Fatima Chaudhry
Why this drug was developed
• According to the Centers for Disease Control and Prevention
(CDC), an estimated 45 million adults in the United States smoke
cigarettes, and more than 8 million of them have at least one
serious illness caused by smoking.
• It is estimated that there are 1.3 billion smokers in the world
•Smoking has very serious health risks, such as heart disease
and lung disease.
•Quitting smoking is very difficult approximately 60% of people
who try to quit smoking relapse within the first year.
•FDA approved methods to help people quit smoking include
nicotine patches and nicotine gum
• these methods have only minimally help people to quit
smoking
What is Chantix?
Claims:
• Chantix is a non-nicotine prescription medicine
specifically developed to help adults quit smoking.
• It works in 2 ways,
• it targets nicotine receptors in the brain, attaches to
them and blocks nicotine from reaching them.
• Chantix also activates these receptors, causing a
reduced release of dopamine compared to nicotine
• The dopamine relieve give the pleasurable effects of
nicotine therefore decreasing withdrawal symptoms
•People on Chantix lose the sense of stratification of
smoking due to the drug
Market Claims:
Pfizer has adopted a softer sell that it hopes will build
Chantix steadily over time. Meanwhile, because
insurers are slow to cover smoking treatments, it has
priced Chantix so that consumers will be willing to pay
for it themselves.
What research supports these claim
Chantix was used in 6 clinical trials in which a total of 3659 chronic
cigarette smokers (more than 10 a day) were treated with Chantix.
In all the studies abstinence from smoking was verified by
measurement of exhaled carbon monoxide at weekly visits.
Among the patients the completion rate was 65%
Published on:
• Pfizer, rxlist.com, and the journal of the American medical
association
Participants in Research:
• Most patients enrolled in these trials were white 79-96%
• Almost equal numbers of male and females.
• The average age was 43 and patients on average had smoked
about 21 cigarettes per day for an average of 25 years.
• 3659 in 6 clinical trials involved in the research
Scientific Method:
• Double-blind, placebo-controlled study conducted between October
2003 and March 2005.
• FDA reviewed a randomized clinical trial of 700 smokers with
cardiovascular disease who were treated with Chantix or placebo. In
this trial, Chantix was effective in helping patients quit smoking and
remain abstinent from smoking for as long as one year. Cardiovascular
adverse events were infrequent overall, however, certain events,
including heart attack, were reported more frequently in patients treated
with Chantix than in patients treated with placebo.
Were the people selling the product involved in the research?
Yes, former smoker Jotham Coe, PhD, (Research Fellow
at Pfizer Global Research and Development) was inspired
to lead a team to develop Chantix and was involved
in the research.
Would I try this product?
Although studies have shown that was a 37.3% quit rate with
1mg once daily, 40% quit rate with 1mg twice daily. I would still
not use this drug because Chantix has many serious side effect.
•nausea
•constipation
•vomiting
•heartburn
•increased or decreased appetite
•trouble falling asleep or staying asleep
•unusual dreams or nightmares
•difficulty in moving your arms or legs
•shortness of breath
•sweating
•nausea, vomiting, or lightheadedness
•slow or difficult speech …e.t.c
In clinical studies, people who took Chantix were more likely to
have a heart attack, a stroke, or other serious problems with their
heart or blood vessels than people who did not receive this
medication.
Pertinent information
• After being approved by the FDA in 2006, Chantix was
given a black-box warning by the FDA in 2009 for the
serious adverse effects caused by the drug
• FDA updated review safety in 2011
• The Federal Aviation Administration and Defense
Department banned Chantix use among pilots and air
traffic controllers. The military also banned Chantix for
missile crews.
• Anti-smoking drug Chantix linked to more than 500
suicides
Danger in Using Chantix
• Some people have changes in behavior, hostility,
agitation, depressed mood, suicidal thoughts or
actions while using Chantix
• Some people had these symptoms when they began
taking Chantix, and others developed them after
several weeks of treatment or after stopping Chantix.
Brain on Chantix
via Nymag.com
Is it a good product?
• In June 2011, Chantix was recalled by the FDA
• In the last five years, 544 suicides and 1,869
attempted suicides have been reported to the FDA as
“adverse events” in connection with Chantix,
according to documents obtained by America Tonight
under the Freedom of Information Act.
• According to AlJazeera.America news, Pfizer has
recently spent close to $300 million to settle 2,700
Chantix lawsuits, and the judge in the case says the
black box warning is sufficient, meaning future
litigation is unlikely.
Saturday Night Live- Chantix
http://katabatic.tv/work/snl-chantix/#.Uy5TWYXNkzQ