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Manufacturer

Pfizer

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Pfizer is one of the world’s largest pharmaceutical companies. It faces lawsuits over several of its popular products, including Lipitor, Zithromax, Effexor and Zoloft.

The company got its start in 1849 when cousins Charles Pfizer and Charles Erhart combined their chemistry and confectionery skills and started a business. They began in Brooklyn, N.Y., with one building used as an office, laboratory, factory and warehouse. One of their first products was Santonin, a cure for intestinal worms, a common ailment of the day. They sold the remedy with an almond toffee flavor and were an instant success.pfizer logo

Today, Pfizer operates in 180 countries and employs more than 110,600 people worldwide, with revenue topping $65 billion in 2011. It operates in five areas: Primary Care; Specialty Care and Oncology; Established Products and Emerging Markets; Animal Health; and Consumer Health Care and Nutrition.

But the company has had more than its share of controversy, including four settlements over charges of illegal marketing in the last decade alone – one totaling $2.3 billion – and countless personal injury lawsuits. Pfizer’s portfolio of problem drugs includes Zithromax, Chantix, Lipitor, Geodon, Trovan, Bextra, Celebrex, Lyrica, Effexor and Zoloft.

History of Pfizer

After its launch in 1849, Pfizer grew during the Civil War, selling painkillers, preservatives, disinfectants and solutions like iodine, morphine, chloroform, camphor and mercurial. As the company expanded, the headquarters were moved to Manhattan in 1868, and a warehouse was opened in Chicago in 1882. The company’s next major discovery was pioneering the mass production of citric acid, which is used in Coca-Cola, Dr. Pepper and Pepsi  – drinks that were growing in popularity. Pfizer’s studies of citric acid and fermentation technology later would assist the company in penicillin production.

By the 20th century, Pfizer had established itself as a successful business. It celebrated its 50th anniversary and continued to increase profits, exceeding sales of $3 million in 1906. In 1941, Pfizer began mass production of penicillin, responding to the U. S. government’s request to provide World War II soldiers with the new antibiotic. By taking an active role in dispersing this antibiotic, Pfizer cemented its place in medical history.

Another major discovery for Pfizer around this time was a fermentation-free method of producing vitamin C. Researchers noted that the vitamin could be used as a defense against scurvy and the common cold. Pfizer built a new plant dedicated to nonstop production and quickly became the world’s top producer of vitamin C

Fast facts about Pfizer
Established: 1849
Founders: Charles Pfizer and Charles Erhart
Headquarters: New York City
Size: More than 110,600 employees worldwide
2011 Revenue: $67 billion

By 1952, Pfizer had moved into eight new international locations — Belgium, England, Cuba, Canada, Brazil, Mexico, Panama and Puerto Rico — and had established its Agricultural Division, which later would be known as Animal Health. As its international business grew, so did its staff. In 1958, international personnel increased from 4,300 to more 7,000.

Pfizer continued to reinvest its profits in new research and development, and began to acquire other companies, like J.B. Roerig  and Co. and Mack Illertissen,  that were already involved in research and development of new pharmaceutical products. Within a few decades, the efforts paid off, as new drugs brought in billions. In 1980, Feldene, an anti-inflammatory pain medication, became Pfizer’s first billion-dollar product. Pfizer created antibiotics; antifungal medications; blood pressure, diabetes and depression drugs; and was named the world’s most admired pharmaceutical company by Fortune magazine in 1997.

The 1990s and early 2000s were a time of blockbuster drugs for Pfizer, including a popular erectile dysfunction drug and Lipitor, a statin drug that proved far better than its competitors in clinical trials. Lipitor was originally developed by Warner-Lambert, which merged with Pfizer in 2000. Lipitor quickly grew to be the largest-selling pharmaceutical of any kind  in history, reaching $9.6 billion in revenue in 2011. Two other major drugs sold in this time period were Chantix (a smoking cessation drug) and Bextra (a painkiller).

In 2009, Pfizer acquired another giant company, Wyeth, broadening its product offerings and expanding its workforce. At the end of 2011, however, Lipitor lost patent protection. In order to combat decreased sales revenue from patent expiration of Lipitor and other drugs, the company cut back on around 600 primary care sales employees.  It stated that the downsizing move would put the company in a place that would best utilize its resources and meet the needs of the business as it continues to change over time.

Fraud Charges and Litigation

Amid all of its success, Pfizer faced a growing number of scandals involving some of its most popular drugs. Since 2002, Pfizer has been forced to make multiple settlements over charges of illegal marketing. Bextra was at the center of one of these cases, costing the company $2.3 billion to settle civil and criminal allegations and setting a record at the time as the largest health care fraud settlement and the largest criminal fine of any kind.

Although Bextra was only approved for arthritis and menstrual cramps, sales representatives reportedly were instructed by Pfizer to tell doctors it could be used for unapproved indications, like acute and surgical pain, and that it could be taken in high doses. However, the drug came with serious heart and skin risks, which caused Pfizer to withdraw it in 2005 and face a criminal investigation for misbranding the drug.

Other drugs that have been associated with illegal marketing charges include Geodon, an antipsychotic, Zyvox, an antibiotic, Lyrica, a drug for nerve pain, Nuerontin, an epilepsy drug, Detrol, used for treatment of overactive bladder and even Lipitor.

In 2002, Pfizer paid a $49 million fine based on claims that it defrauded the Medicaid program and overcharged consumers for Lipitor. Other settlements varied in size – the  Nuerontin settlement, in 2004, cost $430 million, and Detrol, in 2011, cost $14.5 million – but they all cast a looming shadow over the company’s integrity.

Pfizer continues to face legal difficulties. In 2012, it paid $164 million to settle a lawsuit that claimed it misled investors about the clinical results of Celebrex, which is taken for arthritis. A month after that case was finalized, Pfizer settled a class-action lawsuit concerning investors who were misled about the risks associated with the antidepressant drug Pristiq. The Pristiq case cost the company $67.5 million. Pfizer also faces lawsuits over Zoloft, another one of its antidepressants. So far, 184 people have filed claims against Pfizer after Zoloft caused serious adverse effects.

Dangerous Drugs and Birth Defects

Part of Pfizer’s success can be attributed to its antidepressant sales, as it tapped into a growing demand for the prescription drugs. However, two antidepressants sold by the company, Effexor and Zoloft, can lead to serious birth defects if taken during pregnancy. A growing number of families have sued Pfizer after having a child who suffered.

Wyeth, one of the many companies that Pfizer acquired, began marketing Effexor, the first serotonin-norepinephrine  reuptake inhibitor (SNRI) antidepressant, in 1993. By 2007, the drug had been prescribed to more than 17.2 million people, becoming the sixth most prescribed antidepressant in the United States that year.

But Effexor can cause serious side effects, especially for women taking the drug while pregnant. In fact, studies have found that antidepressants like SNRIs and selective serotonin reuptake inhibitors (SSRIs) can increase the risk of birth defects like respiratory distress, anencephaly, craniosynostosis, heart defects, omphalocele, cleft lip and cleft palate.

Pfizer was the creator of another blockbuster antidepressant, an SSRI called Zoloft (sertraline chloride). The FDA approved Zoloft in 1991. By 2002, the drug was the most popular antidepressant nationwide, bringing Pfizer nearly $2.9 billion that year, before losing patent protection in 2006. In total, 30 million people have filled Zoloft prescriptions.

Unfortunately, Zoloft also can cause birth defects, including persistent pulmonary hypertension of the newborn (PPHN), facial malformation and anencephaly, which impedes brain and skull development.

Serious Side Effects Lead to Litigation

Zithromax, one of the most commonly prescribed antibiotics in the world, has just recently been linked to very serious side effects. A 2012 study found that patients taking Pfizer’s popular antibiotic had a higher risk of cardiovascular death than patients taking other antibiotics or none at all. Although the risk for most patients was found to be very low, the high rates of death found in Zithromax users with previous heart conditions was concerning enough for the FDA to issue a warning about the drug in March 2013. Lawsuits are expected to follow.

Pfizer is also facing lawsuits over its blockbuster drug Lipitor, which has been linked to serious side effects, including type 2 diabetes and complications of the muscles, liver and kidneys.

Pfizer’s Future

In 2013, Pfizer is seeking to recover from losses due to the patent expiration of Lipitor. The company hopes to compensate by acquiring smaller drug companies already in the process of producing what could be the next blockbuster drug.

Despite litigation resulting from some of its drugs, Pfizer continues to dominate the pharmaceutical industry. It continues to earn billions off of its primary care drugs like Lyrica, for pain, and Celebrex, for arthritis. Pfizer recently partnered with Bristol-Myers Squibb Company to sell a new blood thinner, Eliquis.