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Wednesday, March 17, 2010
Thursday, March 11, 2010
Animal Testing to be a Thing of thePast
Animal Testing May Be on the Decline
A combination of factors, ranging from increased technological capacity to a burgeoning drug pipeline to increased sensitivity appear to be forcing the medical development industry away from its long-term reliance on animal testing, according to landmark reports issued by the U.S. and other governments recently.
“In June of 2007, the National Academy of Sciences released a report called ‘Toxicology Testing in the 21st Century,’ and it ended up saying that animal studies din’t necessarily give you correct results, and that we should begin to look at the use of human cells in culture,” said Dr. Alan Goldberg, MD, PhD, Director of the Center for Alternatives to Animal Testing at Johns Hopkins University.
“Then in February of this year, the EPA and the NIH signed a memorandum of understanding to indicate they would be working together to generate the high-throughput, in vitro data identified in the National Academy report,” Goldberg said. Elias Zerhouni reportedly said that the report heralded the beginning of the end of animal testing.
“That is a landmark report,” said Samantha Dozier, Ph.D. an advisor on medical testing issues with People for the Ethical Treatment of Animals (PETA). “The notion has just begun to permeate regulatory agencies. The EPA just released a draft of their nanomaterials testing plan. The first tier of this plan uses non-animal test methods,” added Dozier.
Regulatory Clarity
While the agencies that regulate medical device development may not specifically mandate animal testing of devices prior to human use approval, FDA’S prior statements have not been as helpful in eliminating the practice, she said. “According to the Office of Device Evaluation, ‘The FDA’s office has no policy requiring animal tests in devices to demonstrate functional performance,’” Dozier said. “The problem is, the agency operates on an informal guidance system, the preferences they state in their guidances always make strong recommendations, and they won’t approve your device unless you’ve done all the recommended tests,” she explained.
The federal agencies may be following the lead of other organizations like the Organization for Economic Cooperation and Development, a 30-member organization of which the U.S. is a member, which validates test methods, or the European Commission on the Validation of Alternate Methods.
The agencies have found that new methods suffice to test devices and drugs without recourse to harmful animal testing. “They’ve found that the Ames test for bacterial reverse mutation can replace animal genotoxicity testing, according to OECD Guideline 471. The in vitro chromosomal aberration test is OECD Test Guideline 473, and Guideline 428 supports a tissue culture skin irritation test for penetration or absorption,” Dozier continued. Another sufficient replacement is the artificial cerebral aneurysm model, which is growing in popularity, she noted.
A combination of factors, ranging from increased technological capacity to a burgeoning drug pipeline to increased sensitivity appear to be forcing the medical development industry away from its long-term reliance on animal testing, according to landmark reports issued by the U.S. and other governments recently.
“In June of 2007, the National Academy of Sciences released a report called ‘Toxicology Testing in the 21st Century,’ and it ended up saying that animal studies din’t necessarily give you correct results, and that we should begin to look at the use of human cells in culture,” said Dr. Alan Goldberg, MD, PhD, Director of the Center for Alternatives to Animal Testing at Johns Hopkins University.
“Then in February of this year, the EPA and the NIH signed a memorandum of understanding to indicate they would be working together to generate the high-throughput, in vitro data identified in the National Academy report,” Goldberg said. Elias Zerhouni reportedly said that the report heralded the beginning of the end of animal testing.
“That is a landmark report,” said Samantha Dozier, Ph.D. an advisor on medical testing issues with People for the Ethical Treatment of Animals (PETA). “The notion has just begun to permeate regulatory agencies. The EPA just released a draft of their nanomaterials testing plan. The first tier of this plan uses non-animal test methods,” added Dozier.
Regulatory Clarity
While the agencies that regulate medical device development may not specifically mandate animal testing of devices prior to human use approval, FDA’S prior statements have not been as helpful in eliminating the practice, she said. “According to the Office of Device Evaluation, ‘The FDA’s office has no policy requiring animal tests in devices to demonstrate functional performance,’” Dozier said. “The problem is, the agency operates on an informal guidance system, the preferences they state in their guidances always make strong recommendations, and they won’t approve your device unless you’ve done all the recommended tests,” she explained.
The federal agencies may be following the lead of other organizations like the Organization for Economic Cooperation and Development, a 30-member organization of which the U.S. is a member, which validates test methods, or the European Commission on the Validation of Alternate Methods.
The agencies have found that new methods suffice to test devices and drugs without recourse to harmful animal testing. “They’ve found that the Ames test for bacterial reverse mutation can replace animal genotoxicity testing, according to OECD Guideline 471. The in vitro chromosomal aberration test is OECD Test Guideline 473, and Guideline 428 supports a tissue culture skin irritation test for penetration or absorption,” Dozier continued. Another sufficient replacement is the artificial cerebral aneurysm model, which is growing in popularity, she noted.
Wednesday, March 10, 2010
Dollar cost comparisons of in vitro and in vivo methods
Toxicity Endpoint Typical Cost Per Assay
Ocular corrosivity/irritation
In vivo test Ocular irritation $1,800
In vitro test Bovine Corneal Opacity and $1,400
Permeability test
Skin corrosivity
In vivo test $1,800
In vitro test:
EpiDerm™ $850
CORROSITEX™ $725
Skin Sensitization
In vivo test: $3,000 – 6,000
In vitro test: LLNA $3,000
Pyrogenicity: In vitro test: $400
In vivo test: Endosafe-IPT $110
Genotoxicity
Chromosomal aberration
In vitro test: $20,000
In vivo test: $30,000
Sister chromatid exchange
In vitro test: $8,000
In vivo test: $22,000
Unscheduled DNA synthesis
In vitro test: $11,000
In vivo test: $32,000
Chart provided courtesy of PETA
Ocular corrosivity/irritation
In vivo test Ocular irritation $1,800
In vitro test Bovine Corneal Opacity and $1,400
Permeability test
Skin corrosivity
In vivo test $1,800
In vitro test:
EpiDerm™ $850
CORROSITEX™ $725
Skin Sensitization
In vivo test: $3,000 – 6,000
In vitro test: LLNA $3,000
Pyrogenicity: In vitro test: $400
In vivo test: Endosafe-IPT $110
Genotoxicity
Chromosomal aberration
In vitro test: $20,000
In vivo test: $30,000
Sister chromatid exchange
In vitro test: $8,000
In vivo test: $22,000
Unscheduled DNA synthesis
In vitro test: $11,000
In vivo test: $32,000
Chart provided courtesy of PETA
Amendment to TOSCA May Drive Alternatives to Animal Testing
By John J. Otrompke, JD
A legislative office working on an amendment to the Toxic Substances Control Act, the Kid-Safe Act, expected to be introduced in 2010, has asked for language to be included that resembles European Union directives that outlaw animal testing in some cases.
People for the Ethical Treatment of Animals [PETA] has been asked to prepare language which may resemble the text of the EU Cosmetics Directive or European Community Directive 86/609, said Catherine Willet, PhD, science policy advisor at PETA.
The 21st century has been a gaining period for those who want end animal testing, with five tests banned in Europe as of 2009. Other aspects of the European cosmetics directive, which does not apply to medicine, food or other chemicals, are still coming into force. For instance, deadlines for animal tests for skin and eye toxicity are in 2013, Willet said.
Another European restriction, directive 86/609, provides that if a non-animal method exists, animals may not be used to test either cosmetics or medical treatments.
“Right now, this represents an opportunity to get new technology in use,” said Willet. “Most testing uses technology from the 1930s, but there’s been a revolution in biology in the last 30 years. We can design tests much more effectively,” she explained.
For instance, L’oreal recently announced a collaboration with Hurel, which has a technique for combining microenzymes with cultures of human cells. “They develop and grow human cells really well in three-dimensional structures tat mimic tissues,” Willet said.
There are hopes that efforts to revise toxic substance testing legislation will drive improvements in the U.S. as well. “In 1976, most chemicals were grandfathered, and the EPA can only ask for information if there is some sign of a problem,” Willet said. This shortfall in TOSCA has led to periodic efforts to reform the rule, such as a proposed amendment in 2008 which did not get any co-sponsors. The latest incarnation, the Kid-Safe Act, is expected to be announced at the ends of February.
PETA hopes that a revision will include more flexible language for testing. “For instance, if instead of saying for every chemical that exists, you have to do a rabbit reproductive test, you could just say, you have to do an evaluation for reproductive toxicity. That kind of language will drive alternative technologies for doing tests,” Willet explained.
A legislative office working on an amendment to the Toxic Substances Control Act, the Kid-Safe Act, expected to be introduced in 2010, has asked for language to be included that resembles European Union directives that outlaw animal testing in some cases.
People for the Ethical Treatment of Animals [PETA] has been asked to prepare language which may resemble the text of the EU Cosmetics Directive or European Community Directive 86/609, said Catherine Willet, PhD, science policy advisor at PETA.
The 21st century has been a gaining period for those who want end animal testing, with five tests banned in Europe as of 2009. Other aspects of the European cosmetics directive, which does not apply to medicine, food or other chemicals, are still coming into force. For instance, deadlines for animal tests for skin and eye toxicity are in 2013, Willet said.
Another European restriction, directive 86/609, provides that if a non-animal method exists, animals may not be used to test either cosmetics or medical treatments.
“Right now, this represents an opportunity to get new technology in use,” said Willet. “Most testing uses technology from the 1930s, but there’s been a revolution in biology in the last 30 years. We can design tests much more effectively,” she explained.
For instance, L’oreal recently announced a collaboration with Hurel, which has a technique for combining microenzymes with cultures of human cells. “They develop and grow human cells really well in three-dimensional structures tat mimic tissues,” Willet said.
There are hopes that efforts to revise toxic substance testing legislation will drive improvements in the U.S. as well. “In 1976, most chemicals were grandfathered, and the EPA can only ask for information if there is some sign of a problem,” Willet said. This shortfall in TOSCA has led to periodic efforts to reform the rule, such as a proposed amendment in 2008 which did not get any co-sponsors. The latest incarnation, the Kid-Safe Act, is expected to be announced at the ends of February.
PETA hopes that a revision will include more flexible language for testing. “For instance, if instead of saying for every chemical that exists, you have to do a rabbit reproductive test, you could just say, you have to do an evaluation for reproductive toxicity. That kind of language will drive alternative technologies for doing tests,” Willet explained.
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