Splicing Away Regulations - Down on the Animal Pharm
by Susan Wright
Twenty-five years ago, the first rather clumsy genetic engineering techniques were immediately recognized as aimed at the molecular basis of life. The human race had acquired the ability to wreak change on the "interior" as well as the "exterior" of earth's ecosystems. Doors began to open to designer bugs able to make a huge range of proteins for the pharmaceutical and chemical industries, and, further down the road, to genetic techniques capable of revolutionizing the slow-paced plant and animal breeding industries and the treatment of genetic diseases. Government, agribusiness, pharmaceutical and chemical capital has been moving through those doors ever since.
A quarter-century on, the brave new world of genetic engineering is populated by some remarkable and disturbing creations. The crassly utilitarian norms that are guiding innovations have so far produced animals to be used as factories for producing drugs; cows stuffed with bovine growth hormone; plants constructed to grow in soil drenched with herbicides that would normally kill them, as well as every other green thing in sight; bacteria that chew up materials used in weapons systems; and cross-eyed, arthritic pigs that yield more meat. What's most disturbing is that the genetic reconstruction of life is advancing on a global scale with almost no informed public discussion or effective oversight, and in the case of certain military uses, without even public knowledge.
At the outset, it was noticed that gene-splicing had a downside. Grave warnings were issued about its social misuse, about the health and environmental hazards of modified organisms, about the ethical problems of using our technical ingenuity on ourselves and other life-forms. In the course of the debates that followed, millions of pages flowed forth from committees, hearings, international bodies and the courts. And since all this happened in the heyday of the photocopying machine and the U.S. "sunshine" laws, both the controversy and the behind-the-scenes calculations by leaders of science and industry were captured in hard copy. Genetic engineering is perhaps the best-documented technology ever to emerge from a laboratory.
In the early 1970s leaders of biomedical research quickly moved to contain the emerging ethical and social issues. A partial moratorium on research in 1974 was followed by the famous international conference at Asilomar, California, where scientists addressed the hazards of genetic engineering and agreed to impose controls on their own research. These events were celebrated as acts of scientific responsibility. But they were also pre-emptive strikes, demonstrating that control of genetic engineering was best left in the hands of experts, and defining the problem as one that only experts could address --that of "containing" possible biohazards. With that definition, genetic engineers were soon back at work under voluntary controls issued by the National Institutes of Health in 1976.
When intense controversy over these controls erupted shortly after their inception, however, biomedical researchers closed ranks, launching a sophisticated campaign against legislation designed to regulate genetic engineering and investigate its long-term effects. New evidence unavailable to the public at the time of these struggles shows that researchers closeted at the N.I.H. in 1976 decided to conduct a P.R. campaign aimed at persuading the public that hazards were exaggerated.
Claiming that science was under attack, they agreed to direct public attention to the inability of bacteria used for experiments to cause epidemics -- an argument they knew was simplistic and misleading. In the words of one scientist: "In terms of P.R., you have to hit epidemics, because that is what people are afraid of, and if we can make a strong argument about epidemics and make it stick, then a lot of this public thing will go away....It's molecular politics, not molecular biology."
The same group also agreed not to pursue experiments to test worst-case scenarios. Instead, they would do a "slick New York Times type of experiment" -- one likely to produce negative results that would persuade reporters that the field was harmless.
Arguments for the safety of genetic engineering created many converts, just as commercial applications in the field began to loom on the horizon. In 1977 scientists demonstrated that bacteria could be persuaded to make a human protein. If this was possible, why not insulin, growth hormone and supercows making more milk? At this point, the president of the Pharmaceutical Manufacturers Association weighed in against regulation: "It is quite possible that legislation could be so restrictive, so much of a disincentive, that our people wouldn't lose interest...they would go overseas."
Stunned by the ferocity of the scientists' lobbying effort, soothed by the public relations campaign issuing from the N.I.H. and intimidated by the P.M.A.'s threat to move elsewhere, Congress retreated. Concern that the United States would lose out in the "genetic engineering race" became the new mantra. Rapid deregulation followed.
Now we are confronting the legacy of our failure to face the issues posed by genetic engineering. While the techniques have grown in power, precision and range of application, even the limited regulation that was put in place has been virtually dismantled. With one or two exceptions for genes encoding a few o the most dangerous toxins, pretty much any gene can be cloned in any organism. Most experiments and industrial processes involving genetic engineering are overseen only by local committees appointed by the institution doing the cloning.
Furthermore, the fundamental purpose of the original controls -- containment -- has been overturned. In the Reagan years, the N.I.H.'s prohibition on the release of genetically engineered organisms into the environment was replaced by a patchwork of existing regulatory law with plenty of loopholes. In theory, the Agriculture Department and the Environmental Protection Agency regulate releases of novel plants and microbes. In practice, these agencies have already allowed more than 2,000 experimental releases, indicating just how vigorously their "control" is exercised.
Moreover, changes in patent law are fueling aggressive efforts to monopolize novel gene combinations and the living things in which they are introduced. The landmark 1980 Supreme Court decision in Diamond v. Chakrabarty established patentability for any living thing "under the sun made by man." Over the past fifteen years, the Patent Office has taken this decision to cover cells, microbes, plants, animals -- all living things except, presumably, ourselves. But who knows? Lawyer George Annas argues that there's nothing to prevent cloning enthusiasts from pursuing patents for genetically modified human embryos.
The once-unthinkable idea that a microbe, a plant variety or an animal breed could be owned has become accepted practice under the patent law of many industrialized countries. During the recent GATT negotiations, the United States pressed hard for similar practices in the Third World. All genes are now seen as keys to new products. Not only the gene-rich ecosystems of Third World countries but also the cells and genes of indigenous peoples are now envisioned as lucrative targets. In the rush to stake claims on cell-lines and DNA samples, companies and scientists are committing what the Rural Advancement Fund International calls "acts of biopiracy," violating the rights of the people and countries from which the samples are taken. RAFI has launched a campaign to take the issue to the International Court of Justice at the Hague.
A host of transgenic creatures is emerging from genetic engineering laboratories. Typically, these creatures are portrayed as benign additions to the natural world, bringing "better, healthier lives to people," as Amgen regularly tells the listeners of National Public Radio. Few of biotechnology's critics would deny that the field will yield some useful products; Eli Lilly's human insulin and Merck's hepatitis B vaccine already help millions of people. Crops that can grow in the desert or resist major pests, and vaccines for diseases like AIDS and malaria, would be beneficial. Nevertheless, many of the applications prominent on corporate and military agendas pose explosive social, ethical and environmental problems. The following is a small sample:
Agrichemical and seed corporations are well on the way to developing a wide range of transgenic crops and biopesticides. The most visible are those that will reach supermarkets. Calgene's Flavr Savr tomato, which can sit on store shelves for extended periods without turning into mush, made headlines in 1994. But the most lucrative products are emerging with much less fanfare. Over the past decade, corporations and the government have poured millions into developing plants and trees that tolerate the toxic effects of herbicides. According to the Union of Concerned Scientists, the Agriculture Department has received hundreds of applications for field trials of these crops. Two of them -- a cotton resistant to bromoxynil and soybeans resistant to Monsanto's herbicide glyphosate, better known as Roundup -- have already been approved. The E.P.A. must also approve any new use of a herbicide. Last year the agency cleared the way for full-scale commercialization by approving the sale of bromoxynil for a quarter-million acres of bromoxynil-resistant cotton. In the pipeline at the Agriculture Department are measures that will weaken the agency's oversight of trials of transgenic plants and expedite full-scale approvals.
The agrichemical industry claims that engineering herbicide tolerance will encourage the use of a new generation of "environmentally friendly" herbicides. The Biotechnology Working Group, a coalition of environmental, labor and other organizations, says there's no such thing: Herbicides have toxic effects on plants and animals; the more they are used, the greater the likelihood of producing herbicide-resistant weeds, contamination of water supplies and destruction of wildlife habitats. While producers claim that their present efforts are limited to resistance to less toxic herbicides, there is no guarantee they will accept this limitation in the future. Indeed, many research and development efforts have focused on crop resistance to high-toxicity herbicides such as 2,4 D and atrazine.
Environmentalists cite yet other worrisome scenarios for transgenic plants; the truth is, no one is able to predict what might happen in the long run. But if the past behavior of the National Institutes of Health is any guide, the Agriculture Department's risk-assessment program is unlikely to investigate worst-case scenarios or wait years for results before granting approval.
Meanwhile, back at the barn, bio-engineers are turning animals into factories to make drugs in their milk or blood. They're also making pigs and chickens with flesh that can be easily microwaved and bovine growth hormone (BGH) to increase milk production in dairy cows. The latter product has proved particularly controversial. Consumer organizations in the United States an elsewhere argue that injections of the hormone cause health problems in cattle, thereby increasing the use of antibiotics and in turn leaving antibiotic residues in milk. They also point to the risks of increasing the presence in milk of insulin growth factor, which stunts growth. And it's not as if there is a pressing need for milk. Michael Harness of the Consumers Union points out that, because of the existing milk surplus, taxpayers have spent billions of dollars over the past decade keeping milk off the market. One may well ask, Who needs bovine growth hormone? The answer seems to be the four leading corporations -- American Cyanamid, Eli Lilly, Monsanto and Upjohn -- that are promoting BGH worldwide.
Genetically altered humans.
Applying genetic engineering to human s faces major technical hurdles. "Humans are not simply large mice," a recent scientific review states, and the introduction of novel genes to correct for genetic diseases or cancer is no simple mechanical matter. The human body tends to reject anything foreign, like a virus carrying a corrective gene into a diseased cell. Nevertheless, corporations are aggressively promoting human gene therapy even though no genetic cures are yet in sight. Researchers are moving quickly to clinical trials, 62 percent of which are funded by the private sector. The inserted gene, the protein it encodes and the drugs that make the gene function are all seen as likely commercial prospects. "Three for the price of one," was the way an editor of an industry newsletter recently acclaimed the approach.
So far, experimental human gene treatments have been limited to treating life-threatening diseases. They have also been confined to altering somatic cells, as opposed to the sex, or germ-line, cells that pass on altered genes to future generations. But expansion of these horizons is already foreseen. In 1994, the successful replacement of sperm-forming cells of a mouse with similar cells from another mouse at the University of Pennsylvania was hailed as potentially capable of "shaping future generations." Researchers already talk of treating non-life-threatening conditions like dwarfism or infertility.
We are approaching the time, perhaps ten or twenty years away, when gene alteration will be offered as a service. On whom should it be used? For what purposes? Where should the lines for human genetic interventions be drawn? No committee outside the N.I.H. has been established to address these questions. The research-dominated N.I.H., judging from its history, will insure that the boundaries change in tandem with researchers' shifting goals. But with so many of those doing research directly in the pay of the drug companies, who will insure that human needs, not profits, are foremost in the minds of those who decide priorities for human gene alteration?
After maintaining a low profile for use of the biological sciences throughout the turbulent 1970s, the Defense Department quietly initiated military applications of biotechnology in the 1980s. Citing a menacing Soviet biological warfare threat, the department embarked on efforts to use the new biotechnology to make therapeutic agents, detection devices and vaccines to protect against biological weapons.
Vaccines might sound like a viable form of protection, but in practice they present huge problems. There are about thirty known biological weapons agents, and genetic engineering may expand that number almost indefinitely. The long latency period between vaccination and the body's immune response and the logistical problems of manufacturing and deploying vaccines pose further obstacles. Undaunted by the prospect of multiple injections for U.S. soldiers in war zones and the risks such procedures carry [see Laura =46landers, "Mal de Guerre," March 7, 1994], the Pentagon aimed vaccines against more than forty different microbes.
More recently, the military has launched scarier schemes for biotechnology. On the one hand, "anti-materiel" bacteria are being investigated for their capacity to degrade militarily significant substances like rubber, engine lubricants and other critical components of weapons systems. On the other, novel, opiumlike substances whose minute presence induces sleep, euphoria, anxiety, submissiveness or temporary blindness are being pursued for their potential as incapacitants. Genetic engineering offers ways to refine both applications.
In principle, the Biological Weapons Convention and the Chemical Weapons Convention prohibit recourse to the use of such technologies. The biological treaty bans development, production and stockpiling of microbes and toxins made by living things for any weapons purpose. Pursuit of "anti-materiel" bacteria should therefore be taken as a violation. The Chemical Weapons Convention, however, allows development of "riot control agents" for "law enforcement." It is apparently through this loophole that the Pentagon is pursuing work on novel incapacitants. This year, Congress approved $36 million for a new, largely secret "non-lethal" weapons program.
The cornucopia of prizes from genetic engineering projected in the optimistic 1970s is rapidly becoming a mare's-nest of transgenic creations that we neither need nor want. Can we reverse genetically engineered evolution? Not easily, and not without an educated and active public. But there are models for alternative responses. In pre-Thatcher Britain, a broadly composed committee that advised the government on genetic engineering policy moved much more cautiously than its U.S. counterpart, involving unions in policy-making at the local and national levels. In India, a well-informed public debate addressing the social impact of monopolizing life-forms continues. Despite their weaknesses, the treaties bannin biological and chemical weapons show that harmful technology can be curbed when people all over the world press for restraints.
It's time for another Asilomar conference, this time led by those at the receiving end of genetic technology, to take a long look at the genetically reconstructed worlds being designed by corporations and the military. Or must we wait for a genetic Chernobyl?
Susan Wright, a historian of science, teaches at the University of Michigan. She is the author of Molecular Politics (University of Chicago Press) and co-author of Preventing a Biological Arms Race (M.I.T. Press). A recent recipient of a MacArthur Foundation fellowship, her current research focuses on North-South differences over the development and implementation of the Biological Weapons Convention.
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