The story does not provide the cost of varenciline (which must be taken twice daily), or cost comparison with existing treatments. The story frames the data appropriately. The story avoids the use of only relative risk that the company emphasizes in its press release. The drug was given priority status and fast-tracked for approval due to the “significant improvement” over existing therapies for smoking cessation, which weren’t all that signficant. Nausea is the only harm discussed, though there is no mention of the rate or severity of nausea in the treatment and placebo groups, or if participants dropped out of the study due to this side effect. Other side effects of the medication included headaches, insomnia and stomach problems, which are also not mentioned in the story. The story only briefly mentions clinical evidence, and provides an incomplete discussion of the design of the Chantix trials. The numbers were from two fairly well-designed, randomized, double-blind trials (2000 participants), which the story fails to note. Abstinence rates were evaluated between varenicline (Chantix), bupropion (Zyban) and placebo groups at 12 weeks, then continuous abstinence for another 40 weeks. Incidence of nausea, the most common side effect, is not mentioned. There is acknowledgment in the story that the long-term success rate for smoking cessation may be due to a number of combined therapies, including non-drug behavioral treatment. The drug was given priority status and fast-tracked for approval due to the “significant improvement” over existing therapies for smoking cessation, which weren’t all that signficant. There does not seem to be evidence of disease mongering. The story uses federal agency data to describe prevalence of smoking and numbers desiring to quit. The study was funded by Pfizer, which is noted in the story. The story mentions that the inventor of the drug is an employee of Pfizer, so his testimonial on its effectiveness may be somewhat biased. The story mentions other drug treatments such as nicotine replacement therapies and bupropion. There is some discussion of non-drug methods of smoking cessation (e.g. behavioral counseling ) with regards to long-term abstinence. The story mentions recent FDA approval of varenicline for smoking cessation, however, we don’t know if it is available (presumably not as there is no price yet) or when it will become available. The story explains how this drug differs from nicotine replacement, and that it is different from bupropion. Varenicline binds to the nicotine receptor and only partially activates it so there is less stimulation than by nicotine itself. One of the downstream events from nicotine receptor binding is dopamine release in the parts of the brain wired for reward. There is no evidence that the story relied solely on a press release. The author cites, responsibly, multiple national experts who put the drug in perspective.
FDA OKs Pfizer Anti-Smoking Pill