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Biotech companies modify plants' genes to produce human proteins

Firms grow new source for medicines

May 23
San Jose Mercury News

A handful of biotech companies are genetically engineering plants to produce human proteins, turning farms into factories for medications aimed at a host of human diseases.

Large Scale Biology in Vacaville uses genes from lymphoma patients at Stanford to grow a customized cancer vaccine in leafy plants that are close cousins to tobacco.

Epicyte in San Diego uses corn to make human antibodies against herpes and human sperm for gels that can block sexually transmitted disease and prevent conception.

These and other companies are betting that transgenic crops, which can produce as much as 40 pounds of a human protein per acre, will replace more expensive fermentation systems that are the industry standard for brewing up human proteins by the vat.

``Plants are the most efficient producers of proteins on the planet,'' said Epicyte President Mich B. Hein. ``They get their energy from the sun and all their nutrients from the soil. They make proteins essentially for free once they are up and going.''

Cost, however, isn't the only reason for choosing plants over the animal cells widely used by biotechnology companies to produce human proteins. Or for choosing plants over cows and goats that have been genetically transformed to produce human proteins in their milk.

Some worry that cattle are vulnerable to hoof and mouth disease, which could quickly wipe out any herd genetically altered to produce therapeutic proteins. And there is concern that animal cells may harbor viruses or other contagions that could infect humans.

``Proteins in plants don't have issues with mad cow disease or hoof and mouth,'' said John McClellan, director of marketing for ProdiGene in College Station, Texas.

The theory behind producing human proteins in plants -- or in animal cells, bacteria or yeast -- is simple: Pluck the gene, a bit of DNA that carries the instructions for making the protein, out of a human cell and insert it into the other species.

Flood of biotech drugs

Now, 25 years after the birth of the biotechnology industry, there are hundreds of human proteins -- many of them antibodies -- in various stages of testing for treating disease. But, for the moment, there are not enough government-approved manufacturing facilities for the expected flood of biotech drugs.

In 1998, Immunex in Seattle launched Enbrel, a modified human protein grown in animal cells for the treatment of rheumatoid arthritis. The drug has been such a huge success -- with sales of $650 million last year -- that new patients must now sign up and wait their turn before starting on the drug. The waiting should disappear next year when the company opens a manufacturing facility in Rhode Island, but not every firm with a promising protein will be able to find the production capacity it needs.

``The people who come out on top will be the people who secure manufacturing,'' said Immunex spokeswoman Robin Shapiro.

Immunex scientists are considering plants as an alternative way of producing future protein products, but, says Shapiro, ``that's a very long way off.''

The capacity problem is a reason why companies working with genetically modified plants are so hopeful these days, although no plant-grown human or animal protein has yet won Food and Drug Administration approval, although a few are in the early stages of testing in patients.

``We won't really know the answer until we get the first one through,'' said Kurt Hoeprich, director of market development for plant-grown biotech drugs at Dow Chemical. Dow is working with Epicyte to grow corn with antibodies against herpes and human sperm.

Researchers at Large Scale Biology have already shown they can make large quantities of human proteins in tobacco-like plants (Nicotiana benthamiana) grown in greenhouses in Vacaville and Kentucky. One of the proteins grown and extracted with a high degree of purity is alpha-galactosidase, an enzyme missing in patients with Fabry's disease, a rare inherited disorder that can lead to heart and kidney failure. The company has no plans to market the human protein; two other companies are racing to do that. ``We're using it as a model for the process,'' said the company's CEO, Robert L. Erwin.

The plant-based companies are aware of the growing protest movement directed against genetically engineered crops, although the plants targeted in those protests were ones altered to deliver their own pesticides. Last year, the agricultural biotech industry was shaken by the news that a pesticide-containing corn called Starlink -- approved for animal feed but not human consumption -- had entered the food supply.

Environmentalists are concerned the same thing might happen with plants containing pharmaceuticals.

Protecting food supply

``Who wants to have a taco that gives you a drug you don't absolutely need?'' asks Rebecca Goldburg, a senior scientist with Environmental Defense.

Large Scale Biology's Erwin says that using tobacco-like plants that aren't like any crop intended for human use and that don't have the human protein genes in pollen or seeds is the best answer.

The companies that are transforming corn say they are being very careful to keep the pharmaceutical crops far removed from fields where corn is grown for human or animal consumption.

Says Epicyte's Hein: ``The bottom line is to produce in areas where the pollen can't spread to other crops.''

GMA says Massachusetts mandatory labeling bill 'unnecessary and redundant'

May 23
Grocery Manufacturers of America press release

The Grocery Manufacturers of America today urged members of the Massachusetts Joint Committee on Commerce and Labor to reject a state proposal requiring mandatory labels for biotech foods.

``The United States Food and Drug Administration (FDA) already regulates the introduction of and labeling of biotech foods,'' said Lisa Katic, director of science and nutrition policy at GMA. ``This makes mandatory state labeling for genetically-enhanced food products unnecessary and redundant.''

In testimony before Massachusetts lawmakers, Katic pointed out that FDA has been reviewing biotech crops for decades and has determined that these foods are as safe or safer than foods developed through crossbreeding and traditional methods. Katic also noted that in addition to FDA review, food biotechnology is regulated for safety and environmental impact by the U.S. Department of Agriculture and the Environmental Protection Agency.

Katic said that while GMA opposes mandatory labeling, the food industry understands consumers want to learn about the benefits of biotech. ``A label is just not the best vehicle to educate consumers about modern biotechnology in a truthful and non-misleading manner,'' said Katic. ``Based on repeated surveys, we know consumers would view the label as a warning. The scientific evidence points in the exact opposite direction. There is simply no basis for sending this type of warning to consumers.''

To ensure that consumers are informed about biotech foods, GMA member companies have made information available through consumer 1-800 numbers, supermarket brochures and through websites such as the Alliance for Better Foods (http://www.betterfoods.org).

``Current U.S. policy on labeling -- based on science -- has consistently served the best interests of consumers. It would be a mistake to make unnecessary changes to that system and begin a process that could lead to an unmanageable patchwork quilt of state regulations on labeling practices,'' concluded Katic.

GMA (http://www.gmabrands.com) is the world's largest association of food, beverage and consumer product companies. With U.S. sales of more than $460 billion, GMA members employ more than 2.5 million workers in all 50 states. The organization applies legal, scientific and political expertise from its member companies to vital food, nutrition and public policy issues affecting the industry. Led by a board of 44 Chief Executive Officers, GMA speaks for food and consumer product manufacturers at the state, federal and international levels on legislative and regulatory issues. The association also leads efforts to increase productivity, efficiency and growth in the food, beverage and consumer products industry.

U.S. consumers undecided on genetically modified food

May 22
BIGresearch press release

When it comes to eating genetically modified foods and other products, for most U.S. consumers the jury is still out according to just released findings from BIGresearch.

In a study conducted by BIGresearch in April, 5,638 consumers exhibited the following response to questions regarding genetically modified food:

"Would you eat genetically modified food products?" 

Yes 23.0% 
No 30.1% 
Undecided 46.9% 

Further analysis on this question showed women to be decisively more undecided than men, 53.1% to 39.1%. It was noted that consumers whose education is college and post college graduate are evenly split between yes, no and undecided. 

"Do you believe genetically engineered food is safe to eat?" 

Yes 23.5% 
No 21.6% 
Undecided 54.9% 

Further analysis on this question showed women to again be more undecided than men, 62.5% to 46.4%.

It was noted on both of these questions that consumers whose education is college and post college graduate are evenly split between yes no and undecided.

``The large percentage of undecided individuals represents an opportunity for providing information to the general public on the social, legal, and ethical issues associated with genetically modified foods. Shortly, The Ohio State University's College of Food, Agricultural and Environmental Sciences will initiate a research effort to evaluate the information desired and needed by the public not only on genetically modified plants and animals, but on other social issues such as water quality, animal rights, livestock odors, waste disposal, foreign ownership of farms and radiated foods'', said William Flinn, Ph.D., President Emeritus of MUCIA (A consortium of the Big 10 Universities.) and a member of the faculty at The Ohio State University College of Food, Agricultural and Environmental Sciences.

It was also found that on a question regarding whether or not the U.S. Government should support human genetic engineering that 42.0% of consumers responded as undecided with women slightly more undecided 44.8% to 37.8%.

``Based upon preliminary results, the verdict is still out on the likelihood of the U.S. public consuming genetically modified foods. This global controversy is in need of more research and analysis to enable the public, government and business sectors to understand its policy ramifications'', said Joe Pilotta, Ph.D., Vice President of BIGresearch.

About BIGresearch:

BIGresearch gathers very large samples from the world's largest online community of over 51 million e-mail newsletter subscribers and employs new computer intensive statistical methods to extract previously unknown, comprehensible and actionable information for crucial business or policy decision-making. www.bigresearch.com.

Blaze damages horticulture center; eco-terrorists suspected

May 22
Seattle Post-Intelligencer

A three-alarm fire that charred academic offices and laboratories at the University of Washington yesterday may have been set by domestic terrorists targeting biogenetic tree research, authorities close to the investigation said.

The blaze began in the office of an associate professor at the Center for Urban Horticulture. His research was previously targeted by unidentified vandals who chopped down his genetically modified poplars during the World Trade Organization meeting in 1999. The fire is being investigated as "suspicious," although the cause has not been determined, investigators said.

Professor H.D. "Toby" Bradshaw said yesterday he found it peculiar that two plastic reptile boxes from his office, where he usually keeps a pair of corn snakes for use in biology lectures, were set under a serviceberry tree, far away from the blaze. That indicated the blaze may have been deliberately set by someone who broke into his office, he said.

The fire, which took firefighters about four hours to contain early yesterday morning, destroyed years of irreplaceable laboratory samples and research specimens and displaced 28 staff members and students from the center's Merrill Hall.

The UW fire hit at nearly the same time yesterday that a poplar nursery near Clatskanie, Ore., was firebombed. The FBI is investigating whether a radical environmental group called the Earth Liberation Front ignited the fire at Jefferson Poplar Farms that destroyed two buildings and several vehicles.

The letters "ELF" were written on the side of a building, as was the phrase "You cannot control what is wild," said FBI spokeswoman Beth Anne Steele.

No one was hurt in either fire, authorities said.

Special agents from the Bureau of Alcohol, Tobacco and Firearms and the FBI in Seattle tried to search gutted botany labs at the UW for arson evidence and indications that would be typical calling cards of radical environmental groups.

The hallmark of so-called "direct action" by the radical groups Earth Liberation Front and Animal Liberation Front is graffiti scrawled on outside walls or interior hallways; and no such graffiti had been discovered at the UW fire scene last night, two sources said.

Nevertheless, investigators think it likely that the fire could be an incident of domestic terrorism. Genetic manipulation of plants and animals is a hot button for both groups. Barring a disgruntled student, "who else is going to burn a facility like this? There is no profit involved," said one federal source familiar with the organizations.

Another source also pointed out that removing the boxes believed to have contained living snakes from a building about to be set ablaze is an act consonant with the philosophy of both groups, which revere animal life.

ELF has not officially claimed responsibility for either fire. But Craig Rosebraugh, Portland-based spokesman for the ELF Press Office, said that he would not be surprised if he received an anonymous communication from someone at ELF in the near future.

Although there have been several acts of domestic terrorism committed by ALF in the state, ELF has been quiescent here. ELF's activities have been focused so far in Oregon. But one source said that there is little distinction between ELF and ALF.

"Many of the people in the groups are the same people," said the criminal justice source. "To a great extent, these groups don't exist. Someone who protests for animal rights during the day puts on a black mask at night, does an illegal act and is ALF for the night."

Some botany students and spectators at the Center for Urban Horticulture yesterday afternoon said that they were perplexed why groups that claim to support the environment would target a researcher who grows trees.

"Rational people do not do this," Bradshaw said.

"If it was a personal scientific dispute, we'd be debating this in a public forum."

Several professors said they were heartbroken about the loss of research they had collected during decades of horticultural study.

"It's looks bad, that's all I can say," said Tom Hinckley, director of the Center for Urban Horticulture, who lost files, documents and class materials in the fire.

Hinckley said that neither he nor any of the staff know whether data can be retrieved from computers that were either burned, soaked or both. He had back-up disks in his desk drawer, as did many professors.

Horticulture supporters also feared for the center's special library, which houses thousands of rare titles, including unique manuscripts dating as far back as the 1500s.

Because firefighters entering the building covered the bookshelves before turning on the hoses, most books were spared.

Especially rare horticultural journals were kept in a temperature- and humidity-controlled room that was built with fireproof walls.

The blaze, however, traveled from Bradshaw's office and lab on the first floor of the building to the ceiling and through the attic.

Biotech to drive chemical sales, report says

May 22
Reuters

Biotechnology products, or products derived from biotech processes, will account for about 30 percent of the $1.5 trillion chemicals market by 2010, a new report from McKinsey & Co. Inc. says.

Companies like Dow Chemical Co. (DOW.N), DuPont Co. (DD.N), DSM N.V.(DSMN.AS), Alusuisse Lonza Group AG (ALUSn.S), Degussa AG (DGXG.DE), Bayer AG (BAYG.DE) and BASF AG (BASF.DE) have already started getting involved in biotech research and development, the consultants said.

They are urging more companies to look at the potentially cost effective and environmentally friendly processes.

"The findings present real challenges for players in the market, not only in areas such as agrochemicals but also in industrial application," Wiebke Schlenzka a McKinsey consultant told reporters at a briefing in Frankfurt on Tuesday.

In the report, the agrochemicals market is seen rising by over one and a half times to $46.2 billion by 2010 from 1998. Plant biotechnology is expected to generate $20 billion of that. 

While sales of fungicides in crop protection are expected to remain stable, insecticides are seen losing about 30 percent of their market share. Half of all herbicides sales will be lost as the number of genetically modified crops increases.

Speaking at the meeting, Hans Kast, the head of BASF Plant Science Holding GmbH said his company was investing 700 million euros  ($607.1 million) in the unit over the next decade.

"We believe that biotechnology has the ability to open up a new world," for agrochemicals, said Kast.

BASF Plant Science is working on potatoes with modified starch composition for use in industrial applications, such as the paper and glue industries, as well as nutrion enriched-plants which are resistant to cold and drought.

It has biological projects to produce vitamins and proteins like lysin for animal feed. Typically, any new project takes five to 10 years to develop, Kast said.

While there is significant resistance to genetically modified organisms in Europe, with 61 percent of the population in Germany against the planting of modified crops, McKinsey predict that this sentiment will subside from 2005 onwards as more evidence from the U.S. GMO's reduces fears.

The consultants also expect biotechnology to play an increasingly important role in industrial chemical processes over the next decade.

Genetically designed enzymes, cells and organisms can produce or modify chemicals.

For example Dow Chemical Co. and DuPont Co. are both separately  working on biopolymers to compete with synthetically produced polyester and nylon. The companies have large production plants to produce the material, which is derived from renewable resources and is biodegradable. 

Future projects could also include areas such as biosteel, the consultants added.

Scientists have isolated and cloned spider silk genes, which they transferred to goats in 1999, to secrete the proteins in their milk. They are now looking to develop a technical spinning process so that spun biosteel can be used as a substitute metal in the construction of earthquake-resistant bridges.

Biotech rice is headed for landfill burial

4.75 million pounds of modified grain dumped because it lacks EPA approval

May 21
Houston Chronicle

One by one Monday, 18-wheel trucks began hauling away nearly 5 million pounds of genetically modified rice from a Brazoria County farm to a landfill for burial.

The rice, the first to be genetically enhanced, was approved by the U.S. Food and Drug Administration and the United States Department of Agriculture, but approval by the Environmental Protection Agency is pending.

Without EPA approval, the rice cannot be served as food, say officials with Aventis CropScience, which developed the biotech rice.

The rice could have been marketed for human consumption had it remained in storage bins until the EPA granted approval, but Aventis wanted to be sure it could properly manage the experimental crop and track its location, said Peg Cherny, a company spokeswoman.

Aventis has been criticized for losing track of some of its genetically modified StarLink corn, which reached consumers before it had received government approval.

Aventis "didn't want to create an issue" with its biotech rice, Cherny said.

The rice has been dubbed "LibertyLink" because it is resistant to Liberty herbicide, a weedkiller commonly used on corn and canola.

The EPA has granted the biotech rice favorable reviews thus far and could grant final approval within a year, Cherny said.

"We understand some people think we're destroying food that some people would benefit from, but that's the way our system is working right now," Cherny said.

Jacko Garrett, a Brazoria County rice farmer who grew the biotech rice under contract to Aventis, said he understands why the company is destroying it.

"If I was Aventis, I would be doing exactly the same thing," he said. "They've got to be extremely cautious with what they're doing."

Still, Garrett -- whose Share the Harvest foundation donates rice to food banks and famine-plagued countries -- wishes he could have given the rice to the hungry.

"It's a shame to waste this food when there's nothing wrong with it," he said. "But we're going to do whatever they ask us to do. It's their rice."

It will take at least a week to haul all of the rice to the landfill.

Harvested last August, about 250,000 pounds will be retained for Aventis to use for testing.

The rest, about 4.75 million pounds, will be buried.

Indian growers target Europe with non-GM soybeans

May 21
Reuters

London - Indian soymeal producers hope to capitalize on European concerns over genetically modified crops after food scares such as mad cow disease have shaken consumer confidence, an Indian delegation said on Monday.

The delegation, sponsored by the Soybean Processors Association of India (SOPA), has met trade officials in Italy, Spain, France, Germany, the Netherlands and Britain to persuade buyers that their soybean meal is non-GM unlike other producers.

``There is no fear about us having a GM presence in our crops,'' Davish Jain, delegation leader and group managing director of the Prestige Group, told a meeting of UK industry officials.

``Nothing like genetically modified organisms exist in our country. We  do not import GM soybeans, and India is encouraging domestic production of non-GM.''

Europe has become increasingly concerned over genetically-modified food, with sensitivities heightened by outbreaks of (BSE) bovine spongiform encephalopathy, more commonly known as mad cow disease, and foot-and-mouth disease.

Many governments have begun to tighten controls over imports, with buyers demanding certificates from producers to say the consignment is non-GM and traceability for the crops to ensure there has been no contamination from GM crops.

``We are likely to stay with non-GM crops in the next few years...if we assure the proper returns for farmers,'' Jain said.

Jain said some South American countries like Argentina may say they can provide non-GM soymeal while also growing genetically modified crops.

Soybean meal has become increasingly important in Europe after BSE spread across the continent, leading to a ban on meat-based animal feed -- believed by many scientists to be the cause of the spread of the disease.

Many consumers have said they would prefer animals to be fed with non-GM feedstuffs.

``Soybean meal is a vital ingredient for livestock and poultry feeds and carries no risk on grounds of health hazard,'' Jain said, adding that India was free of foot-and-mouth that wreaked havoc for agriculture businesses in Britain since the highly infectious livestock disease hit in late February.

``Having successfully carved a niche of its non-GM soy products in South East Asian countries, India is ready and keen to introduce these products in the European markets.''

India mainly supplies Asia with soymeal, but exported 56,000 tons to France and 6,000 tons in 2000. 

Exports range between 2.5-3 million tons a year, Jain said.