A slow-moving U.S. project to manufacture anti-diarrhea medicine using the milk of transgenic goats is getting a new start in Brazil, where it is receiving heavy funding from the surging South American power.
Researchers at the University of California, Davis, plan to ship goat semen to the Brazilian state of Ceará, where local scientists have received $3.5 million from Brazil’s government to establish a herd of transgenic goats and initiate human trials on their milk.
The Brazil case illustrates how anti-biotech sentiment in the U.S. may be pushing some biotechnologies toward the developing world, where science budgets are growing and scientists are eager to master these new technologies. “In Brazil you have a country that is forward-thinking, and [has] put into place the regulatory apparatus,” says James Murray, a professor at UC Davis who developed the technology for creating goats whose milk is loaded with human proteins that kill bacteria responsible for diarrhea.
Murray says one factor that weighed in the decision to transfer the technology was the long delay by the U.S. Food and Drug Administration in deciding how to regulate engineered food and dairy animals. The FDA studied the question for more than 10 years before issuing its guidance to manufacturers in January 2009, by which time Murray was already in discussions with colleagues in Brazil.
No transgenic animal has yet been approved for use as food anywhere in the world. The FDA is currently weighing its first application, by AquaBounty Technologies, to commercialize a variety of transgenic Atlantic salmon engineered to grow twice as quickly as unaltered salmon. However, the genetically modified salmon, dubbed “Frankenfish” by opponents, have generated substantial controversy in the United States.
Such sentiments weigh on American laboratory research, too. The goat project has been underway at UC Davis for “a couple of decades,” says Murray. It started with experiments using mice. But U.S. support for the idea has hardly been overwhelming. Murray says the project currently survives on a $400,000, three-year grant from the U.S. Department of Agriculture to assess the risks of transgenic animals. “The only money available is to look at environmental safety. It’s a backwards way of funding the research,” says Murray. “We haven’t gotten enough to move the research forward; we are four or five years behind where we should be.”
The view is different in Brazil, a country that is dedicating growing resources to research and development–now about 1.3 percent of its gross domestic product, according to official figures–and is keen to prove it can handle cutting-edge technology.
The Brazilian side of the project is led by professor Aldo Lima of the Federal University of Ceará, and includes a husband and wife team, Luciana and Marcelo Bertolini, who previously worked in Murray’s California lab. According to Lima, Brazil’s Ministry of Science and Technology sought out the researchers as part of a thrust to invest more in biotechnology in underdeveloped regions of Brazil.
The herd will be established by crossing the animals at UC Davis with local goats adapted to tropical conditions. “We were making slow progress, so when it came about that the Brazilians thought it was a good idea to fight diarrhea with [genetic engineering], we decided to contribute the technology,” Murray says.
Although diarrhea isn’t of much concern in the U.S., it’s precisely the kind of challenge that Brazilian scientists need to justify growing investments in R&D. Writing in the journal Nature last year, Luiz Castro, a secretary with the Ministry of Science and Technology, noted that a major problem facing genetics research in Brazil is “the perception that the gene revolution has failed to reach the problems of the poor.”
In Brazil’s poor, arid, northeast region, infant mortality rates remain high. In Ceará, home to the research project, 27 of every 1,000 children die in infancy, a rate four to five times higher than that in the United States. Overall in Brazil, diarrhea is the fifth or sixth most common killer of children under five. Diarrhea kills by draining the body of water and electrolytes, such as sodium and potassium. Standard treatment is rehydration therapy to replace the body’s water supply, and zinc tablets.
The goats created in Murray’s lab have been engineered to express large amounts of human lysozyme, a protein found in human milk, tears, and saliva that destroys the cell walls of bacteria. “What we are trying to do is create a milk that would lessen the chance of the diarrhea organism being established,” says Murray.
With the Brazilian scientists, the team plans to create goats that carry additional genes, including those for lactoferrin, a human milk protein that binds the iron molecules which bacteria need to grow.
Lima, who runs a clinical testing center, says the milk could enter human trials in elementary school children within two years. If it proves effective, the Brazilian researchers hope they can powder the milk and export it around Latin America and to Africa.
Although Brazil is eager to finance the study, the country brings its own challenges, including a famously slow-moving bureaucracy. A government ban on the importation of goat semen kept the researchers waiting over a year to obtain the samples from California that they needed to establish the new herd. In the meantime, they have been carrying out laboratory tests on milk imported from California.
Murray says he’s happy the technology has found a home. “I think it’s brilliant,” he says. “We want to see it used. We don’t care which country does it.”