Pfizer's logo – since January 5, 2021
|Founded||1849New York Cityin|
|Revenue||US$51.75 billion (2019)|
|US$16.30 billion (2019)|
|US$16.27 billion (2019)|
|Total assets||US$167.489 billion (2019)|
|Total equity||US$63.14 billion (2019)|
Number of employees
|c. 88,300 (2019)|
Pfizer Inc. (//) is an American multinational pharmaceutical corporation. Pfizer is one of the world's largest pharmaceutical companies, and was ranked 64th on the 2020 Fortune 500 list of the largest U.S. corporations by total revenue, at $51.75 billion.
Headquartered in Manhattan, Pfizer develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, endocrinology, and neurology. Its products include the blockbuster drug Lipitor (atorvastatin), used to lower LDL blood cholesterol; Lyrica (pregabalin) for neuropathic pain and fibromyalgia; Diflucan (fluconazole), an oral antifungal medication; Zithromax (azithromycin), an antibiotic; Viagra (sildenafil) for erectile dysfunction; Celebrex (also Celebra, celecoxib), an anti-inflammatory drug; and Prevnar 13, a pneumococcal conjugate vaccine.
In 2016, Pfizer Inc. was expected to merge with Allergan to create the Ireland-based "Pfizer plc" in a deal that would have been worth US$160 billion. The merger was called off in April 2016, however, because of new rules from the US Department of the Treasury against tax inversions, a method of avoiding taxes by merging with a foreign company. The company has made the second-largest pharmaceutical settlement with the United States Department of Justice.
Pfizer was a constituent of the Dow Jones Industrial Average from 2004 to 2020, when it was announced that the company would be replaced by Amgen in the Dow Jones. The change took effect at start of trading on August 31, 2020.
Charles Pfizer and his cousin Charles F. Erhart, both of German descent, founded Pfizer in New York City in 1849. They launched the chemicals business, Charles Pfizer and Company, at Bartlett Street in Williamsburg, Brooklyn, where they produced an antiparasitic called santonin. This was an immediate success, although it was the production of citric acid that led to Pfizer's growth in the 1880s. Pfizer continued to buy property to expand its lab and factory. Pfizer's original administrative headquarters was at 81 Maiden Lane in Manhattan. By 1906, sales totaled $3.4 million.
World War I caused a shortage of calcium citrate, which Pfizer imported from Italy for the manufacture of citric acid, and the company began a search for an alternative supply. Pfizer chemists learned of a fungus that ferments sugar to citric acid, and they were able to commercialize production of citric acid from this source in 1919. The company developed expertise in fermentation technology as a result. These skills were applied to the mass production of the antibiotic penicillin during World War II in response to the need to treat injured Allied soldiers. "Pfizer, succeeded in producing large quantities of penicillin using deep-tank fermentation. Its success helped make penicillin available to Allied soldiers by the end of the war."
Penicillin became very inexpensive in the 1940s, and Pfizer searched for new antibiotics with greater profit potential. They discovered Terramycin (oxytetracycline) in 1950, and this changed the company from a manufacturer of fine chemicals to a research-based pharmaceutical company. Pfizer developed a drug discovery program focused on in vitro synthesis in order to augment its research in fermentation technology. The company also established an animal health division in 1959 with a 700-acre (2.8 km2) farm and research facility in Terre Haute, Indiana.
By the 1950s, Pfizer had established offices in Belgium, Brazil, Canada, Cuba, Mexico, Panama, Puerto Rico, and the United Kingdom. In 1960, the company moved its medical research laboratory operations out of New York City to a new facility in Groton, Connecticut. In 1980, they launched Feldene (piroxicam), a prescription anti-inflammatory medication that became Pfizer's first product to reach one billion dollars in total sales. During the 1980s and 1990s, Pfizer Corporation growth was sustained by the discovery and marketing of Zoloft, Lipitor, Norvasc, Zithromax, Aricept, Diflucan, and Viagra.
Development of torcetrapib, a drug that increases production of HDL, or "good cholesterol", which reduces LDL thought to be correlated to heart disease, was cancelled in December 2006. During a Phase III clinical trial involving 15,000 patients, more deaths occurred in the group that took the medicine than expected, and a sixty percent increase in mortality was seen among patients taking the combination of torcetrapib and Lipitor versus Lipitor alone. Lipitor alone was not implicated in the results, but Pfizer lost nearly $1 billion developing the failed drug and the market value of the company plummeted afterwards. That same year, the company also announced it would acquire PowerMed and Rivax.
In September 2009, Pfizer pleaded guilty to the illegal marketing of the arthritis drug Bextra for uses unapproved by the U.S. Food and Drug Administration (FDA), and agreed to a $2.3 billion settlement, the largest health care fraud settlement at that time.
A July 2010 article in BusinessWeek reported that Pfizer was seeing more success in its battle against makers of counterfeit prescription drugs by pursuing civil lawsuits rather than criminal prosecution. Pfizer has hired customs and narcotics experts from all over the globe to track down fakes and assemble evidence that can be used to pursue civil suits for trademark infringement. Since 2007, Pfizer has spent $3.3 million on investigations and legal fees and recovered about $5.1 million, with another $5 million tied up in ongoing cases.
2000: Warner–Lambert acquisition
Pfizer acquired Warner–Lambert in 2000 for $111.8 billion.[third-party source needed] This created what was, at the time, the second-largest pharmaceutical company in the world. Warner–Lambert was founded as a Philadelphia drug store in 1856 by William R. Warner. Inventing a tablet-coating process gained Warner a place in the Smithsonian Institution. Parke–Davis was founded in Detroit in 1866 by Hervey Parke and George Davis. Warner–Lambert took over Parke–Davis in 1976, and acquired Wilkinson Sword in 1993 and Agouron Pharmaceuticals in 1999.
2003: Pharmacia acquisition
The Upjohn Company was a pharmaceutical manufacturing firm founded in 1886 in Kalamazoo, Michigan, by Dr. William E. Upjohn. The company was originally formed to make friable pills, which were designed to be easily digested. Greenstone was founded in 1993 by Upjohn as a generics division. In 1995, Upjohn merged with Pharmacia, to form Pharmacia & Upjohn. Pharmacia was created in April 2000 through the merger of Pharmacia & Upjohn with the Monsanto Company and its G.D. Searle unit. The merged company was based in Peapack-Gladstone, New Jersey. The agricultural division was spun off from Pharmacia, as Monsanto, in preparation for the close of the acquisition by Pfizer.
SUGEN, a company focused on protein kinase inhibitors, was founded in 1991 in Redwood City, California, and acquired by Pharmacia in 1999. The company pioneered the use of ATP-mimetic small molecules to block signal transduction. After the Pfizer merger, the SUGEN site was shut down in 2003, with the loss of over 300 jobs, and several programs were transferred to Pfizer. These included sunitinib (Sutent), which was approved for human use by the FDA in January 2006, passed $1 billion in annual revenues for Pfizer in 2010. A related compound, SU11654 (Toceranib), was also approved for canine tumors, and the ALK inhibitor Crizotinib also grew out of a SUGEN program.
In 2008, Pfizer announced 275 job cuts at the Kalamazoo manufacturing facility. Kalamazoo was previously the world headquarters for the Upjohn Company.
2009: Wyeth acquisition
On January 26, 2009, after more than a year of talks between the two companies, Pfizer agreed to buy pharmaceuticals rival Wyeth for a combined US$68 billion in cash, shares and loans, including some US$22.5 billion lent by five major Wall Street banks. The deal cemented Pfizer's position as the largest pharmaceutical company in the world, with the merged company generating over US$20 billion in cash each year, and was the largest corporate merger since AT&T and BellSouth's US$70 billion deal in March 2006. The combined company was expected to save US$4 billion annually through streamlining; however, as part of the deal, both companies must repatriate billions of dollars in revenue from foreign sources to the United States, which will result in higher tax costs. The acquisition was completed on October 15, 2009, making Wyeth a wholly owned subsidiary of Pfizer.
The merger was broadly criticized. Harvard Business School's Gary Pisano told The Wall Street Journal, "the record of big mergers and acquisitions in Big Pharma has just not been good. There's just been an enormous amount of shareholder wealth destroyed." Analysts said at the time, "The Warner–Lambert and Pharmacia mergers do not appear to have achieved gains for shareholders, so it is unclear who benefits from the Wyeth–Pfizer merger to many critics."
2010: King Pharmaceuticals acquisition
In February 2011, it was announced that Pfizer was to close its UK research and development facility (formerly also a manufacturing plant) in Sandwich, Kent, which at the time employed 2,400 people. However, as of 2014, Pfizer has a reduced presence at the site; it also has a UK research unit in Cambridge.
On September 4, 2012, the FDA approved a Pfizer pill for a rare type of leukemia. The medicine, called Bosulif, treats chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults.
In July 2014, the company announced it would acquire Innopharma for $225 million, plus up to $135 million in milestone payments, in a deal that expanded Pfizer's range of generic and injectable drugs.
On January 5, 2015, the company announced it would acquire a controlling interest in Redvax for an undisclosed sum. This deal expanded the company's vaccine portfolio targeting human cytomegalovirus. In March 2015, the company announced it would restart its collaboration with Eli Lilly surrounding the phase III trial of Tanezumab. Pfizer is expected to receive an upfront sum of $200 million. In June 2015, the company acquired two meningitis drugs from GlaxoSmithKline—Nimenrix and Mencevax—for around $130 million, expanding the company's meningococcal disease portfolio of drugs.
In May 2016, the company announced it would acquire Anacor Pharmaceuticals for $5.2 billion, expanding the company's portfolio in both inflammation and immunology drugs areas. On their final trading day, Anacor shares traded for $99.20 each, giving Anacor a market capitalisation of $4.5 billion. In August, the company made a $40 million bid for the assets of the now bankrupt BIND Therapeutics through the U.S. Bankruptcy Court. The same month, the company announced it would acquire Bamboo Therapeutics for $645 million, expanding the company's gene therapy offerings. Later, in August, the company announced the acquisition of cancer drug-maker – Medivation – for $14 billion. On Medivation's final day of trading, its shares were valued at $81.44 each, giving an effective market capitalisation of $13.52 billion. Two days later, Pfizer announced it would acquire AstraZeneca's small-molecule antibiotics business for $1.575 billion merging it into its Essential Medicines business In the same month the company licensed the anti-CTLA4 monoclonal antibody, ONC-392, from OncoImmune.
In May 2019 the company announced it would acquire Therachon for $810 million, expanding its rare disease portfolio through Therachon's recombinant human fibroblast growth factor receptor 3 compound, aimed at treating conditions such as achondroplasia. In June, Pfizer announced it would acquire Array Biopharma for $10.6 billion boosting its oncology pipeline.
In September 2020, the company announced it had purchased a 9.9% stake in CStone Pharmaceuticals for $200 million (HK$1.55 billion), helping to commercialise its anti-PD-L1 monoclonal antibody, CS1001. In October, Pfizer announced it had acquired Arixa Pharmaceuticals.
2013: Zoetis spin-off
Plans to spin out Zoetis, the Agriculture Division of Pfizer and later Pfizer Animal Health, were announced in 2012. Pfizer filed for registration of a Class A stock with the U.S. Securities and Exchange Commission on August 13, 2012. Zoetis's IPO on February 1, 2013, sold 86.1 million shares for US$2.2 billion. Pfizer retained 414 million Class B shares, giving it an 83% controlling stake in the firm. The offering's lead underwriters were JPMorgan Chase, Bank of America, Merrill Lynch, and Morgan Stanley. Most of the money raised through the IPO was used to pay off existing Pfizer debt.
2015: Hospira acquisition
In February 2015, Pfizer and Hospira agreed that Pfizer would acquire Hospira for $15.2 billion, a deal in which Hospira shareholders would receive $90 in cash for each share they owned. News of the deal sent Hospira share prices up from $63.43 to $87.43 on a volume of 60.7 million shares. Including debt, the deal is valued at around $17 billion. Hospira is the largest producer of generic injectable pharmaceuticals in the world. On the final day of trading, Hospira shares traded for $89.96 each, giving a market capitalization of $15.56 billion.
2015: Attempted Allergan acquisition
On November 23, 2015, Pfizer and Allergan, plc announced their intention to merge for an approximate sum of $160 billion, making it the largest pharmaceutical deal ever, and the third largest corporate merger in history. As part of the deal, the Pfizer CEO, Ian Read, was to remain as CEO and chairman of the new company, to be called "Pfizer plc", with Allergan's CEO, Brent Saunders, becoming president and chief operating officer. As part of the deal, Allergan shareholders would receive 11.3 shares of the company, with Pfizer shareholders receiving one. The terms proposed that the merged company would maintain Allergan's Irish domicile, resulting in the new company being subject to corporation tax at the Irish rate of 12.5%--considerably lower than the 35% rate that Pfizer paid at the time. The deal was to constitute a reverse merger, whereby Allergan acquired Pfizer, with the new company then changing its name to "Pfizer, plc". The deal was expected to be completed in the second half of 2016, subject to certain conditions: US and EU approval, approval from both sets of shareholders, and the completion of Allergan's divestiture of its generics division to Teva Pharmaceuticals (expected in the first quarter of 2016). On April 6, 2016, Pfizer and Allergan announced they would be calling off the merger after the Obama administration introduced new laws intended to limit corporate tax inversions (the extent to which companies could move their headquarters overseas in order to reduce the amount of taxes they pay).
2017: Pfizer Consumer Healthcare
In October 2017, reports emerged that Pfizer was undertaking a strategic review of its consumer healthcare division, with possible results ranging from a partial or complete spin-off or a direct sale. The divestment was expected to raise approximately $15 billion. Reckitt Benckiser expressed interest in bidding for the division earlier in October with Sanofi, Johnson & Johnson, Procter & Gamble and GlaxoSmithKline also being linked with bids for the business. On March 22, Reckitt Benckiser pulled out of the deal, a day later GlaxoSmithKline also pulled out.
In December 2018, GlaxoSmithKline announced that it, along with Pfizer, had reached an agreement to merge and combine their consumer healthcare divisions into a single entity. The combined entity would have sales of around £9.8 billon ($12.7 billion), with GSK maintaining a 68% controlling stake in the joint venture. Pfizer would own the remaining 32% shareholding. The deal builds on an earlier 2018 deal where GSK bought out Novartis' stake in the GSK-Novartis consumer healthcare joint business. The transaction closed in August 2019 and gives GSK three years to publicly list the business in the UK.
2019: Sale of Upjohn and formation of Viatris
In July 2019, Pfizer announced that it would merge its off-patent branded and generic established medicines business, known as Upjohn, with Mylan. The transaction created a new company, Viatris, using a reverse Morris trust structure.[third-party source needed] The new business will trade on the NASDAQ stock exchange under the ticker NASDAQ: VTRS. Pfizer shareholders would own 57% of the new combined business. The Board of Viatris will be composed of Robert J. Coury as Executive Chairman, Michael Goettler as CEO, eight people chosen by Mylan and three chosen by Pfizer. In December 2019, Pfizer chose former CEO and Chairman, Ian Read and Director of Pfizer, James Kilts. In February 2020, Pfizer announced W. Don Cornwell and their final Board selection with Mylan selecting JoEllen Lyons Dillon, Neil Dimick, Melina Higgins, Harry A. Korman, Rajiv Malik, Richard A. Mark, Mark W. Parrish and Pauline van der Meer Mohr as their Board nominees – all directors of Mylan.
2020: COVID-19 vaccine
In May 2020, Pfizer began testing four different COVID-19 vaccine variations. It planned to expand human trials to thousands of test patients by September 2020. The pharma company injected doses of the potential vaccine BNT162b2, which was developed by the German biotechnology company BioNTech, and into the first human participants in the U.S. in early May. Based on the results, Pfizer said they "will be able to deliver millions of doses in the October time frame" and expects to produce hundreds of millions of doses in 2021.
In July 2020, Pfizer and BioNTech announced that two of the partners' four mRNA vaccine candidates had won fast track designation from the FDA. The company began Phase III testing in the last week of July 2020, on 30,000 people and was slated to be paid $1.95 billion for 100 million doses of the vaccine by the United States government. The U.S. deal priced two doses at $39 and the company stated that it would not lower the rates for other countries until the outbreak is no longer a pandemic. Pfizer's CEO stated the companies in the private sector producing a vaccine should make a profit.
In September 2020, Pfizer and BioNTech announced that they had completed talks with the European Commission to provide an initial 200 million vaccine doses to the EU, with the option to supply another 100 million doses at a later date.
In October 2020, it was reported that Pfizer would start testing the COVID-19 vaccine developed by BioNTech on a broader range of subjects including children as young as 12. This would be the first coronavirus vaccine trial to include children in the United States.
On November 9, 2020, Pfizer announced that the vaccine had a nearly 95% efficacy rate with no serious side effects. On November 20, 2020, Pfizer applied for Emergency use authorization from the Food and Drug Administration for the vaccine. On December 2, 2020, the United Kingdom granted emergency use authorization to Pfizer-BioNTech's vaccine, becoming the first country to approve a COVID-19 vaccine that had been tested in a "large clinical trial" of "43,000 people".
On December 4, 2020, Bahrain became the second country to approve emergency use of the Pfizer–BioNTech COVID-19 vaccine for high-risk groups and later announced that the vaccine would be provided free to the public.
On December 8, 2020, Britain began initial distribution of the Covid-19 vaccine. On December 9, 2020, British regulators told hospitals not to give the Pfizer–BioNTech COVID-19 vaccine to people prone to "serious" allergic reactions, after two National Health Service staffers had symptoms of "anaphylactoid reaction".
Also on December 9, 2020, Canada became the third country to approve the Pfizer–BioNTech COVID-19 vaccine, initially purchasing 20M doses and preserving the option to purchase up to 56M additional doses. An initial delivery of 249,000 doses was planned for December with up to 4M more doses planned for delivery by March 2021.
On December 10, 2020, the United States Food and Drug Administration (FDA) held an advisory committee meeting to discuss authorization of the vaccine. An independent panel voted 17-4 in support of the FDA approving the vaccine. On the same day, Saudi Arabia approved the vaccine, becoming the 4th country to do so. The next day, December 11, 2020, the United States officially became the 5th country to approve use of BioNTech's Covid-19 vaccine. The FDA granted Emergency Use Authorization (EUA) and under the United States agreement with Pfizer, Pfizer agreed to an initial distribution of 2.9 million doses on an immediate basis and 100 million doses through March 2021, with the United States providing the vaccine free to the public. On December 14, 2020, Singapore became one of the first in Asia to approve the vaccine through the Health Sciences Authority.
On December 21, 2020, the European Union European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for the vaccine "Comirnaty" developed by BioNTech and Pfizer. On December 27, 2020, the European Union launched a co-ordinate measure to rollout the Pfizer–BioNTech COVID-19 vaccine, which was distributed to all the 27 member states. The top officials of the Union called it a “touching moment of unity”.
Pfizer is organized into nine principal operating divisions: Primary Care, Specialty Care, Oncology, Emerging Markets, Established Products, Consumer Healthcare, Nutrition, Animal Health, and Capsugel.
Research and development
Pfizer's research and development activities are organized into two principal groups: the PharmaTherapeutics Research & Development Group, which focuses on the discovery of small molecules and related modalities; and the BioTherapeutics Research & Development Group, which focuses on large-molecule research, including vaccines. In 2007, Pfizer invested $8.1 billion in research and development, the largest R&D investment in the pharmaceutical industry.
In 2018, Pfizer announced that it would end its work on research into treatments for Alzheimer's disease and Parkinsonism (a symptom of Parkinson's disease and other conditions). The company stated that approximately 300 researchers would lose their jobs as a result.
In 2018, Pfizer signed an agreement with the German biotechnology company BioNTech, to conduct joint research and development activities, to further the advance of mRNA-based flu vaccines. Under the agreement, following BioNTech’s completion of a first in-human clinical study, Pfizer would assume sole responsibility for further clinical development and commercialization of mRNA-based flu vaccines.
In 2020, Pfizer partnered again with BioNTech, to study and develop COVID-19 mRNA vaccine candidates. On July 27, 2020, the companies announced the start of a global (except China) Phase 2/3 safety and efficacy clinical study to evaluate the mRNA vaccine candidate BNT162b2. The companies plan to use Pfizer facilities to manufacture the vaccine if they receive FDA approval.
In November 2020, Pfizer announced that BioNTech's COVID-19 vaccine, tested on 43,500 people, was found 90% effective, which was described as a "milestone."
As of 2017, Pfizer split its business into two primary segments: (1) innovative health, which includes branded drugs and vaccines, and (2) essential health. In 2016, innovative health generated $29.2 billion in revenue and essential health generated $23.6 billion.
Key Pfizer products include a pneumococcal conjugate vaccine, trademarked Prevnar 13; this, along with Pneumosil, produced by the Serum Institute of India, and Synflorix, produced by GlaxoSmithKline, is used for the prevention of invasive pneumococcal infections. The introduction of the original, 7-valent version of the vaccine, developed by Wyeth in February 2000, led to a 75% reduction in the incidence of invasive pneumococcal infections among children under age 5 in the United States. Pfizer acquired Wyeth in 2009 and introduced an improved version of the vaccine in 2010, for which it was granted a patent in India in 2017. Prevnar 13 provides coverage of 13 bacterial variants, expanding beyond the original 7-valent version. As of 2012 the rate of invasive infections among children under age 5 had been reduced by an additional 50%. Prevnar 13 is Pfizer's best-selling product and the best-selling vaccine in the world, with annual sales of $5.8 billion in 2020.
Lyrica, a pregabalin for neuropathic pain, is another key product with sales of $4.6 billion in 2013; the US patent on Lyrica was challenged by generic manufacturers and was upheld in 2014, giving Pfizer exclusivity for Lyrica in the US until 2018. Xeljanz, a tofacitinib) for rheumatoid arthritis and ulcerative colitis, had sales of $1.77 billion in 2018 and in January 2019 it was top drug in the United States for direct-to-consumer advertising, passing Humira.
In addition to marketing branded pharmaceuticals, Pfizer is involved in the manufacture and sale of generics. In the US it does this through its Greenstone subsidiary, which it acquired as part of the acquisition of Pharmacia. Pfizer also has a licensing deal in place with Aurobindo, which grants the former access to a variety of oral solid generic products. Key historical generics include:
- Atorvastatin (trade name Lipitor), a statin for the treatment of hypercholesterolemia. Lipitor was developed by Pfizer legacy company Parke-Davis, a subsidiary of Warner-Lambert and first marketed in 1996. Although atorvastatin was the fifth drug in the class of statins to be developed, clinical trials showed that atorvastatin caused a more dramatic reduction in LDL-C than the other statin drugs. From 1996 to 2012 under the trade name Lipitor, atorvastatin became the world's best-selling drug of all time, with more than $125 billion in sales over approximately 14.5 years. Lipitor alone "provided up to a quarter of Pfizer Inc.'s annual revenue for years." The patent expired in 2011.
- Diflucan (fluconazole), the first orally available treatment for severe fungal infections. Fluconazole is recommended as a first-line treatment in invasive candidiasis and is widely used in the prophylaxis of severe fungal infections in premature infants. Fluconazole is on the World Health Organization's List of Essential Medicines. Patent protection ended in 2004 and 2005.
- Flagyl (metronidazole) is a nitroimidazole antibiotic medication used particularly for anaerobic bacteria and protozoa. It is antibacterial against anaerobic organisms, an amoebicide, and an antiprotozoal. As of 2018, it is second line for first episodes of mild-to-moderate Clostridium difficile infection (formerly was first-line). It is on the World Health Organization's List of Essential Medicines. The original patent protection ended in 1982, but reformulation evergreening occurred thereafter.
- Norvasc (amlodipine), an antihypertensive drug of the dihydropyridine calcium channel blocker class. Amlodipine is on the World Health Organization's List of Essential Medicines, a list of the most important medication needed in a basic health system. Patent protection ended in 2007.
- Zithromax (azithromycin), a macrolide antibiotic that is recommended by the Infectious Disease Society of America as a first line treatment for certain cases of community-acquired pneumonia. Patent protection ended in 2005.
- Zoloft (sertraline), is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It was introduced to the market by Pfizer in 1991. Sertraline is primarily prescribed for major depressive disorder in adult outpatients as well as obsessive–compulsive, panic, and social anxiety disorders in both adults and children. In 2011, it was the second-most prescribed antidepressant on the U.S. retail market, with 37 million prescriptions. The patent expired 2006.
Pfizer has long been known within the industry as one of the more aggressive marketers of their products. Access to Wyeth internal documents has revealed marketing strategies used to promote Neurontin for off-label use. In 1993, the U.S. Food and Drug Administration (FDA) approved gabapentin (Neurontin, Pfizer) only for treatment of seizures. Warner–Lambert, which merged with Pfizer in 2000, used activities not usually associated with sales promotion, including continuing medical education and research, sponsored articles about the drug for the medical literature, and alleged suppression of unfavorable study results, to promote gabapentin. Within 5 years the drug was being widely used for the off-label treatment of pain and psychiatric conditions. Warner–Lambert admitted to charges that it violated FDA regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses, and paid $430 million to resolve criminal and civil health care liability charges. A Cochrane review concluded that gabapentin is ineffective in migraine prophylaxis. The American Academy of Neurology rates it as having unproven efficacy, while the Canadian Headache Society and the European Federation of Neurological Societies rate its use as being supported by moderate and low-quality evidence, respectively.
In September 2009, Pfizer agreed to pay US$2.3 billion to settle civil and criminal allegations that it had illegally marketed four drugs—Bextra, Geodon, Zyvox, and Lyrica—for non-approved uses; it was Pfizer's fourth such settlement in a decade. The payment included $1.3 billion in criminal penalties for felony violations of the Food, Drug and Cosmetic Act, and $1 billion to settle allegations it had illegally promoted the drugs for uses that were not approved by the U.S. Food and Drug Administration (FDA) and caused false claims to be submitted to Federal and State programs. The criminal fine was the largest ever assessed in the United States up to that time. Pfizer has entered an extensive corporate integrity agreement with the Office of Inspector General and will be required to make substantial structural reforms within the company, and maintain the Pfizer website (
pfizer.com/pmc) to track the company's post marketing commitments. Pfizer had to also put a searchable database of all payments to physicians the company had made on the Pfizer website by March 31, 2010.
Peter Rost was vice president in charge of the endocrinology division at Pharmacia before and during its acquisition by Pfizer. During that time he raised concerns internally about kickbacks and off-label marketing of Genotropin, Pharmacia's human growth hormone drug. Pfizer reported the Pharmacia marketing practices to the FDA and Department of Justice; Rost was unaware of this and filed an FCA lawsuit against Pfizer. Pfizer kept him on, but isolated him until the FCA suit was unsealed in 2005. The Justice Department declined to intervene, and Pfizer fired him, and he filed a wrongful termination suit against Pfizer. Pfizer won a summary dismissal of the case, with the court ruling that the evidence showed Pfizer had decided to fire Rost prior to learning of his whistleblower activities.
A "whistleblower suit" was filed in 2005 against Wyeth, which was acquired by Pfizer in 2009, alleging that the company illegally marketed their drug Rapamune. Wyeth is targeted in the suit for off-label marketing, targeting specific doctors and medical facilities to increase sales of Rapamune, trying to get transplant patients to change from their transplant drugs to Rapamune and for specifically targeting African-Americans. According to the whistleblowers, Wyeth also provided doctors and hospitals with kickbacks to prescribe the drug in the form of grants, donations and other money. In 2013, the company pleaded guilty to criminal mis-branding violations under the Food, Drug and Cosmetic Act. By August 2014 it had paid $491 million in civil and criminal penalties.
According to Harper's Magazine publisher John MacArthur, Pfizer withdrew "between $400,000 and a million dollars" worth of ads from their magazine following an unflattering article on depression medication.
The Quigley Company, which sold asbestos-containing insulation products until the early 1970s, was acquired by Pfizer in 1968. Asbestos victims and Pfizer have been negotiating a settlement deal that calls for Pfizer to pay $430 million to 80 percent of existing plaintiffs. It will also place an additional $535 million into an asbestos settlement trust that will compensate future plaintiffs as well as the remaining 20 percent of plaintiffs with claims against Pfizer and Quigley. The compensation deal is worth $965 million all up. Of that $535 million, $405 million is in a 40-year note from Pfizer, while $100 million will come from insurance policies.
Pfizer purchased Shiley in 1979, at the onset of its Convexo-Concave valve ordeal, involving the Bjork–Shiley heart valve. Approximately 500 people died when defective valves failed and, in 1994, the United States ruled against Pfizer for ~$200 million.
A federal lawsuit was filed by a scientist claiming infection by a genetically modified virus while working for Pfizer which resulted in her being intermittently paralyzed. "McClain, of Deep River, suspects she was inadvertently exposed, through work by a former Pfizer colleague in 2002 or 2003, to an engineered form of the lentivirus, a virus similar to the one that can lead to acquired immune deficiency syndrome, also known as AIDS." The court found that McClain failed to demonstrate that her illness was caused by exposure to the lentivirus, but also that Pfizer violated whistleblower laws.
Health insurance company Blue Cross Blue Shield (BCBS) filed a lawsuit against Pfizer for reportedly illegally marketing their drugs Bextra, Geodon and Lyrica. BCBS is reporting that Pfizer used "kickbacks" and wrongly persuaded doctors to prescribe the drugs. FiercePharma reported that "According to the suit, the drugmaker not only handed out those "misleading" materials on off-label uses, but sent doctors on Caribbean junkets and paid them $2,000 honoraria in return for their listening to lectures about Bextra. More than 5,000 healthcare professionals were entertained at meetings in Bahamas, Virgin Islands, and across the U.S., the suit alleges." The case was settled in 2014 for $325M.
Controversy arose over the drug "Celebrex". Brigham Young University (BYU) said that a professor of chemistry, Dr. Daniel L. Simmons, discovered an enzyme in the 1990s that would later lead towards the development of Celebrex. BYU was originally seeking 15% royalty on sales, which would equate to $9.7 billion. The court filings show that a research agreement was made with Monsanto, whose pharmaceutical business was later acquired by Pfizer, to develop a better aspirin. The enzyme that Dr. Simmons claims to have discovered would induce pain and inflammation while causing gastrointestinal problems, which Celebrex is used to reduce those issues. A battle ensued, lasting over six years, because BYU claimed that Pfizer did not give him credit or compensation while Pfizer claims it had met all obligations regarding the Monsanto agreement. This culminated in a $450 million amicable settlement without going to trial. Pfizer said it would take a $450 million charge against first quarter earnings to settle.
Nigeria Trovafloxacin lawsuit
In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives and personnel from a contract research organization (CRO) traveled to Kano to set up a clinical trial and administer an experimental antibiotic, trovafloxacin, to approximately 200 children. Local Kano officials reported that more than 50 children died in the experiment, while many others developed mental and physical deformities. The nature and frequency of both fatalities and other adverse outcomes were similar to those historically found among pediatric patients treated for meningitis in sub-Saharan Africa. In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment. According to the news program Democracy Now!, "[r]esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug." The lawsuits also accuse Pfizer of using the outbreak to perform unapproved human testing, as well as allegedly under-dosing a control group being treated with traditional antibiotics in order to skew the results of the trial in favor of Trovan. While the specific facts of the case remain in dispute, both Nigerian medical personnel and at least one Pfizer physician have stated that the trial was conducted without regulatory approval.
In 2007, Pfizer published a Statement of Defense letter. The letter states that the drug's oral form was safer and easier to administer, that Trovan had been used safely in over 5000 Americans prior to the Nigerian trial, that mortality in the patients treated by Pfizer was lower than that observed historically in African meningitis epidemics, and that no unusual side effects, unrelated to meningitis, were observed after 4 weeks.
In June 2010, the US Supreme Court rejected Pfizer's appeal against a ruling allowing lawsuits by the Nigerian families to proceed.
In December 2010, WikiLeaks released US diplomatic cables, which indicate that Pfizer had hired investigators to find evidence of corruption against Nigerian attorney general Aondoakaa to persuade him to drop legal action. The Washington Post reporter Joe Stephens, who helped break the story in 2000, called these actions "dangerously close to blackmail." In response, the company has released a press statement describing the allegations as "preposterous" and stating that they acted in good faith. Aondoakka, who had allegedly demanded bribes from Pfizer in return for a settlement of the case, was declared unfit for office and had his U.S. visa revoked in association with corruption charges in 2010.
Between 2002 and 2008, Pfizer reduced its greenhouse emissions by 20%, and committed to reducing emissions by an additional 20% by 2012. In 2012, the company was named to the Carbon Disclosure Project's Carbon Leadership Index in recognition of its efforts to reduce greenhouse gas emissions.
Pfizer has inherited Wyeth's liabilities in the American Cyanamid site in Bridgewater, New Jersey. This site is highly toxic and an EPA declared Superfund site. Pfizer has since attempted to remediate this land in order to clean and develop it for future profits and potential public uses. The Sierra Club and the Edison Wetlands Association have come out in opposition to the cleanup plan, arguing that the area is subject to flooding, which could cause pollutants to leach. The EPA considers the plan the most reasonable from considerations of safety and cost-effectiveness, arguing that an alternative plan involving trucking contaminated soil off site could expose cleanup workers. The EPA's position is backed by the environmental watchdog group CRISIS.
In June 2002, a chemical explosion at the Groton plant injured seven people and caused the evacuation of over 100 homes in the surrounding area.
Pfizer is a leading member of the U.S. Global Leadership Coalition, a Washington D.C.-based coalition of over 400 major companies and NGOs that advocates for a larger International Affairs Budget, which funds American diplomatic, humanitarian, and development efforts abroad.
Pfizer is one of the single largest lobbying interests in United States politics. For example, in the first 9 months of 2009 Pfizer spent over $16.3 million on lobbying US congressional lawmakers, making them the sixth largest lobbying interest in the US (following Pharmaceutical Research and Manufacturers of America (PhRMA), which ranked fourth but also represents many of their interests). A spokeswoman for Pfizer said the company “wanted to make sure our voice is heard in this conversation” in regards to the company's expenditure of $25 million in 2010 to lobby health care reform.
According to U.S. State Department cables released by WikiLeaks, Pfizer "lobbied against New Zealand getting a free trade agreement with the United States because it objected to New Zealand's restrictive drug buying rules and tried to get rid of New Zealand's former health minister”, Helen Clark, in 1990.
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