Pharmaceutical Product Development and Liability With Chantix®: A Teaching Case

• DOI: http://doi.org/10.1111/rmir.12037
• Author: Brenda Wells
• Published date: 01 September 2015
• Date: 01 September 2015

Risk Management and Insurance Review

C

Risk Management and Insurance Review, 2015, Vol.18, No. 2, 297-314

DOI: 10.1111/rmir.12037

EDUCATIONAL INSIGHTS

PHARMACEUTICAL PRODUCT DEVELOPMENT AND LIABILITY

WITH CHANTIX R:ATEACHING CASE

Brenda Wells

ABSTRACT

In 2006, Pfizer introduced Chantix Rto the American medical marketplace.

Touted as an effective tool for smoking cessation, the drug experienced first-

year sales of just under $900 million. Withsmokers costing employers thousands

of dollars more each year than nonsmokers, and with public pressure to give

up cigarettes, many embraced Chantix Ras a miracle drug. What many did not

understand was that the drug was rushed to market before extensive testing

and clinical trials could be conducted to prove its safety for a wide variety

of users, especially those with psychiatric conditions. This case tells the story

of ChantixR: how it works, how it came to market, and the more than 2,700

lawsuits that were filed as a result of injuries claimed to be caused by the

drug. Students are given the opportunity to consider the ramifications of risk

management decisions made throughout the development and marketing of

the drug, as well as how litigation involving the medication might have been

handled.

INTRODUCTION

Smoking is the single largest preventable cause of death in the United States (Centers for

Disease Control, 2008). A recent study shows that employees who smoke actually cost

the employer more per year than nonsmokers. Employee wellness programs offered

in the workplace often encourage smoking cessation and have generally been shown

to be good investments for employers (Pelletier, 2005; Baicker et al., 2010). However,

not every approach to smoking cessation is having the positive outcome one might

expect.

In 2006, drug manufacturer Pfizer launched ChantixR, which promised to alleviate the

pains of nicotine withdrawal. ChantixRoffered smokers a chance to kick the expensive

and unhealthy habit and was touted as a medical miracle in the mainstream press. Two

years later, the first of 2,700 lawsuits was filed against Pfizer claiming that ChantixR

caused serious injuries and in some cases, death. Pfizer paid out over $275 million in

settlement funds, yet the drug was not recalled and remains on the market today.

Brenda Wells isat East Carolina University; e-mail: wellsbr@ecu.edu.

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SMOKING,NICOTINE,AND MENTAL HEALTH

The compelling need for a smoking cessation product that truly works can be best

understood by first acknowledging and understanding the prevalence of smoking in the

United States and its associated costs. This section begins with facts about smoking and is

followed by a layman’s explanation of how nicotine works on the brain. Understanding

the chemistry of smoking will be necessary to understand how ChantixRoperates on the

brain. This section concludes with a discussion of smoking and its relationship to mental

illness, which is critical for understanding the seriousness of the side effects claimed to

be caused by the drug.

Smoking in the United States

The deleterious health effects of smoking are well documented. Smoking is linked to

countless health effects including at least 11 types of cancer and numerous reproductive

consequences. Smoking is responsible for one in five deaths each year, more than HIV,

illegal drug use, alcohol use, motor vehicle injuries, suicides, and murders combined

(Centers for Disease, 2004, 2008).

As a result, tobacco has a major impact on national health expenditures. During 2000

to 2004, cigarette smoking was estimated to be responsible for $193 billion in economic

losses in the United States: $96 billion in direct medical costs and $97 billion in lost

productivity (Centers for Disease Control and Prevention, 2008).

Nearly 20 percent of the U.S. population smokes cigarettes (Centers for Disease Control,

2012). While this percentage is on the decline—it was 25 percent in 1993—it still repre-

sents a significant number of people (Centers for Disease Control, 2004). The publication

of the 1964 Surgeon General’s report on smoking and health was the start of a national

antismoking campaign. Since that time, antismoking initiatives and bans on smoking in

public places and work places have drastically reduced cigarette consumption (Pacheco,

2011).

Employees who smoke are estimated to cost an employer $6,000 more per year than a

nonsmoking employee (Berman et al., 2013). As a result, many employers have made

their work campuses smoke-free. Through employee benefit plans, employers also offer

support and resources to help employees quit smoking. About 36 percent of employers

offer rewards for employee participation in a smoking cessation program, and 42 per-

cent surcharge employees who smoke. A small but growing number of employers are

adopting “no-hire” policies for smokers (Towers Watson, 2013).

The Chemistry of Smoking

As nicotine enters the body via a cigarette, it permeates very quickly,crossing the blood–

brain barrier and reaching maximum concentration just 10–20 seconds after inhalation

(Le Houezec, 2003). Nicotine works by binding to brain receptors called nicotinic acetyl-

choline receptors, or nAChRs. The nAChRs with the highest affinity for nicotine contain

two α4andthreeβ2 subunits. The highest concentrations of the high-affinity α4β2

nAChRs exist in the mesolimbic dopaminergic system, which is also commonly known

as the reward center of the brain.

When stimulated by nicotine, these α4β2 nAChRs trigger release of the neurotransmitter

dopamine. Dopamine is a critical element involved in the brain’s reward and pleasure