I spoke at length last week with Dr. Rhodes about ways that we could better determine the effectiveness for DMD of his VECTTOR electrical stimulation system, which Dr. Rhodes says stimulates acupuncture points, reflexology points and free nerve endings. Dr. Rhodes was very up front about the fact that he isn’t a scientist and isn’t an expert on DMD and his actual professional training is in podiatry. He has supplied his VECTTOR machine to 36 families with muscular dystrophy—he didn’t specify how many were DMD, but I got the impression that the majority of them went to families with sons with DMD. The machines cost around $4000 each and Dr. Rhodes owns the company that makes them. He does offer to buy back the machine from any family that is not satisfied with the results (I didn’t ask him if any had ever been returned).

His hypothesis for how the machine works is that it stimulates the release of vasoactive intestinal polypeptide (VIP) and calcitonin gene related peptide (CGRP), which in turn increase blood flow to the muscle. [As an aside here, we know that DMD is caused by the loss of dystrophin and that one of the main functions of dystrophin is to strengthen the muscle cell membrane during contraction and relaxation; however, when dystrophin is missing another molecule that manufactures the vasodilator nitric oxide (NO) is missing from the membrane—the loss of NO activity may impair the ability of the capillaries to maintain blood flow when they are squeezed during muscle contraction and contribute to the muscle damage seen in DMD]. When I spoke with Dr. Rhodes several months ago he mentioned that he had documented these changes in neuropeptide levels working with collaborators outside of Texas but that he didn’t have access to that data now.

Dr. Rhodes told me that every child he saw with muscular dystrophy had a significantly lower skin temperature in the fingers than would be expected, and that every child failed a “perception threshold” test that measures the amount of physical stimulus required for a person to be able to perceive that stimulus. Dr. Rhodes doesn’t know if these abnormal values return to normal with the use of the machine because he typically doesn’t see people for follow-up, but rather stays in touch afterwards by email. He also mentioned that a physician somewhere had tested circulating levels of the inflammatory marker TNF-alpha before and after two boys used the machine and found that the TNF-alpha levels declined significantly; he did admit however, that he doesn’t know how much TNF-alpha levels normally fluctuate. The evidence that Dr. Rhodes does have is detailed testimonials from families who have purchased the system. He is currently trying to collect survey responses from every family with muscular dystrophy who is using the machine.

I spoke with Dr. Rhodes about how we could go about evaluating the effectiveness of the machine in a more systematic manner. To even do a pilot clinical study would likely cost between $60,000-$100,000. A definitive clinical study would probably cost around $350,000. Typically when we spend money on a clinical study we have some objective evidence in hand that justifies the expenditure

In the case of Dr. Rhode’s VECTTOR machine we have only subjective testimonials, which shouldn’t be discounted but should be combined with some objective data. For example, Dr. Rhodes doesn’t actually know if his machine normalizes the perception threshold test that he says is abnormal in boys with DMD. He doesn’t know if VIP and CGRP are increased after using the machine and if so, by how much and for how long. He has heard that TNF-alpha levels are decreased after treatment, but he doesn’t know how much this molecule normally fluctuates. At the very least, before a pilot study should be considered, we should be able to find out if the machine is even affecting these parameters.

I discussed with Dr. Rhodes the possibility of identifying some volunteer physicians and families to test the device more objectively by measuring the concrete physiological changes the machine is supposed to cause. This would be a first step toward determining if a pilot study is warranted. Of course if the machine doesn’t trigger these changes it doesn’t mean that it might not be working through some unknown mechanism, but it does cast more doubt on the whole enterprise. If it does cause the physiological changes that Dr. Rhodes thinks it does, it doesn’t mean that the machine preserves muscle strength as well, but it provides more support for doing the clinical testing to measure muscle strength systematically.

I will be in London next week for the Action Duchenne meeting and Dr. Rhodes is trying to arrange for me to meet with some of the UK families who are using the machine and reporting good results. I will also be speaking with some investigators about how we might set up the collection of the preliminary measurements of physiological changes for the least expense and greatest gain.

This situation is one of the most complicated we face as a community—we have a very well-meaning man who has a proposed therapy for DMD that he really believes works, and yet he admits that he is not a scientist and doesn’t know how to go about testing it convincingly. In the meantime he is selling his machines to ever larger numbers of families, still with no concrete data that it’s effective. Typically when someone makes a claim about a product the responsibility lies with the person making the claim to demonstrate that it’s true.

In the best scenario we will be able to show the machine causes changes in muscle physiology that lead to stabilization of strength as Dr. Rhodes proposes. At worst, we will have put time and money into a project that never had a lot of supporting evidence behind it in the first place and moved resources away from projects that had greater odds of working

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Comment by enicasio rios on September 19, 2012 at 11:04am

hi im enicasio rios i have bmd im 31 i just started using a wheelchair  2 years ago im needing help i want to try the machine  i think it works havent tryed it but would like to if anyone can help me let me know bluepitbulls007yahoo.com

Comment by cheryl cliff on March 25, 2011 at 3:29pm
Thanks Keith, interesting article.  From the looks of it, it appears physicians who are paid by pharma's to promote drugs off label are up against federal watchdogs, for good reason.  Promoting meds is certainly different than practicing medicine.  I do hope those watchdogs stay within certain boundaries though.    I worry if big brother goes a bit further they might take after those of us using deflazacort.  
Comment by Keith Van Houten on March 25, 2011 at 1:42pm

Cheryl - you're right.  Pharma cannot promote off label uses.  Not sure about physicians.

 

But, here's a news report about a physician criminally indicted for promoting off-label use of a drug.  link   This was from 2006, I don't know how it turned out.  Again, I don't know if the law is different for drugs and medical devices.  

Comment by cheryl cliff on March 25, 2011 at 9:36am
Well, not sure I have this correct since I'm not an attorney, but I think it's actually illegal for pharma's to promote off label use.  But this issue might be somewhat different regarding doctors.  Like you Keith, I have no idea how any of this applies to medical devices.     
Comment by Keith Van Houten on March 24, 2011 at 10:24pm

Brenda, it is ILLEGAL to promote off-label usages of FDA approved drugs.  Pfizer paid a $1.3 billion criminal fine (largest criminal fine ever imposed in the US and a $1 billion civil fine in 2009 for off-label promotion.  Perhaps the same rules don't apply to medical devices.  I don't know.

Comment by cheryl cliff on March 22, 2011 at 10:11am

Can't thank you enough Brenda and Pop Jarvis for your storys.  It's wonderful reading about somebody who is having success fighting DMD Brenda, I wish you and your son the very best.  Hopefully someday the issues regarding Dr Rhodes will be sorted out in order to benefit all, one way or the other.  Brenda, your criticism of Pop Jarvis's name and accusation of his "stalking parents" may be your opinion - but other DMD parents don't share that thought.  Although I've received messages via fb, I do not feel the least bit "stalked".  Getting both sides of the story is valuable and appreciated by myself and most likely others as well. 

 

As far as off label use is concerned, saying it is "legal" and therefore justified is a broad overstatement.  While Dr's can perscribe off label doing so can expose them to legal malpractice suits.  And if they don't know it I wouldn't take my son to see them.   MDA and others are testing Viagra for DMD use, therefore removing the off-label status of that medication so Dr's can perscribe it without worry of malpractice. 

 

 

Comment by Brenda Morea on March 22, 2011 at 12:45am
Pop Jarvis or whatever name your going by now, are you still stalking us parents on Facebook??  About the operation of Dr. Rhodes, it was very busy, with many happy clients coming and going during our visit.  Dr Rhodes and his staff with very professional and helpful.  Also, assisting with blood flow and circulation, helps many things, DMD (mda is currently looking at Viagra because of its help with Circulation...oh yeah that would be an off label use by the way), pain, diabetes, asthma, many things are helped with better circulation.  Our experiences have been nothing short of awesome! 
Comment by Brenda Morea on March 22, 2011 at 12:28am

@ Keith it is called "off label use" which means using it for another use besides what FDA approved it for, it is perfectly legal, about 1/5 of our prescription drugs are used off label, and the law gives that right to the Dr not the FDA.  We are also using the Vecttor for our son, We are very pleased with the results.  I would love to see this in the hands of every MD family.  My son is 20 and has been in a chair for 10 years, DMD patients at this age do not improve ever!!  He is improving slow and steady.  It is so awesome, as a parent I know without a doubt that this is helping.  I just wish we had found this much sooner!

Comment by Sharon Hesterlee on January 13, 2011 at 3:09pm
Thanks for the comment--I'm sure everyone reading this thread will appreciate any source of additional first hand information about Dr. Rhodes operation.
Comment by pop jarvis on January 13, 2011 at 2:53pm

Dr Hesterlee,

I feel compelled to weigh in on Dr Donald Rhodes and South Texas Innovative Medicine as a man who drove his daughter to his clinic half - way across the country last November 2009.  I have copies of his old web sites (PROMISING 90% success) and as well as other "interesting " statements he has previously made.  I'm a scientist and a technical man by nature - I'd love to share documentation and observations with you - and "take it for what it's worth".  All I know is that if anyone dear to me was contenplating a trip to South Texas Innovative Medicine - I would IMPLORE them to write me or call me and hear my story - then decide for yourself.  If you are interested in discussing this further please e-mail me jaysenscribe@gmail.com , I 'd also discuss this with you if you are interested (easier on the fingers!)  Thanks for your time, Jaysen

 

Please be very very leery!!  I took my daughter to Dr Rhodes (South Texas Innovative Medicine)in Corpus Christi in November 2009.  He promised (no if's ands or buts) a 90% success rate for Complex Region Pain Syndrome (I printed this web page - he since took it down - I can send you a copy.  To make a long story short, after we spent thounds to get to Corpus Christi and had to buy a $4200 dynatron machine (since his policy was not to lease or rent the machines!)  He was "on the verge" of a big CRPS "breakthrough".  After we got home and had paid our money - his enthusiasm severly waned (he called us within 12 hours when we were interested in coming down!).  If you'll note on his web site -- he has all but abandoned CRPS and it seems like he found a new "untapped" source of desperate parents (like my wife and I).  I'm a 49 year old electrical engineer.  I thought he ran an "interesting" operation from the minute I set foot into his "office"  (If anyone has been there- ask them to describe the "trailer".)  DOn't take my word for it - Ask Dr Rhodes and South Texas Innovative Medicine some TOUGH questions - He atlks a good game - Ask him what his success rate is on CRPS patients.  Ask him when the last time he wrote a paper on a all these great "breakthroughs".  He's been doing this electro-stim for over a DECADE! Please write me or call me popjarvis@gmail.com.  I will tell you EVERYTHING we,ve been through!!

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