This month we feature Part 2 of our interview
with Jeffrey A. Marksberry, MD, who is the Science and Education Director of
Electromedical Products International, Inc (EPI). EPI is the company that developed the
Alpha-Stim technology and manufactures the units. As leading research analyst for studies on
the Alpha-Stim, Dr. Marksberry has vast knowledge of current and past studies on electromedicine, microcurrent, and
Alpha-Stim in particular
New Studies on Alpha-Stim
Interview with Dr. Marksberry, Part 2
Tell me about the new
PTSD studies, as it seems very relevant now that the war in Iraq is coming
to a close. The veterans are coming home, and we need to be able to treat them
somehow.
Well, we have got three studies on PTSD underway, all in
different stages. There is one at the University of North Texas, which is just getting
approval to start by the college. There
is another in San Antonio, and they don’t have
anyone to analyze the data, so we actually got them in touch with some
researchers at the same University, North Texas. So they will have the data and they are going
to analyze that. And the third one is in
press to be published in the next couple months. So there are three. There is also a traumatic
brain injury study at the University
of Baylor, and they are in conjunction
with the VA clinic in Houston.
Aside from studies on
veterans or VA studies, are there any studies happening or being released soon
that you are excited about?
Yeah, actually I got an influx this last month or two of
people wanting to do research. I am the liaison between them and the company,
so we loan them [Alpha-Stim] devices and we help them set protocols. I think the one I’m most excited about is a
Fibromyalgia study. It’s at Virginia University, they finished, and they are
writing it up, and it’s a big study.
They looked at pain with Fibromyalgia, they looked at sleep, and I
believe they also looked at anxiety and depression, but they did FMRI imaging
in the study as well.
We’ve got another one that’s going to start that I’m excited
about is at a VA clinic. We have got
over 27 on-going studies, and all of them but this one are based on CES, but
this one will actually be using the probes, and they are going to double-blind
it.
Really the most gratifying thing I’ve done now is going to
NICoE and seeing their facilities, they are the military leaders on PTSD and
brain injuries. I’ve done two trainings
there. I trained at camp Lejeune,
which is a marine and naval base. That’s
where the Wounded Warrior headquarters are, the battalion, so most of the
Wounded Warrior work comes out of there, and so I trained some of their
doctors. Just seeing them tell you what
they have been doing is amazing stuff.
That’s interesting,
I’ve been doing follow-up for a couple conferences and I was just on the phone
with someone who works with Wounded Warriors.
Tanya does our government services and she works a lot with
Wounded Warrior programs. They call any
soldier that’s injured, or marine or whoever, a wounded warrior. I think it is headquartered at Camp Lejeune, North
Carolina. I
went there and trained some of their mental health and pain doctors. So that was really cool, and they want to
have me back. They are moving offices,
but when they are all set up together they want to have more training so they
can use it and integrate it more.
How does the arsenal
of research on the Alpha-Stim compare to other devices, or even
pharmaceuticals?
Any of our competitors – we absolutely kill them. One time I did a device comparison, so I
found every competitor of ours, of the CES, that I could, and put the name of
the device, the pricing, anything I could find, what they claim they treat,
then research. I think only
Fischer-Wallace has one or two studies they have done – other than that, they
only just claim our research. They will
basically just copy and paste off of our website and put it on theirs. But as far as pharmaceuticals go, they usually only do one or two large-scale
studies before they get approval.
Afterwards, I’m not sure they would do any – unless they want a new
indication. Other researchers,
independents, will do research with it. Once aspirin, you know, is approved
they don’t need anymore research. Other
people will go an tell them, “You better do this study,” and over the years
they get more, but most drugs don’t have a lot of research that they’ve done –
but over the years they get more from independent sources.
I think we stack up pretty well against most pharmaceuticals
for research though. Those companies do
pay for large-scale studies to get first approval, and a lot of times it may
have 2000 patients in it. We don’t have
that kind of study where it’s got 2000 patients in it.
When I was reading
articles about the FDA’s re-classification of the Alpha-Stim, and the FDA’s
Proposed Rule, the FDA was saying, “That was only 20 patients.” So the studies are completely dismissed just
because they are small, but I don’t think that’s valid because it’s a quantity
over quality argument.
You know, when I’m at a conference and a practitioner says,
“Well, you don’t have a big “in.” Where is the 2000 patient study?” I would say, well, you can pick any drug, but
let’s say Zoloft, they have a study with 2300 patients. You can go to their
website and see it. That study, and this
is documented, that study actually started with 5000 patients. Ok? They went through phase one, which was “See
how well it works for everybody.” And
they took the bottom 25% of doctors that were in the study, and if their results
weren’t very good, they got thrown out of the study. And then they did phase two, where every
doctor got paid more to be involved. And
they did another trial, and the bottom 25% were picked out again. They do that
about four or five times until the “best” practitioners, who are really incentivized
to get good results now, because you are getting paid more for every step that
goes on. There is more and more
incentive to stay in the study, and you get better results. They threw out the bottom 25%, so now they
are up to just the best patients and the best doctors that they can get results
with. So there are ways of skewing
things, and just because you have got 2000 patients, it doesn’t mean that it’s
better than something that’s got 100 patients in it.
Right, if I was at a
conference and this question came up, I would be like, “Well, how many patients
do you see?” You know? Do you see 20,
30, or 40 a week? Then what if 80% of
them got better from this? Would you
say, “Oh that’s not very valid. It’s only 20 people.”
Yeah, exactly, and that’s the way you have to think about it,
and people don’t. People get accustomed
to the drug Rep coming in and saying, “We’ve got this study. It had 3000
patients in it. The P value was….” You
know, it’s the quality of the study and not the amount of patients that were in
it.
Last question
then. I don’t want to get you in trouble
with anyone. But I’m curious as to what
you think the future of micro-current, in terms of medicinal use.
I’d say the future would be wide open. Getting the calls that I get on a weekly
basis are amazing. We have our four
indications, which we market for, and know a lot about, but we’ve had, in the
last few months, stories about two people that were in comas, that were in
vegetative states, that came out of the coma.
Actually their spouses started using Alpha-Stim with them. I mean, out of comas, vegetative states. I’ve also talked to two people, and they were
about a week apart, one gentleman, he had a tremor for 25 years. He’s only 37, he’s had a tremor since he was
12. Played the violin, but doesn’t play
as much as he wants to because of his tremor.
Went home for Thanksgiving, and his mom put her Alpha-Stim on him, and
five minutes later his tremor was gone.
I mean, those things aren’t what we market for. I’ve talked to people who are autistic who have
gotten benefits, with ADD, so many things that we don’t, and can’t, market for,
that we get reports from practitioners and patients, is very encouraging. It makes me think that really everyone or
anyone who has got problems and doesn’t feel perfect should at least try it and
see if it helps them or not.
There’s no reason why it shouldn’t be more mainstream and
utilized more.
Is there anything
else you want to add?
We’ve got a lot of studies on the way we are very excited
about. Twenty-seven is a huge
number. And all together we’ve had about
50 studies published. We’re doing a lot
of webinars, excited about that. We
really feel like education for the practitioners is the best way to get them
involved, better than selling more. So
we are really pushing that.
