The claim: Pfizer was sued for $2.3 billion for “bribing doctors and suppressing adverse trial results”
A viral social media post suggests that Americans shouldn’t trust Pfizer — one of the primary producers of coronavirus vaccines — because of a 2009 lawsuit against the pharmaceutical company.
The April 26 Instagram post claims, “Pfizer got sued for $2,300,000,000 in 2009 for ‘bribing doctors and suppressing adverse trial results.'”
The caption reads, “And you still trust them ?? With your babies ???”
The post appears to be referencing a $2.3 billion settlement by Pfizer in 2009, but it’s misleading about the scope of the allegations relating to the settlement.
Fact check: COVID-19 vaccines won’t make the common cold or flu ‘extremely lethal’
USA TODAY has reached out to the poster for comment.
Pfizer settled allegations of bribery, illegal marketing of painkillers
The post appears to reference a settlement involving Pfizer in which the company pleaded guilty to a federal criminal charge relating to the marketing of four drugs. The company agreed to pay $2.3 billion as part of the settlement.
The Pharmacia & Upjohn Company — a subsidiary of Pfizer — agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding the painkiller Bextra “with the intent to defraud or mislead,” according to the Department of Justice.
Under the act, a company must specify the uses of its product in the FDA’s new drug application and not market a product in other ways after that point. The Department of Justice wrote in a press release that Pfizer “promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns.”
The company paid a criminal fine of $1.195 billion. Pfizer also forfeited an additional $105 million. Bextra was withdrawn from the market in 2005.
The Justice Department also said in 2009 that Pfizer paid $1 billion to resolve allegations of civil wrongdoing under theFalse Claims Act that the company illegally promoted Bextra and three other drugs: the antipsychotic Geodon, the antibiotic Zyvox and the anti-epileptic drug Lyrica.
The company also resolved allegations that it paid kickbacks — an illegal payment in exchange for preferential treatment or compensation — to health care providers to encourage them to prescribe the drugs.
Pfizer denied the civil allegations, except acknowledging improper promotion of Zyvox, Reuters reported in 2009.
The company’s general counsel said then that it regretted “certain actions in the past,” but was proud of the action it had taken to strengthen its internal controls, Reuters also reported.
Pfizer did not admit to wrongdoing as part of the settlement.
Fact check: COVID-19 vaccines don’t cause magnetic reactions or contain tracking devices
But none of these allegations related to suppressing evidence of adverse events as the claim asserted, a key topic as some Americans continue to question the safety and effectiveness of vaccines.
Separate lawsuit alleged suppression of adverse effects, study manipulation
The adverse events allegations surfaced in an earlier lawsuit.
In 2004, Pfizer agreed to pay $430 million in a DOJ settlement and pleaded guilty to two violations of the Food, Drug and Cosmetic Act for marketing the drug Neurontin, also known as gabapentin, for unapproved uses.
According to a statement from the DOJ, the Warner-Lambert company — which Pfizer acquired in 2000 — promoted Neurontin “even when scientific studies had shown it was not effective.”
Two examples include the promotion of Neurontin as the sole drug for epileptic seizures — even after the FDA’s rejection of solo use — as well as marketing the drug as effective for treating bipolar disease.
According to reporting from The New York Times, in 2008, experts who reviewed company documents for the plaintiffs against Pfizer concluded the company manipulated studies to support the use of Neurontin. One of the experts, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, said the documents spelled out “a publication strategy meant to convince physicians of Neurontin’s effectiveness and misrepresent or suppress negative findings.”
In a statement, Pfizer said it “cooperated fully with the government to resolve this matter,” adding that the manipulation did not involve Pfizer practices or employees and took place before Pfizer acquired Warner-Lambert.
In 2014, Pfizer agreed to pay an additional $325 million to resolve claims in the decade-long civil lawsuit.
Fact check: India’s COVID-19 surge not connected to vaccinations
Pfizer did not admit wrongdoing as part of the settlement.
Pfizer’s coronavirus vaccine
The Instagram post’s claims, which promote suspicion, went viral at a time when misinformation and hesitancy surrounding the coronavirus vaccines are especially prevalent.
The Pfizer coronavirus vaccine was first authorized for use in people16 years and older under the FDA’s Emergency Use Authorization in December 2020. This came after testing that involved more than 40,000 people.
Following the FDA’s emergency use authorization, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices also voted to recommend the Pfizer vaccine. The committee has also voted to recommend the Moderna and Johnson & Johnson vaccines.
According to the CDC, mRNA vaccines — which include Pfizer’s — have been “held to the same rigorous safety and effectiveness standards as all other types of vaccines in the United States.”
Evidence from clinical trials shows the Pfizer vaccine is 95% effective in the prevention of COVID-19.
In an April press release, Pfizer confirmed “high efficacy and no serious safety concerns” following an updated landmark COVID-19 vaccine study.
Pfizer is now seeking full, regular authorization for its vaccine. On May 12, the CDC signed off on a recommendation for adolescents aged 12 to 15 years old to get the vaccine.
Our rating: Partly False
We rate that claim that Pfizer was sued for $2.3 billion for “bribing doctors and suppressing adverse trial results” PARTLY FALSE, since this claim jumbles and misstates elements of two different cases. Pfizer has settled various lawsuits that involve allegations of kickbacks, fraudulent marketing and data manipulation. The $2.3 billion was the total amount of a settlement involving Pfizer, but not in a case related to suppressing adverse events. That allegation came in an earlier case that began before Pfizer acquired the company involved.
Pfizer did not admit to wrongdoing in its settlements. Additionally, the caption of the post implies that because of the prior lawsuits, Pfizer’s coronavirus vaccines may not be safe, which is false.
Our fact-check sources:
- U.S. Department of Justice, Sept. 2, 2009, Justice Department Announces Largest Health Care Fraud Settlement in Its History
- U.S. Department of Justice, accessed May 19, Pfizer Settlement Agreement
- CNN, April 7, 2005, Pfizer pulls Bextra off the market
- Legal Information Institute, accessed May 19, 21 U.S. Code CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT
- U.S. Food and Drug Administration, June 10, 2019, New Drug Application (NDA)
- The New York Times, May 14, 2004, Pfizer to Pay $430 Million Over Promoting Drug to Doctors
- U.S. Department of Justice, May 13, 2004, WARNER-LAMBERT TO PAY $430 MILLION TO RESOLVE CRIMINAL & CIVIL HEALTH CARE LIABILITY RELATING TO OFF-LABEL PROMOTION
- Pfizer, accessed May 19, 2000: PFIZER JOINS FORCES WITH WARNER-LAMBERT
- California Healthline Daily Edition, May 14, 2004, Pfizer Agrees To Settle Neurontin Whistleblower Lawsuit for $430 Million
- The New York Times, Oct. 8, 2008, Experts Conclude Pfizer Manipulated Studies
- Reuters, June 2, 2014, Pfizer to pay $325 million in Neurontin settlement
- Fierce Pharma, June 2, 2014, Pfizer adds another $325M to Neurontin settlement tally. Total? $945M
- PolitiFact, Dec. 11, 2020, Two vaccine trial participants died, but the FDA didn’t connect their deaths to the vaccine
- Pfizer, April 1, PFIZER AND BIONTECH CONFIRM HIGH EFFICACY AND NO SERIOUS SAFETY CONCERNS THROUGH UP TO SIX MONTHS FOLLOWING SECOND DOSE IN UPDATED TOPLINE ANALYSIS OF LANDMARK COVID-19 VACCINE STUDY
- USA TODAY, May 12, CDC panel recommends Pfizer’s COVID-19 vaccine for kids as young as 12
Thank you for supporting our journalism. You can subscribe to our print edition, ad-free app or electronic newspaper replica here.
Our fact check work is supported in part by a grant from Facebook.
Source: Read Full Article