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Pfizer - >>> Legal issues


https://en.wikipedia.org/wiki/Pfizer#Controversy


Aggressive pharmaceutical marketing

See also: List of largest pharmaceutical settlements and Franklin v. Parke-Davis

Pfizer has been accused of aggressive pharmaceutical marketing.[147][148][149]


Illegal marketing of gabapentin for off-label uses

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 uses 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.[150] In 2004, the company paid $430 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.[151] A Cochrane review concluded that gabapentin is ineffective in migraine prophylaxis.[152] 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.[153]

Illegal marketing of Bextra

In September 2009, Pfizer pleaded guilty to the illegal marketing of arthritis drug valdecoxib (Bextra) and agreed to a $2.3 billion settlement, the largest health care fraud settlement at that time. 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.[154][155] It was Pfizer's fourth such settlement in a decade.[156][157][158] The payment included $1.3 billion in criminal penalties for felony violations of the Federal Food, Drug, and Cosmetic Act, and $1.0 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.[155][156][157][158] Pfizer entered a corporate integrity agreement with the 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.[159]

Termination of Peter Rost

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 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.[160][161]

Illegal marketing of Rapamune

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 uses, 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.[162] 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 million in civil and criminal penalties related to Rapamune.[163]

Illegal marketing

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.[164][165] According to the lawsuit, Pfizer handed out 'misleading' materials on off-label uses, 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.[166][167] 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."[168] The case was settled in 2014 for $325 million.[169] Fearing that Pfizer is "too big to fail" and that prosecuting the company would result in disruptions to 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."[168]

Removal of ads after unflattering article

According to Harper's Magazine publisher John R. MacArthur, Pfizer withdrew "between $400,000 and a million dollars" worth of ads from Harper's Magazine following an unflattering article on depression medication.[170]

Quigley Company asbestos

The Quigley Company, which sold asbestos-containing insulation products until the early 1970s, was acquired by Pfizer in 1968. In June 2013, asbestos victims and Pfizer negotiated a settlement that required Pfizer to pay a total of $964 million: $430 million to 80% of existing plaintiffs and place an additional $535 million into a settlement trust that will compensate future plaintiffs as well as the remaining 20% of plaintiffs with claims against Pfizer and Quigley. Of that $535 million, $405 million is in a 40-year note from Pfizer, while $100 million is from insurance policies.[171]

Shiley defective heart valves

Pfizer purchased Shiley in 1979, at the onset of its Convexo-Concave valve ordeal, involving the Bjork–Shiley valve. Approximately 500 people died when defective heart valves fractured and, in 1994, Pfizer agreed to pay $10.75 million to settle claims by the United States Department of Justice that the company lied to get approval for the valves.[172]

Firing of employee that filed suit

A federal lawsuit was filed by a scientist claiming she got an infection by a genetically modified lentivirus while working for Pfizer, resulting in intermittent paralysis.[173] A judge dismissed the case citing a lack of evidence that the illness was caused by the virus but the jury ruled that by firing the employee, Pfizer violated laws protecting freedom of speech and whistleblowers and awarded her $1.37 million.[174]

Celebrex intellectual property

Brigham Young University (BYU) said a professor of chemistry, Dr. Daniel L. Simmons, discovered an enzyme in the 1990s that led towards development of Celebrex. BYU was originally seeking a 15% royalty on sales, equating to $9.7 billion. A research agreement had been made between BYU and Monsanto, whose pharmaceutical business was later acquired by Pfizer, to develop a better aspirin. The enzyme Dr. Simmons claims to have discovered would induce pain and inflammation while causing gastrointestinal problems and Celebrex is used to reduce those issues. A six-year battle ensued because BYU claimed that Pfizer did not give Dr. Simmons credit or compensation, while Pfizer claimed that it had met all obligations regarding the Monsanto agreement. In May 2012, Pfizer settled the allegations, agreeing to pay $450 million.[175]

Nigeria Trovafloxacin lawsuit

Main article: Abdullahi v. Pfizer, Inc.
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.[176] Local Kano officials reported that more than fifty children died in the experiment, while many others developed mental and physical deformities.[177] 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.[178] In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment.[179] According to 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."[180] The lawsuits also accused 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. Nigerian medical personnel as well as at least one Pfizer physician said the trial was conducted without regulatory approval.[181][182]

In 2007, Pfizer published a Statement of Defense letter.[183] The letter stated that the drug's oral form was safer and easier to administer, that Trovan had been used safely in more than five thousand 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 four weeks.

In June 2010, the US Supreme Court rejected Pfizer's appeal against a ruling allowing lawsuits by the Nigerian families to proceed.[184]

In December 2010, a United States diplomatic cables leak was released by WikiLeaks indicating that Pfizer hired investigators to find evidence of corruption against Nigerian attorney general Aondoakaa to persuade him to drop legal action.[185] The Washington Post reporter Joe Stephens, who helped break the story in 2000, called these actions "dangerously close to blackmail".[180] In response, the company released a press statement describing the allegations as "preposterous" and saying that it acted in good faith.[186] Aondoakka, who had allegedly demanded bribes from Pfizer in return for a settlement of the case,[187] was declared unfit for office and had his U.S. visa revoked in association with corruption charges in 2010.[188][189]

The lawsuits were eventually settled out of court. Pfizer committed to paying 35 million USD "to compensate the families of children in the study", another 30 million USD to "support healthcare initiatives in Kano", and 10 million to cover legal costs. Payouts began in 2011.[190]

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