22 October 2002

'BIOTECH INDUSTRY ADOPTS PRECAUTION' AND OTHER PHARMING STORIES

1. Biotech industry adopts precaution: ALTERED PLANTS BANNED NEAR MAJOR
FOOD CROPS
2. CONTROVERSIAL BIOTECH CORN NEARS EXTINCTION
3. LA Weekly on pharming

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1. Biotech industry adopts precaution: Altered plants banned near major food crops

Washington Post, October 22, 2002 [via Agnet]
Justin Gillis
http://www.washingtonpost.com/wp-dyn/articles/A61908-2002Oct21.html

Spurred by growing fear that drugs or chemicals made in gene-altered plants will taint the food supply, the North American biotechnology industry is, according to this story, adopting a broad moratorium on planting certain types of crops in major food-producing regions.

The voluntary ban, which goes beyond any proposed government regulation, is designed to prevent the spread of exotic genes into field crops likely to be used for food or animal feed. Its most immediate impact will be to bar companies from planting certain types of gene-altered corn in the Midwest farm belt or from planting some types of the rape plant (from which canola oil is produced) on the Canadian prairie, but the ban could eventually apply to numerous crops and regions.

Michael J. Phillips, executive director for food and agriculture at the Biotechnology Industry Organization, was cited as outlining the new policy in an interview yesterday.

The Washington organization, the trade group of the North American biotechnology industry, formally adopted the plan several days ago, after more than a year of intensive discussions. Word of it has been filtering out to interested groups, but the policy has not previously been disclosed to the public.

The story says that though the policy is voluntary, a dozen companies in the United States and Canada that are trying to produce pharmaceuticals and industrial chemicals in plants have endorsed it, and newcomers would be likely to face strong industry pressure to go along. Phillips was further quoted as saying, "If you are in the Midwest corn belt with a test plot today, you will not be there as a BIO member company in 2003."

The policy, he added, is designed to prevent a recurrence of the debacle that struck the food and biotechnology industries two years ago. Genetically engineered StarLink corn, approved only as animal feed, wound up in taco shells and other food products. No illness was convincingly attributed to the contamination, but recalling the tainted products cost companies hundreds of millions of dollars.

The altered genes in StarLink corn merely made the plant more resistant to insects. Biotech companies have far more ambitious plans: They say plants hold enormous promise as factories for producing drugs. Tests have already shown that human genes inserted into the plants can prompt them to make large quantities of medically useful proteins, which can then be refined and bottled like any other drug. Companies are preparing to test treatments made this way for herpes virus, respiratory disease and a host of other ailments. Useful industrial compounds could be made cheaply by the same techniques. But, the story says, there's growing fear, among environmentalists, food producers and even many biotechnology companies, that the exotic genes in these plants could spread to food crops on nearby farms as pollen is transferred by wind or insects. The industry fears that the ensuing public-relations disaster -- "your heart medicine in my cornflakes," in a common catchphrase -- would kill the technology.

Michael H. Pauly, executive director of biotechnology for Epicyte Pharmaceutical Inc. of San Diego, which is a year away from testing a herpes drug grown in corn, was quoted as saying, "I think we can all agree that this industry cannot afford StarLink II. One incident like that is unacceptable. It's going to require a certain standard of behavior from the entire industry."

A company in Texas is already making an industrial enzyme in corn. But no human drug made this way has come to market, and few companies have gotten past test plantings. For that reason, the policy's near-term impact should be limited, forcing companies to move test plots of gene-altered corn from the Midwest, where a handful were planted this season, to states like Arizona and Hawaii, where corn is not a significant food crop. The bigger impact is likely to come over the next three to five years, as companies draw up plans for commercializing drugs now in the early stages of development. While the moratorium could steer projects to some states, others -- particularly the corn states of the Midwest -- are likely to lose small but valuable drug facilities that they had counted in their long-range economic plans. Already, midwestern secretaries of agriculture who know about the new policy have expressed reservations to BIO.

At the other end of the spectrum, many environmental groups are likely to find the voluntary action insufficient. A coalition of these groups, while acknowledging that the technology holds potential for human health, has called for producing gene-altered food plants only inside strictly segregated buildings, or making drugs only in plants never used as food. Matt Rand, biotechnology campaign manager at the National Environmental Trust in Washington, was quoted as saying, "I'm sure the industry is feeling great about this policy, but I still think it's pretty weak," adding that the public should be especially concerned about a new technology when "even the industry lobby group recognizes that there's a problem."

The U.S. Food and Drug Administration and Department of Agriculture and their counterparts in Canada have been devising policies to manage the risk the crops will pose. Generally, the rules are aimed at separating the biotech crops from field crops enough to prevent gene transfer. The BIO moratorium goes beyond these government requirements, but it does permit continued field tests in many states. It bans plantings only in regions where a particular crop is of considerable economic importance, as measured by the USDA, and is also prone to spreading its genes around.  Corn and the canola plant are among the most promiscuous plants in this way.

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2. CONTROVERSIAL BIOTECH CORN NEARS EXTINCTION

October 21, 2002
Knight-Ridder Tribune [via Agnet]
Bill Hord, Omaha World-Herald, Neb.

LINCOLN -- StarLink corn, the biotech product that created an international flap two years ago, is, according to this story, nearly gone from grain channels, but a bad taste lingers among U.S. corn producers. StarLink corn was developed through genetic alteration to kill insects, saving farmers the millions of dollars they spent on insecticides. In 1998, the U.S. government approved the altered corn for livestock but not human food.

StarLink was genetically altered to have a protein -- Cry9c -- that kills insects, saving farmers the cost of applying insecticides. Scientists weren't sure whether Cry9c could cause allergic reactions, so in 1998, regulators approved StarLink for livestock feed but not human food. Then, in September 2000, StarLink was detected in taco shells. The grain industry moved to locate all StarLink corn, segregate it and contain it. The story says that more than 300 food products were recalled. Some food production was shut down. The company that sold StarLink began paying millions of dollars to cover expenses incurred by farmers and grain handlers to test for StarLink corn and store it separately. Some groups filed class-action lawsuits.

And foreign customers became suspicious of U.S. corn. In all, the StarLink debacle will cost hundreds of millions of dollars, but now, however, the StarLink issue has faded into the background. Steve Moline, assistant attorney general in Iowa, where more StarLink was planted than in any other state, was quoted as saying, "We haven't had a StarLink call in a long time."

In addition, no StarLink has been detected in food products since the winter of 2000-2001. America's No. 1 corn customer -- Japan -- has not detected StarLink in a corn shipment for 17 months.

Last week, the Japanese Starch and Sweeteners Industry Association returned to its pre-StarLink routine of providing corn for soda pop and beer without testing to see whether it was biotech corn.

Larry Bohlem, a spokesman for Friends of the Earth, an environmental group whose independent tests found StarLink in food products and sparked the 2000 scare, was quoted as saying, "This shows a measure of confidence that the U.S. has been able to clean up StarLink."

Cary Sifferath, head of the Japan office for the U.S. Grains Council, which promotes exports around the world, was cited as hailing the Japanese decision as a major breakthrough, adding, "They are coming back to predominantly U.S. corn for starch."

That was a rare piece of good news for a U.S. industry that has embraced genetically engineered crops while most of the rest of the world has not. Currently, all corn and soybean varieties grown in the United States are also approved for use in Japan. But since last April, Japan has required that food containing more than 5 percent biotech products be labeled. Since StarLink, Iowa State University has started a voluntary certification program that commits growers, grain handlers and food processors to a careful system for ensuring that non-biotech crops are as pure as possible. Even then, there are no guarantees.

Neil Harl, an Iowa State University economist was quoted as saying, "Just because you have a stack of certificates, doesn't mean you don't have a problem."

Most non-biotech users tolerate some biotech contamination. In Japan and South Korea, it's 5 percent. But European countries just voted to reduce their tolerance level from 1 percent to 1/2 percent.

The story goes on to say that according to Moline, Aventis has reimbursed $9.5 million to Iowa farmers and $5.5 million to Iowa elevators for their StarLink-related costs under an agreement reached with the attorneys general of 17 states, including Nebraska. The total paid to Nebraska farmers and elevators was not available.

Legal and health questions remain. Although one lawsuit in Illinois was settled for $9 million, of which $2.4 million went to the plaintiffs' attorneys, numerous others have yet to be resolved.

Two studies, one by a panel of scientific advisers to the government and one by the Centers for Disease Control, have found no direct evidence that StarLink has created or would create problems with human health.

But the reports didn't conclude that StarLink definitely would not cause allergic reactions. We may never know. After Aventis pulled its application for approval, the government stopped testing to see if StarLink was a health concern.

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3. LA Weekly on pharming

www.alternet.org/story.html?StoryID=14241
Margaret Wertheim, LA Weekly October 7, 2002

Every now and then science throws us a curve ball, a technology at once staggeringly useful and breathtakingly dangerous.  The most obvious case, of course, is nuclear power.  Down on the farm another revolution is brewing, with proponents promising a radical new way to deliver drugs that could in theory solve some of the world‚s most pressing medical problems. The  potential price - as always - is environmental disaster.

An outgrowth of genetic engineering, the technique has been branded "pharming." Rather than manipulating plants to make a firmer tomato or a sweeter peach, "pharmers" insert genes that instruct a plant to manufacture pharmaceutical compounds.  In the future they envisage, flu shots will be replaced by bananas.  Prozac, anyone?  Try this corn puff.  Pharmers dream that all drugs will ultimately be delivered in snacks.

First out of the pipeline will be vaccines.  In August, industry leader ProdiGene began Phase I  clinical trials for a vaccine against traveller's diarrhoea.  Resulting from a dismal species of E.  coli, the condition is also a prime cause of infant mortality in many poorer nations. Instead of pursuing the regular path of cell-culturing and purification, Texas-based ProdiGene hopes to  deliver a vaccine in a simple kernel of corn.

To understand what is at stake here, consider the case of hepatitis B. Worldwide, that virus kills more than 900,000 people a year, many of them in China, where the disease is at almost  epidemic levels. A dose of hep-B vaccine costs around 50 cents, yet even that˜in quantity˜ is beyond the budgets of many developing countries. Besides the cost of the drug itself, vaccination is hampered by the additional expense of needles and by lack of refrigeration.

Vaccines produced the traditional way cost thousands of dollars a gram, but corn can be grown for 5 cents a pound.  Hoping to tap into the huge hepatitis market, ProdiGene is currently conducting field trials on a strain of transgenic corn that has been spliced with hep-B antigens.

ProdiGene even has its eye on AIDS.  Two years ago the company received a $300,000 grant from the National Institutes of Health to research the possibility of a plant-based vaccine against the HIV virus.  As a test of the concept, company scientists are beginning with the primate version, simian immunodeficiency virus, by splicing into corn the SIV genes responsible for producing a protein called GT120, which is known to trigger antibodies against the deadly  invader.  The NIH itself will conduct the clinical trials, and if all goes well it will move on from there to a human version.

In theory, just about any drug could be engineered in a kernel of corn or a grain of rice.  Earlier this year ProdiGene announced it was scaling up transgenic production of aprotinin, a protease inhibitor used in cardiac surgery.  Traditionally extracted from bovine lungs, aprotinin reduces the need for blood transfusions in patients undergoing bypass surgery.  Once the initial splicing is done, such transgenic crops can be grown anywhere, from Nebraska to Nigeria.

Pharmers are also looking to actual farms.  Every year millions of animals have to be vaccinated at enormous expense to their owners and considerable stress to the creatures. Transmissible gastroenteritis virus (TGEV), for example, is a highly contagious disease that kills infant pigs. Clinical trials by ProdiGene have shown that in principle plant-based vaccines can be effective against this pathogen.  As with many biotech products, the development of transgenic vaccines will be driven initially by the demands of animal husbandry.

To protect our health, we have fluoride in our water and iodine in our salt; why not deliver codeine in corn flakes, Wellbutrin in Ho Ho’s? The problem, says Norman Ellstrand, a plant geneticist at UC Riverside, is that transgenic crops are incredibly difficult to isolate.  Scientists now know that genes are routinely passed among plant species, and "gene flow" from genetically manufactured (GM) organisms to wild varieties has been documented all over the world.

That‚s bad enough when a gene involved conveys herbicide resistance, but when you‚re talking about genes for proteins and hormones, the potential for disaster is enormous˜both  for human health and the environment. "We need to be assured of zero tolerance," Ellstrand says, but that’s almost impossible to guarantee.

Genes aren‚t the only things that are hard to contain. Remember the Starlink debacle, when GM maize intended for animal feed found its way into taco shells? Imagine if the modified grain had contained a drug˜any drug. With vast amounts of grain being shipped around the world, Ellstrand believes it won‚t be possible to prevent such mix-ups. Sooner or later, innocent folk  chewing down on corn chips or sesame buns are going to find their bloodstreams coursing with aprotinin or swine vaccine or God knows what else.  According to Jane Rissler of the Union of Concerned Scientists, „The food industry is apoplectic about the possibility of this stuff getting  into the food supply.‰ Rissler and Ellstrand argue that pharming should be strictly limited to non-food crops˜to, say, tobacco or castor beans.

In the developed world, where drugs can be delivered in so many other ways, it seems hard to justify the risk of pharming˜as with nuclear power, we really do have alternatives.  But in the developing world, millions of people die each year from preventable diseases for lack of very basic drugs. That at least is the argument pushed by the biotech industry.  Yet just as people are challenging the GM solution to Africa’s food crisis, so, Rissler says, the Third World’s health problems are not going to be solved by cutting-edge technology.

The idea of helping the Third World with transgenic vaccines is little more than "a ruse," Rissler believes. "It’s selling biotechnology on the back of the poor," by attempting to make it palatable to well-off folks like us.  Rissler points out that to be medically effective drugs have to be delivered in the right dose.  How would people know how much they were supposed to eat? A whole banana, half a banana? Who‚s to say? More critical, how could you be sure that people wouldn‚t overdose? How would you even know you were eating the right variety? After all, a genetically modified banana looks the same as a regular one.  Rissler is sceptical of the medical miracle promised by companies like ProdiGene and suspects that a lot of the blue-sky ideas being bandied about will "never see the light of day as commercial products."

Behind the hype about cheap drugs, Rissler and Ellstrand note that the pharming industry is quietly pursuing a much bigger goal˜engineering into plants genes that encode for all manner of industrially useful compounds, from enzymes to solvents.  Since these don‚t qualify as drugs, they are not regulated by the Federal Drug Administration, and very little information is publicly available about what is going on here.  Earlier this year the U.S. Department of Agriculture updated its guidelines for industrial pharming, but many scientists believe these are  grossly inadequate.

USDA spokesman Jim Rogers acknowledges that „Nobody‚s going to know all the possible risks.  But, he says, "We mitigate these risks to what we feel is appropriate." In the department’s view, "There are adequate safety provisions in place." Not according to Rissler, who opines that "The USDA’s oversight is way too lax."  Given the enormous potential dangers, Rissler insists there ought to be external scientific oversight as well.  What most appals Ellstrand, who sat on a National Academy of Sciences committee that reviewed the regulations for GM crops, is that companies do not have to disclose what genes they are adding, or even what organisms the genes derive from ­ that’s "confidential business information."

Quietly and stealthily, our fields are being turned into industrial factories.  This is potentially the most dangerous technology since nuclear power, yet we have no way of finding out what is being done. It’s yet another way in which for the present administration, Business comes first.