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===Nigeria===
===Nigeria===
In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives traveled to Kano, Nigeria to administer an experimental [[antibiotic]], [[trovafloxacin]], to approximately 200 children. Local Kano officials report that more than 50 children died in the experiment, while many others developed mental and physical deformities.<ref>{{cite web|last=Murray |first=Senan |url=http://news.bbc.co.uk/2/hi/africa/6768799.stm |title=Africa &#124; Anger at deadly Nigerian drug trials |publisher=BBC News |date=June 20, 2007 |accessdate=July 11, 2011}}</ref> The nature and frequency of both fatalities and other adverse outcomes were similar to those historically found among pediatric patients treated for meningitis in Africa.<ref>{{cite journal |author=Powers SK, Dodd S, Freeman J, Ayers GD, Samson H, McKnight T |title=Accuracy of pulse oximetry to estimate HbO2 fraction of total Hb during exercise |journal=J. Appl. Physiol. |volume=67 |issue=1 |pages=300–4 |year=1989 |month=July |pmid=2759956 |doi= |url=}}</ref> In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment.<ref>{{cite news| url=http://news.bbc.co.uk/2/hi/business/1517171.stm |work=BBC News | title=Nigerians sue Pfizer over test deaths | date=August 30, 2001 | accessdate=May 22, 2010}}</ref> Representing the government is Babatunde Irukera. According to news reports, "[r]esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug."<ref name=DN>[http://www.democracynow.org/2010/12/17/wikileaks_cables_pfizer_targeted_nigerian_attorney WikiLeaks Cables: Pfizer Targeted Nigerian Attorney General to Undermine Suit over Fatal Drug Tests], ''[[Democracy Now!]]''</ref> 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. Pfizer denied these claims, and subsequently produced an approval letter for testing from the Nigerian Ethics Committee. The Nigerian government insisted that it was a fake and a panel of Nigerian medical experts agreed that the letter had been concocted and backdated by the company's lead researcher in Kano. They went on to conclude that Pfizer never obtained authorization from the Nigerian government to give the unproven drug to children and infants.<ref>[http://www.washingtonpost.com/wp-dyn/content/article/2006/05/06/AR2006050601338.html Panel Faults Pfizer in '96 Clinical Trial In Nigeria]. ''[[The Washington Post]]''. May 7, 2006</ref>
In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives traveled to Kano, Nigeria to administer an experimental [[antibiotic]], [[trovafloxacin]], to approximately 200 children. Local Kano officials report that more than 50 children died in the experiment, while many others developed mental and physical deformities.<ref>{{cite web|last=Murray |first=Senan |url=http://news.bbc.co.uk/2/hi/africa/6768799.stm |title=Africa &#124; Anger at deadly Nigerian drug trials |publisher=BBC News |date=June 20, 2007 |accessdate=July 11, 2011}}</ref> 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.<ref>{{cite journal |author=Ramakrishnan M, Ulland AJ, Steinhardt LC, Moïsi JC, Were F, Levine OS |title=Sequelae due to bacterial meningitis among African children: a systematic literature review |journal=BMC Med |volume=7 |issue= |pages=47 |year=2009 |pmid=19751516 |pmc=2759956 |doi=10.1186/1741-7015-7-47 |url=}}</ref> In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment.<ref>{{cite news| url=http://news.bbc.co.uk/2/hi/business/1517171.stm |work=BBC News | title=Nigerians sue Pfizer over test deaths | date=August 30, 2001 | accessdate=May 22, 2010}}</ref> Representing the government is Babatunde Irukera. According to news reports, "[r]esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug."<ref name=DN>[http://www.democracynow.org/2010/12/17/wikileaks_cables_pfizer_targeted_nigerian_attorney WikiLeaks Cables: Pfizer Targeted Nigerian Attorney General to Undermine Suit over Fatal Drug Tests], ''[[Democracy Now!]]''</ref> 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. Pfizer denied these claims, and subsequently produced an approval letter for testing from the Nigerian Ethics Committee. The Nigerian government insisted that it was a fake and a panel of Nigerian medical experts agreed that the letter had been concocted and backdated by the company's lead researcher in Kano. They went on to conclude that Pfizer never obtained authorization from the Nigerian government to give the unproven drug to children and infants.<ref>[http://www.washingtonpost.com/wp-dyn/content/article/2006/05/06/AR2006050601338.html Panel Faults Pfizer in '96 Clinical Trial In Nigeria]. ''[[The Washington Post]]''. May 7, 2006</ref>


In 2007, Pfizer published a Statement of Defense letter.<ref>{{cite web|url=http://www.pfizer.com/files/news/trovan_statement_defense_summary.pdf |title=Trovan, Kano State Civil Case – Statement Of Defense |format=PDF |accessdate=July 11, 2011}}</ref> The letter makes several claims, including that Pfizer donated 18 million in Nigerian Naira (NGN) (about $216,000 in 1996 US dollars (USD)),<ref>{{cite web|url=http://www.oanda.com/convert/fxhistory |title=FXHistory – Historical Currency Exchange Rates |publisher=Oanda.com |date=April 16, 2011 |accessdate=July 11, 2011}}</ref> that the drug's oral form was presented as safer and easier to administer, that the administration of Trovan saved lives, and that no unusual side effects, unrelated to meningitis, were observed after 4 weeks.
In 2007, Pfizer published a Statement of Defense letter.<ref>{{cite web|url=http://www.pfizer.com/files/news/trovan_statement_defense_summary.pdf |title=Trovan, Kano State Civil Case – Statement Of Defense |format=PDF |accessdate=July 11, 2011}}</ref> The letter makes several claims, including that Pfizer donated 18 million in Nigerian Naira (NGN) (about $216,000 in 1996 US dollars (USD)),<ref>{{cite web|url=http://www.oanda.com/convert/fxhistory |title=FXHistory – Historical Currency Exchange Rates |publisher=Oanda.com |date=April 16, 2011 |accessdate=July 11, 2011}}</ref> that the drug's oral form was presented as safer and easier to administer, that the administration of Trovan saved lives, and that no unusual side effects, unrelated to meningitis, were observed after 4 weeks.

Revision as of 21:28, 9 February 2013

"Fizer" redirects here. For the American professional basketball player, see Marcus Fizer.

Pfizer, Inc.
Company typePublic
NYSE: PFE
Dow Jones Industrial Average Component
S&P 500 Component
IndustryPharmaceutical
Founded1849 (1849)
Headquarters235 East 42nd Street
New York City, New York, United States
Area served
Worldwide
Key people
Ian Read
(President & CEO)
ProductsList of Pfizer products
RevenueIncrease US$ 67.42 billion (2011)[1]
Increase US$ 12.76 billion (2011)[1]
Increase US$ 10.00 billion (2011)[1]
Total assetsDecrease US$ 188.00 billion (2011)[1]
Total equityDecrease US$ 82.19 billion (2011)[1]
Number of employees
103,700 (2011)[1]
SubsidiariesAgouron Pharmaceuticals, G. D. Searle & Company, Greenstone, Parke-Davis, Pfizer UK, Warner Lambert, Wyeth, Zoetis
WebsitePfizer.com

Pfizer, Inc. (/ˈfaɪzər/) (NYSE: PFE) is an American multinational pharmaceutical corporation headquartered in New York City,[2] and with its research headquarters in Groton, Connecticut, United States. It is the world's largest pharmaceutical company by revenues.[3]

Pfizer develops and produces medicines and vaccines for a wide range of conditions including in the areas of immunology and inflammation, oncology, cardiovascular and metabolic diseases, neuroscience and pain. Pfizer's products include Lipitor (atorvastatin, used to lower LDL blood cholesterol); Lyrica (pregabalin, for neuropathic pain/fibromyalgia); Diflucan (fluconazole, an oral antifungal medication); Zithromax (azithromycin, an antibiotic); Viagra (sildenafil, for erectile dysfunction); and Celebrex/Celebra (celecoxib, an anti-inflammatory drug).

Pfizer was founded by cousins Charles Pfizer and Charles Erhart in New York City in 1849 as a manufacturer of fine chemicals. Pfizer's discovery of Terramycin (oxytetracycline) in 1950 put it on a path towards becoming a research-based pharmaceutical company. Pfizer has made numerous acquisitions, including of Warner–Lambert in 2000, Pharmacia in 2003 and Wyeth in 2009, the latter acquired for US$68 billion.[4][5] Pfizer is listed on the New York Stock Exchange and its shares have been a component of the Dow Jones Industrial Average since April 8, 2004.[6]

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.[7] Pfizer also paid the U.S. government $1.3 billion in criminal fines related to the "off-label" marketing of Bextra, the largest penalty ever rendered for any crime.[8] Called a repeat offender, this was Pfizer's fourth such settlement with the U.S. Department of Justice in the previous ten years.[9][10]

History

1849 to 2000

Charles Pfizer

Pfizer is named after German-American cousins Charles Pfizer and Charles Erhart (originally from Ludwigsburg, Germany) who launched a fine chemicals business, Charles Pfizer and Company, from a building at the intersection of Harrison Avenue and Bartlett Street[11] in Williamsburg, Brooklyn in 1849. There, they produced an antiparasitic called santonin. This was an immediate success, although it was the production of citric acid that really kick-started Pfizer's growth in the 1880s. Pfizer continued to buy property to expand its lab and factory on the block bounded by Bartlett Street; Harrison Avenue; Gerry Street; and Flushing Avenue. That facility was used by Pfizer until 2005, when Pfizer closed its original plant along with several others. Pfizer established its original administrative headquarters at 81 Maiden Lane in Manhattan.[11] By 1906, sales totaled nearly $3 million.

World War I caused a shortage of calcium citrate that 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 were able to commercialize production of citric acid from this source in 1919. As a result Pfizer developed expertise in fermentation technology. These skills were applied to the mass production of penicillin during World War II, in response to a need from the U.S. government. The antibiotic was needed to treat injured Allied soldiers. In fact, most of the penicillin that went ashore with the troops on D-Day was made by Pfizer.

Following the success of penicillin production in the 1940s, penicillin became very inexpensive and Pfizer made very little profit for its efforts. As a result, in the late 1940s Pfizer decided to search for new antibiotics with greater profit potential. The discovery and commercialization of Terramycin (oxytetracycline) by Pfizer in 1950 moved the company on the path of change from a manufacturer of fine chemicals to a research-based pharmaceutical company. To augment its research in fermentation technology, Pfizer began a program to discover drugs through chemical synthesis. Pfizer also established an animal health division in 1959 with an 700-acre (2.8 km2) farm and research facility in Terre Haute, Indiana.

By the 1950s, Pfizer was established in Belgium, Brazil, Canada, Cuba, Iran, Mexico, Panama, Puerto Rico, Turkey and the United Kingdom. In 1960, the Company moved its medical research laboratory operations to a new facility in Groton, Connecticut. In 1980 Pfizer launched Feldene (piroxicam), a prescription anti-inflammatory medication that became Pfizer's first product to reach a total of a billion United States dollars in sales.

During the 1980s and 1990s Pfizer underwent a period of growth sustained by the discovery and marketing of Zoloft, Lipitor, Norvasc, Zithromax, Aricept, Diflucan, and Viagra.

2000 to 2011

Pfizer has recently grown by mergers, including those with Warner–Lambert (2000), with Pharmacia (2003), and with Wyeth (2009).

On June 26, 2006, Pfizer announced that it would sell its Consumer Healthcare unit (manufacturer of Listerine, Nicorette, Visine, Sudafed and Neosporin) to Johnson & Johnson for $16.6 billion.[12][13][14]

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 there were more deaths than expected in the group that took the medicine, and a 60% increase in deaths was seen among patients taking torcetrapib plus Lipitor versus Lipitor alone. There was no suggestion these results called into question the safety of Lipitor. Pfizer lost nearly $1 billion invested developing the failed drug, and the market value of the company plummeted in the aftermath.[15][16][17]

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.[18]

Warner–Lambert acquisition

Pfizer acquired Warner–Lambert in 2000.[19] Warner–Lambert was founded as a drug store in 1856 in Philadelphia 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 in 1999.

Pharmacia acquisition

In 2002, Pfizer merged with Pharmacia. The merger was again driven in part by the desire to acquire full rights to a product, this time Celebrex (celecoxib), the COX-2 selective inhibitor previously jointly marketed by Searle (acquired by Pharmacia) and Pfizer. In the ensuing years, Pfizer commenced with a massive restructuring resulting in numerous site closures and loss of jobs including: Terre Haute, IN; Holland, MI; Groton, CT; Brooklyn, NY; Sandwich, UK and Puerto Rico.

Pharmacia had been formed by a series of mergers and acquisition, with its predecessors including Searle, Upjohn and Sugen.

Searle was founded in Omaha, Nebraska, in 1888. The founder was Gideon Daniel Searle. In 1908, the company was incorporated in Chicago. In 1941, the company established headquarters in Skokie, Illinois. It was acquired by the Monsanto Company, headquartered in St. Louis, in 1985.

The Upjohn Company was a pharmaceutical manufacturing firm founded in 1886 in Kalamazoo, Michigan by Dr. William E. Upjohn, an 1875 graduate of the University of Michigan medical school. The company was originally formed to make friable pills, which were specifically designed to be easily digested. 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, New Jersey. The agricultural division was spun off from Pharmacia, as Monsanto, in preparation for the close of the acquisition by Pfizer.[20]

SUGEN was a company focused on protein kinase inhibitors, 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 the transfer of several programs to Pfizer. These included sunitinib (Sutent), which was approved for human use by the FDA in January 2006, passed $1 bn in annual revenues for Pfizer in 2010.[21] A related compound SU11654 (Toceranib) was also approved for canine tumors, and the ALK inhibitor Crizotinib also grew out of a SUGEN program[22]

In 2008, Pfizer announced 275 job cuts at the Kalamazoo manufacturing facility. Kalamazoo was previously the world headquarters for the Upjohn Company.[23]

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.[24] Wyeth's management team is expected to depart following the merger. The combined company could save US$4 billion annually through the streamlining of operations; 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.[5]

The merger received a vast array of criticism. Harvard Business School’s Gary Pisano told The Wall Street Journal that "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".[25]

The Warner–Lambert and Pharmacia mergers do not appear to have achieved gains for shareholders so it is unclear who will benefit from the Wyeth–Pfizer merger to many critics.[26]

King Pharmaceuticals acquisition

In October 2010, Pfizer agreed to buy King Pharmaceuticals for $3.6 billion in cash or $14.25 per share: an approximately 40% premium over King’s closing share price 11 October 2010.[27]

2011 to present

In February 2011 it was announced that it was to close its research and development facility in Kent, which employs 2,400 people.[28]

In April 2011 Pfizer agreed to sell its Capsugel unit, the world's largest maker of hard capsules, for about $2.38 billion to the private equity firm KKR & Co. The cash will be used for a part of share buyback about $5 billion planned for 2011.[29]

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.[30]

Zoetis

Main article: Zoetis

Plans to break away Zoetis, the Agriculture Division of Pfizer and later Pfizer Animal Health, were officially announced in 2012. Records show that Pfizer officially filled for registration of a Class A stock with the U.S. Securities and Exchange Commission on August 13, 2012.[31] Zoetis' IPO on February 1, 2013 sold 86.1 million shares for US$ 2.2 billion.[32] Pfizer retained 414 million Class B shares giving it an 83% controlling stake in the firm.[33] The offering's lead underwriters were JPMorgan Chase, Bank of America, Merrill Lynch and Morgan Stanley.[32] Most of the money raised through the IPO was used to pay off existing Pfizer debt.[34]

Operations

Pfizer world headquarters
The headquarters of Pfizer Japan in Tokyo

Pfizer is organised into nine principal operating divisions: Primary Care, Specialty Care, Oncology, Emerging Markets, Established Products, Consumer Healthcare, Nutrition, Animal Health and Capsugel.[35]

Research and development

Pfizer's research and development activities are organised 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.[35] In 2007, Pfizer invested $8.1 billion in research and development, the largest R&D investment in the pharmaceutical industry.[36]

Pfizer has R&D facilities in the following locations: Groton, Connecticut; La Jolla, California (around 1,000 staff, focused on cancer drugs);[37] South San Francisco, California; Cambridge, Massachusetts; Kalamazoo, Michigan; St. Louis, Missouri; Sandwich, United Kingdom; and Cambridge, United Kingdom.

In 2007, Pfizer announced plans to close or sell on the Loughbeg API facility, located at Loughbeg, Ringaskiddy Co.Cork Ireland by mid to end of 2008. In 2007, Pfizer announced plans to completely close the Ann Arbor, Nagoya and Amboise Research facilities by the end of 2008, eliminating 2,160 jobs and idling the $300-million dollar Michigan facility, which had seen millions of dollars of expansion in recent years.[38]

On June 18, 2007 Pfizer announced that it would move the Animal Health Research (VMRD) division based in Sandwich, England to Kalamazoo, Michigan.[39] On February 1, 2011 Pfizer announced the closure of the Research and Development centre in Sandwich, with the loss of 2,400 jobs.[40] Pfizer subsequently announced that it would maintain a significant presence at Sandwich, with around 650 staff continuing to be based at the site.[41]

On September 1, 2011 Pfizer announced that it had agreed to a 10-year lease of more than 180,000 square feet of research space from MIT in a building to be constructed at 610 Main Street South, just north of the MIT campus in Cambridge, Massachusetts, US. The space will house Pfizer’s Cardiovascular, Metabolic and Endocrine Disease Research Unit and its Neuroscience Research Unit — and Pfizer anticipates moving into the space once it is completed in late 2013.[42]

Products currently in Pfizer's development pipeline include dimebon and tanezumab.

Senior management

Current members of the board of directors of Pfizer are: Michael S. Brown, M. Anthony Burns, Robert Burt, Don Cornwell, William H. Gray, Frances D. Fergusson, Constance Horner, William R. Howell, Stanley Ikenberry, Ian Read (chairman), George Lorch, John P. Mascotte, Dana Mead, Ruth J. Simmons, and William Steere.

  • Chief Executive Officer (CEO) and Chairman of the Board: Ian Read[43]
  • Chief Financial Officer (CFO) and Senior Vice President: Frank A. D'Amelio
  • Strategy and Business Development and Senior Vice President: William R. Ringo Jr.
  • General Counsel, Corporate Secretary and Senior Vice President: Amy W. Schulman
  • Chief Communications Officer (CCO) and Senior Vice President: Sally Susman
  • President of Global R&D and Senior Vice President: Martin Mackay
  • Senior Vice President and President – Pfizer Global Manufacturing: Natale S. Ricciardi
  • Senior Vice President – Worldwide Human Resources: Chuck Hill
  • President and General Manager Speciality Care and Oncology Business Unit: Geno Germano
  • President and General Manager Primary Care Business Unit: John Young
  • President and General Manager Emerging Markets and Established Products Business Unit: Olivier Brandicourt

Products

Pharmaceutical products

Pfizer's pharmaceutical products include:[44]

Xanax (alprazolam) 2 mg tri-score tablets
Bottles of the antidepressant Zoloft

In addition to marketing branded pharmaceutials, 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.[45] Pfizer also has a licensing deal in place with Aurobindo which grants the former access to a variety of oral solid generic products.[46]

Consumer healthcare products

ChapStick

Pfizer's consumer healthcare products include:

Litigation

Pfizer is party to a number of suits stemming from its pharmaceutical products as well as practices of various companies it has acquired or merged with.[9][10][47]

Kelo case

Pfizer's interest in obtaining property in New London, Connecticut, for expanded facilities led to the Kelo v. New London case before the U.S. Supreme Court.

The Supreme Court's 2005 decision in Kelo v. City of New London handed local governments the right to seize private property for economic development,[48] i. e., offices, a hotel to enhance Pfizer Inc.'s nearby corporate facility. However, following the completion of the aforementioned Wyeth merger, Pfizer announced it will close its research and development headquarters in New London, Connecticut, moving employees to nearby Groton. The property is now owned and operated by Electric Boat.

Quigley Co.

Pfizer acquired Quigley in 1968, and the division sold asbestos-containing insulation products until the early 1970s.[49] Asbestos victims and Pfizer have been negotiating a settlement deal which 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 current 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.

Bjork–Shiley heart valve

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.[50][51]

Off-label promotional practices

Main article: Franklin v. Parke-Davis

Access to pharmaceutical industry documents has revealed marketing strategies used to promote Neurontin for off-label use.[52] 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.[53][54] Today it is a mainstay drug for migraines, even though it was not approved for such use in 2004.[55]

Bextra settlement of off-label marketing investigation

In September 2009, the United States Department of Justice announced that Pfizer had agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed four drugs: Bextra, Geodon, Zyvox, and Lyrica "with the intent to defraud or mislead" by promoting the drugs for non-approved uses[example needed]; this marks Pfizer's fourth such settlement in a decade.[9][10][47] Pharmacia & Upjohn Company, Inc., a Pfizer subsidiary, agreed to plead guilty to mis-branded promotion of Bextra, a felony violation of the Food, Drug and Cosmetic Act. The criminal fine accounts for $1.3 billion of the settlement, and was the largest criminal penalty imposed in American history until the BP plea agreement for the Deepwater Horizon oil spill.[56][57] Pfizer has entered an extensive corporate integrity agreement (CIA) with the Office of Inspector General and will be required to make substantial structural reforms within the company, and maintain the Pfizer website (www.pfizer.com/pmc) to track the company's post marketing commitments. Pfizer must also put a searchable database of all payments to physicians the company has made on the Pfizer website by March 31, 2010.[58] In addition, two former employees were separately indicted and sentenced for their role in marketing of Bextra. A former District Sales manager was found guilty of obstruction of justice for destroying documents pertinent to the investigation, and a Regional Sales Manager pled guilty to the distribution of a mis-branded product.[59][60]

The case is the largest civil settlement against a pharmaceutical company as well.[61] Pfizer paid a $1 billion civil fine 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 including but not limited to Medicare and Medicaid. Under the False Claims Act, damages can be assessed for violations of the federal Anti-Kickback statute, 42 U.S.C. § 1320a–7b(b)[62] and the off-label marketing provision within the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§301-97.[63] Six whistle-blowers will receive $102 million for their participation in the civil investigation, and John Kopchinski, a former sales representative, will receive $51.5 million for his allegations involving the marketing of Bextra.[64]

CNN speculated that Pharmacia & Upjohn, not Pfizer itself, pleaded guilty because prosecutors thought Pfizer was "too big to nail." Companies convicted of major health care fraud are automatically barred from billing Medicare and Medicaid for their products. Prosecutors feared that patients would be harmed by the exclusion of Pfizer drugs from federal healthcare programs.[65]

Nigeria

In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives traveled to Kano, Nigeria to administer an experimental antibiotic, trovafloxacin, to approximately 200 children. Local Kano officials report that more than 50 children died in the experiment, while many others developed mental and physical deformities.[66] 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.[67] In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment.[68] Representing the government is Babatunde Irukera. According to news reports, "[r]esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug."[69] 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. Pfizer denied these claims, and subsequently produced an approval letter for testing from the Nigerian Ethics Committee. The Nigerian government insisted that it was a fake and a panel of Nigerian medical experts agreed that the letter had been concocted and backdated by the company's lead researcher in Kano. They went on to conclude that Pfizer never obtained authorization from the Nigerian government to give the unproven drug to children and infants.[70]

In 2007, Pfizer published a Statement of Defense letter.[71] The letter makes several claims, including that Pfizer donated 18 million in Nigerian Naira (NGN) (about $216,000 in 1996 US dollars (USD)),[72] that the drug's oral form was presented as safer and easier to administer, that the administration of Trovan saved lives, and that no unusual side effects, unrelated to meningitis, were observed after 4 weeks.

In June 1999, the FDA released a public health statement warning against the use of Trovan except in life-or-death situations, due to high risk of liver failure. In some cases, liver damage occurred after only two days of treatment.[73]

In June 2010, the US Supreme Court rejected Pfizer's appeal against a ruling allowing lawsuits by the Nigerian families to proceed.[74]

In December 2010, WikiLeaks released US diplomatic cables, which indicate that Pfizer had "used dirty tricks to avoid clinical trial payout". The company had hired investigators to find evidence of corruption against the Nigerian attorney general to persuade him to drop legal action.[75] Washington Post reporter Joe Stephens, who helped break the story in 2000, called these actions "dangerously close to blackmail."[69] In response, the company has released a press statement describing the allegations as "preposterous" and stating that they acted in good faith.[76]

Lawsuit over GMO virus

A scientist claims she was infected by a genetically modified virus while working for Pfizer. In her federal lawsuit she says she has been intermittently paralyzed by the Pfizer-designed virus. "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, or AIDS."[77] The court found that McClain failed to demonstrate that her illness was caused by exposure to the lentivirus,[78] but also that Pfizer violated whistleblower laws.[79]

Blue Cross Blue Shield lawsuit

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.[80][81] 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."[82] Pfizer has had similar cases brought against it which it has settled with the US federal government and with more than 40 US states.[83] Pfizer denies the allegations.

Wyeth's Rapamune

A "whistleblower suit" was filed in 2005 against Wyeth, which was acquired by Pfizer, 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 increased sales of Rapamune, trying to get current transplant patients to change from their current 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.[84][85] A US House of Representatives committee, led by Rep. Edolphus Towns is currently[when?] investigating these allegations.[86][87]

Brigham Young University

Controversy arose over the drug "Celebrex." Brigham Young University (BYU) said that a professor of chemistry, Dr. Daniel Simmons, discovered an enzyme in the 1990s which 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, 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 in regards to 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.[88]

Environmental record

According to the EPA, Pfizer is among the top ten companies in America with the most numerous emissions sources.[89] A landfill and two wastewater lagoons in Ledyard, CT near the Pfizer plant in Groton, Connecticut, are a source of groundwater pollution in the area. According to the Connecticut Department of Environmental Protection (CT DEP), the Pfizer site is active under the CT DEP Site Remediation program.[90] 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.[91]

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. Members of the surrounding communities have stated that the EPA has been coerced into accepting a plan that is affordable for Pfizer but is not a complete/proper remediation plan for the site, detrimental to the interest of the community. The EPA has suggested a remediation plan that includes environmental caps and redeveloping a portion of it in the future. This redevelopment will occur on the site which is located within a flood plain, something the EPA failed to address in their feasibility study released in early 2012. The mayor of Bridgewater, the New Jersey Department of Environmental Protection, and other key community leaders also came out to endorse the plan without considering the amount of increased flooding that is going to take place if such a plan is implemented.[92]

Political lobbying

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.[93]

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.[94]

Pfizer's primary interests are opposition of Congressional efforts to attach a prescription drug benefit to Medicare and opposition to generic drugs entering US markets.[95] Pfizer also purportedly proposed a ban on all lawsuits against manufacturers of body implant parts which was proposed in the United States Congress as part of tort reform legislation.[96]

According to U.S. State Department cables released by the whistle-blowing site 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.[97][98]

Employment and diversity

Pfizer received a 100% rating on the Corporate Equality Index released by the Human Rights Campaign starting in 2004, the third year of the report. In 2007, Pfizer's Canadian division was named one of Canada's Top 100 Employers, as published in Maclean's magazine, the only research-based pharmaceutical company to receive this honor.[99] In 2008, there was controversy, including inquiries from members of Congress, around Pfizer's practice of replacing US workers with H-1b guest workers[100]

AIDS involvement

Pfizer has been involved in controversies over the medicine Diflucan (generic name fluconazole). In 1998, a campaign by Thai public health groups led to the elimination of the Pfizer monopoly on selling fluconazole in Thailand, and the price of the antifungal drug decreased from 200 baht to 6.5 baht in nine months, vastly expanding access to the medicine for AIDS patients. Faced with pressure for compulsory licenses to the Pfizer patent on this drug, Pfizer later established a program for limited access to the medicine in Africa.[101]

"In the United States, 46 percent of all new HIV/AIDS cases occur in the South. From 2003 to 2006 the Pfizer Foundation has funded 23 innovative HIV/AIDS prevention programs and strengthened the capacity of community-based organizations to reach and serve their communities."[102] Since 2003, Pfizer has committed a $3 million grant toward supporting the Southern HIV/AIDS Prevention Initiative.

However, there were criticisms of the way Pfizer was testing its AIDS drug. "The European AIDS Treatment Group (EATG), collection of activists from 31 European Countries,[103] said the design of the trial for Pfizer's CCR5 inhibitor maraviroc (previously known as UK-427,857) is putting people with HIV infection at unnecessary risk of developing AIDS."[104]

On June 20, 2007, Pfizer received an approvable letter for maraviroc from the FDA advisory board. The letter was a product of expedited review of the novel HIV compound.[105]

In 2001, Pfizer asked the U.S. government to pressure the Brazilian government against issuing compulsory licenses for the patents on the AIDS drug nelfinavir.[citation needed]

In November 2009 Pfizer formed a joint venture with GlaxoSmithKline to create ViiV Healthcare. Viiv Healthcare received all of Pfizer and GlaxoSmithKline's HIV assets.[106]

AIDS drugs previously manufactured by Pfizer which are now produced by ViiV Healthcare include Viracept (nelfinavir mesylate), Selzentry/Celsentri (maraviroc) and Rescriptor (delavirdine mesylate).

See also

References

Notes
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Bibliography

External links


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