Money talks and Chantix (varenicline) walks - the role of financial incentives in inducing healthful behavior

I usually try to keep the posts current, but I missed a WONDERFUL article a few weeks ago in the NEJM, one that is pivotal in its own right, but especially in the context of good decision making about therapeutic choices and opportunity costs.

The article, by Volpp et all entitled: A Randomized, Controlled Trial of Financial Incentives for Smoking Cessation can be found here: http://content.nejm.org/cgi/content/abstract/360/7/699
In summary, smokers at a large US company, where a smoking cessation program existed before the research began were randomized to receive additional information about the program, versus the same information plus a financial incentive of up to $750 for successfully stopping smoking. At 9-12 months, smoking cessation was 10% higher in the financial incentive group (14.7% vs. 5.0%, P<0.001).

In the 2006 JAMA article on varenicline (Chantix) by Gonzales et al (http://jama.ama-assn.org/cgi/reprint/296/1/47.pdf ), the cessation rates at weeks 9-52 were 8.4% for placebo and 21.9% for varenicline, an absolute gain of 13.5%. (Similar results were reported in the study by Jorenby et al: http://jama.ama-assn.org/cgi/content/abstract/296/1/56?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=varenicline&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT ) Now, given that this branded pharmaceutical sells for ~$120 for a 30 day supply, and that, based on the article by Tonstad (http://jama.ama-assn.org/cgi/reprint/296/1/64.pdf ), many patients are continued on varenicline for 24 weeks or more, the cost of a course of treatment with the drug is approximately $720, just about the same as the financial incentives used in the index article.

And all of this begs the question: Is it better to pay $750 for 6 months of treatment with a drug that has [potentially serious] side effects to achieve ~13% reduction in smoking, or to pay patients to quit smoking to achieve a 10% reduction in smoking without harmful side effects and in fact with POSITIVE side effects (money to spend on pleasurable alternatives to smoking or other necessities)?

The choice is clear to me, and, having failed Chantix, I now consider whether I should offer my brother payment to quit smoking. (I expect to receive a call as soon as he reads this, especially since I haven't mentioned the cotinine tests yet.)

And all of this begs the more important question of why we seek drugs to solve behavioral problems, when good old fashioned greenbacks will do the trick just fine. Why bother with Meridia and Rimonabant and all the other weight loss drugs when we might be able to pay people to lose weight? (See: http://jama.ama-assn.org/cgi/content/abstract/300/22/2631 .) Perhaps one part of Obama's stimulus bill can allocate funds to additional such an experiments, or better yet, to such a social program.

One answer to this question is that the financial incentive to study financial incentives is not as great as the financial incentive to find another profitable pill to treat social ills. (There is after all a "pipeline deficiency" in a number of Big Pharma companies that has led to several mergers and proposed mergers, such as the announcement today of a possible merger of MRK and SGP, two of my personal favorites.) Yet this study sets the stage for more such research. If we are going to pay one way or another, I for one would rather that we be paying people to volitionally change their behavior, rather than paying via third party to reinforce the notion that there is "a pill for everything". As Ben Franklin said, "S/He is the best physician who knows the worthlessness of the most medicines."

Have the Peddlers of Antidepressants (Big Pharma) been Successful in Suppressing Negative Trial Results?

Yes, according to this article in yesterday's NEJM:
http://content.nejm.org/cgi/content/short/358/3/252

Talk about publication bias. According to Erick H. Turner, M.D. and coauthors, the selective publication of only "positive" trials, in addition to publishing in a positive light studies that the FDA considered "negative" leads to a 32% increase in the apparent efficacy of antidepressant drugs, on average (range 11-69%). Once again, profit trumps science, safety, and patient and public health.

What can we do about it? First, reduce by one third the effect size of any antidepressant results you see in an industry-sponsored clinical trial. Next, carefully consider whether whatever [probably modest] effect remains is worth the side effects (e.g., increase in suicide), cost, and nuisance of the drug. Third, prescribe generic agents. Fourth, don't allow pharmaceutical reps to speak with you about new products. Fifth, consider alternative treatments.

I am reminded of a curious occurrence relating to a drug that I think is definately worth the cost, side effects, and nuisance associated with it: Chantix (varenicline) - Pfizer's smoking cessation drug. In JAMA in July 2006,
(http://jama.ama-assn.org/content/vol296/issue1/index.dtl)
two nearly identical articles described two nearly identical studies, which shared many of the same authors. What was the intent of this? Why not conduct one larger study? Was the intent to diversify the risk of failure and allow for selective publication of positive results? I'm very interested in any information anyone can provide about this curious arrangement, which appears to be without precedent. Please leave your comments below.