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Read Original Story

Scientists Testing Vaccines to Help Smokers Quit

Rating

3 Star

Scientists Testing Vaccines to Help Smokers Quit

Our Review Summary

This story announces that NicVax (Nicotine Conjugate Vaccine) has been fast-tracked for approval by the FDA. This story clearly describes the current stage in the drug-approval process: The company must conclude several trials before even applying for final FDA approval. However, the story’s enthusiasm for the vaccine at this stage of clinical trails seems to suggest FDA approval is a fait accompli.

This article contains a clear and excellent sketch of how a vaccine might stimulate production of antibodies to dampen specific drug-induced effects of nicotine on the brain, thus reducing the pleasure associated with smoking. We are told that “researchers report high rates of quitting in early studies”, yet the story provides no evidence on the efficacy or safety of the vaccine from these studies. It is not enough to say that there is excitement about the vaccine’s approach. Some data are needed to judge whether excitement is warranted.

Other drugs approved as smoking cession aids such as bupropion (Wellbutrin) and varenicline (Chantix) are mentioned, as are nicotine replacement products such as patches or gum. The story suggests that NicVax may be used in conjunction with these products, yet this has not been tested in clinical trials thus far. Behavioral therapies, of proven benefit and a component of Chantix and Wellbutrin trials, are not mentioned.

The story does not provide the cost of the vaccine, yet there is the suggestion that if it were approved, the vaccine could be a financial boon for Nabi Biopharmaceuticals. Only sources affiliated with the study and Nabi Biopharmaceuticals are cited. The National Institute of Drug Abuse (NIDA) funded early phases of the study with a $4.1 million grant so the director of NIDA pharmacotherapies has an interest in the outcome of the trials. Sources not associated with the NicVax trials are needed for perspective on this novel therapy for smoking cessation.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not provide even an estimate of the cost of the vaccine. There is the suggestion that if the vaccine were approved it could be a financial boon for Nabi Biopharmaceuticals. Consumers want to know what it may cost them.

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

Not Satisfactory

The story claims that this vaccine will help smokers quit by producing antibodies that attach to nicotine molecules and prevent them from reaching the brain, thus reducing the pleasure associated with smoking. The story notes that “researchers report high rates of quitting in early studies”, but there is no data provided to support this statement. It is not enough to say that there is excitement about the vaccine’s approach. Some data are needed to judge whether excitement is warranted. The drug company website provides some preliminary short term results from former trials, and there was a 33% 30-day abstinence rate for active vaccine versus 9% for placebo, but the duration and size of this trial were not mentioned. Would the article’s optimism be dampened by inclusion of this rate?

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

Not Satisfactory

Early studies of NicVax looked at safety, yet we are given no information on adverse events from these early trials or on the potential harms of the vaccine. The story suggests that NicVax may be used in conjunction with other smoking cessation products, yet this has not been tested in clinical trials thus far.

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

Not Satisfactory

The story provides information on the design of the upcoming trial. However, the story provides no evidence about the safety or efficacy of the vaccine from earlier trials. The article also provides a forum for promotional comments by researchers involved in trials that tested tolerability, not efficacy. Additionally, any trial would have to follow patients over years to assess late rates of relapse.

Does the story commit disease-mongering?

Satisfactory

The story provides smoking mortality rates from the Center for Disease Control. Intention to quit survey results are also mentioned, but we are not told the source of these or the 20 percent success rate.

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

Not Satisfactory

Only sources affiliated with the study and Nabi Biopharmaceuticals are cited. The National Institute of Drug Abuse (NIDA) funded early phases of the study with a $4.1 million grant so the director of NIDA pharmacotherapies has an interest in the outcome of the trials. Sources not affiliated with the NicVax trials are needed for perspective on this new therapy for smoking cessation.

Does the story compare the new approach with existing alternatives?

Satisfactory

The article does a good job covering existing drug therapies, but misses behavioral therapies (of proven benefit) entirely.

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

Satisfactory

The story clearly describes the current stage in the drug approval process: The story discusses that NicVax (Nicotine Conjugate Vaccine) has been fast-tracked for approval by the FDA, however, the story also notes that this vaccine is still in Phase 2 clinical trials (tests of safely and efficacy), and additional large-scale, randomized controlled Phase 3 trials are needed before NixVac can apply for final FDA approval.

Does the story establish the true novelty of the approach?

Satisfactory

The story discusses a vaccine to prevent relapse in people trying to quit smoking. The vaccine is designed to diminish pleasure from nicotine, and it is a new approach for treating smoking addiction, though it is still being tested. The article does a good job describing other therapies and the way this approach differs.

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

Satisfactory

It appears that the story does not rely solely on a press release for information used in the story.

Total Score: 5 of 10 Satisfactory

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