Biotechnology and the Social Reconstruction of Molecular Biology*

Biotechnology and the Social Reconstruction of Molecular Biology* Gerald E. Markle and Stanley S. Robin The variegated relationships between science...
Author: Rhoda Caldwell
62 downloads 0 Views 2MB Size
Biotechnology and the Social Reconstruction of Molecular Biology*

Gerald E. Markle and Stanley S. Robin

The variegated relationships between science and technology-in which each may spawn or influence, directly or indirectly, the other-have been especially complex in the field of biotechnology. 1 By the mid-1980s, popular, business, scientific, and scholarly publications have featured scores of articles on biotechnology's growth, fiscal value, and social impact. Most claim that the field will become, in the near future, a major force in human existence. The "products" of biotechnology-the prevention and cure of disease, new and cheaper chemical products, the production of new food sources-are seen as playing a crucial role in employment, productivity, trade, and the quality of human life,? Other writers claim that, to the contrary, biotechnology will have unintended and unanticipated deleterious impacts on the environment and that, in the extreme, biotechnology will usher in an era of eugenics.' Amid such speculations, the possible future of the field's scientific component-molecular biology-has received scant attention. And, the two are inextricably linked. Because an informed science policy on biotechnology must have at its core a specification of the linkages between the theoretical and the commercial, we have attempted in this article to outline some theoretical and empirical relationships between biotechnology and molecular biology and, in so doing, to comment on the probability of some future social constructions of molecular biology.'

Gerald E. Markle and Stanley S. Robin are both professors in the Department of Sociology, Western Michigan University, Kalamazoo, MI 4900B.

Definitions Defining "biotechnology" turns out to be not only diffi~ult, but also interesting and informative, primanly because of the considerable variation in usage." In Great Britain, for example, biotechnology means "the application of biological organisms, systems or processes to manufacturing and service industries", the European Federation of Biotechnology defines the term as lithe integrated .use of biochemistry, microbiology and engineering sciences in order to achieve technological (industrial) application of the capabilities of micro-organisms cultured tissue cells, and parts thereof." Accordin~ to most European definitions, biotechnology includes the processes of baking and brewing as well as recombinant DNA. Indeed at a 1984 donference on "Biotechnology: Long Term Development," European scholars viewed biotechnology as developing slowly and steadily out of 19thcentury industrial processes and thus minimized the historical impact, importance, and uniqueness of recombinant techniques." The U.S. scholars at that conference," however, emphasized the unique nature of, and the historical discontinuities caused by, recombinant techniques. Other definitions of biotechnology seek not just historical roots and professional boundaries, but evaluation, of social utility. The Japanese, for example, consider biotechnology to be "a technology using biological phenomena for copying and manufacturing various kinds of useful substances. II • Revision of a paper presented at the 1984 meeting of the American Association for the Advancement of Science. The authors thank Frances McCrea, James Petersen, Arie Rip and Helenan Robin for helpful comments on the manuscript.

«:> 1985 by the Massachusetts Institute of Technology and the President and Fellows of Harvard College. Published by John Wiley &. Sons Science. Technology. eV Human Values, Volume 10, Issue 1, pp. 70--79 (Winter 1985) CCC 0162-2439/85/010070-10$04.00

Markle and Robin: Molecular Biology The u.s. National Science Foundation defines biotechnology as ';the controlled use of biological agents, such as micro-organisms or cellular components, for beneficial use."? We find such a definitional approach to be untenable. Description is a nominal characteristic requiring consensus about logical consistency and usefulness, but evaluation requires agreement upon substantive values and subsequent analysis of the phenomenon defined. Evaluation must be a postdefinitional act. Whether biotechnology is defined as historically continuous or paradigrnatically discontinuous also shapes any subsequent discussion. The distinction speaks to major differences in perspective, history, and bases of analysis. In this article, we follow the convention of the Office of Technology Assessment IOTAl and distinguish between "old" and "new" biotechnology: The former refers to broad-based European industrial concerns, the latter to the largely U.S. "industrial use of rONA, cell fusion and bioprocessing techniques."s Because this article focuses on biotechnology in the United States, we have therefore confined our analysis to the "new" biotechnology.

Paradigms Lost and Found Biotechnology has its newest set of intellectual roots in the science of molecular biology. In the late" 1940s molecular biology arose from a perceived an~maly in theoretical physics. To physicists Niels Bohr and Erwin Schrodinger,9 the workings of living systems seemed to be inconsistent with, or even in violation of, certain laws . of physics. As Max Delbriick wrote III 1949: "It may turn out that certain features of the living cell, including perhaps even repli.cation, stand .in a mutually exclusive relationshIP to the stnct application of quantum mechanics, and that a new conceptual language has to be developed to embrace this situation."l0 In fact, Delbriick hoped that to be the case; the primary reason to study living systems, he asserted, was to search for new laws of physics. This hope [which Gunther Stent has called a paradox} that genetics would remain incomprehensible within the framework of conventional physics "... remained an important element in the psychological infrastructure of the creators of molecular blology,"!' As the molecular biology paradigm was elaborated in the 1950s and 1960s, new laws of physics were not discovered;

71

but molecular biology emerged as an academic discipline. With some exceptions, molecular biologists pursued theoretical questions, pursued them successfully, and pursued them largely without commercial intent or interest. In 1972, molecular biologists developed techniques with which organisms could be transformed permanently by the insertion of genetic materials from other species. Within the decade, a new industry had developed to transform this recombinant DNA into commercial products and new commercial environments in which genetic scientists conduct their work were established. New technological agenda for scientific activitiesoriented to commercial and socially valued products--were created.

Biotechnology and the Process of Science In our interpretation, "new" biotechnology arose ~ore or less directly from the scientific enterprise. BIOtechnology owes its existence to the influence intellect, and fiscal resources of molecular biologists. The obverse relationship, the effect of the commercial back on the scientific, is not so clear. Our understanding is that science, as well as tech. nology, is socially constructed-that its substance as well as its processes, are products of a com: bination of social forces. Political, academic, and fiscal factors, as well as the internal workings of scientific logic, influence the actual contentproble~ definition and selection, method, etc.of a SCIence. To anticipate the future of molecular biology, according to this logic, we must examine a new force: the social, intellectual, and capital resources newly arising from or altered by the existence of biotechnology. !n wh~t ways, through which dynamics, might this rapidly developing biotechnology alter the nature of molecular biology? In this discussion we offer four possible dynamics: III Financial re: so~rces are.essential to the conduct of the genetic SCIences; biotechnology may provide more funds for basic science, or it may compete for availabl dollars..(2) Biotechnol~gy. involves regulation, lega~ protection, and restriction of in/ormation and commun~ca~on; alterations in formal and informal communication patterns among genetic scientists t~erefore might change the nature of molecular biology. 13) The history of science is replete with

72

Science, Technology, etJ Human Values-Winter 1985

discovery and scientific innovation as the product of happenstance contacts and patterned interaction; biotechnology introduces new environments in which genetic scientists exercise the craft of science and are rewarded for their efforts. [4} Crucial to the future of a science is the process through which problem selection is achieved; the commercial requirements of biotechnology might alter the agenda and conduct of genetic science by influencing problem selection.

Financial Resources In the past, most resources for molecular biology were supplied by the Federal government to universities as primary research sites. During the early and middle 1970s, those resources expanded; in the 1980s, however, levels of support, measured in real dollars, declined. Exactly what is spent on biotechnology is difficult to specify, given problems of definition, as well as systematic collection and collation of data. According to the OTA, in fiscal years 1982 and 1983 the U.S. Federal government spent approximately $511 million per annum on "basic research in biotechnology"defined as "research oriented toward the discovery of an explanation of phenomena.t''? This category includes research on genetic manipulation, hybridomas, monoclonal antibodies, and immobilized enzymes. During the same time period, the government spent between $6.4 million and $30 million per annum on "generic applied research" in biotechnology, defined as research "not committed to open-ended expansion of knowledge ... but less specific ... than the typical industrial product or process development effort.':" Government funding for purely applied research in biotechnology, the OTA reports, is virtually nonexistent and amounts to less than $5 million per year. For our purposes, the most important data would compare public and private funding in biotechnology; but here the data are seriously deficient. According to E.F. Hutton Group Incorporated, in fiscal 1979, NIH grants for academic biomedical research amounted to $1.9 billion; by fiscal 1981, that amount had grown slightly to $2.28 billion. During the same period, private-sector funding to academe for "profit development grants" increased from $100 million to $400-500 million." Thus, in two years, the ratio of Federal support of academic biomedicine to private support of "profit development grants" declined from 19: 1 to 5: 1.

By 1985, "with the combination of further Federal budget tightening and the growing aggressiveness of business development capital and risk capital investment, we may approach a 1: 1 ratio."IS What are the implications of these changing resources? According to scientist Arthur Kornberg, Federal budget cuts pose not only a threat to basic research, but to biotechnology as well. Given the field's strong vested interest in a healthy academic molecular biology, Kornberg argues, both university and industry should lobby for funds for basic research.l" The president of Cetus Corporation has als? endorsed such a partnership, but at the same time he has warned that industry cannot compe~sate for heavy cuts in government funding of basic research. If Federal funds continue· to decline, theoretical studies will suffer unless two unlikely conditions are met: [I] biotechnology pumps large sums of money, derived from profits, back to academe, and (2) these resources are used to support research with little immediate commercial payoff. There is some evidence that industry is moving in these directions. In 1981, for example E.!. duPont de Nemours awarded a $6 million, five-year grant to Harvard University Medical School, and Hoechst AG provided Massachusetts General Hospital a $50 million ten-year grant, for studies in "fundamental molecular genetics."!" Yet, innovative as these grants are, they represent a very small proportion of genetic science research funding. Even if predictions of biotechnology profits are realistic, will these funds be earmarked almost exclusively for research ventures with potential commercial value? Will basic science will be supported at generous levels 'by the fiscal Successes of biotechnology? Biotechnology may also prove a powerful and irresistible competitor with basic genetic science endeavors for mi:;sion-oriented Federal funds. While the line between applied and basic scientific research can be drawn with unrealistic and misleading sharpness, it is not at all clear that the creation of biotechnology will result in -increased or sustained support for traditional molecular biology research.

Regulation: Legal and Informal The early history of recombinant research was marked by controversy over the issue of regulation." Basic and applied recombinant research in academe and .other Federally supported settings

Markle and Robin: Molecular Biology were subject to Federal regulations, with much of its origin and content stemming from the com19 munity of genetic scientists itself. During the late 1970s most molecular biologists came to believe th~t these concerns were excessive. In spite of regulatory agency response to the first human recombinant experiments/o there has been · 21 a progressive relaxation 0 f regu 1anon. The advent of biotechnology appears to have been a factor in the positive political acceptance of a declining need for regulation of rDNA resear~h. The private sector is currently unregulated, despite the initial proclivity ~f p~werf~l con~ressio~:l forces to impose regulation. The ~ndus~al setti g can offer a freer rein to scientists in then research pursuits. Recombinant DNA research, ~n general, through biotechnology, is li~ely to recel~e fur:he~ deregulation through lobbymg .efforts,. indus .ry government cross-hiring, and mcreasmg claims of contributions to the national welfare. . Regulation of rDNA research, however, IS n?t confined to the type of mechanisms created m the mid-1970s. Patent law protects and regu.la.tes commercial activity. The Chakrabarty deCISI?n cleared the way for patent protec~on of commercial rDNA products and processes. As informatl?n becomes patented, its flow is regulated. While some claim that patenting will actually mcrease the strategic flow of information, others [we among them! suspect that proprietary interests have ~nd will continue to affect basic science by altering the £low of information. According to a Genex Corporation prospectus: "All scientific consultants are retained under confidentiality agreements under which they agree not to use or disclose Genex . inf . 1124 The company Cenenpropnetary 1 ormation. tech Incorporated has told its stockholders:

73

static legal systems are not enough ... Governments ... fortunately seem to understand the importance of statutory legal protection ... If sound economicsprevail, more and more countries will enlarge their patent laws to offermeaningful protection.f

Biotechnology accesses a set of institutional practices from the economic and legal spheres which expect and reward industrial secrecy, restricted communication, the purchasing of patent rights, and the exclusivity of cross-patenting. Commercial regulation of scientific information may also proceed without benefit of patents or regulatory agency involvement. Scientists employed by biotechnology companies may find submission of articles and papers monitored to protect commercial secrets in advance of patenting, or in instances where the application of patent law is doubtful. Commercial regulation may also be expressed more dynamically in a hitherto unknown caution in informed exchange among colleagues at meetings and in other private communications. As Julian Davis, former Steenbock Professor of Biomolecular Structure at the University of Wisconsin, and currently director of Biogen's Geneva laboratory, stated: "We wanted to provide a scientific utopia," but Biogen/s proprietary interests "prevent one from talking as freely with one's scientific colleagues as one might."27 Similarly, one MIT molecular biologist noted: "The atmosphere around biology department coffee pots has changed in the last few years." 28 The loss could be that vital and fragile inspiration that is created by the stimulus of a colleague's thought or findings upon one's own work in progress.

The Craft of Science Extensive research and development i.n other product areas continues at a high productlve pace. Some of this you have heard about, but ~~ch you may have not, For business and competitl~e reasons we have chosen to delaydiscussing certain ' until . they are furt her along the develproducts opment pipeline." Domestic agreements and patents are further supplemented by international agre~ments, .such as the Budapest Treaty. These international agreements led one member of ~he Office of Legislation and International Affairs of the Patent and Trademark Office to offer the opinion that: H biotechnology is to be adequately protected,

We view science as a craft." The scientist learns technical and intellectual skills, as well as the value nexus out of which those arise, as part of continuous and ongoing training. The major site at which such acculturation occurs is the place of employment. Despite mythology to the contrary, scientists are employees of organizations rather than free agents; and those organizations must, by their nature, exert some control, subtle and overt, over the scientist. Once the scientist is seen as workingin an ordered environment which limits and constrains his actions and ideas, then it is not too great a step to

74

Science, Technology, eiJ Human Values-Winter 1985

consider science as an ordered phenomenon which is connected to its conditions of production. The structure of scientific production here includes the day-to-day organization of work, the intellectual background to research and process of recruitment, training and elite Iormanon."

As scientists move from the universities to biotechnology firms, their reward structure changes. Biotechnology has created molecular biologists who are entrepreneurs, corporate officers, stockholders, and consultants. Some have occupied these niches while maintaining their academic positions, the competing loyalties of which lead in unknown directions. Donald Kennedy, President of Stanford University and former Director of the FDA, speaking on behalf of the Association of American Universities and National Association of State Universities and Land Grant Colleges, has noted: A large number of our faculty members ... have recently concluded or are now contemplating individual arrangements with mostly young, new biotechnology firms ... We are going to have to measure over the next few years how much of a real loss is experienced in terms of fractional faculty time and energy committed to the research enterprise and to the research training in the university. We are not losing whole people. What we are concerned about is what the ultimate landscape will look like in terms of the loss of parts of people."

Even for bench scientists, salaries have risen dramatically. Biotechnology firms now pay new Ph.D.s' salaries ranging "between $23,000 and $32,000, with most clustering around $30,000."32 As a personnel director of a leading biotechnology firm observed: "They were woefully underpaid until the biotechnology boom allowed for a much needed adjustmene.?" Although it is only possible to assert at this point that those who pursue a career because of the desire to understand are different in important ways from those who pursue a career for monetary gain, it seems reasonable to entertain this idea seriously. The reasons for doing things and the nature of things done are related; Weltanschauung and paradigm are not independent. The impact of biotechnology upon the social construction of molecular biology may be profound if the field systematically recruits scientists with different reward expectations. We need not await a new generation of molecular biologists to observe the impact of biotechnology. The biotechnology industry has been created by

and employs some of the most renowned scientists of our day. As the Senior Vice President for Technology at W.R. Grace and Company stated: "We've been showing up on campuses and we've been hiring what we believe are the best people from the best schools-with very little competitinn.v'" !f a si~nificant number of molecular biologists, including the most accomplished, devote themselves to biotechnology, who is left to pursue science that is not commercially valuablej" Every organizational form, commercial or academic, socializes its members purposively and unintentionally. Heretofore, scientists have had their initial socialization in academe and are now being resocialized by the industry. Crucial to industry are ideologies and thoughtways stressing the service of the theoretical to the commercial. If, through subsidy and contract, industry uses academe as its training ground, might molecular biology in academe be reordered? If scientific leadership turns increasingly to biotechnology, might those in academe be further influenced to devote their time and thought to the exploration of genetic science conceived as useful to biotechnology? Might they train their generations of students to do the same? As a Dean of the University of California asked: "Will the students' research program provide the best possible learning or if the faculty member is associated in some way with a private [biotechnology) lab, will the research be oriented to the interests of the private laboratory? ,,36

Problem Selection No single intellectual act in the development of science is as influential as the aggregate of problem selection among its practitioners. While problem selection is profoundly influenced by the consensus about "next steps" in a paradigmatic science, the agenda for a science may also be influenced or altered by the nature and availability of resources, regulation, and the specifics of recruitment and socialization of scientists. In all but the most arcane scientific pursuits, questions of application and utility-be they military, economic, welfare, or other interests-constitute elements in problem selection. For molecular biologists funded by, employed by, or owning biotechnology enterprises, commercial application may be mandated or strongly requested as the primary or sole criterion of problem selection. Biotechnology firms have already altered the

Markle and Robin: Molecular Biology

nature of problem selection. Problems dependent on the ~laboration of technique, not theory, are emphasized, Hence these corporations focus on the development of biologicals [enzymes, pharmaceuticals, etc.) because of the likelihood of rapid payoff. Problems such as the control and transfer of nitrogen fixation are more complex: Enormous profits are possible, but not until substantial theoretical problems are solved first." Thus, biotechnology entrepreneurs, although interested in this problem, have not made a major commitment to it. Rather, they waft for academe to advance first the needed scientific theory. Finally, theoretical problems, ones that address the nature and meaning of life as part of Max Delbriick's original call, are simply not a part of the commercial agenda, We anticipate that in the presence of force as powerful as biotechnology, commercial application might become the fulcrum of the competing influences in problem selection for all of molecular biology, H that were to happen, the shape of molecular biology would be altered profoundly,

a

The Future of Molecular Biology There are many possible molecular biologies. of the future. How will biotechnology affect whicli molecular biology is created? To address this question, we need some model that allows us to assess how externalities affect science. One such effort , termed the "finalization" model has been M put forth by the Starnberg group in Germany. Finalization scholars view the development of a scientific discipline in three phases. The "exploratory" phase is preparadigmatic and is c?aracterized more by discovery than by expl~natIO~, In the "paradigmatic" phase, normal SCIence. IS practiced and "dogma," such as the Watson-C~ck formulation is elaborated through puzzle-solvmg. In the "po;tparadigmatic" phase, the sc~ence is fully matured., most of its original questIons are . answered. Such a science might stagnate or It might become "open to orientation in accordance with goals which do not originate within science .. , Further theoretical development. , , can then proceed broadly along the path indicated by such external goals, ,,39 This process is termed "finalization." Is molecular biology finalized? The Starnberg group answers this question with a careful distinction, At the level of the individual cell, par-

75

ticularly the bacterial cell, "molecular genetics represents a mature theory for the phenomenon of heredity and the translation of genetic programs into cell-characteristics.v'" Although the theory of molecular genetics is expected to be valid for all processes of heredity, it has not yet fully developed for more complex organisms. Development in molecular cell biology has not yet produced a mature theory. No theoretical solutions have yet been found for its fundamental problems: the question of cellular growth, control and, differentiation, the development of cells in cellular systems and the emergence of forms and figures during 'morphogenesis.r"

Thus it seems useful to view the emerging "new biotechnology" as paradigmatic and to consider the European "old biotechnology" as postparadigmatic.f And it may be more useful to consider a variant of the Starnberg model-i-vfunctionalization"-where a paradigmatic science comes under premature external direction. Such influence may be counterproductive, particularly when fundamental theory is neglected." Sensitized by this argument,. we ~her~fore view molecular biology as a ~aradlgmatlc SCIence with many fundamental questions yet unanswered, And with this backdrop, we pr~pose three ways in which biotechnology could influence the future of molecular biology III It is possible that the development of bio: technology will provide rDNA research with the resources and impetus that will advance the endeavor ~ith a ~ig?r hitherto unknown. Although conventionally It IS thought that application arises from theory, the obverse occurs as well. Commercial and practical applications of scientific knowledge have indeed led to theoretical development and ~e creat~on of new fields of inquiry, Although not immediately evident in the rapidly d~veloping genet~c scie~ces, and the emerging biotechnology, this relationship could well manif~st itself as an intellectual resource provided by ?IOtechnology to molecular biology, The question IS: Could suc~ theory, once developed, be freely ~d broadly reinserted into mainstream molecular biology! .The profits c!eated by biotechnology may pro~I.de funds, eq.U1p research sites, and enhance abilines to recruit and train scientists with unprecedented abundance." Industrial investment . thes,e activities would be motivated by profit p~~ tential, .butI would di .function to advance the current th eorettca irecttons of the science , ThiIS sym-

76

Science, Technology. etJ Human Values-Winter 1985

biotic relationship would require altruistic motives and/or a long-range and farseeing exercise of selfinterest on the part of the biotechnology industrialists. Monies would be so readily available that funding of basic science as a long-range activity would proceed alongside funding of immediately applicable commercial research. Throughout the OTA report on Commercial Biotechnology, there is an implicit endorsement of this view. The development of biotechnology is a priori assumed to be in the national interest; standard criticisms and potential problems are dismissed or minimized. For example, in a nonrandom survey of 15 universities and biotechnology companies, OTA reported that (1)85% "believed that university/industry relationships in biotechnology have had no effect on the way research is done, and virtually all believed that there has been no change in the quality of research"; (2) 85% claimed "that there had been no substantial effect on the exchange of information or the collaboration that has existed among university researchers"; and (3) 50% believed that the quality of students' educations had been enhanced." Even if this optimistic, probiotechnology scenario were true, molecular biology would advance in noncommercial areas only if basic science agenda were not socially and intellectually altered by biotechnology. Given the effects of commercial regulation, the distribution of reward, differential recruitment, altered scientific socialization, and the subtle influences upon problem selection, this eventuality seems remote. (2) An opposing view is that the demands of biotechnology, its monetary power, and its undeniable social utility, will compete with great success for time, epergy, and resources and so retard the growth of noncommercial science. The commercial agenda of biotechnology might replace, almost entirely, the basic scientific pursuits of rONA research. In this outcome, not only commerce but the entire scientific reward system would be geared to support work that could produce marketable products. Basic scientific research would cease or would be conducted at minimal levels while techniques of application would be the focus of scientific endeavors. The subordination of research to commerce has already happened in one major biotechnology finn. Cetus Corp. has instituted policies to change its nature from a research- to a market-oriented company/" In 1983, under new management, Cetus terminated its "new ventures" department which,

with some 40 employees and a budget of $6 million, had concentrated on research. Biogen Incorporated is also in the process of "graduating from a research corporation into a pharmaceutical manufacturer and marketer.v" Even W. R. Grace's massive infusion of capital into biotechnology has been viewed with some cynicism as a "protectionist/expansionist strategy:" Grace claims to be watching the plant-based biotechnologies closely, areas which could threaten their existing nitrogen-based fertilizer business or help them expand into new plant product areas."

Entrepreneurs in biotechnology are not bli~d their needs for the continued development of basic science. They are aware that the paradigmatic agenda and the serendipitous eventualities of basic science are necessary to the continued fiscal success and social usefulness of biotechnology. Thus, the purposeful replacement of basic genetic science with biotechnology is seen as undesirable by all knowledgeable actors. Efforts will be made to assure that the genetic sciences continue in academe and other settings not directly associated with the biotechnology industry. (31 A more likely conjecture than either of the foregoing, it seems to us, is that the demands of biotechnology will alter basic science with a subtlety that will be difficult to perceive. The program of scientific research is created by the collective consensus of scientists. The technological needs of rONA research for commercial purposes may influence the perception of research needs and may alter, in unperceived ways, the program of research previously set by other factors. One way to observe these changes, even in the supposedly internal logic of science, is to note subtle changes in the use of language and in the alteration of concepts. One example is the use of "basic research" in Genentech Inc.'s assurance that: "Genentech scientists are encouraged to pursue both important new product opportunities and basic research which could contribute to future product areas.?" Another example is OTA's constant use of the phrase "basic research in biotechnology." In both these usages, the paradigmatic meaning of "basic research" is being altered. finally, NSF's conflation of the boundaries of biotechnology and its perceived beneficial utility would set out a markedly different analytic framework. to

Markle and Robin: Molecu lar Biology

Conc lusion Scient ists are neithe r pristine characters nor, to use Mannh eim's phrase, "free-floating intellectuals." Social good is not confined to the values of science or academe. Business people are not necessarily "robber-barons." New product developmen t and commercial use are not intrinsically harmfu l. As academics, we have a predilection for academic values (the production of knowledgel over business values (the knowledge of production); but, in a dynamic mix of academe and business enterprises, society may need to be concerned about the character of the former because of the possible dominance of the latter. Biotechnology will change the direction of the genetic sciences. And, in our opinion, the busine ss of biotechnology will promote, and proba~ly coopt, and thus alter the science of molecular blOlogy. In such a situati on, "publi sh or perish," now an indica tor of academic success, will take on the additional dimensions of the "profit or perish" business ethic. Joshua Lederberg has predic.ted ~at: "The possibility of profit ... will be a distorting influence on open communication and on the pursuit of scholarship,,50; but we would argu~ that, rather than be "distor ted," the genetic SCIences are more likely to be "altere d." Whether this is "good" or "bad" certainly is a question for consideration, but it may be more important first .to perceive and understand the genesis and dynamics of any directional change.

Notes 1. For backgro und reading on the emergence of biotechnol ogy and its associa ted industry, see, for.example, Sharon McAuliffe and Kathlee n McAuhffe, Life For Sale (New York: Coward, McCau n & Ceohegan, 1981)i and Edward Yoxen, The Gene Business (New York: Harper & Row, 1983 1: . 2. A reflecti on of this belief is seen 10 the attentio n that the U.S. Federal govern ment is paying to biotechnol ogy. See, for example, U.S. Ho~se .of Representa tives Subcom mittee on InveStigatIOn and Oversig ht of the Comm ittee on Science. an~ Technology, Comme rcializa tion of Academ Ic Biomedical Research (Washington, DC: U.S. Govern ment Printin g Office, 1981); Office of Techno logy Assessme nt Comme rcial Biotechnology; An Internationa l Analys is (Washington, DC: U.S. Govern.menr Printing Office, 1984}; National Science Boa~d, Discuss ion Issues, 1984, Research Related to B1O'

77

technology, Volume s I and II (Washington, DC: Nation al Science Founda tion, 1984), NSB-84-159. 3. Christo pher Edwards, "Fooled Again," Bio/Technology [August 1983). 4. See Office of Techno logy Assessm ent, op. cit., Appendix A, and Nation al Science Board, op. cit., for all country definiti ons used in this section . 5. See, for exampl e, B. Weir, "From 'The Whiske y Age' to the 'Alcoho l Age', 1900-1 939"i and S. Strbanova, "The Mutual Link Betwee n Applied Fermen tation Researc h and the Establi shment of Modem Bioche mistry, " present ed at "Biotec hnology: Long Term Develo pment, " a conference sponsored by the Science Museu m (Britain) and The European Associa tion for the Study of Science and Techno logy, London, 30 March -l April 1984. 6. Lois Peters, "Indust ries and Univer sities in The Contex t of Biotech nology" and Gerald Markle and Stanley Robin, "Biotec hnology and The Future of Molecular Biology," also presented at the conference cited in Note 5. While those in the U.S. and Europe generally define biotechnology differently, there are excepti ons. For exampl e, British scholar Edward Yoxen, op. cit., views biotech nology much as Americ ans do. On the other hand, in 1984, Genex [a "new" Americ an biotech nology corporation] introduce d an enzyme -based liquid drain cleaner a produc t in the traditio n of the European use and meanin g of biotech nology (Genex, 6 August 1984 news release). 7. Nation al Science Founda tion, Biotechnology and NSF: Opport unities for Support of Biotechnology Res~arch an~ Related Activit ies (Washington, DC: Nation al Science Founda tion, 1983), p. 1. 8. O~fice of Te~h~ology Assessm ent, op. cit., p. 3. 9. Niels Bohr, Light and Life," Nature, Volume 131 (1933): .421; Erwin Schrodinger, What is Life! (Cambn dge, England: Cambri dge Univer sity Press 1945). ' 10. Max Delbriick, "Introd uction: Waiting for the Paradox," in Phase and The Origin of Molecular Biology, Gunt~er S. Stent, ed. (Cold Spring Harbor, NY: Cold Spnng Laboratory of Quantit ative Biology 19661, p. 20. ' 11. Gunthe r S. Stent, ibid., p. 4. 12. Of~ce of Techno logy Assessm ent, op. cit., p. 308. 13. Ibid; p. 323. 14. Nelson Schneid er, in Comme rcializa tion of Academic Biomedical Research, Subcom mittee on Investiga tions and Oversig ht of the Commi ttee on Science and Techno logy, U.S. House of Representatives (Washington, DC: U.S. Govern ment Printing Office, 1981). The dollar amoun t of "privat e dev.elopmc~t grants" is elusive . Accord ing to the Nati?nal .Sclence Founda tion, Academ ic Science/Enguieenn g ReJD Funds Fiscal Year 1981, NSF 83308 (Washington, DC: U.S. Govern ment Printin g Office] the total "nonfed eral" (including Institu-

78

Science, Technology, eV Human Values-Winter 1985 tional funds and all other nongovernmental sources, as well as industrial I was $1.7 billion for all of the academic sciences and engineering in 1981. The E. F. Hutton estimates for biomedicine only seem as specific and reliable as available.

15. Ibid.

16. "Biotechnology's Tie toAcademiaAssessed," Chemical and Engineering News (26 April 19821: 21. 17. "Industry Spurs University Research on Genetics," Chemical Week (29 July 1981): 23. 18. Judith P. Swazey, James R. Sorenson, and Cynthia B. Wong, "Risks and Benefits, Rights and Responsibilities: A History of the Recombinant DNA Research Controversy," Southern California Law Review, Volume 51 (1978): 1019; Sheldon Krimsky and David Ozonoff, "Recombinant DNA Research: The Scopes and Limits of Regulation," American Journal of Public Health, Volume 69 (1979): 1252; James D. Watson and John Tooze, The DNA Story (San Francisco, CA: W.H. Freeman, 1981). 19. The story of the Gordon and Asilomar Conferences has been told many times. See, for example, Sheldon Krimsky, Genetic Alchemy (Cambridge, MA: The MIT Press, 1982). 20. Bernard Talbot, Report of the NIH Ad Hoc Committee on the UCLA Report Concerning Certain Research Activities of Dr. Martin J. Cline, 21 May 1981; Stanley S. Robin and Gerald E. Markle, " ... Let No One Split Asunder: Controversy in Human Genetic Engineering," paper presented at the American Sociological Association, San Francisco, CA, 1982. 21. This relaxation has been challenged, with much publicity and some initial success, by Jeremy Refkin. The biotechnology industry has responded sharply. According to Christopher Edwards, editor-in-chief of Bio/Technology, "Rifkin appeals to populist sentiments by selecting facts to support his theories about the evils of technology and modem business" (Edwards, op. cit., p. 459). Rifkin's scare seemed to change Edward's attitude toward Rep. Albert Gore who had held a series of Congressional hearings on the possible regulation of biotechnology. In comparison to Rifkin, Gore was seen as "evaluating scientific evidence as well as policy-related alternatives before forming conclusions regarding legislation or oversight" (ibid.). A year earlier, however, Gore's hearings were characterized as "dramatic" and "fear-provoking" See Christopher Edwards, "American Biotechnology Needs a Strategic Planning Center," Bio/Technology [March 1983): 7. 22. Senator Edward M. Kennedy, letter to Charles A. Thomas, 29 September 1977.

23. Sidney A. Diamond v, Ananda M. Chakrabarty, 447 U.S. 303 (16 June 1980). 24. Genex, Inc., Prospectus (Rockville, MD: Genex, Inc., 1982), p. 24, emphasis added. 25. Genentech,Inc., Third Quarter Report, 1983. Quoted

in Arthur Klausner, "A Little Secrecy Goes a Long Way," Bio/Technology {June 1984j: 494. 26. Quoted in Stanley D. Schlosser, "Patenting Biological Inventions," University of Toledo Law Review, Volume 12 (1981): 944. 27. Quoted in Tabitha Powledge, "Biogen in Transition: From Research Specialist to Manufacturer," Bio/ Technology (July 1983): 402. 28. Jonathan King, in Commercialization of Academic

Biomedical Research, op. cit. 29. For a review of this position, see Daryl Chubin "The Social Trappings of Knowledge," unpublished manuscript. 30. R. D. Whitley, "The Sociology of Scientific Work and the History of Scientific Developments" in Perspectives in the Sociology of Science, Stuart S. Blume, ed. (New York: John Wiley & Sons, 1977.), p.23. 31. Donald Kennedy, in Commercialization 0/ Academic Biomedical Research, op. cit" note 2. 32. "Industry Scientists' Salaries Stabilizing in U.S. as Competition Heats Up," Bio/Technology (October 1983): 642. 33. Ibid., p. 641. 34. Quoted in "W.R. Grace: A Slow-MOVing Giant Leaps into Bioresearch," Bio/Technology (March 19831: 30. 35. In the 11 February 1983 issue of Science devoted to biotechnology there were numerous recruitment advertisements for genetic scientists. Monsanto advertised the completion of facilities to "house 100 scientists working on the development of new products based on the life sciences" [inside back cover). 36. Winston Doud, University/Industry Relations:

Opportunities and Policy Issues in Research and The Creation of Intellectual Property (Madison, WI: University of Wisconsin, 1982), p. 58. 37. As Yoxen, op. cit. note I, p. 128, notes in his section on "The Nitrogen Fix:" "The problem is that qualities are controlled by a considerable number of genes and transferring an entire cluster in a working condition is likely to be formidably difficult. The obvious implication is that this research is unlikely to have any impact on agriculture for a considerable while ... " 38. Wolf Schafer, ed., Finalizationin Science (Dordrecht: D. Reidel publishing Co., 19831. 39. Ibid., p. 8. Of course, external factors may shape a science prior to its finalization. For a discussion and debate on the role' of external factors during the "exploratory" phase of molecular biology, see Prima Abir-Am, "The Discourse of Physical Power and Biological Knowledge on the 1930s: A Reappraisal of The Rockefeller Foundation's 'Policy' in Molecular Biology," Social Studies of Science, Volume 12 [1982):341-382, and the commentary which followed in the May 1984 issue of that journal.

Markle and Robin: Molecular Biology

40. Gemot Bohme, WolfgangVan DenDade and Rainer Hohlfeld, "Finalization Revisited," op. cit., Note 38, p. 147. 41. Rainer Hohlfeld, "Cancer Research: A Study of Praxis-Related Theoretical Developments in Chemistry, The Bioscience and Medicine," op. cit., Note 38, p. 107. 42. Thus, the Starnberg resolution of the tension between the commercial and the postparadigmatic science is inapplicable. For postparadigmatic sciences, van den Daele et aI. state: "The institutionalization of [European] biotechnology reveals a similar pattern [to postparadigmatic discipline in cancer research].The tasks defined by the science policy program for microbiology, i.e., to develop and improve industrially usable microorganisms, attracted only those scientists who had received their training at the few institutions for industrial microbiology that exist in Germany (in particular for zymotechnics]. Conversely, molecular biologists rejected recruitment into biotechnology and related research projects as long as there were still jobs in fundamental research. Work on the more complex systems of industrially exploitable microorganisms does not allow application of the most advanced methods of biology and entails research with 'softer' empirical methods. It is considered in-

79

tellectually less demanding and SCientificallyless rewarding than work at the disciplinary research front." Wolfgangvan den Daele, Wolfgang Khron, and Peter Weingart, "The Political Direction of Scientific Development," in The Social Production of Scientific Knowledge. E. Mendelsohn, P. Weingart and R. Whitley, cds. [Boston, MA: D. Reidel Publishing Co., 19771, p. 238. 43. For a discussion, see Arie Rip, "A Cognitive Approach to Science Policy," Research Policy. Volume 10 (1981): 295-311. 44. See, for example, Joan Amatniek, "College Biotechnology Programs on The Rise," Bio/Technology (August 1983): 467. 45. pp. cit., Note 2, p. 414. 46. Paula Dwyer, "Fildes Shifts Cetus Policies as New Vaccine Is Launched," Bio/Technology (June 1983): 313. 47. Op. cit., Note 27, p. 398. 48. Op. cit., Note 34, p. 31. 49. Genetech, Inc., 1982 Annual Report (South San Francisco, CA: Genetech, Inc., 1983), p, 9. SO. Quote in Charles Weiner, "Relations of Science Government, and Industry: The Case of Recombinant DNA," in Science and The Issues of the Eighties: Policy Outlook, Albert H. Teich and Ray Thornton, eds, (Boulder, co: Westview Press, 19821.