Nicotine delivery system and smartphone app. Image: Chrono Therapeutics
This news release provides an overview of a smoking cessation product developed by Chrono Therapeutics, and discusses its reported benefits in reducing nicotine cravings. The news release cites a clinical trial that involved 24 men, smoking at baseline at least 11 cigarettes daily, who were randomly assigned to have nicotine delivered over a 30-hour time period through a wearable transdermal drug delivery device. Along with delivering nicotine, the device is synced with a smartphone app that provides “behavioral support.” Compared to the control group who received placebo, the device had a statistically significant effect on reducing nicotine cravings, according to the release. Although we appreciate the details regarding the clinical trial, we note that the trial compares the new device to placebo, so does not inform us about the effectiveness compared to other smoking cessation methods. We are also concerned about the transparency of the study data. When we requested the study abstract upon which the release is based, and which was presented at a national medical meeting, we found that the study pertains to a trial group of 12, not 24 as mentioned in the release. The study abstract also references another trial that was to be completed in October 2015, so we’re left confused about which study was presented at the Society for Research on Nicotine & Tobacco annual meeting.
We are also dismayed at the unjustified claims about solving the world’s smoking problem, a bit grandiose for a trial lasting 30 hours that does not measure smoking outcomes. Smoking is a health risk spanning years or decades, and people trying to quit experience high relapse rates.
[Editor’s note: After this review was published the news release issuer provided additional background on the research presented at the medical conference. According to the company’s representative, “Chrono ended up completing that second study in Sept 2015 and this is the study that generated the p-values for the cravings reduction. Therefore, the company presented more data at SRNT, and wrote the press release inclusive of this, beyond what had originally made it into the abstract. Knowing this, and with the presentation attached, I hope this allows for a fairer evaluation of the release, with the fuller data set clarified.” Although this background clears up the discrepancy between the number of volunteers cited in the news release and the study, it doesn’t affect the overall review rating since we apply our review criteria to the release and not the study.]
According to the Centers for Disease Control and Prevention, an estimated 40 million American adults currently smoke, and smoking is the leading cause of preventable disease and death across the nation. Although no one can argue the importance of reducing smoking rates, public health efforts have helped reduce the rate of smoking by almost 5% since 2005. The CDC also estimates that 7 out of 10 smokers want to quit and that the average smoker makes 8-10 attempts. A new option to help people reach their quitting goal is welcome — if it works and is cost-effective.
The news release fails to mention costs, and for a condition such as smoking, which disproportionately affects lower income populations, cost is crucial. The news release is quick to discard the value in nicotine patches and gum, which are available for under $50 at most drugstores. A “transdermal drug delivery device” would be much more expensive than the traditional methods. It wasn’t easy to find a cost for the kit but in 2014 it was reported that the system would cost an individual between $400 and $500 for a 10-week course of therapy.
The news release states that “test subjects had a statistically significant and clinically meaningful reduction in cravings for all assessment methods (p=0.035; p=0.034 and p=0.016, respectively).” Although we appreciate the mention of the p-values, it would have been more helpful to understand what a reduction in nicotine cravings meant in real terms, and if it could be sustained since the trial was only over 30 hours. In addition, it should be made clear that craving reduction is not synonymous with smoking cessation. The news release also uses a quote from a member of Chrono’s Board of Directors who says that this product has “the potential to solve such a serious problem.” There doesn’t seem to be enough evidence to say that this device would “solve” smoking in the United States.
The news release mentions that the subjects in the clinical trial did not have any adverse reactions to the device, and that a skin irritation assessment concluded there was no irritation or erythema. However, the study abstract provided by the news release issuer reported that 25% percent of the volunteers experienced itching.
The news release fails to note the limitation of a trial that only includes up to 24 individuals (12 if going by the abstract presented at a medical conference named in the release) using the device over a short time period of 30 hours. Subjects may have failed to feel any withdrawal symptoms in only 30 hours, and smokers often require several attempts to quit. The news release doesn’t mention whether either group had access to other sources of nicotine.
The news release accurately characterizes smoking as a serious global health problem.
Although the news release is fairly clear that Chronos Therapeutics is the main funder of the clinical trial, it fails to mention that the company had received a study grant from the National Institutes of Health. That’s noted on the study abstract. Further, the release quotes only company executives — the CEO and a member of the board of directors. While we don’t expect a news release to consult an independent source as we would a news story, we’d like to point out that typically, a scientist involved with the research lends more credibility when reporting results.
We’ll give the benefit of the doubt here. The news release does indeed compare this new device to nicotine patches, gum and prescription drugs, but it does so inaccurately. The issue being discussed here is craving control and this trial is moot regarding the control of smoking.
There is no mention of the availability of this device, such as next steps in testing or application for FDA approval. The news release also does not discuss whether this device would require a prescription.
This device provides nicotine in a novel way by administering it according to Chrono’s “peaks and troughs” profile and combining nicotine delivery with smartphone app monitoring. The release establishes this but doesn’t overstate things.
The news release makes numerous unjustifiable claims about the product. Here is a sampling:
“Our goal is to solve this crisis of public health with an innovative, integrated smoking cessation solution, and the data we presented demonstrates that we are on the right path.” It’s unrealistic to claim that this particular nicotine replacement therapy — added to the many available — will solve smoking addiction.
“Chrono’s first application is in smoking cessation, enabling smokers to overcome the world’s deadliest addiction.” There’s no data presented about actual quit rates in this study.
“Achieving statistical significance in a 24-subject trial is very striking and happens infrequently in biopharma; so these results are very encouraging.” A 24 subject trial doesn’t prove anything.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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