April 2007

Axiom defends DRX9000

Board complaints target ads, not effectiveness of spinal decompression device

Axiom Worldwide, USA, has revised its advertising and marketing campaign in response to various issues raised in the spinal decompression industry. It has been reported that several state chiropractic boards have been investigating what they say are unfounded advertising claims made by doctors using the company's DRX9000 device.

Axiom indicates it has taken steps to provide its doctors with advertising that avoids these issues to allow doctors to concentrate on treating their patients without having to get involved with the resolution of the issues raised regarding the older advertising.

While some of the marketing language may change, Axiom stands by its assertion that the DRX9000 spinal decompression system is an effective and valuable therapeutic device supported by numerous studies and real‑life clinical experiences.

After an article on board actions regarding the DRX9000 was published in the January 2007 issue of The Chiropractic Journal (TCJ), Axiom contacted the Journal through its attorneys, demanding a retraction, stating the piece was "replete with factual statements that are untrue, incomplete and clearly intended to defame" the company as well as J.C. Smith, DC, a prominent proponent of the device.

According to the letter from Axiom's legal counsel, "The DRX9000 is not being investigated by any party on the basis that it is a fraudulent device. No one has alleged that the device is fraudulent. The investigations and settlements which you reference in the article focus on advertising claims."

TCJ Publisher Terry A. Rondberg, DC, admitted that the headline, "Device championed by J.C. Smith under fire as fraudulent" was possibly, although unintentionally, misleading.

"However, the article makes clear the complaints state that advertising claims about the device's effectiveness made by doctors using the device may be unfounded, not that the device itself it ineffective," Dr. Rondberg pointed out.

Cases reported in the Journal article included two California DCs who were fined $25,000 for violating false‑advertising laws by publishing the claims made by the company. One of the doctors cooperated with prosecutors and had $17,000 of his fine suspended.

The article also quoted a report in the Monterey (Calif.) Herald, which stated that the "District Attorney's Consumer Protection Unit demanded substantiation of the claims from the chiropractors and the device's distributor, Axiom Worldwide Inc., but has received none."

Axiom claims that, at the time the Journal article was published, the company still had time before the deadline to respond to the Monterey request. Axiom attorneys state that the company has since provided materials to the Monterey District Attorney and is awaiting a meeting.

Another reference in the Journal article was to the announcement made in Nov. 2006 by the Oregon Board of Chiropractic Examiners that it was questioning the company's claims about its device's link to NASA research.

The Oregon Board noted in a press release: "A typical claim is that an 'Accidental Discovery by NASA in Outer Space Quickly and Easily Solves 86% of Back Pain...' Astronauts that left with back pain would come back without it..." The Board went on to state that information it obtained "casts doubt on the validity of these advertising claims."

Axiom states that it has no record of ever receiving a request for information from the Oregon Board and will be asking for an opportunity to meet with the Board through counsel in Oregon.

Since the Journal article was published, the Minnesota Board of Chiropractic Examiners announced that it has received a number of questions about decompression therapy. "The Board has not currently taken a position with regard to this procedure," it announced. "However, new on the scene is a superior court decision regarding the false advertising of this therapy. The Board will be reviewing this decision and may incorporate it into any complaints received regarding such advertising." The court decision referred to was the California case.

Axiom has requested an opportunity to address the Minnesota Board.

Although both the California and Oregon Boards said that the company failed to provide them with substantiating evidence of the validity of their advertising claims, Axiom sent the Journal detailed information on several research projects involving spinal decompression in general, and the DRX9000 in particular.

Among the material submitted is a study presented at the American Academy of Pain Management in 2006. In that study, researchers from Stanford University, Johns Hopkins University, and other institutions, conducted a retrospective analysis of outpatients treated with the DRX9000 for chronic low back pain lasting more than 12 weeks.

They concluded that pain was significantly reduced in the subjects, as was the use of pain relief medications (subject to the limitations set forth in the report). Patients reported a mean 90% improvement in back pain and none required surgery. The study was partially funded by Axiom.

A case study of a 50‑year old male patient, conducted by Terry R. Yochum, DC and Chad Maola, DC, published in Chiropractic Economics as an "educational advertorial" concluded that "Spinal decompression therapy provided an effective means of treatment for this patient's symptoms resulting from discal herniation (extrusion) with associated impingement of the adjacent nerve root."

Dr. Yochum also noted that "Decompression of the spine proved to be superior to the other forms of conservative care when applied to our patient."

Research studies have also been conducted in Russia and the Republic of South Korea, each showing similar results with overall success rates as high as 90%.

As demonstrated by the attention given the issue by the Oregon Board, the advertising claim that appeared to spark the most criticism was Axiom's statement that the device was based on "an accidental NASA discovery" that outer space quickly and easily solved most back pain. John Hubanks, the prosecutor in the California case, countered that NASA has determined space travel has a detrimental impact on the spine.

Axiom distributed a press release "in an effort to quell the rampant rumors and misinformation circulating within the spinal decompression industry regarding its connection to NASA."

While identifying sources for much of the misinformation being circulated as "former disgruntled employees and some of our competitors," the company emphasized it "takes full credit for bringing its technology to market," and pointed out that "NASA did not discover nor does NASA endorse any product manufactured by Axiom Worldwide."

The press release provided lengthy documentation on NASA research on how the human spine responds to micro‑gravity and explained how that research was considered by Axiom in the development of the current DRX9000.

While there may be unresolved questions regarding the original advertising claims for the DRX9000, the company stands strongly behind its product, as do many of its staunch supporters and users.

"I'm pleased by Axiom's pledge to review its advertising campaign and promotional materials," stated Rondberg. "There is research to validate the use of spinal decompression in the treatment of back pain and disc disease and DRX9000 has won support by many practitioners and patients as a mean to reduce pain symptoms, avert surgery and reduce medications."