Watchdog Group Wants FDA to Crack Down on Companies’ Use of Laser Therapy for Smoking Cessation
Calling the low power laser therapy a fraud, the Public Citizen’s Health Research Group has called on the FDA, in its petition, to crackdown on the companies promoting the alleged smoking cessation therapy. According to Dr. Sindey Wolff, the director of the currently contentious watchdog group, the companies using the laser therapy do not have FDA clearance to market the lasers as a viable therapy for helping people to quit their smoking habits, and there has been no scientific evidence that the lasers are safe and effective.
“There is a prohibition on any kind of marketing or advertising for any unapproved uses of an FDA-regulated product,” Wolfe said. “It’s just a massive fraud.”
According to Wolff and his watchdog group, people who are trying to kick their smoking habit are paying hundreds of dollars per session to be zapped by the laser-wielding docs.
Calling their smoking cessation therapy an acupuncture session, companies like Freedom Laser Therapy, Inc, the most prominent of the five companies involved in the watchdog group’s petition to the FDA, charge up to $349 for a thirty minute session, which also includes a kit with vitamins, a booklet, and a video geared to help people to quit smoking.
At this time, the FDA only approves the use of lasers as an effective therapy for temporary relief of pain. They do, however, allow laser therapy to be utilized for investigational purposes in clinical trials, which would be used to prove their efficacy and support the approval of their use for other purposes. The claim by Freedom Laser Therapy is that investigation into the use of lasers as a therapy for smoking cessation is exactly what they are performing during the patients’ visits to their offices, according to company president Craig Nabat.
However, when asked about the data his company has compiled from the thousands of patients his company has enrolled in the alleged smoking cessation clinical research trials being performed at his facilities, Nabat was unable to provide any evidence to support that research was even being conducted which would provide information that would be presented to the FDA.
“We are not documenting exactly how many people are coming through – how successful they are,” he replied in a statement to the Associated Press.
With no data compiled, no rate of efficacy being tracked, nor any patient numbers even being recorded, the companies utilizing the laser treatments are going to have a tough time convincing the FDA or any Investigational Review Board that any clinical research into the use of laser therapy for smoking cessation has been performed at their facilities.
In a traditional acupuncture session, laser therapy is generally utilized when other mechanisms for stimulating the acupuncture points appropriate to the treatment cannot be used. Common reasons for an acupuncturist to utilize laser therapy include extreme needle intolerance or fear, injury or sensitivity to the area surrounding the most desirable acupuncture point for the therapy, high sensitivity to acupuncture, which prompts the acupuncturist to seek out a less intense method of stimulating the acupuncture point, or for use in very small children.
Essentially, in the eyes of practitioners of acupuncture, in nearly all cases, laser therapy would be a less effective method of stimulating the appropriate acupuncture points used for treating smoking addiction.
The watchdog group may be doing a lot more barking as the information about companies’ use of laser therapy utilizing acupuncture points for smoking cessation continues to be collected. The financial considerations alone are enough to get any good watchdog howling. A typical acupuncture session costs approximately $75.00 to $150.00 dollars. The services being provided by the five companies who are providing laser therapy without FDA approval for smoking cessation are, at best, charging their patients several times the price of an acupuncture treatment for what can only be considered to be a “watered down” treatment.
According to the American Lung Association, clinical trials have been conducted investigating the use of laser therapy for smoking cessation. Those studies showed no difference between the effectiveness of the laser therapy and the effects on patients who were placed in the control group, which received no laser therapy.
The FDA says it will be looking into the watchdog group’s petition.
Source: Associated Press, June 22, 2006
