Nicotine Patch Otc
This article explores the OTC nicotine patch studies and the claim that they double a quitter s chances of quitting.
Easy to read patient leaflet for nicotine patch. Includes indications, proper use, special instructions, precautions, and possible side effects.
Nicotine Patch official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more.
When you smoke a cigarette, nicotine enters your body through your lungs and travels to your brain. Nicotine replacement therapy NRT works by substituting the source of nicotine to replace the nicotine you inhale when you smoke. For people who are quitting smoking, NRTs can help by delivering a safer alternative source of nicotine than cigarettes. They also can reduce or eliminate the symptoms of withdrawal, making it easier for some people to quit. NRTs have been extensively tested and used by millions of people, and considered safe and effective ways of quitting smoking.
To optimize your chances of success, medications should be a consideration in your quit day checklist.
Note: The content in this section is for informational purposes. Not all nicotine replacement therapies are right for everyone. Be sure to discuss the option of nicotine replacement therapy with your doctor or healthcare provider.
Types of NRTs
There are many different types of NRTs that are available either over-the-counter or from a prescription from your doctor. They vary in the dose of nicotine they supply and the way in which the nicotine is delivered into the body. As with any medication, talk to your doctor. Not all medications are safe for women who are pregnant and breastfeeding, or for people who may be taking other medications. Types of NRTs include:
Nicotine gum – Nicotine gum is an over-the-counter product that you can buy at your local pharmacy. A piece of nicotine gum is chewed briefly, allowed to rest in the mouth, then chewed again. This process enables nicotine to be absorbed into the body through the mouth lining. Nicotine gum is used for two to three months, up to a maximum of six months.
Nicotine lozenges – Nicotine lozenges come in the form of hard candy and release nicotine into the system as they dissolve in the mouth. Each lozenge lasts for about a half hour and can be used as needed for up to twelve weeks.
Nicotine patch – The nicotine patch is a medication applied to your skin each day. It delivers nicotine through the skin into your body. Some brands of the nicotine patch are available over-the-counter, while others require a prescription from your doctor. The nicotine patch is available in 16-hour and 24-hour doses, and is used for two to three months.
Nicotine nasal spray – Nicotine nasal spray is a prescription medication that you spray into your nostrils every couple of hours. Nicotine nasal spray is used for three months, up to a maximum of six months, and gradually tapered off.
Nicotine inhaler – The nicotine inhaler is a prescription medication that you hold to your mouth and inhale to combat cravings. The inhaler is used for three months, up to a maximum of six months. It is recommended that people use at least 6 cartridges per day in the first three to six weeks, then taper off as cravings become less severe or less frequent.
Bupropion hydrochloride Zyban – These prescription pills, which don t contain any nicotine, are taken daily to combat cravings. The pills should be taken two weeks before quit day, then for seven to twelve weeks after. Doctors sometimes prescribe Bupropion pills along with use of the nicotine patch.
Varenicline Chantix – These prescription pills are taken twice each day. The medicine attaches to nicotine receptors in the brain, reducing the pleasurable effects of smoking and helping to reduce symptoms of withdrawal.
Using NRTs can double your chance of quitting smoking. Remember that medicine alone can t do all the work. Talk to your doctor about the option of NRT and consult other ways to help you be successful, such as quit smoking programs.
How NRTs Work
Unlike cigarettes, which contain thousands of harmful chemicals, nicotine medications contain small doses of nicotine alone to combat cravings and urges to smoke. The amount of nicotine is decreased gradually over that time until nicotine replacement is no longer needed. Because the dose of nicotine is much lower than what a person would receive by smoking a cigarette, becoming addicted to NRTs is rare. That s why NRTs are considered an effective way to help someone who smokes quit for good.
Do I Need an NRT to Quit.
While you can go it alone, nicotine replacement therapy offers another option in helping some people to quit smoking. However, not everyone who decides to quit smoking will want or need to use them. The goal in using nicotine medication is to stop smoking completely. If you plan to take nicotine medications, you should begin using them on your quit day.
NRTs and Smokeless Tobacco
The Food and Drug Administration has not yet approved any nicotine replacement therapies specifically for quitting smokeless tobacco. However, using a NRT may help you quit, or at least deal with nicotine cravings. For smokeless tobacco users, some NRTs may help more than others. Nicotine gum and lozenges are oral substitutes that are the most like using smokeless tobacco, and so may be most effective from a behavioral standpoint. They also let you control your dosage to help reduce cravings. The nicotine inhaler may not be as useful for smokeless tobacco users, as it is designed to look and feel like a cigarette filter tip. The nicotine patch gives a steady dose of nicotine, but may not help with strong cravings.
Answer the following questions to help determine whether an NRT may be right for you:
Are you sure you want to quit smoking for good. Having one or two cigarettes while you use the gum, patch, nasal spray, inhaler, or lozenge is not dangerous, but your goal is to quit smoking for good. Use NRT only when you are ready to stop smoking.
Have you quit smoking before and relapsed since. NRTs may be a good option for you if you ve tried to quit smoking before and have relapsed
Do you smoke 20 or more cigarettes each day. NRTs are usually recommended for people who smoke a pack a day or more.
Are you willing to be patient. Using NRT correctly can take some getting used to. Follow the instructions and give it some time.
Are you pregnant or breastfeeding. Not all NRTs are safe for pregnant or breastfeeding women. Talk to your doctor or other health care provider about your options.
Do you have allergies or asthma. Some NRTs are not recommended for people with these conditions. Ask your doctor, dentist, or pharmacist.
Which NRT is Right for You.
Nicotine replacement therapy offers an increased chance of success when it comes to achieving a smoke-free life. But not all NRTs are right for everyone. It s important first to consider whether you need an NRT to quit, or if you can be successful with a method like cold turkey. If you decide that nicotine replacement therapy may play a role in your plan, use the table below to compare the benefits, drawbacks, and costs of each therapy. Then talk to your doctor about your plans for quitting and which NRT might be right for you.
When choosing a nicotine replacement therapy, think about which method best fits your lifestyle and pattern of smoking. The points below highlight the main differences between NRTs. Refer to the table that follows for a list of benefits and drawbacks of each therapy:
Nicotine gums, lozenges, and inhalers allow you to control your dosage of nicotine to help keep cravings under control.
Nicotine nasal spray works quickly to combat cravings when you need it.
Nicotine inhalers allow you to mimic the use of cigarettes by puffing and holding the inhaler.
Nicotine patches are convenient and only have to be applied once a day.
Both inhalers and nasal sprays require a doctor s prescription.
Some people may not be able to use patches, inhalers, or nasal sprays due to allergies or other conditions.
Prescription or OTC
Potential Benefits
Potential Drawbacks
Nicotine Gum
OTC
Approx. 120 for 2 weeks of use
Convenient
Delivers nicotine into the system more quickly than the patch
Can cause bad taste/ throat irritation
Cannot eat or drink while chewing
Nicotine Lozenge
Approx. 6 per day for average usage and 12 per day for maximum usage
Lasts for 30 minutes or more
Can cause soreness of the teeth and gums, indigestion, and throat irritation
Nicotine Patch
Both available – Talk to your doctor.
Approx. 50 for 2 weeks of use
Easy to use
Few side effects
Delivers nicotine more slowly than other methods
Can cause skin irritation
Can cause racing heartbeat
Nicotine Nasal Spray
Prescription – Talk to your doctor.
Delivers nicotine quickly
Effective at reducing sudden cravings
Can cause nose and sinus irritation at first, but usually goes away
Not recommended for those with asthma and allergies
Nicotine Inhaler
Delivers nicotine to the system as quickly as nicotine gum
Mimic the inhaling action of a cigarette
May cause coughing, mouth or throat irritation
Not recommended for people with asthma or chronic lung disease
Bupropion Hydrochloride
Not recommended for people with seizures, eating disorders, who are pregnant or breastfeeding or taking an MAO Monoamine oxidase inhibitor, a class of anti-depressant drugs.
Varenicline Chantix
Can more than double the chances of quitting smoking
May cause headaches, nausea, vomiting, trouble sleeping, unusual dreams, flatulence gas, and changes in taste
OTC stands for over-the-counter. You can buy this medicine without a prescription at your local pharmacy.
Find a quit smoking program in your area.
Nicotine Replacement Therapies
Does the Over-the-counter Nicotine Patch Really Double Your Chances of Quitting?
Medscape - Indication-specific dosing for Nicoderm CQ, Nicotrol nicotine transdermal, frequency-based adverse effects, comprehensive interactions.
General Information. NicoDerm CQ has been approved as an OTC stop smoking aid. NicoDerm CQ is the first OTC nicotine patch to be available in all prescription.
What if 91 of 100 quitters relying exclusively upon the over-the-counter OTC nicotine patch to help them quit were failing and relapsing within 24 weeks of slapping on that first patch. What if 98 or 99 out of 100 of those relying exclusively upon the OTC nicotine patch for a second or subsequent quitting attempt were smoking again within 24 weeks. What if, in truth, your chances of quitting on your own were greater than if quitting with the patch. What if the few who are quitting while wearing the patch are doing so in spite of it, instead of because of it.
How many times have you heard an over-the-counter nicotine patch commercial proclaim that the patch will double your chances of quitting. Is it true or is it false. Should we
instantly believe everything we read or hear on television without investigating on our own. Experts tell us that smoking is killing half of all who are unable to quit while eventually crippling most lucky enough to survive. Are there certain representations in life that are important enough to invest the time needed to investigate and make up our own minds. I hope that you ll take the time to read the full text of some of the studies cited below and decide for yourself. Your very life may depend on it.
Double your chances of quitting. Your chances. What are your chances of quitting on your own and what are the pharmaceutical companies actually doubling. This article explores all of the over-the-counter nicotine patch study evidence that I have been able to locate. But before going further I feel the need to declare my beliefs and disclose my background. It s my firm conviction that the key to permanent abstinence is in each quitter developing a solid appreciation for the true power of nicotine. By taking the time to master the core withdrawal and recovery principles underlying years of chemical dependency upon nicotine, we can each short-circuit the agony of learning nicotine s true power through the school of hard quit knocks.
A recovered thirty-year three-pack-a-day nicotine addict myself, since 1999 I ve worked to facilitate smoking cessation online at www.WhyQuit.com, and for the past year I ve taught at local two-week clinics here in South Carolina, USA. All of my work since meeting Mr. Joel Spitzer in January 2000 a thirty-year Chicago area cessation instructor has evolved into abrupt nicotine cessation, with or without bupropion. In the almost three years since founding WhyQuit I ve never taken a dime for my work, but then I am exploring ways to stay active in both smoking cessation and nicotine control for the balance of my life. The daily emotional rewards of helping others break free are tremendous.
It s my prayer that every smoker reading this article will not only seek answers regarding the truth behind the OTC nicotine patch, but that they will also invest the time needed to master the Law of Addiction. In summary, there is only one simple rule that we each must follow in order to remain free for life. Just one day at a time, never put any amount of nicotine into our body again - NEVER TAKE ANOTHER PUFF.
Double Your Chances of Quitting Representations
Today is April 8, 2002. I just visited the website of the U.S. Surgeon General which states that the nicotine patch - available over-the-counter will more or less double your chances of quitting and quitting for good. I visited the website of the UK s Department of Health which proclaims that the over-the-counter nicotine patch is effective treatment that doubles rates for people giving up. I also visited the websites of two different patch makers. One asserted that the patch can double your chances of quitting while the other represented that it can double
yourchances of success.
Do the below cited medical studies and reviews support the conclusion that the over-the-counter nicotine patch will NOT double your chances of quitting. Do they support the conclusion that quitting on your own may be just as effective as trying to quit while using the OTC patch. Do the Hays and Davidson OTC patch studies provide evidence that quitters may have a 20 greater chance of quitting on their own than they would by using the OTC patch. Does the Tonnesen study provide evidence that those attempting a second or subsequent OTC patch attempt - alone without any cessation program of any kind - have almost a zero percent chance of succeeding. You be the judge.
Rebuttal Invitation
In fairness to the U.S. Surgeon General, the U.K. Department of Health, major
non-profit organizations, and those companies marketing the OTC nicotine patch,
I hereby extend to each the opportunity to email me john whyquit.com a
rebuttal to the points and arguments made below. I will gladly include
your rebuttal link here within this article. I ask only that you limit
your reply to ANY efficacy evidence associated with the use of the
over-the-counter nicotine patch by first time or subsequent users, the only
subjects addressed in this article.
What are Your Chances of Quitting on Your Own.
Before looking at OTC patch figures it s important to establish a fairly
reliable 24 week success rate for quitting on your own without any help
whatsoever. What are your chances. The most exhaustive review of smoking cessation studies ever
undertaken was published in June 2000 by the U.S. Department of Health and
Human Services and is entitled Clinical Practice Guideline - Treating Tobacco Use and Dependence.
The Guideline was compiled by a panel of eighteen leading experts, eleven of
whom disclose prior financial relationships with pharmaceutical companies in
Guideline Appendix C. Using a Table format, the panel meticulously reviewed, cataloged and combined similar studies in order to give us a single effectiveness figure, as well as a placebo or control group rate, for each method or component of
cessation. The U.S. Guideline quickly became a world standard that was
cited and relied upon by almost every government health agency on earth.
Below is a summary of performance ratings for Guideline placebo and control
groups.
USDHHS Tobacco Cessation Guideline, June 2000
Table
Topic
Control
Arms
Rate
A x R
Physician advice to quitNo advice
7.9
Person-to-person contactNo contact
10.9
327
Total contact timeNo minutes
176
Number of sessionsCan t Use - 0 to 1
12.4 - Various types of clinicians No clinician
10.2
163 Various numbers of clinicians No clinician
10.8
324 Types of formats No format
216 Number of formats No format
216 Number of types of self-help No self-help
14.3
243 Types of counseling/therapy No counseling
11.2
392 Acupuncture Placebo
8.3 Bupropion Placebo
17.3
34.6
Nicotine Gum Placebo
17.1
274
Nicotine Inhaler
Placebo
10.5
Nicotine Nasal Spray Placebo
13.9
41.7 Nicotine Patch Placebo
280 Clonidine Placebo
83.4 Nortriptyline Placebo
11.7
35.1 Over-the-counter nicotine patch Placebo
6.7
20.1 TOTALS
210
11.53
2,423
The Guideline contains the above nineteen tables that have control group or placebo group 24 week cessation rates. Altogether, there were 210 different study arms. A single study can have more than one arm. For example, the 1997 Sonderskov OTC patch study contained two arms, one studying those using the 14-mg. patch, and one for the 21-mg patch.
If you multiply the number of arms within each of the nineteen categories by that category s U.S. Guideline average control group or placebo group rate, and then add up the results 2,422.9 and divide by the total number of arms 210, you re left with an average quitting on your own rate of 11.53 . If truly representative, 11.53 of all quitters quitting on their own will still be free at 24 weeks. Let s calculate a U.S. Guideline average a second way.
First, let s get rid of all of the placebos and use only those studies that had on your own control groups. If we use the same formula but this time remove all data from Tables 24-40 and then recalculate the remaining 138 arms using only Tables 11-20, the average control group rate drops a bit to 11.26.
For good measure, let s address the apples to apples argument and remove all data from the on your own control groups Tables 11-20 and then recalculate the remaining 72 arms using only Tables 24-40. The resulting placebo group 24 week success rate is a bit higher at 12.06.
Is it fair to say that regardless of how we look at the U.S. Guideline data as a whole, that the average on your own rate is in the neighborhood of 11.5 at 24 weeks. Please keep this number in mind while we look at U.S. Guideline Table 40 which tells us the overall effectiveness of the over-the-counter nicotine patch.
OTC Patch Table 40 indicates that it looked at and combined three study arms and found that 11.8 of those wearing the OTC patch remained quit at 24 weeks versus only 6.7 for those wearing the placebo patch. Do two questions immediately come to mind. How can those selling the patch go on T.V. and proclaim to smokers around the world that the patch doubles their chances of quitting when the U.S. government s data indicates that the patch s 11.8 rate was almost identical to the overall Guideline on your own rate of 11.5. The second question is, why did only 6.7 of the OTC placebo group quit for 24 weeks when we know that the average should have been in the neighborhood of 11.5.
Is it fair to stop here and ask why the U.S. Food and Drug Administration is allowing OTC pharmaceutical companies to go on television and tell quitters that the OTC patch will double their chances of quitting when in truth quitters are quitting at almost twice the 6.7 rate that Table 40 indicates was achieved by the placebo groups. Is your chance the same as someone wearing a placebo nicotine patch in some university study. When pharmaceutical companies make such public marketing declarations, are they intentionally substituting a smoker s natural and normal ability to quit on their own with the dismal performance of someone wearing a placebo patch in an OTC patch study.
If true and the OTC patch is no more effective than quitting on your own - without any assistance whatsoever - have millions of quitters missed a golden opportunity to seek out a more effective means of quitting. In that the average smoker only has one quitting attempt every three years, how many thousands of lives are being lost by substituting placebo patch rates for the true on your own rates. Let s take a look at the studies themselves.
How Does the OTC Patch Compare to Our 11.5 On Your Own Rate.
There were two published OTC patch studies containing three arms relied upon in preparing Table 40. The third OTC patch study was published in November 1999, seven months before the Guideline was released in June 2000 but apparently too late for inclusion. The three Guideline OTC patch studies and their findings are as follows:
Nicotine Patches in Smoking Cessation: A Randomized Trial among
Over-the-Counter Customers in Denmark.
American Journal of Epidemiology, 1997, Vol. 145, No. 4, at Pages 309-318
At 26 weeks
14-mg OTC patch 27
Placebo patch 23
At 26 weeks
21-mg OTC patch 11
Placebo patch 4.2
Efficacy and Safety of the Over-the-counter Transdermal Nicotine Patch as an Aid for Smoking CessationArchive of Family Medicine, Vol 7, Nov/Dec 1998, at pages 569-574.
At 24 weeks
22-mg OTC patch 8.2
Placebo patch 4.0
Over-the-counter Nicotine Patch Therapy for Smoking Cessation
American Journal of Public Health 1999 Nov; 89 11, at pages 1701 to 1707.
22-mg OTC patch 8.7
Placebo patch 4.3
It should have been apparent to a sixth grade math student that the three comparable patch studies for the 21-mg and 22-mg patches had an average rate of just 9.3, two full percentage points lower than our established quitting on your own rate of 11.5 . If true, why are governments around the globe helping sell an alleged means of quitting that to date has proven itself to be less effective than quitting on your own. Are our government and non-profit health bureaucrats lazy, dishonest, on the take, asleep at the wheel, or just plain stupid. Maybe it s me. Maybe I m not reading these numbers correctly. Let s look inside the placebo patches for a moment.
Were the Placebo Patches Truly Placebos.
An immediate question that comes to mind is how the 21-mg and 22-mg patch placebo groups achieved 4.0, 4.2 and 4.3 placebo rates when the average of all Guideline data indicates that 11.5 of smokers quitting on their own remain abstinent at 24 weeks. Is it possible to doctor or manipulate a placebo in order to make those using it fail at a rate almost three times higher than they would if they d hadn t worn it. The average 4.2 is 7.3 percentage points lower than should have been expected 11.5.
But before looking inside the placebo patches let s look at the normal withdrawal timing associated with abrupt nicotine cessation quitting. The half-life of nicotine in the human body is about two hours and within 72 hours physiological nicotine withdrawal peaks in intensity as the abrupt cessation quitter s blood serum becomes 100 nicotine clean. Cold turkey quitters normally begin sensing substantial relief within just 72 hours as they not only reach the peak of physical withdrawal s mountain, but also see the actual number of habit crave triggers encountered peak at an average of six.
The withdrawal anxieties of the first 72 hours can be tremendous but what if additional very small quantities of nicotine are put into a placebo patch so that the abrupt cessation quitter s brain dopamine circuits are never allowed to bathe for an entire hour in a zero blood serum nicotine level. What if instead their brain s dopamine neurotransmitters are forced to sense a very small quantity of nicotine arriving beyond the normal 72 hours. Could it alter the timing of peak anxieties. We re not talking about the nicotine levels necessary to establish dependency in the first place, but the minimum amount necessary to alter the intensity of cessation anxiety during and beyond the initial three days of abrupt cessation.
Is it possible to slightly extend or intensify the period of initial abrupt
nicotine withdrawal by placebo manipulation. Could such manipulation be
used by intelligent humans to guarantee that their product would always be at
least twice as effective as the placebo, regardless of how poorly their product
itself performed. I used to think that a placebo was defined as an
inactive substance or preparation used as a control in an experiment or test to
determine the effectiveness of a medicinal drug, but not anymore.
Reading from the first study above, the 1997
Sonderskov
OTC study, we learn that it was funded by Ciba-Geigy the makers of the
Habitrol patch, Ciba-Geigy provided four employees who provided instructions
concerning the trial and distributed trial patches to the participating
pharmacies, a Ciba-Geigy employee was in contact with the participating
pharmacies at least once a week, Ciba-Geigy provided all active and placebo
patches, the study was funded in part by Ciba-Geigy page 317, and the study
admits that Ciba-Geigy inserted an undisclosed amount of nicotine into the each
placebo patch in order to insure that the placebo patches were identical in terms of color and odor page 310.
Although the study admits that at 26 weeks there was no significant
differences in smoking cessation rates seen among smokers who started the
low-dose nicotine or placebo patches, in regard to the 21mg patch arm only
4.2 of those using the placebo laced with an undisclosed amount of nicotine
remained quit at 26 weeks, as compared to our U.S. Guideline average figure of
11.5.
The 4.2 rate achieved by those wearing the doctored placebo patch falls almost
mid-point between the 4.3 Hays OTC placebo patch rate and the 4.0 OTC Davidson placebo rate. Is this really science. Where was the FDA. With thousands of non-addictive dye colors and odors available to select from, why would any scientist select the substance being tested as a placebo masking agent. How much nicotine was fed to the placebo group and why wasn t the exact amount disclosed within the study. With billions of dollars and millions of lives at stake, where in the heck was peer review.
How widespread was this placebo doctoring practice and what levels of nicotine were used in each study. I emailed Dr. Hays, the primary author of the 1999 Hays OTC patch study in which the placebo group achieved just a 4.3 24 week rate. I ask Dr. Hays if he had any of the placebo patches remaining from his study that could be tested and he indicated that he did not. I asked him if the placebo patches in his study had been laced with nicotine and he indicated that he didn t think so. But, in that he encouraged me to contact Elan in Ireland who he said provided the placebo patches, I didn t sense that he had much confidence in his answer. I immediately emailed Elan and they ve yet to reply. Again, what kind of science is this.
The 1997 Sonderskov OTC study isn t the only nicotine patch study in which we know that those using the placebo patch were never allowed to bathe their brains in nicotine free blood serum levels. In the Campbell IA and Prescott RJ study entitled, Transdermal nicotine plus support in patients attending hospital study published in Respiratory Medicine in 1996 in Volume 90 1 : pages 47-51, at page 48 it reads Patients in the P placebo group received a transdermal formulation with a very low content of nicotine 13 of the active form, a dose which is conventionally felt to be too low to affect outcome. Conventionally felt. Whose feelings and where is the published study.
In the Ahluwalia JS, McNagny SE, Clark WS. study entitled Smoking cessation among inner-city African Americans using the nicotine transdermal patch that was published in the Journal of General Internal Medicine JGIM in 1998 in Volume 13 1 : 1-8, at page 2 it reads, Placebo systems contained a pharmacologically irrelevant amount of nicotine in the drug reservoir to mimic the odor of active systems but delivered less than 1 mg of nicotine in 24 hours. How many patch users know what pure nicotine smells like, and why would a placebo patch quitter know how an active patch quitter s patch smelled. It makes absolutely no sense..
In allowing drug companies to market themselves based upon their own dismal
placebo rates and not on objective historical performance standards where such data exists, we not only deceive the public on life threatening health matters but we invite placebo manipulation by those with a financial stake in the
outcome. Where is the study comparing cessation rates between the
doctored placebo patch and the real placebo patch. Was that step
skipped. This just doesn t pass the smell test.
Are OTC Patch Studies More Reliable than Earlier Patch Studies.
The three OTC patch studies, for the very first time, showed the world what the emperor was really wearing. The Hays, Davidson and Sonderskov studies mimicked real world quitting conditions in stripping away the medical universities, layers of study structure, one-on-one education, skills development training, counseling, telephone calls, study support, expense reimbursements, mileage reimbursements, appointment expectations, logs or record keeping, physical examinations, and all other motivational sources for which the nicotine patch had previously been able to claim credit.
Not only did these pick it up and use it studies make the nicotine patch stand on its own two feet, with the exception of 14-mg patch in 1997 Sonderskov study, the results were strikingly consistent. A multitude of earlier patch studies were seriously inflated by study protocols and education factors for which U.S. Guideline Recommendations 5 and 6 education, counseling and support should have received the bulk of the credit.
Until pharmaceutical companies began dreaming about huge profits associated with high volume OTC patch sales and the FDA got involved in OTC study protocols, we each had an excuse for not seeing what was happening here. Not anymore. While backing the nicotine patch car into the garage, we were never afforded a chance to look ahead, from the beginning, to see how much of the patch s effectiveness was attributable to other factors.
Once Elan and Habitrol decided to go OTC and requested studies that the FDA encouraged them to have pre-approved as to format, it was too late to shelve or hide the results. Instead, it was back to the double your chances argument which each of us had been conditioned to accept when we were achieving 22 to 25 rates at 24 weeks, while still dressing the nicotine patch in counseling, contact, telephone calls, education, motivation, skills development programs, and scores of other study protocols.
Are the 21 and 22 mg. OTC nicotine patches with an average quitting rate of just 9.3 less effective than the 11.5 rate achieved by those quitting on their own. If so, who knew this and why do they still remain silent while tobacco continues to kill at the rate of four million a year. Double your chances. Are profits really more important than human lives. Why are we allowing this. Before closing I have one more factor to throw into the mix. I call it the Tonnesen Factor
How Effective is the OTC Patch for Second Time Patch Users.
Not a single government, non-profit or pharmaceutical website that I ve visited informs quitters of their chances or odds during a second or subsequent OTC patch attempt. Instead, they just keep pushing the patch and gum down the throats of every quitter arriving, without regard to their number of prior patch or NRT attempts. Keep in mind that we ll have four million tobacco deaths again this year. I would be willing to bet that tens of thousands who tobacco will claim during the next 365 days will have made at least two serious prior NRT cessation attempts. If the effectiveness rate of the patch drops substantially during second and subsequent attempts and we are all aware of this fact, do organizations advocating the use of NRT have an obligation to disclose this simple truth to those placing their dying faith into the endless stream of double your chances statements.
It s a 1993 study by P. Tonnesen and others entitled Recycling with Nicotine Patches in Smoking Cessation that was published in Addiction, 1993, Apr; 88 4 ; at pages 533-539. This early patch study not only substantiates our 11.5 on your own U.S. Guideline calculation in that 12 of the placebo group quit for 26 weeks, it raises an alarming factor regarding recycling or second time patch users. One of the factors that the Tonnesen study attempted to determine was how failed patch users from a patch study one year earlier would perform during a second attempt at quitting with the patch. As the study summary abstract puts it all of the subjects hadrelapsed in the group previously treated with the active nicotine patch. All of them - 100
If in fact there is a massive group of quitters who are incapable of quitting via a gradual stepped-down nicotine withdrawal approach, as may have been evidenced by the 1993 Tonnesen recycling study, I can understand why the pharmaceuticals what to keep it quiet profits but why are major non-profit and government organizations like the ACS, ALA, ATS, AHA, RWJF, AMA, ALF, ASH, Truth, NHS, CDC, NIH, DHHS, and FDA not demanding that either additional studies be immediately undertaken or that adequate warnings be given to smokers. Why. Are we in this for show or to save life.
Keep in mind that we re not taking about an 11.5 chance at breaking free, a 6.7 chance or even a 4.2 chance. We re talking about organizations making public recommendations that may deprive a large class of quitters of almost all hope of success - a zero percent chance and a wasted opportunity. Are we going to play the blame game later, engage in finger pointing, or pretend that we couldn t read, when thousands of families begin asking why, or are we going to get serious now about doing all within our power to immediately start reducing the carnage.
A Proven Alternative
For the longest time I looked into these issues not because I felt something funny was going on but because NRT marketing was neglecting to tell quitters that high quality local clinic programs around the world were achieving 25 to 40 24 week cessation rates, and that the best of the best were consistently generating 24 week rates in excess of 50. Great programs like Joel Spitzer s abrupt cessation Chicago two week clinic that has consistently generated one year rates near 52, or the Ohbayashi program in Japan that just generated a 58 one year rate, will never be studied by those trying to sell an 9.3 chance of quitting for just 24 weeks by gradual nicotine withdrawal in the form of an OTC nicotine patch.
I m beginning to believe that health bureaucrats are basically lazy humans who truly want to believe in the magic power of a box of nicotine products that they can leave outside their door. I know it s not good to stereotype folks or call names but I m an open minded man whose opinions attempt to reflect the realities around him. Once I begin seeing health professionals get down in the trenches and dirty their hands in helping smokers break free by presenting the highest quality cessation education, motivation, skills development, counseling and support programs possible, my opinion will change.
It s challenging work walking into rooms full of smokers and presenting programs designed to help them reclaim their freedom, health and life expectancy. Instead of studying quality programs that consistently generate 40 to 50 24 week rates and attempting to refine, improve upon them, and clone them on a massive scale, we ve bought into these gradual nicotine withdrawal concepts in a very deadly way. It s time for those organizations taking the money to begin delivering results.
We don t have to wait three years for a smoker to move into the contemplation phase, we can put them there tomorrow. We don t have to wait for their motivation to ripen into reason when we have the tools today to accelerate expectations. We don t have to subject their dreams to methods guaranteed to produce 90 failure rates when we already have the means to make permanent abstinence more likely than not. If you re a government or non-profit health bureaucrat charged with finding ways to help those dependent upon nicotine break free, then I challenge you to roundup a dozen smokers, put them into a room, close the door, and begin your journey in learning what is and isn t effective.
A basic flaw in all the magic bullets and quick fixes to date, and those yet to come, is that they teach nothing. I fear that many of those who renamed nicotine medicine and redefined its administration as therapy would love to do the same with alcohol, cocaine and/or heroin. Above all else, chemical dependency is an intense forced long-term relationship that can become as real and profound in the mind as anyone s love for their mother. We call it junkie thinking. Once we re able to develop a pill or product that makes getting over mom s death easy, we ll be able to do the same with the millions of memories that bond the addict to their dopamine manipulating drug. Until then, it s time to roll up our sleeves and go to work in helping them each develop an understanding of the foundations upon which their dependency has been built.
I, John R. Polito, am 100 solely responsible for the content of this article
and assume full responsibility for its internet publication. It had not
been reviewed by any other person prior its internet publication on April 8,
2002, nor had any other person had any input upon its content. The
views expressed here are my own, in my individual capacity, as a concerned
nicotine cessation and control advocate.
Reference Links
1. Full Text Version of
U.S. Clinical Practice Guideline, June 2000
2. Tonnesen 1993 Patch Recycling Study Abstract
3. Sonderskov 1997 OTC Patch Study
4. Davidson, 1998 OTC Patch Study
5. Hays, 1999 OTC Patch Study
6. Campbell, et al. Respir Med 1996 Jan;90 1 :47-51
- Patients in the P group received a transdermal formulation with a very low
content of nicotine 13 of the active form, a dose which is conventionally
felt to be too low to affect outcome.
7. Ahluwalia JS, et. al., Smoking cessation among inner-city African Americans using the nicotine transdermal patch that was published in the Journal of General Internal Medicine JGIM in 1998 in Volume 13 1 : 1-8, at page 2: Placebo systems contained a pharmacologically irrelevant amount of nicotine in the drug reservoir to mimic the odor of active systems but delivered less than 1 mg of nicotine in 24 hours.
The Real Story Behind the Nicotine Patch and Smoking Cessation. By: Amy Renshaw. A Few Facts on Smoking Smoking is one of the most preventable.
