Wednesday, May 13, 2015

Scaremongering Tactics Against Smoke-Free Tobacco Could Also Undermine Nicotine Medicines

Tobacco prohibitionists routinely cherry-pick data to put tobacco products in the worst possible light.  For example, crusaders have used calls to poison control centers to paint smokeless tobacco (here) and, more recently, e-cigarettes (here) as toxic time-bombs.  To underscore how deceptively simple and grossly misleading such scaremongering can be, I offer this demonstration of selective data analysis applied to nicotine medicines.

Opponents of safer smoke-free tobacco promote nicotine medicines as quit-smoking aids that are “safe and effective.”  In previous posts I have shown that nicotine medicines are not effective; their success rates are pitifully low (here and here). The question remains: Are nicotine medicines safe?

Data from the FDA Adverse Event Reporting System provides the starting point for a scaremonger case against nicotine medicines’ safety.  The FAERS is a collection of volunteered reports from consumers and health professionals, plus mandatory reports from manufacturers.  The dataset is difficult to use and interpret, so I worked with Joe Fuisz and Tom O'Connell of Vapor Tobacco Manufacturing LLC and Paul Danese of to prepare this analysis.

We looked at adverse events linked to nicotine medicines from 2007 to 2014, a period consistent with the availability of e-cigarettes.  Adverse events for e-cigarettes were also recorded by the FDA during this timeframe, however, those numbers may be underestimated, as e-cigs are not considered medicines by most consumers and health professionals.

During this period, there were 690 adverse events related to nicotine gum/lozenges, 2,006 related to patches, 1,123 for the spray and 28 for e-cigarettes.   

Table 1 illustrates the top 5 adverse events for each product.  It is not possible to make direct comparisons or to calculate rates, as these are individual reports, but it is noteworthy that “ineffective” was a top 5 adverse event for both gum/lozenges and patches.  The spray is commonly known to produce throat symptoms and cough, and nausea is also a frequent complaint for smokers who switch to smoke-free tobacco products.

Table 1. Top Five Adverse Events (Number) for Nicotine Medicines and E-Cigarettes, 2007-2014
Gum/Lozenges (690)Patches (2,006)Nasal Spray (1,123)E-Cigarettes (28)
Intentional drug misuse (243)Itching (396)Cough (96)Headache (6)
Nicotine dependence (216)Redness (395)Product quality issue (71)Nausea (5)
Administration error (86)Drug ineffective (368)Throat irritation (64)Dizziness (4)
Drug ineffective (65)Administration error (364)Nausea (63)Muscle spasms
Nausea (56)Nausea (199)Dizziness (47)Chest pain (3)

While the most common adverse events were not serious, the list of outcomes in the following table is worrisome at first glance.  There is no representation in the reporting system that the products “caused” the negative outcomes, but those aiming to trash nicotine medicines would make that linkage and issue press releases with hyperbolic safety warnings to drive their point home.  It’s that simple.

Table 2. Number of Serious Outcomes* for Adverse Events Related to Nicotine Medicines and E-Cigarettes, 2007-2014
OutcomeGum/LozengesPatchesNasal SprayE-Cigarettes
Congenital Anomaly0510
Life Threatening3736

*Numbers are not mutually exclusive

Scaremongering is a despicable, yet all too common practice that undercuts legitimate scientific discourse, distorts public health policymaking and ultimately costs smokers’ lives.  Recreational use of nicotine in smoke-free delivery systems, like recreational use of caffeine, is relatively safe for consumers.  


Anonymous said...

I note the high incidence of adverse events for patches -- presumably because the user cannot titrate nicotine effectively with the patch..... By contrast, the vapor user simply stops puffing when she's had enough.

Michael J. McFadden said...

It would be good to see the background on the numbers in terms of use frequency vs. events, but, even absent that data the numbers are pretty impressive.

Imagine if e-cigs had been a Big Pharma product being pushed for the last ten years, and "Nicotine Patches" were a fairly new and popular product coming mainly from China and cottage industry.

And then look at the figures for the two products in Table 2 -- and try to picture the reaction of the government and media to these "NicoPatchyProductPushers" : They'd be lucky to see the light of day before the turn of the next millenium!

But which group is being vilified?



Unknown said...

It would be interesting to see the actual causes of hospitalization for electronic cigarettes. Misuse of the bottled liquid or injury due to battery malfunction.

Anonymous said...

I'm pissed about my doctor using deceptive tactics to scare me about ST use. I go in for a visit two weeks ago. She says," oh my Dr. (Academic Doctor) you have oral cancer." I go to the oncology department and see a top MD he says," That's no oral cancer. That's a damn canker sore"! So, after my lengthy conversation I came away with the following: He doesn't like these Chinese e cigs, he tells me a ST user who uses it to stay off a 40 cigs a day habit to use Copenhagen and that American Moist Snuff while riskier than Snus is still better than smoking. So, I am none too pleased by the deceptive practices by anti tobacco bullies.

Michael J. McFadden said...

It's *possible* your own doc made a mistake, particularly if she took the step of referring you to the oncologist (I kind of doubt she'd want to look stupid in the Onco's eyes by making an obviously bogus referral.)

But I certainly wouldn't put it past an ordinary doc to look at a canker sore and use it as an excuse to say, "Well, GIVEN YOUR SMOKING/CHEW use, we need to KEEP AN EYE ON THIS EVERY DAY, to watch out for WHEN IT TURNS CANCEROUS."

I believe this sort of false pseudo-diagnosis is probably being practiced on a widespread level regarding COPD. Since the early stages of COPD are somewhat ill-defined, a doc could feel they could get away with diagnosing virtually ANY moderate/heavy smoker over 30 as "having early stages of EMPHYSEMA" -- which, in the mind of the patient, will be translated into "OMG! I'm going to be hooked up to an oxygen bottle in five years for the rest of my LIFE unless I quit right now!"

It's probably an EXTREMELY effective strategy at scaring people into quitting, and I'll bet most docs wouldn't even realize they were trampling their Hippocratic Oath ... their brains would simply move straight into the "End Justifies The Means" mode and they'd feel they were "saving the lives" of so many of their patients who were scared into quitting.

Abominable, and my guess is that it's probably true.


Michael J. McFadden said...

Re your Onco's attitude toward e-cigs: (1) he's just playing it safe -- imagine if he told you they were great and you got cancer five years from now, blamed the ecigs, and sued him for malpractice! and (2) He probably simply hasn't read a whole lot on it and is just taking the "general consensus" (i.e. the biggest noise) as being likely correct, and "better safe than sorry." (3) Give Snuss a try if you haven't: if it's not strong enough at first, use two bags. Much more convenient/nicer in mess-aspects than Cope, but gives very similar enjoyment.