Rights, Liberties and Biotechnology:
Principles for individual and social engagement with the life sciences

by Paul Billings

“Rights, Liberties & Biotechnology” is an adaptation of a talk given by Paul Billings at the Cambridge Forum, a nationally syndicated public radio show, on October 15, 2003.

Over the last several years, I have taught a course in biological anthropology at the University of California at Berkeley. The course illuminates the changes in people and their identities that are being fostered by developments in life sciences and the biotechnology industry. Specifically, we examine changes in the roles individuals play as men and women; as husbands, wives and children; as family members; in considering reproduction and parenting; as members of groups and institutions; as sick and well individuals; as neighbors, community members, and citizens; and as workers and professionals.

As usual, I have learned more from my students than they from me. Two points are salient in their responses to the course. First, descriptions of these changes strike them as profound, and usually elicit deeply personal reactions. Second, they almost universally express helplessness when asked if such changes can be controlled. They view alterations as inevitable.

Why? It is a consequence of their feelings about science, which — with its inexorable questioning, creativity, hypothesis generation, testing, and constant changing of content and truth — they feel cannot be directed or curtailed. With increasing commercialism, commodification, and market and business connections, the Federal-University-Business Complex is real and tangible for them. It is a Goliath present in their every day lives, altering without their input academic environments, careers, and expectations. The outcome of all this change is unknown, uncertain and seemingly uncontrollable.

What are the changes that are most striking now, or soon will be?

Conception outside the body. In-vitro fertilization — and its first success, Louise Brown — are 25 years old, and on the horizon is gestation outside of a woman’s body. Reproductive techniques have created new families, mixing gamete donors, gestation surrogates and parents in previously unseen ways.

Selection of genetic effects on human traits prior to implantation of an embryo or during pregnancy. The selection can be motivated not only by a desire for particular beneficial effects, but for utilitarian purposes, such as post-birth transplantation.

Enhanced testing of newborns which, in addition to screening for illnesses, will test for developmental, mental, behavioral and achievement-associated traits. Soon this may result in lifelong medicalization and risk modification. A harbinger of this development is the the chronic use of Ritalin and psychotropic medications for behavioral modification in children.

Enhancement of humans. Now accomplished primarily by surgical methods and hormone treatments, genetic selection and manipulation will soon be applied for this end. In addition, implanted machines will be used to supplement (or curtail) our thoughts and memories.

Life prolongation. We now prolong life with therapies that include transplantation; over the last several decades, bodies have become chimeric — part animal (xenotransplantation) or machine (dialysis) and part human. Soon we will attempt to directly manipulate genes that impact cellular aging. Group identification. Genetic tests are creating new associations, layered upon others that include race, ethnicity, religion, and location. In the future, tests could be used to choose our mates and neighbors.

Identity testing and profiling. Governments and businesses currently use genetic technologies for their own purposes. Future goals appear to include a biologically tailored army and new insurance practices.

These developments occur amidst an explosion of health-related information. Individuals feel growingly entitled to high-quality information and are increasingly involved in decisions about their care. This also has consequences for professional experts.

What are some of the values embedded in these changes?

Rationality, control, and intervention in human biology and nature.

Enhancement of nature — so-called ‘human-directed evolution’.

The primacy of the market in distributing medical care, and the use of intellectual property to commercialize body parts and genes.

The attribution of individual failure to biological causes rather than historical, cultural, market, or environmental factors.

A narrowing of normalcy. While biological variation is common, rare variants will almost always become associated with trait changes and therefore become objects for discrimination. This affects social tolerance for different types of people, and may alter the care of those with disabilities.

Inconstancy. These changes do not seem to have a soul or core other than that which can be constructed from a minimum set of genes needed for life, as is suggested in the work of Craig Venter. It is a bleak world of human replacement parts and the persistent change characteristic of science.

These changes and values are full of uncertainties and challenges. They diverge from the historic promise of the Life Sciences and biotechnology industry, which was to help cure the sick. The knowledge and products created so far have been used for health purposes, but their reach has been extended to larger, more lucrative and problematic markets.

How should we respond? It seems to me that we should recognize that some — maybe all — of these changes are important, but not resort to Chicken Littlehood nor replace Life Science myths and dogmas with others. These new conditions allow us to re-examine enlightenment values and rights and to reassert them. It provides an opportunity to conceive and enforce new policies that balance old truths with new knowledge and techniques, and with their benefits for the needy. The situation requires facts, patience, the integration of ideas, vision, effectiveness, and participation.

For instance, a traditional idea to consider is that “all people are created equal”. While such an expression may not be scientifically rational, it is surely good. Another traditional belief is the right of everyone to “life, liberty and the pursuit of happiness”. While this is not genomically encoded, nor does it result from good science, it is important to preserve. There are other traditions to be reconsidered and reformulated:

The right to be let alone, to a private space outside of biological and medical surveillance and analysis.

The right to non-discrimination and non-profiling on biological grounds. We may wish to be judged by the content of our character and behavior, not the DNA sequences of our genomes.

Like our historic right to a universal, quality public education and to health care, we may have a right to a publicly accountable, non-conflicted science. Such an enterprise would have its agenda, participants, and limits linked to full consent by the people needed to conduct it, those whom the resultant knowledge will serve, and who are its funders.

The right to technology which defends our individual freedoms and rights, like those which have aided in the release of wrongly convicted people and could have saved others already executed by the State.

The right to control personal information and access to it — to selectively share it with others, and to learn and benefit from these relationships.

For over twenty years, the Council for Responsible Genetics (CRG) has offered analysis and critique of developments in the Life Sciences and biotechnology. It has been dedicated to understanding, balancing and taking action on compelling issues. In the year 2000, CRG adopted and published the Genetic Bill of Rights: ten necessities for preserving the balance between individuals and the Life Science enterprise. Now more than ever, we need organizations like CRG and entitlements like those noted in the Genetic Bill of Rights.

A quarter century ago, at a time of turmoil and political action worldwide, a song captured for me a feeling common in Cambridge, Massachusetts, in my new home of Berkeley, California, and elsewhere in this country:

There’s something happening here.
What it is ain’t exactly clear.
There’s a man with a gun over there.
Telling me I got to beware.
— The Buffalo Springfield, For What It’s Worth

As we confront the hopes and challenges posed by human biological sciences and technologies — endeavors that are ultimately ours — things still ain’t exactly clear. But surely we ought to beware, and to be hopeful. And, as before, to think and act.

A question-and-answer period followed Paul’s opening speech. Below are several exchanges of particular interest.

Question: This past July, the FDA approved Humatrope — Eli Lilly’s human growth hormone — for use in short, but healthy children. Part of the justification for their reasoning was that short children, whether they have a growth hormone deficiency or not, suffer from certain social and psychological stigmas as a result of their shortness.

You spoke of the narrowing of normalcy, and the importance of tolerance for difference. If you were head of the FDA, what would you have done about the use of human growth hormone in children who were short, but not growth hormone deficient?

Answer: I can remember a discussion of the Board of the Council for Responsible Genetics fifteen years ago where it was suggested that, while growth hormone might be developed as a product, intended primarily to treat people of severely short stature, that would be only an initial on-label market entry. It was clear that the big market was in treating people who just wanted to be taller — and it just so happens that a little growth hormone might retard the aging process, too. So that’s another off-label use that might be profitable as well.

If I were running the FDA, I would make companies that want to sell human growth hormone, prior to its introduction, invest lots of money in advertisements about the benefits to our society provided by, and the fine quality of life enjoyed by, people who are below our society’s mean height. Whatever that number is, there are cultures around the world where that is the norm.

What we’re dealing with here is a great deal about fashion, about something that has been created in part by Madison Avenue, and in part by the makers of these kinds of products. I believe in ultimately letting individuals make choices for themselves — but before that occurred, the social environment should be balanced, with issues of fashion, and issues of market creation through the advertising of producers, identified and well-publicized.

What do you think of practices like pre-implantation genetic diagnosis [PGD], the prospect of genetic engineering, and some of these other practices which allow parents to choose children of a particular type? What you do you think of those practices in and of themselves — if they were cheap, easily accessible, and fair, would you see any problem with them?

I certainly wouldn’t see anything wrong with those practices if they were being used to alleviate suffering, or if a family who had experienced the life of a sick child used them to avoid the birth of another child with a high probability of that sickness. Families have a right to make that sort of choice, and we should protect it. But would I condone genetic selection for moral behavior? No. I don’t think we can define what moral behavior is — and so it would be, in principle, about fashion.

After safety, and after the issue of alleviating great suffering, I don’t think there’s much use for a lot of these selective procedures. There’s no benefit to reproductive cloning; it’s perfectly fine for the world to ban it. Most PGD could be replaced by standard pre-natal diagnosis, by adoption, or by other kinds of ways of having families. We need a more balanced ‘menu’, where adoption is easier, and doesn’t cost fifteen or twenty thousand dollars. An adoption in the United States is as costly as a cycle of in-vitro fertilization.

In general, families who take those selective steps — whether they be to avoid an illness, or to create a child who will be an organ donor for another sick child in the family — and families who contemplate enhancement through selection, are changed by that experience. Some of those changes are painful and difficult. Different kinds of relationships, feelings of guilt and utility, clearly arise in some of those families. We need to recognize that, and to present that information to people. Maybe it will dissuade some of them.

What role do you think the government should have in regulating reproductive policies involving genetic selection?

It’s a difficult question, because you have a collision between individual freedoms — individual rights to health care, to guide the course of your pregnancy — and the public or community issues with which they need to be balanced. Certainly, information about these practices, about their consequences, and about the lives of people who have a particular genetic variation need to be given to the end-user.

Right now, most pre-implantation selection is conducted under the auspices of research protocols; what regulation there is occurs as part of the normal regulation of clinical research in this country. The IVF industry is one of the most unregulated medical or health-related enterprises in the country. It is a very big business which, to some extent, is self-policed – and, to a great extent, not policed at all. We can’t even collect very accurate information about what’s going on. For example, it’s well known that, as a result of IVF practices, offspring so conceived have higher instances of chromosomal changes and other genetic conditions. But getting data about this has been very difficult, because the places where those types of study would have to be done aren’t willing to share the information, since it might affect their market share.

The federal government clearly needs to have a role in regulating these practices.

I believe that, over time, and with balanced information, people will use pre-implantation genetic techniques only in very rare instances. We may find that, with more understanding and more information, and with more widely available care for individuals with, for example, Trisomy 21 or Down Syndrome, the pressure to perform such selection procedures might go down.

As biotechnology advances, along with the costs of access to it, how do we prevent or reduce worldwide inequities in the availability of its benefits?

That is an extremely important question. To restate it: We already have an inequitable distribution of goods and services in this country and worldwide, and we’re talking about the development of new tests, new treatments, new products of science and biotechnology, which will inevitably be expensive and will be increasingly unaffordable to most people in the world. Any distribution that would take advantage of those inequities is fundamentally unfair, and has to be dealt with before those technologies are released anywhere. What can we do?

We can recognize that an equitably distributed transfer of wealth from countries, and from sectors of those countries that have already gained so much wealth from technology development, is appropriate. We’re already seeing this. Bill and Melinda Gates, who have clearly benefited from technology, are very actively using some of their wealth — billions of dollars, transferred almost directly — to ensure the distribution of life science products in developing countries, for the benefit of people who could otherwise never afford them. Is there enough wealth in our country to do this for everyone? I don’t know the answer to that, but I do know that we ought to be doing it. We ought to be leading the world’s other wealthy sectors in that transfer. A situation where only five or ten percent of the world’s population benefits from developments in our knowledge about disease causation, from better pharmaceuticals or better treatments, is unacceptable. It is selling out the hope that everyone would benefit from biotechnology.

It would appear, from reading much of the science press, that much of the emphasis of genetics is on inherited diseases, predisposition genes, and so on. This probably represents a very small portion of disease causality globally, and we know that in-utero and ex-utero mutations come about from other kinds of environmental contaminants. We have over 85,000 industrial chemicals, most of which have not been adequately studied. Do you think there is something happening in this research to fill the void, or are we still focusing on inherited traits and predispositions rather than on environmental causes of mutations that might be associated with disease?

You’re absolutely correct that people have estimated the burden of truly genetic or inherited illnesses compared with the overall disease burden, and have found the former to be only a small fraction of the whole. The continued emphasis on genetics is, I think, simply an artifact of our development, over the past twenty-five or thirty years, of very powerful, very effective technology for assessing DNA sequences and the role of genes in experimental systems — and, to some extent, the role DNA plays in human cell systems. We exploited what we could do with the technology at hand. Technologies were also more difficult to develop to the same level of quality in the environmental sector.

My belief is that the paradigm of over-emphasizing genetic technologies and the genome’s role in disease causation is beginning to fail. One sign is the development of systems biology, for which there is currently a rapid proliferation of research centers, academic departments, and institutes. Systems biology is just a another name for the interaction of environment with genetics. It’s dressed up in very fancy bioinformatics, and there are some new systems and new ways of thinking about them, but basically it is the modeling of how environments and genomes interact.

The paradigm of pure genomics is a failure. The reductionism and determinism inherent in it are scientifically bankrupt. The data just isn’t there to support it, and in the future there will be far more attention to environmental influences on genomic effects. Still, at the level of human health, I think we are going to see one more wave of pure genomics — what we might call the fruit of pharmacogenomics, or so-called personalized medicine. This approach says that it really doesn’t matter what caused your illness, because illnesses occur in the body, the biochemistry of which genes have something do with — your ability to metabolize and respond to certain drugs and treatments, and not to others.

We’re going to see pervasive assessments of people’s genomes and proteomes and other-omes, all in the name of tailoring medicine, of reducing adverse reactions and side effects and so forth. As long as the evidence supports the conclusions, and it’s safe, that’s probably good on the whole.

In your positions I see a lot of conflicting values. There’s the value of individual privacy, the value of corporate ownership, the value of the government to protect a common good, and you yourself listed some of the values you saw inherent in the science of genetics as it exists today. Are we as a society approaching a “meta-value,” a way to balance and sort the needs of the individual and the needs of the corporation and need for the common good as we move forward? Or should we do as Bill McKibben has suggested in his latest book: Just stop and work out our other problems, and when we’re ready, move forward again?

I’m very happy that Bill McKibben wrote his book, and I’m very happy with the discussion that he fostered. But I disagree. I don’t think we’re going to find a one-size-fits-all meta-value. In the ways that it can balance forces, we’re going to find a role for the nation-state — but I believe that real power is a bottom-up power. It’s individuals who make decisions about themselves, balancing what I would call enlightenment values with new knowledge about their system’s biology. By sharing that information and by forming groups among diverse types of people who have interest in some of these issues, some of the values will percolate upwards, and will actually create new communities of interest. Those bottom-up, little, regional cultures will set standards and take on cultural practices. These coalescences, their percolation up through our politics, their influence in local elections and state elections and then into national elections, are the vehicles for creating new values.

A re-invigoration, a bottom-up invigoration, is the way to develop a system which respects the individual needs of the people who truly need biotechnologies.

Paul Billings is Adjunct Professor of Anthropology at the University of California, Berkeley and Board Chair of the Council for Responsible Genetics. Paul is also Vice President of Genetics and Genomics for the Laboratory Corporation of America.