There’s an old saying that no good deed goes unpunished. That certainly seems to be true for many breakthroughs in genetic engineering. Here are several particularly egregious examples.
1. “Biopharming” — a new way to make drugs
Diarrhea is the number-two infectious killer of children under the age of five in developing countries, surpassed only by respiratory diseases. It accounts for roughly 2 million deaths a year. But thanks to a simple but ingenious innovation by an emerging biotech company, Ventria Bioscience, those numbers could become a relic of the past, like mortality from smallpox and bubonic plague.
#ad#Since the 1960s, the standard of care for childhood diarrhea in the developing world has been the World Health Organization’s formulation of rehydration solution, a glucose-based, high-sodium liquid that is administered orally. This low-tech product was revolutionary. It saved countless lives and reduced the need for costly (and often unavailable) hospital stays and intravenous rehydration.
However, this product did nothing to lessen the severity or duration of the condition, which over time leads to malnutrition, anemia, and other chronic health risks. The solution (literally and figuratively) may be an ingenious, affordable innovation from Ventria that combines high- and low-tech components to deliver what could be a veritable Holy Grail: two proteins produced inexpensively in rice that radically improve the effectiveness of oral rehydration solutions.
It has been known for decades that breast-fed children get sick with diarrhea and other infections less often than those fed with formula. Research in Peru has shown that fortifying oral rehydration solution with two of the primary protective proteins in breast milk, lactoferrin and lysozyme, lessens the duration of diarrhea and reduces the rate of recurrence. The availability of such an improved oral rehydration solution to people in the developing world would thus be a near-miraculous advance.
Ventria joined with researchers at the University of California, Davis, and at a leading children’s hospital and a nutrition institute in Lima, Peru, to test the effects of adding lactoferrin and lysozyme to a rice-based oral rehydration solution. They found that the addition of the two proteins to the solution reduced the average duration of the children’s illness from more than five days to 3.7. Moreover, over the twelve-month follow-up period, the children who had received the rice-based solution had less than half the recurrence rate of diarrhea (8 percent versus 18 percent in the control sample).
What makes this approach to managing diarrhea feasible is Ventria’s invention of a genetically engineered method that uses rice to produce lactoferrin and lysozyme. This process, dubbed “biopharming,” is an inexpensive and ingenious way to synthesize the large quantities of these proteins that will be necessary. The rice kernel is processed to extract and purify the proteins, which are then used to formulate the improved rehydration solution. They have the same structure and functional properties as the proteins in natural breast milk, and the process is analogous to that used routinely for the production of therapeutic proteins from other organisms, such as bacteria and yeast.
The proven life-saving potential of these products has not prevented activists from opposing them. In Peru, left-wing protesters raised completely baseless and malicious objections to the clinical trials, claiming that the rights of the pediatric subjects were being violated. Typically, the activists grossly misrepresented the facts pertaining to the conduct of the trial and the product iself. The proteins used to supplement the oral rehydration solution are considered Generally Recognized as Safe, or GRAS, by the U.S. Food and Drug Administration, and the protocols, consent forms, and study design of the trial were, in fact, approved not only by the Peruvian Ministry of Health, but also by review panels that oversee clinical trials at the University of California and the Nutritional Institute in Peru. The naysayers seem unimpressed by the fact that the experimental therapy was found to be both safe and effective.
2. Genetically engineered mosquitoes are all the buzz
A second example is a genetically engineered mosquito intended to reduce the mosquito population that carries dengue fever, a debilitating and often fatal disease. With more than one-third of the world’s population living in areas at risk for transmission, dengue infection is a leading cause of illness and death in the tropics and subtropics. As many as 100 million people may be infected yearly, and tens of thousands, mostly children, die. Caused by four different but related viruses, it is spread by the bite of mosquitoes, most commonly the mosquito Aedes aegypti.
A British company, Oxitec, uses ingenious genetic-engineering techniques to create new varieties of the mosquito species that transmit the disease. Their approach introduces a gene that produces a protein that stops mosquitoes’ cells from functioning normally. The modified mosquitoes produce high levels of the protein, which, although not toxic itself, confounds some of the cell’s essential machinery and causes death. The modified males carrying the lethal gene are not affected as long as they are fed a special diet. When they are released, they survive long enough to mate with wild females, but the offspring die.
Working with local health officials and university scientists and after receiving appropriate approvals, Oxitec undertook experimental releases of these modified mosquitoes in the Cayman Islands and in the Juazeiro region of Brazil. According to the published accounts of these releases, the Oxitec approach to controlling mosquito population was highly effective, reducing the infected mosquito population by 80 percent in the Cayman Islands and by 90 percent in Brazil. Oxitec is awaiting Brazilian Health Ministry approval of this approach as an acceptable dengue-control policy.
In the Cayman Islands and Brazil, GeneWatch activists spread alarming, false rumors that the field trials of genetically engineered mosquitoes were dangerous and had been undertaken without informing the public. Similarly, activists have circulated petitions in Key West, Florida — where dengue reappeared three years ago after an absence of more than 70 years — to prevent the release of the mosquitoes there. The sentiments of the director of a mosquito-control agency in Florida illustrate the difficulties of dealing with the activists: “I thought that if I presented the facts in a reasonable manner, people would respond in a reasonable way. But that’s not happening.”
#ad#3. Nice rice prevents blindness and death
The third example is a potential nutritional/medical breakthrough called Golden Rice. Rice is a food staple for billions of people, especially in Asia, and although it is an excellent source of calories, it lacks certain micronutrients necessary for a complete diet. In the 1980s and 1990s, German scientists Ingo Potrykus and Peter Beyer developed rice varieties that are biofortified, or enriched, by the introduction of genes that enable the edible endosperm of rice to produce beta-carotene, the precursor of vitamin A. (It is converted in the human body, as needed, to the active form of the vitamin.)
The scourge of vitamin A deficiency is epidemic among poor people whose diet consists largely of rice (the edible portion of which contains neither beta-carotene nor vitamin A) or other carbohydrate-rich, vitamin-poor sources of calories. In developing countries, 200–300 million children of preschool age are at risk of vitamin A deficiency, which increases their susceptibility to common childhood infections such as measles and diarrheal diseases and is the single most important cause of childhood blindness in developing countries. Every year, about half a million children go blind as a result of vitamin A deficiency, and 70 percent of those die within a year of losing their sight.
To test the Golden Rice, in 2008, researchers from Zehjiang Academy of Medical Sciences, in cooperation with Tufts University, undertook clinical trials in children. These researchers had received approval from the appropriate ethics and institutional-review boards of the respective institutions. As reported in their published paper on the clinical trials, children who ate the Golden Rice had higher levels of vitamin A than if they had consumed traditional rice or other food sources of the vitamin.
Once again, in spite of the unequivocal benefits to public health, activists not only opposed the product but made bogus allegations about its testing. In China, Greenpeace criticized the Golden Rice trial, claiming in a press release that children had been “used as guinea pigs.” Chinese news agencies picked up the story, inaccurately reporting that the researchers had conducted dangerous, unauthorized experiments on poor children, and within days, police had interrogated the researchers and coerced from them statements disavowing the research. Their homes were searched and research documents seized. (Previously, Greenpeace activists had first alleged that Golden Rice would deliver toxic amounts of vitamin A, and when that was shown to be virtually impossible, changed tack and claimed that it would provide too little Vitamin A to be effective.)
4. Life-saving products obstructed by irresponsible activism
Although these three safe, effective, genetically engineered products — which are only a microcosm of what is possible — offer tremendous promise for public health, especially in poorer countries, all have elicited tenacious and cynical antagonism from activists. Part of the ripple effect is that the intransigent opposition to genetic engineering by anti-science, anti-technology groups provides already risk-averse regulators the political “cover” to delay regulatory approvals. The result is that more people — especially children — continue to die unnecessarily and potential innovators are discouraged from entering the field.
Activism intended to delay progress toward life-saving products and technologies is irresponsible and despicable. If actions by leaders of nations resulted in such public-health calamities, they would be accused of crimes against humanity.
The callousness of the anti-genetic-engineering activists should appall us, and if we fail to oppose these malefactors, we should also be ashamed.
— Henry I. Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution. He was the founding director of the Office of Biotechnology at the FDA. Drew L. Kershen is the Earl Sneed Centennial Professor of Law (Emeritus), University of Oklahoma College of Law, in Norman, Okla.