|FOR IMMEDIATE RELEASE|
Wednesday, June, 11, 2003
2:00 p.m. ET
John R. Polito|
Are Teens Getting Hooked on NRT?by John R. Polito
A new study finds that three-quarters of surveyed Memphis high school juniors who used nicotine replacement therapy (NRT) did not do so for purposes of trying to quit. Even more alarming is the study's revelation that among student NRT users 18% were never-smokers.
A study published in the June 2003 edition of Archives of Pediatrics & Adolescent Medicine entitled "Use of Nicotine Replacement Therapy in Adolescent Smokers and Nonsmokers," reflects 1998 survey responses of 4,078 Memphis high school students who were primarily seventeen years of age, and 84% minority students.
Among those responding, 258 (6%) reported being current smokers of at least one cigarette a day, while 216 students ( 5%) reported having used the nicotine patch or gum. A closer look at the 216 users shows that 16% currently use NRT every day, 20% use it several times a week, and 64% have used it at least once but less than weekly.
Although the study ignores smokeless tobacco use, its findings raise serious concerns that students may be establishing chemical dependency upon nicotine without ever using tobacco products. Among the 216 NRT users, 40 represented that they had "never smoked a cigarette, not even a few puffs." Yet, 11 of the same 40 report using NRT several times a week and 7 others say that they use it every day.
Amplifying such concerns are the September 2002 youth dependency study findings of Dr. Joseph DiFranza, published in Tobacco Control, announcing that teens are becoming hooked on tobacco much quicker than previously thought. According to Dr. DiFranza, the onset of loss of autonomy to simply turn and walk away often occurs in a matter of days and after only a few uses.
Although we know that the 21 mg. patch delivers the nicotine equivalent of smoking an entire pack of cigarettes, there is as yet no available research studying the patch's potential for establishing the onset of permanent chemical dependency in youth.
The Memphis youth NRT survey also raises concern over the 17% of students who attempted to stop smoking with the aid of NRT but appear to have instead permanently transferred their chemical dependency to the patch or gum. The study shows that 35 of the 216 students who acknowledged using NRT described themselves of ex-smokers. Six of the 35 asserted "I use the nicotine patch [or gum] several times a week," while five additional ex-smokers declared "I use the nicotine patches [or gum] every day." But does NRT actually aid teens in quitting?
A January 2000 nicotine patch youth quit smoking study (also published in the Archives of Pediatrics & Adolescent Medicine) followed one hundred 13 to 17 year-olds who smoked at least ten cigarettes a day, and as a group averaged 20 a day. Each attempted to quit while using a 15 mg. patch over a six-week period. Finding that 95% had relapsed to smoking within just six-months, the study's authors concluded that the nicotine patch was not effective in treating adolescent smokers.
Other recent dismal NRT study results suggest that health policymakers may want to rethink plans to make a growing array of clean-nicotine devices more available than cigarettes, less expensive, and far easier to obtain.
A California smoker survey published in the Journal of the American Medical Association (JAMA) in September 2002 concluded that "NRT appears no longer effective in increasing long-term successful cessation in California smokers." Even more shocking was a study published in Tobacco Control in March 2003 that combined the results of eight over-the-counter NRT studies and found that 93% of study participants had relapsed to smoking nicotine within six-months.
Attention is naturally beginning to focus upon the question of how the early gum and patch studies were able to appear "effective" while gaining FDA approval as quitting tools. NRT industry consultants respond that quitting is getting harder and that the remaining population of smokers represent the hard-core addicted. In support of their argument they point to recent odds ratio victories over placebo group performance rates in the 4% midyear range, that are vastly inferior to the 10% to 12% placebo and control group rates often seen during studies in the 1980's.
Others disagree citing even poorer NRT performance in youth cessation studies as evidence that the "hard-core addiction" argument is without merit. It is this cessation student's contention that placebo group rates have been seriously affected by study protocols ranging from participants having prior NRT use experience with "the real McCoy," to the practice of doctoring placebo devices with small amounts of nicotine for masking purposes (usually 1 to 3 mg.).
Although researchers "conventionally feel" that the practice does not effect placebo performance, there are no known studies pitting nicotine doctored placebos against nicotine free placebos. Chemical withdrawal symptoms normally begin peaking in intensity within 72 hours of ending all nicotine use, as the brain reward pathways begin bathing in nicotine-free blood serum. Would small amounts of nicotine lock placebo quitters into an unnatural state of serious chronic withdrawal that eventually wears them down?
If the concept of quitting via gradual weaning with clean nicotine is an ineffective and cruel money-grabbing hoax upon smokers, what is effective? Although NRT industry consultants readily admit that local neighborhood quit smoking programs are on average twice as effective as NRT, it's their contention that smokers "do not want and will not use" such programs.
Advocates of such programs assert that massive NRT marketing campaigns - that have included the purchase and use of the trusted influence of most major health nonprofits as NRT storefronts - have all but buried the existence and effectiveness of high quality programs offering cessation education, dependency understanding, coping skills development, counseling, and/or group peer support. They contend that quality local and internet based programs are consistenly generating six-month cessation rates in excess of 30%.
As a rising tide of new nicotine delivery vehicles prepares to flood the market, concerns are shifting from clean nicotine's ineffectiveness as a gradual weaning tool to its use as a cleaner, less destructive and less deadly means of satisfying the nicotine addict's endless chemical need to feed.
Waiting in the wings are your local pharmacist's 27 flavors of nicotine suckers, nicotine water, nicotine cola, a new nicotine straw, nicotine lotion, nicotine wafers, and yes, even Nico-O-Tan! Most of the new delivery vehicles are not being marketed for quitting but as addictive weight-control programs, permanent adrenaline pick-me-ups, or for those times and places where selective indoor burning is neither accepted nor welcomed, such as high school classrooms and smoke-alarmed bathrooms.
Many sincere health officials today advocate a massive movement that attempts to transfer as many nicotine smokers as possible to smokeless tobacco, snuff, Swedish snus, the nicotine inhaler, or any of the new clean nicotine delivery vehicles, as a means to dramatically reduce smoking induced cancer and respiratory deaths by carcinogen reduction and elimination of the more than 500 gases present in each burning cigarette, including carbon monoxide.
In theory it's a wonderful lifesaving exchange yet any attempt at transition would require a massive marketing campaign having a core theme of a "safer" way to experience nicotine. Would the health benefit associated with the percentage of smokers successfully making the transfer exceed the impact that a "safer" message campaign might have on mushrooming the percentage of daily youth nicotine addicts seen in the Memphis study?
Smoking delivers its captivating cargo to the brain almost twice as fast as injected heroin. Unlike heroin that normally travels from an extremity to the heart, over to the lungs, back to the heart and then up to the brain, smoked nicotine is a straight shot into the lungs, over to the heart and into the brain, where it arrives within 8 to 10 seconds. Oral forms of delivery take minutes to reach peak blood serum levels and transdermal nicotine hours.
Will smokers make the transition? As shown in the Memphis study, a significant percentage of youth smokers appear willing to endure slower delivery while using clean-nicotine for the unapproved purpose of complying with urge commands associated with nicotine's two-hour chemical half-life, at least during those times when burning isn't possible.
The Memphis survey asked current smokers who had used NRT to declare whether they had used it to "try to quit smoking" or as a nicotine substitute for those times when they "couldn't smoke." Three of 27 who smoked less than one cigarette a week, 4 of 13 who smoked between one and six cigarettes a week, and 17 of 52 who smoked more than one cigarette daily, indicated that they used NRT when they couldn't smoke.
The authors state that "[e]xperimentation with NRT or use by never smokers is a potential harm of increased availability of these products." "More than half of the students surveyed reported that it is or would be easy to get NRT" which supports their unofficial local study findings that NRT can be "readily purchasable by minors without proof of age." Is the inducement to experiment being fueled by an inconsistent message and lack of warnings?
The pharmaceutical companies have labeled orange flavored nicotine gum as "medicine" and market its use as "therapy." Ironically, when neighborhood pharmacies started pouring syrups to create and sell unapproved orange flavored nicotine suckers, many of the health organizations that had actively helped the NRT industry push its orange flavored gum ran to the FDA arguing that orange suckers were untested, enticing, inherently dangerous and highly addictive.
The European Union's new addiction warning label occupies the entire bottom half of the front face of a pack of cigarettes and in large black letters announces "Smoking is highly addictive, don't start." The entire top half of the pack face of Canada's addiction warning label reads "Warning - Cigarettes are highly addictive - studies have shown that tobacco can be harder to quit than heroin or cocaine." Who is responsible for keeping America's youth in addiction risk darkness?
As shown by the Memphis study, the nico-cat is already out of the bag. The question now is, will continued nicotine marketing and new products entice even greater numbers of youth to experiment with "safer" forms of permanent chemical captivity? One of the fudge factors in almost all NRT studies has been in counting all who remained hooked on the device being tested as having successfully quit. Isn't it time we told our youth the truth?
- June 2003 Memphis NRT study abstract
- September 2002 DiFranza Youth Dependency Study (HONC)
- January 2000 APAM Youth Nicotine Patch Study
- September 2002 California JAMA study abstract
- March 3003 OTC NRT Meta-Analysis - Full Text of Study
- Review of U.S. Guideline Placebo and Control Group Evidence Tables
- Dr. Hughes & Shiffman Respond to Polito's Comments on OTC NRT
- Polito Responds to Dr. Hughes & Shiffman's Comments on OTC NRT
- Link to images of cigarette pack addiction warning labels
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