The post was made based on the information you provided attached to your video.
Have you ever asked them specifically how the original product is “approved” by the FDA for use in eye surgery? Is the original product classified as a drug or a device?
That’s what most of us are interested in, yet the company doesn’t seem willing to disclose this.
They actually told me to “look it up yourself”
So.
Yeah, this. @JessP since they have been helpful to you, ask what the product IS. Companies that sell devices (like Ichon or MAP-5 or polyglycan) are VERY upfront about what their product is and isn’t. They don’t advertise it as a drug–because that is ILLEGAL. It is a device and can be used off label as a drug at the veterinarian’s discretion.
Anyone can access the FDA device library to see if something is approved as a device. It’s also easy to look up things that have been approved as a drug. I have ASKED the FDA about this Summit stuff, and they have no record of it at all. Isn’t that concerning? I would certainly be concerned.
The vets involved with Summit aren’t capable of producing any studies to show it works. They won’t tell consumers what the product IS. They’re marketing something as a drug when it sure doesn’t have the necessary FDA approvals to do so, which is illegal. There is NOTHING that is legitimate about any of this at all, and that is a pretty frightening thing considering the potential ramifications of an injectable product.
First of all, no, when My story was told here, it was not quoting what I said in the Facebook post. I never made a claim that she was fine in 72 hours. Actually, there was a LOT of stretching of the truth when that poster spoke about my horse and experience. But that is to be expected, given the tone of the whole thread.
They say right up front that this is a very pure form of chondroitin sulfate that is used in corneal transplants. Where I am working today, they are doing 3 corneal transplants. I went and looked at the solution they are using. Asked yet again another corneal specialist if he thought there would be an issue with that solution being injected in a muscle. And he concurred.It wouldn’t hurt anything. Will I post on here the name of the product? No. Because you’re on a witch hunt.
Also, I’m a surgical device rep. I understand how the FDA works. This product is not being marketed as a drug nor a device. It is a supplement.
Smart Pak sells a ton of oral chondroitin Sulfate daily. I don’t see anyone having a fit about that.
I also see tons of threads on here supporting Magna Wave. Which is also not an approved device, being used off label, but no one is in an uproar about that either. Hmm. (I’m not bashing MagnaWave…that’s one more thing I did for my mare…she has her own machine).
It it amazes me that many of you are fine with polyglycan, ICHON, or Pentosan, when those have been known to cause some injection site issues. One of them, fairly regularly, as the vets who will write it, advise doing cold/warm compresses post injection to try to prevent issues.
Oh? And what is it called? There are a whole lot of corneal transplant mediums.
It it amazes me that many of you are fine with polyglycan, ICHON, or Pentosan, when those have been known to cause some injection site issues. One of them, fairly regularly, as the vets who will write it, advise doing cold/warm compresses post injection to try to prevent issues.
It amazes me that you’re fine injecting this random substance into your horse given that you’d have these concerns about polyglycan, ichon or pentosan.
I saw your post on FB.
The poster here gave the pertinent details, abdominal and leg trauma resulting in a hitch.
Would you have preferted the poster copy/paste your post? I know it’s “against the rules” of Horse Vet Corner, but??? The poster might have been confused on what timing “protocol” you were using for the loading dose as that’s been a very grey area with the Summit people. But the other details were succinct and correct.
The fact that NO ONE will publicly name the drug so that potential customers can verify its legitimacy makes it VERY suspect. The company is extremely evasive and not transparent at all. These are huge red flags. HUGE. They won’t tell us the name. Won’t provide research. Nothing. These pieces of information have the potential to end the “witch hunt” but since it’s not being provided…
This is being marketed as a supplement. However one of its “claims” is its FDA approved in humans. There’s no record of this on file with the FDA per Simkie’s contact with them. So please show where we are mistaken.
At this point I have images of people mixing this up in their bathtub. Or importing it from a sketchy lab in India.
But hey, if you see the red flags waving and choose to ignore them in an effort to get your mare back in the show pen, go ahead.
In the meantime I’m still waiting to see what drug/device this is (used in humans), still waiting on research studies (it’s been weeks) and still waiting for the vets to own up to a biased perspective— as most of whom post on the threads either have vested interest in the company OR are getting free products.
There is no transparency here, no real repeatable or verifiable research, and those involved act like everyone that’s “not a vet” is incapable of rational thought and such they can pull the wool over our eyes.
Why am I so interested??? Because I have a horse standing in my pasture RIGHT NOW that would really like to not be eating bute on the daily. I’d REALLY like to make him more comfortable in the pasture. I’d REALLY like to see him not hurt after playing. I have no dreams of riding him. I just want him to be more comfortable AND still like his food. But I do not have enough information to make an educated decision about the SAFETY of this product. Anecdotally it appears effective. But I don’t want to find out that all this “supplement” did was mask the pain enough for this horse to breakdown while feeling good and not being aware of what’s happening in his body enough to protect himself.
And if/when FDA smacks down Summit, where will this horse be without his " majikal cure?"
Good point
They are making claims that this product can:
- decrease or even eliminate pain
- increase mobility
- increase the quality and viscosity of intra-articular joint fluid
- improve the cushioning properties of the cartilage pads in joints
I don’t believe any of the chondroitin sulfate supplements on SmartPak’s website are making claims like that. They pretty much just say they “support joint health.” That’s why nobody is having a fit about them.
I’m a member of the horse vet FB group and have been following Summit w/great interest both here and there. I’ve also PMed via Facebook with Dr Farmer.
Today I recieved a vaguely bullying message from one of the “Reps” which also explicitly goes against the rules of the horse vet corner. I feel that those who are interested in the product should be aware of these messages, including their offers to send me and my vet free products. I’m not sure how to interpret this gesture.
I have copied pasted her two messages below and will include my response as well in the interest of transparency.
I also would like to note something that I’ve thought of reading these threads. In the place like HVC on FB where “non-vets” cannot comment, it’s alarming that vets are able to push these products that they profit from with no one being able to call them out, at lest without being banished from the group. Meanwhile members hang on every word. Very scary.
IMO there’s not enough info on this product to make an educated purchase and the company won’t provide info unless pushed extensively.
Hopefully this helps others who are on the fence!!! I apologize for the wall of text.
"Hi ----
My name is ----, I’m a rider and horse trainer in Florida. I wanted to reach out to you personally because I have seen several of your numerous comments regarding Summit all over social media. I would appreciate the chance to talk to you on the phone, if you’d be willing to give me a call. I have several different top vets who I use for different things in my program, repro vets, sports medicine vets, emergency vets and surgeons (all of whom I’ve discussed Summit with, and all of whom are now using it in their practices – some using it both IM and IA). One of my vets was involved in the development and launch of Summit for horses and dogs, that’s how I learned about it. And when I tried it on my daughter’s lame pony and some of my older stiffer broodmares and saw a dramatic improvement I got on board to help them market it, because I am embedded in the Hunter/Jumper world and really wanted to help get it out there to people. I’ve been using Legend, Adequan, Polyglycan and Pentosan on my horses for years. I found Summit to be much more effective, and that is a really exciting thing to me because its been years since any new options have become available.
Now that you know where I’m coming from I am hoping to understand where you are coming from. I am confused about why you want to respond so negatively to these people online who are saying their horses are doing so much better since starting Summit, even with video evidence, I mean how is that a bad thing? Why would you attack those posts with such negativity? Most of these people have tried everything else possible with no or little improvement, and now their animals are doing great, I just don’t get why you would degrade that? I find it hard to believe you woke up one morning and decided to go on a crusade against chondroitin sulfate, as it has been around for 40+ years and hundreds of studies have been done on it (I am happy to provide you with links to many of those studies if you would like), proving again and again chondroitin sulfate is one of the safest treatments of osteoarthritis in the world. That would be like going on a crusade against glucosamine or vitamin E or something else just as safe and well-known, it just doesn’t make sense. So it must be the fact that there is a new company, called Summit, that just rubs you the wrong way or you don’t like change/new things, so now you spend your days finding and commenting negatively on any post about it you can find? Or is it that you work for Adequan and are threatened that there is something else out there available for the first time in forever, and you want to just demean and degrade anything that may be an alternative? I mean both products are chondroitin, just developed in different ways. Ours is just a single pure, organically derived molecule with no synthetics and no other molecules attached to it. So what gives? Is it your mission to hunt down and demean anything out there being used ‘off-label’? Do you do this to every post regarding Pentosan (which is not FDA approved for injectable use in horses and is sold without a prescription)? Do you do this to every post regarding the IV use of Polyglycan – because its not FDA approved for that use either, it is only approved as a post surgical lavage, along with about 30-40% of all other meds on every vet’s truck that is used ‘off-label’. Are you against people using CBD oil for their children with seizures? Because that’s not FDA approved, but you’d be hard-pressed to find any medical professional that doesn’t acknowledge the results it offers. The FDA has zero concern that we are marketing something already deemed completely safe and considered a “supplement” and in a form that’s already been approved for use in human surgeries. BTW, this product was also studied at UCLA for use in reducing pulmonary embolisms after orthopaedic surgeries.
At this point, we have no intention of going through the FDA approval process, although there is little doubt we would gain it for this particular application. It isn’t illegal to do it this way, and it facilitates us keeping the price down at a range that many people can afford it that can’t afford the other joint supplements on the market. But most of all we want to help as many horses and dogs (and people) as we can, and from our viewpoint, the results speak for themselves.
I completely understand your not wanting to use Summit, and if that’s the case then for sure you should not use it, and no one is trying to make you. But you seem to be extremely interested in it judging by the ferocity of your following of it, and I would be happy to send you some doses for free if you are interested in trying it, and would be more than happy to send some doses to your vet to try it as well. I’ll also happily have our on-staff veterinarian, and our main scientist who originally developed Summit, call and speak directly to your veterinarian if you would like that to happen as well. Above all I would love to understand why you are so vehemently against something that people are clearly stating has helped their animals?
One thing that is too bad about social media is people tend to talk to people in a much harsher way than they would in a face-to-face conversation. And even if you are an Adequan rep with the sole purpose to undermine a new product that is showing good results, I just can’t imagine you would be actually be disappointed that the animals are doing better, that would just be mean. So all I can figure is you’re feeling threatened or bothered by there possibly being competition to something that has held a monopoly in the market for so long.
This is a brief list of just some of the high-ranking international FEI riders and others who currently are competing all of their horses on it, just to give you an idea that it is not just backyard people who are using Summit already. There are over 2,000 horses currently on Summit, and we have not had one single adverse reaction, nor have we had a single person tell us they didn’t see good results or aren’t happy with it.
Sharn Wordley, Olympian, New Zealand
Alexis Trosch, World Equestrian Games, Argentina
Roberto Teran, Winner of the AIG Million $ GP, Colombia
Marilyn Little, Double Gold Medalist Pan Am Games, USA
Rowan Willis, 2nd Place AIG Million $ GP, UK/Australia
Paulo Santana, Bronze Medalist, Brazil/El Salvador
Gianni Gabrielli, international FEI rider, Argentina
Tanner Korotkin, top junior rider, USA
Kelly Farmer, #1 ranked hunter rider, USA
Mary Eufemia, top hunter rider, USA
I am happy to connect you with any of these riders/trainers as well, if you’d like to hear it directly from their mouth what their experience has been since starting their horses on Summit. Just let me know if you are interested.
I am all for dialogue, and respectful questions and interactions, I just wish innocent horse owners and other random people out there trying to do the best they can for their animals didn’t have to get attacked in the process.
I look forward to hearing from you anytime!!
Sincerely,
And the developer, who first produced Summit, under it’s original name Condranol in 1979, also developed it with Cedars-Sinai Hospital in LA. It was FDA approved. Just because its approval has not been kept in the ‘active’ status does not mean it wasn’t FDA approved. Your saying your ‘friend contacted the FDA and it was never approved’ is a lie you are spreading. It is no longer active, which is common with products developed almost 40 years ago. This scientist moved on and devoted his life to kidney disease and pediatric kidney transplants and no longer continued to work on this, so let it go inactive. His wife owns FEI dressage horses, which is how he first discovered how much benefit it can give to horses when used IM. He is a very well-respected world-renowned scientist and surgeon, he has worked with numerous hospitals and universities around the world developing numerous different things. To insinuate it is a lie is in bad faith, without research, and only intending to do damage when you don’t actually know what you’re talking about. I don’t think that is very kind. I just don’t understand. Why don’t you let me have him call and speak with your vet directly and then let me know what you think?"
My reply:
Hi ----!
First of all, the only place on social media I’ve posted is Horse Vet Corner. So I’m confused by your statement that I’m “posting all over social media.”
Secondly, I appreciate your reaching out to me wanting a “respectful dialogue” however the following paragraph of your words really DOES rub me the wrong way–almost attacking if you will-- and certainly not respectful to attribute my request for actual scientific information as a character flaw.
“So it must be the fact that there is a new company, called Summit, that just rubs you the wrong way or you don’t like change/new things, so now you spend your days finding and commenting negatively on any post about it you can find? Or is it that you work for Adequan and are threatened that there is something else out there available for the first time in forever, and you want to just demean and degrade anything that may be an alternative?”
-I do not work for Adequan. I find it insulting thar a quest for knowledge, proof, and information is viewed as me working for a competitor.
-I first pursued this product with great interest as i had intended to try it with several of my horses with varying issues. One of whom saw no improvement on Adequan. So on paper this fits the bill for me so to speak.
-subsequent interactions and information from Dr Farmer and others was not reassuring in any way (I can detail these points if you are interested)
However the things that I want, that people who are scientifically minded, want to know
-what is this product that’s FDA approved
-how is it currently being used
-where are the studies??? I’ve been promised these for weeks, and all I got was a short partially plagiarized paper on what Chondroitin is and how it’s used in the body and how it’s sourced. Anyone with Google could have written it.
And yes there’s certainly “proof” that previously greviously lame animals are suddenly sound and then PUT IN WORK. This to me is extremely alarming. Not reassuring. I’ve not been given enough information on what’s happening here medically/scientifically to know if this is masking pain while allowing previous injuries or degenerative processes to continue, causing more harm over time as the horse is worked.
Finally, at least two of the Summit sponsored riders are involved with abuse type cases or drug violations. This is also not reassuring.
Asking for proof of efficacy and safety isn’t unreasonable, nor is asking “what is it” and being provided with the studies they claim are out there.
At this point, being told there “are studies” is woefully insufficient.
This looks like the first patent: https://patents.google.com/patent/US3895106?oq=ininventor:"Lester+M.+Morrison"
And this looks like the second: https://patents.google.com/patent/CA1179264A/en?inventor=Lester+M+Morrison
Well everything coming from these Summit people is 100% appalling. Now they’re privately bullying people who ask to see proof of efficacy.
I think you should also post that paper you received. Let’s air this out in the light of day.
Sad day when vets are totally ignorant of the value of a blinded trial and transparency. What the hell are they teaching in vet school these days??
YO, SUMMIT: we know you’re reading. We know you’ve created alters here to try to pimp your product. You want to be taken seriously?? Stop this shit. Contact Frisbie and have him run a real, actual clinical trial for you. Stop bullying people, stop deleting comments on FB you don’t like, stop saying this crap is FDA approved when you outright REFUSE to say what it is, exactly. If it’s Condranol, it’s not FDA approved as ANYTHING. Stop claiming there are trials when there aren’t. Stop saying there is tons of support in the literature when you refuse to provide links to those papers (and there isn’t that support, anyway.)
This is shady snake oil bullshit. And we’re on to you.
Here is the paper Simkie referenced, and I’m sure that since Summit purports to be a company that values transparency they won’t mind.
Summitt Chondroitin Sulfate A (Chondroitin-4-sulfate)
March 7, 2018
Summitt chondroitin sulfate A (CSA) is in the family of compounds called acid mucopolysacchrides, a major component of vertebrate connective tissues, such as bone and cartilage. This family of compounds includes heparin, hyaluronic acid, proteoglycans, etc. CSA is an important structural component of cartilage and provides much of its resistance to compression.The importance of CSA to humans and mammalian health was shown by Dr. Lester Morrison, a pioneer in furthering research of CSA and its application to prevention and amelioration of coronary heart disease (1). The objective of Dr. Morrison was to supplement the well-established deficiencies of CSA in the walls of aged coronary arteries and aorta.The CSA product that Dr. Morrison researched and the Summitt CSA is manufacturedfrom bovine cartilage (trachea) where it is present in high concentrations and can be isolated in a very pure form.
Chondroitin sulfate A is not a synthetic chemical but is a naturally occurring agent normally present in the blood and connective tissues of all living animals as well as man.
CSA plays an important role in maintaining the structure and function of bone and cartilage. Aggrecan, a large aggregating proteoglycan, is one of the major structural components of cartilage. Its core protein is composed of domains of which CSA is an important component. These domains play various roles to maintain cartilage structure and function. An N-terminal globular domain binds hyaluronan and link protein to form huge aggregates. The chondroitin sulfate (CS) chains attach to the CS domain and provide a hydrated, viscous gel that absorbs compressive load (2). Through water resorption, CSA gives cartilage elasticity and resistance to compression in joint cartilage and facilitates physical movement (3).
Osteoarthritis (OA) is a good example of deterioration of cartilage structure and function. Clinical studies have revealed that selective administration of micronutrients, such as CSA and hyaluronic acid, can result in reduction of OA symptoms. These products have a chondroprotective action; they stimulate cartilage metabolism and repair and reduce inflammation within the cartilage that leads to breakdown of the cartilage structure. In contrast to drugs, such as NSAIDs, they have an excellent safety profile, with as few adverse events as placebo (2).The of CSA is further shown by the fact that CSA is the predominant acid mucopolysaccharide in human plasma. Predictive of a repair or regenerative role for chondroitin sulfates in cells of the adult is the fact that they are the most prevalent acid mucopolysaccharides in several tissues during embryonic, fetal and early post-fetal life. Interestingly, they decrease in the respective tissues during maturation and decline even further with aging (1).
References:
- Morrison & Schjeide, Coronary Heart Disease and the Mucopolysaccharides (Glycosaminoglycans), 1974; Charles C. Thomas.
- Watanabe H, Yamada Y, Kimata K., Roles of aggrecan, a large chondroitin sulfate proteoglycan, in cartilage structure and function. J Biochem. 1998 Oct;124(4):687-93.
- Watanabe H., Glycoscience Biology of Medicine, Springer Publications.
- Jerosch, J., Effects of Glucosamine and Chondroitin Sulfate on Cartilage Metabolism in OA: Outlook on Other Nutrient Partners Especially Omega-3 Fatty Acids, Int J Rheumatol. 2011; 2011: 969012.
In light of the recent post… I’ve had another thought. So, let’s say for a moment that I decide to go forward with Summit and use it on my 100% sound, 10 year old OTTB mare that I event as a “joint supplement” to keep her joints healthy. Summit as I’ve been told multiple times by multiple “reps” is an extremely effective anti-inflammatory. So, let’s say, I’m running said mare around an xc course and she pulls a ligament slightly down by her fetlock (let’s say, base of check ligament). Now, she’s on Summit. An extreme anti-inflammatory, which now prevents swelling from occurring in this location. (Extreme anti-inflammatory is my wording… they say it drastically reduces inflammation - same thing IMO). So, my mare is pretty resilient, so this little pull does not make her lame from pain. There is no swelling to let me know that she has something going on, and so I just keep riding. Next thing you know, we’ve torn the ligament due to not allowing it time to heal properly.
This situation, is seriously real. Many horses are very tough. Would never take a step off from a pull, or maybe even a twist of a joint, but a swelling would indicate to US as the rider that something is going on inside.
Just another one of my thoughts, and concerning (to me) realization I have come to.
There is so much wrong in what @AllegedAdequanRep posted (from Summit) that I don’t even know where to start.
The only reference for Condranol is a Drug Master File from 1979, but a DMF isn’t in any way, shape, or form an FDA approval. What is the approved product that referenced the DMF?
This really shouldn’t be so hard.
It is that hard though, apparently.
And to some a DMF looks impressive and like it’s what they claim, FDA approval.
I’m not FDA savvy. I could have been fooled. But I posted here. Sorry Summit for asking hard questions publicly.
That … “paper” (that’s supposed to be a STUDY???) is hilarious. It reads like a middle schooler’s attempt at explaining what chondroitin is. And a whole paragraph is lifted directly from here. Come on, I know it’s in the bibliography, but you don’t get to just copy/paste to create a large portion of your “study”! :lol:
I was curious what inclusion in the DMF meant. And I found this. So Condranol is inactive type II:
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
“I” = Inactive. This means a DMF that has been closed, either by the holder or by the FDA.
There is no indication that this stuff was ever approved as a DRUG by the FDA, so that seems to indicate that it was used in the preparation of something else. And it’s no longer active, so it can’t be used anymore in the preparation of something else. FDA drug (and device?) approval doesn’t just poof, so that’s another hint that condranol was just an ingredient in something else.
Can anyone who is more familiar with the FDA DMFs confirm?
And really…if this stuff is all that they say, it would have been picked up, approved and marketed a LONG time ago. Someone would be making millions on it. Someone WOULD have made millions on it. It would not have languished away for half a century before vets who are incapable of understanding a blinded study “found” it (how??) and are selling it for a few bucks a vial out of some huge generosity. This is ALL hogwash.
Good summary of a DMF:
[URL=“https://www.thebalance.com/drug-master-file-dmf-2663082”]https://www.thebalance.com/drug-master-file-dmf-2663082
Not all DMFs are reviewed by the FDA, and the possession of a DMF for a product does not ensure that a manufacturer is producing that product or able to supply it to the United States.
In the past, filing a DMF was a way for less established firms to claim a degree of credibility when trying to sell into the U.S. market and other regulated markets.
However, since DMFs are only reviewed when an ANDA or NDA references them, a DMF that has not been referenced is of questionable value even if the DMF holder thinks having a DMF makes them look legitimate. Filing DMFs without any customers in the U.S. has become much less common, so more recent DMFs are a better indicator of intent to manufacture than older DMFs.
I sent an email with some questions to the DMF FDA peeps! I will post the response when I receive
Oh, also noticed that the old chondranol website is gone. Poof! It was there when we started this thread, gone now. Was at https://www.condranol.com/
Oh. So. Poking around on the Summit FB page and other assorted info online.
Heather Farmer is the Dr Farmer (I didn’t know, I’m not part of the FB vet group) owner person of this Summit stuff. Maybe even the author of the “study” AllegedAdequanRep received? She was taken to court for violating a non compete when she got terminated from a clinic in Florida. Classy.
Her husband, also listed as owner of Summit, is Dorian Farmer. That’s a nice arrest record, huh?
They might not be the BEST people to take at their word, YKWIM?