Clinic offers stop-smoking regimen that scares doctors
Clinic offers stop-smoking regimen that scares doctors
Couple say their experience backs experts' worries
Candy Pope said a treatment advertised as a sure way to quit smoking had serious side effects for her including hallucinations. It involves drugs that are FDA-approved but not for smoking cessation. PHOTOS BY JOHN PARTIPILO / THE TENNESSEAN
By CLAUDIA PINTO
Staff Writer
Published: Sunday, 07/02/06
A $400 treatment touted as a sure way to quit smoking is being offered at a Nashville doctor's office, even though medical experts say there's no valid proof it's effective - and can be dangerous.
Advertised on the radio and offered at Covenant Family Practice on Dickerson Pike, the treatment includes injections of three drugs that are FDA- approved, but not for smoking cessation. The medications in the shot can cause hallucinations, heart palpitations, paranoia and other serious side effects, including coma, experts say.
"It's just incredible to me that they're doing this," said Dr. Christopher Holstege, one of the nation's top toxicologists and the University of Virginia Health System's director of the division of medical toxicology. "It just doesn't make sense.
"I don't know of any literature that says this is effective for quitting smoking. These drugs can cause hallucinations. They can make your heart beat so fast that if you have heart problems it can cause you to have a heart attack."
Dr. Robert A. Wilson, who administers the shots at Covenant Family Practice, did not return three phone calls seeking comment. Through a receptionist, he referred all questions to officials at a Tampa, Fla.-based company called Welplex - which has franchise agreements with doctors to offer the treatment at 23 clinics in 11 states, including the Nashville clinic that began offering the treatment in January.
Kendahl Maxwell, Wel-
plex's administrator in Florida, said the treatment is safe and effective.
Listeners to the radio advertisements are guided to the Welplex Web site, where they can make appointments for treatment.
The site boasts "a better than 8-out-of-10 chance of succeeding," and lists an array of medical "references" supporting its claim.
But medical experts with the American Medical Association, the University of Virginia Health System and Vanderbilt University Medical Center who reviewed the Web site for The Tennessean found its claims dubious.
Dr. Ronald M. Davis, president-elect of the American Medical Association, said he finds an eight-out-of-10 success rate "highly improbable."
"The most effective smoking cessation programs typically achieve 1-year success rates of between 20 and 35 percent," he said.
Welplex provided additional "research" to The Tennessean to support its claims. But independent medical experts found this equally questionable.
Shots, then hallucinations
Candy Pope, of Shelbyville, says when she heard an ad on the radio recently that a simple treatment could help her quit smoking she decided to try it. She persuaded her husband, Jim, to try it too.
The 58-year-old woman, who smokes more than a pack a day, went to the Web site to learn more and then called a number listed to set up an appointment.
Within days, Welplex officials sent the Popes a letter confirming a June 13 appointment and assuring them that "Patients will leave the clinic a nonsmoker."
The only drawback mentioned is that they would "be a little lightheaded for five to six hours following treatment." And the Popes were advised to bring a designated driver. Their friend, Judith Moore, a retired doctor, wanted them to quit smoking, and Moore said she was happy to oblige.
At the Covenant clinic, the Popes each received three injections and were given a supply of pills to take over the next two weeks.
Candy Pope said that on the drive home from the doctor's office, she became disoriented, agitated, and tried to jump out of the back seat of the moving car.
"I could have died," she said. "Judy was able to lock the doors so that I couldn't jump out."
Jim Pope said about 20 minutes after he got the shots in his neck and behind both ears, he too started experiencing strange sensations. The 68-year-old man, with high blood pressure, said he remembers his heart beating "like a drum" and trying to talk, but not being able to speak.
Once he got home, he said, hallucinations began. He said he saw things crawling on the ceiling and other things that didn't exist.
"In my bedroom, I could see my dog that passed away two years ago," Jim Pope said. "I reached out to him, but he wasn't there."
Moore, who is a retired family physician, said in all her years as a doctor she's never seen patients act like this. The couple, she said, was "really out of it" - talking gibberish and displaying bizarre behavior.
None of them had any idea what was in the shots. And Moore said Welplex offered no emergency number to call.
"I was scared enough to stay the night with them," Moore said.
And Moore is relieved she did, because sometime after midnight Jim Pope decided to take a drive.
"He picked up the car keys and headed for the door," Moore said. "I said, 'Where are you going?' And he said, 'I'm going to the store to get my medication.' Well, of course, the drugstore was closed at that hour. If he had gotten out there, there's no telling what he would have done."
Within a couple of days, Candy and Jim Pope were both smoking again, and they feel conned by Welplex and the doctor who gave them the shots.
"We've been brought up to trust doctors. To do what doctors say," Candy Pope said. "There was nothing in the literature about hallucinations. If I had known, I never would have taken the stuff."
Even small doses called risky
Dr. Glenn Catalano, chief of mental health at the James A. Haley Veterans' Hospital in Tampa, said he's not surprised by what happened to the Popes. He co-wrote a paper that was published in the Annals of Clinical Psychiatry in 2004 about how smoking-cessation shots can cause people to experience a temporary mental break.
He said the paper was inspired by a 59-year-old man who received the shots and started hearing the voices of family members' saying they were going to kill him for his "fortune." As the voices become more frequent, he contemplated suicide and had "homicidal" urges towards his wife for her "betrayal."
"We've seen at least three other patients who have come in with this since then," Catalano said.
Catalano and other medical experts said the bottom line is that these drugs can be dangerous, even in small doses. Tolerance depends on several factors, including weight and genetic predisposition.
"If you are seeing things and you go out to drive or cook dinner, that's not safe," he said.
Still, Welplex insists the treatment is safe and effective.
The patented treatment includes three drugs - atropine, scopolamine and chlorpromazine - that act "to block the central nicotine receptors in the brain," according to documents sent to The Tennessean by Welplex's Maxwell.
She said in an e-mail that the documentation should be "self evident to one skilled in the art of pharmacology and toxicology." She said in a subsequent interview that any doctor who disagreed "needs to go back for further training because they are really missing the boat on knowledge that they obviously don't have."
Maxwell also sent The Tennessean a paper titled "Retrospective Study for Anticholinergic Blockade in Smoking Cessation," by Dr. Ronald E. Perry. Perry says in this paper that 200 randomly selected patients who had been through the Welplex treatment were contacted. Of these, he reported 88 percent were smoke-free after 60 days and 56 percent were smoke-free at one year.
However, both the AMA's Davis and Dr. David DiPersio, a clinical pharmacist at Vanderbilt University Medical Center's medical intensive care unit, found this paper of questionable value.
"The retrospective study described in the paper by Dr. Perry does not provide valid evidence on the effectiveness of the treatment," Davis said. "To establish the efficacy of a treatment, randomized controlled clinical trials are generally necessary. ... The study described in the paper by Dr. Perry falls short of that, is subject to methodological biases, and would probably not be accepted for publication in good peer-reviewed journals."
DiPersio said: "Retrospective studies cannot demonstrate proof. I can't imagine anyone with a medical degree agreeing to the premise of this treatment."
Dr. Tony George, an associate professor of psychiatry at Yale School of Medicine and the director for the Program for Research in Smokers with Mental Illness at Connecticut Mental Health Center in New Haven, said the underlying premise of the Welplex treatment is a mystery to him.
"Atropine and scopolamine ... really do not bind to nicotintic acetylcholine receptor subtypes, so this claim is very puzzling to me," George said. "As a clinical pharmacologist and tobacco treatment person, I ... am just beside myself when I hear about folks that are just exploiting smokers to make a buck with untested and irrational treatments."
Vanderbilt's DiPersio warns the elderly are especially at risk.
"Older people tend to be highly sensitive to this. It can make them crazy," DiPersio said. He noted that the elderly population typically takes other medications that might not mix well with atropine, scopolamine and chlorpromazine.
Atropine is typically used to dilate the eyes, scopolamine for motion sickness and chlorpromazine for psychiatric illness.
"These drugs are never used in combination for anything," DiPersio said.
Published: Sunday, 07/02/06
http://www.tennessean.com/apps/pbcs.dll/article?Date=20060702&Category=NEWS07&ArtNo=607020349&SectionCat=&Template=printart
