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 FDAble.com 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 | ||||
|---|---|---|---|---|
| Outcome | Gum/Lozenges | Patches | Nasal Spray | E-Cigarettes |
| Congenital Anomaly | 0 | 5 | 1 | 0 |
| Disability | 4 | 7 | 13 | 1 |
| Hospitalization | 17 | 101 | 78 | 7 |
| Life Threatening | 3 | 7 | 3 | 6 |
| Death | 6 | 18 | 8 | 0 |
*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.
