Dr. Hughes and Shiffman do their academic best to try and convince those making worldwide cessation policy decisions that, after 20 years of NRT research that consumed the lion's share of all cessation research dollars, a 93% midyear relapse rate demonstrates an "effective" means for smokers to quit. Rubbish! It's a sad day indeed when NRT researchers celebrate a 93% failure rate by declaring odds ratio victories over nicotine doctored placebos. 1

Does anyone truly think it's harder to quit today than it was twenty years ago or have those marketing NRT simply conditioned smokers into believing it is? Why have NRT researchers remained silent as millions upon millions was spent in an attempt to undermine the credibility of cold turkey (abrupt cessation) quitting in the minds of smokers? Is it possible that years of bashing self-reliance has had a negative impact upon cessation expectations?

What Dr. Hughes, Dr. Shiffman and most other NRT researchers continue to refuse to study is the amazing performance of pre-NRT abrupt cessation programs that combined varying forms of education, skills development, counseling, group support and long term reinforcement follow-up while achieving midyear rates of 30%, 40% and even 50%. Are smokers needlessly dying because pharmaceutical companies won't profit from behavioral programs? Have we spent 90% of our research dollars on 10% of the problem - chemical dependency?

Maybe NRT researchers can be forgiven for not taking the time to study the world's finest programs before embarking upon their gradual nicotine weaning magic bullet quest, but how could they ignore the amazing performance of many of the placebo groups within their own published NRT studies? How could they fail to notice that the studies in which the placebo group excelled were often caked in layers and layers of education, skills development, counseling, group support and reinforcement protocols?

How can Dr. Hughes and Dr. Shiffman sell 7% at six months, when 21% of the cold turkey quitters (the placebo group) in the 1994 Fiore NRT study remained nicotine free at six months, 22% in the 1995 Herrera study were free at ONE YEAR, and when 37% in the 1988 Areechon study, 43% in the 1987 Hall study, and 45% in the 1982 Fagerström study were all still standing tall at six months?

Should we continue to keep OTC NRT on center stage and continue to neglect research into refining, developing, deploying and encouraging the use of proven behavioral programs that we know are capable of delivering at least a 600% greater chance of midyear freedom?

We don't have to be NRT experts to take our own poll of all quitters who we know have been off of all nicotine for over one year. How did they do it? Isn't it time to listen and trust in the long term cessation evidence surrounding each of us?

John R. Polito john@whyquit.com

1. Sanderskov J, Olsen J, Sabroe S, et al. Nicotine patches in smoking cessation, a randomized trial among over-the-counter customers in Denmark. Am J Epidemiol 1997; 145: 309-18, at 312 "...placebo patches contained a pharmacologically negligible amount of nicotine."

The authors concede that programs offering cessation education, skills development, counseling and/or group support "on average" produce quit rates more than double (15%) their meta-analysis OTC NRT finding of 7% at midyear. Although most of us are aware of at least one short term abrupt cessation program consistently achieving midyear rates in the 30 to 50% range, I thought that confronting the authors with midyear placebo group performance rates of 37%, 43% 45%, from their own NRT studies, would cause them to reflect upon just how ineffective OTC NRT really is. I was wrong. Instead, they ignore placebo performance when clothed in behavioral protocols while telling us that 30 to 50% "vastly overstates" behavioral intervention's realities.

Assume for the sake of argument that there are scores of abrupt cessation programs around the globe that are today consistently achieving midyear rates in the 30 to 50% range. Further assume that those conducting them are willing to share their content, allow us to borrow their most effective elements, and that we can combine, refine, present and consistently produce 30 to 50% midyear nicotine cessation using a laptop, PowerPoint and a scripted presentation. Would the current 5% behavioral program attendance rate cited by the authors be the best we should hope for when the product being offered is at least 428% as effective as OTC NRT?

The authors conclude that the vast majority of smokers [do] not want and will not use behavioral treatment. I encourage readers to visit the "how to quit smoking" pages of government web sites or of those health organizations that you know are receiving large annual NRT pharmaceutical industry contributions. I submit that smokers cannot want or even be curious about interventions or effectiveness ratings that are intentionally hidden from view. I submit that if NRT commercials were up- front in disclosing OTC NRT's 93% midyear relapse rate that sales would decline dramatically, and quitters would immediately begin searching for more effective tools.

Remember when NRT didn't have 5% participation? Imagine the potential of a government-sponsored cessation marketing campaign that could honestly declare that a short twelve-hour behavioral program was affording those in attendance a 428% greater chance of quitting than OTC NRT products requiring weeks or even months of dedicated use. Could participation increase to 20%? Imagine teaming up with local businesses and health care providers to offer donated attendance incentives such as free temporary fitness center passes, pulmonary function exams, cardiovascular exams, or tickets to local health related attractions.

Forget about the possibilities for now. Accepting the authors' 15% behavioral program efficacy concession, in what T.V. commercial are those pushing the concept of gradual nicotine weaning telling smokers that their neighborhood abrupt cessation programs are, on average, twice as effective as OTC NRT? Instead, they condition viewers to believe that attempting cessation without OTC NRT doubles their chances of relapse.

The authors argue that behavioral programs are more expensive than NRT. I just visited DrugStore.com where an eight-week supply of Nicoderm CQ was $192 (U.S.) and Nicotrol was $200. Twenty-four patch quitters would spend $4,608 on patches while producing just 1.7 midyear quitters, at a cost of $2,711 per successful quitter. The same funds spent on a twelve-hour behavioral clinic generating a 30% midyear rate would produce 7.2 success stories, at a cost of $640 per quitter.

My next free two-week clinic commences on the 25th at the College of Charleston. As usual, there is no pay, and I, along with scores of other skilled facilitators, would gladly fly anywhere in the world for the opportunity to help smokers break free while at the same time being compensated at a rate less than what it costs to produce a single midyear NRT quitter $2,711).

I know that many researchers have devoted substantial portions of their lives to the development of NRT only to end up, here, acknowledging a 93% midyear relapse rate. This isn't a good day for any of us. I apologize if any researcher feels their integrity is being impugned by my continuing to seek answers to such questions as the extent of the practice of placebo nicotine doctoring. But in that the authors declare odds ratio victories over placebos known to have been doctored, and both authors are paid consultants for NRT pharmaceutical companies and clearly have access to those who provided placebo devices for most NRT studies, I must again ask, how many OTC NRT studies employed placebo nicotine doctoring, what amounts of nicotine were used in each study's placebo device, and what studies were undertaken to verify that the practice does not extend the intensity and/or duration of normal abrupt cessation?

Dr. Pierce's NRT survey published in JAMA on September 11, 2002 concluded that "NRT appears no longer effective in increasing long-term successful cessation in California smokers." In November 2002, Dr. Boyle's Minnesota insurance benefit review published in Health Affairs concluded that the use of NRT did not ....."result in higher rates of quitting smoking." Is it just possible that out in the "real world" where surveyed smokers know whether or not they successfully quit last year, where they have their own understanding of what it means to be quit, and where they know whether or not they bought and used OTC NRT, that NRT truly is showing zero value as a cessation tool?

Is it just possible that the study practice of "declaring" someone still receiving a steady diet of nicotine from the NRT device, as having already successfully "quit," allowed NRT a natural short-term advantage when competing against "real" nicotine quitters, that just doesn't get acknowledged by those being surveyed in the real-world?

Have you ever stopped to reflect upon how the odds ratios in the 2002 lozenge studies would have turned out if abstinence was defined to commence upon the cessation of all nicotine intake? It's amazing how one simple study definition - cessation - can create billions worth of efficacy. Imagine such definitions being used with alcohol replacement therapy (ART) where you know you're drunk but the researchers keep telling you that you've already quit.

John R. Polito

The industry cries that it's against youth smoking are a great line of talk; action is of course another matter. This research finding is a fine case in point. If the industry were really against youth smoking, it would respond to this finding by immediately cutting all advertising and promotion that portrayed or suggested a connection between the product and being thin. To do otherwise, to keep running such ads, would, in the light of this finding, be promoting the product in a way known to appeal to children.

Once again, this industry's cries that it is "against youth smoking" are not accompanied by action.

Analysis: The Survey as a PR Tactic

"Business at New York bars and restaurants has plummeted by as much as 50 percent in the wake of the smoking ban - and the drop has already sparked layoffs and left some establishments on the brink of shutting their doors, a Post survey has found."

--Cig Ban Leaves Lot Of 'Empties', NY Post, 5/12/03

On May 12, 2003, the New York Post ran two stories on a survey it had done amongst 50 "randomly selected" New York City bars and restaurants. 1,2.

The media universally accepted the survey at face value and promulgated it, repeating the survey's findings without qualification, and leaving the impression that restaurant business really had fallen off by as much as 50 percent.

The AP distributed its recap of the survey around the world 3;. The Washington Post's "Media Critic," Howard Kurtz, quoted the NY Post story on it sans criticism. 4 A Connecticut newspaper used it to rail against an incipient state-wide smoking ban. 5 New Zealand's Hospitality Association--attributing the survey to the New York Times--used it to argue against smokefree legislation. 6 And for Rush Limbaugh, of course, the survey was the very pinnacle of scientific endeavor. 7

However, this survey had glaring faults, in design and execution.

1. It seems unlikely that this was a "random" survey.

The "random" claim, repeated by the Post as late as May 24, 2003,8 is on its face, a sham--at least 3 of those reported on were noted ban opponents. The law of averages argues against these 3 randomly turning up in a survey of 50 of the 13,000 bars and restaurants in New York City. 8 The obvious question is, how many other survey subjects were known opponents?

2. The survey design mimics a notorious industry PR tactic, the "30% Myth."

The Post survey follows in the footsteps of a tried-and-true Philip Morris diversionary tactic that has been used so often it was exposed by Consumer Reports back in 1994. 10 Such surveys are usually deployed 1) during legislative battles or 2) shortly after a smoking ban has gone into effect.

3. The actual survey data was not provided in the Post's story.

Here are the facts behind the survey:

1. At least two prominent 1995 smoking ban opponents were featured in the NY Post's "random survey:" Joan Borkowski 11 and Buzzy O'Keefe. 12 Desi O'Brien, proprietor of Langan's, had previously voiced his opposition to the 2003 ban in at least two newspaper articles 13,14 --one of which was from the NY Post itself. No restaurateur's former activism was mentioned. In addition, one surveyed bar was named "Smoke." Citing such a plethora of opponents in a short article on a 50-restaurant survey doesn't sound random.

2. One of these opponents was something more than that. Joan Borkowski, owner of Billy's Tavern, was given a whole article, "1870 Bar May Get $nuffed Out." But the Post neglected to inform its readers that 8 years before, Borkowski was the leader of a Philip Morris-funded front group (New Yorkers Unite!) fighting the 1995 smoking ban. At that time, Borkowski was involved in the release of 2 opinion surveys. One survey were commissioned by the Philip Morris-funded National Smokers Alliance, the other by the Philip Morris-funded United Restaurant Hotel Tavern Association. Borkowski released the surveys in association with the National Smokers Alliance. 11 Both surveys found that after the 1995 ban, restaurant business went down.

3. As is usual in these circumstances, the dire estimates and predictions were later proven wrong by real studies based on tax data. 15 This was predictable, because the year before, Consumer Reports had already exposed the "30% Myth" in a 1994 article on such Philip Morris-funded surveys. 10 (See excerpt below.)

4. It should be noted that such survey results are greatly influenced by previous PR. A tobacco company (or its PR firm or front group) can prepare the ground by unleashing an ad campaign trumpeting business losses. It may also even directly contact restaurateurs--through personal canvassing or direct mailings--and present to them its harrowing tales and prognostications. A few months later, a restaurateur may well repeat such assertions for surveyors.

5. The PR power of such a survey is expanded even further when restaurateurs in other locales read unquestioning news coverage of it, presented as fact. Thus, one scientifically-questionable survey can sow powerful seeds for more surveys around the country, and even the world.

6. From 1989 to 2001, the New York Post's owner, Rupert Murdoch, sat on the Board of Directors of Philip Morris. 16 The Post's editorials since 1989 have been consistently against tobacco control. 17

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1. Cig Ban Leaves Lot Of 'Empties' Source: New York Post Date: 2003-05-12

2. 1870 Bar May Get $nuffed Out Source: New York Post Date: 2003-05-12

3. Bars And Restaurants Blame Sharp Drop In Business On Smoking Ban Source: AP Date: 2003-05-12 URL: http://www.sun-sentinel.com/business/local/ny-bc-ny--s mokingban-nyc0512may12,0,3930062.story?coll=sfla- business-headlines

4. Media Notes: How Many Votes Is A Picture Worth? Source: The Washington Post Date: 2003-05-13 Author: Howard Kurtz / Washington Post Staff Writer URL: http://www.washingtonpost.com/wp-dyn/articles/A4436 7-2003May12.html

5. Snuffing business  Source: Waterbury (CT) Republican-American Date: 2003-05-15 URL: http://classifieds.rep-am.com/webarchive/editorials/5rz p.htm

6. Bars To Close Under Smoke-free Law Source: nzoom.com (TVNZ) Date: 2003-05-18 URL: http://onenews.nzoom.com/onenews_detail/0,1227,190 979-1-7,00.html

7. 2nd Study Confirms 2nd Hand Smoke Harmless Source: Rush Limbaugh Site Date: 2003-05-16 URL: http://rushlimbaugh.com/home/daily/site_051603/conte nt/cutting_edge.guest.html

8. Smoking Ban Ignites Passions Source: CNN Date: 2003-03-31 URL: http://edition.cnn.com/2003/WORLD/europe/03/31/biz.tr av.smoking/

9. Smoke Screens  Source: New York Post Date: 2003-05-24 Author: STEPHANIE GASKELL and DAREH GREGORIAN

10. Where There's Smoke Consumer Reports May 1994

11. The Great 1995 New York Smoke-Out Smoke Screen THE NEW YORK OBSERVER MAY 29. 1995 URL: http://www.nypost.com/news/regionalnews/76479.htm

12. Ban Draws Fire at Eateries New York Daily News April 11, 1995 By MARK MOONEY and CORKY SIEMASZKO Daily News Staff Writers

13. Our Troops Fight For Freedom While Our Pols Restrict It Source: New York Post Date: 2003-03-31 Author: STEVE DUNLEAVY URL: http://www.nypost.com/commentary/72314.htm

14. Resentment Smolders As Smoking Ban Takes Hold Source: Irish Echo Date: 2003-04-04 Author: Stephen McKinley URL: http://www.irishecho.com/newspaper/story.cfm?id=130 48

15. "Tobacco Industry Political Influence and Tobacco Policy Making in New York 1983-1999" Source: Center for Tobacco Control Research and Education. Tobacco Control Policy Making: United States. Date: February 1, 2000. URL: http://repositories.cdlib.org/ctcre/tcpmus/NY2000

16. Philip Morris Website Date: Downloaded May 24, 2003 URL: http://www.altria.com/investors/annual_report/board/bo ard01.asp?flash=true

17. New York Post Editorials Date: Downloaded June 9, 2003 URL: http://www.tobacco.org/articles.php?media_id=1003&p attern=editorial

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Excerpt from:

Where there's smoke Consumer Reports May 1994

SELF-SERVING SURVEYS

THE 30 PERCENT MYTH

When pro-tobacco forces in California want to scare communities away from public-smoking bans, they sometimes use seemingly objective surveys that show restaurants losing an average of 30 percent of their revenue after bans go into effect. The figure and the surveys that produced it are far less scientific than they have been made to appear.

Restaurants in Beverly Hills, for example, are said to have lost 30 percent of their business during a smoking ban that became effective in 1987. The number has been quoted in The Los Angeles Times and Time magazine. It comes from a survey by the Beverly Hills Restaurant Association, a group organized by a public-affairs consultant named Rudy Cole. The survey asked restaurants how much business they thought they lost during the ban; it didn't attempt to quantify those losses using any sort of objective measure. "That was not a scientific survey," Cole admits.

A more rigorous study, this one of taxable sales at Beverly Hills restaurants, was later conducted by the accounting firm Laventhol & Horwath. It showed a more modest average drop: 6.7 percent.

The 30 percent figure surfaced again in the city of Bellflower, a Los Angeles suburb that banned restaurant smoking from March 1991 to June 1992. Shortly after the rule took effect, restaurateurs received survey questionnaires sponsored by Restaurants for a Sensible Voluntary Policy. That group was supported by the Tobacco Institute and had Rudy Cole as its executive vice president. The survey itself was prepared by an employee of the Dolphin Group, a public-relations agency that serves Philip Morris USA.

The Bellflower survey--again based on anecdotal responses-also reported that restaurants lost an average of about 30 percent of their customers. But a study of sales receipts commissioned by the city of Bellflower showed that restaurant revenues actually rose by 2.4 percent during the smoking ban. Stanton Glantz and Lisa Smith, researchers at the University of California, San Francisco, studied sales data in 13 communities that had banned restaurant smoking-.-including Bellflower and Beverly Hills. They found no significant longterm drop anywhere.

Pro-tobacoo forces circulated the Bellflower survey in California towns considering antismoking rules. One version said the survey was sponsored by the California Business and Restaurant Alliance. It didn't mention that the alliance is run by an executive of the Dolphin Group, Philip Morris' PR firm. The statistic gained even wider currency when the Tobacco Institute cited the Beverly Hills survey in ads run in restaurant-industry publications, urging restaurateurs to fight smoking bans.

A star is born

An informal survey of restaurateurs in Bellflower, Calif., (top) became a formal report showing the alleged economic impact of a smoking ban. Both were sponsored by groups connected to the tobacco industry. One version of the report (middle) suggested-incorrectly-that it was commissioned by the city's mayor, Survey statistics were reported as news in Bellflower (bottom) and other California towns considering smoking bans.