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Responding to Dr. Gentempo's complaints

A response from Dr. Terry A. Rondberg, Publisher, The Chiropractic Journal and CEO, The World Chiropractic Alliance

It is unfortunate that Dr. Patrick Gentempo is trying to divert attention away from the charges of false advertising and fraud by saying that the recent news reports about CLA are "unfounded attacks" on him. Rather than confront the real issues, he is using emotional manipulation to get doctors to support him.

There is no "conspiracy" or "smear campaign" against Dr. Gentempo or his company. There is no malice involved. What possible motive would state boards, NASA, the Senate, and The Chiropractic Journal have for such an action? The sole purpose of publishing the report by Dr. David Marcarian was to inform the profession of serious allegations about certain advertising claims being used by CLA and some of its clients.

Please, read the original article and you'll see for yourself that the investigation does NOT involve the Subluxation Station itself, CLA or its leaders. It focuses ONLY on certain advertising claims that are being scrutinized by state boards. Also keep in mind that The Chiropractic Journal contacted Dr. Gentempo prior to publishing the report and asked him to provide his side of the story. He refused to do so.

Now, let's take a few minutes to review Dr. Gentempo's recent response to the Journal article. His statements are in black; our explanations and responses are in red.

Also, please look through the documented evidence to support all allegations made in the original article by David Marcarian.

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Chiropractic Leadership Alliance (CLA) has come under unfounded attack from a few hostile individuals who would like to see CLA injured. They will not succeed. Chiropractic has been under such negative smear campaigns since its inception and still stands strong.

The article did NOT attack anyone or any company. It reviewed documented evidence and discussed charges being made by state boards around the country. Dr. Gentempo's attempt to correlate this issue with anti-chiropractic campaigns during the past century is blatantly manipulative.

It is the policy of CLA to promote its products and services in a positive fashion. We choose to emphasize the value of our products and we do not initiate attacks on others. Furthermore, we do not employ half-truths, straw men, and outright falsehoods to mislead potential clients. Some of our competitors have a different way of doing business.

Is it "positive" to say that a news report is untruthful despite documented evidence to back it up? Instead of attacking the messengers, CLA could have (and should have) responded to the charges.

I am asking for your help and I urge our friends, colleagues, and clients to stand up for CLA and the truth – and further, I ask that you take a stand and join us on the high road. CLA’s commitment and ability to help the practicing chiropractor is needed now more than ever. Our Insight technology with its Neurospinal Function index (NSFi), coupled with our proven practice strategies for today’s environment has translated into escalating success for CLA and more importantly, the DC’s we serve.

Again, rather than asking doctors to blindly support CLA, why not respond to the charges?

The July 1, 2009 issue of The Chiropractic Journal has a front page article in which they attack CLA. The allegations made in this article are unfounded and we intend to set the record straight. Further, David Marcarian, who sells a product directly competitive with CLA’s Insight, is given credit as the articles author. It is easy to see what type of ‘game’ is being played here.

David Marcarian was asked to look into this matter because, having actually worked on NASA-related research and on sEMG technology, he was familiar with the complex issues involved. It is unfortunate that Dr. Gentempo feels simply being a competitor makes Dr. Marcarian dishonest. Most doctors and chiropractic companies enjoy a more positive and mutually supportive relationship with their "competitors" and consider them colleagues rather than enemies.

Some of the spurious allegations in this article to the uninformed reader are seemingly quite serious – but in reality are preposterous. Our well earned reputation is our most precious asset, so I want to give you straight talk and evidence. It is particularly important to me that our CLA family members and colleagues know the real story. Further, a scare tactic in the article implies that owners of the Insight Subluxation Station may be at some risk for having one. This is a contemptible ploy by a competitor and is not true.

Again, this is strictly an emotional appeal without any factual rebuttal of the charges. The warnings included in the article were not "scare tactics" but based on disciplinary actions being taken and/or considered by state boards. The article never stated that any doctor was in jeopardy merely by owning or using the Subluxation Station, but by using some of the advertising verbiage used and provided by CLA.

In viewing this matter, I urge you to start by considering the sources who made the allegations:

1. The author and "lead investigator", David Marcarian, owns a company which sells a product that directly competes with CLA’s Insight product.

Again, to assume an expert such as David Marcarian is dishonest simply because he competes with CLA is narrow minded. We need to examine the evidence, not attack the person who presents that evidence.

2. The Chiropractic Journal is a publication of the World Chiropractic Alliance, whose president, Richard Barwell, DC, sells another competitive product.

First of all, Dr. Barwell markets the NeuroInfiniti instrumentation, which is NOT an sEMG device. Using Dr. Gentempo's reasoning, anyone who sells any chiropractic device is CLA's "competitor" and therefore unreliable. Secondly, although Dr. Barwell is president of the World Chiropractic Alliance, he is not involved in any way in the publication of The Chiropractic Journal. He had no knowledge of or participation in the investigative report on CLA. Dr. Gentempo is once more attempting to divert attention away from the issues by attacking individuals.

3. The publisher of The Chiropractic Journal is Terry Rondberg, DC. Dr. Kent and I have completely disassociated ourselves from Rondberg some time ago due to not wanting to be associated with Rondberg’s behaviors and directions.

What does this have to do with the issues at hand? Dr. Gentempo has not been involved in the WCA for years (although he continued to write for and advertise in the Journal) and Dr. Kent publicly stated that he resigned due to other commitments. During the many years that the WCA and Journal supported and publicized CLA, Dr. Gentempo never had any problem with my "behaviors and directions." When, after reviewing several different types of chiropractic devices, I chose to align myself with NeuroInfiniti, he suddenly decided to disassociate himself with me. Sadly, as Dr. Gentempo has shown repeatedly in the past, he cannot tolerate competition and looks at competitors as adversaries. I supported him for many years and have NEVER written an article criticizing or denigrating him or any CLA product or service. Now, when we dare to discuss openly the charges being leveled against the advertising claims for the Subluxation Station, he tries to suggest that my "behaviors and directions" are involved.

I know there is a likelihood that you don’t read The Chiropractic Journal. At this point, I understand some of you will rightly stop reading this message and recognize that these competitors are unlikely to be an unbiased source of information and have self-serving reasons to promote misinformation. However, if these ridiculous accusations are something you have the time and inclination to get to the bottom of – read on and you will observe the truth of the situation.

Again, Dr. Gentempo is using emotional manipulation to win support without addressing the real issues. If he didn't think you -- like most members of the profession -- read The Chiropractic Journal, why would he bother responding to its article?

What follows is a point-by-point refutation of the key charges from this alleged investigation. Further, at the end of this message there is a link to supportive documentation including a comprehensive timeline of events which sets the record straight.

 

What our competitors claim in The Chiropractic Journal article:

The facts:

Now read the full story:

The article begins by stating that "two chiropractors were fined $25,000 for claiming the chiropractic diagnostic machine they used was a ‘NASA designed device’" – I believe this was one ploy to promote fear for Insight clients.

The facts and the inference of this story are both untrue. First, the device in question was a treatment device, not a diagnostic instrument, as you can see for yourself by visiting this link to the reference cited by Marcarian in the article: Article

Second, this story is clearly intended to infer that Insight users may be at risk for disciplinary action, but there is no reason to believe that any doctor who has correctly represented the Insight’s Space Certification status or the fact that the Insight is an FDA Registered, Class II Medical Device has any such risk.

The Chiropractic Journal took direct quotes from the article in question in order to provide evidence that doctors ARE being held responsible for the advertising claims they make for their diagnostic or treatment devices.

The article made it clear that the device involved in that particular case was NOT the Subluxation Station (if the case had involved the Subluxation Station, that fact would have been mentioned.) However, the report points out that the issues involved are the same: false marketing claims.

In addition, Dr. Gentempo is deliberately clouding the issue. The article specifically discusses advertising phrases that imply that the Subluxation Station is in some way connected to or approved by NASA. Doctors using that language are already being investigated by some state boards. The danger is REAL and it is irresponsible for Dr. Gentempo not to admit this.

They suggest that CLA has made misrepresentations to NASA concerning the involvement of CLA’s chief engineer, Lee Brody, in NASA related research.

Completely untrue. We have independent corroboration of Mr. Brody’s involvement in this NASA related research. This include a newspaper article from an official publication of Boston University (click link to view article) , confirmation of other scientists who worked with Mr. Brody and laboratory records describing his involvement in the NASA related research. Mr. Brody had a falling out with the director of the lab, Dr. Carlo De Luca when he left Boston University. Dr. De Luca has misrepresented Mr. Brody’s true role while at the lab which is really the tipping point of this supposed controversy. As a recent update, NASA’s counsel e-mailed CLA on June 22, 2009 that: "We appreciate the update regarding Mr. Brody's participation and are sorry to hear about his falling out with his former colleagues."

The Journal article provides direct statements from Boston University’s General Counsel’s Office that Mr. Lee Brody does NOT have the research experience or credentials claimed by CLA.

Dr. Gentempo is suggesting that several officials from the University are deliberately lying simply because of a "falling out."

Dr. Gentempo's sole "evidence" is a one-paragraph mention of Brody's research in an old school newspaper (the image Dr. Gentempo included shows no date or attribution, so is impossible to research).

 

The article contains the following statement: "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."

Not only have we proven that Mr. Brody was involved with NASA research, there is no dispute that patented EMG technology and know-how used in the NASA sponsored research cited in the NASA Spinoff article was licensed to CLA’s manufacturer (Brody’s company). The question that NASA is reevaluating is whether or not the licensed EMG technologies meet the specific technical criteria for NASA Spinoff status. Before our competitor (Marcarian) sought to make trouble with NASA, NASA did indeed approve the Insight as a Spinoff technology. Please note, all this is independent of the Insight’s Space Certification designation which is what you see in our ads and on the label of our instrument.

Contrary to Dr. Gentempo's claim, CLA has NOT proven that Mr. Brody was involved in NASA research. Officials of the Boston University have categorically denied he had any such involvement.

Spinoff magazine has since rejected the Subluxation Station as space "spinoff" technology and has publicly announced that "NASA will no longer recognize the Insight Subluxation Station as a Spinoff." Their published statement is included in the documentation provided by David Marcarian.

In addition, Mr. Marcarian did not "make trouble with NASA." He simply investigated the claims and reported on the results of his investigation.

Incredibly, the article states that Patrick Gentempo was found by a US Senate Investigation to be in violation of two federal statutes.

This is one of the boldest lies! There has been no US Senate Investigation, and certainly no determination that I have violated any federal laws, PERIOD! Such claims are utterly false and defamatory.

In the course of his investigation, Mr. Marcarian was questioned by a member of the Senate serving on the Senate Commerce, Science and Transportation committee.

This senator contacted NASA directly to investigate the claims and forwarded the findings to Mr. Marcarian. These documents were also made available along with the report.

While the investigation is still at the unofficial stage, it did indeed include possible federal statute violations. The violations mentioned by Marcarian in his report refer to the misuse of NASA endorsements.

Marcarian claims that when he contacted the NASA Spinoff author and the magazine’s editors that NASA responded by ceasing its recognition of CLA as a Spinoff technology.

On March 24, 2008 the Spinoff editor responded to Marcarian’s inquiry via e-mail. Here is a quote from that e-mail from NASA: "… we at NASA Spinoff have done our due diligence in researching this story. It has been fact checked and approved by several different offices within and outside of NASA."

Again, there is written documentation that Spinoff magazine withdrew its endorsement of the Subluxation Station as "spinoff" technology."

In a letter from NASA dated April 3, 2009, Mary Kerwin states: "The NASA office of General Counsel conducted a thorough evaluation of the claims by the CLA of a partnership connection between agency research and their Insight Subluxation Station. NASA has been unable to adequately corroborate those claims, and, as a result, will no longer recognize the Insight Subluxation Station as a Spinoff."

Dr. Gentempo cites much older material rather than address the real issue and the evidence presented by The Chiropractic Journal.

Marcarian disparages the value of Space Certification at great length.

Could this be because Marcarian himself applied for Space Certification in August 2007, but did not receive it?

Mr. Marcarian did not disparage the value of the Space Certification. He merely pointed out the fact that such certification is "purchased" for a fee and the certification itself is marketed as an advertising tool. The article DOES note that, contrary to CLA claims, the Space Foundation is NOT officially connected to or founded by NASA.

The article asserts that a US Senate investigation concluded that this was the "worse fraud in NASA Spinoff history".

There was no "US Senate investigation". Marcarian asked a senator to inquire on his behalf. This is not a "Senate investigation". And further, there is no assertion of fraud at all. The plain fact of the matter is that on June 26, 2009, Mary D. Kerwin, NASA’s Acting Administrator for Legislative and Intergovernmental Affairs, in a letter to Georgia Senator Isakson (who inquired on this matter on behalf of Dr. Gentempo and CLA), wrote, "NASA has made no statements regarding the nature or character of the CLA product itself, nor has NASA otherwise characterized CLA or its claim".

When Senators investigate something, it is reasonable to call it a Senate investigation. The article never stated or suggested that this was a formal or full Senate or Senate Committee investigation.

Furthermore, the investigation documentation includes a copy of a letter from NASA which contains a statement directly relating to the Subluxation Station.

A true copy of the letter can be viewed -- in its entirety -- in the CLA documentation.

Marcarian says in the article that he was "asked by the US Senate to provide evidence proving that CLA did not…"

Could anyone believe that the United States Senate one day decided to approach Marcarian because the Senate needed his assistance on this matter? I am sure you realize the kind of matters the Senate as a body does concern itself with.

The misuse of the NASA agency logo or name is a serious offense and one that DOES interest the US Senate.

In fact, earlier this year, Sen. John D. Rockefeller, Chairman of the Senate Committee on Commerce, Science, and Transportation, sent a letter to the National Aeronautics and Space Administration (NASA) requesting documents related to a Florida company that allegedly used NASA research grant money to buy cars and real estate.

Any suggestion of impropriety is thoroughly investigated by the Senate, including misuse of NASA logos and endorsement claims.

In the ultimate display of the true intentions of this so-called investigation by our competitor, Marcarian states, "Some legal experts have argued that doctors may have the right to have the lease company transfer the full amount of the lease to a legitimate product…" (This statement speaks volumes as to the motives of this article.)

No legitimate ‘legal expert’ would make such a statement.

Several legal and financial experts HAVE made such statements and they stand on their own merit.

 (Dr. Gentempo continues:)

Let me summarize:

1. CLA has not made any misrepresentations to NASA.

How can Dr. Gentempo make such a claim? Here are just a few of the statements on the Internet used by CLA and clients about the Subluxation Station:

"The technology - known as the Insight Discovery Subluxation Station - was born from a partnership between NASA and the Chiropractic Leadership Alliance (CLA), a New Jersey-based company."

"The Insight uses technology developed for NASA to measure the effects of space on the spines of space shuttle astronauts."

"Technology That Has Been Used By NASA: The Insight Subluxation Station objectively evaluates patterns of spinal and nerve function."

"Its space experiment based technology is called the Insight Subluxation Station and is a neurospinal screening and evaluation system based on the NASA research conducted by Brody and the SEMG methodology."

"Spinal care technology developed for astronauts is now available for better chiropractic care."

"We have invested fully into our practice to better the health of our practice members and purchased the Insight Millennium Subluxation Station which was certified by the space foundation and co-founded with NASA."

"We are pleased to use NASA certified technology. Each person is examined by the Insight Subluxation Station™, a non intrusive technology which is a neuro-spinal screening and evaluation system originally designed to measure changes in the spinal muscles of astronauts."

"The Insight Subluxation Station, which is certified by the Space Foundation in cooperation with NASA, helps us to identify these problems before they become symptomatic."

2. CLA applied for and was granted Space Certification for the Insight. Our Space Certification is valid and in full force (click link to see letter from the Space Foundation).

No one disputes that CLA was "granted" a Space Certification by the Space Foundation. The issue concerned the misrepresentation by CLA and some of its clients that the Foundation is directly associated with NASA when it is, in fact, a totally private organization that charges substantial fees for its "Certification" and markets that certification as an effective sales tool. The charges against CLA involve the suggestion that the certification was granted by NASA. The Space Foundation is a highly respected and excellent program but it was neither co-founded by nor is officially connected to NASA.

3. Space Certification is not the same as NASA Spinoff status. CLA did not apply for NASA Spinoff status - NASA gave it to us after performing its own due diligence.

Again, no one denies that Spinoff magazine granted the Subluxation Station status as a "space technology spinoff." However, that status was withdrawn after a NASA investigation revealed there was no basis for such status.

4. The Space Foundation, a non-profit entity, DOES work in cooperation with NASA.

A review of the Space Foundation website reveals that is has no official connection with NASA. While it, like many space-related organizations, may work "in cooperation with" NASA, it is NOT part of the US space agency.

5. The Insight is manufactured in an FDA registered facility and is an FDA-registered Class II medical device. The registered indications for use are consistent with our chiropractic applications and protocols. Documentation can be accessed per: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23358

The Chiropractic Journal acknowledged that the Subluxation Station has an FDA 510(k) registration. The report simply pointed out that, contrary to public belief, that does NOT mean the device was tested and/or found to be either safe or effective. The 510(k) registration simply means that a device demonstrates a "substantial equivalence" to a device marketed before 1976, when the Medical Device Amendment was passed. CLA clients are using claims such as:

"We start your evaluation using a high-tech, FDA-approved diagnostic tool known as the Insight Millennium™ Subluxation Station..."

"The Insight Subluxation Station is an advanced, state-of-the-art instrument certified by The Space Foundation in cooperation with NASA, is FDA and Health Canada registered..."

"(The doctor) uses the Insight Subluxation Station™, a state-of-the-art, NASA-certified and FDA-approved technology to perform outcome assessment studies ..."

Referring to the device as "FDA approved" is inaccurate and misleading to the public and such claims are also being investigated by several state boards.

6. There is no reason to believe that any doctor is legally or financially at risk for promoting the Insight based on its Space Certification and status as an FDA Registered, Class II Medical Device. These are facts. It is really a low-brow tactic for a competitor to try to scare our clients in such an unscrupulous way.

Dr. Gentempo has very carefully worded this statement. He does NOT deny that doctors can be legally and/or financially at risk for promoting the Subluxation Station as a NASA-developed or FDA "approved" device. It is clear that they ARE being held accountable for such false advertising.

I think our competitors’ actions and motives here are quite transparent. I trust your ability to judge for yourself.

This is NOT about CLA's perceived "competitors." State boards are NOT in a conspiracy against CLA nor is anyone else. But there is a great need to address these serious concerns and Dr. Gentempo is failing to do so.

CLA’s track record speaks for itself. I invite you to check the facts. CLA’s passionate purpose is to support you by revolutionizing the practice and perception of chiropractic worldwide. We envision world leadership of healthcare in a chiropractic model. We care about you, the DC and staff in the field, working hard to bring the chiropractic lifestyle to those in your community. The last thing we need is this kind of undignified behavior dragging everyone down while those perpetrating it try to increase their personal gain at the expense of every hard working chiropractor. Check the facts. Read the literature. Call if you have questions.

CLA has an excellent track record and has contributed a great deal to the chiropractic profession. The Subluxation Station has served doctors well for many years, as have Drs. Gentempo and Kent. No one is disputed any of that. The ONLY issue being scrutinized involves the advertising claims being made that can put doctors in jeopardy. A review of the marketing claims made by CLA and some of its clients show clearly that they contain false and/or misleading statements.

In closing, I again ask all the friends and clients of CLA to please stand up for us by setting the record straight for anyone you come in contact with that brings this issue up and to further express your outrage toward those who are trying to undermine what is good for this profession and its future.

Why should friends and clients of CLA set the record straight when CLA itself refuses to address the problems concerning the false and misleading claims being made about the Subluxation Station. A simple statement noting that some of the claims were, in fact, inaccurate, out of date, or misleading, could have prevented the board actions, this investigation, and the ongoing turmoil involving the device. When you make a mistake, admit it, correct it, and go on from there.

 

 

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