Wat Culd Go Rong
By Alex Beamer
Agricultural biotechnology has entered a new age. No longer do researchers limit themselves to inserting genes that result in plants with traits like herbicide tolerance and insect resistance, making crops cheaper and easier for farmers to grow. Now they genetically engineer plants to make them produce medical drugs and industrial chemicals—in essence turning crops into biological factories that make substances entirely unrelated to the original plant. Welcome to the new age of “pharm crops”.
Unless the growing of these crops is stringently regulated, they pose serious risks. You could end up with drug-laced corn flakes on your table.
A (Pharm) Apple A Day Keeps The Doctor Away?
Pharm crops are produced by the same methods used to genetically engineer food crops. Briefly, scientists use recombinant DNA techniques to locate and isolate genes of pharmaceutical or industrial interest. These “transgenes” are then inserted into a crop plant using one of several methods now standard in the industry. The resulting pharm plant then produces the protein product (“novel protein”) encoded by the transgene as if it were one of its own naturally occurring genes. Finally, seeds are mass-produced and a new pharm crop can be planted with the expectation to harvest the desired product.
Farmers grow pharm crops in the same way they do unaltered crops and, in most cases, the novel proteins will be extracted from the harvested plants and purified. But in a twist of almost sci-fi proportions, in which the incredible future of medicinal plants meets the ancestral past, it is hoped that the medicine produced in pharm plants will soon be delivered directly to the person in need of the medicine, simply by eating the fruit or other parts of the plant.
A number of corporations and universities are working on developing these pharm crops, with competition so stiff that many of the products being developed are kept secret to maintain market advantage. Some of the known medical products being developed right now are enzymes to treat Fabry’s and Gaucher’s diseases, proteins called defensins that may be a replacement for antibiotics, anticoagulants, blood substitutes, hormones, and drugs for treating liver cirrhosis, cystic fibrosis, HIV, and hepatitis B and C. Additionally, pharm crops are being used to produce complex biological products such as antibodies, vaccines and blood products for human and veterinary medicine. Industrial chemicals are also being developed such as those used in the manufacture of paper, personal care items, and laundry detergents.
Producing novel proteins with pharm crops promises to replace older technologies that are much more expensive and sometimes controversial to use. It is thought that pharm crops can produce these products at 1% to 10% of the cost of currently used technologies. (Older technologies include bacterial fermentation, mammalian cell cultures and transgenic mammals.) If true, this will lead to reduced costs for expensive drugs and large profits for the companies that make them. Drugs that are too expensive or too difficult to produce now may be affordable to produce using pharm crops, with the added benefit that using plants rather than animals avoids animal rights issues.
Given the vast potential rewards, companies are competing hard to get in on the ground floor of this new technology hoping to become dominant players in this emerging industry. And just to give you an idea of how big this new industry may become, some experts predict that the market for these pharmaceutical and industrial proteins could reach $200 billion by the year 2010. That’s just five years away. With economic incentives like that, no wonder the next wave of agricultural biotechnology—pharm and industrial crops—is moving toward the marketplace like a tsunami.
Currently there are no pharm crop-produced pharmaceutical products on the market, though several are nearing the end of the development pipeline. There are at least two research chemicals and one industrial chemical that are marketed now with several more expected soon. Field trials involved in the development of pharm crops started in 1991 and have been steadily increasing over the years. The U.S. Department of Agriculture has allowed more than 200 field trials of pharm and industrial plants in more than 30 states. Corn is this new industry’s poster child, having been used in nearly three-quarters of these tests. Other crops tested include tomato, rice, barley, alfalfa, sugarcane, soybean, potato, lettuce, lupine, tobacco, and rapeseed (canola). Oregon had one field trial in 1996, but no testing is going on at this time.
Now The Bad News
Many of the novel substances produced in pharm crops exhibit high levels of biological activity and are intended to be used for particular purposes, under very controlled circumstances. None of these substances is intended to be incorporated in food or to be broadcast into the environment. The main concern at this point is that non-food substances will contaminate the food supply and the environment. Substances intended for use as human drugs are especially problematic because they are designed and constructed to be biologically active in the human body.
The magnitude of the risks such crops pose depends on many factors including which chemicals are involved, what organisms or environments are exposed, and the level and duration of the exposure. Humans, animals and the environment at large may be at risk. The novel chemicals produced by pharm plants are generally proteins or short polypeptides. Some novel proteins, in turn, produce chemicals that usually are not proteins. Both proteins and non-proteins can harm people and animals, and can act, among other things, as toxins, hormones, or allergens.
As an example, take the case of Avidin, a novel protein that was isolated from transgenic corn. Since 1997, it has been available and used as a research chemical. Avidin binds extremely tightly to biotin, an essential B vitamin nutrient necessary for basic metabolism in almost all organisms. In a worst case scenario, if Avidin got mixed in our food supply, it could bind with the biotin in our bodies and create biotin deficiency, which would raise serious problems. In addition, any animal browsing or living in an Avidin-corn field (deer, squirrels, mice, birds, etc.), as well as the plants, earthworms, and soil microorganisms in the local environment are all at serious risk.
The Avidin-corn example applies across the entire spectrum of this new industry. Since most pharm plants are also the crops that provide food for people and feed for livestock, a major concern has to be the contamination of the food and feed supplies. Pharm plants have two major routes into the food system: seed mixing and pollen flow. Physical mixing of seeds can occur during seed production, on the farm as a result of using the same machinery to plant or harvest both food crops and pharm crops, during seed storage or transport, or at the grain elevator or mill. Such scenarios are not stretch-of-the-imagination projections. It has happened with the GMO corn called Starlink that is approved for animal feed but not human consumption. A large quantity of Starlink corn got mixed into corn for human consumption and processed into various food products. Massive recalls were necessary for the contaminated products.
Pollen flow is a more indirect way of introducing new genes into food, but one that is nearly impossible to stop. Wind-borne pollen from corn (currently the most popular pharm crop) can travel more than 50 yards (and sometimes miles), making possible the fertilization of nearby corn intended for food, by the pharm corn plants. As a result, unsuspecting farmers who did not plant pharm corn could nevertheless wind up with food crops contaminated with drugs, harvest them, and offer them for sale to mills. If seed corn is contaminated with drug genes, farmers could unknowingly plant food or animal feed corn containing biologically active proteins. Canola, which is also being used as a pharm crop, can spread its pollen up to fifteen miles, and not only fertilize other canola plants, but other crop plants including turnip, Chinese cabbage, rutabaga, and fodder rape.
The US Department of Agriculture (USDA) and the Food and Drug Administration (FDA) are the two US governmental agencies with primary responsibility for regulating pharm crops. The USDA oversees the environmental phases of pharm-crop production while the FDA steps in to regulate drug production and purity, clinical testing, and commercialization.
My grocery store, LifeSource Natural Foods in Salem, Oregon, joins many concerned organizations in strongly advocating for Congress, the USDA and FDA to place a moratorium on growing pharm crops until standards and procedures are put into place that ensure zero contamination of the food supply and environment. Here on our local level, the Oregon Chapter of Physicians for Social Responsibility is trying to get the 2005 Oregon Legislature to approve a bill placing a four-year moratorium on any outdoor growing of pharm crops, and the use of any food crops, indoor or outdoor. (For more information about this bill talk with Rick North at 503-968-1520.)
The next wave of agricultural biotechnology—the pharm and industrial crops—is moving fast. These biological factories for a variety of chemical products present the need for important new public policies that demand a vigorous public debate. I write this article in hopes it will help raise the profile of this issue with readers, and engage you in guiding the future of these important new applications of biotechnology.
Resources for more information and activism: websites: UCS.org, OCA.org, FriendsofEarth.org, TheCampaign.org, oregonPSR.org. LifeSource also carries the new Movie: The Future of Food
Alex Beamer owns and operates LifeSource Natural Foods in Salem, Oregon. He can be reached at [email protected].
