When Worlds Collide: Science, Politics, and Biotechnology

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"Although everybody with a political agenda routinely professes great respect for the wisdom of the American people, the actual behaviors reveal not respect but thinly veiled contempt."

W. T. Anderson, Reality Isn't What It Used to Be: Theatrical Politics, Ready-to-Wear Religion, Global Myths, Primitive Chic, and Other Wonders of the Postmodern World (New York: Harper & Row, 1993)
In the imposing main building of my alma mater, the Massachusetts Institute of Technology, stands a frieze honoring the immortals of science: Archimedes, Newton, and Pasteur, among others. It reminds those who enter that science and its practitioners can profoundly change the world and our understanding of it.

Somewhere perhaps in a dark, dank M.I.T. basement there should be a monument dedicated to those who have impeded science: a troglodyte frieze. It would immortalize, for example, the persecutors of Galileo and the advocates of Lysenko. And those of us who have served as midwives to the birth of the new biotechnology could add some contemporary figures: zealots who push for governmental overregulation in the name of consumer or environmental protection, and sophists who spark fear in the hearts of the naive with chilling predictions of "Andromeda Strains" and dysphemisms like "eugenics" and "Frankenfood."

I have been wrong consistently about the durability of the debate over whether the use of the new biotechnology that is, recombinant DNA (gene-splicing) techniques confers incremental risk that calls for extraordinary regulatory requirements. In the early 1980s I thought that a proposal by eminent molecular biologists David Baltimore and Allan Campbell a proposal to make the recombinant DNA (rDNA) guidelines of the National Institutes of Health (NIH) voluntary rather than compulsory would put the debate to rest. Baltimore and Campbell were members of the NIH Recombinant DNA Advisory Committee (RAC). The main premise of the NIH guidelines that rDNA techniques are somehow different from all other methods of genetic manipulation in terms of risk is incorrect. NIH acceptance of Baltimore and Campbell's proposal would have been at least a tacit acknowledgment of this.

As had been the case with the NIH recombinant-DNA guidelines, ill-conceived policy efforts by other agencies were abetted by agency officials, academic scientists, and company executives, all apparently seeking public approval of a nebulous sort.

What Price Vanity?

As the Food and Drug Administration's representative on the RAC, I supported the Baltimore-Campbell reform effort. Although the majority of the RAC members agreed that rDNA methods and products did not warrant precautions different from those applied to standard laboratory practices (guidelines for laboratory handling even of the most virulent bacterial and viral pathogens were, and continue to be, voluntary), they rejected Baltimore and Campbell's proposal. The same committee members stated emphatically that adoption of the proposal would diminish the role of the RAC unacceptably. They argued that RAC meetings had an important public-relations function and provided a prestigious biotech forum in which anyone could participate. In part, their position may have stemmed from collective angst over an earlier scientific generation's Manhattan Project, from the consciousness-raising of the 1960s, and from professional vanity. Who wants to discard as superfluous something that lends distinction to oneself?

Alas, vanity has its price. The RAC's retention of compulsory rDNA guidelines seemed a signal that the risks of the new genetic methods worried the NIH and the scientific community.

I was slow to learn. I believed that further scientific scrutiny would settle the debate over whether biotech risk results primarily from (a) the technique used or (b) the characteristics of what the technique generates. I was mistaken.

Based on empirical data and extrapolation from general scientific principles, the scientific consensus on the nature of biotech risk has long been unequivocal. The consensus holds that biotech risk is primarily a function of the characteristics of a product whether the product is a recombinant organism to be field-tested or a purified derivative and that the risk is not a function of the genetic-modification method itself. This consensus has been put forth by many national and international groups, repeatedly and in remarkably congruent terms.

The U.S. National Academy of Sciences (NAS) conveyed the biotech consensus definitively, concluding in a 1987 white paper: "[A]ssessment of the risks of introducing R-DNA-engineered organisms into the environment should be based on the nature of the organism and the environment into which the organism is introduced, and not on the method by which it was produced."

Scientific Consensus Rejected

The NAS white paper quoted above went largely unheeded. The U.S. Environmental Protection Agency (EPA) and the U.S. Department of Agriculture (USDA) continued to roll out scientifically indefensible regulatory schemes that took to new heights federal agencies' averseness to novelty and risk (however negligible).

As had been the case with the NIH recombinant-DNA guidelines, ill-conceived policy efforts by other agencies were abetted by agency officials, academic scientists, and company executives, all apparently seeking public approval of a nebulous sort. Of course, by giving such encouragement, these individuals created a pretense of civic-mindedness for themselves and their institutions. This is the moral equivalent of basking in the glory of giving someone else's money to charity.

Regressive EPA and USDA policy decisions reverberated through the 1980s like a Chinese firecracker exploding in slow motion. Bureaucrats eager to expand their regulatory domains, companies desperate to calm jittery investors (or regarding regulation as a market-entry barrier to competitors), and academic scientists eager for public support constituted the gunpowder. Media dissemination of the alarmist claims of antibiotech groups lit the fuse.

Prominent opponents of the new biotechnology are not quixotic ideologues but well-financed specialists pursuing single-issue activism.

The tolerance accorded to the activists and their apocalyptic forecasts has surprised me. Many quarters have given considerable credence to the views of professional propagandists like the Union of Concerned Scientists' Margaret Mellon, the Environmental Defense Fund's Rebecca Goldburg, and the Foundation on Economic Trends' Jeremy Rifkin. To my astonishment, in the 1980s, after the release of the NAS white paper, the agitators' protest was met with yet another major study of the risks of the new biotechnology a half-million-dollar undertaking by the National Research Council (NRC), the research arm of the NAS.

The resulting NRC report, published in 1989, wholly confirmed the conclusions and recommendations of the earlier NAS report. This did not surprise me, nor did the agitators' shrugging off of the report. What did surprise me was that the Reagan and Bush administrations and the Congressional, academic-research, and industrial communities nevertheless allowed the EPA and the USDA to proceed with burdensome and scientifically indefensible biotech regulations.

I was unaware of the magnitude of the activists' financial resources. Prominent opponents of the new biotechnology are not quixotic ideologues but well-financed specialists pursuing single-issue activism. The same activists have battled biotechnology for more than 20 years and have on occasion been moderately successful. They appear at public hearings claiming, without corroboration, to represent numerous concerned citizens. I have wondered, for instance, how the rank and file of the National Wildlife Federation would have polled on their organization's bitter, tenacious opposition to the development of a recombinant rabies vaccine for animals in the wild.

The professional activists have spun controversies marked by surrogate issues. The foci of these issues have ranged from utterly baseless safety questions and so-called consumers' rights, to implausible economic forecasts for small farms. The activists have claimed that even precise, minimal genetic modifications will have unpredictable, potentially disastrous effects.

For example, they predicted that field trials of a recombinant bacterium designed to prevent freezing of crops ("ice-plus" Pseudomonas syringae stripped of the gene that promotes ice-crystal formation in plant tissues) could disrupt weather patterns and air traffic control. They have held that using bovine somatotropin (bST) to increase milk production in dairy cows will cause breast cancer in women who drink milk. They have whinged endlessly about the horrors of "moth genes in our tomatoes."

The activists' broadest demand is twofold: (1) that all bioengineered foods undergo clinical trials before marketing, and (2) that product labels on bioengineered foods indicate which techniques, materials, and sources were used. Antibiotech antics have ranged from the merely silly to the pernicious. In the 1970s activists disrupted a scientific conference, chanting: "We shall not be cloned." (I would hope not!) Agricultural test fields have repeatedly been vandalized. A few hard-core activists have campaigned relentlessly against all applications of biotechnology, including the development of pharmaceuticals for treating or preventing AIDS, cancer, heart attacks, hepatitis, and rabies and the testing of gene therapy for incurable childhood diseases. In a well-orchestrated antibiotech campaign, Consumers Union groundlessly accused Michael Taylor, then Deputy Commissioner of the Food and Drug Administration (FDA), of conflict of interest with respect to biotech policy formulation and product evaluation.

Conspiracy Theory

I have consistently been taken aback by the ease with which opponents of biotech can capitalize not only on the public's scientific naiveté, but also on other's concern about this naiveté. Antibiotech critics successfully gambled that government regulators, industry executives, and university scientists would panic over the possibility that the biotech hoopla would stir the public. Yet nearly all public-opinion polls showed that the public was not up in arms about biotechnology.

I do not understand what the activists hope to gain by keeping improved staple crops out of farmers' hands and prolonging farmers' reliance on high-acreage, input-intensive methods.

The motif of antibiotech activism is by no means new. It resonates with historian Richard Hofstadter's classic analysis, in The Paranoid Style in American Politics (1952), of religious and political movements in American politics. Hofstadter described the "central image" of the religious and political activists' obsession as "a vast and sinister conspiracy, a gigantic and yet subtle machinery of influence set in motion to undermine and destroy a way of life." According to Hofstadter, the activists' "paranoid style" is marked by a "leap in imagination that is always made at some critical point in the recital of events."

Susanne L. Huttner, Ph.D., director of the University of California Systemwide Biotechnology Research and Education Program, has placed antibiotech activists squarely in Hofstadter's crosshairs: Viewed from Hofstadter's model of the paranoid style, the activists ascribe the "conspiracy" to international agribusiness; the "leap in imagination" is their assertion that the new biotechnology is somehow adverse to the "Holy Grail" of "sustainable agriculture," and indeed, basically bad for agriculture, farmers, and developing nations.

But the activists' position does not square with biotechnology's utility in the development of plants with increased resistance to disease, insects, and drought; its utility in the development of grains with enhanced nutrient content or with a new molecule that immunizes people to a highly prevalent, deadly disease; and its utility in the development of veterinary diagnostic methods and vaccines.

The Bad Seed?

Only a fool would entrust to antibiotech groups responsibility for defining the public interest or for estimating the potential benefits of basic research and product development. The scientific community spanning government, industry, and academia should not dignify activists' campaigns when the tenets of the campaign are incompatible with both empirical findings and scientific principles of risk analysis.

Greenpeace International, for example, may have attained the nadir of antibiotech activism when, on April 6, 1995, it announced that it had "intercepted a package containing rice seed genetically manipulated to produce a toxic insecticide, as it was being exported . . . [and] swapped the genetically manipulated seed with normal rice." This is probably the result of an educational deficiency, lack of a functioning "moral compass," and excessive viewing of the likes of Mission Impossible.

The rice seeds stolen by Greenpeace, genetically engineered for increased resistance to insects, had been en route from the Swiss Federal Institute of Technology, in Zurich, to the International Rice Research Institute, in the Philippines. There, researchers would have field-tested the recombinant seeds to determine whether their yield would continue to be high with less use of chemical pesticides. In the Philippines and many other developing countries in Asia, where rice is a staple, the need for disease- and insect-resistant rice is enormous.

In the arena of biotech policymaking, the policymakers have used the high-profile demands of antiscience groups to make extreme regulatory nostrums seem justified.

Greenpeace interfered with this research project only because rDNA technology had been applied to the seeds. Every year Greenpeace disregards thousands of products of conventional genetic modification shipped to and from the International Rice Research Institute and other agricultural research centers around the world.

Evidently mindless of its folly (and no doubt breathless from its adventure), Greenpeace proclaimed:

Transports of hazardous waste have to be approved by both export and import countries as well as by all transit countries along the way. In Switzerland, the Federal Office of the Environment (BUWAL) watches over the exports of toxic wastes. Unlike chemical substances, genetically engineered organisms have the potential to multiply, spread and simply get out of control. Obviously such organisms constitute a danger for people and for the environment. . . . It should be clear that the export of genetically manipulated organisms needs to be even more tightly regulated than the export of toxic wastes.

Attack of the Killer Tomatoes?

To bring about overregulation of politically disfavored products or technologies, antitechnology groups blur distinctions between inherently dissimilar products like seeds and toxic wastes. Who will underwrite unjustifiable regulation more stringent than the regulation of "the export of toxic wastes"? In Greenpeace's brave new world, innovative biotech methods and products would end up sequestered in industrialized countries, whose populations can afford consumer products with prices inflated by overregulation. If Greenpeace were to prevail, the exchange of plant hereditary material and the adaptation of crops for cultivation by indigenous farmers would end. How is Greenpeace serving the public interest?

New varieties of tomato are not and should not be regulated as stringently as new drugs. To obtain FDA approval of any new drug, the manufacturer must submit the findings of clinical trials. But standards crafted by professional societies and adopted voluntarily by plant breeders have been used routinely and effectively for decades to test new varieties of fruits, vegetables, and grains and to certify the seeds of new cultivars. Plant breeders test yield, flavor, toxicity, and properties such as resistance to insects, molds, and viruses. Unsafe, unstable, or otherwise unacceptable plants are neither continued in breeding programs nor introduced into commerce.

Jeremy Rifkin, founder of the Foundation on Economic Trends, in early 1997 characterized biotechnology as threatening "a form of annihilation every bit as deadly as nuclear holocaust" and civilization as "on the cusp of a frightening new era of cloning, genetic engineering, and eugenics." Rifkin has opposed biotech applications ranging from cancer therapy to crop improvement and has deluged federal agencies with petitions to deny product approvals.

Harvard evolutionary biologist Stephen Jay Gould, by his own admission, has tried to be sympathetic to Mr. Rifkin's views; but even Gould is overwhelmed by Rifkin's "extremism" and "lack of integrity." Professor Gould has described Rifkin's antibiotech book, Algeny (the title derives from the words "alchemy" and "genetics") as "a cleverly constructed tract of anti-intellectual propaganda masquerading as scholarship" whose author "shows no understanding of the norms and procedures of science." Indeed, Dr. Gould said he had not "ever read a shoddier work."

Plant breeding has an impressive record of safety based on professional, rather than government-imposed, standards of practice. Yet Rifkin, Greenpeace, the Environmental Defense Fund, the Union of Concerned Scientists, and other antibiotech groups demand extensive, government-mandated environmental and human testing of new agricultural biotech products. Profit margins for both fresh and processed foods are extremely narrow, and the markets are highly competitive. The antibiotech activists are counting on new regulations to increase the cost of developing biotech products and to make such products unaffordable to most farmers and consumers. While I have learned much from the product-versus-process debate, I do not understand what the activists hope to gain by keeping improved staple crops out of farmers' hands and prolonging farmers' reliance on high-acreage, input-intensive methods.

The Road to Hell Is Paved with Good Intentions

Far too often, government policymakers have welcomed antitechnology activists to their advisory committees, hearings, conferences, and bosoms. Biologist Donald Kennedy, former FDA Commissioner and former Stanford University president, has analyzed various aspects of government policymaking. Kennedy has observed that when a public policy results from responding politically to a popular movement without understanding its motivation, the policy is usually flawed:

"We did what they wanted, but after we did it they turned out to want something else" is among the oldest of political complaints. It has all kinds of bad consequences. Not only is the wrong policy put in place, but those who have tried to be responsive experience alienation and disillusionment when they discover that they have not provided any satisfaction.

Kennedy chides policymakers: "Frequently decision-makers give up the difficult task of finding out where the weight of scientific opinion lies, and instead attach equal value to each side in an effort to approximate fairness. In this way extraordinary opinions, even those like Mr. Rifkin's, are promoted to a form of respectability that approaches equal status."

Kennedy is too charitable. In the arena of biotech policymaking, the policymakers have used the high-profile demands of antiscience groups to make extreme regulatory nostrums seem justified.

Although freedom of expression and vigorous debate are conducive to science and science policymaking, we must distinguish science from pseudoscience. Organizers of NIH-sponsored conferences on genetics do not invite creationists; and applied-physics meetings do not include presentations of the newest designs for perpetual-motion machines.

There are well-intentioned members of the academic, government, industrial, and nonprofit communities who would attempt rational public dialogue with antibiotech activists. I advise against it.

As political columnist George Will has observed, the hidden agenda of some activists is to expand the domain of some people's political will over others'. The antibiotech activists' agenda is to dictate what scientific research may be done, how it may be done, and which types of products may be produced and marketed. Their rhetoric and actions have been incompatible with scientific discourse, with the scientific method, and with the primacy of empirical evidence. Because of their mendacity the activists not unlike scientists who fabricate "data" should forfeit participation in dialogues among the community of scholars.

Henry I. Miller, M.D., a member of ACSH's board of directors, is a Senior Research Fellow at the Hoover Institution and a consulting professor at Stanford University's Institute for International Studies. He is the author of Policy Controversy in Biotechnology: An Insider's View (Academic Press, 1997).

(From Priorities, Vol. 9, No. 4)