Calmare Therapeutics Inc (fka CTTC)

[Vaffan-Coulo]

Well, so far I haven't heard anything from Dr. Starkweather about the peculiar "chameleon" calmare data that she apparently possesses! Call me impatient, but, what the heck, I went ahead and shot off an email to the VCU "Office of Research Integrity and Ethics":

"Hello, I read with interest a just published article by Dr. Angela Starkweather, faculty member of the school of nursing:

"Decreased Low Back Pain Intensity and Differential Gene Expression Following Calmare®: Results From a Double-Blinded Randomized Sham-Controlled Study - Starkweather - 2015 - Research in Nursing & Health - Wiley Online Library"

First, I am familiar with this device and I recalled that the authors had presented data about presumably the same group of patients at a nursing conference about a year ago:

"B3-1: Scrambler Therapy for Persistent Low Back Pain: Results of a Double-Blind, Randomized Sham-Controlled Pilot Study Authors lists: Presenting Author: Angela R. Starkweather"

Note that "Calmare" is the "brand name" of the "scrambler" device. It struck me as very odd that the journal article reported completely DIFFERENT results from those provided in the conference abstract. Indeed, the conference reported results that were remarkably SUPERIOR to those offered in the journal! The conference results were quite striking with pain reported decreasing from "8" to "1," allodynia reduced from 77% to 15%, and opioid use reduced by 50%. NONE of that appears in the journal article! It hardly makes sense to ignore results like that, now,does it? Nevertheless, I could find NO reference to any of it in the journal article!

Even more confusing, however, is that BOTH sets of data are different than what was supplied to a physician for use on his website:

"Studies & Trials - Calmare Pain Management
By Christian Becker, MD Chronic and Interventional Pain Management © 2014 Calmare Pain Management Trial of Calmare Scrambler therapy in 226 patients ..."

At the bottom of the page is a graph describing "Scrambler Therapy for Persistent Low Back Pain: Results from a Double-Blinded, Randomized Sham-Controlled Pilot Study, Angela Starkweather, Ph.D. Virginia Commonwealth University School of Nursing, Virginia Commonwealth University, March 2014, unpublished data."

THERE, the pain appears to have decreased from only 4.8 to 3.2! Given that the data was "unpublished," I have to presume that Dr. Starkweather or one of her co-author's supplied it BEFORE the conference abstract was released.

It's a bit alarming to see data presumably collected from the same patients changing according to where it's being presented, wouldn't you agree?

It's also a bit disturbing -- even a bit suspicious -- to see "scrambler therapy" being transformed into its "brand name" for the purpose of being published in a respected medical journal. The company promoting and selling the "calmare" -- "Calmare Therapeutics" -- is a "penny stock" trading on the "pink sheets" for around 20 cents a share. It is involved in a number of lawsuits for having failed to comply with various contracts and now appears to be almost bankrupt:

color us almost belly up

The company refers to Dr. Starkweather's nursing conference abstract in its promotions at investor conferences -- see page 16:

plueeeeze buy our stock

In August of last year, "Zacks," a popular stock "research" service reported:

"A new CEO was brought on board to orchestrate a turnaround which includes the plan to run two pivotal clinical studies to support an FDA PMA submission and improved reimbursement status."

For details, see:

you get what ya pay for

Then, lo and behold, only a few months later, here arrives a journal article featuring the brand name prominently in the title and reporting data that could be used "to support an FDA PMA submission and improved reimbursement status." Yet it DOESN'T use the arguably "too good to be believed" data reported in the conference abstract, but a completely different, ever so much more "believable," set of data!

Finally, it's interesting to note that the journal article makes no reference to a previously published trial:

"A randomized, double-blind study of “Scrambler” therapy versus sham for painful chemotherapy-induced peripheral neuropathy (CIPN). | 2013 ASCO Annual Meeting | Abstracts | Meeting Library"

That study reported that the "calmare" not only had no effect on pain, it couldn't even be differentiated from a "sham." In personal correspondence with me, Dr. Starkweather acknowledged that she had reviewed Dr. Campbell's results before starting her own study. Now, granted, failing to demonstrate scientific objectivity by ignoring past research contrary to your own -- research that would NOT "support an FDA PMA submission and improved reimbursement status" -- is certainly not unethical. However, within the context of this device's history overall, coupled with the peculiar changing data and appearance of the "brand name," it nevertheless contributes to one's wondering whether there are some ethical issues that might need to be addressed."

And, just to cover all the bases and since Ms. Starkweather gets NIH funding for her other research, I thought it best to let NIH's own "Office of Research Integrity" know about the problems she seems to have with data consistency! Wouldn't want no taxpayer dollars flushed down some QUACK, pseudoscientific, fraudster toilet, now, would we?