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boon
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| "This letter concerns your firm’s distribution of unapproved animal drugs for the prevention, mitigation, or treatment of Equine Protozoal Myeloencephalitis (EPM) in horses."
https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnf... |
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  That's White "Man" to You
Posts: 5515
 
| And this is further proof that the government intervening in the lives of private citizens has no beneficial value. If people want to use the drug, then get out of thier way and let them use it. They understand the risk and don't need someone to tell them that it might be unsafe. The FDA is a bloated waste of tax payer dollars, and is in the same catagory as the EPA and IRS. |
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That's White "Man" to You
Posts: 5515
| The other part of this that really ****es me off is that no requirements should be so difficult and complex that a government agency should ever reccomend hiring someboy that specialized in your complex "statutory & regulatory requirements". Goverment is not an industry, understanding government should not be an industry, shame on you Eric Nelson, go get a real job that contributes, rather than consumes. |
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 Champ
Posts: 19623
 
Location: Peg-Leg Julia Grimm |  Whiteboy. Especially when they approve drugs ALL THE TIME that are dangerous. It's not like they do their job well and protect us from anything. |
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 Shelter Dog Lover
Posts: 10277
| Whiteboy - 2017-12-08 12:56 PM And this is further proof that the government intervening in the lives of private citizens has no beneficial value. If people want to use the drug, then get out of thier way and let them use it. They understand the risk and don't need someone to tell them that it might be unsafe. The FDA is a bloated waste of tax payer dollars, and is in the same catagory as the EPA and IRS.
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That's White "Man" to You
Posts: 5515
| OregonBR - 2017-12-08 1:29 PM
Whiteboy. Especially when they approve drugs ALL THE TIME that are dangerous. It's not like they do their job well and protect us from anything.
Exactlly. They only create hoopes which hard working people must jump through. So whats the motive of those hoopes?...follow the cash... |
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 BHW Resident Surgeon
Posts: 25352
Location: Bastrop, Texas | I can't speak to the FDA's meddling in veterinary medicine, but I have experience dealing with them in the pharmaceutical R&D industry.
I worked as a medical investigator for a company in Fargo that was a contract research organization (CRO). This was one of the largest, independent CROs in the country.
I'll tell you this. The FDA is extremely strict about adherence to certain scientific standards and ethics. If you are hired by a company like Pfizer, to perform a double-blind study of a drug, that company can present a study proposal/design, etc, but they cannot be directly involved in the study, the collection of data, and the statistical analysis. The reason for that is obvious, I should think. Our integrity was on the line. If a CRO was ever caught fudging numbers, altering data, or manipulating the data in any way, the FDA could shut the doors at the drop of a hat, in order to perform a thorough, systematic, comprehensive audit. Sometimes they performed a random audit of randomly selected studies to make sure there weren't any irregularities. Those random audits did not involve shutting down any operations, but they were always a potential threat.
The company I worked for was the PRACS Institute. I worked for them for 10 years. About a year before I stopped doing that work, the company was sold to another CRO, CETERO Research. We had research facilities across the country. About 5 years ago, the FDA discovered that scientists were dry-labing numbers and fudging data.
That lab in Houston was shut down, and, no question about it, the scientists were dead in the water. This resulted in an order that CETERO had to repeat every single study that they performed over the 5 previous years. Well, that was not feasible, and I could see the handwriting on the wall, so I resigned. Basically the laziness and dishonesty of just a couple of researchers ended up destroying a nationwide research organization. Pay checks were delayed, cutbacks were made, but the end result was bankruptcy. A brand new 600 bed research facility was vacated.
You know what? That was a consequence they earned. They were caught cheating on scientific studies of drugs on which people's lives can depend. If we cannot hold our pharmaceutical industry to the highest standards, then what CAN we do?
Don't get me wrong. The FDA is a massive, bureaucratic pain in the a$$, but they are a necessary evil. They are the best at what they do in the world. Have they ever missed the mark or failed? Yes.
Has there been corruption? Absolutely, but I'll tell you one thing, we'd be worse off without them.
As to animal science, I can't comment, and I won't defend them, but I suspect they have tried to apply the same standards to the medicines we give our animals.
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 Accident Prone
Posts: 22277
Location: 100 miles from Nowhere, AR | Lots of vets are using those same medications (active ingredient) to treat EPM, so does this have to do with marketing methods and claims? |
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Nut Case Expert
Posts: 9305
Location: Tulsa, Ok | I really can't imagine a world of unregulated manufacture, compounding and distribution of drugs. |
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 Jr. Detective
Location: Beggs, OK | Three 4 Luck - 2017-12-08 3:16 PM Lots of vets are using those same medications (active ingredient) to treat EPM, so does this have to do with marketing methods and claims?
My issue with Pathogenes has more to do with some inconsistencies in the blood testing that they do. I've used their drugs a few times because I knew what I wanted to treat, but definitely not because I was convinced of the "science". |
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That's White "Man" to You
Posts: 5515
| SC Wrangler - 2017-12-08 4:13 PM
I really can't imagine a world of unregulated manufacture, compounding and distribution of drugs.
This is a far cry from performance enhancements which i'm assuming you are thinking. This is desperate people trying to find thier pet some comfort. The regulation will only drive the price of the product up, so that fewer can afford it. This is also very very different from human drugs. |
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BHW Resident Surgeon
Posts: 25352
Location: Bastrop, Texas | Someone please define "performance enhancements" to me. Are we talking about things like herbal remedies? Ventipulmin? Steroids?
The FDA doesn't, as a rule, regulate herbal supplements, except in cases where they falsely claim these are a cure for a disease. |
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That's White "Man" to You
Posts: 5515
| Bear - 2017-12-08 5:06 PM
Someone please define "performance enhancements" to me. Are we talking about things like herbal remedies? Ventipulmin? Steroids?
The FDA doesn't, as a rule, regulate herbal supplements, except in cases where they falsely claim these are a cure for a disease.
frog juice. |
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BHW Resident Surgeon
Posts: 25352
Location: Bastrop, Texas | Ahhhh I forgot about the frog juice. |
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 You get what you give
Posts: 13030
Location: Texas | I don't think the FDA did anything wrong. There has to be a governing body to make sure people don't sell drugs that could potentially either NOT do anything, make a horse or person sick or worse, kill them. Not saying that these products will, but if they don't enforce the rules then something like that could happen.
Decoquinate is low on the list of effectiveness in treating EPM anyway. You can still get levamisole so it's not like they are banning that drug. Just stopping Pathogenes from breaking the law apparently. |
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You get what you give
Posts: 13030
Location: Texas | Why should Pathogenes be defended for claiming a product is safe for use in horses when there is no proof it's actually safe? It hasn't gone through the rigors of testing in order to be considered safe... why should people buy a drug- not a supplement, a drug- with claims of safety that aren't backed??
And according to this report... you can't legally charge money for investigational drugs, which is what they tried to but didn't even complete paperwork for in regards to their drugs... So they were charging people for medications that, if they were appropriately using for investigational drugs, they shouldn't have been making money off of.
Edited by casualdust07 2017-12-08 8:04 PM
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Location: Not Where I Want to Be | casualdust07 - 2017-12-08 8:59 PM Why should Pathogenes be defended for claiming a product is safe for use in horses when there is no proof it's actually safe? It hasn't gone through the rigors of testing in order to be considered safe... why should people buy a drug- not a supplement, a drug- with claims of safety that aren't backed?? And according to this report... you can't legally charge money for investigational drugs, which is what they tried to but didn't even complete paperwork for in regards to their drugs... So they were charging people for medications that, if they were appropriately using for investigational drugs, they shouldn't have been making money off of.
I don't know why that would surprise you.
They've been charging people to conduct research for months now. |
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Shelter Dog Lover
Posts: 10277
| casualdust07 - 2017-12-08 7:52 PM I don't think the FDA did anything wrong. There has to be a governing body to make sure people don't sell drugs that could potentially either NOT do anything, make a horse or person sick or worse, kill them. Not saying that these products will, but if they don't enforce the rules then something like that could happen. Decoquinate is low on the list of effectiveness in treating EPM anyway. You can still get levamisole so it's not like they are banning that drug. Just stopping Pathogenes from breaking the law apparently.
I agree with your point about deceptive products that have no scientific backing. My issue with the FDA is the numerous drugs that they do allow that are later recalled because of serious issues. |
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Nut Case Expert
Posts: 9305
Location: Tulsa, Ok | Whiteboy - 2017-12-08 4:53 PM SC Wrangler - 2017-12-08 4:13 PM I really can't imagine a world of unregulated manufacture, compounding and distribution of drugs. This is a far cry from performance enhancements which i'm assuming you are thinking. This is desperate people trying to find thier pet some comfort. The regulation will only drive the price of the product up, so that fewer can afford it. This is also very very different from human drugs.
You assume WRONG. I am talking about unregulated manufacture and distribution of drugs with no oversight. Think snake oil salesman selling colored water or drugs with untested and dangerous ingredients. You really think anyone with a test tube in their garage should be compounding drugs for unfettered constumption. I get that the FDA is a huge government clusterflock but the alternative is pretty scary. |
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You get what you give
Posts: 13030
Location: Texas | 1DSoon - 2017-12-09 4:05 AM
casualdust07 - 2017-12-08 8:59 PM Why should Pathogenes be defended for claiming a product is safe for use in horses when there is no proof it's actually safe? It hasn't gone through the rigors of testing in order to be considered safe... why should people buy a drug- not a supplement, a drug- with claims of safety that aren't backed?? And according to this report... you can't legally charge money for investigational drugs, which is what they tried to but didn't even complete paperwork for in regards to their drugs... So they were charging people for medications that, if they were appropriately using for investigational drugs, they shouldn't have been making money off of.
I don't know why that would surprise you.
They've been charging people to conduct research for months now.
I never said I was surprised. I purposely haven’t done business/ sent sample there.
Edited by casualdust07 2017-12-10 3:33 PM
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BHW Resident Surgeon
Posts: 25352
Location: Bastrop, Texas | rodeomom3 - 2017-12-09 7:16 AM
casualdust07 - 2017-12-08 7:52 PM I don't think the FDA did anything wrong. There has to be a governing body to make sure people don't sell drugs that could potentially either NOT do anything, make a horse or person sick or worse, kill them. Not saying that these products will, but if they don't enforce the rules then something like that could happen. Decoquinate is low on the list of effectiveness in treating EPM anyway. You can still get levamisole so it's not like they are banning that drug. Just stopping Pathogenes from breaking the law apparently.
I agree with your point about deceptive products that have no scientific backing. My issue with the FDA is the numerous drugs that they do allow that are later recalled because of serious issues.
That has always happened, though. Clinical trials for safety and efficacy only test for a relatively short period of time. Sometimes serious adverse events start popping up years after the product hits the market. You have to have enough of them to become statistically significant and that might take years. In other words, say someone is prescribed a new NSAID that is said to have fewer GI side effects. It's been FDA approved. It has stood up to the standards of safety and efficacy. Two years after taking the drug on a fairly frequent basis, they suffer a fatal heart attack. Statistically, you will have this happen. Then someone suspects the incidence of serious cardiovascular side effects is increased in people taking the drug.
This sets off a careful look at patients who have been prescribed the drug, and it is determined that the drug is associated with increased CV adverse events. The drug is either voluntarily taken off the market, or the FDA removes it.
This actually happened with a drug, Vioxx, about 15 years ago. The drug company, Merck, voluntarily removed it, on advice from the FDA.
They would have been forced to remove if if they hadn't acted. This late-appearing side effect cost Merck about $10 Billion. So if you want to know why medicine costs so much, this is one reason. There are others. The FDA has a very tough job to do....but they are the best at what they do in the world. They are a pain in the as$, though. |
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Letter to Pathogenes, Inc. - FDA Warning