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Letter to Pathogenes, Inc. - FDA Warning

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Jump to page : 		Last activity 2017-12-10 7:16 PM
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Bear
Reg. Dec 2007
Posted 2017-12-10 7:16 PM
Subject: RE: Letter to Pathogenes, Inc. - FDA Warning



BHW Resident Surgeon


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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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