Twenty-five years ago, Pfizer sent a team to Kano, Nigeria, during a meningococcal meningitis outbreak. They conducted an “open label” (unblinded) clinical trial involving 200 children, half of whom were given Pfizer’s new antibiotic Trovan and half of whom received the gold standard treatment, ceftriaxone. Watchdogs noted that Pfizer used substantially lower doses of ceftriaxone to rig the trials in favor of Trovan.
At the time of the Kano trial, Pfizer was pushing for approval from the Food and Drug Administration of their latest potential billion-dollar cash cow for pediatric use. Eleven Nigerian children died, five after receiving Pfizer’s product and six after receiving lower-than-normal doses of the older drug.
Pay close attention, parents. A Washington Post investigation reported that one 10-year-old girl suffering from meningitis was not taken off experimental Trovan and given standard, proven treatments by Pfizer’s clinical trial operators—when it was clear that her condition was deteriorating. One of her eyes froze. She lost strength and then died. A Nigerian doctor who supervised the studies for Pfizer admitted that his office had “backdated an approval letter” for the human trials, which “may have been written a year after the study had taken place.” Informed consent was undermined by language and education barriers.
One outraged African newspaper demanded that the government “tell us whether our children were used as guinea pigs and, if so, who committed such criminality and who is liable.” After years of protracted litigation with the pharmaceutical behemoth, Nigerian families reached a $75 million out-of-court settlement sealed with a confidentiality clause.
A separate whistleblower lawsuit filed by Pfizer’s former associate medical director for central research and Yale pediatric infectious disease specialist, Juan Walterspiel, alleged that the company fired him in retaliation for warning before and after the deadly Kano fiasco that the study methods were “improper and unsafe.” Walterspiel further claimed that Pfizer had bribed Nigerian officials to continue the study and cut safety corners because “stock options and bonuses [were] at stake.”
Pfizer tried to suppress Walterspiel’s allegations but was forced into a settlement after WikiLeaks published diplomatic cables showing that Pfizer had attempted to dig up dirt on a Nigerian prosecutor to bully him into dropping lawsuits by state and federal authorities in Africa.
A secret internal Nigerian government report, leaked years after it had been written, concluded that Pfizer violated international law by conducting an “illegal trial of an unregistered drug” and failing to inform children’s parents that the meningitis treatment was experimental. The government panel called the Trovan tragedy a “clear case of exploitation of the ignorant.”
If you think this corruption was all an anomaly or misunderstood altruism or “misinformation,” I encourage you to start doing your own homework before your child’s health and life become just another cost of doing Big Pharma business.
Search the internet and PubMed (while you still can) for “Pfizer,” “Celebrex,” “Bextra,” “Geodon,” “Zyvox,” “Lyrica” and “Neurontin.”
Find out more about why Pfizer paid the largest fine for health care fraud in American history ($2.3 billion) in 2009 to resolve allegations that it illegally caused false claims to be submitted to the government and paid kickbacks to health care providers to induce them to prescribe their products.
Learn more about the nearly 3,000 people who developed suicidal thoughts and severe psychological disorders after taking Pfizer’s smoking cessation drug, Chantix. Pfizer paid out nearly $300 million to settle those cases. Or the nearly 10,000 women who won claims of $1 billion after developing breast cancer linked to Pfizer’s Prempro hormone replacement therapy.
And just remember, parents, that the pandemic profiteers who stand to gain unprecedented, multibillion-dollar windfalls from endless vaccine boosters administered cradle to grave around the world have the most terrifying man-made immunity ever created: immunity from liability for their corner-cutting, life-endangering business model.
The Kano trovafloxacin trial litigation arose out of a clinical trial conducted by the pharmaceutical company Pfizer in 1996 in Kano, Nigeria, during an epidemic of meningococcal meningitis. To test its new antibiotic, trovafloxacin (Trovan), Pfizer gave 100 children trovafloxacin, while another 100 received the gold-standard anti-meningitis treatment, ceftriaxone, a cephalosporin antibiotic. Pfizer gave the children a substantially reduced dose of the ceftriaxone (specifically, 33mg/kg) relative to that described on the US FDA-approved prescribing information. The allegation is that this was done to skew the test in favor of its own drug. Pfizer claimed that the dose used was sufficient even though a clinical trial performed by Médecins Sans Frontières recommends a dose of 50-100mg/kg.
Five children given trovafloxacin died, as did six of those given ceftriaxone. The lead investigator, Abdulhamid Isa Dutse, later provided a letter of approval for human trials that was found to be falsified. The Nigerian government called the trial "an illegal trial of an unregistered drug". It has been alleged that participants and their families were not told that they were part of a trial, and that Médecins Sans Frontières was offering the standard treatment in another part of the same building. Pfizer acknowledged reducing the dose of the standard treatment, but said this was done tominimize injection-site pain and that the mortality rates in both the trovafloxin and ceftriaxone arms of its trial were lower than among those treated with chloramphenicol by Médecins Sans Frontières.
The survivors of the trial tried to bring a number of legal actions against Pfizer in the United States. These resulted in four judicial opinions, the first three dismissing the claims on procedural grounds. According to Ben Goldacre, Pfizer argued that it was not required to obtain informed consent for experimental drug trials in Africa, and that any case should be heard in Nigeria. In May 2006 Representative Tom Lantos of California, the senior Democrat on the House International Relations Committee, described the findings of a report compiled about the case by the Nigerian government as "absolutely appalling" and called for Pfizer to open its records. In January 2009 the United States Court of Appeals for the Second Circuit ruled that the Nigerian and their families were entitled to bring suit against Pfizer in the United States under the Alien Tort Statute. Pfizer subsequently settled the case out of court with a $75 million settlement that was subject to a confidentiality clause.
Pfizer has been accused of aggressive pharmaceutical marketing.
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. 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. 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.
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. It was Pfizer's fourth such settlement in a decade. 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. 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.
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.
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. 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.
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. 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. 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." The case was settled in 2014 for $325 million. 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."
Justice Department Announces Largest Health Care Fraud Settlement in Its History
Pfizer to Pay $2.3 Billion for Fraudulent Marketing
WASHINGTON – 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.
Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called "off-label" uses – i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.
In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company.
As part of the settlement, Pfizer also has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter.
Whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are pending in the District of Massachusetts, the Eastern District of Pennsylvania and the Eastern District of Kentucky triggered this investigation. As a part of today’s resolution, six whistleblowers will receive payments totaling more than $102 million from the federal share of the civil recovery.
The U.S. Attorney’s offices for the District of Massachusetts, the Eastern District of Pennsylvania, and the Eastern District of Kentucky, and the Civil Division of the Department of Justice handled these cases. The U.S. Attorney’s Office for the District of Massachusetts led the criminal investigation of Bextra. The investigation was conducted by the Office of Inspector General for the Department of Health and Human Services (HHS), the FBI, the Defense Criminal Investigative Service (DCIS), the Office of Criminal Investigations for the Food and Drug Administration (FDA), the Veterans’ Administration’s (VA) Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management (OPM), the Office of the Inspector General for the United States Postal Service (USPS), the National Association of Medicaid Fraud Control Units and the offices of various state Attorneys General.
"Today’s landmark settlement is an example of the Department of Justice’s ongoing and intensive efforts to protect the American public and recover funds for the federal treasury and the public from those who seek to earn a profit through fraud. It shows one of the many ways in which federal government, in partnership with its state and local allies, can help the American people at a time when budgets are tight and health care costs are increasing," said Associate Attorney General Tom Perrelli. "This settlement is a testament to the type of broad, coordinated effort among federal agencies and with our state and local partners that is at the core of the Department of Justice’s approach to law enforcement."
"This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs, securing their future for the Americans who depend on these programs,"said Kathleen Sebelius, Secretary of Department of Health and Human Services"The Department of Health and Human Services will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it. But we will also look for new ways to prevent fraud before it happens. Health care is too important to let a single dollar go to waste."
"Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers, and costs the government billions of dollars," said Tony West, Assistant Attorney General for the Civil Division. "This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare."
"The size and seriousness of this resolution, including the huge criminal fine of $1.3 billion, reflect the seriousness and scope of Pfizer’s crimes," said Mike Loucks, acting U.S. Attorney for the District of Massachusetts. "Pfizer violated the law over an extensive time period. Furthermore, at the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct by its then newly acquired subsidiary, Warner-Lambert, Pfizer was itself in its other operations violating those very same laws. Today’s enormous fine demonstrates that such blatant and continued disregard of the law will not be tolerated."
"Although these types of investigations are often long and complicated and require many resources to achieve positive results, the FBI will not be deterred from continuing to ensure that pharmaceutical companies conduct business in a lawful manner," said Kevin Perkins, FBI Assistant Director, Criminal Investigative Division.
"This resolution protects the FDA in its vital mission of ensuring that drugs are safe and effective. When manufacturers undermine the FDA’s rules, they interfere with a doctor’s judgment and can put patient health at risk," commented Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania. "The public trusts companies to market their drugs for uses that FDA has approved, and trusts that doctors are using independent judgment. Federal health dollars should only be spent on treatment decisions untainted by misinformation from manufacturers concerned with the bottom line."
"This settlement demonstrates the ongoing efforts to pursue violations of the False Claims Act and recover taxpayer dollars for the Medicare and Medicaid programs," noted Jim Zerhusen, U.S. Attorney for the Eastern District of Kentucky.
"This historic settlement emphasizes the government’s commitment to corporate and individual accountability and to transparency throughout the pharmaceutical industry," said Daniel R. Levinson, Inspector General of the United States Department of Health and Human Services. "The corporate integrity agreement requires senior Pfizer executives and board members to complete annual compliance certifications and opens Pfizer to more public scrutiny by requiring it to make detailed disclosures on its Web site. We expect this agreement to increase integrity in the marketing of pharmaceuticals."
"The off-label promotion of pharmaceutical drugs by Pfizer significantly impacted the integrity of TRICARE, the Department of Defense’s healthcare system," said Sharon Woods, Director, Defense Criminal Investigative Service. "This illegal activity increases patients’ costs, threatens their safety and negatively affects the delivery of healthcare services to the over nine million military members, retirees and their families who rely on this system. Today’s charges and settlement demonstrate the ongoing commitment of the Defense Criminal Investigative Service and its law enforcement partners to investigate and prosecute those that abuse the government’s healthcare programs at the expense of the taxpayers and patients."
"Federal employees deserve health care providers and suppliers, including drug manufacturers, that meet the highest standards of ethical and professional behavior," said Patrick E. McFarland, Inspector General of the U.S. Office of Personnel Management. "Today’s settlement reminds the pharmaceutical industry that it must observe those standards and reflects the commitment of federal law enforcement organizations to pursue improper and illegal conduct that places health care consumers at risk."
"Health care fraud has a significant financial impact on the Postal Service. This case alone impacted more than 10,000 postal employees on workers’ compensation who were treated with these drugs," said Joseph Finn, Special Agent in Charge for the Postal Service’s Office of Inspector General. "Last year the Postal Service paid more than $1 billion in workers’ compensation benefits to postal employees injured on the job."
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