Friday, May 22, 2009

FDA - what's going on there?

I got this comment on another post, but I'm assuming that this comment is in regards to my last post about using the Polyglycan instead of the Legend and Adequan -

"The issue really is do you want to use a product that is not FDA approved and therefore requires no testing and can claim anything they want on an animal you love to save a few bucks. There is a reason is cheaper. "

This looks valid on the surface, but let me give some information out about the FDA. FDA approval just means that the FDA has approved a certain device, protocol, or drug for a specific procedure or treatment. It does not mean that items that are not FDA approved are harmful, aren't functional, or don't have any benefits. In fact, we use non-FDA approved protocols, solutions, and devices in our lab routinely. And it's LEGAL and safe.

Here's how this works - and by the way this is an extremely simplified version, and applies to human subjects. Non-approved items may be used under two circumstances -

1) The item and/or it's use has been published in peer-reviewed journal articles as being effective in whatever capacity that you want to use it in. For example, lets say that the FDA has approved whisks for the use of scrambling eggs. However, there are articles that say that forks are very effective in scrambling eggs. Forks are FDA approved for using as eating utensils, but not for scrambling eggs. Since there is literature backing up the use of forks for scrambling eggs, then forks may be used without FDA approval for egg scrambling.

2) In order to get data for the published journal articles mentioned above, an investigator (scientist or physician) must submit a proposal for research with the Institutional Review Board, or IRB. The IRB looks at the proposal and will grant permission for the research study to proceed. Patients who fit the criteria of the study are asked if they would like to participate, and will then sign papers that give consent. The papers outline the risks and benefits of the research, and no patient is obligated to participate. These experimental studies are how medicine and technology advance and new procedures become available. Using the whisk example, perhaps chefs would be asked if they would like to try scrambling eggs with forks instead, and give their opinions on the ease and success of the procedure.

So, it's true that Polyglycan is not FDA approved for use as a joint supplement. It is approved, however, as a wound lavage (wash) used in joint surgery. Here is a quote from the web site on the properties of Polyglycan - "Introducing Polyglycan into the synovial space as a post-surgical lavage and fluid replacement will assist in the normalization of the joint following arthrotomy."

Using Polyglycan as a joint supplement is off label use, and the company makes no claims that it works as a joint supplement. In fact, I'm sure if I called them they would strongly advise against using it in a way that it is not approved for. It says so right on the bottle, for one thing.

As for off label use, is my vet doing anything illegal by prescribing this for my horse in an off-label use?

Searches for articles on PubMed (The National Institutes of Health and US National Library of Medicine database which lists all medical published literature) using each of the three main components of Polyglycan plus the words "equine joint" came back with the following numbers of published articles -

Hyaluronic acid sodium salt - 92
Sodium chondroitin sulfate - 32
N-acetyl-D-glucosamine - 5

The answer is NO, my vet is not doing anything illegal. By having many published articles using components of this product, FDA approval is not necessary. Of course the FDA would prefer if you didn't use it, but it's not breaking the law if you do. Dr. B not only has read the articles but has treated other horses with it and has had good results.

And come on, people! I'm a scientist! Of course I did my homework before injecting my horse with something in an off-label use.

Now, Adequan (and probably Legend too, but I haven't been able to find any) has their own studies that show that it is more effective than the Polyglycan. And that's okay. I understand why. They are trying to make money with the product that they developed, tested, and approved. Just for fun, I did a search for whisks and forks. The least expensive whisk was $9.99. The cheapest fork was 63 cents.

Here is my point in a nutshell. Just because the FDA has approved something does not mean it is the only appropriate, effective, safe, and legal product available. Items that are not FDA approved can be used within certain guidelines, and can be just as effective, or possibly more so. Being a well informed owner can help too, so do your homework before just accepting what your vet (or doctor, for that matter) is telling you.


Heather said...

I have heard of Endurance riders giving a shot of Adequan after each competition they do. This is 'off label' as it is not following the recommended dosage over a 5 day (or more) period. The thinking is that it will help reduce any damage from the endurance ride and will keep the horses joints healthier in the long run.
I know you are not a vet, but I was curious as to what you thought about this method? Does Adequan need to build up over a period of days to work? Can it be used as a preventative?
Of course, these are off-label uses and the answers can't be found on Adequan's web site.

dressagemom said...

I just recently saw an ad in a horse magazine (Dressage Today) which gave the effects of Adequan on the joint over a 48 hour period I think. I'll have to find the article.

I don't know if Adequan needs to build up to be effective, but it might work better. Since I've never used it I can
t say for sure, but I did use a loading dose when I started Legend. I don't know if it worked any better, but I didn't do the loading dose when I started up again after not giving the shots for a few years.

And I think that most people do the loading dose for repair of damage and then a maintenance dose as a preventitive, so I guess it could work that way. If you look at the data in the ad it seems like you have to do the five shots though.

Mac v Mac said...

Great post DM! Love your blog.

From one researcher (student variety) to another.

Header Image from Bangbouh @ Flickr