Re. this: "Trevor Klee...realized this would be too expensive to do in humans in the current funding environment, and has pivoted to getting his medication approved for a feline autoimmune disease as both a proof-of-concept and as a cheaper, faster way to start making revenue. ... He still anticipates eventually moving back to humans."
This is a very common trap. I don't know of a single case where it worked out for the humans. A company wants to develop a drug for humans, but FDA approval is too expensive, so they get it approved in dogs, horses, or cats, thinking they'll make enough money to push it through approval for humans. They never do; it's hard enough to keep a new pet-drug business above water. Then their patent expires, and the drug will never, ever be approved for humans, because nobody will pay for FDA approval of an unpatentable drug.
Until just a few years ago, this was almost acceptable, because you could go to Agway or a foreign website and buy the drug for your dog and take it yourself. But governments and industry have taken EXTREMELY aggressive steps in the past few years to prevent this.
An example is Adequan. It temporarily cures arthritis in humans. It cures arthritis in me! But it will never, ever be legal for humans in the US or Europe, because it was developed in the 1980s and the patent expired long ago. But it is approved for dogs, horses, and pigs in the US.
Until very recently, I could easily buy it over-the-counter in any country but America, or order it thru ebay or from any overseas veterinary website. But organizations have just taken many steps to prevent any humans from taking Adequan, including:
- turning it into a prescription-only drug in all Western nations
- (I presume) prosecuting online pharmacies that don't comply (as they all suddenly went out of business or stopped selling it)
- purging overseas pharmacies that sell it over-the-counter from search engine results
- purging pharmacies that sell it without prescription from TrustPilot listings
- creating an organization to rate the "safety" of online pharmacies, which actually rates their compliance with import regulations
- investigating ebay sales of Adequan to verify possession of a veterinary prescription
- banning ebay users who sell it to people who have no such prescription
- delisting Adequan sales on ebay entirely
- in my state, creating laws for dog licensing that forbid veterinarians from treating unlicensed dogs, and forbid licensing dogs without proof of legal ownership of the dog, including an investigation process to verify possession of alleged stray dogs, so that you can't even get Adequan by borrowing your neighbor's arthritic dog, licensing it, and taking it to the vet to get Adequan (I tried)
I can't think of any reason anyone might have to prevent people from taking Adequan, so I think it's just part of a general tightening of access to veterinary drugs, which has been going on for about the past 5 years. The drugs for which doing this makes some sense -- antibiotics -- were left for last, but the US govt. has finally gotten around to them, and IIRC sometime next year it will become impossible to buy any veterinary antibiotics without a prescription.
Re. this: "Trevor Klee...realized this would be too expensive to do in humans in the current funding environment, and has pivoted to getting his medication approved for a feline autoimmune disease as both a proof-of-concept and as a cheaper, faster way to start making revenue. ... He still anticipates eventually moving back to humans."
This is a very common trap. I don't know of a single case where it worked out for the humans. A company wants to develop a drug for humans, but FDA approval is too expensive, so they get it approved in dogs, horses, or cats, thinking they'll make enough money to push it through approval for humans. They never do; it's hard enough to keep a new pet-drug business above water. Then their patent expires, and the drug will never, ever be approved for humans, because nobody will pay for FDA approval of an unpatentable drug.
Until just a few years ago, this was almost acceptable, because you could go to Agway or a foreign website and buy the drug for your dog and take it yourself. But governments and industry have taken EXTREMELY aggressive steps in the past few years to prevent this.
An example is Adequan. It temporarily cures arthritis in humans. It cures arthritis in me! But it will never, ever be legal for humans in the US or Europe, because it was developed in the 1980s and the patent expired long ago. But it is approved for dogs, horses, and pigs in the US.
Until very recently, I could easily buy it over-the-counter in any country but America, or order it thru ebay or from any overseas veterinary website. But organizations have just taken many steps to prevent any humans from taking Adequan, including:
- turning it into a prescription-only drug in all Western nations
- (I presume) prosecuting online pharmacies that don't comply (as they all suddenly went out of business or stopped selling it)
- purging overseas pharmacies that sell it over-the-counter from search engine results
- purging pharmacies that sell it without prescription from TrustPilot listings
- creating an organization to rate the "safety" of online pharmacies, which actually rates their compliance with import regulations
- investigating ebay sales of Adequan to verify possession of a veterinary prescription
- banning ebay users who sell it to people who have no such prescription
- delisting Adequan sales on ebay entirely
- in my state, creating laws for dog licensing that forbid veterinarians from treating unlicensed dogs, and forbid licensing dogs without proof of legal ownership of the dog, including an investigation process to verify possession of alleged stray dogs, so that you can't even get Adequan by borrowing your neighbor's arthritic dog, licensing it, and taking it to the vet to get Adequan (I tried)
I can't think of any reason anyone might have to prevent people from taking Adequan, so I think it's just part of a general tightening of access to veterinary drugs, which has been going on for about the past 5 years. The drugs for which doing this makes some sense -- antibiotics -- were left for last, but the US govt. has finally gotten around to them, and IIRC sometime next year it will become impossible to buy any veterinary antibiotics without a prescription.