Is Nicotine Replacement Therapy
The Smoker's Last Best Hope?
by John R. Polito, November 14, 2000
Nicotine Replacement Therapy or NRT
NRT is short for Nicotine Replacement Therapy. It includes all nicotine patches, nicotine gums, nicotine sprays and nicotine inhalers. It does not include non-nicotine products like Wellbutrin or Zyban (both are "bupropion"). With approximately 50 million smokers in the United States, and 15.7 million attempting to quit each year, NRT sales are expected to bring drug manufacturers billions in profits. In the United States the pharmaceutical industry is extremely active in marketing these products to smokers. In order to get smokers to believe in the merits of NRT, drug companies have been purchasing and using powerful and trusted influence, financing their own studies to prove their own products "effective," and through the use of direct advertising leading smokers to believe that NRT is far more "effective" than is actually the case.
This article explores how corporate profits, university grants, charitable donations, and lazy lifetime health bureaucrats, may be playing a large role in the demise of "highly effective" abrupt nicotine cessation programs around the world, and abrupt nicotine cessation in general. Is it possible that science, education and government are being manipulated by the drug industry in order to make billions of dollars from those dependent upon nicotine? Is it possible that abrupt nicotine cessation or "cold turkey" quitting may actually be equal or superior to the billions being spent on expensive NRT products? The bottom line is that it really doesn't matter. If a smoker can quit using ANY method, wonderful! That's our goal. But it's time to explore legitimate quitter concerns. Each year the lives of millions depend upon accurate information. Those trying to quit have a right to answers!
The U.S. Clinical Practice Guideline
0n June 27, 2000, the United States Government issued a 179 page smoking cessation reference manual entitled "Clinical Practice Guideline for Treating Tobacco Use and Dependence ." In the " Guideline " the U.S. government strongly advocates that all quitters be encouraged to purchase expensive NRT products and attempt cessation by gradually weaning themselves off nicotine over a period of weeks or months. The Guideline was quickly adopted around the globe as the new cessation "Bible." Except by implication (the poor placebo) the merits of abrupt nicotine cessation are not discussed. Traditional self reliance has been all but abandoned by our government in favor of medicine's wonderful new "medical cure." But why?
What Happened to Cold Turkey Quitting?
As mentioned, the NRT drug industry is buying reputable influence. The SmithKline Beecham CHC, the drug company that manufactures Nicorette , has the following statement at its web site: "SmithKline Beecham CHC makes an annual grant to the American Cancer Society to support its cancer fighting mission in return for the use of its name and logo." The American Cancer Society's on-line financial records indicate that both SmithKline Beecham CHC (manufacturer of Nicorette and Nicoderm CQ ) and Novartis (manufacturer of the Habitrol patch) are making large contributions to the Society.
The American Cancer Society's on-line "Quitting Tips" page showers extensive praise upon NRT while all but ignoring CT. It echos our government's position that NRT is now the only way to quit. Its "Tips" sheet advises those seeking to beat addiction to nicotine and, "nicotine replacement therapy is recommended in the US Agency on Health Policy and Research Clinical Practice Guidelines on Smoking Cessation, for all smokers except pregnant women and people with heart or circulatory diseases" (emphasis added).
A Vermont Attorney General's Report states that in June 1996, SmithKline Beecham CHC entered into an agreement with the American Cancer Society, Inc. in which it agreed to pay the American Cancer Society royalties of $1 million during the first year of the licensing agreement, and certain additional royalties, in exchange for the exclusive right to use the Cancer Society's name (report since removed from Vermont AG site but see this Missouri AG article). The attorney generals of 12 states attacked SmithKline Beecham CHC for the deceptive manner in which it was using the American Cancer Society's name in asserting that NicoDerm CQ was more effective or superior to any other nicotine patch, when there were no clinical study establishing that one nicotine patch was superior to any other (also see an April 1999 State's Attorney Generals' Report - see pgs 10, 18 and 19). It was relatively easy to see that nicotine is nicotine.
As the 1999 Attorneys General detail, the American Lung Association was receiving over $2.5 million a year from McNeil Consumer Products Company, a subsidiary of Johnson & Johnson and the manufacturer of Nicotrol, for the use of the American Lung Association's name in marketing the Nicotrol patch. It is interesting that Nicotrol is the only NRT product referenced by "name" on the American Lung Association's "Quitting Smoking" web page, where it is mentioned twice. You'll also note that the American Lung Association devotes the bulk of its "Quitting" page to NRT with no mention whatsoever of CT or self reliance. The American Heart Association's literature is also void of any specific guidance on how to take the cold out of quitting cold. No documents have been located indicating that any NRT drug company is making substantial contributions to the Heart Association.
As mentioned, the United States Government's Clinical Practice Guideline for Treating Tobacco Use and Dependence has totally abandoned CT and self reliance in favor of NRT. In connection with the Guidelines, the government has published a Consumer Guide on how to quit smoking. Again, the "Guide" follows the "Guidelines" in abandoning CT and instead tells smokers that NRT "medications" will "double" their chances of quitting, without defining what "double" actually means. The guide is fairly short and directs smokers desiring further information to contact the American Cancer Society or the American Lung Association, as well as other groups.
To date, the American Medical Association's on-line smoking cessation materials haveNOT abandoned CT in favor of NRT in that NRT is not even mentioned at the AMA's site. Interestingly, our government does NOT list the AMA as a reliable source of additional quitting information. The Canadian government's new site has done a wonderful job of presenting cessation as a menu of options. BBC Health recently reported that 89% of all recent quitters quit smoking cold turkey. If true, then what in the heck is going on here? Have we lost our minds? Smokers are human beings too and not just drug depositories for the next generation of nicotine peddler. By the way, have you ever wondered where they get the nicotine from that they put into the patches and gums?
It is not my intent to imply that there is any wrongdoing within our national heath organizations. The American Cancer Society and the American Lung Association have both contributed greatly and their causes and have helped save millions and millions of lives. It is my intent, as seen above, to show that mutual economic relationships do exist. It is my intent to show that these relationships are affecting the information being made available to smokers as they battle to save their lives, before the arrival of bad news. It is my intent to help people understand that medical universities, the primary authors of the Guidelines, are receiving millions of dollars to produce NRT study results, and as we speak they are applying for even more. It is my intent to show that "Cold Turkey" has not taken a backseat to NRT, but instead has been kicked entirely out of the car. It is my intent to show that some studies have found that the long-term success rates of CT are superior to NRT. There isn't a dime to be made of CT quitting and NRT sales will generate billions and billions. In fairness to CT, it's time to explore the facts.
America's medical university professors and doctors have played a major role in formulating the government's new "NRT Guidelines." Over the past two decades they have received millions upon millions of dollars of NRT drug company money that was given to them to conduct studies proving that the drug company's gums, patches, sprays and inhalers were "effective" and superior to CT quitting. Their competition, cold turkey, had no spokesman and no voice. Without the blessings of science there was no money to be made off of selling nicotine to nicotine addicts.
In performing hundreds of university studies, many of which used public and private money while still having drug company involvement, thousands of instant "smoking cessation medical experts" were created. Medical journal articles were written, reputations were built and the study of NRT almost became an industry within itself. A quick examination of the millions of "public" dollars being spent on recent studies, and the subjects being studied, is shocking (National Institute of Health's Grants Searcher - type "smoking nicotine " as your search terms and then "Submit Query"). Unlike the public expenditures, we have no idea of exactly how much and to whom the drug companies have given their millions.
Are smokers being led to believe that NRT is their last best hope of ever quitting? If so, where will they turn if the "best" doesn't work for them? Will some surrender "all hope" of ever quitting? Will their loss of hope cause them to join the ranks of the 430,000 in the U.S. or the 1,200,000 in Europe who annually lose their lives to smoking? I pray that it won't happen but fear that it is.
Most smokers that I speak with believe what they're being told in drug company advertisements, by our university professors, by our national health organizations and by their government. How could we expect them to believe otherwise? But again, are they being told the whole truth or are they being fed false hope? Why lead them to believe that they will fail if they go it alone? Is it necessary to do so? It 's my opinion that greed is causing the over inflation of the merits of one method, while intentionally destroying the merits of the other. I have no problem with any smoker giving NRT a try. I tried them both more than once. But slamming willpower and self determination as a viable and "effective" alternative is dead wrong and in my opinion the NRT companies are doing the killing. It's my hope that our government, national health organizations, medical universities, and drug companies, will open their eyes to the significance and honesty of the message that's being sent.
Is NRT Effective?
How are the pharmaceutical companies marketing NRT? What do their T.V. commercials say? Are the advertisements leading smokers to believe that most smokers who buy and properly use NRT products are successful in quitting? Sure they do. Listen closely the next time that an ad comes on televison. They all use two key words - NRT will "DOUBLE" your chances of quitting because NRT has been proven "EFFECTIVE." What does "effective" mean, who payed to prove it and what exactly are we doubling? If 90% of NRT users were successful in quitting for one full year, would that be "effective"? Absolutely. But what if NRT had an 85 to 90% failure rate, would that be "effective"? Of course not! Then why are our pharmaceutical companies, health organizations, universities and government telling every smoker out there that NRT is "effective?" The truth is that almost 9 out of 10 NRT users don't make it to the promised land. Where do they turn after their hopes are shattered?
We're usually told to read the fine print if we want to know the truth. Does a smoker who is about to rely upon NRT as their "last best hope," have a right to know that almost 9 in 10 NRT quitters fail? Try and think like a pharmaceutical company for a minute here. If you had to tell smokers that unless they sought out professional counseling or participated in some form of clinic or group, to compliment their use of NRT, that they were almost surely doomed to fail, would they continue to buy your product? Would you continue to make billions and billions by selling nicotine to nicotine addicts? Surely the drug companies must be telling smokers exactly how "effective" their products are, aren't they? You be the judge.
I've listed most of major official web site links to the NRT sites in the first few paragraphs above. Don't trust me, click on some of them and carefully look for any definition of "effective," look for how they define "double," or look for "any" study statistics whatsoever telling smokers what the actual one year success rate is for their particular product. I'll wait here. Unless data or definitions have recently been added or I missed something, there are "NO" definitions, "NO" explanations, "NO" study results, "NO" data, "NO" nothing! Who is going to spend hard earned money on a product that fails all but a few? Who will be the lucky 1 in 9 or 1 in 10 that succeeds?
Arresting a lifetime addiction to smoking nicotine is the greatest challenge many of us will ever faced. Smokers deserve the truth - we can handle it! The truth is that NRT is not EFFECTIVE and, contrary to all the hype, it is NOT a smoker's last best hope of freedom! You can't buy determination in a pill, a patch, gum or a spray. It comes from the gut, from dreams and desires of someday breaking free. It's sad that NRT is being given the entire center stage when the star of the show should be a smoker's determination. What we need to be doing is to bathe that determination in motivation, feed it a sound addiction education, and then wrap it snugly and support it against relapse for life. Not only is NRT taking credit for its own glory, it takes credit for the 5% who would have made it to a year anyway, without NRT's help. How EFFECTIVE does that make NRT? One in twenty? Will smokers put their hope and dollars into a product that will gives zero benefit 18 out of 20 who use it?
Fostering motivation, providing a sound education and quality support against relapse - these are the keys to permanent abstinence, not NRT not CT but WE! Today more than ever we have a golden opportunity to use the power of the internet to motivate, educate and provide real-time on line support to tens of millions of smokers. Have those in charge of policy, and the purse, accepted the challenge? Clearly not. Instead, they seem to be standing in the wings while a new breed of nicotine pusher takes the smoker's money while promising a magic cure that has been scientifically predetermined to fail the vast majority who will use it.
There are programs and support groups experiencing 30% to 50% long-term success rates without NRT. If our medical universities, government and health organizations really want to help smokers, they need to study "why" the successful clinics and support groups are successful. When they find the answer, they need to use the internet to attempt to recreate the successful program's results on a grand scale. Maybe someday medicine will find a "cure" for smoking but we shouldn't create false hope or discard proven methods when what we advocate generates 8 or 9 losers for every winner. It's just not acceptable. This isn't a track meet with just one winner, this is life or death for all the runners. We must do better.
Today there are 49 million ex-smokers in the United States. How many quit "cold turkey"? I believe that if we conducted a survey of all former smokers that almost 90% would tell us that they quit cold turkey. I challenge our doctors and universities who have now written and published over 3,000 tobacco articles since 1995 (Clinical Practice Guidelines at page iii) to do one more study and write one more article that either proves me wrong or right. Just one simple question - how did you quit smoking? In that NRT has been around for over a decade, don't you think that if NRT was truly "effective" that we'd be hearing some numbers by now? Wouldn't you want to brag about it? They know exactly how many NRT quitters are quitting for a year. Look at their fancy web sites and the information that they're collecting. Why aren't they telling us? Could a lie now end up costing them millions or billions later on? I believe that their actual numbers will always remain the best kept secret in town.
How are NRT and CT Quitting Different?
When a tobacco user quits cool turkey their blood becomes nicotine free within 72 hours. Also at about the 72 hour mark the intensity of withdrawal reaches its peak. On average, day three brings the quitter 6.1 craves. It is during these extremely crucial hours of intense withdrawal that most "cold turkey" quitters relapse. By day five the average number of craves has dropped to about 3 per day, and by day ten it has fallen to an average of just 1.4 ("Coping in Real Time", O'Connell, 1998 Research in Nursing & Health, 21 at 487-497). Although true physical nicotine withdrawal is nearing its end, psychological withdrawal (habit conditioning) continues and will be fairly gradual in its decline, yet far less intense and to a large degree manageable. Although it often occurs earlier, usually between day 60 and 90, psychological withdrawal will have diminished to the point that the quitter will be experiencing at least some days that are totally free of anxiety or craves.
On the other hand, the NRT user delays physical withdrawal until the 60 or 90 day mark, depending upon the length of time that NRT is ingested into the blood. Often their resolve and determination are beginning to wane just when they're being asked to quit using their NRT device. Although reduced, it is then that all NRT users will begin experiencing at least "some" symptoms of physical nicotine withdrawal. Over and over during Freedom's early days, we watched with horror as our NRT users experienced the pain and suffering of delayed withdrawal, at or near the time that our successful "cold turkey" quitters were basking in freedom's glory! But, watching NRT's delayed physical withdrawal was extremely discouraging for new CT quitters while in the throngs of "Hell Week."
Seeing so many NRT users experience physical withdrawal and/or relapse at the three, four, five or even six month mark led many new CT quitters to believe that their future held the same. It was hard to blame them for wanting to throw in the towel so early. Many did. Although we did have a few of our NRT users go the distance and remain tobacco free at one year, we learned that it isn't really a good idea to mix NRT quitters with CT quitters in the support group setting, as they tend to be demoralizing to each other. On the front end, the NRT user's hell week wasn't any cakewalk either as the two pack a day smoker using a 21mg. patch is still missing about a pack of nicotine a day.
In defending the merits of methods of cold turkey quitting, I don't want to leave any smoker with the belief that they can't quit while using NRT, because clearly some can and do If you're now using NRT as part of your quit and you are having success, by all mean continue on. This article isn't intended to discourage your efforts. It's intended to give hope to all those who've given NRT repeated tries and are quickly losing all hope.
At Freedom from Nicotine, probably the only nicotine free quit smoking site on the internet, the enemy is nicotine. Cigarettes, pipes, snuff, chew, snus, cigars, gums, patches, sprays, inhalers and now e-cigarettes are all simply the delivery device for one of the wold's most addictive substances. We see our primary mission as educating our new members and assisting them in completing "Hell Week," which we then promptly rename "Glory Week." If a quitter can climb to the top of withdrawal's mountain so that each can see, feel and taste the glory that lies beyond, it isn't hard to keep them going. They quickly realize that the prospect of victory is at last within their reach.
Although we call ourselves a "CT" site (only to identify our primary cessation method), we truly are a "WE" forum. We realize that we have lots of room for improvement but with each passing day we become more proficient at delivering quality internet cessation support. We fully realize that NRT is having modest success, but at Freedom we have decided to no longer encourage the feeding of nicotine to nicotine addicts as a means of achieving long-term success and a nicotine free life. At Freedom, we will never accept leaving 85 to 90% of our brother and sister addicts behind. Freedom fills a void. It provides a home and haven for both the strong and the disenchanted. But, with the all NRT hype and everyone telling us we're wrong, it can be a difficult keeping new quitters focused on the task at hand when all around them they hear about the "double effective" way.
What Do The Studies Say?
Don't look to the new Clinical Practice Guidelines if you're searching for long-term abstinence rates of 1 year or greater. What you'll find instead is that the authors have focused on a 5 month standard that tends to make NRT look better than it actually is. Physicians are being asked to rely upon this short-term data to exclude CT as a viable cessation alternative, when some of the recent long-term data paints a different picture. This short-term study philosophy is very much in line with the Guidelines declaration that smoking should be looked at as a "chronic disease" and that it is wrong if we try and define success 'only on the basis of permanent abstinence." Instead, the Guidelines tell us that we should have an " expectation that patients may have periods of relapse" (Guidelines, pg. 9). Imagine a smoker's thoughts when the first read or hear that they have a chronic disease and that even if they do try to quit that it's perfectly normal to expect to relapse, but not to worry as we no longer base success on quitting for keeps.
Even if these words were not intended to be heard by the ears of smokers, it's a terrible expectation to instill in physicians who will be treating nicotine addiction. Imagine the doctor telling the patient, "hey buddy, you quit for just five months and that'll be good enough for me!" Expectations have a tendency to bare fruit. Remind me not to send my smoking friends to the doctors that the authors of the Guidelines plan to train. Anyway, let me give you a brief rundown of the Guidelines conclusions regarding NRT and their five month "findings." Can you sense that I'm not buying all these numbers. Keep reading, please!
First, the Guidelines conclude that "all smokers trying to quit, except in the presence of special circumstances" should "receive pharmacotherapy (that's a doctor word for drugs) for smoking cessation" (pg. 26). It identifies four FDA approved nicotine pharmacotherapies: nicotine gum, the nicotine inhaler, nicotine nasal spray and the nicotine patch (pg. 26). So as to not offend any of the drug companies, the Guidelines take the 5th Amendment and tell us that they don't have enough data to rank each drugs effectiveness against the other (pg. 26). Consider that statement in relation to how CT is being treated, and also notice the contradiction in that they go on to present different success rates as presented in the tables below.
Published Guideline Five Month Abstinence Rates - The first table below is entirely from the June, 2000 Guideline's tables for nicotine gum, the patch, spray and the inhaler. These published, relatively short-term , findings compare each nicotine delivery device's success rate with the combined placebo or Cold Turkey (CT) group's five month abstinence rate. To arrive at these percentages, various studies were selected that met certain established criteria and then formulas were used to combine the results into the figures seen in the first table below. Thirteen (13) studies were combined to arrive at the nicotine gum results, twenty-seven (27) for the nicotine gum, four (4) for the inhaler, and three (3) for the spray. There were hundreds of studies to select from but it was felt by the panel that these specific studies met the established inclusion criteria.
SPRAY AND INHALER WARNING - Although our government is handing physicians across America the incredible spray and over-inflated inhaler figures cited below, to aid to helping their patients quit, EVERYONE should seriously question their validity. It doesn't take a rocket scientist to figure out that cocaine is cocaine and nicotine is nicotine, regardless of the manner in which it's ingested into the body. Also note a further down in the reading that most of the studies used to establish these two rates were bought and paid for by NRT drug companies. There is a very recent study that if credible could make the Guidelines spray and inhaler tables, and their advertised success rates, either a hoax and joke - take your pick. This study compared all four NRT delivery devices (the patch, gum, spray and inhaler) and found no appreciable difference in their 3 month success rates. It concluded that:
"When asked about nicotine replacement treatment products available, physicians should note that, despite low compliance with the recommended dose of the spray and inhaler and differences in product ratings, overall, there are no notable differences between the products in their effects on withdrawal, discomfort, perceived helpfulness, or general efficacy."
Archives of Internal Medicine, September 1999, Vol. 159, No. 17, Randomized Comparative Trial of Nicotine Polcrilex, a Transdermal Patch, Nasal Spray, and an Inhaler.
Published Five Month Rates from U.S. Guidelines
Method Being Compared CT NRT Margin Nicotine Gum at 5 months 17% 24% +7% Nicotine Patch at 5 months 10% 17% +7% Nicotine Inhaler at 5 months 11% 23% +12% Nicotine Spray at 5 months 14% 31% +17%
Unpublished Guideline One Year Abstinence Rates from Selected Studies
The below abstinence rate table was created by me. It contains selected long-term results from 15% of the studies used by our government to establish the short-term 5 month rates in the first table above. Many of the 47 studies that were used to establish the published short-term success in the first table above, also contained long-term results of a year or more. Although most of the studies containing long-term results found that NRT out-performed CT, what troubles me is that so many didn't. In that millions of lives are at stake, I hope that it troubles you too. Below is a group of Guideline studies that contain selected findings in which the "long-term" success rates for the Cold Turkey quitters were either equal to or better than those of NRT quitters.
Method Being Compared CT NRT Margin Nicotine Gum to Major Depression Smokers at 1 YearJournal of Consult. & Clinical Psych. 1996;64(5):603 33% 22% - 11% Nicotine Gum with Booklet for Both at 1 YearBritish Medical Journal 1983; 286(6366):595 11% 10% - 1 % Nicotine Gum at 1 YearAddictive Behaviors 1983; 8(3):253 13% 8% - 5% Nicotine Gum at 4 YearsPreventive Medicine 1997; 26(1):25 7% 6% - 1 % Nicotine Patch at 1 YearPreventive Medicine 1995; 24(1):41 13% 13% 0 % Nicotine Patch at 1 YearNew England Journal of Medicine, 1999;340(9):685 16% 16% 0 % Patch with Book & Video for Both Groups at 1 YearJournal of Consult. & Clinical Psych. 1997; 65(4):633 10% 7% - 3 %
I recently cited the above studies to a reputable French cessation physician and his reaction astonished me. Let me quote his email, "It makes no sense to select 5 studies over 100 studies. These will fall precisely in the 5% error margin!" I replied and advised him that there were far fewer than 100 studies that were used by my government to establish our national cessation policy (in fact, the above 4 gum studies represent the long-term rates from 33.3% (4 of 12) of all gum studies used by the US government to recommend nicotine gum to the world). His reply was, "Very few scientists specialized in the field of tobacco dependence would share your views." I couldn't agree with him more! In that most NRT studies are bought and paid for by pharmaceutical companies, I can only wonder how many of them had their results SHELVED or HIDDEN when they came back showing that "cold turkey" was just as effective as NRT. We'll never know will we!
Although I pray that the physicians who performed the studies used to compute the Guideline's short-term abstinence rates were honest and reputable men and women, it bothers me that most of the studies which found NRT significantly superior to CT were bought and paid for by the very drug company that made the NRT delivery device being tested. It also bothers me tremendously that some of the studies were done by physicians who received money from the NRT drug companies or physicians who owned stock in NRT drug companies. The United States Government has used these studies to establish the way that physicians across America help patients to quit. If this is the normal way that things are done, it's a very sad way to do business. I thought it only happened in politics. I was wrong. The fox is again in the hen house.
The above findings showing CT superior or equal to NRT can not be summarily dismissed by our government in that it paid for most of them. The 1983 Addiction Behaviors study was paid for by a grant from the National Institute on Drug Abuse and the Veterans Administration, the 1996 Journal of Consulting and Clinical Psychology study was supported by a grant from National Institute on Drug Abuse and the Department of Veterans Affairs, the 1983 British Medical Journal study was funded in part by the British Health Education Council and the 1997 Journal of Consulting and Clinical Psychology study was funded by a grant from the U.S. Public Health Service Department. Who financed the studies that found NRT so highly successful?
I'm heartened that at least some of the NRT studies tell us exactly who funded them. Two even go so far as to disclose that the physicians doing the studies had financial relationships with the drug companies. Many are silent on these issues. I was not aware that pharmaceutical companies were hiring or paying university teaching physicians. I am now. My concern here is that we are basing our entire national smoking cessation policy upon a study financing system that doesn't pass the smell test. Let me give you a few examples of what troubles me. Again, I want you to know that I have no evidence whatsoever of any wrongdoing by any physician that is mentioned by name, nor any university associated with any of these studies, nor of any wrongdoing on the part of any drug company. The appearance of impropriety is a legitimate basis for public concern. The NRT studies identified below were ALL used by the U.S. Government in arriving at the NRT Guidelines ratings listed in the first table above. More than twice the number of studies as I've listed below, involved NRT drug manufacturer funding. Who received how much? I have no earthly idea.
Who Stands to Profit from NRT Studies?
The Study Troubling Guideline Study Statements NRT Rates 1991 six month patch study published in JAMA ; 266(22):3133 comparing a new "Nicoderm" patch manufactured by Alza Corp. and marketed by Marion Merrell Dow Inc. "This investigation was supported by a grant from Alza Corp. Drs Christen, Hatsukami, Rennard, Lichtenstein, Heatley, Repsher, Fortmann, Killen, Hughes, and Glover and Mr. Daughton have received fees from Marion Merrell Dow Inc for consultancies and honoraria for educational activities. Authors employed by Marion Merrell Dow Inc (Drs Rolf and Nowak and Messrs Ackerman and Malone) and those employed by Alza Corp (Drs Causey and Knowles and Mss Voss-Roberts, Prather, Trunnell, and Moos) own shares of company stock. Dr. Biglan's spouse owns stock in Alza Corp." 6 Month Rates: NRT 26% vs. CT 12% (+14%) 1993 nicotine inhaler study published in JAMA 1993; 269(10):1268-71. Kabi Pharmacia Therapeutics manufactures a nicotine inhaler. "This investigation was supported by a grant from Kabi Pharmacia Therapeutics, Helsingborg, Sweeden." 1 Year Rates: NRT 26% vs. CT 10% (+16%) 1996 nicotine inhaler study published in Addiction 91(9):1293-1306 Pharmacia & Upjohn is manufacturer of a nicotine inhaler. "This study was funded by the first author's VA Merit Review and by Pharmacia & Upjohn, Sweden." 1 Year Rates: NRT 13% vs. CT 8% (+5%) 1997 nicotine inhaler study published in Archives of Internal Medicine;157(15):1721-8. Pharmacia & Upjohn is manufacturer of a nicotine inhaler. "This study was supported by a grant from Pharmacia & Upjohn, Helsingborg, Sweden (Dr Wiklund)." 1 Year Rates: NRT 28% vs. CT 18% (+10%) 1998 nicotine patch study published in Archives of Internal Medicine 7(5):425-30. Marion Merrell Dow, Inc. markets the Nicoderm patch. "Supported by a grant from Marion Merrell Dow Inc, Kansas City, Mo." 1 Year Rates: NRT 15% vs. CT 9% (+6%) 1995 nicotine nasal spray study published in Addiction, 90:1671-1882. Pharmacia manufactures a nicotine spray. "This study was funded by the first author's VA Merit Review and Pharmacia (Sweden)" 1 Year Rates: NRT 18% vs. CT 8% (+10%) 1991 nicotine patch study published in the New England Journal of Medicine; 325(5):311-5. Two of the authors were Dr. Sawe and Dr. Tonnesen. Kabi Pharmacia Therapeuties manufactures a nicotine patch "Supported in part by a grant from Kabi Pharmacia Therapeuties. Dr. Tonnesen has been a consultant for Kabi Pharmacia Therapeutics, developer of the nicotine patch, and has received grants from the company. Dr. Sawe is medical director of of Kabi Pharmacia Therapeutics" 1 Year Rates: NRT 17% vs. CT 4% (+13%) 1994 six month nicotine patch study published in Chest 105(2):524-533. Elan Pharmaceutical is a manufacturer of nicotine patches. "This study was supported by a research grant provided by Elan Pharmaceutical Research Corporation." 6 Month Rates: NRT 34% vs. CT 21% (+13%)
There are scores of studies out there comparing the success rates of CT quitters to NRT users. Sadly, none of the studies compare apples to apples or oranges to oranges. Instead of comparing nicotine fed quitters (NRT) to nicotine free quitters (CT at 72 hours), they watch as a very high percentage of the CT quitters relapse before the completion of week one, and then use those relapses to claim that NRT is "effective." In the 1996 patch study by Yudkin, published in the British Journal of General Practice in Issue 46 (not available on-line), of the CT quitters who remained 100% nicotine free for one week, 28% went on to remain nicotine free at 1 year. The trick is in getting the CT quitters through that first week.
Instead of science trying to find ways to help the body and blood of a cold turkey quitter become nicotine free even faster than 72 hours, our government uses questionable studies to conclude that ALL nicotine addicts should be fed massive doses of nicotine. Why have these scientists ignored the fact in almost every NRT study done to date, the cold turkey quitters who remained nicotine free at the end of three months out-performed the 3 month NRT quitters, in having a higher percentage remain free for a year. Doesn't that beg them to revisit their discarded CT thinking? I guess not.
I should also note that in some of the studies used to establish the Guideline rates, the CT quitter is fed small amounts of nicotine (usually less than 1 mg.) in the "placebo" patch or gum. As you can imagine, this puts the CT quitter into a state of serious and chronic nicotine withdrawal which deprives their bodies of their natural right to become nicotine free within the first 72 hours. The NRT quitter is made somewhat comfortable while the CT quitter's resolve is bled to death in less than a week I believe that those studies that did lace their placebos with small doses of nicotine, did so in an attempt to stop the CT quitter from quickly realizing that their gum was nicotine free and a waste of time. Imagine being in a study where you thought you'd be getting "free" nicotine patches or free nicotine gum and you didn't. If you didn't get "the real thing" and you were fairly disappointed, how strong would your motivation be to continue. I ask this question because the studies are all written as if the smokers can't tell the difference between gum that contains nicotine and gum that doesn't. I beg to differ : )
Two quick asides. In 1996 the California Tobacco Study, one of the largest on-going group studies in the world, found that at 6 months there was almost no difference in the success rates of CT and NRT. As for the future of NRT? Well, now the entire NRT marketing machine is looking at a whole new way to make money off of smokers. It's no secret that NRT makers will soon be in direct competition with cigarette makers. Believe it or no, NRT manufacturers are now looking to market NRT not for purpose of quitting, but instead to help smokers reduce the number of cigarettes they smoke, while using NRT to make up for their body's missing nicotine. What will they think up next? FLASH - I just received e-mail from Grumpy who advises that NRT drug companies are now putting nicotine into lollipops. Oh my goodness!
It is my personal opinion that the tremendous "superiority" of NRT over CT is probably the biggest fraud perpetrated upon smokers since the 1960's tobacco ads that used physicians to convince smokers that one brand was healthier than another. Do we feed alcohol to alcoholics or heroin to heroin addicts to help them break free? I've been told that my analogy is way out in left field somewhere and maybe it is, but the more I read, the more I wonder. NRT's primary argument is that it buys smokers time to recondition the habit or psychological portion of their dependency. If it is so effective then why are we not feeding alcohol to alcoholics via needles and IV bags so that they can break the bottle or can to mouth portion of their dependency? Would the results be the same?
If there is benefit to NRT, why should that make physicians so hell bent on destroying the credibility of a quitting approach that has helped over 45,000,000 living Americans lead "long-term" nicotine free lives? Why? The only reason that I attack NRT in this article is because human greed is trying to kill a wonderful turkey, and in doing so the hope of millions. It may yet have some benefit. I don't know. But after reading this giant pile of "scientific" studies that now rest at my feet, I'm left with tons of questions and serious doubts. What I am sure about is that NRT has never made a single smoker quit, it's far overrated and regardless of what my government says, it will never be a smoker's "last best hope of quitting," because they'll always have themselves!
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 November 14, 2000, 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
November 14, 2000
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