FDA closer to approving biotech salmon, critics furious

(Reuters) - A controversial genetically engineered salmon has moved a step closer to the consumer's dining table after the U.S. Food and Drug Administration said Friday the fish didn't appear likely to pose a threat to the environment or to humans who eat it.

AquAdvantage salmon eggs would produce fish with the potential to grow to market size in half the time of conventional salmon. If it gets a final go-ahead, it would be the first food from a transgenic animal - one whose genome has been altered - to be approved by the FDA.

The AquAdvantage Atlantic salmon egg was developed by AquaBounty Technology to speed up production to meet global seafood demand.

In a draft environmental assessment, the FDA affirmed earlier findings that the biotech salmon was not likely to be harmful. It said it would take comments from the public on its report for 60 days before making a final decision on approval.

"With respect to food safety, FDA has concluded that food from AquAdvantage salmon is as safe as food from conventional Atlantic salmon, and that there is a reasonable certainty of no harm from consumption," the FDA assessment states.

AquaBounty officials said they were caught by surprise by the news that its product was a step closer to approval as years of controversy had followed the company's application for a go-ahead from the regulator. They said they did not know the timing or details of the process the FDA will follow following the 60-day comment period.

"We are encouraged that the environmental assessment is being released and hope the government continues the science-based regulatory process," said AquaBounty Chief Executive Ronald Stotish.

Critics say the new salmon is a "dangerous experiment" and have pressured the FDA to reject it. They say the FDA has relied on outdated science and substandard methods for assessing the new fish.

"We are deeply concerned that the potential of these fish to cause allergic reactions has not been adequately researched," said Michael Hansen, a scientist at the Consumers Union. "FDA has allowed this fish to move forward based on tests of allergenicity of only six engineered fish, tests that actually did show an increase in allergy-causing potential."

There were also concerns the FDA would not require the genetically modified salmon to be labeled as such, and some critics said they may file a lawsuit to prevent what they fear could be the imminent approval of the engineered fish.

"Congress can still keep FDA from unleashing this dangerous experiment," said Wenonah Hauter, executive director of Food & Water Watch, a consumer advocacy group. "Although this latest FDA decision is a blow to consumer confidence, we encourage everyone to contact their members of Congress and demand this reckless decision be overturned."

The Center for Food Safety, another non-profit consumer protection group, was highly critical of the FDA report, and officials said they might sue the regulator over the issue.

"It is extremely disappointing that the Obama Administration continues to push approval of this dangerous and unnecessary product," said Andrew Kimbrell, executive director of the Center for Food Safety. "The GE salmon has no socially redeeming value. It's bad for the consumer, bad for the salmon industry and bad for the environment."

FDA spokeswoman Morgan Liscinsky said no final decisions have been made on labeling or on the application for approval.

"The release of these materials is not a decision on whether food from AquAdvantage Salmon requires additional labeling; nor is it a decision on the new animal drug application currently under review. It also does not provide a final food safety determination," Liscinsky said.

The AquAdvantage salmon would be an all-female population with eggs produced in a facility on Prince Edward Island in Canada and shipped to a "grow-out facility" in Panama, where they would be reared to market size and harvested for processing.

(Editing by Bernadette Baum; and Peter Galloway)

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Analysis: Scientists getting closer to artificial pancreas

French surgeon performs an operation to fit a prosthesis onto a pancreas tumour to facilitate circulation in the biliary tract on a patient in an operating room at the Ambroise Pare hospital in Marseille, southern France March 25, 2008.

Credit: Reuters/Jean-Paul Pelissier

By Julie Steenhuysen

CHICAGO | Fri Jun 24, 2011 5:05pm EDT

CHICAGO (Reuters) - Researchers are coming closer to developing an "artificial pancreas," a long-sought system of insulin pumps and glucose sensors that deliver insulin to diabetics, mimicking the function of a real pancreas.

The devices have been in development for more than three decades, but lawmakers and diabetes advocates are ramping up the pressure and U.S. regulators this week outlined a regulatory path for a preliminary version of the device.

And while a seamless device that tracks a diabetic's blood sugar and automatically administers the right dose of insulin is still years away from commercial use, results of several studies being presented this week at the American Diabetes Association meeting in San Diego show real promise.

In one, researchers from Boston University and Massachusetts General Hospital tested a system using Abbott Laboratories' FreeStyle Navigator continuous glucose monitor and two insulin pumps made by Insulet Corp, all controlled by a laptop.

The system, which is designed to better mimic the body's natural mechanism of controlling both high and low blood sugar, was portable enough to allow adults with type 1 diabetes to roam around a hospital and use an exercise bike.

At the end of the 51-hour study, which involved daily exercise, two nights and six meals -- all of which affect a diabetic's blood sugar levels -- six patients had an average blood glucose in the normal range -- in the high 140s, which is about the equivalent of an A1c reading of about 7.

"It is very good. This is what we would call near normal blood glucose," said Dr. Steven Russell of Massachusetts General Hospital in Boston who is developing the system with Edward Damiano, a biomedical engineer at Boston University.

In another study, a team at Mayo Clinic hooked patients up with devices called accelerometers that tracked movements and found that even moderate exercise plays a role in glucose. The team, led by Yogish Kudva, will incorporate this data into a sophisticated software program that acts as the "brain" of an artificial pancreas system, analyzing blood sugar and calculating when diabetics need a dose of insulin.

The team plans to start a clinical trial with the system this year or early next year, Kudva says.

CLOSING THE LOOP

So-called closed-loop systems -- in which a computer calculates a person's insulin dose and delivers insulin automatically through an insulin pump -- are a far cry from the earliest version of an artificial pancreas developed in the late 1970s, says Dr. Aaron Kowalski of the Juvenile Diabetes Research Foundation or JDRF.

"The problem is it was the size of a refrigerator," said Kowalski, who oversees the group's Artificial Pancreas Project, a multimillion-dollar initiative aimed at accelerating progress toward a closed-loop automated insulin-delivery system .

With that device, patients were hooked up to an IV and could not leave their hospital bed.

Researchers have since been working to develop a so-called artificial pancreas to deliver insulin to patients with type 1 diabetes, an autoimmune disease in which the body destroys its own ability to make insulin, rendering sufferers unable to properly break down sugar.

People with the condition must frequently monitor and take insulin to regulate blood sugar and prevent diabetic complications such as eye damage, kidney failure and heart disease.

An estimated 3 million Americans have type 1 diabetes, usually diagnosed in childhood or in young adults.

The JDRF is working with Johnson & Johnson's Animas unit, which makes insulin pumps, and DexCom Inc, which makes continuous glucose monitoring devices.

Kowalski said nearly five years into the project, researchers are showing promising results, but he is frustrated with the pace of progress.

"People need better tools. Despite insulin pumps and continuous glucose monitors, there are still big challenges in diabetes management," Kowalski said.

The group on Wednesday urged a Senate hearing to call on the FDA to stop delaying the study and approval of an artificial pancreas.

They cited a study published in the British Medical Journal that found that if an artificial pancreas were available, Medicare would save nearly $2 billion over 25 years in costs related to diabetes complications.

The group is pushing to move beyond studies in academic settings and begin studies of the devices outside of the hospital setting.

"It's great that we can do this in academic centers, and we're learning a ton, but we need to get these projects to reach people with diabetes," he said.

"We need to see these products commercialized. That is the big challenge, and that is why we are working with the FDA."

FDA WANTS APPROVAL, TOO

Charles "Chip" Zimliki, chairman of the U.S. Food and Drug Administration's Artificial Pancreas Critical Path Initiative, which was created in 2006 to accelerate the availability of an artificial pancreas system, says he is eager to have a system approved.

"The FDA wants the artificial pancreas on the market as much as anyone else does. We just have to operate within U.S. laws to make sure it is safe and effective," Zimliki said.

Last week, the agency released guidance for how to develop a low glucose suspend system, an automatic shut-off mechanism used with an insulin pump. Medtronic already sells pumps with this the feature in Europe. It safeguards against a dangerous drop in glucose levels by temporarily halting glucose delivery.

By year-end, FDA plans to release detailed guidance on more complicated closed-loop systems, Zimliki said.

"We think of this system, the artificial pancreas, as one unit. There is going to have to be agreement among various companies to determine who is the reporting party for submitting it," he said.

"That is a relatively new idea with respect to these systems."

Zimliki, who is a type 1 diabetic, thinks the first approved devices will be ones that deliver insulin only, but he is very encouraged by the system being developed by the team at Boston University and Massachusetts General.

"They have what I call the Cadillac of closed-loop systems," he said. In addition to delivering insulin, the device also delivers an infusion of glucagon, a hormone released by the pancreas to raise blood sugar levels.

"They are showing some very promising results," he said.

(Reporting by Julie Steenhuysen, editing by Matthew Lewis)

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