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.

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.

Curating Your Personal Genome?

When a member of the PGP-10 and an investor in 23andMe writes about curating one's online, personal data, a lot of people listen. Unfortunately, Esther Dyson (writing in MIT's Technology Review) does not mention the decision to share medical information or how she plans to curate her own genomic data online. Dyson rightly notes that "current website 'privacy' policies don't suffice. They're full of abstractions, euphemisms, and generalities, such as, 'We may, at any point in time, provide certain Specified Information to selected Marketing Partners ... .'" She appears to favor a complex, itemized consent policy, one that would allow users to opt in or out of sharing specific categories of information (user name, address, credit history, etc.) with a list of potential users (advertisers and other companies).

Imagine a similar consent for medical records sharing. For example, could someone like Esther consent to share her genome with a 23andMe social network, but not with researchers in this network? Or, perhaps, Esther could chose to share some of her genomic information, but not all of it. Then, again, maybe Esther would be willing to share her prescription history with an academic researcher, but not with pharmaceutical companies. The options could go on and on, resulting in an increasing complex array of choices.

Esther Dyson is obviously a very sophisticated information agent, but (as the opportunity to share medical information online increases) will the average user and patient be prepared to make informed decisions about the risks and benefits of participating? - J.O.

DNA Biobanks: The Five Minutes Between Nashville and Dundee

Here at PredictER we're very interested in the attitudes of healthcare professionals regarding DNA biobanking. In fact, we recently collaborated in a study of attitudes at a local children's hospital. Thus, I was excited to read the results of similar survey research from Vanderbilt University School of Medicine. David A. Leiman, Nancy M. Lorenzi and some other bioinformatics folk in Nashville appear to have been working on this topic for a few years now - beginning with focus groups in 2000 and including a recent international, comparative survey. In "US and Scottish Health Professionals' Attitudes toward DNA Biobanking" [J Am Med Inform Assoc. 2008 May-Jun;15(3):357-62. Epub 2008 Feb 28. | PMID: 18308988], the authors compare the attitudes of healthcare professionals in Nashville with the attitudes of those in Dundee, Scotland. While they expected that the difference between a mostly private (U.S.) and a more socialized (U.K.) healthcare system would impact attitudes, they discovered that the attitudes were not that far apart. Presumably, the authors thought that U.S. health professionals would worry that genetic information might be misused by insurance companies in the private healthcare system and, thus, would be less likely to support biobanking. As it turns out the attitudes of the two survey groups were very similar. Of the fifteen questions in common, significant differences in attitude were found on only three questions. The Dundee professionals were slightly less supportive of creating a DNA biobank and (most importantly) were less comfortable with the idea that they might be asked to consent patients for DNA samples.

In the discussion of the results the authors speculate that time constraints in Scotland might be at the root of this slight difference in professionals' attitudes about "consenting" patients into participating in the biobank:

While many U.S. practices are expected to see patients 12-15 minutes, Scottish doctors are expected to perform the same visit in 7-10 minutes. The additional burden of consenting, or even explaining a biobank project, may be an overwhelming challenge to integrate into the existing workflow.

Those "extra" five minutes of time in which to meet a patient's needs in the U.S., therefore, might account for the greater support ("Strongly Agree" versus "Agree") for DNA biobanking. The authors also mention the difficult nature of obtaining consent for this research – without a complicated: "Traditional consent procedures require researchers to contact participants each time a new investigation is undertaken with the same existing information". Let's hope that the validity of the patient's consent isn't sacrificed to better accommodate the busy schedules of the healthcare professionals. - J.O.

GINA, The Good News: Engaging the Public

This is the third post in a series of posts in which I share what I see as the ups and downs of the Genetic Information Nondiscrimination Act of 2008 (GINA or H.R. 493). In this post I address a potential positive:

A little discussed portion of GINA may be cause for celebration. Title II, Section 208, Subsection (b) of GINA calls for the establishment of the Genetic Nondiscrimination Study Commission after GINA has been enacted for six years. The purpose of the Commission is to evaluate the status of genetic science, genetic discrimination, public perception, and other factors, and to make recommendations to Congress regarding possible future legislation. Here, it would seem as though Congress has exercised a reasonable amount of foresight. Scientific knowledge is expanding at an amazing rate; faster than society and its laws can react, resulting in public fear and apprehension. Public fears are important and they must be listened to; public fears shouldn't always determine legislative action, but they cannot be brushed aside or ignored. In this case, Congress seemed to understand this dichotomy. They did the research. They listened to experts, and they acted. – Sam Beasley

ELSI After Francis Collins: What Now?

In an editorial published today, "This time it's personal" (Nature 453, 697 (2008) | doi:10.1038/453697a ), Nature adds to the many comments on Francis Collins's announcement that he will step down from his 15 year position as head of the US National Human Genome Research Institute (NHGRI). Like most comments on Collins's career at NHGRI, the editorial praises the leader for his ambition, political acumen, and emphasis on the ethical implications of genomic research. In addition to leading the Institute to the successful sequencing of the genome in 2003, Collins helped to initiated the International HapMap Project, ENCODE, and the 1,000 Genomes Project. He also lobbied for the passage of GINA (H.R. 493) and was a constant advocate for the inclusion of public outreach and ethics education in genomic research.

Collins's emphasis on the ethical issues and the NHGRI's ELSI program laid the conceptual groundwork that informs much of the work we do here at PredictER. In fact, thanks to the support of The Richard M. Fairbanks Foundation, Inc, the Indiana University Center for Bioethics has been answering Collins's call to address the ethical implications of genetic and genomic research by focusing on both research ethics and medical ethics as the science is translated into current and future predictive health care.

The editorial also mentions some of the challenges that the next director of NHGRI will face. These challenges include a shrinking budget and waning political support:

Although Collins says he has no concrete plans … the future of NHGRI is more cloudy than his own. The funding situation of the NIH has been gloomy for years, with flat budgets stifling many potentially worthy projects. And with Collins gone, the NHGRI may become more of a target for politicians who feel it has run its course.

Of course, the challenges also include existing and unanticipated ethical and legal issues. As the Nature editorial notes: "Genomics is now at a point where the science and technology are moving much faster than society's ability to assimilate and make sense of the information".

One challenge that this editorial does not mention directly, but seems, nevertheless, to be implied by the shrinking public budget, is the fact that much predictive health research will be (and currently is) receiving commercial support. This should not be a surprise. If we want genomic research to result in better personalized medicine, we should expect that the life science industry will invest in the research. At the same time, however, there's no better moment than now to accelerate the investigation of the specific ethical issues of doing commercially supported genomic and predictive health research. For example, here are a few questions that jump to my mind:

Must a research biobank disclose to donors in the informed consent policy that research results may result in commercial products?

Must or should these biobanks share the income from tissue or data sales with donors?

Should pharmacogenomic companies and other patent holders be expected to share financial rewards with research participants or even with the communities to which these participants belong? - J.O.