"Real-World"
Nicotine Patch and Gum Rates
by John R. Polito, June 30, 2002
Nicotine Cessation Counselor
A review of a study entitled " Real-world efficacy of prescription and over-the-counter
nicotine replacement therapy ," by Shiffman S, et. al., published May 2002
in Addiction, Issue 97(5) at Pages 505-516
Quitting in the real-world is a vastly different experience from involvement in
some fancy university medical study that tries to determine the six month success
rate for those quitting while using products like the nicotine patch or nicotine
gum.
Quitters in university medical studies often receive some form of behavioral counseling
(possibly group sessions), are given detailed instruction on quitting, receive
free nicotine patches or nicotine gum, undergo selective participation screening,
give detailed histories, are tested, make repeated visits to university medical
centers, receive follow-up telephone calls, possible one-on-one counseling, are
paid for participation in the study or receive expense reimbursement, and have
expectations of being tested at future appointments to see if they cheated or
relapsed.
In the "real-world", the average uneducated, uncounseled, and unsupported
abrupt nicotine cessation quitter simply picks a date, quits and receives an 11%
chance of quitting for six months. In the "real world," the gradual
nicotine withdrawal quitter either buys an over-the-counter (OTC) nicotine product
at the local store, or obtains a prescription (Rx) for a nicotine product from
their doctor and heads for the nearest pharmacy.
The latest gradual nicotine withdrawal study to hit the street is the Shiffman
(et al) " Real-world " nicotine patch and gum study that was published
in the May, 2002, edition of Addiction, at pages 505 to 516. Shiffman attempted
to make this study as close to real-world quitting conditions as possible by removing
as many study influences as practical while still being able to verify and evaluate
results. The study followed 2,367 OTC nicotine patch users and 2,981 OTC nicotine
gum users. It also telephoned 269 Rx nicotine patch users and 155 Rx nicotine
gum users six months after having had their prescription filled to see if they’d
quit.
Those participating in the OTC portions of the study bought their nicotine delivery
devices with money from their own pockets ($42 for 14 patches or $35 for 96 pieces
of gum) in either a pharmacy or from a mock store display. Those participating
in the six month portion of the prescription nicotine patch and gum studies had
no idea that they would even be participating in a study until they were called
after six months and offered $50 (U.S.) for a sample of their breath to verify
their claim of having quit.
Although the OTC patch and gum purchasers received a product users guide and an
audio tape with quitting tips, there were no other education, counseling or support
components. As you review the below findings keep in mind that all historical
data indicates that unassisted cold turkey quitters have an 11% chance of quitting
for six months (the average of all June 2000, USDHHS Guideline Meta Tables for
control groups).
In the Shiffman "Real-world" study, only 3% of those using the Rx nicotine
patch and 9.2% of those using the OTC patch were not smoking at six months. In
the nicotine gum groups, only 7.7% of the Rx gum group and 8.4% in the OTC gum
group were not smoking at six months. Sadly, the average for the four groups was
just 7%.
Prior to pharmaceutical companies labeling nicotine as medicine, calling it therapy,
and marketing it as the newest magic cure, high quality abrupt nicotine cessation
programs around the globe were achieving 30%, 40%, and in some cases even 50%,
six month cessation rates. These programs imparted knowledge and developed skills
while providing high quality counseling and support. Sadly, the credibility of
vastly superior programs has been seriously undermined, eroded and in some cases
destroyed, by slick pharmaceutical marketing campaigns that brainwashed quitters
into believing that these inferior nicotine delivery devices were twice as effective
as anything else available.
The patch rates obtained in this study are frighteningly consistent with the 24
week results produced in the 1998 Davidson OTC patch study (8.2%) and the 1999
Hays OTC patch study (7.7%). They’re consistent in each producing rates
that are substantially less than a quitter's own natural abilities.
A few interesting facts from the study. Of the 2,367 OTC patch participants:
1. The average age was 43.
2. The number of prior failed quit attempts was five.
3. Only 8% of quitters were first time quitters.
4. The average number of cigarettes smoked per day was 27.
5. The average number of years smoked was 24 years.
6. The number one reason given for wanting to quit was health.
7. Of the 2,367 OTC patch users in the study 2,150 relapsed within six months.
8. Of the 2,981 OTC gum users in the study 2,729 relapsed within six months.
9. If a nicotine patch purchaser ripped the patch off after only using it one
day and then continued on and successfully quit on their own, this study appears
to have given the nicotine patch full credit for their victory.
10. If a nicotine gum purchaser stopped chewing the gum after just one day, and
went on to successfully quit on their own, this study appears to have given the
nicotine gum full credit for their victory.
A quitter only musters the determination for one serious quitting attempt every
three years. If the above statistics from this study are reflective of all smokers
then smokers are averaging just one serious attempt every four years (this was
their sixth attempt, on average, and the average smoker had smoked nicotine for
24 years). The OTC gum and patch portions of this NRT study squandered the dreams
of 4,879 humans who were desperate to break nicotine's powerful grip upon their
life. With nicotine dependency claiming the lives of half of all long-term smokers,
one-quarter in middle age (an average of 22.5 years early), how many of the 4,879
who relapsed have run out of quitting opportunities?
It seems to me that those conducting such large scale bare-bones studies have
both legal and moral obligations to immediately follow-up and offer all involved
who relapsed a free nicotine cessation program of the highest caliber possible.
These are not rats, mice or statistics, they're human beings! Those administering
this study are fully aware that quality programs offering education, skills development,
counseling and support (both short and long term) are available and consistently
achieving 40% six months cessation rates. To do otherwise is to watch science
deprive 31% or 1,512 members of the OTC gum and patch groups of their right to
freedom. This is not some game!
I, John R. Polito, am 100% solely responsible for the content of this article
and assume full responsibility for its internet publication. It had not been reviewed
by any other person prior its internet publication on June 30, 2002, nor had any
other person had any input upon its content. The views expressed here are my own,
in my individual capacity, as a concerned nicotine cessation and control advocate.
A link to the above review was emailed to Dr. Shiffman on June 30, 2002, together
with a request that he try to help the 4,879 who relapsed in the OTC patch and
gum arms of the study.
John R. Polito
Nicotine Cessation Counselor
709 Black Oak Blvd.
Summerville, SC 29485
john@whyquit.com
06/30/2002