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The end of the soliton laser…

By Jan Tunér

PBM is a very effective method for treating a great variety of medical conditions and the scientific background itself should be sufficient for selling such devices. Yet, several manufacturers are launching privately invented explanations to make their particular products even more attractive. Unfortunately, such inaccurate claims prevent the recognition of PBM as a state-of-the-art treatment.

One player on the North American market has been Qlasers (2035 Inc.), founded and headed by Larry Lytle of Rapid City.  Mr. Lytle is a former dentist, but his license was withdrawn in 1998 due to malpractice (1). The year before losing his license, Lytle started production of therapeutic lasers, here referred to the Qlaser, although his lasers have had many names during the years.  Mr. Lytle used the usual FDA ‘loophole’ to obtain a “premarket notification (510(k)) for the Q1000 Laser and 660 Enhancer Probe (QLaser System), K080513, with an intended use ‘for providing temporary relief of pain associated with osteoarthritis of the hand, which has been diagnosed by a physician or other licensed medical professional.” Nevertheless, these lasers were marketed for a plethora of medical indications, including cancer. We know that a therapeutic laser can be useful for a lot of indications, but the FDA only allows marketing for the specific indication mentioned in the approval. In 2011 Lytle received a warning letter from the FDA (2) but this was ignored and the marketing continued. Lytle tried to get around the rules by creating an association and only selling lasers to “members”, and by claiming the devices were for veterinary use. Neither trick was accepted by the FDA, or by the court later on. The message from the court is crystal clear: All sales of the Qlaser product are banned, and the consequences for the company will be serious.

Oddly enough, Mr. Lytle had presentations at dental meetings, although he was a dentist without a license. The mechanisms presented were generally in the pseudoscientific area. One particular trick was the alleged solition waves produced by the Qlasers. These were said to be of great importance and only available with the Qlasers. The Qlasers were no different than regular lasers on the market, certainly not better and certainly not producing any solitons.

But this is not the end of the story. Production and sales of the Qlaser are still on under the umbrella of the “Pastoral Medical Association”. Here, we see no signs of Mr. Lytle and no particular claims. Instead there is this:

Terms of Services

Destiny Services LLC and QLasercare make no medical treatment claims for the products offered on this Web site or on any promotional or educational literature. By accepting delivery of these products you (1) accept complete responsibility for the use of these devices and acknowledge that they are completely under your personal control; (2) agree to hold Destiny Services LLC and QLasercare and all representatives thereof completely harmless for lack of results or for any disorders, allergies, diseases, pain, or any other malady alleged to be caused by your use of any low level laser product sold by QLasercare; (3) agree that any dispute or claim arising out of any QLasercare business transaction shall be resolved by binding arbitration under the rules of the American Arbitration Association; and (4) agree that any demand for arbitration must be made in writing within 90 days of the event giving rise to the demand and that the arbitral award is final and binding on both parties.

So it actually says “Buy our products but we take no responsibility whatsoever. Suit yourself.” We shall see what the court has to say about this strategy. Clever, but not honest.

While on the subject of pseudoscience, it is interesting to note that Ryan Maloney, former Medical Director for Erchonia Medical has publicly given credit on numerous occasions for having a PhD, and even states it in this video: https://youtu.be/q9MkziaORCk. However, this is not the case. Further to that, Mr. Maloney now admits that the Zerona laser promoted for weight loss is merely an instrument to motivate patients to keep a diet and to exercise, while the laser actually has no significant contribution of its own. This can be seen on https://www.youtube.com/watch?v=1hb0GhjuSqo&feature=youtu.be. While late, we welcome Mr. Maloney to the crowd of reformed sinners. Thank you to Phil Harrington, DC, for providing the information about Erchonia.

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