One of the most insidious things about FDA regulation is that the people harmed don't even know it, since the advances that would've saved them never make it to market in the first place.
"But in a prime example of both the democratization and demonetization of technology, Ishee taught himself to do genetic engineering right in his own backyard shed, using a kit and some DNA he ordered online.
“I think every dog breeder wants better tools than just breeding. But everybody assumes it’s impossible, or crazy expensive, so I never considered actually trying,” Ishee said. That changed after he saw a TED talk about genetic engineering, namely because of the ease and low cost of ordering custom synthesized DNA.
He continued, “The biggest thing here is the collapsing price of DNA sequencing and synthesis. You can order synthetic DNA for about nine cents a base pair. When I ordered my construct a year and a half ago, I paid 23 cents a base pair. Six years before that it would’ve been $1.30 a base pair. When it gets down to pennies, people will be able to do much more complex things.”
It’s this very idea, though—of anyone being able to do complex gene editing at home with supplies ordered online—that’s caused a tightening of regulations, most recently from the FDA.
As of mid-January, the FDA updated its guidance for animals produced using genome editing to classify the edited portion of the animal’s genome as a veterinary drug. This means the animals themselves are subject to the same regulations as new animal drugs.
While acknowledging that genome editing technology could have “potentially profound beneficial effects on human and animal health,” the FDA statement also mentions possible unwanted impacts on the environment and ecosystem, as well as on individual genomes.
The new guidelines threw a wrench into Ishee’s next project: to use gene editing to rid dalmations of hyperuricemia. A mutation on the dogs' SLC2A9 gene leads to excess uric acid in the blood, which causes painful bladder stones to form and can even cause the bladder to burst.
To breed out this mutation, a breeder would have to wait for a positive mutation to randomly appear—and since it’s a closed and inbred population, that could take decades. CRISPR gene editing could do it in months.
Besides a series of complex approvals and permissions, though, the FDA regulations also involve hefty fees, reaching into six figures per animal. It’s a sum that’s feasible for a large corporation, but not so much for a breeder. No large corporation is likely to take on projects similar to Ishee’s, because there’s not much money to be made. If pet owners are happy—or unaware—as is, why invest in creating healthier dogs?"
https://singularityhub.com/2017/02/26/would-you-want-a-dog-that-was-genetically-engineered-to-be-healthier/?utm_content=buffer6da0e&utm_medium=social&utm_source=facebook-hub&utm_campaign=buffer
"But in a prime example of both the democratization and demonetization of technology, Ishee taught himself to do genetic engineering right in his own backyard shed, using a kit and some DNA he ordered online.
“I think every dog breeder wants better tools than just breeding. But everybody assumes it’s impossible, or crazy expensive, so I never considered actually trying,” Ishee said. That changed after he saw a TED talk about genetic engineering, namely because of the ease and low cost of ordering custom synthesized DNA.
He continued, “The biggest thing here is the collapsing price of DNA sequencing and synthesis. You can order synthetic DNA for about nine cents a base pair. When I ordered my construct a year and a half ago, I paid 23 cents a base pair. Six years before that it would’ve been $1.30 a base pair. When it gets down to pennies, people will be able to do much more complex things.”
It’s this very idea, though—of anyone being able to do complex gene editing at home with supplies ordered online—that’s caused a tightening of regulations, most recently from the FDA.
As of mid-January, the FDA updated its guidance for animals produced using genome editing to classify the edited portion of the animal’s genome as a veterinary drug. This means the animals themselves are subject to the same regulations as new animal drugs.
While acknowledging that genome editing technology could have “potentially profound beneficial effects on human and animal health,” the FDA statement also mentions possible unwanted impacts on the environment and ecosystem, as well as on individual genomes.
The new guidelines threw a wrench into Ishee’s next project: to use gene editing to rid dalmations of hyperuricemia. A mutation on the dogs' SLC2A9 gene leads to excess uric acid in the blood, which causes painful bladder stones to form and can even cause the bladder to burst.
To breed out this mutation, a breeder would have to wait for a positive mutation to randomly appear—and since it’s a closed and inbred population, that could take decades. CRISPR gene editing could do it in months.
Besides a series of complex approvals and permissions, though, the FDA regulations also involve hefty fees, reaching into six figures per animal. It’s a sum that’s feasible for a large corporation, but not so much for a breeder. No large corporation is likely to take on projects similar to Ishee’s, because there’s not much money to be made. If pet owners are happy—or unaware—as is, why invest in creating healthier dogs?"
https://singularityhub.com/2017/02/26/would-you-want-a-dog-that-was-genetically-engineered-to-be-healthier/?utm_content=buffer6da0e&utm_medium=social&utm_source=facebook-hub&utm_campaign=buffer