It’s getting towards the end of the year. That means lots of top ten lists and product reccs in advance of the holidays. This list, over at FastCompany magazine’s website, took things a little further by including whiz-bang veterinary products and services along with pricey niceties like GPS collars and pet-dedicated flights. Nestled among these was Vet-Stem’s product: stem cell therapy for the dog that has everything...even osteoarthritis.
It seems stem cell therapy for ailing pets continues to gain momentum as as way to treat painful joints not amenable to surgical intervention or when surgery is deemed too invasive or stressful. Its success in the equine world for the same indications means that there’s reason to believe it’ll work for pets. Problem is, the literature is still sketchy.
Part of the problem is that we have only a very rudimentary understanding of how stem cells––harvested from a patient’s own fat and injected back into joints––can help reduce the pain and swelling located there. It makes some sense from a 30,000 foot vantage point...but not so much at the nit-picky cellular level.
But the larger problem lies in the lack of evidence on behalf of the product's efficacy. While a reasonable cluster of these exists for the equine community, only two canine studies have thus far been conducted. And I’m less than impressed. Though peer-reviewed, both were undertaken by the company that holds the patent on the process (Vet-Stem): One on the efficacy of the procedure in canine elbows included only 14 patients, while the hip disease study boasted little better with a sample size of 21. Each found the statistics as favoring the procedure...but not by a wide margin.
And still clients clamor for it. Even upon learning that stem cell therapy is an expensive, hit-or-miss prospect with very little research to back up its success in dog joints, they demand it.
And why shouldn’t they? If the alternatives don’t sound appetizing and the risk of the procedure (a two-step anesthetic process for fat collection and subsequent joint injection) seems more about their wallets than its inherent dangers to their pets, I can see why Fluffy’s owners might prefer it to a full-on hip replacement. But then, we know a whole lot more about hip replacements than we do about stem cells.
Which gets me to wondering...why is the state of veterinary research in such sad shape that we have to rely on companies to fund their own studies? I understand the economics that lie beneath, but I can’t help think there has to be a better way.
For example: With as many canine patients receiving stem cell therapy for their joints, how is it that they’ve not been tracked and monitored and their anonymous data compiled by an independent source? After all, owner reluctance would almost certainly prove no barrier.
While I certainly understand the high price of conducting prospective studies, it would seem that veterinarians, owners and the company would all have a stake in furthering research and share the burden to varying degrees. I mean, how hard is it to creatively organize a decent trial...with a reasonable sample sizes...with acceptable control groups (e.g., dogs who receive NSAIDs instead of stem cells)?
It’s a problem that dogs human medicine along with our side of things. And yet it’s rare that creative solutions arise to tackle even the seemingly simple task of compiling outcome data retrospectively. And why? In my opinion it’s largely because medicine prefers to outsource the study of emerging therapies like this one to the capitalist projects perceived to have most to gain from their outcome. But this represents a catch-22, doesn’t it? Who among us would wholly respect clinical data when it’s compiled by the most financially invested party?
In Vet-Stem’s case it’s their downfall in my eyes. But it needn’t be their undoing. What would it take to require that company-certified (yet independent) clinicians collect key data points in exchange for certification? That’s how Penn-HIP works. That’s the kind of initiative some vaccine companies take before they widely distribute their biologicals.
To my way of seeing things, our veterinary research needs to get lots more creative before we can get to where we’re going with a minimum of R&D outlays that serve only to raise the price of the product at the expense of the data’s credibility. Maybe what the veterinary industry needs is the occasional workings of a practical brain to dot their DVM/VMD ranks with a dash of simple strategic thinking. Maybe then veterinarians like me would be more willing to recommend the potentially masterful bit of veterinary innovation Vet-Stem offers.
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We've been using Vet-Stem and PRP for a number of equine conditions (arthritis, soft tissue injuries, etc.) for almost 5 years now. The jury is still out on its efficacy for arthritis, but it's so effective for soft-tissue injuries that both vets and insurance companies recommend using it. My horse's insurance company will actually re-insure a tendon/ligament (after 1 year) if you use stem cell therapy to treat the initial injury; if you don't, future injuries to the same area aren't covered by insurance.
In general, for osteoarthritis, we still prefer Adequan (every 4 days for 28 days, 2-3X a year) and intra-articular injections with HA + steroids.
Sarah November 7th, 2009 12:44:07 PM
And may I suggest public access to the information as it's being collected. People who develop/discover/experience problems run to the internet and start sharing so a very unbalanced picture tends to develop. There's all this talk about the awful information we get on the internet so how about giving us real data?
PJB November 7th, 2009 03:25:44 PM
As it's being collected? Is that wise? How easy it would be to form a fuzzy image (one you have just characterized as "unbalanced") when a year or a certain sample size could yield a clearer, more helpful one.
Dr. Patty Khuly November 7th, 2009 04:30:57 PM
I could live with a reasonable delay. And I'd like to think the opinions would be more balanced if the doctors are the ones filling the databases with all results rather than just the patients/clients experiencing problems which is what I tend to see in chat rooms, email groups, etc. Unfortunately, many aren't going to wait 5 years, 10..., when their pets are suffering and that's often what it takes to get complete results. We certainly need something faster and better than that. I also tend to think we'd all be more rational in analyzing the data if we could see the process.
PJB November 7th, 2009 05:42:40 PM
PJB: What do you think of this?
Dr. Patty Khuly November 7th, 2009 06:52:05 PM
I like the website and the apparent concept. It concerns me that their "partner" base in big pharma, even though they are listed last, I'm sure they are providing the majority of funding. The data is collected, anonymized and then provided to partners. The patients get to share with each other but the data appears to be going to and for the use of the partners rather than back to that patient base. Looks good for big pharma (and health care plans, their secondary market) but there's sure nothing there to indicate the patients or treating physicians will have access to the data, let alone the public. Reminds me of biofeedback without the feedback which isn't very useful to the patient.
A while back I discovered that many countries provide free access to many medical and science journals. That was frustrating. Even that would be an improvement for us. The other day, you linked to something I could only access the abstract on; tough to discuss something I can't read... I'm sure doctors must find it frustrating to have limited access to the various medical databases and it's sure to limit the cross-over knowledge base. (BTW, I feel the same way about legal databases. Every time a decent one starts to develop on the web, one of the biggies buys it out and makes it a subscription only website.)
PJB November 7th, 2009 09:04:38 PM
Great comments Dr. Patty. I agree with your frustration at quality data. But in this world, very few are willing to step up and pay for and do the clinical trial work. We were not required to do the two clinical studies at Vet-Stem before release, but chose to do so out of good conscience and desire for supporting data. These studies, although relatively small, cost over $100,000! We have also collected and publish random surveys (www.vet-stem.com) of veterinary and client/owner outcome results. We have also presented in oral and written abstract form over 20 times at scientific meetings to try to get out the best data to the veterinary community. I have conducted over 1,000 clinical studies in my career, many submitted to the FDA on behalf of veterinary and human pharma companies...I love data. I welcome any assistance, especially impartial and independent, to review our data or collect outcome results independently. We are here to help animals and bring regenerative medicine to our companions. Thoughts?? Bob Harman, DVM, MPVM, CEO, Vet-Stem.
Bob Harman, DVM, MPVM November 8th, 2009 12:03:34 AM
PJB: I have the same reservations. But how else would a company like this get started? Yes, I'd prefer to see a non-invested consumer products manufacturer as lead advertiser/funding source with pharma nonexistent in their funding stratagem, but that's not always doable. IMO, the data can still be valuable and independently collated this way, regardless of whether big pharma spent their dollars shoring up the site's backbone.
We all stand to benefit from this kind of data collection, preferable though other (far more expensive) methods might be. This approach is so much more efficient than what industry/academic channels manage that I can't help but compare it to Banfield's approach.
In Banfield's case, the data is amassed through their thousands of hospitals' networked database of diagnostic and treatment codes. And while this most benefits Banfield (they surely sell the data to big pharma, academia, et. al.), it provides a source of data heretofore unavailable to veterinary medicine. Moreover, Banfield has offered its muscle––gratis––on more than one occasion (reference the pet food recall and its distribution of renal failure data in the weeks surrounding it).
On balance, its not a perfect system, nor is a pharma-underwritten patient-based method, but it's another tool in our arsenal. A good one.
Dr. Patty Khuly November 8th, 2009 07:56:43 AM
Thanks for responding, Dr. H. Would it not help to require your certified clinicians to report their findings in a structured way to a centralized database accessible to all certified clinicians? Is there a privacy concern or clinician disquiet on the issue?
I'd love to see companies like yours advance your products through less "organic" methods than word of mouth and FastCompany-style say-sos. Independent clinician data (certified by Vet-Stem though they might be) would add significant crunch from the POV of potential adopters like me. And it wouldn't cost a lot.
Dr. Patty Khuly November 8th, 2009 07:58:06 AM
"how else would a company like this get started?" Not claiming to have the answers. Like most, better at seeing the problem/issues :) However, it doesn't seem to me to be too much of a burden to require the research on any drug, product, or procedure that makes it to market be made publicly available at the time of initial marketing or before. Personally, I'd rather see my federal dollars spent on informing us than on funding private research, especially if that research stays private. In addition to that, those who participate in trials of products/procedures should really get unfettered access to the results especially on stuff that doesn't make it to market since it may well have long term consequences for the participants.
What I see in that website is profiting off sick people's desperation. They participate in hopes that something will eventually benefit them. Personally, I wouldn't be willing to participate or give up that much personal information unless they were willing to feed the data back to the participants. After all, that only seems fair to me. Give the "partners" a 6 month head start and then cough it up. They get the head start and that equals profit, just not as much but that should be sufficient. (Sorry, in this economy, I'm so tired of the greed driving us all into a hole.)
The purpose of patents and the like is to protect the income stream, not limit access to the data. Widespread access is what scientists need to build on existing science and data and we end up funding the same research multiple times when it can be hidden and that's a waste for us all in addition to slowing down progress.
Hope the weather your way isn't getting too wicked!
PJB November 8th, 2009 01:40:12 PM
Well said! The two published stuies in dogs include an open-label (non-blinded) tudy run by the company, which is a very low level of evidence for obvious reasons. The other was well-designed and properly blinded/randomized, but only a minority of the subjective measures of efficacy showed a significant improvement, and there were no objective measures such as force plate analysis.
This therapy is the perfect example of taking a promising idea and marketing well before the data exists to justify it. And despite the glowing testimonials (which history has shown are not predictive of actual efficacy despite being very compelling), most such therapies don't fufill their early promise. There are serious ethical problems with selling an expensive and invasive procedure with unproven safety and efficacy.
SkeptVet November 8th, 2009 01:46:00 PM
Here's another example of the stem cell bandwagon and the problems with it:
http://skeptvet.com/Blog/2009/10/veterinary-stem-cell-research-is-this-the-best-we-can-do/
SkeptVet November 8th, 2009 01:47:27 PM
The data is right here. Over 2,000 clinical trials and tens of thousands of studies.
DO STEM CELL TREATMENTS WORK?
http://repairstemcell.wordpress.com/2009/10/10/do-stem-cell-treatments-work/
David Granovsk November 8th, 2009 07:43:01 PM
David: Thank you for your perspective but here we are not troubled by evangelical extremists nor are we concerned with studies conducted on humans. Animal studies in joints are the subject of this discussion. Your 'Google alerts' steered you wrong.
Dr. Patty Khuly November 8th, 2009 08:21:51 PM
"What I see in that website is profiting off sick people's desperation. They participate in hopes that something will eventually benefit them."
Funny, I don't see it at all like that. I see it as a bunch of civically-minded individuals stepping up to contribute to a better way of acquiring data that will help us all.
Dr. Patty Khuly November 9th, 2009 06:27:01 AM
Looked into this a while back. Studies done without a control will not be awarded a 5th Grade Science Fair prize. Or even a passing grade!
Also, the study I read from this company measured success by gait improvement over time. As in the animal has learned to compensate well.
Robert November 9th, 2009 09:21:24 AM
"I see it as a bunch of civically-minded individuals stepping up to contribute to a better way of acquiring data that will help us all." I see that too; just don't think it excludes or precludes profiteering on the other side :)
PJB November 9th, 2009 10:27:09 AM
Reading this, it sounds like we're all singing the same song. While we may be initialy skeptical about a new product, we want good, hard core research to convince us of its efficacy. Everyone seems to agree we need large sample sizes of blinded and honest data, well-compiled and analysed. However, only Dr. Harman has ponied up to cash.
Research like this is not done by some omnipotent government agency with benign objectives and limitless resources (that doesn't exist). There is no veterinary NIH. Everyone who wants good research needs to look into helping fund some veterinary research foundation so that all this research can actualy get done. The companies do the best they can, and then get assailed for having funded the research themselves. If not them, then whom?
Marc November 10th, 2009 08:38:55 AM
Marc
Research is great. However, doing a study without a control is a complete waste of money and time.
I hope this is not an example of this company doing "the best they can."
Robert November 10th, 2009 08:59:09 AM
Wow...I can see there is a real passion for this topic. And rightly so. We have spent over $1M in clinical development studies over the last few years in collection of data and analysis to assure that we are moving in the right direction. We have put out several clinical follow up studies in addition to the double-blinded hip study. To date, we are the only authors of such studies in dogs (many in humans). We hope that Universities will soon be publishing more supportive data. We are paying for a force-plate style study starting in early 2010 to provide additional support. We still lose money every month at Vet-Stem but are committed to see this through to help the many thousands of patients that exist with severe pain and no options. Thanks for the encouragement and suggestions. We take volunteers and donations as well! By the way, we do pro bono (free) work for some shelter/service dog organizations to help do our part.
Bob Harman, DVM, MPVM November 10th, 2009 09:27:34 AM
"We are paying for a force-plate style study starting in early 2010 to provide additional support"
While I appreciate the good intentions, and I hope that the Vet-Stem approch turns out to be as beneficial as you believe, I can't help pointing out that this sort of statement illustrate the problem with industry-sponsored research. It's not really about big bad companies concerned only about making money, as many people choose to charicature the biotecha dn pharmaceutical industry. Sure, financial motives can cloud judgement, but I think the bigger problem is that the research is being done by people already 100% convinced of the efficacy of the treatment, and it is being done "to provide support" for what you already believe to be true. This level of bais is really tough to compensate for even with reasonably good research designs, and so unfortunately it makes the value of the data much lower. \
Your point about where else is the money going to come from is a huge one, of course. For better or (I think) for worse, the for-profit sector is simple better able and better motivated to pursue speculative research, so it's hard to stay a purist about replication of data by disinterested parties when the reality is such is hard to fund. Obviously, I'd like to see much more private and government funding for this, in human and veterinary medicine, but I'm enough of a realist to accpet the low liklihood of that. Unfortunately, that doesn't change the reality of the deep inherent bias of a company reseraching its own product. I appreciate your motives and the work you're doing, but I'm still skeptical about the product and reluctant to expose my clients and patients to an invasive and expensive process with such problematic data behind it.
SkeptVet November 10th, 2009 05:15:18 PM
On October, 21-24st the corporation <a href="http://denas.od.ua/">«DENAS МS»</a> has taken part in the annual international congress EuroSpine-2009 devoted to problems of treatment of diseases of a backbone. On action which passed in Warsaw, A.A.Vlasov, the deputy director of medicine of Corporation, has acted with the report. Preparation for participation to the congress has begun several months ago: the Application blank and the report “Randomized placebo controllable research of efficiency DENS therapy at patients with osteoporosis crisis of vertebras” have been sent to congress organising committee. In some months the medical centre of corporation has received the invitation to the Action. Formation of the list of reports of the congress was preceded by strict and careful selection: one third has been chosen from the sent works. Representation DENS was included into number of the reports which are worthy. The leading manufacturers of medical technics and known medical institutions of Poland, Great Britain, USA, France, Italy, Greece and other countries have presented their methods of treatment and rehabilitation of patients with diseases and backbone traumas. (It is important also that on EuroSpine-2009 the Corporation DENAS MS was only one Russian company, whose report has been included in the action program). The overwhelming majority of works (about 95 %) has been devoted to the surgical treatment. Other reports concerned ways of rehabilitation by means of physical culture, medicines and others. And only one participant of the congress – corporation «DENAS МS», – has shown possibilities of treatment of spinal patients by means of physiotherapy.
yaon November 11th, 2009 03:53:18 AM
Skeptivet: True on the bias but it applies to most science by virtue of the almighty scientific method. No one likes to see a failed hypothesis, much though it may contribute to science at large.
On a happier note, I also thought I'd point out that two dogs that underwent Vet-Stem treatments are competing in this week's agility World Championship in Phoenix. Ace and Vixen, sample size of two though they may be, are apparently doing well enough to remain competitive.
Dr. Patty Khuly November 11th, 2009 07:04:13 AM
I'm glad those dogs are doing well, but the reality is that such stories create the impression that the treatment is beneficial without actually demonstrating it. How many competitors in the trials underwent acupuncture, chiropractic, were prayed for be their owners, etc. All the folks who believe in those interventions, much less plausible than stem cell therapy, will also cite the dogs' performance as a suggestion that these thera[ies "worked."
The value of the scientific method, and the reason it's worth sticking to despite the fact that it's expensive and cumbersome and time-consuming, is that it is more reliable that the admitttedly compelling but ultimately untrustworthy bases of belief we use routinely, such as anecdotes like this.
SkeptVet November 11th, 2009 11:01:08 AM
This therapy is the perfect example of taking a promising idea and marketing well before the data exists to justify it. And despite the glowing testimonials (which history has shown are not predictive of actual efficacy despite being very compelling), most such therapies don't fufill their early promise. There are serious ethical problems with selling an expensive and invasive procedure with unproven safety and efficacy.
Gaggia November 16th, 2009 09:30:53 AM
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