SC 39553 Research Project Part 1

Zoloft

Austin Bowles

Greg Cambra

C.J. Grimes

Erica Stefanek

Kiara Walton

SC 3953 Dr. Ken Kim

I. Table of Contents

II. Situation Analysis

1. Company Analysis Pg. 3

2. Product/Brand Analysis Pg. 4

3. Competitive Analysis Pg. 5

4. Consumer Market Analysis Pg. 6

5. Macro Environmental Considerations Pg. 8

III. Problems and Opportunities Analysis (SWOT) Pg. 9

IV. Recommended Research Emphasis Pg. 12

V. Comprehensive Research Problem Statement Pg. 14

VI. Bibliography Pg. 16

VII. Appendix Pg. 19

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II. Situation Analysis

1. Company (organization) Analysis

Zoloft is manufactured by Pfizer, a company that prides itself on its scientific research

and charitable works. Pfizer has prioritized its research and development efforts where they

would have the most scientific and commercial undertaking. Pfizer's interests are in oncology,

vaccines and neuroscience, among other health related studies. They develop products that

matter most to people. They go out of their way to ensure that patients around the globe can

utilize the benefits of Pfizer's products.

Pfizer endeavors to keep ethics foremost in all its pursuits. They understand their

responsibility to monitor the safety of their products. They perform a multitude of tests and keep

track of their patients' status throughout the development and use of the product (pfizer.com).

Pfizer has also created Policies on Business Conduct. Originally known as the "Blue

Book," Policies on Business Conduct is a compilation of company regulations that sustains the

values of the company. This document summarizes information concerning business ethics,

employment, conflicts of interest, intellectual property and confidential information, use of

electronic systems, business practices, global business, and corporate citizenship. All of these

policies help implement responsible business (pfizer.com).

In addition to policies, Pfizer has its Corporate Compliance Program. This program

shows the joint mission of colleagues ranging from the highest levels of management to junior

employees. This program incorporates concepts from the "Compliance Program Guidance for

Pharmaceutical Manufacturers," which was developed by the United States Department of

Health and Human Services, Office of Inspector General.

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2. Product/Brand (program/issue) Analysis

Pfizer's Zoloft was the second-leading SSRI (selective serotonin reuptake inhibitor), or

anti-depressant, in 1999. It brought more than $2 billion to Pfizer. It is quite an accomplishment

to be successful in the SSRI market because it is expensive and time-consuming because of

development costs and required testing (ftc.gov).

Sertraline is the generic term for Zoloft. It is used to treat depression, obsessive-

compulsive disorder, panic attacks, and other stress and anxiety disorders. Zoloft works by

increasing the amounts of serotonin, which is a natural substance in the brain that helps maintain

mental balance. It comes in tablet and liquid form and is to be taken once a day. Taking more or

less than the prescribed dosage can result in undesirable side effects (www.nlm.nih.gov).

Like other medications, Zoloft has a range of possible side effects. There is a suicide risk

for patients younger than 25. For patients over 25, there is still a slight suicide risk, but it

decreases with usage. The most common side effects are sexual dysfunction and nausea. Some

psychiatric side effects include anxiety, and insomnia. Some gastrointestinal side effects are

nausea, diarrhea, dyspepsia, and anorexia. The more serious psychological side effects are

suicide, worsening depression and mania. There are also some serious uncommon side effects,

such as, neuroleptic malignant syndrome, seizures, hypertension, dehydration, altered platelet

function leading to bleeding, acute closed angle glaucoma, and hypoglycemia

(sideeffectz.com/zoloftsideeffects).

According to the FDA, there are five patients out of every 1,000 patients, ages 18-24,

who experience suicidal thoughts or behavior. This conclusion is based on studies of 11

antidepressants in more than 77,000 patients. However, this risk is considered diminutive

compared to the benefits of antidepressants (www.sleepandhealth.com/fda-seeks-antidepressant-

suicide-warning).

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There is currently a lawsuit against Pfizer because it has been linked to developmental

birth defects and persistent pulmonary hypertension in newborn infants whose mothers took

Zoloft during pregnancy. However, only those who were not warned of the side effects or fall

under some other special circumstance are entitled to collect damages as compensation. It is

difficult to sue manufacturers for negative side effects, such as suicide attempts, after the

warnings were in place. Some conditions, like a doctor not monitoring the patient, can result in a

lawsuit against the doctor (injury-law.freeadvice.com/injury-law/drug-toxic.../zoloft-

lawsuit.htm).

3. Competitive Analysis

Zoloft has been a successful antidepressant in the past. However, Zoloft lost its patent in

2005, and the compound that makes Zoloft became generic. As a result, Zoloft became an

inexpensive product that many can obtain cheaply. Zoloft’s direct competitors didn’t gain much

from the patent loss. The loss of the Zoloft patent has cost Pfizer, the company that makes

Zoloft, an estimated $2 billion. Zoloft patent's loss will create an increase in sales for generic

drug makers. (Smith)

In 2012, Zoloft has no data on its current standing in the overall antidepressant market.

Paxil and Lexapro have $2,069,000 invested into the antidepressant market. Without sufficient

CMR data, it is impossible to get an exact measurement of Zoloft SOV. The data on many of

Zoloft’s indirect competitors was unavailable as well. As a result, it is not measurable as to how

much of Zoloft’s market is taken by Zoloft’s indirect competitors. (CMR)

Despite the media outlet usage, Zoloft still has found some success in the female market.

According to MRI data, Widowed Caucasian females still use Zoloft to great effect. The index

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data shows that Zoloft is successful and has exceeded the 100 base level. However, the

competition is knowable about using these markets as well. Unfortunately, the demographics that

Zoloft has shown success in are not highly populated. Without the patent, Zoloft is a generic

antidepressant with little ability to saturate its potential market efficiently. (MRI)

With the MRI, Zoloft’s success can be measured within its current markets. The

competition has documented there CMR, but Zoloft has not. Without the CMR, Zoloft cannot be

measured in comparison to its direct and indirect competitors.

4. Consumer /Market Analysis

The current consumer market for the anti-depressant drug Zoloft is one-sided to say the

least. The majority of the market is made up primarily of woman. The market for men is almost

absent. According to a 2010 Health and Beauty MRI, women are 44 percent more likely to use

Zoloft than the normal population, while men are 47 percent less likely to use it. The trend of

women is dominating Zoloft’s current consumer market.

With women being the primary consumers of Zoloft, age comes into the spectrum next.

According to the MRI data, adults of any gender ages 18-24 are two percent less likely to buy

Zoloft than the normal population. This is a drastic difference from women ages 25-54, who are

54 percent more likely than the normal population to use Zoloft. The men of this age group, 25-

54, are 45 percent less likely than the normal population to use Zoloft, according to the MRI.

When it comes to deciding what the initial market is for Zoloft, consumers are primarily women,

regardless of age.

Another statistic to consider when determining who is using Zoloft is women in the

workforce. Individuals who work are also a big portion of Zoloft users. People with

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“professional” types of jobs, such as business professionals, are 43 percent more likely than the

normal population to use Zoloft, according to the MRI data. This could be because of stress-like

symptoms within the workforce or even monetary issues that come with having a professional

job position. Whatever the issue is, a market worth advertising to is the market of business

professionals.

A further major market to look into for Zoloft users is the market of television. It appears

that daytime TV accounts for the most Zoloft users out of any other time of the day, with 90

percent of daytime TV watchers being more likely to use Zoloft than the normal population,

according to the MRI data. This statistic would seem to be accurate, considering that many

individuals dealing with depression are without jobs and at home during the day watching

television. To expand upon the market of TV, there are primary networks that Zoloft users are

found using. By far the most accessed type of TV network by Zoloft users is inspirational

television. According to the MRI data, 163 percent of inspirational TV watchers are more likely

to use Zoloft than the normal population; easily making this is one of the most effective markets

reached. This also appears to be a precise statistic. It would make sense that those facing

depression would look for inspiration and joy, even in watching TV.

An additional market for products today is the Internet. The Zoloft market is not an

exception to this. The primary Internet market for users of Zoloft is the web site iVillage. This

web site produces a 112 percent increase in the likelihood of a person to use Zoloft, according to

the MRI data, making it by far the biggest Internet market. The trend of woman users is also

apparent here, because iVillage is a web site primarily used by women, as it is a web site that

specializes in articles on pregnancy, parenting, health and beauty tips.

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Next, an even broader market for Zoloft users today is the magazine industry. It is the

market most users of Zoloft seem to be reached by. According to the MRI data, women who

read the magazine First for Women are 197 percent more likely to use Zoloft than the normal

population. This is the biggest market for any category of Zoloft users. Another magazine that

attains many Zoloft users is Audubon. According to the MRI data, an individual who reads

Audubon is 166 percent more likely to use Zoloft than the normal population. This magazine is

not directed to specifically woman, but it does target the age group of 25-54 year olds.

In conclusion, the data provided by the MRI is applicable in describing the current

market of the consumer of Zoloft, and it paints a picture of the potential product market. It is

concurred that with this data, women are the most apt to use Zoloft. It can also be concluded that

individuals from the ages of 24-54 are more likely to use Zoloft than other age groups. The data

that represents successes in reaching targets in the workforce, on TV, on the Internet and in

magazines can conclude that much of the effort being put into the research of these markets can

be utilized in researching lacking Zoloft markets. Two primary markets that are lacking in

Zoloft users, according to the MRI data, are Zoloft users that are men and users that are under the

age of 25. It would be beneficial to begin research on these market areas, in order to possibly

expand the population that uses Zoloft in each of the markets.

5. Macro Environmental Consideration

The recent global economic recession has had a significant impact on the usage rates of

antidepressants like Zoloft. With limited positions in the workplace, increasing demands have

increased stress levels for those currently employed, as cited by a recent British poll. For those

who have lost or not found their place in workforce, the day-to-day economic pressures have

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turned an increasing number to seeking medication. The current economic situation has had an

effect on the antidepressant market as a whole, not specifically Zoloft. In continuing with the

theme of economic impacts, Zoloft’s parent company, Pfizer, has seen an increase in stock price

since 2010.

Zoloft has suffered some bad press in recent years due to the actions of its parent

company. Some of the scandals include Pfizer executives bribing government officials for better

price control, as was the case in the Philippines, and other illegal marketing practices. Social

outcry against these practices has reached a global level. Pfizer has had to recall a large supply of

the antidepressant due to allegations Zoloft caused birth defects. These defects were not linked

solely to Zoloft, but to SSRIs in general.

Americans have seen a sharp increase in antidepressant usage over the past few decades.

Some scholars and pharmaceutical experts estimate the increase to be 400 percent since 1988.

The practice of overprescribing has become prevalent due to this increase. Reports conflict as to

the total number of these instances in the United States. Some state as low 20 percent of

prescription antidepressant drug users do not show signs of depression or were no screened.

Others state as high as 60-70 percent. The negative stigma attached to doctors who overprescribe

have led an increasing number of medical practitioners to shy away from prescribing

antidepressants, thus hurting sales of products such as Zoloft.

III. Problems and Opportunities Analysis (SWOT)

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Strengths

Top-selling pharmaceutical company in the United States

Research and Development department is one of the industry’s best

Success of new Lyrica, Sutent and Chantix, along with recent developments have boosted

sales confidence

Active patents

Easily recognizable Zoloft commercial

Reputation of strong sales

Global networking

New cost-cutting practices

Share buybacks

Large revenue to pull from

Weaknesses

Market focus is on men and women over 30, leaving the youth largely ignored

Recovery from lack of a “blockbuster” product in last decade

Lack of exploration in biologic markets

Great amount of attention and resources spent on only a small group of products

Co-marketing with other companies limit global impact

No following through on products locked up in development

Loss of consumer confidence do to previous lawsuits and health violations

Opportunities

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Room in biologic market

Available revenue to bolster other products

Acquisition of smaller firms in last decade

Anti-depressant usage among youth is increasing

Recent economic recession leading to increasing financial stress, a leading cause of

depression

Advancements in technologies to decrease development time for new products

Emergence of new global markets

Threats

Increasing competition from generic supplements

Scandal and negative image from health violations

Economic recession impact consumer’s willingness to buy

Large merger and acquisition activity can cut into Pfizer profits

Lawsuits injure credibility

Widespread, strong competition

Patent expiration on big name products (notably Zoloft)

Sale of OTC sector

IV: Recommended Research Emphasis

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After analyzing the situation and the S.W.O.T analysis for Pfizer, which also produces

the anti- depressant Zoloft; our team came up with several findings. These findings will lead us

to potentially seeking the problem areas that come with Zoloft users.

Pfizer is one of the top selling pharmaceutical companies in the United States and

because of this; it’s brought more than $2 billion active patents to the company. It also has one of

the best research and development departments in the industry that created benefits for the

company and gained respect from its fellow users. Pfizer develops many cost cutting products

that people want. They take pride in monitoring and testing the safety of their products, which

generates more active patents and brand- loyalty (ftc.gov).

Although Pfizer has one of the best research and developmental departments, they also

have a history of not following through on product development. This could be a potential

problem where the company would seek revenue loss and lose its built up credibility. Another

problem is the great amount of attention and resources spent on only a small group of products.

Advancements in technologies to decrease development time for new products could create a

gateway that would potentially save time and money. With the increasing competition from

generic supplements Pfizer would not want to make that mistake.

Pfizer has created policies on business conduct to go along with their global market. They

make sure the patents around the globe can utilize the benefits of Pfizer’s products and because

of that they have developed great global networking. Although they have developed a great

relationship with the global market; co- marketing with other companies may limit the global

impact. More focus on a few co- marketing companies that would benefit by increasing active

patents and bringing in more revenue would potentially help Pfizer (Pfizer.com).

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After analyzing the consumer market for Pfizer’s anti- depressant drug (Zoloft), we

discovered that its one sided and the majority of the market is primarily made up of women.

Statistically, women in the workforce ages 25-45 are 43 percent more likely to use Zoloft.

According to the MRI data, stress-like symptoms that come with having a professional job are

increasing this market. Although their market seems to be one- sided other opportunities in

researching the anti-depressant usage among the youth could potentially help Pfizer.

Another popular market that has brought patents to Pfizer is the TV commercial

advertisement of their Zoloft anti-depressant. According to the MRI data, 90 percent of daytime

TV watchers are more likely to use Zoloft than the normal population. Pfizer has expanded their

choice of networks, giving potential Zoloft users a chance to become active patents. Inspirational

television has been the most popular network for depressed people who are looking for

inspiration and joy through TV watching.

Additional rising markets that have opened up are magazines and internet users. The

primary Zoloft users have adopted a web site called iVillage. According to the MRI data, the

web site produces a 112 percent increase in the likelihood of a person to use Zoloft. An even

broader market for Zoloft users today is the magazine industry. According to the MRI data,

women who read the magazine First for Women are 197 percent more likely to use Zoloft. This

data not only gives us a picture of Zoloft’s potential market, but also represents success in

reaching targets in the workforce of using this product. The research of these markets can be

utilized in researching possible lacking in the Zoloft markets. According to the MRI data, two

primary markets that are suffering in Zoloft users are users that are men and under the age 25.

After looking at this information it would be beneficial to begin research on these market areas,

which could increase Zoloft users in a variety of markets.

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Zoloft has a range of possible side effects includes a suicide risk for patients younger

than 25, sexual dysfunction, nausea, diarrhea, dyspepsia, anorexia, and insomnia etc. Other

serious uncommon side effects include narcoleptic malignant syndrome, seizures, hypertension,

dehydration etc (Sideeffectz.com/zoloftsideeffects).

Currently, Pfizer has been linked to several developmental birth defects creating a

lawsuit against the company. Persistent pulmonary hypertension in newborn infants whose

mothers took Zoloft during pregnancy also created damages. Although warning labels were in

place, only those who were not warned or fall under special circumstances are entitled to collect

damages as compensation (injury-law.freeadvice.com/injury-law/drug-toxic…/Zoloft-

lawsuit.htm).

Pfizer’s loss of consumer confidence do to previous lawsuits and health violations has

developed a weakness and credibility loss in their market. More research and product

development could potentially cut down those risks.

Overall, the data we found lead us to several problems that could eventually be fixed with

more research. A few areas of concern include Zoloft’s target market and the need to expand its

area of focus, the accuracy and safety of their product development, how much Pfizer’s global

networking with co- marketing companies help their company, and how to prevent potential

lawsuits from health violations of Zoloft.

Problem Statement

The issues with credibility are defined by Pfizer's inability to follow through with product

development. Zoloft's many side effects is damaging to Pfizer's credibility. If the company would

follow through with product development, there is a chance that there would be fewer side

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effects, or at least it would look like Pfizer is doing everything in its power to keep its consumers

safe. Keeping customers safe and happy as well as preserving the name of the company justifies

this research. As for informational needs, the consumers need to know that they can count on

Pfizer to treat the safety and needs of the consumer as a priority. The public must be certain that

Zoloft has been properly tested and that the risk of side effects is unavoidable.

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VI. Bibliography

About Pfizer http://www.pfizer.com/about/corporate_compliance/corporate_compliance.jsp

Berkot, B. (October 12, 2010). Pfizer to buy King Pharma for $3.6 billion in cash. Reuters.

Retrieved from: http://www.reuters.com/article/idUSN1216434820101012. 

Edwards, Jim. (2009, July 15). Pfizer "Bribe" scandal in Philippines heats up; company offered posters

to the President. Retrieved from http://www.cbsnews.com/8301-505123_162-

42842137/pfizer-bribe-scandal-in-philippines-heats-up-company-offered-posters-

to- the-president/ .

FDA seeks antidepressant suicide warning. www.sleepandhealth.com/fda-seeks-antidepressant-

suicide-warning

FTC Order Clears Way for $90 Billion Merger of Pfizer Inc. and Warner-Lambert Company Commission Consent Agreement will Protect Competition for Several Key Drugs (June 19, 2000).www.ftc.gov/opa/2000/06/pfizer.shtm

FTC order prevents anticompetitive effects from Pfizer’s acquisition of Wyeth. Federal Trade

Commission. (2009). Retrieved from http://www.ftc.gov/opa/2009/10/pfizer.shtm.

Hoovers. (2011). Pfizer Inc. Retrieved from

http://subscriber.hoovers.com/H/company360/overview.html?

companyId=11175000000000

In the matter of Johnson & Johnson and Pfizer Inc. Federal Trade Commission. (2007).

Retrieved from:

http://www.ftc.gov/os/caselist/0610220/0610220c4180decisionorder_publicversion.pdf

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Johnson, C. (September 3, 2009). In settlement, a warning to drugmakers: Pfizer to pay record

penalty in improper-marketing case. The Washington Post.  Retrieved from:

http://www.washingtonpost.com/wp-dyn/content/article/2009/09/02/AR2009090201449_pf.h

tml.

Lane, C. (2009, May 11). Overprescribing antidepressants. Retrieved from

http://www.psychologytoday.com/blog/side-effects/200905/overprescribing-

antidepressants .

Medline Plus Drug Information: Sertraline

www.nlm.nih.gov/medlineplus/druginfo/meds/a697048.html

Research and Development at Pfizer http://www.pfizer.com/research/

Saftlas, H. (September 12, 2006). A healthy prognosis for Pfizer. Bloomberg Businessweek.

Retrieved from:

http://www.businessweek.com/investor/content/sep2006/pi20060912_393574.htm.

Szalavitz, M. (2011, October 20). What does a 400% increase in antidepressant use really

mean? Retrieved from http://healthland.time.com/2011/10/20/what-does-a-400-increase-

in-antidepressant-prescribing-really-mean/ .

Smith, Aaron. “Who stands to gain when Zoloft goes generic?” CNN. 4 April. 2006 <http://money.cnn.com/2006/04/04/news/companies/antidepressants/index.htm>

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Tsao, A. (December 1, 2004). Pfizer’s show of strength. Bloomberg Businessweek. Retrieved

from:

http://www.businessweek.com/bwdaily/dnflash/nov2004/nf2004121_7792_db016.htm.

Zoloft Lawsuits, Litigation and Lawyers.

injury-law.freeadvice.com/injury-law/drug-toxic.../zoloft-lawsuit.htm

Zoloft CMR

Zoloft MRI

Zoloft Side Effects. sideeffects.com/zoloftsideeffects

Paton, N. (2010). Stress on the up after economic downturn. Occupational Health, 62(6).

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VII. Appendix

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http://ajp.psychiatryonline.org/article.aspx?articleid=177037

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drugabuse.gov

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