CLA claims scrutinized for fraud

by David Marcarian, Lead Investigator

NASA denies connection to Subluxation Station

In 2007, two chiropractors were fined $25,000 for claiming the chiropractic diagnostic machine they used was a "NASA-designed device." According to a report in the San Jose Mercury News ("Back-Pain Treatment Scrutinized" by Barbara Feder-Ostrov, April 19, 2007), this wasn't an isolated case. "The companies that make them (the chiropractic devices) and the chiropractors who buy them are coming under increasing scrutiny from local district attorneys and federal officials for fraudulent advertising and unproven claims of effectiveness."

Although the fines were later reduced, the case spotlighted a vital legal point: doctors are ultimately responsible for the claims they make -- even if they are simply repeating the information provided by the company selling the devices.

That point has been brought up again in recent months in regards to the Subluxation Station marketed by the Chiropractic Leadership Alliance (CLA). After receiving a number of complaints and questions from doctors using the Subluxation Station, the World Chiropractic Alliance (WCA) began an investigation into allegations that many of the advertising claims used to sell the machine were fraudulent or misleading.

In particular, the criticisms involved CLA's claims that:

***  the Subluxation Station had direct or indirect ties to NASA

***  the Subluxation Station's "certification" by the Space Foundation was connected to NASA

***  the CLA head engineer responsible for designing the Subluxation Station conducted research at Boston University for NASA

***  the Subluxation Station has been "approved" by the FDA

The accusations were so serious that a US Senate Investigation reviewed them and concluded that it was "the worst fraud in NASA Spinoff Magazine history."

Patrick Gentempo, DC, CEO of the CLA, was found by a US Senate Investigation to be in violation of two federal statutes (18 USC Sec 1001 and 1017) for using a false NASA endorsement.

The first violation involves the advertising claims that CLA employed to promote its Insight Subluxation Station. The instrumentation was marketed as a "NASA-designed product" yet, according to information uncovered during the Senate investigation, the Subluxation Station was never officially or unofficially associated with NASA in any way.

The second charge was that CLA has urged its clients to falsely promote the value of chiropractic care through a CLA/Space Foundation press release. The press release claims, "Once you have the technology (purchase the Insight Subluxation Station) you will be able to use a press release and print out a certificate with the Space Foundation Logo to help raise the Credibility of Chiropractic in your office and community."

The press release asserts "the Subluxation Station uses Technology Developed for NASA to measure the effects of space on the spines of space shuttle astronauts."

The facts are that Space Foundation is a private, independent company that has no direct connection with NASA. Its "certification" is available for a fee as a marketing strategy. The Foundation's own website boasts that "Certification will tie your business to the power and excitement of space exploration and show your customers how space technology improves their lives right here on Earth... Through the marketing efforts of the Space Foundation, products with the seal prominently displayed benefit from the synergy of millions of space messages delivered each year. The Space Foundation actively works to support the marketing efforts of each certified partner to promote your company and product in the marketplace."

In addition, the Foundation offers "exclusivity" for an additional fee. The website state: "Category exclusivity is a highly desirable option. Select partners can enjoy the added benefit of exclusivity within a defined product or service market sector. This requires a minimum ten year commitment to promote space awareness within your marketing efforts. An annual exclusivity fee, in addition to the certification term fee, is negotiated on a case-by-case basis... Category exclusivity offers your company automatic recognition as a Space Foundation Corporate Patron member with its own set of benefits and opportunities." CLA is listed as a "Corporate Patron Level Partner."

Since I am a former NASA researcher and have spent considerable time evaluating the CLA claims, I was asked by the US Senate to provide evidence proving that CLA did not, in fact, perform the research it claimed responsibility for in NASA's Spinoff magazine, a compendium of devices developed at NASA that "spin off" into commercial application.

As part of the investigation, I also reviewed the research CLA implied responsibility for. The CLA website and marketing materials stated: "The United States space program has used surface EMG for space flight analysis. CLA's head engineer, Lee Brody, was involved in two of the studies, which took place as part of a joint MIT/Boston University research project funded by NASA."

Another reference to Brody on the CLA site stated: "NASA funded a study in which researchers from Boston University and the Massachusetts Institute of Technology used SEMG to measure the muscle activity of astronauts during strenuous activities directly before and after space shuttle missions. The research, done at the NeuroMuscular Research Center at Boston University under the direction of engineer Lee Brody, resulted in the design and implementation of two experimental protocols. To determine and map changes in muscles of shuttle astronauts, the team designed a protocol to measure signals from a leg muscle during a series of exercises."

I reviewed the research and recognized it as the work of a famous researcher at Boston University. I contacted Boston University and received confirmation that the claims made by CLA were completely false.

As part of the investigation into CLA, my attorney contacted Lee Brody and asked him to provide evidence that the product had ties to NASA. Brody's response, dated May 30, 2008, noted "I ... recommend that you directly contact the publication's (Spinoff magazine) authors."

Dennis Hart, of Boston University’s General Counsel’s Office was contacted, and made the following public statement:

"This is in regard to your inquiries regarding Dr. Lee Brody and an article in the NASA publication Spinoff in 2007.

"This research was done at the Neuromuscular Research Center at Boston University.

"This research, however, was not done under the direction of engineer Lee Brody, as the article states.

"Personnel at the Neuromuscular Research Center have reviewed Center files. According to Center records and the recollection of Center director Dr. Carlo De Luca, Brody did not make any contributions to the project or either experimental protocol."

With this evidence, I did as Brody suggested and contacted the author of the Spinoff article, and the magazine's editors. Upon learning of my investigation findings, the government space agency stated that "NASA will no longer recognize the Insight Subluxation Station as a Spinoff." It is obvious from their decision that the product never had any connection with NASA and the statements about Brody's work with NASA were false.

Faced with the US Senate investigation, NASA was forced to admit its error and wrote a retraction. I had uncovered the first fraud case in more than 1,600 articles published by Spinoff magazine. NASA has not yet concluded its own investigation and criminal charges may follow.

It is tempting to write these "errors" off as over-zealous marketing efforts but the problem becomes much more serious when we realize they have placed hundreds -- possibly thousands -- of chiropractors in jeopardy. Doctors who use CLA's false advertising statements in their own marketing material and on their websites can and have been brought up before their state regulatory boards for disciplinary action.

One doctor in NJ is currently under investigation for widespread use of these false NASA claims. He may lose his license over the false claims. In California last month, the World Chiropractic Alliance asked the board to allow doctors time to change their advertising before subjecting them to disciplinary action.

"It is the position of the World Chiropractic Alliance that these doctors should not be penalized for using the marketing verbiage provided to them by CLA and should be given ample time to correct their print and electronic advertising before any action is taken against them," the WCA noted in its statement before the California Board of Chiropractic Examiners.

What to do next

As this situation winds its way through the legal system and government channels, there are a few steps all chiropractors can take to prevent this from becoming a major scandal for the profession.

First, protect yourself. If you are making any NASA claims regarding the Insight Subluxation Station stop immediately. Change your website content, print advertising and patient education material to delete any questionable claims about the device's association with NASA or its status as an FDA "approved" device.

Next, defend chiropractic's high standards by countering any negative publicity that the CLA investigation may generate. USA Today is following the story and may soon expose the fraud in its pages, possibly leading to negative publicity for our entire profession. If the chiropractic profession, as a whole, takes a strong stand against any fraudulent or even borderline marketing claims, we can turn this into a positive story about how we properly "police ourselves."

Finally, seek legal advice if you feel your consumer rights were violated or if you were influenced to purchase the product due to the false NASA/Space Foundation claims. Some legal experts have argued that doctors may have the right to have their lease company transfer the full amount of the lease to a legitimate product, or require a full refund from the company you purchased or leased from. At least one precedent has been set in this regard, with a doctor arguing to the lease company that his license would be on the line if he used this product, with the lease company ending up releasing him from the contract.

For more information, or to review all declassified documents involved in this investigation, go to www.myovision.com where all declassified documents are presented. Any classified documents will be presented as they become available.

 (David Marcarian, MA, is the founder of Precision Biometrics, and inventor of the revolutionary MyoVision 3G Wirefree PhysioMonitoring System. A NASA-trained sEMG researcher, Marcarian was awarded a $450,000 NIH grant to develop the MyoVision, a device he developed in part at NASA-Ames Research Center. Marcarian won one of the largest PI awards in US history, and established the validity of MyoVision technology in a major State Superior Court Decision in Florida. Recently, Dr. John Gerhardt, author of the AMA publication: "The Practical Guide to Range of Motion Assessment" endorsed the MyoVision 3G product. Marcarian now trains doctors worldwide through his comprehensive training course: "MyoVision Team Elite." He can be contacted at Info@myovision.com or 800-969-6961.)