The title of Pivot Health Technologies' (PHT) August 21, 2023 press release announces that “Pivot’s smoking cessation quit rate reaches 44% in randomized controlled trial, with significantly higher biovalidated quit rates than control program at one year.”

For more than two decades I’ve documented quitting product and program marketing claims ranging from wishful thinking to outright deception. The burning question is always the same. When does a claim cross ethical and honesty lines? When does it become unfair and deceptive?

If PHT’s press release title leaves you thinking that 44% of smokers using its Pivot stop smoking program quit for an entire year, it didn’t happen. But the body of PHT’s press release is two letters away from doubling down on that claim.

“The study compared Pivot Breathe to QuitGuide, the gold standard, digital smoking cessation solution from the National Cancer Institute (NCI),” readers are told.

“Pivot participants reached a 44% quit rate at 1 year, and demonstrated statistically superior biovalidated quit rates and continuous abstinence rates over the NCI control solution” (emphasis added).

Can you see the wiggle room in both the press release title and quoted article text? In part, it’s associated with PHT’s unmentioned definition of the word “at.”

Originally, a 2017 hi-tech stages of change smartphone app, Pivot Breathe was uniquely poised to take direct aim at helping awaken the more than two-thirds of entrenched zombie-like smokers, motivating them to seriously consider breaking free.

The most glaring difference between the NCI’s QuitGuide app and PHT’s Pivot app is Pivot’s smoking mindfulness tool, a cutting-edge exhaled carbon monoxide breath sensor that’s wider but about the length of an e-cigarette.

Circulatory disease’s silent killer, a cloud of toxic carbon monoxide (CO) is inhaled and enters the bloodstream with every puff. Robbing the body of the ability to build cardiovascular endurance, CO’s affinity for attaching to hemoglobin in blood cells (COHb) is 250 times greater than for oxygen.

Handing smokers smoking mindfulness akin to weight control mindfulness generated by using bathroom scales, the Pivot breath sensor provides instant feedback as to the body’s CO level.

The Pivot Breath sensor displays CO measurements in parts per million (ppm). Also color-coded, a green range reading is consistent with not smoking (CO 0-6 ppm), orange suggests possible smoking (7-9 ppm) and red indicates smoking (≥10 ppm).

The average elimination half-life of CO in smokers is roughly 4-5 hours. Pivot breath sensor users quickly discover that the less they smoke, the lower their CO level. As found by a 2021 study, while the first cigarette of the day can elevate their CO level to 15 ppm, within 120 minutes of not smoking, their CO meter reading can be at or near 10 ppm.

Using Bluetooth, the breath sensor is paired with the Pivot mobile phone app, which allows for the recording of CO readings.

The app also provides a year of non-pushy yet proactive live text coaching, additional motivational exercises, quitting tips, a link to an online Pivot support group, and the ordering of nicotine replacement products (NRT). What more could a smoker possibly need?

The problem? While quality cessation motivation enhancement resources are desperately needed, unless, as here, smokers are given the entire 1-year program for free, plus 3 months of free NRT, plus promising to pay them up to $465, how do you motivate the entrenched smoker to spend $129.99 to accomplish something that they don’t yet want?

Enter PHT’s newest study which limits participation to smokers with “Plans to quit smoking in the next 30 days.” It’s a PHT dream to corporate survival “stage of change” megaphoned by its “44% quit rate at 1 year” claim.

How did PHT define long-term successful quitting when registering this study (NCT04955639) with ClinicalTrials.gov in June 2021? There, the only declared and defined 6-month or longer outcome measure mentioned was “Biochemically confirmed continuous abstinence [Time Frame: 6 months, one year].”

Providing two bites of the study press release apple (11/01/22 and 08/21/23), PHT decided to publish short and longer-term study findings separately.

Findings up to 6 months were published on November 24, 2022. There, “biovalidated continuous abstinence at 26 weeks was Pivot, 21% (20/94) versus QuitGuide, 10% (9/94).” What about the 1-year rate?

PHT's August press release includes a link to the new study’s “abstract.” But the abstract doesn’t mention a rate anywhere near 44 percent. Instead, it places Pivot’s 52-week “biochemically confirmed continuous abstinence” at “19% (18/94) versus QuitGuide 9% (8/94).”

So, what’s up? Where does the 44% claim come from?

7-Day PPA “Responder” Rate: 44%

The abstract invites readers to download a free preprint PDF copy of the study. There, study Table 3 shares a smorgasbord of 12 different ways that PHT calculated 1-year rates.

Which one did PHT choose for its press release? You guessed it, the highest.

Intention to treat (ITT) analysis counts all study participants who fail to return for study follow-up as having relapsed to smoking. While 94 participants were randomized to the Pivot arm, 5 didn’t return to take the final 1-year survey.

PHT’s featured 44% rate ignores the 5 who didn’t show. It’s called a responder rate and, for obvious reasons, responder rates generally overestimate successful quitting.

Here, vastly more significant, the 44% rate reflected 7-day point prevalence abstinence (7-day PPA). It means that “at” 52 weeks 39 of 89 Pivot program survey takers claimed that they had not smoked any cigarettes during the past week.

That’s right, not “a year" but 1 week “at” 1 year. And given the record number of quit smoking attempts claimed to have been made during the study, it matters.

The 94 Pivot arm quitters averaged a whopping 7 quitting attempts during the year-long study. On average, 3 of those attempts (2.8) were made between weeks 26 and 52. Averaging 9.5, the number of quit attempts claimed by the 94 QuitGuide app users was even higher.

That raises a host of unanswered questions. What motivated the study's unprecedented number of attempts? Pivot's breath sensor, Pivot's text coaching, or the promise to both Pivot and QuitGuide participants of receiving ongoing payments for participation and validating cessation?

And what quitting method was used during each successful quitter’s final attempt?

Should full credit be awarded to the Pivot app if the participant quit by switching to e-cigarettes, or at least to using e-cigarettes as an aid in blowing <10 ppm on the study's three CO breath tests?

Baseline participant data is documented in study Table 1. It tells us that 35% of Pivot arm members had experience in making e-cig quitting attempts. It also indicates that 10 of 94 Pivot arm members (10.6%) were both smoking and vaping when the study commenced, twice the QuitGuide rate (5.3%).

How much of Pivot's efficacy belongs to taking Chantix or varenicline (which 24.5% had previously tried), Zyban or bupropion (previously used by 27.7%), going cold turkey (which 71% had experienced), or possibly becoming a persistent long term NRT user (which a 2003 study found occurred in 6.7% of nicotine gum users)?

If PHT collected alternative quitting method data, it wasn’t shared.

30-Day PPA ITT: 36%

Looking at 30-day PPA as shared in Table 3, PHT knew when making its 44% claim that 5 of the 39 who claimed 7-day PPA at 1 year had admitted to smoking within the past 30 days. That left 34 (36%) who claimed to have not smoked for at least 30 days.

Biovalidated Abstinence: 31%

According to Table 3, “biovalidated abstinence” diminished 1-year success claims by an additional 5 Pivot quitters. How was that defined?

Participants who claimed 7-day PPA on their 52-week survey (and previously on 12 and 26-week surveys) were invited to a smartphone biovalidation video session to be conducted within a week, for which they would be paid an additional $50 if “completed.”

There, participants were monitored as they blew into their CO breath sensor and then displayed the meter’s results.

While 39 Pivot participants had claimed 7-day PPA at 1 year, 8 failed to show for video validation and 2 others admitted to smoking before taking the breath test.

As a result of video breath testing, 29 of the original 94 Pivot participants (31%) produced CO readings of <10 ppm.

But if motivated by money to complete “biovalidation,” how hard would it have been to cheat? More about that in a moment.

Self-Reported Continuous Abstinence: 20%

The next Table 3 quitting definition category presented is “self-reported continuous abstinence. Here the keyword is "continuous."

According to the study, “Self-reported continuous abstinence was defined as self-report of 7-day (or greater) PPA at 12 weeks, self-report of 30-day PPA at 26 weeks and 52 weeks, no more than 5 cigarettes between 12 weeks and 26 weeks, and 0 cigarettes between 26 weeks and 52 weeks.”

Did you catch that? PHT’s definition of “continuous” isn’t continuously not smoking from your original quitting day until the date that abstinence is assessed.

PHT’s Swiss cheese definition of "continuous" appears to not only have allowed smoking of up to 5 cigarettes between 3 and 6 months, but unlimited smoking for the first 11 weeks.

While the PHT press release celebrates a “44% quit rate at 1 year,” just 20% of Pivot group members (19 of 94) fit the definition of “self-reported continuous abstinence.”

Biovalidated Continuous Abstinence: 19%

Again, the only long-term quitting standard mentioned when PHT registered its study with the U.S. government was “Biochemically confirmed continuous abstinence.”

There, it was defined as a “Self-report of smoking no more than five cigarettes from 12 weeks after enrollment, and biochemical confirmation of abstinence on all previous and present biovalidation tests.”

“Biochemical confirmation” was defined as “Participants who report they have achieved at least 7-day point prevalence abstinence at 3 months, 6 months and/or one year will undergo a videoconference visit with study staff in which they provide a witnessed breath sample using a provided personal mobile carbon monoxide breath sensor. Breath sample values less than 10 ppm (parts per million) will be considered consistent with biochemical abstinence.”

As shown in Table 3, as defined, 18 of 94 Pivot users (19.2%) achieved “biovalidated continuous abstinence."

An ironic aside, that’s 44% of the success suggested by PHT’s “44% quit rate at 1 year” claim.

Pivot vs. QuitGuide

The most important unanswered question is, under real-world hands-off observational use conditions, will PHT’s Pivot Breathe app be at least twice as effective as the NCI’s QuitGuide app?

Although both the short and long-term studies are well-written and packed with details, 5 of 6 of the study’s authors are salaried PHT employees (who also receive stock options) and include the company's President and CEO. The remaining author is a paid statistical consultant.

While study integrity is rarely pivotal in deciding to elevate a $129.99 private quitting program over a free government one, PHT’s 44% press release claim, the study’s moving goalposts, and butchery of the word “continuous,” do not instill confidence.

How will trading financial incentives for out-of-pocket costs change things?

In addition to receiving up to $465 in study participation payments, both Pivot and QuitGuide app users received up to 3 months of free nicotine patches, gum, or lozenges. Alternatively, and likely twice as expensive, they could order nicotine patches plus either nicotine gum or lozenges, what's referred to as combination therapy.

Given the high level of NRT use within both arms (used by 99% of Pivot participants and 82% using QuitGuide), with most orders requesting combo-therapy, and the high number of app openings within the first 3 months (Pivot 158 vs. QuitGuide 87), the long-term validated continuous abstinence rates for both arms are hugely disappointing.

Demanding more time, patience, and dedication than abrupt nicotine cessation, gradual stepped-down nicotine weaning isn't easy. I've long believed that the greater the incentive to use NRT and the greater the user's level of ongoing counseling and support, the more likely their chances of success. Now, I'm a bit less sure.

Challenging our biases, what would be fascinating would be to create and pit a zero lapse tolerant smart turkey version of Pivot against PHT's and the NCI's slip forgiving NRT rooted apps.

CO Reduction Experts

With two notable distinctions, QuitGuide users were also sent Pivot breath sensors to video validate the CO levels of participants claiming 7-day PPA at 12, 26, and 52 weeks.

While Pivot group members were mailed their breath sensor shortly after randomization and were encouraged to use it “4 times per day,” the Pivot breath sensors sent to QuitGuide users were mailed shortly before the first “biovalidation” at week 12 and were somehow limited to generating a maximum of 10 breath samples.

According to the short-term study, “After their first biovalidation visit, participants in the control arm [QuitGuide] were instructed to not use the breath sensor beyond the visit and to place the sensor in a safe place to access for use at a future biovalidation visit should there be one. For subsequent biovalidation visits, participants used their existing breath sensor or were mailed a new one as needed.”

Regarding Pivot’s 19.2% vs. 8.5% “biovalidated continuous abstinence" efficacy victory over QuitGuide, it raises the question, was superiority earned or learned?

Could having become experts at reducing CO readings have combined with a vape or two, a leftover patch, or a few pieces of nicotine gum, instilling confidence in some Pivot arm participants that they could easily produce a <10 ppm CO reading?

Could it have motivated some to falsely claim 7-day PPA, earning them a video validation invitation and a shot at an extra $150 ($50 per validation)?

I don’t know. What I do know is that, to their credit, the authors recognized this concern.

According to the study, “the half-life of CO is, on average, 4 hours and is influenced by activity level (i.e., shorter half-life when exercising and longer when sleeping). Accordingly, smokers may be able to abstain from smoking for several hours before providing a breath sample and obtain a CO value consistent with ‘not smoking.’”

What I do know is that here, where I live, Food Lion and Publix grocery stores are across the street from Aldi. While the Food Lion and Publix parking lots are often filled with stray shopping carts, there's rarely a stray at Aldi. Why? Because Aldi customers receive .25 cents for returning their cart to the store.

While PHT's Pivot efficacy findings need both independent validation and observational effectiveness confirmation, what motivation is there to do so when the word “at” is likely already making you millions?

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John R. Polito received his JD from the University of South Carolina School of Law in 1985, where he graduated Wig & Robe. He is a former 3-pack-a-day thirty-year smoker and the 1999 founder of WhyQuit. A nicotine cessation educator since 2000, John mentored under Joel Spitzer for two decades, presenting more than 100 live nicotine dependency recovery programs modeled after Joel's programs. He is the author of "Freedom from Nicotine - The Journey Home," "Smart Turkey," 6 peer-reviewed journal articles, and founder and director of Turkeyville, a 17,000-member Facebook support group exclusively for cold turkey quitters. Email: johnpolito54@gmail.com

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