Public Citizen petitioned the Food and Drug Administration to halt five companies from promoting low-power laser therapy for smoking cessation. The companies do not have FDA clearance to market the lasers for that purpose, nor is there any scientific evidence they are safe or effective, said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.
"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."
The FDA will evaluate the petition, spokeswoman Susan Cruzan said. The FDA has cleared the so-called biostimulation lasers or laser acupuncture devices to be marketed only to help provide temporary pain relief, according to its Web site.
Freedom Laser Therapy Inc., singled out in the petition as the most prominent of the five companies, charges smokers as much as $349 for a 30-minute laser "acupuncture" session and kit with vitamins, booklet and video.
FDA regulations do allow the therapy to be used in investigational clinical trials or studies — exactly what Freedom Laser Therapy said it is carrying out at its two locations, in Santa Monica, Calif., and Royal Oak, Mich., president Craig Nabat said.
The company charged thousands of smokers to participate in the trials so far but has not collected data on whether the program successfully helped them quit, said Nabat, who wants to open franchises nationwide.
"We are not documenting exactly how many people are coming through — how successful they are," said Nabat, adding that client referrals vouch for the program's effectiveness.
Dr. Norman Edelman, chief medical officer of the American Lung Association, said any institutional review board likely would find such trials unethical.
Early attempts at following up with all clients proved laborious, expensive and ultimately fruitless, Nabat said.
"When we do follow-up phone calls, people don't call us back," added the self-described entrepreneur and inventor of an infomercial product called The Findit Keyfinder.
There is no evidence laser therapy works in helping smokers quit, Edelman said. And not collecting data means there never will be any evidence.
The companies claim laser therapy triggers the release of endorphins, or the body's natural painkillers, that can help smokers cope with withdrawal.
But reviews of medical literature turn up few reports of well-run clinical trials that examined laser stop-smoking therapy, according to both the American Lung Association and Public Citizen. The few studies that have been done show no difference in success rates between patients zapped with a laser and those receiving a placebo or sham treatment, Wolfe said.
Laser Therapeutics Inc., a Centerville, Mass., laser importer and distributor, has completed laser therapy trials and is preparing to seek FDA approval for their use in smoking cessation, said Neil Camera, a company officer. Camera said the results of the trials were confidential, but that the company planned to submit its application within the next 90 days. It supplies Freedom Laser Therapy and several of the other companies listed in the petition.
The FDA warned Laser Therapeutics in October 2004 concerning its failure to properly monitor clinical laser trials.