Editing Pfizer (section)

===Aggressive pharmaceutical marketing===
{{See also|List of largest pharmaceutical settlements|Franklin v. Parke-Davis}}
Pfizer has been accused of aggressive [[pharmaceutical marketing]].<ref>{{Cite news |url=https://nymag.com/nymetro/health/features/3122/ |title=Inside the Happiness Business |last=Kirkpatrick |first=David D. |work=[[New York (magazine)|New York]] |date=May 15, 2000}}</ref><ref>{{Cite journal |last=Oldani |first=Michael |date=2002 |title=Tales from the Script |url=https://digitalassets.lib.berkeley.edu/anthpubs/ucb/text/kas087-006.pdf |journal=Kroeber Society Papers |volume=87 |pages=147–176 |via=University of California Berkeley}}</ref><ref>{{Cite journal |last=Oldani |first=Michael J. |date=2004 |title=Thick Prescriptions: Toward an Interpretation of Pharmaceutical Sales Practices |journal=Medical Anthropology Quarterly |volume=18 |issue=3 |pages=325–356 |doi=10.1525/maq.2004.18.3.325 |issn=1548-1387 |pmid=15484967}}</ref>

====2004 Illegal marketing of gabapentin for off-label uses settlement====
In 1993, the [[Food and Drug Administration]] (FDA) approved [[gabapentin]] only for treatment of [[seizures]]. [[Warner–Lambert]], which merged with Pfizer in 2000, used [[continuing medical education]] and [[medical research]], sponsored articles about the drug for the medical literature, and alleged suppression of unfavorable study results, to promote gabapentin. Within five years, the drug was being widely used for [[off-label use]]s such as treatment of pain and psychiatric conditions. Warner–Lambert admitted to violating FDA regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses.<ref>{{Cite journal |vauthors=Steinman MA, Bero LA, Chren MM, Landefeld CS |date=August 2006 |title=Narrative review: the promotion of gabapentin: an analysis of internal industry documents |journal=[[Annals of Internal Medicine]] |volume=145 |issue=4 |pages=284–93 |doi=10.7326/0003-4819-145-4-200608150-00008 |pmid=16908919 |doi-access=free}}</ref> In 2004, the company paid $430{{nbsp}}million in one of the largest settlements to resolve criminal and civil health care liability charges. It was the first off-label promotion case successfully brought under the [[False Claims Act]].<ref>{{Cite journal |last=Henney JE |date=August 2006 |title=Safeguarding patient welfare: who's in charge? |journal=[[Annals of Internal Medicine]] |volume=145 |issue=4 |pages=305–7 |doi=10.7326/0003-4819-145-4-200608150-00013 |pmid=16908923 |s2cid=39262014}}</ref> A Cochrane review concluded that gabapentin is ineffective in migraine prophylaxis.<ref>{{Cite journal |vauthors=Mulleners WM, McCrory DC, Linde M |date=August 2014 |title=Antiepileptics in migraine prophylaxis: An updated Cochrane review |journal=Cephalalgia |volume=35 |issue=1 |pages=51–62 |doi=10.1177/0333102414534325 |pmid=25115844 |s2cid=43079346|doi-access=free }}</ref> 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.<ref>{{Cite journal |vauthors=Loder E, Burch R, Rizzoli P |date=June 2012 |title=The 2012 AHS/AAN guidelines for prevention of episodic migraine: a summary and comparison with other recent clinical practice guidelines |journal=Headache |volume=52 |issue=6 |pages=930–45 |doi=10.1111/j.1526-4610.2012.02185.x |pmid=22671714 |doi-access=free |s2cid=540800}}</ref>

====2009 Illegal marketing of Bextra settlement====
In September 2009, Pfizer pleaded guilty to the illegal marketing of [[arthritis]] drug [[valdecoxib]] (Bextra) and agreed to a $2.3{{nbsp}}billion settlement, the largest [[health care fraud]] settlement at that time.<ref>{{cite web |title=Justice Department Announces Largest Health Care Fraud Settlement in Its History |url=https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history |publisher=[[United States Department of Justice]] |access-date=2022-05-15 |archive-url=https://web.archive.org/web/20220512181155/https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history |archive-date=May 12, 2022 |date=2009-09-09 |quote=American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together "Pfizer") have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.}}</ref> Pfizer promoted the sale of the drug for several uses and dosages that the [[Food and Drug Administration]] specifically declined to approve due to safety concerns. The drug was pulled from the market in 2005.<ref>{{Cite news |url=https://www.nytimes.com/2009/09/03/business/03health.html |title=Pfizer pays $2.3 billion to settle marketing case |first=Gardiner |last=Harris |work=[[The New York Times]] |date=September 2, 2009 |url-access=limited}}</ref> It was Pfizer's fourth such settlement in a decade.<ref name=Settle/><ref name=Improper>{{Cite news |last=Johnson |first=Carrie |date=September 3, 2009 |title=In Settlement, A Warning To Drugmakers: Pfizer to Pay Record Penalty In Improper-Marketing Case |newspaper=[[The Washington Post]] |url=https://www.washingtonpost.com/wp-dyn/content/article/2009/09/02/AR2009090201449_pf.html}}</ref><ref name=fine/> The payment included $1.195{{nbsp}}billion in criminal penalties for felony violations of the [[Federal Food, Drug, and Cosmetic Act]], and $1.0{{nbsp}}billion to settle allegations it had illegally promoted the drugs for uses that were not approved by the [[Food and Drug Administration]] (FDA) leading to violations under the [[False Claims Act]] as reimbursements were requested from Federal and State programs. The criminal fine was the largest ever assessed in the United States to date.<ref name=Settle>{{Cite news |last=Harris |first=Gardiner |title=Pfizer Pays $2.3 billion to Settle Marketing Case |work=[[The New York Times]] |url=https://www.nytimes.com/2009/09/03/business/03health.html |date=September 3, 2009}}</ref><ref name=Improper/><ref name=fine>{{Cite news |title=Pfizer agrees record fraud fine |work=[[BBC News]] |url=http://news.bbc.co.uk/2/hi/business/8234533.stm |date=September 2, 2009}}</ref> Pfizer entered a [[corporate integrity agreement]] with the [[Office of Inspector General (United States)|Office of Inspector General]] that required it to make substantial structural reforms within the company, and publish to its website its post approval commitments and a searchable database of all payments to physicians made by the company.<ref>{{Cite web |title=Corporate Integrity Agreement between the Office of the Inspector General of the Department of Health and Human Services and Pfizer Inc. |url=https://oig.hhs.gov/fraud/cia/agreements/pfizer_inc.pdf |website=[[Office of Inspector General (United States)|Office of Inspector General]] |date=August 31, 2009 |url-status=live |archive-url=https://web.archive.org/web/20110715112330/http://oig.hhs.gov/fraud/cia/agreements/pfizer_inc.pdf |archive-date=July 15, 2011}}</ref>

====Termination of Peter Rost====
[[Peter Rost (doctor)|Peter Rost]] was vice president in charge of the [[endocrinology]] division at [[Pharmacia]] before its acquisition by Pfizer. During that time he raised concerns internally about [[kickback (bribery)|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 employed, 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.<ref>{{Cite web |title=ROST v. PFIZER, INC. |publisher=Casetext |url=https://casetext.com/case/rost-v-pfizer-2}}</ref><ref>{{Cite news |url=https://www.nytimes.com/2005/06/08/business/at-pfizer-the-isolation-increases-for-a-whistleblower.html |title=At Pfizer, the Isolation Increases for a Whistle-Blower |first=Alex |last=Berenson |authorlink=Alex Berenson |work=[[The New York Times]] |date=June 8, 2005 |url-access=limited}}</ref>

====2014 Illegal marketing of Rapamune settlement====
A "whistleblower suit" was filed in 2005 against [[Wyeth]], which was acquired by Pfizer in 2009, alleging that the company illegally marketed [[sirolimus]] (Rapamune) for [[off-label use]]s, targeted specific doctors and medical facilities to increase sales of Rapamune, tried to get transplant patients to change from their transplant drugs to Rapamune, and specifically targeted [[African-Americans]]. According to the whistleblowers, Wyeth also provided doctors and hospitals that prescribed the drug with kickbacks such as grants, donations, and other money.<ref>{{Cite magazine |url=https://www.fiercepharma.com/pharma/congress-joins-probe-into-wyeth-s-rapamune-marketing |title=Congress joins probe into Wyeth's Rapamune marketing |first=Tracy |last=Staton |magazine=Fierce Pharma |date=June 14, 2010}}</ref> In 2013, the company pleaded guilty to criminal mis-branding violations under the [[Federal Food, Drug, and Cosmetic Act]]. By August 2014, it had paid $491{{nbsp}}million in civil and criminal penalties related to Rapamune.<ref>{{Cite magazine |url=https://www.fiercepharma.com/regulatory/pfizer-settles-more-off-label-marketing-cases-tied-to-rapamune |title=Pfizer settles more off-label marketing cases tied to Rapamune |first=Eric |last=Palmer |magazine=Fierce Pharma |date=June 14, 2010}}</ref>

====2014 Illegal marketing settlement====
In June 2010, health insurance network [[Blue Cross Blue Shield]] (BCBS) filed a lawsuit against Pfizer for allegedly illegally marketing drugs Bextra, Geodon and Lyrica. BCBS alleged that Pfizer used kickbacks and wrongly persuaded doctors to prescribe the drugs.<ref>{{Cite news |title=Blue Cross Names and Shames Pfizer Execs Linked to Massages-for-Prescriptions Push |url=https://www.cbsnews.com/news/blue-cross-names-and-shames-pfizer-execs-linked-to-massages-for-prescriptions-push/ |first=Jim |last=Edwards |work=[[CBS News]] |date=June 10, 2010}}</ref><ref>{{Cite news |url=https://www.bizjournals.com/austin/stories/2010/06/07/daily52.html |title=Blue Cross Blue Shield of Texas sues Pfizer |last=Bounds |first=Jeff |work=[[American City Business Journals]] |date=June 10, 2010}}</ref> According to the lawsuit, Pfizer handed out 'misleading' materials on [[off-label use]]s, sent over 5,000 doctors on trips to the [[Caribbean]] or around the United States, and paid them $2,000 honoraria in return for listening to lectures about Bextra.<ref>{{Cite magazine |url=https://www.fiercepharma.com/pharma/bcbs-names-pfizer-managers-kickback-suit |title=BCBS names Pfizer managers in kickback suit |magazine=Fierce Pharma |first=Tracy |last=Staton |date=June 11, 2010}}</ref><ref>{{Cite news |url=https://www.dallasnews.com/business/2010/06/11/blue-cross-blue-shield-of-texas-sues-pfizer-over-drug-marketing/ |title=Blue Cross Blue Shield of Texas sues Pfizer over drug marketing |work=[[The Dallas Morning News]] |date=June 11, 2010 |url-access=subscription}}</ref> Despite Pfizer's claims that "the company's intent was pure" in fostering a legal exchange of information among doctors, an internal marketing plan revealed that Pfizer intended to train physicians "to serve as public relations spokespeople."<ref name=toobig/> The case was settled in 2014 for $325{{nbsp}}million.<ref>{{Cite news |title=Pfizer Agrees to $325 Million Neurontin Marketing Accord |url=https://www.bloomberg.com/news/2014-06-02/pfizer-agrees-to-325-million-settlment-over-neurontin.html |first=Christie |last=Smythe |work=[[Bloomberg News]] |date=June 2, 2014 |url-access=subscription}}</ref> Fearing that Pfizer is "[[too big to fail]]" and that prosecuting the company would result in disruptions to [[Medicare (United States)|Medicare]] and [[Medicaid]], federal prosecutors instead charged a subsidiary of a subsidiary of a subsidiary of Pfizer, which is "nothing more than a shell company whose only function is to plead guilty."<ref name=toobig>{{cite news |url=https://edition.cnn.com/2010/HEALTH/04/02/pfizer.bextra/index.html |title=Feds found Pfizer too big to nail |last1=Griffin |first1=Drew |last2=Segal |first2=Andy |work=[[CNN]] |date=April 2, 2010}}</ref>