If Wishes Were Horses, This Would Be the Kentucky Derby

GENEVA, Switzerland—The 58th World Health Assembly (the World Health Organization's policy-making body) under way here brings to mind the cliché about the contestants in the Miss America pageant who, when asked what would be their one wish if anything would be granted, all gave the same vapid answer, “World peace.” Dozens of presentations and scores of pamphlets and documents here outline grandiose, wholly unachievable goals for the improvement of public health around the world. For example, by 2015, they expect immunization to “reduce child mortality by two-thirds,” “improve maternal health by reducing the maternal mortality rate by three-quarters, and “combat HIV/AIDS, malaria and other major diseases.” But wishing for it doesn't make it so. Ironically, several UN policies and programs—even some sponsored by WHO itself—erect obstacles against the availability of safe, effective new technologies that could make some of the elusive public health goals more approachable.For example, the UN's involvement in the excessive, unscientific regulation of biotechnology—also known as gene-splicing, or genetic modification (GM)—slows agricultural and pharmaceutical research and development and promotes environmental damage. Ultimately, it could prolong famine and water shortages for millions in less developed countries, and even obstruct and increase development costs for vaccines incorporated into edible fruits and vegetables. By eliminating the need for refrigeration and needles and syringes, to say nothing of elaborate manufacturing facilities, such vaccines can be produced inexpensively and require far less distribution infrastructure than similar products made with conventional technology. In fact, these techniques might be the only realistic alternative for producing sufficient influenza vaccine for all regions affected in the event of the expected pandemic.During the past decade, delegates to the UN-sponsored Convention on Biological Diversity negotiated a “biosafety protocol” to regulate the international movement of gene-spliced organisms. A travesty of sound science, it is based on the bogus “precautionary principle” which dictates that every new product or technology—including, in this case, an improvement over less precise technologies—must be proven completely safe before it can be used.An ounce of prevention is certainly desirable, but because nothing can be proved totally safe—at least, not to the standard demanded by many activists and regulators—the precautionary principle has become a self-defeating impediment to the development of new products. Precautionary regulation shifts the burden of proof from the regulator, who previously had to demonstrate that a new technology was likely to cause some harm, to the innovator, who now must demonstrate that the technology will not cause harm under any circumstances.This shift is ominous, because it frees regulatory bodies to require any amount and kind of testing that they wish. Rather than creating a uniform, predictable, and scientifically sound framework for effectively managing legitimate risks, the UN's biosafety protocol establishes an ill-defined global regulatory process that encourages overly risk-averse, incompetent, or corrupt regulators to hide behind the precautionary principle in delaying or deferring approvals.Other UN agencies have gotten into the act. In 2003 the Codex Alimentarius Commission, the joint food standards program of the UN's WHO and its Food and Agriculture Organization, singled out only food products made with gene-splicing techniques for Draconian and bizarre regulatory procedures and restrictions—regulatory requirements that cannot be met by conventionally-produced foods, which are made with less precise and predictable technology.Overly burdensome standards for gene-spliced foods are ominous not only because of their direct effects on research and development, but also because they will keep beneficial new crop plants out of the hands of the resource-poor farmers in less developed countries who need them most. Scientists worldwide agree that gene-splicing is merely a refinement, or improvement, over less precise and predictable genetic techniques that have been used for centuries, an exquisite tool that can help to develop plants with higher yields and innovative traits. Thousands of greenhouse and field studies, as well as widespread commercialization in a half-dozen advanced countries, have documented that the risks of gene-spliced plants and foods are minimal, their benefits palpable, and their future potential extraordinary. Globally, the adoption of gene-spliced crops annually reduces pesticide use by tens of millions of pounds and saves millions of tons of topsoil from erosion. In less developed countries like <?xml:namespace prefix = st1 ns = “urn:schemas-microsoft-com:office:smarttags” />China and South Africa, the few available gene-spliced plant varieties have increased crop yields, raised the incomes of resource-poor farmers, and reduced occupational exposure to chemical pesticides. Wider adoption and diffusion of gene-spliced crops could improve human nutrition, reduce the amount of land and water needed to produce food, and spare ecosystems from fragmentation and development. But these advances are being drastically limited by the unscientific, hugely burdensome UN-based regulatory regimes.Even Miss America contestants should be able to understand that the precautionary principle-driven standards and regulations the UN defends actually harm the environment and public health, stifling the development of environmentally friendly innovations that can increase agricultural productivity, help clean up toxic wastes, conserve water, supplant agricultural chemicals, and reduce the contamination of grain by fungal toxins. Many UN experts themselves warn that the greatest single threat to the planet's environment comes from the world's burgeoning population and its demand that ever more land be devoted to food production. But the regulatory regimes promoted by various UN agencies and projects deny less developed countries precisely the kind of technology they need. Another policy that has visited untold harm on the poor in tropical climates is the heinous 2001 United Nations Persistent Organic Pollutants Convention, which stigmatizes DDT as one of the world's “dirty dozen” worst pollutants, and makes it exceedingly difficult for developing countries—many of which are plagued by malaria, West Nile virus infections and other insect-borne diseases—to use the chemical.In 1972, on the basis of data on toxicity to fish and migrating birds (but not to humans), the U.S. Environmental Protection Agency banned virtually all uses of the pesticide DDT, an inexpensive and effective pesticide once widely deployed to kill disease-carrying insects. Similar bans spread around the world. The absurdity of the ban on DDT is illustrated by the fact that regulators banned it largely because of toxicity to birds: Now it's unavailable to combat West Nile virus infections, a mosquito-borne viral disease that is killing birds by the millions!Not only did government regulators minimize scientific evidence of the effectiveness and relative safety of DDT, they also failed to appreciate the distinction between its large-scale use in agriculture and more limited application for controlling carriers of human disease. Although DDT is a (modestly) toxic substance, there is a big difference between applying large amounts of it in the environment—as farmers did before it was banned—and applying it carefully and sparingly to fight mosquitoes and other disease-carrying insects. A basic principle of toxicology is that the dose makes the poison.Regulators who have stigmatized and banned DDT also failed to take into consideration the inadequacy of alternatives. Because it persists after spraying, DDT works far better than many pesticides now in use, some of which are toxic to fish and other aquatic organisms. Also, the need to spray other insecticides repeatedly—especially in marshlands and forests, where mosquito-breeding areas are large—drives up costs and depletes public coffers. Pyrethroid pesticides, the most common alternative to DDT, are inactivated within an hour or two.How do such travesties of regulation arise? Through a kind of “Emperor's New Clothes” process at meetings such as the one currently under way in Geneva, in which self-interested and not terribly astute participants move a flawed proposal through the approval procedures, all the while pretending that it makes sense: a triumph of bureaucratic process over substance. <?xml:namespace prefix = u2 /><?xml:namespace prefix = o ns = “urn:schemas-microsoft-com:office:office” />

But although the process appears to be transparent, it is corrupt. The UN uses coercion to induce countries to sign on to agreements to regulate gene-splicing excessively, such as the Cartagena Protocol and the Codex standards. For example, the United Nations Environment Program (UNEP) has distributed scores of millions of dollars to help developing countries set up infrastructure for “building capacity for assessing risks, establishing adequate information systems and developing expert human resources in the field of biosafety.” But as Harvard's Calestous Juma has said, creating gratuitous regulatory infrastructure without supporting technology development is like offering swimming lessons to inhabitants of the Sahara Desert. The UNEP program's “capacity building” applies only to the regulation of gene-spliced products, and many of the countries for which the project is intended lack virtually any regulation of acknowledged high-risk activities, such as public transport and dangerous occupations, and their expenditures on public health are woefully inadequate. It is not unusual in poor tropical countries, for example, to observe pre-teens performing welding or using dangerous machinery, with no protective gear and wearing only shorts or a loincloth. Malaria, schistosomiasis, and bacterial and viral diseases that have been all but eradicated from industrialized countries remain epidemic in many underdeveloped nations. Surely the UN's largesse would be spent much more productively if it were allocated to address any of these more important problems.The UNEP's cynical offers of bribes to get countries to ratify its regulations offer Faustian bargains to less developed nations. They receive small grants up front, but in the long term, unscientific, excessive regulation of this promising new technology—and the resulting uncertainty among innovators about their ability to conduct research and market products—ensures that the biotechnology revolution all but passes them by. Such strategies—on which the UN bureaucrats publicly congratulate themselves—are outrageous.Perhaps the most bizarre agenda item at this World Health Assembly is a proposal to require prominent warnings that pathogenic microorganisms are present in infant formula. Yes, infant formula.The supporters of such labeling claim that the use of infant formula can lead to malnutrition and respiratory infections leading to death—which is, of course sheer nonsense. These attacks are scientifically unfounded and misguided; similar to other food products, infant formula manufacturers must assure that it is neither adulterated nor misbranded. In plain English, the product may not be harmful or labeled inaccurately. But like the tomatoes, potatoes, yogurt and milk we buy at the supermarket, preparations of formula are “clean” but not sterile. They may contain harmless microorganisms (as does the air we breathe), while by contrast, drugs like injectable vaccines and intravenous fluids are completely sterile.The infant formula initiative is the opening salvo in an ideological campaign to smear a safe and useful product. If the activists are successful at banning or severely restricting it, the consequences could be dire.The participants in elaborate but pathetic exercises like this World Health Assembly are long on self-congratulation and grand pronouncements but short on critical thinking. There is no recognition that any inroads will require the creation of ever-greater wealth, which depends on continuing innovation and the adoption of new technology—which, in turn, depends on free markets, protection of intellectual property and reasonable, science-based oversight of research and development. UN agencies find themselves in the same predicament as the lost tourist who asks a local how to get to his destination. The fellow answers, “Well, first of all, I wouldn't start from here.” Given the absence at the UN of a meritocracy, sound judgment and accountability, we don't see how they'll get where they say they'd like to go.