Robert Cook-Deegan: 'How can you patent a gene?'

Robert Cook-Deegan is the author of "The Gene Wars: Science, Politics and the Human Genome." He is a former director of the Biomedical Ethics Advisory Committee of the U.S. Congress. He was also an adviser to the National Center for Human Genome Research. He was interviewed by CNN in 1999.

CNN: Well it's interesting that you entitled your book "Gene Wars." What is the war part?

COOK-DEEGAN: The wars came from several things. One was a war between factions within the scientific community about whether there should be a human genome project at all. I mean now in 1999 it seems like how it could ever have been in doubt. But 15 years ago it was really a vigorous debate. And tempers were high. And there was something of a war in trying to get the genome project started. The name actually came from the end of the book which is when Jim Watson and the director of the NIH, Bernardine Healy, parted company. ...

CNN: Parting over what?

COOK-DEEGAN: Two issues. One was over DNA patent. And that was the issue that was below the surface. The surface issue was allegations that Jim had financial holdings that put him in a difficult position as the director of the government program. Turns out that that ... Jim's financial holdings were really no different and what he was asking for was really not different than most NIH directors had. But that was the bone of contention. That was the origin of the final controversy. But I think it was the straw that broke the camel's back.

CNN: Hm-mmm.

COOK-DEEGAN: Underneath the surface was this debate about DNA patenting that drove a wedge between Jim Watson and Bernardine Healy.

CNN: And what are the sides of that debate?

COOK-DEEGAN: [SIGHS]

CNN: Let me make it more fundamental -- what is DNA patenting?

COOK-DEEGAN: Well see -- interestingly it was not the issue of should there be any patents at all on DNA that drove them apart. Rather, it was -- How much do you need to know before you can get that patent? That's what was driving the wedge between Healy and Watson. It's not a simple yes or no situation in connection with DNA patents.

Maybe I should just go through kind of how various people look at DNA patenting question. There is an initial instinct that -- I think most people that I talk to -- like I go to a cocktail party or something like that and I mention DNA patenting. Almost everybody has the same initial reaction which is, "How can you patent a gene? I mean it's in my body, it's in your body. How can you patent that?" But it turns out that since ... sometime in the middle 1980's it's been possible to patent genes. We've been doing it a lot. By 1993 when most of the stuff flared up, there were over a thousand patents that had been issued based on DNA structure. So it wasn't a new thing when this debate broke out in 1991-1993.

The rationale for how can you patent a gene even though it is in your body is the same as the rationale for why you can patent a Franklin stove, right? The stove does not exist in nature. You take the metal. You take iron that's in ores in the ground. You mine it. You turn it into steel or iron and you turn it into something useful. The rationale for DNA patenting is -- you aren't patenting the gene in your body or my body. You are taking the gene -- you are isolating it, and you are turning it into a useful form. So for you to get a patent on a fragment of DNA you have to prove that you've done something that is new, that is novel. That it's going to be useful to somebody. And that it wasn't really obvious how to do it. That is, Joe on the street wouldn't' be able to stumble upon this. You have to do something inventive. And so if you meet those three criteria for any kind of invention, including finding a fragment of DNA, then you can patent it. So that had been true for the better part of the decade when this debate broke out.

The debate that broke out in connection with NIH was not whole-length genes. What several scientists had begun to do -- and Craig Venter of NIH in particular, had begun to do -- was to try to use kind of a quick scan of the juicy bits of the genome. That is, you go in and you use the cell's own machinery to decode those parts of the DNA in your body. Each cell in your body has a full set of all of these genes. But it turns out that only about three to five percent of the DNA in each cell is actually turned into protein. And most of the juicy bits are those parts that are turned into protein. And what Craig had begun to do is to tag -- to take -- basically the easiest part to grab. There are mechanisms to grab just that kind of DNA, using the thing that comes out of it, RNA.

You take the parts that are turned into RNA, you grab those pieces of RNA that are turned into protein. And then you take a piece of the sequence. And if you take a piece of the sequence that is long enough to get into the unique part of that gene essentially what you have got is the tail-end of each new gene with a very simple mechanism. You have one kind of way of grabbing it that grabs all of these RNA's. And you have a sequencing mechanism so you do the same thing to each strip of RNA. Turn it into DNA and then decode it. And you've got a unique or theoretically unique tag for each part of the genome that is turned into protein.

Now, once you got a tag for the gene it turns out you can use that tag to go in and fish that gene out of the genome. There are all sorts of mechanisms. Once you've got that piece of information you can go in and grab the gene. So if you think 'Oh, the sequence for that gene looks like maybe this is going to be a protein that would stick on the surface of a cell and respond to a drug.' A receptor on the surface of a nerve cell, for example. That is what Craig was studying. And it's a really efficient way to try to find out families of proteins that look the same and that look like they are going to be useful. So you have a sequence that says 'Gosh, this fragment looks a lot like this other gene that does that same thing. And so maybe if we look at the twelve genes that look like this one -- we'll have a whole family of proteins that do similar functions.'

And that might be the first step in developing a drug for schizophrenia or depression or Alzheimer's disease. So that is the rationale. And the value in that framework. You can see that there is immense value in being able to do that. Craig was one of the first people to realize that the intellectual value could be translated into patentable material.

CNN: With commercial value.

COOK-DEEGAN: Yeah. Commercial value. Interestingly, the idea of patenting that stuff did not come from Craig. It came from a lawyer who was working with Genentech who wrote a letter to the lawyer at NIH and that lawyer got a hold of Craig and said 'This other lawyer told me you are doing some stuff that might be valuable. Maybe we should file a patent application.' And that is what they did.

Craig, as far as I know, had already submitted his paper explaining that he was going to do this for a large number of genes when he first had this conversation with his patent lawyer at NIH. Once they had filed that patent application, it precipitated a really nasty debate within molecular biology. The crux of that debate being 'This is a pretty straightforward procedure. And can you really patent -- is this enough? Is it inventive enough and is it useful enough to meet those criteria. Should it be patentable?'

That was the level of debate. And there was another level of debate which was not so much about the patent criteria but do they really deserve it? If you've done so little work should you be able to lock up the whole gene?

And the fear was that having gotten a tag part of the gene patented, it might block other people coming along later from either being able to patent the full-length gene. That is, once you've figured out the whole, you fish this thing out of the genome and then you decode the whole length of the gene. Would it block that from being patentable? It looks like the answer to that is probably no. But there was some concern about that.

But an even larger concern was you take a very straightforward technique, you get in there at the front edge -- should you be able to lock up all this intellectual property. Are you creating a situation that is kind of like the toll booth at the mouth of the canyon, right? In the history of genetics, Little Cottonwood Canyon outside of Salt Lake City is very important. It's where the idea for the human genome project was first developed. And that area is very interesting, because it was originally a silver mining area. It's a very steep canyon. There is only one mouth. And there were a lot of people that wanted to go prospecting. They wanted to go find gold in them thar hills. Maybe it was silver. One smart enterprising guy bought the land at the mouth of Little Cottonwood Canyon to charge a toll.

CNN: Not to prospect -- just to charge.

COOK-DEEGAN: To charge the toll right. So the people he was charging the money on were the people who were going to go search for the silver. -- and that's, that's what the debate was about. People don't like paying tolls. And they don't like it because of the money. They don't like it because it hinders their own independence of action. And that was the fear about ESTP patenting -- that's what these things are called -- express sequence tags.

CNN: That Craig --

COOK-DEEGAN: That Craig was working on right. That's right. The concern was Craig was going to be in a position that anytime somebody found one of the genes that he had tagged previously they would have to pay him a toll. They would have to cut him in on the action. They would have to cross-license their patent with his patent or the validity of their patent might be threatened. And if you are going to market a drug, patent protection is incredibly important. It is way more important in drug development than it is in almost every other industry. You know, aircraft manufacturing, automobiles, transistors. There have been patent battles there, but for drug development it's not just important, it's like bedrock.

Having a patent on a therapeutic drug is the only way that you can protect that chemical entity from your competitors while you are paying for the very expensive clinical trials that allow you to go from the discovery to the market. It is a very protracted process, usually 10 or 12 years.

There is this problem with the free rider. That is, if one company spends all that money to discover the drug -- which is basically the cheap part. And then to go through you know, 20 or 30 clinical trials, each of which may cost a few million dollars. If at the end of that all you have to do is manufacture the chemical in a factory and then sell it, that is actually pretty easy to do. And the cost is in the discovery, the intellectual process of discovering the drug and in pumping it through the clinical trial system and getting approval from the FDA.

So you won't have drugs discovered in the private market system if you don't have very strong intellectual property protection. And it's the patents on those chemical entities that allow them to make the money back at the back end of that process. You get it on to the market, you can charge monopoly rents. And get your money back for the research and investment that you have already spent.

So patents are incredibly important in therapeutic pharmaceuticals. Every drug maker knows that. Every biotech company knows that. So patents are really important and having somebody who had patents at the front end in a toll booth on all subsequent patents coming out of most human genes would have been a pretty serious threat. It would mean there is one player that everybody has to go to. if they want to play in this game.

CNN: Got to go to him or you got to race him --

COOK-DEEGAN: That's right, and several companies took this strategy. Craig became the head of a non-profit organization. Wally Steinberg, what they call an angel...do you know this stuff?

CNN: Well, no -- what does it mean?

COOK-DEEGAN: There are two kinds of markets for starting up a new company in hi-tech. There are venture capital firms that are kind of groups of investors that are willing to invest early in a new technology. And then there are angels. These are usually individuals or a small group of individuals that work more informally. They have access to capital and are willing to cut a deal on a handshake.

Wally Steinberg was somewhere between an angel and a venture capitalist. He had kind of features of both. He got really intrigued in the wake of this controversy about DNA patenting. He got very intrigued in Craig's approach, and they did a handshake deal for Craig to form this non-profit institute, which was the core. It was going to do the sequencing in large scale with lots of machines, things Craig could not really do in the government. Not nearly as fast because he couldn't' get access to the capital.

So they brought a lot of sequencing machines and a lot of computers and got a lot of smart people to go work at the Institute for Gemnomic Research. Around that was built a for-profit shell -- Human Genome Sciences. Now they have since parted company. And they've taken different scientific directions. But the original idea was you had this idea of quickly scanning the genome.

Human Genome Sciences has continued to do that. So did another company out on the West Coast, more or less the same time, maybe even a little bit earlier. It's called Insight, out of Palo Alto. A lot has been following the same strategy. Using sequence to tag genes. And now that they have been doing that for six or seven years, they have tagged almost all the genes in the genome long ago. Many years ago.

So they are now trying to decode the juicy bits first. And then they are constructing even broader maps. And what they are creating is informational resources for anybody who is trying to get hold of human genes. They won't have to do that sequencing themselves. It is sitting in a database at one of these firms. There is also a public sector effort to do the same thing. Merck financed a university-based effort to do the same kind of work at Washington University in St. Louis.

So you got three parallel efforts that were started at more or less the same time. One of them is public domain. One of them Human Genome Sciences and one is Insight. So there is a competitive framework for doing more or less the same kind of sequence-first gene hunting that Craig pioneered when he was at the National Institutes of Health.

CNN: Before you go on to explain what has happened with that framework, what abouot the cocktail party question. Which is, if I understand you correctly, the debate isn't about the ethics of awarding the patent on a gene. It's about whether Craig Venter has done enough work to deserve a patent, to earn a patent. Would that be correct?

COOK-DEEGAN: Well, actually both debates. Those are both actually active questions in different groups. The first debate is quite active. --

CNN: And that is.

COOK-DEEGAN: About whether it is moral to patent a gene at all. If you look there is a statement on that from the Pope. Now it's not a formal, but the Pope gave a lecture to the pontifical academy of sciences where it's almost a throw-away line. But he does say of course you wouldn't want to patent genes.

That is the first thing people wonder. Why should you be able to patent genes in the first place? So that hasn't gone away, and in fact you will even find some people in the biotech business who kind of wonder that same thing: 'How did we get down this road?'

But within the scientific community the second question was the one that was the most divisive. Which is 'Has he done enough work to earn the intellectual property? Has he done enough work to stake a claim.' And that that is where the scientific community parted ways with NIH and Craig.

CNN: Of course you know, historically, in the United States in the history of patents and claims it didn't take much to stake a claim. You could go out west and put a stake claim and say 'I believe that there is ore-bearing rock here,' and on that basis I can buy that for five dollars an acre. We do have a tendency to give away mineral rights or intellectual property rights.

COOK-DEEGAN: That's right. And the analogy holds to some extent. There is a way in which the analogy doesn't hold completely, and it's part of the reason that some scientists have been uncomfortable with it. The way a chemical patent works like drug company. I'll be as specific as I can.

The drug company finds a new structure, a new chemical structure, and it patents it. Pharmaceutical firms have thousand and thousands and thousands of these chemical they've synthesized over the years in their laboratories. They will not push it forward to a patent until they have some inkling that it might be useful for something. But typically you don't know precisely what it is going to be useful for. So you patent the structure.

And that allows you to invest the money to find out what it is really useful for. And for all the things that are patented, a small fraction, I don't know what the fraction is of patented chemicals by pharmaceutical firms actually make it to the market. But it's a small number. Less than 10 percent certainly.

...it's a small number that tells you you invest that money in the patent only when there is some inkling but you don't really know what it's going to be used for. Now, the reason that works is the patent not the chemical structure is strong enough. The way the courts have interpreted that kind of patent is that it is strong enough that even if you find a use that you didn't specify when you found the chemical, it is still covered by the patent. Because you've patented the structure. And that is the same framework that the courts have applied to DNA patents. That is, you are patenting the structure.

And that is different from the mining claim. The mining claim is you are claiming mineral rights for gold or silver or whatever. It doesn't say you have kind of a notion of a window of uses that might come out of it. That's what people are worried about in connection with genes. That is different from chemical entities. It's very clear there are a limited number of genes a hundred thousand or so. It's very clear that those are going to be really, really important for understanding human biology.

The fear was, because there is a limited set of genes and because this technique can quickly find them and tag them, that essentially there would be an intellectual property right. Not to this piece of land in little Cottonwood Canyon. But rather all of the genes that had not already been discovered. And anybody subsequently coming up and doing the biology to actually explain how it is useful would be constrained by having to license with the guy that got there first.

That debate hasn't gone away. There are, I don't know the exact numbers, but the patents office has said publicly that there is, I think, 500,000 or 1.5 million of these express sequence tags on which patent applications have been filed. That tells you that is way more than there are human genes in the genome. So most human genes have been tagged more than once. And there are pieces of paper in the patent office being looked at, and it's not clear what the rules are yet.

Only one patent has been issued of that type as of this date in 1999 and there seems to be a possible difference between the scope of claims. It seems likely that the court of appeals might narrow what is patentable even when the patent office grants patent claims. So there is a lot of uncertainty about whether these patents would hold up in court if they were ever challenged. There is a lot of uncertainty about billions of dollars being invested in the research in the face of what the patent rights are.

CNN: Is there also uncertainty about whether EST's will yield the knowledge that we hope? We're talking now about the end result. About being able to lock up the knowledge. But the way I understood the reading, there is some risk whether this process is kind of shredding and overlaying and whether it will be the kind of guide that we hope it will be -- the true answer.

COOK-DEEGAN: There's only a very limited amount of information you get from one of these tags. One of the limits, for example, is the initial NIH patent application didn't say where the gene was located in the genome. That is actually a pretty easy thing to do. You take your unique sequence and you see where it sticks when it goes onto a chromosome.

CNN: You just scan across the chromosome?

COOK-DEEGAN: It's not quite that simple, but it's not hard to figure out where that gene is located on the chromosomes once you've found that sequence information. They weren't' doing that. That's a useful piece of information. You know for most genes, the first time you come across them you don't know what they do. So, for example, in that first NIH patent application, maybe 15 or 20 percent -- a relatively small number of the genes -- had any functional information at all.

Now the ones that are most interesting are the ones that you can kind of guess. The ones that I was talking about before. You look at the sequence and you say 'Oh, my gosh, that looks like a receptor molecule. It looks like this molecule that we have been trying to develop a drug for for 10 years.' And yet there is another receptor that the sequence is the same and therefore maybe its function is the same or similar.

So by using the genetics you can come up with a whole family of genes you didn't know were there that are extremely practical. They might be a relatively small number and looked like they might be similar to things that are already known. Most of the genes that you come across using this technique for the first time, you don't have a clue what they do. And there is nothing in the databases that tells you that.

What you then have to do is you have to fish out the gene, get the protein that it codes for and figure out what it does. Now that is a lot of work, and that was the concern. It was 'Is it is going to cost a whole lot more money?' It's a whole lot more intellectual effort and yet this person who got into the genome with this high, capital- intensive thing is going to be able to lock it all up. Not lock it up, but you are going to deal with that person even if you don't want to. And does that person deserve it based on what they've done?

CNN: It also sounds as though there might be a little bit of disingenuous talk from Craig who talks about racing for the cure. His urgency, as he explains it to me, he knows how many people have died from cancer in a given period of months. But if he is charging a toll to me and I may be the guy approaching the cure, or an answer, doesn't he actually in some ways slow down the cure?

COOK-DEEGAN: It's possible. There is this talk now that what has happened in biology in general and drug discovery in particular over the last is that the basis for competition in finding new drugs to treat illness has shifted very far into science. It used to be more chemical synthesis and the ability to identify molecules and test them and screen them. It has shifted now way up into molecular biology.

So a lot of biotech firms and pharmaceutical firms in their labs are doing stuff that looks very much like university scientists who are funded by NIH. They are doing very similar experiments, using similar methods and trying to answer similar question. They are not exactly the same. There is a lot of overlap. And the farther you go into science, the more troublesome that question goes. Because if what happens is you start putting up fences, which is what patents are. Patents exclude other people from being able to make, use or sell your invention.

So the power of the patent is the ability to exclude others. And if you keep doing that further and further up in the science, can you slow the flow of innovation because you've got dams going to far up stream. It's not clear that that's the case. It's also not clear that that is an unsolvable problem, because it's happened in other fields.

This happened in aircraft manufacturing. There were a few patents early in the history of -- of aircraft engines that were really crucial. And the people making those engines kept bumping into each other. Nobody could get enough of the whole technology to build the most efficient engine that they all wanted to build. They kept hitting each other. And what they ended up doing was forming a consortium and agreeing to share the technology among themselves.

So there are ways to solve that. And in fact we've gotten an instance of that happening just in the last few months in genome research. A bunch of pharmaceutical firms have gone together and established that are these variations in human DNA. They don't know what they do. But what they are very useful for doing is mapping and finding genes and negotiating their way through this sea of DNA. Finding out where those variations are is really valuable -- so valuable that they don't want them locked up by one or a few players. So the pharmaceutical companies have gotten together to fund the research and dump them into the public domain and make it available to everybody.

Their rationale for doing that is not out of the goodness of their hearts. It's to prevent somebody later being able to come to them and tell them they can't develop that drug because he's got a license for the technology that they used to discover it, that they had to infringe on my patent to find that drug and they've got to pay him.

That kind of framework is beginning to evolve, but it's not clear how it's going to play out. My sense is that genomics is historically right now not too different from operating systems. It's a loose analogy but it's not too different.

CNN: On computers

COOK-DEEGAN: On computers. You know sometime in the early 1980's when Apple had its operation system and Microsoft was the vendor for the DOS system for PC's and UNIX was the thing that people used at universities and big corporations. Nobody at that time quite understood how important those things were except a few people...

There is kind of a Darwinian process of selection for the successful business strategy, but it's not clear at the time what that strategy is. Somebody is right, but it is hard to say right now who it is. And there are a lot of different strategies being pursued simultaneously. Different companies pursing different strategies.

CNN: In genomics?

COOK-DEEGAN: In genomics, yeah. There are companies that are doing the sequence first. They have done this quick genome-scan using sequence tags. And then they are going to full-length genes. They are trying to figure out what those do, patent them and hope that either they become therapeutic pharmaceuticals themselves or they are targets for developing a small molecule that will fit in there.

So there are companies that are starting with that sequence tag first. The new firm Celera, and now Insight, have joined in the race. They want to do a whole. They want to sequence the whole genome, put it in a database and charge for access to the database. Kind of a subscription model of genomics. There are lots and lots of firms that are going after individual genes and university scientists going after individual genes, just like they have for the past 30 years. And some people pursuing each of those strategies are going to be successful, but probably one of those overall strategies is going to prove to more successful than the others.

CNN: So what are we to think then of a federally funded U.S. program and its techniques? Is that just the sort of the bailiwick of plodders who are underfunded? Or should we think of them as the more thorough sort.

COOK-DEEGAN: To characterize the folks in genomics as plodders is stretching things beyond the meaning of the words. Nobody is plodding in this business, but there is a difference of philosophy. And in fact it's one of the things that has changed in the 1980's. It used to be -- and we still tend to think -- that those of us in this policy business tend to think first of science, biomedical research in particular, as being a federal thing. A government thing. And a lot of it is.

But since sometime in the late 1980's the private sector has been putting more money into medical research than NIH has. Consistently. So we've got now two decades of growth in the private sector that is faster than in the public sector. And it is no longer the case that the public sector can set the strategies that the National Institutes of Health and the Department of Energy pursue. It cannot be conceived of as completely independent of what is going on in the private sector.

CNN: Also, the federal programs like the Department of Energy's or National Institutes of Health can no longer dictate the terms under which science is pursued?

COOK-DEEGAN: You know I don't think there was ever a question of dictating. Because if you are the only player you are not dictating. You're doing your thing. So you are not really trying to control other players. You are trying to create knowledge and that is what NIH does. It funds publicly based science.

What's new now is it takes a lot of capital to do the cutting edge work in genomics, especially you need computers. You probably need computers even more than you need sequencers and mapping machines and robotics. It's really high-tech stuff. This is not cottage industry stuff anymore.

That has changed only in the last seven or eight years, so there is a big advantage to the private sector. The private sector is good at getting capital concentrated and getting things to go fast, and that is what has been happening. That is what has happened with human genome sciences. Insight for this tagging business and now Celera is doing the same thing. And Insight again for the broad-based sequencing efforts. They can get the money to get the computers and the sequencers and all this other stuff.

In a way, that is much slower and more difficult if you are doing this through a grant mechanism, because that process takes a few years. You know you have to plan in advance what your budget is going to be, and you have to figure out how many people are going to have to do what. You can't turn on a dime. I don't think it's fair to say that those scientists are plodding because they aren't. They are working really hard and they are moving really, really fast. It's just that they have constraints on how much equipment they can buy and how fast they can move, and universities are not set up to do highly capital intensive work. But they are doing a lot more of it. You go up to the Whitehead Institute or Washington University or the Sanger Center, they are high-tech. They are state-of-the-art. They are great. But even there they can't spend $300 million dollars on equipment.

CNN: Would they even have been able to justify trying to get that were it not for the private sector competition which everybody wants to down play but which is there?

COOK-DEEGAN: It is competition and I think it's really healthy competition. One of the wonderful things about the genomic project early on was that it became something that both the National Institutes of Health and the Department of Energy wanted to do. And there was a period for about five years when there was jockeying back and forth.

This is a very healthy situation when you have competition in two organizations -- both of which want this thing to be a flagship. They want to do a good job of it. They want it to be out there. They want the world to know about it. You've got great accountability when that is the situation. And things move fast. That is wonderful. That is the good aspect about competition. It causes waste and it causes duplication. It causes political friction. But it also causes things to move fast and there is great accountability when people are paying attention.

What we've now got is the same kind of competition between publicly funded efforts and the private sector, and I think that is pretty healthy too. Because the public sector has a strong incentive to move faster than it otherwise would. The private sector has been seriously constrained in how much stuff it can keep secret when there is going to be a public domain that is being created in parallel. That's better for all of us.

The history of these sequence-first tagging efforts, except for the Merck-funded effort, is that information is still unavailable to most scientists. The system as a whole is going to move faster if everybody has got access to that information rather than having it bottled up. So if the sequence information on the whole human genome comes available faster to everybody we are all better off.

If that happens because there is competition between the public sector and the private sector, that is what it is all about, guys. I mean, that is wonderful. That is exactly the kind of outcome you would want out of an innovation system.

Now, did we plan it that way? No. We're America. We don't do that. I think that is how it has worked out. Now could they have even asked for that kind of money? They could ask. It's very hard. Because they're competing for dollars. They are already centers that I named that are richly funded compared to the groups that are working at the same university. And it's not that the science they are doing is more valuable. But if they lock up all of the resources, they are going to have to go to lunch with their buddies who are being starved, and even if they aren't starved they're going to feel like they are being starved relative to these guys who are getting all these sequencing machines. So it's probably not something you would even want to try.

I mean why would you put a highly capital intensive, very focused function in the middle of a university campus? When we did that during the war it worked because everybody during World War II was trying to develop technologies. After the war, it turned out it was much better to have the specialized facilities to do that kind of thing. Lincoln Labs, the applied physics lab up at Johns Hopkins, turned out to be better to kind of move those things off-campus because they have a different function. And it's better if they are at arms length. It's great that they are associated with universities, but it's better if they are not dominating university culture.

CNN: If I asked you what if a corporation said we're going to help develop a bomb sooner than the publicly funded effort?

COOK-DEEGAN: But that is what they do right?

CNN: Yes.

COOK-DEEGAN: They are part of the process. If you look at, for example, the development of the transistor or radar or the things of the microelectronics revolution that grew out of World War II, the history of those technologies is very much imbedded in a hybrid of publicly funded and privately funded R and D. The transistor was invented at Bell Labs, which was part of AT&T. Nothing more revolutionary has happened this century, and that came out of a private research lab.

They were physicists -- solid-state physicists -- and they were doing quantum mechanical analysis that allowed them to discover the transistor. This was not a Tom Edison story. This was science, with an applied end. But it was real science, and they were real physicists doing real physics when they did that work.

CNN: The value of that story for understanding now?

COOK-DEEGAN: It's similar to genomics. There is this tendency when you are thinking about the genome project to go where Craig did. Which is these things are really, really useful or you think there's a Nobel Prize at the end of the pathway. But the fact is that since its inception, molecular biology has almost never had to make a choice between what's useful and what is scientifically beautiful. They tend to be pretty much in alignment.

So the genome project comes along, and the idea is to do huge maps that everybody can use and it sounds like grunt work. But you know what? If you look at the history of molecular biology, it has always been technology driven. And what it is doing is it's taking the biggest, the best technologies that are applicable to these problems and it turns out that when you apply those technologies, you create information faster than if you don't use the technologies. That information then becomes the grist for the scientific mill.

So they are in alignment here. You've got science and technology incredibly tightly interwoven, and that's why there is a publicly and a privately funded mix of R and D in this equation. It's funny that it took as long as 1993 before the private investment started. But since then, private sector has been putting more money into genomics than the public sector each year.

CNN: I think most of our viewers, most of us, are still surprised for example that if you buy these new genetically engineered potatoes that those are a patented gene. The nature of these projects have yielded results that are commercial and scientific, and the commercial part happened without most of us being aware of that.

COOK-DEEGAN: You know that is probably truer in a thing like agriculture where the patents are beginning to matter more than they used to, and the reason that it's noticeable is because it's perturbing. I mean it used to be a farmer could just use his seeds over and over again and there was a natural cycle and that is being disturbed now in pharmaceuticals, which is the stuff that is most directly relevant to most of human genetics.

The courts had a hard time deciding whether you should be able to patent a living organism, but the question of whether you could patent a gene was not a huge controversy. That went on without a whole lot of sturm-und-drang in the court system and the patent office

CNN: Why?

COOK-DEEGAN: Well because it's an invention right? It meets these criteria? Is it new? Is it inventive and is it useful? Yes, yes, yes. It wasn't a big question. Now, obviously the facts that there is this intuition, the cocktail party level intuition that tells you that there is not a complete meshing of that culture with --

CNN: Popular awareness.

COOK-DEEGAN: With popular awareness, right. And the popular awareness is associated with discovering a gene. They are used to reading The New York Times, right? The gene for Huntington's disease or gene for Alzheimer's disease is discovered, but they are not so much aware of what is going on under the surface there.

Who paid for that research? Is it being patented? And those stories are now coming more into the limelight. Because the science is more commercially relevant. There is more money to be made. And the connections between the money and the science are a lot tighter than they used to be in molecular biology.

CNN: Are we scared more, too, because this is really talking about the essence of life?

COOK-DEEGAN: Yeah. I think that's right. You are talking about things that are part of you. And there is something about living organisms that's different from Franklin stoves. So there's kind of a fuzziness about thinking about what genes mean. In one sense, there is a tendency to think that when you have got a gene you've got the whole thing, right? That we are a bag of a 100,000 genes.

Well, no, of course we aren't. And in fact the thing that is most distinctive about the human organism is we've got this brain whose function is to adapt to the environment. So there's a structure there but the structure is incredibly intricate. Way, way, way ,way , way more intricate than a 100,000 could code for. There are as many brain cells up here as there are stars in the universe. And they are all connected. They've got 10,000 connections each, so you are talking about a number that is so large that it is almost completely meaningless. And you only got 100,000 genes.

Obviously you don't have a little map in there that says this cells is connected to that cell is connected to that cell in the genes. It is just not going to happen. And you also know that these genes are specifying probably the timing of development and how things connect up in some of the gross geography. That everybody's brain folds in a slightly different way, and your fingerprints are unique. Identical twins don't have the same fingerprints, and they don't have the same pattern inside the retina.

There are a lot of things that aren't just genes. Behavior. Two twins aren't the same people. We know that on an intuitive level, and yet we do tend to have this belief that the genes are it. I don't know how we reconcile those two things, but I guess we don't. We are just confused about it. The kind of essence of human -- we know that is somehow connected to the biology and yet over here it's just a structure. We are just patenting a structure, and those are two truths that I think we believe in simultaneously and we are working out how we are going to bring them together. But we haven't worked it out. We are muddling through.

CNN: I would like them to discover the gene for asthma so that then I have a cure for asthma. But I don't want them to know if they do a genetic scan of me that I am susceptible to asthma because my employer might deny me my insurance or something.

COOK-DEEGAN: Yeah, but they are the same thing, right? They actually have already found a lot of genes associated with different disorders. My own area was Alzheimer's disease. We've got at least four genes, maybe five, that have already been pretty well characterized.

They range from very strong -- that you're going to get the disease if you live long enough in this family; those are rare -- to the much more common which indicate you are at higher risk if you have this gene and that gene.

We are just at the start of that story. There are going to be more and more things that are involved in that whole process. In the case of cancer, hundreds of genes are involved, and dozens are directly involved. You pick it, diabetes....

CNN: Each one of which will bring this conundrum or this kind of contradiction between the benefit of understand the gene and what it does and the cost of knowing it. The cost of has knowledge in terms of privacy and public policy.

COOK-DEEGAN: That's right. What we want out of this is we want the benefits of the new technologies. We want more accurate diagnosis. We want better treatments. We want to live longer and better.

CNN: And what we fear --

COOK-DEEGAN: That science gives us some of the knowledge we need to do that and the genetics is a part of the science that's been moving very, very fast. So we want that to go forward, right? At the same time, when you discover the gene for one of these forms of Alzheimer's disease, you've got a test. You've automatically got a test for detecting whether people have that flavor of the gene and whether they are more likely to develop Alzheimer's disease.

So if they want to go out and buy long-term care insurance in 10 years, are they going to be able to do that? Either we're going to make a social choice that everybody gets treated the same because you don't choose your genes or we're just going to accept that they've got those genes, they have to pay higher rates for their long-term care insurance than the rest of us.

I don't know which way it's going to go. The way it's going right now is there's going to be this stratification. Some people are going to be at higher risk genetically and they're going to have to pay more. That conflicts with our intuition that things it ought not to be that way. I mean, we should be able to be accountable for those things we have some control over --

CNN: Like behavioral illnesses.

COOK-DEEGAN: Yeah. It's OK if you charge more for life insurance for smokers, but is it OK if you charge more for somebody who's predisposed to breast cancer because they've got a mutant gene that they didn't choose, they didn't choose their parents. It seems like it's not fair.

CNN: And the reason why this is such a big deal is that the science is getting us down to the point where we'll be confronted with this question before we've worked out what we want to do as a society.

COOK-DEEGAN: Sure, that's how it always works in things that are related to technology. I shouldn't say always. It usually works that things happen in the world and we erect legal structures and the social structures in reaction to the changes. It's rare that we can get a bead on how the changes are affecting us. Now, one of the things that's really interesting about the genome project is that for the first time to my knowledge on any technical project, part of the project is dedicated to trying to anticipate the harm and make sure that it doesn't happen.

There's a, there's a program that's sponsored by both the NIH and the Department of energy to look at ethical, legal and social implications. We did that in this country and almost every other country except the United Kingdom has done the same thing in their genome projects. So it's, it's interesting in this area, in part because of the history of genetics. There there has been an effort at least to think about the policy before the technologies are fully there.

My sense, though, is that it's hard to do policy, it's hard to pass laws and usually there has to be some sort of crisis or some sort of big thing that happens in the world before change. We didn't get a privacy law on what videos you rent until Robert Bork was on national television and vilified for renting a few things when he was a Supreme Court nominee. So it took a huge event associated with something that everybody thought was really unfair, a misuse of information to get that kind of a privacy law. We don't have those privacy laws yet for medical information. They're pending, they're introduced, but we don't have them.

And the commercial stuff -- I don't know. My sense is that it's going to sort out like it has in other industries. We may have some choke points and for a few years we may have people yelling at each other and vying for control. Some of 'em will win and some of 'em won't and that's, you know, that's what [economist] Joseph Shumpeter used to write about, isn't it? The destructive capitalism.

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