Governing the Genome

Governing the Genome

Which genetic modifications should be encouraged and which outlawed?


The telephone rings, and it's Mercy Viana, a press officer at the White House, responding to a query about President George W. Bush's Council on Bioethics, the creation of which was announced during the President's August national address on stem-cell policy. Asked when it will be formed, Viana replies, "We don't comment on timetables." Asked about the process by which the members of the council will be selected, Viana replies, "We don't comment on process."

Against the backdrop of war, the withholding of information about an emerging advisory council seems of little moment. Still, there may be some value in noting that the President's new council will not only advise on stem cells but also "consider all of the medical and ethical ramifications of biomedical innovation." In the era of the sequenced human genome, advances in cloning technology and ongoing experimentation with human genetic engineering, this is no small matter.

Indeed, while the debates over genetic "biomedical innovation" have not yet reached a status worthy of the metaphorical invocation of war, the battle has begun. Preceding a House of Representatives vote in July to ban human cloning, including the cloning of embryos for research, University of Chicago bioethicist Leon Kass publicly endorsed the ban as a means "to seize the initiative and to gain some control of the biotechnical project," which he, and others, believe to be the "eugenic redesign of future generations." The one known fact about the President's bioethics council is that Leon Kass has been appointed as its chair.

Is Kass correct in his view? A little more than a decade after the launch of the Human Genome Project, five and a half years since the appearance of the cloned sheep Dolly and sixteen months after the completion of a draft sequence of the human genome's 3 billion bits of DNA, are we headed, as Kass perceives it, toward "the soft dehumanizations of well-meaning but hubristic biotechnical 're-creationism'"–a prospect that he compares to "the cruel dehumanizations of Nazi and Soviet tyranny"?

A random survey of recent newspaper headlines gives some cause for concern. "Eggs May Be Fertilized Without Sperm," "Britain's First 'Designer Baby' to Be Born Soon" and "Fertility Ethics Authority Approves Sex Selection" are just a sampling of recent stories that tell of the accelerating conjunction of genetics and the fertility clinic, the site where the initial battle over the human genomic future will be waged. The gee-whiz science story here (and it's not a small one) is that we are nearing the point where we will unravel one of the great mysteries: How does a single fertilized egg cell become a human being? How does the genome of that first single cell and all the cells that follow "know" precisely how and when to turn on and off the genetic code so that a baby is formed and develops into adulthood? The molecular and cellular answers are beginning to come into view.

But along with that view comes a sense of the changes it might demand in our conceptions of who we are and, more daunting, the opportunities it might present to alter who we are. Deepening the anxieties generated by these advances is the reality that no one, not even the most advanced scientist, knows at this point how far-reaching or how limited the potential for genetic engineering of the human will turn out to be.

"Biology will become an engine of transformation of our society," writes Nobelist and Cal Tech president David Baltimore in a preface to the published human genome sequence. "Instead of guessing about how we differ one from another, we will understand and be able to tailor our life experiences to our inheritance. We will also be able, to some extent, to control that inheritance." In these three sentences, Baltimore expresses why genomic knowledge threatens to take us to the brink of social chaos. The detailed knowledge of our genomes–all 3 billion bits of DNA, which include all our genetic material with its genetic certainties, numerous genetic probabilities and its predicted "load" of five to ten potentially lethal genes carried by each of us–means that a genetic reordering of our individual lives and our society is coming in the workplace, in the classroom, in our courts, in our coupling and in our children. While the transition will be at times tumultuous, most scientists believe it ultimately should prove manageable, just as we have socially accommodated other biomedical knowledge through legal and regulatory protections.

But when it comes to the ability to control that inheritance, there is little historical or ethical precedent to serve as a guide–just science-fiction stories. Will human beings become simply another GMO (genetically modified organism), like Monsanto's Roundup Ready soybean? Or will the genetic revolution realize the dream of addressing enormous swaths of human suffering? Will it even be able, as some hope and others dread, to extend its reach into the suffering that some believe lies embedded in that vague tissue called human nature? Will we treat modifying genes that contribute to disease differently from those that contribute to cognitive features that we label intelligence? Will we monitor athletes for genetic additions that improve performance? (The International Olympic Committee has already called a meeting to address this issue.) How will government intervene between prospective parents and their decisions about the genetic makeup of their children? Will access to genetic enhancements create entirely new and wider social divisions, including, as some have suggested, "the creation of a master race"?

These questions are the central concerns of a growing number of geneticists, sociologists, bioethicists and legal scholars. In September a group of progressive scholars and activists, led by health law experts George Annas and Lori Andrews, gathered to draft an international treaty to ban species-altering experiments. While they might be able to agree on a broad accord banning human cloning, as well as germline genetic modification (genetic alterations inheritable by future generations), they also have serious differences. Some want to emphasize protection of individual autonomy in decision-making, while others want to more aggressively assert a societal prerogative. These types of differences flared up in the Congressional debate over the ban on human cloning. While some of these scholars, and most Congressional Democrats, wanted to protect the ability of scientists to clone embryos for research purposes, some reproductive rights advocates, environmentalists and socialists forged a coalition with religious conservatives, ranging from Pat Robertson to the Pope, to ban all cloning.

The division among progressive allies is a signal of the genomic politics to come. While progressives have traditionally sided with scientific advance, an emerging group wants to shut down certain lines of research until protections against a genetically modified human future are in place. They share Kass's concern about the possibility of a regime of reproductive eugenics that would allow parents or society to select genetic traits of children, and the subsequent creation of a genetically superior ruling caste. On the other side are both those who view genetics simply as an extension of existing biomedical practice and eugenics enthusiasts who embrace the possibilities for genetic enhancement and alteration. But all agree with philosopher of science Philip Kitcher's conclusion that since we have "left the garden of genetic innocence, some form of eugenics is inescapable."

Right now we still don't even know how many genes there are, what their functions are or how they are regulated across a human life span. Furthermore, the most pronounced result of the human genome project so far is the lack of any major genetic discoveries related to common diseases. Not since the identification of genetic variants related to breast cancer in 1994 has there been an announcement of such a discovery. Some scientists suggest that this indicates that when it comes to complex diseases, and even more so to complex human traits, it will be a matter of many, many genes each contributing a little. While some think this complexity undercuts any simplistic notions of genetic determinism or genetic alteration, others take a more measured view. Explains University of California geneticist Charles Langley, who once served on the National Institutes of Health (NIH) genome project's planning committee, "The complexity doesn't mean that we won't understand it. It just means that we won't understand it as planned."

But the billions of public and private dollars now invested globally in understanding how the genome works and what will be necessary to manipulate it leave few in doubt that we will come to understand it and devise the tools to manipulate it. For the reality is that once we discover the means to manipulate DNA for therapeutic purposes in our drive to cure disease, we will have discovered the means for manipulating DNA for any other purpose, such as genetic enhancement or even, as some have suggested, incorporating genes from other species into the human genome.

No matter what roadblocks might be placed in the way, the human genome is now and forever in our midst, and its manipulation will be difficult to simply prohibit. Neither the relatively small-scale technology required nor the individual or societal belief in biological benefits will be easily reined in by a regulatory body. As with the cult that is now trying to clone humans, those who want to engage in the practice will almost always be able to find scientists for sale and an accommodating locale. So what, then, should be done to manage this new knowledge? Learning how to govern the genome will be among humanity's crucial tasks for the foreseeable future.

While most scientists foresee the first wave of genomic knowledge and power as at least a decade away, all use the same phrase when it comes to the prospect of genetically enhancing and altering the human species: It's not too early to begin the discussion.

If there has been a focal point of bioengineering concern for scientists, it has been the genetic engineering of the human germline–alteration of the reproductive cells or the tissues that produce them such that any genetic changes will be passed on to all future generations, a prospect that Britain's leading science journal, Nature, recently called "biology's last taboo." Germline engineering has already been done with mice and other mammals, with whom we share a considerable part of our genetic heritage. While the efficiency is still far too low to even consider using similar techniques on humans, scientists express no doubt that it is simply a matter of time and effort before we get there.

Certainly Eric Lander, the director of the genome center at MIT's Whitehead Center, believes so. Just weeks before the June 26, 2000, White House announcement of the finished draft genome sequence, Lander called for a ban on human germline engineering. "Already there are well-meaning discussions about improving the human DNA," he warned his audience. "I find this somewhat hubristic myself. It's been 3.5 billion years in the making. We've been able to read it for the last, oh, I don't know, year or so. And we suddenly think we could write the story better? It's very amusing." Added Lander, "I would have a ban in place, an absolute ban in place on human germline gene therapy. Not because I think for sure we should never cross that threshold, but because I think that is such a fateful threshold to cross that I'd like society to have to rebut that presumption someday, to have to repeal a ban when it thought it was time to ever try something like that."

In part, Lander was responding to the enthusiastic support for germline engineering expressed by a group of his fellow biologists at a UCLA conference two years before. "Evolution can just be damn cruel, and to say that we've got a perfect genome and there's some sanctity? I'd like to know where that idea comes from, because it's utter silliness," declared the cold-eyed, ever-provocative Nobelist James Watson at the time. Watson had no doubt where the real ethical dilemma lies. "Some people are going to have to have some guts and try germline therapy without completely knowing that it's going to work…. The biggest ethical problem we have is not using our knowledge…people not having the guts to go ahead and try and help someone." At the June 2000 press conference, I asked Watson what he thought of his friend Lander's proposal for a statutory ban on germline engineering. "Disaster," he spat back without hesitation. "It's germline, if anything, that one day will save us." Save us from what? "Oh, something like AIDS," he suggested.

Last fall a working group convened by the American Association for the Advancement of Science (AAAS) weighed in, agreeing with Watson on his antimystical view of the genome but aligning itself with Lander's perspective on the need to impose an obstacle to proceeding until we as a society have made a conscious choice to do so. What institutional body should make the decision to go ahead or not was left open by the AAAS working group. They could not reach agreement among themselves. Currently, the Recombinant DNA Advisory Committee (RAC) has authority over publicly funded gene experiments, and has so far refused granting permission for anything involving germline engineering.

But scientists or clinicians operating outside of public funding or publicly funded institutions are under no obligation to bring their procedures before the RAC for approval. So it came as no surprise when a New Jersey fertility clinic this past May announced that it had developed and performed an in vitro fertilization procedure that inadvertently resulted in the newborns having genes from three adults–and that this new genetic hybrid was evidenced in all the cells of the babies, including their germline cells. For now, the Food and Drug Administration has stepped in to declare the clinic's fertilization procedure as coming under its authority and only to be used with FDA approval.

That in no way, however, addresses the more encompassing scenario of parents beginning to select genetic traits at the embryonic stage. Already, negative selection is performed at fertility clinics where embryos undergo pre-implantation screening for disease genes. Eventually, most believe, this will be expanded to include positive selection of genes for specific traits, and finally enhancement or alteration of genes. When this occurs, as in the New Jersey case, changes made to the embryo show up in all the developing organism's cells, including its germline cells. Whether it is Lander's call for an absolute ban, the AAAS recommendation of a moratorium or the demand by some for a permanent prohibition against germline engineering, an act by Congress will ultimately be required so that the private sector is covered as well.

The quandaries posed by genetic engineering stir the greatest concern when it comes to neurogenetics–alteration of those genes that are found to contribute to the complex traits we call intelligence or personality. At the July 1999 annual summer symposium on genetics held at the Jackson Laboratory in Bar Harbor, Maine, LeRoy Walters, the director of the Kennedy Institute of Ethics, urged the gathered geneticists to consider the possibility of establishing a base line for that portion of intelligence that is genetically determined. For anyone falling below the base line, he argued, government should guarantee access to neurogenetic enhancement to achieve the minimum. Otherwise, Walters warned, we stand in danger of identifying and dooming a new genetic underclass.

There are those who, while agreeing with Walters's assessment of the problem, vociferously argue against his proposed solution of a government genetic welfare program. Biomedical legal scholar Max Mehlman, director of the Case Western Reserve Law & Medicine Center, is one of them. "I hate to be hyperbolic," Mehlman says, "but I see this as the most fundamental challenge to our notions of humanity and society in our existence as a species. The possibilities range from creation of what I call a gene-nobility all the way to what some people predict are divergent intelligent species. That's not going to happen in twenty years. But, again, there's no technological impediment…to that happening in a few generations." Mehlman, who opposes any state control of genetics but also worries about an unregulated genetic market, proposes the opposite of a government genomic guarantee. Instead, in a paper written under a grant from the NIH human genome center and published last year in the Iowa Law Review, Mehlman has proposed an extensive system of universal genomic profiling under which genetic enhancements would be controlled throughout an individual's life. A genome profile taken at birth would be regularly checked to see whether enhancements had been performed. Genetic enhancements would be controlled just as narcotics are today. While acknowledging that such a future looks like a genetic police state, for Mehlman this remains a superior alternative to state-sponsored genetics or a society with a genetic underclass locked into eternal subservience by a ruling, self-perpetuating genetic aristocracy.

When confronting such pivotal debates and decisions we imagine ourselves a democratic nation and rhetorically desire the broadest participation. But at the same May 2000 conference at which Eric Lander made his proposal for a germline ban, US Supreme Court Justice Stephen Breyer told the audience of geneticists and science policy-makers that he believes genetic technology matters should first be shaped and "focused by previous conversations between…economists, scientists, the biotechnology industry, and those familiar with the operation of the capital markets." Only "eventually" does Justice Breyer see inviting "the public at large" to this "conversation." As an example of the wisdom of this approach, Justice Breyer pointed to the success of the Harvard Electric Policy Group in forging the consensus for deregulation of electric utilities.

Given the false promises and disastrous results of that deregulation, Justice Breyer's call for a best and brightest to predetermine the parameters of public genomic policy might seem somewhat problematic. Yet Justice Breyer was really doing no more than describing the existing reality, whereby a genomic cognoscenti is having a conversation to decide what questions will be considered legitimate, who will be allowed to ask them and who will be permitted to answer. Already, entire categories of questions have been moved beyond the bounds of respectable inquiry. For example, the conversation is such that no one in the United States may now legitimately dissent from the patenting of genes, even if the American College of Medical Genetics and James Watson are more closely in agreement with Jeremy Rifkin's call for a public trust to hold the human genome than they are with the biotechnology industry's desire to grow the list of Molecular Millionaires. Nor may one now advocate a temporary ban on genetic testing until appropriate protections are in place. Even though two successive reports by the now-defunct Congressional Office of Technology Assessment raised the option of a moratorium on workplace genetic testing as a means of protecting workers in lieu of strong genetic antidiscrimination laws, no such action was ever taken. In the meantime, the Republican leadership in Congress has successfully buried proposed genetic antidiscrimination legislation for the past five years.

Where can we look for an alternative to Breyer's paradigm of our genomic futures being determined by science and industry elites? At first blush, one might consider the groups formed by individuals whose families suffer from genetic disorders. But these groups are formed in the legitimately desperate search for cures. Only belatedly do they come to recognize the inextricable relation between genetic justice and social justice. Many of these groups have united in the Genetic Alliance, whose executive director, Mary Davidson, explains that often such groups come together to fund the search for the gene or genes responsible for their suffering. Only after the genetic source of their suffering has been found and they are informed that a cure is most likely decades away, she says, do they realize that protection from genetic discrimination might be needed. Some of the groups have also come to discover that the sample tissues and funds they donated in the search for the mutant gene have been used to create an exclusive patent for the research doctor and medical institution they turned to for help. They may also discover that neither they nor their group receive any portion of the royalties or licensing fees now required of those who use the genetic test developed with their help. In the case of Canavan's disease, for example, the Children's Hospital of Miami has attached a fee so large that some community screening groups have been forced to drop the test for the disease. Indeed, a 1999 survey by the American College of Medical Genetics indicates that 25 percent of doctors refuse to use certain genetic tests that they themselves developed due to concern over patenting or licensing issues.

There is also a further complication: Most of these groups, including the Genetic Alliance itself, receive substantial funding from the pharmaceutical companies and the biotechnology industry, and in some cases are very closely associated with them. This dilemma is best exemplified by a group called the Genome Action Coalition, which was initiated by a Washington, DC, lobbying firm several years ago in response to a vacuum of legislative leadership on human genome issues. Lyle Dennis, the GAC lobbyist, says that not only are the genetic disorder groups timid in pressing their industry funders on contentious issues but the pharmaceutical and biotech industries themselves cower before the insurance conglomerates that decide which drugs, medical products and procedures qualify for reimbursement.

The universities used to be a kind of bastion for publicly minded intellectuals and scientists. But with the passage of the Bayh-Dole Act of 1980, under which universities may patent their discoveries and license them for commercialization by private corporations, the universities have become intertwined with the biotech industry–indeed, they have in a real sense become corporate subsidiaries, increasingly driven in their research by the same motive for profit. A recent report of the Business-Higher Education Forum shows that American universities in fiscal year 1999 filed for 7,612 patents, executed 3,295 licenses and options with business, and received an adjusted gross licensing income of $641 million. Some prominent social scientists who might in the past have publicly criticized the diminishment of free scientific inquiry and communication tell me they are silenced by fear of retaliation.

Meanwhile, even many of those most prominently associated with the legal and bioethical issues of the human genome project are joining the private-sector ranks. Philip Reilly, formerly head of the Shriver Center for Mental Retardation, now serves as CEO of Interleukin Genetics. Stanford's David Cox, who served on the original Ethical, Legal and Social Issues Working Group of the genome project and the National Bioethics Advisory Commission, has become chief scientific officer of the Perlegen Sciences Corporation. Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics, has joined the scientific advisory board of the Celera Corporation. The problem is not whether what they are doing is wrong, for they all continue to do interesting and important work, but rather to whom the public should look to defend its interests.

Asked whether joining the ranks of industry compromises his ability to serve as a bioethical guide, Caplan responds, "I think the genetic revolution is going to be privatized and going to be a business. It is simply inevitable." He adds, "I'm happy to be a handmaiden to industry as long as they don't mind my biting their hand…. I want to get in there early and try to make them responsible. Staying away from them makes no sense. I think you've got to go in there and push them. Am I optimistic? No. But it turns out Congress isn't any better than Celera. Celera gets the idea that it's very important for them to stand up for informed consent and consumers' right to know. They worry that they could get their business crunched if they don't." But a colleague of Caplan's, Penn medical sociologist Charles Bosk, wonders whether bioethics is inherently incapable of confronting ethical issues that challenge economic interests, such as gene patenting or "the replacement of professional values with corporate ones." And even if Caplan is right, the question remains: To whom can the public look to defend its interests?

Whether it's the White House's widely publicized concern for the Catholic vote in key electoral states in making its stem-cell decision, or NIH scientists providing the White House with a politically acceptable but false count of viable stem-cell lines, or Bristol-Myers Squibb's saturation advertising campaign with Tour de France champ Lance Armstrong touting the day when we will all be carrying our complete genetic information on a card, what's depressingly clear is that the political, market and media forces so familiar to us are now shaping the future of the human genome.

But other forces are beginning to come into play. The cloning controversy in particular has been serving as a surrogate battle for those who oppose human genetic engineering, led by Leon Kass, the President's bioethics adviser. Kass argued in print just this past May that although the public demand for cloning is extremely low, and most people are decidedly against it, the battle over cloning is a "unique practical opportunity" to combat "the impending prospects of germline genetic manipulation or other eugenic practices." Kass invoked the brave new world image to recommend a ban on embryo cloning, even cloning for research purposes.

This is the mindset that has impelled some progressives to make common cause with House majority whip Tom DeLay and the pro-life forces who want to ban embryo research cloning. Their political calculation, explicitly expounded by Kass and others, is that by focusing on as unpopular a prospect as human cloning, they can seize control of critical portions of the biomedical agenda, constrict its inquiries, alter the pace of biotech developments and provide a precautionary pause during which more extensive, global prohibitions can be put into place. In doing so, they aim to prevent a future of reproductive eugenics, in which selection of genetic traits occurs in conjunction with technically assisted reproduction procedures.

In particular, they view the refining of embryo cloning techniques as a crucial technological bridge to human genetic engineering that should be blocked. Cloned embryos are viewed as the basic material that would permit the necessary genetic manipulations prior to reproductive use. As "end of history" social theorist Francis Fukuyama recently expressed it, "The real problem is that human cloning constitutes the opening wedge for human genetic engineering."

Whether or not these advocates of a roadblock are correct in their tactics is questionable. Certainly there is validity to the view that the line between basic and applied research in the life sciences is porous: Identify a gene, and you've identified a test for that gene. But any effort that requires a government-mandated dissolution of basic scientific inquiry poses serious moral questions and its own set of social hazards.

Formulating a progressive position on governing the genome–one that defends basic scientific research, prevents the misuse of genetic technology and upholds the right of individuals to genetic justice and genetic privacy–will be difficult. The single reform that would be most meaningful in removing the incentives for genetic discrimination is hardly ever mentioned anymore: a system of universal healthcare. With so much of insurance responsibility placed on employers, we now guarantee that insurers and business management will engage in genetic discrimination as a matter of fiduciary responsibility.

Another reform demanding immediate attention is regulation of the fertility industry, now regarded as the Wild West of medicine. Some contend that the current state of genomic science does not yet allow anyone to know precisely what limits should be appropriately placed on those who utilize reproductive technologies for genetic alterations or enhancements. But surely the first step is to create oversight and collect the data that would allow us to begin such considerations.

If we wish to stand by our democratic belief in the right of people to participate in choosing their destiny, the most pressing task is to educate the public and its elected representatives. Perhaps this could be conscientiously approached with the help of a body composed of genuinely independent experts and public representatives, funded by major foundations. Such a body would not be an ultimate solution but rather would provide a focal point and a voice that could counterbalance the commercial forces that increasingly dominate the biomedical establishment and our legislative bodies. Undertaking a grassroots campaign in every Congressional district in support of Eric Lander's proposed ban on germline manipulation could be one powerful educational force.

America's last dalliance with eugenics, including a leadership role played by many progressives, resulted in the forced sterilization of tens of thousands of people, restrictive immigration laws and promotion of a racist mythology. These measures found an admiring, envious group of scientists in 1930s Germany. But back then there was an ill-founded notion that some sort of immutable "germ plasm" determined heredity. With the actual molecular basis of heredity coming into our hands, how shall we govern the genome? Will we once again fall prey to some ideological fad that becomes translated into a thinly justified biomedical intervention? Or, as founding genome project bioethicist Eric Juengst worries, could we get everything "right," and still end up with a society that none of us would wish to live in? Or will it be, as geneticist J.B.S. Haldane foresaw seventy-five years ago, that "the tendency of applied science is to magnify injustices until they become too intolerable to be borne, and the average man, whom all the prophets and poets could not move, turns at last and extinguishes the evil at its source"? Whether the source of "evil" is identified as existing in the technology or the social conditions under which it is applied is the question that progressives, and all humanity, will need to address.

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