Turning point for the human species.

Trial lawyers should prepare for the brave new worm of genetic research and human cloning.

George Annas--chair of the Health Law Department of the Boston University School of Public Health and a founder of the human rights group Global Lawyers and Physicians--believes that the advent of human cloning has the potential to be no less than the turning point in the evolution of the species. In this interview with TRIAL Associate Editor Carolyn Magnuson, he discusses the legal and social implications of cloning and genetic engineering.

Lawyers, Annas believes, need to take the lead in promoting justice as these technologies develop. He advocates establishing an international group of decision makers to debate and review proposals for and limits on cloning and genetic research before we can't turn back. Magnuson spoke with Annas at his office at the Boston University School of Public Health.

You recently published an article entitled Prospects and Perils of Human Genetic Engineering. What are the prospects?

The prospects include engineering much more effective drugs that could, potentially, deal with some of the major scourges of humanity: Alzheimer's disease, senile dementia, cancer, and heart disease. There are prospects for stem cell research, for example, that could lead to the ability to grow new tissue, such as new nerve tissue that could help people who have suffered spinal cord injuries to walk again. Or scientists may be able to grow new heart tissue that could repair tissue that's killed in a heart attack.

Those are exciting prospects. I don't think we're looking 5 to 10 years in the future, I think we're looking more like 25 to 50 years in the future, but that's not long in the history of the human species.

I favor continued research in all these areas.

And the perils?

The perils are trying to create and improve people with these technologies. There is a risk that children will come to be treated more like products or commodities than like the unique, priceless children that they are.

The ultimate horror is that we could eventually develop two totally different classes of humans, one genetically modified and perhaps "superior," the other the product of natural evolution and "inferior" by comparison.

Put another way, genetic technology has the potential, if it works, to create a whole separate human species, a so-called gene-rich species that is genetically enhanced. Maybe 100 years from now, when there are enough of them, they will come to see the rest of us, our children's children, as obsolete and even "subhuman" and therefore suitable and usable as workers or slaves to the "superior" human.

The downside is we genetically engineer a new and "improved" human species that either we will destroy because we perceive them as a threat, or they will destroy us because they see us as subhuman or obsolete.

How would you describe where we are in this process now?

I think we're right on the brink of having to make some very critical societal decisions about the direction in which the human species should go.

We need to decide whether we want to try to modify what it means to be human by using genetic engineering techniques to add new genes and gene combinations to human embryos to try to make so-called "better babies" or better humans. This is the dream of many geneticists. They hope to be able to make a human being that can live a lot longer, be healthier and stronger and smarter. I'm quite skeptical of that, but people will almost certainly try to do this through genetic alterations unless society outlaws such experimentation.

We should have learned over the last 50 years that we can't have two different subsets of humans. We're all in this together. If anyone has human rights, everyone must have them. Everybody must be equal in human dignity. To try to change the nature of the species--that is, to alter the fundamental characteristics of what it means to be human--is just too dangerous for all of us.

So even though "enhancing" humans seems like a good idea, there is no way to prevent the use of genetic technology for this purpose from exacerbating inequalities and undermining our commitment to human rights.

Nonetheless, a societal decision not to use genetic technology for enhancement will be perhaps the most difficult we have ever made.

So cloning isn't something we can simply experiment with? You're saying that if we do it, we alter the human species?

That's right. Two points are worth making here. The first is that if you use cloning even once to create a new person, you've altered the definition of what it means to be human.

What it means to be human now is that you're the product of an egg and a sperm, even if you had a test-tube birth or in-vitro fertilization. But once you do human cloning and the result is a human, you don't have to have sexual reproduction to be human--or two parents, one male and one female. You could be the product of asexual reproduction with just one genetic parent. And that's a fundamental difference in what it means to be human.

We haven't even thought through what that would mean. We don't even know whom to consider the parents of a child born by asexual reproduction; for example, the parents of the person being cloned are both the genetic parents and the social grandparents of the "clone."

Will the clone (and all children) be thought of more like a manufactured product? Will clones be seen as copies, and thus as second-class citizens? Clones are certainly persons under the Constitution, but they are diminished from the original, just as we always see copies as less valuable than the original.

The second point is that the only efficient way we can now think of to do genetic modifications that will be inherited (so-called germ-line genetic modifications) is to use cloning technology to alter the somatic cells whose DNA will be used to replace the DNA in a human egg. So preventing cloning could effectively prevent germ-line alterations.

That is why the cloning debate goes far beyond the question of making genetic replicas. And that is why we should not engage in cloning just because we have the technology that makes it possible.

The genetic technologies we can employ now are so powerful and have such wide implications for the future of the human species that we need to develop some kind of international, democratic, open mechanism to debate the use of genetic technologies. These technologies could dramatically alter how we think of ourselves in ways that would be detrimental to the majority of humankind.

Before we even experiment with genetic technologies?

Yes. The environmental movement has developed the precautionary principle, which I like quite a lot. It essentially is that if you are proposing to change the environment in a way that might cause great and irreversible harm, and the benefits of the change are speculative, you should not be permitted to do it until you can demonstrate (to a democratically accountable body) that the benefits are likely to outweigh the harms.

People continue to argue about this in the environmental field, but it makes perfect sense in the biological field. You certainly shouldn't experiment with the human genome if you think you could create toxins that could be harmful to the entire species unless you have an extraordinary need for it and there is a likelihood of extraordinary benefits to the human species as well.

Not long ago, researchers in Australia were experimenting with monkey pox and trying to figure out ways to mediate the immune system in mice so that a mouse contraceptive would be more effective. In their experiments, the scientists created a super strain of monkey pox: It killed mice that were immune to it. Essentially, they accidentally made a biological weapon for use on mice, but theoretically, you could accidentally create a similar biological weapon for use on human beings. The point is that we should not permit experiments that we know can create human biological weapons by chance.

You shouldn't do experiments that put the whole human race at risk. For example, some scientists working for biotechnology Companies in England and Canada propose using the hearts from genetically engineered pigs in human beings for transplants. There's a shortage of hearts, so the thought is we either use a mechanical device--and those have not been successful--or an animal heart donor.

The problem with the genetically engineered pig heart is that there is a slight possibility that a pig virus could mutate in the human recipient and create a virus lethal to humans, like the AIDS virus, for example. No one knows how likely that is, but if there is any real risk of this happening, it seems to me that you cannot experiment with pig hearts in humans.

You shouldn't be permitted to put the entire human species at risk, even a small risk, for the sake of saving the lives of a few hundred people with heart transplants, when there are alternatives. There's no way the world can consent to that, at least not without a long and informed debate. No individual scientist or physician has a moral or social warrant to engage in experiments that risk the entire species without the equivalent of informed consent from the species. We do need alternative sources of hearts for transplant, but unleashing a lethal virus is too high a price to pay.

But if I'm the one who needs the heart transplant, and I have no alternative, I'll tell you, "Sign me up. I'll take one from the pig. I'm going to die anyway." Can't I consent to that as an individual?

That's exactly the problem. You can't. Your situation has coerced you into consenting. You'll take anything. If I have a monkey heart, you'll take the monkey heart. You'll take anything because you're dying.

That's a major problem with doing research on dying patients. Dying patients will often consent to anything their doctor recommends if they think it will help them. And in any event, you can't authorize your physician to put the entire world at risk for your own sake; there are interventions that simply should not be offered to anyone, including dying patients.

How soon, in your view, will we see human cloning?. Is it inevitable?

I think it probably is more likely than not that someday, somewhere in the world, someone will produce a human clone.

Of course, there are things like biological terrorism that are probably inevitable, too. The fact that someone is going to try to do it somewhere in the world is certainly no reason not to try to stop it. Inevitability is not ethics.

I also think that most of the impetus to do human cloning is novelty; it's the race to be the first one to do it. Like almost everything in science and medicine, you get credit only for being first. Nobody remembers, or very few people remember, the second person to do a human heart transplant, for example.

So there is, and there will be, a great desire on the part of some fringe physician or scientist to be the first person to clone a human being. But once the first one is cloned, that, I think, will be almost the end of cloning per se (although it may be just the beginning of genetic engineering). This is because there are only two reasons to clone a human in the first place.

The first is if neither member of a couple has any eggs or sperm, so the couple can't produce a baby that has any genetic relationship to either of them. If they really want a genetic relationship, then arguably the only way they could do that with existing technology is through cloning. There are not many couples like that. Most couples can be helped either by the new reproductive technologies or by adoption, and most of them are happy with the outcome. But a tiny number of couples may want to engage in cloning.

Then there's another tiny number of people who may think--although they're wrong about this--that if their child dies young and tragically they can get the child back by cloning him or her and making a genetic duplicate.

I think both of these reasons for cloning a human being are misguided. The real interest that the general population will have in cloning will be in using a cloning technique to make so-called "better babies." And that's what most parents want--not a baby just like them, not a child just like them, but a child who's going to have a better life than they had. Most of us would be happy to have a healthy baby, but we'd like its opportunities to be better than ours.

So the idea that you could add genes to your baby and make a baby that may have some advantage over other babies would be very appealing to many Americans. Many parents already put their babies and children into enrichment programs and early education programs to try to give their children a head start. Many women also change their diets, stop smoking and drinking, and get good prenatal care to produce a better baby. To try to give your child a genetic head start would, I think, be irresistible for parents who could afford to pay, for it.

This could be very problematic for society. It's a road I don't think we should go down. But it's one I could see us going down very quickly as a result of advertising, peer pressure, and so on. Why wouldn't you want to give your own child a head start? Why would you want to withhold enhancements from your child? Parents who don't "take advantage" of the new genetics will soon be seen as bad or even neglectful parents.

From what you're saying, it sounds like the use of cloning technology will not be on an individual basis, or there won't be much interest after the first human clone. Will we see human cloning on a mass scale--for example, 84 copies of the same person?

I don't think you'll ever see that. I don't see the point of that. Eighty-four copies of a famous person, for example, would just lead to 84 different people with the same genetic composition--and perhaps to the parents arguing about which is most "truly" like the original celebrity who was cloned. My Mark McGwire, for example, will either hit more home runs in his Little League games than yours (if he grows up to play Little League at all), or he won't. In any event, all 84 will likely disappoint their parents in their baseball careers (or lack of them).

The most frequent argument made for mass cloning would be to make an army, a group of commandos, for example. Or, some people argue, a basketball team, but I think that's too trivial.

The truth of the matter is, if you made commandos by cloning, someday you'd get a group of commandos, but it would take at least 17 or 18 years to grow them up to the point where they can actually be soldiers. It's much easier and much more efficient to just pick out 20 people today who are very similar to each other and train them for a year. They're much better commandos, or at least as good as your commando team is going to be if you get them through cloning. And you've got them in a year, instead of 20 years.

There's no real use for large numbers of genetically identical clones, either born at the same time or born years apart. You can freeze the embryos and use them later, but I don't think there's any point to that.

That's why the people who favor cloning have ultimately settled on infertile couples as the only rationale that might legitimize cloning. All the other reasons turn out to be science fiction. In the real world, there are much more efficient ways to achieve the same goal, mostly through education and cosmetic surgery and just plain physical work.

But it keeps Hollywood busy.

It certainly does. We get lots of good movies--like The Boys from Brazil and Sleeper--and some bad movies as well.

You're in favor of an outright ban on human cloning?.

I am. I think we should ban human cloning and genetic engineering and then the burden of proof would shift. Right now, the burden of proof is on people who want to stop those developing the clones: They have the burden to show Congress (or whoever is in charge) that this is so dangerous we shouldn't do it.

So with the current state of the law, if you want to proceed with caution, you are essentially trying to prove what isn't known.

Exactly. You're speculating. You're not only speculating, you're speculating on the negative. But speculation on the benefits is equally terrible.

So the only way you can change the burden of proof and put it on people who want to change the species (or the climate or anything else) is to outlaw it. Then they have to go to Congress, or wherever the legal authority is, to persuade them that the ban should be lifted because they've now been able to figure out how to do this safely, or they've now come up with a compelling societal benefit.

It's not that I'm saying we can never clone or never do genetic engineering, but I'm certainly saying that given what we know now, we should not do it. When we can persuade the Congress or the United Nations or whoever we finally put in charge of this that we now know enough to attempt genetic engineering without putting the whole world at risk, we can come back and make the argument.

But you're advocating this should be beyond Congress's authority. You're advocating an international body.

Ultimately, I think we need an international democratically accountable regulatory agency, yes. This is because we're now dealing with something we've never dealt with before: experimental interventions that will potentially affect everybody on the planet.

I think that certainly the establishment of an international authority is the first step. I used to think that this was probably not realistic, but no longer. The whole movement toward globalization--including the International Criminal Court and the increasing status of the Universal Declaration of Human Rights--indicates that we're moving in a direction where this is possible.

And thankfully, no one is genetically modifying human beings yet, so we have at least a little time to develop an effective regulatory framework.

What are the more immediate social effects that could result from genetic engineering? Are there other social changes before we get to the point of enslaving a "lower" species of human?

The primary social change, if you're not going to develop a separate species, would be to widen the gap between the rich and the poor. The rich and poor are not separate species, but it often seems like they are because their lives are so different; more than 1 billion people in the world, for example, live on less than a dollar a day and have no access to basics like clean water and decent nutrition. But let's think just about the United States.

Almost all the new genetic techniques, if they work, will be very expensive. The first question will be whether private health insurance or Medicare/Medicaid will cover a procedure. Traditionally, Medicaid has not covered treatments for poor people to have more children, so only privately insured or wealthy people would have access to the new reproductive technologies.

So we greatly exacerbate social inequality with genetic technology, as we do with many expensive technologies. That's the direction society has been going, but this makes it much worse, adding a biological component to a monetary one. I think that's a major problem.

A related problem is overconcentration on genetic solutions to health problems. Rather than trying to change the environment or get people to live healthier lives or put more money into prevention, we keep trying to put money into these technological fixes--whether it's a surgical fix, a genetic fix, or a medical fix.

What is the outlook for genetic research litigation?

I think the whole area of research, of medical research in general and genetic research specifically, is growing so fast that even people in the field have a hard time keeping up with it. We've tripled the number of research subjects in clinical trials in the United States in the last five years. It's been incredible growth, most of it in the private sector, although the public sector is growing fast as well.

Almost everybody recognizes that the rules we have--the federal regulations that govern research, which now date back to 1974--are wholly inadequate to protect human subjects.

We've got lots of difficulties in trying to protect human subjects, and on top of those problems we have layers of conflicts of interest. There are physicians who get paid per subject to enroll their patients in research, which I think should not be permitted. Or they're working for biotechnology companies or pharmaceutical companies where they're paid to do the research or, even worse, they own stock in the company doing the research. Under those circumstances, it's impossible for them to protect the rights and welfare of research subjects.

There have been a series of lawsuits in the last couple of years in this area, but I think it is going to be wide open for negligence and conflict-of-interest litigation in the next ... well, starting now.

Is the court system equipped to deal with either the volume or the level of complexity that litigation stemming from these new technologies would involve?

I think the court system is well equipped to deal with the complex issues these types of cases present. I'm not part of the crowd that thinks the law is always way behind the science. I think 9 times out of 10 there is law on every subject. There's already lots of law relevant to cloning. There's law on embryo research. There's law on medical malpractice. There's law on standard of care, use of laboratories, and so on. Just because there's not a law on new stem-cell research doesn't mean there aren't any laws on research that apply. The structure of the law is already set up.

What types of litigation do you see arising?

One of the big areas is going to be the area of property in the body (for example, property in the skin, cells, or DNA). The issue has really been litigated only once, in the John Moore case, when the California Supreme Court basically said everybody could own your cells except you. [Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990).]

That is just wrong. Of course, the biotech industry thinks that's the greatest case ever litigated in the United States. It just has to be wrong, it cannot be true, that everybody can own your body and your cells except you.

I'd like to see a legal principle develop that says nobody can own your bodily tissues. But that's not likely to happen because there's too much money involved. At some point, it has to be recognized that yes, individuals do have a stake in their own cells, in their own DNA, even though they didn't produce them. If someone takes your cells and DNA and makes a patentable product out of them, you should know about it and have a financial stake in it if you want. But that issue will have to be litigated again before the basic rights of individuals to their own DNA are recognized.

Right now, it's standard practice in the United States for companies conducting human-subjects research to add a little line to the consent form that says if we make something commercially viable out of your cells, it's ours. You waive all your rights. Well, you can't waive all your rights without knowing what they are.

So if I participate in a study and I have a particular gene that contributes to development of a product, I should be paid part of the profits?

Yes. I've suggested in the past that you should get 1 percent to 5 percent of total profits for your contribution. The company should get most of the reward--they do almost all of the work. But without your DNA, they have nothing. Of course, without them, you'd have nothing, too.

I also think, however, that it's time to rethink the Patent Office's enthusiastic granting of patents for human genes and gene fragments. My own view is that while we should continue to patent drugs (although for a shorter period of time than 20 years), we should outlaw the patenting of human genes and DNA fragments, at least those that don't directly code for a useful human drug.

Should workers expect that either their employers or their insurers are going to analyze their genes at some point?

Yes. Unless there's legislation against it, there's no question that as soon as genetic testing gets cheaper, it will be routine. They should definitely expect that. That is why my colleagues and I drafted the Genetic Privacy Act for the National Human Genome Project in the mid-1990s. We believe no one should be able to collect your DNA, analyze your DNA, store samples of your DNA, or disclose the results of any DNA tests to anyone without your informed authorization. I think most people agree, but we will need legislation to ensure these rights.

Should there be an outright ban on genetic testing of employees?

I think so. There should be an outright ban on genetic testing of anyone, including workers, without their informed authorization. Employers have argued that they will want to test workers to see if they have any genetic predisposition for occupational diseases that are common in particular workplaces. The theory is that such testing could help avoid disease for the workers and health care costs for the employers.

But it could also prevent the worker from being hired in the first place. I think that if you have a genetic test that can help your workers, you should be able to persuade them that that's true and get their authorization. Otherwise, you shouldn't be permitted to do the genetic testing.

Should we be concerned that the defendant in a personal injury case might use genetic testing to argue that a plaintiff was predisposed to an illness or injury?

It's already happening. In a recent case, a railroad company had been secretly testing some of its employees for a gene that was said to be related to carpal tunnel syndrome. The company said it was using the test results to help it defend on-the-job injury claims, arguing that the employee had a genetic susceptibility to injury, that the injury was not employment-related.

The Equal Employment Opportunity Commission brought a lawsuit to halt this testing on the basis that there was no business justification for it. The Burlington Northern Santa Fe Railroad almost immediately settled the case by agreeing to stop the testing and not resume it without worker consent. Hopefully, this case will discourage further employer testing without consent. [See EEOC settles first ADA challenge to genetic testing in workplace on page 104 of this issue.]

Unless you have clear rules prohibiting genetic testing of employees, the defense is always going to look for a different explanation for the injury so that the defendant won't have to pay for it. Genetics seems to be a nice excuse: The defendant can argue that it didn't cause your injury, your parents caused it.

Are we equipped to pass new legislation quickly enough to keep pace with the speed of this technology?

Yes, provided we can persuade people of the importance of such legislation. We've certainly persuaded much of the world of the importance of free trade, and we have moved very quickly (many would argue too quickly) to eliminate tariff barriers and to unify intellectual property law around the world. We have not yet, however, adequately protected wages, worker health and safety, or the environment. Nonetheless, I think the world trade example has shown that it's possible to change world law very quickly and to involve the people of the world in that process.

The Internet has helped a lot in giving nongovernmental and civil society organizations around the world the ability to communicate effectively with each other and organize to promote specific agendas. It is no longer governments alone, for example, that will affect the behavior of transnational corporations; nongovernmental organizations and organized citizen groups will probably be the most important forces propelling change.

I've argued that lawyers and physicians are best equipped to do international work in the area of emerging genetic technologies because, even though we're licensed in specific jurisdictions, the professions transcend international boundaries. Social justice and equality are multinational and international, and physicians' dedication to health is obviously multinational.

The entire human rights and health movement is a natural one to bring doctors and lawyers together to work to improve the living conditions of all citizens of the planet.

Professionals, especially lawyers, have a special obligation to promote human rights and health. Social justice and equality are put at stake by the new genetics and the new science; democracy and human rights are probably the only forces strong enough to protect our species from overzealous scientists and corporations.