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Anti-smoking drug receives FDA approval

Rating

3 Star

Anti-smoking drug receives FDA approval

Our Review Summary

This is an evening network newscast story on the recent FDA approval of the drug varenicline (trade name Chantix) for smoking cessation. Given the time constraints of this news story, the reporters do an excellent job of even-handedly presenting the new drug in the context of other therapies for smoking cessation. Varenicline may be an option for those who have not been able to quit smoking using other drug treatments, such as the anti-depressant bupropion (trade name Zyban) or nicotine replacement therapy.

Varenicline was given priority status and fast-tracked for approval due to the “significant improvement” over existing therapies for smoking cessation; however, the long-term benefit of varenicline over exiting therapies is not very significant. Approval of varenicline was largely based on two double-blind, randomized studies of 2000 smokers in which the drug was compared with bupropion (trade name Zyban) and a placebo. The studies were both funded by Pfizer, maker of varenicline.

The news story presents longer-term (1 year) abstinence rates, which are important for evaluating smoking cessation therapies. Unfortunately, there is no discussion of side effects. Nausea, headaches, insomnia and other stomach problems were more common in the varenicline group, but none of these are mentioned in the broadcast.

The cost of a 12-week course of varenicline is provided in context with a message that smoking is a strong addiction and that reliance on a pill alone may not be enough. There is a behavioral component to smoking cessation that is recognized even by Pfizer, which, in the press release announcing approval of varenicline for smoking cessation, also announces plans to offer varenicline users an interactive on-line support program.

(Publisher’s Note: Although this review points out some flaws, this NBC story is to be applauded for what it achieved in the usual limited time afforded TV news stories. That same night, the ABC and CBS network newscasts ran stories on the same topic, but their stories each ran only about 15 seconds and contained little information.)

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story mentions 12-week cost of varenicline (which must be taken twice daily), but the story would have been better if it gave cost comparison with existing treatments.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The story is even handed and this new therapy is not embraced as a magic bullet. Numbers are framed appropriately, however there is no quantiative comparison of one-year abstinence rates with existing drug and non-drug therapies.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

There is no discussion of any side effects of the drug. Nausea, headaches insomnia and other stomach problems were the most common in the vanenicline group, but none of these are mentioned in the broadcast.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

There is brief discussion of abstinence rates, but no mention of the design of the varenicline trials. Without describing the trials as controlled, blinded, randomized, or not, it is impossible to assess the strength of the information.The numbers were from two fairly well-designed randomized, double-blind trials (N=2000 total). Abstinence was evaluated between varenicline, bupropion (Zyban) and placebo groups at 12 weeks, then continuous abstinence for another 40 weeks.

Does the story commit disease-mongering?

Satisfactory

There does not seem to be evidence of disease mongering, though there is the question of whether 32 million trying to quit would need drug treatment. Prevalence rates of addicted smokers are from the Center for Disease Control.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

Data is presented on screen as provided by Pfizer, the funder of the two varenicline trials. Dr. Riggotti, who is cited, is not affliated with the varenicline study. She is an anti-smoking advocate and the Director of the Tobacco Research and Treatment Center at Massachusetts General Hospital. If time allowed, another outside expert opinion would be appropriate.

Does the story compare the new approach with existing alternatives?

Satisfactory

Mentions other drug treatments such as nicotine replacement therapies with similar one-year abstinence rates. No mention of behavioral component of treatment or that varenicline was compared with bupropion, which has also had similar abstinence rates when compared against placebo in randomized controlled studies. There is acknowledgment in the story that the long-term smoking cessation might be accomplished by a number of available therapies, and varenicline is only one option.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The story mentions recent FDA approval of the drug to aid in smoking cessation, however, there is no discussion of when it will be available. The drug was given priority status and fast-tracked for approval due to the “significant improvement” over existing therapies for smoking cessation.

Does the story establish the true novelty of the approach?

Not Satisfactory

The story does a good job of listing this as just one more measure in the arsenal of smoking cessation aids. But there is not much discussion of how this is different from nicotine itself as varenicline is described as binding to the same receptor. The critical difference (and the reason this is truly novel) is that it is a partially active drug (that is it does not create the same intensity of effect as nicotine) and that it does not bind to all the subtypes of nicotine receptors.

Does the story appear to rely solely or largely on a news release?

Satisfactory

No evidence the story relies solely on a press release. There are sources cited not affiliated with the studies or Pfizer.

Total Score: 6 of 10 Satisfactory

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