Biological weaponry

A discussion of biological weaponry (BW), including how advances in the biosciences greatly expand the possible types of weapons far beyond the traditional use of infectious agents and biological toxins, represents a new direction for discussion within Geneforum.

In one sense, this is not a topic of immediate relevance in the world, that is, nobody, save perhaps for a few misguided souls, seems to be trying to use them. At least as far as we know. And it is known, or strongly suspected, that a number of countries are still developing offensive weapons, including at least one of the staunchest allies of the United States. The Biological Weapons Convention entered into force in 1975 and has been ratified by most (with a few notable exceptions) countries of the world.

As a topic with possibly catastropic implications, however, it is a most timely and relevant one for Geneforum.

Last night, on PBS, a documentary was aired that covered the history of BW in the United States, up to the renunciation of the development and testing of such weapons by then Preseident Nixon in 1969. The most alarming thing to me was not even the secret testing that was done on animals and human volunteers, but the fact that the use of a widely desseminated microbial agent as a means of inflicting death and disability on the scale of nuclear weapons was even considered seriously at all. The development and use of such weapons, designed only to kill huge numbers of human beings, had a large cadre of cheerleaders within the U.S. government, as committed and as enthusiastic as the scientists working on the Manhattan Project and the promoters of nuclear weapons as a primary instrument of political strategy as as a means of obtaining and securing power. What seems not to have been discussed, at least openly, is any justification for perpetrating the death of millions of human beings. Our society, at least officially, frowns upon murder and it is illegal. And mass murder is even worse. Yet it is a well entrenched element of national policy and today more money is spent in at least the United States' annual budget to continually expand our capacity to kill human beings.

Why should biological weapons be considered any worse than chemical or nuclear weapons, or bombs or guns or knives? All are instruments of war, whose primary function is to inflict death. As a moral or ethical issue, should we not then consider the morality or war to be the governing topic, not merely the repugnance of a particular category or weapons? Personally, I don't think there can be a separation. We may deal with the control of particular categories of weapons, but we may never lose our perspective and cease to question our society and our leaders why the pursuit of war and the concomitant death and destruction that always ensues should ever be undertaken.

With that preamble, and getting us back to think about the dark side of the spectacular advances in genetics and cell biology, let us look at some possible applications to BWs that lie outside the traditional ways of thinking, i.e., highly virulent infection of threat of a pandemic. I ask you to ponder the following:

• With an extensive knowlege of viral genomes, and using as a starting point viral vectors developed to construct transgenic animals or for human gene therapy, it is possible to add other genes and gene families, that could be used to inflict pathology or one sort or another on its human host.

• Contraceptive vaccines were developed and tested beginning in the early 1980s. Combining such technology with advanced vaccine delivery systems (nasal sprays or oral vaccines), it is at least theoretically possible to administer such a vaccine to a large population without its knowledge. An anti-fertility weapon would be devastating and demoralizing to a population. Read/see "Children of Men" by P.D. James, and/or the subsequent movie made from the novel.
  

• The use of techniques to control the expression of a specific gene are now being explored as cancer therapeutics and for other medical application (e.g., anti-sense oligonucleotides). The use of such methods to block the expression of an essential gene product could lead to the gradual demise of a human being over a period of weeks or months as the essential protein was depleted and not replenished. Clinically, this could appear as a natural disease, although probably not diagnosed or perhaps misdiagnosed. Without a the use of novel diagnostic methods, the cause of death would probably not even show up in a thorough autopsy. This could consititute a clean and nearly undetectable means of assassination, or, if administered to a large population, a new type of "disease" that would be very difficult to prepare against in advance.
  

In my view, the problem is not that science and the technology it spawns has the potential for the most nefarious of misuse. Essentially all technology can be misused. The challenge is how we can bring about a global society that is governed by a respect for life, where war itself, not merely the means to conduct it, would be unthinkable.

Burke Zimmerman

 

 

 

 

2008 Olympics and Genetics

"We are not yet at a point where we can identify a potential future Olympic champion from genetic tests but we may not be very far away," said one of the authors of the British Association of Sport and Exercise's (BASE) position paper on "Genetic Research and Testing in Sport and Exercise Science."

However, BASE calls for more genetic research in the sport and exercise sciences because of the anticipated benefits for public health. It wants researchers to take a more active role in debating the implications of their work with the public.

"If a powerful muscle growth gene was identified, on the one hand this could help develop training programmes that increase muscle size and strength in athletes, but even more importantly the knowledge could be used to develop exercise programmes or drugs to combat muscle wasting in old age," said Dr Alun Williams from Manchester Metropolitan University, one of the report's authors.

The organization's well written statement concludes:

"...genetic research in the sport and exercise sciences offers the potential to make major new discoveries, which will further our understanding of the physiology and pathophysiology of sport and exercise. Important applications may result and we are likely to gain insight into the mechanisms that control some of the most studied variables in sport and exercise science. Genetic research is ethically assessed like other medical research and, given that this process is deemed robust, genetic research should be a welcome addition to the sport and exercise sciences. However, unwanted or illegal applications can result from genetic and other research even if this research is deemed to be ‘ethical’. For example, the production of recombinant human erythropoietin (EPO) has not only improved the treatment of anaemic patients but has led to the misuse of EPO by endurance athletes which has probably led to the death of several athletes. Researchers should therefore try to anticipate the potential negative effects of their work and engage publicly in debates about their research."

Earlier this year, scientists at the Taipei Physical Education College announced that they are developing a gene bank containing DNA from super performing athletes from Taiwan. Here's an interesting quote:

Hsu claimed that by looking at the saliva of New York Yankees pitcher Wang Chien-ming, the reseachers can find out why Wang plays so well and whether other children who like to play baseball could one day become a second Wang Chien-ming.

Currently, the TPEC Ace Athlete Genome Bank has collected genetic samples from several top Taiwan athletes who have won Olympic medals, including taekwondo fighters Chen Shih-hsin, Chu Mu-yen and Huang Chih-hsiung.

After analyzing the three Olympic medalists' saliva, Hsu said, the researchers have found that Chen not only have "deletion (D) "polymorphism in the Angiotensin Converting Enzyme (ACE) gene of her 17th chromosome, the "insertion (I) " polymorphism -- usually only found in ace male athletes' genes -- also exists in the ACE gene of her 17th chromosome.

Geneforum sponsored an event a few years ago on the future of genetics and sports. Materials from the event, along with other interesting articles on genetics and sports, are available in the Gene Doping Forum.

(Image: From BASE's report)

Expert Presentations on Genetic Enhancement and Sports

Click the links below to access powerpoint, audio and video files. Note: You may want to download the powerpoint slides prior to accessing the video/audio files.

• Tom Goldman, Sports Correspondent, National Public Radio's Morning Edition
• Theodore Friedmann, M.D., Director of the Program in Gene Therapy at UCSD [powerpoint]
• Mari Holden, Silver Medalist, 2000 Olympics, Road Cycling [powerpoint]
• Maxwell Mehlman, JD, Director, Law-Medicine Center and Professor of Biomedical Ethics at Case Western Reserve University [powerpoint]

Complete information about the event is available here.

UPDATE: The Seattle Times is publishing "Getting a Boost," a three-part series on performance-enhancing drugs in sports. The first article appeared on Sunday (10/9), entitled: "Experts predict gene doping is next temptation for athletes." In addition to the article, there are a number of sidebar interviews with a full spectrum of perspectives, including a former US Olympic rower, a Olympic coach, and Dr. Friedmann.

Gene testing and the olympics

TURIN, Italy - Drug testing at the XX Winter Olympic Games will be more sophisticated, more refined, and more prevalent than it was four years ago in Salt Lake City, says TIM PANACCIO of the Philadelphia Inquirer.  He adds the following, and quotes Dick Pound, chairman of the World Anti-Doping Agency (WADA):

Among WADA's biggest challenges is testing for genetic doping. Blood samples taken at these Games will be stored for as long as four years, officials said, in hopes that the science of genetic testing will evolve on a parallel level of those using genetics for performance enhancement.

"The experts we have tell us they don't think it (genetic doping) is going to apply here," Pound said. "Even the information coming out of the trials tell us it's more inquiries than (identifying) a genetic doping agent.

"In future Games, we have to operate on the assumption there will be people out there willing to do it." Andrew Pipe, who heads the Independent Observer team at the Turin Games, said that the next phase of grand-scale testing in the future will be "retro testing" of old samples versus new samples on a genetic basis. "The state of the art approaches to detection of standards will be applied to this setting," he said, adding that he feels the procedures used now are already on the leading edge of technology.

According to the New York Academy of Sciences and the University of San Diego, which conduct programs in gene therapy, the idea behind genetic doping is to build skeletal muscle and increase production of red blood cells.

Such doping is seen as a performance enhancer under WADA's guidelines.

Whether or not gene doping is a reality, it's being looked for in Turin. Geneforum has been interested in gene doping for some time. Take part in the process by completing the gene doping survey.

Marie Godfrey, PhD

Geneforum Interview with Dr. Eric T. Juengst - Enhancement Genetics: Let the Games Begin

A Geneforum Interview with Dr. Eric T. Juengst
Professor of Medical Ethics, Oncology, and Philosophy of Science
Center for Biomedical Ethics
Case Western Reserve University

by Mark Compton

When the US National Institutes of Health first set up the National Center for Human Genome Research, concerns about the ethical dimensions of the research were so great that 5 percent of all the funds allocated to the Human Genome Project were set aside to study just those very issues. The NIH's Ethical, Legal and Social Implications Branch (ELSI, for short) was created as a result. And the first chief of that operation, from 1990 until 1994, was Dr. Eric Juengst.

Now teaching medical ethics, oncology and the philosophy of science at the Case Western Reserve University School of Medicine, Juengst remains actively involved in efforts to set public policy. Besides serving on a steering committee that develops new initiatives for ELSI, he's also a member of the US Recombinant DNA Advisory Committee and the Federal Bureau of Investigation's DNA Advisory Board.

All of which serves to give Juengst a front-row seat to the competition to develop winning genetic interventions. But, as he freely concedes, it remains to be seen whether efforts to improve on natural genetics will ultimately prove to be a triumph of intrepid scientific endeavor or just another human comedy.

[The views and opinions expressed by the participants in this interview are not necessarily those of Geneforum, and the publication of this interview should in no way be construed as an endorsement of those views.]

[Mark Compton]: Johann Olav Koss, the Norwegian speed skating champion who won an Olympic gold medal in 1994, has since become a physician. So it was interesting to read recently that he'd been quoted as saying he believed athletes may already be employing gene engineering to achieve enhanced performance. But don't we have a way to go before we have safe and effective interventions for increasing fast-twitch muscle fibers, strength and oxygen-carrying capacity?

[Eric Juengst]: Yes, we certainly do have a way to go. But I don't think Koss could have been thinking about gene transfer experiments. He must have been talking about biosynthetic hormones and other biologicals produced through genetic engineering.

Something that's injected or taken orally as opposed to something that's inserted directly into a cell?

Right. Like EPO blood doping to increase the oxygen-carrying capacity of your blood. Well, that's a product of genetic engineering in the sense that the compound is produced by bacteria in some biotech lab. But it's not genetic engineering in the sense of actually altering the athlete's genes.

I take it, then, that you don't believe anyone is foolish enough to attempt any of the primitive gene replacement interventions that might be available at this point.

I make no representations as to degrees of foolishness. It's true that in elite sports the competition is fierce enough to drive people to do all kinds of foolish things. And it's conceivable to me that athletes and their physicians somewhere along the line might embark on just the sort of course you're suggesting. I just don't believe it would work.

But as it stands—given the obvious risks—wouldn't such treatments be in clear violation of traditional medical ethics?

Yes—as is the abuse of performance-enhancing drugs, but that's already very much in evidence today.

So an athlete bent on achieving an advantage through gene replacement is likely to have no difficulty in locating an obliging physician?

Right. Obliging physicians are not in short supply. As to whether those physicians will have the requisite technical know-how, that may be another matter.

The New York Times recently reported that as part of a 1995 survey, nearly 200 aspiring American Olympians were asked if they would take a banned substance that would guarantee victory in every competition for five years but then would cause death. More than half said they would. Despite the American tradition of giving individuals a huge amount of autonomy over their bodies, can researchers and health providers ethically permit themselves to be swayed by values that are so obviously skewed?

No, they shouldn't. But that striking survey just points out how coercive sports competition can be. And in a sense, that's the leg physicians and scientists have to stand on when they say their duty requires them to draw a line on this issue. Rather than focusing on whether we're interfering with the athletes' freedoms—their autonomy to do as they wish with their bodies—what I think we should bear in mind is that what these individuals do with their bodies ends up having a direct impact on what other athletes do with their bodies.

So people end up being persuaded to follow this path simply because they feel that not to do so would put them at a significant competitive disadvantage?

Right. The presumption is that they're all in this game together and that the pressure to win forces them to keep up with all the latest advantages, whether that's clapped skates, fiberglass vaulting poles or shark swimsuits. If anyone has one, then everyone needs to have one in order to compete. And the same goes for modifications of their own bodies. In the medical provider community, we've traditionally said, "You're free to do what you like, up to the point where your actions start affecting the interests of other people."

But even apart from considerations of social pressure, wouldn't a physician be morally obliged to at least explore the implications—that is, to encourage the patient to step back and weigh all the risks against the potential benefits?

Right. That age-old axiom in medical ethics, "first do no harm," would come into play and should give any physician pause. The risks of this are so very high that you, Mr. Athlete, need to think about the benefit:risk ratio. The question is: What considerations do you allow as part of that calculation? On strictly medical grounds, it's pretty clear that the risks outweigh the benefits. But if we're going to let the athlete factor in his own life plans, his own values, his own interests as part of the calculus, then maybe the equation balances or even comes out in favor of the interventions.

Now, of course, for all the risks and uncertainties that seem so clear today, isn't it possible that gene replacement interventions might someday prove to be quite safe and effective?

Yes. I don't think the wind is totally out of the sails for gene therapy. Obviously, in the 10 years of experience we've had, it's proven more difficult and complicated than the pioneers first thought. But that probably shouldn't come as a surprise. Biology is always more complicated than we think.

And really, is 10 years all that much time?

Exactly. I think we will, with time, develop techniques that get around a lot of the problems we're facing today. For example, one of the promising things on the horizon is the advent of new capabilities for getting DNA into human cells, which should allow us to abandon the use of viruses altogether.

And the significance of that is due to the difficulties with targeting viruses?

Yes. Difficulties with targeting and also with the kinds of immune reactions that can lead to dramatic complications, even death. And that's precisely what can happen when the body recognizes a virus as something it's seen and tried to fight off before. A better alternative would be to go with an artificial chromosome, a completely constructed package for the modified DNA that could be insinuated into the cell, where it would then behave just like the rest of our chromosomes.

With the artificial chromosomes, would it also be possible to incorporate "on" and "off" switches?

Right. That's another advantage—in theory, at least. The idea is that they could be controlled by the patient or his doctors by way of medication. You'd take a particular drug that would help to regulate the artificial chromosomes.

I can see that in certain situations—the stimulation of growth hormone, for example—you'd clearly want to be able to find the off switch at some point.

That's right. And maybe even some other capabilities beyond what the regular cellular regulatory systems would be able to provide.

Is it feasible that the day will come when technical issues are no longer even a consideration?

No, I think technical considerations will always be an issue because as we resolve certain problems, new ones will arise. We'll always be trying to do more difficult things. So that's always going to be a part of the equation, but in the foreseeable future I expect we'll be able to do some significant set of gene transfer interventions with relative safety.

Just for the sake of exploring some of the ethical dimensions, then, let's make the optimistic assumption that refined techniques capable of the success rates we tend to associate with proven medical procedures will someday be achieved. I really wonder how much angst all this will cause a few years from now. I mean, for example, a Newsweek report appearing shortly after a 1998 UCLA gene engineering conference suggested that while the genetic engineers at the conference were ethically reconciled with somatic gene therapies (which treat patients but leave their genetic legacies unaltered), they were far more dubious about germline gene replacements (which affect not only the patient but also all of the patient's descendents). In fact, it was reported in that same article that "the overwhelming majority of scientists and ethicists oppose gene therapy that changes the germline." But now, barely three years later, it would seem that—within the genetic research community, at least—most qualms having to do with germline therapies for serious human diseases have been laid to rest. Instead, most of the questions and criticisms now seem to be reserved for gene manipulations aimed at achieving enhancements beyond good health. I'm reminded of the furor and moral outrage surrounding the introduction of in-vitro fertilization techniques just over a decade ago. Now, in-vitro procedures have become quite commonplace. Does this all suggest, ultimately, that we can get used to just about anything?

Yes. I think we can get used to just about anything. The question is: Should we? Because there are a lot of things—social, environmental and interpersonal—that we live with but probably shouldn't. Does that represent a kind of complacent acceptance of a fait accompli? Or is it the result of some real change in people's thinking? I think it's a little too early to say the tide has shifted where gene therapy is concerned. If you polled the scientific community, I think you'd still find that the majority of scientists express concerns over germline interventions.

That is, if you expanded the survey to more than just the ideologically pure types that tend to appear at conferences?

Right. It's actually quite interesting to note that the main proponents for germline gene therapy in the literature over the past few years—with the exception of some prominent scientists like Lee Silver and Jim Watson—have been non-scientists. The people who've really taken up the cause, by and large, are ethicists and even some theologians.

Really?

Yes. Ted Peters at the Graduate Theological Union in Berkeley is a good example. In contrast, scientists—according to my observations, at least—remain quite cautious. For example, the report from the AAAS (the American Association for the Advancement of Science) on this topic of germline interventions takes quite a cautionary approach in its conclusions. It says that if we were ever to contemplate developing therapies aimed at the germline, the studies done to ensure their safety and efficacy would essentially have to be performed over multiple generations in order to see the effects in the offspring and their offspring. So, according to that view, we should settle back for the next 100 years before we even begin to think about launching into this.

I somehow doubt everyone is going to be quite that patient.

Right. So clearly, the sociology of the debate is still very unsettled. It's an open question, with arguments to be made on both sides. But that's different from a few years ago when everybody—critics and proponents alike—could happily agree to bracket off the whole topic for later consideration. The scientific possibilities just didn't seem quite so imminent back then. What's changed is that the science is getting much closer. I think we always believed we'd be able to work out the kinks in somatic cell gene therapy before we'd even have to think about tangling with all the ethical issues surrounding germline interventions.

So, basically, germline has appeared on the radar screen much earlier than anticipated.

That's right. And that's partly because we've discovered that it's very hard to make somatic cell interventions work the way we want them to. One way to achieve greater efficiency—to raise the levels of gene expression—is to make the changes earlier in development, pre-natally.

That certainly would eliminate the targeting problem as well.

Right. So, rather than waiting for somatic cell therapy to be perfected, we find ourselves looking at doing interventions that are functionally equivalent to germline interventions in order to achieve the goals originally set out for somatic cell therapy.

So we're more or less stumbling into germline intervention instead of addressing it directly. Isn't there some danger in that?

Sure. And that's exactly what we're seeing with the mitochondrial transplants. We've definitely stumbled into intervening in the human germline by injecting cytoplasm from one set of eggs, including mitochondria which contain their own DNA, into the eggs of another woman in order to improve her chance of fertility. That's already happened, so we've already crossed the germline barrier in that respect. And that's something that happened completely off the radar screen of public policy debate because it wasn't initially perceived as a form of germline engineering. We just weren't looking in that particular direction when it came to pass.

So the gendarmes were unaware? But was that step across the germline entirely inadvertent?

Well, it wasn't an accident because, in the paper the researchers [J. A. Barritt, et. al.] published in Human Reproduction, they were quite proud to announce that these births represented the first successful germline modification of human beings.

Always better to ask forgiveness than permission, I say.

Actually, I've used that phrase myself.

Okay, so germline interventions are with us. That's reality. But there's still the question as to where they're appropriate and where they aren't. For the most part, scientists seem to distinguish between interventions that fight serious disease and those aimed at attaining certain improvements. Assuming there is, in fact, an important moral distinction to be made between combating human disease and enhancing human traits, how do you go about drawing the line? And where do you draw that line?

That's a good question. But it's hard to answer because every trait spans an entire spectrum of considerations.

Okay, but what would be some of your chief criteria? Let's approach it that way.

The way I've seen this debate evolve is that we have three basic classes of interventions. One includes those interventions aimed at treating classic diseases—diseases that follow the medical paradigm of being diagnosable and causing suffering and having specific causes. That's one end of the spectrum. At the other end of the spectrum are those interventions that don't seem to treat a disease at all but are instead specifically aimed at enhancing normal human traits. And then in the middle—the interesting place where we're going to have to draw this line—are interventions aimed at enhancing normal traits in order to prevent classic diseases. For example, what if we want to upgrade someone's immune system so as it will be better at seeking out and destroying cancer cells? Well, in fact, there's a big class of gene therapy protocols, called Cancer Vaccination Protocols. And no one has raised the red flag and tagged these as "enhancements" because they're so clearly aimed at preventing serious disease.

Presumably, there would also be some family history or some other indicator that would merit that sort of prophylactic therapy in the first place. So we're not exactly talking about handing out sugar cubes in the school gym, are we?

No. But as time goes on and we're able to do more of this kind of preventive gene therapy, you can probably see the rationale for interventions on that scale should we, for example, develop an effective gene therapy protocol aimed at treating hypercholesterolemia. That's a fairly common genetic disease, and the people it affects have high rates of heart disease because they have way too much cholesterol built up in their bloodstream. So, let's say a gene therapy approach has been developed that gives their blood cells an enhanced ability to clean cholesterol out of the bloodstream. Well, if it works for these patients to compensate for their high cholesterol, then what about in me? Why wouldn't I want to prevent the accumulation of cholesterol in my bloodstream? That way, I'd be able to enjoy all the fatty foods I wanted.

Moreover, from a public policy perspective, wouldn't society want you to have that therapy if it meant reducing the potential for you occupying a hospital bed for much of the rest of your life?

Sure. The thrust of public policy in recent years has been in the direction of preventive care, so this would fit right in with that. But if we go very far down that path, we begin to make significant changes in the human form and function that look an awful lot like the sort of improvements and enhancements we've been worrying about. Because along with that comes all the problematic public policy choices of who gets access to these prophylactic enhancements and who doesn't.

Going back to the vaccination notion, let's say we find some way to treat HIV effectively. Given what's happening in South Africa today, would it not be better to administer that treatment via widespread germline therapy instead of being faced with the need to vaccinate every generation from here to eternity?

That's right That's the argument for attempting to develop germline interventions. It's much better to do it once and fix the problem for the whole family line.

But, you know, I'm not sure we've quite nailed this issue yet of how to distinguish medically necessary germline therapies from purely optional enhancement interventions. That still seems rather murky to me.

Well, clearly the distinction lies somewhere in this preventative zone we're discussing. I mean, let's say we've come up with an intervention that enhances cognition and memory and so can serve as a prophylactic against Alzheimer's disease. How could we stand in the way of the widespread use of something like that? Even if we knew it was being used "off label," as it were, by students to increase their performance in the classroom? And that's the route by which virtually all enhancement interventions will come into society. They'll first be introduced as interventions designed to treat disease. The RAC [the National Institutes of Health's Recombinant DNA Advisory Committee] is in no danger of having to face the enhancement issue head-on because it will never review a protocol labeled as an enhancement intervention per se. Those applications will always be couched as treatments for some serious disease. So if we're going to police enhancements—if we're really going to try to hold that line—it simply can't be done at the level of basic research, because there'll always be legitimate justifications for just about any sort of treatment. No, if we're going to police this, it's going to have to be at the level of the user or the physician.

I'm not sure which of the two would be trickier.

Both are going to be difficult. But chances are the medical community will be easier to police because you can at least appeal to their sense of professional autonomy and integrity.

You can also threaten to take away their license to practice.

Right. But with parents and individuals, we're in much the same boat as we are with athletes. That is, you don't want to end up inadvertently caving in to dubious social pressures. For example, let's just say society is prejudiced against very short people, and that my wish is that I could do something to erase that prejudice. But, of course, I can't. And, meanwhile, I certainly want to give my kids every advantage I can, so if there's something I can do that promises to make my children taller, I'm likely to be interested—even though that would only end up feeding into the very problem I find so offensive.

It's this problem of complicity that's so incredibly hard to police because, on the face of it, parents' motivations are often perfectly understandable. Their first obligations are clearly to their own offspring, and if that ends up adding a brick to the wall of some social injustice...well, that's beyond the scope of their responsibility. So this is all somewhat akin to the discussion that used to go on in the African-American community about the ethics of passing for white—using skin lighteners or hair straighteners or anything of that sort in an attempt to look more white. One point of view is that measures such as that simply feed racism and should be discouraged as a consequence.

But, by and large, most people aren't looking to martyr themselves for social justice. They just want a nicer house, a bigger car, a better job.

Exactly. And who can blame them? So that will become society's challenge—to police users by influencing them through consciousness raising, education and other soft measures. Basically, that means solving the problem at the social level rather than at the individual one. And what that probably means is that, ultimately, in much the same way that we currently protect people with disabilities from discrimination, it may someday be important to develop comparable protections for people who either choose not to jump on the enhancement bandwagon or simply can't afford to.

So, in effect, we can pretty much plan on the playing field getting tilted. But if that happens, will we still even by playing the same game anymore?

Right. And we already see examples of exactly what you're talking about in sports where, in addition to the American Power Lifting Association, we now also have the American Drugfree Power Lifting Association. But whereas in sport, you can arbitrarily change the rules of the game, it's much more difficult to accomplish that in the world of social practices, where people compete for jobs, spouses and pretty much everything else.

Even within the athletic realm, to the degree that sports becomes essentially a test of "who's got the better biotech sponsor?", does athletic competition really have any meaning any longer?

Precisely. And I think that's the very philosophical problem that Koss and other athletes are beginning to point out. Just what human excellences are we supposed to be celebrating here?

Stealth perhaps?

Yes. Very good. And drug tolerance.

But if the short fellow who's deeply pained by his lack of stature truly and desperately wants an added jolt of human growth hormone—all risks aside—what business is it of anybody else? Where's the ethical quandary in that?

There hardly is one for the individual.

Even if he's playing into a social stereotype?

Right. That's why if we're going to try to address that problem, we're going to have to do it at a societal level instead of trying to police the end users.

So it's really the Prohibition issue all over again, isn't it?

That's right. It would just be a different form of Prohibition, and we'd probably be just about as effective in policing it.

And yet, as with drugs and alcohol, there also are real dangers associated with gene therapy. I mean, even assuming a virtually unlimited list of relatively safe enhancements, do we have the wisdom to make intelligent choices? That is, are we old enough yet to start playing with the power tools?

I think that's a very good question. There's plenty of evidence that suggests we're not old enough yet. One of my major concerns has to do with how genetic engineering might be used to either reinforce or destabilize the various racial and social categories already used to discriminate between people.

Are you alluding to the use of eugenics?

Yes, in a way—but also to scientific racism in a much broader sense. The attempt to use DNA and genetic markers to widen the social cracks we've driven between ourselves pains me deeply. On the one hand, the population geneticists say, "Don't worry, all the genomic evidence suggests that what we see as races and ethnicities and peoples are much harder to distinguish at the genetic level and that evidence will actually serve to undermine those social constructs." But that's not what's happening because so much of the research is itself structured in terms of those very constructs.

And, you know, I just don't hear racists making much reference to the Human Genome Project. The fact that all races look pretty much the same at the microbiological level is just one of those realities that doesn't seem to be an operative part of the debate.

Exactly. It's so nice that the population geneticists are impressed, but what about those other folks we really need to worry about?

And, in any event, racists have staunchly refused to be confused by the facts right along.

On the other hand, there are subtler forms of racism or social labeling that could be undone by genetics. I'm thinking here of the ways in which genetic research might serve to either confirm or debunk people's origin stories. So one test of our social maturity might be: Are we mature enough yet to really be able to handle knowledge of where we came from? We might find out we all have much more in common than we really want to admit.

That would be wonderful. But, even putting all those racial prejudices aside, is there any reason to believe people are wise or sophisticated enough to make intelligent genetic choices?

Or will those choices just end up being swayed by advertising as usual—with generations of parents going through genetic fads and fashions in much the same way we go through kids' names from generation to generation? Now that's a sobering thought. We could end up with a whole slew of little Brittany Spears types.

Sadly, that seems less a possibility than a probability, doesn't it?

Yes, I think so. Proponents for genetic engineering make the argument that it will encourage human diversity because we'll be able to let a thousand flowers bloom and people will go off in all kinds of interesting directions, each according to his or her own values. But I think we're about as likely to do that with genetics as with any of our other resources.

The law of unintended consequences certainly has to be considered here as well. For example, it's easy to imagine that a man who wishes to enhance his artistic side may instead find himself getting more in touch with his inner schizophrenic. And who should be held to account for that? To what degree should medical professionals be responsible for saving people from their own ill-advised impulses?

Well, they have a lot of responsibility. I think that has to be part of the process of producing safe and effective interventions. Just as we worry about the side effects of any therapeutic drug, we also need to worry about the possible downside of any genetic intervention. It might be, as you suggest, that we find the genes we've tampered with are involved in many more biological processes than just the one we were interested in. Or it might mean that a positive change in one place creates problems in other places. So unforeseen consequences will always be a major consideration. And that means part of the challenge of research in this area must always be to come up with clever ways to anticipate the unanticipated.

As to the germline enhancements at the heart of the so-called "designer baby" controversy, might parents be deceiving themselves when they go looking for genetic silver bullets? After all, it's said that in the horse racing game —where bloodlines have always mattered—Secretariat looked to be muscle-bound and Seabiscuit (the legendary racehorse of the '30s) looked more like a cow pony. They were hardly the paragons of textbook perfection that horse breeders typically look for, and yet both horses achieved a level of greatness that may never be equaled again.

I think the first generation of designer babies will take a lot of wind out of the sails because people will see just how unpredictable the process is.

Are we talking Franken-babies here?

No—probably just normal kids that don't end up developing the special traits in just the way that mom and dad had hoped. In some ways, I can't wait for the first clone of an adult because I'm sure that will be a kid who goes out of his way to be as different as possible from his adult source.

I assume that first wave is likely to include some celebrity genetic material.

No doubt. We already have experience with the Nobel Laureate Sperm Bank, which got a lot of attention a couple of decades ago when it was first set up. You'd think we'd be hearing now about a whole new generation of geniuses, but somehow there's not much talk about the Nobel Laureate Sperm Bank anymore.

As a rule, do most people even have the ability to distinguish good traits from bad? That is, assuming that I can plausibly make the argument that Stephen Hawking brings at least as much value to the world as Michael Jordan does, how good are the chances that parents would choose for their children the sort of physical challenges Dr. Hawking has had to face? I ask that because Stephen Hawking himself has said his disease is not only a big part of who he is, but that it has also contributed significantly to his achievement and his success. By editing out impediments, might we in fact be doing our progeny a disservice?

Possibly. That's one of the things people with disabilities have often pointed out—that their disabilities bring them other gifts that allow them to contribute to the larger society in different ways. From the prospective parents' point of view, are they likely to opt to avoid the known disadvantages that come with a congenital disability, or will they be content to hope for an unpredictable positive turn? I think it's likely most people will make the safe decision, which probably suggests we're at risk of losing some of these special contributions.

By infringing on the natural diversity of humanity, aren't we in danger of reviving eugenics, the ideal of breeding a master race made up of perfect individuals?

It would take an amazingly successful advertising firm to sell the entire species on one particular model. If that was the case, we'd have eugenics by advertiser. For the foreseeable future, though, I think that human genetic diversity is not in great danger. Also, don't forget that there will still be plenty of people going about reproduction in the old-fashioned way. In the distant future, it might be a different story but then there'll probably be other considerations to weigh as well. Maybe we'll be flung amongst the planets by that time.

Still, if we end up sliding down the slippery path of eugenics, don't we lose some of what makes us human in the process?

No, I think our humanity is capable of accommodating all manner of atrocities. Our humanity actually isn't all that special is what I guess I'm trying to say. It would be perfectly human of us to grind ourselves into extinction. In fact, there's a special issue of a journal I subscribe to called Politics in the Life Sciences which had a symposium issue on "Is Humanity Destined to Self-Destruct?" It was a bit gloomy but that's why some of these theologians are somewhat enthusiastic about germline gene therapy. In effect, they see man's place in the universe not just as God's subjects but also as God's hands—sort of elevating us to co-creator status. So they're quite happy to talk about our trans-human future—consciously engineering ourselves out of our humanity and into whatever our next state of being is supposed to be.

Go forth and propagate new species.

Yes! Exactly.

In that same vein, Princeton molecular biologist Lee Silver, in his book "Remaking Eden: How Cloning and Beyond Will Change the Human Family," foresees a future society segregated between the "GenRich" and the "Naturals." The GenRich, blessed with certain synthetic genes, would control society and most of its wealth. The Naturals, meanwhile, would supply the labor. Is this all pure SciFi, or is Silver really onto something here?

I think it's mostly science fiction. The history of social stratification has shown that an aristocracy has a hard time maintaining a permanent sort of control—the kind you'd need in order to get a biological subspecies developed. Inevitably, the revolution comes. And as the have-nots become the haves, they gain access to the same genetic advantages. Ultimately, the playing field—if not entirely evened—at least gets very muddied. The book I always think of when I'm talking about this is the Dr. Seuss book about the creatures that have stars on their bellies: "The Star-Bellied Sneetches." The sneetches that don't have any stars on theirs make up the underclass. But a man comes along with a star machine, and soon all the unstarred sneetches manage to buy stars for their bellies, which understandably makes all the starred ones who'd been part of the aristocracy quite concerned. So they go to the man and he tells them that, yes, he does happen to have a star-removing system as well. Pretty soon, there's a constant flow of sneetches through both machines.

Well, there you have it then. It's also been said that the best antidote to the bias and injustice of eugenics would be a good, powerful dose of democracy. Is that how you see it?

That's right. If we're talking about democracy in the sense of public awareness and discussion of the techniques that are coming along, I wholeheartedly agree. That's the very way in which we'll be able to develop reasonable policies. And that's the whole philosophy behind having something like the Recombinant DNA Advisory Committee, whose job it is to review newly developed gene transfer protocols. Of course, that's the reason we're so concerned about inadvertent ventures into germline experimentation. Whether or not the incident in question [at St. Barnabas in New Jersey] was a serious form of germline gene therapy, the fact is that it was never discussed in public. And we need to have those public dialogues if we want this whole business of genetic science to progress in a fair way.

Why would there be any resistance to that? Because it's bothersome, it gets underfoot, it slows things down?

Sure, it slows things down. And from the researchers' point of view, the problem with that is that it's not necessarily in the best interests of the people they're trying to help. In this case, the researchers were helping clients at an infertility clinic who saw this technique as a way of improving their chances of having a child.

So the scientists weren't just angling to write a paper, to gain notoriety, to strut their stuff in front of their peers?

Let's be charitable.

What is it about public discussion that's so powerful? That is, what value do we as a society gain from subjecting reprogenetic technologies and policies to public scrutiny?

We gain a couple of things, actually. The most obvious is simply a form of societal informed consent. People will learn what's coming and we can use the policy-making process to decide whether we want to go down that road or not. Another benefit is that the scientific community, by engaging the public, can learn about what lies ahead for them should they manage to bring the technology in question to fruition. That's to say that in the course of a public discussion, issues come up—risks and wrinkles you never would have thought of otherwise. Also, researchers can learn about some additional applications of the technologies that may end up informing the way they do their work. So, for example, a relatively innocent proposal to study human genetic variation by sampling the world's isolated indigenous populations and comparing their DNA markers was kind of blown wide open by a public discussion that brought to light many of the issues such a research program could raise for those indigenous populations. And many of those issues took the scientists completely by surprise. One of the objections raised, for example, was that this was just the sort of information the oppressors were looking for—a good genetic marker that would serve to set the indigenous people apart, allowing eradication programs to proceed.

This would be the star they'd have to wear?

Exactly.

Even without obtaining valuable feedback like that, though, aren't we still justified in insisting upon dialogue, if only because these capabilities are ones that could easily have profound implications for all of us?

That's right. Science doesn't happen in a vacuum anymore. So in a way, we're all part of the scientific process.

As a practical matter, assuming proven enhancement interventions actually become available, is there any public policy that could possibly be effective in precluding their use?

We've been looking at that and it's awfully hard to imagine a policy that wouldn't be so draconian as to be unpalatable, at least here in America. Because basically what you'd have to do is treat these manipulations in the same way we treat other illegal substances and illegal interventions—which is to say by criminalizing them. And it's hard to imagine doing that for interventions that are ostensibly aimed at simple improvements since, on the whole, we tend to favor people trying to better themselves.

It's questionable even in the most authoritarian society whether access can be effectively precluded to something people really want. Because we can assume that people of means will always have access to enhancement interventions—whether somatic or germline—no matter what the laws say. Can we also assume, then, that restrictions on gene therapy can thus only serve to further stack the deck against the already disadvantaged?

Oh, that's an interesting point. That would be a consideration. I'd say there are three possible approaches to the problem. One would be to say: further restrictions are just going to exacerbate the differences, so let's just make some minimal level of enhancements available to all. That would be the Egalitarian Approach. Do away with the difference that wealth makes by making this a public good. Another approach would be to take a classically liberal model and say: "Well, it's okay that the rich will have access to these interventions because we can expect there to be some trickle-down benefits." If we can help to ensure that trickle-down effect by, for example, packaging a musical ability gene or a financial acuity gene with an altruism gene, then perhaps we should do so. So the idea would be to regulate the product, limiting customers only to certain packages. They would get some socially useful attribute bundled along with whichever one they find personally interesting. I tend to think of that as Genetic Liberalism. Then another possibility would be what I call Genetic Maoism—which would be to bundle desirable traits that confer some sort of advantage with some kind of compensating disadvantage. So yes, you'd be able to get the intelligence gene, but it would come along with a high propensity for depression. So take your pick and make your choice. None of the three policy approaches I've just outlined have any serious proponents that I know of. They might provide the basis for a good science fiction novel, however.

About the Interviewer

Mark Compton monitors trends in information technology and biotechnology from a comfortable perch midway between the Silicon Valley and Oregon's Silicon Forest.

Online Survey Results on Gene Doping

Following the Geneforum/PSU Public Forum on Gene Doping, geneforum posted an online survey on its Web site. Below are the results from that survey.

See results

Oregon State-Wide Telephone Survey Results on Gene Doping

In August 2004, Davis, Hibbits & McCaig, Inc. conducted a state-wide telephone survey of 500 Oregonians on the topic of gene doping. Below are the results from the survey.

See results

Researchers look to head off gene doping before it starts

Monday, February 07, 2005
THE OREGONIAN

Rachel Bachman

(February 7) For decades, doping in sports has been a mismatched race: the drug-taking athletes and their agents sprinting in front, sports' governing bodies and their tests lagging behind.

The new threat to competitive sports is not a drug. It does not leave evidence in the bloodstream or urine. Yet it has created super-muscular mice in lab tests and has athletes and coaches salivating over its potential.

It is called gene doping, and it could offer athletes an undetectable way to get ahead.

The difference this time around is that almost no athletes, if any, have tried the technique. For once, anti-doping advocates seem to have a head start on the cheats.

Today, a few leading researchers will convene at the World Anti-Doping Agency in Montreal to attack the issue of testing for gene doping, the practice of introducing specific genes into the body to stimulate muscle growth, metabolism or endurance.

On Friday morning, Portland State will play host to a panel discussion on human genetic enhancement featuring one of the world's leading authorities on the subject, Dr. Theodore Friedmann. Discussion organizer, Greg Fowler, a geneticist at Oregon Health & Science University and Founder and Executive Director of Geneforum (www.geneforum.org) said he hopes the discussion will further a national conversation on the implications of genetic manipulation for athletic gain.

Friedmann, director of the Program in Gene Therapy at UC San Diego, said society already has accepted treatments such as mood-lifting drugs and plastic surgery.

"So the question of course is: If you can improve a human being's performance in many ways with drugs, why not with genes?" Friedmann said. "What is the scientific or ethical or policy difference between the two? That, a lot of people are struggling with." What is gene doping?

Gene transfer involves the delivery of synthetic genes into human cells, where they become indistinguishable from a person's DNA. Once installed, the genes can slow muscle atrophy, speed up the body's metabolism or augment the muscles helpful for certain activities. One study, for instance, produced genetically altered "marathon mice" able to run an hour longer than unmodified mice.

Studies of gene transfer, focusing on its therapeutic potential against diabetes, muscular dystrophy and other genetically based ailments, have been around for decades. But in recent years, they have produced dramatic successes.

Those results have tantalized athletes, who always have thirsted for the next big advantage.

H. Lee Sweeney, a physiologist at the University of Pennsylvania, and his partners treated mice with a synthetic gene that made their muscles grow 15 percent to 30 percent larger than normal, even though the mice were sedentary. No sooner had Sweeney announced his study results than he was fielding phone calls from athletes and coaches, he told the Los Angeles Times.

One high school football coach asked whether Sweeney could inject his players with the gene that had bulked up the mice. The risks

Human trials in gene therapy have produced mixed results. In 1999, 18-year-old Jesse Gelsinger died suddenly after undergoing experimental gene therapy for a metabolic disorder. Although gene therapy successfully has treated children with the immune-system failure called "bubble-boy disease," it also has misfired, causing leukemia.

The danger is that unlike drug therapies, it is difficult to turn off gene therapy. Once the genes are in the body, they are there to stay.

"That really again emphasizes the fact that you don't use these tools frivolously, for anything other than serious disease, and not for tampering with enhancement kinds of goals," Friedmann said. The challenges

Gene doping is on WADA's list of prohibited substances and methods yet it remains an irresistible idea to many athletes.

"Another problem is that the money required to do such work, set up a laboratory and go in this direction, is not enormous and by athletic standards is absolute chicken feed," Friedmann said. "So if I were really a rogue and intent on doing this and evading all the relevant oversight mechanisms, I could do sort of a ham-fisted, bad job of it.

"But to do it well and rigorously and carefully and safely in athletes, I could not."

Another scheduled panelist for the PSU forum, Maxwell Mehlman, said the threat of gene doping is another example of sports' losing battle against humans' attempts to gain an athletic advantage. Mehlman, a professor of biomedical ethics at Case Western Reserve University in Cleveland, said catching doping athletes grows more difficult with each leap in technology.

"At some point, I think we really have to rethink, 'Is it worth it?' " Mehlman said. "Ultimately, is it worth it to continue to have the pleasure of watching people target-practice with muzzleloaders? Or is it time to just say, 'Well, it's just too hard because we can't tell the difference between muzzleloaders and automatic machine guns anymore without a great deal of too much effort. So we'll just have shooting.' " The future

Lance Deal, a 1996 Olympic silver medalist in the hammer throw and an assistant track and field coach at Oregon, said he considers athletes manipulating themselves to be cheating.

"If they decided to find something that would cure my defect in my ear so I could hear on one side . . . yeah. Sure," Deal said. "But that's so I can hear my daughter. That's not so I can get a silver medal in the Olympics."

Yet as Sweeney wrote in his story in the July issue of Scientific American, the 2004 Athens games might have been the last Olympic games without genetically enhanced athletes.

Friedmann, the leader of WADA's gene doping panel, said he is confident that effective, manageable testing methods can be found. But when asked for the worst-case scenario for gene doping in sports, Friedmann invoked the scandal involving the Bay Area Laboratory Co-Operative, implicated in the doping of numerous high-profile athletes.

Gene doping, Friedmann said, "is a genetic equivalent of BALCO. It can happen."

###

Rachel Bachman: 503-221-4373; rachelbachman@news.oregonian.com

Copyright 2005 Oregon Live. All Rights Reserved.

Results from Oregon College Athlete Gene Doping Survey

In 2005, Geneforum approached athletic directors at Portland State University and University of Oregon to ask whether their athletes would be willing to participate in an online survey on the subject of gene doping. Below are summary results from the 115 athletes that completed the survey.

See results

Summary of Public Values Raised During 2005 Public Forum on Gene Doping

Following is a summary (by category) of the issues (public values) raised during the open discussion of ~160 guests which followed the (factual) remarks of panelists Ted Friedmann, M.D. – Director, Program in Gene Therapy, UCSD; Mari Holden – 2000 Olympic Silver Medalist in Cycling; Max Mehlman, J.D.-- Director, Law-Medicine Center and Professor of Biomedical Ethics, Case Western Reserve University.

Read report

Survey Results from 2005 Public Forum on Gene Doping

Below are survey results from the Feb. 11, 2005 public forum co-sponsored by Geneforum and Portland State University. Following presentations from 4 panelists, an audience of ~160 was asked to answer the following questionnaire and then participate in an open discussion.

See results

Action Alert Tell the Senate to take action on GINA!

Action Alert
Tell the Senate to take action on GINA NOW!

The Genetic Information Nondiscrimination Act, or GINA, (S.358) is on the verge of passing after 12 long years! The House bill (H.R.493) passed 420-3 on April 25 and the Senate bill has been reported out of committee. We just need the full Senate to vote on the bill to get it to the President’s desk!

Tell your senators to push for GINA to come to the floor for a vote! A list of senators and their contact information is below. Please take a few minutes to tailor the sample letter below on your letterhead and fax it to the Senate (or call, or email them - http://www.senate.gov/). Feel free to insert personal reasons for your support of the bill into the text.

There is power in numbers! Tell your friends, family, coworkers, and other members of your organization to take action now. We must make a big impact on this issue, and if every senator is contacted multiple times, we can make it happen! [Coalition for Genetic Fairness can also hand deliver a big pile of letters if you want to also fax us a copy: 202.966.8553]

Sample Letter

Dear Senator ____,

I support the Genetic Information Nondiscrimination Act, or GINA, (S.358). I am writing to ask for your support for this legislation to come to the floor and pass.

It is astounding that this bill, which the Senate has passed unanimously in the 108th and 109th Congresses, has not passed in the 110th yet. The House passed it 420-3 on April 25, 2007. This bill protects all Americans from the misuse of genetic information in employment and health insurance decisions. With these protections in place, Americans will be able to use genetics in medicine without fear of misuse of their genetic information.

More than 140 national patient groups, academic institutions, research centers, companies, women’s organizations, labor organizations, and the millions of Americans endorse this legislation. We represent every sector of society in this nation, and we urge passage of GINA.

Thank you for your time.

Best,
___

List of Senators

Senator Phone Fax
Daniel Akaka (D-HI) 202.224.6361 202.224.2126
Lamar Alexander (R-TN) 202.224.4944 202.228.3398
Wayne Allard (R-CO) 202.224.5941 202.224.6471
Max Baucus (D-MT) 202.224.2651 202.224.0515
Evan Bayh (D-IN) 202.224.5623 202.228.1377
Robert Bennett (R-UT) 202.224.5444 202.228.1168
Joseph Biden (D-DE) 202.224.5042 202.224.0139
Jeff Bingaman (D-NM) 202.224.5521 202.224.2852
Christopher Bond (R-MO) 202.224.5721 202.224.8149
Barbara Boxer (D-CA) 202.224.3553 202.956.6701
Sherrod Brown (D-OH) 202.224.2315 202.228.6321
Sam Brownback (R-KS) 202.224.6521 202.228.1265
Jim Bunning (R-KY) 202.224.4343 202.228.1373
Richard Burr (R-NC) 202.224.3154 202.228.2981
Robert Byrd (D-WV) 202.224.3954 202.228.0002
Maria Cantwell (D-WA) 202.224.3441 202.228.0514
Benjamin Cardin (D-MD) 202.224.4524 202.224.1651
Thomas Carper (D-DE) 202.224.2441 202.228.2190
Robert Casey (D-PA) 202.224.6324 202.228.0604
Saxby Chambliss (R-GA) 202.224.3521 202.224.0103
Hillary Rodham Clinton (D-NY) 202.224.4451 202.228.0282
Tom Coburn (R-OK) 202.224.5754 202.224.6008
Thad Cochran (R-MS) 202.224.5054 202.224.9450
Norm Coleman (R-MN) 202.224.5641 202.224.1152
Susan Collins (R-ME) 202.224.2523 202.224.2693
Kent Conrad (D-ND) 202.224.2043 202.224.7776
Bob Corker (R-TN) 202.224.3344 202.228.0566
John Cornyn (R-TX) 202.224.2934 202.228.2856
Larry Craig (R-ID) 202.224.2752 202.228.1067
Mike Crapo (R-ID) 202.224.6142 202.228.1375
Jim DeMint (R-SC) 202.224.6121 202.228.5143
Christopher Dodd (D-CT) 202.224.2823 202.224.1083
Elizabeth Dole (R-NC) 202.224.6342 202.224.1100
Pete Domenici (R-NM) 202.224.6621 202.228.3261
Byron Dorgan (D-ND) 202.224.2551 202.224.1193
Richard Durbin (D-IL) 202.224.2152 202.228.0400
John Ensign (R-NV) 202.224.6244 202.228.2193
Michael Enzi (R-WY) 202.224.3424 202.228.0359
Russ Feingold (D-WI) 202.224.5323 202.224.2725
Dianne Feinstein (D-CA) 202.224.3841 202.228.3954
Lindsey Graham (R-SC) 202.224.5972 202.224.3808
Charles Grassley (R-IA) 202.224.3744 202.224.6020
Judd Gregg (R-NH) 202.224.3324 202.224.4952
Chuck Hagel (R-NE) 202.224.4224 202.224.5213
Tom Harkin (D-IA) 202.224.3254 202.224.9369
Orrin Hatch (R-UT) 202.224.5251 202.224.6331
Kay Bailey Hutchison (R-TX) 202.224.5922 202.224.0776
James Inhofe (R-OK) 202.224.4721 202.228.0380
Daniel Inouye (D-HI) 202.224.3934 202.224.6747
Johnny Isakson (R-GA) 202.224.3643 202.228.0724
Tim Johnson (D-SD) 202.224.5842 202.228.5765
Edward Kennedy (D-MA) 202.224.4543 202.224.2417
John Kerry (D-MA) 202.224.2742 202.224.8525
Amy Klobuchar (D-MN) 202.224.3244 202.228.2186
Herbert Kohl (D-WI) 202.224.5653 202.224.9787
Jon Kyl (R-AZ) 202.224.4521 202.224.2207
Mary Landrieu (D-LA) 202.224.5824 202.224.9735
Frank Lautenberg (D-NJ) 202.224.3224 202.228.4054
Patrick Leahy (D-VT) 202.224.4242 202.224.3479
Carl Levin (D-MI) 202.224.6221 202.224.1388
Joseph Lieberman (D-CT) 202.224.4041 202.224.9750
Blanche Lincoln (D-AR) 202.224.4843 202.228.1371
Trent Lott (R-MS) 202.224.6253 202.224.2262
Richard Lugar (R-IN) 202.224.4814 202.228.0360
Mel Martinez (R-FL) 202.224.3041 202.228.5171
John McCain (R-AZ) 202.224.2235 202.228.2862
Claire McCaskill (D-MO) 202.224.6154 202.228.6326
Mitch McConnell (R-KY) 202.224.2541 202.224.2499
Robert Menendez (D-NJ) 202.224.4744 202.228.2197
Barbara Mikulski (D-MD) 202.224.4654 202.224.8858
Lisa Murkowski (R-AK) 202.224.6665 202.224.5301
Patty Murray (D-WA) 202.224.2621 202.224.0238
Ben Nelson (D-NE) 202.224.6551 202.228.0012
Bill Nelson (D-FL) 202.224.5274 202.228.2183
Barack Obama (D-IL) 202.224.2854 202.228.5417
Mark Pryor (D-AR) 202.224.2353 202.228.0908
Jack Reed (D-RI) 202.224.4642 202.224.4680
Harry Reid (D-NV) 202.224.3542 202.224.7327
Pat Roberts (R-KS) 202.224.4774 202.224.3514
John Rockefeller (D-WV) 202.224.6472 202.224.7665
Ken Salazar (D-CO) 202.224.5852 202.228.5036
Bernard Sanders (I-VT) 202.224.5141 202.228.0776
Charles Schumer (D-NY) 202.224.6542 202.228.3027
Jeff Sessions (R-AL) 202.224.4124 202.224.3149
Richard Shelby (R-AL) 202.224.5744 202.224.3416
Gordon Smith (R-OR) 202.224.3753 202.228.3997
Olympia Snowe (R-ME) 202.224.5344 202.224.1946
Arlen Specter (R-PA) 202.224.4254 202.228.1229
Debbie Stabenow (D-MI) 202.224.4822 202.228.0325
Ted Stevens (R-AK) 202.224.3004 202.224.2354
John Sununu (R-NH) 202.224.2841 202.228.4131
Jon Tester (D-MT) 202.224.2644 202.224.8594
Craig Thomas (R-WY) 202.224.6441 202.224.1724
John Thune (R-SD) 202.224.2321 202.228.5429
David Vitter (R-LA) 202.224.4623 202.228.5061
George Voinovich (R-OH) 202.224.3353 202.228.1382
John Warner (R-VA) 202.224.2023 202.224.6295
Jim Webb (D-VA) 202.224.4024 202.228.6363
Sheldon Whitehouse (D-RI) 202.224.2921 202.228.6362
Ron Wyden (D-OR) 202.224.5244 202.228.2717

Arguments against the genetic nondiscrimination bills

A new bill recently introduced in the U.S. House of Representatives would prohibit employers from making hiring/firing and promotional decisions based on genetic information showing a worker may contract a disease in the future, and would also prevent health plans from denying coverage or charging higher premiums using those same genetic tea leaves. (United Press International in today's online newspaper)

The article, in addition to providing reasons for the bill, supplies a good summary of the reasons some legislators are against the bill known as GINA (Genetic Information Nondiscrimination Act). Here are some of the statements in Laura Gilchrist's article, Analysis: Genes and job discrimination.

Some may think the bill is not strong enough:

The proposed legislation, co-sponsored by Reps. Louise Slaughter, D-N.Y., and Judy Biggert, R-Ill., would be limited to cases where an employer intentionally seeks out genetic information about a worker and misuses that information. The bill even carves out a so-called "water-cooler" exception to protect employers from liability under the law if they come across the sensitive data inadvertently.

The bill also requires that a worker first take his case to the Equal Employment Opportunity Commission before going to court, and damages caps are built into the law; for example, companies with fewer than 100 workers would pay no more than $50,000 in damages, while firms with more than 500 workers would have a damages limit of $300,000.

Others are concerned that the bill "recommends" genetic testing, while prohibiting discrimination based on test results.

"There is a clash between people who want to save money and those who say (a genetic-information non-discrimination law) will cause frivolous lawsuits," Biggert said.

Other policy experts said the bill should still allow companies to collect such data if they can show the genetic information is relevant to a specific job or to worker safety, and that the bill should make clear that it is not a ticket for workers to sue their employers for failing to provide coverage for certain medical conditions.

Speaking in opposition to the bill,

Mohit Gose, spokesman for the trade group America's Health Insurance Plans, told United Press International that his group generally supports the new legislation's goal of prohibiting genetic information-based discrimination in coverage and premium policies, but said insurers should still be able to use the information for "improving the quality of healthcare being provided."

"We continue to work with the House and the Senate to ensure that (its passage) has no inadvertent consequences that could impede (health) quality improvement activities," he said.

Others argue that genetic testing is so new that discrimination isn't occurring yet and we're wasting time passing unneeded legislation.

"Trying to stay ahead of the curve through legislation is a recipe for unintended consequences," Jack Calfee, resident scholar with the free market-oriented think tank American Enterprise Institute, told UPI. "These bans have a way of expanding through legislation and regulatory proceedings and become much broader than contemplated when they were written," he said. "Let's see if it's a problem for employers and employees before we legislate."

Committee Ranking Member Rep. John Kline, R-Minn., also noted the apparent lack of evidence as yet that genetic data are being misused by companies and insurers. "We don't necessarily need a broad, federal mandate," he said. "If legislation is needed -- and the jury is still out -- we should target the solution to the problem, rather than going after a mosquito with a machine gun."

While there have been few discrimination cases stemming from the testing so far, employees of Burlington Northern Railroad did bring a successful case against their former company.

Geneforum's policy is to address issues in their early stages, before great damage has occurred. People in a number of surveys have indicated that they value their genetic privacy. I think this value, and the right to work and to have health insurance regardless regardless of genetic "predisposition", should be addressed while genetic testing is still in its infancy.

Marie Godfrey, PhD

 

 

Could you face genetic discrimination?

Tomorrow (January 30), at 10:30 am EST, the House Subcommittee on Health, Employment, Labor, and Pensions will hold a hearing on The Genetic Information and Nondiscrimination Act (GINA). If your Representative is not yet a sponsor of the bill--as mine is not--you may want to join me and encourage that person to sign on.

The list of sponsors can be found at http://thomas.loc.gov/cgi-bin/bdquery/z?d110:HR00493:@@@P%5d. This particular bill is even supported by President Bush. Details are available at http://www.geneticfairness.org/act.html

You can call (best option) or send an e-mail to your Representative. The time it takes is well worth it. Here are some details of interest--taken directly from the information provided by the Coalition for Genetic Fairness:

Why We Need GINA

1) We are all affected.

• Each of us carries a handful of genetic anomalies. Some of those might cause us to be affected by genetic conditions. Some of those will not affect our health, but may affect the health of our children.

• Currently, 1200 genetic tests exist which can diagnose thousands of health conditions. This number has grown from just 100 genetic tests 10 years ago. With more genetic tests in the pipeline, increased genetic information will become accessible through testing.

• Genetic information is invaluable. It provides a key to our makeup that we can use to proactively manage our health. However, this same information may also be misused and put us at risk for genetic discrimination. Cases of genetic discrimination have already been documented in the United States, and without laws to address the issue adequately, such cases will likely continue.

• We need legal protection so that all Americans are free to put their health concerns first without fear of discrimination.

2) Current laws do not adequately protect us from genetic discrimination.

• The current patchwork of state laws leaves individuals vulnerable. A few states have strict protections against genetic discrimination, but most states have little to no protection. This leaves individuals with little knowledge about how much their genetic information is protected from state to state. In addition, companies who deal in any kind of health information are left with no national framework to guide how they handle genetic test results and genetic information privacy.

• Genetic information is not properly covered under HIPAA privacy guidelines. Current HIPAA guidelines do not prohibit insurers from requiring genetic testing or from denying coverage based on genetic information. Genetic information is becoming increasingly more ingrained in medicine, and as such, will serve to complicate privacy law if steps are not taken now to close gaps in policy.

3) We all lose under current guidelines.

• Fear of misuse of genetic information is preventing people from getting genetic tests done. Refusal to utilize effective genetic tests hurts individuals, researchers, doctors, and companies. Individuals’ lack of testing denies them important medical information that they could otherwise use to proactively manage their health. The information garnered by genetic tests also helps doctors to prescribe treatments and lifestyle changes with increased success. The same information can be used by researchers to effectively create targeted drugs and develop treatments. In addition, companies developing these important tests cannot recoup research costs, and therefore, are unable to invest in further development.

• Fear of discrimination is also causing a large number of people to opt out of clinical trials. Fewer participants in clinical trials leads to slower development of treatments and beneficial drugs. With the exponential increase in genetic tests being developed, lack of participation in trials will most likely prove to be a severe limiting factor. In addition, clinical trials provide patients in late stages of disease with access to breakthrough treatments that would normally be unavailable.

4) We can all benefit from protections offered in the Genetic Information Nondiscrimination Act.

The Genetic Information Nondiscrimination Act protects all Americans by:

• Prohibiting insurers in both the group and individual health insurance market from 1) “requesting or requiring” genetic testing of an individual or his family or 2) using genetic information to determine eligibility or establish premiums.

• Prohibiting employers, including employment agencies and labor organizations, from 1) “requesting or requiring” genetic testing of an individual or his family or 2) using genetic information to make hiring or promotional decisions, or when determining eligibility for training programs.

Americans support the Genetic Information Nondiscrimination Act. An overwhelming majority of Americans (85%) believe that if someone has a genetic test, their employer should not have the right to know the results. Republicans, Democrats, and individuals from all racial and ethnic groups, religions, and income and education levels share this opinion. [Survey conducted in 2002 by the Genetics and Public Policy Center, Johns Hopkins University.]

Marie Godfrey, PhD

Faces of Genetic Discrimination

See the attached article (28 pages long) for stories on people who have faced genetic discrimination.

Marie Godfrey, PhD

Genetic discrimination bill active again

The following comes from a bulletin I received a few minutes ago from the Genetic Alliance. If you are concerned about the potential effects of genetic testing--whether for privacy or insurance coverage--you will want to check this out and make your opinion known.

Genetic Information Nondiscrimination Act Introduced in House!

The Genetic Information Nondiscrimination Act (GINA) was introduced in the House of Representatives as H.R. 493 on January 16. Over 140 original cosponsors joined sponsors Rep. Slaughter (NY-28), Rep. Biggert (IL-13), Rep. Eshoo (CA-14), and Rep. Walden (OR-2) in supporting GINA's introduction. House and Senate bill sponsors will build stronger support in their chambers with your grassroots help. Genetic Alliance is collecting letters of support from our community and to present GINA's House and Senate sponsors. You can simply customize a template letter and send it to us to deliver with all of the other letters. Please join us in this effort and take a few minutes to make your voice heard!

Click here to learn more about the GINA letter drive

Click here to help build cosponsors for GINA

Click here to learn more about GINA

Join the Genetic Alliance push if you are in favor of the bill, or write a letter of your own. Equally important: if you have doubts, questions, reservations about the substance of the bill (you'll have to read it of course), say or do something. We at geneforum bring you information like this so that you can voice YOUR opinions. If you want more information on genetic discrimination, ask a question here, or consult other Genetizen blogs about the subject.

Marie Godfrey, PhD

 

GINA passes in the House

Today, the Genetic Information Nondiscrimination Act (H.R.493) passed the House of Representatives. Representative Slaughter (D-NY) and Representative Biggert (R-IL), GINA’s lead sponsors, spoke to the need for protections against genetic discrimination and thanked the House chairs of the committees of jurisdiction for their work to move the bill. Members of the House from both sides of the aisle stood in support of GINA and called for a favorable vote on the legislation. The bill was passed with a 420-3 vote under the suspension of the rules.

Thanks for all your help.

Marie Godfrey, PhD

Senate committee to review genetic nondiscrimination

Tomorrow (January 31) at 10 am EST, the Senate committee on Health, Education, Labor, and Pensions will "mark-up" the Senate version of the genetic nondiscrimination bill discussed today by a House committee. Word from the rumor mill is that the meeting will be open to the public. I don't know whether it will be broadcast on t.v.

You can check out the text of each of the bills by going to http://thomas.loc.gov/ and searching for H. R. 493 for the House and S. 358 for the Senate.

I wrote to my Utah Representative, Rob Bishop, about the bill in the House and he called me tonight with some questions. I hope my answers were helpful to him.

Marie Godfrey, PhD

Ways to protect people from discrimination based on genetic information

Michael Hill, in a recently released story in the Baltimore Sun, provides a series of questions and answers about genetic discrimination. The answers come from Karen Rothenberg, dean of the University of Maryland's School of Law and founding director of the school's Law and Health Care program. Last week, she testified in Washington before a House subcommittee considering a bill designed to protect workers from discrimination by employers and insurers on the basis of genetic information.

Here are some of the questions and her answers:

If potential discrimination has been an issue for such a long time, why is it just getting written into a federal law?

Early on, I was part of a series of working groups that put together a framework for a legislative approach to the issue because I had researched early state legislative approaches. When it appeared that we were not going to get it through initially on the federal level, we adopted a two-stage approach -- state-by-state efforts and continuing work on the federal level -- going back as early as 1995. Maryland is one of a number of states that took action on this, though it is impossible for any single state to cover all the issues.

In Washington, on and off, we have made some progress. We would get something watered down through the Senate and not through the House. It looks possible that this year something could happen.

As a matter of social policy, this issue is extremely important. What we are saying is that we should not allow discrimination because somebody gets genetic information that tells them that something in their genetic code says they have a predisposition to heart disease or cancer or whatever.

I think what we as a society have to say is, "Look, we all have a number of mutations in our genetic makeup that predispose us to diseases or conditions."

The people and the genetic predictors that get singled out are the ones that researchers happen to have looked at. . . We should not discriminate against somebody because we have identified some predictor in their genetic code. That is important in every state, and it is important nationwide.

Why would people want to get genetic information about themselves if they are worried about discrimination? Doesn't testing usually just tell you something you can't do anything about?

Remember, there is a wide range of genetic information. Some can paralyze you and there is nothing you can do about it. But others can mean you can make a change in your lifestyle or medical choices.

Let's say a disease, colon cancer, has already been diagnosed, then, for example, a genetic test might say something about what sort of treatment you should get, what kind of drugs, whether it should be chemotherapy or radiation or radical surgery. At that point, you may make a risk/benefit analysis, weighing privacy and discrimination concerns against medical decisions.

What you have to remember is that most people who get colon cancer do not have a genetic explanation, at least at this point. Then there are people in the same family, and one gets it and the other doesn't. They grew up in same environment, ate the same food, breathed the same air and for some reason one gets sick and the other doesn't. They may or may not have the genetic predisposition. Even if someone does have that predisposition, it interacts with the environment in a way that we do not understand. So it really makes no sense to use these genetic markers for employment or insurance or any other reason like that. Even if we knew for sure, this is a civil rights issue. People should not fear discrimination based on their genetic code.

Then there is the impact on the future of genetic research. People should not be afraid to participate in big clinical trials that can advance our knowledge of dealing with diseases, afraid that the information the researchers find out about them can be used against them. Some people will want their individual results if available, some will not. Again it is a risk/benefit analysis, deciding if the results are of value to them. But what will they do the next time they are filling out a form that asks about medical tests? Does this include genetic information? When you don't get the results, you don't have any of those issues.

My bottom line is that if we as a society choose to invest in this research, it should not be to penalize or hurt people; it should be to empower them.

In the end, can we pass laws to address all of these problems? Is it really possible to legislate such discrimination out of existence?

You can never guarantee legislation will eliminate hate or fear, but we can try. This is particularly important post-9/11 when the government is looking into so many aspects of people's private lives. What I worry about is that your genetic code, as opposed to your race or your gender, is invisible. If you make a claim of discrimination based on race or gender, you are not revealing any secrets. But that might be the case for a healthy person who is claiming discrimination because of some genetic predisposition. So they risk their loss of privacy and, unless they are protected, they have no discrimination claim.

It is one thing, as we have done in many states, to tell insurance companies that they cannot discriminate, cannot refuse to issue policies, based on genetic information. But the fact is that in our society, most insurance comes through employers. So if an employer denies you a job because of what that company knows about your DNA, it is in effect denying you insurance.

And remember, many of these employers are self-insured so they are essentially directly denying you the insurance they underwrite.

One thing you have to realize is that there are ways for employers to get such information that legislation will never deal with. An interviewer doesn't have to ask if you have a lot of breast cancer in your family. Say I call a reference you give me and that reference says, "She's a fantastic worker, such a hard worker that she never missed a beat even over the last few years when three or four members of her family got breast cancer."

There is not going to be anything illegal about that. But try proving discrimination if you don't get the job. It will be difficult.

I don't think any legislation can do all that. But legislation can send a strong message about social policy. People should be respected for who they are, not denigrated because of some difference in their genetic makeup.

The full article is available at http://www.baltimoresun.com/

news/opinion/ideas/bal-id.profile04feb04,0,5307542.story

Marie Godfrey, PhD

Everyone wants your DNA--whose is it anyway?

In contrast to Kaiser Permanente's recent acknowledgement that they are planning to use tissues, including DNA, from their patients for unspecified resarch unless individuals opt-out by submitting a letter to them, the Ministry of Health in New Zealand announced today that residents of that country are being asked to comment on proposed guidelines for such unspecified research. In an article, the ministry's chief clinical adviser, Sandy Dawson, stated:

New Zealand already has clear guidelines on the ethical collection, use and disposal of tissues for research which is specified at the time that consent is given. These proposed guidelines provide additional guidance for ethics committees and researchers to cover situations where tissues can be stored and used for to find answers to research questions that arise in future.

According to the article, "human tissue is defined as any material that is, or includes, human cells. It includes all or any part of a body, a foetus or the body of a still-born child, human stem cells, other human cells and blood."

New Zealand research groups are among those who want to bank human tissue for future, unspecified research. Kaiser Permanente, deCODE genetics (Iceland), biobank of the UK, and many other groups are already building or working with their "biobanks". Several days ago you had an invitation to give comment on a US genetic advisory committee proposal for a biobank--at the same time NIH has already begun initial work on such a project. Hmmm, should we wonder whether the branches of our government are not talking to each other?

What's happening? Are the decisions being made for us? Do we have any say in the matter?

Becoming informed--even realizing that these things are happening around us--is a good first step. Reading and commenting on notices for public input are other ways. If you want to read what New Zealand proposes, go to http://www.moh.govt.nz/moh.nsf/indexmh/guidelines-use-of-human-tissue and download a copy of the proposed guidelines.

For the US proposals (for what they're worth), check out the blog entry YOUR comments needed on whether NIH should start a population study on Genes, Environment, and Disease.

Marie Godfrey, PhD

Geneforum Interview with George Annas: Genetic Turf Wars: Whose DNA is it anyway?

An Interview with George J. Annas
Professor & Chair of the Health Law Department
Boston University School of Public Health

by Mark Compton, November 2000

Over the past decade, George Annas has come to be considered one of the nation's foremost experts on genetic privacy. That's largely because in 1995 he was the principal author of a model designed to serve as the basis for federal gene privacy legislation. Although Congress has since remained divided over the issue, the Annas model has been adopted - to greater or lesser degrees - by a number of states that have passed genetic privacy acts of their own.

The first state to take action was Oregon. But now Oregon's Genetic Privacy Act is being reviewed, largely at the urging of biotechnology industry leaders who believe the law inhibits their ability to collect the massive amounts of data required for disease association studies. Of particular interest to industry lobbyists is a clause in the statute which establishes that each individual owns his or her own DNA and thus is entitled to exercise autonomy over its use. Researchers would like to strike that clause. Annas wonders at their motivations.

[Mark Compton]: At present, Oregon's Genetic Privacy Act explicitly defines a DNA sample as being the property of the person from whom the sample was harvested. But various researchers, pharmaceutical companies and biotechnology organizations have objected to this provision, arguing that it unduly interferes with their ability to collect disease association data. Having heard these complaints, the Oregon legislature is currently considering removal of the property clause, substituting in its place some as-yet-unspecified legal remedies. If the legislators decide individuals should not be permitted to assert property rights over their own DNA samples, what implications would you expect?

[George J. Annas]: That property notion was developed on the basis of the common-sense notion that no one should have greater authority over your own body and DNA than you. The other underlying premise is that the simplest way to protect that autonomy is to say simply that you own your DNA and if anybody else wants to use it, they can only do so with your authorization. The idea that anyone else can own your DNA - like the biotech companies or the researchers - while you can't strikes me as nonsense. It can't possibly be that everyone else in the world can own my DNA, but I can't. So when researchers at biotech companies complain about the property notion potentially interfering with what they're doing, what they're really balking at is having to go to the trouble of getting explicit authorization from individuals before using their DNA for commercial or research purposes. But that's something they should be doing anyway. So basically what they're arguing is that they should be allowed to take DNA without consent. And I just don't find that persuasive and I hope that ultimately the Oregon legislature doesn't either.

Should researchers get out of line somehow, would you think they'd have less to fear if the only recourse was state-imposed "legal remedies" as opposed to the current property clause?

Well, without knowing what the legal remedies are, it's hard to say. But again, I think it's likely that someone who can assert ownership, especially in the US, will have a stronger claim than someone who cannot assert ownership to an asset that's been misused or exploited for commercial gain.

Since Oregon's Genetic Privacy Act currently includes no enforcement provisions, might it be argued that the substitution of legal remedies for property rights actually puts some teeth into the statute?

It's possible. But again, that depends on what the remedies are. Ultimately, what you want to protect is genetic privacy - to protect individuals from having their DNA taken without their consent and then used without their authorization. So if we can achieve that end through criminal penalties, that would be fine.

Of course, generally in such cases, industry can be expected to have a hand in helping the legislators define appropriate remedies.

I certainly would not be surprised at that - in which case, I think it's unlikely criminal penalties will be seriously considered.

To get closer to some of the implications, there's a topical issue I'd like to explore. Just recently, a California startup called DNA Sciences mounted a splashy, nationwide public relations campaign announcing its goal to seek out as many as 100,000 DNA donors for a so-called Gene Trust. Billing its effort as a search for knowledge with the potential to change medicine forever, DNA Sciences is directing its appeal entirely to altruism, promising no compensation apart from free diagnostic tests for contributors (assuming, of course, that any such tests are ever developed). To your way of thinking, does this sort of appeal rise to the level of informed consent?

It certainly does not rise to the level of informed consent and I would be surprised, actually, if very many people end up taking them up on this offer based on their vague promise to protect privacy even as they go about collecting personal information about each donor. This is the very type of thing that demonstrates the need for state and federal legislation to protect individuals. Because there is no enforcement whatsoever behind these promises. People are being asked to act strictly on faith. And what do we actually know about this "Gene Trust"? Who's the trustee? For whose benefit is this being done? And if DNA Sciences chooses not to live up to their promises, what can be done about it? The answer is: nothing.

Also, although DNA Sciences and other groups like it routinely promise to preserve donor anonymity, is that even possible in an Internet-powered culture where we're repeatedly reminded that information wants to be free?

I don't think the assurances are worth much so long as it's possible to link the DNA sample with identifiable information about the donor. But generally when people talk about anonymous use of DNA, what they really mean is that it's going to be coded. And my argument is that the person who has that code can break that code. So that's not good enough. I think if you're going to use anonymous DNA, you have to have DNA that's not linkable, which is to say there's no possibility of somebody going back through the records later to find that individual.

But of course, from the researchers' perspective, maintaining that all-important context is vital if they're trying to develop disease association data.

Well, some have certainly made that argument. And, in some studies, identifiable DNA is undeniably important. But if that's the case, they should just go ahead and get the individual's authorization before moving forward. And that's not really all that hard to do.

So long as the authorization rises to the level of informed consent.

Exactly right. If the researchers decide to do a new project, they should be required to go back and get additional consent. But again, that shouldn't be hard because the only reason for keeping an identifier in the first place is to allow them to go back to the donor. So the argument that it's impossible to go back or cumbersome to do so is not particularly compelling - especially when they're arguing at the same time that they need to keep the identifier so they can go back and learn more whenever they feel the need to do so.

So let's say a donor's privacy actually is broached. What potential implications might that individual face?

It depends on what's in their DNA. Suppose there's an indication that they're at higher risk for a form of cancer or for early Alzheimers disease. If their employer finds out about that, they might not get promoted or they may even lose their job. If a life insurer finds out, they may not be able to get life insurance. Or they may only be able to obtain health insurance policies at prohibitively high rates. More important to me, the subjects themselves may end up finding out something about themselves they really don't want to know. For example, we haven't found the early Alzheimers gene yet, but assuming we do, researchers might find that a person is at a higher risk for getting early Alzheimers, and learning this may discourage that person from getting advanced training or going to medical school or doing any number of other things they might otherwise do - thinking they're not going to live all that long anyway. Or their spouse might start to think differently of them. Or their children might think differently of them.

So there's an element of self-fulfilling prophecy here?

No question about it. We know how much people agonize already over their health and get screened all the time for various forms of cancer, high blood pressure, cholesterol … you name it. You can magnify that 100 times with genes because we think of them as being that much more predictive. They're not really as deterministic as all that, but we tend to treat them almost as if they were magic. And in this case, perception is reality since there's a distinct possibility we would discriminate against ourselves should we suddenly learn we're at extremely high risk for various lethal disorders.

And might not the anxiety thus engendered be sufficient in and of itself to induce various adverse health effects?

That's very possible as well and there are many respected professionals who believe that's the case. Certainly, before we get into using DNA for clinical diagnostics, we need to have at least a couple hundred thousand genetic counselors who are able to talk to people intelligently about what genetics means. Because, at this point, it's certainly clear that very few people understand anything at all about the field - including physicians.

And apart from that education, is there some special informed consent that should accompany those kinds of diagnostics?

Absolutely. And we're just in the infancy of trying to figure out how to get informed consent prior to applying a wide panel of genetic tests, for example. It's one thing to get informed consent prior to a very narrow test, say, for the cystic fibrosis gene or even the breast cancer gene, but it's quite another thing to get informed consent prior to administering a battery of 1000 tests. And there are DNA chips being developed even now that will be capable of doing just that. In the future, it's conceivable that 10,000 - or even 100,000 - genetic tests could be run at the same time. I personally don't think it's possible to give informed consent to any and all DNA-based tests a researcher might ever choose to run. That would require something more like a waiver of consent, saying you really don't care what the researchers do. But I think that with genetic tests, which are potentially so life-changing, you'd be well advised to be quite specific with your consents.

Because once the veil of privacy has been pierced, is there really anything that can be done to make a person whole?

I think not, which is one reason why I've suggested that parents should not be allowed to test their children for diseases that aren't going to manifest until adulthood unless there's some way the disease can be prevented or mitigated during childhood. Otherwise, you take away the child's right not to know about their genetic predispositions. It's very important that decisions about testing be left for the individual to make once they're able to grasp all the implications.

And if the privacy of family members of a DNA donor should be compromised, what sort of recourse would currently be available to them? Perhaps more tellingly, what sort of recourse should be available to them, given the assumption that they provided no consent whatsoever - either informed or otherwise - to have their genetic material examined?

Right. It would be difficult under current law for them to show that they've been harmed. Usually, in malpractice law, we talk about specific harms - for example, a physical harm, medical bills or loss of earnings. So unless you can demonstrate that you were fired because somebody else in your family notified your employer of a genetic concern, it would be very difficult to get any satisfaction whatsoever under current law. The physician could always say he passed word to other family members about the genetic predisposition because he thought they might be in danger. And that's exactly why I think we need specific legislation that says doctors can never tell relatives about what they've found - only you can. And that, in turn, would protect doctors from malpractice actions for keeping those secrets. Because if we had a federal privacy law, everybody would know exactly what the rules were and would be able to act accordingly.

As for protecting individuals from unwanted information divulged by family members, I don't suppose we can really write legislation for that.

No, I don't think we can. That's part of being in a family. We often disclose and know a lot more about our family members than we may really want to know. But that's all part of the deal. Still, that can present problems. Take the example of twins who are both at risk for Huntington's Disease. If they're identical twins, that means either they both have the Huntington's gene or neither one of them has it. So if one wants to get tested and the other one doesn't, who should win in that case? Historically, the policy has been that a geneticist shouldn't test one unless both want to know. Personally, I think that's wrong. I think the right to know probably should trump the right not to know. So, in that case, the other one who doesn't want to know is probably going to have to move and not come in contact with their sibling. But I think the people who want to be tested should have a right to that information.

Another property consideration we haven't touched on yet has to do with the matter of compensation. Some believe DNA donors should be compensated in some way if lucrative discoveries are made on the basis of their DNA material. But without provisions that recognize a property right to one's own genetic material, are claims of that sort likely to gain any traction?

It's hard to see on what basis people could be compensated if the law doesn't believe they own the DNA in the first place. I guess if the researchers had some sort of agreement with the donors from the outset, then there might be a basis. But those kinds of agreements are all very problematic. It's unlikely in any event that any one individual's DNA is going to be all that valuable. Most studies are going to involve DNA from tens of thousands of people. But in the rare case where one person's DNA turns out to be valuable - like the John Moore case - yes, I think those individuals should be compensated.

John Moore?

Yes. There's a celebrated California case in which a man named John Moore had been diagnosed as having hairy cell leukemia. His spleen was subsequently removed, but the doctors didn't tell him they were going to give the spleen to a biotech company, which in turn used the tissue to develop an immortal cell line that could be used for therapeutic purposes. The patent for that cell line turned out to be wo