Corpus delicti
It is easy to let all the effects of biotechnology--all the ways in which we can win and lose--be subsumed in the category "economy." Indeed, some would argue that it is the fundamental social category. It certainly is the context in which biotechnology has evolved. Still, as I recommended in the first chapter of this study, we should consider questions outside a rigid economic framework, in order to arrive at concrete answers to the question of who the winners and losers will be. I will start with the intimately related issues of health and the environment.
In the short term, as a result of modern biotechnology, there will almost certainly be some winners in the area of health. Medical biotechnology has made enormous advances in the last 10 to 15 years in understanding and treating the genetic and biochemical components of acute and chronic diseases. Daily, researchers and "biotechnicians" make advances in slowing the progress of AIDS and various forms of cancer. Furthermore, certain conditions are undoubtedly congenital and can be treated most directly and effectively through biotechnology. They include phenylketonuria, Parkinsonism, cystic fibrosis, sickle-cell anemia, and some types of diabetes. One of medical biotechnology's outstanding achievements is the production of human insulin for the treatment of diabetes, through cell lines of Escherichia coli bacteria. Strains of bacteria and viruses associated with certain diseases have been genetically engineered to produce appropriate anti-bodies, while supposedly not expressing their virulent properties (Fincham and Ravetz 1991). Lastly, "gene therapy" is touted as one of biotechnology's great gifts to humanity. Its premise is that once the "missing" or "defective" genes responsible for a disease are identified, biochemicals synthesized in the laboratory by the "good" genes can be administered to patients, or the genetic material itself can be introduced into their cells (Carey 1994; Fincham and Ravetz 1991; Newman 1989).
Modern medicine tends to be a field of urgency. We cannot be expected to wait for a drug slowly to be refined, as we would wait for a wine to age, as a disease ravages society or our bodies. With this attitude in mind, biotechnology holds the promise of accelerated product development through an efficient, reductionistic identification of disease-causing agents (OTA 1991). For example, the chemistry of specific genes, such as the production of a certain hormone, are studied, in order to reproduce them in the laboratory. Reductionism taken to extremes, regards every active gene as causing a specific effect, just as it regards every human body as responding to treatment in exactly the same way.
With so many promises, who or what could be the losers in development of medical biotechnology? We can begin with failures and the money spent on them.
Part of the dive in the biotechnology stock market in 1991 was attributed to the failure of genetically engineered drugs. Five companies poured hundreds of millions of dollars into into developing drugs to combat sepsis, a deadly type of blood poisoning, which can threaten patients undergoing surgery. All their efforts failed. Sepsis turns out to be a complex syndrome which cannot be treated easily with one drug. One of these companies, Centocor, produced an antisepsis drug that itself had lethal side-effects (Hamilton 1994).
To the mind of most geneticists, gene therapy is still largely speculative, and many of its experiments have failed. Still, millions of dollars are pumped into its R&D, and it receives much publicity, most of it positive. Not long ago a front-page article in the Washington Post announced the first "success" of gene therapy: Two young girls suffering from a rare immune-system disorder, adenosine deaminase deficiency, who had survived five years of treatment. However, its author qualifies the celebration by adding, deep in the article, "Enthusiasm is somewhat tempered, however, because it remains unclear how much of the girls' improvement can be attributed to their new genes and how much is due to a new drug they also have been taking" (Weiss 1995b: A1).
Some of the failures stem from a technical lack of accounting for two classes of phenomena well known to geneticists: pleiotropy and epistasis. Pleiotropy means that no unique correspondence exists between a gene and its expression; one gene can have an effect on multiple traits. Epistasis refers to one gene modifying another's expression (Rissler and Mellon 1993, 1996).
A considerable amount of public and private money and material are diverted to the R&D and application of medical biotechnology. The NIH allots a large portion of its budget for sponsoring research in biotechnology and its sister field virology (OTA 1991). The resources that are spent on medical biotechnology are taken away from other approaches. For example, such alternative therapy for AIDS as dietary regimen, herbal medicine, and physical therapy all are losing funding and public support, because of the virological reductionism advanced by industry and the government in explaining its cause. All this despite a number of serious, troubling questions about the number and kind of factors involved in the syndrome's manifestation and transmission. (See Eisenberg et al. 1993.)
As biotechnological drugs and gene therapy are promoted as the ultimate cure to our ills, preventive medicine loses ground. Take, for instance, the widely publicized research into the link between breast cancer and genes. In October of 1996, Myriad Genetics, Inc., declared that it had discovered two mutant genes responsible for breast and ovary cancer: BCRA1 and BCRA2. It further announced that it had invented a test for detecting these genes in blood samples. By the company's own estimates, these genes account for only five to ten percent of these cancers. The test, conducted only by Myriad Genetics technicians, costs $2,400. A financial analyst in Boston estimates the potential market for the test at $400 million to $500 million. Critics have voiced concerns not only about the extraordinary profits to be made from the test, but also about the possibility of job or insurance discrimination against persons found to be carrying the genes. They are also concerned about the lack of research being done to find the underlying causes, including environmental factors, of the remaining 90 to 95 percent of cases of breast and ovary cancer. They are also quick to recognize that a profit cannot be secured from eradicating the causes of disease (MBCC 1996; Saltus 1996).
Holistic medicine, which attempts to take into account as many factors as possible in the origin and course of a disease, also is discouraged, as dogmatically reductionist medicine tied to biotechnology develops. Although "holistic medicine" sounds like "new age" jargon to many, two classic areas of Western medicine, epidemiology and medical geography, fit the description. These fields too have been neglected. It is curious to me that there is a popular notion that early modern medicine was crude and rather haphazard, while a careful study of it reveals that it was very attentive to a diverse of potential environmental factors, its obvious mistakes and misunderstandings notwithstanding. We should be more critical before applauding ourselves for our progress.
Patients themselves will often bear to final costs of genetic reductionism and the industry it serves. The connection between modern medicine and the pharmaceutical industry is well established. Doctors are known to spend much of their time promoting new drugs and testing them on patients. This is especially true in hospitals. Some treatments may be successful; others may have harmful side-effects. There is no reason to believe this state of affairs is going to change with the pharmaceutical industry acquiring more biotechnology. In the U.S., since the Supreme Court ruled in Moore v. the Regents of the University of California that patients have no "property right" to their bodily tissues, reason exists to believe that it will intensify (Kimbrell 1993).
To the extent that the advancement of medical biotechnology reduces the number of our medical options, we all lose.
Risks in the environment
Genetically engineered biochemicals have been released into the environment, and will continue to be released for the foreseeable future.
Let us begin with "enhancement" chemicals, which are deliberately administered to animals. Bovine somatotropin (BST), also called bovine growth hormone, is one of the best known. It is a hormone synthesized with components of genetically engineered E. coli bacteria. Cows to which it is administered produce 15% more milk on the average than cows without BST treatment. (This has familiar economic implications: production costs should fall for farmers using BST, eventually driving farmers who do not use it out of the market.) Its producer, Monsanto, points out that BST "is produced naturally" in cows, and it insists that the genetically engineered version is essentially the same proteinic hormone. However, concerns about the risks to human health of BST-milk focus on, inter alia, its content of fatty acids with longer chain-lengths than those of natural milk and the possible incorporation of stray amino acids in the engineered hormone, with consequences for the endocrine system. Among cows, the use of BST is linked to reduced fertility, decreased endocrine function, disturbances in bone growth, and increased incidence of mastitis, among other ill effects. Long-term effects on humans and other animals are yet unknown (Lacey and Heritage 1994). There are numerous other uncertainties involved in genetically engineering biochemicals, such as the effect on health of the widespread splicing of a gene from the Bacillus thuringiensis (Bt) bacterium into various crop plants, which causes them to secrete an insecticide toxin (Anonymous n.d.; Juma 1989; Rissler and Mellon 1993).
At least one genetically engineered biochemical, L-tryptophan, has been shown positively to have deleterious effects. L-tryptophan is an amino acid found naturally in meat, dairy products, and grains. The genetically engineered version, made by fermentation using certain bacteria cultured in glucose and anthranilic acid, is not perfectly identical to its natural prototype. The synthetic product is used as a nutritional supplement in foods. Between 1989 and 1992, over 1,500 cases of persons in the U.S. and other countries contracting eosinophilia, a blood disease, 38 of which resulted in death, were positively correlated to the ingestion of synthetic L-tryptophan. The product had been banned by the U.S. FDA in 1990 (Talman and Puckey 1993).
An experiment in biotechnological nutritional enhancement has demonstrated the possible dangers to human health of genetic pleiotropy. Researchers at the University of Nebraska recently published their discovery that a high-protein albumin expressed in Brazil nuts causes an allergic reaction, like one associated with Brazil nuts, when the albumin is genetically reproduced in soy beans (Nordlee et al. 1996). Even if all the hypothetical direct risks to human health prove to be unfounded--and the real ones are found trivial--there will remain the toll on health taken by economic and social disintegration, like that described in the last chapter. Malnutrition, starvation, and epidemic disease bode of the coming age.
Risks to ecosystems
Probably more has been written about the risks biotechnology poses to ecosystems than on any other non-technical aspect of biotechnology. Rissler and Mellon (1996) offer the best overview. I will try not to repeat too much of what they have detailed. Risks to ecosystems are, of course, eventually risks to human health--and health is something that none of us wants to lose. Importantly, ecosystems also comprise agricultural land.
Genetically engineered organisms pose the greatest risks to ecosystems, since they can become dynamic living parts of them. The major application of agricultural biotechnology is the creation of crop plants which are tolerant to specific herbicides. In the United States, herbicide-tolerant crops account for about 40% of all biotechnology field tests, and in the industrialized world they account for about 57% (Rissler and Mellon 1996). For example, Calgene created a variety of cotton engineered to resist the effects of Rhône-Poulenc's Bromoxynil. Bromoxynil has been shown to cause birth defects in animals and has been categorized as toxic to human physical growth and development (Rissler and Mellon 1993). Another example, already mentioned in the previous section, is Monsanto's Roundup Ready line of crop plants. Monsanto's arguments that such crops will cut down on wasteful and possible harmful use of their herbicide do not preclude the possibility of an expanded and secured market for Roundup, which would increase its overall use. Monsanto maintains that Roundup is not harmful to human health if applied properly, and that it does not linger in the environment. Nevertheless, the long-term effects of prolonged exposure to concentrations of the herbicide are unknown.
A great number of crop plants are being engineered for the capacity to persist in marginal environments and to propagate quickly. Both these traits confer to plants the potential to become noxious weeds, overrunning human and nonhuman ecosystems, displacing and killing plants and animals, upsetting the food chain, and permanently altering habitats. Furthermore, there is the risk that these "weedy" characteristics could be passed on to wild relatives of crop plants by gene "introgression": the flow of genes from one plant species to another, mainly through cross-pollination (Rissler and Mellon 1996). This could have devastating consequences, considering that some of the weeds most pernicious to agriculture worldwide are species of the oat, barley, potato, mustard, carrot, and sorghum genera (Juma 1989). Invasive and persistent natural alien species in the U.S., such as kudzu and the paper bark tree, cost the tens of millions of dollars in control measures (Rissler and Mellon 1996).
Some crop plants have been engineered with viral-coat protein genes as mechanisms of resistance to viruses. The viral genes inserted into these plants could give rise to new viruses, through natural genetic recombination and other molecular biological processes already observed in genetically engineered plants. New viral pathogens could have an enormous impact on economically important crops, requiring considerable control costs (Rissler and Mellon 1996).
The use of genetically engineered Bt crop plants, mentioned above, may increase the resistance of insect pests to the insecticide. If the Bt gene is spliced into a number of different plants, chance of widespread resistance is multiplied (Rissler and Mellon 1996). Dow-Elanco, Ciba-Geigy, Monsanto, and Zeneca are among companies researching and developing a range of Bt crop plants, including maize and cotton. (Anonymous n.d.). Widespread resistance would have a detrimental impact on organic and low-input farming, which rely on the Bt toxin in its naturally occurring bacterial form (Rissler and Mellon 1996). Monsanto's Bt-engineered "Bollgard" cotton was grown on nearly two million acres of U.S. farmland in 1996. Insect pests made major inroads against this crop, leading many to doubt the efficacy of genetically engineered "bio-pesticides" (Fox 1996a).
Of great concern also is the way in which genetically engineered crops--like their Green Revolution predecessors--are being designed solely for high marketable yield (grain, fruit, oil, etc.), which requires heavy doses chemical fertilizers and commensurate excessive use of water, ultimately resulting in contaminated and degraded soils and water shortages. (See Shiva 1991 for an overview.) In addition, since genetically engineered crop plants, like conventional hybrids, are designed to yield a uniform product--a commodity of known value--their promotion will aggravate the already accelerating worldwide "genetic erosion," by which traditional cultivated varieties, with greater genetic diversity and potentially desirable traits, are displaced and eradicated (Rissler and Mellon 1996).
All these ecological risks are felt most poignantly in centers of crop diversity--regions in which the greatest genetic and specific diversity of crop plants exists, in the form of wild relatives and cultivated varieties. Although the major crop plants of the U.S. have centers of diversity in other countries, the U.S. is still the center of diversity of such significant crops as cranberries, sunflowers, pecans, black walnuts, and muscadine grapes, among others (Juma 1989; Rissler and Mellon 1996).
Plants are not the only organisms that might threaten ecosystems. Genetically engineered microorganisms (GEMs) are being developed for increased frost resistance in plants, enhanced nitrogen fixation, and bio-remediation (Juma 1989). The genetically engineered bacterium Klebsiella planticola has been used for R&D in the last of these areas. When this GEM was tested in complex soil microcosms (self-contained units with field conditions, incubated in growth chambers), it killed wheat planted in the units. Microcosms containing the "parent" bacterium and experimental controls with no added bacteria had no noticeable effect on wheat. The engineered K. planticola was tested under several different environmental conditions, and the mechanism by which the wheat was killed or negatively affected differed from case to case. Furthermore, a variety of K. planticola engineered to turn crop waste into ethanol was found to have an unexpected side-effect: The GEM cut in half the amounts of mycorrhizal fungi in the soil, crucial for nitrogen fixation. If such a GEM survived readily and spread widely, it could entail expensive control measures (Holmes and Ingham 1994).
"Higher" animals are also being engineered for various purposes. They include insects, mice, and fish. The genetic engineering of fish, in particular, raises serious ecological issues. Although people around the world have practiced aquiculture on a small scale for centuries, fish remain relatively undomesticated. Unlike cows and other livestock, they can survive and breed in nature. They are also capable of traveling far and invading new ecosystems. Since fish inevitably escape from ponds and sea pens, genetically engineered varieties could multiply and out-compete endemic species. Genetic engineering of fish is moving ahead rapidly; some companies hope to begin selling fast-growing salmon to fish farmers in a few years (Anonymous 1995). Meanwhile, there is no comprehensive regulation in the U.S. governing genetically engineered animals--not even the requirement to notify the public of releases (Kapuscinski and Hallerman 1990; Mellon, pers. comm.).
Transboundary movement of the products of biotechnology is also a profound concern. Not only will genetically engineered compounds and organisms be transported deliberately across international borders in the course of trade, but engineered, self-propagating organisms will spread wherever the ecological conditions are suitable. It should be needless to say that natural phenomena do not respect social categories. Therefore, it is worrisome that currently no comprehensive, legally binding international regulation of the unique products of modern biotechnology exists. Attempts to establish such, as a protocol to the CBD, have been frustrated by the governments of industrialized countries and their supporters in the biotechnology industry. This ranks among the major political setbacks in countering the furious growth of the biotechnology industry.