How to quit smoking cigarettes

Pfizer’s five initial clinical trials of varenicline were published in July and August 2006. Three are comparable in that they involved a 12-week treatment period using 1mg of Chantix twice daily. In the Chantix study headed by Gonzales, 21.9% of Chantix users were still not smoking at one year. In Oncken the rate was 22.4% and in Jorenby 23%.

That’s an average one-year rate of 22% or, on the flip side, a relapse rate of 78%. But these rates were achieved under highly artificial clinic study conditions. History and common sense teach that use under real-world conditions will likely generate a significantly higher failure rate. The question is, how high?

Pfizer funded and co-authored the five initial studies and was involved in all study elements including design and monitoring. Pfizer appears to have spared no expense in creating what may be the most intense clinic quitting experiences ever. Frankly, it is surprising that the intensity of support and interaction did not produce even higher rates. Real-world quitters, alone with their pills, or even participating in Pfizer’s GetQuit support plan, will be fighting under entirely different battlefield conditions. What was it like inside an early Chantix study?

Varenicline users received their varenicline for free in all clinical trials. They were reimbursed travel expenses associated with visiting their health provider to obtain it. They attended sixteen clinic visits involving brief one-on-one sessions with counselors trained in motivation and coping skills development. They received up to eight follow-up telephone support calls from their varenicline provider. In the earliest trials, they received two full physical exams, pondered the significance of a stream of questions in provider administered surveys, had their urine and blood checked seven times, sensed the seriousness associated with undergoing six EKGs, and watched their weight, vital signs and expired carbon monoxide breath tests recorded sixteen times?

How much of Chantix’s 22% one-year quitting rate is due to Chantix and how much attributable to the 26 times in the Jorenby study that participants spent one-on-one time with their Chantix provider? How many real-world quitters will have the support benefit of 26 sessions with their prescribing physician? Any? If so, at what financial cost? If not, at what cost in terms of performance?

April 16, 2008 - With free ongoing individual or group counseling and support, UK Stop Smoking Services may offer cessation services of higher caliber than present in Pfizer’s clinical trials. Table 6, PDF page 12 of a new study shows that at 4 weeks after starting varenicline treatment that 63% of Champix users were still not smoking as compared to 51% who, of their own accord, quit without it.

At four weeks varenicline users were still under its influence, had not yet adjusted to living without chemically enhanced dopamine levels, yet its advantage over those quitting without it was then modest. It shows what would have happened if Pfizer had pitted varenicline against those wanting to quit cold turkey instead of quitters wanting medication but instead getting assigned to the placebo group and thrown into full blown nicotine withdrawal.

While 51% of non-medication UK quitters were still smoke-free at 4 weeks, in Pfizer’s clinical trials only about 18% of placebo group quitters in the Jorenby study, 21% in the Oncken study and about 23% in the Gonzales study were smoke-free at 4 weeks. We know that varenicline’s 12 week rate will decline by roughly half between weeks 12-52. We also know that cold turkey quitters able to quit for a full month will from then on show significantly lower relapse rates than pharmacology quitters who have yet to end pharmacology use. It’s why conducting intellectually honest clinical trials is so important. It’s why, with billions in profits at stake, we should not expect to see it happen.

On some unknown date during 2007 Pfizer started offering Chantix users live telephone support. Why? We don’t know. What we do know is that since Chantix’s approval in May 2006 that Pfizer’s GetQuit Chantix support website has allowed it to collect a massive body of nearly “real-world” use data (at least for customers having Internet access), data that so far has been treated as if “top secret.” Users going to Pfizer’s GetQuit site are now offered a “Choice of regular check-in e-mails or phone support for up to a full year.” I reviewed a number of Pfizer’s early support emails and was generally in agreement with most user comments I’d received indicating that Pfizer’s email support was pretty lame. The only comments I’ve so far received regarding telephone support have been positive.

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