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

GINA, The Bad News: Adverse Selection

This is the second 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).

Although the legislation will hopefully do much to encourage research and protect predictive health patients, GINA is not all roses. The legislation has numerous critics who have good reasons to be critical. For starters, it sets the stage for adverse selection to occur in the health insurance industry.

Adverse selection happens when an information gap emerges between the beneficiary and the insurer; if the beneficiary knows much more than the insurer, then the insurer is unable to accurately assess the beneficiary’s risk. This information imbalance results in more claims being made than the insurer reasonably predicted. GINA facilitates this phenomenon by allowing beneficiaries access to genetic information, but denying it to insurers. If, for example, a beneficiary finds out from a genetic test that he has a significantly increased risk of developing prostate cancer, he would use that information in deciding whether or not to purchase insurance, but the insurer would be unaware of that increased risk in deciding in which group the individual should be placed, what rate he should be charged, etc.

This is potentially a big problem in the insurance industry, because insurers need to be able to accurately determine risk in order to prevent claims exceeding predicted levels. In the long run, inaccurate risk predictions in the industry will result in rate hikes, and rate hikes will drive healthier participants out of groups. In a the worst case scenario, this could start a downward spiral in the direction of group or insurer insolvency. - Sam Beasley

The Good News: GINA; The Bad News ... ?

A few weeks ago, congress passed the Genetic Information Nondiscrimination Act of 2008 (GINA), a much anticipated piece of legislation, nearly thirteen years in the making. Since the first version of the bill prohibiting genetic discrimination was introduced in Congress in 1995, the legislation has received significant bipartisan support and support from both the Clinton and Bush White Houses. Until recently, however, even in the face of all of that support, just a few members of Congress were able to block the legislation's progress. An agreement has finally been reached, and GINA is now the law of the land; it was signed by President Bush on Wednesday, May 21st.

Regular readers of PredictER Blog know that we have been following GINA; now that it has been signed, it's time to kick the tires and to see what we've got. This is the first of a series of posts in which I share what I see as the ups and downs of this legislation. I'll alternate between the good news and the bad news and conclude with an overall "thumbs up" or "thumbs down". For this post, some good news:

GINA really is a big deal, in the legislative sense. It provides (at least in theory) significant protection from discrimination based upon genetic information in the employment and health insurance contexts. Studies by the NIH and other institutions have revealed that the vast majority of the American public is afraid of being discriminated against in these arenas and believes that it would be wrong for employers and insurers to do so. Furthermore, additional studies have revealed that a significant number of people who would be likely to benefit medically from genetic tests choose to forgo them for fear that they will lose their job, or health care coverage depending upon the results. Along the same lines, many people are choosing not to participate in important research that requires subjects to undergo genetic testing out of fear of discrimination. Clearly, then, GINA should help to allay public apprehensions and to encourage both the pace of research and the practice of personalized medicine.

But … stay tuned for the "bad news". – Sam Beasley

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?"

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.

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]

GINA: Behind-the-Scenes Veto Threat

What kept the "Genetic Information Nondiscrimination Act" out of the omnibus? Apparently "Dr. No" (Sen. Coburn, the GINA's persistent foe) wasn't alone in his opposition to the legistlation. "Capitol Hill Watch" by Kaisernetwork.org relays this bit of back-room negotiating from CQ Today (14 January 2008):

A "behind-the-scenes veto threat from the White House apparently kept a popular genetics anti-discrimination measure" (HR 493) from being attached to the FY 2008 omnibus spending bill (PL 110-161), CQ Today reports. Regan Lachapelle, a spokesperson for Senate Majority Leader Harry Reid (D-Nev.), said senior administration negotiators told Senate Democrats that Bush would veto the package if the genetics measure was included. The legislation would bar employers and insurers from using information from genetic testing to determine how much a person's insurance premiums should be or other business decisions, including hiring. According to CQ Today, "Congress will work to clear the bill early this session".

Congress will work to clear ... that's a rather vague forecast. - J.O.

GINA? Not in the omnibus.

In a recent email to the Genetic Alliance listserv, Sharon F. Terry (President and CEO, Genetic Alliance) announced that the Genetic Information Nondiscrimination Act (S.358) "is not included in the omnibus bill that will come out of the rules committee tonight [Dec. 16] in the House". Terry adds that the House "is worried about a veto from the President, and wants the omnibus to be as noncontroversial as possible".

Two versions of the omnibus, H.R. 2764: Department of State, Foreign Operations, and Related Programs Appropriations Act, 2008, have now passed in both the House and the Senate. Before sending the bill to the President, a conference committee of senators and representatives will work to justify differences in the versions. - J.O.

Consultation paper on proposed Equality Bill for Great Britain

From the PHG Foundation Newsletter, 14 June 2007. Stewart, Alison. “Discrimination Law Review outlines proposals for a single Equality Bill for Great Britain”:

Genetic predisposition to disease is considered specifically. The consultation paper proposes there should be no specific legislative prohibition of discrimination on the grounds of genetic predisposition. It notes that there have been very few documented cases of unfair discrimination against people with a genetic predisposition to disease, and that current non-legislative provisions such as the voluntary moratorium on the use of genetic test results in insurance underwriting, and the Information Commissioner’s code of practice for use of genetic test results by employers, appear to be working satisfactorily. It also rejects the suggestion that people with a genetic predisposition to disease should be considered ‘disabled’ while they are still asymptomatic.

However, the paper does endorse the view that “no-one should be unfairly discriminated against on the basis of their genetic characteristics” and proposes that the situation should be kept under review, with the possibility of further non-legislative measures being introduced in the future if justified by the emergence of any evidence of unfair discrimination.

[PredictER Note: SEE Chapter 8.23-8.31, “The Grounds of Discrimination: Genetic predisposition” IN A Framework for Fairness: Proposals for a Single Equality Bill for Great Britain. Discrimination Law Review. London: Department for Communities and Local Government (www.communities.gov.uk), June 2007.]