John Mack says the FDA is asleep at the switch and device-makers are taking advantage.
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Most consumers don’t really understand the difference between a device and a drug, and distributors take advantage of that. Two egregious examples of devices being used as drugs in the horse world, in which manufacturers, distributors and veterinarians share responsibility:
1. MAP-5 is a semen extender device that some use as a “generic” version of Legend, a drug (hyaluronic acid, rel. low mol. weight) given intravenously as a maintenance treatment for osteoarthritis.
2. Chondroprotec (a PSGAG product), IMO, is even more egregious. It is labeled as a device to use to flush skin wounds, but the very name Chondroprotec suggests that it is for joints, and it is packaged to look identical to an injectable drug. As a result, it is used as a “generic Adequan”, Adequan being a a PSGAG licensed as a drug for IM and IA administration, also used long-term for osteoarthritis maintenance in horses.
Of course, besides manufacturers and distributors being less than forthcoming, there are several things that contribute to the use of these devices as drugs in horses:
1. Adequan and Legend are expensive (well, for horse people) drugs that are generally not covered even by equine major medical insurance, being maintenance drugs and not one-time treatments. To have my veterinarian come out and administer one dose of Legend IV (done every 3-4 weeks ad infinitum) costs $110 for the drug and administration (plus a $65 farm call charge).
2. PSGAG’s, as I understand it, do not refer solely to one molecule, but rather a group of related molecules, so it is easy to assume that the active ingredients in Chondroprotec and Adequan are the same, when in fact they may be completely different molecules with completely different actions in the body.
3. You’re probably wondering where the veterinarian is in all this. Malpractice suits are rarer in vet medicine, new drug testing is less onerous so there are more of these non-traditional drugs, and vets in general are more likely to say, hey, I think that’s safe, let’s go ahead and give it a go, see if it works.
P.S. I will be beside myself with joy if Adequan and Legend are ever approved for the human market. Of course, the price will probably be something like $400/dose.
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