RAY SUAREZ: For more we're joined by Lee Silver, a professor of molecular biology and public affairs at Princeton University; he's the author of Remaking Eden: How Genetic Engineering and Cloning Will Transform the American Family, and Richard Gibbs, the director of the Human Genome Sequencing Center at the Baylor College of Medicine in Houston. The center is part of the federally-funded group working to map the human genome.
Well, Lee Silver, here we have two different approaches toward getting a lot of the same work done. What's at stake here?
LEE M. SILVER, Princeton University: Well, what is at stake is a huge amount of money that can be made by understanding how human genes work in normal people and how they misfunction in people that have diseases. And pharmaceutical companies and biotech companies want to be able to use this information to develop drugs and protocols to overcome human disease.
RAY SUAREZ: But that's an essentially different result if one wins or the other wins in this race to finish first?
LEE M. SILVER: This is a question of control and profits. The Human Genome Project was begun entirely with federal money because in the beginning scientists didn't believe that it would be possible for private companies to want to do this. But now since Craig Venter has entered the race a couple of years ago it's very clear that private companies are willing to invest the money in getting to raw sequenced data.
RAY SUAREZ: Mr. Gibbs, what do you see as being at stake here?
RICHARD GIBBS, Baylor College of Medicine: As Lee said, a lot of money. This information is tremendously valuable. It's the information that stimulates biomedical research and can speed disease cures and many other desirable things in the near future, and the way that information is distributed will depend on how quickly and efficiently and the mode of those subsequent discoveries.
RAY SUAREZ: But when you say a lot of money is at stake, did the Clinton-Blair announcement this week change the landscape any? Does it mean that these discoveries will get out into the public domain more cheaply?
RICHARD GIBBS: Well, I guess the landscape changed as reflected in the stock markets. As far as the actual work goes, it's been going on with free, public data release from the public side for -- since the beginning of the program. This may pressure the private side to be more enthusiastic about the collaboration that's been discussed in the past, and as it generally ups the ante and clears the confusion just through disseminating information, I think it will lead to a general improvement in the whole geography.
RAY SUAREZ: Well, Lee Silver, if I'm a researcher working on heart disease or trying to unlock some mysteries of cancer, who am I rooting for at this point?
LEE M. SILVER: Well, I think you'd probably be rooting for the public consortium, but I think it's important to understand that down the road the drugs and the therapies are going to be developed by private drug companies, by pharmaceutical companies and biotech companies, who are going to make money by exploiting the information in the genome. So the question is, at what point are they allowed to make money? How much information -- how much do they have to know how about a gene works before they're able to patent that and make money off of it?
RAY SUAREZ: So, Mr. Gibbs, we have two different visions of the future, one saying that the profit motive brings these things along more quickly and another saying that the widest possible dissemination means the widest possible number of heads is working on the problem?
RICHARD GIBBS: Well, I think that the two visions are not so very different. They have the same beginning point with the generation of the information. And they have the same end point with the generation of disease cures and better drugs and so forth. What is different is something in the middle there. And you might imagine that it's the placement of a tall booth close to the production of the information on the one hand that can discourage broader interest in the development of these cures and drugs versus a system where the information is available to everybody and therefore stimulates the widest range of possible research.
RAY SUAREZ: Well, on some parts of the whole genome, the billions of separate letters and bits that have already been sequenced, there are preliminary patent applications waiting at the patent office to be decided upon. Does that, in effect, wall off a discovery, set up that toll booth that you talked about?
RICHARD GIBBS: I think to some extent at least the issues of intellectual property gathering have already passed, and that is, that patents are already out there awaiting to be decided by the patent office, whether they'll be awarded. To some extent that's true.
RAY SUAREZ: Well, Lee Silver, maybe you should weigh in here. Are we walking on new territory?
LEE M. SILVER: I think what is important to understand is that this is a dispute over intellectual property and it's a dispute that can be decided by the patent office and by regulatory committees in Washington. It's not a dispute over ethics. And I think it's important not to bring in the notion that this information has moral value of some kind. It's really a question of who gets to use it at what point and when people can apply for patents so that they can profit from their discoveries.
RAY SUAREZ: But, discoveries as opposed to inventions, that's a very different way of looking at patents in the first place, isn't it?
LEE M. SILVER: Well, the patent office decides whether or not a particular invention has use, has value, and the patent office should decide which of these companies is able to protect its information and to use its information to develop drugs and therapies.
RAY SUAREZ: But are we at that point yet with some of these genes if they've been mapped, aren't there some of them that have been mapped but we don't know what the map tells us?
LEE M. SILVER: We're at all different points with many different genes. Some genes have been taken all the way forward into drugs or therapies. And nobody disputes the patents that have been placed on the use of those genes. And there are many, many genes where we don't understand the function at all. And the dispute is whether or not scientists should have the right to patent the genes before we understand how they work. That's a problem for the patent office to decide, not for bioethicists to decide.
RAY SUAREZ: Does it matter to the public, Richard Gibbs, who wins this race and under what circumstances?
RICHARD GIBBS: Oh, yes, it does. I think we should be clear about one thing though and that is that the public genome program is in no way in opposition to the development of biotechnology - and through the patenting system. The public program is a strong supporter of the patenting system. It is really the singular issue of the level of function that is as scribed to genes before they are patentable that gives us great concern. I think a good analogy would be a land grab. Most of us are enthusiastic about oil drillers or gold miners who work their own patch and discover riches, but less enthusiastic about the idea of vast amounts of territory being claimed without any real knowledge of what's in it.
RAY SUAREZ: Good analogy, Lee Silver, a land grab?
LEE M. SILVER: Well, I think Dr. Venter has indicated that he's going to publish the raw data. The raw data is the first step. All he wants to do is make money off interpreting that data with sophisticated software and other biotechnological tools. And I don't think that should be stopped.
RAY SUAREZ: And if I understand you correctly, Richard Gibbs, you're not against people who risk capital to develop information being able to make a buck off of that?
RICHARD GIBBS: That's right. You know, the differences between the two sides of this argument come down to some very fine, and in some ways, technical points. One of them is the idea of what is function. How do you as scribe function to the gene? The criteria for that are being argued among scientists. We couldn't really expect at this stage a simple formula to be applied to that by the patent office. And the other issue is free data release. What is that? It's used quite loosely. And on the public side we are talking strictly about free unencumbered immediate data release; whereas other definitions have other strings attached to them and some delay perhaps.
RAY SUAREZ: Well, in trying to understand this all, Lee Silver, I was thinking of somebody walking along a coast line and trying to draw a map and a ship off the coast trying to draw the same map. Wouldn't it have been better for the two sides to have found some way to work together at some point?
LEE M. SILVER: Well, they actually have worked together on preliminary projects to look at the genetic information in simple organisms like a fly which they have worked together on very, very well. For reasons that I don't understand they were not able to work together on the human genome. There is a huge amount of money at stake here. Really it's a question of where the money is going to go: In the beginning or at the end?
RICHARD GIBBS: May I comment on that? The fly program, part of which was done here in Houston at Baylor College of Medicine, was a successful collaboration. There are many elements of it that worked just the way they should, but the fact is that the stakes are just not as high with the fly genome. The stakes are very high with the human genome. That's why we have a difference in the model.
RAY SUAREZ: But if the federal government and the Human Genome Project is able to release large amounts of data before Celera does, what difference does that end up making, if any?
RICHARD GIBBS: Well, I think once again, here's where we see the role of the public program. History has shown that when data of these type are generated in the private sector and then ultimately released to the public, it has only been in response to the pressure of the emerging public data set. So in a sense the public program is just doing its job now. And if you can imagine a scenario where the public program did not exist, then we wouldn't be sitting here having this conversation at all about whether or not the data from the private sector would be released or released in a way we like to see it. This is the role of the public program: To provide the pressure as well as to independently strive to reach the same goal if it fails in other quarters.
LEE M. SILVER: Well, there is unexpected competition from the private companies which the Human Genome Project didn't originally expect. One of the things it's done is push the public effort faster than it expected to go in the beginning. That's actually a very good thing.
RICHARD GIBBS: It is a good thing. To some extent we were naive not to expect stiff competition. This is after all the most important project that biology has ever done and perhaps the most important project that humanity has ever done. So the idea that there would not be stiff competition now seems with hindsight to be a little optimistic.
RAY SUAREZ: Gentlemen, thank you both very much.
May 22, 2013
