The Transcript, Part II

Message (1/22/97, 9:27 am)
From Michael Garland

Sorry to be late with this. I see some of you are already in your second round of comments. Vacation delayed me. No sympathy for that excuse, I presume.

I will address the problem of public participation in the development, implementation, and evaluation of health policy. I will draw on nearly fifteen years work with Oregon Health Decisions, a civic organization dedicated to facilitating public participation in health policy issues in Oregon.

Policy issues are real time affairs. Some decision is on the table. The table may be either governmental (legislative or regulatory or administrative) or private sector (powerful industries whose actions affect the whole society significantly). An example from Oregon is this state's "Genetic Privacy Act" passed in the 1995 legislative session and now being implemented.

Besides an issue, there has to be a "receptor site." This is a legislative committee, an agency, a commission that seeks public input into its decision making process, agrees to use the input, has a plan or method for integrating public input into its process. (If there is no receptor site, no collaborative relation, then the process is thrown into the protest mode. Here the public, spurred on by social critics, organizes different ways to send messages into the policy arena, trying to win the attention of policy leaders. I'm not going to describe that protest mode further.)

Social infrastructure (organizations, leadership, communication links) and method join with issue and receptor site to complete the formula for public participation. Some organization (or coalition) takes the lead in developing communication strategies so that information flows into the policy arena that is a valid and authentic expression of the values of "the public." By the public I mean the political community, or the "polis" of Aristotle. All whose common good is bound up in the mutual dependency and shared authority of a democracy. (It seems we'll have some work making clear which aspect of social existence we are all talking about--market, collectivity, polis.)

Multiple strategies can and should be used, since public participation should involve three broad goals: education, transfer of information, and nourishing the sense of community.

This approach also calls for a clear and planned partnership between experts and the general public. Genetic experts should be called upon to provide facts and projections of probabilities based on the best science. They have to work out among themselves what is the "best science" at the moment that policy decisions are required--usually before all the data is unambiguous, requiring a large dose of "expert opinion." The public should be called upon to articulate the values that comprise their common good and which are relevant to the specific policy issue at hand. For example, what are all the values involved in establishing policy about genetic privacy?

The policy process is a never ending game. Each solution is the basis for the next problem. Maintaining the infrastructure and social energy for public involvement is a constant need. The greatest barriers to public involvement come from a weak sense of community in the United States (hyper-individualistic culture), alienation from political life (a minority of eligible voters actually vote), cynicism about politics and power (a culture of disbelief: leaders are expected to manipulate rather than communicate), and the feeling of being voiceless in matters political.

My comments will develop within the above framework. I welcome reactions. Now I have to run off to "participate" in the health policy arena by attending a meeting of the Oregon Medicaid Advisory Committee.

A bumper sticker caught my attention the other day. It summarizes my philosophy of public participation. "Commit deliberate acts of planned and organized solidarity."

Michael Garland

Message (1/23/97, 1:58 pm)
From Eric Juengst

Colleagues!

Here are my responses to Alex's requests for a synopsis of my presentation and a list of approaches for stimulating public dialogue. Below that, I've added my comments and questions about the contributions that have already been posted. This was a good idea, Fowlers!

"Beyond the Science: Ethics and the Human Genome Project"

In this presentation I plan to focus on what the HGP has to do with the "public" at a relatively high level of resolution: at the level of the individual families which make it up. I think that one of the largest, but most neglected, effects of genome research on the public will be the complications that increased genetic risk testing will create for the lives of extended families. At the same time that geographical dispersions and sociological changes (like serial monogamy and blended families) make extended family bonds easier to attenuate and harder to encourage, the fruits of genome research will increasingly raise questions about what it means to have biological kin. Do I have any familial obligations to cooperate with kin intent on learning their (our) genetic risks? Do they have any familial obligations to disclose the risks they discover to me and mine? While for public policy and professional ethics there are normative traditions and theories to draw upon, we do not have many well worked out, widely shared theories of the mutual moral obligations of kin. In part, this is because we have so many firmly held specific theories on this subject, each based in the odd histories of our own families.

In this talk, I will not propose a theory of the proper moral dynamics of family life for universal adoption. Sorry. What I will try to do is to outline the kinds of "familial ethics" questions that the public should expect to face in the wake of increased genetic risk testing, and to discuss them from the perspectives of three kinds of American families: the Traditional Sessile Family ("The Waltons"), the Socially Constructed Family ("The Bradys") and the Dysfunctional Family ("The [Bart] Simpsons"). Thus, I will not spend much time on the public policy problems of protecting genetic privacy and preventing genetic discrimination that usually preoccupy discussion of the ethical implications of the HGP. I hope Mark's talk will address those, since they do seem to be the Congress's primary interests in this area.

Approaches to Stimulating Public Dialogue

1. Get Media Coverage. There seem to be three effective ways of doing this:
   1. Create a public scandal. I'm not kidding: this works great. Look at the public dialogue around assisted suicide that Dr. Kevorkian has generated. More recently, and more locally, a sensationalized Cleveland newspaper series about research on human subjects has generated a renewed public discussion of those issues in Ohio, leading our Senator Glenn to help rescue the new National Bioethics Advisory Commission so that it can re-address those issues. Or how about the resignation in high dudgeon of Dr. Watson, and its affect on public awareness of the DNA patenting issues? Not to mention the Tuskeegee Syphilis study, the Recombinant DNA debate, and The Band Played On: all springboards for major public discussions of science policy. Some worry that scandals do more harm than good to a constructive science/society relationship, but the track record rarely bears that out: the policy outcomes of all of these episodes are generally counted as real progress on both sides of fence. How about this for the HGP: Just how did the HGP get the human DNA now being sequenced anyway, and how did its sources get elected to represent the species?
   2. Insult some group. Unfortunately, this works pretty well too. Recall the effect of Gay outrage on HIV research policies, the creation of the Women's Health Initiative, and the demise (or disguise) of the PHS "Violence Initiative." The public dialogue created by this approach does tend to be concentrated within the slighted group, which is a limitation. But with the HGP, it's plausible that we might eventually have find a way to offend just about everyone.
   3. Get written in to a prime-time script. Here's a less contentious way to get the HGP into everyone's "back fence" conversations: weave it through a season's worth of a prime time series like ER or Melrose Place. As a bioethics teacher, I used to be able to use just about every episode of L.A. Law to trigger class discussion. I don't know any examples of national science policy flowing from TV shows, but I would not be surprised if public awareness of some science policy issues (Alzheimer's disease, earthquake readiness, biohazards) weren't founded on them.

2. Create a lay constituency and a lay cause. One of the most interesting examples of public stimulation I've seen was the production of a brochure by the Alliance of Genetic Support Groups on questions to ask your friendly neighborhood geneticist when invited to participate in a gene-hunting study. As it went out through that network we actually saw the impact in the form of researchers coming back to NIH to get advice on how to respond to the rather troublesome questions that their subjects were now asking. At the moment, the issues surrounding BRCA1 testing are getting renewed public attention because of the formation of a coalition of Jewish women's groups created to publicize them. There seem to be three strategies for attracting the critical mass necessary for creating such constituencies: see a) through c) above.

Comments:

Ron: The HGP will affect Christendom (which, I gather, is what you will mean by "the public") in lots of other contexts besides reproductive genetic testing, and I wonder if you'd want to touch on them as well. I'd be interested, for example, in knowing what the Church(es) would have to say about the family dynamics issues that adult screening for BRCA1, can raise: what does it mean to "Honor Thy Father and Thy Mother" in these situations? What do we owe our kin by way of cooperation or disclosure in risk testing? Another issue of interest to many in the AAAS audience would probably be what various doctrines of stewardship teach us about the intellectual property and patenting issues that swirl around the HGP. Should the consciences of a Presbyterian and a Greek Orthodox scientist be equally calm at staking claim to a stretch of DNA? What should a Finno-American Secular Humanist scientist like Burke know about these views in dealing with these publics?

Michael and Celeste: Does Celeste's critique of "artificially manipulated dialogues puppeteered by experts"(!) as a vehicle for public participation apply to the process that Michael describes and that the Oregon Health Decisions project exemplifies? Her description certainly sounds like many of the "Public Forums" on the HGP that I've attended.

Eric T. Juengst, Ph.D. (etj2@po.cwru.edu)

Message (1/24/97, 1:56 pm)
From David Micklos

Greg, Alex, and Panel Folks,

Follows is a summary of my remarks for the AAAS meeting, "Educating Precollege Students for the Gene Age."

The premise of my talk is that systematic genetics education, beginning in elementary school, is the most reliable method for building a genetically literate public in the Gene Age. The adult population is essentially a lost cause in genetics education. Adults have great difficulty learning about modern genetics or making informed decisions, because they have not developed cognitive structures upon which to "hang" new information. The mature public's difficulty in learning about science can be equated to the difficulty of learning a foreign language in adulthood.

These contentions are supported by research and data from several fields: 1) Mass communications research shows that mass media messages have very limited and short-lived effects. 2) Cognitive science research suggests that primary memory banks are filled up relatively early in life -- with associational learning layered on these pre-existing foundational learnings. 3) Learning and memory research shows long-term memory is facilitated by "spaced training" -- repeated exposures punctuated by rest intervals. 4) Survey and educational indicators show that most Americans have had too little formal science and math education.

A prescription for education in the Gene Age includes:

• Use genetics as model for whole learning -- integrating biology, chemistry, physics, math, social studies, and current affairs.
• Vertically integrate genetics into science instruction at several stages in student development.
• Begin systematic genetics education in upper elementary school.
• Focus effort on integrating a modern genetics approach in middle school life science.
• Use authentic analogs of genome research at higher levels.

Using this approach would emphasize three themes in the modern concept of genetics:

• Show the common genetic ancestry of all living things.
• Show that people are more alike genetically than they are different.
• Allow simple organisms to be used as models for gene function in complex organisms.

• Show the uniqueness of each living thing.
• Are the basis for identifying and comparing genes.
• Are the basis for diagnosing disease and identifying individuals.

• Genes and environment work together to set the parameters of life and health.
• Understanding how genes work is a prerequisite to putting genes to work in health care and industry.
• Genes provide entry to metabolic pathways and rational targets for drug discovery.

Cheers, David Micklos

Message (1/31/97, 1:21 pm)
From Celeste Condit

Greetings colleagues. My apology for a slow reply to Mr. Zimmerman's queries, but many things press on us. Anyway, I want to reply in two ways. First, I believe that Dr. Zimmerman's separation of "now biotech issues" from "other/future issues" is artificial and not particularly useful. I don't see a clean line between the case of liver transplants and vaccines and other issues. While each particular sub-treatment has its own particular concerns and we need to address these with specificity, I can't really tell why current issues raise no concerns but future ones do. Obviously, one of the biggest areas of concern for ELSI issues is reproduction, and I focus my own work heavily in that area. However, (and this is "second") there are also issues with regard to vaccines and liver transplants. Any action taken in a marketplace has an effect on all of the participants in the marketplace (and often those excluded from the marketplace). Given that resources are not infinite, the decision to use very expensive technologies for liver transplants are always also decisions not to use resources in other ways. Given that health insurance systems are always collective (whether public or private) this necessarily means that either everyone in the system will pay more for health insurance (and thus, pay less for other things...e.g. education, crime prevention, insert your favorite program) or that others in the system will be deprived of health care they want/need. The same is true of the choice to enforce vaccination, even with a better vaccine. There is a trade-off between the costs of avoidance for all and the costs of curing a few. These "rationing" problems present difficulties throughout medicine today. However, because genetics is largely an "anticipatory" medicine, genetic research and technologies may tend to raise the issues with greater urgency and force. Genetics thus becomes a focal site for discussion of the values and concerns. Moreover, in Dr. Zimmerman's original message and in his reply to me, he presents the class Enlightenment vision of an orderly, relatively simple universe in which "man"-the-controller can anticipate and control all elements of the equation. But post-Newtonian physics, chaos theory, and other post-modern theories have made two important points. 1) the universe is always indeterminate in such a way that patterns may arise that are comprehensible but none-the-less not amenable to precise prediction and control, and 2) (easier to understand) control always costs, such that at some point the advantages of control reach a point of diminishing, and even negative returns.

So, while in theory it might sound wonderful if we can fully target every medical intervention to the precise genetic configuration of the individual, thus being more "effective" and having fewer "side effects" to the individual patient, more recent theories suggest that we ought to expect that the complexity of interactions in each human subsystem will work to thwart such perfect targeting, and that such direct targeting may have individual or social costs that make the "side effects" and "inefficiencies" much more problematic than the advantages of the targeting.

To some extent, of course, this is an empirical question about costs/benefits. However, in the past, medical science has been so sure that intervention and control were always so good that it has led to medical interventions that are difficult to justify in terms of research, but we are paying for them none-the-less. Thus, we should start out not with the frame "control is always good and no problems can arise" but rather "control is sometimes good but we need to cast a wide net for the costs of control and expect to make cost-benefit analyses rather than merely assuming all costs are worth bearing." This is the point of some of the feminist research on the use of reproductive technologies---the focus has been exclusively on the benefits and the costs to women have been ignored. The same will be true of reproductive genetics, but also of any genetic screening program. So this is why I think that multiple components of the "public" (beyond merely a direct market sector) ought to be thinking about the impacts of even the most arcane and specialized genetic technologies/research.

Celeste

Message (1/31/97, 4:00 pm)
From Glen Evans

I have enjoyed the discussion so far among the various speakers and the exchange of opinions about the genome project. However, I now realize that I am the lone participate who is actually in the trenches of the HGP, so to speak, since the majority of my activities are now actually generating human DNA sequence. Thus, with this background in mind, and well aware of the distinguished panel of experts also speaking in the session, I will try to give my comments from the perspective of the academic research scientist.

Given my current activities, I would first like to talk about the nitty-gritty of the genome project and what the public should know about what is going on. This will include what the genome project actually, the goals and time lines, the accomplishments so far and the "excitement pervading the scientific community over this effort, as well as what "product" actually is, What the "public is getting for their $3,000,000,000. This will include some fairly detailed real life examples of current discoveries and similarities to science fiction of just a few years ago (i.e., Jurassic Park). I'll also point out the "non-human" aspects which are the model organisms also being sequenced as part of the human genome project. I'll point out the implications in major areas such as medicine, agriculture, biotechnology, evolution, development and others.

I will then talk about the immediate issues, ethical and educational dilemmas if you will, as well as longer term issues and when they are likely to arise. This will be more of an overview than a detailed discussion of each topic. This will include issues like insurance, genetic privacy, gene therapy, genes for personality (i.e., the dog genome project) and biological warfare to name a few. Longer term issues include germline vs. somatic gene therapy, new eugenics and artificial life. I would consider the "public" for this argument as two populations: first, the US taxpayers who are paying for the generation of this information and its deposition into the public domain and 2) the world human population, in the third world, who may benefit (or suffer the consequences) of the information without having asked for it. And the question of what does the human genome have to do with the public is a real one. It might be better phrased as what consequences of the availability of the human genome DNA sequence that will affect the public and what measure should be taken to allow the public to prepare for it. Finally, I'll also try to suggest some mechanisms (particularly education at the primary school and high school level which may change our Nations thinking about science in general and genetics in particular.

Hope this helps,

Glen Evans

Message (1/31/97, 1:47 pm)
From Fatimah L.C. Jackson

"Involving Ethnic Communities' Concerns and Priorities in Human Genome Research"

Advances in DNA technology have made widespread genetic testing highly feasible and virtually inevitable. Two central questions remain, however: will comprehensive molecular genetic testing be harmful to targeted groups and once initiated, will such testing be helpful to such groups? Unfortunately, the capacity to test comes in the wake of a history of "bad science" initiatives that were specifically directed at such groups, particularly African Americans. Testing became yet another tool of coercion, subjugation, and oppression. Will the HGP simply reiterate these moral and ethical errors? On the other hand, the most important scientific and biomedical merits of molecular genetic testing among ethnic communities will be largely determined by the relevance of the sampling strategies and the underlying research hypotheses to the explicit priorities of tested groups. Genetic testing must address the research issues of studied groups and not just the priorities of scientists. It is essential that ethnic communities wishing to be included in the HGP be educated about the resolution power of the existing technology (its strengths and limitations) and permitted to meaningfully collaborate in the development of hypotheses, research design, the collection, analysis, and interpretation of data, and the development of subsequent policy initiatives.

Fatimah L.C. Jackson

Message (1/4/97, 2:08 pm)
From Greg Fowler

Thank you for your excellent and informative postings in response to the first -- and in some cases -- second round of inquiries as to your construct for "the public" and some strategies and approaches for how to translate its collective (individual?) values into real-time policy.

What you said was most interesting and has already served well to provide a solid foundation for the Feb. 17 symposium in Seattle. My understanding of your collective view of "the public," which needs to be kept "broad and inclusive," comprises a wide spectrum of "...individuals who share their values and social narratives to the construction of a social discourse." These various subsets of "many publics" include:

• the ethnic,
• religious (only Christian?),
• "extended family members,"
• the "memory-bank" functional (i.e., primary and secondary school
• students),
• the "U.S. taxpayer,"
• the disenfranchised, and
• "the polis."

The size, composition, education and financial security of each will predictably play a role in the type, level and quality of participation in discourse about the new genetics.

On the basis of everyone's ability to carry on some kind of discourse at some level of articulation about something, "the public" is, then, "everyone" -- especially, those who "should play a role...in shaping how society should deploy...technologies and the information correlated with them." Is this what you said? I'm not sure...help me out with this one.

What I think I did hear, however, is what you think "the public" is not. It is a "large entity" which is not to be conflated with "the market," especially the consumer of pharmaceutical products. Anything else you want to add here?

As you all know, discussing real-time strategies for tapping into public values about the HGP is a major focus of our symposium. This process will require certain steps:

• identifying and "connecting" with those values (about the HGP)
• through "public discourse," and
• channeling these values through the proper "receptor site(s)" into
• the policy-making process.

A "scandal," "insult" and (yet another) "prime-time Melrose Place" would get the ball rolling. Interestingly, the "sensationalist" or "protest" approach for getting the attention of "the public" you suggest is not all that remote from the more "conservative suggestion" of "getting an issue on the [policy] table which requires a decision," a "hot issue," if you will, which will serve to "engage" the lay public in thinking, discussing and, therefore, sharing values about it [one of the main points of the excellent article which was suggested to us by Alex -- and a cornerstone of the Oregon Health Decisions approach aimed at enhanced public participation in the policy-making process through "local conversations" and "legislative fora."]

The "protest" strategies (as well as films like "Lorenzo's Oil" and "Jurassic Park") may be only calling attention to the lack of the public voice in the policy-making process and, consequently, a short-lived formula for generating long-term "horizontal" discussions focused on "balancing scientific views with public perspectives including the lay public, humanists, social scientists, and religious and political leaders" -- a "partnership" between experts and the general public. In your view, "public fora" and "traditional surveys" are not effective means to this end: "Remediation does not lie in technical experts constructing artificial debate venues, pumping the participants full of technical information, and then taking dictation from the outcome," you say. But, then, how does the "hot issue" get onto the legislative table?

Several of you emphasized the critical aspect of "education" as central to the process of achieving "scientific literacy," inferring (in my reading) that a basic understanding of the HGP (in this case) would be required for meaningful participation in any policy-making decision regarding its application. Further, a few of you thought that this effort should be concentrated in the primary and secondary school curriculum in lieu of strategies designed for the extant adult populations. The public is not ignorant and irrational. "Substantial segments of the [adult?] public are capable of making critical judgments and independent interpretations and valuations of the HGP," you say.

There is no doubt that enhanced science education in the primary and secondary schools is a major key to the challenges of helping to reinvigorate "participatory democracy" in this country, and with regard to the HGP "...to change our thinking about science, in general, and (the new) genetics, in particular." However, I wonder about the long-term efficacy of not including the adult laity, drawn from all ethnic communities, in the conversation? Judging by the public discourse generated by the Tuskegee Syphilis Study and the physician-assisted suicide initiative here in the Oregon -- not to mention the Recombinant DNA debate, itself -- isn't it possible to generate "mass media messages" with long-lived effects augmenting the "whole-learning" approach to "systematic genetics education?" Is "education" a type/form of public discourse?

The "media" as a useful resource for enhancing public discourse was not a major topic of discussion. Perhaps, this was because you basically agree with the statement that "Reporters tend to write in a vacuum with only limited feedback from their audiences...[with more weight being placed]...on the views (values?) of the scientific world...[than]...other (public?) voices."

Round II

Given the above contributions, what strategy, or combination of strategies, will, in your view, prepare the public to deal responsibly -- and to participate effectively in the policy-making decision -- with the social consequences of the availability of the human genome DNA sequence? Does the "scientific community," itself, have a critical role to play? Is that part of "the public" taking its educational responsibility seriously?

Do you agree that "the greatest barrier to public involvement comes from a weak sense of community...[characterized by]...hyperindividualism, alienation from political life, cynicism about politics and power, and the feeling of being voiceless in political matters"?

Do you agree with the views that "the concerns" of the public about the new genetics primarily revolve around the "pragmatic" and "immediate issues" raised by HGP research: "safety and efficacy, safety of technologies, insurance discrimination, privacy, gene therapy, behavior control, biological warfare, or the "long-term" ones such as germline vs. somatic gene therapy, eugenics, and artificial life? How would you go about getting data on the matter? How might we "tap into the values" underlying concerns of "the public?

Well, this is enough for this posting. The above comments and questions are ones which I gleaned and generated, respectively, from your collected wisdom. I look forward to some responses to my "readings"

Greg

[At this point in the discussion, the symposium participants were faxed copies of a "Decision Analytic Feedback for Virtual Conference" (this will be added soon!) in an attempt to use a value tree and decision table to graphically represent the comments posted thus far.]

Continue with Part III