagement and community consultation in genetic research will appreciate Daniel Hausman's article "Protecting Groups from Genetic Research" (Bioethics 2008; 22 (3):157-65). Hausman provides a clear, well-written taxonomy of group types and potential harms to these types as a result of genetic research. He identifies three kinds of groups: structured groups – those with corporate interests distinct from the interests of their individual members (for example, indigenous groups with existing or potential corporate property); identifying groups – unstructured groups (Italian Americans or Ashkenazi women, for example); and potentially identifying groups – those that may be identified as a result of genetic research.

Hausman's taxonomy of harms includes two process-related harms (disrupting and stigmatizing harms) and two outcomes-related harms (undermining and stereotyping harms). Disrupting harms occur, he writes, "when the research process – regardless of its findings – harms a structured group". For example, "taking tissue samples in genetics research might have a ritual significance that could undermine group solidarity". The author thinks that these harms are relatively infrequent in genetic research.

Stigmatizing harms, in contrast, are more common. This process-related harm affects individuals of an identifying group when the mere existence of a genetic research study stigmatizes members of the group.

The third harm, undermining, (an outcomes-related harm) occurs when structured groups are hurt by the findings of genetic research. For examples, Hausman provides the refutation of beliefs about group origins, the loss of potential commercial gain, and the generation or justification of discriminatory treatment.

The fourth kind of harm, also an outcomes-related harm, stereotyping, affects members of identifying groups. If a member of an ethic group were denied insurance coverage because of a genetic susceptibility was perceived to be common to this group, this individual would be the victim of stereotyping.

As would be expected, given the complexities of developing local, national and international research oversight, civic legislation and public consultation, Hausman's proposed protections against these harms are not as well-defined. Here are a few highlights: IRBs - The author does not think that expanding IRB oversight is answer. He writes, "IRBs are not well suited to implement the necessary regulation ... there would be a duplication of oversight, and research would be stymied ... [and they] are not the right bodies to regulate the risks that scientific research poses to third parties." Group engagement – Although he thinks that efforts toward community consultation in genetic research grow "out of an admirable concern to be respectful to individuals and groups that the research may put at risk," the author argues that consultation is primarily valuable when conducting research with structured groups. In contrast, he thinks that consultation with identifying groups facing stereotyping harms (African Americans, for example) is "often infeasible". He writes, "Indeed, by lending salience to social groups, that may in fact be genetically heterogeneous, group consultation may be counterproductive". To protect groups from stereotyping, Hausman hesitatingly (fearing, perhaps, a decline in public support for research) advocates regulation.

Readers looking for more detailed suggestions for protecting groups from genetic research may be frustrated by this article. For example, the author concludes, regarding harms to indigenous groups, that "whoever regulates research (to the extent that research is regulated) should be concerned about the risks of undermining ... and should demand that researchers provide those they study with detailed information and the opportunity to make their concerns heard by political and regulatory authorities". To my ears, such a statement sounds too much like: someone should pick up this trash ... which is not an effective way to motivate people to clean a room. Readers may also wonder if Hausman too quickly dismisses the possibility of protecting the third group type in his taxonomy, "potential identifying" groups. While it is true that one can not consult with a group that is yet to be identified, does this mean that some protections can not be explored or established in advance?

While I hope that Hausman, or someone else, will pick up the loose ends that this article did not have the room to address, his taxonomy of groups and potential harms is very useful. If you can find a copy of this article (subscription required, unfortunately), it's worth reading. –J.O.

Reference: Hausman D. Protecting groups from genetic research. Bioethics 2008; 22 (3):157-65. [Abstract - CiteULike | doi:10.1111/j.1467-8519.2007.00625.x]