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Scientists fret over FDA slowness on genetically altered animals

Approval of foods from genetically modified animals is unjustifiably slow, scientists say; some are looking abroad.

October 01, 2012|By Rosie Mestel, Los Angeles Times
  • AquaBounty's genetically modified salmon, rear, is shown with an unmodified salmon of the same age.
AquaBounty's genetically modified salmon, rear, is shown with an… (AquaBounty Technologies )

Scientists have created a genetically modified milk that lacks a key protein involved in triggering allergies — an impressive technical feat that won plaudits in the biotechnology world.

But the development, published Monday in the journal Proceedings of the National Academy of Sciences, isn't likely to lead soon to less-allergenic milk. The process for getting government approval to sell food derived from genetically engineered animals appears to be a hopeless logjam.

A salmon with designer DNA has been in regulatory limbo since the Food and Drug Administration concluded that the fish appeared to be safe and without environmental risk two years ago. The company behind the fish, AquaBounty Technologies, is still waiting for the final regulatory steps and a sign-off from the FDA.

A herd of so-called enviropigs engineered to digest plant phosphorus more efficiently — cutting feed costs as well as levels of polluting phosphorus in their manure — was euthanized this year because of funding difficulties and public wariness about genetically modified organisms. Cell and semen samples have been banked in cold storage until the regulatory climate and societal attitudes improve, according to the Canadian scientist who was in charge of the project.

Goats that produce a protein in their milk that can help fight diarrhea in young children are being moved from California to Brazil for commercial development in what some scientists see as a more biotechnology-friendly locale.

Scientists are working on a range of products in various stages of development, including virus-resistant chickens, meat with healthier fat and mastitis-resistant dairy cows that would require fewer antibiotics.

But the slow pace of progress on AquaBounty's application has had a chilling effect on animal biotech efforts — which are conducted in academic laboratories and small companies, not by the multinational corporations that develop genetically modified plants. Efforts have been foundering for lack of funding, or moving overseas.

AquaBounty Technologies has enough money to survive until the end of January, said Ronald Stotish, president and chief executive of the company, based in Maynard, Mass.

In frustration, more than 50 scientists and biotechnology leaders sent a letter to President Obama last month asking him to urge the FDA to move forward on the AquaBounty salmon decision.

"There is much more at stake here than just a fish," the scientists wrote.

UC Davis animal geneticist James Murray was one of those who signed the letter. He has engineered goats to produce the human protein lysozyme in their milk, which helps shape the bacterial flora in the gut and improve gastrointestinal health. Should his goats or someone else's transgenic animals come before the FDA, "we need them to make a decision," he said. "We need the political process to allow the science-based regulatory process to work."

Murray said he had arranged to move his transgenic goats to Brazil for development there because he saw no opportunity for regulatory approval or funding in the United States in the near future.

The new study on hypoallergenic cow milk was conducted at AgResearch in Hamilton, New Zealand, a government-owned research institution. Scientists genetically engineered cow cells to suppress the gene for a protein in whey — called beta-lactoglobulin, or BLG — that is present in cow milk but not in human milk.

Beyond creating milk that was less likely to cause allergies, the scientists wanted to understand the function of BLG in milk, an extremely complicated fluid packed with proteins, fats and sugars.

To remove the protein, the scientists engineered cow cells to make tiny RNA molecules that would interfere with the activity of the BLG gene, effectively silencing it. Then they used cloning technology to create a female calf from the genetically modified cells. Analysis of a small amount of milk obtained from the calf through hormonal induction found no traces of BLG.

For reasons the scientists do not understand, the milk contains elevated levels of a group of other proteins called casein, which also can trigger an allergic reaction. But that could be helpful for cheese-making, they said.

The calf is now about 11 months old, and the scientists intend to breed it next year so they can analyze the milk more extensively, said study coauthor Stefan Wagner, an animal geneticist at AgResearch. Among other things, they plan to see how it differs from conventional cow milk and test its allergy-reducing potential in mice, he said.

Dr. Robert Wood, director of pediatric allergy and immunology at Johns Hopkins Children's Center in Baltimore, said he doubted the milk in the study would help his patients. Though it's true that many children can't tolerate BLG, they usually are allergic to a variety of milk proteins, including casein. The higher casein therefore presents "probably the worst-case scenario for most of our patients," he said.

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