February 1, 2011 (Vol. 31, No. 3)

Henry I. I. Miller, M.D. Physician and fellow Stanford University

Widespread Use of Vitamin A Enriched Rice Forestalled by Gratuitous Regulation

As a scientist and humanitarian, Swiss plant biologist Ingo Potrykus is right up there with Jonas Salk, who introduced the first polio vaccine; Maurice Hilleman, who invented dozens of vaccines, including 8 of the 14 that are currently recommended; and Norman Borlaug, the “Father of the Green Revolution,” who saved perhaps a billion lives and improved the health of uncountable others.

Or, more accurately, he would be if wrong-headed government regulation had not stalled his once-in-a-lifetime, life-saving innovation.

Potrykus is the co-creator of Golden Rice, a collection of new rice varieties biofortified or enriched, by the introduction of genes that express beta-carotene, the precursor of vitamin A. (It is converted in the body, as needed, to the active form.)

Why are these new varieties so important? After all, most physicians in North America and Europe never see a single case of vitamin A deficiency in their professional lifetimes. The situation is very different in poor developing countries, however. Vitamin A deficiency is epidemic among the poor, whose diet is heavily dominated by rice (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 can be devastating and even fatal. It increases 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 500,000 children become blind as a result of vitamin A deficiency, and 70% die within a year of losing their sight.

Why not simply supplement children’s diets with vitamin A in capsules or add it to some staple foodstuff, the way that we add iodine to table salt to prevent hypothyroidism and goiter? A good idea in theory, except that neither the resources—hundreds of millions of dollars annually—nor the infrastructure for distribution are available.

Genetic engineering offers a better, cheaper, more feasible solution: Golden Rice, which actually incorporates beta-carotene into the genetically altered rice grains. The concept is simple: Although rice plants do not normally synthesize beta-carotene in the endosperm (seeds) because of the absence of two necessary enzymes of the biosynthetic pathway, they do make it in the green portions of the plant. By using genetic engineering techniques to introduce the two genes that express these enzymes, the pathway is restored and the rice grains accumulate therapeutic amounts of beta-carotene.

Golden Rice is the prototype of second-generation agbiotech products, which provide direct benefits to consumers, as opposed to plants that offer only improvements in agronomic properties that are important to farmers.

Henry I. Miller, M.D.

Golden Rice offers the potential to make contributions to human health and welfare as monumental as any in history. With wide use, it could save hundreds of thousands of lives a year and enhance the quality of life for millions more.

But one aspect of this shining story is tarnished. Intransigent opposition by antiscience, antitechnology activists—Greenpeace, Friends of the Earth, and a few other groups—has spurred already risk-averse regulators to adopt an overly precautionary approach that has stalled approvals.

There is absolutely nothing about Golden Rice that should require endless case-by-case reviews and bureaucratic dithering. As the scientific journal Nature editorialized in 1992, a broad scientific consensus holds that “the same physical and biological laws govern the response of organisms modified by modern molecular and cellular methods and those produced by classical methods. …[Therefore] no conceptual distinction exists between genetic modification of plants and microorganisms by classical methods or by molecular techniques that modify DNA and transfer genes.”

Putting it another way, government regulation of field research with plants should focus on the traits that may be related to risk—invasiveness, weediness, toxicity, and so forth—rather than on whether one or another technique of genetic manipulation was used.

In spite of its vast potential to benefit humanity—and negligible likelihood of harm to human health or the environment—Golden Rice remains hung up in regulatory red tape with no end in sight. In a July commentary in Nature, Potrykus pointed out that Golden Rice has been “stalled at the development stages for more than ten years by the working conditions and requirements demanded by regulations.”

By contrast, plants constructed with less precise techniques such as hybridization or mutagenesis generally are subject to no government scrutiny or requirements (or opposition from activists) at all. And that applies even to the numerous new plant varieties that during the past half century have resulted from “wide crosses,” hybridizations that move genes from one species or genus to another—across what used to be thought of as natural breeding boundaries.

Pulling no punches, Potrykus holds gratuitous regulation “responsible for the death and blindness of thousands of children and young mothers.” At the very least, the politicians, activists, and regulators who have insisted on, implemented, and maintained those regulations are guilty of what the legal system calls “reckless disregard for life.”

In an editorial in the journal Science, Nina Fedoroff, an eminent plant geneticist and professor at Pennsylvania State University who recently completed a three-year stint as senior scientific adviser to U.S. Secretary of State, wrote: “A new Green Revolution demands a global commitment to creating a modern agricultural infrastructure everywhere, adequate investment in training and modern laboratory facilities, and progress toward simplified regulatory approaches that are responsive to accumulating evidence of safety. Do we have the will and the wisdom to make it happen?”

The Golden Rice story makes it clear that the answer is, not yet.

Henry I. Miller, M.D. ([email protected]), a physician and molecular biologist, is a fellow at Stanford University’s Hoover Institution.

Previous articleJ.P. Morgan Healthcare Conference—Wednesday, January 14 Update
Next articleValeant to Buy Generics and OTC Drugs Firm PharmaSwiss for €350M