DARK SCIENCE AL GORE AND THE FDA

Gore’s approach to regulation is shaped by a radical “green” ideology and a d esire to purge dissenting views from the councils of government. Unfortunately, the president’s science adviser, John H. Gibbons, who should provide a counterw eight to Gore’s extreme and uninformed ideas, seems to have been selected for h is low profile and docility. As a result, the vice president’s influence is largely unopposed — especially in biotechnology, a field in which he styles himself an expert.

Biotechnology refers to the manipulation of genes in cells or organisms to create or improve products. These products range from disease-resistant crops and bacteria that synthesize human drugs to better-tasting foods and healthier oils. While a senator, Gore took a particular interest in issues relating to biotechnology. He praised Algeny, Jeremy Rifkin’s bizarre antibiotechnology diatribe, and is quoted on the cover pronouncing it “an important book” and an “insightful critique of the changing way in which mankind views nature.”

In a 1991 article in the Harvard Journal of Law and Technology, Gore revealed a remarkable lack of insight into biotechnology’s past, present, and future. He disdainfully described investors’ eager reception of Genentech, Inc. ‘s stock offering in 1980 as the first sellout of the “tree of knowledge to Wall Street.” He ignored biotechnology’s pre-Genentech commercial successes, although fermentation using microorganisms to produce antibiotics, enzymes, vaccines, foods, beverages, and other products was a $ 100 billion industry even before gene splicing. Gore observed that companies” selection of products for research and development is driven by commercial motives like profit and patent protection, rather than by “the public’s interest.” He disparaged the notion of letting the marketplace decide and deplored appropriately-minimal government oversight of experiments entailing negligible risk as a regulatory ” vacuum.”

At bottom, Gore seemed to consider the new technologies in some way sinister. “The decisions to develop ice-minus [bacteria], herbicide-resistant plants, and bovine growth hormone,” he wrote, “. lent credibility to those who argued that biotechnology would make things worse before it made things better.” This is a truly puzzling characterization of the harmless and ubiquitous ice-minus bacterium, used to prevent frost damage to crops, and of the development of environmentally friendly herbicide-resistant plants that will reduca the use of agricultural chemicals and provide farmers with additional tools. Gore’s antipathy to genetic engineering reflects a suspicion of science and technology generally that is on full display in his 1993 bestseller, Earth in the Balance.

Gore’s central thesis is that we need to take “bold and unequivocal action . . . [to] make the rescue of the environment the central organizing principle for civilization.” Repeatedly, he uses the Holocaust as a metaphor for environmental destruction and suggests that polluters and those with too much faith in technological advances are as sinister as the criminals of World War II.

Gore examines the political, “economic,” psychological, sociological, and religious roots of the pollution problem. Classical economics, in his view, ” defines productivity narrowly and encourages us to equate gains in productivity with economic progress. But the Holy Grail of progress is so alluring that economists tend to overlook the bad side effects that often accompany improvements.” This shortcoming of markets he likens to “the moral blindness implicit in racism and anti-Semitism.” Part of Gore’s remedy is to redefine concepts like growth, productivity, and gross national product. The purpose of this revision is clear: It enables governments to obscure the costs of environmental protection by calling them “benefits” and forces businesses to list as “costs” some wealth-creating activity otherwise considered beneficial to society. The consequence for regulators is a willingness to pile stifling costs on business in the name of the environment.

The vice president’s New Age philosophizing leaves few cliches unexplored. Sexism gets a bashing, as Gore argues that our approach to technological development has been shaped by aggressive male domination instead of by the nurturing instinct of women. Predictably, too, Gore opines that our civilization is “addicted to the consumption of the earth itself.” His psychoanalysis of mankind’s drive to pollute continues:

In psychological terms, our rapid and aggressive expansion into what remains of the wildness of the earth represents an effort to plunder from outside civilization what we cannot find inside. Our insatiable drive to rummage deep beneath the surface of the earth, remove all the coal, petroleum, and other fossil fuels we can find, then burn them as quickly as they are found — in the process filling the atmosphere with carbon dioxide and other pollutants — is a willful expansion of our dysfunctional civilization into vulnerable parts of the natural world.

But Gore’s attitudes are more deeply rooted than the trendy jargon he uses. A t a philosophical level, he disparages the Cartesian method, the heart of scien tific inquiry, for disconnecting man from nature and religion. Gore is suspicio us of the value-neutral nature of science, skeptical of its objectivity. He writes: “But for the separation of science and religion, we might not be pumping so much gaseous chemical waste into the atmosphere and threatening the destruction of the earth’s climate balance.” ( But for the separation of science and religion, we would likely still be saddled with the pre-Copernican notion that the sun and planets revolve around the Earth.)

The environmental agenda Gore sets out in Earth in the Balance calls for massive direct and indirect government intervention, including a $ 100 billion green Marshall Plan, to stave off environmental Armageddon. Since early in the Clinton administration, he has been well positioned to pursue his ends: By executive order on September 30, 1993, President Clinton placed the vice president in charge of regulatorly priorities. Thus was Gore handed, if not the power fully to realize his regulatory Weltanschauung, at least considerable latitude to put his ideology into action. The fate of the new biotechnology as regulated by two federal agencies — the Environmental Protection Agency and the Food and Drug Administration — illustrates the result.

Under the Clinton administration, EPA’s policies have inhibited whole sectors of U.S. industry that are attempting to use biotechnology to remediate toxic wastes and develop alternatives to chemical pesticides. This did not have to be so. Over the last 15 years, the scientific community has developed an intellectually solid foundation for government oversight of biotechnology. In essence, and i:a plain language, the National Academy of Sciences; and others concluded that the new methods of genetic manipulation are not fundamentally different from, or riskier than, older methods long used in microbiology and agriculture, such as hybridization or mutagenesis. Whether a new product is risky — whether its introduction into a new environment, for example, threatens that environment, or whether it can safely be consumed by humans — does not derive frc, m how the product was developed but must be judged from the characteristics of the product itself. Thus, a field trial of genetically improved wheat, corn, tomatoes, or petunias is likely to carry negligible risk, while an experiment with an aggressive plant like kudzu or bamboo, or with a pathogenic virus, probably carries higher risk and therefore should be subject to greater government scrutiny.

The scientific consensus notwithstanding, the Clinton-Gore EPA has proposed new regulations triggered by the use of advanced biotechnology rather than by any risks associated with its products. This approach was characterized in a 1993 report by the British House of Lords Select Committee on Science and Technology as “excessively precautionary, obsolescent, and unscientific.” Nevertheless, the EPA is using it in regulating field trials of biotechnology- produced microorganisms used for pest control, oil-spill cleanup, and other purposes. These regulations place an extraordinary burden on researchers.

In addition, the EPA last year proposed regulations that would require the review of a category of product that until now has required no regulation at all: new varieties of plants genetically improved for enhanced resistance to disease or pathogens. The upshot is that small-scale testing of new varieties of tomatoes, potatoes, marigolds, and the like — if and only if they are produced by genetic engineering — will be regulated more stringently than chemicals similar to DDT, parathion, or the lethal satin. You don’t have to be a scientist to know that this makes no sense.

Of even greater concern than regressive regulatory policies like these is the raw political influence brought to bear on regulatory agencies’ decisions about individual products. Under the Clinton administration, both misguided regulation and capitulation to political pressure have been present at the FDA, which oversees food, drugs, and medical devices.

$ TOne simple example of capitulation, from outside the field of biotechnology, is the female condom. Because of this device’s dubious reliability, FDA professionals were reluctant to approve it. Its annual failure rate in normal use was 26 percent, more than twice the failure rate of male condoms and 20 times the rate of hormonal contraceptives. However, word came down that the politicos in the office of the secretary of health and human services wanted the condom approved. Damn science and medicine, it had the support of feminists. Approval soon followed.

Biotechnology policy and product review again provide illuminating examples o f the rise of political influence at the agency. The FDA had maintained a consi stent and generally positive record in biotech regulation over 15 years. From t he agency’s earliest contact with products of gene splicing in 1979, senior pol icymakers decided that scientific considerations would dictate regulation. They actually anticipated the scientific consensus described above. Th us, the FDA regulated the first new biotechnology products — human insulin, hepatitis vaccine, AIDS diagnostic kits, and so forth — no differently from products made by other methods. All were measured against the same criteria of safety and efficacy, the same standards of purity and potency. The predictability and impartiality of the regulatory review process stimulated researchers, companies, and investors to favor this industrial sector. As a result, more than 1,000 new biotech products were approved for marketing, including some genuine milestones in the treatment of diseases ranging from cancer to cystic fibrosis and multiple sclerosis. Millions of patients have received these safe and effective products, and hundreds more are in development.

During the past three years, however, the FDA’s biotechnology policy has undergone a sea change. This was accomplished in several ways. First, it is no coincidence that FDA Commissioner David Kessler is the only senior political appointee from the Bush administration still in government. He has survived by being willing to craft any policy, make any decision, cut any corner, in order to satisfy his political masters. Second, the vice president’s influence is pervasive. Instructions from the Clinton administration are relayed from Gore’s senior adviser for domestic policy, Greg Simon, via FDA’s political commissar, a former Gore Senate s*affer named Jerold Mande, and several other senior off*cials with close personal or family ties to the vice president. Directives from the White House pertain to regulatory policies, decisions on individual products, and personnel changes. Their effect has been to undermine the scientific paradigm that has governed FDA policy for 15 years.

Signaling the reversal, FDA announced last year that it would soon require food manufacturers to notify the agency before marketing foods manufactured with new biotechnology techniques, while exempting those crafted with older, cruder techniques. Notification would be required regardless of possible risk. Similarly, FDA’s Center for Veterinary Medicine announced that it would, in effect, regulate the application of new biotechnology techniques to animals, instead of considering the likely risks from given products. With these moves, the agency appears to be seeking new regulatory dominions, despite its chronic complaints of inadequate resources. And never mind that the new policies will inevitably discourage the use of the newer, more precise techniques, denying consumers the choice of more nutritious, tasty, effective, and convenient products.

Confronted by a deregulation-minded Republican Congress, FDA shelved the biotech food notification proposal in February 1995, at least temporarily, but not before it had subjected a new long-shelf-life tomato to a four-year review. For comparison, the reviews of the first two new biotech therapeutics in the early 1980s — human insulin and human-growth hormone-required five and eleven months, respectively. The Clinton-Gore FDA’s review of the bovine milkstimulating drug bST (bovine somatotropin) reflected the same spirit. On instructions from Jerold Mande, Kessler directed a vigorous FDA-wide search for reasons not to approve it. Two completely superfluous meetings of advisory committees were held (at taxpayers’ expense) during the final stages of bST’s evaluation, as a fishing expedition for arguments against approval. In the end, the product was reluctantly approved, under threat of lawsuits from Monsanto.

Other changes within FDA also reflect the new order. Since the 1992 elections, Kessler has eliminated the two policy offices having extensive involvement with the biotechnology industry (the Office of Biotechnology and the Office of Small Business, Scientific, and Trade Affairs). Direction on science policy, and sometimes even on civil service personnel matters, now comes through Mande, whose title is executive assistant to the commissioner; his portfolio was described by Linda Suydam, until recently FDA associate commissioner for operations, as “areas that are of high visibility and/or of interest to the White House.”

The outcome of any given agency decision is less important than the fact that the regulatory process is no longer impartial, depending on law and science, but permits politicians to dictate to regulators. The new biotechnology has enormous potential for good. But the policies of the Clinton- Gore FDA — which afford no conceivable public health advantage-generate uncertainty. They raise doubts about the fairness of regulation and timeliness in getting products to market, and they send consumers mixed messages about product safety. Inevitably, such uncertainties discourage investment in innovation. Ultimately, they reduce the availability of new products and thus can be deemed a detriment to public health.

FDA’s recent actions are damaging enough, but they leave the door open to oth ers that would be positively nefarious. If t he White House has directed agencies’ decisions for reasons of ideology, how far-fetched is the idea that it might do so for reasons of politics? Who would be surprised, say, by White House encouragement to delay approval of a product made by a company known for giving generously to Republican causes or to expedite a product made by a company friendly to the administration? To those who would say that such unethical and illegal actions are unthinkable, particularly in an administration that promised its leaders would be moral exemplars, read on.

Since A1 Gore became vice president, he and Greg Simon have been intolerant of any challenge to their view of science policy. They have gone to extremes that Hazel O’Leary could only dream of, in order to purge their enemies — extremes reminiscent of the Nixon administration.

To control science and technology policy and to rid the civil service of dissent, Gore and Simon have interfered improperly in personnel matters. Thus, while working for the vice president, Simon threatened a high-ranking official at the Department of Energy with retaliation if she hired the former assistant director of the National Science Foundation, David Kingsbury. Simon and Kingsbury had clashed on biotechnology policy in earlier years; while a congressional staffer, Simon had hounded Kingsbury from government with unsubstantiated charges of conflict of interest. Also while working for the vice president, Simon improperly ordered FDA to remove a senior civil servant from his position. An FDA official admitted that this was retribution for the ” transgression” of having implemented Reagan-Bush-era policies. Gore himself dismissed Will Happer, a senior scientist at the Department of Energy, because Happer refused to ignore scientific evidence that conflicted with the vice president’s theories on ozone depletion and global warming. Similar incidents have occurred at the departments of State, Energy, and Interior, and at EPA, where civil servants have been moved to less visible positions or temporarily replaced during interactions with the White House for their own “protection.”

One has to wonder how much of this the president knows. The vice president’s policies and actions conflict, after all, with Clinton’s repeated promises to give the country “leaner, but not meaner,” government. It is possible, of course, that on that point, as on others, Clinton has changed his mind.

Henry I. Miller, M. D., is the Robert Wesson Fellow of Scientific Philosophy and public Policy at the Hoover Institution and a consulting professor at Stanford University’s Institute for International Studies. From 1979 to 1994, he held various positions at the FDA involved with biotechnology product review and policy-making.