Both these missions, says Wofsy, may be perfectly valid, but they ought to be kept separate.
As competition heats up to secure the services of individual biologists, so does competition between universities themselves. Thus, Wofsy points out, 'If MIT makes a deal in excess of a hundred million dollars with the Whitehead family, other universities must scramble for comparable coups - at stake is the ability to compete, claims to status and ranking, the familiar game of "Who's Number One?".'
The answer to the last question is, for the moment, MIT. Harvard Medical School trails well behind with $6 million received from DuPont for a new genetics department. The agreement specifies that Harvard will hold the patents resulting from discoveries financed by this grant, while DuPont will receive exclusive rights to make use of such patents through licensing arrangements. While $6 million may be real money for Harvard Med, it is peanuts for DuPont, whose total research budget was $571 million in 1981, the year it made the Harvard deal. Company spokespersons say that DuPont will not attempt to set the research agenda but is, rather, 'interested in contributing to basic research in the molecular genetics field, with the opportunity to draw on the results'.24
Another corporate contract involves Harvard's teaching hospital (Massachusetts General) which is bound to the West German pharmaceuticals giant, Hoechst. Mass General will get $70 million over ten years to establish a new department of molecular biology; it will allow the company to obtain the research findings before anyone else does and to take out exclusive licences on 'related commercial procedures'. Both granter and grantee have refused to release full details of their contract; even Congress is worried that a foreign corporation may reap the benefits of research at least partly acquired through US public funding.25
Other deals include Montsanto and Rockefeller University ... Montsanto and Washington University, Saint Louis ... Celanese and Yale ... MIT and Exxon. One amazing transformation is that of the Stanford University Department of Medicine. Under the terms of its contract with Syntex, each of the eighty members of this department must spend up to eight days a year consulting for this biotech firm. Since this could be judged to be beyond the university pale, the department undergoes metamorphosis as it enters into contract with Syntex and becomes the 'Institute of Biological Investigation'. Wofsy characterizes this deal as one of the 'more open, less sleazy' ones.
These contracts, however, are dwarfed by what has been termed the 'merger' of MIT and the 'Whitehead Institute for Biomedical Research', a wholly private entity. The WIBR, adjoining the MIT campus, will devote itself to molecular genetic research and developmental biology. So far so good. What makes it a new breed of cat is its 'joint faculty' with MIT (salaries paid by Whitehead), its ownership of all patents resulting from research carried out by this joint faculty, and its unprecedented right to initiate the appointments of up to fifteen faculty members.26
Some influential figures have been troubled by the blurring of corporate-university frontiers. President Donald Kennedy of Stanford declared to a Congressional committee in 1981 that too many university biologists with stockholdings in biotech companies are 'abandoning informal and formal communication' because of the profit-seeking that is 'contaminating' free and open scientific inquiry. 'At least three or four times in the past year', biologists giving papers at scientific meetings 'refused to divulge some technique because it was now proprietary', Kennedy testified."
Some months later, Kennedy, apparently less troubled, convened the Pajaro Dunes Conference on 'Commercialism and University Research'. Co-hosts were the Presidents of Harvard, MIT, Cal Tech and the University of California. Who, then, were the guests? The presidents and chief executive officers of eleven biotech corporations, the lot funded by a $50,000 grant from the Henry J. Kaiser Foundation. The meeting was organized without the participation of the university community - much less that of the public - and was closed to the press. One journalist noted:
If Pajaro Dunes was supposed to reassure the public that the integrity of its research dollar was unsullied by intermingling with corporate funds, the image it projected - a kind of Yalta of the mind, dividing up the future of public health research behind closed doors - achieved the opposite.28
How Long is the Arm of the Law?
'If I had a child headed into a career now, I'd want him to be a patent lawyer - preferably a biotechnology patent lawyer,' said the president of a Massachusetts biotech firm in 1984. New products and processes, new corporate-university relationships require regulatory mechanisms and orderly procedures which only the law can provide. Corporations hate unpredictability and must know what the rules are, if only to get round them.
Alas, predictability is elusive. Here are some of the elements adding to the confusion. Biotechnology is not a very precise concept. It certainly is an industry, but one with fuzzy edges, not based on a single product like, say, the microchip. While discussion here is limited to the implications of rDNA technology, which presents formidable legal problems of its own, there are lots of other biological products and processes the law must also deal with: conventional seed and plant breeding, cloning, cell fusion, fermentation technology, manipulation of human or animal embryos in vitro, etc.
Some law deals with products, some with processes. In the ambiguous brave new world now taking shape in the lab, various kinds of conventional law may - or may not - apply: patent law, licensing law, professional and trade secrets law, copyright law, etc. Further muddle is assured because legal systems, precedents and applications differ in Europe, the United States and Japan, the principal markets for biotech products. Here are the legal decisions we have to go on:
In 1972, Ananda Chakrabarty, a General Electrics scientist, applied for a patent on a lab-created micro-organism which might be used to 'eat' oil slicks at sea. When the US Patent Office refused, the matter was litigated and eventually reached the Supreme Court. Although Chakrabarty's bacterium wasn't created using recombinant DNA techniques, the Court's opinion has been considered the legal basis for rDNA products as well. It reads:
The laws of nature, physical phenomena and abstract ideas have been held not to be patentable. Thus a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E = mc2 ... Such discoveries are 'manifestations of nature, free to all men and reserved exclusively to none'. Judged in this light, respondent's micro-organism plainly qualifies as patentable subject matter. [It] is not a hitherto unknown natural phenomenon, but a non-naturally occurring manufacture or composition of matter - a product of human ingenuity 'having a distinctive name, character and use'... His discovery is not nature's handiwork, but his own.29
The second legal consideration concerns the actual process of recombining DNA. Paul Berg of Stanford was the first person to combine genetic material from two different organisms and received the Nobel Prize in 1980 for his work. It did not occur to him to take out a patent on a scientific discovery, but Berg is an old-school type.
His method was pathbreaking but laborious; not what scientists would call especially 'elegant'. Simultaneously, biochemists Stanley Cohen (Stanford) and Herbert Boyer (UC-San Francisco) were developing a universal gene-splicing method. A small ring of genetic material called a plasmid is removed from an E. coli bacterium and opened up with a restriction enzyme; a gene is snipped from a different organism using the same enzyme; the gene is spliced into the plasmid, which goes back into a bacterium; the bacterium divides every twenty minutes or so, replicating all its genes, including the new one. The new organism can thus be called upon to produce human insulin, bovine growth hormone, interferon, etc.
The Cohen-Boyer discovery was to methodology what the Crick-Watson breakthrough was to description of structure - with the added advantage that the method had numerous immediate practical applications. The way Time Magazine told it,
At first, Cohen and Boyer balked at seeking a patent for their work. But Stanford's licensing
director ... changed their minds by citing the case of Alexander Fleming who had refused to take out a patent, thinking that this would ensure penicillin's widespread availability. Instead, since no company would take the financial risk of making it without patent protection, the wonder drug did not go into production until World War II, some 14 years after Fleming had identified it.30
So Cohen and Boyer filed and were awarded a patent on their process; the Supreme Court decision was held to apply to method as well as to life-forms themselves. Herb Boyer is a rich man, but that is because of his involvement with Genentech, not because of the patent, whose royalties go to Stanford.
The rule of thumb for biologists has since become 'patent first, publish later' (if at all). Genentech's legal counsel, Tom Kiley, explains that the smaller, weaker biotech companies will use patents to 'squeeze more royalty payments' to try to stay in business. This 'portends a litigious shake-out period' whose end result, Kiley believes, will be 'an industry characterized not by monopoly but by oligopoly, with relatively friendly competition and restrained use of litigation'.31 In other words, biotechnology will come to resemble any other 'mature' US industry, where competitive price-cuts advantageous to consumers are scarcely the norm.
One legal expert, Professor Irving Kayton, argues that patent law is not the best vehicle for regulating biotechnology and calls for the application of copyright law for lab-created organisms, considered as condensed information. He says that copyright law would solve the dilemma of the corporate or university scientist whose institutions now more and more restrict the right to publish. 'Universities recognize that gold mines as well as test-tubes... are scattered around their microbiological laboratories and that the gold is recoverable only by perfecting their property rights.' Business-academic arrangements centre on such protection. However, says Kayton, 'immediate publication and copyright protection are completely compatible. Since the creation of a genetically engineered work itself generates the protection provided by copyright, publication of research findings on the day they are made will in no way impair copyright protection of those results.32
His argument has yet to be tested in court. It might, however, be the only legal way to preserve academic freedom of inquiry in the sciences. If copyright law were applied to biotech products, it would be no more shocking to reward a microbiologist who hits the research jackpot than a professor of history or literature who writes a bestseller.
Safety and the State
During the early '70s, news started circulating in the scientific community that certain rDNA experiments planned, including one in Paul Berg's lab, might have unforeseen consequences for health and safety. In a move unprecedented in the history of science, a group of scientists led by Berg called for a moratorium on rDNA research.33 The self-imposed moratorium was soon followed thereafter by a conference at Asilomar, California (February 1975). There, 140 participating scientists elaborated guidelines for physical and biological containment, that is, different levels of lab security and isolation according to the type of experiment; or the use of enfeebled strains of bacteria unable to survive outside the protective lab environment.
Despite Asilomar, the safety debate continued for several years. The forces inside the scientific community calling for self- regulation were the stronger: although there is a Recombinant DNA Advisory Committee at the National Institutes of Health, it is just that - advisory. Meanwhile, alarm about accidents in the lab has subsided: the mayor of Cambridge, Mass., will not find green monsters crawling out of the sewers as he feared, and scientists making remarks like some heard on the eve of Asilomar ('We are on the threshold of a biological Hiroshima') would today be laughed out of the room.
However, this doesn't mean that there should not be a safety debate on rDNA - it means simply that it should be scaled up from the lab level to that of the manufacturing facility. In Britain, the head of a team of microbiologists in the Health and Safety Executive (a counterpart to OSHA in the US) has said, 'even in microbially low-risk processes, like the processes carried out so far, which do not involve infectious or toxic hazards, allergenic risks arising from workers' exposure to foreign proteins or poly-peptides have to be considered'. Companies that do not design their plants properly could expose employees to allergies and to far more serious auto-immune diseases. Correct design can be expensive: G. D. Searle spent £15 million on a genetic engineering pilot plant near London. 'A lot of money should be spent on redesigning filters and continuous monitoring of airborne contamination and the health of workers is essential,' says a professor at the British Centre for Applied Microbiology Research.34
So long as biotech companies remain 'research boutiques' they will probably not pose major health and safety hazards. More and more of them, however, will try to make the jump towards manufacturing in order to cash in on their research investment. They will also try to avoid government regulation (for example by the Environmental Protection Agency) and will challenge it in court. This will make the legal jungle that much thicker, and meanwhile companies may be producing biotech products unsafely. The 'biological Hiroshima', if it strikes, will be a white- collar, not a white-coat, crime.35
Playing God?
At first the ethical debate on genetic engineering was grafted on to the safety debate; today it has tended to become the province of not particularly well-briefed clerics. The manifesto authored and organized by Jeremy Rifkin (and signed by everyone from the presiding bishop of the Episcopal Church to the Rev Jerry Falwell of the Moral Majority) is, in my view, unfortunate because it is wide of the mark and likely to co-opt subsequent debate on the real issues, moral and otherwise. The resolution calls for prohibition of all human gene engineering, including that which might prevent, treat or eradicate diabetes, cancer, sickle-cell anaemia, etc.36* Rifkin says if such diseases can be cured through genetic intervention, then why not proceed to other 'disorders' which would - one gets the feeling - be defined by bodies with Hitlerian overtones. Aside from the fact that direct modification of the human genome (as opposed to diagnosis and treatment of illness caused by defective genes) is far down the road, I can only agree with David Baltimore (Director of the MIT-Whitehead joint venture) with whom I would agree on little else. He says, '[The signers of the resolution] seem happy to subject future children to torture, deformity and idiocy. What is a group of clergy doing taking that position? I can't believe they have taken into account the suffering of these people.'37
A real discussion of the moral issues involved (assuming direct prenatal genetic intervention becomes possible) would surely include the social pressures to 'engineer' one's children (first-class, blue-eyed, WASP genes if you have money; if not, no). Such a debate should also deal once and for all with the imbecile but ever-recurring theme, welcomed and refurbished by the right wing in every succeeding generation, of 'genetic (or biological) destiny' as a justification for all sorts of political and social inequalities.38
IV
With the foregoing in mind, we will now make an attempt to assess the likely effects of biotechnology on relations between States, particularly between northern industrial countries and the Third World, and on various social groups in the industrialized countries, especially the US.
The biotech industry is likely to exacerbate competition and conflict between the industrialized countries, while simultaneously promoting the 'transnationalization of capital'. The US is ahead of the game for the moment, but other nations have recognized the value of biotech as an industry which will give a new lease on life to market economies. The US advantage rests partly on the willingness of venture capitalists to take long financial shots on fledgling companies. Major banks are also setting up specific units to invest in high-tech R&D; Morgan Stanley hired two Genentech executives to manage its unit.39
Britain, France, Germany and Japan rely more on State funding than on private capital, though the latter is not absent. In Britain, for example, the Government Chemist, Dr Ronald Coleman, has established an 'Action Group' made
up of industrial researchers to monitor what Britain is and isn't doing in biotech. The group identifies priority research areas, promotes links between industry and academia and publishes a directory of biotech firms and venture capital firms willing to invest in them.40
Japan is, not surprisingly, closing the gap that temporarily separates it from the top. Between 1977 and 1981, 60 per cent of all bio-industry (not just rDNA) patents were awarded to Japanese companies. Most of the 200-0dd Japanese companies now active in biotech are established firms moving out of more traditional areas like food processing or chemicals. Private investment in biotech rose 45 per cent between 1980 and 1982, according to the Ministry of Trade and Industry. MITI also started its own biotech research programme in 1981 and will divide $128 million between 113 companies over a ten-year period.41
Biotech corporations are already outdistancing attempts by governments to keep them 'national'. Genentech and Mitsubishi have agreed, for example, to develop jointly (and eventually to market) human serum albumin which could become immensely rewarding, since the world consumes 100 million tons of it per year. State intervention cannot really stop the transnationalization process, particularly since no international legal machinery exists on which to base it.
States may, however, refuse to take corporate activity lying down. As an Under-Secretary of State in the Carter administration put it, 'We have entered an era in which the interactions between science and technology and foreign affairs are increasingly recognized as continuous and central to many of the important foreign policy problems with which we are dealing.' The OECD has likewise acknowledged the vital role of control over science in the continuing predominance of the developed countries: 'Intellectual capital - scientific resources and the aptitude for technological innovation - constitutes the major asset of industrialized nations in the new modes of international competition and interdependence.'42 Corporations are still likely to win the day, with the result that governments will be even more dependent upon, and subservient to, their interests than they are today.