Newest mRNA data
5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
History
Pfizer made itself the largest pharmaceutical company in the world in large part by purchasing its competitors. In the last dozen years it has carried out three mega-acquisitions: Warner-Lambert in 2000, Pharmacia in 2003, and Wyeth in 2009. Then, in 2015, Pfizer announced a $160 billion deal to merge with Allergan and move its headquarters to Ireland to avoid U.S. taxes but subsequently had to abandon the plan.
Pfizer has also grown through aggressive marketing—a practice it pioneered back in the 1950s by purchasing unprecedented advertising spreads in medical journals. In 2009 the company had to pay a record $2.3 billion to settle federal charges that one of its subsidiaries had illegally marketed a painkiller called Bextra. Along with the questionable marketing, Pfizer has for decades been at the center of controversies over its pricing, including a price-fixing case that began in 1958.
In the area of product safety, Pfizer’s biggest scandal involved defective heart valves sold by its Shiley subsidiary that led to the deaths of more than 100 people. During the investigation of the matter, information came to light suggesting that the company had deliberately misled regulators about the hazards. Pfizer also inherited safety and other legal controversies through its big acquisitions, including a class action suit over Warner-Lambert’s Rezulin diabetes medication, a big settlement over PCB dumping by Pharmacia, and thousands of lawsuits brought by users of Wyeth’s diet drugs.
Also on Pfizer’s list of scandals are a 2012 bribery settlement; massive tax avoidance; and lawsuits alleging that during a meningitis epidemic in Nigeria in the 1990s the company tested a risky new drug on children without consent from their parents.
Advertising and Marketing Controversies After the Second World War, Pfizer caused a scandal when it circumvented the traditional drug distribution networks and began marketing its products (especially the antibiotic Terramycin) directly to hospitals and physicians, making unprecedented use of splashy advertisements in the Journal of the American Medical Association. A prominent article in the Saturday Review in 1957 denounced the company for tactics such as running ads for its antibiotics that displayed the names of doctors who were supposedly endorsing the product but who turned out to be fictitious.
In 1991 Pfizer paid a total of $70,000 to 10 states to settle charges relating to misleading advertising for its Plax mouth rinse.
1996 the Food and Drug Administration ordered Pfizer to stop making unauthorized and misleading medical claims for its antidepressant Zoloft.
In 2000 the FDA warned Pfizer and Pharmacia, co-marketers of the arthritis drug Celebrex, that the consumer ads they were running for the medication were false and misleading. Two years later, the FDA ordered Pfizer to stop running a series of magazine ads that the agency said misleadingly suggested that its cholesterol-lowering drug Lipitor was safer than competing products.
In 2003 Pfizer paid $6 million to settle with 19 states that had accused the company of using misleading ads to promote its Zithromax medication for children’s ear infections.
In 2004 Pfizer’s Warner-Lambert subsidiary agreed to pay $430 million to resolve criminal and civil charges that it paid physicians to prescribe its epilepsy drug Neurontin to patients with ailments for which the medication was not approved. Documents later came to light suggesting that Pfizer arranged for delays in the publication of scientific studies that undermined its claim for the other uses of Neurontin. In 2010 a federal jury found that Pfizer committed racketeering fraud in its marketing of Neurontin; the judge in the case subsequently ordered the company to pay $142 million in damages.
In 2007 Pfizer subsidy Pharmacia & Upjohn agreed to pay $34.7 million to settle federal charges relating to the illegal marketing of its Genotropin human growth hormone.
In 2009 Pfizer agreed to pay $2.3 billion to resolve criminal and civil charges relating to the improper marketing of Bextra and three other medications. The amount was a record for a healthcare fraud settlement. John Kopchinski, a former Pfizer sales representative whose complaint helped bring about the federal investigation, told the New York Times: “The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player.” As part of the settlement, Pfizer had to enter into a Corporate Integrity Agreement with the Inspector General of the Department of Health and Human Services.
In 2010 Pfizer disclosed that during a six-month period the previous year it had paid $20 million to some 4,500 doctors and other medical professionals for consulting and speaking on the company’s behalf. This was the first time the company had made public its spending of this kind.
In 2011 Pfizer agreed to pay $14.5 million to resolve federal charges that it illegally marketed its bladder drug Detrol.
In 2011 the FDA told Pfizer that its "Online Resources" webpage on Lipitor contained misleading statements.
In July 2012 Pfizer agreed to remove claims related to breast and colon health from its advertising for Centrum multivitamins as part of an agreement to settle a lawsuit brought by the Center for Science in the Public Interest charging that the claims were unsubstantiated.
In November 2012 Pfizer disclosed that it had taken a charge against earnings of $491 million in connection with an "agreement in principle" with the U.S. Department of Justice to settle charges relating to the improper marketing of the kidney transplant drug Rapamune by Wyeth. That agreement was finalized in July 2013. Pfizer later reached a $35 million settlement of Rapamune charges brought by more than 40 state attorneys general.
Bribery and Improper Payments
In 1976 Pfizer was one of the many companies that disclosed that it had made questionable payments to foreign government officials. The company said that about $265,000 had been paid to officials in three countries but did not identify them.
In August 2012 the U.S. Securities and Exchange Commission announced that it had reached a $45 million settlement with Pfizer to resolve charges that its subsidiaries, especially Wyeth, had bribed overseas doctors and other healthcare professionals to increase foreign sales.
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