Does the Over-the-counter Nicotine Patch
Really Double Your Chances of Quitting?
by John R. Polito, April 8, 2002
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!
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 (firstname.lastname@example.org) 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 11 Physician advice to quit No advice 9 7.9 71 12 Person-to-person contact No contact 30 10.9 327 13 Total contact time No minutes 16 11 176 14 Number of sessions Can't Use - 0 to 1 43 12.4 - 15 Various types of clinicians No clinician 16 10.2 163 16 Various numbers of clinicians No clinician 30 10.8 324 17 Types of formats No format 20 10.8 216 18 Number of formats No format 20 10.8 216 19 Number of types of self-help No self-help 17 14.3 243 20 Types of counseling/therapy No counseling 35 11.2 392 24 Acupuncture Placebo 7 8.3 58 25 Bupropion Placebo 2 17.3 34.6 26 Nicotine Gum Placebo 16 17.1 274 27 Nicotine Inhaler Placebo 4 10.5 42 28 Nicotine Nasal Spray Placebo 3 13.9 41.7 29 Nicotine Patch Placebo 28 10 280 30 Clonidine Placebo 6 13.9 83.4 31 Nortriptyline Placebo 3 11.7 35.1 Over-the-counter nicotine patch Placebo 3 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 Cessation Archive 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. At 24 weeks 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.
John R. Polito
Nicotine Cessation Educator
Revised - 05/15/2002
1. Full Text Version of U.S. Clinical Practice Guideline, June 2000
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."
March 21, 2002 - E-mailed all USDHHS Guideline Panel Members at the email addresses provided at U.S. Surgeon General's website, advising each of the above concerns.
March 21, 2002 - E-mailed the "Tobacco Cessation Guideline List of Supports at those e-mail addresses listed at the U.S. Surgeon General's website.
March 25, 2002 - E-mailed FDA advising it of the concerns raised above.
April 1, 2002 - Letter and e-mail from FDA indicating that info provided was being reviewed and upon completion a "detailed response of their findings" would be provided.
April 10, 2002 - Harry A. Lando, PhD, a U.S. Guideline Panel expert and the scientific editor for the "1988 Report of the Surgeon General: Nicotine Addiction" sends reply e-mail recommending that the issues raised be discussed in public.
April 10, 2002 - A link to the above article is posted at ASH UK's forum (ASH link since removed)
April 26, 2002 - 4th OTC study published (patch and gum) in Addiction, Volume 97, Issue 5, Page 505, May 2002, by Shiffman, Saul, et. al., and is entitled "Real-world efficacy of prescription and over-the-counter nicotine replacement therapy." I have only been able to review and obtain a cite to the study abstract (summary) but it presents the following twenty-six week factual findings:
May 8, 2002 - The FDA writes a reply letter in which its only substantive comment is that "[h]istoric quit rates may reflect a different population than smokers of today or smokers enrolled in recent controlled clinical trials." The letter does not attempt to explain how the natural ability of smokers to quit could have declined by 268% (from 11.% to 4.1% at 24 weeks) during the time period since the first OTC study was published in 1997, nor does it provide any evidence that quitters in the four OTC studies were any less motivated than quitters in prior studies. The letter does not mention the Tonnesen 1993 patch recycling study, nor does it mention the fact that placebo patches were admittedly doctored with nicotine. The FDA letter was prepared by Mr. Lee Lemley, FDA Policy Analyst, whose email address is LemleyL@cder.fda.gov
- OTC nicotine gum (2,981 smokers) - 8.4%
- Rx nicotine gum (324 smokers) - 7.7%
- OTC nicotine patch (2,367 smokers) - 9.2%
- Rx nicotine patch (669 smokers) - 3%
May 11, 2002 - The FDA's written letter of May 8th was received on May 11th and I replied via e-mail a few hours later posing the same three concerns as I've posed all along (1- allowing NRT companies to redefine "your" chances; 2 - nicotine doctored placebos with no published doctoring study; and 3 - Tonnesen recycling without study follow-up). I also asked the following. In light of the fact that the FDA apparently no longer believes in its own Department's control group meta analysis table figures as published in the June 2000 Guideline, whether it was now the FDA's position that all abrupt cessation "on your own" quitters have only a 4%, 4.1%, or 4.3% chance of quitting for 24 weeks, and if not what is a quitters natural "on your own" chances at 24 weeks? I asked the FDA to cite any study comparing quit rates between abrupt cessation quitters and those being fed nicotine in placebo nicotine patches, and to cite any follow-up studies that were contrary to Tonnesen's 1993 patch recycling study findings.
May 11, 2002 - ASH UK, Directed by Mr. Clive Bates, one of the most vocal proponents of NRT in the world, deletes the discussion thread posted on April 10, and Mr. Bates then posts toanother thread (that has since been deleted) stating, "The unaided quit rate is about 3% success per attempt. NRT doubles that to 6%." It's my belief that Mr. Bates may have been citing some previously unpublished inside information regarding one year OTC NRT data. If correct, it not only continues to beg the question of doctored placebos and the resulting accuracy of his 3% one year figure, it does not address the NRT industry's total failure to either follow-up on the Tonnesen recycling findings with additional recycling studies or warn those using OTC NRT of their dramatically diminished chances. Mr. Bate's figures are also important in that they shed naked light on NRT by revealing that at best it provides benefit to just 3 in 100 quitters (6% patch group minus the 3% who would have quit without it). If true, why are world health leaders continuing to push a product that provides no long term benefit to 97% who use it? Is NRT an effective use of the extremely limited and precious funding resources being dedicated by governments to foster cessation?
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