FDA Now Killing Horses

[Lloyd Danforth]

http://hosted.ap.org/dynamic/stories/U/US_DEAD_POLO_HORSES?SITE=FLTAM&SECTION=US


The Lechuza polo team had hoped to get a compound similar to a name-brand supplement used safely around the world to help horses with exhaustion but hasn't been approved by the Food and Drug Administration.

[KBCraig]

Quick, sic Steve Sprowl on the FDA!

(I suspect he'd go after the pharmacist, though.)

[AntonLee]

look at Steve go. . . around the corner, up the hill. . . ohhhh no

looks like fatty fell down again, this time it wasn't a bullet but the crisco he carries in his pants for lubing between his legs

[Pat McCotter]

Quick, sic Steve Sprowl on the FDA!

(I suspect he'd go after the pharmacist, though.)

The FDA is interested in the pharmacy - now that this has happened.

http://hosted.ap.org/dynamic/stories/U/US_DEAD_POLO_HORSES?SITE=FLTAM&SECTION=US
FDA spokeswoman Siobhan DeLancey said the agency's interest is now "heightened" with news the deaths could have been caused by a medical mistake at a pharmacy - one that not only produces drugs for animals, but also people.

[MistyBlue]

FDA didn't approve it because it's a compound that hasn't worked for animals before.
Not defending the FDA...they can be right morons...but in this actual case it isn't an FDA issue at all.
The team wanted to use Biodyl for exhaustion recovery. It's approved in Europe but not in the USA. Biodyl is not tested safe which is why the FDA hasn't approved it here. The investigation is if the pharmacy made a compound trying to reproduce Biodyl and made major fatal errors in the compound amounts or if the pharmacy used illegal Biodyl. Or if there was a case of tainted products used.
At this time the pharmacy manager is stating that they did not know the correct amounts to use for 1000 lb animals and the problem may lie there...possibly over estimating amount usage by measuring for "by the lb."
Either way...it had to have been devastating to see horses dropping like that. Not to mention the enormous loss of income to the team owner...only 8 were insured. Each high competition pony is usually worth about $100k and up. My guess is that the pharmacy will settle.
I'm not 100% positive, but I doubt the NHPSCA has anything to do with the US Polo rules and regs in FL or the AVMA usage of approved or non-approved supplements.

[NJLiberty]

Well having been audited by both the FDA and the European version of the same while working for a Swiss based pharmaceuticals company, the European's are a lot more hard core than the FDA. The FDA doesn't accept the European findings, regardless of what it shows because that generates no income for them. You could have the safest most wonderful product in the world, marketed all over the world with no incidents and great results, and the FDA wouldn't approve it without going through the same BS they put everything else through.

The FDA isn't about safety, or effectiveness, it is about money and control. They are extremely anal and vindictive about things they can fine you for, and sweep the rest under the rug. If you ever want to know why pharmaceuticals cost so much, you can start with the FDA. The costs to get the FDA to validate a drug are enormous, as well as the costs associated with keeping them happy. For instance, every year I produced a very thick book with the water testing data for the facility. It was 4 to 5 inches thick, double sided pages, etc. Mind you, this data was all available on the computers, but they wanted it in a book form in a specific format that made it impossible for me to easily render it from the computer data. When they would do the audits they would generally glance at the summary page and that was all. That book took several weeks to put together each year of not just my time, but also several members of the microbiology departments time, as well as the cost of producing and binding the book...and all of that to collect dust on a shelf next to the previous years' books. It is remarkable what they worry about that has nothing to do with the safety or the effectiveness of a drug.

They also chew up most of the years a drug is under patent during their approval process. The drug goes under patent as soon as the compound is originally developed. By the time it finally clears the hurdles and reaches the market the companies only have a short time to make back their entire investment before it becomes generic or goes OTC, as well as lay in the money for the inevitable lawsuits from the "suffering for profit" crowd that want to blame the pharmaceutical companies for everything under the sun, whether they deserve it or not.

It is a ridiculous system that is about as broken as a system could be. Perhaps the FDA (if they have to exist at all) should go back to their original mission of investigating snake oil salesmen and be once again forbidden from being involved in prescription medications.

I feel sorry for the horses that were killed. It is too bad the pharmacy seemed to have little or no experience making this compound. What a waste.

George

[AntonLee]

but I doubt the NHPSCA has anything to do with the US Polo rules and regs in FL or the AVMA usage of approved or non-approved supplements.

give them a few minutes, I'm sure they can claim authority over anything if they want to.

[Pat McCotter]

FDA didn't approve it because it's a compound that hasn't worked for animals before.
Not defending the FDA...they can be right morons...but in this actual case it isn't an FDA issue at all.
The team wanted to use Biodyl for exhaustion recovery. It's approved in Europe but not in the USA.

Also, Biodyl is made by an American company:

"While Biodyl isn't approved in the U.S., the supplement made in France by Duluth, Ga.-based animal pharmaceutical firm Merial Ltd. is widely used abroad."

[MistyBlue]

I know Pat...it doesn't make sense to me either. I don't think this case is directly FDA related...but I do think the FDA could benefit from an enormous kick in the butt.