Big Pharma and the Business of Smoking Cessation

The big pharmaceutical companies are generating multi-billion dollar revenues from the sale of drugs and other products that claim to help a smoker to quit smoking. Who can question the value of such products?  Do they deliver all that they promise? If they did not, would the big pharma companies tell us? In a word, no. By their own claim, the manufacturer of the best selling smoking cessation drug was claiming a quit smoking success rate, based on pre-marketing trials, of 45% after 12 weeks and 20% after 1 year. Even here it is apparent that there is a vey large drop-off or relapse rate, from 12 weeks to 1 year, and who knows what would be shown had they measured the success rate at 18 or 24 months. This information was obtained from a website called, “healthknot.com,” which also had some other very illuminating assertions. Healthknot.com states a meta-analysis of NRT therapies in the late 1980’s into 1990’s showed that “real world” studies of NRT success rates, compared to their random clinical trial results were very different. Whereas NRT “showed” effective quit rates of 23% to 43% after 1 year, real world observation shows a “true” quit rate of about 7%, a huge discrepancy. If we apply the same type of drop-off for the drugs Big Pharma are selling to aid smoking cessation, instead of a success rate of 20%+ at 1 year, the actual rate is likely to be far lower.

Why is this true? Again, the website, “helathknot.com” has some insight as to why this may be true. Specifically this website states, “Wide discrepancy between clinical and real-world effectiveness of smoking-cessation therapies results not only from tailoring both, selection of participants and conditions favorable to the desired outcome, but also from the inherent flaws. It is only logical that the majority of those attracted to participation in this type of studies have decided that they need a pill to help them quit smoking. This by itself results in an effective participant profile bias against those willing to try to quit on their own. Furthermore, it is no secret that most of the participants in quit-smoking studies can determine, rather quickly, whether they are receiving an effective agent, or placebo (presenting these type of studies as "blind" is both, silly and misleading). It is a simple human psychology - in addition to greater suffering from withdrawal symptoms - that makes those realizing that they are on placebo more likely to fall back on their nicotine fix.”

It is also a fact that Big Pharma is not obligated by law or regulation to publish all of the clinical trials they conduct. For example, if they conduct ten trials and only two indicate a favorable outcome for their drug, they do not need to publish, promote or make available the other eight less favorable trials. Does all of this mean that Big Pharma is deliberately being misleading? Perhaps not, but it does strongly infer that the so-called claimed success rates in tightly-controlled clinical trials, may have limited “real-world” significance and validity for everyday smokers who want to quit smoking.

Of course, Big Pharma does not market these drugs entirely on their own; they have legions of highly dedicated tobacco treatment specialists and smoking cessation clinics around the country who promote the use of these drugs, and NRT, as effective therapies to aid smokers in quitting and acting as advocates for Big Pharma's products. While these well-intentioned folk are undeniably motivated, mostly, by pure and altruistic motivations to help smokers quit and do good for society, they are also undeniably a cog in the huge marketing wheel of Big Pharma. Those promoting these drugs and NRT certainly feel that they are the best and most effective protocols available commercially to aid in smoking cessation, but, unfortunately, these interventions are also of limited value in the real world. A success rate of 7% to 10% may be truly double the placebo or non-intervention success rate, but, really, is this very impressive?

The business of Big Pharma, as it is for all capitalistic businesses, is to maximize their revenue and to generate a large profit, and the marketing of smoking cessation drugs, and NRT products are quite profitable. The smoking cessation business is worth around 1.5 billion in revenue to industry and probably generates a very high profit margin, as evidenced by the many millions Big Pharma is spending on Direct to Consumer advertising for their products. They do it because it works!

The website, “whyquit.com” cites the following, “the American Cancer Society's 2003 Cancer Facts and Figures report asserts that 91.4% of all successful long-term quitters quit entirely on their own. More recently, a 2006 Australian study found that 88% of all successful quitters quit smoking cold turkey and that cold turkey quitters were twice as likely to succeed as those using the nicotine patch, nicotine gum, nicotine inhaler or Zyban (bupropion).” Clearly, people do quit, and quit for life, using the “cold-turkey” approach, and far more have successfully quit going cold-turkey than all of the NRT and smoking cessation drug users combined, although, the absolute success rate in any given year is still very low.

If “cold-turkey” can work, and maybe have a much lower long-run relapse rate than commercially available products, how useful are the NRTs and other cessation drugs? They have a legitimate place in the toolkit of all tobacco treatment practitioners, but, they do not live up to their hype, they are not highly effective, and they receive so much attention. This attention is not because they are very effective, but, because the other alternatives available today are so very ineffective.

The time is right and the opportunity is very obvious for other alternatives to be made available to aid in the battle to combat smoking and aid those smokers who want to quit.