If approved AquAdvantage would be the first GE animal greenlighted for human consumption.
By Ari LeVaux, AlterNet
Posted on March 7, 2012
AquaBounty Technologies, maker of genetically engineered salmon, is almost out of money. It's been more than two decades since the prototype of its AquAdvantage salmon was spliced into existence, and a decade since AquaBounty applied for FDA approval, but the fish remains on the sidelines of a salmon-hungry market.
The approval process is the first use of FDA's guidelines for GE animals, and if approved AquAdvantage would be the first GE animal greenlighted for human consumption. Further complicating matters, the FDA chose to treat the salmon as a "New Animal Drug," rather than a food. The drug per se is the genetically engineered part of each piece of AquAdvantage DNA, and is found in every cell of the fish.
The AquAdvantage salmon is an Atlantic salmon with genes inserted from a Chinook salmon and an ocean pout. The Chinook gene codes for growth hormone, and the pout gene keeps the Chinook gene locked in the "on" position. The extra growth hormone helps the AquAdvantage salmon reach market size twice as fast as non-GE salmon.
The approval process hasn't moved significantly since September 2010, when FDA announced it would redo a previous environmental assessment on the fish. The assessment is problematic because the fish aren't produced in the U.S. Eggs fertilized on Prince Edward Island, Canada, are shipped to a containment facility in interior Panama.
Meanwhile, the regulation of AquAdvantage salmon as a new animal drug, rather than as food, is causing side effects of its own. On February 8, an alliance of consumer advocacy groups submitted a petition to FDA requesting that AquAdvantage salmon be regulated as a food.
FDA regulation as a food additive is called for, says the petition, in cases where "breeding or selection through genetic engineering reasonably expects to alter the substance's nutritive value or the concentration of constituents."
One such constituent is IGF-1, a hormone found in some animal products that's linked to cancer in high doses. The petitioners suspect AquAdvantage salmon of harboring elevated levels of IGF-1, and challenge AquaBounty's claim that IGF-1 levels in AquAdvantage salmon are no greater than in normal salmon. The petition says AquaBounty's own data suggest IGF-1 levels could be higher in the GE salmon.
Since the fish is being considered as a new animal drug, the scientific issues around AquAdvantage salmon are being reviewed by FDA's Veterinary Medicine Advisory Committee (VMAC). The VMAC has been criticized for not containing experts in relevant fields, like allergenicity, or endocrinology. "Most of the people on VMAC are veterinarians that deal with large animals," said Michael Hansen, chief scientist of the Consumers Union, by phone.
Two weeks before the most recent VMAC meeting, in September 2010, FDA announced it considered AquAdvantage salmon to be safe. Huge public protests filled the unusually short 14-day comment period that followed. At the September VMAC meeting it was announced that a new environmental assessment would be done.
According to the transcript of the VMAC meeting, Dr. Gary Thorgaard of Washington State University said: "I would not feel alarmed about eating this kind of fish certainly. I am not worried about it." Nonetheless, Thorgaard, a fish geneticist, voiced concern about the environmental risk of an AquAdvantage salmon escaping into the wild, and endorsed the idea of a new EA.
Earlier in the meeting Dr. Erik Silberhorn, who produced an environmental safety assessment on behalf of AquaBounty, was asked for information on native fish and amphibians in the area surrounding the grow-out facility in Panama.
"No I do not have information on native fish ..." Silberhorn replied. "The assessment of the local environment is still under the jurisdiction of the Panamanian government, and the same thing would occur in Canada."
It's appropriate that Panama and Canada should be in charge of protecting their own environments. But will they? And when the "drugs" in question can swim thousands of miles across international borders and potentially mate with fish from elsewhere, a fish pharm becomes a matter of global reach and responsibility. If it gets approved in Panama, where will the next facility be?
AquaBounty's method for sterilizing its salmon is 98.9 percent effective, according to its own data. The environmental significance of that fertile 1.1 percent was compelling enough to help AquaBounty get a $500,000 FDA grant, in September 2011, to improve its sterilization practices.
Oddly, the sterility numbers the company reports far exceed the FDA requirement of 95% sterility. If the company is already exceeding the threshold by nearly four percentage points, why would it need grant money to further improve sterility techniques?
Things aren't adding up on AquaBounty's balance sheet either. On March 22, shareholders will vote on a proposed restructure to trim costs, raise operating capital, and continue waiting out the FDA approval process. A private sale of stock to company insiders will raise enough funds to float the company for 10 months more of its upstream voyage.
AquaBounty acknowledged in a February 22 letter to shareholders it "does not expect significant sales until 2014 and thus anticipates a need to raise further funds before that time." This raises the question: why fundraise for 10 months when you need, in a best-case scenario, about two years?
AquaBounty stock currently sits at $4 a share, down from $150 in 2006, when the company went public. The last time ABTX showed any life was in August, 2010, when the FDA announced it considered AquAdvantage safe. The stock had shot from $4 to $25 in days, before settling back down after the VMAC meeting, two weeks later, when the significance of a new EA set in.
More positive remarks from FDA could send the stock back up again, giving AquaBounty the opportunity to raise more capital. Maybe that's what AquaBounty is hoping will happen in the next ten months. Or perhaps the company is biding its time to see who wins the election, or is waiting for another FDA grant to come in. Or maybe 10 month's worth is all the money AquaBounty could raise at this juncture, which wouldn't bode well for its future stability.
AquaBounty did not respond to requests for comment, so we're stuck guessing why, after a 23-year haul, it's kicking the can ten months down the road.
By Ari LeVaux, AlterNet
Posted on March 7, 2012
AquaBounty Technologies, maker of genetically engineered salmon, is almost out of money. It's been more than two decades since the prototype of its AquAdvantage salmon was spliced into existence, and a decade since AquaBounty applied for FDA approval, but the fish remains on the sidelines of a salmon-hungry market.
The approval process is the first use of FDA's guidelines for GE animals, and if approved AquAdvantage would be the first GE animal greenlighted for human consumption. Further complicating matters, the FDA chose to treat the salmon as a "New Animal Drug," rather than a food. The drug per se is the genetically engineered part of each piece of AquAdvantage DNA, and is found in every cell of the fish.
The AquAdvantage salmon is an Atlantic salmon with genes inserted from a Chinook salmon and an ocean pout. The Chinook gene codes for growth hormone, and the pout gene keeps the Chinook gene locked in the "on" position. The extra growth hormone helps the AquAdvantage salmon reach market size twice as fast as non-GE salmon.
The approval process hasn't moved significantly since September 2010, when FDA announced it would redo a previous environmental assessment on the fish. The assessment is problematic because the fish aren't produced in the U.S. Eggs fertilized on Prince Edward Island, Canada, are shipped to a containment facility in interior Panama.
Meanwhile, the regulation of AquAdvantage salmon as a new animal drug, rather than as food, is causing side effects of its own. On February 8, an alliance of consumer advocacy groups submitted a petition to FDA requesting that AquAdvantage salmon be regulated as a food.
FDA regulation as a food additive is called for, says the petition, in cases where "breeding or selection through genetic engineering reasonably expects to alter the substance's nutritive value or the concentration of constituents."
One such constituent is IGF-1, a hormone found in some animal products that's linked to cancer in high doses. The petitioners suspect AquAdvantage salmon of harboring elevated levels of IGF-1, and challenge AquaBounty's claim that IGF-1 levels in AquAdvantage salmon are no greater than in normal salmon. The petition says AquaBounty's own data suggest IGF-1 levels could be higher in the GE salmon.
Since the fish is being considered as a new animal drug, the scientific issues around AquAdvantage salmon are being reviewed by FDA's Veterinary Medicine Advisory Committee (VMAC). The VMAC has been criticized for not containing experts in relevant fields, like allergenicity, or endocrinology. "Most of the people on VMAC are veterinarians that deal with large animals," said Michael Hansen, chief scientist of the Consumers Union, by phone.
Two weeks before the most recent VMAC meeting, in September 2010, FDA announced it considered AquAdvantage salmon to be safe. Huge public protests filled the unusually short 14-day comment period that followed. At the September VMAC meeting it was announced that a new environmental assessment would be done.
According to the transcript of the VMAC meeting, Dr. Gary Thorgaard of Washington State University said: "I would not feel alarmed about eating this kind of fish certainly. I am not worried about it." Nonetheless, Thorgaard, a fish geneticist, voiced concern about the environmental risk of an AquAdvantage salmon escaping into the wild, and endorsed the idea of a new EA.
Earlier in the meeting Dr. Erik Silberhorn, who produced an environmental safety assessment on behalf of AquaBounty, was asked for information on native fish and amphibians in the area surrounding the grow-out facility in Panama.
"No I do not have information on native fish ..." Silberhorn replied. "The assessment of the local environment is still under the jurisdiction of the Panamanian government, and the same thing would occur in Canada."
It's appropriate that Panama and Canada should be in charge of protecting their own environments. But will they? And when the "drugs" in question can swim thousands of miles across international borders and potentially mate with fish from elsewhere, a fish pharm becomes a matter of global reach and responsibility. If it gets approved in Panama, where will the next facility be?
AquaBounty's method for sterilizing its salmon is 98.9 percent effective, according to its own data. The environmental significance of that fertile 1.1 percent was compelling enough to help AquaBounty get a $500,000 FDA grant, in September 2011, to improve its sterilization practices.
Oddly, the sterility numbers the company reports far exceed the FDA requirement of 95% sterility. If the company is already exceeding the threshold by nearly four percentage points, why would it need grant money to further improve sterility techniques?
Things aren't adding up on AquaBounty's balance sheet either. On March 22, shareholders will vote on a proposed restructure to trim costs, raise operating capital, and continue waiting out the FDA approval process. A private sale of stock to company insiders will raise enough funds to float the company for 10 months more of its upstream voyage.
AquaBounty acknowledged in a February 22 letter to shareholders it "does not expect significant sales until 2014 and thus anticipates a need to raise further funds before that time." This raises the question: why fundraise for 10 months when you need, in a best-case scenario, about two years?
AquaBounty stock currently sits at $4 a share, down from $150 in 2006, when the company went public. The last time ABTX showed any life was in August, 2010, when the FDA announced it considered AquAdvantage safe. The stock had shot from $4 to $25 in days, before settling back down after the VMAC meeting, two weeks later, when the significance of a new EA set in.
More positive remarks from FDA could send the stock back up again, giving AquaBounty the opportunity to raise more capital. Maybe that's what AquaBounty is hoping will happen in the next ten months. Or perhaps the company is biding its time to see who wins the election, or is waiting for another FDA grant to come in. Or maybe 10 month's worth is all the money AquaBounty could raise at this juncture, which wouldn't bode well for its future stability.
AquaBounty did not respond to requests for comment, so we're stuck guessing why, after a 23-year haul, it's kicking the can ten months down the road.
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