Friday, July 14, 2006 | 7:37 a.m.
A Washington-based watchdog group has asked the federal Food and Drug Administration to stop several companies, including one based in Las Vegas, from advertising laser therapy as a way to stop smoking.
Public Citizen filed a petition asking that Las Vegas-based New Beginnings Laser Therapy and four other companies stop "illegally promoting low-power laser therapy for smoking cessation."
The group bases its claim, in part, on a research study that indicates laser treatment is no more effective for smoking cessation than a placebo.
Nancy Monaco, New Beginnings owner, said her company never intended to mislead anyone about what she said is the role laser therapy plays in helping people quit smoking.
"Laser therapy takes away the physical pain of withdrawal," Monaco said. "The therapy is approved (by the FDA) to treat temporary pain."
Her company charges customers $299 for the initial treatment with free follow-up or "booster" treatments for up to six months if necessary.
Monaco admitted, however, that some of her company's ads encouraging people to "stop smoking now" or to quit in "as little as 20 minutes" may have run afoul of FDA guidelines. She said any such mistakes have been inadvertent. The company is reviewing its advertising and has already made changes to better explain the connection between laser therapy and smoking cessation, she said.
"We welcome the FDA getting involved," Monaco said. "There may have been some things that we didn't know we were doing wrong, but there are no laws and no direction."
Her company sought direction from the FDA in March 2005, according to Monaco, advising the agency of its intent to market laser therapy for smoking cessation.
The FDA replied that lasers were not approved as a technique for smoking cessation, but issued no warnings or guidance with regard to marketing practices, she said.
The therapy, also known as laser acupuncture, uses a laser light to stimulate nerve endings to produce endorphins, the body's natural painkiller and mood enhancer. Therapy providers claim the endorphins help relieve the physical withdrawal symptoms that occur when someone quits smoking.
Dr. Sidney Wolfe, director of Public Citizen, said the problem is that the targeted companies are not marketing themselves as pain treatment clinics, but rather as smoking cessation centers:
"It's illegal. They can't market in this way. End of story."
Wolfe said that by jointly advertising smoking cessation and laser therapy, the companies are establishing a link that has not been verified clinically and therefore is forbidden by the FDA.
Indeed, the word laser is prominent in the names of all the companies listed on the petition and all identified laser therapy prominently in their smoking cessation advertising.
The other companies identified in the petition are Anne Penman Laser Therapy, which also has an office in Las Vegas, Laser Concepts, The Stop Smoking Laser Center and Freedom Laser Therapy Inc.
An Anne Penman Laser Therapy advertisement in the 2006 phone book for Las Vegas, under the heading of Smokers' Information and Treatment Centers, boldly states, "STOP SMOKING TODAY!"
Beneath it is a larger ad for Laser Concepts of Nevada, which has three locations in Las Vegas and, according to its Web site, is part of Monaco's New Beginnings. That ad says, "Walk into the office a Smoker, walk out a Non Smoker."
While the Public Citizen petition claims all of the companies violate FDA regulations, it calls Freedom Laser Therapy Inc., based in Santa Monica, Calif., the most blatant offender.
"Freedom Laser Therapy has positioned itself most prominently before the public by way of multiple local and national television appearances and thus has likely had the greatest impact on the general public," the petition states.
That company's claims of high success rates, decades of successful use in other countries and the support of international clinical trials for the treatment are either unsubstantiated or just plain false, Wolfe said.
Craig Nabat, founder of Freedom Laser Therapy, said the company has voluntarily removed all advertising materials from its Web site and is having them reviewed by an Institutional Review Board (IRB).
An IRB is a group that has been formally designated by the FDA to review and monitor biomedical research involving human subjects.
"We are doing our due diligence," Nabat said. "We don't want our industry to have a black eye."
He defends his company's marketing methods, pointing out that it also participates in clinical trials. He said the company has tracked statistical data from its customers for three years and the information is being scrutinized by the review board.
Eileen Sonsini, co-owner of the Anne Penman franchise in Las Vegas, said that company is scheduled to begin a clinical trial as well and has no plans to alter its advertising:
"We haven't been doing anything wrong, so there is no need to change."
Companies that are part of clinical trials are permitted to advertise in order to solicit participation in a study. Wolfe contends, however, that the companies violate FDA rules because not only do they promote the treatment through advertising, they also tout the safety, effectiveness and superiority of the technique.
Some companies claim success rates as high as 85 percent, and all offer testimonials from satisfied customers, but Wolfe said that alone proves nothing:
"There is a lot more to a clinical trial than just collecting anecdotes. You have to prove scientifically that the treatment actually works."
A double-blind study, in which some participants get treatment and some do not, is widely accepted by researchers as the most accurate research. There is no bias because neither the researcher nor the participants know beforehand who is actually getting treated.
The Cochrane review, an independent collaboration that indexes research studies, identifies only one double-blind study completed for the use of lasers in smoking cessation.
In that study, the number of people who quit smoking after receiving the laser treatment was almost identical to the group that did not get the laser - about 25 percent.
Wolfe said this result, especially the high placebo response, makes the treatment suspect, to say the least. And at a cost of up to $400 it is an "expensive experiment" for consumers, he said.
"Not to mention, it could discourage someone from getting a proven, effective treatment for smoking cessation."
Wolfe cites nicotine replacement therapy products such as gum or a patch, which have FDA approval, as examples of proven treatments.
Suzan Cruzan of the FDA confirmed that no laser device is currently approved for smoking cessation and that the FDA is looking into the Public Citizen petition.
Typically, the FDA seeks voluntary correction if a company is determined to be in violation. But sanctions could include seizure of products, enjoining and prosecution of violative firms and individuals, and civil monetary penalties.
Wolfe said the law on medical-device regulation is so clear that if the FDA doesn't act, it is asleep at the wheel. While he does not insist that the companies be put out of business, the remedy he expects offers few alternatives.
"They (the lasers) may be used for other things, put on the shelf for awhile, or the companies may go out of business," he said. "But these lasers will be illegal as they pertain to smoking cessation."
If Wolfe's assessment is correct, the burgeoning industry could be wiped out almost overnight. The five companies named in the petition have more than 50 locations nationwide, operated mostly by independent franchise owners.
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