October 1, 2011 (Vol. 31, No. 17)

Usher Fleising, Ph.D.

Looking at the Birth and Development of the Industry from an Anthropological Perspective

On March 9, 1981, Time ran a cover story, “Shaping Life in the Lab,” about the investment frenzy over the high technology of genetic manipulation and its prospects for future growth. Stock offerings for one company jumped from $35 a share to $89 in minutes.

Funds were being diverted into small companies with no products but with expertise and know-how in gene splicing. This fresh alchemy promised revolutionary drugs for healing, a new green revolution for feeding the hungry, and environmentally safe processes for mining, refining, and removing toxic waste. Just two months prior to the cover story, Mary Ann Liebert launched Genetic Engineering News.

There were, however, questions about the wisdom of tinkering with genes. Time quoted biologist Robert Sinsheimer, then Chancellor of the University of California at Santa Cruz: “Do we really wish to replace the fateful but impartial workings of chance with the purposeful self-interested workings of human will?”


Usher Fleising, Ph.D.

But the overwhelming sense in this story was that of an industry in its early stages of growth, a genie already out of the bottle, and of a society that would manage the benefits and the risks of this next technological adventure.

Biotechnology stories are dramas of social living. The narratives are about scientists manipulating the building blocks of life, venture capitalists showering them with money, and self-proclaimed public guardians of risk warning of contagion from things that you cannot see. Victor Turner, an ethnographer, suggested that disruptive social processes wherever they occur (e.g., a labor strike or Watergate) can be described as a social drama in four acts: breach, crisis, redress, and reintegration (or schism).


Some cultural observers maintain that from the beginning, biotech activities can be seen as a kind of play taking place within a theater of emotions where the acts include breach, crisis, redress, and re-integration. [Paul Fleet/fotolia]

Breach

The beginning of social drama is breach—when a person or subgroup breaks a rule, norm, law, or custom either deliberately or by inward compulsion (as, for example, in pursuing scientific research). While many people stumbled into biotechnology, there was a core in the middle 1970s that deliberately, and with determination, went about turning the intellectual property of Nobel Prize research into marketable commodities. Between 1960 and 1972, 14 of 31 Nobel awards in physiology or medicine were awarded to classical genetics and molecular biology.

Intellectual investment in molecular medicine led to the disruptive recombinant DNA technology and, for some, a crisis of technological and moral risk.

Recombinant DNA technology, developed in 1973, gave molecular scientists the ability to join together pieces of genetic material from different species creating chimera and fashioning the conditions for sequencing the human genome. That this breach was consequential became public when molecular scientists in a fit of self-reflection placed a voluntary moratorium on recombinant DNA research in 1974.

On the economic front, declining public funding support for universities and demands from the public for payback from earlier investments in scientific research led to schemes to strategically ally industries with universities to make money for both. In 1980, 80% of the $1 billion spent on biotechnology research (worldwide) came from academic sources. By 1986, industry accounted for 67% of the $6 billion spent on biotechnology research.

According to one industry analyst, this was the moment when “disease became a market opportunity,” a metaphor not infrequently repeated at biofinance conferences. Individuals trained in public labs, with thoughts of university positions to follow, found themselves thinking about how their experiments would look in the next quarterly business report.

Crisis

The ethos that disease could be publicly proclaimed a market opportunity was anathema to those who championed the ideology that government, not the private sector, is ultimately responsible for the health of the nation. It initiated crises in universities, pharmaceutical organizations, and in the theatre for public assessment of technology. The culture of the university at first resisted the intrusion of private money into molecular research, and the very notion of a technology transfer office challenged the ideals of university-based science.

For pharmaceutical organizations, the patent-protected medicine cupboard was emptying and they looked to the biotechs for a fix. Not many understood how to integrate the new paradigm for making medicine into their team’s consciousness.

In the public domain, fears of contagion required attention as public distrust of science escalated from the nuclear scares of Three Mile Island and Chernobyl, and the toxic sludge of Love Canal unmasked the hubris of better living through chemistry.

In crisis, identities are formed as alliances are sought, positions are established, and ambitions are declared. Much of this is on display in cultural performances—trade shows, road shows, the traveling “beauty pageants” of influential scientists and investment bankers, speeches by leaders, names, logos, and marketing images.

The performance part of crisis is revealed, for example, in appeals to biblical and mythological images and in the rhetoric of science and industry “stars.” Perhaps the most repeatedly quoted mythical reference to the power of biogenetic engineering was Nobel laureate Walter Gilbert’s comment reported in Science that, “The total human sequence is the grail of human genetics.”

Ron Cape, the founder of Cetus, captured for his audiences the simultaneity of the sacred and the profane when he regularly introduced biotechnology as a conflation of “genetics, genesis, genitals, and money!” This unnatural arrangement is a rhetorical aphorism, a terse truth bringing together what sentiment might wish to keep apart. Science harnessed DNA (the master transformer), and business declared its ambition to deliver salvation from disease and suffering.

Scientific journals and magazines commonly displayed on their covers chimera and mythic-like images for their narratives of biotechnology. Biotech firms adopted New Age names such as Millennium, Shaman, Isis, and Sphinx. Sequana is named after a Celtic Goddess. A landscape of magic and fantasy became part of the performance ritual for presenting biotechnology to the public. Even as biotech founders were wringing their hands over how their public image would suffer from the release of “Jurassic Park,” biotech suppliers added carnivorous dinosaurs and Frankenstein golems to the cows, sheep, and mice used in biotechnology advertising. Why? Monsters and medicine have a long history of association.

Babylonian chimerical monsters of disease look like the angry dinosaurs mentioned earlier. Cross-culturally and throughout time there is a moral ambivalence that pervades the relationship between healer and patient. Deeply rooted cultural-emotional baggage is called out for contemporary reference.

Fusing the mysteries of religion and mythology with the mysteries of science is to plead for special status because the “gods” can provide extraordinary gifts. The language and images are ideological markers crafted by those elite who draw upon heritage and tradition to turn the extraordinary into the ordinary.

The investment response to biotechnology was not surprising since the only sector that kept growing while everything else rusted in the 1980s was the pharmaceutical business. Pharmaceuticals were recession proof. The venture capital financial subculture and its offspring, computer millionaires, became angels to aspiring drug companies. They delivered cash, prestige, and legitimacy to their molecular biology friends and relatives. Networks are short among the knowledge class.

Redress

For many, the stuff promised by technology was (is) scary or just plain yucky (such as pigs that bleed human blood and xenotransplantation). There are people for and people against and they argue with passion and the passion is on display in courts of law, the regulatory theatre, and in the conference halls and on the streets outside the biotech trade shows. Social drama is agonistic and requires cultural resources in the form of rituals for reconciliation to initiate redress.

Redress in the form of administrative and property law, and environmental and health regulatory oversight, was mustard for action against the crisis of engineering with biology. A potent example is the case of property law. Is it permissible to patent and thereby own a living organism?

Given the history of the United States as regards slavery and the ownership of persons, how would the courts rule? The Supreme Court of the United States in 1980 rejected the notion that living matter is per se not patentable. Eventually, patents were even granted for mice guaranteed to get cancer.

Rendering ordinary the products of biotechnology can only come after the ritual process—clinical trials and/or environmental assessments. The granting of licenses, the issuing of patents, and the blessing of property rights rebalances the social order.

When boundaries are crossed, the crossing is hedged about with ritual. The boundaries in the case of regulating the products of biotechnology are boundaries of commoditization. In order to secure a license to sell, or to claim property rights, there is a “time-out” procedure of assessment, and a state of liminality according to anthropologists, when ambiguity reigns and anxiety mounts.

To protect the public from potential bodily harm—from illness, teratogenesis, or death—the FDA, or the EPA, rule on the trade-off between the benefit and risk of approving (or not) the marketing of drugs, or engineered plants and animals.

Redress also has an organizational dimension. The new biotechnology, in directly challenging traditional methods for drug discovery, had consequences for how groups were organized. Within the pharmaceutical sector a shift in technical and organizational efforts toward adoption of biotechnology had implications for the survival of the firm.

Studies have confirmed that major and radical organizational change was a way that pharmaceutical companies survived the arrival of the new biotechnologies. The greatest impact appears to have been in the area of drug discovery, which, of course, provides the raw material for the other functions of the firm—clinical testing, obtaining regulatory approval, manufacturing, and marketing.

Re-Integration

Thus, biotechnology carved two sets of reforms to ethical norms out of the American constitution: one expanded the domain of property protection to living organisms, and a second edited the norms for industry-university relationships. Universities opened technology transfer divisions and established bureaucracies for transforming intellectual capital to money. Tax credit regimes were reformed to encourage the transfer of knowledge to the private sector.

A third set of ethical norms involved matters of risk. Recombinant technology was declared safe, and guidelines were established for release of genetically modified organisms for gene therapy and many other procedures.

The breach of shaping life in the lab begat the crisis of how to manage the fear and the hope of the new alchemy, which demanded redress in government institutions and the organizations of capital to tame the monster.

Usher Fleising, Ph.D. ([email protected]), is a professor emeritus, anthropology, at the University of Calgary.

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