Staring sullenly at passing cars and shaking off flies, the cows at Trans Ova Genetics are indistinguishable from the thousands of others in this remote corner of northwest Iowa. But a red sign near an entrance hints that Trans Ova’s cows are not exactly normal. It reads: “For Bio Security. Authorized Personnel Only.”
In a scenario worthy of a science-fiction story, the cows at Trans Ova are on the cutting edge of the nation’s efforts to defend itself against a potential bioterrorism attack. Trans Ova’s cows have been bred with human genes, cloned and inoculated with such biological agents as anthrax, smallpox and botulism in the hope that they eventually will produce human antibodies that could be administered as an antidote after a biological attack.
“What these animals will make will be the first defense against an anthrax attack,” said Todd Stahl, operations director at Trans Ova’s Genetics Advancement Center.
The Defense Department, which contributed $3.3 million to the Trans Ova project, is also turning to the barnyard for ways to save lives in the event of a chemical weapons attack.
At a decommissioned Air Force base in upstate New York, genetically altered goats are producing a human “bioscavenger” protein that could be injected into people to protect them against nerve agents such as VX and sarin gas. Such inoculations may eliminate the need for soldiers to wear gas masks on the battlefield.
“The potential is for us to respond to these terrorist attacks with innovation,” said Jeff Turner, founder of Montreal-based Nexia Biotechnologies, whose company was awarded a $2.67 million contract from the Army in April. “It all starts with a little goat.”
`Pharming’ industry
The bioterrorism research is an offshoot of the emerging field of animal and plant biotechnology. Known as “pharming,” the idea is to genetically alter plants and animals so they will produce pharmaceutical products, an approach that many believe could be cheaper and more reliable than conventional methods for making drugs.
In the 20 or so years since the industry started, scientists have produced human blood protein in cow’s milk, human growth hormones in mouse urine and a vaccine for E. coli in tomato juice. But as of yet, none of it has been approved for use on humans, an issue that manufacturers attribute to the complexities and high costs of the research and to the vagaries of the approval process.
The U.S. Food and Drug Administration is working on a plan to regulate genetically modified animals for a variety of uses, from drugs to food.
The issues are complex for regulating plant and animal biotechnology. For instance, plants engineered to create medicines have sprouted in fields of standard crops, a problem that has prompted calls for a ban on pharmaceutical plants in areas where food crops are grown.
Genetic engineering also has raised concerns about what would happen if biotech animals escape into the wild, and ethical concerns about how genetic modification affects an animal’s quality of life.
Process unnerves some
Meanwhile, polls indicate that the science of tinkering with an animal’s DNA makes many people uneasy.
“I’m stunned that they are allowed to put human genes in farm animals,” said Peter Rosset, co-director of the non-profit Institute for Food and Development Policy, also known as Food First. “I’m not a religious or spiritual person, but I think some things go beyond the pale, such as creating hybrid organisms that are part human and part cow.”
Rosset said he also considers the research “very dangerous” because of the chance that the animals could escape or become part of the human food chain.
“I’m quite sure that they feel that they have all kinds of safeguards,” he said. “But accidents happen.”
Proponents of plant and animal biotechnology argue that the potential human benefits are enormous and that FDA approval is only a matter of time.
“It is just like any other industry,” said Eddie Sullivan, director of operations at Hematech, one of Trans Ova’s partners in the search for a bioterrorism antidote. “It has to go through a growth phase, learning how to deal with the technology, learning how to marry the technology with what’s needed in the world.
“I think the potential is huge,” he said. “I think it will keep gathering steam.” But he acknowledged that there will be “issues that will have to be overcome.”
The cows at Trans Ova are part of a bioterrorism project developed by Hematech and the pharmaceutical arm of Kirin Brewery of Japan. Researchers hope the science also will be applicable to other diseases, from immune deficiencies to cancer.
It begins with cow ovaries that are collected at local slaughterhouses. The genetic material is sucked out of the cow eggs using a tiny pipette. A cow skin cell, meanwhile, is manipulated to include an artificial chromosome that contains human genes.
The skin cell and egg are placed next to each other and fused. By simulating fertilization with chemicals, an embryo develops from the newly fused cell, and it eventually is transferred to a surrogate cow. Nine months later, cloned calves are born that will produce human antibodies.
Sullivan said the system to produce the calves is “fairly inefficient” — only about 10 to 15 percent of the fused cells are successfully reprogrammed to become a new calf. As a result, the cost of producing a transgenic cow is about $25,000.
Embryos then cloned
Because of the difficulty and cost, the genetically engineered embryos are cloned. “It is simply a tool to produce the herd as rapidly as possible,” he said.
Once a calf is delivered, it is given a vaccine to spur it to develop human antibodies, a key defense against disease and infection.
“The entire premise is we can vaccinate the cows to almost any human disease, a bacteria, a viral or a toxin,” Sullivan said. “We can produce human antibodies against any of those types of human diseases and use those to treat patients.”
Nexia’s Turner said he too is confident about the prospects of his goats producing an antidote to combat chemical weapons.
The goats have been genetically altered to produce significant amounts of a human protein, butyrylcholinesterase, (BChE for short) that is produced naturally in small amounts in human blood. The BChE protein binds to toxins in the bloodstream and negates the toxic effects.
“We know that the goats can produce the human bioscavengers in their milk, and we know we can purify it,” said Turner, adding that the military is testing his product on animals.
While both products require several more years of testing and refinement before they are available for human applications, military officials said initial results from the experiments have been promising.
“This project has met all the Department of Defense milestones,” Pentagon spokesman Jim Turner said of the Iowa project.
