I haven't finished the entire article yet but thanks for posting it. I will say, in advance of that, that I've been using Polyglycan on my older retired jumper and it has been remarkable in keeping him sound and comfortable. As good as Legend, in my own experience thus far. He gets 5 cc's IV every 10 days, more or less depending on how much he's ridden in a particular week.
"I have never let my schooling interfere with my education." - Mark Twain
Thanks for posting the article. It was interesting and informative to read.
Here is my 2 cents...
I agree that MAP-5, Polyglycan and ChondroProtec may be questionable at best as valid treatments for equine joint disease because they are relatively new products for that purpose. Long term side effects, efficacy and results have not been studied. However, Pentosan Polysulfate has been used safely and effectively in Australia for over a decade. The drug is already licensed and approved there as well. Is it really neccessary to re invent the wheel here in the U.S with FDA approval of Pentosan Polysulfate in order for horse owners and vets to feel comfortable using it?
Many horse owners and vets are comfortable using Pentosan Polysulfate from well known and trusted compounding pharmacies for the reasons stated above and I can't say I see any fault in that. Adequan and Legend are FDA approved products but there is equal risk in those products being ineffective for a particular horse as well.
These ARE drugs. Calling them "medical devices" is just a means of dodging FDA approval. However, FDA approval is a tedious and expensive process.
I think it's possible for a critical-minded professional (like a vet) to make some extrapolations and hypothesize that these drugs might be safely and effectively used for equine problems without necessarily calling the entire kit and kaboodle "snake oil" or tantamount to using brandy to treat colic, etc. But this would imply that the decision to use these things is made with the FULL informed consent of the horse's owner that it is an unapproved treatment.
IME, however, there is LITTLE TO NO "informed consent" used by vets when prescribing these prodcuts. I've asked a number of vets about them and have gotten everything from "never heard of it" to "I don't believe in that stuff" to "sometimes it helps" to "let's talk about the actual research" as a reply. IME I've had to be the one initiating the discussion--vets who don't know me have never offered anything but a specific product, no discussion of the risks, benefits, and alternatives. Vets who DO know me expect a barrage of questions.
It appears that there's a whole lot of bandwagon-jumping going on, and I for one wonder about just who is driving said wagon--is it vets or is it owners? What is the motive? Profit? Desperation? Ignorance? A desire to learn more with 'field trials' on actual animals? All of the above?
I'd wager it's "all of the above".
The lack of informed consent in veterinary circles is shocking to me. I cannot IMAGINE recommending ANY product, drug, or treatment without full disclosure of whether it's approved, off label, new, old, etc. In fact, it's malpractice to fail to have this discussion on some level, ESPECIALLY for anything that's even minimally invasive. And since my general sense among vets I've worked with is that they are more interested in helping the animal than in necessarily toeing some sort of party line, I wonder how much pressure from horse owners is behind all of these products being used willy-nilly.
Just because a drug is approved in a foreign country does not mean it will meet FDA guidelines. Many countries, including those in Europe, allow human experimentation to validate drugs and procedures. That is why American companies do initial research in Europe, Africa and South America.
Yes, in race horses, Pentosan Polysulfate has shown to have efficacy in Australia, there is still a limited number of specimens to measure actual efficacy. The Australian studies I saw still alluded to significant risk of bleeding if the drug is used inappropriately. Of course, the FDA does not oversee veterinary meds and devices so in the US it is moot. It allows unscrupulous vets to sell dangerous or ineffective porducts, e.g. Gamboa and Carolina Gold, without risk.
Just because a drug is approved in a foreign country does not mean it will meet FDA guidelines.
One of the most famous examples in human medicine was the use of thalidomide as an antiemetic for morning sickness (and several other uses). Approved for use in other countries, the FDA denied approval in this country.
Of course, the FDA does not oversee veterinary meds and devices so in the US it is moot. It allows unscrupulous vets to sell dangerous or ineffective porducts, e.g. Gamboa and Carolina Gold, without risk.
Just to clarify one thing- the FDA DOES oversee veterinary drugs in the US. Veterinary devices are another story, however (don't get me started on that part). There is a bit of a compounding issue WRT veterinary compounds (in terms of things not being as strictly enforced at the moment), but it is something the Agency is aware of and will work on it when resources allow.
A very good article. I really think a lot of horse owners and unfortunately, some vets, simply do not understand or (choose to ignore, because of the much cheaper cost) the risks of using compounded drugs, especially sterile injectibles. I've posted in the past that I thought FDA guidance allowed for the compounding of drugs like Pentosan, but I just re-read the guidance and I have to say, I think it is at best a grey area. 21 CFR 530.13(b) pretty clearly states that it's only acceptable if there is no other approved drug out there that will treat the condition (so, for joint issues, Adequan & Legend).
I also did a quick search on FDA's enforcement reports, and came up with this one for a vet compounding pharmacy distributing pentosan that was found to have fungal growth in their clean room. I'm sure there are more out there.
I won't be surprised at all if the more ethical compounding pharmacies stop offering Pentosan and some of the other products mentioned in the article, either voluntarily or because FDA begins to look closer into this issue (I always think of the FDA as the Eye of Sauron and woe is you if the Eye turns it's attention to you! )
I think bulletin boards like COTH make it easy for people to jump on the bandwagon of "everyone else is doing it" without having to be educated on the issues and risks (I've spent 15 years in the manufacturing and formulation development side of the pharma industry, so I feel fairly comfortable making these evaluations for myself). In fact, I feel like I bear some responsibility for some of the bandwagon jumping with the omeprazole threads, which is for the most part why I stopped posting on them. Not that I'm not going to keep using the Abler granules, but I'm not actively going to enAble (pun intended ) other people to import off-shore drugs.