Print

Email story

Comment

Email editor

Smoked out?

There's an easy, patented way to quit, for only $400. Ready to sign up? Well ...

By SCOTT BARANCIK
Published September 9, 2006

Attention cigarette smokers: If your patch has petered out, your gum grown cold, and your luck with lasers and hypnotists run dry, a Tampa company says it has a $400 cure.

Welplex Inc.'s patented program - a couple of shots of FDA-approved medicine, two weeks of pills and a pamphlet on behavior modification - is a snap. Your addiction will end immediately, the company says, with few or no symptoms of withdrawal. More than half of its patients are still smoke-free a year after treatment.

"The patent encompasses the best that medical science has to offer for the treatment of nicotine addiction," says a page on Welplex's Web site, www.nosmoke2000.com. With an estimated 438,000 Americans dropping dead each year from cigarettes, it's a powerful marketing statement.

But critics are concerned:

- The drugs used by Welplex and its 10-state, 22-city chain of franchises are approved by the Food and Drug Administration - but not for treating nicotine addiction.

- Though Welplex says its anticholinergic drugs cure addiction and withdrawal symptoms instantaneously, the Surgeon General's 200-page "clinical practice guideline" for treating tobacco dependence never mentions them.

- Several experts have questioned the scientific rigor of the "clinical" study, conducted by the company itself, that serves as the basis for Welplex's purported success.

- Atlanta's Fox News staff recently contacted 21 local Welplex patients a few weeks after they received treatment. All but three had resumed smoking.

- Though Welplex says serious side effects are rare, a Georgia couple interviewed by Fox was so despondent during treatment that they decided to give away their business, children and cats - and live on canned green beans under a bridge. University of South Florida psychiatry professor Glenn Catalano coauthored a study about a 59-year-old patient who became psychotic after treatment and considered killing himself and his wife.

Norman Edelman, chief medical officer of the American Lung Association, was blunt in his assessment of Welprex's treatment protocol. "The public should not use medications, especially ones that are proven to have side effects, unless their efficacy and safety have been established," he said. "I'm saying this to physicians as well as the public."

Welplex's founder and owner, Clearwater resident Paul J. Hudson, declined to be interviewed. Tampa physician Steven Schweinshaupt, who offers Welplex's treatment locally, did not return a call Friday. But Rick Fee, a Tampa lawyer who is representing Welplex in an unrelated intellectual property lawsuit, says Hudson is a convenient target for competitors who resent the patent he received in 2000.

"The U.S. Patent and Trademark Office doesn't hand out patents willy-nilly," Fee said. "People don't get patents on snake oil."

Two documents provided by Fee, including a seven-page report on the rationale for treating nicotine addiction with anticholinergic drugs and a 14-page protocol for administering Welplex's treatment, were authored by a medical toxicologist. Welplex's Web site says the company is planning a "double-blind, placebo-controlled clinical study" on its effectiveness, but its Phoenix franchisee's Web site says it's unlikely to seek FDA approval because of the substantial costs involved.

Welplex's Web site and the outgoing message on its local voice mail describe a procedure that cures smokers both rapidly and inexpensively.

The three-step process begins with a 1½-hour visit to the local franchisee's clinic. There, the patient fills out a medical questionnaire, watches a video describing the procedure and its effects, and receives an EKG test, a lung-function test and a brief physical exam. Once cleared, the patient is injected with a trio of drugs that are supposed to block signals from the brain's nicotine receptors.

Before leaving, the patient receives (Step 2) a self-help manual on the psychological aspects of addiction and (Step 3) a two-week prescription for anticholinergic pills, which Welplex says will shield patients from the final stages of withdrawal.

"The brain actually enjoys the experience," Welplex's local recorded message says. "Patients will notice about 5 to 7 minutes after treatment that their urges and cravings are gone!"

Hudson, the company's 53-year-old founder, did not invent the trio of drugs or the concept of behavior modification. His patented idea was to combine the initial injections, low-level pills and behavior modification in one program.

Competition for smokers - an estimated 70 percent of the country's 44-million adult puffers want to quit, according to the Centers for Disease Control and Prevention - is stiff. This week, Welplex filed suit against a California company for allegedly ripping off its program. It filed a similar suit earlier this year against an Indiana company that later agreed to drop its allegedly infringing Web site.

Times staff researcher Angie Drobnic Holan contributed to this report. Scott Barancik can be reached at barancik@sptimes.com or (727) 893-8751.

[Last modified September 8, 2006, 23:37:27]