The MacNeil/Lehrer Report; Biotechnology

Dr. PETER FARLEY: We`re definitely looking at a biological revolution. The decade of the `80s is going to be the age of biology.

MacNEIL: In the `age of biology` are we witnessing the beginning of a new industrial revolution? I TitlesI

MacNEIL: Good evening. Six weeks ago we reported on a breakthrough that caused great excitement among scientists: the use of genetic engineering to produce interferon. Interferon is a substance produced naturally by human cells when attacked by a virus. Scientists hope that it will be a `wonder drug` able to fight many diseases, including perhaps cancer. So-it was good news that it will be available in much larger and cheaper quantities. But equally exciting was the method used: altering the genetic structure in simple bacteria to make the bacteria actually manufacturer the substance desired. That`s only one example of a revolutionary scientific field called biotechnology, a field that promises to turn the biology lab into a major arm of industry. To some visionaries, biotechnology marks a new industrial revolution, which the United Slates can lead. To others, it is frought with dangers because it involves new forms of life. Tonight, the promises and the risks of biotechnology. Jim?

LEHRER: Robin, like so many things heralded as new breakthroughs, biotechnology isn`t really all that new. For instance, the simple and ancient process of fermentation is a form of biotechnology. Everything from yogurt and coffee to beer and pickles have been produced for years through biology: putting a cucumber in vinegar or brine, say, and turning it into a pickle. The new breakthrough is the extension of uses for biotechnology, as dramatic new ways to control natural biological processes are discovered. Those who know say it is now an industry that is about where the electronics held was in the `50s: a handful of small companies headed by scientists and engineers with a lot of ideas and dreams. The largest of these companies is the Cetus Corporation of Berkeley. California. Our science reporter. Anita Harris, recently visited the company, and here is her report.

ANITA HARRIS: Cetus president Dr. Peter Farley is one of the new entrepreneurs of biology. Farley left medicine to get a master`s degree in business. He and a colleague founded the Cetus Company nine years ago -- the idea of starting a business based on the discoveries of microbiology. Dr. Farley hopes his business will be worth a billion dollars by 1990.

Dr. FARLEY: Clearly we`re dealing now with the decade of biology. In the last ten years the groundwork has been built up. and now as we roll into the `80s there`s no question it`s biology`s turn.

HARRIS: Well, what`s so exciting about it?

Dr. FARLEY: Well, in the last five or six years, we`ve developed -- we, the biological community, have developed basic tools that are just incredibly powerful compared to what came before. And we`re going to find that we can apply biology across the spectrum of different industries.

HARRIS (voice-over): If Farley is right, within ten years biotechnology will have an impact on a whole series of industries. In the energy field, micro-organisms bred in a laboratory would produce alcohol more economically, boosting its potential as a substitute for gasoline. On the farm, genetic engineering will improve crop yields, and may reduce the need for oil-based fertilizers. Within five years, micro-organisms will be used to makes chemicals for antifreeze and plastics. Dr. Farley says there will be major dislocations in the chemical industry because of the work his company and others are doing. In mining, specially bred bacteria may be used to increase the recovery of metals. The first product of biotechnology to reach the market will be pharmaceuticals, made cheaply by fermentation. Already, breakthroughs in genetic engineering have been making headlines. Scientists have found cheaper ways to produce insulin for diabetes; and interferon, potentially the wonder drug of the "80s that may cure some cancers and the common cold. In the future, there`s a promise of new, cheap, effective vaccines for today`s incurable diseases. It`s all just beginning, new industries taking form in laboratories like this one at Cetus.

Dr. FARLEY: Biotechnology, as we identify this new field, is really the ability to harness individual micro-organisms. Now what is a microscopic organism? -- a `bug` as we call it in the jargon. Basically, a little chemical factory. That organism`s only role in life is to make more organisms. But in the meantime, it`s just a bundle of chemistry, so that in essence, biotechnology is harnessing the incredibly complex chemistry that exists within these micro-organisms.

HARRIS: In what areas will we first see the results of your work?

Dr. FARLEY: Well, one of the most immediate applications is in the energy field, and that`s the basic production of alcohol with new techniques. As we all know, alcohol`s immediate application is [as] a substitute for gasoline. At the moment, we make that alcohol from corn. But we all know there`s a finite, limited amount of corn that we can grow in this country. And if we`re ever going to make a real dent in our gasoline needs, we`ve got to engineer micro-organisms that can eat, that can ferment, things other than corn, so that we can make alcohol from pulp and paper waste, or from certain grasses, or from various types of plant life -- even trees.

HARRIS: What does it mean to engineer a micro-organism?

Dr. FARLEY: Well, what we can now do -- you know, nature for eons and eons has been carrying out just natural mutations, to change an organism as it evolves from one set of characteristics to another. And this is what Darwin was all about, and it`s how we all evolved. What we`ve been able to do is to speed up evolution, if you will. We can now literally get our hands on the genetic makeup of micro-organisms, and pick the characteristics that we want. For instance, in the case of the alcohol-producing organism, we wanted it to work at a higher temperature, we wanted it to work in the presence of higher levels of alcohol. We were able to build into that organism the capability of doing that. Now, this may have taken literally hundreds and thousands of years to happen in nature. We`re able to accomplish it in less than two years` time in the laboratory.

MacNEIL: Including Cetus, that firm, about five companies do the bulk of the biotechnology work in this country. One of them is the Genex Corporation of Rockville, Maryland, which was founded three years ago. Its president is Dr. Leslie Glick, former chairman of the physiology department at the Roswell Park Division of the New York State University at Buffalo. Dr. Glick, are you as bullish as Mr. Farley, whom we just heard at Cetus, about this new industry?

Dr. LESLIE GLICK: I think a lot of things are going to happen, but I don`t think that major industries are going to be dislocated. I think, in fact, that the chemical industry is going to use these techniques.

MacNEIL: You mean, they`ll just simply buy in the process and start using it itself?

Dr. GLICK: Well, not only buy in the process; I think they`re going to be developing many processes. They`re going to use this technology. In some cases they will use it through the independent genetic engineering firms like Cetus, Genentech, Genex, Biogen, but in other cases they`re going to be developing it in-house. What we have to do is carve out a niche for ourselves.

MacNEIL: I`ve seen estimates that this new industry could produce, or replace, or displace, industries which now account for, at one level, $12 billion a year in business and, at another level, $20 billion. Are those wild exaggerations, or are those within reason?

Dr. GLICK: Oh, I think the level of business generated by means of genetic engineering technology would easily surpass those.

MacNEIL: Easily surpass those?

Dr. GLICK: And I don`t mean, incidentally, next year or five years, but if you consider what it might be like in the year 2000, with 1980 dollars, yes.

MacNEIL: What is your firm, Genex, working on right now? What products are you working towards and how soon would you be in a position to manufacture some of them, do you think?

Dr. GLICK: Well, first of all, with respect to specifics, it`s very difficult for me to answer that, because of a number of contractual obligations we have. We are working in the area of amino acids. Amino acids are used as feed additives. We are working with various pharmaceutical products. We are involved in the field of energy. It is difficult for me to be able to name individual products.

MacNEIL: You mean, for competitive reasons you don`t want to be too specific.

Dr. GLICK: For competitive, and for legal reasons, with partners and joint ventures and clients.

MacNEIL: Looking down the line, how far could this go. I mean, just as a wild Right of fancy, is it conceivable you could develop organisms that could create petroleum?

Dr. GLICK: Well, petroleum, you know, is a biological material.

MacNEIL: Right.

Dr. GLICK: It just took a very long time to do that. To tell you the truth, we actually did go through an economic process, in terms of actually making oil, so to speak, from some feedstocks now available. It turns out, OPEC would really have to increase the price of oil.

MacNEIL: I see. Although you don`t want to discuss particular products you may be trying to make, when are the first of these useful products, that one might call industrial products, liable to be marketable?

Dr. GLICK: We shall make an announcement before the end of this year dealing with a specialty chemical, and I believe we`ll begin to actually manufacture it sometime next year.

MacNEIL: A chemical that is now made by another process? Or something that isn`t made, that can`t be made?

Dr. GLICK: It is made by another process, yes.

MacNEIL: I see. Are you able to attract, through private sources, enough capital, and is the industry generally attracting enough risk capital to make you grow as fast as you want to grow?

Dr. GLICK: Fortunately, the answer to that question is `yes`. We have been attracting enough capital. I think that is -- I can say the same for the rest of the genetic engineering industry. And I think we are fortunate, as an industry, in that we happen to be with the right technology at the right time.

MacNEIL: Where would you place the United States, finally, in the competitive scale with other countries abroad?

Dr. GLICK: I don`t think there`s any question but that we are at this point in time far ahead in developing recombinant DNA technology commercially.

MacNEIL: That is, basic genetic engineering?

Dr. GLICK: Yes.

MacNEIL: Well, thank you. Jim?

LEHRER: What the government`s role should, or should not, be in this developing new industry is the subject of a lot of concern and study. Congress asked its Office of Technology Assessment to look at that question. The OTA is now doing so under the direction of Dr. Zsolt Harsanyi. Dr. Harsanyi`s on leave from the department of microbiology at the Cornell University Medical Center in New York, where he headed the department of genetics. Doctor, first, do you agree that this field is as promising as those in industry, such as Dr. Glick, believe it is?

Dr. ZSOLT HARSANYI: Well, you could actually be sitting across from me in my office right now, because a number of corporation representatives do come to me and ask that very question. They do talk to a lot of people in the industry right now --

LEHRER: What do you tell them?

Dr. HARSANYI: -- and they all ask the question, `Is it all promise, or is there something we should be worried about?` And our answer is very simple, that we have to deal with this whole situation in terms of cautious optimism.

We do sec that there is a tremendous amount of potential, and the reason for this potential has to do with the fact that we are dealing with a society that is moving toward depending on renewable resources. There is just so much oil left. We know there`s just so much of a whole lot of other substances in the ground that we are depending on now. And in the future, we will have to generate these substances from which we will be making our chemicals, making our energy sources, and so forth.

LEHRER: What, specifically, does Congress want your help in deciding?

Dr. HARSANYI: The Office of Technology Assessment is essentially an earning warning system of sons. We try to find out what are the social impacts, the political impacts, the psychological/technological type impacts. And, as an early warning system, we have to make an assessment of the impacts of applied genetics and biotechnology on all these different levels. We are essentially an information service.

LEHRER: All right, let`s go through those. Give me an example of the kind of questions that you`ve been asked to answer. Or the kinds of questions that might come up in the social area.

Dr. HARSANYI: In the social area, it would be very, very important to answer what kind of manpower needs we might have, what kind of manpower dislocations -- this overlaps with the economic questions, too. But some people have contacted their congressmen and worried about the possible ethical implications of manipulating life at lower organisms and so forth. And one of the questions might be, `What are the problems that we`ll be facing of an ethical nature in the future?`

LEHRER: And you`re going to try to come up with an answer.

Dr. HARSANYI: We`re not necessarily going to come up with an answer, but we`re going to come up with ways or means by which the government could help answer some of these questions ultimately.

LEHRER: You mentioned economics. Dr. Glick just said that right now there`s plenty of private money available for this kind of research. Is one of the considerations that you all -- one of the things that you all are considering also is whether the federal government ought to get into this in a big way financially?

Dr. HARSANYI: Yes, absolutely. This will be one of the possible options, simply because this is one of the options which a number of other nations have actually decided to take. We have a whole list of different organizations and groups, interactions between government and industry and universities and various nations that we can use as models for this, too.

LEHRER: Where does the United -- Dr. Glick said that in DNA the United Slates is the leader. Would you agree with that? That right now, in terms of this whole area of biotechnology that the United States is ahead?

Dr. HARSANYI: I would agree that with regard to recombinant DNA the United Slates is clearly ahead. With regard to biotechnology -- what we really refer to as the fermentation industries -- I would definitely say we are not the leaders.

LEHRER: When will you make your report to Congress?

Dr. HARSANYI: Our report is due to go to the Technology Assessment Board, which is the 12-congressional-man group that we are dealing with, and that would be end of August.

LEHRER: I see. Will that be made public at the time?

Dr. HARSANYI: Yes it will.

LEHRER: Thank you. Robin?

MacNEIL: One scientist who has expressed concerns about the rapid development of biotechnology is a professor of molecular biology at M.I.T., the Massachusetts Institute of Technology. He is Dr. Jonathan King. We just heard it suggested that industry representatives are often asking, `Is this all promise, or are there something that we have to be worried about?` What do you think we have to be worried about?

Dr. JONATHAN KING: Well, in the first place, 1 certainly agree that these technologies, the biological technology is going to usher in a whole new era of transformation of manufacturing processes, of using biological melhodol-ogies. But the very reason that`s so powerful -- because the machines, the factories reproduce themselves, the organisms that produce the chemicals grow and reproduce -- means that you have a new kind of hazard. And the chemical industry, and the radiation industry, and the oil industry, if you have a spill, if you have pollution, it doesn`t grow and reproduce itself. But in the area of biotechnology, if by accident or by oversight or by negligence you produce an organism that does have deleterious consequences, and it gets out to the environment, you can`t just clean it up, because it may establish and be out there permanently. So that the possible irreversibility of the side effects means you have to have special concern. Secondly, many of these organisms are derivatives or cousins of organisms that are agents of human disease. That`s why so much is known about them by microgeneticists: we studied them because they were related to micro-organisms that cause disease. So that origin of some of these organisms that will become machines raises another question.

MacNEIL: Machines that could produce new and worse diseases? Or more virulent --

Dr. KING: More problematic diseases. Or else, you know, if the bug is supposed to convert corn mash into alcohol gets into some corn mash that`s not designated for alcohol but for cattle feed, I mean, then you could have a -- you know, you could have problems without new diseases.

MacNEIL: I see. Is it conceivable that some of these micro-organisms or bacteria could get out of these places and actually cause epidemics or cause danger to human health?

Dr. KING: Ah, it`s certainly possible. For example, at the present time, there`s no regulation over the industrial development of recombinant DNA technology. There`s regulation within the university research sphere, but not within the corporate sphere.

MacNEIL: Do you think this should continue to be managed by private industry, or should be managed by government?

Dr. KING: Well, first, and I don`t think Dr. Farley brought it out when he talked about the development of technology, this entire technology has been developed in the public sector by government funds, by billions of dollars that, you know, came from the sweat of the taxpayers` brow. Now, after 30 years of all this development, right, private interests are coming in to kind of skim off the cream. So, in a sense, I don`t like the corporate development, just on that grounds alone. I think it should stay in the public sector. Secondly, because of this qualitative difference in the hazards, because of the self-reproducing nature of the hazards and the biological technology, I just think that it`s very unlikely that the net social benefit is going to be met by the private interests represented by the investors in, for example, Cetus Corporation.

MacNEIL: To what extent do you think that the corporation should not be running it? I mean, should it all be government? Should there be government corporations set up to manufacture this sort of thing? Is that what you mean?

Dr. KING: Yeah. Yeah, I think it should stay entirely in the public sector. If it turns out that some particular corporation has facilities that are not available in the public sector, then the National Institutes of Health can license, can contract out for that production.

MacNEIL: Are you suggesting that only on health -- public safety grounds, or on ethical and moral grounds?

Dr. KING: Well, now, the other component that we haven`t touched on here -- a little bit in a different realm, but not totally -- is that the technology for modifying micro-organisms and viruses that have all these properties is the same technology for modifying the cells of mammals and for human genetic engineering. At the present time, at least on this program, we`re talking about the production technology. But another side of the coin is the medical technology -- and also it fits in agricultural technology, when you`re modifying chickens or --

MacNEIL: Turkeys. We once did a program on it.

Dr. KING: Or turkeys. So when you talk about applying these technologies to modifying, for example, human beings, now that raises very, very deep and very difficult social questions.

MacNEIL: May I suggest we don`t get into that right now, because we`ve got enough to chew on, on this now.

Dr. KING: Fair enough. Just coming back to the hazard on -- I would say that we should have learned lessons from the nuclear and the chemical industries that this particular technology should stay in the public sector.

MacNEIL: Thank you. Jim?

LEHRER: Dr. Glick, I take it that you would disagree with that.

Dr. GLICK: Yes, I do. 100 percent. For many reasons, I suspect that Dr. King and I have completely different philosophical outlooks.

LEHRER: Well, let`s go to what he said specifically. First of all, that all of this technology has been funded by public funds over the last 30 years, and that you and other companies are coming along now and trying to skim it off the top for profit?

Dr. GLICK: I think that`s true of any basic research, whether it affects the pharmaceutical industry, the chemical industry, or any industry. If I understand the rationale for putting funds into basic research -- not the scientist`s rationale, hut from the standpoint of the public -- it is to benefit the public. Now the logical extension. 1 think, of Dr. King`s argument, is that the government should get into the manufacturing business, it should get into marketing, it should get into sales, if should get into finance and development. It`s gonna have to raise money to do this. Where`s it going to raise the money from? It`s going to have to send out detail men. sales forces and. more important, it`s gonna have to motivate people to do this. I mean, the reason why I`m in the business I am in is not because I can see immediately any large amount of money that I can personally make from this. It`s because I like doing something that is not part of a whole army of people.

LEHRER: Let`s ask Dr. King that. Is that what you`re saying. Dr. King, that the government should do the whole thing, including selling these products?

Dr. KING: Well, 1 would say the government should do the pan that`s needed. And this has happened historically in the vaccine business, where when originally there weren`t commercial facilities for the production of vaccine, the government did produce vaccine and distribute it, and did an excellent job of it. So. in terms of socially needed products, I don`t see any problem with the government, you know, providing it.

LEHRER: Yeah, let me just ask Dr. Harsanyi. is this question of the government taking over this area, is that one of the questions you`re outfit is considering?

Dr. HARSANYI: It will definitely be one of the options, one of the potential options. If you look at the systems in others countries, such as Germany or Great Britain, and the questions that the various working committees ask, one of the first questions they ask is `Will this new technology, whatever it is, if it happens to be biotechnology, will this new technology be developed by industry on its own?` If it is not such an industry, then the government says `it`s time for us to step in.` There`s - - this question of the use of basic research. This is just the problem here. Nobody realized the value of basic research: what this could be used for. There are many examples in Great Britain of discoveries which are now being marketed, are being used, and they were not patented because at the time people did not realize how valuable they are.

LEHRER: Being marketed by private companies? How does --

Dr. HARSANYI: Absolutely. Companies in this country who are using new cell technologies making antibodies in large quantities. And they were never patented because the government decided --

LEHRER: We just have one minute left. Dr. Glick, what about also Dr. King`s point about the hazards that arc involved in this?

Dr. GLICK: I don`t think that the hazards are anywheres [sic] what they were cracked up to be four years ago. In other words, I think there`s steadily increasing evidence that the hazards are going down. They are possible, but they`re becoming only remotely probable.

LEHRER: Is the possibility of government regulation to prevent this kind of potential hazard that Dr. King mentioned, a very good possibility now. Dr. Harsanyi?

Dr. HARSANYI: It`s a good possibility, yes.

LEHRER: Would you be -- I assume you`d be in favor of that, right. Dr. King .`

Dr. KING: Yeah. I`d like to see much stronger participation by Environmental Protection Agency. Occupational Safety & Health Administration in these processes.

LEHRER: I see. Could you live with federal regulation?

Dr. GLICK: Oh yes. I`m in favor, as a matter of fact, of the NIH guidelines -- those are the guidelines that universities have to follow -- I`m in favor of industry following them. By law.

LEHRER: Thank you. Robin?

MacNEIL: Yes. Well, Dr. Glick and Dr. Harsanyi and Dr. King, thank you. Good night, Jim.

LEHRER: Good night, Robin.

MacNEIL: That`s all for tonight. We will be back tomorrow night. I`m Robert MacNeil. Good night.